chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac disorder, Cardiac stress test, Cardiac valve disease, Echocardiogram
Clinical narrative: afib; My heart has not been beating right since vaccinated/ showed heart not pumping only at 35 %; heart rate was high; leakage of two valves; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 18:45 (Lot number: 30130BA) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart disease", start date: 1980 (unspecified if ongoing), notes: Heart disease back in 1980 and valve, replacement with mechanical 2002; "valve replacement", start date: 2002 (unspecified if ongoing). Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not received other vaccine in four weeks. Covid tested post vaccination. No known allergies. Concomitant medication(s) included: ALPRAZOLAM; DILTIAZEM; ZETIA; WARFARIN. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 12Oct2021, outcome "not recovered", described as "afib"; CARDIAC DISORDER (non-serious) with onset 12Oct2021, outcome "not recovered", described as "My heart has not been beating right since vaccinated/ showed heart not pumping only at 35 %"; HEART RATE INCREASED (non-serious) with onset 12Oct2021, outcome "not recovered", described as "heart rate was high"; CARDIAC VALVE DISEASE (non-serious) with onset 12Oct2021, outcome "not recovered", described as "leakage of two valves". The events "afib", "my heart has not been beating right since vaccinated/ showed heart not pumping only at 35 %", "heart rate was high" and "leakage of two valves" were evaluated at the physician office visit and emergency room visit. Patient's heart had not been beating right since vaccinated. Went to walk-in as primary would no see me. They did an ekg as patient's heart rate was high. Ekg per walk-in Detected an issue. Sent to Er. They said she was fine except heart rate was high. Hospital was full and sent her home. Followed up with cardiologist with stress test, halter monitor and last test of Echo showed heart not pumping only at 35%, leakage of two valves, afib. The patient underwent the following laboratory tests and procedures: cardiac stress test: (12Oct2021) unknown result; echocardiogram: (12Oct2021) heart not pumping only at 35%,leakage of two valve; electrocardiogram: (12Oct2021) per walk-in detected an issue; heart rate: (12Oct2021) high; sars-cov-2 test: (21Oct2021) negative. It was unknown if therapeutic measures were taken as a result of atrial fibrillation, cardiac disorder, heart rate increased, cardiac valve disease.  No follow-up attempts are needed. No further information is expected
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate, Heart rate increased, SARS-CoV-2 test
Clinical narrative: afib; My heart has not been beating right since vaccinated/ showed heart not pumping only at 35 %; heart rate was high; leakage of two valves; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 18:45 (Lot number: 30130BA) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart disease", start date: 1980 (unspecified if ongoing), notes: Heart disease back in 1980 and valve, replacement with mechanical 2002; "valve replacement", start date: 2002 (unspecified if ongoing). Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not received other vaccine in four weeks. Covid tested post vaccination. No known allergies. Concomitant medication(s) included: ALPRAZOLAM; DILTIAZEM; ZETIA; WARFARIN. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 12Oct2021, outcome "not recovered", described as "afib"; CARDIAC DISORDER (non-serious) with onset 12Oct2021, outcome "not recovered", described as "My heart has not been beating right since vaccinated/ showed heart not pumping only at 35 %"; HEART RATE INCREASED (non-serious) with onset 12Oct2021, outcome "not recovered", described as "heart rate was high"; CARDIAC VALVE DISEASE (non-serious) with onset 12Oct2021, outcome "not recovered", described as "leakage of two valves". The events "afib", "my heart has not been beating right since vaccinated/ showed heart not pumping only at 35 %", "heart rate was high" and "leakage of two valves" were evaluated at the physician office visit and emergency room visit. Patient's heart had not been beating right since vaccinated. Went to walk-in as primary would no see me. They did an ekg as patient's heart rate was high. Ekg per walk-in Detected an issue. Sent to Er. They said she was fine except heart rate was high. Hospital was full and sent her home. Followed up with cardiologist with stress test, halter monitor and last test of Echo showed heart not pumping only at 35%, leakage of two valves, afib. The patient underwent the following laboratory tests and procedures: cardiac stress test: (12Oct2021) unknown result; echocardiogram: (12Oct2021) heart not pumping only at 35%,leakage of two valve; electrocardiogram: (12Oct2021) per walk-in detected an issue; heart rate: (12Oct2021) high; sars-cov-2 test: (21Oct2021) negative. It was unknown if therapeutic measures were taken as a result of atrial fibrillation, cardiac disorder, heart rate increased, cardiac valve disease.  No follow-up attempts are needed. No further information is expected
