chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL, TDAP, TYP, ANTH, SMALL, TDAP, TYP
Symptoms: Chills, Feeling abnormal, Hangover, Migraine, Pain
Clinical narrative: This case was received by Sanofi Pasteur on 10 May 2010 via QScan search on the VAERS database under reference number 379784. A 26 year-old male patient received the following vaccines: ACAM2000 (Sanofi Pasteur Biologics Co., lot number VV04-003A), TYPHIM VI (Sanofi Pasteur, lot number B09802), anthrax (Emergent Biosolutions, lot number FAV223) and BOOSTRIX (GlaxoSmithKline, lot number AC52B049A) on 12 January 2010. Seven days post vaccination the patient reported runny nose, chills and aching. The patient also reported waking up with migraines (no prior history of headaches), extreme hangover type feeling and per the patient "just not feeling right". The patient did not seek medical care for this event. It was reported that the patient recovered. No additional information was provided.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL, TDAP, TYP, ANTH, SMALL, TDAP, TYP
Symptoms: Rhinorrhoea
Clinical narrative: This case was received by Sanofi Pasteur on 10 May 2010 via QScan search on the VAERS database under reference number 379784. A 26 year-old male patient received the following vaccines: ACAM2000 (Sanofi Pasteur Biologics Co., lot number VV04-003A), TYPHIM VI (Sanofi Pasteur, lot number B09802), anthrax (Emergent Biosolutions, lot number FAV223) and BOOSTRIX (GlaxoSmithKline, lot number AC52B049A) on 12 January 2010. Seven days post vaccination the patient reported runny nose, chills and aching. The patient also reported waking up with migraines (no prior history of headaches), extreme hangover type feeling and per the patient "just not feeling right". The patient did not seek medical care for this event. It was reported that the patient recovered. No additional information was provided.
Age: 44.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Muscle strain, Pain
Clinical narrative: This case was received on 10 May 2010 via a QScan search on the VAERS database, under reference number 379932.  A 44 year old male patient received a percutaneous injection in the left arm of ACAM2000, (lot number not reported) on 06 January 2010.  Thirty-one days after vaccination, the patient injured his left arm while lifting a bucket of water.  The patient reported feeling a "pop" in his left arm, followed by a sharp pain directly underneath the smallpox vaccination site.  The patient reported that the pain was intense at times and also swelling of the left upper arm.  The pain increased with use and immobilization provided relieve.  The appearance of the smallpox vaccination site was noted as a reddish circle.  The patient was seen by a healthcare provider on Day 33.  No additional information was provided.  NOTE:  Although the manufacturer was reported as unknown in the case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination.  List of documents held by sender:  none.
Age: 44.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Sleep disorder
Clinical narrative: This case was received on 10 May 2010 via a QScan search on the VAERS database, under reference number 379932.  A 44 year old male patient received a percutaneous injection in the left arm of ACAM2000, (lot number not reported) on 06 January 2010.  Thirty-one days after vaccination, the patient injured his left arm while lifting a bucket of water.  The patient reported feeling a "pop" in his left arm, followed by a sharp pain directly underneath the smallpox vaccination site.  The patient reported that the pain was intense at times and also swelling of the left upper arm.  The pain increased with use and immobilization provided relieve.  The appearance of the smallpox vaccination site was noted as a reddish circle.  The patient was seen by a healthcare provider on Day 33.  No additional information was provided.  NOTE:  Although the manufacturer was reported as unknown in the case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination.  List of documents held by sender:  none.
Age: 44.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Injection site erythema, Oedema peripheral, Pain in extremity
Clinical narrative: This case was received on 10 May 2010 via a QScan search on the VAERS database, under reference number 379932.  A 44 year old male patient received a percutaneous injection in the left arm of ACAM2000, (lot number not reported) on 06 January 2010.  Thirty-one days after vaccination, the patient injured his left arm while lifting a bucket of water.  The patient reported feeling a "pop" in his left arm, followed by a sharp pain directly underneath the smallpox vaccination site.  The patient reported that the pain was intense at times and also swelling of the left upper arm.  The pain increased with use and immobilization provided relieve.  The appearance of the smallpox vaccination site was noted as a reddish circle.  The patient was seen by a healthcare provider on Day 33.  No additional information was provided.  NOTE:  Although the manufacturer was reported as unknown in the case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination.  List of documents held by sender:  none.
