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Found 493310 cases where Symptom is Immune system disorder or Immunodeficiency or Immunoglobulins decreased or Lymphadenopathy

Case Details (Sorted by Age)

This is page 304 out of 494

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VAERS ID:301015 (history)  Vaccinated:2007-12-19
Age:22.0  Onset:2007-12-19, Days after vaccination: 0
Gender:Male  Submitted:2007-12-27, Days after onset: 8
Location:Georgia  Entered:2007-12-27
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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1581IMLA
Administered by: Military     Purchased by: Military
Symptoms: Injection site erythema, Injection site swelling, Joint stiffness, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)
Write-up: 3 cm erythematous raised area over vaccination site. Has soreness and stiffness to arm and shoulder joint. No meds

VAERS ID:301103 (history)  Vaccinated:2007-12-21
Age:22.0  Onset:2007-12-21, Days after vaccination: 0
Gender:Male  Submitted:2007-12-27, Days after onset: 6
Location:Unknown  Entered:2007-12-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE.
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500498P IN 
Administered by: Military     Purchased by: Military
Symptoms: Oedema mouth, Sneezing
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow)
Write-up: PT HAD NO PREVIOUS HISTORY OF INFLUENZA VACCINE. HE STATED THE HE "NEVER RECEIVED FLU SHOT BEFORE, EVER". IMMEDIATE ORAL SWELLING, SNEEZING, UNLABORED RESPIRATION, ALERT AND ORIENTED X 3. SEEN IN ER AND WAS DISCHARGED WITH PREDNISONE, CLARITIN AND BENADRYL.

VAERS ID:301165 (history)  Vaccinated:2007-12-13
Age:22.0  Onset:2007-12-16, Days after vaccination: 3
Gender:Female  Submitted:2007-12-28, Days after onset: 12
Location:Delaware  Entered:2007-12-28
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 1/2/08-records received- PMH: Hyperlipidemia.
Diagnostic Lab Data: Cardiac echo completed 21 DEC 07 as well as stress test which was completed 27th DEC. Echo abnormal. Seen by at cardiac diagnostic center DEC 26th and was diagnosed with cardiomyopathy DEC 27th 07 1/2/08-records received-EKG normal sinus rhythm. Echocardiogram left ventricular sysytolic function moderately reduced. Ejection fraction 35-40%, moderate global hypokinesis of left ventricle. Trace mitral regurgitation. Trace tricuspid regurgitation. Mild pulmonary hypertension. Negative treadmill stress test for exercise induced ischemia.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1581IMLA
SMALL: SMALLPOX (NO BRAND NAME)UNKNOWN MANUFACTURER40200762OTLA
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURERC2826AA1IMRA
Administered by: Military     Purchased by: Military
Symptoms: Cardiac stress test, Cardiomyopathy, Dizziness, Echocardiogram abnormal, Ejection fraction decreased, Hypokinesia, Loss of consciousness, Mitral valve incompetence, Syncope, Tricuspid valve incompetence
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Syncopal episode x 2 DEC 16th 2007 occured @ 1030 PM lasting over a minute with lightheadedness in the shower. 01/02/08-records received for DOS 12/26/07-DX: Syncope. HX: Full syncope episode while in shower. Head eaten very little all day, during hot shower felt lightheaded and passed out.

VAERS ID:301507 (history)  Vaccinated:2007-11-06
Age:22.0  Onset:0000-00-00
Gender:Male  Submitted:2007-12-21
Location:Unknown  Entered:2008-01-02, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1101SCUN
Administered by: Military     Purchased by: Military
Symptoms: Expired drug administered
SMQs:
Write-up: Anthrax lot #FAV110 administered after expired date due to administrative oversight. No adverse reaction at this time. Report submitted per authority direction.

VAERS ID:301524 (history)  Vaccinated:2007-11-19
Age:22.0  Onset:0000-00-00
Gender:Male  Submitted:2007-12-21
Location:Unknown  Entered:2008-01-02, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1102SCUN
Administered by: Military     Purchased by: Military
Symptoms: Expired drug administered, No adverse reaction
SMQs:
Write-up: Anthrax Lot # FAV110 administered after expired date due to administrative oversight. No adverse reaction at this time. Report submitted per agency direction.

VAERS ID:301527 (history)  Vaccinated:2007-11-15
Age:22.0  Onset:0000-00-00
Gender:Male  Submitted:2007-12-21
Location:Unknown  Entered:2008-01-02, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1102SCUN
Administered by: Military     Purchased by: Military
Symptoms: Expired drug administered
SMQs:
Write-up: Anthrax lot #FAV110 administered after expired date due to administrative oversight. No adverse reaction at this time. Report submitted per authority direction.

VAERS ID:301544 (history)  Vaccinated:2007-11-07
Age:22.0  Onset:0000-00-00
Gender:Male  Submitted:2007-12-21
Location:Unknown  Entered:2008-01-02, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1102SCUN
Administered by: Military     Purchased by: Military
Symptoms: Expired drug administered
SMQs:
Write-up: Anthrax lot #FAV110 administered after expired date due to administrative oversight. No adverse reaction at this time. Report submitted per authority direction.

VAERS ID:301578 (history)  Vaccinated:2007-11-15
Age:22.0  Onset:0000-00-00
Gender:Male  Submitted:2007-12-21
Location:Unknown  Entered:2008-01-02, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1102SCUN
Administered by: Military     Purchased by: Military
Symptoms: Expired drug administered
SMQs:
Write-up: Anthrax lot #FAV110 administered after expired date due to administrative oversight. No adverse reaction at this time. Report submitted per milvax direction.

VAERS ID:301587 (history)  Vaccinated:2007-12-13
Age:22.0  Onset:0000-00-00
Gender:Male  Submitted:2007-12-28
Location:Hawaii  Entered:2008-01-02, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
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HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB288AA0IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB144AD0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Unevaluable event
SMQs:
Write-up: No adverse events. Adult was vaccinated with pediatric dose of hepatitis B Engerix B.

VAERS ID:301631 (history)  Vaccinated:2007-12-18
Age:22.0  Onset:2007-12-19, Days after vaccination: 1
Gender:Female  Submitted:2007-12-31, Days after onset: 12
Location:Pennsylvania  Entered:2008-01-03, 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: None
Preexisting Conditions: PCN allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1210U1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pain at immunization site which expanded approx. 10 cm proximally & distally, lasted 2 weeks. No signs secondary infection. Rx''ed with NSAIDS, supportive measures.

VAERS ID:301797 (history)  Vaccinated:2007-12-07
Age:22.0  Onset:2007-12-28, Days after vaccination: 21
Gender:Female  Submitted:2008-01-07, Days after onset: 10
Location:California  Entered:2008-01-07
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: B-HCG LOW FOR GESTATIONAL AGE. NO DEFINITE FETAL POLE SEEN ON ULTRASOUND AS OF YET. MEAN GESTATIONAL SAC SIZE 15 MM, JUST BELOW DISCRIMINATORY LEVEL OF 16 MM.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500501P0IN 
Administered by: Military     Purchased by: Military
Symptoms: Abortion threatened, Blood gonadotrophin decreased, Drug exposure during pregnancy, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: PATIENT WAS UNAWARE SHE WAS PREGNANT AT TIME OF FLU MIST ADMINISTRATION. AFTERWARDS SHE FOUND OUT SHE WAS PREGNANT. IT APPEARS SHE WAS APPROXIMATELY 4 WKS PREGNANT AT TIME OF ADMINISTRATION. PATIENT IS NOW EXPERIENCING THREATENED ABORTION. SHE HAS BEEN BLEEDING AND CRAMPING FOR LAST SEVERAL WEEKS. THERE IS STILL FETAL HEART SOUNDS, BUT PER OB-GYN ER NOTE, APPEARED TO BE TISSUE PROTRUDING FROM CERVICAL OS.

VAERS ID:302033 (history)  Vaccinated:2007-12-28
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-01-04
Location:North Dakota  Entered:2008-01-09, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Slight fatigue, congestion
Preexisting Conditions: Asthma
Diagnostic Lab Data: PLT 122; WBC 4.2; Mono (-); AST 113; ALT 101
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1513U0SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthma, Condition aggravated, Liver function test abnormal, Pyrexia, Thrombocytopenia, Varicella
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Thrombocytopenia, Abn LFT''s, fever. Varicella rash, increased asthma symptoms.

VAERS ID:302260 (history)  Vaccinated:2007-11-03
Age:22.0  Onset:2007-11-04, Days after vaccination: 1
Gender:Male  Submitted:2007-11-04, Days after onset: 0
Location:Washington  Entered:2008-01-10, Days after submission: 67
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2516AA4IMLA
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Pallor, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: L upper arm 1 cm & 3 (1-3 mm) urticarial wheals (lesions). Central blanching & surrounding 3 cm area of erythema and redness. Started 20 min ago just after lunch. Had influenza vaccine yesterday.

VAERS ID:302661 (history)  Vaccinated:2008-01-05
Age:22.0  Onset:2008-01-05, Days after vaccination: 0
Gender:Female  Submitted:2008-01-07, Days after onset: 2
Location:West Virginia  Entered:2008-01-14, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB183AA0IN 
Administered by: Other     Purchased by: Military
Symptoms: Incorrect route of drug administration, Rhinalgia
SMQs:
Write-up: RN administered hepatitis A intranasal when should have been given intra-muscular. The patient was to receive a FluMist vaccine that is given intra-nasal. Patient states that her nose is sore but is not having any other problems.

VAERS ID:302704 (history)  Vaccinated:2007-12-17
Age:22.0  Onset:2007-12-28, Days after vaccination: 11
Gender:Female  Submitted:2008-01-14, Days after onset: 17
Location:Florida  Entered:2008-01-15, 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 PMH: traumatic L4 compression fracture 9 yrs prior to admit w/multiple back surgeries, extensive hardware & pain management services w/recent revision of implantable TENS insertion. Anxiety & depression. Allergies: tetrocycline & monocycline.
Diagnostic Lab Data: Unknown LABS: Initial labs WNL. Initial LP done w/CSF WNL. Antibody (+). Initial MRI of 12/30 WNL. Repeat MRI of 1/9/08 c/w ADEM. Repeat MRI prior to transfer to rehab c/w persistent encephalitis.
CDC Split Type: WAES0801USA01659
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Antibody test positive, Balance disorder, Confusional state, Dizziness, Extubation, Gait disturbance, Headache, Intensive care, Intubation, Leukoencephalomyelitis, Mechanical ventilation, Mental status changes, Nausea, Nuclear magnetic resonance imaging brain abnormal, Unresponsive to stimuli, Urinary incontinence, Urinary tract infection, Vaccination complication, Vomiting
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Demyelination (narrow), Vestibular disorders (broad), Vasculitis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad)
Write-up: Information has been received from a physician, via a company representative, concerning a 22 year old female patient, who on an unspecified date was vaccinated with the first dose of Gardasil (lot # not reported). "About two weeks after" the vaccination, also described as "recently," the patient was diagnosed with encephalomyelitis, and was hospitalized (details not provided). The physician noted that the patient experienced confusion and headaches. He added that the patient was not vaccinated at his office, but at an OB/GYN office. At the time of this report, the outcome of the events was unknown. The reporting physician considered encephalomyelitis to be disabling. Additional information has been requested. 2/29/08 Reviewed hospital medical records of 12/28/2007-1/15/2008 admission. FINAL DX: acute disseminated encephalomyelitis secondary to suspected Gardisil vaccination; chronic back pain secondary to traumatic fall. Consults: critical care, ID, neuro & neurosurgery. HPI: Patient went to ER due to HA, dizziness & N/V for a few days beginning 10-12 days s/p vaccination. Seen by pcp & dx w/UTI, tx w/antibiotics. No improvement & went to ER. Quickly developed mental status changes & was unresponsive to stimuli. Transferred to ICU & intubated. Failed extubation & was re-intubated. Able to progress & successfully extubated. Tx w/antibiotics, antivirals & high dose steroids. Progressed very slowly & incompletely, able to walk only a few steps, off balance & incontinent of urine. Transferred to inpatient rehab center.

VAERS ID:302771 (history)  Vaccinated:2008-01-15
Age:22.0  Onset:2008-01-15, Days after vaccination: 0
Gender:Female  Submitted:2008-01-15, Days after onset: 0
Location:Missouri  Entered:2008-01-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1448U IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: lightheaded and dizziness; Rev''d Sprite

VAERS ID:302858 (history)  Vaccinated:2000-05-01
Age:22.0  Onset:0000-00-00
Gender:Male  Submitted:2008-01-16
Location:Unknown  Entered:2008-01-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: History of relapsing polychondritis at the age of 5 or 6 years; Schaumann''s disease at 11 years old treated with a brace; Henoch-Schonlein purpura secondary to Dapsone therapy, treated with steroid therapy. The subject developed fatigue, headache, joint pain, and muscle pain in 1997; he did not recall a tick bite or bull''s eye rash, but Lyme serology was positive; he was treated wi
Diagnostic Lab Data: Activated partial thromboplast 23Oct2004 27.9sec 22-34; Angiotensin converting enzyme 30Sep2004 36U/L 9-67; Antinuclear antibody 30Sep2004 positive; C-reactive protein 30Sep2004 0.1mg/dL 0-0.8; C-reactive protein 25Apr2007 less than .1mg/d
CDC Split Type: A0599975A
Vaccination
Manufacturer
Lot
Dose
Route
Site
LYME: LYME (LYMERIX)GLAXOSMITHKLINE BIOLOGICALS 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Activated partial thromboplastin time normal, Activities of daily living impaired, Angiotensin converting enzyme, Antinuclear antibody positive, Anxiety, Arthralgia, Asthenia, Babesiosis, Back pain, Blood immunoglobulin G normal, Blood immunoglobulin M increased, Blood thromboplastin normal, Burning sensation, C-reactive protein normal, CSF cell count normal, CSF test abnormal, Cardiac disorder, Cardiolipin antibody, Cardiolipin antibody negative, Chills, Chronic inflammatory demyelinating polyradiculoneuropathy, Depressed level of consciousness, Depression, Dermatitis contact, Disturbance in attention, Dyspnoea, Ehrlichia serology, Electromyogram abnormal, Exercise tolerance decreased, Eye disorder, Fall, Fatigue, Gait disturbance, Gastrointestinal disorder, HLA marker study, Headache, Heart rate irregular, Hepatitis acute, Hyperhidrosis, Hypersomnia, Hypoaesthesia, Immunology test, Influenza like illness, Insomnia, International normalised ratio normal, Joint stiffness, Joint swelling, Lumbar radiculopathy, Lyme disease, Memory impairment, Mental impairment, Mood swings, Muscle twitching, Muscular weakness, Musculoskeletal chest pain, Musculoskeletal stiffness, Nervous system disorder, Nuclear magnetic resonance imaging normal, Pain, Pain in extremity, Palpitations, Paraesthesia, Pharyngolaryngeal pain, Polymerase chain reaction, Prothrombin time normal, Psychomotor hyperactivity, Pyrexia, Red blood cell sedimentation rate normal, Somnolence, Speech disorder, Staring, Supraventricular tachycardia, Tremor, Ultrasound abdomen normal
SMQs:, Rhabdomyolysis/myopathy (broad), Hepatitis, non-infectious (narrow), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Demyelination (narrow), Corneal disorders (broad), Retinal disorders (broad), Cardiac arrhythmia terms, nonspecific (narrow), Depression (excl suicide and self injury) (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMErix (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMErix (unknown). At an unspecified time after vaccination with LYMErix, the subject experienced joint pain, joint swelling, shooting pains, diffuse muscle weakness, fatigue, possible autoimmune disease, activities of daily living impaired, neurological problem, cognitive dysfunction, tingling, numbness, throbbing back pain, gastrointestinal problems, heart problems, flu-like symptoms, anxiety, tremor, muscle stiffness, joint stiffness, generalized twitching to face and whole body shakes. At the time of reporting the outcome of the events was unspecified. This information was received on 07 January 2008 via medical records. The subject had a history of positive Lyme serology with fatigue, headaches, joint pain, and muscle pain in 1997, which improved following a course of doxycycline. The subject, who was a male in his twenties, received his first, second and third doses of LYMErix in July 1999, August 1999, and May 2000. In 2001, the subject developed tension around his right eye and then in the massetter muscle of the right side. In December 2003, he experienced "eight months stretch of flare-up" with fever, chills, and palpitations. He was diagnosed with supraventricular tachycardia. On an unspecified date, was diagnosed with Lyme disease. On 18 May 2004, therapy with doxycyline was started at 100 mg twice daily. On 01 July 2004, he complained of persisting Lyme symptoms included headache of increased frequency, mental fog, arthralgias "more at the spine", hypersomnolence, and fatigue. Assessment also included anxiety, depression, and neurasthenia/fatigue. A spinal tap in July 2004 showed elevated Lyme serologies. His dose of doxycycline was decreased to 100 mc once daily. By 13 July 2004, Lyme symptoms had w

VAERS ID:302871 (history)  Vaccinated:2007-12-04
Age:22.0  Onset:2007-12-11, Days after vaccination: 7
Gender:Male  Submitted:2008-01-16, Days after onset: 36
Location:North Carolina  Entered:2008-01-16
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, no birth defects or medical conditions
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (NO BRAND NAME)UNKNOWN MANUFACTURERAHABB043AB2UNUN
SMALL: SMALLPOX (DRYVAX)PFIZER/WYETH40200760OTUN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURZ110220UNUN
Administered by: Military     Purchased by: Military
Symptoms: Arthralgia, Erythema, Fatigue, Influenza, Injection site erythema, Lymphadenopathy, Malaise, Mass, Pain
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Arthritis (broad)
Write-up: Description: 22 y/o AD SM received primary SPV, typhoid, and Twinrix on 4 Dec 2007. Noted the development of lymphadenopathy near the clavicle on 12/11 followed by erythema around the inoculation site migrating up the right neck and towards the axilla. Patient also developed flu-like symptoms by 12/12/07. Symptom: Lymphadenopathy, subclavicular. Start: 12/11/2007. Comment: Patient noted a lump around his clavicle. Symptom: Flu-like symptoms <96 hours. Start: 12/12/2007. Comment: SM developed malaise, fatigue, aches in addition to his inoculation site concerns. Symptom: Joint pain, isolated. Start: 12/12/2007. Comment: Bilateral knee pains reported during illness.

VAERS ID:303121 (history)  Vaccinated:2007-12-03
Age:22.0  Onset:2007-12-05, Days after vaccination: 2
Gender:Female  Submitted:2008-01-07, Days after onset: 33
Location:New Jersey  Entered:2008-01-16, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypersensitivity
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA02325
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1061U1UNLA
Administered by: Private     Purchased by: Other
Symptoms: Axillary pain, Chest pain, Injection site pain, Lymphadenopathy, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: Information has been received from a healthcare professional (who is also the patient) who on an unspecified date was vaccinated (route and site not reported) with the 2nd dose of Gardasil (lot# not reported). On 04-DEC-2007, after receiving the 2nd dose of Gardasil, the patient experienced inflamed lymph node, a pain all throughout her left arm which was the injection site and across her chest. No diagnostic laboratory test were performed. Per the patient, the "swelling has improved and so has the pain". At the time of this report the patient was recovering. Additional information has been requested. 04/07/2008 Initial and follow-up information has been received from a medical assistant (who is also the patient) with allergies to azithromycin and benzoyl peroxide, who on 03-DEC-2007 was vaccinated in the left arm with the 2nd dose of GARDASIL (lot# 658538/1061U). There were no illnesses at the time of the vaccination. On 05-DEC-2007 (previously reported as 04-DEC-2007), the patient experienced inflammed lymph nodes, a pain all throughout her left arm which was the injection site and across her chest. It was reported that no palpable axillary lymph nodes were on the physical examination. However, the patient reported that there was increased pain with palpation of left axilla. There was no adenopathy at other sites. No diagnostic laboratory test were performed. Per the patient, the "swelling has improved and so has the pain". At the time of this report the patient was recovering. On 22-DEC-2007 that patient was vaccinated in the right arm with a third dose of hepatitis B virus vaccine (unspecified). Additional information has been requested.

VAERS ID:303138 (history)  Vaccinated:2007-11-12
Age:22.0  Onset:2007-11-16, Days after vaccination: 4
Gender:Female  Submitted:2008-04-07, Days after onset: 142
Location:Utah  Entered:2008-01-16, Days after submission: 81
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: WAES0712USA01781
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1266U0IMLA
Administered by: Private     Purchased by: Other
Symptoms: Joint stiffness, Musculoskeletal stiffness
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad)
Write-up: Information has been received from a registered nurse concerning a 22 year old female who on 12-NOV-2007 was vaccinated in the left deltoid with the first dose of Gardasil (lot # 659437/1266U). On 16-NOV-2007 the patient complained of stiff neck, stiff joints and stiff fingers. The patient''s status was not reported. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/7/2008. Information has been received from a registered nurse concerning a 22 year old year old white female weighing 127 pounds and height of 63 inches who at 4:21 PM on 13-NOV-2007 (also reported as 12-NOV-2007) was vaccinated IM in the left deltoid with the first dose of GARDASIL (lot # 659437/1266U). On 16-NOV-2007 the patient complaint of stiff neck, stiff joints and stiff fingers. The patient''s status was not reported. Additional information has been requested.

