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Case Details (Sorted by Age)

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VAERS ID:311706 (history)  Vaccinated:2008-04-09
Age:19.0  Onset:2008-04-09, Days after vaccination: 0
Gender:Female  Submitted:2008-04-30, Days after onset: 21
Location:North Carolina  Entered:2008-05-06, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Depo Provera 104mg SQ
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 BIOLOGICALSAHABB103AA2IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB103AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2720AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Pt reported a pruritic rash over abdomen and back that started soon after 04/09/08 clinic visit and lasted a few days.

VAERS ID:311741 (history)  Vaccinated:2008-04-30
Age:19.0  Onset:2008-05-02, Days after vaccination: 2
Gender:Female  Submitted:2008-05-06, Days after onset: 4
Location:Rhode Island  Entered:2008-05-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Infected ear piercing
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (IMOVAX)SANOFI PASTEURA04831IMRA
Administered by: Private     Purchased by: Private
Symptoms: Paraesthesia oral, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow)
Write-up: Hives and tingling mouth. 2+ to 3+ diffuse hives head to toe. As of 5/5/08 pt is still getting hives. IV steroids in ER on 5/3/08. Prescribed prednisone x 4 days, zantac, and benadryl.

VAERS ID:311747 (history)  Vaccinated:2008-05-01
Age:19.0  Onset:2008-05-02, Days after vaccination: 1
Gender:Female  Submitted:2008-05-06, Days after onset: 4
Location:Michigan  Entered:2008-05-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Acutane
Current Illness: None
Preexisting Conditions: Acne
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB208AA0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2604AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2889AA0IMRA
Administered by: Public     Purchased by: Private
Symptoms: Dyspnoea, Injection site bruising, Injection site erythema, Injection site swelling, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)
Write-up: 5-2-08 Body Aches, 5-3-08 Fever, Body Aches & shortness of Breath took advil symptoms resolved by 5-4-08. Had developed increased Redness, swelling and brusing at the injection site (right deltoid) 5-2-2008. The patient called the family physician and he recommended taking benadrylx2.

VAERS ID:311931 (history)  Vaccinated:2008-01-09
Age:19.0  Onset:2008-02-01, Days after vaccination: 23
Gender:Female  Submitted:2008-05-08, Days after onset: 96
Location:Unknown  Entered:2008-05-09, 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: YAZ
Current Illness: Contraception; Allergic reaction to antibiotics
Preexisting Conditions: PMH: Hashimoto''s thyroiditis at age 7, hypothyroidism; pneumonia at age 9; vascular gum irregularity; irregular periods; MVA 4 yrs ago;anxiety. Allergy: zithromax, hives. On Yasmin contraceptive & minocycline for acne. Family hx: heart disease, Hashimotos disease & goiter.
Diagnostic Lab Data: LABS: CT brain WNL. MRI & MRA WNL. Repeat MRI abnormal w/possible focal demyelination. Carotid duplex WNL. Echocardiogram WNL. TEE WNL. Vit B12 194 (L). Influenza A&B neg. ECG w/sinus tachycardia. ANA (H). MRA of neck WNL.
CDC 'Split Type': WAES0805USA00064
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1063U1IMRA
Administered by: Private     Purchased by: Other
Symptoms: Angiogram, Antinuclear antibody increased, Anxiety, Cerebellar artery occlusion, Cerebrovascular accident, Demyelination, Diplopia, Dizziness, Dysstasia, Echocardiogram, Echocardiogram normal, Electrocardiogram abnormal, Gait disturbance, Influenza serology negative, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia, Pyrexia, Scan brain, Sinus tachycardia, Ultrasound Doppler, Vitamin B12 abnormal, Vitamin B12 deficiency, Vomiting, Wallenberg syndrome, Weight increased
SMQs:, Acute pancreatitis (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), Ischaemic cerebrovascular conditions (narrow), Haemorrhagic cerebrovascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Demyelination (narrow), Vestibular disorders (broad), Ocular motility disorders (broad)
Write-up: Information has been received from a consumer concerning her 20 year old daughter with allergy to azithromycin (ZITHROMAX) who on 09-NOV-2007 was vaccinated with the first dose of GARDASIL, 0.5 mL, (injection form) (Lot # not reported). On 09-JAN-2008, the patient was vaccinated with the second dose of GARDASIL, 0.5 mL, (injection form) (Lot # not reported). Concomitant therapy included drospirenone (+) ethinyl estradiol (YAZ). On 01-FEB-2008, after getting the second dose of GARDASIL, the patient experienced a stroke and was hospitalized. The patient stayed in the hospital for one week. At the time of this report, the patient was recovering from the event. The causality of the event was not reported. No product quality complaint was involved. Additional information has been requested. 6/3/08 Reviewed hospital medical records for 2/4-2/8/2008. FINAL DX: small right CVA; vitamin B12 deficiency; sinus tachycardia; Wallenberg syndrome. Records reveal patient experienced dizziness, left sided numbness, diplopia, fever & vomiting x 2 days. Developed sinus tachycardia & anxiety controlled w/meds. Cardio & neuro consults done. Improved left face & arm paresthesias but left thigh & lower leg paresthesias persisted at d/c to home. Difficulty getting OOB & walking. To have outpatient PT/OT as well as f/u w/neuro & cardio. 9/5/08 Reviewed heme, neuro & rheum consultant medical records of 3/10-5/30/2008. FINAL DX: CVA, lateral medullary syndrome (Wallenberg''s) related to the occlusion of the posterior inferior cerebellar artery. Records reveal patient experienced recent CVA, 20# weight gain since CVA.

