chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC13, PPV
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: pneumonia; pneumonia; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team..  A 68-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as single dose (Batch/Lot number: unknown) for immunisation; pneumococcal vaccine polysacch 23v (PNEUMOVAX), as single dose (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), PNEUMONIA (hospitalization, medically significant), outcome "unknown" and all described as "pneumonia". A 68-year old female patient who had previously been vaccinated with Prevnar 13 and Pneumovax. About 5 months ago, the patient was hospitalized due to pneumonia and was in the hospital "quite a while" due to the pneumonia.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine towards the onset of pneumonia in this patient cannot be completely excluded.  Further information like confirmative pathological/serotype results are needed for full medical assessment.
Age: 42.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She has been vaccinated with the Pfizer COVID vaccine, and is currently COVID positive; She has been vaccinated with the Pfizer COVID vaccine, and is currently COVID positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2), on 17Aug2021 as dose 1, single (Batch/Lot number: unknown) and on 22Sep2021 as dose 2, single (Lot number: FE3592) at the age of 42 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 22Sep2021 as dose number unknwon, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "COVID-19", start date: 2021, stop date: 2021, notes: She got COVID the first time before the vaccines in Spring of 2021. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Jan2023, outcome "not recovered" and all described as "She has been vaccinated with the Pfizer COVID vaccine, and is currently COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jan2023) Positive, notes: She was COVID positive. She took a home test on Monday at 03:00 am. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: She was COVID positive. She took a home test on Monday at 03:00 am. She was starting to have extreme pain from COVID. She went to the doctor. She was prescribed Paxlovid. She had pain for 3 days and only slept for 6 hours so her doctor said to try Paxlovid, Batch/lot number: 663457, Dosage text: 5 Blister cards, 300mg with 100mg dose pack, Tablet, Expiry Date of Paxlovid: Feb2024. The problem improve as a result of Paxlovid. Paxlovid: Dosage permanently discontinued. This was her second time having COVID. The first time was before her vaccines, but she has been vaccinated with the Pfizer COVID vaccine. She got her prescription filled and took it as soon as possible. She was still battling COVID though. She got two doses of the Pfizer COVID vaccine: first dose: Pfizer BioNTech given on 17Aug2021, lot number: FC7180 or could be FC3180- the handwriting is terrible on the card. Second dose: lot: FE3592; given on 22Sep2021. She got COVID the first time before the vaccines in Spring of 2021.This is the first time she has had it since the vaccines. Prior Vaccinations (within 4 weeks): If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s):Vaccine Name: Flu vaccine. No concomitant drugs taken within two weeks before the event onset. No Relevant Tests.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 20Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 30Jun2022 as dose 4 (booster), single (Lot number: FK9895), in right arm for covid-19 immunisation. The patient had no relevant medical history and no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "SUSPECTED COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jan2023) Negative, notes: negative test (PCR) on the following Monday; (Jan2023) Positive, notes: tested positive (weakly) with home tests for about a week; (Jan2023) Negative, notes: tested negative on home tests; (02Feb2023) Positive, notes: with two home tests. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 12Jan2023 to 16Jan2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive Other medication in 2weeks. The patient received Anti-viral product, brand Paxlovid for COVID 19 Treatment started on 22Jan2023 and stopped on 26Jan2023. The patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "adhd" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No Known allergies. Paxlovid, treatment start date=25Jan2023, treatment stop date=30Jan2023.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Pain assessment
Clinical narrative: facial palsy (facial weakness); This is a literature report.  An adult female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Drug allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FACIAL PARALYSIS (medically significant), outcome "unknown", described as "facial palsy (facial weakness)". The patient underwent the following laboratory tests and procedures: Pain assessment: 3, notes: After 1st dose.  The reporter considered "facial palsy (facial weakness)" related to BNT162b2.; Sender's Comments: Based on a drug event temporal association and on the compatibility with the known adverse event profile of the suspect vaccine BNT162B2, the company cannot completely exclude a reasonable possibility that the suspect vaccine BNT162b2 may have contributed to the onset of the event "facial palsy (facial weakness)". The impact of this report on the benefit/risk profile of the Pfizer product 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.,Linked Report(s) : US-PFIZER INC-PV202300017736 Same article/Drug and Different patient/event;US-PFIZER INC-202300053481 Same article/drug and different patient/event;
