chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Gait inability, Mobility decreased, Myalgia
Clinical narrative: severe lower back pain; inability to walk; muscle aches; impaired mobility; inability to work; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 3 via an unspecified route of administration, administered in arm left on 27Sep2021 15:45 (at the age pf 39 years old, Lot Number: FF8839) as dose 3 (booster), single for covid-19 immunisation. Medical history included known allergies: cipro, sulfa drugs, gabapentin. Concomitant medication in two weeks included bupropion hydrochloride (WELLBUTRIN). No other vaccine in four weeks. The patient previously received dose 1 (lot number EL9264) on 06Feb2021 01:15 PM and dose 2 (lot number EN6203) on 27Feb2021 10:00 AM of BNT162B2 in left arm for covid-19 immunisation, gabapentin and experienced drug allergy. After booster shot (3rd dose) patient developed severe lower back pain to the point of inability to walk on 28Sep2021 10:00 AM. Currently seeking medical treatment 10 days out. Shot was received on Monday. On Tuesday usual side effects of muscle aches started 28Sep2021, but this time sever lower back pain. Days 3-5 condition did not worsen or improve. Days 6-10 continued escalation to the point of impaired mobility, inability to work, and seeking medical care. Events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Treatment included TBD. The outcome of events was not recovered. No Covid prior vaccination. No Covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received a vaccine of moderna after i stated when scheduling appt that NO i was no immunosuppressed. Facility should have at that poiny stated i was not eligble at this time but it allowed me to schedule appt.Pharmacist gave me a FULL DOSE OF MODERNA THST WAS NOT YET APPROVED BY FDA TO GIVE AS A BOOSTER SHOT! I HAD A TERRIBLE REACTION THAT DAY ARM RED SWOLLEN fever 103.3 called vaccination site ..called my md ..vaccination site manageradmitted they messed up by allowing me to schedule appt and giving me full dose of non approved booster moderna ..went to my md 3 days later whens ymptoms hadnt gone away.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Received a vaccine of moderna after i stated when scheduling appt that NO i was no immunosuppressed. Facility should have at that poiny stated i was not eligble at this time but it allowed me to schedule appt.Pharmacist gave me a FULL DOSE OF MODERNA THST WAS NOT YET APPROVED BY FDA TO GIVE AS A BOOSTER SHOT! I HAD A TERRIBLE REACTION THAT DAY ARM RED SWOLLEN fever 103.3 called vaccination site ..called my md ..vaccination site manageradmitted they messed up by allowing me to schedule appt and giving me full dose of non approved booster moderna ..went to my md 3 days later whens ymptoms hadnt gone away.
Sex: F
Vaccine: COVID19, TDAP, UNK, COVID19, TDAP, UNK
Symptoms: Product use issue, Pruritus
Clinical narrative: Severe itching on both hands and elbows; This case was reported by a consumer via other manufacturer and described the occurrence of itching both hands in a 74-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE (FLU SHOT)) for prophylaxis and COVID-19 VACCINE PFIZER (batch number FF2587, expiry date unknown) for covid-19 prophylaxis.   Previously administered products included Penicillin. Additional patient notes included Ethnicity - Caucasian.   On 27th September 2021, the patient received Boostrix and FLUZONE (FLU SHOT). On 27th September 2021 11:45, the patient received COVID-19 VACCINE PFIZER. On 27th September 2021 21:00, less than a day after receiving Boostrix, the patient experienced itching both hands. The patient was treated with cetirizine hydrochloride (Zyrtec) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the itching both hands was not recovered/not resolved.   It was unknown if the reporter considered the itching both hands to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Boostrix on the arm, Fluzone on the left upper arm, Covid-19 vaccine Pfizer on right arm. The patient experienced severe itching on both sides of both hands, plus both e bows. 9 hours 15 minutes after the Covid-19 vaccine Pfizer vaccine the patient developed itching both hands. Less than a day after receiving Fluzone, the patient experienced itching both hands. It was unknown if the reporter considered the itching both hands to be related to Fluzone and Covid-19 vaccine Pfizer.