VAERS ID:311941 (history)  Vaccinated:2008-04-19
Age:19.0  Onset:2008-04-24, Days after vaccination: 5
Gender:Male  Submitted:2008-04-30, Days after onset: 6
Location:North Carolina  Entered:2008-05-09, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NKDA; FACIAL ACNE
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (NO BRAND NAME)UNKNOWN MANUFACTURER 0IDUN
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURERA05220IMUN
Administered by: Military     Purchased by: Military
Symptoms: Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: 19 y/o male ADSM is referred from clinic to FBVHC for evaluation of skin rash eruption in temporal relationship with the receipt of Smallpox vaccine. Symptom: Pruritus Start: 04/24/2008 Comment: Related to skin rash. Symptom: Rash, diffuse Start: 04/24/2008 Comment: See summary for description.

VAERS ID:312179 (history)  Vaccinated:2008-04-30
Age:19.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-01
Location:Texas  Entered:2008-05-13, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: migraines, allergic rhinitis, post concussion syndrome
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2403AA1IMRA
Administered by: Private     Purchased by: Private
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: Patient was given Menactra on 4/30/08 & it was later discovered that she had Menactra on 5/23/06.

VAERS ID:312218 (history)  Vaccinated:2008-05-05
Age:19.0  Onset:2008-05-06, Days after vaccination: 1
Gender:Male  Submitted:2008-05-07, Days after onset: 1
Location:Massachusetts  Entered:2008-05-13, 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:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2560AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 5-5-08 MENACTRA 3:30 pm. 5-6-08 awake with headache, sore left arm site of injection. 5-7-08 painful, red, warm to touch, swollen left deltoid site of injection.

