chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Bundle branch block right, Echocardiogram normal, Ejection fraction normal, Electrocardiogram PR interval, Electrocardiogram QT shortened
Clinical narrative: Initial solicited report received from an investigator (Defense Health Agency) in the above mentioned trial on 21 September 2017. An 18 year-old male subject with dizziness/fainting spells and no other significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 21 July 2017. On 31 July 2017, 10 days after vaccination the subject was diagnosed with I30.9 acute pericarditis, unspecified and I51.4 myocarditis, unspecified. The lab data included, ECG- Abnormal, and Echocardiogram - Normal, Troponin I result abnormal 00.14, all three done were on 31 July 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the events, I30.9 acute pericarditis, unspecified and I51.4 myocarditis, unspecified was not reported. Relationship to investigational product according to company: associated Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none.; Sender's Comments: This case involves an 18-year-old male subject with significant medical history of dizziness or fainting spells who developed myocarditis unspecified and acute pericarditis unspecified with favorable temporal association post vaccination with ACAM2000. Myocarditis and pericarditis are listed event for ACAM2000 vaccine. Alternative etiologies could be pulmonary edema, pulmonary embolism, aortic dissection, esophageal rupture and pneumothorax. History of allergies or trauma was not reported. Based on missing additional information on confirmation of diagnosis with CK-MB assays, myocardial biopsy, role of study vaccine can not be ruled out.
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Electrocardiogram ST segment elevation, Electrocardiogram T wave normal, Electrocardiogram abnormal, Left ventricular hypertrophy, Myocarditis
Clinical narrative: Initial solicited report received from an investigator (Defense Health Agency) in the above mentioned trial on 21 September 2017. An 18 year-old male subject with dizziness/fainting spells and no other significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 21 July 2017. On 31 July 2017, 10 days after vaccination the subject was diagnosed with I30.9 acute pericarditis, unspecified and I51.4 myocarditis, unspecified. The lab data included, ECG- Abnormal, and Echocardiogram - Normal, Troponin I result abnormal 00.14, all three done were on 31 July 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the events, I30.9 acute pericarditis, unspecified and I51.4 myocarditis, unspecified was not reported. Relationship to investigational product according to company: associated Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none.; Sender's Comments: This case involves an 18-year-old male subject with significant medical history of dizziness or fainting spells who developed myocarditis unspecified and acute pericarditis unspecified with favorable temporal association post vaccination with ACAM2000. Myocarditis and pericarditis are listed event for ACAM2000 vaccine. Alternative etiologies could be pulmonary edema, pulmonary embolism, aortic dissection, esophageal rupture and pneumothorax. History of allergies or trauma was not reported. Based on missing additional information on confirmation of diagnosis with CK-MB assays, myocardial biopsy, role of study vaccine can not be ruled out.
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pericarditis, Troponin I increased
Clinical narrative: Initial solicited report received from an investigator (Defense Health Agency) in the above mentioned trial on 21 September 2017. An 18 year-old male subject with dizziness/fainting spells and no other significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 21 July 2017. On 31 July 2017, 10 days after vaccination the subject was diagnosed with I30.9 acute pericarditis, unspecified and I51.4 myocarditis, unspecified. The lab data included, ECG- Abnormal, and Echocardiogram - Normal, Troponin I result abnormal 00.14, all three done were on 31 July 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the events, I30.9 acute pericarditis, unspecified and I51.4 myocarditis, unspecified was not reported. Relationship to investigational product according to company: associated Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none.; Sender's Comments: This case involves an 18-year-old male subject with significant medical history of dizziness or fainting spells who developed myocarditis unspecified and acute pericarditis unspecified with favorable temporal association post vaccination with ACAM2000. Myocarditis and pericarditis are listed event for ACAM2000 vaccine. Alternative etiologies could be pulmonary edema, pulmonary embolism, aortic dissection, esophageal rupture and pneumothorax. History of allergies or trauma was not reported. Based on missing additional information on confirmation of diagnosis with CK-MB assays, myocardial biopsy, role of study vaccine can not be ruled out.