VAERS ID:303143 (history)  Vaccinated:2006-12-29
Age:22.0  Onset:2006-12-29, Days after vaccination: 0
Gender:Female  Submitted:2008-04-07, Days after onset: 464
Location:New York  Entered:2008-01-16, Days after submission: 81
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ADDERALL XR; YASMIN
Current Illness:
Preexisting Conditions: Attention deficit/hyperactivity disorder; Allergic reaction to antibiotics (Macrobid, Lorabid)
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA02119
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0384U2IMRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site pain, Muscle atrophy, Pain, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a physician concerning a caucasian 23 year old female with a history of attention deficit/hyperactivity disorder, allergic reaction to Macrobid and an allergic reaction to Lorabid who on 29-Dec-2006 was vaccinated intramuscularly with her first dose of GARDASIL in the left arm (lot #654389/0961F). Concomitant therapy included amphetamine aspartate/amphetamineSO4/dex (ADDERALL XR bid) and drospirenone (+) ethinyl estradiol (YASMIN). On 02-May-2007 the patient was vaccinated intramuscularly with her second dose of GARDASIL in the left arm (lot #657617/0384U). The patient complained of pain and throbbing during both injections. On approximately 16-May-2007 the patient returned to the office with a dent with pain and ache in her left arm a few inches below the injection site. On 10-Oct-2007 the patient was vaccinated intramuscularly with her third dose of GARDASIL in the right arm (lot #657617/0384U). On 30-Nov-2007 the patient was seen by the orthopedist for the dent in her arm. He feels it is muscle mass deterioration related to absorption of the GARDASIL. The patient has not recovered. The nurse also mentioned many other patients have had pain at the injection site. Additional information has been requested.

VAERS ID:303157 (history)  Vaccinated:0000-00-00
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-01-08
Location:Unknown  Entered:2008-01-16, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Not reported
Current Illness: Unknown
Preexisting Conditions: The subject''s medical history, concurrent medical conditions, and concomitant medications were not reported. It was noted that the subject had received the hepatitis B vaccination series at a "different clinic" than that of the reporting nurse.
Diagnostic Lab Data: Diagnostic results: At the time of reporting, on 12 April 2007, the subject''s hepatitis antibody titers were "lower than what they should be".
CDC Split Type: A0647264A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Laboratory test abnormal, Therapeutic response decreased
SMQs:, Lack of efficacy/effect (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a 22-year-old female subject who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis. On unspecified date(s), the subject received the series of three doses of hepatitis B vaccine. At an unspecified time after completion of the vaccination series with hepatitis B vaccine, the subject experienced decreased therapeutic response. The reporting nurse stated that the subject''s hepatitis B antibody titers were "currently lower than what they should be and may need further immunization". At the time of reporting the outcome of the event was unspecified. Follow up information was received from the healthcare professional on 04 May 2007. The healthcare professional indicated that she did not report this case to a regulatory authority.

VAERS ID:303448 (history)  Vaccinated:2007-11-22
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-01-07
Location:Unknown  Entered:2008-01-16, 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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA01439
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Information has been received from a physician concerning his 22 year old daughter with no medical history and/or drug reactions/allergies who on during the week of 22-NOV-2007 was vaccinated IM with the third dose of Gardasil (lot # not reported). Dates of previous doses were not reported. There was no concomitant medication. "After administration of the third dose of the vaccine, the patient''s arm became red and swollen. Her arm improved after 3 days. The patient''s status was reported as recovered. No laboratory diagnostic tests were performed. There was no product complaint involved. Additional information has been requested.

VAERS ID:302945 (history)  Vaccinated:1983-02-13
Age:22.0  Onset:1983-07-03, Days after vaccination: 140
Gender:Male  Submitted:2008-01-11, Days after onset: 8958
Location:Florida  Entered:2008-01-17, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: appendectomy, tonsillectomy
Diagnostic Lab Data: Frequent tuberculosis test: negative - 1983 to present; Syphilis test: negative - 1983, 1989, 2007; HIV/AIDS test: negative - 2000 to present; Chest x-rays of lungs: positive - 1983 to present, reveals large lymph nodes; Liver enzymes test: High 2003 to 2007; Prostate test: negative within normal limits 2003 - 2008; Computerized tomography (CT) scan: 1983, 1989 revealed lymphadenopathy; Magnetic resonance (MRI) scan: 1994, 2004; Arterial blood gas test: 1983 to 1989 yearly; Lung function/Breathing test: 1983 to 1989 yearly; Electrocardiogram (EKG)/Pulse Oximetry 1983 to 1989 yearly, 1999; Blood test: 1983 to present, Sugar level normal; Muscle functioning/Coordination test: 1983 to 1989 yearly; Biopsy: 1983 Lymph nodes in chest and neck exa
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER 3UNUN
Administered by: Military     Purchased by: Military
Symptoms: Adjustment disorder with depressed mood, Alopecia, Amnesia, Anger, Angiotensin converting enzyme, Anxiety, Asthenia, Autoimmune disorder, Blindness, Borderline personality disorder, Boredom, Bowel movement irregularity, Bronchoscopy, Burning sensation, Cardiovascular disorder, Chest X-ray abnormal, Chest discomfort, Chronic sinusitis, Computerised tomogram abnormal, Cough, Depression, Dry eye, Dyspnoea, Fatigue, Granuloma, HIV test negative, Headache, Hepatic enzyme abnormal, Herpes zoster, Homicidal ideation, Impulsive behaviour, Inflammation, Insomnia, Intraocular pressure increased, Laboratory test normal, Liver disorder, Liver function test normal, Loss of consciousness, Lymphadenopathy, Lymphadenopathy mediastinal, Memory impairment, Mental impairment, Muscular weakness, Myodesopsia, Narcissistic personality disorder, Nervousness, Night sweats, Pollakiuria, Sarcoidosis, Scan gallium abnormal, Suicidal ideation, Syphilis test negative, Tremor, Tuberculin test negative
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Suicide/self-injury (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (narrow), Glaucoma (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (narrow), Depression (excl suicide and self injury) (narrow), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (broad)
Write-up: Loss of vision, inflammation, herpes zoster, night sweats, loss of hair, fatigue, unconsciousness, nervous problems, frequent urination, frequent bowel movement, chronic sinusitis, swollen lymph nodes in neck, lungs, underarms, groins, chest, etc; depression, shortness of breath and irritation in chest, a cough (dry). Before receiving Hepta vac B serum, I was never diagnosed with these medical problems before (lackadaisical state of mind), liver problems. 2/12/1983 Started to experience adverse reactions to Hepta Vac B serum after 2 second shot of three. Antigens introduced caused immune system to go into autodrive, creating an autoimmune disease tendencies. 6/1983 Went to the medical clinic complaining of a dry cough that would not go away. During the examination, physician discovered enlarged lymphnoids in the neck, underarms, groins. X-ray showed lymphnoids in chest enlarged. All test negative for any diseases. 8/1983 Sent to medical center for a battery of diagnostic testing. Stayed there for 3 month. Physician evaluation from the battery of tests concluded no origin or disease that causing autoimmune tendency, immune system sent in overdrive. They diagnosed the problem, medical condition as Sarcoidosis. *Note: Before entering the military I was given a physical, no enlarged lymphnoids. No health problems 8/1982. Health problems associated due to the adverse reaction from 1983 to present: 1. Herpes Zoster: 5/1983 to 6/1983, symptoms - painful rash on left side upper body and chest area. Topical medication to relieve pain. 2. Night sweats 3/1983 to 10/91 - profuse sweating at night regardless of temperature or climate. Time course: stopped in 10/91 (1991). 3. Hair Loss: Legs and buttock in winter months/cold climate; Time course - 5/1993 to present. 4. Inflammation of various organs and lymphatic system. A lymphadenopathy: enlargement of lymph nodes in chin, neck, underarms, groin area, chest. Diagnosed by physician 6/1983. Symptoms: weakness, case to get tried during exerting physical exercising, shortness of breath, dry cough, muscle weakness, fatigue, irritation in chest. Restricted blood flow - weakened or long term destruction of various organs and healthy functioning. (Battery of test every year 1983 to 1989 to see condition affecting health, functioning of organs: lungs, heart, liver, kidneys, brain, etc). Kidneys - frequent urination, burning sensation, increase urges to urinate, especially at night. Loss of sleep, physical exertion going back and forth to the restroom at night (4/1983 to present), prostate test negative. Medication prescribed: Terazosin and Doxazosin. Lungs - enlarged lymph nodes in lungs. Weakness, easily fatigued, shortness of breath, muscle weakness, heavy breathing, dry cough. No tuberculosis test negative, irritation in chest. Chest x-ray''s. Lung functioning test every year 1983 to 1989 (blood gas) [Frequent Colds - 1983 to 2004] Time course:1983 to present. Liver - liver enzyme test high, autoimmune symptoms. Hepatitis panel for A, B, C negative test result 2003 to present. Being monitored by physician. Prostate - affected by muscle in the organ. Medication Terazosin and Doxazosin. Test result: Is normal (PSA) limits. Time course - 2000 to present (sharp pain in that region). Eyes - vision loss, floaters, dry eyes. Elevated pressure in both eyes. Diagnosed by optometrist, inflammation of the eyes. Medications given - 2007 October. Prednisolone acetate, ophthalmic suspension 1%; Cyclopentolate Hydrochloride ophthalmic solution 1%. Time course: 1983 to present (inflammation and elevated pressure cured due to medication0. Sinus problems/Chronic Sinusitis - inflammation, sinus flow at night, heavy mucus build up, obstruction of nasal pathways/passage way, running nose, headaches, sinus infections, stuff up nose and bleeding. Operation in 1982 to snip sinus so breathing can improve. Time course: 1983 to present (Various medication and sprays ineffective). Neurology/neurasthenia - feeling anxious,

VAERS ID:302957 (history)  Vaccinated:2008-01-14
Age:22.0  Onset:2008-01-15, Days after vaccination: 1
Gender:Female  Submitted:2008-01-17, Days after onset: 2
Location:Pennsylvania  Entered:2008-01-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: unknown
Preexisting Conditions: allergy to pencillin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.?0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Rash, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Patient received first Gardasil injection on Monday January 14, 2007. She noted an itchy red rash extending from the injection site Right deltoid across upper chest and across upper back the next day.

VAERS ID:303680 (history)  Vaccinated:2007-06-12
Age:22.0  Onset:2007-06-12, Days after vaccination: 0
Gender:Female  Submitted:2008-01-15, Days after onset: 217
Location:New York  Entered:2008-01-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Herpes virus infection
Diagnostic Lab Data: Cervical smear 06/12/07 negative; Cervical smear 12/04/07 positive 02/10/2010 Cervical smear, 06/12/07, negative (with candida inflamed); Cervical smear, 12/04/07, asc-us high risk HPV detected; Cervical smear, 01/04/07, negative (thin prep)
CDC Split Type: WAES0712USA07861
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Human papilloma virus test positive, Inflammation, No reaction on previous exposure to drug, Smear cervix abnormal
SMQs:
Write-up: Information has been received from a physician concerning a 22 year old female with a history of positive for antibodies for herpes virus of unknown type, who on 12-JUN-2007 was vaccinated with the first dose of Gardasil and the PAP test done on that day was normal. On 16-Aug-2007 the patient received the second dose and on 04-Dec-2007 received the third dose and a PAP test taken that day was positive for high risk HPV. Medical attention was sought. At the time of report the patient had not recovered. No product quality compliant was involved. Additional information has been requested. 02/10/2010 On 12-Jun-2007 the patient received the second dose IM in the right deltoid and tjet pap test done that day was normal with candids inflammed, and on 04-Dec-2007 received the third dose IM in the left deltoid and an PAP test tanke that day was positive for high risk HPV. Concomitant medication included Othro trycyclan to SC pills (manufacturer unknown). Medical attention was sought. At the time of report the patient had not recovered. No product quality complaint was involved. Additional information has been requested.

VAERS ID:303706 (history)  Vaccinated:0000-00-00
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-01-15
Location:Unknown  Entered:2008-01-21, 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: Cervical smear abnormal
CDC Split Type: WAES0712USA08037
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Smear cervix abnormal
SMQs:
Write-up: Information has been received from a consumer concerning her 22 year old daughter who had no relevant medical history or drug reactions/allergies, who in September 2007 (exact date not reported), was vaccinated (site and route not reported) with the 3rd dose of the Gardasil vaccine (lot # not reported). The patient was concomitantly taking fish oil. The patient''s mother reported that her daughter had an abnormal pap smear. The patient''s mother was told that the, "the pap smear showed abnormal cell growth". The patient was scheduled for cryosurgery for 18-Dec-2007. At the time of this report the patient had not recovered. Additional information has been requested. Information has been received from a registered nurse concerning her 22 year old daughter who has no relevant medical history or drug reactions/allergies, who on unspecified date was vaccinated with a first and second dose of HPV vaccine (lot #, route and site not reported) in September 2007 (exact date not reported), was vaccinated (site and route not reported) with the 3trd dose of the HPV vaccine (lot # not reported). The patient was concomitnantly taking fish oil. The patient''s mother reported that her daughte had an abnormal pap smear. The patient''s mother was told that the "the pap smear showed abnormal cell growth". The patient was scheduled for cryosurgery for 18-Dec-2007. At the time of this report the patient had not recovered. Follow up information was received on 24-MAR-2008. The registered nurse reported that her daughter''s biopsy was negative and the her daughter recovered (date unspecified) from her outpatient procedure. Additional information has been requested.

VAERS ID:303723 (history)  Vaccinated:2007-12-17
Age:22.0  Onset:2007-12-17, Days after vaccination: 0
Gender:Female  Submitted:2008-01-15, Days after onset: 29
Location:New York  Entered:2008-01-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BACTRIM
Current Illness:
Preexisting Conditions: Penicillin allergy
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA08097
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1448U2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 22 year old female with a history of penicillin allergy and no pertinent medical history who on 17-DEC-2007 was vaccinated with a third dose of GARDASIL (lot# 659653/1448U) 0.5mL IM. Concomitant therapy included sulfamethoxazole/trimethoprim (BACTRIM) which the patient has been taking for more than one week. On 17-DEC-2007 a few hours her third dose of GARDASIL the patient developed a red rash on her chest, back and arms. At the time of reporting the patient was recovering. No other information was available. Additional information has been requested.

VAERS ID:303999 (history)  Vaccinated:2007-08-28
Age:22.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Female  Submitted:2008-01-15, Days after onset: 140
Location:New Jersey  Entered:2008-01-21, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA01199
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0928U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a registered nurse concerning a 22 year old black female classroom assistant, who on 28-AUG-2007 at 13:50 was vaccinated intramuscularly in the left deltoid with a first dose of GARDASIL (Lot# 658554/0928U). On 28-AUG-2007 at 14:00 the patient developed bumps on her face, the rash radiated to her neck and right flank area. It was reported that the patient was at camp a few days before the injection and did not recall any problems. The rash was worse on the second day. The patient''s primary care physician treated her with cortisone. The patient recovered in approximately 1 week on an unspecified date. The patient was advised by her primary care physician to see a dermatologist. Additional information is not expected.

VAERS ID:304008 (history)  Vaccinated:2007-10-15
Age:22.0  Onset:2007-10-15, Days after vaccination: 0
Gender:Female  Submitted:2008-01-15, Days after onset: 92
Location:Maine  Entered:2008-01-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA01898
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Medication error, No adverse reaction
SMQs:
Write-up: Information has been received from a registered nurse concerning a 22 year old female who on 15-OCT-2007, was vaccinated with a dose of Gardasil (possible lot#''s 0523U, 1425F, 0515U) that was improperly stored reaching 32 degrees F on 4 occasions 10/02/2007, 10/03/2007, 10/09/2007 and 10/11/2007. No problems were reported. It was unknown whether medical attention was sought. There was no product quality complaint. This is one of several reports from the same source.

VAERS ID:303238 (history)  Vaccinated:2008-01-17
Age:22.0  Onset:2008-01-17, Days after vaccination: 0
Gender:Female  Submitted:2008-01-17, Days after onset: 0
Location:Arizona  Entered:2008-01-22, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: NSAIDS, Phenergan allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2154CA0UNLA
Administered by: Public     Purchased by: Public
Symptoms: Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Pt states she gets nervous and breaks out into hives after shots, pt did not have hives but an itchy rash after a meningococcal vaccine. Benadryl 25 mg po given and it resolved.

VAERS ID:303751 (history)  Vaccinated:2008-01-23
Age:22.0  Onset:0000-00-00
Gender:Male  Submitted:2008-01-24
Location:Minnesota  Entered:2008-01-28, 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: No
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB443BA1UNUN
TDAP: TDAP (ADACEL)SANOFI PASTEURC2844AA1UNLA
Administered by: Public     Purchased by: Public
Symptoms: Wrong drug administered
SMQs:
Write-up: Tdap given 1-23-08 when Td should have been given. Last Tdap was given 1-22-07. Td #1 8-2-06, Tdap #2 1-22-07.

VAERS ID:303798 (history)  Vaccinated:2008-01-22
Age:22.0  Onset:2008-01-23, Days after vaccination: 1
Gender:Male  Submitted:2008-01-29, Days after onset: 6
Location:Massachusetts  Entered:2008-01-29
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
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0989U IMLA
Administered by: Unknown     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: Arm pain, swelling and redness for about 5 days beginning the day after injection in left Deltoid. Responded to ibuprofen and recovered in about 6 -7 days without antibiotic use.

VAERS ID:303899 (history)  Vaccinated:2008-01-24
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-01-24
Location:North Carolina  Entered:2008-01-29, 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: Prenatal vitamins
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS808220IMLA
Administered by: Other     Purchased by: Other
Symptoms: Pruritus, Rash, Rash macular, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Developed facial warmth, then another person noticed blotches on her face and arms. Then she felt itching.

VAERS ID:303974 (history)  Vaccinated:2008-01-25
Age:22.0  Onset:2008-01-26, Days after vaccination: 1
Gender:Female  Submitted:2008-01-30, Days after onset: 4
Location:Texas  Entered:2008-01-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NKDA, Hypothyroid, ADD
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1062U0IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Dizziness, Gaze palsy, Laboratory test, Muscle twitching, Nausea, Neurological examination, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Pt''s mother presented at clinic reporting possible reaction to Gardasil. States daughter got the Gardasil Friday afternoon. Sat "about 24 hours later" pt was at a dress fitting, states pt hadn''t eaten was standing x 20 min and got nauseous and light headed then fainted. States she was out for several minutes and had "some twitching" and "her eyes rolled back". States called emergency line and then went to ER where they spent several hrs, test run there were negative, but they have been advised to get a neuro work up and pt is not to drive. Mother reports no F/H of seizures and the only thing that was different in pt''s life was the Gardasil. States she went online and fainting is one of the side effects listed for Gardasil. States doesn''t want to have unnecessary testing done if this was caused by the Gardasil. Mother states she is not sure she wants pt to get another Gardasil injection.

VAERS ID:304202 (history)  Vaccinated:2007-02-01
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-01
Location:New Jersey  Entered:2008-02-04, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown PMH: BCPs.
Diagnostic Lab Data: Colposcopy; cervix conization 05/03/07; Pap test - abnormal
CDC Split Type: WAES0801USA05252
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0187U IMUN
Administered by: Other     Purchased by: Other
Symptoms: Adnexa uteri pain, Biopsy cervix abnormal, Cervical conisation, Cervical dysplasia, Cervix carcinoma stage 0, Colonoscopy normal, Colposcopy, Dyspareunia, Fatigue, Papilloma viral infection, Pelvic pain, Smear cervix abnormal
SMQs:, Reproductive premalignant disorders (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Malignant tumours (narrow), Uterine and fallopian tube malignant tumours (narrow), Uterine and fallopian tube tumours of unspecified malignancy (broad)
Write-up: Information has been received from a nurse concerning a 23 year old female patient who in February 2007, was vaccinated IM with a dose of Gardasil (lot# 656049/0187U). Subsequently the patient was diagnosed with cervical cancer and was hospitalized. The cold knife cone biopsy was performed on 03-May-2007 and "margins were clear". The cervix was still intact. In June 2007 the patient was recovered. The reporting investigator considered cervical cancer to be disabling. Upon internal review cervical cancer considered to be an other important medical event. No product quality complaint was involved. Additional information has been requested. 4/7/09 Received consultant medical records of 5/23/07-7/28/2008. FINAL DX: adenocarcinoma in situ Records reveal patient dx 3/2006 via LEEP procedure. Subsequent Pap smear abnormal w/HGSIL, cervical biopsies 2/07. Cold knife cone procedure in OR on 5/3/07 c/w CIN 2 w/marked changes of HPV infection. RTC 2/6/08 w/right pelvic pain & fatigue. Had recent colonoscopy for loose stools which was WNL. Colposcopy done at that visit was WNL. Referred to PCP for fatigue. RTC 7/28/08 w/fatigue, bilateral intermittent ovarian pain & pain w/intercourse. BCP d/c 7/08. Colposcopy done WNL. Referred for pelvic US.