VAERS ID:312294 (history)  Vaccinated:2007-03-19
Age:19.0  Onset:2007-05-19, Days after vaccination: 61
Gender:Female  Submitted:2008-05-13, Days after onset: 360
Location:Pennsylvania  Entered:2008-05-14, 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 = 4/16/2007); Group B betahaemolytic streptococcal positive
Preexisting Conditions:
Diagnostic Lab Data: chest X-ray 01/28/08 right lower lobe pneumonia; cesarean section 01/28/08; respiratory rate 01/18/08 increased; vaginal Streptococcus positive
CDC 'Split Type': WAES0709USA00587
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0955F0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Caesarean section, Drug exposure during pregnancy, Foetal disorder, Streptococcus identification test positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)
Write-up: Information has been received through the Pregnancy registry concerning a 19 year old female patient, who on 19-MAY-2007 was vaccinated with a second dose of Gardasil. It was reported that the patient was 20 weeks pregnant. The patients last menstrual period was 16-APR-2007 and her estimated delivery date was 21-JAN-2008. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. Follow up information was received on 24-MAR-2008 and 02-APR-2008. The patient delivered a baby boy on 28-JAN-2008 (weeks from LMP-40). The baby was born with pneumonia. He weighed 9 lbs. 2 oz. The baby''s pediatrician was called on 02-APR-2008. The nurse confirmed the patient had well visits and was seen multiple times during the month of February for pneumonia and what looked like abdominal pain. A request for Medical Records was faxed to the nurse to obtain the baby''s records. Follow up information received in the form of physician''s notes, indicated that on 28-JAN-2008, the infant first had a "vacuum attempt without success and positive meconium." The physician noted the infant was status post "C-section for failure to progress," and added that the mother was group B strep positive. After birth, the infant had an increased respiratory rate and "was on oxyhood overnight." The chest X-ray revealed right lower lobe pneumonia. Treatment in the hospital included IV ampicillin and gentamycin, and the infant "continued to do well with respiratory rate decreasing and 99% spO2 room air, feeding well." The infant was discharged on 02-FEB-2008 ("two days ago"). On 04-FEB-2008, the infant was seen in follow up at the physician''s office, and was "improving clinically" the physician''s assessment was pneumonia due to streptococcus, group B. Mild facial jaundice was documented. He was also diagnosed with diaper rash-candida, also noted as etoxicum rash; nystatin was prescribed, with follow up in 2 days. The infant was continued on AUGMENTIN. On 06-FEB-2008, the infant was seen by the physician and was improved clinically, with no jaundice noted and only mild etoxicum rash. On 14-FEB-2008, the infant visited the physician for a recheck, with notes of visiting the emergency department, 4 days earlier (10-FEB-2008), because he was "wheezing and crying uncontrollably." Treatment at the ED included Vaponeb, and he improved. At home, the mother used a nebulizer a few times. The physician indicated the infant had "cephalohematoma right posterior scalp." and also noted "well baby. Pneumonia resolved." On 22-FEB-2008, the infant was brought to the physician with "purple feet," and was also noted as being inconsolable, with pulling his legs up and crying. The physician indicated that infant had a "little color change with cold reassurance," and colic was diagnosed. Treatment included nutramagen movement, tight swaddle and white noise. The physician also noted the head had no abnormalities, lesions or masses. On 24-MAR-2008, the infant was brought to the physician with a runny nose and congestion, and reports that "he spits up almost every feeding." The diagnosis was "well baby" The infant was vaccinated with DTaP (+) poliovirus vaccine inactivated (+) tetanus toxoid (manufacturer not specified), HIB (manfacturer not specified), PREVNAR and ROTATEQ. The physician noted that the infant had no previous immunization reaction. Upon internal review, "C-section for failure to progress" was determined to be serious as an other important medical event. Additional information is not expected.

VAERS ID:312473 (history)  Vaccinated:2008-03-12
Age:19.0  Onset:2008-03-12, Days after vaccination: 0
Gender:Male  Submitted:2008-05-16, Days after onset: 65
Location:West Virginia  Entered:2008-05-16
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: none
CDC 'Split Type': WV0812
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS09371IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:
Write-up: None

