chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX, FLUX, FLU3
Symptoms: Anaphylactic reaction, Apnoea, Cardioversion, Death, Hypotension
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in an elderly female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified). Concurrent medical conditions included hypertension and penicillin allergy. On an unspecified date the subject received unspecified dose of Influenza vaccine (unknown route, unknown lot number). 2 minutes after vaccination with Influenza vaccine, the subject experienced anaphylaxis, apnea, respiratory arrest, hypotension and swelling of tongue. The subject was treated with adrenaline (Epinephrine) and defibrillation. The subject died, cause of death is not specified. It was unknown whether an autopsy was performed. The Vaccine Program was established in 1986 in response to vaccine safety concerns. A unique feature is a table of compensable injuries, the VIT. Anaphylaxis is a listed adverse event with an interval of 0 to 4 hours for several vaccines. In 2009, the program charged the Institute with the task of completing a comprehensive review of the medical literature regarding adverse events related to vaccines so that the VIT could be updated. Concurrent with the Institute review, the author undertook a systematic analysis of the programs anaphylaxis case experiences. The program administrative database was queried for all cases submitted to the program alleging anaphylaxis or anaphylactic shock for the 10-year period from January 1, 2000, through December 31, 2009. Cases were categorized as anaphylaxis, possibly allergic-not anaphylaxis, and not anaphylaxis or allergic. The anaphylaxis cases all met the BC case definition and were further subdivided into 3 levels of diagnostic certainty using major and minor criteria, with level 1 being the greatest level of certainty. Possibly allergic cases were defined as those for which there were signs and/or symptoms compatible with an allergic reaction occurring within 4 hours of injection but that did not meet any of the BC case definitions for anaphylaxis. All of our anaphylaxis cases met the BC diagnostic certainty and, with an interval of 0 to 4 hours, are consistent with the current VIT. This case was classified at level 2 certainty. This review represented the first systematic approach in analyzing the program experience with anaphylaxis and will be useful when the VIT is updated. This was one of 9 cases reported in the same article and represented 8 different vaccines containing at least 11 different vaccine antigens.
Sex: F
Vaccine: FLUX, FLUX, FLU3
Symptoms: Respiratory arrest, Swollen tongue
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in an elderly female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified). Concurrent medical conditions included hypertension and penicillin allergy. On an unspecified date the subject received unspecified dose of Influenza vaccine (unknown route, unknown lot number). 2 minutes after vaccination with Influenza vaccine, the subject experienced anaphylaxis, apnea, respiratory arrest, hypotension and swelling of tongue. The subject was treated with adrenaline (Epinephrine) and defibrillation. The subject died, cause of death is not specified. It was unknown whether an autopsy was performed. The Vaccine Program was established in 1986 in response to vaccine safety concerns. A unique feature is a table of compensable injuries, the VIT. Anaphylaxis is a listed adverse event with an interval of 0 to 4 hours for several vaccines. In 2009, the program charged the Institute with the task of completing a comprehensive review of the medical literature regarding adverse events related to vaccines so that the VIT could be updated. Concurrent with the Institute review, the author undertook a systematic analysis of the programs anaphylaxis case experiences. The program administrative database was queried for all cases submitted to the program alleging anaphylaxis or anaphylactic shock for the 10-year period from January 1, 2000, through December 31, 2009. Cases were categorized as anaphylaxis, possibly allergic-not anaphylaxis, and not anaphylaxis or allergic. The anaphylaxis cases all met the BC case definition and were further subdivided into 3 levels of diagnostic certainty using major and minor criteria, with level 1 being the greatest level of certainty. Possibly allergic cases were defined as those for which there were signs and/or symptoms compatible with an allergic reaction occurring within 4 hours of injection but that did not meet any of the BC case definitions for anaphylaxis. All of our anaphylaxis cases met the BC diagnostic certainty and, with an interval of 0 to 4 hours, are consistent with the current VIT. This case was classified at level 2 certainty. This review represented the first systematic approach in analyzing the program experience with anaphylaxis and will be useful when the VIT is updated. This was one of 9 cases reported in the same article and represented 8 different vaccines containing at least 11 different vaccine antigens.
