National Vaccine
Information Center

Your Health. Your Family. Your Choice.

MedAlerts Home
Search Results

This is VAERS ID 275438

History of Changes from the VAERS Wayback Machine

First Appeared on 12/31/2007

275438
VAERS Form:
Age:19.0
Gender:Female
Location:California
Vaccinated:2007-03-12
Onset:2007-03-26
Submitted:2007-04-02
Entered:2007-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0263U / 0 LA / IM

Administered by: Other      Purchased by: Unknown
Symptoms: Cor pulmonale, Coronary artery thrombosis, Pulmonary congestion, Pulmonary embolism, Echocardiogram abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-03-26
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit? (V2.0) No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC 'Split Type':

Write-up:Given Gardasil vaccine dose #1 3/12/07. No adverse reaction reported. Collapsed and died on 3/26/07 secondary emboli (records unavailable). 4/3/07 T/C to coroners bureau to request prelim COD. Spoke w/investigating deputy who stated autopsy done at Medic"al Center. T/C to physician at Medical Center who is actually a cardiologist, not pathologist, who had responded to the code & pronounced. Spoke w/secretary who states from Death Certificate COD is sudden cardiac death and pulmonary embolism. Echocardi


Changed on 12/8/2009

275438 Before After
VAERS Form:
Age:19.0
Gender:Female
Location:California
Vaccinated:2007-03-12
Onset:2007-03-26
Submitted:2007-04-02
Entered:2007-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0263U / 0 LA / IM

Administered by: Other      Purchased by: Unknown Other
Symptoms: Convulsion, Cor pulmonale, Coronary artery thrombosis, Pulmonary congestion, Pulmonary embolism, Pulmonary oedema, Thrombosis, Sudden cardiac death, Echocardiogram abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-03-26
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No Yes
ER or ED Visit? (V2.0) No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin birth control pills; hormal contraceptives
Current Illness: None
Preexisting Conditions: None PMH: contraception; Non-smoker
Allergies:
Diagnostic Lab Data: echocardiogram, 03/26?/07, very enlarged right ventricle and small left ventricle as well as large blood clots (see narrative)
CDC 'Split Type': (blank) WAES0705USA05011

Write-up:Given Gardasil vaccine dose #1 3/12/07. No adverse reaction reported. Collapsed and died on 3/26/07 secondary emboli (records unavailable). 4/3/07 T/C to coroners bureau to request prelim COD. Spoke w/investigating deputy who stated autopsy done at Medic"al Medical Center. T/C to physician at Medical Center who is actually a cardiologist, not pathologist, who had responded to the code & pronounced. Spoke w/secretary who states from Death Certificate COD is sudden cardiac death and pulmonary embolism. Echocardi Echocardiogram revealed very enlarged right ventricle & small left ventricle as well as large blood clots within both the right atrium & right ventricle. 6/25/07 Received Autopsy Report which reveals following anatomic diagnosis: 1. Pulmonary embolism, occlusive a. pulmonary trunk, left hilar & peripheral vessels b. acute cor pulmonale (by echocardiogram) 2. Pulmonary congestion & edema, bilatera a. no evidence of anomalous coronary artery distribution b. no evidence of ventricular dysplasia This is in follow-up to report(s) previously submitted on 6/11/2007. Information has been received on request from the FDA under the Freedom of Information Act and from a physician who presented at the "Global Advisory Committee on Vaccine Safety World Health Organizaqtion" concerning a 19 year female nonsmoker with no history who on 12-MAR-2007 was vaccinated IM into the left arm with a first dose of GARDASIL lot #655849/0263U). Concomitant therapy included oral contraceptives. There was no adverse reaction reported. Subsequently on 26-MAR-2007 the patient, while exercising on a field collapsed, began convulsing and died secondary to emboli. An autopsy was done and on the death certificate the following is documented "sudden cardiac death and pulmonary embolisem." An Echocardiogram revealed a very enlarged right ventricle and small left ventricle as well as large blood clots within both the right atrium and right ventricle. Coronary artery thrombosis and thrombosis were alsor reported. Upon internal review convulsing was considered an other important medica


Changed on 3/2/2010

275438 Before After
VAERS Form:
Age:19.0
Gender:Female
Location:California
Vaccinated:2007-03-12
Onset:2007-03-26
Submitted:2007-04-02
Entered:2007-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0263U / 0 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Convulsion, Cor pulmonale, Coronary artery thrombosis, Pulmonary congestion, Pulmonary embolism, Pulmonary oedema, Thrombosis, Sudden cardiac death, Echocardiogram abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-03-26
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit? (V2.0) No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin birth control pills; hormal contraceptives
Current Illness: None
Preexisting Conditions: None PMH: contraception; Non-smoker
Allergies:
Diagnostic Lab Data: echocardiogram, 03/26?/07, very enlarged right ventricle and small left ventricle as well as large blood clots (see narrative)
CDC 'Split Type': WAES0705USA05011