Age: 28.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: C-reactive protein normal, Cardiac enzymes normal, Chest pain, Echocardiogram normal, Electrocardiogram abnormal
Clinical narrative: This case was received on 10 May 2010 via a QScan search on the VAERS database, under reference number 381106. A 28 year-old patient received ACAM2000 (lot number W04003A) on 12 January 2010. Seven days after vaccination, the patient developed chest pain. She was diagnosed with possible pericarditis. Cardiac enzymes were negative; CBC normal; chemistry normal; thyroid studies negative; C-reactive protein normal; ESR normal; and echocardiogram was normal. An electrocardiogram showed QRS abnormalities; normal sinus rhythm with sinus arrhythmia; inf-lat ST elevation; CRO pericarditis versus early repolarization/normal variant. The patient recovered. There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date.
Age: 28.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Full blood count normal, Laboratory test normal, Pericarditis, Red blood cell sedimentation rate normal, Thyroid function test normal
Clinical narrative: This case was received on 10 May 2010 via a QScan search on the VAERS database, under reference number 381106. A 28 year-old patient received ACAM2000 (lot number W04003A) on 12 January 2010. Seven days after vaccination, the patient developed chest pain. She was diagnosed with possible pericarditis. Cardiac enzymes were negative; CBC normal; chemistry normal; thyroid studies negative; C-reactive protein normal; ESR normal; and echocardiogram was normal. An electrocardiogram showed QRS abnormalities; normal sinus rhythm with sinus arrhythmia; inf-lat ST elevation; CRO pericarditis versus early repolarization/normal variant. The patient recovered. There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date.
Age: 28.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: C-reactive protein normal, Cardiac enzymes normal, Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation
Clinical narrative: This case was received on 10 May 2010 via a QScan search on the VAERS database, under reference number 381106. A 28 year-old patient received ACAM2000 (lot number W04003A) on 12 January 2010. Seven days after vaccination, the patient developed chest pain. She was diagnosed with possible pericarditis. Cardiac enzymes were negative; CBC normal; chemistry normal; thyroid studies negative; C-reactive protein normal; ESR normal; and echocardiogram was normal. An electrocardiogram showed QRS abnormalities; normal sinus rhythm with sinus arrhythmia; inf-lat ST elevation; CRO pericarditis versus early repolarization/normal variant. The patient recovered. There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date.
Age: 28.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Electrocardiogram abnormal, Full blood count normal, Laboratory test normal, QRS axis abnormal, Red blood cell sedimentation rate normal
Clinical narrative: This case was received on 10 May 2010 via a QScan search on the VAERS database, under reference number 381106. A 28 year-old patient received ACAM2000 (lot number W04003A) on 12 January 2010. Seven days after vaccination, the patient developed chest pain. She was diagnosed with possible pericarditis. Cardiac enzymes were negative; CBC normal; chemistry normal; thyroid studies negative; C-reactive protein normal; ESR normal; and echocardiogram was normal. An electrocardiogram showed QRS abnormalities; normal sinus rhythm with sinus arrhythmia; inf-lat ST elevation; CRO pericarditis versus early repolarization/normal variant. The patient recovered. There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date.
Age: 28.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Sinus arrhythmia, Thyroid function test normal
Clinical narrative: This case was received on 10 May 2010 via a QScan search on the VAERS database, under reference number 381106. A 28 year-old patient received ACAM2000 (lot number W04003A) on 12 January 2010. Seven days after vaccination, the patient developed chest pain. She was diagnosed with possible pericarditis. Cardiac enzymes were negative; CBC normal; chemistry normal; thyroid studies negative; C-reactive protein normal; ESR normal; and echocardiogram was normal. An electrocardiogram showed QRS abnormalities; normal sinus rhythm with sinus arrhythmia; inf-lat ST elevation; CRO pericarditis versus early repolarization/normal variant. The patient recovered. There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date.
