chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia, Tinnitus
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE FLUCTUATION (non-serious) with onset 2021, outcome "not recovered", described as "BP swings"; FATIGUE (non-serious) with onset 2021, outcome "not recovered"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "not recovered", described as "brain fog"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered", described as "light-headedness/dizziness"; PARAESTHESIA (non-serious) with onset 2021, outcome "not recovered"; TINNITUS (non-serious) with onset 2021, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Clinical course: Since receiving the vaccine a year ago, patient has been suffering "long COVID" like symptoms: BP swings, light-headedness/dizziness, tinnitus, Paranesthesia, fatigue and brain fog. Patient reported that a brief internet search seemed to indicate that they were not the only one. Patient was querying if remedies for such side effects were pursued of if some was already available. Patient reported that this condition was quite debilitating.   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: Erectile dysfunction, Psoriasis, Therapeutic product effect decreased
Clinical narrative: impotent; Drug effect decreased; Psoriasis flare-up; 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-163-4469214-00.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Batch/Lot number: unknown), on 15May2021 as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown) at 2x/week (unk, 2x/week (citrate free)), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERECTILE DYSFUNCTION (medically significant), outcome "not recovered", described as "impotent"; THERAPEUTIC PRODUCT EFFECT DECREASED (non-serious), outcome "unknown", described as "Drug effect decreased"; PSORIASIS (non-serious), outcome "not recovered", described as "Psoriasis flare-up". The action taken for adalimumab was dosage not changed.  Clinical Course: It was reported that, on unknown dates, the patient experienced Covid vaccine made patient impotent, plaque psoriasis flares came back and Humira worked in the beginning but not working now. 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 considered "impotent" related to BNT162b2. The reporter's assessment of the causal relationship of "drug effect decreased" and "psoriasis flare-up" 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 the event "impotent' and "Psoriasis flare-up" was probable related to the suspect Humira. The reporter's assessment of the causal relationship of "drug effect decreased" with the suspect Humira was not provided.  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 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick/ill; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient. A female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Immune compromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1), for covid-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick/ill". Additional Information: other medications Including over-the-counter medications, nutritional and herbal supplements, etc. family history, social history and other relevant information (Use this space to include any additional information that may be relevant, including any additional Events or Suspect Products.) was reported as unknown. 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: Chills, Drug ineffective, Musculoskeletal stiffness, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: caught COVID; caught COVID; His main COVID symptoms were stiff neck and chills; His main COVID symptoms were stiff neck and chills; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 77-year-old male patient received BNT162b2 (BNT162B2), 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 "caught COVID"; MUSCULOSKELETAL STIFFNESS (non-serious), CHILLS (non-serious), outcome "recovered" and all described as "His main COVID symptoms were stiff neck and chills". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Approximately 3 weeks after receiving his 2nd COVID booster shot, this man went on a cruise and caught COVID despite wearing a mask.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: Mild fatigue; felt different; This is a spontaneous report received from a contactable reporter(s) (Other HCP), Program ID:  A female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Batch/Lot number: Unknown), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "Mild fatigue"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "felt different". Additional information: Patient had a mild reaction (mild fatigue, felt "different") to the second dose of Comirnaty vaccine. It resolved quickly. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Antibody test, Drug ineffective, Psoriasis, Pulmonary mass
Clinical narrative: Covid-19; Covid-19; Upper abdominal pain; issues with lungs/growth appearing on lungs; psoriasis symptoms came back; This is a solicited report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. Other Case identifier: 22K-163-4468308-00 (AbbVie).  A 43-year-old female patient received BNT162b2 (BNT162B2), on 15Jun2021 as dose 1, single (Batch/Lot number: unknown) and on 07Jul2021 as dose 2, single (Batch/Lot number: unknown) at the age of 42 years, all intramuscular for COVID-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown), oral for rheumatoid arthritis. 