chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: His friend is 80 years old and his wife is 80 years old and the entire family including children and grandchildren have tested positive for covid on home tests.; His friend is 80 years old and his wife is 80 years old and the entire family including children and grandchildren have tested positive for covid on home tests.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID.  An 80-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and 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 "His friend is 80 years old and his wife is 80 years old and the entire family including children and grandchildren have tested positive for covid on home tests.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: The caller said he's calling on behalf of his friend who has travelled with his family to France. His friend is 80 years old and his wife is 80 years old and the entire family including children and grandchildren have tested positive for covid on home tests.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: His friend is 80 years old and his wife is 80 years old and the entire family including children and grandchildren have tested positive for covid on home tests.; His friend is 80 years old and his wife is 80 years old and the entire family including children and grandchildren have tested positive for covid on home tests.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 80--old female patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "His friend is 80 years old and his wife is 80 years old and the entire family including children and grandchildren have tested positive for covid on home tests.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for covid on home tests.  Clinical course: The caller said he's calling on behalf of his friend who has traveled with his family. His friend was 80 years old and his wife was 80 years old and the entire family including children and grandchildren have tested positive for covid on home tests. The 80-year-old wife was now in hospital. Everybody involved has been vaccinated and boosted. Caller wants to know where they can get Paxlovid or if they can send them the medication Paxlovid. Sending as precautionary AE.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Blood potassium, Blood potassium increased, Bone pain, Chills
Clinical narrative: Hives; enlarged lymph node in one armpit; Pain in bone/extremities; Pain in bone/extremities; Joint pain; Upper body pain; Chills; Aches; Shivers; Headache; Fever; Mild elevation in potassium levels; Nausea, queasy; This is a spontaneous report received from contactable reporter(s) (Other HCP and Nurse). Other Case identifier(s): 2022US001981 (Radius).  A 76-year-old female patient received BNT162b2 (BNT162B2), on 05Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in arm for covid-19 immunisation; abaloparatide (TYMLOS), from 10Jan2022 (Batch/Lot number: unknown) to 24Apr2022 at 80 ug 4x/day (80 ug, 4x/day (80 mcg, qd)), subcutaneous for osteoporosis. The patient's relevant medical history included: "Allergy: Sulfacetamide powder" (ongoing), notes: allergies to erythromycin, prazosin, clarithromycin, and sulfacetamide powder. Concomitant medication(s) included: VITAMIN D3; VITAMIN B12 NOS; ESTRACE. Past drug history included: Allergy: erythromycin for Drug hypersensitivity, notes: allergies to erythromycin, prazosin, clarithromycin, and sulfacetamide powder.; Allergy: prazosin for Drug hypersensitivity, notes: allergies to erythromycin, prazosin, clarithromycin, and sulfacetamide powder.; Allergy: clarithromycin for Drug hypersensitivity, notes: allergies to erythromycin, prazosin, clarithromycin, and sulfacetamide powder. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacturer unknown.), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 05Apr2022, outcome "not recovered", described as "Aches"; CHILLS (non-serious) with onset 05Apr2022, outcome "not recovered"; PYREXIA (non-serious) with onset 05Apr2022, outcome "unknown", described as "Fever"; HEADACHE (non-serious) with onset 05Apr2022, outcome "not recovered"; CHILLS (non-serious) with onset 05Apr2022, outcome "not recovered", described as "Shivers"; ARTHRALGIA (non-serious) with onset 06Apr2022, outcome "recovering", described as "Joint pain"; BONE PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 06Apr2022, outcome "recovering" and all described as "Pain in bone/extremities"; PAIN (non-serious) with onset 06Apr2022, outcome "recovering", described as "Upper body pain"; BLOOD POTASSIUM INCREASED (non-serious) with onset Apr2022, outcome "unknown", described as "Mild elevation in potassium levels"; NAUSEA (non-serious) with onset Apr2022, outcome "recovered", described as "Nausea, queasy"; URTICARIA (non-serious), outcome "not recovered", described as "Hives"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "enlarged lymph node in one armpit". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for abaloparatide was temporarily withdrawn on 24Apr2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Lymphadenopathy, Nausea, Pain, Pain in extremity
Clinical narrative: Hives; enlarged lymph node in one armpit; Pain in bone/extremities; Pain in bone/extremities; Joint pain; Upper body pain; Chills; Aches; Shivers; Headache; Fever; Mild elevation in potassium levels; Nausea, queasy; This is a spontaneous report received from contactable reporter(s) (Other HCP and Nurse). Other Case identifier(s): 2022US001981 (Radius).  A 76-year-old female patient received BNT162b2 (BNT162B2), on 05Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in arm for covid-19 immunisation; abaloparatide (TYMLOS), from 10Jan2022 (Batch/Lot number: unknown) to 24Apr2022 at 80 ug 4x/day (80 ug, 4x/day (80 mcg, qd)), subcutaneous for osteoporosis. The patient's relevant medical history included: "Allergy: Sulfacetamide powder" (ongoing), notes: allergies to erythromycin, prazosin, clarithromycin, and sulfacetamide powder. Concomitant medication(s) included: VITAMIN D3; VITAMIN B12 NOS; ESTRACE. Past drug history included: Allergy: erythromycin for Drug hypersensitivity, notes: allergies to erythromycin, prazosin, clarithromycin, and sulfacetamide powder.; Allergy: prazosin for Drug hypersensitivity, notes: allergies to erythromycin, prazosin, clarithromycin, and sulfacetamide powder.; Allergy: clarithromycin for Drug hypersensitivity, notes: allergies to erythromycin, prazosin, clarithromycin, and sulfacetamide powder. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacturer unknown.), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 05Apr2022, outcome "not recovered", described as "Aches"; CHILLS (non-serious) with onset 05Apr2022, outcome "not recovered"; PYREXIA (non-serious) with onset 05Apr2022, outcome "unknown", described as "Fever"; HEADACHE (non-serious) with onset 05Apr2022, outcome "not recovered"; CHILLS (non-serious) with onset 05Apr2022, outcome "not recovered", described as "Shivers"; ARTHRALGIA (non-serious) with onset 06Apr2022, outcome "recovering", described as "Joint pain"; BONE PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 06Apr2022, outcome "recovering" and all described as "Pain in bone/extremities"; PAIN (non-serious) with onset 06Apr2022, outcome "recovering", described as "Upper body pain"; BLOOD POTASSIUM INCREASED (non-serious) with onset Apr2022, outcome "unknown", described as "Mild elevation in potassium levels"; NAUSEA (non-serious) with onset Apr2022, outcome "recovered", described as "Nausea, queasy"; URTICARIA (non-serious), outcome "not recovered", described as "Hives"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "enlarged lymph node in one armpit". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for abaloparatide was temporarily withdrawn on 24Apr2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives; enlarged lymph node in one armpit; Pain in bone/extremities; Pain in bone/extremities; Joint pain; Upper body pain; Chills; Aches; Shivers; Headache; Fever; Mild elevation in potassium levels; Nausea, queasy; This is a spontaneous report received from contactable reporter(s) (Other HCP and Nurse). Other Case identifier(s): 2022US001981 (Radius).  