Age: 41.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Acute myocardial infarction, Electrocardiogram abnormal
Clinical narrative: This report was received from the investigator in a trial on 05 March 2010. A 41-year-old male subject received ACAM2000 (lot number not reported) on 14 May 2009. Two days prior, on 12 May 2009, the subject received anthrax vaccine (manufacturer and lot number were not reported. Thirteen days after receipt of ACAM2000, the subject reportedly experienced an acute myocardial infarction. An electrocardiogram, performed Day 13, was reported as abnormal. The outcome was not reported. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 35.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Angina pectoris
Clinical narrative: This report was received from the investigator in a trial on 12 April 2010. A 35 year-old male subject received the following vaccines on 15 March 2009: ACAM2000 (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported). Nine days after vaccination, the subject reportedly experienced angina pectoris. The subject had a history of high blood pressure, elevated cholesterol, abnormal electrocardiogram, dizziness/fainting spells, shortness of breath, asthma and numbness or paralysis. The outcome was not reported. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Encephalitis, Nuclear magnetic resonance imaging spinal cord abnormal
Clinical narrative: This report was received from the investigator in a trial on 12 April 2010. A 29 year-old male subject with medical history significant for headaches and numbness or paralysis received ACAM2000 (lot number not reported) on 05 December 2008. The subject also received anthrax vaccine (manufacturer and lot number were not reported) that same day. Sixteen days prior, the subject received TYPHIM VI (lot # not reported) and anthrax vaccine (manufacturer and lot # not reported). Thirteen days after receipt of ACAM2000, the subject was reportedly diagnosed with encephalitis of unspecified cause. An MRI of the spinal cord on 18 December 2008 was abnormal, no other details were provided. No other information was provided. The outcome was not reported. Note: There is no reported causality assessment as this a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pericardial disease, Pericarditis, Troponin I increased
Clinical narrative: This report was received from the investigator in the trial on 12 April 2010. A 27 year-old male subject received the following vaccine on 15 January 2009: ACAM2000 (lot number not reported). Twenty days after vaccination, the subject was diagnosed with unspecified acute pericarditis and unspecified disease of the pericardium. The subject had no reported medical history. The subject had an abnormal Troponin I on 28 January 2009 (results 00.71). No other information was provided. The outcome was not reported.  There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study.
Age: 57.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericardial disease
Clinical narrative: This report was received from the investigator in a trial on 12 April 2010. A 57 year-old male subject received ACAM2000 (lot number not reported) on 24 February 2009; and anthrax vaccine (other manufacturer and lot number not reported) on 17 February 2009. On 09 March 2009 (13 days after vaccination with ACAM2000 the subject was diagnosed with unspecified disease of the pericardium. The subject had a history of abnormal electrocardiogram (date not provided). On 25 February 2009, the subject had an electrocardiogram which was abnormal. On 11 March 2009, the subject had an echocardiogram which was normal. The outcome was not reported. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Pericardial disease
Clinical narrative: This report was received from the investigator in a trial on 12 April 2010. A 25 year-old male subject received the following vaccines on 06 March 2009: ACAM2000 (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported). Twelve days after vaccination, the subject was diagnosed with unspecified disease of the pericardium. The subject had a history of headaches. No further information was provided. The outcome was not reported. There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Chest discomfort, Electrocardiogram normal
Clinical narrative: Initial report received on 16 April 2010 from an investigator participating in a trial. A 26 year-old female subject received ACAM2000 (lot number not reported) and tetanus vaccine (manufacturer and lot number not reported) on 05 April 2010. Five days after vaccination the subject developed severe chest pressure. The subject was subsequently hospitalized on Day 9 for a cardiology evaluation. The subject had no relevant medical history. An electrocardiogram performed on the day of admission was reported as normal. Per the investigator, the subject's symptoms, proximity to vaccination and hospital discharge regimen could be consistent with vaccine-induced myopericarditis. The final diagnosis is pending. The subject was discharged from the hospital on Day 10. Per the investigator, the event was assessed as possibly related. Follow-up received from the investigator on 29 April 2010. The subject was seen for Visit 2 on 14 April 2010 and in addition to the symptom of chest pressure, the subject reported the following adverse events: mild shortness of breath, mild fatigue, nausea, sweats and mild swollen lymph nodes in the neck on the left side. The onset for all symptoms was 10 April 2010 (five days after vaccination). None of these events were assessed as serious. At Visit 2, the subject had a Troponin I drawn which was <0.10 (negative) and an electrocardiogram which on final report was normal. The subject reported that several tests were performed (electrocardiogram, echocardiogram, and laboratory work) and all were normal. The subject was discharged with prescriptions for Ibuprofen (400 mg), acetaminophen (325 mg) and NEXIUM (40 mg). The subject was placed on light duty with orders to report back to Cardiology in 4 weeks. The final diagnosis is pending. Hospital records have been requested. List of documents held by sender (29 April 2010): none.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Chest discomfort, Dyspnoea, Echocardiogram normal, Electrocardiogram normal, Fatigue
