chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Flushing, Hyperhidrosis, Immediate post-injection reaction, Injection site haemorrhage
Clinical narrative: Patient received the vaccination in deltoid of left arm, after removing needle, patient was bleeding from the injection site more than expected from not being on any type of blood thinning medicine. Patient remained in same chair for a few minutes. He then walked to the checkout counter after getting some Tylenol. He stood at the self checkout for a minute and then fell back on to floor. He was sweating and was flush in the face. No reported shortness of breath or any other symptoms. The patient was returned to the pharmacy self ambulating. He was seating in a chair and given a bottle of water. He reported having worked a 12 hour shift and been awake for longer than 24 hours. This course of time from vaccination to time of returning to pharmacy would have been approximately 5-8 minutes. Patient remained seated for over and hour and drank 16 fl oz of water.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Generalized Hive-Like Rash
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus, Injection site rash, Pruritus
Clinical narrative: itching between elbow and shoulder, near the injection site and all around that area/had Itching and bothered where the needle went in and now is red and irritated; had Itching and bothered where the needle went in and now is red and irritated; a little red rash from where it was injected; where the needle went in it was irritated/had Itching and bothered where the needle went in and now is red and irritated; This is a spontaneous report from a contactable female consumer (patient herself) of 90-years-old received second dose of bnt162b2 (BNT162B2 Pfizer-Biontech covid-19 vaccine, Formulation: Solution for injection, Lot number and Expiry date were not reported) via an unspecified route of administration on 28Jan2021 Thursday in right arm and first dose (Lot number: Either EX3246 or EL3246) via an unspecified route of administration in left arm on 07Jan2021 around 13:30 to 14:00 both as single dose for covid-19 immunisation. Medical history includes glaucoma in her eyes, has drip down her nose, sinus, flu shot and includes she got irritated in the area for a day or two whenever the flu shot taken. No family history was reported. The patient's concomitant medications were not reported. Prior to the vaccination, the patient had not received any other vaccine within 4 weeks. On 28Jan2021, the patient experienced irritation and had itching, redness and rash where the needle went in. And later itches between elbow and shoulder in the area where the vaccine went in and around back and front. Patient's lab tests were not reported. No therapeutic measures were taken. The caller asked if the itching was normal and asked what to. The outcome of the events was unknown.   Information about Batch/Lot number has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysphonia, Dyspnoea, Nausea
Clinical narrative: Spoke with pt 1/11/2021 at 1615 and he was doing well, speaks clearly, does have a mild headache, sore arm, and dizzy sensation if moves too fast. He was given NFW today and can return in am to fire house/station. ---- EVENT: This employee reports received 2nd shot and about 10 min later he felt nauseated. The nausea progressed to a gagging, which made him vomit, his throat was hoarse constantly trying to clear, had problems exhaling, could speak easily, felt flushed, mild headache, - staff checked vital signs (normal) and given epi. Taken to ER where skin noted bright red all over (torso, face, extremities), but no further n/v/gagging/sob. ER gave IVNS, IV Benadryl, Solu-medrol, Pepcid, and Zofran. Monitored forSpoke with pt 1/11/2021 at 1615 and he was doing well, speaks clearly, does have a mild headache, sore arm, and dizzy sensation if moves too fast. He was given NFW today and can return in am to fire house/station. ---- EVENT: This employee reports received 2nd shot and about 10 min later he felt nauseated. The nausea progressed to a gagging, which made him vomit, his throat was hoarse constantly trying to clear, had problems exhaling, could speak easily, felt flushed, mild headache, - staff checked vital signs (normal) and given epi. Taken to ER where skin noted bright red all over (torso, face, extremities), but no further n/v/gagging/sob. ER gave IVNS, IV Benadryl, Solu-medrol, Pepcid, and Zofran. Monitored for 2 hours and sent home with coworkers with resolution of all symptoms. 1/15/2021 f/u: advised doing well, no further issues. review as of 4/01/2021 shows he received flu vaccine on 1/22/21 w/o issues.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysphonia, Dyspnoea, Erythema, Flushing