Write-up:Given Gardasil vaccine dose #1 3/12/07. No adverse reaction reported. Collapsed and died on 3/26/07 secondary emboli (records unavailable). 4/3/07 Spoke w/investigating deputy who stated autopsy done at Medical Center. T/C to physician at Medical Center who is actually a cardiologist, not pathologist, who had responded to the code & pronounced. Spoke w/secretary who states from Death Certificate COD is sudden cardiac death and pulmonary embolism. Echocardiogram revealed very enlarged right ventricle & small left ventricle as well as large blood clots within both the right atrium & right ventricle. 6/25/07 Received Autopsy Report which reveals following anatomic diagnosis: 1. Pulmonary embolism, occlusive a. pulmonary trunk, left hilar & peripheral vessels b. acute cor pulmonale (by echocardiogram) 2. Pulmonary congestion & edema, bilatera a. no evidence of anomalous coronary artery distribution b. no evidence of ventricular dysplasia This is in follow-up to report(s) previously submitted on 6/11/2007. Information has been received on request from the FDA under the Freedom of Information Act and from a physician who presented at the "Global Advisory Committee on Vaccine Safety World Health Organizaqtion" concerning a 19 year female nonsmoker with no history who on 12-MAR-2007 was vaccinated IM into the left arm with a first dose of GARDASIL lot #655849/0263U). Concomitant therapy included oral contraceptives. There was no adverse reaction reported. Subsequently on 26-MAR-2007 the patient, while exercising on a field collapsed, began convulsing and died secondary to emboli. An autopsy was done and on the death certificate the following is documented "sudden cardiac death and pulmonary embolisem." An Echocardiogram revealed a very enlarged right ventricle and small left ventricle as well as large blood clots within both the right atrium and right ventricle. Coronary artery thrombosis and thrombosis were alsor reported. Upon internal review convulsing was considered an other important medica


Changed on 4/7/2010

275438 Before After
VAERS Form:
Age:19.0
Gender:Female
Location:California
Vaccinated:2007-03-12
Onset:2007-03-26
Submitted:2007-04-02
Entered:2007-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0263U / 0 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Convulsion, Cor pulmonale, Coronary artery thrombosis, Pulmonary congestion, Pulmonary embolism, Pulmonary oedema, Thrombosis, Sudden cardiac death, Echocardiogram abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-03-26
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit? (V2.0) No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin birth control pills; hormal contraceptives
Current Illness: None
Preexisting Conditions: None PMH: contraception; Non-smoker
Allergies:
Diagnostic Lab Data: echocardiogram, 03/26?/07, very enlarged right ventricle and small left ventricle as well as large blood clots (see narrative)
CDC 'Split Type': WAES0705USA05011

Write-up:Given Gardasil vaccine dose #1 3/12/07. No adverse reaction reported. Collapsed and died on 3/26/07 secondary emboli (records unavailable). 4/3/07 Spoke w/investigating deputy who stated autopsy done at Medical Center. T/C to physician at Medical Center who is actually a cardiologist, not pathologist, who had responded to the code & pronounced. Spoke w/secretary who states from Death Certificate COD is sudden cardiac death and pulmonary embolism. Echocardiogram revealed very enlarged right ventricle & small left ventricle as well as large blood clots within both the right atrium & right ventricle. 6/25/07 Received Autopsy Report which reveals following anatomic diagnosis: 1. Pulmonary embolism, occlusive a. pulmonary trunk, left hilar & peripheral vessels b. acute cor pulmonale (by echocardiogram) 2. Pulmonary congestion & edema, bilatera a. no evidence of anomalous coronary artery distribution b. no evidence of ventricular dysplasia This is in follow-up to report(s) previously submitted on 6/11/2007. Information has been received on request from the FDA under the Freedom of Information Act and from a physician who presented at the "Global Advisory Committee on Vaccine Safety World Health Organizaqtion" concerning a 19 year female nonsmoker with no history who on 12-MAR-2007 was vaccinated IM into the left arm with a first dose of GARDASIL lot #655849/0263U). Concomitant therapy included oral contraceptives. There was no adverse reaction reported. Subsequently on 26-MAR-2007 the patient, while exercising on a field collapsed, began convulsing and died secondary to emboli. An autopsy was done and on the death certificate the following is documented "sudden cardiac death and pulmonary embolisem." An Echocardiogram revealed a very enlarged right ventricle and small left ventricle as well as large blood clots within both the right atrium and right ventricle. Coronary artery thrombosis and thrombosis were alsor reported. Upon internal review convulsing was considered an other important medica


Changed on 7/31/2010

275438 Before After
VAERS Form:
Age:19.0
Gender:Female
Location:California
Vaccinated:2007-03-12
Onset:2007-03-26
Submitted:2007-04-02
Entered:2007-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0263U / 0 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Convulsion, Cor pulmonale, Coronary artery thrombosis, Pulmonary congestion, Pulmonary embolism, Pulmonary oedema, Thrombosis, Sudden cardiac death, Echocardiogram abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-03-26
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit? (V2.0) No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin birth control pills; hormal contraceptives
Current Illness: None
Preexisting Conditions: None PMH: contraception; Non-smoker
Allergies:
Diagnostic Lab Data: echocardiogram, 03/26?/07, very enlarged right ventricle and small left ventricle as well as large blood clots (see narrative)
CDC 'Split Type': WAES0705USA05011