Clinical narrative: Initial report received on 16 April 2010 from an investigator participating in a trial. A 26 year-old female subject received ACAM2000 (lot number not reported) and tetanus vaccine (manufacturer and lot number not reported) on 05 April 2010. Five days after vaccination the subject developed severe chest pressure. The subject was subsequently hospitalized on Day 9 for a cardiology evaluation. The subject had no relevant medical history. An electrocardiogram performed on the day of admission was reported as normal. Per the investigator, the subject's symptoms, proximity to vaccination and hospital discharge regimen could be consistent with vaccine-induced myopericarditis. The final diagnosis is pending. The subject was discharged from the hospital on Day 10. Per the investigator, the event was assessed as possibly related. Follow-up received from the investigator on 29 April 2010. The subject was seen for Visit 2 on 14 April 2010 and in addition to the symptom of chest pressure, the subject reported the following adverse events: mild shortness of breath, mild fatigue, nausea, sweats and mild swollen lymph nodes in the neck on the left side. The onset for all symptoms was 10 April 2010 (five days after vaccination). None of these events were assessed as serious. At Visit 2, the subject had a Troponin I drawn which was <0.10 (negative) and an electrocardiogram which on final report was normal. The subject reported that several tests were performed (electrocardiogram, echocardiogram, and laboratory work) and all were normal. The subject was discharged with prescriptions for Ibuprofen (400 mg), acetaminophen (325 mg) and NEXIUM (40 mg). The subject was placed on light duty with orders to report back to Cardiology in 4 weeks. The final diagnosis is pending. Hospital records have been requested. List of documents held by sender (29 April 2010): none.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Hyperhidrosis, Laboratory test normal, Lymphadenopathy, Nausea, Troponin I
Clinical narrative: Initial report received on 16 April 2010 from an investigator participating in a trial. A 26 year-old female subject received ACAM2000 (lot number not reported) and tetanus vaccine (manufacturer and lot number not reported) on 05 April 2010. Five days after vaccination the subject developed severe chest pressure. The subject was subsequently hospitalized on Day 9 for a cardiology evaluation. The subject had no relevant medical history. An electrocardiogram performed on the day of admission was reported as normal. Per the investigator, the subject's symptoms, proximity to vaccination and hospital discharge regimen could be consistent with vaccine-induced myopericarditis. The final diagnosis is pending. The subject was discharged from the hospital on Day 10. Per the investigator, the event was assessed as possibly related. Follow-up received from the investigator on 29 April 2010. The subject was seen for Visit 2 on 14 April 2010 and in addition to the symptom of chest pressure, the subject reported the following adverse events: mild shortness of breath, mild fatigue, nausea, sweats and mild swollen lymph nodes in the neck on the left side. The onset for all symptoms was 10 April 2010 (five days after vaccination). None of these events were assessed as serious. At Visit 2, the subject had a Troponin I drawn which was <0.10 (negative) and an electrocardiogram which on final report was normal. The subject reported that several tests were performed (electrocardiogram, echocardiogram, and laboratory work) and all were normal. The subject was discharged with prescriptions for Ibuprofen (400 mg), acetaminophen (325 mg) and NEXIUM (40 mg). The subject was placed on light duty with orders to report back to Cardiology in 4 weeks. The final diagnosis is pending. Hospital records have been requested. List of documents held by sender (29 April 2010): none.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Vaccination complication
Clinical narrative: Initial report received on 16 April 2010 from an investigator participating in a trial. A 26 year-old female subject received ACAM2000 (lot number not reported) and tetanus vaccine (manufacturer and lot number not reported) on 05 April 2010. Five days after vaccination the subject developed severe chest pressure. The subject was subsequently hospitalized on Day 9 for a cardiology evaluation. The subject had no relevant medical history. An electrocardiogram performed on the day of admission was reported as normal. Per the investigator, the subject's symptoms, proximity to vaccination and hospital discharge regimen could be consistent with vaccine-induced myopericarditis. The final diagnosis is pending. The subject was discharged from the hospital on Day 10. Per the investigator, the event was assessed as possibly related. Follow-up received from the investigator on 29 April 2010. The subject was seen for Visit 2 on 14 April 2010 and in addition to