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune hepatitis, Biopsy, Blood immunoglobulin G, Disease recurrence, Hepatic enzyme
Clinical narrative: Flare of AIH/Recurrence of AutoimmuneHepatitisAfter COVID-19Vaccination; Flare of AIH/Recurrence of AutoimmuneHepatitisAfter COVID-19Vaccination; This is a literature report.  A 35-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "autoimmune hepatitis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine - manufacturer unknown (DOSE 1, SINGLE), for COVID-19 immunisation.  The following information was reported: AUTOIMMUNE HEPATITIS (medically significant), DISEASE RECURRENCE (medically significant), all with latency 14 days after the suspect product(s) administration, outcome "recovered" and all described as "Flare of AIH/Recurrence of AutoimmuneHepatitisAfter COVID-19Vaccination". The patient underwent the following laboratory tests and procedures: Biopsy: confirmed AIH 5 years ago; Blood immunoglobulin G: n/a; Hepatic enzyme: Elevation; aminotransferases: Increased; 4, notes: Probability : Non-probable; 6, notes: Probability : probable; Serology test: anti-smooth muscle antibody; Smooth muscle antibody: Elevation. Therapeutic measures were not taken as a result of autoimmune hepatitis, disease recurrence.; Sender's Comments: Based on the temporal relation, the association between the events of autoimmune hepatitis and disease recurrence and the suspect product cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product 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.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Serology test, Smooth muscle antibody
Clinical narrative: Flare of AIH/Recurrence of AutoimmuneHepatitisAfter COVID-19Vaccination; Flare of AIH/Recurrence of AutoimmuneHepatitisAfter COVID-19Vaccination; This is a literature report.  A 35-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "autoimmune hepatitis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine - manufacturer unknown (DOSE 1, SINGLE), for COVID-19 immunisation.  The following information was reported: AUTOIMMUNE HEPATITIS (medically significant), DISEASE RECURRENCE (medically significant), all with latency 14 days after the suspect product(s) administration, outcome "recovered" and all described as "Flare of AIH/Recurrence of AutoimmuneHepatitisAfter COVID-19Vaccination". The patient underwent the following laboratory tests and procedures: Biopsy: confirmed AIH 5 years ago; Blood immunoglobulin G: n/a; Hepatic enzyme: Elevation; aminotransferases: Increased; 4, notes: Probability : Non-probable; 6, notes: Probability : probable; Serology test: anti-smooth muscle antibody; Smooth muscle antibody: Elevation. Therapeutic measures were not taken as a result of autoimmune hepatitis, disease recurrence.; Sender's Comments: Based on the temporal relation, the association between the events of autoimmune hepatitis and disease recurrence and the suspect product cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product 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: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 84-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 84 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) 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), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Positive, notes: positive test 9 days after completion of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information : The patient received paxlovid for COVID 19 treatment from 21Jan2023 to 25Jan2023. Vaccine was received. Other medication in 2 weeks recived (Warfarin, Potassium, Atenolol and Thyroxine).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Blood test, Nasopharyngeal swab, Pain in extremity
Clinical narrative: burning pain in my hands inside of arms where they bend at the elbow and behind my knees; burning pain in my hands inside of arms where they bend at the elbow and behind my knees; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: CYCLOBENZAPRINE. Vaccination history included: Bnt162b2 (Dose number 1), for COVID-19 Immunization; Bnt162b2 (Dose number 2), for COVID-19 Immunization; Bnt162b2 (Dose number 3), for COVID-19 Immunization; Bnt162b2 (Dose number 4), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), outcome "not recovered" and all described as "burning pain in my hands inside of arms where they bend at the elbow and behind my knees". The events "burning pain in my hands inside of arms where they bend at the elbow and behind my knees" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, arthralgia. Additional information: It was a report about covid vaccine. There is no other vaccine in four weeks. Other medications in two weeks: Cyclobenzaprine. Since receiving 5 of the Pfizer vaccines, patient have been having burning pain in the hands inside of arms where they bend at the elbow and behind the knees. They feel like debilitating pains and has made it difficult to do daily task and job at work. The patient had gone to the PCP and had blood labs done, but can't figure out why this has happened. AE resulted in Doctor or other healthcare professional office/clinic visit. No known allergies. No covid prior vaccination. There was covid tested post vaccination: Nasal Swab on 18Oct2021: Positive.