Sex: F
Vaccine: COVID19, TDAP, UNK, COVID19, TDAP, UNK
Symptoms: Pruritus
Clinical narrative: Severe itching on both hands and elbows; This case was reported by a consumer via other manufacturer and described the occurrence of itching both hands in a 74-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE (FLU SHOT)) for prophylaxis and COVID-19 VACCINE PFIZER (batch number FF2587, expiry date unknown) for covid-19 prophylaxis.   Previously administered products included Penicillin. Additional patient notes included Ethnicity - Caucasian.   On 27th September 2021, the patient received Boostrix and FLUZONE (FLU SHOT). On 27th September 2021 11:45, the patient received COVID-19 VACCINE PFIZER. On 27th September 2021 21:00, less than a day after receiving Boostrix, the patient experienced itching both hands. The patient was treated with cetirizine hydrochloride (Zyrtec) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the itching both hands was not recovered/not resolved.   It was unknown if the reporter considered the itching both hands to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Boostrix on the arm, Fluzone on the left upper arm, Covid-19 vaccine Pfizer on right arm. The patient experienced severe itching on both sides of both hands, plus both e bows. 9 hours 15 minutes after the Covid-19 vaccine Pfizer vaccine the patient developed itching both hands. Less than a day after receiving Fluzone, the patient experienced itching both hands. It was unknown if the reporter considered the itching both hands to be related to Fluzone and Covid-19 vaccine Pfizer.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Erythema
Clinical narrative: BODY RASH.  REDNESS.  PEELING.  PATIENT SAW DERMATOLOGIST AND SENT TO ER TO RULE OUT STEVENS-JOHNSON SYNDROME.  GIVEN STEROIDS, SINGULAIR, AND H2 ANTAGONIST
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Rash, Skin exfoliation
Clinical narrative: BODY RASH.  REDNESS.  PEELING.  PATIENT SAW DERMATOLOGIST AND SENT TO ER TO RULE OUT STEVENS-JOHNSON SYNDROME.  GIVEN STEROIDS, SINGULAIR, AND H2 ANTAGONIST
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arrhythmia, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Blood electrolytes normal, Blood pressure increased
Clinical narrative: Patient  is a previously healthy 16 yo male who presented to an outside ED for severe substernal chest pain. Patients states that at 1 pm on the day prior to admission, he started to experience 4-5/10 substernal chest pain. He spoke to his sister who suggested he rest and drink a glass of milk. Patient states that he tried a hot shower which helped a little but by 9 pm the chest pain increased in severity to 8-9/10. He denies fever, SOB, dizziness, palpitations, N/V. He called his bother who brought him to the ED. History significant for receiving second Pfizer COVID vaccine 3 days prior. Labs at outside ED were significant for high sensitivity Troponjin elevated to 1447, CK = 1342, CRP= 2.89. EKG demonstrated ST elevation in anterior inferior leads as well as lateral precordial leads. Electrolytes, CBC wnl, LFTs mildly elevated AST at 88. Echo reported to be normal function and intracardiac structure. He was afebrile with a HR of 81, RR =20, BP= 173/91 decreased to 112/66 after falling asleep, Oxygen Sats =100%. He denies any substance abuse and there is no cardiac family history. No significant PMH. Of note chest pain is positional.  He was initially admitted to the Hospital. Pt was stable on arrival and not tachycardic. Trended troponin I. Serial EKGs obtained. Consulted cards, ID, and rheumatology. He was able to be transferred to the floor.  He initially had well-controlled pain on Toradol alone, but had one overnight episode of severe pain treated with Morphine once. His max Troponin levels was 29 and it continued to improve with drastic improvement with IV steroids. His most recent Troponin was 3.34 on 10/22. Echo 10/19 with low normal LV systolic function (EF 57%), mild inferior septal  hypokinesia, abnormal diastolic function. Echo 10/21 with normal LV systolic function, EF 61%, normal diastolic function. Cardiac MRI on 10/21 with multiple areas of patchy subepicardial and mid-myocardial pattern of hyperenhancement in the lateral wall as well as the distal septum and apex, consistent with presence of myocardial scarring/fibrosis, normal LV size/systolic function, LV EF 58%, normal RV size/systolic function, RV EF 59%. Pediatric cardiology recommended discharge on 10/22 with an oral steroid taper.   Presentation was felt to be consistent with post-COVID vaccine myocarditis.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: C-reactive protein increased, Chest pain, Echocardiogram abnormal, Ejection fraction, Electrocardiogram ST segment elevation
Clinical narrative: Patient  is a previously healthy 16 yo male who presented to an outside ED for severe substernal chest pain. Patients states that at 1 pm on the day prior to admission, he started to experience 4-5/10 substernal chest pain. He spoke to his sister who suggested he rest and drink a glass of milk. Patient states that he tried a hot shower which helped a little but by 9 pm the chest pain increased in severity to 8-9/10. He denies fever, SOB, dizziness, palpitations, N/V. He called his bother who brought him to the ED. History significant for receiving second Pfizer COVID vaccine 3 days prior. Labs at outside ED were significant for high sensitivity Troponjin elevated to 1447, CK = 1342, CRP= 2.89. EKG demonstrated ST elevation in anterior inferior leads as well as lateral precordial leads. Electrolytes, CBC wnl, LFTs mildly elevated AST at 88. Echo reported to be normal function and intracardiac structure. He was afebrile with a HR of 81, RR =20, BP= 173/91 decreased to 112/66 after falling asleep, Oxygen Sats =100%. He denies any substance abuse and there is no cardiac family history. No significant PMH. Of note chest pain is positional.  