Clinical narrative: Spoke with pt 1/11/2021 at 1615 and he was doing well, speaks clearly, does have a mild headache, sore arm, and dizzy sensation if moves too fast. He was given NFW today and can return in am to fire house/station. ---- EVENT: This employee reports received 2nd shot and about 10 min later he felt nauseated. The nausea progressed to a gagging, which made him vomit, his throat was hoarse constantly trying to clear, had problems exhaling, could speak easily, felt flushed, mild headache, - staff checked vital signs (normal) and given epi. Taken to ER where skin noted bright red all over (torso, face, extremities), but no further n/v/gagging/sob. ER gave IVNS, IV Benadryl, Solu-medrol, Pepcid, and Zofran. Monitored forSpoke with pt 1/11/2021 at 1615 and he was doing well, speaks clearly, does have a mild headache, sore arm, and dizzy sensation if moves too fast. He was given NFW today and can return in am to fire house/station. ---- EVENT: This employee reports received 2nd shot and about 10 min later he felt nauseated. The nausea progressed to a gagging, which made him vomit, his throat was hoarse constantly trying to clear, had problems exhaling, could speak easily, felt flushed, mild headache, - staff checked vital signs (normal) and given epi. Taken to ER where skin noted bright red all over (torso, face, extremities), but no further n/v/gagging/sob. ER gave IVNS, IV Benadryl, Solu-medrol, Pepcid, and Zofran. Monitored for 2 hours and sent home with coworkers with resolution of all symptoms. 1/15/2021 f/u: advised doing well, no further issues. review as of 4/01/2021 shows he received flu vaccine on 1/22/21 w/o issues.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea, Pain in extremity, Retching, Tryptase
Clinical narrative: Spoke with pt 1/11/2021 at 1615 and he was doing well, speaks clearly, does have a mild headache, sore arm, and dizzy sensation if moves too fast. He was given NFW today and can return in am to fire house/station. ---- EVENT: This employee reports received 2nd shot and about 10 min later he felt nauseated. The nausea progressed to a gagging, which made him vomit, his throat was hoarse constantly trying to clear, had problems exhaling, could speak easily, felt flushed, mild headache, - staff checked vital signs (normal) and given epi. Taken to ER where skin noted bright red all over (torso, face, extremities), but no further n/v/gagging/sob. ER gave IVNS, IV Benadryl, Solu-medrol, Pepcid, and Zofran. Monitored forSpoke with pt 1/11/2021 at 1615 and he was doing well, speaks clearly, does have a mild headache, sore arm, and dizzy sensation if moves too fast. He was given NFW today and can return in am to fire house/station. ---- EVENT: This employee reports received 2nd shot and about 10 min later he felt nauseated. The nausea progressed to a gagging, which made him vomit, his throat was hoarse constantly trying to clear, had problems exhaling, could speak easily, felt flushed, mild headache, - staff checked vital signs (normal) and given epi. Taken to ER where skin noted bright red all over (torso, face, extremities), but no further n/v/gagging/sob. ER gave IVNS, IV Benadryl, Solu-medrol, Pepcid, and Zofran. Monitored for 2 hours and sent home with coworkers with resolution of all symptoms. 1/15/2021 f/u: advised doing well, no further issues. review as of 4/01/2021 shows he received flu vaccine on 1/22/21 w/o issues.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Spoke with pt 1/11/2021 at 1615 and he was doing well, speaks clearly, does have a mild headache, sore arm, and dizzy sensation if moves too fast. He was given NFW today and can return in am to fire house/station. ---- EVENT: This employee reports received 2nd shot and about 10 min later he felt nauseated. The nausea progressed to a gagging, which made him vomit, his throat was hoarse constantly trying to clear, had problems exhaling, could speak easily, felt flushed, mild headache, - staff checked vital signs (normal) and given epi. Taken to ER where skin noted bright red all over (torso, face, extremities), but no further n/v/gagging/sob. ER gave IVNS, IV Benadryl, Solu-medrol, Pepcid, and Zofran. Monitored forSpoke with pt 1/11/2021 at 1615 and he was doing well, speaks clearly, does have a mild headache, sore arm, and dizzy sensation if moves too fast. He was given NFW today and can return in am to fire house/station. ---- EVENT: This employee reports received 2nd shot and about 10 min later he felt nauseated. The nausea progressed to a gagging, which made him vomit, his throat was hoarse constantly trying to clear, had problems exhaling, could speak easily, felt flushed, mild headache, - staff checked vital signs (normal) and given epi. Taken to ER where skin noted bright red all over (torso, face, extremities), but no further n/v/gagging/sob. ER gave IVNS, IV Benadryl, Solu-medrol, Pepcid, and Zofran. Monitored for 2 hours and sent home with coworkers with resolution of all symptoms. 1/15/2021 f/u: advised doing well, no further issues. review as of 4/01/2021 shows he received flu vaccine on 1/22/21 w/o issues.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Decreased appetite, Electrocardiogram, Fluid intake reduced
Clinical narrative: Jan 12, 2021 headache, nausea, diarrhea,  then near coma, slept 24/7, not eating drinking, incontinent Jan 16, 2021 ER visit Hospital, negative for infections Jan 19, 2021 ER visit, transfer to another facility stay till Feb 18, 2021. slight improvement Feb 19, 2021 Hospice came to help with home care, till March 1, 2021 March 1, 2021 began further decline, leading to death at home on March 22, 2021
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypersomnia, Unresponsive to stimuli, Urine analysis