Sex: M
Vaccine: COVID19
Symptoms: Biopsy heart, Brain natriuretic peptide, C-reactive protein, Cardiomyopathy, Catheterisation cardiac
Clinical narrative: cardiomyopathy; This is a literature report for the following literature source(s):   A 28-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: CARDIOMYOPATHY (medically significant) with onset 2021, outcome "unknown". The patient underwent the following laboratory tests and procedures: Biopsy heart: no inflammatory infiltrates or granulomas; Brain natriuretic peptide: 1,399; Catheterisation cardiac: no significant CAD; PCWP 20; PAP 43/26 (33 mmHg); mild pHTN; C-reactive protein: < 0.5; Echocardiogram: severe 4 chamber dilatation; LVEF 15-20%, notes: elevated LVEDP; Red blood cell sedimentation rate: 12; Troponin: 0.03. Therapeutic measures were taken as a result of cardiomyopathy.; Sender's Comments: Based on the available information in the case, an association between the reported events CARDIOMYOPATHY  and The suspected drug cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Red blood cell sedimentation rate, Troponin
Clinical narrative: cardiomyopathy; This is a literature report for the following literature source(s):   A 28-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: CARDIOMYOPATHY (medically significant) with onset 2021, outcome "unknown". The patient underwent the following laboratory tests and procedures: Biopsy heart: no inflammatory infiltrates or granulomas; Brain natriuretic peptide: 1,399; Catheterisation cardiac: no significant CAD; PCWP 20; PAP 43/26 (33 mmHg); mild pHTN; C-reactive protein: < 0.5; Echocardiogram: severe 4 chamber dilatation; LVEF 15-20%, notes: elevated LVEDP; Red blood cell sedimentation rate: 12; Troponin: 0.03. Therapeutic measures were taken as a result of cardiomyopathy.; Sender's Comments: Based on the available information in the case, an association between the reported events CARDIOMYOPATHY  and The suspected drug cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
Sex: M
Vaccine: COVID19
Symptoms: Brain natriuretic peptide, Cardiomyopathy, Catheterisation cardiac, Echocardiogram, Magnetic resonance imaging heart
Clinical narrative: cardiomyopathy; This is a literature report.  A 22-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: CARDIOMYOPATHY (medically significant) with onset 2021, outcome "unknown". The patient underwent the following laboratory tests and procedures: Brain natriuretic peptide: 2,187; Catheterisation cardiac: no significant CAD; PCWP 13; PAP 42/19 (28 mmHg); mild pHTN; Echocardiogram: LVEF 15%; moderately reduced RV function;, notes: LV, RV, and left atrial dilatation; elevated LVEDP; LVEF 3033%., notes: Repeat TTE in 1 month:; Magnetic resonance imaging heart: moderate to severely dilated LV; no LGA; Red blood cell sedimentation rate: 10; Troponin: < 0.03. Therapeutic measures were taken as a result of cardiomyopathy.; Sender's Comments: The causal association between the event Cardiomyopathy and the suspect drug BNT162b2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate, Troponin
Clinical narrative: cardiomyopathy; This is a literature report.  A 22-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: CARDIOMYOPATHY (medically significant) with onset 2021, outcome "unknown". The patient underwent the following laboratory tests and procedures: Brain natriuretic peptide: 2,187; Catheterisation cardiac: no significant CAD; PCWP 13; PAP 42/19 (28 mmHg); mild pHTN; Echocardiogram: LVEF 15%; moderately reduced RV function;, notes: LV, RV, and left atrial dilatation; elevated LVEDP; LVEF 3033%., notes: Repeat TTE in 1 month:; Magnetic resonance imaging heart: moderate to severely dilated LV; no LGA; Red blood cell sedimentation rate: 10; Troponin: < 0.03. Therapeutic measures were taken as a result of cardiomyopathy.; Sender's Comments: The causal association between the event Cardiomyopathy and the suspect drug BNT162b2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
Sex: F
Vaccine: COVID19
Symptoms: Brain natriuretic peptide, Cardiomyopathy, Catheterisation cardiac, Echocardiogram, Magnetic resonance imaging
Clinical narrative: cardiomyopathy; This is a literature report for the following literature source(s):   A 42-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1). The following information was reported: CARDIOMYOPATHY (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Brain natriuretic peptide: 310; Catheterisation cardiac: no significant CAD; PCWP 15; PAP 33/16 (23 mmHg); mild pHTN; Echocardiogram: LVEF 2025%; LV dilatation; elevated LVEDP; Magnetic resonance imaging: dilated LV; no LGA; Red blood cell sedimentation rate: 17. Therapeutic measures were taken as a result of cardiomyopathy.  