Write-up:Given Gardasil vaccine dose #1 3/12/07. No adverse reaction reported. Collapsed and died on 3/26/07 secondary emboli (records unavailable). 4/3/07 Spoke w/investigating deputy who stated autopsy done at Medical Center. T/C to physician at Medical Center who is actually a cardiologist, not pathologist, who had responded to the code & pronounced. Spoke w/secretary who states from Death Certificate COD is sudden cardiac death and pulmonary embolism. Echocardiogram revealed very enlarged right ventricle & small left ventricle as well as large blood clots within both the right atrium & right ventricle. 6/25/07 Received Autopsy Report which reveals following anatomic diagnosis: 1. Pulmonary embolism, occlusive a. pulmonary trunk, left hilar & peripheral vessels b. acute cor pulmonale (by echocardiogram) 2. Pulmonary congestion & edema, bilatera a. no evidence of anomalous coronary artery distribution b. no evidence of ventricular dysplasia This is in follow-up to report(s) previously submitted on 6/11/2007. Information has been received on request from the FDA under the Freedom of Information Act and from a physician who presented at the "Global Advisory Committee on Vaccine Safety World Health Organizaqtion" concerning a 19 year female nonsmoker with no history who on 12-MAR-2007 was vaccinated IM into the left arm with a first dose of GARDASIL lot #655849/0263U). Concomitant therapy included oral contraceptives. There was no adverse reaction reported. Subsequently on 26-MAR-2007 the patient, while exercising on a field collapsed, began convulsing and died secondary to emboli. An autopsy was done and on the death certificate the following is documented "sudden cardiac death and pulmonary embolisem." An Echocardiogram revealed a very enlarged right ventricle and small left ventricle as well as large blood clots within both the right atrium and right ventricle. Coronary artery thrombosis and thrombosis were alsor reported. Upon internal review convulsing was considered an other important medica


Changed on 8/31/2010

275438 Before After
VAERS Form:
Age:19.0
Gender:Female
Location:California
Vaccinated:2007-03-12
Onset:2007-03-26
Submitted:2007-04-02
Entered:2007-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0263U / 0 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Convulsion, Cor pulmonale, Pulmonary congestion, Sudden cardiac death, Echocardiogram abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-03-26
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit? (V2.0) No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin birth control pills; hormal contraceptives
Current Illness: None
Preexisting Conditions: None PMH: contraception; Non-smoker
Allergies:
Diagnostic Lab Data: echocardiogram, 03/26?/07, very enlarged right ventricle and small left ventricle as well as large blood clots (see narrative)
CDC 'Split Type': WAES0705USA05011

Write-up:Given Gardasil vaccine dose #1 3/12/07. No adverse reaction reported. Collapsed and died on 3/26/07 secondary emboli (records unavailable). 4/3/07 Spoke w/investigating deputy who stated autopsy done at Medical Center. T/C to physician at Medical Center who is actually a cardiologist, not pathologist, who had responded to the code & pronounced. Spoke w/secretary who states from Death Certificate COD is sudden cardiac death and pulmonary embolism. Echocardiogram revealed very enlarged right ventricle & small left ventricle as well as large blood clots within both the right atrium & right ventricle. 6/25/07 Received Autopsy Report which reveals following anatomic diagnosis: 1. Pulmonary embolism, occlusive a. pulmonary trunk, left hilar & peripheral vessels b. acute cor pulmonale (by echocardiogram) 2. Pulmonary congestion & edema, bilatera a. no evidence of anomalous coronary artery distribution b. no evidence of ventricular dysplasia This is in follow-up to report(s) previously submitted on 6/11/2007. Information has been received on request from the FDA under the Freedom of Information Act and from a physician who presented at the "Global Advisory Committee on Vaccine Safety World Health Organizaqtion" concerning a 19 year female nonsmoker with no history who on 12-MAR-2007 was vaccinated IM into the left arm with a first dose of GARDASIL lot #655849/0263U). Concomitant therapy included oral contraceptives. There was no adverse reaction reported. Subsequently on 26-MAR-2007 the patient, while exercising on a field collapsed, began convulsing and died secondary to emboli. An autopsy was done and on the death certificate the following is documented "sudden cardiac death and pulmonary embolisem." An Echocardiogram revealed a very enlarged right ventricle and small left ventricle as well as large blood clots within both the right atrium and right ventricle. Coronary artery thrombosis and thrombosis were alsor reported. Upon internal review convulsing was considered an other important medica


Changed on 1/4/2011

275438 Before After
VAERS Form:
Age:19.0
Gender:Female
Location:California
Vaccinated:2007-03-12
Onset:2007-03-26
Submitted:2007-04-02
Entered:2007-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0263U / 0 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Convulsion, Cor pulmonale, Pulmonary congestion, Sudden cardiac death, Echocardiogram abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-03-26
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit? (V2.0) No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin birth control pills; hormal contraceptives
Current Illness: None
Preexisting Conditions: None PMH: contraception; Non-smoker
Allergies:
Diagnostic Lab Data: echocardiogram, 03/26?/07, very enlarged right ventricle and small left ventricle as well as large blood clots (see narrative)
CDC 'Split Type': WAES0705USA05011

