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Found 6,988 cases where Vaccine is HPV4 and Serious

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VAERS ID: 305012 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-02-14
Entered: 2008-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Blood aluminium increased, Depression, Mental disorder, Serum serotonin decreased
SMQs:, Dementia (broad), Depression (excl suicide and self injury) (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA01915

Write-up: Information has been received from a medical assistant concerning a female in her early 20''s who on an unspecified date in 2007 the patient received her first dose of GARDASIL injection. Concomitant therapy on the same date also included another vaccine (therapy unspecified). On an unspecified date the patient received her second dose of GARDASIL. The patient had a "nervous breakdown; some kind of anxiety or severe depression". The patient was admitted to the hospital and was found to have decreased serotonin levels and aluminum toxicity. The dates of the hospitalization are not known but the patient was discharged and was started on an antidepressant (therapy unspecified). The patient has not received her third dose yet. At the time of reporting the patient was recovering. Additional information has been requested.


VAERS ID: 305013 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2007-05-18
Onset:2007-05-18
   Days after vaccination:0
Submitted: 2008-02-14
   Days after onset:272
Entered: 2008-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0389U / 1 LA / IJ

Administered by: Other       Purchased by: Other
Symptoms: Drug exposure during pregnancy, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = 4/25/2007) Penicillin allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown Ultrasound, 06/27/07, dating; Ultrasound, 08/31/07, dating .
CDC Split Type: WAES0802USA02045

Write-up: Information has been received from representative via a nurse practitioner concerning a 15 year old (also reported as 16 year old) female with a penicillin allergy who on an unspecified date was vaccinated with GARDASIL (lot# unknown). The patient''s date of last menstrual period was 25-APR-2007. Subsequently, the patient developed blood clots and was hospitalized. Medical attention was sought. The representative reported that the number of doses administered were unknown, the number of days the patient was hospitalized was unknown and the details for the patient''s pregnancy was unknown. Follow-up information was received from the nurse practitioner. The patient was administered GARDASIL on 18-MAY-2007. The patient was scheduled to be induced on 09-FEB-2008 since she was past her due date which was 30-JAN-2008. The details regarding the intervention for the blood clot in the hospital was unknown. Further information was not available. Additional information has been requested. This is in follow-up to report (s) previously submitted oon 2/14/2008; 2/25/2008. Follow-up information was received from a physician''s office via phone. The patient''s name was updated. On 8-FEB-2008, the patient went into the hospital with contractions. The patient failled to progression and then the patient was induced. The patient delivered "as far as they know a healthy boy". The baby weighed 7 pounds 10 ounces. Follow-up information was received via pregnancy forms. On 27-JUN-2007 and 31-AUG-2007 ultrasounds were performed for dating of the pregnancy. During the pregnancy the patient had deep vein thrombosis in the left leg and a urinary tract infection. On 30-JUN-2007 the patient was given MACROBID 100 mg BID for 7 days for UTI, LOVENOX 1.5 mg on 30-NOV-2007 and heparin was given subcutaneously on 15-JAN-2008. The patient gave birth on 08-FEB-2008 41 weeks from LMP. Additional information is not expected.


VAERS ID: 305120 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-02-18
Entered: 2008-02-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: 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), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA02071

Write-up: Information has been received from a certified nurse midwife concerning an 18 year old female who on an unspecified date was vaccinated with dose unspecified of Gardasil. On an unspecified date, the patient fainted in the physician''s office waiting room after receiving the vaccination. The patient hit her head on the counter and sustained unspecified head trauma. The patient was hospitalized. At the time of reporting, the outcome was unknown. Additional information has been requested.