VAERS ID:312479 (history)  Vaccinated:2008-04-04
Age:19.0  Onset:2008-05-01, Days after vaccination: 27
Gender:Female  Submitted:2008-05-16, Days after onset: 15
Location:Texas  Entered:2008-05-16
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: none~ ()~~0~In Patient|none~ ()~~0~In Sibling
Other Medications: none
Current Illness: none
Preexisting Conditions: none. PMH: none
Diagnostic Lab Data: pancytopenia, increased liver enzymes; bone marrow biopsy on 5-5-08 showed acute myelogenous leukemia;Gardasil series: 9-26-07, 11-21-07 & 4-4-08 (#13does not allow Gardasil to be entered). Labs and Diagnostics: Urine dipstick orange with
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0525U2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal discomfort, Acute myeloid leukaemia, Back pain, Bilirubinuria, Biopsy bone marrow abnormal, Blood culture negative, Colitis, Computerised tomogram abnormal, Fungal infection, Gastrointestinal tract mucosal discolouration, Gene mutation identification test positive, HLA marker study, Haematochezia, Haematocrit decreased, Haemoglobin decreased, Hepatic enzyme increased, Hepatitis A antibody, Hepatitis B e antigen negative, Hepatitis B surface antigen negative, Hepatitis C antibody negative, Hypotension, Malaise, Mean cell volume abnormal, Multiple gated acquisition scan normal, Nausea, Occult blood positive, Pancytopenia, Pharyngolaryngeal pain, Platelet count decreased, Protein urine present, Pyrexia, Red blood cell count decreased, Sputum culture positive, Thrombosis in device, Ultrasound Doppler abnormal, Ultrasound abdomen abnormal, Ultrasound pelvis, Urine analysis abnormal, Urine bilirubin increased, Urine ketone body present, Urobilin urine present, Vitamin B12 abnormal, Vomiting, Weight decreased, White blood cell count decreased
SMQs:, Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal haemorrhage (narrow), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Cardiomyopathy (broad), Malignant tumours (narrow), Chronic kidney disease (broad), Malignant lymphomas (broad), Myelodysplastic syndrome (broad), Noninfectious diarrhoea (broad)
Write-up: weight loss, nausea & vomiting, malaise. 5/20/08 Office records received including vax record. Seen for sick visit 5/01/08 with c/o nausea, vomiting, and stomach feeling whoozy x 1 month. Impression Nausea & Vomiting. Tx with metoclopramide. Seen again 5/5/08 with c/o sore throat, nausea, back pain. Impression: N&V, Bilirubinuria, pancytopenia. Referral made to Oncologist. 07/01/2008 MR received for DOS 05/7-31/2008 with D/C DX: Acute Myeloid Leukemia. Pt presented with pancytopenia for eval to r/o acute leukemia. Bone marrow bx confirmed AML. Started on chemo which initially was well tolerated but later developed severe abdominal c/o with hematochezia. DX with pancolitis, likely infectious. Pt had intermittent high fevers and hypotension. Pt developed a clot in her PICC line and it was removed. Blood counts somewhat recovered and pt d/c 5/31/08.

VAERS ID:312509 (history)  Vaccinated:2008-05-12
Age:19.0  Onset:2008-05-12, Days after vaccination: 0
Gender:Female  Submitted:2008-05-16, Days after onset: 4
Location:Louisiana  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
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2351AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Anorexia, Erythema, Fatigue, Headache, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad)
Write-up: Right upper arm redness, fever, headache, loss of appetite, fatigue.

VAERS ID:312548 (history)  Vaccinated:2008-02-28
Age:19.0  Onset:2008-04-07, Days after vaccination: 39
Gender:Female  Submitted:2008-04-07, Days after onset: 0
Location:Virginia  Entered:2008-05-19, Days after submission: 42
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Pregnancy
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1287U1IMUN
Administered by: Private     Purchased by: Private
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Positive pregnancy on 4/7/08, 5 6/7 week gestation.

VAERS ID:312600 (history)  Vaccinated:2008-05-19
Age:19.0  Onset:2008-05-19, Days after vaccination: 0
Gender:Female  Submitted:2008-05-19, Days after onset: 0
Location:Missouri  Entered:2008-05-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None Noted
Preexisting Conditions: None Noted
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1758U1IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyspnoea, Nausea, Tremor, Vertigo
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow)
Write-up: Vaccine Admin. at 10:30 AM. Pt called the office at 1:00PM with complaints of nausea, shakiness, vertigo and SOB. Pt told to go to ER & call PMD. Pt went to Medical Center and was treated with Prednisone, Benadryl and Xanax(all of this per pt). At approx. 2pm pt called back and talked to RN..pt feeling much better after ER visit and treatment given.