He was initially admitted to the Hospital. Pt was stable on arrival and not tachycardic. Trended troponin I. Serial EKGs obtained. Consulted cards, ID, and rheumatology. He was able to be transferred to the floor.  He initially had well-controlled pain on Toradol alone, but had one overnight episode of severe pain treated with Morphine once. His max Troponin levels was 29 and it continued to improve with drastic improvement with IV steroids. His most recent Troponin was 3.34 on 10/22. Echo 10/19 with low normal LV systolic function (EF 57%), mild inferior septal  hypokinesia, abnormal diastolic function. Echo 10/21 with normal LV systolic function, EF 61%, normal diastolic function. Cardiac MRI on 10/21 with multiple areas of patchy subepicardial and mid-myocardial pattern of hyperenhancement in the lateral wall as well as the distal septum and apex, consistent with presence of myocardial scarring/fibrosis, normal LV size/systolic function, LV EF 58%, normal RV size/systolic function, RV EF 59%. Pediatric cardiology recommended discharge on 10/22 with an oral steroid taper.   Presentation was felt to be consistent with post-COVID vaccine myocarditis.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Full blood count normal, Inflammatory marker test, Intensive care, Laboratory test normal, Liver function test increased
Clinical narrative: Patient  is a previously healthy 16 yo male who presented to an outside ED for severe substernal chest pain. Patients states that at 1 pm on the day prior to admission, he started to experience 4-5/10 substernal chest pain. He spoke to his sister who suggested he rest and drink a glass of milk. Patient states that he tried a hot shower which helped a little but by 9 pm the chest pain increased in severity to 8-9/10. He denies fever, SOB, dizziness, palpitations, N/V. He called his bother who brought him to the ED. History significant for receiving second Pfizer COVID vaccine 3 days prior. Labs at outside ED were significant for high sensitivity Troponjin elevated to 1447, CK = 1342, CRP= 2.89. EKG demonstrated ST elevation in anterior inferior leads as well as lateral precordial leads. Electrolytes, CBC wnl, LFTs mildly elevated AST at 88. Echo reported to be normal function and intracardiac structure. He was afebrile with a HR of 81, RR =20, BP= 173/91 decreased to 112/66 after falling asleep, Oxygen Sats =100%. He denies any substance abuse and there is no cardiac family history. No significant PMH. Of note chest pain is positional.  He was initially admitted to the Hospital. Pt was stable on arrival and not tachycardic. Trended troponin I. Serial EKGs obtained. Consulted cards, ID, and rheumatology. He was able to be transferred to the floor.  He initially had well-controlled pain on Toradol alone, but had one overnight episode of severe pain treated with Morphine once. His max Troponin levels was 29 and it continued to improve with drastic improvement with IV steroids. His most recent Troponin was 3.34 on 10/22. Echo 10/19 with low normal LV systolic function (EF 57%), mild inferior septal  hypokinesia, abnormal diastolic function. Echo 10/21 with normal LV systolic function, EF 61%, normal diastolic function. Cardiac MRI on 10/21 with multiple areas of patchy subepicardial and mid-myocardial pattern of hyperenhancement in the lateral wall as well as the distal septum and apex, consistent with presence of myocardial scarring/fibrosis, normal LV size/systolic function, LV EF 58%, normal RV size/systolic function, RV EF 59%. Pediatric cardiology recommended discharge on 10/22 with an oral steroid taper.   Presentation was felt to be consistent with post-COVID vaccine myocarditis.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis, Pericarditis, Red blood cell sedimentation rate increased, Troponin increased, Ventricular hypokinesia
Clinical narrative: Patient  is a previously healthy 16 yo male who presented to an outside ED for severe substernal chest pain. Patients states that at 1 pm on the day prior to admission, he started to experience 4-5/10 substernal chest pain. He spoke to his sister who suggested he rest and drink a glass of milk. Patient states that he tried a hot shower which helped a little but by 9 pm the chest pain increased in severity to 8-9/10. He denies fever, SOB, dizziness, palpitations, N/V. He called his bother who brought him to the ED. History significant for receiving second Pfizer COVID vaccine 3 days prior. Labs at outside ED were significant for high sensitivity Troponjin elevated to 1447, CK = 1342, CRP= 2.89. EKG demonstrated ST elevation in anterior inferior leads as well as lateral precordial leads. Electrolytes, CBC wnl, LFTs mildly elevated AST at 88. Echo reported to be normal function and intracardiac structure. He was afebrile with a HR of 81, RR =20, BP= 173/91 decreased to 112/66 after falling asleep, Oxygen Sats =100%. He denies any substance abuse and there is no cardiac family history. No significant PMH. Of note chest pain is positional.  He was initially admitted to the Hospital. Pt was stable on arrival and not tachycardic. Trended troponin I. Serial EKGs obtained. Consulted cards, ID, and rheumatology. He was able to be transferred to the floor.  He initially had well-controlled pain on Toradol alone, but had one overnight episode of severe pain treated with Morphine once. His max Troponin levels was 29 and it continued to improve with drastic improvement with IV steroids. His most recent Troponin was 3.34 on 10/22. Echo 10/19 with low normal LV systolic function (EF 57%), mild inferior septal  hypokinesia, abnormal diastolic function. Echo 10/21 with normal LV systolic function, EF 61%, normal diastolic function. Cardiac MRI on 10/21 with multiple areas of patchy subepicardial and mid-myocardial pattern of hyperenhancement in the lateral wall as well as the distal septum and apex, consistent with presence of myocardial scarring/fibrosis, normal LV size/systolic function, LV EF 58%, normal RV size/systolic function, RV EF 59%. Pediatric cardiology recommended discharge on 10/22 with an oral steroid taper.   Presentation was felt to be consistent with post-COVID vaccine myocarditis.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram abnormal, Myocarditis, Troponin increased
