chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2022 as dose number unknown, single (Lot number: FK9893) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid).  Clinical course: It was reported that, the patient received other medication in two weeks. Adverse event: Bitter taste in throat. However, patient was writing because she had a positive reaction that she can only say was due to taking Paxlovid. she had palmarplantar dermatitis and her hands completely cleared up/ were totally smooth while/ immediately after taking the medication. The skin on her fingers had begun to peel since, but she still had better finger tips (no splits) than before. She would hope you could develop this into a prescribed medication for further use by people like her. Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date=03Jul2022, Treatment stop date=08Jul2022.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Alopecia" (unspecified if ongoing); "connective tissue disorder" (unspecified if ongoing); "eczema" (unspecified if ongoing); "asthma" (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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received treatment with Paxlovid for Covid-19. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 at 14:00 as dose 1, single (Lot number: EP7534), in left arm, on 12Apr2021 as dose 2, single (Lot number: EW0153), in left arm and on 22Nov2021 at 14:00 as dose 3 (booster), single (Lot number: FH8028) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (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: Negative, notes: After testing negative; positive, notes: Experienced rebound Covid 7 days. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had not received other medication in 2 weeks. Anti viral details reported to be COVID 19 Treatment, brand name was Paxlovid, treatment was started on 18Jul2022 and was stopped on 22Jul2022, lot number 1910754A, indication included Treatment of COVID-19. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
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). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Oct2021 at 14:00 as dose 3 (booster) single (Lot number: FC3592) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (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. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. Treatment of COVID-19 as Paxlovid, started from 26Jul2022 to 01Aug2022.
Sex: F
Vaccine: COVID19
Symptoms: Antiacetylcholine receptor antibody, Antibody test, Blood pressure diastolic, Blood pressure systolic, Blood thyroid stimulating hormone
Clinical narrative: Postural orthostatic tachycardia syndrome; The initial case was missing the following minimum criteria: Unidentifiable patient. Upon receipt of follow-up information on 03Aug2022, this case now contains all required information to be considered valid.  This is a literature report.  A 21-year-old female patient received BNT162b2 (BNT162B2), as dose 1, 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: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (medically significant), 12 days after the suspect product(s) administration, outcome "recovering". The patient underwent the following laboratory tests and procedures: Antibody test: positive, notes: Mildly  with a titer of 0.07 nmol/L (normal less than 0.02); Blood pressure diastolic: 14; Blood pressure systolic: 16; Blood thyroid stimulating hormone: Normal; Echocardiogram: Showed normal biventricular size and function; Electrocardiogram: Showed normal sinus rhythm; Electrocardiogram ambulatory: Showed normal sinus rhythm; Full blood count: Normal; Heart rate variability test: Normal; 47; Autonomic testing: showed orthostatic tachycardia without OH, consist, notes: ent with a diagnosis of POTS; Unremarkable; Normal; Maximum heart rate: 136; Sweat test: Normal; Tilt table test: Prominent orthostatic tachycardia (above), HR delt, notes: a 47 bpm, max HR 136 bpm with no significant orthostatic hypotension (below); Valsalva maneuver: Normal; Antiacetylcholine receptor antibody (normal high range 0.02): 0.07 nmol/L. Therapeutic measures were taken as a result of postural orthostatic tachycardia syndrome.; Sender's Comments: Based on the known safety profile and information in the case report a casual association between reported event Postural Orthostatic tachycardia Syndrome 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,Linked Report(s) : US-PFIZER INC-PV202200037945 Same article/drug/event and different patient;US-PFIZER INC-202201040964 Same article/ drug/event and different patient.;US-PFIZER INC-202201040965 Same article/ drug/event and different patient.;
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Full blood count, Heart rate variability test