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Nasal congestion, Off label use
Clinical narrative: tested positive for COVID; tested positive for COVID; fever of 102.3 F; body aches; congestion; Dose 1: Moderna, Dose 2: Moderna; Dose 1: Moderna, Dose 2: Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Nov2021 (Lot number: FH8020) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 039B21A, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 23Apr2021, when the patient was 43 years old, for COVID-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: 031A21A, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 26Mar2021, when the patient was 43 years old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jan2022 01:30, outcome "recovering" and all described as "tested positive for COVID"; PYREXIA (non-serious) with onset 21Jan2022 01:30, outcome "recovering", described as "fever of 102.3 F"; PAIN (non-serious) with onset 21Jan2022 01:30, outcome "recovering", described as "body aches"; NASAL CONGESTION (non-serious) with onset 21Jan2022 01:30, outcome "recovering", described as "congestion"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 21Jan2022 01:30, outcome "recovering" and all described as "Dose 1: Moderna, Dose 2: Moderna". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19, pyrexia, pain, nasal congestion, off label use, interchange of vaccine products.  Clinical information: The patient did not take other vaccine in four weeks and did not take other medications in two weeks. The patient did not have COVID prior vaccination and tested COVID positive post vaccination. On Thursday, 20Jan2022 (at approximately 5:24 PM), he tested positive for COVID. In the early morning of Friday, 21Jan2002 (at approximately 1:30 AM), he developed a fever of 102.3 F, body aches, and congestion. At the time that event was being submitted, he no longer have fever and the body aches had improved significantly.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; fever of 102.3 F; body aches; congestion; Dose 1: Moderna, Dose 2: Moderna; Dose 1: Moderna, Dose 2: Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Nov2021 (Lot number: FH8020) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 039B21A, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 23Apr2021, when the patient was 43 years old, for COVID-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: 031A21A, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 26Mar2021, when the patient was 43 years old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jan2022 01:30, outcome "recovering" and all described as "tested positive for COVID"; PYREXIA (non-serious) with onset 21Jan2022 01:30, outcome "recovering", described as "fever of 102.3 F"; PAIN (non-serious) with onset 21Jan2022 01:30, outcome "recovering", described as "body aches"; NASAL CONGESTION (non-serious) with onset 21Jan2022 01:30, outcome "recovering", described as "congestion"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 21Jan2022 01:30, outcome "recovering" and all described as "Dose 1: Moderna, Dose 2: Moderna". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19, pyrexia, pain, nasal congestion, off label use, interchange of vaccine products.  Clinical information: The patient did not take other vaccine in four weeks and did not take other medications in two weeks. The patient did not have COVID prior vaccination and tested COVID positive post vaccination. On Thursday, 20Jan2022 (at approximately 5:24 PM), he tested positive for COVID. In the early morning of Friday, 21Jan2002 (at approximately 1:30 AM), he developed a fever of 102.3 F, body aches, and congestion. At the time that event was being submitted, he no longer have fever and the body aches had improved significantly.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 27Nov2021 (Lot number: FK5615) at the age of 10 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 06Nov2021, when the patient was 10 years old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jan2022 17:30, outcome "recovering" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical information: The reporter's son tested positive for COVID on Thursday, 20Jan2022. The only symptom resent was cough. No known allergies. No other medical history. Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. No other medications in two weeks.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Constipation, Heart rate, Heart rate increased