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 "not recovered" and all described as "COVID-19"; ABDOMINAL PAIN UPPER (non-serious), outcome "not recovered", described as "Upper abdominal pain"; PULMONARY MASS (non-serious), outcome "unknown", described as "issues with lungs/growth appearing on lungs"; PSORIASIS (non-serious), outcome "unknown", described as "psoriasis symptoms came back". Clinical course: report by a consumer of an adult female with events of non-serious (as reported) COVID-19 and pain in right upper abdomen side with upadacitinib. There was no reported medical history. On unknown dates, the patient experienced issues with lungs/growth appearing on lungs, no antibodies reported for COVID after receiving the two doses and psoriasis symptoms came back. It was reported that the Pfizer BioNTech COVID-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The patient underwent the following laboratory tests and procedures: Antibody test: no antibodies reported for COVID after receiving the two doses; SARS-CoV-2 test: Unknown results. The action taken for upadacitinib was unknown.  Causality for upadacitinib: The reporter's causality for the events of COVID-19 and pain in right upper abdomen side with upadacitinib was a reasonable possibility (also reported as probable).  The reporter considered "COVID-19" and "upper abdominal pain" related (reported as probable) to BNT162b2. The reporter's assessment of the causal relationship of "issues with lungs/growth appearing on lungs" and "psoriasis symptoms came back" with the suspect product 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 the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Covid-19; Covid-19; Upper abdominal pain; issues with lungs/growth appearing on lungs; psoriasis symptoms came back; This is a solicited report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. Other Case identifier: 22K-163-4468308-00 (AbbVie).  A 43-year-old female patient received BNT162b2 (BNT162B2), on 15Jun2021 as dose 1, single (Batch/Lot number: unknown) and on 07Jul2021 as dose 2, single (Batch/Lot number: unknown) at the age of 42 years, all intramuscular for COVID-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown), oral for rheumatoid arthritis. 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 "not recovered" and all described as "COVID-19"; ABDOMINAL PAIN UPPER (non-serious), outcome "not recovered", described as "Upper abdominal pain"; PULMONARY MASS (non-serious), outcome "unknown", described as "issues with lungs/growth appearing on lungs"; PSORIASIS (non-serious), outcome "unknown", described as "psoriasis symptoms came back". Clinical course: report by a consumer of an adult female with events of non-serious (as reported) COVID-19 and pain in right upper abdomen side with upadacitinib. There was no reported medical history. On unknown dates, the patient experienced issues with lungs/growth appearing on lungs, no antibodies reported for COVID after receiving the two doses and psoriasis symptoms came back. It was reported that the Pfizer BioNTech COVID-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The patient underwent the following laboratory tests and procedures: Antibody test: no antibodies reported for COVID after receiving the two doses; SARS-CoV-2 test: Unknown results. The action taken for upadacitinib was unknown.  Causality for upadacitinib: The reporter's causality for the events of COVID-19 and pain in right upper abdomen side with upadacitinib was a reasonable possibility (also reported as probable).  The reporter considered "COVID-19" and "upper abdominal pain" related (reported as probable) to BNT162b2. The reporter's assessment of the causal relationship of "issues with lungs/growth appearing on lungs" and "psoriasis symptoms came back" with the suspect product 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 the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Brief resolved unexplained event, Myalgia, Pain, Paralysis, Walking disability
Clinical narrative: almost killed me, right hand is paralyzed; almost killed me, right hand is paralyzed; cant walk; in pain; muscles hurt; 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 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood transfusions" (unspecified if ongoing), notes: Had two blood transfusions. The patient's concomitant medications were not reported. The following information was reported: PARALYSIS (hospitalization, medically significant, life threatening), BRIEF RESOLVED UNEXPLAINED EVENT (hospitalization, medically significant, life threatening), outcome "unknown" and all described as "almost killed me, right hand is paralyzed"; WALKING DISABILITY (hospitalization), outcome "unknown", described as "cant walk"; PAIN (hospitalization), outcome "unknown", described as "in pain"; MYALGIA (hospitalization), outcome "unknown", described as "muscles hurt". Clinical information: Patient reported that Pfizer I took your vaccine and it almost killed me, my right hand is paralyzed. I can't walk, I am in pain 24/7 all of my muscles hurt. This started with the first injection. Soon I couldn't walk. The pain is unbearable. I am in prison in (state name) at (facility name). They don't know what to do for me. They hope it will go away, it has gotten a lot worse both hands my back. I had two blood transfusion. I am out of ICU and back at the prison under close watch, I am fighting this with all my prayers. I hope that you will help me to live with this monster or get rid of it.  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: Blood disorder
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the parent. A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD DISORDER (non-serious), outcome "unknown", described as "He said that his son got a blood disorder from Pfizer Covid 19 vaccine". Additional information: The reporter called on behalf of his son. He told that he wants to file a lawsuit against Pfizer. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Upper limb fracture, Vaccination site pain