Clinical narrative: Postural orthostatic tachycardia syndrome; The initial case was missing the following minimum criteria: Unidentifiable patient. Upon receipt of follow-up information on 03Aug2022, this case now contains all required information to be considered valid.  This is a literature report.  A 21-year-old female patient received BNT162b2 (BNT162B2), as dose 1, 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: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (medically significant), 12 days after the suspect product(s) administration, outcome "recovering". The patient underwent the following laboratory tests and procedures: Antibody test: positive, notes: Mildly  with a titer of 0.07 nmol/L (normal less than 0.02); Blood pressure diastolic: 14; Blood pressure systolic: 16; Blood thyroid stimulating hormone: Normal; Echocardiogram: Showed normal biventricular size and function; Electrocardiogram: Showed normal sinus rhythm; Electrocardiogram ambulatory: Showed normal sinus rhythm; Full blood count: Normal; Heart rate variability test: Normal; 47; Autonomic testing: showed orthostatic tachycardia without OH, consist, notes: ent with a diagnosis of POTS; Unremarkable; Normal; Maximum heart rate: 136; Sweat test: Normal; Tilt table test: Prominent orthostatic tachycardia (above), HR delt, notes: a 47 bpm, max HR 136 bpm with no significant orthostatic hypotension (below); Valsalva maneuver: Normal; Antiacetylcholine receptor antibody (normal high range 0.02): 0.07 nmol/L. Therapeutic measures were taken as a result of postural orthostatic tachycardia syndrome.; Sender's Comments: Based on the known safety profile and information in the case report a casual association between reported event Postural Orthostatic tachycardia Syndrome 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,Linked Report(s) : US-PFIZER INC-PV202200037945 Same article/drug/event and different patient;US-PFIZER INC-202201040964 Same article/ drug/event and different patient.;US-PFIZER INC-202201040965 Same article/ drug/event and different patient.;
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Maximum heart rate, Postural orthostatic tachycardia syndrome, Sweat test, Tilt table test
Clinical narrative: Postural orthostatic tachycardia syndrome; The initial case was missing the following minimum criteria: Unidentifiable patient. Upon receipt of follow-up information on 03Aug2022, this case now contains all required information to be considered valid.  This is a literature report.  A 21-year-old female patient received BNT162b2 (BNT162B2), as dose 1, 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: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (medically significant), 12 days after the suspect product(s) administration, outcome "recovering". The patient underwent the following laboratory tests and procedures: Antibody test: positive, notes: Mildly  with a titer of 0.07 nmol/L (normal less than 0.02); Blood pressure diastolic: 14; Blood pressure systolic: 16; Blood thyroid stimulating hormone: Normal; Echocardiogram: Showed normal biventricular size and function; Electrocardiogram: Showed normal sinus rhythm; Electrocardiogram ambulatory: Showed normal sinus rhythm; Full blood count: Normal; Heart rate variability test: Normal; 47; Autonomic testing: showed orthostatic tachycardia without OH, consist, notes: ent with a diagnosis of POTS; Unremarkable; Normal; Maximum heart rate: 136; Sweat test: Normal; Tilt table test: Prominent orthostatic tachycardia (above), HR delt, notes: a 47 bpm, max HR 136 bpm with no significant orthostatic hypotension (below); Valsalva maneuver: Normal; Antiacetylcholine receptor antibody (normal high range 0.02): 0.07 nmol/L. Therapeutic measures were taken as a result of postural orthostatic tachycardia syndrome.; Sender's Comments: Based on the known safety profile and information in the case report a casual association between reported event Postural Orthostatic tachycardia Syndrome 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,Linked Report(s) : US-PFIZER INC-PV202200037945 Same article/drug/event and different patient;US-PFIZER INC-202201040964 Same article/ drug/event and different patient.;US-PFIZER INC-202201040965 Same article/ drug/event and different patient.;
Sex: F
Vaccine: COVID19
Symptoms: Valsalva maneuver
Clinical narrative: Postural orthostatic tachycardia syndrome; The initial case was missing the following minimum criteria: Unidentifiable patient. Upon receipt of follow-up information on 03Aug2022, this case now contains all required information to be considered valid.  This is a literature report.  A 21-year-old female patient received BNT162b2 (BNT162B2), as dose 1, 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: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (medically significant), 12 days after the suspect product(s) administration, outcome "recovering". The patient underwent the following laboratory tests and procedures: Antibody test: positive, notes: Mildly  with a titer of 0.07 nmol/L (normal less than 0.02); Blood pressure diastolic: 14; Blood pressure systolic: 16; Blood thyroid stimulating hormone: Normal; Echocardiogram: Showed normal biventricular size and function; Electrocardiogram: Showed normal sinus rhythm; Electrocardiogram ambulatory: Showed normal sinus rhythm; Full blood count: Normal; Heart rate variability test: Normal; 47; Autonomic testing: showed orthostatic tachycardia without OH, consist, notes: ent with a diagnosis of POTS; Unremarkable; Normal; Maximum heart rate: 136; Sweat test: Normal; Tilt table test: Prominent orthostatic tachycardia (above), HR delt, notes: a 47 bpm, max HR 136 bpm with no significant orthostatic hypotension (below); Valsalva maneuver: Normal; Antiacetylcholine receptor antibody (normal high range 0.02): 0.07 nmol/L. Therapeutic measures were taken as a result of postural orthostatic tachycardia syndrome.; Sender's Comments: Based on the known safety profile and information in the case report a casual association between reported event Postural Orthostatic tachycardia Syndrome 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,Linked Report(s) : US-PFIZER INC-PV202200037945 Same article/drug/event and different patient;US-PFIZER INC-202201040964 Same article/ drug/event and different patient.;US-PFIZER INC-202201040965 Same article/ drug/event and different patient.;