Clinical narrative: Jan 12, 2021 headache, nausea, diarrhea,  then near coma, slept 24/7, not eating drinking, incontinent Jan 16, 2021 ER visit Hospital, negative for infections Jan 19, 2021 ER visit, transfer to another facility stay till Feb 18, 2021. slight improvement Feb 19, 2021 Hospice came to help with home care, till March 1, 2021 March 1, 2021 began further decline, leading to death at home on March 22, 2021
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Cognitive disorder, Computerised tomogram abdomen, Computerised tomogram head, Electrocardiogram
Clinical narrative: Jan 12, 2021 headache, nausea, diarrhea,  then near coma, slept 24/7, not eating drinking, incontinent Jan 16, 2021 ER visit Hospital, negative for infections Jan 19, 2021 ER visit, transfer to another facility stay till Feb 18, 2021. slight improvement Feb 19, 2021 Hospice came to help with home care, till March 1, 2021 March 1, 2021 began further decline, leading to death at home on March 22, 2021
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fibrin D dimer, Food refusal, Full blood count, General physical health deterioration, Loss of personal independence in daily activities
Clinical narrative: Jan 12, 2021 headache, nausea, diarrhea,  then near coma, slept 24/7, not eating drinking, incontinent Jan 16, 2021 ER visit Hospital, negative for infections Jan 19, 2021 ER visit, transfer to another facility stay till Feb 18, 2021. slight improvement Feb 19, 2021 Hospice came to help with home care, till March 1, 2021 March 1, 2021 began further decline, leading to death at home on March 22, 2021
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Metabolic function test, SARS-CoV-2 test, Urine analysis
Clinical narrative: Jan 12, 2021 headache, nausea, diarrhea,  then near coma, slept 24/7, not eating drinking, incontinent Jan 16, 2021 ER visit Hospital, negative for infections Jan 19, 2021 ER visit, transfer to another facility stay till Feb 18, 2021. slight improvement Feb 19, 2021 Hospice came to help with home care, till March 1, 2021 March 1, 2021 began further decline, leading to death at home on March 22, 2021
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bedridden, Death, Decreased appetite, Depressed level of consciousness, Diarrhoea
Clinical narrative: Jan 12, 2021 headache, nausea, diarrhea,  then near coma, slept 24/7, not eating drinking, incontinent Jan 16, 2021 ER visit Hospital, negative for infections Jan 19, 2021 ER visit, transfer to another facility stay till Feb 18, 2021. slight improvement Feb 19, 2021 Hospice came to help with home care, till March 1, 2021 March 1, 2021 began further decline, leading to death at home on March 22, 2021
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fluid intake reduced, General physical health deterioration, Headache, Hypersomnia, Incontinence
Clinical narrative: Jan 12, 2021 headache, nausea, diarrhea,  then near coma, slept 24/7, not eating drinking, incontinent Jan 16, 2021 ER visit Hospital, negative for infections Jan 19, 2021 ER visit, transfer to another facility stay till Feb 18, 2021. slight improvement Feb 19, 2021 Hospice came to help with home care, till March 1, 2021 March 1, 2021 began further decline, leading to death at home on March 22, 2021
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Viral test negative
Clinical narrative: Jan 12, 2021 headache, nausea, diarrhea,  then near coma, slept 24/7, not eating drinking, incontinent Jan 16, 2021 ER visit Hospital, negative for infections Jan 19, 2021 ER visit, transfer to another facility stay till Feb 18, 2021. slight improvement Feb 19, 2021 Hospice came to help with home care, till March 1, 2021 March 1, 2021 began further decline, leading to death at home on March 22, 2021
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Swollen tongue
Clinical narrative: Hives Swollen - Left side of face Swollen Tongue  She took Benadryl and felt better. It took couple of days for swelling to go down.  The two weeks later, patient had symptoms again. Ambulance came and took her to ER.  Then a month later she had symptoms again with a stroke and heart attack.  March 30th - Shingles
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Herpes zoster, Myocardial infarction, Swelling face, Swollen tongue
Clinical narrative: Hives Swollen - Left side of face Swollen Tongue  She took Benadryl and felt better. It took couple of days for swelling to go down.  The two weeks later, patient had symptoms again. Ambulance came and took her to ER.  Then a month later she had symptoms again with a stroke and heart attack.  March 30th - Shingles
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Hives Swollen - Left side of face Swollen Tongue  She took Benadryl and felt better. It took couple of days for swelling to go down.  The two weeks later, patient had symptoms again. Ambulance came and took her to ER.  Then a month later she had symptoms again with a stroke and heart attack.  March 30th - Shingles
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Feeling hot, Headache, Hypoaesthesia, Injection site erythema
Clinical narrative: Patient was is in pain: headache or migraine . Onsite EMS was called vitals HR 88 BP 118/70   99% O2.  Patient treated, transported to the hospital.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Laboratory test, Paraesthesia