A 76-year-old female patient received BNT162b2 (BNT162B2), on 05Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in arm for covid-19 immunisation; abaloparatide (TYMLOS), from 10Jan2022 (Batch/Lot number: unknown) to 24Apr2022 at 80 ug 4x/day (80 ug, 4x/day (80 mcg, qd)), subcutaneous for osteoporosis. The patient's relevant medical history included: "Allergy: Sulfacetamide powder" (ongoing), notes: allergies to erythromycin, prazosin, clarithromycin, and sulfacetamide powder. Concomitant medication(s) included: VITAMIN D3; VITAMIN B12 NOS; ESTRACE. Past drug history included: Allergy: erythromycin for Drug hypersensitivity, notes: allergies to erythromycin, prazosin, clarithromycin, and sulfacetamide powder.; Allergy: prazosin for Drug hypersensitivity, notes: allergies to erythromycin, prazosin, clarithromycin, and sulfacetamide powder.; Allergy: clarithromycin for Drug hypersensitivity, notes: allergies to erythromycin, prazosin, clarithromycin, and sulfacetamide powder. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacturer unknown.), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 05Apr2022, outcome "not recovered", described as "Aches"; CHILLS (non-serious) with onset 05Apr2022, outcome "not recovered"; PYREXIA (non-serious) with onset 05Apr2022, outcome "unknown", described as "Fever"; HEADACHE (non-serious) with onset 05Apr2022, outcome "not recovered"; CHILLS (non-serious) with onset 05Apr2022, outcome "not recovered", described as "Shivers"; ARTHRALGIA (non-serious) with onset 06Apr2022, outcome "recovering", described as "Joint pain"; BONE PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 06Apr2022, outcome "recovering" and all described as "Pain in bone/extremities"; PAIN (non-serious) with onset 06Apr2022, outcome "recovering", described as "Upper body pain"; BLOOD POTASSIUM INCREASED (non-serious) with onset Apr2022, outcome "unknown", described as "Mild elevation in potassium levels"; NAUSEA (non-serious) with onset Apr2022, outcome "recovered", described as "Nausea, queasy"; URTICARIA (non-serious), outcome "not recovered", described as "Hives"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "enlarged lymph node in one armpit". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for abaloparatide was temporarily withdrawn on 24Apr2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 antibody test, Suspected COVID-19
Clinical narrative: Suspected clinical vaccination failure (vaccination failure); Suspected COVID-19 infection; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 20220606884(0.0) (Janssen), 20220542436 (Janssen).  A male patient received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for immunisation, covid-19 immunisation. The patient's family history included: "Asthma flares" (ongoing), notes: Patient's concurrent conditions included: asthma flares (everyone in immediate family has asthma). The patient's concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 20Apr2022, outcome "recovered" (2022), described as "Suspected COVID-19 infection"; DRUG INEFFECTIVE (medically significant) with onset 20Apr2022, outcome "recovered" (2022), described as "Suspected clinical vaccination failure (vaccination failure)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (20Apr2022) Unknown Results, notes: Around 20Apr2022, the patient experienced covid-19. Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  Clinical course: The patient recovered at home and was not treated. The casual relationship between Drug: Janssen covid-19 vaccine and events was Possible.  Company Remarks: covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. The events has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events (s) than the drug. Specifically: special situations. Therefore, this event is considered not related.   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: Drug ineffective, Suspected COVID-19
Clinical narrative: I still got sick no matter cause I'm fully vaccinated; I still got sick no matter cause I'm fully vaccinated; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (175705). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (COMIRNATY), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I still got sick no matter cause I'm fully vaccinated".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Anti-thyroid antibody, Autoimmune thyroiditis, Blood thyroid stimulating hormone, Thyroid stimulating immunoglobulin, Thyroiditis