Clinical information: All patients commonly reported clinical symptoms of heart failure including fatigue, orthopnea, paroxysmal nocturnal dyspnea, and peripheral edema within 3 weeks from receiving the 2nd dose of the Pfizer COVID-19 vaccine. Patients had no prior known cardiac history or predisposing conditions. Diagnostic workup including a left heart catheterization showed normal coronaries. Echocardiograms showed significantly reduced left ventricular EF =25%. Patients were confirmed to have non-inflammatory cardiomyopathy via endomyocardial biopsy or cardiac magnetic resonance imaging which did not reveal either tissue edema or hyperemia. Since diagnosis, patients were started on guideline directed medical therapy or heart failure while being considered for advanced therapies. The relationship between the novel mRNA COVID-19 vaccine and cardiomyopathy is an area in need for further investigation. Whether or not the vaccine is a contributing factor remains to be unclear. Yet, the symptoms development following vaccine administration along with the exclusion of other potential etiologies, raises the question of whether they are truly related. Despite the unclear mechanism, management remains to be with guideline-directed medical therapy and advanced therapies, as indicated. EF recovery and improved clinical outcomes can be achieved in some patients.; Sender's Comments: The causal association between the event Cardiomyopathy and the suspect drug BNT162b2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate
Clinical narrative: cardiomyopathy; This is a literature report for the following literature source(s):   A 42-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1). The following information was reported: CARDIOMYOPATHY (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Brain natriuretic peptide: 310; Catheterisation cardiac: no significant CAD; PCWP 15; PAP 33/16 (23 mmHg); mild pHTN; Echocardiogram: LVEF 2025%; LV dilatation; elevated LVEDP; Magnetic resonance imaging: dilated LV; no LGA; Red blood cell sedimentation rate: 17. Therapeutic measures were taken as a result of cardiomyopathy.  Clinical information: All patients commonly reported clinical symptoms of heart failure including fatigue, orthopnea, paroxysmal nocturnal dyspnea, and peripheral edema within 3 weeks from receiving the 2nd dose of the Pfizer COVID-19 vaccine. Patients had no prior known cardiac history or predisposing conditions. Diagnostic workup including a left heart catheterization showed normal coronaries. Echocardiograms showed significantly reduced left ventricular EF =25%. Patients were confirmed to have non-inflammatory cardiomyopathy via endomyocardial biopsy or cardiac magnetic resonance imaging which did not reveal either tissue edema or hyperemia. Since diagnosis, patients were started on guideline directed medical therapy or heart failure while being considered for advanced therapies. The relationship between the novel mRNA COVID-19 vaccine and cardiomyopathy is an area in need for further investigation. Whether or not the vaccine is a contributing factor remains to be unclear. Yet, the symptoms development following vaccine administration along with the exclusion of other potential etiologies, raises the question of whether they are truly related. Despite the unclear mechanism, management remains to be with guideline-directed medical therapy and advanced therapies, as indicated. EF recovery and improved clinical outcomes can be achieved in some patients.; Sender's Comments: The causal association between the event Cardiomyopathy and the suspect drug BNT162b2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Echocardiogram, Heart rate, Heart rate increased, Laboratory test
Clinical narrative: his heart went to 187; he is having a heart problem; Supraventricular tachycardia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A 27-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "It was just a muscle under his armpit." (unspecified if ongoing), notes: Was having something in his armpit about 6 months prior to having the vaccine in Sep. The patient's concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (medically significant), outcome "unknown", described as "his heart went to 187"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "he is having a heart problem"; SUPRAVENTRICULAR TACHYCARDIA (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Echocardiogram: Negative, notes: Had a scan, an MRI, an echo, and everything was negative; Heart rate: 187, notes: In Sep he was about to go to sleep and his heart went to 187; everything: Negative, notes: Had a scan, an MRI, an echo, and everything was negative; Magnetic resonance imaging: Negative, notes: Had a scan, an MRI, an echo, and everything was negative; Scan: Negative, notes: Had a scan, an MRI, an echo, and everything was negative.  Clinical Course: After receiving Pfizer COVID-19 Vaccine he was having a heart problem. He did not have any heart problem before until he took the Pfizer COVID-19 vaccine. Has supraventricular tachycardia now. Never had a past medical issue. Was having something in his armpit about 6 months prior to having the vaccine in Sep. Had a scan, an MRI, an echo, and everything was negative. It was just a muscle under his armpit. In Sep he was about to go to sleep and his heart went to 187. Was about to shock him. Has to wear a heart monitor for 2 weeks and takes it off today. His HCP said it was from the vaccine and a lot of people 30 and younger with no prior conditions are developing problems and most are supraventricular tachycardia. Never had a heart problem in his life.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Scan, Supraventricular tachycardia