Clinical narrative: Heart flutter; random rapid heart beat; Comstipation lasting a month; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 (Batch/Lot number: unknown) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Sarcoidosis" (unspecified if ongoing); "Known allergies: shellfish" (unspecified if ongoing). Concomitant medication(s) included: LAMICTAL; LEVOXYL; PREVACID. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 11Apr2021, when the patient was 45 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 21Apr2021, when the patient was 45 years old, for Covid-19 immunization. The following information was reported: CARDIAC FLUTTER (medically significant) with onset 15Dec2021, outcome "not recovered", described as "Heart flutter"; HEART RATE INCREASED (medically significant) with onset 15Dec2021, outcome "not recovered", described as "random rapid heartbeat"; CONSTIPATION (non-serious) with onset 15Dec2021, outcome "not recovered", described as "Constipation lasting a month". The patient underwent the following laboratory tests and procedures: heart rate: (15Dec2021) rapid. Therapeutic measures were taken as a result of cardiac flutter, heart rate increased, constipation and included treatment with Laxatives and Valium. Clinical Course: It was reported that the patient did not take other vaccine in four weeks. No Covid prior to vaccination. Covid tested post vaccination was unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tic
Clinical narrative: Developed serious tics out of the blue about 3 or 4 days later and never has a history before.; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 28Dec2021 16:45 (Lot number: 33036BD) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient had no covid prior vaccination. There were no concomitant medications. There were no other vaccine in four weeks, no other medications in two weeks. The following information was reported: TIC (disability) with onset 31Dec2021, outcome "not recovered", described as "developed serious tics out of the blue about 3 or 4 days later and never has a history before.". The event "developed serious tics out of the blue about 3 or 4 days later and never has a history before." was resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) negative, notes: Rapid at pediatrician; Nasal Swab. Therapeutic measures were taken as a result of tic included so far, treatment with magnesium and B6.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Mental disorder, Tension headache, Tunnel vision, Visual field defect
Clinical narrative: tunnel vision; tension headache; brain fog; visual field disorientation; felt like things in my periphery were harder to process; felt mentally a beat behind; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Mar2021 12:00 (Lot number: ER8732) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Dose brand=Pfizer, Lot number=FD7218, Dose time=04:00PM, Vaccine location=Left arm), administration date: 07Mar2021, when the patient was 30 years old, for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: TUNNEL VISION (medically significant), outcome "recovered", described as "tunnel vision"; TENSION HEADACHE (non-serious), outcome "recovered", described as "tension headache"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "brain fog"; VISUAL IMPAIRMENT (non-serious), outcome "not recovered", described as "visual field disorientation"; VISUAL FIELD DEFECT (non-serious), outcome "not recovered", described as "felt like things in my periphery were harder to process"; MENTAL DISORDER (non-serious), outcome "not recovered", described as "felt mentally a beat behind". The events "tunnel vision", "tension headache", "brain fog", "visual field disorientation", "felt like things in my periphery were harder to process" and "felt mentally a beat behind" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of tunnel vision, tension headache, feeling abnormal, visual impairment, visual field defect, mental disorder. Additional Information: Reporter reported that No Covid was reported prior to vaccination and Not Covid tested post the vaccination. No other vaccine was taken in four weeks and no other medication was reported in 2 weeks. No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: tunnel vision; tension headache; brain fog; visual field disorientation; felt like things in my periphery were harder to process; felt mentally a beat behind; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Mar2021 12:00 (Lot number: ER8732) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Dose brand=Pfizer, Lot number=FD7218, Dose time=04:00PM, Vaccine location=Left arm), administration date: 07Mar2021, when the patient was 30 years old, for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: TUNNEL VISION (medically significant), outcome "recovered", described as "tunnel vision"; TENSION HEADACHE (non-serious), outcome "recovered", described as "tension