VAERS ID:304279 (history)  Vaccinated:0000-00-00
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-04
Location:Unknown  Entered:2008-02-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Tri-Cyclen (ethinyloestradiol + norgestimate + oral contraceptive placebo)
Current Illness: Unknown
Preexisting Conditions: The subject played competitive soccer for approximately ten years and "did quite a lot of heading the ball"; no episodes of loss of consciousness.
Diagnostic Lab Data: Diagnostic results: 01 April 2004: Magnetic resonance imaging of lumbosacral spine was normal; 07 April 2004: Magnetic resonance imaging of the brain revealed two globular areas of abnormal signal in the left internal capsule and subcortica
CDC Split Type: A0604565A
Vaccination
Manufacturer
Lot
Dose
Route
Site
LYME: LYME (LYMERIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Antiphospholipid antibodies negative, Aphonia, Areflexia, Arthralgia, Autoimmune disorder, Back pain, Balance disorder, Borrelia burgdorferi serology negative, Brain stem auditory evoked response abnormal, CSF immunoglobulin increased, CSF myelin basic protein normal, CSF oligoclonal band present, Cognitive disorder, Computerised tomogram abdomen normal, Computerised tomogram normal, Demyelination, Dysphonia, Electromyogram abnormal, Electrophoresis protein, Factor V Leiden mutation, Factor V deficiency, Fatigue, Gait disturbance, Headache, Hypoacusis, Hypoaesthesia, Hypoaesthesia oral, Immunology test, Influenza like illness, Joint swelling, Lumbar puncture abnormal, Multiple sclerosis, Muscle spasticity, Muscular weakness, Musculoskeletal pain, Nervous system disorder, Neurological symptom, Neuropathy, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal, Pain, Pain in extremity, Paraesthesia, Paraesthesia oral, Physiotherapy, Radiculopathy, Serology normal, Somatosensory evoked potentials, Swelling, Tinnitus, Vestibular disorder, Vestibulitis, Vision blurred, Visual disturbance, Visual evoked potentials abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Vestibular disorders (narrow), Arthritis (broad)
Write-up: This case was reported by a lawyer and described the occurrence of joint pain in a female subject of unspecified age who was vaccinated with LYMErix (GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMErix (unknown). On an unspecified date after vaccination with LYMErix, the subject experienced joint pain and swelling, fatigue, numbness, tingling, brain lesions, cognitive problems, muscle weakness, head pain, headaches, visual problems, flu-like symptoms, decreased activities of daily life, and rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with LYMErix. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 21 January 2008 via medical records. On 07 April 2007, magnetic resonance imaging of the brain showed two abnormal lesions, which the subject''s neurologist noted "may be the result of head trauma related to heading the ball on the soccer field". At that time, the subject was 22 years old. On 14 April 2004, the subject presented to a neurologist for evaluation of what happened to be femoral neuropathy or possibly L4 radiculopathy. Complaints included low back pain, numbness and pain in the right leg, and leg weakness especially when climbing stairs or with knee exertion. It was noted that the low back pain had developed approximately two months prior to examination, "after she began doing a lot of kick boxing". Examination revealed full strength throughout "except for mild weakness of iliopsoas graded at 5 and of quadriceps graded at 4+ to 5-, all on the right side", absent right knee jerk, absent adductor jerks, hypesthesia to pin and touch especially over the pre-tibial region and slightly over the lateral aspect of the calf. She was assessed to have femoral neur

VAERS ID:304451 (history)  Vaccinated:2008-01-15
Age:22.0  Onset:2008-01-26, Days after vaccination: 11
Gender:Male  Submitted:2008-02-06, Days after onset: 11
Location:Virginia  Entered:2008-02-06
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Penicillin
Diagnostic Lab Data: CKMB 39.4 (0.6-6.3); Troponin I 8.64 (0-0.5mg/ml); Myoglobin 269 (0-170); CK 632 (49-397)
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV 159 UNUN
SMALL: SMALLPOX (DRYVAX)PFIZER/WYETH 1IDLA
Administered by: Military     Purchased by: Military
Symptoms: Acute coronary syndrome, Blood creatine phosphokinase MB increased, Catheterisation cardiac normal, Cellulitis, Chest pain, Hyperhidrosis, Myocardial infarction, Myoglobin blood increased, Troponin I increased
SMQs:, Rhabdomyolysis/myopathy (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: Early AM hours awoke with c/o chest pain and diaphoresis-taken to Hosp. ER cardiac enzymes positive for acute coronary syndrome-cardiac catherization done 1-27-08 (normal findings) Discharged eve of 29 Jan to parent''s care (Parents called to bedside due to condition) transferred to another hospital 01 Feb 08 for admission and further testing. Given meds p.o. (Plavix, Toprol XL, Pendil, Zocor, ASA)

VAERS ID:304479 (history)  Vaccinated:2008-02-04
Age:22.0  Onset:2008-02-04, Days after vaccination: 0
Gender:Female  Submitted:2008-02-06, Days after onset: 2
Location:New York  Entered:2008-02-06
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
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS804350UNLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0061U0UNRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Significant local reaction at injection site with significant redness, warmth, slight swelling & soreness for 2 days.

VAERS ID:304678 (history)  Vaccinated:0000-00-00
Age:22.0  Onset:0000-00-00
Gender:Male  Submitted:2008-02-05
Location:Illinois  Entered:2008-02-11, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2486AA IMUN
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF)BERNA BIOTECH, LTD3001291 PO 
Administered by: Public     Purchased by: Private
Symptoms: Pruritus generalised, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: 2-5-08. 1:30pm Call from "patient" saying he is itching "all over" since he started taking Oral Typhoid. He took 1 pill on 1/30, 2/1, and 2/3. Says he has no visible rash today but he did have last night. Recommended to contact his physician how and to not take any further medicine until he consults with Dr. He said he didn''t want to contact his Dr. I again stressed the importance of not continuing his medication and contacting hid Dr.

VAERS ID:304780 (history)  Vaccinated:2008-01-29
Age:22.0  Onset:2008-02-08, Days after vaccination: 10
Gender:Male  Submitted:2008-02-12, Days after onset: 4
Location:Hawaii  Entered:2008-02-12
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: PCN
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (DRYVAX)PFIZER/WYETH 0IDLA
Administered by: Military     Purchased by: Military
Symptoms: Furuncle, Injection site discharge, Injection site pain, Injection site swelling, Purulent discharge
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 11 days after primary vaccination, patient developed a subcutanous furuncle, pain, swelling at site of vaccination. Pt treated at local Emergency Room where moderate amount of pus was expressed. Pt relates working out a lot with a lot of sweating around vaccine site prior to boil developing. After expression of pus, wound was dressed and pain & swelling symptoms resolved. Pt was otherwise without significant symptoms.

VAERS ID:305128 (history)  Vaccinated:2008-02-18
Age:22.0  Onset:2008-02-18, Days after vaccination: 0
Gender:Female  Submitted:2008-02-19, Days after onset: 1
Location:Georgia  Entered:2008-02-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Muscle spasms, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Pt. called the afternoon of injection with c/o severe cramps, nausea and vomiting. (Did also start menses.) Called pt. back this am and is doing better.

VAERS ID:305430 (history)  Vaccinated:2007-12-28
Age:22.0  Onset:2007-12-30, Days after vaccination: 2
Gender:Female  Submitted:2008-02-14, Days after onset: 46
Location:Connecticut  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Asthma
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0801USA00938
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1063U1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injected limb mobility decreased, Injection site mass, Injection site pruritus, Injection site swelling
SMQs:, 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 registered nurse concerning a 22 year old white female with a history of mild asthma who on 28-DEC-2007 was vaccinated with a second dose of Gardasil (lot# 658563/1063U) IM in the left deltoid. There was no concomitant medication. On 30-DEC-2007 the patient noted itching at the site. On 02-JAN-2008, the patient noted pain with movement of the left arm and swelling. The patient called the office on 03-JAN-2008. The patient was seen the same day and there was no redness. The patient had a 2-3 cm subcutaneous mass at the injection site. Medical attention was sought. The patient was treated with diphenhydramine hcl (BENADRYL) and warm soaks. No further information was provided. The patient recovered on 14-JAN-2008. It was recommended that there was no third injection to be administered. Additional information is not expected.

VAERS ID:305614 (history)  Vaccinated:2007-12-28
Age:22.0  Onset:2007-12-28, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 48
Location:Georgia  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Epilepsy
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA01713
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1287U0UNLA
Administered by: Private     Purchased by: Other
Symptoms: Cyanosis, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from a physician concerning a 20 year old female who was vaccinated with a dose of Gardasil. Within seconds, the patient turned blue and passed out and was out for about one to one and a half minutes. Unspecified medical attention was sought. At the time of this report, the patient''s outcome was unknown. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2008. Information has been received from a physician concerning a 23 year old female with epilepsy who on 28-DEC-2007 was vaccinated into the left deltoid with a first dose of dose of GARDASIL vaccine (lot#655327/12870U). Within seconds, the patient turned blue and passed out and was out for about one to one and a half minutes. It was also reported that the patient went to check out 15 minutes later and fell to the floor. 911 was called after the clinical staff rendered emergency care. Unspecified medical attention was sough. At the time of this report, the patient''s outcome was unknown. On 28-DEC-2008, the patient recovered. No product quality complaint was involved. Additional information is not expected.

VAERS ID:305617 (history)  Vaccinated:2007-12-27
Age:22.0  Onset:2007-12-27, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 49
Location:South Carolina  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Hemoglobin, 11.7%; blood glucose glucometry, 12/27/07, 136 ml/dL
CDC Split Type: WAES0801USA01807
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1267U0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Blood glucose normal, Haemoglobin decreased, Head injury, Headache, Loss of consciousness, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from a physician concerning a female who sometime during the week of 31-DEC-2007 was vaccinated with the first dose of Gardasil 0.5 mL IM. As the patient was walking out of the office (approximately 31-DEC-2007), she passed out on the desk and hit her head. She went to the ER (details not provided). The outcome of the event was not reported. The physician stated that she thought it was a vasovagal reaction. Additional information has been requested. 07/08/08 Information has been received from a physician and a licensed practical nurse concerning a female student who on 27-DEC-2007 (previously reported as the week of 31-DEC-2007) was vaccinated intramuscularly in the right deltoid with her first dose of GARDASIL (Lot # 659439/1267U). On 27-DEC-2007, the patient experienced a vasovagal episode. As the patient was walking out of the office, she passed out on the desk and hit her head on the counter and the floor. The patient complained of a headache. The patient was immediately taken to the ER by a staff member. The patient had a fingerstick blood sugar performed in the office (136 mg/dL) and a blood test for hemoglobin level (11.7%). On an unspecified date, the patient recovered from the vasovagal episode; passing out and hit her head on the counter and floor and severe head pain. Additional information is not expected.

VAERS ID:305640 (history)  Vaccinated:2007-12-06
Age:22.0  Onset:2007-12-20, Days after vaccination: 14
Gender:Female  Submitted:2008-02-14, Days after onset: 56
Location:Unknown  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Specific allergy (drug)
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA02504
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Skin exfoliation, Skin wrinkling
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (broad)
Write-up: Information has been received from a mother concerning her 22 year old daughter with allergies to unspecified therapy "SEPICOL" and therapy unspecified "SEPICHLOR" who on 06-DEC-2007 was vaccinated with Gardasil (first dose fo three). There were no concomitant medications. On 20-DEC-2007, "two weeks after the dose was administered", the patient experienced roughness and wrinkles on her knuckles and they felt like rubber. A short time later, the skin on her hands, knees and elbows peeled. The patient''s roughness on her knuckles and wrinkles on her knuckles and knuckles felt like rubber and skin on hands, knees and elbows began peeling persisted. The mother reported that she was unsure whether or not her daughter would receive the second and third doses. Additional information is not available.

VAERS ID:305668 (history)  Vaccinated:2007-12-27
Age:22.0  Onset:2008-01-08, Days after vaccination: 12
Gender:Female  Submitted:2008-02-14, Days after onset: 37
Location:Unknown  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ORTHO-CYCLEN
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Hematology
CDC Split Type: WAES0801USA02858
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Haematology test, Pain in extremity
SMQs:, Arthritis (broad)
Write-up: Information has been received from a health professional concerning a 22 year old female who on 21-JUN-2007 was vaccinated with her first dose of Gardasil. Concomitant therapy included ORTHO-CYCLEN. On 27-DEC-2007 the patient was vaccinated with her third dose of Gardasil (lot# 659055/1522U). On 08-JAN-2008 the patient experienced severe joint pain in lower extremities, pain in her ankle and in her foot. The patient''s severe joint pain in lower extremities, pain in her ankle and in her foot persisted. She saw her family physician who told her to take ibuprofen (ADVIL). She also had blood work done. Additional information has been requested.

VAERS ID:305676 (history)  Vaccinated:2008-01-11
Age:22.0  Onset:2008-01-11, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 34
Location:New Jersey  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: YASMIN
Current Illness:
Preexisting Conditions: Penicillin Allergy; Allergic reaction to antibiotics
Diagnostic Lab Data: None
CDC Split Type: WAES0801USA02926
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Initial and follow up information has been received from a healthcare professional, concerning a 22 year old caucasian female patient, with allergies to penicillin, amoxicillin and cefaclor (CECLOR) and a recent unspecified infection with azithromycin (Z-PAK) completed just prior to vaccination, who on 11-JAN-2008 was vaccinated IM, with the first dose, 0.5 ml, of GARDASIL (lot #659055/1522U). Concomitant therapy included YASMIN. After the vaccination, the patient experienced dizziness and lightheadedness. She was placed in a reclined position and observed for 30 minutes, and was then able to leave. However, later in the day, she called to report that she was still dizzy, lightheaded, nausea, and she had a low grade fever (temperature not taken with thermometer). On 14-JAN-2008, the patient felt better and had recovered. Additional information is not expected.

VAERS ID:305810 (history)  Vaccinated:2007-06-22
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-14
Location:New York  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: Sulfonamide allergy; Penicillin allergy; Allergic reaction to antibiotics
Diagnostic Lab Data: muscular biopsy
CDC Split Type: WAES0801USA03297
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0742U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Biopsy muscle, Myofascitis
SMQs:
Write-up: Information has been received from a physician concerning a 22 year old female with a history of sulfonamide allergy, penicillin allergy and Levaquin allergy on 22-JUN-2007 was vaccinated intramuscularly with her first dose of GARDASIL (lot# 657868/0523U). Concomitant therapy included hormonal contraceptives (unspecified). The patient received a second dose of GARDASIL (lot# 654539/0742U). Subsequently the patient experienced macrophagic myofascitis about two weeks after being vaccinated. The physician states that the patient has been treated with corticosteroids and has improved. The patient had a muscle biopsy and sought medical attention in the office. Therapy was discontinued. Additional information has been requested.

VAERS ID:305979 (history)  Vaccinated:2008-01-21
Age:22.0  Onset:2008-01-22, Days after vaccination: 1
Gender:Female  Submitted:2008-02-14, Days after onset: 23
Location:Unknown  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergic reaction to bee sting
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA04689
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a nurse practitioner concerning a 22 year old female patient with allergic reactions to bees who on 21-JAN-2008, was vaccinated IM with a first dose of Gardasil. On approximately 22-JAN-2008, within 24 to 48 hours of being vaccinated, the patient experienced hives on both arms. Unspecified medical attention was sought. The nurse practitioner recommended that the patient take BENADRYL. It was reported, after the patient took the BENADRYL, her symptoms resolved. No product quality complaint was involved. Additional information has been requested. Information has been received from a nurse practitioner concerning a 22 year old female patient with allergic reactions to bees and a questionable allergy to "ncodan" who on 21-JAN-2008, was vaccinated IM into the left deltoid with a furst dose of HPV vaccine (lot # 654539/0742U). On approximately 22-JAN-2008, within 24 to 48 hours of being vaccinated, the patient experienced hives on both arms. Unspecified medical attention was sought. No laboratory diagnositc studies were performed. The nurse practitioner recommended that the patient take BENADRYL. It was reported, after the patient took the BENADRYL, her symptoms resolved. No product quality complaint was involved. Additional information is not expected.

VAERS ID:305988 (history)  Vaccinated:2007-11-19
Age:22.0  Onset:2007-11-19, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 87
Location:North Carolina  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0801USA04785
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1062U0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site pruritus
SMQs:
Write-up: Information has been received from a registered nurse concerning a 22 year old female who on 19-NOV-2007 was vaccinated intramuscularly in the left deltoid with her first dose of GARDASIL (Lot #658560/1062U). Concomitant therapy included vitamins (unspecified). On the evening of 19-NOV-2007 the patient experienced itching at injection site. The patient self-medicated with over-the-counter BENADRYL which provided good relief of the symptoms. Subsequently, the patient recovered from itching at injection site. On 21-NOV-2007, the patient was vaccinated with the influenza virus vaccine (unspecified). On 22-JAN-2008, patient reported the adverse symptoms during an office visit. Additional information has been requested. Information has been received from a registered nurse concerning a 22 year old female who on 19-NOV-2007 was vaccinated intramuscularly in the left deltoid with her first dose of HPV vaccine (lot # 658560/1062U). On the evening of 19-NOV-2007 the patient experienced itching at injection site. The patient self-medicated with over-the-counter BENADRYL which provided good relief of the symptoms. Subsequently, the patient recovered from itching at injection site. On 21-NOV-2007, the patient was vaccinated withthe influenza virus vaccine (unspecified). On 27-JAN-2008, patient reported the adverse symptoms during an office visit.

VAERS ID:306015 (history)  Vaccinated:2007-11-14
Age:22.0  Onset:2007-11-16, Days after vaccination: 2
Gender:Female  Submitted:2008-02-14, Days after onset: 90
Location:New Jersey  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA05746
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1265U0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Rash
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a health professional concerning a 22 year old white female who on 14-NOV-2007 was vaccinated with a dose of Gardasil (lot# 659435/1265U). On 16-NOV-2007 the patient felt dizzy. On 17-NOV-2007 the patient developed rash. On 19-NOV-2007 the patient''s rash subsided. The outcome of dizziness and nausea were unknown. Additional information has been requested.

VAERS ID:306120 (history)  Vaccinated:2008-01-30
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-14
Location:Unknown  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PENTASA
Current Illness:
Preexisting Conditions: Crohn''s disease
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA00149
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a nurse concerning her 22 year old daughter with a history of crohn''s disease who on 30-JAN-2008 was vaccinated with the first dose of GARDASIL (lot number not reported). Concomitant therapy included PENTASA. Subsequently the patient experienced vomiting and nausea. It was reported that the vomiting has resolved but the daughter is still nauseated. No further information is available.

VAERS ID:305404 (history)  Vaccinated:2008-02-21
Age:22.0  Onset:2008-02-21, Days after vaccination: 0
Gender:Female  Submitted:2008-02-21, Days after onset: 0
Location:New York  Entered:2008-02-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BCP
Current Illness: None
Preexisting Conditions: NKA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1287U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Blood pressure decreased, Dizziness, Immediate post-injection reaction, Vision blurred
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Five minutes post injection pt c/o dizziness and blurred vision. BP decreased. Symptoms started subsiding after 5 minutes. Discharged to home with no further complaints 20 min post injection.

VAERS ID:305702 (history)  Vaccinated:2008-02-11
Age:22.0  Onset:2008-02-12, Days after vaccination: 1
Gender:Male  Submitted:2008-02-15, Days after onset: 3
Location:New York  Entered:2008-02-26, Days after submission: 11
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: CBC; CMP
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU23843A0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain, Chills, Full blood count, Headache, Metabolic function test, Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: H/A, chills, n/v, abd pain, fever.

VAERS ID:305747 (history)  Vaccinated:2008-02-22
Age:22.0  Onset:2008-02-24, Days after vaccination: 2
Gender:Male  Submitted:2008-02-26, Days after onset: 2
Location:South Carolina  Entered:2008-02-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None known.
Diagnostic Lab Data: 3/31/08-records received- Labs: WBC 13.2, neutrophil % 82.6, lymphocyte % 7.8. Strep culture negative.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB107AA1IMUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA029820IMUN
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUF082AA0SCUN
Administered by: Military     Purchased by: Military
Symptoms: Hypersensitivity, Lymphocyte percentage decreased, Neutrophil percentage increased, Oedema peripheral, Pallor, Rash erythematous, Rash maculo-papular, Streptococcus identification test negative, White blood cell count increased
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Pt. received 2nd shot series for Boot Camp. Series consisted of IPV, YF, and Hep A/B #2. Pt had blanching, diffuse, mac/papular rash t/o his body. Vital Signs stable and no pain, itch, or burning. 3/31/08-records received for DOS 2/24-2/26/08-DX DC: Allergic reaction. Presented with erythematous rash on all areas of the body, both knees red and edematous. Mild swelling of hands.

VAERS ID:306462 (history)  Vaccinated:2007-10-08
Age:22.0  Onset:2007-10-09, Days after vaccination: 1
Gender:Female  Submitted:2008-01-30, Days after onset: 113
Location:Michigan  Entered:2008-02-26, Days after submission: 27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Tri-Cyclen
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: 07AV00502SP
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV2030SCLA
Administered by: Other     Purchased by: Private
Symptoms: 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: Subject reports receiving AVA vaccine #1 on 10/8/07. She states she started having pain at the injection site on the evening of 10/9/07. Complained of slight injection site swelling and injection site warmth. Denies any systemic effects. 10-17-07 subject reports that symptoms resolved as of 10-12-07.

VAERS ID:306073 (history)  Vaccinated:2007-10-22
Age:22.0  Onset:2007-10-24, Days after vaccination: 2
Gender:Female  Submitted:2007-10-24, Days after onset: 0
Location:Tennessee  Entered:2008-02-28, Days after submission: 127
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergy to penicillin.
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS80686 UNLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Oedema peripheral, Skin warm, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: 2 days after receiving flu shot, hot, red, swollen, tender, no fever or chill, loss of use of arm. Full range of motion of shoulder.

VAERS ID:306189 (history)  Vaccinated:2008-02-20
Age:22.0  Onset:2008-02-27, Days after vaccination: 7
Gender:Female  Submitted:2008-02-29, Days after onset: 2
Location:Montana  Entered:2008-02-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (DRYVAX)PFIZER/WYETH40200760IDLA
Administered by: Military     Purchased by: Military
Symptoms: Axillary mass
SMQs:
Write-up: Small lump under left arm that is approx. the size of a quarter. No itching or bruising at the site. Member was firing M4, M-9, & MCS 870 Modular Combat Shotgun from 0715 to 2359 with both arms on the 27th of Feb 2008. No other problems with vaccination site at this time.