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Paralysis
Clinical narrative: stroke; He temporarily was paralyzed on his right side; This is a spontaneous report received from non-contactable reporter(s) (Pharmacist) from a sales representative. The reporter is the patient.  A 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: Covid-19 vaccine (Dose number: 1), for COVID-19 Immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke"; PARALYSIS (medically significant), outcome "unknown", described as "He temporarily was paralyzed on his right side". Clinical course: Pharmacist said that he experienced a stroke after his 2nd Pfizer vaccine. He temporarily was paralyzed on his right side. He was now back working and said he still had some 'remnants' of the stroke. Event took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events CEREBROVASCULAR ACCIDENT , PARALYSIS  and the vaccine (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: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID positive home test on 02Aug2022; COVID positive home test on 02Aug2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose number unknown, 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) all with onset 02Aug2022, outcome "unknown" and all described as "COVID positive home test on 02Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Aug2022) Positive, notes: COVID positive home test on 22Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200036717 same reporter/ drug/ event, different patient;
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4488813-00 (AbbVie).  A 69-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; adalimumab (HUMIRA), as citrate free (Batch/Lot number: unknown) subcutaneous for psoriasis. 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) all with onset 2022, outcome "recovering" and all described as "COVID-19 treatment". The action taken for adalimumab was unknown. Clinical course: It was unknown if patient was enrolled in a Covid-19 Vaccine Trial.   The reporter considered "covid-19 treatment" related to BNT162b2.  The reporters causality for the event of Covid with Adalimumab was not provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dysstasia, Eye pain, Headache, Heart rate increased
Clinical narrative: Fever, extreme disorientation, "I must be dying" level of whole body pain, extreme headache, neck glands pain, inability to stand up, elevated heart rate, eye pain.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Pain, Pyrexia
Clinical narrative: Fever, extreme disorientation, "I must be dying" level of whole body pain, extreme headache, neck glands pain, inability to stand up, elevated heart rate, eye pain.
Sex: U
Vaccine: COVID19
Symptoms: Epstein-Barr virus infection, Epstein-Barr virus test, Illness
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MOD22-020223 (Moderna), 145640 (Moderna). A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Sep2021 as dose number unknown (booster) , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "mono and dysplasia", start date: Jul2021, stop date: Jul2021; "mono and dysplasia", start date: Jul2021, stop date: Jul2021. The patient's concomitant medications were not reported. Vaccination history included: coviD-19 vaccine moderna (Dose 2 Lot# 020B21A), administration date: 01Apr2021, for Covid-19 immunization; Covid-19 vaccine moderna (Dose 1), for Covid-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got a Pfizer booster in September of 2021 & got sick again but only for a couple of days"; EPSTEIN-BARR VIRUS INFECTION (non-serious), outcome "unknown", described as "Epstein Barr". Relevant laboratory tests and procedures are available in the appropriate section. Additional information : Patient reporting her experiences after receiving two primary doses (2nd dose Lot# 020B21A on 01Apr2021) and of the Moderna COVID-19 Vaccine. Caller says she has not had COVID that she knows off. Within 24 hours of the 2nd dose she became sick with what she says are COVID symptoms. She couldn't breath, was out of breath just walking down the hall, chronic fatigue, and mouth and throat lesions. The breathing and COVID symptoms lasted for 19 days. The lesions and fatigue continued. She eventually went to an urgent care who told she has strep, for which they never tested her. She had thrush on her tongue, her throat was full, she had lesion on her tongue, the roof of her mouth and down her throat and she couldn't swallow. She had a horrible cough and lost her voice. Which she just got back after speech therapy for 4 months. She saw a dentist then eventually went to [Place name withheld] & was diagnosed with mono and dysplasia in Jul2021. She now has to take meds with pudding due to her continued swallowing issues. She got a Pfizer booster in Sep2021 and got sick again but only for a couple of days. On 04May2022 she had some specialized testing done and was diagnosed with Epstein Barr. She says the lesions have only been gone for a couple of months. Consent granted for follow-up by the safety team with her, her doctor, and the vaccination facility. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: PNC20, TTOX