Clinical narrative: Broken right elbow; left side arm pain; 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-163-4469622-00.  A 61-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: UPPER LIMB FRACTURE (medically significant), outcome "recovering", described as "Broken right elbow"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "left side arm pain". The action taken for adalimumab was unknown. Clinical course: On unknown dates, the patient experienced left side arm pain due to COVID-19 vaccine and broken right elbow. The reporter's causality for the events of left side arm pain and broken right elbow was not provided with Humira (Adalimumab). The reporter's causality for the events of left side arm pain was possible while for broken right elbow was not reported with BNT162b2.  The reporter's assessment of the causal relationship of "broken right elbow" 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 "left side arm pain" related to BNT162b2.  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 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: M
Vaccine: COVID19
Symptoms: Biopsy kidney, Biopsy skin, Blood creatinine, Complement factor, Cutaneous vasculitis
Clinical narrative: IgA-dominant leukocytoclastic vasculitis; IgA nephropathy; Within 2 days, the rash reappeared; proteinuria; This is a literature report.  A 50-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "rash".  The following information was reported: CUTANEOUS VASCULITIS (medically significant), outcome "recovered", described as "IgA-dominant leukocytoclastic vasculitis"; IGA NEPHROPATHY (medically significant), outcome "recovered"; RASH (non-serious), 2 days after the suspect product(s) administration, outcome "recovered", described as "Within 2 days, the rash reappeared"; PROTEINURIA (non-serious), outcome "recovered". The patient underwent the following laboratory tests and procedures: Biopsy kidney: IgA nephropathy; Biopsy skin: revealed IgA-dominant leukocytoclastic vasculitis; Blood creatinine: 0.9 mg/dl; Complement factor: normal; Immunology test: IgA nephropathy; On examination: healing papules were noted, notes: on his legs but otherwise exam  was normal; Microscopy: revealed acanthocytes; Serology test: Negative; Urine analysis: proteinuria; Urine protein/creatinine ratio: 1.1, notes: g/g; 0.7, notes: g/g. Therapeutic measures were taken as a result of cutaneous vasculitis, iga nephropathy, rash, proteinuria.; Sender's Comments: Based on the available information, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: IgA nephropathy, Immunology test, Investigation, Microscopy, Proteinuria
Clinical narrative: IgA-dominant leukocytoclastic vasculitis; IgA nephropathy; Within 2 days, the rash reappeared; proteinuria; This is a literature report.  A 50-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "rash".  The following information was reported: CUTANEOUS VASCULITIS (medically significant), outcome "recovered", described as "IgA-dominant leukocytoclastic vasculitis"; IGA NEPHROPATHY (medically significant), outcome "recovered"; RASH (non-serious), 2 days after the suspect product(s) administration, outcome "recovered", described as "Within 2 days, the rash reappeared"; PROTEINURIA (non-serious), outcome "recovered". The patient underwent the following laboratory tests and procedures: Biopsy kidney: IgA nephropathy; Biopsy skin: revealed IgA-dominant leukocytoclastic vasculitis; Blood creatinine: 0.9 mg/dl; Complement factor: normal; Immunology test: IgA nephropathy; On examination: healing papules were noted, notes: on his legs but otherwise exam  was normal; Microscopy: revealed acanthocytes; Serology test: Negative; Urine analysis: proteinuria; Urine protein/creatinine ratio: 1.1, notes: g/g; 0.7, notes: g/g. Therapeutic measures were taken as a result of cutaneous vasculitis, iga nephropathy, rash, proteinuria.; Sender's Comments: Based on the available information, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Serology test, Urine analysis, Urine protein/creatinine ratio
Clinical narrative: IgA-dominant leukocytoclastic vasculitis; IgA nephropathy; Within 2 days, the rash reappeared; proteinuria; This is a literature report.  A 50-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "rash".  The following information was reported: CUTANEOUS VASCULITIS (medically significant), outcome "recovered", described as "IgA-dominant leukocytoclastic vasculitis"; IGA NEPHROPATHY (medically significant), outcome "recovered"; RASH (non-serious), 2 days after the suspect product(s) administration, outcome "recovered", described as "Within 2 days, the rash reappeared"; PROTEINURIA (non-serious), outcome "recovered". The patient underwent the following laboratory tests and procedures: Biopsy kidney: IgA nephropathy; Biopsy skin: revealed IgA-dominant leukocytoclastic vasculitis; Blood creatinine: 0.9 mg/dl; Complement factor: normal; Immunology test: IgA nephropathy; On examination: healing papules were noted, notes: on his legs but otherwise exam  was normal; Microscopy: revealed acanthocytes; Serology test: Negative; Urine analysis: proteinuria; Urine protein/creatinine ratio: 1.1, notes: g/g; 0.7, notes: g/g. Therapeutic measures were taken as a result of cutaneous vasculitis, iga nephropathy, rash, proteinuria.; Sender's Comments: Based on the available information, the causal association between the reported events 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.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Dehydration, Fall
Clinical narrative: Fell due to slippery floor; Stomach swollen; Dehydrated; 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-163-4467672-00.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 26Aug2021 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years and on 16Sep2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1159933) at 40 mg (40 mg (citrate free (1 in 2 wk))), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FALL (hospitalization) with onset 31May2022, outcome "unknown", described as "Fell due to slippery floor"; DEHYDRATION (non-serious) with onset 2022, outcome "unknown", described as "Dehydrated"; ABDOMINAL DISTENSION (non-serious), outcome "recovering", described as "Stomach swollen". The action taken for adalimumab was unknown.  The reporter considered "fell due to slippery floor" and "stomach swollen" related to BNT162b2. The reporter's assessment of the causal relationship of "dehydrated" 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. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the 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: M