Clinical narrative: Patient  is a previously healthy 16 yo male who presented to an outside ED for severe substernal chest pain. Patients states that at 1 pm on the day prior to admission, he started to experience 4-5/10 substernal chest pain. He spoke to his sister who suggested he rest and drink a glass of milk. Patient states that he tried a hot shower which helped a little but by 9 pm the chest pain increased in severity to 8-9/10. He denies fever, SOB, dizziness, palpitations, N/V. He called his bother who brought him to the ED. History significant for receiving second Pfizer COVID vaccine 3 days prior. Labs at outside ED were significant for high sensitivity Troponjin elevated to 1447, CK = 1342, CRP= 2.89. EKG demonstrated ST elevation in anterior inferior leads as well as lateral precordial leads. Electrolytes, CBC wnl, LFTs mildly elevated AST at 88. Echo reported to be normal function and intracardiac structure. He was afebrile with a HR of 81, RR =20, BP= 173/91 decreased to 112/66 after falling asleep, Oxygen Sats =100%. He denies any substance abuse and there is no cardiac family history. No significant PMH. Of note chest pain is positional.  He was initially admitted to the Hospital. Pt was stable on arrival and not tachycardic. Trended troponin I. Serial EKGs obtained. Consulted cards, ID, and rheumatology. He was able to be transferred to the floor.  He initially had well-controlled pain on Toradol alone, but had one overnight episode of severe pain treated with Morphine once. His max Troponin levels was 29 and it continued to improve with drastic improvement with IV steroids. His most recent Troponin was 3.34 on 10/22. Echo 10/19 with low normal LV systolic function (EF 57%), mild inferior septal  hypokinesia, abnormal diastolic function. Echo 10/21 with normal LV systolic function, EF 61%, normal diastolic function. Cardiac MRI on 10/21 with multiple areas of patchy subepicardial and mid-myocardial pattern of hyperenhancement in the lateral wall as well as the distal septum and apex, consistent with presence of myocardial scarring/fibrosis, normal LV size/systolic function, LV EF 58%, normal RV size/systolic function, RV EF 59%. Pediatric cardiology recommended discharge on 10/22 with an oral steroid taper.   Presentation was felt to be consistent with post-COVID vaccine myocarditis.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Blood electrolytes normal, Blood pressure increased, C-reactive protein increased
Clinical narrative: Patient  is a previously healthy 16 yo male who presented to an outside ED for severe substernal chest pain. Patients states that at 1 pm on the day prior to admission, he started to experience 4-5/10 substernal chest pain. He spoke to his sister who suggested he rest and drink a glass of milk. Patient states that he tried a hot shower which helped a little but by 9 pm the chest pain increased in severity to 8-9/10. He denies fever, SOB, dizziness, palpitations, N/V. He called his bother who brought him to the ED. History significant for receiving second Pfizer COVID vaccine 3 days prior. Labs at outside ED were significant for high sensitivity Troponjin elevated to 1447, CK = 1342, CRP= 2.89. EKG demonstrated ST elevation in anterior inferior leads as well as lateral precordial leads. Electrolytes, CBC wnl, LFTs mildly elevated AST at 88. Echo reported to be normal function and intracardiac structure. He was afebrile with a HR of 81, RR =20, BP= 173/91 decreased to 112/66 after falling asleep, Oxygen Sats =100%. He denies any substance abuse and there is no cardiac family history. No significant PMH. Of note chest pain is positional.  He was initially admitted to the Hospital. Pt was stable on arrival and not tachycardic. Trended troponin I. Serial EKGs obtained. Consulted cards, ID, and rheumatology. He was able to be transferred to the floor.  He initially had well-controlled pain on Toradol alone, but had one overnight episode of severe pain treated with Morphine once. His max Troponin levels was 29 and it continued to improve with drastic improvement with IV steroids. His most recent Troponin was 3.34 on 10/22. Echo 10/19 with low normal LV systolic function (EF 57%), mild inferior septal  hypokinesia, abnormal diastolic function. Echo 10/21 with normal LV systolic function, EF 61%, normal diastolic function. Cardiac MRI on 10/21 with multiple areas of patchy subepicardial and mid-myocardial pattern of hyperenhancement in the lateral wall as well as the distal septum and apex, consistent with presence of myocardial scarring/fibrosis, normal LV size/systolic function, LV EF 58%, normal RV size/systolic function, RV EF 59%. Pediatric cardiology recommended discharge on 10/22 with an oral steroid taper.   Presentation was felt to be consistent with post-COVID vaccine myocarditis.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Diastolic dysfunction, Echocardiogram normal, Ejection fraction, Ejection fraction normal
