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Administered by: Unknown Purchased by: Unknown
Life Threatening? No Write-up: Pt recv''d Pneumovax,meningococcal, & ACTHIB vax. Subsequently, pt exp stroke-like symptoms. Pt sought unspecified medical attention. (OMIC) | ||||||||||||||||||||||||||||||||
Administered by: Private Purchased by: Other
Life Threatening? No Write-up: Pt with a history of multiple myeloma received injections of Pnu-Imune 23, Act-HIB (Aventis Pasteur SA) and Menomune-a/c/y/w 135 (Aventis Pasteur Inc) vaccines on 9-FEB-2000. Later that day he experienced "stroke-like symptoms" and was brought to emergency room. After extensive testing it was determined he had an embolic stroke and the reporter did not feel it was related to the vaccines. | ||||||||||||||||||||||||||||||||
Administered by: Unknown Purchased by: Unknown
Life Threatening? No Write-up: It was reported that an adult male pt received a Menomune A/C/Y/W-135 vaccination on 3/6/00. Reportedly, the pt died on 4/14/00. dx''d with purulent meningitis. Autopsy done at medical examiner''s office. Further medical follow-up is requested and ongoing. On 05/22/2001, the autopsy and medical examiners reports were received. Autopsy report revealed the following findings from the head and central nervous system. "The leptomeninges overlying the frontal lobes have yellow-green opacified material present, consistent with purulent meningitis process." From the correspondence received from a physician it was stated "This case was associated with large numbers of gram positive diplococci having the morphology consistent with S. pneumonia. A silver stain and a PAS did not support the presence of any other organism." | ||||||||||||||||||||||||||||||||
Administered by: Other Purchased by: Public
Life Threatening? No Write-up: Earache; diarrhea and vomiting; on menses. CDC confirmed and notified in 9/01 that the cause of death as fulminant meningococcus. Typing was C from ear drainage. Autopsy results received confirming this also. | ||||||||||||||||||||||||||||||||
Administered by: Public Purchased by: Unknown
Life Threatening? No Write-up: myocarditis | ||||||||||||||||||||||||||||||||
Administered by: Private Purchased by: Other
Life Threatening? No Write-up: From telephone contact received at Aventis Pasteur Inc. on 09/05/2002, it was reported that an 18-year-old male was vaccinated on 09/04/2002 with Menomune A/C/Y/W-135 (lot# UB295AA). On 09/05/2002, patient''s parent called 911 after he collapsed. Patient expired. Autopsy is being performed. Follow-up (#1) telephone call to the Coroner''s Office on 09/17/2002: "No information, no preliminary results" available at this time. Investigator collected 7 doses of fluid and powder. Toxicology results will take 8-12 weeks. Family history positive for asthma. Coroner''s case number is 2002-02746. From additional correspondence received at Aventis Pasteur Inc. on 02/12/2003, it was reported that the patient with no illnesses at time of vaccination and had no pre-existing diagnosis received first dose of MENOMUNE (expiration date 10/22/2003) subcutaneously in the left arm at 15:30 on 09/04/2002. The patient was not responsive on 09/05/2002. No cause of death was determined on the preliminary coroner''s report on 09/06/2002. As per the reporter, a copy of this report has been sent to VAERS on 09/09/2002. Follow-up #2 correspondence received on 02/13/2003: From telephone contact to the Coroner''s office, the toxicology was negative and the cause of death remains undetermined. A copy of the autopsy has been requested. Reported on 03/20/2003: "From follow-up #3 information received at Aventis Pasteur Inc. on 03/07/2003, it was reported that the decendant''s Histological Examination from the autopsy report showed that the heart had few round cells in the epicardium, otherwise non-contributory. Also, on histological exam the thyroid, spleen, kidney, lung, pancreas and the liver were all non-contributory. All toxicology labs were negative. The investigator''s notes showed that the decendant had symptoms of the common cold about 3 months ago and was losing his hair, he was prescribed Propecia. Autopsy on file: Case is closed. | ||||||||||||||||||||||||||||||||
Administered by: Unknown Purchased by: Unknown
Life Threatening? No Write-up: From initial information at manufacturer, it was reported that a 19 year old female patient received Menomune A/C/Y/W 135, UB034AA, on 7/2/01. Route/site were not reported. Patient had cultures sero group C. On 2/15/03, patient had blood cultures and was positive for ? of meningitis group C. Patient was hospitalized for 4 days, then died on 2/18/03. | ||||||||||||||||||||||||||||||||
Administered by: Military Purchased by: Unknown
Life Threatening? No Write-up: From initial information received on 8/7/03 from a medical professional, regarding an adverse event occurring in the US, it was reported that an 18year old male patient received MENOMUNE, lot number UB245AA, FLUZONE (lot number not reported), TUBERSOL (lot number not reported), HEPATITIS A VACCINE (lot number and manufacturer not reported, HEPATITIS B VACCINE (lot number and manufacturer not reported), MMR (lot number not reported), and PNEUMOVAX (lot number not reported) administered on 11/14/02. All vaccines were administered on the same date. The patient died on 12/15/02. The CDC investigation confirmed that the patient was positive for serogroup C, Meningococcal infection. The onset date of signs and symptoms were not reported. An autopsy was performed, however, results were not available at the time of this report. Follow-up information: Information has been received from a health professional concerning an 18 year old male patient who was healthy with no adverse entry who on 11/14/2002 was vaccinated with a dose of MMRII (Lot # not reported). Concomitant therapy on 11/14/2002 included a dose of hepatitis A vaccine (inactive) (manufacturer unknown) (Lot # not reported), a dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) (Lot # not reported), a dose of pneumococcal vaccine 23 polyvalent (MSD) (Lot # not reported), a dose of tuberculin in purified protein derivative (TUBERSOL) (Lot # not reported), a dose of influenza virus vaccine (FLUZONE) (Lot # not reported) and a dose of meningococcal polysaccharide vaccine (MENOMUME-A/C/Y/W-135) (Lot # UB245AA). Subsequently the patient died on 12/15/2002. It was confirmed that the patient was positive for serogroup C Meningococcal infection. The onset date of signs and symptoms were not reported. An autopsy was performed; however, the results were not available at the time of the report. From additional information received on 08/12/2003 from a pathology department, it was reported that the patient presented with an acute onset of a rash on his feet that spread to his face over a period of a few hours, after a 3 day history of a cough and sore throat. The symptoms progressed rapidly to severe respiratory distress and shock. The patient was treated with advanced cardiac life support in the ICU (intensive care unit) and died within three hours of presenting to the hospital. The patient died at 1:01 pm on 12/15/2002; the autopsy was done the following day and showed that the cause of death was Neisseria Meningitidis Septicemia (Meningococcemia). Gross autopsy findings included evidence acute shock syndrome with diffuse petechia and hemorrhage to multiple organs, visceral congestions, shock kidneys, and a blothcy erythematous rash to the organs and a few scattered foci of acute inflammation within the myocardium and meninges. The clinical presentation, autopsy findings, and laboratory PCR results were consistent with Neisseria Meningitidis (meningococcal) Septicemia (special pathogens branch # M10158). The manner of death was natural. The CDC confirmed that the patient was positive for serogroup C Meningococcal infection. Final anatomical diagnosis from the autopsy report included: Diffuse discrete petechiae and small hemorrhages involving multiple organs, serosa and mucosal surfaces (intestines, mesentery, epicardium, myocardium, renal cortex, adrenals, lungs, pharynx, bronchi, skeletal muscle and conjuctica), pulmonary edema and visceral congestion, bilateral pleural and pericardial effusions, blotchy erythematous rash on face, trunk, arms and legs, shock kidneys with diffuse pale cortices. there was no purulent meningeal exudates present. The PCR results were positive for Neisseria Meningitidis Serogroup C. Microscopic findings included: Numerous fibrin micro thrombi in heart, lungs, liver, glomeruli, brain and oropharynx and scattered small foci of acute inflammation in meninges and myocardium associated with hemorrhage and focal myocyte necrosis. Microscopic descriptions included: Trachea-diffuse mucosal and submucosal hemorrhage without inflammation. Lung-diffuse alveolar damage with numerous scattered fibrin and conspicous granulocytes present in red pulp. Liver-sinusoidal congestion with sinusoids distended by granulocytes and scattered fibrin micro thrombi. Prostate and bladder-mucosal and glandular autolysis, no pathologic diagnosis. There were no radiographs taken. Toxicology results included: Volatiles-the blood and vitereous fluid were examined for the presence of ethanol at a cutoff of 20 mg/dl. No ethanol was detected. The following drugs were detected: Positive Lidocaine-Lidocaine was detected in the liver by gas chromatography and confirmed by gas chromatography/mass spectrometry. Positive Atropine-Atropine was detected in the liver by gas chromatography/mass. | ||||||||||||||||||||||||||||||||
Administered by: Military Purchased by: Military
Life Threatening? No Write-up: Patient did vigorous physical training session just before dinner, went to dinner, didn''t feel well (upset stomach), went to barracks, apparently fell out of top bunk, was unresponsive. CPR started promptly with physician assistant attending. EMS arrived, patient was in asystole with no response to ACLS protocols. Transported to ER and ACLS continued with no response. Post-mortem x-ray showed no skeletal fracture or dislocation. Well known to unit PA; high blood pressure; 15-year smoking history, new heart murmur 1/6 systolic. Preliminary autopsy findings: ASCVD w/ left main coronary artery occluded 90%, left anterior descending coronary artery occluded 85%. Final autopsy report awaits tissue and toxicology findings. Add''l medical records will be provided once available. Pt did vigorous physical training session just before dinner, went to dinner, didn''t feel well (upset stomach), went to baracks, apparently fell out of top bunk, was unresponsive. CPR started promptly with physician assistant attending. EMS arrived, pt was in asystole with no response to ACLS protocols. Transported to ER and ACLS continued with no response. Post-mortem x-ray showed no skeletal fracture or dislocation. Well known to unit PA; high blood presure; 15-year smoking history, new heart murmur 1/6 systolic. Diagnosed with URI on 09/30/2003 and treated with Deconamine SR BIDx 10d. Preliminary autopsy findings: ASCVD with left main coronary artery occluded 90%, left anterior descending cornonary artery occluded 85%. Final autopsy report awaits tissue and toxicology findings. Nurse follow up on 11/08/04 states: "Severe Atherosclerotic Cardiovascular Disease." | ||||||||||||||||||||||||||||||||
Administered by: Unknown Purchased by: Unknown
Life Threatening? No Write-up: high fever, dizziness, nausea, congestion and diffculty breathing, wheezing, extremely bad headache, like a bad migraine. Patient passed out while driving her car and crossed over the highway into oncoming traffic and was killed instantly. Four different individuals have given us details of her being so sick that she couldn''t even hold her head up. 11/11/04 Medical records received from PCP. Autopsy Report received on 11/22/2004 states pt expereinced blunt force injuries. | ||||||||||||||||||||||||||||||||
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