Age: 10.0
Sex: M
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Pruritus generalised, Skin reaction, Urticaria
Clinical narrative: Patient developed itching all over and hives within minutes of administration of vaccines. Oral administration of BENADRYL 25 mg was ordered within minutes of reporting symptoms and exam by physician of airway and skin reaction. Symptoms subsided within minutes.
Age: 4.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient given extra dose of varicella. MMR with varicella and a varicella dose. Provider did not realize MMR with varicella. No adverse reactions. Medical director, VAERS notified, record entered and family notified.
Age: 65.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Arthralgia, Joint swelling, Swollen tongue
Clinical narrative: Patient got her shot on 09/16/2017 for FLUAD and PREVNAR 13. She came on 09/23/2017 and stated she had a reaction . Her tongue swelled and her hip area became swollen  and achy too. She said she took Benadryl and she felt better and didn't go to the hospital.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient complained on 9/24/17 that her arm was still achy and it was hard to raise it high.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Injection site erythema, Injection site oedema
Clinical narrative: Redness and edema at site in left deltoid. Temp of 101.2 po. 650mg of Tylenol given.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Blood test, Contusion
Clinical narrative: Exactly 1 week of getting her second round of the HepA vaccine she began to have a strange bruising like rash begin on 09-07-2017 we took her to the Emergency Room where she was misdiagnosed. 2 days later her face and eyes began to swell along with her hands, ankles, and knees. The rash/bruising continued to get worse. 09-09-2017 she was diagnosed with HSP or Henoch-Schonlein Purpura. We have gone to the ER 4 times, urgent care, her PCP, and 2 specialists (blood and kidney). Just about all of the doctors seen have told us the HepA vaccine very likely triggered the HSP because she was perfectly healthy before getting the shot. In the past 19 days my 3 year old has gone through pure hell. Several breakouts a day, large bruising all over her body, lots of swelling, itching, pain in her joints on a daily basis that have been crippling at times, pain in her stomach and back.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Eye swelling, Gait inability, Henoch-Schonlein purpura, Joint swelling, Peripheral swelling
Clinical narrative: Exactly 1 week of getting her second round of the HepA vaccine she began to have a strange bruising like rash begin on 09-07-2017 we took her to the Emergency Room where she was misdiagnosed. 2 days later her face and eyes began to swell along with her hands, ankles, and knees. The rash/bruising continued to get worse. 09-09-2017 she was diagnosed with HSP or Henoch-Schonlein Purpura. We have gone to the ER 4 times, urgent care, her PCP, and 2 specialists (blood and kidney). Just about all of the doctors seen have told us the HepA vaccine very likely triggered the HSP because she was perfectly healthy before getting the shot. In the past 19 days my 3 year old has gone through pure hell. Several breakouts a day, large bruising all over her body, lots of swelling, itching, pain in her joints on a daily basis that have been crippling at times, pain in her stomach and back.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Pruritus, Rash, Swelling, Swelling face, Urine analysis
Clinical narrative: Exactly 1 week of getting her second round of the HepA vaccine she began to have a strange bruising like rash begin on 09-07-2017 we took her to the Emergency Room where she was misdiagnosed. 2 days later her face and eyes began to swell along with her hands, ankles, and knees. The rash/bruising continued to get worse. 09-09-2017 she was diagnosed with HSP or Henoch-Schonlein Purpura. We have gone to the ER 4 times, urgent care, her PCP, and 2 specialists (blood and kidney). Just about all of the doctors seen have told us the HepA vaccine very likely triggered the HSP because she was perfectly healthy before getting the shot. In the past 19 days my 3 year old has gone through pure hell. Several breakouts a day, large bruising all over her body, lots of swelling, itching, pain in her joints on a daily basis that have been crippling at times, pain in her stomach and back.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia, Tremor
Clinical narrative: PATIENT REPORTED FEVER, CHILLS AND SEVERE SHAKING AS WELL AS SEVERE SORENESS FOR 24 HOURS AFTER DOSE.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M041181 and expiration date 31-MAY-2018 and lot # M038728 and expiration date 25-APR-2018 (dose and frequency were not reported) for prophylaxis. There were no adverse symptoms reported. Administered doses of vaccine experienced the temperature excursion from 47 to 77 degrees Fahrenheit for 34 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA005381: US-009507513-1709USA005380: US-009507513-1709USA005382: US-009507513-1709USA002048.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via pharmacist and refers to a patient of unknown gender between 12 and 15 month. No information regarding the patient's medical history, concomitant therapies and concurrent conditions was provided. On an unknown date, the patient was vaccinated with two doses of M-M-R II (dose, route of administration, lot# and expiration date were not reported) on one day. The M-M-R II was reconstituted with sterile diluent. No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician who referred to multiple patients of unknown demographics. There was no information about the patients concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 34 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA005552: US-009507513-1709USA005524.