Write-up:Given Gardasil vaccine dose #1 3/12/07. No adverse reaction reported. Collapsed and died on 3/26/07 secondary emboli (records unavailable). 4/3/07 Spoke w/investigating deputy who stated autopsy done at Medical Center. T/C to physician at Medical Center who is actually a cardiologist, not pathologist, who had responded to the code & pronounced. Spoke w/secretary who states from Death Certificate COD is sudden cardiac death and pulmonary embolism. Echocardiogram revealed very enlarged right ventricle & small left ventricle as well as large blood clots within both the right atrium & right ventricle. 6/25/07 Received Autopsy Report which reveals following anatomic diagnosis: 1. Pulmonary embolism, occlusive a. pulmonary trunk, left hilar & peripheral vessels b. acute cor pulmonale (by echocardiogram) 2. Pulmonary congestion & edema, bilatera a. no evidence of anomalous coronary artery distribution b. no evidence of ventricular dysplasia This is in follow-up to report(s) previously submitted on 6/11/2007. Information has been received on request from the FDA under the Freedom of Information Act and from a physician who presented at the "Global Advisory Committee on Vaccine Safety World Health Organizaqtion" concerning a 19 year female nonsmoker with no history who on 12-MAR-2007 was vaccinated IM into the left arm with a first dose of GARDASIL lot #655849/0263U). Concomitant therapy included oral contraceptives. There was no adverse reaction reported. Subsequently on 26-MAR-2007 the patient, while exercising on a field collapsed, began convulsing and died secondary to emboli. An autopsy was done and on the death certificate the following is documented "sudden cardiac death and pulmonary embolisem." An Echocardiogram revealed a very enlarged right ventricle and small left ventricle as well as large blood clots within both the right atrium and right ventricle. Coronary artery thrombosis and thrombosis were alsor reported. Upon internal review convulsing was considered an other important medica medical event. The original reporting source was not provided. A standar lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expaned 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 Center for Biologics Evaluation and Research and was released. No further information is available. This report was filed with the FDA. The VAERS number is 275438.


Changed on 4/13/2011

275438 Before After
VAERS Form:
Age:19.0
Gender:Female
Location:California
Vaccinated:2007-03-12
Onset:2007-03-26
Submitted:2007-04-02
Entered:2007-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0263U / 0 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Convulsion, Cor pulmonale, Coronary artery thrombosis, Pulmonary congestion, Pulmonary embolism, Pulmonary oedema, Thrombosis, Sudden cardiac death, Echocardiogram abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-03-26
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit? (V2.0) No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin birth control pills; hormal contraceptives
Current Illness: None
Preexisting Conditions: None PMH: contraception; Non-smoker
Allergies:
Diagnostic Lab Data: echocardiogram, 03/26?/07, very enlarged right ventricle and small left ventricle as well as large blood clots (see narrative)
CDC 'Split Type': WAES0705USA05011

Write-up:Given Gardasil vaccine dose #1 3/12/07. No adverse reaction reported. Collapsed and died on 3/26/07 secondary emboli (records unavailable). 4/3/07 Spoke w/investigating deputy who stated autopsy done at Medical Center. T/C to physician at Medical Center who is actually a cardiologist, not pathologist, who had responded to the code & pronounced. Spoke w/secretary who states from Death Certificate COD is sudden cardiac death and pulmonary embolism. Echocardiogram revealed very enlarged right ventricle & small left ventricle as well as large blood clots within both the right atrium & right ventricle. 6/25/07 Received Autopsy Report which reveals following anatomic diagnosis: 1. Pulmonary embolism, occlusive a. pulmonary trunk, left hilar & peripheral vessels b. acute cor pulmonale (by echocardiogram) 2. Pulmonary congestion & edema, bilatera a. no evidence of anomalous coronary artery distribution b. no evidence of ventricular dysplasia This is in follow-up to report(s) previously submitted on 6/11/2007. Information has been received on request from the FDA under the Freedom of Information Act and from a physician who presented at the "Global Advisory Committee on Vaccine Safety World Health Organizaqtion" concerning a 19 year female nonsmoker with no history who on 12-MAR-2007 was vaccinated IM into the left arm with a first dose of GARDASIL lot #655849/0263U). Concomitant therapy included oral contraceptives. There was no adverse reaction reported. Subsequently on 26-MAR-2007 the patient, while exercising on a field collapsed, began convulsing and died secondary to emboli. An autopsy was done and on the death certificate the following is documented "sudden cardiac death and pulmonary embolisem." An Echocardiogram revealed a very enlarged right ventricle and small left ventricle as well as large blood clots within both the right atrium and right ventricle. Coronary artery thrombosis and thrombosis were alsor reported. Upon internal review convulsing was considered an other important medical event. The original reporting source was not provided. A standar lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expaned 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 Center for Biologics Evaluation and Research and was released. No further information is available. This report was filed with the FDA. The VAERS number is 275438.


Changed on 5/13/2011

275438 Before After
VAERS Form:
Age:19.0
Gender:Female
Location:California
Vaccinated:2007-03-12
Onset:2007-03-26
Submitted:2007-04-02
Entered:2007-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0263U / 0 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Convulsion, Cor pulmonale, Coronary artery thrombosis, Pulmonary congestion, Pulmonary embolism, Pulmonary oedema, Thrombosis, Sudden cardiac death, Echocardiogram abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-03-26
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit? (V2.0) No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin birth control pills; hormal contraceptives
Current Illness: None
Preexisting Conditions: None PMH: contraception; Non-smoker
Allergies:
Diagnostic Lab Data: echocardiogram, 03/26?/07, very enlarged right ventricle and small left ventricle as well as large blood clots (see narrative)
CDC 'Split Type': WAES0705USA05011