Clinical narrative: Patient  is a previously healthy 16 yo male who presented to an outside ED for severe substernal chest pain. Patients states that at 1 pm on the day prior to admission, he started to experience 4-5/10 substernal chest pain. He spoke to his sister who suggested he rest and drink a glass of milk. Patient states that he tried a hot shower which helped a little but by 9 pm the chest pain increased in severity to 8-9/10. He denies fever, SOB, dizziness, palpitations, N/V. He called his bother who brought him to the ED. History significant for receiving second Pfizer COVID vaccine 3 days prior. Labs at outside ED were significant for high sensitivity Troponjin elevated to 1447, CK = 1342, CRP= 2.89. EKG demonstrated ST elevation in anterior inferior leads as well as lateral precordial leads. Electrolytes, CBC wnl, LFTs mildly elevated AST at 88. Echo reported to be normal function and intracardiac structure. He was afebrile with a HR of 81, RR =20, BP= 173/91 decreased to 112/66 after falling asleep, Oxygen Sats =100%. He denies any substance abuse and there is no cardiac family history. No significant PMH. Of note chest pain is positional.  He was initially admitted to the Hospital. Pt was stable on arrival and not tachycardic. Trended troponin I. Serial EKGs obtained. Consulted cards, ID, and rheumatology. He was able to be transferred to the floor.  He initially had well-controlled pain on Toradol alone, but had one overnight episode of severe pain treated with Morphine once. His max Troponin levels was 29 and it continued to improve with drastic improvement with IV steroids. His most recent Troponin was 3.34 on 10/22. Echo 10/19 with low normal LV systolic function (EF 57%), mild inferior septal  hypokinesia, abnormal diastolic function. Echo 10/21 with normal LV systolic function, EF 61%, normal diastolic function. Cardiac MRI on 10/21 with multiple areas of patchy subepicardial and mid-myocardial pattern of hyperenhancement in the lateral wall as well as the distal septum and apex, consistent with presence of myocardial scarring/fibrosis, normal LV size/systolic function, LV EF 58%, normal RV size/systolic function, RV EF 59%. Pediatric cardiology recommended discharge on 10/22 with an oral steroid taper.   Presentation was felt to be consistent with post-COVID vaccine myocarditis.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram ST segment elevation, Full blood count normal, Intensive care, Liver function test increased, Magnetic resonance imaging abnormal
Clinical narrative: Patient  is a previously healthy 16 yo male who presented to an outside ED for severe substernal chest pain. Patients states that at 1 pm on the day prior to admission, he started to experience 4-5/10 substernal chest pain. He spoke to his sister who suggested he rest and drink a glass of milk. Patient states that he tried a hot shower which helped a little but by 9 pm the chest pain increased in severity to 8-9/10. He denies fever, SOB, dizziness, palpitations, N/V. He called his bother who brought him to the ED. History significant for receiving second Pfizer COVID vaccine 3 days prior. Labs at outside ED were significant for high sensitivity Troponjin elevated to 1447, CK = 1342, CRP= 2.89. EKG demonstrated ST elevation in anterior inferior leads as well as lateral precordial leads. Electrolytes, CBC wnl, LFTs mildly elevated AST at 88. Echo reported to be normal function and intracardiac structure. He was afebrile with a HR of 81, RR =20, BP= 173/91 decreased to 112/66 after falling asleep, Oxygen Sats =100%. He denies any substance abuse and there is no cardiac family history. No significant PMH. Of note chest pain is positional.  He was initially admitted to the Hospital. Pt was stable on arrival and not tachycardic. Trended troponin I. Serial EKGs obtained. Consulted cards, ID, and rheumatology. He was able to be transferred to the floor.  He initially had well-controlled pain on Toradol alone, but had one overnight episode of severe pain treated with Morphine once. His max Troponin levels was 29 and it continued to improve with drastic improvement with IV steroids. His most recent Troponin was 3.34 on 10/22. Echo 10/19 with low normal LV systolic function (EF 57%), mild inferior septal  hypokinesia, abnormal diastolic function. Echo 10/21 with normal LV systolic function, EF 61%, normal diastolic function. Cardiac MRI on 10/21 with multiple areas of patchy subepicardial and mid-myocardial pattern of hyperenhancement in the lateral wall as well as the distal septum and apex, consistent with presence of myocardial scarring/fibrosis, normal LV size/systolic function, LV EF 58%, normal RV size/systolic function, RV EF 59%. Pediatric cardiology recommended discharge on 10/22 with an oral steroid taper.   Presentation was felt to be consistent with post-COVID vaccine myocarditis.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging heart, Myocardial fibrosis, Myocarditis, Troponin I, Ventricular hypokinesia
Clinical narrative: Patient  is a previously healthy 16 yo male who presented to an outside ED for severe substernal chest pain. Patients states that at 1 pm on the day prior to admission, he started to experience 4-5/10 substernal chest pain. He spoke to his sister who suggested he rest and drink a glass of milk. Patient states that he tried a hot shower which helped a little but by 9 pm the chest pain increased in severity to 8-9/10. He denies fever, SOB, dizziness, palpitations, N/V. He called his bother who brought him to the ED. History significant for receiving second Pfizer COVID vaccine 3 days prior. Labs at outside ED were significant for high sensitivity Troponjin elevated to 1447, CK = 1342, CRP= 2.89. EKG demonstrated ST elevation in anterior inferior leads as well as lateral precordial leads. Electrolytes, CBC wnl, LFTs mildly elevated AST at 88. Echo reported to be normal function and intracardiac structure. He was afebrile with a HR of 81, RR =20, BP= 173/91 decreased to 112/66 after falling asleep, Oxygen Sats =100%. He denies any substance abuse and there is no cardiac family history. No significant PMH. Of note chest pain is positional.  He was initially admitted to the Hospital. Pt was stable on arrival and not tachycardic. Trended troponin I. Serial EKGs obtained. Consulted cards, ID, and rheumatology. He was able to be transferred to the floor.  He initially had well-controlled pain on Toradol alone, but had one overnight episode of severe pain treated with Morphine once. His max Troponin levels was 29 and it continued to improve with drastic improvement with IV steroids. His most recent Troponin was 3.34 on 10/22. Echo 10/19 with low normal LV systolic function (EF 57%), mild inferior septal  hypokinesia, abnormal diastolic function. Echo 10/21 with normal LV systolic function, EF 61%, normal diastolic function. Cardiac MRI on 10/21 with multiple areas of patchy subepicardial and mid-myocardial pattern of hyperenhancement in the lateral wall as well as the distal septum and apex, consistent with presence of myocardial scarring/fibrosis, normal LV size/systolic function, LV EF 58%, normal RV size/systolic function, RV EF 59%. Pediatric cardiology recommended discharge on 10/22 with an oral steroid taper.   Presentation was felt to be consistent with post-COVID vaccine myocarditis.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Grip strength decreased, Muscular weakness, Musculoskeletal disorder, Pain in extremity