Sex: M
Vaccine: VARZOS
Symptoms: Anticoagulant therapy, Mobility decreased, Myalgia, Stent placement
Clinical narrative: This spontaneous report was received from a 65 year old male patient, who referred to himself. The patient had no drug reactions or allergies. The patient was receiving corticosteroids for about 10 years. He received his last injection in May 2017. On an unknown date in June 2017, the patient was vaccinated with ZOSTAVAX subcutaneously for prevention of shingles (dose, side of administration, lot # and expiration date were not reported). On an unknown date in 2017 (reported as about 12 hours after receiving ZOSTAVAX, he could not move his arm (unspecified arm). About 48 hours after receiving ZOSTAVAX, every muscle in his body began to hurt. The patient stated he heard that ZOSTAVAX should not be given to patients who use corticosteroids. The patient reported that he had a stent (reported also as stint) in his heart and he took some unspecified blood thinners (dates unspecified). He stated that he has never had any of these types of side effects from any medications or injections in the past, and they could only be a result of the ZOSTAVAX injection. The patient sought a medical attention by seeing his physician. The physician was not able to determine the cause of his symptoms. The outcome of the events was reported as not recovered. The patient reported also that he was not at liberty to give his physicians information at this time, but he might be able to provide it later. Upon internal review, the events of "stent in his heart" and "he took some unspecified blood thinners" were considered to be medically significant.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Head injury, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a 71-year-old female patient, who was reporting on herself. The patient's concurrent conditions included bronchiectasis with mycobacterium avium complex (MAC) lung disease. The patient did not have any drug reactions or allergies. On 13-SEP-2017, the patient was vaccinated with a single dose of PNEUMOVAX 23 injection, 0.5 ml via subcutaneous route (lot # and expiration date were not reported) for prevention of pneumococcal disease. There were no problems. Concomitant therapies included hydrochlorothiazide (HCTZ), VENTOLIN and medication reported as TORVORTATON. On 14-SEP-2017 (reported as the following evening after the injection), the patient experienced tenderness at the injection site, pain and swelling from the injection site to her elbow, achy, chills and a fever. These adverse reactions lasted on and off for the next 3 days. The patient was treating herself for the pain and swelling with over the counter medications, TYLENOL and BENADRYL at night. On 16-SEP-2017 (reported as on the 3rd day after the injection), the patient was vomiting and was very weak and shaky and during the nausea, she passed out and hit her head on the toilet. The patient did not seek medical attention and no laboratory diagnostics were performed. The outcome of nausea, weakness, shaking, vomiting, passing out and hitting her head was reported as recovering/resolving. The outcome of tenderness at the injection site, pain and swelling from the injection site to the elbow, achy, chills and a fever was reported as recovered/resolved on 16-SEP-2017. The relatedness between the adverse event and PNEUMOVAX 23 was not reported.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Loss of consciousness, Nausea, Pain, Pyrexia, Tremor
Clinical narrative: This spontaneous report was received from a 71-year-old female patient, who was reporting on herself. The patient's concurrent conditions included bronchiectasis with mycobacterium avium complex (MAC) lung disease. The patient did not have any drug reactions or allergies. On 13-SEP-2017, the patient was vaccinated with a single dose of PNEUMOVAX 23 injection, 0.5 ml via subcutaneous route (lot # and expiration date were not reported) for prevention of pneumococcal disease. There were no problems. Concomitant therapies included hydrochlorothiazide (HCTZ), VENTOLIN and medication reported as TORVORTATON. On 14-SEP-2017 (reported as the following evening after the injection), the patient experienced tenderness at the injection site, pain and swelling from the injection site to her elbow, achy, chills and a fever. These adverse reactions lasted on and off for the next 3 days. The patient was treating herself for the pain and swelling with over the counter medications, TYLENOL and BENADRYL at night. On 16-SEP-2017 (reported as on the 3rd day after the injection), the patient was vomiting and was very weak and shaky and during the nausea, she passed out and hit her head on the toilet. The patient did not seek medical attention and no laboratory diagnostics were performed. The outcome of nausea, weakness, shaking, vomiting, passing out and hitting her head was reported as recovering/resolving. The outcome of tenderness at the injection site, pain and swelling from the injection site to the elbow, achy, chills and a fever was reported as recovered/resolved on 16-SEP-2017. The relatedness between the adverse event and PNEUMOVAX 23 was not reported.