VAERS ID:306225 (history)  Vaccinated:2008-02-27
Age:22.0  Onset:2008-02-27, Days after vaccination: 0
Gender:Male  Submitted:2008-02-29, Days after onset: 2
Location:Arizona  Entered:2008-02-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TTOX: TETANUS TOXOID (NO BRAND NAME)SANOFI PASTEURU1856AA0IMUN
Administered by: Other     Purchased by: Private
Symptoms: Chills, Pain, Paraesthesia, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad)
Write-up: Donor states a few hours after injection he felt all over body aches; fever/chills with some tingling in hands that have persisted for 2 days so far; no Shortness of breath; No rash

VAERS ID:306320 (history)  Vaccinated:2008-02-25
Age:22.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Female  Submitted:2008-02-27, Days after onset: 1
Location:Illinois  Entered:2008-03-03, 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: Nuvaring
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB438AA2IMLA
Administered by: Other     Purchased by: Other
Symptoms: Flushing, Oedema, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: Patient stated itching approximately 27 hours after vaccine. Returned to have edema and flushing approximately 5" in diameter from IM site. Patient denies any pain or discharge.

VAERS ID:306354 (history)  Vaccinated:2007-04-24
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-03
Location:Pennsylvania  Entered:2008-03-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 7/9/2007)
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA04668
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.0960F0IMUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Information has been received through the Merck pregnancy registry from a Registered Nurse concerning a 23 year old female who on 24-APR-2007 was vaccinated with GARDASIL (Lot #654535/0960F). Concomitant vaccinations on 24-APR-2007 included MENACTRA, (manufacturer unspecified) and hepatitis A virus vaccine (manufacturer unspecified). The patient received the second dose of GARDASIL (Lot #657006/0188U) on 18-SEP-2007 and then experienced a miscarriage on 06-JAN-2008. The patient received the third dose of GARDASIL on 06-FEB-2008. The patient received the third dose of GARDASIL on 06-FEB-2008. The patient''s estimated delivery date was 16-APR-2008. The patient became pregnant prior to receiving the second dose. Upon internal review, miscarriage is considered to be an other important medical event. Additional information has been requested.

VAERS ID:306407 (history)  Vaccinated:2008-01-25
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-26
Location:Minnesota  Entered:2008-03-04, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1446U0IMRA
Administered by: Private     Purchased by: Public
Symptoms: Wrong drug administered
SMQs:
Write-up: 1) Adacel vaccine ordered; pt did not receive vaccine on exam day; came in next day for injections only; vaccine not listed on the visit slip under the memo section; dictation not back from transcription. Pt speaks Spanish. Pt has not Gardasil vaccinations up to this report.

VAERS ID:306507 (history)  Vaccinated:2008-02-25
Age:22.0  Onset:2008-03-03, Days after vaccination: 7
Gender:Male  Submitted:2008-03-05, Days after onset: 2
Location:Oklahoma  Entered:2008-03-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (DRYVAX)PFIZER/WYETH40200760IDLA
Administered by: Military     Purchased by: Military
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Local reaction, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Large local reaction around injection site with 8x8 cm area of erythema, swelling and TTP 1 week after administration. Area swelling and redness did not extend beyond shoulder or elbow. Pt was restricted from some duties becuase of arm pain.

VAERS ID:306824 (history)  Vaccinated:2007-08-15
Age:22.0  Onset:2007-08-22, Days after vaccination: 7
Gender:Male  Submitted:2007-10-15, Days after onset: 54
Location:California  Entered:2008-03-06, Days after submission: 143
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: The patient had viral symptoms at the time of vaccination.
Diagnostic Lab Data:
CDC Split Type: 200702891
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2605A UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Dehydration, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Eosinophilic pneumonia (broad), Arthritis (broad)
Write-up: Initial report received from a physician on 23 August 2007. A 22-year-old male patient was given Daptacel (lot number not reported) in August 2007 and developed mild nonspecific pain and achiness within the first 48 hours after the vaccination. These symptoms resolved but he developed muscle aches and joint pains on day 7. These symptoms resolved within 24 hours of their onset. It turns out that on day 7, he was working outdoors in $g100 degree weather and he experienced dehydration. Once he was rehydrated and rested, he felt fine. The physician is no longer concerned that the symptoms are due to Daptacel. Follow-up information received on 15 October 2007 from a health care professional. The patient''s date of birth was provided making the patient 22-years-old at the time of the event. Daptacel, lot number C2605AA, was administered in the left deltoid. Illness at the time of vaccination included viral symptoms. Past medical history was none.

VAERS ID:306829 (history)  Vaccinated:2008-01-28
Age:22.0  Onset:2008-01-30, Days after vaccination: 2
Gender:Male  Submitted:2008-01-30, Days after onset: 0
Location:North Carolina  Entered:2008-03-11, Days after submission: 40
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: not feeling well with shot on 1/28/08
Preexisting Conditions: none
Diagnostic Lab Data: None
CDC Split Type: NC08032
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2862AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Chills, Headache, Influenza, Pulmonary congestion, Pyrexia, Vomiting
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: 01/30/08 730AM vomiting x1, fever 100.5, headache, chills - No treatment; 1030 AM "feels little better"; 1200AM "vomited x4 and still has headache"; was not feeling well before shot on 1-28. 01/31/08- no nausea and vomiting - still has chills, chest congestion - MD appt. 2/16/08; 2/18/08 received call back from client - evaluated by me on 2/1/08 "flu or view" "not related to shot(Tdap)/ I''m back to full health" RN

VAERS ID:306854 (history)  Vaccinated:2008-03-03
Age:22.0  Onset:2008-03-03, Days after vaccination: 0
Gender:Female  Submitted:2008-03-04, Days after onset: 1
Location:Michigan  Entered:2008-03-11, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB525BA1UNRA
Administered by: Other     Purchased by: Other
Symptoms: Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad)
Write-up: Tenderness right deltoid muscle, no erythema.

VAERS ID:306889 (history)  Vaccinated:2008-02-29
Age:22.0  Onset:0000-00-00
Gender:Male  Submitted:2008-03-11
Location:Kansas  Entered:2008-03-11
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: Follow up call 3-11-08. Client reported feeling better. Numbness better with Tylenol. Plan to follow up with immigration physician.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0807U SCLA
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU2152CA IMRA
Administered by: Public     Purchased by: Private
Symptoms: Hypoaesthesia facial
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: 10-08 - Came into clinic numbness from chin to right side of neck.

VAERS ID:306924 (history)  Vaccinated:2008-02-27
Age:22.0  Onset:2008-02-29, Days after vaccination: 2
Gender:Male  Submitted:2008-03-01, Days after onset: 1
Location:Unknown  Entered:2008-03-12, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Milk Allergy
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1733SCRA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURZ11021IMLA
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Erythema and pruritus on (R) arm from shoulder to forearm, extending to (R_ flank. Lasted 24 hrs, then resolved spontaneously.

VAERS ID:306938 (history)  Vaccinated:2008-03-03
Age:22.0  Onset:2008-03-11, Days after vaccination: 8
Gender:Male  Submitted:2008-03-12, Days after onset: 1
Location:California  Entered:2008-03-12
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: hay fever
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1730SCLA
Administered by: Military     Purchased by: Military
Symptoms: Injection site rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: PT was administered the Smallpox vaccine on 3 Mar 2008. This administration was the first vaccination of 15 jabs. PT was diagnosed with a rash surrounding the site of vaccination as well as Urticaria on the chest and stomach 12 Mar 2008. PT has not taken any medication and first noticed the urticaria 11 Mar 2008.

VAERS ID:307808 (history)  Vaccinated:2007-02-23
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-14
Location:Unknown  Entered:2008-03-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Pap test abnormal
CDC Split Type: WAES0802USA05666
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Smear cervix abnormal
SMQs:
Write-up: Information has been received from a health professional concerning a 22 year old female who on 23-FEB-2007 was vaccinated with her second dose of GARDASIL. Subsequently the patient experienced an abnormal pap at an unknown date. The patient sought unspecified medical treatment. The nurse noted that the patient has not returned for her third dose yet. No other information was provided. Additional information has been requested.

VAERS ID:307839 (history)  Vaccinated:2007-10-04
Age:22.0  Onset:2007-11-20, Days after vaccination: 47
Gender:Female  Submitted:2008-03-14, Days after onset: 114
Location:Unknown  Entered:2008-03-17, 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: Miscarriage
Diagnostic Lab Data: ultrasound, 01/17/08, EDD 01SEP2008
CDC Split Type: WAES0802USA06152
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0263U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Metrorrhagia, Muscle spasms, Ultrasound scan
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received via the Merck pregnancy registry, from a licensed practical nurse (LPN), concerning a 23 year old female patient, with a history of miscarriage at 13 weeks, who on 04-OCT-2007 was vaccinated with the first dose of Gardasil (lot # 655849/0263U). On 20-NOV-2007 the patient experienced her last menstrual period, and became pregnant on approximately 04-DEC-2007. On 04-DEC-2007, she was vaccinated with the second dose of Gardasil (lot # 655154/1210U). On 08-JAN-2008, prenatal vitamins were initiated for the pregnancy. On approximately 17-JAN-2008 the patient developed spotting and cramping; an ultrasound was performed, and the original estimated date of delivery of 26-AUG-2008 was changed to 01-SEP-2008. The outcome of spotting and cramping was not specified. No further details were provided. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:307256 (history)  Vaccinated:2008-03-18
Age:22.0  Onset:2008-03-18, Days after vaccination: 0
Gender:Female  Submitted:2008-03-18, Days after onset: 0
Location:Maryland  Entered:2008-03-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data: Patient rested until vital signs were stable and provider released pt to return to school. Pt was able to tolerate PO fluids without difficulty.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB139AA1IMLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURZ096020IMLA
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUF139AA0SCLA
Administered by: Military     Purchased by: Military
Symptoms: Cold sweat, Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Patient received the vaccines (Typhoid, Hep A, Yellow Fever, & PPD). After receiving the vaccines the patient became light-headed and clammy but stayed alert and oriented.

VAERS ID:307266 (history)  Vaccinated:2008-03-13
Age:22.0  Onset:2008-03-13, Days after vaccination: 0
Gender:Female  Submitted:2008-03-13, Days after onset: 0
Location:New York  Entered:2008-03-18, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0073X1IMUN
Administered by: Other     Purchased by: Public
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Peripheral coldness
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad)
Write-up: Dizziness, sweaty, skin cold to touch, weakness.

VAERS ID:307396 (history)  Vaccinated:2008-03-17
Age:22.0  Onset:2008-03-18, Days after vaccination: 1
Gender:Male  Submitted:2008-03-19, Days after onset: 1
Location:Unknown  Entered:2008-03-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1734SCLA
Administered by: Military     Purchased by: Military
Symptoms: Abdominal pain, Burning sensation, Cough, Headache, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Fever, Coughing, Body Ache, Headache. Pt c/o burning sensation on top portion of body two days after vaccination. Also, upper torso abdominal pain to LU quadrant for 1.5 days. Headache, "all over" throbbing.

VAERS ID:307942 (history)  Vaccinated:0000-00-00
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-07
Location:Unknown  Entered:2008-03-19, 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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: serum hepatitis B - negative titer
CDC Split Type: WAES0702USA01052
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Hepatitis A antibody negative, Hepatitis B test negative
SMQs:
Write-up: Information has been received from a registered nurse concerning a 22 year old nurse female employee with no known medical history on allergies, who received three doses of RECOMBIVAX HB. The patient "currently" has a negative hepatitis B titer. Unspecified medical attention was sought. Follow up information indicated the patient had negative antibodies. It is not known "which series she received". No additional information is expected.

VAERS ID:308036 (history)  Vaccinated:0000-00-00
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-07
Location:Georgia  Entered:2008-03-19, 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: hormonal contraceptives
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: serum hepatitis B ?/?/07 - negative Hepatitis B antibody titer
CDC Split Type: WAES0704USA03174
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Hepatitis B antibody negative
SMQs:
Write-up: Information has been received from a registered nurse concerning a 22 year old female healthcare worker with no known history who in 1999 - 2000 was vaccinated with a first, second and third dose of RECOMBIVAX HB. Concomitant therapy included hormonal contraceptives (unspecified). Subsequently "now" in 2007 the patient has a negative hepatitis B antibody titer. Unspecified medical attention was sought. No other adverse experiences were related to this event. There was no product quality complaint involved. Additional information has been requested.

VAERS ID:308042 (history)  Vaccinated:0000-00-00
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-07
Location:Unknown  Entered:2008-03-19, Days after submission: 11
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: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0704USA06277
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Information was received from a pharmacist concerning a 22 year old female who in "1992 when she was 5 years old", was vaccinated with a dose of RECOMBIVAX HB, manufacturer unknown. Subsequently, she developed hives. It was reported that the patient recovered. No quality complaint was involved. Additional information has been requested.

VAERS ID:308185 (history)  Vaccinated:2007-07-17
Age:22.0  Onset:2007-07-21, Days after vaccination: 4
Gender:Male  Submitted:2008-03-07, Days after onset: 230
Location:South Carolina  Entered:2008-03-19, 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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: body temp 07/21/07 102 degre
CDC Split Type: WAES0707USA03732
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0108U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Back pain, Body temperature increased, Lymphadenopathy, Oral herpes, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Oropharyngeal infections (narrow)
Write-up: Information has been received from a registered nurse concerning a 22 year old male with no known allergies or pertinent medical history who on 17-JUL-2007 was vaccinated intramuscularly with 1 ml second dose of RECOMBIVAX HB (Lot# 652715/0108U). There was no concomitant medication. Subsequently 21-JUL-2007 the patient developed a fever of 102 degrees Fahrenheit, swelling of the glands of his neck, fever blisters on his lips, and back pain. The nurse noted that the patient''s brother was experiencing the same symptoms, but had not been vaccinated. Unspecified medical attention was sought. At the time of this report the patient had not recovered. No further information was available. There was no product quality complaint involved. There was no product quality complaint involved. Additional information has been requested.

VAERS ID:307571 (history)  Vaccinated:2008-03-13
Age:22.0  Onset:2008-03-16, Days after vaccination: 3
Gender:Female  Submitted:2008-03-20, Days after onset: 4
Location:New York  Entered:2008-03-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: none
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0926U0IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA1188 IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2769AA IMLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURZ09600IMRA
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUF175AA0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: "Patient" noticed site tenderness, posterior left upper arm region (where sq yellow fever was administered) on 3/16/08 and then visualized redness about 1 1/2 "diameter, warmth. On 3/20 still w/erythema. No induration, fever. Will see again if not improved or resolved by 3/25.

VAERS ID:307976 (history)  Vaccinated:2008-03-14
Age:22.0  Onset:2008-03-23, Days after vaccination: 9
Gender:Male  Submitted:2008-03-24, Days after onset: 1
Location:Wisconsin  Entered:2008-03-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: not known
Preexisting Conditions: NKA
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSUNKNOWN0SCRA
SMALL: SMALLPOX (DRYVAX)PFIZER/WYETHUNKNOWN0IDLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURA022120IMRA
Administered by: Military     Purchased by: Military
Symptoms: Immunisation reaction, Musculoskeletal stiffness, Myositis, Pain in extremity, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad)
Write-up: Patient presented to ER on 3/23/08 with c/o left arm pain and fever s/p smallpox vaccination on 3/14/08. States sx. started this date. Diagnosed with myositis and given Vicodin. F/U at Medical Clinic on 3/24/08 with continued c/o left arm pain and stiffness. Diagnosed with localized reaction to smallpox vaccination. Motrin and rtc as needed.

VAERS ID:308082 (history)  Vaccinated:2008-03-11
Age:22.0  Onset:2008-03-11, Days after vaccination: 0
Gender:Female  Submitted:2008-03-25, Days after onset: 14
Location:California  Entered:2008-03-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Patient denied
Preexisting Conditions: Allergy to sulfur
Diagnostic Lab Data: None performed - 2 hours patient stating she did not have money for tests.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1287U0IMRA
Administered by: Other     Purchased by: Unknown
Symptoms: Asthenia, Dizziness, Dyspnoea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient stated onset began immediately after receiving vaccination - stated feeling light headed, weakness and feeling faint (she did not let staff know). That night she went to bed and her legs felt like 1/2 left leg went to sleep. The next day after school, she took a nap and woke up feeling shortness of breath and went to the urgent care. She continued having symptoms as of 3/22/08.

VAERS ID:308243 (history)  Vaccinated:2008-03-11
Age:22.0  Onset:2008-03-11, Days after vaccination: 0
Gender:Male  Submitted:2008-03-26, Days after onset: 15
Location:Kansas  Entered:2008-03-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Iodine (Swelling), Seafood
Diagnostic Lab Data: ED notes not available. Patient stated he was given Benadryl and was told he was allergic to Yellow Fever Vaccine. Referral to civilian allergist pending for testing to vaccine and components.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUF082AA0SCLA
Administered by: Military     Purchased by: Military
Symptoms: Chest pain, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: Patient c/o chest pain and SOB approximately 1 hour post vaccination. Called clinic and instructed to call 911 to be transported to ED for treatment.

VAERS ID:308401 (history)  Vaccinated:2007-12-20
Age:22.0  Onset:2007-12-20, Days after vaccination: 0
Gender:Female  Submitted:2008-03-24, Days after onset: 94
Location:New York  Entered:2008-03-27, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: latex, Augmentin, Penicillin, Amoxicillin, Prednisone
Diagnostic Lab Data: None done
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1264U1IMRA
Administered by: Private     Purchased by: Other
Symptoms: Blister, Erythema, Injection site erythema, Local reaction, Skin exfoliation
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Patient reports local erythema with peeling skin at vaccination site when received #1 HPV on 8/1/07. Patient reports dose #2 HPV on 12/20/07 presented with more involved local reaction. She had "burn type" local reaction - erythema 3" diameter with blistering and peeling that lasted 2 weeks. She reports it was similar to her latex reactions.

VAERS ID:308648 (history)  Vaccinated:2008-02-25
Age:22.0  Onset:2008-02-25, Days after vaccination: 0
Gender:Female  Submitted:2008-03-27, Days after onset: 30
Location:Oregon  Entered:2008-03-31, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Levaza 28; Iron; Macrodatin
Current Illness: None
Preexisting Conditions: Penicillin; Recurrent UTI; Anemia - Iron def
Diagnostic Lab Data: CBC, CMP, CRP, ESR, UA Dip
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0525U0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2863AA IMRA
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain upper, Arthralgia, C-reactive protein, Full blood count, Headache, Laboratory test, Myalgia, Pyrexia, Red blood cell sedimentation rate, Throat tightness, Urine analysis
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Arthritis (broad)
Write-up: Extreme joint pain, sore muscles, headache, stomach ache, fever, throat tightness.

VAERS ID:308652 (history)  Vaccinated:2008-03-26
Age:22.0  Onset:2008-03-26, Days after vaccination: 0
Gender:Female  Submitted:2008-03-28, Days after onset: 2
Location:Louisiana  Entered:2008-03-31, 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: None reported
Preexisting Conditions: None reported
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TETANUS DIPHTHERIA (NO BRAND NAME)AVENTIS PASTEURU1993AA0IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Diarrhoea, Dizziness, Feeling hot, Headache, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Angioedema (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow)
Write-up: 3-28-08 Today, pt. reported, approx 30 mins. 3-26-08 after receiving Td imm-onset of dizziness, R sided throbbing headache & R arm soreness-headache & dizziness went away after eating a meal. Exp''d diarrhea thru-out night. On 3-27-08-$garm soreness still present with "a little swelling". Felt feverish-took Benadryl for swelling. Today (3-28-08)-headache present "across forehead, little dizziness & increased R arm swelling & decreased soreness.

VAERS ID:308838 (history)  Vaccinated:2008-04-02
Age:22.0  Onset:2008-04-03, Days after vaccination: 1
Gender:Male  Submitted:2008-04-03, Days after onset: 0
Location:Texas  Entered:2008-04-03
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; no prior adverse vaccine reactions
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABAVERT)NOVARTIS VACCINES AND DIAGNOSTICSA025920IMLA
Administered by: Military     Purchased by: Military
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: 1 hr after Rabies #1 patient experienced generalized hives. No other systemic symptoms. Treated in ED with steroids and antihistamines with prompt resolution of symptoms. No other vaccines administered. only taking his usual daily Adderall. no NSAIDs or Tylenol. Rash started on L arm where vaccine was administered.

VAERS ID:308839 (history)  Vaccinated:2008-03-31
Age:22.0  Onset:2008-04-01, Days after vaccination: 1
Gender:Female  Submitted:2008-04-03, Days after onset: 2
Location:Indiana  Entered:2008-04-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Asthma, sinusitis. Allergic to PCN, Amoxicillin, Eryc (Peds dose)
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2775AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Feeling hot, Headache, Injection site pain, Lymphadenopathy, Nausea
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Student rec''d Tdap on 3/31/08. The next evening developed: HA, felt feverish, 2 lymph nodes swollen and painful at the base of the left posterior supraclavicular region. Also, nauseated. Student refused recommend MD evaluation. Instructed to cont. Tylenol for HAs and injection site pain.

VAERS ID:308887 (history)  Vaccinated:2007-12-18
Age:22.0  Onset:2007-12-18, Days after vaccination: 0
Gender:Female  Submitted:2008-04-03, Days after onset: 106
Location:Wisconsin  Entered:2008-04-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 11/13/2007)
Preexisting Conditions:
Diagnostic Lab Data: diagnostic laboratory; ultrasound
CDC Split Type: WAES0803USA04374
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Influenza, Laboratory test, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received for the Merck Pregnancy Registry for GARDASIL from a 22 year old female consumer with no pertinent medical history or drug reactions/allergies who on 18-DEC-2007 was vaccinated with a first dose of GARDASIL injection. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. The consumer reported that she received the first dose of GARDASIL while she was pregnant. The consumers LMP was 13-NOV-2007. The caller was admitted to the hospital overnight for 1 day for the flu. Medical attention was sought. There was no side effects reported as a result of her getting the dose of GARDASIL. On an unspecified date the patient had a diagnostic laboratory test and an ultrasound performed. Results were not given. The estimated date of delivery is 19-AUG-2008. No additional information was given. Additional information has been requested.