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, Vaccination site pain
Clinical narrative: rheumatoid arthritis flare ups right wrists mainly focus/on right leg; vaccine caused sore arm for an hour; 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-163-4364525-00.  A 75-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for rheumatoid arthritis; adalimumab (HUMIRA), first regimen (Lot number: 1160839) and second regimen (Lot number: 1160838), all subcutaneous for rheumatoid arthritis. The patient's relevant medical history was not reported. Concomitant medication(s) included: METHOTREXATE. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "rheumatoid arthritis flare ups right wrists mainly focus/on right leg"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "vaccine caused sore arm for an hour". The action taken for adalimumab and adalimumab was unknown. Clinical course: Causality for Humira (Adalimumab): The reporter's causality for the event(s) of rheumatoid arthritis flare ups right wrists mainly focus/on right leg and vaccine caused sore arm for an hour was not provided. The reporter's causality for the events 'Rheumatoid arthritis flare up' was not Reported & causality for the events 'Vaccination site pain' was Possible.   The reporter's assessment of the causal relationship of "rheumatoid arthritis flare ups right wrists mainly focus/on right leg" 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 "vaccine caused sore arm for an hour" related to BNT162b2.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the limited information available, a possible contributory role of the Comirnaty vaccine cannot be completely 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 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: F
Vaccine: COVID19
Symptoms: Diabetes mellitus, Hypersensitivity, Rheumatoid arthritis
Clinical narrative: Diabetes; Arthritis/set off her arthritis really bad; Allergy; 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-163-4467544-00.  A 76-year-old female patient received BNT162b2 (BNT162B2), as dose number unkown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown), oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "Diabetes"; RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Arthritis/set off her arthritis really bad"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergy". The action taken for upadacitinib was unknown. Clinical course: Solicited report by a consumer of an elderly female with events of non-serious allergies, diabetes and Covid vaccine effected Arthritis or storm effects Arthritis with RINVOQ (UPADACITINIB). On unknown dates, the patient experienced Allergies, Diabetes and Covid vaccine effected Arthritis or storm effects Arthritis. Pfizer BioNtech Covid-19 Vaccine (Tozinameran) was also considered suspect. The patient had allergies really bad. She had diabetes. She had the covid vaccine and it set off her arthritis really bad. When it storms it really bothers her arthritis. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's assessment of the causal relationship of "diabetes" and "allergy" 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 "arthritis/set off her arthritis really bad" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive with Covid-19/experienced a cough and a raspy voice as her symptoms; tested positive with Covid-19/experienced a cough and a raspy voice as her symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CKD" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "dyslipidemia" (unspecified if ongoing); "5-favor blood disorder" (unspecified if ongoing); "has a pacemaker" (unspecified if ongoing). Concomitant medication(s) included: COUMADIN; AMIODARONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Jul2022, outcome "unknown" and all described as "tested positive with Covid-19/experienced a cough and a raspy voice as her symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2022) Positive, notes: tested positive with Covid-19 on 14Jul2022. Therapeutic measures were taken as a result of drug ineffective, covid-19 treated with monoclonal antibody infusion on 14Jul, and is doing all right.  Clinical course: She was on Coumadin and Amiodarone and numerous other medications for her co-morbid conditions. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200986996 same reporter/product/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Rheumatoid arthritis, Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: Rheumatoid arthritis flare up; Injection site bleeding; Pain during injection; Arthralgia aggravated; Pain aggravated; 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-163-4463646-00.  A 71-year-old female patient received BNT162b2 (BNT162B2), in Jan2022 as dose number unknown (booster), single (Batch/Lot number: unknown), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis flare up"; VACCINATION SITE HAEMORRHAGE (non-serious), outcome "unknown", described as "Injection site bleeding"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Pain during injection"; ARTHRALGIA (non-serious), outcome "recovering", described as "Arthralgia aggravated"; PAIN (non-serious), outcome "recovering", described as "Pain aggravated". The action taken for adalimumab was unknown.  The reporter considered "rheumatoid arthritis flare up", "injection site bleeding", "pain during injection", "arthralgia aggravated" and "pain aggravated" related to BNT162b2.  