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a 71-year-old female patient, who was reporting on herself. The patient's concurrent conditions included bronchiectasis with mycobacterium avium complex (MAC) lung disease. The patient did not have any drug reactions or allergies. On 13-SEP-2017, the patient was vaccinated with a single dose of PNEUMOVAX 23 injection, 0.5 ml via subcutaneous route (lot # and expiration date were not reported) for prevention of pneumococcal disease. There were no problems. Concomitant therapies included hydrochlorothiazide (HCTZ), VENTOLIN and medication reported as TORVORTATON. On 14-SEP-2017 (reported as the following evening after the injection), the patient experienced tenderness at the injection site, pain and swelling from the injection site to her elbow, achy, chills and a fever. These adverse reactions lasted on and off for the next 3 days. The patient was treating herself for the pain and swelling with over the counter medications, TYLENOL and BENADRYL at night. On 16-SEP-2017 (reported as on the 3rd day after the injection), the patient was vomiting and was very weak and shaky and during the nausea, she passed out and hit her head on the toilet. The patient did not seek medical attention and no laboratory diagnostics were performed. The outcome of nausea, weakness, shaking, vomiting, passing out and hitting her head was reported as recovering/resolving. The outcome of tenderness at the injection site, pain and swelling from the injection site to the elbow, achy, chills and a fever was reported as recovered/resolved on 16-SEP-2017. The relatedness between the adverse event and PNEUMOVAX 23 was not reported.
Sex: M
Vaccine: PPV, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 62 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-SEP-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # L019836 with an expiration date 24-MAR-2017 for prophylaxis (dose and route of administration were not reported). No adverse effects was reported. There was no product quality complaint reported.
Sex: M
Vaccine: PPV, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 62 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 17-SEP-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # L019836 with expiration date of 24-MAR-2017, for prophylaxis (strength, dose, route and frequency were not reported). No adverse effects were reported.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager refers to a 11 year old patient. No information about the patient's pertinent medical history, concomitant medications or drug reactions or allergies was reported. On 26-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # M044717, expiry date: 19-JUL-2019) (dosing details were not reported) for prophylaxis. The administered dose of GARDASIL 9 underwent a temperature excursion at 35 degree Fahrenheit for 5 full days. No adverse effects reported. No previous temperature excursions reported.  This is one of several reports reports received from the same reporter. Additional information is not expected as no further information is available.; Sender's Comments: US-009507513-1708USA002323: US-009507513-1708USA005405: US-009507513-1709USA012713:US-009507513-1709USA012714:
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager refers to a 13 year old patient. No information about the patient's pertinent medical history, concomitant medications or drug reactions or allergies was reported. On 26-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # M044717, expiry date: 19-JUL-2019) (dosing details were not reported) for prophylaxis. The administered dose of GARDASIL 9 underwent a temperature excursion at 35 degree Fahrenheit for 5 full days. No adverse effects reported. No previous temperature excursions reported.  This is one of several reports reports received from the same reporter. Additional information is not expected as no further information is available.; Sender's Comments: US-009507513-1708USA002323: US-009507513-1709USA012712: US-009507513-1708USA005405: US-009507513-1709USA012714:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager refers to a 11 year old patient. No information about the patient's pertinent medical history, concomitant medications or drug reactions or allergies was reported. On 18-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # M044717, expiry date: 19-JUL-2019) (dosing details were not reported) for prophylaxis. The administered dose of GARDASIL 9 underwent a temperature excursion at 35 degree Fahrenheit for 5 full days. No adverse effects reported. No previous temperature excursions reported.  This is one of several reports reports received from the same reporter. Additional information is not expected as no further information is available.; Sender's Comments: US-009507513-1708USA002323: US-009507513-1709USA012712: US-009507513-1709USA012713: US-009507513-1708USA005405:
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Myocarditis, Troponin I increased