Clinical narrative: Patient was is in pain: headache or migraine . Onsite EMS was called vitals HR 88 BP 118/70   99% O2.  Patient treated, transported to the hospital.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: Patient was is in pain: headache or migraine . Onsite EMS was called vitals HR 88 BP 118/70   99% O2.  Patient treated, transported to the hospital.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody negative, Arteriogram coronary normal, Chest pain, Chills, Coxsackie virus test negative
Clinical narrative: 01/22/2021  Event Description  40 year old male with no prior cardiac left sided chest pain radiating to left arm and shoulder starting approx. 24 hours after 2nd Pfizer COVID 19 vaccination. Went to ED on 1/24 for increasing CP, left arm pain/numbness. EKG demonstrated elevated ST elevations and troponins were elevated on admission concerning for STEMI; LHC was negative for any CAD. Cardiac MRI demonstrated sub-endocardial enhancement consistent with myocarditis.   Comments    Diagnostic Tests  1/24: PCXR- Normal 1/24: Coronary Angiogram - normal coronary arteries 1/24: Echocardiogram - Normal 1/25-Cardiac MR - findings highly suggestive of myocarditis (i.e infectious or perhaps post-vaccine) as evidenced by  confluent sub-epicardial hyperenhancement on myocardial delayed enhancement (MDE) imaging in the inferoseptal, inferior, inferolateral, anterolateral and anterior segments of the basal to mid left ventricle.   Laboratory Data  1/24/21 Troponin:495, 662.0, 602.3 1/28/21: 29. Covid PCR - negative 1/24/2021. No recent illnesses  Still taking colchicine 0.6 mg BID until 4/25/2021. ASA high dose regime restarted 2/5/2021 to continue until CP resolves, then taper.  Pt still with a sensation of "rubbing" in chest, worse with exertion as of 4/1/2021. F/U appointment with Cardiology on 4/5/2021. All infectious workup negative to date for any acute infection that may be the etiology of myocarditis. Viral studies (CMV, HSV, Parvo, HIV, EBV IgM, Cocsackie IgM negative)  Social History:    Tobacco: ¼ to ½ ppd for 10 years; stopped o/a 21 JAN 2021 Alcohol: 1 drink per week Recreational / Illicit: denies
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cytomegalovirus test negative, Electrocardiogram abnormal, Epstein-Barr virus antibody negative, HIV test negative, Hyperhidrosis
Clinical narrative: 01/22/2021  Event Description  40 year old male with no prior cardiac left sided chest pain radiating to left arm and shoulder starting approx. 24 hours after 2nd Pfizer COVID 19 vaccination. Went to ED on 1/24 for increasing CP, left arm pain/numbness. EKG demonstrated elevated ST elevations and troponins were elevated on admission concerning for STEMI; LHC was negative for any CAD. Cardiac MRI demonstrated sub-endocardial enhancement consistent with myocarditis.   Comments    Diagnostic Tests  1/24: PCXR- Normal 1/24: Coronary Angiogram - normal coronary arteries 1/24: Echocardiogram - Normal 1/25-Cardiac MR - findings highly suggestive of myocarditis (i.e infectious or perhaps post-vaccine) as evidenced by  confluent sub-epicardial hyperenhancement on myocardial delayed enhancement (MDE) imaging in the inferoseptal, inferior, inferolateral, anterolateral and anterior segments of the basal to mid left ventricle.   Laboratory Data  1/24/21 Troponin:495, 662.0, 602.3 1/28/21: 29. Covid PCR - negative 1/24/2021. No recent illnesses  Still taking colchicine 0.6 mg BID until 4/25/2021. ASA high dose regime restarted 2/5/2021 to continue until CP resolves, then taper.  Pt still with a sensation of "rubbing" in chest, worse with exertion as of 4/1/2021. F/U appointment with Cardiology on 4/5/2021. All infectious workup negative to date for any acute infection that may be the etiology of myocarditis. Viral studies (CMV, HSV, Parvo, HIV, EBV IgM, Cocsackie IgM negative)  Social History:    Tobacco: ¼ to ½ ppd for 10 years; stopped o/a 21 JAN 2021 Alcohol: 1 drink per week Recreational / Illicit: denies
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging heart, Malaise, Myocarditis, SARS-CoV-2 test negative, Treponema test negative
Clinical narrative: 01/22/2021  Event Description  40 year old male with no prior cardiac left sided chest pain radiating to left arm and shoulder starting approx. 24 hours after 2nd Pfizer COVID 19 vaccination. Went to ED on 1/24 for increasing CP, left arm pain/numbness. EKG demonstrated elevated ST elevations and troponins were elevated on admission concerning for STEMI; LHC was negative for any CAD. Cardiac MRI demonstrated sub-endocardial enhancement consistent with myocarditis.   Comments    Diagnostic Tests  1/24: PCXR- Normal 1/24: Coronary Angiogram - normal coronary arteries 1/24: Echocardiogram - Normal 1/25-Cardiac MR - findings highly suggestive of myocarditis (i.e infectious or perhaps post-vaccine) as evidenced by  confluent sub-epicardial hyperenhancement on myocardial delayed enhancement (MDE) imaging in the inferoseptal, inferior, inferolateral, anterolateral and anterior segments of the basal to mid left ventricle.   Laboratory Data  1/24/21 Troponin:495, 662.0, 602.3 1/28/21: 29. Covid PCR - negative 1/24/2021. No recent illnesses  Still taking colchicine 0.6 mg BID until 4/25/2021. ASA high dose regime restarted 2/5/2021 to continue until CP resolves, then taper.  Pt still with a sensation of "rubbing" in chest, worse with exertion as of 4/1/2021. F/U appointment with Cardiology on 4/5/2021. All infectious workup negative to date for any acute infection that may be the etiology of myocarditis. Viral studies (CMV, HSV, Parvo, HIV, EBV IgM, Cocsackie IgM negative)  Social History:    Tobacco: ¼ to ½ ppd for 10 years; stopped o/a 21 JAN 2021 Alcohol: 1 drink per week Recreational / Illicit: denies