Write-up:Given Gardasil vaccine dose #1 3/12/07. No adverse reaction reported. Collapsed and died on 3/26/07 secondary emboli (records unavailable). 4/3/07 Spoke w/investigating deputy who stated autopsy done at Medical Center. T/C to physician at Medical Center who is actually a cardiologist, not pathologist, who had responded to the code & pronounced. Spoke w/secretary who states from Death Certificate COD is sudden cardiac death and pulmonary embolism. Echocardiogram revealed very enlarged right ventricle & small left ventricle as well as large blood clots within both the right atrium & right ventricle. 6/25/07 Received Autopsy Report which reveals following anatomic diagnosis: 1. Pulmonary embolism, occlusive a. pulmonary trunk, left hilar & peripheral vessels b. acute cor pulmonale (by echocardiogram) 2. Pulmonary congestion & edema, bilatera a. no evidence of anomalous coronary artery distribution b. no evidence of ventricular dysplasia This is in follow-up to report(s) previously submitted on 6/11/2007. Information has been received on request from the FDA under the Freedom of Information Act and from a physician who presented at the "Global Advisory Committee on Vaccine Safety World Health Organizaqtion" concerning a 19 year female nonsmoker with no history who on 12-MAR-2007 was vaccinated IM into the left arm with a first dose of GARDASIL lot #655849/0263U). Concomitant therapy included oral contraceptives. There was no adverse reaction reported. Subsequently on 26-MAR-2007 the patient, while exercising on a field collapsed, began convulsing and died secondary to emboli. An autopsy was done and on the death certificate the following is documented "sudden cardiac death and pulmonary embolisem." An Echocardiogram revealed a very enlarged right ventricle and small left ventricle as well as large blood clots within both the right atrium and right ventricle. Coronary artery thrombosis and thrombosis were alsor reported. Upon internal review convulsing was considered an other important medical event. The original reporting source was not provided. A standar lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expaned 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 Center for Biologics Evaluation and Research and was released. No further information is available. This report was filed with the FDA. The VAERS number is 275438.


Changed on 6/11/2011

275438 Before After
VAERS Form:
Age:19.0
Gender:Female
Location:California
Vaccinated:2007-03-12
Onset:2007-03-26
Submitted:2007-04-02
Entered:2007-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0263U / 0 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Convulsion, Cor pulmonale, Coronary artery thrombosis, Pulmonary congestion, Pulmonary embolism, Pulmonary oedema, Thrombosis, Sudden cardiac death, Echocardiogram abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-03-26
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit? (V2.0) No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin birth control pills; hormal contraceptives
Current Illness: None
Preexisting Conditions: None PMH: contraception; Non-smoker
Allergies:
Diagnostic Lab Data: echocardiogram, 03/26?/07, very enlarged right ventricle and small left ventricle as well as large blood clots (see narrative)
CDC 'Split Type': WAES0705USA05011

Write-up:Given Gardasil vaccine dose #1 3/12/07. No adverse reaction reported. Collapsed and died on 3/26/07 secondary emboli (records unavailable). 4/3/07 Spoke w/investigating deputy who stated autopsy done at Medical Center. T/C to physician at Medical Center who is actually a cardiologist, not pathologist, who had responded to the code & pronounced. Spoke w/secretary who states from Death Certificate COD is sudden cardiac death and pulmonary embolism. Echocardiogram revealed very enlarged right ventricle & small left ventricle as well as large blood clots within both the right atrium & right ventricle. 6/25/07 Received Autopsy Report which reveals following anatomic diagnosis: 1. Pulmonary embolism, occlusive a. pulmonary trunk, left hilar & peripheral vessels b. acute cor pulmonale (by echocardiogram) 2. Pulmonary congestion & edema, bilatera a. no evidence of anomalous coronary artery distribution b. no evidence of ventricular dysplasia This is in follow-up to report(s) previously submitted on 6/11/2007. Information has been received on request from the FDA under the Freedom of Information Act and from a physician who presented at the "Global Advisory Committee on Vaccine Safety World Health Organizaqtion" concerning a 19 year female nonsmoker with no history who on 12-MAR-2007 was vaccinated IM into the left arm with a first dose of GARDASIL lot #655849/0263U). Concomitant therapy included oral contraceptives. There was no adverse reaction reported. Subsequently on 26-MAR-2007 the patient, while exercising on a field collapsed, began convulsing and died secondary to emboli. An autopsy was done and on the death certificate the following is documented "sudden cardiac death and pulmonary embolisem." An Echocardiogram revealed a very enlarged right ventricle and small left ventricle as well as large blood clots within both the right atrium and right ventricle. Coronary artery thrombosis and thrombosis were alsor reported. Upon internal review convulsing was considered an other important medical event. The original reporting source was not provided. A standar lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expaned 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 Center for Biologics Evaluation and Research and was released. No further information is available. This report was filed with the FDA. The VAERS number is 275438.


Changed on 11/14/2011

275438 Before After
VAERS Form:
Age:19.0
Gender:Female
Location:California
Vaccinated:2007-03-12
Onset:2007-03-26
Submitted:2007-04-02
Entered:2007-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0263U / 0 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Circulatory collapse, Convulsion, Cor pulmonale, Coronary artery thrombosis, Mydriasis, Pulmonary congestion, Pulmonary embolism, Pulmonary oedema, Pupil fixed, Resuscitation, Thrombosis, Sudden cardiac death, Echocardiogram abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-03-26
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit? (V2.0) No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin birth control pills; hormal contraceptives
Current Illness: None
Preexisting Conditions: None PMH: contraception; Non-smoker
Allergies:
Diagnostic Lab Data: echocardiogram, 03/26?/07, very enlarged right ventricle and small left ventricle as well as large blood clots (see narrative)
CDC 'Split Type': WAES0705USA05011