headache"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "brain fog"; VISUAL IMPAIRMENT (non-serious), outcome "not recovered", described as "visual field disorientation"; VISUAL FIELD DEFECT (non-serious), outcome "not recovered", described as "felt like things in my periphery were harder to process"; MENTAL DISORDER (non-serious), outcome "not recovered", described as "felt mentally a beat behind". The events "tunnel vision", "tension headache", "brain fog", "visual field disorientation", "felt like things in my periphery were harder to process" and "felt mentally a beat behind" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of tunnel vision, tension headache, feeling abnormal, visual impairment, visual field defect, mental disorder. Additional Information: Reporter reported that No Covid was reported prior to vaccination and Not Covid tested post the vaccination. No other vaccine was taken in four weeks and no other medication was reported in 2 weeks. No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Affective disorder, Cognitive disorder, Depersonalisation/derealisation disorder, Eye disorder, Feeling abnormal
Clinical narrative: tunnel vision; tension headache; brain fog; visual field disorientation; felt like things in my periphery were harder to process; felt mentally a beat behind; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Mar2021 12:00 (Lot number: ER8732) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Dose brand=Pfizer, Lot number=FD7218, Dose time=04:00PM, Vaccine location=Left arm), administration date: 07Mar2021, when the patient was 30 years old, for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: TUNNEL VISION (medically significant), outcome "recovered", described as "tunnel vision"; TENSION HEADACHE (non-serious), outcome "recovered", described as "tension headache"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "brain fog"; VISUAL IMPAIRMENT (non-serious), outcome "not recovered", described as "visual field disorientation"; VISUAL FIELD DEFECT (non-serious), outcome "not recovered", described as "felt like things in my periphery were harder to process"; MENTAL DISORDER (non-serious), outcome "not recovered", described as "felt mentally a beat behind". The events "tunnel vision", "tension headache", "brain fog", "visual field disorientation", "felt like things in my periphery were harder to process" and "felt mentally a beat behind" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of tunnel vision, tension headache, feeling abnormal, visual impairment, visual field defect, mental disorder. Additional Information: Reporter reported that No Covid was reported prior to vaccination and Not Covid tested post the vaccination. No other vaccine was taken in four weeks and no other medication was reported in 2 weeks. No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Heterophoria, Impaired work ability, Ophthalmological examination abnormal, Photophobia
Clinical narrative: tunnel vision; tension headache; brain fog; visual field disorientation; felt like things in my periphery were harder to process; felt mentally a beat behind; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Mar2021 12:00 (Lot number: ER8732) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Dose brand=Pfizer, Lot number=FD7218, Dose time=04:00PM, Vaccine location=Left arm), administration date: 07Mar2021, when the patient was 30 years old, for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: TUNNEL VISION (medically significant), outcome "recovered", described as "tunnel vision"; TENSION HEADACHE (non-serious), outcome "recovered", described as "tension headache"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "brain fog"; VISUAL IMPAIRMENT (non-serious), outcome "not recovered", described as "visual field disorientation"; VISUAL FIELD DEFECT (non-serious), outcome "not recovered", described as "felt like things in my periphery were harder to process"; MENTAL DISORDER (non-serious), outcome "not recovered", described as "felt mentally a beat behind". The events "tunnel vision", "tension headache", "brain fog", "visual field disorientation", "felt like things in my periphery were harder to process" and "felt mentally a beat behind" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of tunnel vision, tension headache, feeling abnormal, visual impairment, visual field defect, mental disorder. Additional Information: Reporter reported that No Covid was reported prior to vaccination and Not Covid tested post the vaccination. No other vaccine was taken in four weeks and no other medication was reported in 2 weeks. No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Reading disorder, SARS-CoV-2 test negative, Strabismus, Visual impairment