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: 01/22/2021  Event Description  40 year old male with no prior cardiac left sided chest pain radiating to left arm and shoulder starting approx. 24 hours after 2nd Pfizer COVID 19 vaccination. Went to ED on 1/24 for increasing CP, left arm pain/numbness. EKG demonstrated elevated ST elevations and troponins were elevated on admission concerning for STEMI; LHC was negative for any CAD. Cardiac MRI demonstrated sub-endocardial enhancement consistent with myocarditis.   Comments    Diagnostic Tests  1/24: PCXR- Normal 1/24: Coronary Angiogram - normal coronary arteries 1/24: Echocardiogram - Normal 1/25-Cardiac MR - findings highly suggestive of myocarditis (i.e infectious or perhaps post-vaccine) as evidenced by  confluent sub-epicardial hyperenhancement on myocardial delayed enhancement (MDE) imaging in the inferoseptal, inferior, inferolateral, anterolateral and anterior segments of the basal to mid left ventricle.   Laboratory Data  1/24/21 Troponin:495, 662.0, 602.3 1/28/21: 29. Covid PCR - negative 1/24/2021. No recent illnesses  Still taking colchicine 0.6 mg BID until 4/25/2021. ASA high dose regime restarted 2/5/2021 to continue until CP resolves, then taper.  Pt still with a sensation of "rubbing" in chest, worse with exertion as of 4/1/2021. F/U appointment with Cardiology on 4/5/2021. All infectious workup negative to date for any acute infection that may be the etiology of myocarditis. Viral studies (CMV, HSV, Parvo, HIV, EBV IgM, Cocsackie IgM negative)  Social History:    Tobacco: ¼ to ½ ppd for 10 years; stopped o/a 21 JAN 2021 Alcohol: 1 drink per week Recreational / Illicit: denies
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arteriogram coronary normal, Arthralgia, Chest X-ray normal, Chest pain, Echocardiogram normal
Clinical narrative: 01/22/2021  Event Description  40 year old male with no prior cardiac left sided chest pain radiating to left arm and shoulder starting approx. 24 hours after 2nd Pfizer COVID 19 vaccination. Went to ED on 1/24 for increasing CP, left arm pain/numbness. EKG demonstrated elevated ST elevations and troponins were elevated on admission concerning for STEMI; LHC was negative for any CAD. Cardiac MRI demonstrated sub-endocardial enhancement consistent with myocarditis.   Comments    Diagnostic Tests  1/24: PCXR- Normal 1/24: Coronary Angiogram - normal coronary arteries 1/24: Echocardiogram - Normal 1/25-Cardiac MR - findings highly suggestive of myocarditis (i.e infectious or perhaps post-vaccine) as evidenced by  confluent sub-epicardial hyperenhancement on myocardial delayed enhancement (MDE) imaging in the inferoseptal, inferior, inferolateral, anterolateral and anterior segments of the basal to mid left ventricle.   Laboratory Data  1/24/21 Troponin:495, 662.0, 602.3 1/28/21: 29. Covid PCR - negative 1/24/2021. No recent illnesses  Still taking colchicine 0.6 mg BID until 4/25/2021. ASA high dose regime restarted 2/5/2021 to continue until CP resolves, then taper.  Pt still with a sensation of "rubbing" in chest, worse with exertion as of 4/1/2021. F/U appointment with Cardiology on 4/5/2021. All infectious workup negative to date for any acute infection that may be the etiology of myocarditis. Viral studies (CMV, HSV, Parvo, HIV, EBV IgM, Cocsackie IgM negative)  Social History:    Tobacco: ¼ to ½ ppd for 10 years; stopped o/a 21 JAN 2021 Alcohol: 1 drink per week Recreational / Illicit: denies
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Hypoaesthesia, Magnetic resonance imaging abnormal, Magnetic resonance imaging heart
Clinical narrative: 01/22/2021  Event Description  40 year old male with no prior cardiac left sided chest pain radiating to left arm and shoulder starting approx. 24 hours after 2nd Pfizer COVID 19 vaccination. Went to ED on 1/24 for increasing CP, left arm pain/numbness. EKG demonstrated elevated ST elevations and troponins were elevated on admission concerning for STEMI; LHC was negative for any CAD. Cardiac MRI demonstrated sub-endocardial enhancement consistent with myocarditis.   Comments    Diagnostic Tests  1/24: PCXR- Normal 1/24: Coronary Angiogram - normal coronary arteries 1/24: Echocardiogram - Normal 1/25-Cardiac MR - findings highly suggestive of myocarditis (i.e infectious or perhaps post-vaccine) as evidenced by  confluent sub-epicardial hyperenhancement on myocardial delayed enhancement (MDE) imaging in the inferoseptal, inferior, inferolateral, anterolateral and anterior segments of the basal to mid left ventricle.   Laboratory Data  1/24/21 Troponin:495, 662.0, 602.3 1/28/21: 29. Covid PCR - negative 1/24/2021. No recent illnesses  Still taking colchicine 0.6 mg BID until 4/25/2021. ASA high dose regime restarted 2/5/2021 to continue until CP resolves, then taper.  Pt still with a sensation of "rubbing" in chest, worse with exertion as of 4/1/2021. F/U appointment with Cardiology on 4/5/2021. All infectious workup negative to date for any acute infection that may be the etiology of myocarditis. Viral studies (CMV, HSV, Parvo, HIV, EBV IgM, Cocsackie IgM negative)  Social History:    Tobacco: ¼ to ½ ppd for 10 years; stopped o/a 21 JAN 2021 Alcohol: 1 drink per week Recreational / Illicit: denies