the symptom of chest pressure, the subject reported the following adverse events: mild shortness of breath, mild fatigue, nausea, sweats and mild swollen lymph nodes in the neck on the left side. The onset for all symptoms was 10 April 2010 (five days after vaccination). None of these events were assessed as serious. At Visit 2, the subject had a Troponin I drawn which was <0.10 (negative) and an electrocardiogram which on final report was normal. The subject reported that several tests were performed (electrocardiogram, echocardiogram, and laboratory work) and all were normal. The subject was discharged with prescriptions for Ibuprofen (400 mg), acetaminophen (325 mg) and NEXIUM (40 mg). The subject was placed on light duty with orders to report back to Cardiology in 4 weeks. The final diagnosis is pending. Hospital records have been requested. List of documents held by sender (29 April 2010): none.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Echocardiogram normal, Electrocardiogram normal, Pericardial disease, Troponin I
Clinical narrative: Initial report received on 16 April 2010 from an investigator participating in a trial. A 26 year-old female subject received ACAM2000 (lot number not reported) and tetanus vaccine (manufacturer and lot number not reported) on 05 April 2010. Five days after vaccination the subject developed severe chest pressure. The subject was subsequently hospitalized on Day 9 for a cardiology evaluation. The subject had no relevant medical history. An electrocardiogram performed on the day of admission was reported as normal. Per the investigator, the subject's symptoms, proximity to vaccination and hospital discharge regimen could be consistent with vaccine-induced myopericarditis. The final diagnosis is pending. The subject was discharged from the hospital on Day 10. Per the investigator, the event was assessed as possibly related. Follow-up received from the investigator on 29 April 2010. The subject was seen for Visit 2 on 14 April 2010 and in addition to the symptom of chest pressure, the subject reported the following adverse events: mild shortness of breath, mild fatigue, nausea, sweats and mild swollen lymph nodes in the neck on the left side. The onset for all symptoms was 10 April 2010 (five days after vaccination). None of these events were assessed as serious. At Visit 2, the subject had a Troponin I drawn which was <0.10 (negative) and an electrocardiogram which on final report was normal. The subject reported that several tests were performed (electrocardiogram, echocardiogram, and laboratory work) and all were normal. The subject was discharged with prescriptions for Ibuprofen (400 mg), acetaminophen (325 mg) and NEXIUM (40 mg). The subject was placed on light duty with orders to report back to Cardiology in 4 weeks. The final diagnosis is pending. Hospital records have been requested. List of documents held by sender (29 April 2010): none.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Cardiac enzymes normal, Chest discomfort, Cough, Dyspnoea, Echocardiogram normal
Clinical narrative: Initial report received on 16 April 2010 from an investigator participating in a trial. A 26 year-old female subject received ACAM2000 (lot number not reported) and tetanus vaccine (manufacturer and lot number not reported) on 05 April 2010. Five days after vaccination the subject developed severe chest pressure. The subject was subsequently hospitalized on Day 9 for a cardiology evaluation. The subject had no relevant medical history. An electrocardiogram performed on the day of admission was reported as normal. Per the investigator, the subject's symptoms, proximity to vaccination and hospital discharge regimen could be consistent with vaccine-induced myopericarditis. The final diagnosis is pending. The subject was discharged from the hospital on Day 10. Per the investigator, the event was assessed as possibly related. Follow-up received from the investigator on 29 April 2010. The subject was seen for Visit 2 on 14 April 2010 and in addition to the symptom of chest pressure, the subject reported the following adverse events: mild shortness of breath, mild fatigue, nausea, sweats and mild swollen lymph nodes in the neck on the left side. The onset for all symptoms was 10 April 2010 (five days after vaccination). None of these events were assessed as serious. At Visit 2, the subject had a Troponin I drawn which was <0.10 (negative) and an electrocardiogram which on final report was normal. The subject reported that several tests were performed (electrocardiogram, echocardiogram, and laboratory work) and all were normal. The subject was discharged with prescriptions for Ibuprofen (400 mg), acetaminophen (325 mg) and NEXIUM (40 mg). The subject was placed on light duty with orders to report back to Cardiology in 4 weeks. The final diagnosis is pending. Hospital records have been requested. List of documents held by sender (29 April 2010): none.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Electrocardiogram normal, Lymph node pain, Lymphadenopathy, Myopericarditis, Night sweats