VAERS ID:309025 (history)  Vaccinated:2008-03-20
Age:22.0  Onset:2008-03-20, Days after vaccination: 0
Gender:Female  Submitted:2008-04-07, Days after onset: 18
Location:Colorado  Entered:2008-04-07
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: PCN, sulfa drugs
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1630SCLA
Administered by: Unknown     Purchased by: Military
Symptoms: Dizziness, Headache, Injection site erythema, Injection site inflammation, Malaise, Nausea, Pruritus
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (broad)
Write-up: Headache, dizziness, general sick feeling, nausea, redness and inflammation at injection site, itching.

VAERS ID:309108 (history)  Vaccinated:2008-02-08
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-04-08
Location:Minnesota  Entered:2008-04-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 9/13/2007); Food allergy
Preexisting Conditions: Menstruation irregular
Diagnostic Lab Data: urine beta-human 02/08/08 $g.25 mlu/ - positive;
CDC Split Type: WAES0802USA02572
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB367AA0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1211U0IMLA
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU1923HA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Abortion induced, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Initial and follow-up information has been received for the Merck Pregnancy Registry for GARDASIL from a nurse concerning a 22 year old female with food allergies to sunflower oil, eggs and mayo, no illnesses at the time of the vaccination and a history of irregular menstruation related to the past use of medroxyprogesterone acetate (DEPO PROVERA) who on 08-FEB-2008 was vaccinated IM with the first dose of GARDASIL (Lot# 644322/1211U) in the left deltoid. Concomitant therapy included a first dose of ENGERIX-B (lot# AHBVB367AA) IM in the right deltoid and a first dose of DECAVAC (U1923HA) IM in the left deltoid. On 08-FEB-2008 a urine pregnancy test was performed. The test was positive for pregnancy ($g.25mlu/mol). Medical attention was sought in the office. The nurse also reported that this patient might elect to terminate this pregnancy (unrelated to vaccines received). The patient''s outcome is unknown. No product quality complaint was involved. On an unspecified date the patient had an elective abortion which was reported as having "nothing to do with receiving the vaccine". The patient''s outcome was unknown. Upon internal review elective abortion is considered to be an other medical event. Additional information is requested.

VAERS ID:309215 (history)  Vaccinated:2008-04-02
Age:22.0  Onset:2008-04-02, Days after vaccination: 0
Gender:Female  Submitted:2008-04-09, Days after onset: 7
Location:Colorado  Entered:2008-04-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Sulfa drugs and PCN allergy
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1631SCRA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURZ06641IMLA
Administered by: Unknown     Purchased by: Military
Symptoms: Dizziness, Erythema, Headache, Injection site inflammation, Injection site rash, Malaise, Nausea, Pruritus
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Headache, dizziness, nausea, redness, itchy, and inflammation at injection site. Measured at 3 inches raised at injection site. "Sick feeling".

VAERS ID:309234 (history)  Vaccinated:2008-01-11
Age:22.0  Onset:2008-01-11, Days after vaccination: 0
Gender:Female  Submitted:2008-04-09, Days after onset: 88
Location:California  Entered:2008-04-10, 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: vitamins (unspecified)
Current Illness: Pregnancy NOS (LMP = 11/28/2007)
Preexisting Conditions:
Diagnostic Lab Data: ultrasound, 01/11/08, reason-early pregnancy ultrasound results-1 gestational sac, positive yolk sac fetal pole; ultrasound, 01/31/08; ultrasound, 02/01/2008, single, CRL approximately 7.9 weeks, no fetal heart tones with embryonic demise
CDC Split Type: WAES0803USA05021
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1448U1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Foetal disorder, Ultrasound scan abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Information has been received from a physician concerning a 22 year old female with no medical history and no concurrent conditions, who on 11-JAN-2008 was vaccinated with a second dose of Gardasil (Lot# 659653/1448U). Concomitant therapy included prenatal vitamins (unspecified). Subsequently, the patient was pregnant. The estimated conception date was 12-DEC-2007, the patient''s last menstrual period was 28-NOV-2007, and the estimated delivery date was 03-SEP-2008. On 11-JAN-2008 an ultrasound was performed and showed one gestational sac, and was positive for yolksac fetal pole. On 31-JAN-2008 and 01-FEB-2008 repeat ultrasounds were performed and showed a single intrauterine pregnancy, crown-rump length (CRL) was approximately 7.9 weeks, there was no fetal heart tones with embryonic demise. The patient did not have any previous pregnancies and no full-term deliveries. On 08-FEB-2008 the patient experienced a spontaneous abortion nine weeks and one day from her last menstrual period. The products of conception were examined and were normal appearing. The fetus was not normal due to chromosomes 69XXY. At the time of the report, the outcome of the patient was unknown. Upon internal review spontaneous intrauterine embryonic demise was considered to be an other important medical event. Additional information has been requested.

VAERS ID:309818 (history)  Vaccinated:0000-00-00
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-26
Location:Unknown  Entered:2008-04-16, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA02799
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster, Secondary transmission
SMQs:
Write-up: Information has been received from a health professional concerning a 22 year old female employee, with no history of shingles, who worked in a small area where close to 1000 doses of Zostavax (Oka/Merck) was administered to patients since August 2006. It was confirmed that the patient was not vaccinated with Zostavax (Oka/Merck). Subsequently the patient was diagnosed with shingles by her physician and treated. No product quality complaint was involved. No other information was provided. Follow-up information from a health professional indicated that the patient had either recovered completely or was recovering. All lesions were either gone or almost completely dried up. This is one of several reports from the same source. Additional information has been requested.

VAERS ID:310296 (history)  Vaccinated:2007-02-05
Age:22.0  Onset:2007-04-01, Days after vaccination: 55
Gender:Female  Submitted:2008-04-07, Days after onset: 372
Location:Delaware  Entered:2008-04-16, 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: Pregnancy NOS (LMP = Unknown); Papilloma viral infection; Asthma exercise induced
Preexisting Conditions: Non-smoker; Recurrent urinary tract infection
Diagnostic Lab Data: biopsy 1/24/07 - HPV; colposcopy 07/09/07; ultrasound 07/03/07 - 12w 6d; biopsy 07/09/07 - CIN 2; ultrasound 08/15/07 - 18w 3d, BR, ant plac; colposcopy 10/22/07 - small focal area 5 o''clock, 3mm focal area; total serum human 05/07/07 - positive; vaginal Streptococcus 12/05/07 - positive; Pap test 06/12/07 - ASCUS, cannot rule out HGSIL; body temp 01/??/08 104 degrees; Pap test 07/09/07 - ASCUS
CDC Split Type: WAES0706USA02574
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0962F0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Biopsy cervix abnormal, Cervical dysplasia, Colposcopy, Drug exposure during pregnancy, Genital haemorrhage, Haemorrhage, Pregnancy test positive, Smear cervix abnormal, Streptococcus identification test positive, Ultrasound scan
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Reproductive premalignant disorders (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow), Uterine and fallopian tube malignant tumours (broad), Uterine and fallopian tube tumours of unspecified malignancy (broad)
Write-up: Initial and follow up information has been received from a nurse, via the Merck pregnancy registry, concerning a 22 year old female patient, non-smoker with exercise-induced mild asthma (since age 12, no medication), human papilloma virus, and a history of frequent urinary tract infection post-coital, who on 05-FEB-2007 was vaccinated with the first dose, 0.5 ml, of GARDASIL (lot #654510/0962F), and on 17-APR-2007 with the second dose, 0.5 ml, of GARDASIL (lot #654702/0011U). On 07-MAY-2007, the patient had a blood test which confirmed she was pregnant. Date of the LMP and estimated date of conception and delivery were not provided. During pregnancy, the patient took prenatal vitamins PRIMACARE ONE). On 12-JUN-2007, the patient had a Papanicolaou (PAP) test, that revealed atypical squamous cells of undetermined significance (ASCUS), cannot rule out HOSIL (high grade squamous intraepithelial lesion). On 02-JUL-2007 the patient experienced spotting. On 03-JUL-2007, the patient visited the physician was diagnosed with a small subchorionic hemorrhage; an ultrasound indicated she was at 12 weeks, 6 days gestation, with estimated date of confinement of 09-JAN-2008. On 09-JUL-2007, she had an pap smear result of ASCUS, with 2 lesions (Reid''s index score 1 lesion at 12, score 2 at 5-6 without Lugol''s). A colposcopy was performed, and a biopsy showed cervical intraepithelial neoplasm (CIN) grade 2. On 15-AUG-2007, an ultrasound indicated she was at 18 weeks, 3 days gestation. On 22-OCT-2007, a repeat colposcopy revealed a small focal area 5 o''clock, 3 mm focal area of HPV (right upper inner labia minora). On 05-DEC-2007, the patient was found to be streptococcus B positive, with a note to "treat in labor." On 16-JAN-2008, the patient, with continued CIN II, had a normal spontaneous vaginal delivery, at full-term gestation, and delivered an 8 lb 8 oz, female infant (no complications or abnormalities noted). Beginning after delivery, she experienced "significant symphysitis." In late January 2009 (noted in obstetrician''s notes on 01-FEB-2008 as "several days ago"), the patient saw her primary care physician for treatment of a fever up to 104 degrees, which was attributed to flu symptoms; on 01-FEB-2008, she had a normal post partum exam with only some residual symphysis discomfort to palpation. ON 25-FEB-2008, at 6 weeks post partum, the patient had a benign post partum exam, with no complaints and no gross HPV lesions. Additional information is not expected. Follow up from the patient indicated that her baby was healthy and normal and was "doing fine." Additional information has been requested.

VAERS ID:310307 (history)  Vaccinated:2007-05-01
Age:22.0  Onset:2007-06-01, Days after vaccination: 31
Gender:Female  Submitted:2008-04-07, Days after onset: 311
Location:Unknown  Entered:2008-04-16, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0803USA00353
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia
SMQs:, Arthritis (broad)
Write-up: Information has been received from a 22 year old female patient who in May 2007, was vaccinated with a first 0.5 mL dose of Gardasil. On an unspecified date in 2007, she was vaccinated with a second dose and in November 2007, she was vaccinated with her third dose of Gardasil. There was no concomitant medication. In June 2007, the patient experienced joint pain that first occurred in her upper shoulder then spread to her wrist, hip and knees. She reported that joint pain occurred since a month after the first dose of Gardasil and was still occurring. Additional information is not available.

VAERS ID:310469 (history)  Vaccinated:2007-08-01
Age:22.0  Onset:2007-08-01, Days after vaccination: 0
Gender:Female  Submitted:2008-04-14, Days after onset: 257
Location:New York  Entered:2008-04-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Latex allergy; Penicillin allergy; Allergic reaction to antibiotics; Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0803USA03905
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0522U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Skin exfoliation, Vaccine positive rechallenge
SMQs:, Severe cutaneous adverse reactions (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Information has been received from a health professional concerning a female with a latex allergy, penicillin allergy, augmentin allergy, amoxicillin allergy and prednisone allergy who on 01-AUG-2007 was vaccinated intramuscularly with her first dose of GARDASIL (lot# 657737/0522U). Concomitant therapy included and eczema drug. On approximately 01-AUG-2007 the patient experienced redness and warmth at the injection site. On 20-DEC-2007 the patient was vaccinated intramuscularly with her second dose GARDASIL (lot# 658488/1264U). On approximately 20-DEC-2007 the patient experienced redness and warmth at the injection site and peeling of the skin in a 3 inch area at the injection site. Subsequently, the patient recovered from redness and warmth at the injection site, and peeling of the skin at the injection site. Additional information has been requested. 02/17/2010 Subsequently, the patient recovered from redness and warmth at the injection site, and swelling of the skin at the injection site.

VAERS ID:310663 (history)  Vaccinated:2008-03-14
Age:22.0  Onset:2008-03-14, Days after vaccination: 0
Gender:Female  Submitted:2008-04-14, Days after onset: 31
Location:Unknown  Entered:2008-04-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA02940
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a Nurse Practitioner concerning a 22 year old female who on 14-MAR-2008 was vaccinated by injection with a first dose of Gardasil (lot # not reported) and fainted 15 minutes later. No product quality complaint was involved. The patient sought unspecified medical attention. Additional information has been requested.

VAERS ID:310986 (history)  Vaccinated:2008-01-09
Age:22.0  Onset:2008-01-10, Days after vaccination: 1
Gender:Female  Submitted:2008-04-14, Days after onset: 94
Location:Pennsylvania  Entered:2008-04-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0803USA04388
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a nurse practitioner concerning a 22 year old female who on 09-JAN-2008 was vaccinated IM with a 0.5 mL dose of GARDASIL (no lot# provided). On 10-JAN-2008 the patient developed an itchy rash under her arm in the axilla area and rash later spread over her whole body. Subsequently, the patient recovered from itchy rash under her arm in the axilla area and over her whole body. The patient sought medical attention via the family physician. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report previously submitted on 04/14/2008: Followup information has been received from the certified registered nurse practitioner (CRNP). It was reported that the 22 year old female, weighing 175 pounds, height of 65.75 inches, with no pre-existing allergies, birth defects or medical conditions, on 09-JAN-2008 (incorrectly reported as 19-Jan-2008) was vaccinated IM in the left deltoid with the first 0.5 mL dose of GARDASIL (no lot# provided). On 10-JAN-2008 (incorrectly reported as 20-Jan-2008) the patient developed a red, itchy rash under her arm which later became widespread. When the patient returned to the office for the second dose, she notified the physician of the rash she developed after receiving the first dose. It was reported that no treatment was tendered and "self-limited." The patient did not receive the second dose due to the rash she had developed after receiving the first dose. It was reported by the CRNP that she does not think the patient will finish the series due to the rash. No laboratory diagnostics tests were performed. It was also reported that the patient''s 3 year old son had a virus and a rash a week prior to the patient receiving the first dose, so patient does not know if the rash she developed was due to the vaccine or the virus and rash her son had. The patient''s son is not a patient of that office and they have no information on the son''s medical history. It was reported that the patient recovered on an unspecified date (previously reported as 17-Jan-2008). No further information is expected.

VAERS ID:311124 (history)  Vaccinated:2008-03-19
Age:22.0  Onset:2008-03-22, Days after vaccination: 3
Gender:Female  Submitted:2008-04-14, Days after onset: 23
Location:Unknown  Entered:2008-04-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NUVARING
Current Illness: Sulfonamide allergy
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA04951
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dyspnoea, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)
Write-up: Information has been received from a nurse concerning a 22 year old female with sulfonamide allergy who on 19-MAR-2008 was vaccinated IM with a first dose of Gardasil (lot # not provided). Concomitant therapy included NUVARING. On 22-MAR-2008, three days later, the patient experienced shortness of breath and nausea. On an unspecified date, the patient recovered from shortness of breath and nausea. It is unknown if the patient sought medical attention. No product quality complaint was involved. Additional information has been requested.

VAERS ID:309860 (history)  Vaccinated:2008-03-18
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-31
Location:Massachusetts  Entered:2008-04-17, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B015AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: No adverse event, Wrong drug administered
SMQs:
Write-up: NONE. No adverse event occured. We were instructed to file thi by our local DPH immunization manager because Boostrix not Adacel.

VAERS ID:309900 (history)  Vaccinated:2008-03-11
Age:22.0  Onset:2008-03-21, Days after vaccination: 10
Gender:Male  Submitted:2008-04-17, Days after onset: 27
Location:North Carolina  Entered:2008-04-17
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: No chronic medical conditions; NKDA; No birth defects. PMH: childhood hospitalization for measles & respiratory illness. Smoker & ETOH user.
Diagnostic Lab Data: Labs: 3/11/08; CBC: PLT 170K; WBC 8.7; HGB 13.8; HCT 41.1%; 3/17/08 CBC: PLT 129K; WBC 6.4; HGB 14.3; HCT 43%; 3/21/08 CBC: PLT 71K; WBC 7.5; HGB 14.5; HCT 43.5%; 4/15/08 CBC: PLT 137K; WBC 6.4; HGB 14.5; HCT 43.5%. LABS: Pre-vaccination plts 170K, post vaccination plts 129K with a low on 3/21/08 of 70K. Most recent plts 174K on 5/13/08.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
SMALL: SMALLPOX (NO BRAND NAME)UNKNOWN MANUFACTURER 0 UN
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURERA05220UNUN
Administered by: Military     Purchased by: Military
Symptoms: Axillary pain, Platelet count decreased, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad)
Write-up: 22 year old patient received ACAM2000, Typhoid, and Hepatitis A vaccines on 11 March 2008. He was found on follow-up lab testing to have developed Thrombocytopenia (last PLT 70K) after an initially normal PLT count of 170K before beginning the study. 6/24/08 Reviewed medical records of 4/15/2008. FINAL DX: thrombocytopenia Records reveal patient was in good health on day of vaccination. Had 1-2 days of mild axillary pain s/p vaccinations.

VAERS ID:310486 (history)  Vaccinated:2007-11-27
Age:22.0  Onset:2007-11-27, Days after vaccination: 0
Gender:Female  Submitted:2008-04-21, Days after onset: 145
Location:Colorado  Entered:2008-04-22, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 11/5/2007); Asthma exercise induced
Preexisting Conditions: Abortion spontaneous
Diagnostic Lab Data: ultrasound, 12/18/07, fetus was 6 weeks and one day; urine beta-human, 12/12/07, Pregnancy; urine beta-human, 12/14/07, Pregnancy test; laboratory test, 02/28/08, Negat; Quad marker screen test
CDC Split Type: WAES0712USA08445
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1267U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Intra-uterine death, Laboratory test normal, Ultrasound scan, Urine human chorionic gonadotropin positive
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Initial and follow up information has been received from the Merck Pregnancy Registry for Gardasil from a Registered Nurse (R.N.) and doctor''s office concerning a 22 year old female patient with a history of spontaneous abortion and exercise induced asthma who on 27-NOV-2007 was vaccinated with a first dose of Gardasil (lot # 659439/1267U). The nurse reported that the patient received her first injection and found out she was pregnant. On 12-DEC-2007 and on 14-DEC-2007 urine beta-human chorionic gonadotropin test (HCG) was done. On 18-DEC-2008 she had an ultrasound done where fetus was determined to be 6 weeks and one day. The ultrasound did not demonstrate any defects at that time. The last menstrual period (LMP) was reported as 05-NOV-2007 and estimated delivery due date (EDC) reported as 11-AUG-2008. No adverse effects to pregnancy at this time of this reports. The patient was placed on prenatal vitamins (unspecified). No additional information is available. In follow up information from the doctor''s office it was reported that on 28-FEB-2008 a quad pregnancy screen test was done and the result was negative. On 29-MAR-2008 patient experienced a fetal death ($g 20 weeks) which was "20.4" weeks from her LMP. The products of conception were examined and was described to have 17 weeks demise. The weight of product conception was one hundred twenty five grams and was reported as visually normal. It was also reported that it was unknown if the fetus was normal. Upon internal review fetal death $g 20 weeks determined to be an other medical event. No other information is available at this time. Additional information is not expected.

VAERS ID:310504 (history)  Vaccinated:2008-04-10
Age:22.0  Onset:2008-04-10, Days after vaccination: 0
Gender:Female  Submitted:2008-04-17, Days after onset: 7
Location:North Carolina  Entered:2008-04-22, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2766AA0IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Injected limb mobility decreased, Pain in extremity
SMQs:
Write-up: Patient states right arm from elbow to shoulder is in severe pain with any movement. States pain level is a 4/10 scale at rest also. States progressively worse.

VAERS ID:310606 (history)  Vaccinated:2008-04-19
Age:22.0  Onset:2008-04-20, Days after vaccination: 1
Gender:Female  Submitted:2008-04-20, Days after onset: 0
Location:Wisconsin  Entered:2008-04-22, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BCP
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: erythematic area -localized reaction
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURERFAV1630IDLA
Administered by: Other     Purchased by: Military
Symptoms: Injection site erythema, Injection site irritation, Injection site mass, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Burning for about 90 sec after injection. Lump at injection site now, slight burning following morning with redness surrounding lump.

VAERS ID:310611 (history)  Vaccinated:2008-02-21
Age:22.0  Onset:2008-02-21, Days after vaccination: 0
Gender:Female  Submitted:2008-02-22, Days after onset: 1
Location:Wisconsin  Entered:2008-04-22, Days after submission: 59
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
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB521AA0IMLA
Administered by: Other     Purchased by: Unknown
Symptoms: Heart rate decreased, Hypoaesthesia, Pain in extremity, Pharyngolaryngeal pain
SMQs:, Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad)
Write-up: Within 5min of injection. She complained of pain numbness down right arm. Also complained of right throat pain. denied sob. diaphoretic; Ice pack given, rest. pulse 82

VAERS ID:310881 (history)  Vaccinated:2008-02-24
Age:22.0  Onset:2008-04-22, Days after vaccination: 58
Gender:Male  Submitted:2008-04-23, Days after onset: 1
Location:Puerto Rico  Entered:2008-04-24, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: Post anthrax vaccine mild skin reaction without systemic adverse reactions
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)MICHIGAN DEPT PUB HLTHFAV1763UNLA
Administered by: Military     Purchased by: Military
Symptoms: Injection site mass
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Left deltoid area lump where the immunization was given.