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Pain, Pain in extremity, SARS-CoV-2 test negative, Troponin increased
Clinical narrative: 01/22/2021  Event Description  40 year old male with no prior cardiac left sided chest pain radiating to left arm and shoulder starting approx. 24 hours after 2nd Pfizer COVID 19 vaccination. Went to ED on 1/24 for increasing CP, left arm pain/numbness. EKG demonstrated elevated ST elevations and troponins were elevated on admission concerning for STEMI; LHC was negative for any CAD. Cardiac MRI demonstrated sub-endocardial enhancement consistent with myocarditis.   Comments    Diagnostic Tests  1/24: PCXR- Normal 1/24: Coronary Angiogram - normal coronary arteries 1/24: Echocardiogram - Normal 1/25-Cardiac MR - findings highly suggestive of myocarditis (i.e infectious or perhaps post-vaccine) as evidenced by  confluent sub-epicardial hyperenhancement on myocardial delayed enhancement (MDE) imaging in the inferoseptal, inferior, inferolateral, anterolateral and anterior segments of the basal to mid left ventricle.   Laboratory Data  1/24/21 Troponin:495, 662.0, 602.3 1/28/21: 29. Covid PCR - negative 1/24/2021. No recent illnesses  Still taking colchicine 0.6 mg BID until 4/25/2021. ASA high dose regime restarted 2/5/2021 to continue until CP resolves, then taper.  Pt still with a sensation of "rubbing" in chest, worse with exertion as of 4/1/2021. F/U appointment with Cardiology on 4/5/2021. All infectious workup negative to date for any acute infection that may be the etiology of myocarditis. Viral studies (CMV, HSV, Parvo, HIV, EBV IgM, Cocsackie IgM negative)  Social History:    Tobacco: ¼ to ½ ppd for 10 years; stopped o/a 21 JAN 2021 Alcohol: 1 drink per week Recreational / Illicit: denies
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Viral test negative
Clinical narrative: 01/22/2021  Event Description  40 year old male with no prior cardiac left sided chest pain radiating to left arm and shoulder starting approx. 24 hours after 2nd Pfizer COVID 19 vaccination. Went to ED on 1/24 for increasing CP, left arm pain/numbness. EKG demonstrated elevated ST elevations and troponins were elevated on admission concerning for STEMI; LHC was negative for any CAD. Cardiac MRI demonstrated sub-endocardial enhancement consistent with myocarditis.   Comments    Diagnostic Tests  1/24: PCXR- Normal 1/24: Coronary Angiogram - normal coronary arteries 1/24: Echocardiogram - Normal 1/25-Cardiac MR - findings highly suggestive of myocarditis (i.e infectious or perhaps post-vaccine) as evidenced by  confluent sub-epicardial hyperenhancement on myocardial delayed enhancement (MDE) imaging in the inferoseptal, inferior, inferolateral, anterolateral and anterior segments of the basal to mid left ventricle.   Laboratory Data  1/24/21 Troponin:495, 662.0, 602.3 1/28/21: 29. Covid PCR - negative 1/24/2021. No recent illnesses  Still taking colchicine 0.6 mg BID until 4/25/2021. ASA high dose regime restarted 2/5/2021 to continue until CP resolves, then taper.  Pt still with a sensation of "rubbing" in chest, worse with exertion as of 4/1/2021. F/U appointment with Cardiology on 4/5/2021. All infectious workup negative to date for any acute infection that may be the etiology of myocarditis. Viral studies (CMV, HSV, Parvo, HIV, EBV IgM, Cocsackie IgM negative)  Social History:    Tobacco: ¼ to ½ ppd for 10 years; stopped o/a 21 JAN 2021 Alcohol: 1 drink per week Recreational / Illicit: denies
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Laboratory test, Neck pain, X-ray
Clinical narrative: unable to move left shoulder, constant pain, worse with movement, resulting in visit to clinic twice for same pain, discharged from clinic twice
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Pain
Clinical narrative: unable to move left shoulder, constant pain, worse with movement, resulting in visit to clinic twice for same pain, discharged from clinic twice
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cellulitis, Chills, Erythema, Lymphoedema, Nausea
Clinical narrative: cellulitis in RUE with persistent exacerbation RUE chronic lymphedema
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain of skin, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: cellulitis in RUE with persistent exacerbation RUE chronic lymphedema
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cellulitis, Lymphoedema
Clinical narrative: cellulitis in RUE with persistent exacerbation RUE chronic lymphedema