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. Initial solicited report received on 21 September 2017 from an investigator (Health Agency) in a trial. A 34 year-old male subject with medical history of High Blood Pressure, Elevated Cholesterol. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 01 March 2017. On 12 March 2017, 11 days after vaccination the subject was diagnosed with I51.4 myocarditis, unspecified. The lab data of ECG- Normal, done on 12 March 2017, and Echocardiogram - Normal done on 13 March 2017, Troponin I result abnormal 00.62 done on 14 March 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the event, I51.4 myocarditis, unspecified was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a 34-year-old male subject with significant medical history of high blood pressure and elevated cholesterol who developed acute myocarditis and myocarditis unspecified with favorable temporal association post vaccination with ACAM200. Myocarditis is a listed event for ACAM2000 vaccine. Alternative etiologies could be myocardial infarction, pulmonary edema and coronary artery vasospasm. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, myocardial biopsy, role of study vaccine cannot be ruled out.
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Echocardiogram abnormal, Electrocardiogram ST segment normal, Electrocardiogram T wave normal, Electrocardiogram normal
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. Initial solicited report received on 21 September 2017 from an investigator (Health Agency) in a trial. A 34 year-old male subject with medical history of High Blood Pressure, Elevated Cholesterol. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 01 March 2017. On 12 March 2017, 11 days after vaccination the subject was diagnosed with I51.4 myocarditis, unspecified. The lab data of ECG- Normal, done on 12 March 2017, and Echocardiogram - Normal done on 13 March 2017, Troponin I result abnormal 00.62 done on 14 March 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the event, I51.4 myocarditis, unspecified was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a 34-year-old male subject with significant medical history of high blood pressure and elevated cholesterol who developed acute myocarditis and myocarditis unspecified with favorable temporal association post vaccination with ACAM200. Myocarditis is a listed event for ACAM2000 vaccine. Alternative etiologies could be myocardial infarction, pulmonary edema and coronary artery vasospasm. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, myocardial biopsy, role of study vaccine cannot be ruled out.
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Left ventricular enlargement, Myocardial necrosis marker increased, Myocarditis, Myocarditis infectious, Sinus tachycardia
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. Initial solicited report received on 21 September 2017 from an investigator (Health Agency) in a trial. A 34 year-old male subject with medical history of High Blood Pressure, Elevated Cholesterol. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 01 March 2017. On 12 March 2017, 11 days after vaccination the subject was diagnosed with I51.4 myocarditis, unspecified. The lab data of ECG- Normal, done on 12 March 2017, and Echocardiogram - Normal done on 13 March 2017, Troponin I result abnormal 00.62 done on 14 March 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the event, I51.4 myocarditis, unspecified was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a 34-year-old male subject with significant medical history of high blood pressure and elevated cholesterol who developed acute myocarditis and myocarditis unspecified with favorable temporal association post vaccination with ACAM200. Myocarditis is a listed event for ACAM2000 vaccine. Alternative etiologies could be myocardial infarction, pulmonary edema and coronary artery vasospasm. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, myocardial biopsy, role of study vaccine cannot be ruled out.
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Troponin I increased
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. Initial solicited report received on 21 September 2017 from an investigator (Health Agency) in a trial. A 34 year-old male subject with medical history of High Blood Pressure, Elevated Cholesterol. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 01 March 2017. On 12 March 2017, 11 days after vaccination the subject was diagnosed with I51.4 myocarditis, unspecified. The lab data of ECG- Normal, done on 12 March 2017, and Echocardiogram - Normal done on 13 March 2017, Troponin I result abnormal 00.62 done on 14 March 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the event, I51.4 myocarditis, unspecified was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a 34-year-old male subject with significant medical history of high blood pressure and elevated cholesterol who developed acute myocarditis and myocarditis unspecified with favorable temporal association post vaccination with ACAM200. Myocarditis is a listed event for ACAM2000 vaccine. Alternative etiologies could be myocardial infarction, pulmonary edema and coronary artery vasospasm. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, myocardial biopsy, role of study vaccine cannot be ruled out.