Sex: F
Vaccine: FLUX, FLUX, FLU3
Symptoms: Anaphylactic reaction, Apnoea, Cardioversion, Death, Hypotension
Clinical narrative: Initial case was retrieved from the scientific literature on 08 June 2011. "The National Vaccine Injury Compensation Program (VICP) was established in 1986 in response to vaccine safety concerns. A unique feature is a table of compensable injuries, the Vaccine Injury Table (VIT). Anaphylaxis is a listed adverse event with an interval of 0 to 4 hours for vaccines containing tetanus toxoid (tetanus, diphtheria, and pertussis vaccine and tetanus-diphtheria [Td] vaccine), pertussis (diphtheria, pertussis, and tetanus [DPT] and diphtheria and tetanus toxoids with acellular pertussis [DTaP] vaccines), MMR, IPV, and hepatitis B virus (HBV). In 2009, the VICP charged the Institute of Medicine with the task of completing a comprehensive review of the medical literature regarding adverse events related to vaccines so that the VIT could be updated. Concurrent with the Institute of Medicine's review, we undertook a systematic analysis of the VICP''s anaphylaxis case experience. The VICP administrative database was queried for all cases submitted to the VICP alleging "anaphylaxis or anaphylactic shock" for the 10-year period from January 1, 2000, through December 31, 2009." The patient captured in this case was one of 8 noted in the above reference that experienced anaphylaxis after vaccination. A geriatric female patient (age not reported), with a medical history of hypertension and a penicillin allergy, received an injection (route and site not reported) of INFLUENZA VACCINE, manufacturer and lot number not reported, on an unknown date. On an unknown date, within 2 minutes of receiving the vaccine, the patient developed anaphylaxis with symptoms of apnea, tongue swelling, hypotension and respiratory arrest. The patient required defibrillation and was treated with three doses of epinephrine. The patient died (date not reported). The outcome was reported as fatal. The reporter in this case is the same as cases: 2011-03324, 2011-03328, 2011-03329, 2011-03330, 2011-03331, 2011-03332, and 2011-03333. Documents held by sender: None.
Sex: F
Vaccine: FLUX, FLUX, FLU3
Symptoms: Respiratory arrest, Swollen tongue
Clinical narrative: Initial case was retrieved from the scientific literature on 08 June 2011. "The National Vaccine Injury Compensation Program (VICP) was established in 1986 in response to vaccine safety concerns. A unique feature is a table of compensable injuries, the Vaccine Injury Table (VIT). Anaphylaxis is a listed adverse event with an interval of 0 to 4 hours for vaccines containing tetanus toxoid (tetanus, diphtheria, and pertussis vaccine and tetanus-diphtheria [Td] vaccine), pertussis (diphtheria, pertussis, and tetanus [DPT] and diphtheria and tetanus toxoids with acellular pertussis [DTaP] vaccines), MMR, IPV, and hepatitis B virus (HBV). In 2009, the VICP charged the Institute of Medicine with the task of completing a comprehensive review of the medical literature regarding adverse events related to vaccines so that the VIT could be updated. Concurrent with the Institute of Medicine's review, we undertook a systematic analysis of the VICP''s anaphylaxis case experience. The VICP administrative database was queried for all cases submitted to the VICP alleging "anaphylaxis or anaphylactic shock" for the 10-year period from January 1, 2000, through December 31, 2009." The patient captured in this case was one of 8 noted in the above reference that experienced anaphylaxis after vaccination. A geriatric female patient (age not reported), with a medical history of hypertension and a penicillin allergy, received an injection (route and site not reported) of INFLUENZA VACCINE, manufacturer and lot number not reported, on an unknown date. On an unknown date, within 2 minutes of receiving the vaccine, the patient developed anaphylaxis with symptoms of apnea, tongue swelling, hypotension and respiratory arrest. The patient required defibrillation and was treated with three doses of epinephrine. The patient died (date not reported). The outcome was reported as fatal. The reporter in this case is the same as cases: 2011-03324, 2011-03328, 2011-03329, 2011-03330, 2011-03331, 2011-03332, and 2011-03333. Documents held by sender: None.