Clinical narrative: tunnel vision; tension headache; brain fog; visual field disorientation; felt like things in my periphery were harder to process; felt mentally a beat behind; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Mar2021 12:00 (Lot number: ER8732) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Dose brand=Pfizer, Lot number=FD7218, Dose time=04:00PM, Vaccine location=Left arm), administration date: 07Mar2021, when the patient was 30 years old, for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: TUNNEL VISION (medically significant), outcome "recovered", described as "tunnel vision"; TENSION HEADACHE (non-serious), outcome "recovered", described as "tension headache"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "brain fog"; VISUAL IMPAIRMENT (non-serious), outcome "not recovered", described as "visual field disorientation"; VISUAL FIELD DEFECT (non-serious), outcome "not recovered", described as "felt like things in my periphery were harder to process"; MENTAL DISORDER (non-serious), outcome "not recovered", described as "felt mentally a beat behind". The events "tunnel vision", "tension headache", "brain fog", "visual field disorientation", "felt like things in my periphery were harder to process" and "felt mentally a beat behind" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of tunnel vision, tension headache, feeling abnormal, visual impairment, visual field defect, mental disorder. Additional Information: Reporter reported that No Covid was reported prior to vaccination and Not Covid tested post the vaccination. No other vaccine was taken in four weeks and no other medication was reported in 2 weeks. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Constipation, Heart rate, Heart rate increased
Clinical narrative: Heart flutter; random rapid heart beat; Comstipation lasting a month; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC FLUTTER (medically significant), outcome "unknown", described as "Heart flutter"; HEART RATE INCREASED (medically significant), outcome "unknown", described as "random rapid heart beat"; CONSTIPATION (non-serious), outcome "unknown", described as "Comstipation lasting a month". The patient underwent the following laboratory tests and procedures: heart rate: random rapid.    The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: contracted Covid after the first dose of the Pfizer BioNTech Covid-19 vaccine; contracted Covid after the first dose of the Pfizer BioNTech Covid-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A 9 year-old female patient received bnt162b2 (BNT162B2), administration date 24Nov2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "contracted Covid after the first dose of the Pfizer BioNTech Covid-19 vaccine".  Additional information: Caller called on behalf of her 9-year-old daughter who got her 1st dose of the Pfizer BioNTech Covid-19 vaccine shot on 24Nov2021 but we then contracted Covid 3 weeks after and were symptomatic through the end of December. Her daughter had not gotten her 2nd dose. She would like to know how to move forward with her vaccine.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Colectomy, Condition aggravated, Short-bowel syndrome
Clinical narrative: Colectomy, Short-bowel syndrome, Condition aggravated"; Colectomy, Short-bowel syndrome, Condition aggravated"; Colectomy, Short-bowel syndrome, Condition aggravated"; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4235970-00 (ABBVIE).  A 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 26Sep2021 (Batch/Lot number: unknown) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) at citrate free for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, ROUTE OF ADMINISTRATION: Intramuscular), administration date: 03Mar2021, when the patient was 68 years old, for COVID-19 immunization; Bnt162b2 (Dose:2, ROUTE OF ADMINISTRATION: Intramuscular), administration date: 26Mar2021, when the patient was 69 years old, for COVID-19 immunization. The following information was reported: COLECTOMY (non-serious), SHORT-BOWEL SYNDROME (non-serious), outcome "unknown" and all described as "Colectomy, Short-bowel syndrome, Condition aggravated""; CONDITION AGGRAVATED (non-serious), outcome "not recovered". The action taken for adalimumab was unknown.  Additional information: She was having flare up with her bowels. she had short gut syndromes and pouchiest. The reporter's causality for the event(s) of COLECTOMY, SHORT GUT SYNDROME and FLARE WITH BOWEL was not provided. AbbVie's opinion is that there is no reasonable possibility that the events of COLECTOMY, SHORT GUT SYNDROME and FLARE WITH BOWEL are related to HUMIRA(ADALIMUMAB).  The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the related events and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Henoch-Schonlein purpura, Joint swelling, SARS-CoV-2 test, Vasculitic rash