Clinical narrative: Thyroiditis after coronavirus disease 2019 (COVID-19) mRNA vaccine; Thyroiditis after coronavirus disease 2019 (COVID-19) mRNA vaccine; This is a literature report.  A 35-year-old male 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: AUTOIMMUNE THYROIDITIS (medically significant), THYROIDITIS (medically significant), all with latency 10 days after the suspect product(s) administration, outcome "recovering" and all described as "Thyroiditis after coronavirus disease 2019 (COVID-19) mRNA vaccine". The patient underwent the following laboratory tests and procedures: Anti-thyroid antibody: Negative; Negative, notes: Negative; Blood thyroid stimulating hormone: <0.01 MiU/mL, notes: <0.01; Low; Thyroid stimulating immunoglobulin: Negative, notes: Negative; Thyroxine free: 2.52 ng/dL; Tri-iodothyronine: 328 ng/dL, notes: elevated; Ultrasound thyroid: A heterogeneous and swollen thyroid, lacking, notes: nodules. Therapeutic measures were taken as a result of autoimmune thyroiditis, thyroiditis.; 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.,Linked Report(s) : US-PFIZER INC-202200889142 Same article/drug/event and Different patient.;
Sex: M
Vaccine: COVID19
Symptoms: Thyroxine free, Tri-iodothyronine, Ultrasound thyroid
Clinical narrative: Thyroiditis after coronavirus disease 2019 (COVID-19) mRNA vaccine; Thyroiditis after coronavirus disease 2019 (COVID-19) mRNA vaccine; This is a literature report.  A 35-year-old male 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: AUTOIMMUNE THYROIDITIS (medically significant), THYROIDITIS (medically significant), all with latency 10 days after the suspect product(s) administration, outcome "recovering" and all described as "Thyroiditis after coronavirus disease 2019 (COVID-19) mRNA vaccine". The patient underwent the following laboratory tests and procedures: Anti-thyroid antibody: Negative; Negative, notes: Negative; Blood thyroid stimulating hormone: <0.01 MiU/mL, notes: <0.01; Low; Thyroid stimulating immunoglobulin: Negative, notes: Negative; Thyroxine free: 2.52 ng/dL; Tri-iodothyronine: 328 ng/dL, notes: elevated; Ultrasound thyroid: A heterogeneous and swollen thyroid, lacking, notes: nodules. Therapeutic measures were taken as a result of autoimmune thyroiditis, thyroiditis.; 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.,Linked Report(s) : US-PFIZER INC-202200889142 Same article/drug/event and Different patient.;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I had a double dose 23Mar2021, 29Apr2021 then boosted Nov2021. Came down with COVID-19 on 20Jun2022; I had a double dose 23Mar2021, 29Apr2021 then boosted Nov2021. Came down with COVID-19 on 20Jun2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Batch/Lot number: unknown), on 29Apr2021 as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (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) all with onset 20Jun2022, outcome "unknown" and all described as "I had a double dose 23Mar2021, 29Apr2021 then boosted Nov2021. Came down with COVID-19 on 20Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jun2022) UNKNOWN RESULTS, notes: Came down with COVID-19 on 20Jun2022. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  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: Anti-thyroid antibody, Basedow's disease, Blood thyroid stimulating hormone, Thyroid function test, Thyroid stimulating immunoglobulin
Clinical narrative: Graves disease; This is a literature report. The full publication has been requested.   A 30-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: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: BASEDOW'S DISEASE (medically significant), 28 days after the suspect product(s) administration, outcome "recovered", described as "Graves disease". The patient underwent the following laboratory tests and procedures: Anti-thyroid antibody: 15 IU/ml; Blood thyroid stimulating hormone: Less than 0.005, notes: Low; normalized, notes: after 6 weeks; Thyroid function test: Low TSH (Less than 0.005 uIU/mL), elevated T3, notes: (161 pmol/L) and FT4 (22.9 pmol/L); Thyroid stimulating immunoglobulin: 0.95 IU/l; Thyroxine: 22.9 pmol/L, notes: elevated; normalized, notes: after 6 weeks; Tri-iodothyronine: 161 pmol/L, notes: Elevated; Weight: Loss. Therapeutic measures were taken as a result of basedow's disease. The patient was treated with Methimazole and atenolol.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event: "Basedow's disease" 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 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.