VAERS ID:311037 (history)  Vaccinated:2008-04-09
Age:22.0  Onset:2008-04-10, Days after vaccination: 1
Gender:Male  Submitted:2008-04-21, Days after onset: 11
Location:Washington  Entered:2008-04-28, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Broken nose
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1740UNUN
JEV: JAPANESE ENCEPHALITIS (JE-VAX)SANOFI PASTEUREJN234A0UNUN
RAB: RABIES (IMOVAX)SANOFI PASTEURA02570UNUN
SMALL: SMALLPOX (NO BRAND NAME)UNKNOWN MANUFACTURERVV04003A0 LA
Administered by: Military     Purchased by: Unknown
Symptoms: Malaise, Rash generalised, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Received several vaccines to include smallpox 9 APR 08. Presented with 1 day old overall rash, mild malaise, Temp 100.4. Rash mildly pruritic. Had Clindamycin 1 week for nasal fracture. No Hx of allergy to Clindamycin.

VAERS ID:312038 (history)  Vaccinated:2007-11-21
Age:22.0  Onset:2007-11-22, Days after vaccination: 1
Gender:Male  Submitted:2007-11-27, Days after onset: 5
Location:Pennsylvania  Entered:2008-04-28, Days after submission: 152
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had a history of mitral valve prolapse and an allergy to amoxicillin. At the time of vaccination, the patient had just completed "VeraMist".
Diagnostic Lab Data:
CDC Split Type: 200704013
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU1950C UNUN
Administered by: Private     Purchased by: Other
Symptoms: Fatigue, Oedema peripheral, Pruritus, Rash generalised
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Initial report received from a consumer on 26 November 2007. A 22-year-old male patient with a medical history of mitral valve prolapse and an amoxicillin allergy, had received an injection of DECAVAC (route and site not reported), lot number U1950CA on 21 November 2007 and the following day, complained of fatigue. On 26 November 2007, five days post vaccination, the patient awoke with a red rash over most of his body. Both feet and hands were swollen and itchy. The patient went to the emergency room and received treatment with ATARAX and PREDNISONE (dose pack). The patient had not received any other vaccines during the four weeks prior to receipt of DECAVAC. At the time of the report, the patient had not recovered from the event. No further information was provided.

VAERS ID:311439 (history)  Vaccinated:2008-05-01
Age:22.0  Onset:2008-05-01, Days after vaccination: 0
Gender:Female  Submitted:2008-05-01, Days after onset: 0
Location:Ohio  Entered:2008-05-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Migraines, Endometriosis
Diagnostic Lab Data: None known
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0073X0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Asthenia, Body temperature increased
SMQs:, Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad)
Write-up: Temperature per patient 99.2 - patient took Tylenol. Weakness - no treatment done.

VAERS ID:311587 (history)  Vaccinated:2008-04-28
Age:22.0  Onset:2008-04-29, Days after vaccination: 1
Gender:Female  Submitted:2008-04-30, Days after onset: 1
Location:Iowa  Entered:2008-05-05, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2688AA0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Abdominal pain upper, Chills, Nausea, Pyrexia, Retching
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: 4-29-08 - 1:00 AM - Fever/chills. 4-29-08 - 8:00 AM - Nausea/chills, stomach cramping. Dry heaves - done at 10:00 AM. Fever gone at 8:00 PM on 4-29-08.

VAERS ID:311588 (history)  Vaccinated:2008-04-16
Age:22.0  Onset:2008-04-17, Days after vaccination: 1
Gender:Female  Submitted:2008-04-30, Days after onset: 13
Location:Washington  Entered:2008-05-05, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vyvance; Desogen
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: CBC WNL; ESR WNL; ANA neg; RF pending
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1968U1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Antinuclear antibody negative, Full blood count normal, Injected limb mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness, Red blood cell sedimentation rate normal, Rheumatoid factor
SMQs:, Rhabdomyolysis/myopathy (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad)
Write-up: Left shoulder pain, stiffness, decreased range of motion. Persistent/worsening since vaccine administered on 4/16/08.

VAERS ID:311787 (history)  Vaccinated:2008-04-25
Age:22.0  Onset:2008-04-25, Days after vaccination: 0
Gender:Female  Submitted:2008-05-06, Days after onset: 11
Location:Unknown  Entered:2008-05-07, 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: Unknown
Current Illness: Penicillin allergy; Papilloma viral infection
Preexisting Conditions:
Diagnostic Lab Data: colposcopy, 04/25/08, colposcopy of the vagina
CDC Split Type: WAES0804USA06460
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Blindness transient, Colposcopy, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad)
Write-up: Information has been received from a 22 year old female patient who is allergic to amoxicillin and had human papilloma viral infection. On 25-APR-2008 she was vaccinated with a first dose of Gardasil. She reported that approximately twenty minutes after vaccination she began to feel nauseous. In addition, her vision was adversely affected. She began to see black dots and then "everything went black" and she had a temporary total loss of vision for ten to fifteen seconds. She reported that she laid down for ten minutes and she seemed fine after that. The only other symptom she had been experiencing was abdominal cramping as of 26-APR-2008. She had a colposcopy of the cervix on the same day she received the injection. The patient reported to be recovering. Upon internal review temporary total loss of vision was determined to be an other important medical event. No further information is available.

VAERS ID:311808 (history)  Vaccinated:2008-05-01
Age:22.0  Onset:2008-05-01, Days after vaccination: 0
Gender:Female  Submitted:2008-05-06, Days after onset: 5
Location:California  Entered:2008-05-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin, Nexium, Singulair
Current Illness: allergic rhinitis, anxiety
Preexisting Conditions: allergic rhinitis, anxiety
Diagnostic Lab Data: Pulse ox 98%
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB2240A0UNLA
Administered by: Other     Purchased by: Private
Symptoms: Feeling hot, Nystagmus, Oxygen saturation normal, Vertigo, Vomiting
SMQs:, Acute pancreatitis (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Ocular motility disorders (narrow)
Write-up: 1 hour after getting vaccine felt hot, developed vertigo and threw up. Lateral gaze nystagmus demonstrated. 3 days later symptoms had cleared.

VAERS ID:312188 (history)  Vaccinated:2007-10-31
Age:22.0  Onset:2007-11-01, Days after vaccination: 1
Gender:Female  Submitted:2008-05-05, Days after onset: 186
Location:Florida  Entered:2008-05-13, Days after submission: 8
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: Allergy: PCN 5/14/08-records received-Head injury August 2007 causes persistent pain. History of headaches. Depression as well as anxiety. Panic attacks.
Diagnostic Lab Data: 1-17-08 (approx) Labwork all WNL; 1-28-08 X-ray temporomandibular joint - NSG; 4-01-08 CT Scan - neg 5/14/08-records received-HCG, total not pregnant. 5/15/08-records received- X-ray TMJ bilateral: no significant abnormalities involving
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2465AA0UNRA
Administered by: Other     Purchased by: Private
Symptoms: Anxiety, Computerised tomogram normal, Headache, Hypoaesthesia, Laboratory test, Pain in extremity, Pain in jaw, Paraesthesia, Pregnancy test negative, X-ray
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Osteonecrosis (broad)
Write-up: 11-01-07 c/o tingling (R) arm and fingers, progressed to (L) arm and fingers over several weeks then progressed to legs in Dec. 2007. 1-03-08 to PCP for same complaints. 4-01-08 to ER with same symptoms as well as tingling (R) side face. 4-23-08 To neurologist for symptoms. Workup continuing. 5/14/08-records received for DOS 4/23/08-Impression:paresthesia. Anxiety-unspecified.Presented to neurologists with C/O sore, numb as well as tingly right arm, began in October 2007 shortly after receiving the flu shot. Pins and needles underneath her skin with sharp shooting pains in arms and legs. Numbness is not constant, comes and goes. PE normal. Paresthesias are improving. Requesting an MRI for persistent head pain. 5/15/08-records received for DOS /3/08-Assessment:jaw pain causing headaches.

VAERS ID:312492 (history)  Vaccinated:2008-05-15
Age:22.0  Onset:0000-00-00
Gender:Unknown  Submitted:2008-05-16
Location:Missouri  Entered:2008-05-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None in for PE
Preexisting Conditions: Hydrocodone makes jittery
Diagnostic Lab Data: Peak Flow 450 normal for her expected height. She seemed to be doing fine when seen, but told to follow up if not back to normal or other problems.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2927AA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyspnoea, Injection site swelling, Local reaction, Nausea, Palpitations, Tenderness, Tremor
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)
Write-up: Nausea starting approximately 1 hr after vaccination. Local tenderness. Heart pounding, somewhat short of breath and Shakey. Was seen by Dr the following day. Had just very slight swelling over injection site, but throat non erythemitious , neck supple, lungs CTA, Heart with regular rate and rhythem without any click murmur or rubs. No JVD, Neg HJR.

VAERS ID:312626 (history)  Vaccinated:2008-05-05
Age:22.0  Onset:2008-05-05, Days after vaccination: 0
Gender:Female  Submitted:2008-05-19, Days after onset: 14
Location:Pennsylvania  Entered:2008-05-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lutera
Current Illness: None
Preexisting Conditions: Seasonal allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)MASS. PUB HLTH BIOL LABA004B0IMRA
Administered by: Other     Purchased by: Private
Symptoms: Dizziness, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient immediately began feeling lightheaded and nauseated. Then patient became dizzy and fainted. Patient was revived. Upon awakening, patient remained dizzy and had trouble talking. BENADRYL was administered. Patient slept off the symptoms and was fine next day.

VAERS ID:312810 (history)  Vaccinated:2008-03-14
Age:22.0  Onset:2008-03-14, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 61
Location:Mississippi  Entered:2008-05-19, Days after submission: 5
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: WAES0804USA00906
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: 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 a 22 year old female who on 31-JUL-2007 was vaccinated with her second dose of GARDASIL (lot# not reported). On 14-MAR-2008 the patient was vaccinated with her third dose of GARDASIL (lot# not reported). On approximately 14-MAR-2008 the patient experienced a raised area at the injection site. The area was the size of an egg. The patient''s raised area at the injection site persisted and was coming to the office on 02-APR-2008 for an examination. Additional information has been requested.

VAERS ID:312827 (history)  Vaccinated:2007-12-11
Age:22.0  Onset:2008-02-02, Days after vaccination: 53
Gender:Female  Submitted:2008-05-14, Days after onset: 101
Location:Unknown  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Pregnancy NOS (LMP = 2/2/2008)
Preexisting Conditions:
Diagnostic Lab Data: Beta-human chorionic
CDC Split Type: WAES0804USA01179
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Drug exposure during pregnancy, Headache, Injection site discomfort, Pregnancy test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received through the pregnancy registry concerning a 22 year old female patient with no known drug allergies and no medical history reported, who on 11-DEC-2007 and 01-APR-2008 was vaccinated with the first and second doses of GARDASIL respectively. There was no concomitant medication. The patient reported that after receiving the second dose of GARDASIL she found out she was pregnant. She reported that her last menstrual period was from 02-FEB-2008 till around 14-FEB-2008 and that she was eight weeks and three days pregnant. She also reported that after receiving the second dose, on approximately 01-APR-2008, of GARDASIL her head, stomach and her arm hurt at the injection site. Unspecified medical attention was sought. Diagnostic laboratory studies included a pregnancy test. At the time of this report the patient''s outcome was unknown. No product quality complaint was involved. Additional information has been requested.

VAERS ID:312853 (history)  Vaccinated:0000-00-00
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-14
Location:Unknown  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA01550
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a health professional concerning a 22 year old female who was vaccinated on an unspecified date with her first dose of GARDASIL (lot# not reported). Subsequently the patient experienced a rash on her neck and chest the same day as the vaccination. Subsequently, the patient recovered from rash on neck and rash on chest. The patient sought unspecified medical attention. Additional information has been requested.

VAERS ID:312857 (history)  Vaccinated:2007-06-14
Age:22.0  Onset:2007-06-17, Days after vaccination: 3
Gender:Female  Submitted:2008-05-14, Days after onset: 332
Location:Unknown  Entered:2008-05-19, Days after submission: 5
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: diagnostic laboratory, results not reported; computed axial, results not reported
CDC Split Type: WAES0804USA01748
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Computerised tomogram, Dizziness, Laboratory test, Oral contraception, Syncope, Vaccine positive rechallenge
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a 22 year old female with no pertinent medical history, who on 14-JUN-2007 was vaccinated with a first dose of GARDASIL. Concomitant therapy included ORTHO TRI-CYCLEN. On 17-JUN-2007 the patient fainted. The patient went to the emergency room and was later released. Subsequently, the patient recovered. In August 2007, the patient was vaccinated with a second dose of GARDASIL. In August 2007 2 weeks after vaccination, the patient experienced fainted. Subsequently, the patient recovered. In March 2008, the patient was vaccinated with a second dose of GARDASIL. In approximately March 2008, 3 weeks after vaccination, the patient experienced fainted. The patient was seen by a physician. Unspecified blood tests and computed axial tomography were performed (results not reported). At the time of the report, the patient was recovering. She reported that she "still feels like fainting and dizzy." Additional information has been requested.

VAERS ID:312866 (history)  Vaccinated:2008-04-03
Age:22.0  Onset:2008-04-03, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 41
Location:Unknown  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ORTHO TRI-CYCLEN LO
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA01851
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1287U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain, Oral contraception
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a health professional concerning a 22 year old female who on 30-JAN-2008 was IM vaccinated with her first dose of GARDASIL (lot number 655327/1287U). Concomitant therapy included ORTHO TRI-CYCLEN LO. On 03-APR-2008 the patient was IM vaccinated with her second dose of GARDASIL (lot number 655327/1287U) and experienced injection site pain. The patient''s injection site pain persisted. Additional information has been requested.

VAERS ID:312869 (history)  Vaccinated:2008-04-02
Age:22.0  Onset:2008-04-03, Days after vaccination: 1
Gender:Female  Submitted:2008-05-14, Days after onset: 41
Location:Connecticut  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0804USA01961
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0151X0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Information has been received from a office manager concerning a 22 year old female who on 02-APR-2008 was vaccinated IM with the first dose of GARDASIL (Lot #0151X). Concomitant therapy included hormonal contraceptives (unspecified). On 03-APR-2008, the patient experienced numbness in both of her hands and went away over the weekend (approximately 05-APR-2008). The numbness recurred on 07-APR-2008. Medical attention was sought through a call to the office. Patient outcome was unknown. No product quality complaint was involved. Additional information was received from a health care professional indicating that on 03-APR-2008 the patient experienced numbness in both hands that lasted 2 days. The numbness went away over the weekend but has since returned as of 07-APR-2008. Additional information has been requested. 02/17/2010 Additional information was received from a health acre professional indicating that there has been no further communictaion from the patient to the office. This is in follow-up to report[s] previously submitted on 5/14/2008. Additional information was received from a health care professional indicating that there has been no further communication from the patient to the office.

VAERS ID:312913 (history)  Vaccinated:2007-01-19
Age:22.0  Onset:2007-01-19, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 480
Location:Nebraska  Entered:2008-05-19, 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: MICROGESTIN
Current Illness: Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0804USA02492
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1427F0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Headache
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Information has been received from a medical assistant concerning a female with a codeine allergy who on 19-JAN-2007 was vaccinated intramuscularly with her first dose of GARDASIL (lot# 655619/1427F). Concomitant therapy included MICROGESTIN. On approximately 19-JAN-2007 the patient experienced dizziness and headaches for one week. Subsequently, the patient recovered from dizziness and headaches. On 23-MAR-2007 the patient was vaccinated intramuscularly with her second dose of GARDASIL (lot# 657006/0188U) and did not experienced any symptoms. The patient sought medical attention by telling the physician about her symptoms. Additional information has been requested.

VAERS ID:313059 (history)  Vaccinated:2008-04-11
Age:22.0  Onset:2008-04-12, Days after vaccination: 1
Gender:Female  Submitted:2008-05-14, Days after onset: 32
Location:New Jersey  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA02889
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1757U2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
SMQs:, 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 nurse concerning a 22 year old female with no previous medical history and no known drug allergies, who on 27-SEP-2007 was vaccinated with a first dose of GARDASIL (Lot # 659435/1263U). On 21-NOV-2007 she was vaccinated with a second dose of GARDASIL (Lot# 659435/1263U. On 11-APR-2008 she was vaccinated IM in the left deltoid with the third 0.5 ml dose of GARDASIL (Lot # 659182/1757U). There was no concomitant medication. On 12-APR-2008 the patient experienced redness, swelling, and hardness at the injection site following the last injection of vaccine. The patient called an office for medical attention. On 16-APR-2008 the patient stated the redness and swelling had resolved. The patient was not treated. The redness and swelling had improved. Unspecified medical attention was sought. Patient outcome was recovering. No product quality complaint was involved. Additional information has been requested.

VAERS ID:313278 (history)  Vaccinated:2008-02-22
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-14
Location:Georgia  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA05338
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site anaesthesia
SMQs:
Write-up: Information has been received from a nurse concerning a 22 year old female who on 22-FEB-2008 was vaccinated with GARDASIL (Lot # site and route not reported). Subsequently the patient experienced numbness at injection site. No further information was available. Additional information has been requested.

VAERS ID:312693 (history)  Vaccinated:2008-05-12
Age:22.0  Onset:2008-05-14, Days after vaccination: 2
Gender:Female  Submitted:2008-05-14, Days after onset: 0
Location:Minnesota  Entered:2008-05-20, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Penicillin
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (IMOVAX)SANOFI PASTEURA02573IMLA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Feeling hot, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Came in on 5/14/08 to have injection site of left arm examined. Is red, hot and complained of soreness area measures 3" x 1 1/2".

VAERS ID:312950 (history)  Vaccinated:2008-05-09
Age:22.0  Onset:2008-05-10, Days after vaccination: 1
Gender:Female  Submitted:2008-05-20, Days after onset: 10
Location:Connecticut  Entered:2008-05-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type: CT200804
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2616AA0SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: 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: Significant swelling and pain at injection site with fever over 101.5 degrees F developed within 18 hours of injection and lasted for more than 3 days.

VAERS ID:312964 (history)  Vaccinated:2008-04-02
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-21
Location:North Carolina  Entered:2008-05-22, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PROVERA
Current Illness:
Preexisting Conditions: Genital wart; Wart excision; Condyloma
Diagnostic Lab Data: abdominal ultrasound, 04/??/08, normal; serum alkaline, 04/??/08, 283; serum C-reactive, 04/??/08, high; blood culture, 04/??/08, negative for infection; serum electrolytes test, 04/??/08, normal; serum glucose, 04/??/08, normal
CDC Split Type: WAES0805USA03398
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1266U IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Blood alkaline phosphatase increased, Blood culture negative, Blood electrolytes normal, Blood glucose normal, C-reactive protein increased, Hepatic enzyme increased, Joint swelling, Myalgia, Nausea, Pain, Pyrexia, Rash, Ultrasound abdomen normal, Vomiting, Weight increased
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Information has been received from a certified medical assistant concerning a 22 year old female with a history of removal of condylomas/genital warts, and a family history of breast cancer, who on 02-APR-2008 was vaccinated IM in the left upper quadrant of the thigh with a dose of GARDASIL (Lot# 659437/1266U). Concomitant therapy included PROVERA. On 04-APR-2008 the patient felt ill, feverish and achy. On 05-APR-2008 the patient developed a rash and swollen joints which were painful. The patient went to the emergency room and it was suspected that the patient had chicken pox, which was later ruled out. At this time the patient was not admitted to the hospital. On 09-APR-2008 the patient was admitted to the hospital for possible inflammatory arthritis, possible lupus, or possible rheumatoid arthritis. The patient experienced nausea, vomiting, and a rash with myalgia and arthralgias. Other symptoms included swelling and aches in her joints, elevated liver enzymes, fever, malaise, body aches, a rash over her trunk, arms, and legs, and an immediate weight gain of 20 pounds. It was unknown when the weight gain actually started. Rheumatoid studies were conducted. The patient''s phosphatase level was 283 and her Creatinine reactive protein test was high. The patient''s electrolytes, glucose, and abdominal ultrasound were normal and the blood culture was negative for infection. The patient was treated with intravenous fluid, intravenous pain medications, SOLU-MEDROL and MOTRIN. The patient was admitted to the hospital for three days and discharged with a diagnosis of a possible reaction to the vaccination. It was reported that there was a 75% resolution of acute symptoms with the use of SOLU-MEDROL and MOTRIN. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.

VAERS ID:313130 (history)  Vaccinated:2008-04-15
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-16
Location:New Mexico  Entered:2008-05-23, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Penicillin; Amoxicillin; CECLOR
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1757U1IMLA
Administered by: Military     Purchased by: Unknown
Symptoms: Injection site mass, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 1 month after vaccine, patient still has soreness and knot at site of administration.