VAERS ID: 305121 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2007-11-01
Onset:2007-11-01
   Days after vaccination:0
Submitted: 2008-02-18
   Days after onset:109
Entered: 2008-02-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0802USA02114

Write-up: Information has been received from a consumer concerning her 16 year old daughter with no medical history and no drug allergies, who in November 2007, was vaccinated IM with a 0.5 mL first dose of Gardasil. Concomitant vaccination included Recombivax. Subsequently, the patient was pregnant. In November 2007, the patient had a miscarriage at approximately 16 weeks. The gestation period at the time of the first dose was unknown. The patient was hospitalized for approximately 2-3 days. No laboratory diagnostics were performed. The patient did not discontinue her dosing schedule. The patient was vaccinated with a second dose of Gardasil on 08-FEB-2008. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Upon internal review miscarriage was determined to be an other important medical event. Additional information has been requested.


VAERS ID: 305129 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Michigan  
Vaccinated:2008-02-18
Onset:2008-02-18
   Days after vaccination:0
Submitted: 2008-02-19
   Days after onset:1
Entered: 2008-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1266U / 3 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Face injury, Fall, Mouth haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Per father''s report during phone call 2/19/08, child was diagnosed with 3 fractures in her jaw - one in front, and one on either side of her face. Is to undergo surgery today - plate, screws, and mouth wired (per father). LABS: CT scan & x-ray revealed anterior mandibular symphysis fracture & bilateral mandibular subcondylar fractures.
CDC Split Type:

Write-up: Client received third dose of HPV vaccine. Her brother received vaccines after she did. About ten minutes passed between the time she got her shot and the family was leaving the clinic. While walking down the hall to exit, patient fell forward and collapsed on her face. Bleeding from mouth, scraped chin. Unable to determine source of bleeding because child could not open her mouth more than 1/2 inch. After juice and cold compresses were used, parents left to take her to emergency room. Used wheelchair to go to car. 3/25/08 Reviewed hospital medical records of 2/18-2/20/2008. FINAL DX: Multiple mandible fractures, surgically reduced. Records reveal patient experienced syncope s/p vaccination. Seen at outlying ER & transferred to higher level of care. In recuperative stage. Jaw was broken, surgically repaired. Last contract with client was 3/11/08. Mouth was rubber-banded together - still healing.


VAERS ID: 305156 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: New York  
Vaccinated:2008-02-04
Onset:2008-02-04
   Days after vaccination:0
Submitted: 2008-02-11
   Days after onset:7
Entered: 2008-02-19
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1062U / 1 LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Ear pain, Facial pain, Headache, Hypoaesthesia, Muscular weakness, Nuclear magnetic resonance imaging normal, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Guillain Barre Syndrome 2/05, Bactrim 3/10/08-records received-PMH: GBS 3 years ago, diagnosed by EMG. Chronic headaches and stomaches may be related to anxiety. Bladder infection 2 weeks ago.
Allergies:
Diagnostic Lab Data: MRI spine negative 3/10/08-records received-MRI lumbar spine, normal.
CDC Split Type:

Write-up: Pain in face, ears. Pain and weakness and numbness in legs. Improved 2/11/08 still with headache & leg pains. 3/10/08-records received for DOS 2/5-2/6/08-Admission diagnoses weakness, decreased sensation and facial pain. Condition improved at time of discharge. C/O facial pain, leg pain, weakness, headache one hour after vaccination. Face felt burning and shooting pain to ears. Shooting pain in legs, trouble walking, tired, lethargic. Rash and swelling of eyes. PE: tenderness in palpation of spine, decreased sensation below L1.


VAERS ID: 305313 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: California  
Vaccinated:2007-05-18
Onset:2007-05-18
   Days after vaccination:0
Submitted: 2008-02-14
   Days after onset:272
Entered: 2008-02-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Deep vein thrombosis, Drug exposure during pregnancy, Incorrect route of drug administration, Injection site pain, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA00548