Write-up:Given Gardasil vaccine dose #1 3/12/07. No adverse reaction reported. Collapsed and died on 3/26/07 secondary emboli (records unavailable). 4/3/07 Spoke w/investigating deputy who stated autopsy done at Medical Center. T/C to physician at Medical Center who is actually a cardiologist, not pathologist, who had responded to the code & pronounced. Spoke w/secretary who states from Death Certificate COD is sudden cardiac death and pulmonary embolism. Echocardiogram revealed very enlarged right ventricle & small left ventricle as well as large blood clots within both the right atrium & right ventricle. 6/25/07 Received Autopsy Report which reveals following anatomic diagnosis: 1. Pulmonary embolism, occlusive a. pulmonary trunk, left hilar & peripheral vessels b. acute cor pulmonale (by echocardiogram) 2. Pulmonary congestion & edema, bilatera a. no evidence of anomalous coronary artery distribution b. no evidence of ventricular dysplasia This is in follow-up to report(s) previously submitted on 6/11/2007. Information has been received on request from the FDA under the Freedom of Information Act and from a physician who presented at the "Global Advisory Committee on Vaccine Safety World Health Organizaqtion" concerning a 19 year female nonsmoker with no history who on 12-MAR-2007 was vaccinated IM into the left arm with a first dose of GARDASIL lot #655849/0263U). Concomitant therapy included oral contraceptives. There was no adverse reaction reported. Subsequently on 26-MAR-2007 the patient, while exercising on a field collapsed, began convulsing and died secondary to emboli. An autopsy was done and on the death certificate the following is documented "sudden cardiac death and pulmonary embolisem." An Echocardiogram revealed a very enlarged right ventricle and small left ventricle as well as large blood clots within both the right atrium and right ventricle. Coronary artery thrombosis and thrombosis were alsor reported. Upon internal review convulsing was considered an other important medical event. The original reporting source was not provided. A standar lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expaned 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 Center for Biologics Evaluation and Research and was released. No further information is available. This report was filed with the FDA. The VAERS number is 275438.


Changed on 12/14/2011

275438 Before After
VAERS Form:
Age:19.0
Gender:Female
Location:California
Vaccinated:2007-03-12
Onset:2007-03-26
Submitted:2007-04-02
Entered:2007-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0263U / 0 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Alanine aminotransferase increased, Apnoea, Aspartate aminotransferase increased, Blood albumin decreased, Blood gases abnormal, Blood potassium increased, Carbon dioxide decreased, Cardio-respiratory arrest, Circulatory collapse, Convulsion, Cor pulmonale, Coronary artery thrombosis, Grand mal convulsion, Heart sounds abnormal, Hypotonia, International normalised ratio increased, Lymphocyte count increased, Mydriasis, Myoglobin blood increased, Prothrombin time prolonged, Pulmonary congestion, Pulmonary embolism, Pulmonary oedema, Pupil fixed, Resuscitation, Thrombosis, Unresponsive to stimuli, Vomiting, White blood cell count increased, Sudden cardiac death, Right ventricular hypertrophy, Neutrophil percentage increased, Troponin I increased, Band neutrophil percentage increased, Blood alkaline phosphatase increased, Jugular vein distension, Calcium ionised increased, Electrocardiogram ST-T change, Partial seizures, Echocardiogram abnormal, Metamyelocyte percentage increased, Endotracheal intubation

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-03-26
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit? (V2.0) No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin birth control pills; hormal contraceptives
Current Illness: None
Preexisting Conditions: None PMH: contraception; Non-smoker
Allergies:
Diagnostic Lab Data: echocardiogram, 03/26?/07, very enlarged right ventricle and small left ventricle as well as large blood clots (see narrative)
CDC 'Split Type': WAES0705USA05011

Write-up:Given Gardasil vaccine dose #1 3/12/07. No adverse reaction reported. Collapsed and died on 3/26/07 secondary emboli (records unavailable). 4/3/07 Spoke w/investigating deputy who stated autopsy done at Medical Center. T/C to physician at Medical Center who is actually a cardiologist, not pathologist, who had responded to the code & pronounced. Spoke w/secretary who states from Death Certificate COD is sudden cardiac death and pulmonary embolism. Echocardiogram revealed very enlarged right ventricle & small left ventricle as well as large blood clots within both the right atrium & right ventricle. 6/25/07 Received Autopsy Report which reveals following anatomic diagnosis: 1. Pulmonary embolism, occlusive a. pulmonary trunk, left hilar & peripheral vessels b. acute cor pulmonale (by echocardiogram) 2. Pulmonary congestion & edema, bilatera a. no evidence of anomalous coronary artery distribution b. no evidence of ventricular dysplasia This is in follow-up to report(s) previously submitted on 6/11/2007. Information has been received on request from the FDA under the Freedom of Information Act and from a physician who presented at the "Global Advisory Committee on Vaccine Safety World Health Organizaqtion" concerning a 19 year female nonsmoker with no history who on 12-MAR-2007 was vaccinated IM into the left arm with a first dose of GARDASIL lot #655849/0263U). Concomitant therapy included oral contraceptives. There was no adverse reaction reported. Subsequently on 26-MAR-2007 the patient, while exercising on a field collapsed, began convulsing and died secondary to emboli. An autopsy was done and on the death certificate the following is documented "sudden cardiac death and pulmonary embolisem." An Echocardiogram revealed a very enlarged right ventricle and small left ventricle as well as large blood clots within both the right atrium and right ventricle. Coronary artery thrombosis and thrombosis were alsor reported. Upon internal review convulsing was considered an other important medical event. The original reporting source was not provided. A standar lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expaned 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 Center for Biologics Evaluation and Research and was released. No further information is available. This report was filed with the FDA. The VAERS number is 275438.