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Pericardial disease, Troponin I increased
Clinical narrative: Initial solicited report received on 21 September 2017 from an investigator (Defense Health Agency) in the trial. This case involves a 24 year old male subject with no significant medical history. The subject received concomitant medication with Typhoid, Parenteral; japanese encephalitis - im (1); anthrax (1) on 05 May 2017. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 01 June 2017. On 11 June 2017, 10 days after vaccination the subject was diagnosed with I40.9 acute myocarditis, unspecified and on 14 June 2017, 13 days after vaccination the subject was diagnosed with I31.9 Disease of pericardium, unspecified. The subject's lab data included, Troponin I result abnormal 00.34, ECG- Abnormal both done on 11 June 2017 and Echocardiogram - Normal done on 12 June 2017. MRI of brain; spinal cord; heart; or Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the events I40.9 acute myocarditis, unspecified and I31.9 Disease of pericardium, unspecified; was not reported. Relationship to investigational product according to company: associated List of documents held by sender: none. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study.; Sender's Comments: This case involves a healthy 24-year-old male subject who developed acute myocarditis unspecified and unspecified disease of pericardium with favorable temporal association post vaccination with ACAM2000. Subject had confounding factors as concomitant administrations of typhoid parenteral, Japanese encephalitis and Anthrax vaccine. Myocarditis and pericardial disease are listed event for ACAM2000 vaccine. Alternative etiologies could be pulmonary edema, pulmonary embolism, aortic dissection, esophageal rupture and pneumothorax. History of allergies or trauma was not reported. Based on missing additional information on confirmation of diagnosis with CK-MB assays, myocardial biopsy, role of study vaccine can not be ruled out.
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Discomfort, Echocardiogram normal, Ejection fraction normal, Electrocardiogram QT prolonged, Electrocardiogram T wave abnormal
Clinical narrative: Initial solicited report received on 21 September 2017 from an investigator (Defense Health Agency) in the trial. This case involves a 24 year old male subject with no significant medical history. The subject received concomitant medication with Typhoid, Parenteral; japanese encephalitis - im (1); anthrax (1) on 05 May 2017. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 01 June 2017. On 11 June 2017, 10 days after vaccination the subject was diagnosed with I40.9 acute myocarditis, unspecified and on 14 June 2017, 13 days after vaccination the subject was diagnosed with I31.9 Disease of pericardium, unspecified. The subject's lab data included, Troponin I result abnormal 00.34, ECG- Abnormal both done on 11 June 2017 and Echocardiogram - Normal done on 12 June 2017. MRI of brain; spinal cord; heart; or Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the events I40.9 acute myocarditis, unspecified and I31.9 Disease of pericardium, unspecified; was not reported. Relationship to investigational product according to company: associated List of documents held by sender: none. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study.; Sender's Comments: This case involves a healthy 24-year-old male subject who developed acute myocarditis unspecified and unspecified disease of pericardium with favorable temporal association post vaccination with ACAM2000. Subject had confounding factors as concomitant administrations of typhoid parenteral, Japanese encephalitis and Anthrax vaccine. Myocarditis and pericardial disease are listed event for ACAM2000 vaccine. Alternative etiologies could be pulmonary edema, pulmonary embolism, aortic dissection, esophageal rupture and pneumothorax. History of allergies or trauma was not reported. Based on missing additional information on confirmation of diagnosis with CK-MB assays, myocardial biopsy, role of study vaccine can not be ruled out.