Additional information: The reporter's causality for the event(s) of sometimes there was a drop of blood at the injection site/had more than a drop of blood/had bleeding more than before and rheumatoid arthritis flare up with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of sharp pain/pain during injection, having more pain to knee and hand than normally right after an injection/increased symptoms compared to normal post injection days unknown onset and having more pain to knee and hand than normally right after an injection/increased symptoms compared to normal post injection days unknown onset was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely 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.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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-163-4467502-00 (AbbVie).  A 60-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2020 as dose 1, single (Batch/Lot number: unknown) and on 01May2020 as dose 2, single (Batch/Lot number: unknown) at the age of 58 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for product used for unknown indication. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The action taken for adalimumab was unknown.  Clinical course: The reporter's causality for the event(s) of COVID with Humira (Adalimumab) was no reasonable possibility. Causality as per reporter (Drug/Vaccine): Not related for COVID-19. The reporter's causality for the event(s) of COVID with Pfizer BioNTech Covid-19 Vaccine (Tozinameran) (Tozinameran) as per reporter: Probable. 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 reporter considered "covid-19" 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 provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Colitis ulcerative, Feeding disorder
Clinical narrative: ulcerative colitis flare up; Upset stomach; could not eat; 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-163-4467226-00.  A 48-year-old female patient received BNT162b2 (BNT162B2), on 30Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 16Feb2022 (ongoing) (Lot number: 1161756) at citrate free, subcutaneous for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (1)First Dose (1 in 1 Once), Route of Admin: Intramuscular, Therapy Dates/Duration: 1) 09Aug2021 - 09Aug2021), administration date: 09Aug2021, when the patient was 48-year-old, for COVID-19 Immunization. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 2022, outcome "not recovered", described as "Upset stomach"; FEEDING DISORDER (non-serious) with onset 2022, outcome "not recovered", described as "could not eat"; COLITIS ULCERATIVE (medically significant) with onset 2022, outcome "not recovered", described as "ulcerative colitis flare up". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "ulcerative colitis flare up", "upset stomach" and "could not eat" 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.  Clinical course: It was unknown if patient was enrolled in a covid-19 vaccine trial.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely 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, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; MARKETING PROGRAM NAME NOT APPLICABLE  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-163-4469159-00.  A 50-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 number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. The action taken for adalimumab was dosage permanently withdrawn.  The reporter considered "covid-19" 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 available information , there is reasonable possibility of causal association between the events Drug Ineffective and COVID 19 and the suspect drug BNT162b2.
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Knee arthroplasty, Shoulder operation
Clinical narrative: Shoulder operation; Left knee replacement; Limping; Left arm was numb; 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-163-4467523-00.  A 50-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) as unk (cf) (Batch/Lot number: unknown) subcutaneous for ankylosing spondylitis. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose number 1, Route of Administration: Intra-muscular), administration date: 06Oct2021, when the patient was 49-year-old, for COVID-19 immunization; BNT162b2 (Dose number 2, Route of Administration: Intra-muscular), administration date: 03Nov2021, when the patient was 50-year-old, for covid-19 immunization, reaction(s): "Left arm was numb". The following information was reported: SHOULDER OPERATION (medically significant), outcome "unknown"; KNEE ARTHROPLASTY (medically significant), outcome "unknown", described as "Left knee replacement"; GAIT DISTURBANCE (medically significant), outcome "unknown", described as "Limping"; HYPOAESTHESIA (medically significant), outcome "recovered", described as "Left arm was numb".  The reporter's assessment of the causal relationship of "shoulder operation", "left knee replacement", "limping" and "left arm was numb" 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.  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 reported events gait disturbance and hypoesthesia with the suspect drug BNT162B2 cannot be excluded. Events shoulder operation and knee arthroplasty considered unrelated to the suspect drug BNT162B2. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Seizure, Suspected COVID-19
Clinical narrative: a seizure and had to be hospitalized within 24 hours of receiving the vaccine; had COVID; had COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 4220-2126614789.  A 38-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 included: "Multiple sclerosis" (ongoing). Concomitant medication(s) included: OCREVUS; KEPPRA [LEVETIRACETAM]. The following information was reported: SEIZURE (hospitalization, medically significant), outcome "unknown", described as "a seizure and had to be hospitalized within 24 hours of receiving the vaccine"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "had COVID".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.