Clinical narrative: his heart went to 187; he is having a heart problem; Supraventricular tachycardia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A 27-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "It was just a muscle under his armpit." (unspecified if ongoing), notes: Was having something in his armpit about 6 months prior to having the vaccine in Sep. The patient's concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (medically significant), outcome "unknown", described as "his heart went to 187"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "he is having a heart problem"; SUPRAVENTRICULAR TACHYCARDIA (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Echocardiogram: Negative, notes: Had a scan, an MRI, an echo, and everything was negative; Heart rate: 187, notes: In Sep he was about to go to sleep and his heart went to 187; everything: Negative, notes: Had a scan, an MRI, an echo, and everything was negative; Magnetic resonance imaging: Negative, notes: Had a scan, an MRI, an echo, and everything was negative; Scan: Negative, notes: Had a scan, an MRI, an echo, and everything was negative.  Clinical Course: After receiving Pfizer COVID-19 Vaccine he was having a heart problem. He did not have any heart problem before until he took the Pfizer COVID-19 vaccine. Has supraventricular tachycardia now. Never had a past medical issue. Was having something in his armpit about 6 months prior to having the vaccine in Sep. Had a scan, an MRI, an echo, and everything was negative. It was just a muscle under his armpit. In Sep he was about to go to sleep and his heart went to 187. Was about to shock him. Has to wear a heart monitor for 2 weeks and takes it off today. His HCP said it was from the vaccine and a lot of people 30 and younger with no prior conditions are developing problems and most are supraventricular tachycardia. Never had a heart problem in his life.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dysstasia, Joint stiffness, Joint swelling, Rheumatoid factor
Clinical narrative: Both knees began to ache and turn stiff; Both knees began to ache and turn stiff; Can hardly stand up; His knees became puffy, pink, swollen, and warm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 2, single (Lot number: EN6198) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing). Concomitant medication(s) included: TOPROL XL taken for blood pressure measurement (ongoing); LIPITOR (ongoing); SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE. Vaccination history included: BNT162b2 (1st dose: pfizer EN5318), administration date: 24Jan2021, when the patient was 67-year-old, for COVID-19 immunization, reaction(s): "both knees began to ache and turn stiff", "both knees began to ache and turn stiff", "can hardly stand up", "his knees became puffy, pink, swollen, and warm"; Flu shot (He gets a Flu shot every year.), for Immunization. The following information was reported: ARTHRALGIA (non-serious), JOINT STIFFNESS (non-serious) all with onset 2021, outcome "not recovered" and all described as "Both knees began to ache and turn stiff"; DYSSTASIA (non-serious) with onset 2021, outcome "not recovered", described as "Can hardly stand up"; JOINT SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "His knees became puffy, pink, swollen, and warm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, joint stiffness.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202300053948 Same patient/vaccine/event, different dose;
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Both knees began to ache and turn stiff; Both knees began to ache and turn stiff; Can hardly stand up; His knees became puffy, pink, swollen, and warm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 2, single (Lot number: EN6198) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing). Concomitant medication(s) included: TOPROL XL taken for blood pressure measurement (ongoing); LIPITOR (ongoing); SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE. Vaccination history included: BNT162b2 (1st dose: pfizer EN5318), administration date: 24Jan2021, when the patient was 67-year-old, for COVID-19 immunization, reaction(s): "both knees began to ache and turn stiff", "both knees began to ache and turn stiff", "can hardly stand up", "his knees became puffy, pink, swollen, and warm"; Flu shot (He gets a Flu shot every year.), for Immunization. The following information was reported: ARTHRALGIA (non-serious), JOINT STIFFNESS (non-serious) all with onset 2021, outcome "not recovered" and all described as "Both knees began to ache and turn stiff"; DYSSTASIA (non-serious) with onset 2021, outcome "not recovered", described as "Can hardly stand up"; JOINT SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "His knees became puffy, pink, swollen, and warm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, joint stiffness.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202300053948 Same patient/vaccine/event, different dose;
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dysstasia, Joint stiffness, Joint swelling, Rheumatoid factor