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Electrocardiogram T wave inversion, Electrocardiogram abnormal, Myocarditis, Pericardial disease, Sinus tachycardia
Clinical narrative: Initial solicited report received on 21 September 2017 from an investigator (Defense Health Agency) in the trial. This case involves a 24 year old male subject with no significant medical history. The subject received concomitant medication with Typhoid, Parenteral; japanese encephalitis - im (1); anthrax (1) on 05 May 2017. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 01 June 2017. On 11 June 2017, 10 days after vaccination the subject was diagnosed with I40.9 acute myocarditis, unspecified and on 14 June 2017, 13 days after vaccination the subject was diagnosed with I31.9 Disease of pericardium, unspecified. The subject's lab data included, Troponin I result abnormal 00.34, ECG- Abnormal both done on 11 June 2017 and Echocardiogram - Normal done on 12 June 2017. MRI of brain; spinal cord; heart; or Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the events I40.9 acute myocarditis, unspecified and I31.9 Disease of pericardium, unspecified; was not reported. Relationship to investigational product according to company: associated List of documents held by sender: none. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study.; Sender's Comments: This case involves a healthy 24-year-old male subject who developed acute myocarditis unspecified and unspecified disease of pericardium with favorable temporal association post vaccination with ACAM2000. Subject had confounding factors as concomitant administrations of typhoid parenteral, Japanese encephalitis and Anthrax vaccine. Myocarditis and pericardial disease are listed event for ACAM2000 vaccine. Alternative etiologies could be pulmonary edema, pulmonary embolism, aortic dissection, esophageal rupture and pneumothorax. History of allergies or trauma was not reported. Based on missing additional information on confirmation of diagnosis with CK-MB assays, myocardial biopsy, role of study vaccine can not be ruled out.
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Troponin I increased
Clinical narrative: Initial solicited report received on 21 September 2017 from an investigator (Defense Health Agency) in the trial. This case involves a 24 year old male subject with no significant medical history. The subject received concomitant medication with Typhoid, Parenteral; japanese encephalitis - im (1); anthrax (1) on 05 May 2017. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 01 June 2017. On 11 June 2017, 10 days after vaccination the subject was diagnosed with I40.9 acute myocarditis, unspecified and on 14 June 2017, 13 days after vaccination the subject was diagnosed with I31.9 Disease of pericardium, unspecified. The subject's lab data included, Troponin I result abnormal 00.34, ECG- Abnormal both done on 11 June 2017 and Echocardiogram - Normal done on 12 June 2017. MRI of brain; spinal cord; heart; or Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the events I40.9 acute myocarditis, unspecified and I31.9 Disease of pericardium, unspecified; was not reported. Relationship to investigational product according to company: associated List of documents held by sender: none. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study.; Sender's Comments: This case involves a healthy 24-year-old male subject who developed acute myocarditis unspecified and unspecified disease of pericardium with favorable temporal association post vaccination with ACAM2000. Subject had confounding factors as concomitant administrations of typhoid parenteral, Japanese encephalitis and Anthrax vaccine. Myocarditis and pericardial disease are listed event for ACAM2000 vaccine. Alternative etiologies could be pulmonary edema, pulmonary embolism, aortic dissection, esophageal rupture and pneumothorax. History of allergies or trauma was not reported. Based on missing additional information on confirmation of diagnosis with CK-MB assays, myocardial biopsy, role of study vaccine can not be ruled out.
Sex: F
Vaccine: SMALL
Symptoms: Guillain-Barre syndrome
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. Initial solicited report received from an investigator (Health Agency) in a trial on 21 September 2017. A 44 year-old female subject with palpitations/pounding heart without exercise, Abnormal ECG (electrocardiogram in the past), and no other significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 02 August 2017. On 25 August 2017, 23 days after vaccination the subject was diagnosed with G61.0 Guillain-Barré syndrome. For subject, Troponin I, ECG, Echocardiogram not performed. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the event, G61.0 Guillain-Barré syndrome was not reported. Relationship to investigational product according to company: not associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a 44-year-old female subject who developed Guillain-Barre syndrome 23 days after receiving a dose of ACAM2000 vaccine. GB syndrome is very rarely observed after ACAM2000 (three cases in 590400 vaccinees). Alternative etiologies need to be ruled out. Based on data available, the sponsor assesses this event as not related to study vaccine.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Within a few hours below the injection sight, not at the site, a 3"x3" area of skin turned very red and was very hot to touch and tender. The muscle was sore, as was expected following the injection. The 3x3 area was inflamed and stayed red, hot to touch and at times was bumpy under the skin as the area moved down towards the elbow over a 4 day period. Every few hours you could see the red patch had moved downwards on the arm. The whole arm wasn't increasing with the size of the patch, the patch area was moving without expanding.