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: joint pain; inability to move knees and fingers; This is a spontaneous report received from a contactable reporter (consumer or other non HCP).  A female patient in her 60's received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 01Aug2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; tetanus vaccine (TETANUS VACCINE), on 01Aug2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: JOINT RANGE OF MOTION DECREASED (non-serious) with onset 01Aug2022, outcome "unknown", described as "inability to move knees and fingers"; ARTHRALGIA (non-serious) with onset 01Aug2022, outcome "unknown", described as "joint pain".  Additional information: Patient received Apexxnar (PCV20) vaccine (as reported) on August 1st, began experiencing joint pain and the inability to move knees and fingers. Patient is mid-60s, female. Patient received tetanus shot and Apexxnar at the same visit. Event took place after use of product.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Acquired gene mutation
Clinical narrative: changed my dna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from legal division, Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose number unknown, 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: ACQUIRED GENE MUTATION (non-serious), outcome "unknown", described as "changed my dna".  Additional information: Caller stated that did the vaccine and it was changed my DNA. Patient said that I am suing you if you do not pay me and have lawyers that are prepared to go forward. AE was reported, email forwarded to legal as FYI. I did the vaccine, and it changed my DNA. I am suing you if you do not pay me. I have lawyers that are prepared to go forward.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Cardiovascular symptom, Myocarditis, SARS-CoV-2 test, Supraventricular extrasystoles
Clinical narrative: Arrhythmia Yes, developed very frequent; Myocarditis Yes, developed very frequent; symptomatic PAC's + PVC's after 2nd vaccine dose; symptomatic PAC's + PVC's after 2nd vaccine dose; Cardiovascular Yes; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 08Jan2021 as dose 2, single (Lot number: EL1284) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VITAMIN D [COLECALCIFEROL]; CLARITIN [LORATADINE]. Vaccination history included: BNT162b2 (DOSE 1(single), Route of Administration: Intramuscular, Covid-19 Vaccine Name: Pfizer, Batch/Lot: EH9899.), administration date: 18Dec2020, when the patient was 55-year-old, for COVID-19 immunization, reaction(s): "Treatment of COVID-19". The following information was reported: ARRHYTHMIA (medically significant), outcome "unknown", described as "Arrhythmia Yes, developed very frequent"; MYOCARDITIS (medically significant), outcome "unknown", described as "Myocarditis Yes, developed very frequent"; SUPRAVENTRICULAR EXTRASYSTOLES (non-serious), VENTRICULAR EXTRASYSTOLES (non-serious), outcome "unknown" and all described as "symptomatic PAC's + PVC's after 2nd vaccine dose"; CARDIOVASCULAR SYMPTOM (non-serious), outcome "unknown", described as "Cardiovascular Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Positive; (10May2022) Negative.  Clinical information: The patient was non smoker. The patient did not display clinical signs at rest indicative of severe systemic illness. The patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: Arrhythmia Yes, developed very frequent; Myocarditis Yes, developed very frequent; symptomatic PAC's + PVC's after 2nd vaccine dose; symptomatic PAC's + PVC's after 2nd vaccine dose; Cardiovascular Yes; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 08Jan2021 as dose 2, single (Lot number: EL1284) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VITAMIN D [COLECALCIFEROL]; CLARITIN [LORATADINE]. Vaccination history included: BNT162b2 (DOSE 1(single), Route of Administration: Intramuscular, Covid-19 Vaccine Name: Pfizer, Batch/Lot: EH9899.), administration date: 18Dec2020, when the patient was 55-year-old, for COVID-19 immunization, reaction(s): "Treatment of COVID-19". The following information was reported: ARRHYTHMIA (medically significant), outcome "unknown", described as "Arrhythmia Yes, developed very frequent"; MYOCARDITIS (medically significant), outcome "unknown", described as "Myocarditis Yes, developed very frequent"; SUPRAVENTRICULAR EXTRASYSTOLES (non-serious), VENTRICULAR EXTRASYSTOLES (non-serious), outcome "unknown" and all described as "symptomatic PAC's + PVC's after 2nd vaccine dose"; CARDIOVASCULAR SYMPTOM (non-serious), outcome "unknown", described as "Cardiovascular Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Positive; (10May2022) Negative.  Clinical information: The patient was non smoker. The patient did not display clinical signs at rest indicative of severe systemic illness. The patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation.