Sex: M
Vaccine: HEP, IPV, HEP, IPV, HEP, IPV
Symptoms: Anaphylactic reaction, Circulatory collapse, Death, Dyspnoea, Epistaxis
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in an infant male subject who was vaccinated with HEPATITIS B vaccine (manufacturer unspecified), IPV (non-GSK). The subject had no relevant medical history. On an unspecified date the subject received unspecified dose of HEPATITIS B vaccine (unknown route, unknown lot number), unspecified dose of IPV (non-GSK) (unknown route, unknown lot number).
Sex: M
Vaccine: HEP, IPV, HEP, IPV, HEP, IPV
Symptoms: Hyperhidrosis, Loss of consciousness, Respiratory arrest, Tryptase, Unresponsive to stimuli
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in an infant male subject who was vaccinated with HEPATITIS B vaccine (manufacturer unspecified), IPV (non-GSK). The subject had no relevant medical history. On an unspecified date the subject received unspecified dose of HEPATITIS B vaccine (unknown route, unknown lot number), unspecified dose of IPV (non-GSK) (unknown route, unknown lot number).
Sex: M
Vaccine: HEP, IPV, HEP, IPV, HEP, IPV
Symptoms: Anaphylactic reaction, Death, Epistaxis, Respiratory arrest, Tryptase increased
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in an infant male subject who was vaccinated with HEPATITIS B vaccine (manufacturer unspecified), IPV (non-GSK). The subject had no relevant medical history. On an unspecified date the subject received unspecified dose of HEPATITIS B vaccine (unknown route, unknown lot number), unspecified dose of IPV (non-GSK) (unknown route, unknown lot number).
Sex: M
Vaccine: HEP, IPV, HEP, IPV, HEP, IPV
Symptoms: Unresponsive to stimuli
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in an infant male subject who was vaccinated with HEPATITIS B vaccine (manufacturer unspecified), IPV (non-GSK). The subject had no relevant medical history. On an unspecified date the subject received unspecified dose of HEPATITIS B vaccine (unknown route, unknown lot number), unspecified dose of IPV (non-GSK) (unknown route, unknown lot number).
Sex: M
Vaccine: HEP, IPV, HEP, IPV, HEP, IPV
Symptoms: Anaphylactic reaction, Death
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in an infant male subject who was vaccinated with HEPATITIS B vaccine (manufacturer unspecified), IPV (non-GSK). The subject had no relevant medical history. On an unspecified date the subject received unspecified dose of HEPATITIS B vaccine (unknown route, unknown lot number), unspecified dose of IPV (non-GSK) (unknown route, unknown lot number).
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Cardiac enzymes, Chest pain, Echocardiogram, Electrocardiogram, Myopericarditis
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Nuclear magnetic resonance imaging, Pericarditis
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Lumbar puncture normal, Pericardial disease, Troponin I
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Abdominal pain, Abdominal rigidity, Abdominal tenderness, Activated partial thromboplastin time normal, Activated partial thromboplastin time shortened
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Adenovirus test, Albumin globulin ratio, Anaemia, Angiogram, Anti-cyclic citrullinated peptide antibody negative
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Antinuclear antibody negative, Aspartate aminotransferase increased, Asthenia, Atelectasis, Atrial septal defect
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Back pain, Bilirubin conjugated increased, Blood albumin decreased, Blood alkaline phosphatase normal, Blood creatine phosphokinase MB increased
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Blood creatine phosphokinase decreased, Blood culture negative, Blood thyroid stimulating hormone normal, Blood urea increased, Brain natriuretic peptide normal
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: C-reactive protein increased, CSF glucose normal, CSF lymphocyte count, CSF monocyte count, CSF protein normal
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: CSF white blood cell count negative, Cardiomegaly, Chest X-ray abnormal, Chest discomfort, Chest pain
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Chills, Clostridium test negative, Cold sweat, Computerised tomogram abdomen abnormal, Computerised tomogram pelvis abnormal
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Computerised tomogram thorax abnormal, Coxsackie virus test negative, Dyspnoea, Echocardiogram abnormal, Echovirus test negative
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Ejection fraction decreased, Electrocardiogram ST segment abnormal, Electrocardiogram T wave abnormal, Electrocardiogram T wave inversion, Fibrin D dimer decreased
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Generalised oedema, Globulins increased, HIV test negative, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Headache, Hepatic steatosis, Hepatosplenomegaly, Hyperhidrosis, Injection site erythema
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Injection site swelling, International normalised ratio normal, Laboratory test normal, Leukocytosis, Lipase normal
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Lymph node pain, Lymphadenopathy, Lymphocyte percentage decreased, Malaise, Metabolic function test normal