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Lot number: ER8737) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing). Concomitant medication(s) included: TOPROL XL taken for blood pressure abnormal (ongoing); LIPITOR (ongoing); SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE. Vaccination history included: pfizer vaccine (Lot no: EN5318, Dose : 1), administration date: 24Jan2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "both knees began to ache and turn stiff", "both knees began to ache and turn stiff", "can hardly stand up", "his knees became puffy, pink, swollen, and warm"; pfizer vaccine (Lot no: EN5318, Dose : 2), administration date: 22Feb2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "both knees began to ache and turn stiff", "both knees began to ache and turn stiff", "can hardly stand up", "his knees became puffy, pink, swollen, and warm"; Flu shot (He gets a Flu shot every year.), for Immunization. The following information was reported: ARTHRALGIA (non-serious), JOINT STIFFNESS (non-serious) all with onset 2021, outcome "not recovered" and all described as "Both knees began to ache and turn stiff"; DYSSTASIA (non-serious) with onset 2021, outcome "not recovered", described as "Can hardly stand up"; JOINT SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "His knees became puffy, pink, swollen, and warm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, joint stiffness.  Additional information:He gets a Flu shot every year. He did get his Flu shot in late Sep2022 and had a reaction to it. It was elevated heart rate and rapid breathing; it was the stronger dose. NDC/lot/expiration: Unknown He considers himself fairly healthy. It didn't seem like osteoarthritis. He did have a meniscus trim in Jan2022. His Knees were in great shape with no arthritis or roughness then. There was a little reduction from spacing from inside to outside, but minimal. From Jan2022 and Jan2023, the space was now gone. They tested him for Rheumatoid arthritis factor it was negative. He has been on the same medications for a long time. Prior Vaccinations (within 4 weeks): none, If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. He gets a Flu shot every year.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): PFIZER INC-202300053948 Same patient/vaccine/event, different dose;
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Lot number: ER8737) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing). Concomitant medication(s) included: TOPROL XL taken for blood pressure abnormal (ongoing); LIPITOR (ongoing); SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE. Vaccination history included: pfizer vaccine (Lot no: EN5318, Dose : 1), administration date: 24Jan2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "both knees began to ache and turn stiff", "both knees began to ache and turn stiff", "can hardly stand up", "his knees became puffy, pink, swollen, and warm"; pfizer vaccine (Lot no: EN5318, Dose : 2), administration date: 22Feb2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "both knees began to ache and turn stiff", "both knees began to ache and turn stiff", "can hardly stand up", "his knees became puffy, pink, swollen, and warm"; Flu shot (He gets a Flu shot every year.), for Immunization. The following information was reported: ARTHRALGIA (non-serious), JOINT STIFFNESS (non-serious) all with onset 2021, outcome "not recovered" and all described as "Both knees began to ache and turn stiff"; DYSSTASIA (non-serious) with onset 2021, outcome "not recovered", described as "Can hardly stand up"; JOINT SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "His knees became puffy, pink, swollen, and warm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, joint stiffness.  Additional information:He gets a Flu shot every year. He did get his Flu shot in late Sep2022 and had a reaction to it. It was elevated heart rate and rapid breathing; it was the stronger dose. NDC/lot/expiration: Unknown He considers himself fairly healthy. It didn't seem like osteoarthritis. He did have a meniscus trim in Jan2022. His Knees were in great shape with no arthritis or roughness then. There was a little reduction from spacing from inside to outside, but minimal. From Jan2022 and Jan2023, the space was now gone. They tested him for Rheumatoid arthritis factor it was negative. He has been on the same medications for a long time. Prior Vaccinations (within 4 weeks): none, If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. He gets a Flu shot every year.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): PFIZER INC-202300053948 Same patient/vaccine/event, different dose;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 5 (booster), single (Lot number: GJ3277), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 11Apr2021 as dose 2, single (Lot number: EW0151), in left arm, on 13Nov2021 as dose 3 (booster), single (Lot number: FD0809), in left arm and on 02May2022 as dose 4 (booster), single (Lot number: FJ4991), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Season allergies" (unspecified if ongoing), notes: Season allergies. The patient's concomitant medications were not reported. The patient was an endurance athlete. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jan2023) Negative; (28Jan2023) Negative; (02Feb2023) Positive, notes: still tested Positive on 02Feb2023. Therapeutic measures were taken as a result of drug ineffective, COVID-19: the patient received Paxlovid from 22Jan2023 to 26Jan2023 for treatment of COVID-19. The patient tested negative on 27Jan2023 and 28Jan2023 and then original symptoms returned on 30Jan2023 (brain fog, fever, chills, sweating, headache, congestion, cough, achiness) plus one additional symptom, loss of smell and taste. Symptoms were miserable through 02Feb2023 when the patient started to improve (still tested positive on 02Feb2023).