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chronic obstructive pulmonary disease, Inappropriate schedule of product administration, Pulmonary congestion
Clinical narrative: Congestion in lungs; Chronic obstructive pulmonary disease; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 12Jun2021 as dose 2, single (Lot number: EW0186), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood in sputum", start date: 09Feb2021 (unspecified if ongoing), notes: None urgent care; "Blood in sputum", start date: 12Apr2021 (unspecified if ongoing), notes: None hospital. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Time: Afternoon, Anatomical Site of injection: left upper arm, Route of administration: Intramuscular, Batch/Lot number: Pfizer BioNTech EW0186), administration date: 26May2021, when the patient was 70-year-old, for COVID-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 12Jun2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious) with onset 11Nov2021, outcome "unknown"; PULMONARY CONGESTION (medically significant) with onset 12Nov2021, outcome "unknown", described as "Congestion in lungs". The patient underwent the following laboratory tests and procedures: Chest X-ray: (09Feb2021) Negative, notes: Negative for Pneumothorax; (11Nov2021) Follow up suggested, notes: Chronic obstructive pulmonary disease.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Migraine, Pain
Clinical narrative: My adult son is getting me grain s after getting your booster shot/ Migraine headache; the pain of the headache; stated that now he is in a lot of pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the parent.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 21Jul2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "mentally challenged (Medical condition)" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 Immunization. The following information was reported: MIGRAINE (non-serious) with onset 2022, outcome "unknown", described as "My adult son is getting me grain s after getting your booster shot/ Migraine headache"; PAIN (non-serious) with onset 2022, outcome "unknown", described as "stated that now he is in a lot of pain"; HEADACHE (non-serious) with onset 2022, outcome "unknown", described as "the pain of the headache". The events "my adult son is getting me grain s after getting your booster shot/ migraine headache" and "the pain of the headache" required emergency room visit. Therapeutic measures were taken as a result of headache.  Additional information: it was reported that he was at the emergency room twice and they definitely said it was from the shot. The patient was taking a very small amount of blood thinner.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID; COVID; This is report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4489583-00.  A 38-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) and in Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 37 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for psoriatic arthropathy; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular 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 Jun2022, outcome "unknown" and all described as "COVID". The action taken for adalimumab was unknown.  Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded.  The reporter's causality for the event(s) Drug: HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB) and the event COVID-19 Causality as per reporter (Drug/Vaccine) was Not Reported Causality as per reporter between PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN) and the event COVID-19 was Possible Causality as per reporter between MODERNA COVID-19 VACCINE(ELASOMERAN)(Injection) (ELASOMERAN (TOZINAMERAN) and the event COVID-19 was Possible The reporter considered "covid" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted when received.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug.
Age: 57.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID; COVID; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4490359-00 (AbbVie).  A 58-year-old male patient received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 24Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 57 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown), subcutaneous for psoriasis. 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 Jan2022, outcome "unknown" and all described as "COVID". It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken for adalimumab was dosage not changed.  The reporter considered "covid" related to BNT162b2. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product bnt162b2 cannot be ruled out.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: experienced only mild arm soreness with the vaccinations; experienced only mild arm soreness with the vaccinations as well as minimal fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6202) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "experienced only mild arm soreness with the vaccinations"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "experienced only mild arm soreness with the vaccinations as well as minimal fatigue".