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Mitral valve incompetence, Monocyte percentage increased, Myocardial necrosis marker, Nausea, Neck pain
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Neutrophil percentage increased, Night sweats, Nuclear magnetic resonance imaging heart, Pain, Painful respiration
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Pericardial effusion, Pericarditis, Phonophobia, Photophobia, Pleural effusion
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Protein total increased, Prothrombin time prolonged, Pyrexia, Red blood cell count decreased, Red blood cell sedimentation rate increased
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Red cell distribution width increased, Serum ferritin increased, Sinus bradycardia, Thyroxine free normal, Tricuspid valve incompetence
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Troponin I normal, Troponin normal, Tuberculin test negative, Ultrasound abdomen abnormal, Urine analysis normal
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Viral infection, White blood cell count increased
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Blood cholesterol normal, Blood triglycerides normal, C-reactive protein increased, Chest X-ray normal, Chest pain
Clinical narrative: This study case was received from the investigator in a trial on 06 June 2011. A 21 year-old male subject with no significant medical history was found to have non-specific myocarditis 17 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) on 04 January 2011. Relevant laboratory data included: an abnormal Troponin I result with the highest recorded value of 00.59, an abnormal ECG, a normal Echocardiogram and an abnormal MRI (heart). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Drug screen negative, Dyspnoea, Echocardiogram, Electrocardiogram T wave inversion, Electrocardiogram abnormal
Clinical narrative: This study case was received from the investigator in a trial on 06 June 2011. A 21 year-old male subject with no significant medical history was found to have non-specific myocarditis 17 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) on 04 January 2011. Relevant laboratory data included: an abnormal Troponin I result with the highest recorded value of 00.59, an abnormal ECG, a normal Echocardiogram and an abnormal MRI (heart). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Fibrin D dimer normal, Full blood count normal, High density lipoprotein decreased, Hypoaesthesia, Laboratory test normal
Clinical narrative: This study case was received from the investigator in a trial on 06 June 2011. A 21 year-old male subject with no significant medical history was found to have non-specific myocarditis 17 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) on 04 January 2011. Relevant laboratory data included: an abnormal Troponin I result with the highest recorded value of 00.59, an abnormal ECG, a normal Echocardiogram and an abnormal MRI (heart). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Limb discomfort, Lipids, Low density lipoprotein normal, Metabolic function test normal, Pain
Clinical narrative: This study case was received from the investigator in a trial on 06 June 2011. A 21 year-old male subject with no significant medical history was found to have non-specific myocarditis 17 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) on 04 January 2011. Relevant laboratory data included: an abnormal Troponin I result with the highest recorded value of 00.59, an abnormal ECG, a normal Echocardiogram and an abnormal MRI (heart). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Pain in jaw, Paraesthesia, Red blood cell sedimentation rate normal, Sensation of pressure, Tenderness
Clinical narrative: This study case was received from the investigator in a trial on 06 June 2011. A 21 year-old male subject with no significant medical history was found to have non-specific myocarditis 17 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) on 04 January 2011. Relevant laboratory data included: an abnormal Troponin I result with the highest recorded value of 00.59, an abnormal ECG, a normal Echocardiogram and an abnormal MRI (heart). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Troponin I increased, Troponin T increased
Clinical narrative: This study case was received from the investigator in a trial on 06 June 2011. A 21 year-old male subject with no significant medical history was found to have non-specific myocarditis 17 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) on 04 January 2011. Relevant laboratory data included: an abnormal Troponin I result with the highest recorded value of 00.59, an abnormal ECG, a normal Echocardiogram and an abnormal MRI (heart). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Blood cholesterol normal, Blood triglycerides normal, C-reactive protein, Chest X-ray normal, Chest discomfort
Clinical narrative: This study case was received from the investigator in a trial on 06 June 2011. A 21 year-old male subject with no significant medical history was found to have non-specific myocarditis 17 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) on 04 January 2011. Relevant laboratory data included: an abnormal Troponin I result with the highest recorded value of 00.59, an abnormal ECG, a normal Echocardiogram and an abnormal MRI (heart). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.