Clinical narrative: hand weakness; hand pain; loss of function of her hand; This case was reported by a consumer via call center representative and described the occurrence of hands weakness of in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th August 2021, the patient received the 1st dose of Shingrix. In September 2021, less than a month after receiving Shingrix, the patient experienced hands weakness of, pain in hand and upper extremity dysfunction. On an unknown date, the outcome of the hands weakness of, pain in hand and upper extremity dysfunction were recovered/resolved.   It was unknown if the reporter considered the hands weakness of, pain in hand and upper extremity dysfunction to be related to Shingrix.   Additional details were provided as follows: The case was reported by the patient. The patient received her 1st dose of Shingrix and about one month later, she again had pain, weakness and loss of function in her left hand and again she recovered. The reporter had nothing else to report. The reporter consented to follow up. For tolerance in 1st occurrence of events, refer case US2021212536, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021212536:same reporter
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Muscular weakness, Musculoskeletal disorder, Pain in extremity
Clinical narrative: hand weakness; hand pain; loss of function of her hand; This case was reported by a consumer via call center representative and described the occurrence of hands weakness of in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th August 2021, the patient received the 1st dose of Shingrix. In September 2021, less than a month after receiving Shingrix, the patient experienced hands weakness of, pain in hand and upper extremity dysfunction. On an unknown date, the outcome of the hands weakness of, pain in hand and upper extremity dysfunction were recovered/resolved.   It was unknown if the reporter considered the hands weakness of, pain in hand and upper extremity dysfunction to be related to Shingrix.   Additional details were provided as follows: The case was reported by the patient. The patient received her 1st dose of Shingrix and about one month later, she again had pain, weakness and loss of function in her left hand and again she recovered. The reporter had nothing else to report. The reporter consented to follow up. For tolerance in 1st occurrence of events, refer case US2021212536, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021212536:same reporter
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: ADMINISTRATION ERROR/INCORRECTLY STORED VACCINE ADMINISTERED; VACCINE STORED OUTSIDE OF THE ACCEPTABLE LIMITS; This spontaneous report received from a pharmacist concerned a 60 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212A21A expiry: 21-DEC-2021) dose was not reported, administered on 20-OCT-2021 14:30 for prophylactic vaccination. No concomitant medications were reported.  On 20-OCT-2021, the patient experienced administration error/incorrectly stored vaccine administered. On 20-OCT-2021, the patient experienced vaccine stored outside of the acceptable limits. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error/incorrectly stored vaccine administered and vaccine stored outside of the acceptable limits was not reported. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION ERROR/INCORRECTLY STORED VACCINE ADMINISTERED; VACCINE STORED OUTSIDE OF THE ACCEPTABLE LIMITS; This spontaneous report received from a pharmacist concerned a 60 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212A21A expiry: 21-DEC-2021) dose was not reported, administered on 20-OCT-2021 14:30 for prophylactic vaccination. No concomitant medications were reported.  On 20-OCT-2021, the patient experienced administration error/incorrectly stored vaccine administered. On 20-OCT-2021, the patient experienced vaccine stored outside of the acceptable limits. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error/incorrectly stored vaccine administered and vaccine stored outside of the acceptable limits was not reported. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, FLU4
Symptoms: Chest pain, Computerised tomogram thorax abnormal, Dyspnoea, Pulmonary thrombosis
Clinical narrative: Patient's daughter called the pharmacy stating that the patient developed blood clots after the vaccine, which resulted in the patient being hospitalized on 10/12/21. Patient's daughter said her mother's doctor and nurse practitioner claimed that the flu and COVID vaccines should have been separated by 14 days, but we explained that the CDC recommendation at the time was that both could be given at the same time (one in each arm, or both in the same arm at least an inch apart).  We are not sure what tests were done while the patient was hospitalized, but the patient's daughter insisted that a report be made to VAERS in response to the incident. Patient has since been discharged from the hospital and is now under home healthcare for clot treatment.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, FLU4
Symptoms: Thrombosis