Clinical narrative: Terrible vasculitis rash; Multiple joint swelling/pain; Multiple joint swelling/pain; Recently diagnosed with HSP (Henoch-Schonlein purpura); This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the parent.  A 17 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 25May2021 (Lot number: EW0183) at the age of 16 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "PCOS" (unspecified if ongoing), notes: PCOS. Concomitant medication(s) included: LEVOTHYROXINE; LEXAPRO. Vaccination history included: Bnt162b2 (Vaccine location: Left arm, Lot number: EW0179,, Administrator route: Intramuscular,, Dose number: 1), administration date: 04May2021, when the patient was 16 years old, for COVID-19 immunization. The following information was reported: HENOCH-SCHONLEIN PURPURA (non-serious) with onset 16Jan2022, outcome "not recovered", described as "Recently diagnosed with HSP (Henoch-Schonlein purpura)"; VASCULITIC RASH (non-serious), outcome "unknown", described as "Terrible vasculitis rash"; JOINT SWELLING (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "Multiple joint swelling/pain". The event "recently diagnosed with hsp (henoch-schonlein purpura)" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of henoch-schonlein purpura.  Additional information: The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. The patient did not have any allergies. The patient received treatment with Tylenol.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Basedow's disease, Dyspnoea, Investigation, Palpitations, Tremor
Clinical narrative: Graves' disease; heart palpitation; weight loss; shortness of breath; hand shaking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Oct2021 16:00 (Lot number: 30155BA) at the age of 26 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3184, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 18Sep2021, when the patient was 26 years old, for COVID-19 immunization. The following information was reported: BASEDOW'S DISEASE (medically significant) with onset 31Oct2021, outcome "not recovered", described as "Graves' disease"; PALPITATIONS (non-serious) with onset 31Oct2021, outcome "not recovered", described as "heart palpitation"; WEIGHT DECREASED (non-serious) with onset 31Oct2021, outcome "not recovered", described as "weight loss"; DYSPNOEA (non-serious) with onset 31Oct2021, outcome "not recovered", described as "shortness of breath"; TREMOR (non-serious) with onset 31Oct2021, outcome "not recovered", described as "hand shaking". The events "graves' disease", "heart palpitation", "weight loss", "shortness of breath" and "hand shaking" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: investigation: graves' disease. Therapeutic measures were taken as a result of basedow's disease, palpitations, weight decreased, dyspnoea, tremor.  Clinical course: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination. Reported Event: I was experiencing heart palpitation, weight loss, shortness of breath, and hand shaking. After several test, I was diagnosed with Graves' disease. Treatment received for the adverse event: Taking medications. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient not been tested for COVID-19. Hospitalization Prolonged: NO  Follow-Up (25Jan2022): Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Graves' disease; heart palpitation; weight loss; shortness of breath; hand shaking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Oct2021 16:00 (Lot number: 30155BA) at the age of 26 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3184, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 18Sep2021, when the patient was 26 years old, for COVID-19 immunization. The following information was reported: BASEDOW'S DISEASE (medically significant) with onset 31Oct2021, outcome "not recovered", described as "Graves' disease"; PALPITATIONS (non-serious) with onset 31Oct2021, outcome "not recovered", described as "heart palpitation"; WEIGHT DECREASED (non-serious) with onset 31Oct2021, outcome "not recovered", described as "weight loss"; DYSPNOEA (non-serious) with onset 31Oct2021, outcome "not recovered", described as "shortness of breath"; TREMOR (non-serious) with onset 31Oct2021, outcome "not recovered", described as "hand shaking". The events "graves' disease", "heart palpitation", "weight loss", "shortness of breath" and "hand shaking" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: investigation: graves' disease. Therapeutic measures were taken as a result of basedow's disease, palpitations, weight decreased, dyspnoea, tremor.  Clinical course: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination. Reported Event: I was experiencing heart palpitation, weight loss, shortness of breath, and hand shaking. After several test, I was diagnosed with Graves' disease. Treatment received for the adverse event: Taking medications. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient not been tested for COVID-19. Hospitalization Prolonged: NO  Follow-Up (25Jan2022): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Seizure