Sex: M
Vaccine: COVID19
Symptoms: Thyroxine, Tri-iodothyronine, Weight
Clinical narrative: Graves disease; This is a literature report. The full publication has been requested.   A 30-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: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: BASEDOW'S DISEASE (medically significant), 28 days after the suspect product(s) administration, outcome "recovered", described as "Graves disease". The patient underwent the following laboratory tests and procedures: Anti-thyroid antibody: 15 IU/ml; Blood thyroid stimulating hormone: Less than 0.005, notes: Low; normalized, notes: after 6 weeks; Thyroid function test: Low TSH (Less than 0.005 uIU/mL), elevated T3, notes: (161 pmol/L) and FT4 (22.9 pmol/L); Thyroid stimulating immunoglobulin: 0.95 IU/l; Thyroxine: 22.9 pmol/L, notes: elevated; normalized, notes: after 6 weeks; Tri-iodothyronine: 161 pmol/L, notes: Elevated; Weight: Loss. Therapeutic measures were taken as a result of basedow's disease. The patient was treated with Methimazole and atenolol.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event: "Basedow's disease" 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 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.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Loss of consciousness
Clinical narrative: anxiety; blacked out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19-year-old patient received BNT162b2 (BNT162B2), on 20Apr2021 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: LOSS OF CONSCIOUSNESS (medically significant) with onset 22Apr2021, outcome "unknown", described as "blacked out"; ANXIETY (hospitalization), outcome "unknown". The event "blacked out" required physician office visit.  Clinical course: The patient stated that I got my first covid vaccine by you guys. The second day after I got it, I was working and randomly blacked out, and nothing felt real. ever since my anxiety has been so bad, and these moments keep happening. Today I went to the hospital and was told that the Pfizer vaccine triggered my anxiety into something worse than it ever had been. I am LIVID and would like to speak to someone about this. thank you! hello! my name is (name- withheld), and I am 19 years old. back on 20Apr2021 I got my first covid vaccine by you guys. The second day after I got it, I was working and randomly blacked out, and nothing felt real. ever since my anxiety has been so bad, and these moments keep happening. Today I went to the hospital and was told that the Pfizer vaccine triggered my anxiety into something worse than it ever had been. I am LIVID and would like to speak to someone about this.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; 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-163-4443553-00.  A 42-year-old female patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown), on 15Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 28Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for psoriatic arthropathy, psoriasis. The patient had no relevant medical history and no known allergies. There were no concomitant medications. It was unknown if the patient was enrolled in a COVID-19 vaccine trial. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovering" and all described as "COVID-19". The action taken for adalimumab was dosage permanently withdrawn. In Jun2022, the patient experienced COVID-19. Pfizer BioNTech COVID-19 vaccine (tozinameran) was also considered suspect.  The reporter considered "covid-19" related to BNT162b2.  The reporter's causality for the event (s) of COVID-19 with HUMIRA (Adalimumab) was no reasonable possibility.  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 known drug safety profile, there is reasonable possibility of causal association between the events VACCINATION FAILURE and COVID-19 and BNT162B2.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; 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-163-4444009-00 (Abbvie).  A 71-year-old patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 18Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 70 years, all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Lot number: 1163244) at 15 mg 1x/day, oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID positive. The action taken for upadacitinib was unknown.  The reporter's assessment of the causal relationship of "covid-19" 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 information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events VACCINATION FAILURE and COVID-19 and BNT162B2.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Lack of efficacy - COVID-19 2nd booster; Lack of efficacy - COVID-19 2nd booster; 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 4 (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Lack of efficacy - COVID-19 2nd booster". Event took place after use of product. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Psoriatic arthropathy