Clinical narrative: Initial report received on 16 April 2010 from an investigator participating in a trial. A 26 year-old female subject received ACAM2000 (lot number not reported) and tetanus vaccine (manufacturer and lot number not reported) on 05 April 2010. Five days after vaccination the subject developed severe chest pressure. The subject was subsequently hospitalized on Day 9 for a cardiology evaluation. The subject had no relevant medical history. An electrocardiogram performed on the day of admission was reported as normal. Per the investigator, the subject's symptoms, proximity to vaccination and hospital discharge regimen could be consistent with vaccine-induced myopericarditis. The final diagnosis is pending. The subject was discharged from the hospital on Day 10. Per the investigator, the event was assessed as possibly related. Follow-up received from the investigator on 29 April 2010. The subject was seen for Visit 2 on 14 April 2010 and in addition to the symptom of chest pressure, the subject reported the following adverse events: mild shortness of breath, mild fatigue, nausea, sweats and mild swollen lymph nodes in the neck on the left side. The onset for all symptoms was 10 April 2010 (five days after vaccination). None of these events were assessed as serious. At Visit 2, the subject had a Troponin I drawn which was <0.10 (negative) and an electrocardiogram which on final report was normal. The subject reported that several tests were performed (electrocardiogram, echocardiogram, and laboratory work) and all were normal. The subject was discharged with prescriptions for Ibuprofen (400 mg), acetaminophen (325 mg) and NEXIUM (40 mg). The subject was placed on light duty with orders to report back to Cardiology in 4 weeks. The final diagnosis is pending. Hospital records have been requested. List of documents held by sender (29 April 2010): none.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Orthopnoea
Clinical narrative: Initial report received on 16 April 2010 from an investigator participating in a trial. A 26 year-old female subject received ACAM2000 (lot number not reported) and tetanus vaccine (manufacturer and lot number not reported) on 05 April 2010. Five days after vaccination the subject developed severe chest pressure. The subject was subsequently hospitalized on Day 9 for a cardiology evaluation. The subject had no relevant medical history. An electrocardiogram performed on the day of admission was reported as normal. Per the investigator, the subject's symptoms, proximity to vaccination and hospital discharge regimen could be consistent with vaccine-induced myopericarditis. The final diagnosis is pending. The subject was discharged from the hospital on Day 10. Per the investigator, the event was assessed as possibly related. Follow-up received from the investigator on 29 April 2010. The subject was seen for Visit 2 on 14 April 2010 and in addition to the symptom of chest pressure, the subject reported the following adverse events: mild shortness of breath, mild fatigue, nausea, sweats and mild swollen lymph nodes in the neck on the left side. The onset for all symptoms was 10 April 2010 (five days after vaccination). None of these events were assessed as serious. At Visit 2, the subject had a Troponin I drawn which was <0.10 (negative) and an electrocardiogram which on final report was normal. The subject reported that several tests were performed (electrocardiogram, echocardiogram, and laboratory work) and all were normal. The subject was discharged with prescriptions for Ibuprofen (400 mg), acetaminophen (325 mg) and NEXIUM (40 mg). The subject was placed on light duty with orders to report back to Cardiology in 4 weeks. The final diagnosis is pending. Hospital records have been requested. List of documents held by sender (29 April 2010): none.
Age: 38.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Electrocardiogram normal, Pericarditis, Troponin increased
Clinical narrative: This study case was received from the investigator on 23 April 2010. A 38 year-old male subject with a medical history significant for high blood pressure and elevated cholesterol received the following vaccines on 06 July 2009: ACAM 2000 (lot number not reported); TYPHIM VI (lot number not reported) and anthrax (manufacturer and lot number not reported). Eighteen days post vaccination the subject was diagnosed with acute pericarditis, unspecified. It was also reported that on 17 July 2009 the subject had an abnormal troponin (actual result was 00.81) and a normal electrocardiogram. No other information was provided. There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study.
Age: 33.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Acute myocardial infarction, Electrocardiogram abnormal
Clinical narrative: This report was received from the investigator in a trial on 23 April 2010. A 33 year-old male subject with a history of chest pain received the following vaccines on 24 June 2009: ACAM2000 (lot number not reported); TYPHIM VI (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported). Fifteen days after vaccination, the subject was diagnosed with an acute myocardial infarction of the inferolateral wall. The subject's record also included ICD-9 code with the same diagnosis date. Nine days after vaccination the subject had an abnormal electrocardiogram. The outcome was not reported. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: FLUX, SMALL, ANTH, FLU3, SMALL
Symptoms: Acute myocardial infarction, Echocardiogram normal, Electrocardiogram abnormal, Troponin I increased
Clinical narrative: This report was received from the investigator in a trial on 23 April 2010. A 20 year-old male subject with a history of chest pain and headaches received the following vaccines on 02 April 2009: ACAM2000 (lot number not reported); influenza split virus vaccine (manufacturer unknown, lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported). Five days after vaccination, the subject was diagnosed with an acute myocardial infarction, subendocardial infarction. The subject's record also included ICD-9 code with the same diagnosis date. The subject had the following investigations: an electrocardiogram on 14 April 2009 reported as abnormal; a Troponin I level on 20 April 2009 reported as 0.04, abnormal; and an echocardiogram on 08 May 2009 reported as normal. The outcome was not reported. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 41.0