Changed on 6/14/2014

275438 Before After
VAERS Form:
Age:19.0
Gender:Female
Location:California
Vaccinated:2007-03-12
Onset:2007-03-26
Submitted:2007-04-02
Entered:2007-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0263U / 0 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Alanine aminotransferase increased, Apnoea, Aspartate aminotransferase increased, Blood albumin decreased, Blood gases abnormal, Blood potassium increased, Carbon dioxide decreased, Cardio-respiratory arrest, Circulatory collapse, Convulsion, Cor pulmonale, Coronary artery thrombosis, Grand mal convulsion, Heart sounds abnormal, Hypotonia, International normalised ratio increased, Lymphocyte count increased, Mydriasis, Myoglobin blood increased, Prothrombin time prolonged, Pulmonary congestion, Pulmonary embolism, Pulmonary oedema, Pupil fixed, Resuscitation, Thrombosis, Unresponsive to stimuli, Vomiting, White blood cell count increased, Sudden cardiac death, Right ventricular hypertrophy, Neutrophil percentage increased, Troponin I increased, Band neutrophil percentage increased, Blood alkaline phosphatase increased, Jugular vein distension, Calcium ionised increased, Electrocardiogram ST-T change, Partial seizures, Echocardiogram abnormal, Metamyelocyte percentage increased, Endotracheal intubation

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-03-26
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit? (V2.0) No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin birth control pills; hormal contraceptives
Current Illness: None
Preexisting Conditions: None PMH: contraception; Non-smoker
Allergies:
Diagnostic Lab Data: echocardiogram, 03/26?/07, very enlarged right ventricle and small left ventricle as well as large blood clots (see narrative)
CDC 'Split Type': WAES0705USA05011

Write-up:Given Gardasil vaccine dose #1 3/12/07. No adverse reaction reported. Collapsed and died on 3/26/07 secondary emboli (records unavailable). 4/3/07 Spoke w/investigating deputy who stated autopsy done at Medical Center. T/C to physician at Medical Center who is actually a cardiologist, not pathologist, who had responded to the code & pronounced. Spoke w/secretary who states from Death Certificate COD is sudden cardiac death and pulmonary embolism. Echocardiogram revealed very enlarged right ventricle & small left ventricle as well as large blood clots within both the right atrium & right ventricle. 6/25/07 Received Autopsy Report which reveals following anatomic diagnosis: 1. Pulmonary embolism, occlusive a. pulmonary trunk, left hilar & peripheral vessels b. acute cor pulmonale (by echocardiogram) 2. Pulmonary congestion & edema, bilatera a. no evidence of anomalous coronary artery distribution b. no evidence of ventricular dysplasia This is in follow-up to report(s) previously submitted on 6/11/2007. Information has been received on request from the FDA under the Freedom of Information Act and from a physician who presented at the "Global Advisory Committee on Vaccine Safety World Health Organizaqtion" concerning a 19 year female nonsmoker with no history who on 12-MAR-2007 was vaccinated IM into the left arm with a first dose of GARDASIL lot #655849/0263U). Concomitant therapy included oral contraceptives. There was no adverse reaction reported. Subsequently on 26-MAR-2007 the patient, while exercising on a field collapsed, began convulsing and died secondary to emboli. An autopsy was done and on the death certificate the following is documented "sudden cardiac death and pulmonary embolisem." An Echocardiogram revealed a very enlarged right ventricle and small left ventricle as well as large blood clots within both the right atrium and right ventricle. Coronary artery thrombosis and thrombosis were alsor reported. Upon internal review convulsing was considered an other important medical event. The original reporting source was not provided. A standar lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expaned 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 Center for Biologics Evaluation and Research and was released. No further information is available. This report was filed with the FDA. The VAERS number is 275438.


Changed on 2/14/2017

275438 Before After
VAERS Form:
Age:19.0
Gender:Female
Location:California
Vaccinated:2007-03-12
Onset:2007-03-26
Submitted:2007-04-02
Entered:2007-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0263U / 0 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Alanine aminotransferase increased, Apnoea, Aspartate aminotransferase increased, Blood albumin decreased, Blood gases abnormal, Blood potassium increased, Carbon dioxide decreased, Cardio-respiratory arrest, Circulatory collapse, Convulsion, Cor pulmonale, Coronary artery thrombosis, Grand mal convulsion, Heart sounds abnormal, Hypotonia, International normalised ratio increased, Lymphocyte count increased, Mydriasis, Myoglobin blood increased, Prothrombin time prolonged, Pulmonary congestion, Pulmonary embolism, Pulmonary oedema, Pupil fixed, Resuscitation, Thrombosis, Unresponsive to stimuli, Vomiting, White blood cell count increased, Sudden cardiac death, Right ventricular hypertrophy, Neutrophil percentage increased, Troponin I increased, Band neutrophil percentage increased, Blood alkaline phosphatase increased, Jugular vein distension, Calcium ionised increased, Electrocardiogram ST-T change, Partial seizures, Echocardiogram abnormal, Metamyelocyte percentage increased, Endotracheal intubation