Clinical narrative: severe psoriatic arthritis flares; 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 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "psoriatic arthritis" (ongoing). The patient's concomitant medications were not reported.  The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "unknown", described as "severe psoriatic arthritis flares". Therapeutic measures were taken as a result of psoriatic arthropathy.  Clinical course: Patient started having severe psoriatic arthritis flares almost immediately after got the Pfizer coronavirus vaccine Seems it was not possible to seek any remedy for that but I was having difficulty accessing biologics for the psoriatic arthritis I was on Enbrel but my Dr was out of samples and it was difficult to obtain Thought it was worth asking if Pfizer would offer me a supply of their biosimilars for psa.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aldolase, Antibody test, Antinuclear antibody, Biopsy
Clinical narrative: Anti-MDA5 dermatomyositis; This is a literature report.  A 28-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "Brooke-Spiegler syndrome" (unspecified if ongoing), notes: a rare, autosomal dominant condition associated with nodular, adnexal tumors. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, Single 21 days prior), for COVID-19 immunisation. The following information was reported: DERMATOMYOSITIS (medically significant), 14 days after the suspect product(s) administration, outcome "recovered", described as "Anti-MDA5 dermatomyositis". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase (normal high range 40): 55 IU/l; Aldolase: normal; Antibody test: resulted strongly positive for both MDA5 and TIF-, notes: gamma; Antinuclear antibody: negative; Biopsy: unknown results; Biopsy skin: showed findings consistent with dermatomyositis; Blood creatine phosphokinase: normal; Blood lactate dehydrogenase: normal; Chest X-ray: confirming no lung involvement; Computerised tomogram thorax: confirming no lung involvement; Dermoscopy: revealed dilated capillary, notes: loops and ragged cuticles with periungual erythema ; Full blood count: normal; Metabolic function test: elevated; Neurological examination: 4/5, notes: on deltoid as well as iliopsoas with moderate difficulty rising from a seated position with the rest of the muscle strength within normal limits; Physical exam: revealed erythema and, notes: scaling of entire scalp, forehead, cheeks, nose (diffuse Gottron's sign) with V-sign over the chest, and Gottron's papules seen overlying bilateral MCPs and IP joints of hands; Red blood cell sedimentation rate: normal; Weight: loss. Therapeutic measures were taken as a result of dermatomyositis.  The lot number for BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . 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.,Linked Report(s) : US-PFIZER INC-PV202200000729 same article/drug/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Blood creatine phosphokinase, Blood lactate dehydrogenase, Chest X-ray, Computerised tomogram thorax
Clinical narrative: Anti-MDA5 dermatomyositis; This is a literature report.  A 28-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "Brooke-Spiegler syndrome" (unspecified if ongoing), notes: a rare, autosomal dominant condition associated with nodular, adnexal tumors. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, Single 21 days prior), for COVID-19 immunisation. The following information was reported: DERMATOMYOSITIS (medically significant), 14 days after the suspect product(s) administration, outcome "recovered", described as "Anti-MDA5 dermatomyositis". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase (normal high range 40): 55 IU/l; Aldolase: normal; Antibody test: resulted strongly positive for both MDA5 and TIF-, notes: gamma; Antinuclear antibody: negative; Biopsy: unknown results; Biopsy skin: showed findings consistent with dermatomyositis; Blood creatine phosphokinase: normal; Blood lactate dehydrogenase: normal; Chest X-ray: confirming no lung involvement; Computerised tomogram thorax: confirming no lung involvement; Dermoscopy: revealed dilated capillary, notes: loops and ragged cuticles with periungual erythema ; Full blood count: normal; Metabolic function test: elevated; Neurological examination: 4/5, notes: on deltoid as well as iliopsoas with moderate difficulty rising from a seated position with the rest of the muscle strength within normal limits; Physical exam: revealed erythema and, notes: scaling of entire scalp, forehead, cheeks, nose (diffuse Gottron's sign) with V-sign over the chest, and Gottron's papules seen overlying bilateral MCPs and IP joints of hands; Red blood cell sedimentation rate: normal; Weight: loss. Therapeutic measures were taken as a result of dermatomyositis.  The lot number for BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . 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.,Linked Report(s) : US-PFIZER INC-PV202200000729 same article/drug/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Dermatomyositis, Dermoscopy, Full blood count, Metabolic function test, Neurological examination