Sex: M
Vaccine: ANTH, HEP, SMALL, TYP, ANTH, HEP, SMALL, TYP
Symptoms: Cardiomyopathy, Condition aggravated
Clinical narrative: This report was received from the investigator in a trial on 06 May 2010. A 41 year-old male subject received the following vaccines on 29 July 2009: ACAM2000 (lot number not reported); TYPHIM VI (lot number not reported); anthrax vaccine (other manufacturer, lot number not reported); and hepatitis B vaccine (other manufacturer, lot number not reported). One day after vaccination, the subject was diagnosed with cardiomyopathy. No additional information was provided and the outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Myocarditis, Troponin I increased
Clinical narrative: This report was received from the investigator in a trial on 06 May 2010. A 25 year-old male subject received ACAM2000 (lot number not reported) on 22 July 2009. Fourteen days after vaccination, the subject was diagnosed with non-specific myocarditis. Twenty-two days after vaccination, the diagnosis of acute myocarditis was reported. The subject had a history of elevated cholesterol, shortness of breath, asthma, eczema, headaches and psychiatric illness. On Day 14 (05 August 2009), the subject's Troponin I was 4.66 (abnormal). The subject had a normal echocardiogram on Day 15 (06 August 2009) and a normal electrocardiogram on Day 22 (13 August 2009). The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Prinzmetal angina
Clinical narrative: This report was received from the investigator in a trial on 06 May 2010. A 29 year-old male subject received the following vaccines on 11 May 2009: ACAM2000 (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported). The subject previously received TYPHIM VI (lot number not reported on 20 April 2009. Twenty eight days after receiving the ACAM2000, the subject was diagnosed with prinzmetal angina. The subject had a history of hypertension. An echocardiogram performed on 08 June 2009 and an electrocardiogram performed on 10 June 2009 were both normal. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Myocarditis, Nuclear magnetic resonance imaging normal, Troponin I increased
Clinical narrative: This study case was received from the investigator on 06 May 2010. A 20 year-old male subject with no significant medical history was vaccinated with ACAM2000 on 07 August 2009. Fifteen days post-vaccination on 27 August 2009, the subject was diagnosed with other and unspecified acute myocarditis and the following day on 28 August 2009 a diagnosis of non-specified myocarditis was reported. The subject had an abnormal troponin I (8.9) on 18 August 2009, an abnormal electrocardiogram on 18 August 2009, an abnormal echocardiogram on 19 August 2009 and a normal MRI of the heart on 01 September 2009. No other information was provided. The outcome of the subject was not reported. List of documents held by sender: None. Note: Additional information will be requested from the investigator. There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study.
Sex: U
Vaccine: YF, YF
Symptoms: Hypoaesthesia, Hypoaesthesia facial, Paraesthesia, Pruritus, Rash erythematous
Clinical narrative: Initial report received from a health care professional on 05 May 2010. An unidentified patient, with medical history not reported, had received an injection of YF VAX (Lot number not reported) on 23 March 2010 and developed hives widespread over the body. The hives, which were red, raised and itchy, appeared on the patient's shoulders, hips, and trunk. The patient was seen in the emergency room and had been placed on ZYRTEC with some improvement. Recently the patient reported numbness and tingling in the left hand and left side of face. The patient was being seen by an allergist. The outcome for the events was reported as not recovered. Documents held by sender none.
Sex: U
Vaccine: YF, YF
Symptoms: Urticaria
Clinical narrative: Initial report received from a health care professional on 05 May 2010. An unidentified patient, with medical history not reported, had received an injection of YF VAX (Lot number not reported) on 23 March 2010 and developed hives widespread over the body. The hives, which were red, raised and itchy, appeared on the patient's shoulders, hips, and trunk. The patient was seen in the emergency room and had been placed on ZYRTEC with some improvement. Recently the patient reported numbness and tingling in the left hand and left side of face. The patient was being seen by an allergist. The outcome for the events was reported as not recovered. Documents held by sender none.
Sex: U
Vaccine: YF, YF
Symptoms: Hypoaesthesia, Hypoaesthesia facial, Paraesthesia, Pruritus, Urticaria
Clinical narrative: Initial report received from a health care professional on 05 May 2010. An unidentified patient, with medical history not reported, had received an injection of YF VAX (Lot number not reported) on 23 March 2010 and developed hives widespread over the body. The hives, which were red, raised and itchy, appeared on the patient's shoulders, hips, and trunk. The patient was seen in the emergency room and had been placed on ZYRTEC with some improvement. Recently the patient reported numbness and tingling in the left hand and left side of face. The patient was being seen by an allergist. The outcome for the events was reported as not recovered. Documents held by sender none.