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: recently got COVID; recently got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP)). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, 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 "unknown" and all described as "recently got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical course: A patient was wondering how long she was going to wait before she can get her booster shot because she recently got COVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Febrile neutropenia, Immunisation reaction
Clinical narrative: side effects of covid-19 vaccinations; neutropenic fever; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4491485-00.  A 64-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; ibrutinib (IMBRUVICA), (Batch/Lot number: unknown), oral. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEBRILE NEUTROPENIA (medically significant) with onset Jul2022, outcome "recovered" (Jul2022), described as "neutropenic fever"; IMMUNISATION REACTION (non-serious), outcome "recovering", described as "side effects of covid-19 vaccinations". The action taken for ibrutinib was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's assessment of the causal relationship of "neutropenic fever" and "side effects of covid-19 vaccinations" with the suspect product(s) BNT162b2 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.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully 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: Face crushing, Swelling
Clinical narrative: face losing volume/Unevenness on left side right below eye between cheek and temple; couple of lumps below left eye more towards center of eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): GL-080222-19087.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 27May2021 as dose 1, single (Batch/Lot number: unknown), on 17Jun2021 as dose 2, single (Batch/Lot number: unknown), on 20Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 21Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; poly-L-lactic acid (SCULPTRA), since 13Apr2022 (Batch/Lot number: unknown). The patient's relevant medical history included: "dental cleaning" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Restylane; Voluma. The following information was reported: FACE CRUSHING (medically significant), outcome "unknown", described as "face losing volume/Unevenness on left side right below eye between cheek and temple"; SWELLING (non-serious), outcome "unknown", described as "couple of lumps below left eye more towards center of eye". The action taken for poly-L-lactic acid was unknown. Therapeutic measures were not taken as a result of face crushing, swelling..  Clinical course: Patient was injected with Sculptra on 13Apr2022 in the cheeks, nasolabial, chin, and temple. Noticing unevenness more now in past couple weeks, maybe a month later. Unevenness on left side right below eye between cheek and temple, couple of lumps below left eye more towards center of eye. No treatment received. Injecting provider was contacted. Nurse saw here the other day and was going to try to fix it in the next treatment. She said it had to do with her face losing volume, nothing to do with the treatment. No medical history/allergies reported. Patient has received Restylane and Voluma in the past. No medications used routinely. Patient received Pfizer COVID-19 vaccines. 1st vaccine: 27May2021, 2nd vaccine: 17Jun2021, boosters: 20Dec2021 and 21Apr2021 (as reported). No other vaccinations in past 6-12 months, no illness in month prior to treatment. Patient had a dental cleaning sometime last month.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Crohn's disease, Diagnostic procedure, Pain, Pyrexia
Clinical narrative: crohn's spread from large intestine to small intestine/flare up of crohn's disease; pain; temperature; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 22K-163-4385075-00 (Company).  A 20-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Batch/Lot number: unknown) at citrate free (1 in 2 weeks) and second regimen (Batch/Lot number: unknown) at citrate free (1 in 10 days), all subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant), outcome "not recovered", described as "crohn's spread from large intestine to small intestine/flare up of crohn's disease"; PAIN (non-serious), outcome "not recovered"; PYREXIA (non-serious), outcome "recovered", described as "temperature". The patient underwent the following laboratory tests and procedures: Diagnostic procedure: Crohn's had spread, notes: Crohn's had spread from large intestine to small intestine. The action taken for adalimumab was unknown. Clinical course: On unknown dates, the patient experienced Crohn's spread from large intestine to small intestine/flare up of Crohn's disease, pain and temperature. On an unknown date, temperature resolved. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the information was not available in the patient's file.  The reporter's assessment of the causal relationship of "crohn's spread from large intestine to small intestine/flare up of crohn's disease" with the suspect product(s) BNT162b2 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. The reporter considered "pain" and "temperature" related to BNT162b2.  Causality for Humira (adalimumab): the reporter's causality for the event(s) of Crohn's spread from large intestine to small intestine/flare up of Crohn's disease with Humira (adalimumab) was a reasonable possibility. the reporter's causality for the event(s) of pain and temperature was not provided.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.  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: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Sudden hearing loss, Tinnitus
Clinical narrative: sudden hearing loss; severe tinnitus in right ear; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000002642.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2022 as dose 2, single (Lot number: EN6205) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 2022, outcome "unknown", described as "severe tinnitus in right ear"; SUDDEN HEARING LOSS (medically significant) with onset 2022, outcome "unknown".  Clinical course: On 17Jul2022, it was reported that a patient started treatment on 12Mar2022 with Pfizer Biontech Covid-19 vaccine dose 2 for an unknown indication. It was reported the patient experienced sudden hearing loss and severe tinnitus in right ear.   No further follow-up is anticipated.