VAERS ID:313144 (history)  Vaccinated:2008-04-03
Age:22.0  Onset:2008-04-04, Days after vaccination: 1
Gender:Female  Submitted:2008-05-22, Days after onset: 48
Location:North Carolina  Entered:2008-05-23, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown. PMH: Polycystic Ovary Syndrome
Diagnostic Lab Data: diagnostic laboratory, 04/09?/08, Rocky Mountain Fever titer (normal); erythrocyte, 04/09?/08, slightly elevated; serum C-reactive, 04/09?/08, 29.9; serum ANCA, 04/09?/08, Normal; serum hepatitis A, 04/09?/08, normal; serum rheumatoid factor, 04/09?/08, Normal; hepatic function tests, 04/09?/08, Abnormal; body temp, 04/04/08, 102; serum ANA, 04/09?/08, Normal; serum hepatitis B core, 04/09?/08, normal; serum hepatitis C, 04/09?/08, normal; Lyme disease assay, 04/09?/08, normal. Labs and Diagnostics: RF (-), CRP 29, Electrolytes WNL, Alk phos 283, total bili 0.98, ALT 246, AST 128. Sed rate 43. complement C3 219, C442, Lyme (-), Blood cx (-), CBC unremarkable. Ca++ and albumin low.
CDC Split Type: WAES0805USA02288
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal tenderness, Alanine aminotransferase increased, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Arthralgia, Arthritis reactive, Aspartate aminotransferase increased, Asthenia, Blood albumin decreased, Blood alkaline phosphatase increased, Blood bilirubin increased, Blood calcium decreased, Blood culture negative, Body temperature increased, Borrelia burgdorferi serology negative, C-reactive protein increased, Complement factor C3 increased, Complement factor C4 increased, Fatigue, Full blood count normal, Gait disturbance, Hepatitis A virus, Hepatitis B test negative, Hepatitis C test negative, Immunisation reaction, Joint swelling, Joint warmth, Liver function test abnormal, Mouth ulceration, Presyncope, Pyrexia, Rash erythematous, Rash generalised, Rash macular, Red blood cell sedimentation rate increased, Rheumatoid factor negative, Serology normal, Serum sickness, Urticaria
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Acute pancreatitis (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Biliary system related investigations, signs and symptoms (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Arthritis (narrow), Tumour lysis syndrome (broad)
Write-up: Initial and follow up information has been received from a physician and by telephone call from the healthcare professional concerning a 22 year old female patient with family history of rheumatoid arthritis and autoimmune disease who on 03-APR-2008 was vaccinated IM with a dose of GARDASIL (lot # not available). The physician reported that the patient experienced serum sickness, full body rash, and severe arthritis and joint pain. She was taken to the emergency room and was admitted to the hospital. In follow up telephone call the health care professional reported that on 04-APR-2008 patient developed fatigue, temperature of 102, weakness, near syncope episode at work, blanchable rash all over body, very achy joints hands, knees and ankles, and had trouble walking. She went to the emergency room (E.R.) on 04-APR-2008 and was sent home. On 05-APR-2008, she went to the ER and was told she had chicken pox and was sent home. On 08-APR-2008 the patient went to the ER and was sent home. On 09-APR-2008 the patient was admitted to the hospital. The patient''s final diagnosis was reactive arthritis, possible reaction to GARDASIL, urticaria associated with reactive arthritis, abnormal liver function test (LFT''s) possibly related to fatty liver or polycystic ovary syndrome or possibly related to reactive arthritis. Her hepatitis A, hepatitis B and hepatitis C, Lyme, Rocky Mountain fever, serum antinuclear antibodies (ANA), serum antineutrophil cytoplasmic antibody (ANCA) test was normal. Her Rheumatoid factor tests were all normal and her sed rate was slightly elevated. Serum C Reactive protein test was 29.9. The patient was treated with intravenous (IV) steroids and improved. She was in the hospital for four days. On 21-APR-2008, the patient was seen in the office and it was noted that she was "remarkably better". Skin rash was resolved, ache in joints/stiffness still there especially after sleeping. Fever was gone. The patient was recovering. Additional information has been requested. 06/04/2008 MR received from DOS 4/09-11/2008 with D/C DX: Reactive Arthritis: Possible reaction to Gardasil vaccine (symptoms began 3 days after the injection and peaked at ~7-8 days after the injection). Urticaria associated with Reactive Arthritis. Abnormal LFTs: possibly related to fatty liver or polycystic ovary syndrome or reactive arthritis. Hx of polycystic ovarain syndrome-on Provera for menses. Pt presented with c/o fatigue, fever, a near syncopal episode, weakness, joint pain, macular rash and difficulty walking x 6-7 days. PE (+) for mouth ulcerations, abdominal tenderness, macular erythematous rash and marked swelling of the PIP, DIP and MTP joints of the hands and ankles, with associated tenderness. Swelling also noted at wrists with tenderness and limited ROM. (+) warmth of the joints. LFTs markedly abnormal. Txd with Solumedrol then Medrol dosepack with partial resolution of sx.

VAERS ID:313145 (history)  Vaccinated:2007-07-23
Age:22.0  Onset:2007-07-29, Days after vaccination: 6
Gender:Female  Submitted:2008-05-22, Days after onset: 298
Location:Unknown  Entered:2008-05-23, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: DIAMOX, mg; TEGRETOL, mg; YAZ
Current Illness: Convulsion disorder
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0805USA03350
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Condition aggravated, Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a Registered Nurse (R.N.) and by telephone concerning a 22 year old female patient with a history of seizure for which she was on therapy. On 23-MAY-2007 patient was vaccinated with a first dose of GARDASIL and on 23-JUL-2007 she was vaccinated with a second dose of GARDASIL in another doctor''s office. No lot number was provided. Concomitant therapy included TEGRETOL, DIAMOX and YAZ. The nurse reported that on 29-JUL-2007, patient had a seizure type episode six days after she received her second dose of GARDASIL. The patient sought unspecified medical attention. She reported that patient had no seizures since this incident. No further information was provided. Upon internal review seizure was determined to be an other important medical event. Additional information has been requested.

VAERS ID:313192 (history)  Vaccinated:2008-05-23
Age:22.0  Onset:2008-05-23, Days after vaccination: 0
Gender:Male  Submitted:2008-05-23, Days after onset: 0
Location:Illinois  Entered:2008-05-23
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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1837U2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood pressure, Body temperature, Dizziness, Feeling hot, Heart rate, Injection site warmth, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Approximately 10 minutes after administration of injection, pt felt extremely hot and some lightheadedness and nausea. VS 158/89 pulse 95 temp 98.1 F. Pt sat down and was given some water. Pt recovered from all symptoms in under 15 mins. Area surrounding IM site remains warm to touch, no hardening, no hives.

VAERS ID:313704 (history)  Vaccinated:2008-01-11
Age:22.0  Onset:2008-01-25, Days after vaccination: 14
Gender:Female  Submitted:2008-05-16, Days after onset: 111
Location:Unknown  Entered:2008-05-23, 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:
Current Illness: Pregnancy NOS (LMP = 1/9/2008)
Preexisting Conditions:
Diagnostic Lab Data: ultrasound - showed heartbeat, beta-human chorionic - normal
CDC Split Type: WAES0802USA05814
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Foetal heart rate, Genital haemorrhage, Pregnancy test positive, Ultrasound scan abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: This is in follow-up to report(s) previously submitted on 5/16/2008. Information has been received from a certified nurse midwife (CNM), for VARIVAX (Merck), via the Merck pregnancy registry product, concerning a 22 year old female patient with no pertinent medical history, who on 11-JAN-2008 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # not reported). There was no concomitant medication. On approximately 25-JAN-2008 (2 weeks after vaccination) the patient became pregnant. Subsequently the patient experienced spotting after intercourse, but was otherwise "doing well". A beta-human chorionic gonadotropin (HCG) test was normal, and an ultrasound "showed" the heartbeat (dates not reported). The estimated date of delivery was 15-OCT-2008 (estimated date of LMP 09-JAN-2008). Follow up information has been received from a certified nurse midwife via a telephone call, indicating the patient transferred her prenatal care at 34 weeks gestation. The reporter heard from another healthcare professional that the baby (L.D. # 47305)was fine and doing well. The reporter offered to contact the patient and asked her to call us and provided for specific information. Additional information has been requested.

VAERS ID:313999 (history)  Vaccinated:2008-01-14
Age:22.0  Onset:2008-01-15, Days after vaccination: 1
Gender:Female  Submitted:2008-05-16, Days after onset: 121
Location:Louisiana  Entered:2008-05-23, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0801USA03873
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1023U0SC 
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a registered nurse concerning a female who on 14-JAN-2008 was vaccinated SC with her first 0.5 mL dose of varicella virus vaccine live (Oka/Merck). On approximately 15-JAN-2008 within a day or two after vaccination, the patient developed an area of redness and induration at the injection site. The patient contacted the physician by phone for medical attention. The patient was treated with Zyrtec. The outcome was unknown. There was no product quality complaint. Follow-up information has been received from the reporting registered nurse concerning a 22 year old white female who on 14-JAN-2008 was vaccinated SC with her first dose of varicella virus vaccine live (Oka/Merck) (lot# 658411/1023U). There was no illness at the time of vaccination. On 15-JAN-2008 the patient experienced redness, induration and heat at the injection site. The patient sought medical attention through a doctor visit. No labs or diagnostic studies were performed. On approximately 19-JAN-2008 about 5 days after injection, the patient recovered. This is one of several reports from the same source. Additional information has been requested.

VAERS ID:313218 (history)  Vaccinated:2008-04-28
Age:22.0  Onset:2008-05-08, Days after vaccination: 10
Gender:Male  Submitted:2008-05-26, Days after onset: 18
Location:Unknown  Entered:2008-05-26
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: Unknown birth defects - history of diaphragmatic hernia as newborn, tracheal stenosis, possible VSD, possible PDA. Pt had well-healed sternotomy incision. PMH: cardiac surgery as a NB. Congenital tracheomalcia. Diaphragmatic hernia/repair
Diagnostic Lab Data: EKG - anterior fascicular block. CK-MB<1, Myoglobin 39, troponin 0. CXR - staples in area of trachea. Pt had history of cardiac surgery as newborn - possible VSD, possible PDA, possible tracheal stenosis surgery. Labs and Diagnostics: Cardiac enzymes WNL. EKG (+) for anterior fasicular block, otherwise WNL. EKG with ST elevation and sinus arrhythmia. PFTs (+) for expiratory airflow obstruction. Hgb 17.3. Hct 52.4. TEE (+) for dilated coronary sinus. CT chest (+) for inner vessel nodularity in lungs.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A1IDLA
Administered by: Military     Purchased by: Military
Symptoms: Blood creatine phosphokinase MB, Body temperature increased, Breath sounds abnormal, Bundle branch block left, Cardiac enzymes normal, Chest X-ray abnormal, Chest pain, Computerised tomogram abnormal, Dyspnoea exertional, Echocardiogram, Echocardiogram abnormal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Erythema multiforme, Fatigue, Haematocrit increased, Haemoglobin increased, Malaise, Pericarditis, Polycythaemia, Pulmonary function test abnormal, Pyrexia, Rash, Rash papular, Troponin
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Hypersensitivity (narrow)
Write-up: Pt c/o chest pain and fever 10 days post-vaccination. EKG - anterior fascicular block (no old EKG for comparison. Hospitalized on ward in ship, enzymes remained normal throughout course of treatment. Treated with Motrin for presumed pericarditis. Pain resolved over 4 days, remained afebrile. PE - diffuse, multiformed papular rash, non-pruritic over trunk. 8/18/08 Email received with case summary included. Pt presented with chest pain 12 days s/p smallpox vax. Earlier he had developed an erythema multiforme reaction several days after the vax. 12/8/08 Additional MR received. Pt presented 5/9/08 with c/o substernal chest pressure and pain, dyspnea on exertion and erythma multiform rash. ST elevations noted on EKG. PE (+) for T= 100.3''F. DX: Pericarditis. Chest pain resolved w/in 24 hrs. F/U 6/18/08 with c/o increasing fatigue and SOB with exertion. Unable to complete daily exercises as before. Chest soreness follwing exercise. PE (+) for raspy airway sounds, otherwise WNL. Feeling tired and poorly. Polycythemia noted 7/14/08.

VAERS ID:313480 (history)  Vaccinated:2008-05-06
Age:22.0  Onset:2008-05-08, Days after vaccination: 2
Gender:Female  Submitted:2008-05-27, Days after onset: 19
Location:New York  Entered:2008-05-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Loestrin
Current Illness: none
Preexisting Conditions: none. PMH:none, no seizure hx
Diagnostic Lab Data: Ct scan - temporal fracture with frontal and bilateral temporal lobe contusions with SA blood. Csf bloody with increased WBC and protein. Repeat CSF was improved. EEG with b/l slowing , repeat:worse, 3RD better but still slow. none showed
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2938AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Blood creatine phosphokinase increased, Blood culture negative, Blood prolactin increased, Brain contusion, CSF neutrophil count increased, CSF protein increased, CSF white blood cell count increased, Cerebral haemorrhage, Computerised tomogram abnormal, Convulsion, Depressed level of consciousness, Electroencephalogram abnormal, Enterovirus serology test negative, Headache, Nausea, Nuclear magnetic resonance imaging brain abnormal, Polymerase chain reaction, Pyrexia, Red blood cells CSF positive, Scan brain, Skull fracture, Skull fractured base, Subarachnoid haemorrhage, Vitamin B12 abnormal, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Haemorrhagic cerebrovascular conditions (narrow), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: 36 hours after receiving a physical exam, which included administration of Adacel vaccine as well as placement of a PPD, patient complained of headache and vomiting. She was taken to an ER where she was found to have a skull fracture and hemorrhagic brain contusions. It was concluded during her hospital stay that she most likely had a seizure. 05/28/2008 MR received for DOS 5/08-16/2008 with D/C DX: Intracerebral hemorrhage. Pt awoke on 5/08/08 with severe L sided headache, nausea and vomiting and intermittant decreased responsiveness. Temporal bone fracture and subarachnoid hemorrhage noted on head CT as well as tomporal and frontal contusions. Pt developed low grade fever that pm. PEs were WNL during hospitalization. Likely pt had seizure in her sleep resulting in fx and SAH. D/C on seizure precautions.

VAERS ID:314320 (history)  Vaccinated:2008-05-13
Age:22.0  Onset:2008-05-13, Days after vaccination: 0
Gender:Female  Submitted:2008-05-29, Days after onset: 16
Location:Unknown  Entered:2008-05-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Convulsion
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0805USA04693
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Nervousness, Tongue biting
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a nurse practitioner concerning a 22 year old female who on 13-MAY-2008 was vaccinated with a first dose of GARDASIL IM. On 13-MAY-2008 the patient experienced a seizure after receiving GARDASIL. The patient was found on the floor, in the fetal position with her hands drawn up to her chest, was shaking and bit her tongue after receiving GARDASIL. The same thing occurred when the patient was at the dentist. The nurse practitioner suggested that the patient go to the emergency room (ER), but declined. The patient was fine before leaving the office and drove home. At the time of reporting the patient had recovered on an unspecified date. Upon internal review seizure is considered to be an other medical event. Additional information has been requested.

VAERS ID:314525 (history)  Vaccinated:0000-00-00
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-30
Location:Massachusetts  Entered:2008-06-02, 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: Convulsion disorder
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0805USA05092
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Condition aggravated, Confusional state, Convulsion, Injection site erythema, Injection site pain
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a registered nurse concerning her 22 year old daughter with a history of a seizure disorder who "recently" (date unspecified), was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL. Two hours post vaccination, the patient developed pain and redness at the injection site. About four hours post vaccination, the patient had a seizure and seemed confused for the next 24 hours. The patient sought unspecified medical attention. The patient has since recovered. No product quality complaint was involved. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.

VAERS ID:314721 (history)  Vaccinated:2008-04-23
Age:22.0  Onset:2008-04-23, Days after vaccination: 0
Gender:Female  Submitted:2008-05-27, Days after onset: 34
Location:California  Entered:2008-06-03, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Tri-Cyclen Lo
Current Illness:
Preexisting Conditions: PCN allergy
Diagnostic Lab Data: HSV culture negative. Labs: HSV cx (-).
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0152X0IMUN
Administered by: Other     Purchased by: Unknown
Symptoms: Blister, Burning sensation, Disturbance in attention, Erythema, Fungal infection, Herpes simplex serology negative, Herpes zoster, Pain, Rash, Sleep disorder, Vaginal infection, Vulvovaginal pruritus
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow)
Write-up: GARDASIL given 4-23-08 - That evening developed red patch upper chest -$g blistered -$g 4/20 spread along T3 dermatome. By 4-27-08. Pain along rash. 4-28-28 Treated with acyclovir 800 mg 5x/day x10days. 06/23/2008 MR received from OBGYN. Pt presented to office with red, blistery rash on R side of chest in T3 dermatome and itching and burning in vaginal area. DX: Shingles. Yeast vaginitis. Seen again 5/5/08 with rash better. C/o difficulty sleeping and concentrating.

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

VAERS ID:315019 (history)  Vaccinated:2008-05-28
Age:22.0  Onset:2008-05-29, Days after vaccination: 1
Gender:Female  Submitted:2008-06-04, Days after onset: 6
Location:Massachusetts  Entered:2008-06-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None PMH: tumor on heel, sepsis left calf, immune deficiency, metrorrhagia & dysmenorrhea, lazy eye as child. ETOH use.
Diagnostic Lab Data: CAT scan 5/30/08, X-rays 5/30/08, heart EKG 5/30/08, MRI 6/3, MRA 6/3. LABS:cervical x-rays WNL. CT angiogram WNL. EKG sinus bradycardia. CBC, chemistry & UA all WNL. MRI/MRA WNL. CBC, chemistry & UA all WNL.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: Angiogram, Angiogram normal, Asthenia, Blindness transient, Bradycardia, Computerised tomogram normal, Dizziness, Electrocardiogram abnormal, Fatigue, Full blood count normal, Headache, Laboratory test normal, Migraine, Neurological examination normal, Nuclear magnetic resonance imaging normal, Ophthalmological examination normal, Orthostatic hypotension, Presyncope, Pupils unequal, Spinal X-ray normal, Syncope vasovagal, Urine analysis normal
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Glaucoma (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: 05/29/08 - 8 pm - notice different size pupils, headache. 5/30/08 - 1 pm - dizziness, 30 second loss of vision, headache, uneven pupils. 6/4 uneven pupils, headache. 8/26/08 Reviewed ER medical records of 6/05/2008. FINAL DX: probable migraine HA Records reveal patient experienced HA, transient visual disturbance & intermittent unequal pupils. Referred to neuro & neuro-opthalmologist & those reports are included. Neuro exam was WNL. Neuro-Ophtho exam of 6/19/08 revealed significant orthostatic blood pressure changes with normal neuro/eye exam. Recommended additional cardiology w/u to include transesophageal echocardiogram, tilt table test & catecholamine blood test. 6/6/08 Reviewed PCP medical records. FINAL DX: vasovagal syncope Records reveal patient experienced good health on day of vax. Only complaint re BCP which caused nausea. Seen in ER on 5/30 w/episode of bilateral loss of vision that day. Had seen chiropractor & also exercised earlier that day. While stretching her neck during exercise, felt lightheaded & weak then lost vision in both eyes & felt faint. Symptoms resolved spontaneously in approx 20 seconds. Seen by PCP & sent to ER. Neuro consult done. Continued to feel lightheaded while in ER otherwise asymptomatic. Placed in cervical collar. F/U visit to PCP on 6/2 for continued vision difficulties & dizziness. Optho eye examination WNL. Eye exam on 6/2 revealed PERL. Concured w/ER diagnosis 6/13/08 Reviewed ER medical records of 5/30/2008. FINAL DX: near syncope Records reveal patient had seen chiropractor 5/30 for neck manipulation then went to gym for work out. While stretching neck laterally, had lightheadedness & felt weak then gradually lost vision in both eyes & became very light headed & felt like she was going to pass out. In ER, placed in cervical collar & felt better. 7/11/08 Reviewed opthamologist & neurologist medical records of 6/2-6/19/2008. FINAL DX: transient vision loss Records reveal patient experienced sudden onset dizziness & loss of visio

VAERS ID:315009 (history)  Vaccinated:2008-06-05
Age:22.0  Onset:2008-06-05, Days after vaccination: 0
Gender:Female  Submitted:2008-06-05, Days after onset: 0
Location:Texas  Entered:2008-06-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0073X2IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Eye movement disorder, Fall, Head injury, Heart rate normal, Hypotonia, Injection site pain, Loss of consciousness, Respiratory rate
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), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Patient came to pharmacy to recieve the third in a series of Gardasil Shots. She confirmed she had no ill responses from her first two shots (I had asked her as I had not given the first two shots). I administered the vaccination, applied a bandaid to the injection site, and massaged the site briefly. We stood there for a few minutes, so I could observe the patient, talking about her work. After a few minutes she started to rub her arm, I asked her if it was bothering her more then the first two shots, and she said yes, that it was stinging a little more then the first two. Her eyes began to flutter so I grabbed her by her wrists. She begain to buckle at the knees and was falling towards the counter. I caught her head with my forearms, then she went completly limp. She then went backwards as she landed in a sitting position. i tried to lay her out softly but lost my grip, falling the rest of the way and hitting the back of her head on the floor. We raised her feet and called 911. She had normal breaths and pulse until emergancy help arrived a few minutes later. She came to and was coherent shortly after she had passed out.

VAERS ID:315134 (history)  Vaccinated:2007-04-09
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-06-04
Location:North Carolina  Entered:2008-06-06, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = Unknown); Allergic reaction to antibiotics
Preexisting Conditions: Vomiting
Diagnostic Lab Data: Beta-human chorionic, performed in office prior to vaccination.
CDC Split Type: WAES0704USA04780
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0384U IMLA
Administered by: Other     Purchased by: Other
Symptoms: Abortion induced, Drug exposure during pregnancy, Pregnancy test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Information has been received from a registered nurse through a Merck Pregnancy Registry concerning a 22 year old female with a drug reaction to erythromycin (vomiting) with no pertinent medical history. The patient had done a few home pregnancy tests prior to the administration of the GARDASIL. On 09-APR-2007 prior to vaccination, the patient had a pregnancy test in the physician''s office and was vaccinated intramuscularly, into the left arm with a 0.5 mL dose of GARDASIL, (Lot # 657617/0384U). There was no concomitant medication. It was reported that the patient was pregnant after receiving the vaccine. Follow up phone call information obtained from a registered nurse reported that the patient had an early termination of pregnancy. No complications were reported, and the patient subsequently finished the GARDASIL series. Upon internal review, early termination of pregnancy was considered to be an other important medical event. No further information is expected.

VAERS ID:315237 (history)  Vaccinated:2008-06-05
Age:22.0  Onset:2008-06-05, Days after vaccination: 0
Gender:Female  Submitted:2008-06-06, Days after onset: 1
Location:New Jersey  Entered:2008-06-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1757U1UNRA
Administered by: Private     Purchased by: Other
Symptoms: Blood pressure, Fall, Head injury, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Pt fainted after GARDASIL vaccine injected. Pt fell to the floor. Pt helped back on table. Pt. c/o head injury, ice applied to bump in back of head, water, juice given. BP prior injection 106/60 and after injection 110/70 x 2. Pt to ER for evaluation and follow up.