Clinical narrative: Patient's daughter called the pharmacy stating that the patient developed blood clots after the vaccine, which resulted in the patient being hospitalized on 10/12/21. Patient's daughter said her mother's doctor and nurse practitioner claimed that the flu and COVID vaccines should have been separated by 14 days, but we explained that the CDC recommendation at the time was that both could be given at the same time (one in each arm, or both in the same arm at least an inch apart).  We are not sure what tests were done while the patient was hospitalized, but the patient's daughter insisted that a report be made to VAERS in response to the incident. Patient has since been discharged from the hospital and is now under home healthcare for clot treatment.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Itching all over the body,  5 inch welt around where I got the shot, fiebre, joint pain
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Injection site reaction, Pruritus, Urticaria
Clinical narrative: Itching all over the body,  5 inch welt around where I got the shot, fiebre, joint pain
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Pulmonary embolism
Clinical narrative: Pt. states that after receiving the 2nd dose of Moderna 10/13/2021, started experiencing symptoms 10/14/2021 of severe pain throughout the back, neck, and arm (injection site). 10/19/2021 suffered a Pulmonary Embolism (located in the lung *Left lower lobe) 2 days Hospitalized. Discharged 10/21/2021
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Injection site pain, Neck pain, Pulmonary embolism
Clinical narrative: Pt. states that after receiving the 2nd dose of Moderna 10/13/2021, started experiencing symptoms 10/14/2021 of severe pain throughout the back, neck, and arm (injection site). 10/19/2021 suffered a Pulmonary Embolism (located in the lung *Left lower lobe) 2 days Hospitalized. Discharged 10/21/2021
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Chest pain like squeezing first on the left side then succeeding pain on the right chest. Last about a minute or less.  Several times this in an hour this morning.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Neuralgia
Clinical narrative: Severe nerve pain in left shoulder and neck lasting a couple of weeks.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Headache, Vomiting
Clinical narrative: Vomiting, headache, dehydration
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Condition aggravated, Diverticulitis, Echocardiogram, Electrocardiogram
Clinical narrative: SVT episode of 30 min with intermittent shorter episodes for 4 days. Previously asymptotic since cardiac ablation in 2017, ECG, echo and holter monitor  Diverticulitis, no previous occurrences, CBC, CMP, CT scan, IV antibiotics and oral antibiotics
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory, Full blood count, Metabolic function test, SARS-CoV-2 test negative, Supraventricular tachycardia
Clinical narrative: SVT episode of 30 min with intermittent shorter episodes for 4 days. Previously asymptotic since cardiac ablation in 2017, ECG, echo and holter monitor  Diverticulitis, no previous occurrences, CBC, CMP, CT scan, IV antibiotics and oral antibiotics
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Magnetic resonance imaging, Myalgia, X-ray
Clinical narrative: Muscle soreness - started with upper legs, spread to back (lower and upper) and neck. Got progressively worse over several months. Has not abated.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: whole body pain, fever, headache.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node glands on left side of body under arm pit same side as shot was given
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in hands and feet for a few hours. Went away after taking vitamin b complex.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Gastric disorder, Pain, Pain in extremity
Clinical narrative: Extremely sore arm to the point where it hurt to lift it.  Then shivers, chills and upset gastric system.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity, Syncope
Clinical narrative: Pt fainted, came to after a few seconds. alert and conversing. then started having severe cramping with pain in his hands. Emts were called to check him out. pt recovered and left with family member.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac discomfort, Dyspnoea
Clinical narrative: ? Shortness of breath ? Feelings of having a fast-beating, fluttering, or pounding heart
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site haematoma, Injection site pain, Injection site warmth
Clinical narrative: Patient experienced site reaction that started 2 days after injection that included redness (circular in size about 3 inches x 3.5 inches in diameter) with tenderness to palpation, and warmth at that site. Additionally, she has small palpable hematoma at injection site with bruising 6 days after injection.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Lymph node pain, Lymphadenopathy
Clinical narrative: 10/17 PAINFUL SWOLLEN LYMPH NODES ON LEFT SIDE, 10/18 SHINGLES
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test positive
Clinical narrative: Case experienced no Covid-19 symptoms. Tested positive for Covid-19 on 10/08/2021. She was admitted to Hospital on 10/6/21, testing negative for Covid-19 on 10/6/21. Patient was transferred on 10/8/21 to a mental health facility, and was discharged on 10/15/21.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bile duct stone, COVID-19, Chills, Cough, Decreased appetite
Clinical narrative: Case was initially hospitalized for a ERCT bowel duct stone while traveling in TX (08-05-21 to 08-15-21). Upon returning home, symptom onset was 8/21/2021; symptoms inlcuded fever, cough, runny nose, congestion, fatigue, poor appetite, chills, nausea, diarrhea. Case tested positive for Covid-19 with a PCR test type, on 8/22/21. She was hospitalized at local HCF from 8-25-21to 8-30-21.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Endoscopic retrograde cholangiopancreatography, Fatigue, Nausea, Pyrexia