Age: 27.0
Sex: M
Vaccine: ANTH, JEVX, SMALL, TYP, ANTH, JEVX, SMALL, TYP
Symptoms: Electrocardiogram abnormal, Pericarditis, Troponin I
Clinical narrative: This report was received from the investigator in trial on 20 May 2010. A 27 year-old male subject received the following vaccines on 27 October 2009: ACAM2000 (lot number not reported); TYPHIM VI (sanofi pasteur, lot number not reported), anthrax (manufacturer and lot number not reported) and Japanese Encephalitis (manufacturer and lot number not reported). The subject was vaccinated with influenza, LIVE intranasal (manufacturer and lot number not reported) three weeks prior. Six days after smallpox vaccination on 02 November 2009, the subject was diagnosed with acute pericarditis unspecified. The subject had an abnormal electrocardiogram on 02 November 2009 and had a normal troponin I test on 13 November 2009. No other information was provided. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Myocarditis, Troponin I increased
Clinical narrative: This report was received from the investigator in a trial on 20 May 2010. A 20 year-old male subject with medical history significant for dizziness/fainting spells received the following vaccine on 17 October 2009: ACAM2000 (lot number not reported). The subject was vaccinated two weeks prior to that on 03 October 2009 with influenza split virus vaccine (manufacturer and lot number not reported). Nineteen days after vaccination with ACAM2000, on 05 November 2009, the subject was diagnosed with non-specific myocarditis. The subject had an abnormal electrocardiogram result on 30 October 2009 and an abnormal troponin I result of 7.90 on 30 October 2009. Echocardiogram results were not reported. No other information was provided. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Electrocardiogram abnormal, Myocarditis, Troponin I increased
Clinical narrative: This report was received from the investigator in a trial on 20 May 2010. A 20 year-old male subject with medical history significant for dizziness/fainting spells received the following vaccine on 17 October 2009: ACAM2000 (lot number not reported). The subject was vaccinated two weeks prior to that on 03 October 2009 with influenza split virus vaccine (manufacturer and lot number not reported). Nineteen days after vaccination with ACAM2000, on 05 November 2009, the subject was diagnosed with non-specific myocarditis. The subject had an abnormal electrocardiogram result on 30 October 2009 and an abnormal troponin I result of 7.90 on 30 October 2009. Echocardiogram results were not reported. No other information was provided. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study.
Age: 28.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Nuclear magnetic resonance imaging normal, Pericardial disease, Troponin I
Clinical narrative: This report was received from the investigator in a trial on 20 May 2010. A 28 year-old male subject with no relevant medical history received the following vaccines: ACAM2000 (lot number not reported) on 06 January 2010; and TYPHIM VI (lot number not reported), anthrax vaccine (other manufacturer and lot number not reported), and hepatitis B vaccine (other manufacturer and lot number not reported) on 05 January 2010. Sixteen days after receipt of ACAM2000 subject was diagnosed with unspecified disease of the pericardium. On Day 12 (18 January 2010), the subject had a normal Troponin I level. On Day 13 (19 January 2010), the subject had an abnormal electrocardiogram and a normal echocardiogram. On Day 19 (25 January 2010), the subject had an MRI of the heart which was normal. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Electrocardiogram abnormal, Pericardial disease, Troponin I
Clinical narrative: This report was received from the investigator in a trial on 20 May 2010. A 22 year-old male subject with a history of palpitations/pounding heart without exercise, chest pain, chest pressure, pericarditis and abnormal electrocardiogram, received ACAM2000 (lot number not reported) on 05 August 2009. The subject had previously received anthrax vaccine (other manufacturer and lot number not reported) on 23 July 2009. On Day 7 (12 August 2009), the subject had a normal Troponin I level and an abnormal electrocardiogram. Eight days after receipt of ACAM2000, the subject was diagnosed with unspecified disease of the pericardium. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Laboratory test, Pericardial disease
Clinical narrative: This report was received from the investigator in a trial on 20 May 2010. Additional information was received on 24 May 2010 from the investigator. A 29 year-old male subject whose medical history was not available received the following vaccines: ACAM2000, (lot number not reported) on 18 December 2008; and anthrax vaccine (other manufacturer and lot number not reported), and hepatitis B vaccine (other manufacturer and lot number not reported) on 09 December 2008. Nine days after receipt of ACAM2000, the subject was diagnosed with unspecified disease of the pericardium. Results of diagnostic testing were not available. The outcome was not reported. Additional information will be requested from the investigator. There is no report of causality assessment as this is a safety surveillance (data mining, non-interventional) study.
Age: 29.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Diagnostic procedure, Pericardial disease
Clinical narrative: This report was received from the investigator in a trial on 20 May 2010. Additional information was received on 24 May 2010 from the investigator. A 29 year-old male subject whose medical history was not available received the following vaccines: ACAM2000, (lot number not reported) on 18 December 2008; and anthrax vaccine (other manufacturer and lot number not reported), and hepatitis B vaccine (other manufacturer and lot number not reported) on 09 December 2008. Nine days after receipt of ACAM2000, the subject was diagnosed with unspecified disease of the pericardium. Results of diagnostic testing were not available. The outcome was not reported. Additional information will be requested from the investigator. There is no report of causality assessment as this is a safety surveillance (data mining, non-interventional) study.