VAERS ID:312797 (history)  Vaccinated:2007-11-14
Age:19.0  Onset:2007-11-15, Days after vaccination: 1
Gender:Female  Submitted:2008-05-14, Days after onset: 180
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:
Current Illness:
Preexisting Conditions: Allergic reaction to antibiotics
Diagnostic Lab Data:
CDC 'Split Type': WAES0804USA00354
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1062U0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Chills, Headache, Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received concerning a 19 year old female with a history of allergic reaction to antibiotics who on 14-NOV-2007 was vaccinated IM in the deltoid with the first dose of GARDASIL (658560/1062U). Concomitant therapy included LOESTRIN. On 15-NOV-2007 the patient experienced nausea, vomiting, fever, chills and headache. Additional information received from NSC call (14-APR-2008): The caller states that she continues to receive letters from WPS about WAES 0804USA00354. The caller does not know who the WPS letter was addressed to. The caller was unable to locate the SR associated with this WAES #. The caller states that she has returned a previous letter from WPS and does not want to receive any more letters. Additional information is not expected.

VAERS ID:312798 (history)  Vaccinated:2007-10-18
Age:19.0  Onset:2007-10-18, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 209
Location:New York  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: Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type': WAES0804USA00384
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1264U0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Rash generalised, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 19 year old female with penicillin allergy who on 18-OCT-2007 was vaccinated intramuscularly in the left deltoid with a first dose of GARDASIL (Lot # 658488/1264U). There was no concomitant medication. On 18-OCT-2007, within hours of vaccination, the patient developed hives all over her body. Subsequently, several days later, the patient recovered from hives all over her body without any treatment. Additional information has been requested.

VAERS ID:312813 (history)  Vaccinated:2008-03-01
Age:19.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-14
Location:Tennessee  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: Unknown
CDC 'Split Type': WAES0804USA00975
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This is in follow-up to report(s) previously submitted on 5/14/2008. Information has been received from a medical assistant concerning a female in her teens with no pertinent medical history who in March 2008, was vaccinated with a first dose of GARDASIL from her OB/GYN. There was no concomitant medication. Subsequently, "soon after administration" the patient developed persistent nausea for the last 2 weeks. The patient has an appointment to see the office (her primary physician). At the time of reporting the patient had not recovered. Additional information has been requested. Follow-up information was received from a health care professional. The office did not administer the GARDASIL however the patient was presented to the office on 02-APR-2008 and stated she might have had a reaction to the GARDASIL. Her symptoms were nausea. The patient also had recently began taking a new birth control pill (unspecified). The physician had seen the patient and explained that he could not determine if the nausea was due to the vaccine. The physician felt like it was more possible that it was due to the change in her OCP. The patient was prescribed medication for nausea. At the time of reporting it was unknown if the patient had recovered. Additional information is not expected.

VAERS ID:312845 (history)  Vaccinated:2007-01-09
Age:19.0  Onset:2007-03-01, Days after vaccination: 51
Gender:Female  Submitted:2008-05-14, Days after onset: 439
Location:Nevada  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:
CDC 'Split Type': WAES0804USA01411
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Private     Purchased by: Private
Symptoms: Skin papilloma
SMQs:
Write-up: Information has been received from a physician concerning a 20 year old female who on 09-JAN-2007 was vaccinated in the right arm with the first dose of GARDASIL (lot# not reported). On 09-MAR-2007 the patient was vaccinated in the left arm with the second dose of GARDASIL (lot# not reported). On 11-JUL-2007 the patient was vaccinated in the right arm with the third dose of GARDASIL (lot# not reported). Per the reporter, the patient experienced one large plantar wart on her right heel immediately following the second dose of GARDASIL. The patient was treated by a podiatrist and had the wart burned off, but 7 more warts branched out on the heel. These were treated with a combination of burning or surgical removal. The patient is still being treated by the podiatrist who feels this is related to GARDASIL. The primary care physician does not feel this is related to GARDASIL. The patient''s warts have persisted. No additional information is available at this time. Additional information has been requested.