Clinical narrative: Case was initially hospitalized for a ERCT bowel duct stone while traveling in TX (08-05-21 to 08-15-21). Upon returning home, symptom onset was 8/21/2021; symptoms inlcuded fever, cough, runny nose, congestion, fatigue, poor appetite, chills, nausea, diarrhea. Case tested positive for Covid-19 with a PCR test type, on 8/22/21. She was hospitalized at local HCF from 8-25-21to 8-30-21.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Case was initially hospitalized for a ERCT bowel duct stone while traveling in TX (08-05-21 to 08-15-21). Upon returning home, symptom onset was 8/21/2021; symptoms inlcuded fever, cough, runny nose, congestion, fatigue, poor appetite, chills, nausea, diarrhea. Case tested positive for Covid-19 with a PCR test type, on 8/22/21. She was hospitalized at local HCF from 8-25-21to 8-30-21.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Hypoaesthesia, Influenza like illness
Clinical narrative: While waiting during the initial 15 minutes, I began to feel lightheaded with slight shortness of breath for about 3-5 minutes, The symptoms wore off I waited additional 15 mins with no issue. While driving home face became slighty numb for nearly 20mins. Decided to rest later that evening felt flu like symptoms.  Never had issues with needles or lightheaded issues
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain, Chills, Computerised tomogram, Electrocardiogram abnormal
Clinical narrative: The evening after receiving 2nd Covid vaccine my son developed chills.  The next day he was fatigued, left arm was sore from shot, headache, and muscle aches.  Day 3 in addition to the symptoms listed he developed chest pain. Day 4 the chest pain was so intense he asked to go to urgent care.  He said he could feel it was his heart and the pain was a constant.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Myocarditis, Pain in extremity
Clinical narrative: The evening after receiving 2nd Covid vaccine my son developed chills.  The next day he was fatigued, left arm was sore from shot, headache, and muscle aches.  Day 3 in addition to the symptoms listed he developed chest pain. Day 4 the chest pain was so intense he asked to go to urgent care.  He said he could feel it was his heart and the pain was a constant.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis, X-ray
Clinical narrative: The evening after receiving 2nd Covid vaccine my son developed chills.  The next day he was fatigued, left arm was sore from shot, headache, and muscle aches.  Day 3 in addition to the symptoms listed he developed chest pain. Day 4 the chest pain was so intense he asked to go to urgent care.  He said he could feel it was his heart and the pain was a constant.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: muscle pain, a headache, shivering, fatigue
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Myalgia, Pain
Clinical narrative: Patient developed myalgia, fever, and chills as well as achiness to the left arm after vaccination. These symptoms resolved within 24 hours after vaccination. On the 3rd day after vaccination, the patient developed vague, sharp, stabbing pain in the back of the head with radiation to the right temporal region.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Patient developed myalgia, fever, and chills as well as achiness to the left arm after vaccination. These symptoms resolved within 24 hours after vaccination. On the 3rd day after vaccination, the patient developed vague, sharp, stabbing pain in the back of the head with radiation to the right temporal region.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased
Clinical narrative: This was the COVID Pfizer booster.   I normally take 35 units of Toujeo to control diabetes.  The morning after my booster 9/28 , my Fasting Glucose was 82 , the following morning 9/29 it was 68 and the following morning 9/30 it was 45.  That evening I did not take my Toujeo and my fasting was 69 on 10/1.  That evening of 10/1,  I took 24 units of Toujeo.  My fasting sugar on 10/2 was 95, on 10/3 it was 113 and I returned to my regular dosage of Toujeo and my sugars are running about 100 to 120.   I had a wellness exam today and the doctor encouraged me to do this report
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis, Maternal exposure during breast feeding, Wrong technique in product usage process
Clinical narrative: Improper sterile technique used. Alcohol swabbed skin 1 second then injected Before dry. Unknown technique used for drawing up injection. Causing bacteria Infection (cellulitis)of the arm spreading rapidly. Also causing the patient to no longer be able to breastfeed due to treatment required. Ruining her breastfeeding journey at only 5 wks post partum.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Moderate body aches, chills, moderate headache, fatigue, nausea
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Blood pressure increased
Clinical narrative: Day 2: soreness under right arm in arm pit  blood pressure rise, from 110/70 to 135/89 (hypertension pre-existing)
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blood test, Chest X-ray, Chest pain, Chills
Clinical narrative: Chills, head ache, back pain and kidney pain, all within 1 week  On April 25, 2021 attended emergency and was sent home.  They found nothing   Chills, head ache, chest and kidney pain on October 13, 2021   Went to Hospital and received a d-dimer test.  Cat Scan showed Pulmonary Embolism left lung
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax abnormal, Fibrin D dimer, Headache, Pulmonary embolism, Renal pain
Clinical narrative: Chills, head ache, back pain and kidney pain, all within 1 week  On April 25, 2021 attended emergency and was sent home.  They found nothing   Chills, head ache, chest and kidney pain on October 13, 2021   Went to Hospital and received a d-dimer test.  Cat Scan showed Pulmonary Embolism left lung