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: BODY ACHES; EXTREME CHILLS; FEVER; EXTREME FATIGUE; This spontaneous report received from a patient concerned a 38 year old. The patient's weight was 104 pounds, and height was 180.34 centimeters. The patient's concurrent conditions included abstains from alcohol, and non smoker, and other pre-existing medical conditions included the patient had no allergies and did not had drug abuse. the patient had no other medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 11:00 AM for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: COVID-19 virus test (NR: not provided) TEST WAS NEGATIVE. On 09-MAR-2021, the subject experienced body aches. On 09-MAR-2021, the subject experienced extreme chills. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced extreme fatigue. Laboratory data included: Body temperature (NR: not provided) 102 (unit not specified). On 10-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100 Degree. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme chills, fever, and extreme fatigue on 24-MAR-2021, and the outcome of body aches was not reported. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: BODY ACHES; EXTREME CHILLS; FEVER; EXTREME FATIGUE; This spontaneous report received from a patient concerned a 38 year old. The patient's weight was 104 pounds, and height was 180.34 centimeters. The patient's concurrent conditions included abstains from alcohol, and non smoker, and other pre-existing medical conditions included the patient had no allergies and did not had drug abuse. the patient had no other medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 11:00 AM for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: COVID-19 virus test (NR: not provided) TEST WAS NEGATIVE. On 09-MAR-2021, the subject experienced body aches. On 09-MAR-2021, the subject experienced extreme chills. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced extreme fatigue. Laboratory data included: Body temperature (NR: not provided) 102 (unit not specified). On 10-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100 Degree. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme chills, fever, and extreme fatigue on 24-MAR-2021, and the outcome of body aches was not reported. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: BODY ACHES; EXTREME CHILLS; FEVER; EXTREME FATIGUE; This spontaneous report received from a patient concerned a 38 year old. The patient's weight was 104 pounds, and height was 180.34 centimeters. The patient's concurrent conditions included abstains from alcohol, and non smoker, and other pre-existing medical conditions included the patient had no allergies and did not had drug abuse. the patient had no other medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 11:00 AM for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: COVID-19 virus test (NR: not provided) TEST WAS NEGATIVE. On 09-MAR-2021, the subject experienced body aches. On 09-MAR-2021, the subject experienced extreme chills. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced extreme fatigue. Laboratory data included: Body temperature (NR: not provided) 102 (unit not specified). On 10-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100 Degree. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme chills, fever, and extreme fatigue on 24-MAR-2021, and the outcome of body aches was not reported. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: BODY ACHES; EXTREME CHILLS; FEVER; EXTREME FATIGUE; This spontaneous report received from a patient concerned a 38 year old. The patient's weight was 104 pounds, and height was 180.34 centimeters. The patient's concurrent conditions included abstains from alcohol, and non smoker, and other pre-existing medical conditions included the patient had no allergies and did not had drug abuse. the patient had no other medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 11:00 AM for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: COVID-19 virus test (NR: not provided) TEST WAS NEGATIVE. On 09-MAR-2021, the subject experienced body aches. On 09-MAR-2021, the subject experienced extreme chills. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced extreme fatigue. Laboratory data included: Body temperature (NR: not provided) 102 (unit not specified). On 10-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100 Degree. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme chills, fever, and extreme fatigue on 24-MAR-2021, and the outcome of body aches was not reported. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gingival swelling, Lip swelling, Muscle spasms, Peripheral swelling, Pruritus
Clinical narrative: After receiving vaccine patient experienced hives on upper arms and chest and states she experienced muscle spasms. Patient denied any medication or transportation.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling of eyelid, Swollen tongue, Urticaria
Clinical narrative: After receiving vaccine patient experienced hives on upper arms and chest and states she experienced muscle spasms. Patient denied any medication or transportation.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Urticaria
Clinical narrative: After receiving vaccine patient experienced hives on upper arms and chest and states she experienced muscle spasms. Patient denied any medication or transportation.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood test normal, Chest X-ray normal, Chest discomfort, Discomfort