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-03-26
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit? (V2.0) No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin birth control pills; hormal contraceptives
Current Illness: None
Preexisting Conditions: None PMH: contraception; Non-smoker
Allergies:
Diagnostic Lab Data: echocardiogram, 03/26?/07, very enlarged right ventricle and small left ventricle as well as large blood clots (see narrative)
CDC 'Split Type': WAES0705USA05011

Write-up:Given Gardasil vaccine dose #1 3/12/07. No adverse reaction reported. Collapsed and died on 3/26/07 secondary emboli (records unavailable). 4/3/07 Spoke w/investigating deputy who stated autopsy done at Medical Center. T/C to physician at Medical Center who is actually a cardiologist, not pathologist, who had responded to the code & pronounced. Spoke w/secretary who states from Death Certificate COD is sudden cardiac death and pulmonary embolism. Echocardiogram revealed very enlarged right ventricle & small left ventricle as well as large blood clots within both the right atrium & right ventricle. 6/25/07 Received Autopsy Report which reveals following anatomic diagnosis: 1. Pulmonary embolism, occlusive a. pulmonary trunk, left hilar & peripheral vessels b. acute cor pulmonale (by echocardiogram) 2. Pulmonary congestion & edema, bilatera a. no evidence of anomalous coronary artery distribution b. no evidence of ventricular dysplasia This is in follow-up to report(s) previously submitted on 6/11/2007. Information has been received on request from the FDA under the Freedom of Information Act and from a physician who presented at the "Global Advisory Committee on Vaccine Safety World Health Organizaqtion" concerning a 19 year female nonsmoker with no history who on 12-MAR-2007 was vaccinated IM into the left arm with a first dose of GARDASIL lot #655849/0263U). Concomitant therapy included oral contraceptives. There was no adverse reaction reported. Subsequently on 26-MAR-2007 the patient, while exercising on a field collapsed, began convulsing and died secondary to emboli. An autopsy was done and on the death certificate the following is documented "sudden cardiac death and pulmonary embolisem." An Echocardiogram revealed a very enlarged right ventricle and small left ventricle as well as large blood clots within both the right atrium and right ventricle. Coronary artery thrombosis and thrombosis were alsor reported. Upon internal review convulsing was considered an other important medical event. The original reporting source was not provided. A standar lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expaned 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 Center for Biologics Evaluation and Research and was released. No further information is available. This report was filed with the FDA. The VAERS number is 275438.


Changed on 9/14/2017

275438 Before After
VAERS Form:(blank) 1
Age:19.0
Gender:Female
Location:California
Vaccinated:2007-03-12
Onset:2007-03-26
Submitted:2007-04-02
Entered:2007-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0263U / 0 1 LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Convulsion, Echocardiogram abnormal

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-03-26
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit? (V2.0) No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin birth control pills; hormal contraceptives
Current Illness: None
Preexisting Conditions: None PMH: contraception; Non-smoker
Allergies:
Diagnostic Lab Data: echocardiogram, 03/26?/07, very enlarged right ventricle and small left ventricle as well as large blood clots (see narrative)
CDC 'Split Type': WAES0705USA05011

Write-up:Given Gardasil vaccine dose #1 3/12/07. No adverse reaction reported. Collapsed and died on 3/26/07 secondary emboli (records unavailable). 4/3/07 Spoke w/investigating deputy who stated autopsy done at Medical Center. T/C to physician at Medical Center who is actually a cardiologist, not pathologist, who had responded to the code & pronounced. Spoke w/secretary who states from Death Certificate COD is sudden cardiac death and pulmonary embolism. Echocardiogram revealed very enlarged right ventricle & small left ventricle as well as large blood clots within both the right atrium & right ventricle. 6/25/07 Received Autopsy Report which reveals following anatomic diagnosis: 1. Pulmonary embolism, occlusive a. pulmonary trunk, left hilar & peripheral vessels b. acute cor pulmonale (by echocardiogram) 2. Pulmonary congestion & edema, bilatera a. no evidence of anomalous coronary artery distribution b. no evidence of ventricular dysplasia This is in follow-up to report(s) previously submitted on 6/11/2007. Information has been received on request from the FDA under the Freedom of Information Act and from a physician who presented at the "Global Advisory Committee on Vaccine Safety World Health Organizaqtion" concerning a 19 year female nonsmoker with no history who on 12-MAR-2007 was vaccinated IM into the left arm with a first dose of GARDASIL lot #655849/0263U). Concomitant therapy included oral contraceptives. There was no adverse reaction reported. Subsequently on 26-MAR-2007 the patient, while exercising on a field collapsed, began convulsing and died secondary to emboli. An autopsy was done and on the death certificate the following is documented "sudden cardiac death and pulmonary embolisem." An Echocardiogram revealed a very enlarged right ventricle and small left ventricle as well as large blood clots within both the right atrium and right ventricle. Coronary artery thrombosis and thrombosis were alsor reported. Upon internal review convulsing was considered an other important medical event. The original reporting source was not provided. A standar lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expaned 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 Center for Biologics Evaluation and Research and was released. No further information is available. This report was filed with the FDA. The VAERS number is 275438.


New Search

Link To This Search Result:

http://www.medalerts.org/vaersdb/findfield.php?IDNUMBER=275438&WAYBACKHISTORY=ON


Copyright © 2017 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166