Age: 0.5
Sex: F
Vaccine: FLU4
Symptoms: Hypotonia, Injection site reaction, Laboratory test, Myelitis transverse, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Patient with sudden lack of weight bearing, limp to R leg, progressed to bilateral legs and lack of tone to central core.
Age: 0.5
Sex: F
Vaccine: FLU4
Symptoms: Weight bearing difficulty
Clinical narrative: Patient with sudden lack of weight bearing, limp to R leg, progressed to bilateral legs and lack of tone to central core.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Blood magnesium normal, Blood phosphorus decreased, Blood sodium decreased, Chills, Dehydration
Clinical narrative: Unable to walk, weakness in legs, high fevers 104 on going for 3 days, sweating, cold shaking chills, neck pain, jaw pain, intense headaches, ear pain went to pcp, said would be better in a couple days, next day was worst, went to ER. treated with Soidum Cloride 0.9 1000mL IV ketorlac 15mg IV push sodium phosphate 1000 mg by mouth was dehydated from sweating HIGH  FEAVER for so many days,  this day 6/26/2017 and is still dealing with this health issue don"t know were to go for help with my condition. DR. and hospital havven't really helped.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Ear pain, Feeling cold, Gait inability, Headache, Hyperhidrosis
Clinical narrative: Unable to walk, weakness in legs, high fevers 104 on going for 3 days, sweating, cold shaking chills, neck pain, jaw pain, intense headaches, ear pain went to pcp, said would be better in a couple days, next day was worst, went to ER. treated with Soidum Cloride 0.9 1000mL IV ketorlac 15mg IV push sodium phosphate 1000 mg by mouth was dehydated from sweating HIGH  FEAVER for so many days,  this day 6/26/2017 and is still dealing with this health issue don"t know were to go for help with my condition. DR. and hospital havven't really helped.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Neck pain, Pain in jaw, Pyrexia, Tremor
Clinical narrative: Unable to walk, weakness in legs, high fevers 104 on going for 3 days, sweating, cold shaking chills, neck pain, jaw pain, intense headaches, ear pain went to pcp, said would be better in a couple days, next day was worst, went to ER. treated with Soidum Cloride 0.9 1000mL IV ketorlac 15mg IV push sodium phosphate 1000 mg by mouth was dehydated from sweating HIGH  FEAVER for so many days,  this day 6/26/2017 and is still dealing with this health issue don"t know were to go for help with my condition. DR. and hospital havven't really helped.
Age: 21.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Erythema, Injection site pain, Joint stiffness, Paraesthesia, Peripheral swelling
Clinical narrative: 10-15 minutes after the shots, left arm began to tingle. By the end of the day, both arms were tingling, right shoulder was sore and stiff, one finger on each hand was red and swollen.
Age: 9.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Nausea, Pyrexia, Throat tightness
Clinical narrative: 5-8 hours after dose #3 and dose #4 of Rabies vaccine she started running fever 103 axillary. She C/O nausea both times. Child reported her throat felt tight and she had a headache. After reaction to dose #3, symptoms lasted close to 12 hours. She is now approx 14 hours after dose #4 symptoms have lasted about 14 hours and she still is feeling well.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Dysgeusia, Flushing, Immediate post-injection reaction, Paraesthesia, Urticaria
Clinical narrative: Immediately after the medicine was injected I had a flushing tingling feeling start at center of face and spread outwards and I had a funny taste in mouth. About 11 days after vaccine I broke out in hives and it lasted for approximately a week. Still feel a little tingly but rash is gone.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Limb discomfort, Paraesthesia
Clinical narrative: PATIENT HAD SHOT ON FRIDAY MORNING. REPORTED ARM AND LEG TINGLING AND ARM FEELING HEAVY. WENT TO EMERGENCY ROOM ON SUNDAY (2 DAYS LATER). THEY TOLD HER SHE HAD AN ALLERGIC REACTION TO FLU SHOT.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Sluggishness
Clinical narrative: Pain in left arm at injection site and arm feels "sluggish".
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13
Symptoms: Rash
Clinical narrative: Woke up this morning with a rash on her neck, belly, back, and legs.