Clinical narrative: Dizziness, shortness of the breath, swelling of the throat.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Ear swelling, Electrocardiogram normal, Eye swelling
Clinical narrative: Dizziness, shortness of the breath, swelling of the throat.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mouth swelling, Pharyngeal swelling, Swelling face, Swollen tongue
Clinical narrative: Dizziness, shortness of the breath, swelling of the throat.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Pharyngeal swelling
Clinical narrative: Dizziness, shortness of the breath, swelling of the throat.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness, Tongue pruritus
Clinical narrative: Shot received around 12:35 pm, started experiencing itching and swelling of the tongue immediately  and a tightness in the throat started right after.  Alerted EMTS by 12:50pm.  EMT's administered benadryl on site and monitored.  Blood pressure became extremely high and caused extra concern.    It was advised to consider going to hospital but stated would go if it became worse.  1:15 Benadryl started to take hold and some relief was received.   Called Dr from the car on the way home (about 1:45pm) and was advised to monitor closely and if it became worse to go to the hospital. Itching and sensitivity to items continued for 3 to 4 days after the shot.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Hypertension, Swollen tongue, Throat tightness, Tongue pruritus
Clinical narrative: Shot received around 12:35 pm, started experiencing itching and swelling of the tongue immediately  and a tightness in the throat started right after.  Alerted EMTS by 12:50pm.  EMT's administered benadryl on site and monitored.  Blood pressure became extremely high and caused extra concern.    It was advised to consider going to hospital but stated would go if it became worse.  1:15 Benadryl started to take hold and some relief was received.   Called Dr from the car on the way home (about 1:45pm) and was advised to monitor closely and if it became worse to go to the hospital. Itching and sensitivity to items continued for 3 to 4 days after the shot.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Underdose
Clinical narrative: DRUG ADMINISTRATION ERROR; ANOTHER DOSE OF THE VACCINE; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced another dose of the vaccine. On 10-MAR-2021, the subject experienced drug administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug administration error and another dose of the vaccine was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Extra dose administered, Product administration error
Clinical narrative: DRUG ADMINISTRATION ERROR; ANOTHER DOSE OF THE VACCINE; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced another dose of the vaccine. On 10-MAR-2021, the subject experienced drug administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug administration error and another dose of the vaccine was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Extra dose administered, HIV infection, Hepatitis, Product administration error
Clinical narrative: DRUG ADMINISTRATION ERROR; ANOTHER DOSE OF THE VACCINE; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced another dose of the vaccine. On 10-MAR-2021, the subject experienced drug administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug administration error and another dose of the vaccine was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Immunisation, Syringe issue
Clinical narrative: DRUG ADMINISTRATION ERROR; ANOTHER DOSE OF THE VACCINE; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced another dose of the vaccine. On 10-MAR-2021, the subject experienced drug administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug administration error and another dose of the vaccine was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Underdose
Clinical narrative: DRUG ADMINISTRATION ERROR; POSSIBLE EXTRA DOSE ADMINISTERED; This spontaneous report received from a patient concerned a 37 year old female. The patient's concurrent conditions included inflamed nerves, non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no known allergies and no history of drug abuse. The patient was previously treated with gabapentin for inflamed nerves. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25/MAY/2021) dose was not reported, administered on 10-MAR-2021 05:15 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, Laboratory data included: HIV infection (NR: not provided) not reported, and Hepatitis (NR: not provided) not reported. On 10-MAR-2021, the subject experienced drug administration error. On 10-MAR-2021, the subject experienced possible extra dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug administration error and possible extra dose administered was not reported. This report was non-serious. This report was associated with product quality complaint: 90000173646.; Sender's Comments: V1: Follow up information received in the current version has no impact on previous assessment. Medical assessment comment not required as per standard procedure as the case assessed as non-serious.