VAERS ID:316020 (history)  Vaccinated:2008-05-18
Age:22.0  Onset:2008-05-19, Days after vaccination: 1
Gender:Male  Submitted:2008-06-11, Days after onset: 23
Location:Wisconsin  Entered:2008-06-11
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
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMRA
YF: YELLOW FEVER (NO BRAND NAME)UNKNOWN MANUFACTURER 1IMRA
Administered by: Military     Purchased by: Unknown
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Mass
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: The area in which the vaccine was administered turned red, and became very sore. A lump was present immediately after and never dissipated. The lump still remains.

VAERS ID:316247 (history)  Vaccinated:2008-06-04
Age:22.0  Onset:2008-06-13, Days after vaccination: 9
Gender:Male  Submitted:2008-06-14, Days after onset: 1
Location:Unknown  Entered:2008-06-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURW04003A0OTLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURA03942IMRA
Administered by: Military     Purchased by: Military
Symptoms: Cellulitis, Dermatitis allergic, Lymphangitis
SMQs:, Hypersensitivity (narrow)
Write-up: Robust take vs cellulitis w/ lymphangitis. Allergic dermatitis of neck/shoulder/upper chest. Treated with PO benadryl and QID dicloxacillin.

VAERS ID:316333 (history)  Vaccinated:2008-06-11
Age:22.0  Onset:2008-06-12, Days after vaccination: 1
Gender:Female  Submitted:2008-06-16, Days after onset: 4
Location:California  Entered:2008-06-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONS 0SC 
Administered by: Military     Purchased by: Military
Symptoms: Dyspnoea, Pruritus generalised, Rash generalised, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: Pt received 1st dose of anthrax vaccine on 6/11/08 and reported to the ER on the morning of 6/15/08. She was complaining of itching and red bumbs all her body. States she had wheezing and shortness of breath the morning after the injection and the rash is getting worse. Treated with benedryl and ordered to follow up with her primary care clinic.

VAERS ID:316814 (history)  Vaccinated:2007-07-02
Age:22.0  Onset:2008-03-17, Days after vaccination: 259
Gender:Female  Submitted:2008-06-13, Days after onset: 88
Location:Unknown  Entered:2008-06-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = Unknown)
Preexisting Conditions:
Diagnostic Lab Data: ultrasound, X 3 normal; Apgar score, 02/28/08, 8/9
CDC Split Type: WAES0708USA01526
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0245U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Herpes zoster, Ultrasound scan normal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Initial and follow up information has been received for the Pregnancy Registry for GARDASIL from a Registered Nurse (R.N.) concerning a 22 year old female patient who on 02-JUL-2007 was vaccinated with a first dose of GARDASIL lot #656050/0245U. The nurse reported that patient received the injection during pregnancy. No adverse reactions were reported. Unspecified medical attention was sought by the patient. In follow up information the doctor''s office reported that patient had shingles approximately at 26 weeks of her pregnancy. She had ultrasound x3 was done and they were reported as normal. On 28-FEB-2008 she delivered a female normal baby 39 weeks from her last menstrual period. The baby weighed 6 lb 8 oz and was 21 inches in length. Her Apgar score was 8/9. There was no congenital abnormalities reported. Additional information is not expected. Pediatric medical records were received and reviewed concerning a female normal infant which reported the following: On 07-MAR-2008 the one week old infant weighted 9 7 pounds and 4 ounces. The physical exam and development were normal. On 17-MAR-2008 the infant weighted 7 pounds 12 ounces with clothes. Patient had stuffy nose, no fever and also white cuating of tongue which was diagnosed as thrush and URI. Heart and lung examinations were negative. Abdomen, nott. The infant was treated with saline nose drops and nystatin suspension 60 ml, 1 ml QD. On 08-APR-2008 the approximately 2 month old infant weighted 9 pounds 2 ounces with clothes. Her height was 22.5 inches. Infant is doing well except for thrush. Ear, nose, throat (ENT) examination showed tongue coated white. Heart and lung examinations were negative. Abdomen soft. Infant continued with nystatin suspension treatment. On 22-APR- 2008 lab and diagnostic test from the newborn screening lab report were within normal limits. The patient still had thrush. On 09-MAY-2008 the approximately 2 month old female infant was vaccinated with PEDIARIX, PREVNAR. The infant with age appropriate growth and development weighted: 12 pounds. Height: 24 inches, and (FOC): 41.4. Physical exam revealed positional plagiocephaly (infant was encourged to look towards left) and constipation. Reinforced safe sleep practices, supervised (tummy time) were recommended. Also 1 ounce of prune juice added to 1 or 2 bottles of formula per day was recommened. In June 2008, the approximately 3 month old infant with age appropriate growth and development weighted 15 pounds and 1 ounce. Height : 25.5 inches and FOC: 43.0. Physical exams were normal. Ocassional constipation was noted. Reinforced safe sleep practices supervised were recommended (tummy time). On 19-JUN-2008, mild eczema-like rash was noted on left cheek treated with EUCERIN. On 15-JUL-2008 the approximately 4 month and a half old infant was vaccinated with PEDIARIX, PREVNAR. Weight: 16 pounds. Height: 26.25 inches and FOC: 44.4. Physical and development exams were normal. As stated above, the infant experienced constipation, mild eczema-like rash on left cheek while on therapy with Hib conj vaccine (OXPC) (MSD) (WAES 089USA01524). No further information is available.

VAERS ID:316844 (history)  Vaccinated:2008-05-09
Age:22.0  Onset:2008-05-09, Days after vaccination: 0
Gender:Female  Submitted:2008-06-13, Days after onset: 35
Location:Connecticut  Entered:2008-06-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES0805USA02339
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1757U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a licensed practical nurse concerning a 22 year old female with no concomitant medications or pertinent medical history, who on 09-MAY-2008 was vaccinated with the first dose of GARDASIL, 0.5ml, IM, (Lot # 659182/1757U). Later that same day she developed diarrhea, was afebrile and had no nausea or vomiting. The patient sought medical attention over the phone and was advised by the doctor to take IMODIUM as needed. As of the date of the report (12-MAY-2008), she continued with diarrhea, and had not recovered. No product quality complaint was involved. Additional information has been requested.

VAERS ID:317052 (history)  Vaccinated:0000-00-00
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-06-13
Location:Unknown  Entered:2008-06-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Sulfonamide allergy; Allergy to vaccine
Preexisting Conditions: Kidney stone; Renal disorder
Diagnostic Lab Data: None
CDC Split Type: WAES0806USA00053
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain, Injection site swelling, Malaise, Nausea, Pyrexia, Vaccine positive rechallenge, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a 22 year old female with sulfonamide allergy to an unspecified pertussis vaccine and a history of kidney stone and other kidney problems who in January 2008, was vaccinated with the first dose of GARDASIL (lot#, dose and route not reported). Concomitant therapy included YAZ and ZOLOFT. In January 2008, after first dose of GARDASIL the patient reported that the injection site was very swollen and painful for approximately 4 weeks. She noted that after the second dose of GARDASIL (lot #, date, dose and route not reported) the injection site became swollen and painful. The patient also noted that 5-6 hours after vaccination she developed a fever, began vomiting, and proceeded to feel nauseous and sick for approximately 3 weeks. At the time of the report, the patient reported that she no longer felt sick; however the injection site was still swollen and painful. Unspecified medical attention was sought. No further information was available. Additional information is not expected.

VAERS ID:317057 (history)  Vaccinated:2007-12-27
Age:22.0  Onset:2008-01-01, Days after vaccination: 5
Gender:Female  Submitted:2008-06-13, Days after onset: 163
Location:Unknown  Entered:2008-06-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown. PMH: ADD. Anxiety.
Diagnostic Lab Data: Labs and Diagnsotics: CT scan of adrenal glans WNL. CXR WNL. EKG in sinus tach. at 103. PFTs WNL. Chemistry significant for Na+ 131, K+ 5.5. ACTH $g1250. Prolactin 45.3. Cortisol total 4.5. Adrenal autoantibody titre$g1:8. Aldosterone <3.0
CDC Split Type: WAES0806USA00259
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0927U1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Addison's disease, Autoantibody positive, Blood aldosterone decreased, Blood corticotrophin increased, Blood cortisol decreased, Blood potassium increased, Blood pressure decreased, Blood prolactin increased, Blood sodium decreased, Chest X-ray normal, Computerised tomogram normal, Dyspnoea, Electrocardiogram abnormal, Heart rate increased, Hypoxia, Laboratory test abnormal, Orthostatic hypotension, Oxygen saturation decreased, Pain, Pulmonary function test normal, Respiratory rate increased, Sinus tachycardia, Tachycardia, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad)
Write-up: Information has been received from a nurse concerning a 19 year old female who on unspecified date was vaccinated with dose 1 and dose 2 of GARDASIL (Lot #''s not provided). Subsequently, on an unspecified date the patient was diagnosed with Addison''s disease. Additional information has been requested. 07/14/2008 MR received for DOS 5/08-12/2008 with D/C DX: Addison''s Disease, postural hypotension and hypoxia. Pt presented to ER with 1 wk hx of episodes of shortness of breath with tachycardia, most recently accompanied by emesis (last 3 days) and sometimes pain. BP did drop and HR&RR up with orthostatics. With ambulation O2 sat dropped to 85%. Treated with Cortisone. To f/u as outpt. 9/25/2008 MR received from PCP including various hospital diagnostics. Seen in F/U for above hospital visit./

VAERS ID:316401 (history)  Vaccinated:2008-06-17
Age:22.0  Onset:2008-06-17, Days after vaccination: 0
Gender:Female  Submitted:2008-06-17, Days after onset: 0
Location:Maryland  Entered:2008-06-17
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE REPORTED
Preexisting Conditions: NONE KNOWN
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1741SCLA
Administered by: Military     Purchased by: Military
Symptoms: Chest discomfort, Chills, Dizziness, Dyskinesia, Dyspnoea, Eye pain, Hypersensitivity, Muscle twitching, Nausea, Neck pain, Pain, Pain in extremity, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (narrow), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: At approx. 08:00 this morning, the patient arrived to facility, was processed and screened for her 2nd dose of Antrax Vaccine in her left deltoid region. She sat in the waiting area for 20 minutes and was released without incident. She said approx. 12:00, she experienced chills & fever, nausea, dizziness, difficulty breathing, tightness in her chest, neck pain, pain in her right eye and right arm and uncontrollable jerking and twitching. She was assessed by Dr. Treatment: IV of Lactated Ringers, 02 via nasal cannula, and Phenergan 25 mg at 14:35hr. Pt was transferred at 15:00 to Hospital. 6/27/08-ER records received for DOS 6/17/08-Impression: allergic reaction to Anthrax vaccine. C/O diffuse body pain, sudden onset of chest tight, PE WNL. Treated with Promethazine, symptoms improved.

VAERS ID:316452 (history)  Vaccinated:2008-06-05
Age:22.0  Onset:2008-06-06, Days after vaccination: 1
Gender:Female  Submitted:2008-06-10, Days after onset: 4
Location:Colorado  Entered:2008-06-17, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Will refer to allergist for allergy testing for yeast.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1978U0IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Pruritic rash lower extremities and distal upper extremities. Not raised. Started 1 day after 1st HPV shot.

VAERS ID:316569 (history)  Vaccinated:2008-05-14
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-06-18
Location:Wisconsin  Entered:2008-06-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Desogen
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Says bx showed "dead cells".
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U2IMLA
Administered by: Public     Purchased by: Other
Symptoms: Biopsy lymph gland, Local swelling, Lymphadenopathy
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient phoned student health clinic on 6/11/08. She was back home and says she had a reaction to the HPV vaccine, which she got on 5/14/08. Says got "swollen lymph nodes" in the groin area which were biopsied. Says developed swollen nodes a few days after vaccine, but did not go to get seen until back home over 1 wk later. Is due to have other nodes biopsied soon.

VAERS ID:317284 (history)  Vaccinated:0000-00-00
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-30
Location:Unknown  Entered:2008-06-18, Days after submission: 19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0704USA03521
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site cyst
SMQs:
Write-up: Information has been received from a health professional concerning a 22 year old female with no known allergies who, "21 years ago," in approximately 1986, was vaccinated with a dose of MMR II. Post vaccination the patient developed a cyst at the injection site. The patient recovered. At the time of this report, no other information was available. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.

VAERS ID:317363 (history)  Vaccinated:2007-05-01
Age:22.0  Onset:2007-05-01, Days after vaccination: 0
Gender:Male  Submitted:2008-05-30, Days after onset: 395
Location:New York  Entered:2008-06-18, Days after submission: 19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0708USA03162
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Headache, Mumps, Parotitis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow)
Write-up: Information has been received from a physician concerning a 23 year old white male with no pertinent medical history and no drug reactions/allergies, who in May 2007, was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) in another country. There was no concomitant medication. In May 2007, the patient developed fever, right sided parotitis and headache. Another physician diagnosed the patient as having Mumps. The outcome is reported as recovered two weeks after onset date reported by the patient. No further information is available. There were no lab diagnostics studies performed. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.

VAERS ID:317475 (history)  Vaccinated:2007-08-28
Age:22.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Female  Submitted:2008-05-30, Days after onset: 276
Location:Arizona  Entered:2008-06-18, Days after submission: 19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Drug hypersensitivity; General physical condition
Preexisting Conditions: Immunisation; Rash
Diagnostic Lab Data: laboratory test - MMR titer negative
CDC Split Type: WAES0710USA02358
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC. 0UNUN
Administered by: Private     Purchased by: Other
Symptoms: Dizziness, Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pain, Injection site papule, Measles antibody negative, Mumps antibody test negative, Nausea, Rash, Rubella antibody negative
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician''s assistant concerning a 22 year old healthy female employee with an aspirin allergy and no other drug allergies and no pertinent medical history who on approximately 28-AUG-2007 was vaccinated with the first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There was no concomitant medication. Following vaccination on approximately 30-AUG-2007 the patient developed an immediate rash on the upper extremities, nausea, lightheadedness which lasted for 2 days, then resolved. On approximately 30-AUG-2007, there was also an injection site reaction that with a 20 mm in diameter circular red and raised lesion with central induration that was tender to the touch for 5 weeks. There was no wheezing or shortness of breath reported. On 04-OCT-2007, the patient returned for a second vaccination with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) and was examined. The patient had a negative titer for M-M-R. No other labs or diagnostic studies were performed. The patient was noted to be recovering. There was no product quality complaint. Follow-up information from the reporting physician assistant indicated that the 22 year old female phlebotomist had a history of rash following immunization with a dose of diphtheria toxoid (+) tetanus toxoid in 2006, "ROS negative" was vaccinated on approximately 28-AUG-2007 with the first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Illness at the time of vaccination was denied. On 28-AUG-2007 following vaccination, the patient developed multiple rashes to the upper extremities and felt nauseous and was lightheaded for 2 days. The patient was seen at clinic on 04-OCT-2007. The patient did not return for a follow-up visit. Additional information has been requested.

VAERS ID:317575 (history)  Vaccinated:0000-00-00
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-30
Location:New Jersey  Entered:2008-06-18, Days after submission: 19
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: None
Diagnostic Lab Data: diagnostic laboratory - Rubella titer-negative
CDC Split Type: WAES0803USA01550
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Rubella antibody negative
SMQs:
Write-up: Information has been received from a certified medical assistant concerning a 22 year old female with no reported medical history or drug allergies who on an unspecified date was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) and on an unspecified date had a negative Rubella titer. The patient''s outcome at the time of reporting was unknown. No other information was available. Additional information has been requested.

VAERS ID:317262 (history)  Vaccinated:2008-05-09
Age:22.0  Onset:2008-05-10, Days after vaccination: 1
Gender:Female  Submitted:2008-06-24, Days after onset: 45
Location:Michigan  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: Allergy to PCN
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2927AA0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Cold sweat, Gait disturbance, Injection site erythema, Injection site mass, Injection site pruritus, Nausea, Pain in extremity, Pyrexia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: -Weakness(barely able to walk) - pain in arm so severe it cause nausea - fever - bump, redness and itching at injection site - fever like symptoms x4days - cold sweats in sleep;(took 2 Aleve every 12 hours x 4days); -$g when I stopped symptoms returned.

VAERS ID:317341 (history)  Vaccinated:2008-06-03
Age:22.0  Onset:2008-06-04, Days after vaccination: 1
Gender:Female  Submitted:2008-06-24, Days after onset: 20
Location:Unknown  Entered:2008-06-25, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: diagnostic laboratory, bloodwork unspecified; magnetic resonance, no results reported; electroencephalography, no results reported; electrocardiogram, no results reported; vascular imaging, no results reported; diagnostic laboratory, basica
CDC Split Type: WAES0806USA03341
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anorexia, Blindness, Blood test, Dizziness, Electrocardiogram, Electroencephalogram, Fatigue, Headache, Laboratory test, Migraine, Nausea, Nuclear magnetic resonance imaging, Vascular imaging
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Vestibular disorders (broad)
Write-up: Information has been received from a consumer concerning his 22 year old female friend with no pertinent medical history, drug reactions or allergies, who on 03-JUN-2008 was vaccinated with the first dose of GARDASIL, 0.5 ml, IM. There was no concomitant medication. It was reported that "the night after the vaccination," (04-JUN-2008), his friend developed "dizziness", nausea, headaches, migraine headaches, fatigue, 30 second periods of vision loss and loss of appetite. She had visited different hospitals in the area and had been admitted" a few times." The hospitalizations were for unknown periods of stay. The patient had unspecified bloodwork, magnetic resonance imaging (MRI), electroencephalography (EEG), electrocardiogram (EKG), magnetic resonance angiography (MRA) and "basically anything you can test for." There were no specifics in reference to the testing provided, and no results were reported. The patient is reportedly recovering. The patient will not be continuing the series. Additional information has been requested.

VAERS ID:317580 (history)  Vaccinated:2008-06-20
Age:22.0  Onset:2008-06-23, Days after vaccination: 3
Gender:Female  Submitted:2008-06-23, Days after onset: 0
Location:Ohio  Entered:2008-06-26, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergic to Ceclor
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0250X UNUN
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Pt had first GARDASIL injection on 6/20/08 and developed itching and redness of both lower legs - "below the knee" today. No rash or "Bumps" - No shortness of breath etc.

VAERS ID:317596 (history)  Vaccinated:2007-05-25
Age:22.0  Onset:2007-05-26, Days after vaccination: 1
Gender:Female  Submitted:2008-05-29, Days after onset: 369
Location:Unknown  Entered:2008-06-26, Days after submission: 28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: N/A
Preexisting Conditions: 05/26/2007 Redness/Swelling $g120mm w/o Complications (Resolved)
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)MICHIGAN DEPT PUB HLTHFAV109 UNUN
Administered by: Military     Purchased by: Military
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: SM developed redness, swelling, pain at anthrax injection site within 24 hrs.

VAERS ID:317722 (history)  Vaccinated:2008-06-05
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-06-23
Location:Nevada  Entered:2008-06-27, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
SMALL: SMALLPOX (NO BRAND NAME)UNKNOWN MANUFACTURER 0OTUN
Administered by: Military     Purchased by: Unknown
Symptoms: Rash erythematous, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Bumps, reactions on stomach, back, neck, chest, breast, arms, underarms. Itchy, red, noticeable.

VAERS ID:317750 (history)  Vaccinated:2008-06-25
Age:22.0  Onset:2008-06-25, Days after vaccination: 0
Gender:Female  Submitted:2008-06-27, Days after onset: 2
Location:Delaware  Entered:2008-06-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Depo Provera
Current Illness: none
Preexisting Conditions: Penicillan, ceclor, bactrim, percocet, codeine
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0389U0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Blood pressure decreased, Dizziness, Dyskinesia, Dyspnoea, Hyperhidrosis, Hypoventilation, Loss of consciousness, Pallor, Urticaria
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: Within 5 minutes of receiving HPV vaccine, patient c/o dizziness and passed out. Was aroused in seconds, jumped up violently and thrashed about then passed out a second time. Trouble breathing, blood pressure dropped from 110/76 to 90/62 and broke out in hives over all of torso. Very pale, sweaty and very shallow breathing. 911 was then contacted. Just prior to their arrival (about 7 minutes) pt aroused and was able to sit up at take in a dose of liquid Benadryl. She was stable at time of departure on ambulance, but hives were worsening.

VAERS ID:318041 (history)  Vaccinated:2008-06-23
Age:22.0  Onset:2008-06-23, Days after vaccination: 0
Gender:Male  Submitted:2008-06-23, Days after onset: 0
Location:Georgia  Entered:2008-07-01, 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:
Current Illness: None
Preexisting Conditions: iodine, shellfish, NKDA, none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB224BA1IMRA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURA05220IMRA
Administered by: Military     Purchased by: Other
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Dizziness, increase heart rate, hives, and shortness of breath. Treatment, vital signs and epinephrine 0.3 mg, EMS called and soldier transported to hospital via stretcher.

VAERS ID:318115 (history)  Vaccinated:2008-06-27
Age:22.0  Onset:2008-06-27, Days after vaccination: 0
Gender:Male  Submitted:2008-06-27, Days after onset: 0
Location:Missouri  Entered:2008-07-02, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB224AA0UNRA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURA09230UNLA
Administered by: Other     Purchased by: Unknown
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Client received HEPATITIS A vaccine and TYPHOID VI vaccine and had syncopal episode immediately after 2nd vaccination, lasting 10 seconds. Recovered with adverse effects after lying supine for 15 minutes.