Write-up: Information has been received from a health professional concerning a female who was vaccinated with the first dose of Gardasil. Subsequently the patient experienced pain when receiving the vaccine and subsequent doses were given in the buttocks. Medical attention was sought. The patient''s outcome is unknown. No product quality complaint was involved. Additional information has been requested. 03/25/2010 The patient''s date of last menstrual period was 25-APR-2007. Subsequently, the patient developed blood clots and was hospitalized. Medical attention was sought. The representative reported that the nubmer of doses administered were unknown, the number of days the patient was hospitalized was unknown and the details for the patient''s pregnancy was unknown. Follow-up information was received from the nurse practioner. The patient was administerd GARDASIL on 18-MAY-2007. The patient was scheduled to be induced on 09-FEB-2008 since she was past her due date which was 30-JAN-2008. The details regarding the intervention for the blood clot in the hospital was unknwon. Follow up information was received from the physician''s office via phone. THe patient''s name was updated. On 8-FEB-2008, the patient went into the hospital with contractions. The patient failed to progression and then the patient was induced. The patient delivered "as far as they know a healthy boy". The baby weighed 7 pounds 10 ounces. Follow-up information was received via pregnancy forms. On27-JUN-2007 and 31-AUG-2007 ultrasounds were performed for dating of the pregnancy. During the pregnancy the patient had deep vein thrombosis in the left leg and a urinary tract infection. On 10-JUN-2007 the patient was given nitrofurantoin (MACROBID) 100mg BID for 7 days for UTI, enoxaparin sodim (LOVENOX)1.5 mg on 30-NOV-2007 and heparin was given subcutaneously on 15-JAN-2008. The patient gave birth on 08-FEB-2008 41 weeks from LMP. Additional information is not expected.


VAERS ID: 305256 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2007-12-06
Onset:2008-02-05
   Days after vaccination:61
Submitted: 2008-02-20
   Days after onset:15
Entered: 2008-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1266U / 2 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Acute lymphocytic leukaemia, Blood uric acid increased, CSF glucose normal, CSF protein normal, CSF test normal, Fatigue, Full blood count abnormal, Neutrophil count decreased, Platelet count decreased, Red blood cell sedimentation rate increased, Transfusion, White blood cell count decreased
SMQs:, Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Seasonique since 12.13.07
Current Illness: None
Preexisting Conditions: None except allergic to ibuprofen & penicillin PMH: on BCP from GYN for heavy periods & anemia w/improvement. Allergies: ibuprofen, PCN. PMH: mennorhagia. Hospitalizations: IDA @ 1yo, FUO @ 5yo. Bone marrow biopsy.
Allergies:
Diagnostic Lab Data: 2.12.08, labs, WBC 2.9 (absolute neutrophils 986); platelets 60,000; occasional blasts; bone marrow LABS from PCP: 2/12/08 abso lymphs 986 (L) w/occasional blast seen. Plts 60 (L)Urine w/+ RBCs. Hospital LABS: Initial WBC 2.6 (L), segs 29% (L), lymphs 48% (H), plts decreased. Sed rate 83 (H).. Initial chemistry: uric acid 6.6 (H), LDH 950 (H), alk phos 189 (H), total bilirubin 1.6 (H). CSF: protein 27 (N), glucose 58. Blood c/s neg. CXR WNL. Abdominal US revealed marked hepatosplenomegaly. 1/20/2010 Still undergoing chemotherapy monthly for leukemia- A.L.L. As per verbal report from May 2-23-09- "no leukemia cells, spinal fluid".
CDC Split Type:

Write-up: Very fatigued since 2.5.2008. Seen by me, pediatrician on 2.8.08 and 2.11.08. Blood work done 2.12.08 showed occasional blasts and patient had blood marrow done. Now DX to have A.L.L. and chemo Rx started. 2/26/08 Reviewed pcp medical records & vax records. FINAL PCP DX: Acute lymphocytic leukemia (pre B-cell). Received HPV #1 0680U on 9/18/07 at GYN office & Menactra U2385BA on 8/7/07 Fluzone U2451AA on 1/4/2008 at pcp office. Seen 11/07 for cough, sinus pressure, fever, tight chest, ear ache, HA; sibling w/similar symptoms 10 days prior. Dx w/sinusitis, otalgia & cough. Tx w/antibiotics. Returned to office 1/4/08 w/o complaints for flu shot. Returned to office 2/8/08 c/o of extreme fatigue beginning approx 2/5/08, stomach pain & intermittent hiccups. Dx w/malaise & fatigue, r/o mono. Referred for labs. Returned to office 2/11/08 w/continued fatigue, pallor, feeling miserable, SOB, nausea, decreased appetite, earache. Temp 100.7 at that time. 2/13/08 notified by lab of abnormal CBC & referred to hospital. 2/18/08 Received call from parent w/dx of ALL (pre-B cell). Admitted 2/13-2/23/08. Placed in study & will receive most tx as outpatient. 3/11/08 Reviewed hospital medical records for admission 2/13-2/23/2008. FINAL DX: acute lymphocytic leukemia Patient experienced extreme fatigue, excessive sleepiness, SOB, low grade fever, abdominal distention w/tenderness, petechiae on LEs, pancytopenia & hepatosplenomegaly. Consults done by heme/onc. Transfused x 2. Follow-up: Patient is still being treated for high risk A.L.L. at medical center. Report received from hematooncologist (dated 4.14.08) is attached. Please contact them for further information. I have reported this as part of on going surveillance post-licensure for new vaccines.


VAERS ID: 305259 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: California  
Vaccinated:2008-02-12
Onset:2008-02-12
   Days after vaccination:0
Submitted: 2008-02-13
   Days after onset:1
Entered: 2008-02-20
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1426F / 2 RA / UN

Administered by: Private       Purchased by: Public
Symptoms: Blood pressure, Cold sweat, Electrocardiogram normal, Fall, Foaming at mouth, Grand mal convulsion, Heart rate, Laboratory test normal, Loss of consciousness, Pallor, Tongue biting
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No hx seizure
Allergies:
Diagnostic Lab Data: All labs normal; EKG normal; 1700 BP 60/41, pulse 52; 1708 80/52; 1716 100/58 2/25/08-records received-EKG right bundle branch block with intraventricular conduction delay.
CDC Split Type:

Write-up: Pt received vaccine, took 6 steps, fell to the ground unconscious and had a 60 sec grand mal seizure then regained consciousness. BP after seizure 60/40 pale clammy skin. Pt had bit her tongue and had foam around her mouth. BP raised in 7 mins. Benadryl at 1500 25mg. 2/25/08-records receivedfor DOS 2/12/08-Impression: Syncopal episode. Presented to ED after experiencing syncopal episode immediately upon injection of vaccine. PE: unremarkable.


VAERS ID: 305538 (history)  
Form: Version 1.0  
Age: 9.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-10-23
Onset:2007-12-06
   Days after vaccination:44
Submitted: 2008-02-22
   Days after onset:78
Entered: 2008-02-25
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0742U / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Bronchospasm, Dyspnoea, Pallor, Peak expiratory flow rate decreased, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: peak expiratory flow normal at baseline; peak expiratory flow diminished $g 50% with exercise
CDC Split Type: WAES0802USA01950

Write-up: Information has been received from an agency concerning a 9 year old female with no medical history and no drug allergies, who on 23-OCT-2007 was vaccinated intramuscularly in the left arm with a first dose of Gardasil (Lot# 654539/0742U). There was no concomitant medication. There were no illnesses at the time of the vaccination. On 06-DEC-2007 the patient experienced bronchospasm. On 26-DEC-2007 the patient was seen in the office for a new onset of moderate to severe exercise induced bronchospasm. The patient had no atopic history, no history of eczema, asthma, and no family history. The patient''s symptoms developed about 6 weeks after receiving her first dose of the vaccination. The patient was started on empiric therapy, yet the physician was concerned that her condition may have been prompted by the vaccination. The patient''s peak flows were normal at baseline and markedly diminished $g50% with exercise, resulting in pallor, severe dyspnea, and wheezing after only minimal exertion in a previously healthy athletic child. The patient was vaccinated with a second dose of Gardasil. The physician was following her very closely. At the time of the report, the patient''s outcome was unknown. The physician considered the bronchospasm to be life threatening. The VAERS ID# is 301146. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the agency and was released. Additional information is not expected.


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