Clinical narrative: Anti-MDA5 dermatomyositis; This is a literature report.  A 28-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "Brooke-Spiegler syndrome" (unspecified if ongoing), notes: a rare, autosomal dominant condition associated with nodular, adnexal tumors. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, Single 21 days prior), for COVID-19 immunisation. The following information was reported: DERMATOMYOSITIS (medically significant), 14 days after the suspect product(s) administration, outcome "recovered", described as "Anti-MDA5 dermatomyositis". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase (normal high range 40): 55 IU/l; Aldolase: normal; Antibody test: resulted strongly positive for both MDA5 and TIF-, notes: gamma; Antinuclear antibody: negative; Biopsy: unknown results; Biopsy skin: showed findings consistent with dermatomyositis; Blood creatine phosphokinase: normal; Blood lactate dehydrogenase: normal; Chest X-ray: confirming no lung involvement; Computerised tomogram thorax: confirming no lung involvement; Dermoscopy: revealed dilated capillary, notes: loops and ragged cuticles with periungual erythema ; Full blood count: normal; Metabolic function test: elevated; Neurological examination: 4/5, notes: on deltoid as well as iliopsoas with moderate difficulty rising from a seated position with the rest of the muscle strength within normal limits; Physical exam: revealed erythema and, notes: scaling of entire scalp, forehead, cheeks, nose (diffuse Gottron's sign) with V-sign over the chest, and Gottron's papules seen overlying bilateral MCPs and IP joints of hands; Red blood cell sedimentation rate: normal; Weight: loss. Therapeutic measures were taken as a result of dermatomyositis.  The lot number for BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . 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.,Linked Report(s) : US-PFIZER INC-PV202200000729 same article/drug/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Physical examination, Red blood cell sedimentation rate, Weight
Clinical narrative: Anti-MDA5 dermatomyositis; This is a literature report.  A 28-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "Brooke-Spiegler syndrome" (unspecified if ongoing), notes: a rare, autosomal dominant condition associated with nodular, adnexal tumors. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, Single 21 days prior), for COVID-19 immunisation. The following information was reported: DERMATOMYOSITIS (medically significant), 14 days after the suspect product(s) administration, outcome "recovered", described as "Anti-MDA5 dermatomyositis". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase (normal high range 40): 55 IU/l; Aldolase: normal; Antibody test: resulted strongly positive for both MDA5 and TIF-, notes: gamma; Antinuclear antibody: negative; Biopsy: unknown results; Biopsy skin: showed findings consistent with dermatomyositis; Blood creatine phosphokinase: normal; Blood lactate dehydrogenase: normal; Chest X-ray: confirming no lung involvement; Computerised tomogram thorax: confirming no lung involvement; Dermoscopy: revealed dilated capillary, notes: loops and ragged cuticles with periungual erythema ; Full blood count: normal; Metabolic function test: elevated; Neurological examination: 4/5, notes: on deltoid as well as iliopsoas with moderate difficulty rising from a seated position with the rest of the muscle strength within normal limits; Physical exam: revealed erythema and, notes: scaling of entire scalp, forehead, cheeks, nose (diffuse Gottron's sign) with V-sign over the chest, and Gottron's papules seen overlying bilateral MCPs and IP joints of hands; Red blood cell sedimentation rate: normal; Weight: loss. Therapeutic measures were taken as a result of dermatomyositis.  The lot number for BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . 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.,Linked Report(s) : US-PFIZER INC-PV202200000729 same article/drug/event, different patient;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: developed flu like symptoms and tested positive for COVID; the patient developed flu like symptoms and tested positive for COVID. He also reported nasal congestion, sore throat and tiredness.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP).  A 50-year-old male patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Batch/Lot number: unknown), on 15Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 08Dec2021 as dose 3 (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: VACCINATION FAILURE (medically significant) with onset 21Jun2022, outcome "unknown", described as "developed flu like symptoms and tested positive for COVID"; COVID-19 (medically significant) with onset 21Jun2022, outcome "recovering", described as "the patient developed flu like symptoms and tested positive for COVID. He also reported nasal congestion, sore throat and tiredness.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course -Description of Event: I am reporting on my brother. This 50-year-old male received the COVID vaccine on 22Feb2021, 15Mar2021 and 08Dec2021. On 21Jun2022 the patient developed flu like symptoms and tested positive for COVID. He also reported nasal congestion, sore throat, and tiredness. On 22Jun2022 he started Paxlovid and his symptoms are improving. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: significant joint aches; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 3 (booster), 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: 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious), outcome "not recovered", described as "significant joint aches".  Additional information: Reporter withheld shared that following his third dose of the vaccine he experienced significant joint aches starting within the first three days, lessening but still continuing 6 months later.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.