VAERS ID:312861 (history)  Vaccinated:2007-09-11
Age:19.0  Onset:2007-09-11, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 246
Location:Massachusetts  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': WAES0804USA01782
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from a physician concerning a 19 year old female who on 11-SEP-2007 was vaccinated intramuscularly with her second dose of GARDASIL (lot# reported "0232U"). Within 2 minutes of getting GARDASIL, the patient experienced lightheaded and passed out. The patient has a history of getting lightheaded with vaccines. The patient was monitored until feeling better then left the office. Subsequently, the patient recovered from lightheaded and passing out. Additional information has been requested.

VAERS ID:312880 (history)  Vaccinated:2008-01-02
Age:19.0  Onset:2008-01-16, Days after vaccination: 14
Gender:Female  Submitted:2008-05-14, Days after onset: 118
Location:Unknown  Entered:2008-05-19, 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: Penicillin allergy; Sulfonamide allergy
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type': WAES0804USA02220
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1487U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Lip swelling, Oedema peripheral, Swelling face, Vaccine positive rechallenge
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a nurse practitioner through the patient''s mother concerning her 19 year old daughter with an allergy to penicillin and sulfanomide who on 02-JAN-2008 was vaccinated IM in the deltoid with the first 0.5 ml dose of GARDASIL (Lot # 659055/1522U) and on 05-MAR-2008 was vaccinated IM in the deltoid with the second 0.5 ml dose of GARDASIL (Lot # 659657/1487U). Concomitant therapy included LEVORA. Approximately two weeks after receiving the first dose of GARDASIL the patient experienced swelling of lips. Approximately two weeks after receiving the second dose of GARDASIL the patient experienced more severe swelling of lips, swelling of the face and swelling of the hands. The patient was treated by an unspecified primary care physician after the second occurrence of swelling with unspecified steroids. The symptoms resolved by an unspecified date. No other symptoms or treatment reported. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/5008. Initial and follow up information has been received from a nurse practitioner through the paitent''s mother concerning her 19 year old daughter with an allergy to penicillin and sulfonamide who on 02-JAN-2008 was vaccinated IM in the deltoid with the first 0.5 ml dose of GARDASIL vaccine (Lot # 659059/1522U) and on 05-MAR-2008 was vaccinated IM in the deltoid with the second 0.5 ml dose of GARDASIL vaccine (Lot # 539657/1487U). Other medication included 10 mg PO LEVORA started on02-JAN-2008 for dysmenorrhoea. Phone call from patient''s mother on 09-APR-2008 indicated that the patient has swelling of lips 2 weeks after vaccine (16-JAN-2008). The second dose of the vaccine, 2 weeks after injection (19-MAR-2008) the patient noted swelling of lips, face and hands. The patient was treated by an unspecified primary care physician after the second occurrence of swellilng with prednisolone. The symptoms resolved by an unspecified date. No other symptoms or treatment reported. No product quality complaint was involved. Additional information has been requested.

VAERS ID:313058 (history)  Vaccinated:0000-00-00
Age:19.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-14
Location:Michigan  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: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0804USA02848
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Vaccine positive rechallenge
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Information has been received from a nurse concerning her 19 year old daughter who in 2007 was vaccinated with three dose series (0.5 ml) of GARDASIL (No lot numbers were provided). The patient experienced dizziness after each dose of the three doses series of GARDASIL. The dizziness only lasted approximately 24 hours after each injection. Medical attention was not sought. Patient outcome was recovered on an unspecified date. No product quality complaint was involved. No further information is available.

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