Clinical narrative: Off-label use; to get the booster, they didn't have Moderna as a booster and I got that for my initial two shots; Booster; Seizures; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 19Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (1st shot), for COVID-19 Immunization; Moderna covid-19 vaccine (2nd shot), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "to get the booster, they didn't have Moderna as a booster and I got that for my initial two shots"; IMMUNISATION (medically significant) with onset 19Jan2022, outcome "unknown", described as "Booster"; SEIZURE (medically significant) with onset Jan2022, outcome "unknown", described as "Seizures".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Nausea
Clinical narrative: fever; chills; extreme nausea; fatigue lasted around 72 hours; Aches; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Mar2021 09:00 (Lot number: ER2613, Expiration Date: Aug2021) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension", start date: 2020 (ongoing), notes: Pertinent Details: Metoprolol 125mg; "Covid-19", start date: 11Dec2020 (unspecified if ongoing); "Sick" (unspecified if ongoing); "Fatigue" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for hypertension. The following information was reported: PYREXIA (disability) with onset 18Mar2021 11:00, outcome "recovered" (22Mar2021), described as "fever"; CHILLS (disability) with onset 18Mar2021 11:00, outcome "recovered" (22Mar2021), described as "chills"; NAUSEA (disability) with onset 18Mar2021 11:00, outcome "recovered" (22Mar2021), described as "extreme nausea"; FATIGUE (disability) with onset 18Mar2021 11:00, outcome "recovered" (22Mar2021), described as "fatigue lasted around 72 hours"; PAIN (disability) with onset 18Mar2021 11:00, outcome "recovered" (22Mar2021), described as "Aches"; HEADACHE (disability) with onset 18Mar2021 11:00, outcome "recovered" (22Mar2021), described as "Headache". The patient underwent the following laboratory tests and procedures: body temperature: (18Mar2021) fever. Therapeutic measures were taken as a result of pyrexia, chills, nausea, fatigue, pain, headache.  Clinical information: Patient took off work because patient felt so awful. Patient still got omicron, although mask and take other precautions. No any prior vaccinations within 4 weeks. No any specific relevant test for thromboembolic events with thrombocytopenia. The event require the initiation of new medication/other treatment includes advil, Tylenol and Zofran. Patient was contracted Covid-19 11Dec2020, and stayed sick two weeks, with fatigue lingering 2 months. No hospitalization or ER visits.   No follow-up attempts are possible. No further information is expected
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fever; chills; extreme nausea; fatigue lasted around 72 hours; Aches; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Mar2021 09:00 (Lot number: ER2613, Expiration Date: Aug2021) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension", start date: 2020 (ongoing), notes: Pertinent Details: Metoprolol 125mg; "Covid-19", start date: 11Dec2020 (unspecified if ongoing); "Sick" (unspecified if ongoing); "Fatigue" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for hypertension. The following information was reported: PYREXIA (disability) with onset 18Mar2021 11:00, outcome "recovered" (22Mar2021), described as "fever"; CHILLS (disability) with onset 18Mar2021 11:00, outcome "recovered" (22Mar2021), described as "chills"; NAUSEA (disability) with onset 18Mar2021 11:00, outcome "recovered" (22Mar2021), described as "extreme nausea"; FATIGUE (disability) with onset 18Mar2021 11:00, outcome "recovered" (22Mar2021), described as "fatigue lasted around 72 hours"; PAIN (disability) with onset 18Mar2021 11:00, outcome "recovered" (22Mar2021), described as "Aches"; HEADACHE (disability) with onset 18Mar2021 11:00, outcome "recovered" (22Mar2021), described as "Headache". The patient underwent the following laboratory tests and procedures: body temperature: (18Mar2021) fever. Therapeutic measures were taken as a result of pyrexia, chills, nausea, fatigue, pain, headache.  Clinical information: Patient took off work because patient felt so awful. Patient still got omicron, although mask and take other precautions. No any prior vaccinations within 4 weeks. No any specific relevant test for thromboembolic events with thrombocytopenia. The event require the initiation of new medication/other treatment includes advil, Tylenol and Zofran. Patient was contracted Covid-19 11Dec2020, and stayed sick two weeks, with fatigue lingering 2 months. No hospitalization or ER visits.   No follow-up attempts are possible. No further information is expected