chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing), notes: take cholesterol meds. The patient took concomitant medications.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 01Mar2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive; (Mar2022) Positive, notes: 01Mar2022 after 10 days, 5 or 6 days fine, Then reinfected/Positive antigen; (May2022) Positive; (20May2022) Negative, notes: antigen test. Therapeutic measures were taken as a result of covid-19, drug ineffective.  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, Joint swelling, Soft tissue inflammation, X-ray
Clinical narrative: right knee replacement began to ache and feel as if it was swollen; right knee replacement began to ache and feel as if it was swollen; soft tissue is inflamed; 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 2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "knee replacement surgery" (unspecified if ongoing), notes: had no issues with replacement for 5 years after surgery. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: unknown), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Lot Number: unknown), for Covid-19 immunization. The following information was reported: ARTHRALGIA (non-serious), JOINT SWELLING (non-serious) all with onset 2022, outcome "recovering" and all described as "right knee replacement began to ache and feel as if it was swollen"; SOFT TISSUE INFLAMMATION (non-serious) with onset 2022, outcome "recovering", described as "soft tissue is inflamed". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had gotten only Pfizer Covid shots and 1 booster. 2 weeks after getting the booster, the right knee replacement began to ache and felt as if it was swollen, still 3 months later minimal change in what the patient felt. X-rays showed nothing wrong with replaced knee, just that soft tissue was inflamed. Ice and stretching was recommended. The patient had no issues with replacement for 5 years after surgery.  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: Arthralgia, Headache, Vaccination site pain
Clinical narrative: excruciating headaches like migraine, with sensitivity to light; pain at injection site; body aches that started with the joints; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "excruciating headaches like migraine, with sensitivity to light"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at injection site"; ARTHRALGIA (non-serious), outcome "unknown", described as "body aches that started with the joints".  Additional information: The patient reported that she experienced excruciating headaches like migraine, with sensitivity to light, pain at injection site, body aches that started with the joints.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Psoriasis
Clinical narrative: Psoriasis flare up/break out on left butttocks; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20220607090(0.0) (Janssen Research & Development, LLC).  A male patient in his 50's received BNT162b2 (BNT162B2), as dose 2 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 10Apr2021 as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), on 20Oct2017 (ongoing) (Batch/Lot number: unknown) subcutaneous for psoriatic arthropathy, psoriasis. The patient's relevant medical history included: "Psoriatic Arthritis" (ongoing), notes: continue yes; "Moderate to severe  Chronic Plaque Psoriasis" (ongoing), notes: continue yes; "Interchange of vaccine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PSORIASIS (non-serious), outcome "not recovered", described as "Psoriasis flare up/break out on left butttocks"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "sore arm". The action taken for adalimumab was unknown.  Additional information: The patient received covid-19 vaccine (dose number 1) (suspension for Injection), intramuscular, on 10Apr2021 for prophylactic vaccination. Age at time vaccination 53 years old. The batch number was not reported. On an unspecified date, the patient experienced psoriasis flare up/ breakout on left but tocks and sore arm (dose number 1). The patient received non-company suspect drug Humira (adalimumab) solution for injection in pre filled pen on 27Oct2017 for Psoriatic  arthritis and moderate  to severe chronic plaque psoriasis. The patient had not recovered from psoriasis flare up/ break our on left but tocks, and the outcome of sore arm was not reported. Action taken with Tozinameran was not reported and dose of Adalimumab was not changed. The reporter and the manufacturer assessed the causality of events as possibly related to Janssen coviD-19 vaccine; however the causality between the events and other vaccines was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, 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). Other Case identifier(s): 22K-163-4443272-00.  An elderly female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous. 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 "COVID-19". The action taken for adalimumab was unknown. Clinical course: It was unknown if the patient was enrolled in a COVID-19 Vaccine trial. On unknown dates, the patient experienced covid-19. The reporter's causality for the event of covid-19 with HUMIRA (Adalimumab) was no reasonable possibility and the causality as per report for the event of covid-19 was not related. The causality as per report for the event of covid-19 with BNT162b2 was possible.  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: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Pruritus, Weight, Weight decreased
Clinical narrative: Itchy skin; covid virus; covid virus; Lost weight; 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-163-4403544-00.  An 86-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunization; 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: WEIGHT DECREASED (non-serious) with onset 2020, outcome "not recovered", described as "Lost weight"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2021, outcome "recovered" and all described as "covid virus"; PRURITUS (non-serious), outcome "recovered", described as "Itchy skin". The patient underwent the following laboratory tests and procedures: Weight: (unspecified date) gained 5 pounds back; (2020) Lost 20 pounds; (2021) Lost 8 pounds. It was unknown if the patient was enrolled in a Covid vaccine trial.  The reporter's assessment of the causal relationship of "covid virus" 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 "lost weight" related to BNT162b2. The reporter considered "itchy skin" not related to BNT162b2. Causality for coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE): The reporter's causality for the event of lost 20 pounds and lost 8 pounds was related (also reported as possible), for the event of itchy skin was Not related and for the event covid virus was not provided. Causality for adalimumab (HUMIRA): The reporter's causality for the event of lost 20 pounds and lost 8 pounds was no reasonable possibility (also reported as not related), for the event of itchy skin and for the event covid virus was not provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Lupus-like syndrome
Clinical narrative: Drug-induced lupus erythematosus; Blisters; 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-163-4443322-00.  A 57-year-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), all intramuscular for covid-19 immunization; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LUPUS-LIKE SYNDROME (medically significant), outcome "recovered", described as "Drug-induced lupus erythematosus"; BLISTER (non-serious), outcome "unknown", described as "Blisters". The action taken for adalimumab was unknown. Clinical course was reported as, The patient had Humira caused medically induced lupus episode and also caused huge blisters on her chest also. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter considered "drug-induced lupus erythematosus" and "blisters" related to BNT162b2. Causality for adalimumab (HUMIRA): The reporter's causality for the event(s) of Humira caused medically induced lupus episode and blisters on chest with Humira (Adalimumab) was a reasonable possibility (also reported as Probable).  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 , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug-induced lupus erythematosus" and "blisters". 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, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: diagnosed with COVID-19; sars cov2 infection; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient. Other Case identifier(s): MOD22-016024 (Moderna).  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "diagnosed with COVID-19"; COVID-19 (medically significant), outcome "unknown", described as "sars cov2 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Unknown Results, notes: he was diagnosed with Covid-19.  Clinical course was reported as, Update 23Jun2022, HCP reported that he was diagnosed with Covid-19 after receiving the Primary series of the Moderna Covid-19 vaccine and a Pfizer booster. Does not know he was diagnosed. He declined to provide further information at this time. As he is on vacation at his sons college orientation. HCP requested information needed to report via email. Pharmacist will email required safety information to (email withheld)   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 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.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Your Covid vaccine doesn't work I've had Covid twice since getting it both doses I've gotten and still got it; Your Covid vaccine doesn't work I've had Covid twice since getting it both doses I've gotten and still got it; 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), 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 "not recovered" and all described as "Your Covid vaccine doesn't work I've had Covid twice since getting it both doses I've gotten and still got it". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: I've had Covid twice since getting it both doses.  Clinical information: Patient reported that your Covid vaccine doesn't work I've had Covid twice since getting it both doses I've gotten and still got it Your Covid vaccine doesn't work I've had Covid twice since getting it both doses I've gotten and still got it.  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: COVID-19, Drug ineffective
Clinical narrative: this past week I came down with it and if it wasn't for this company and this vaccine that I got from this company, I may have ended up in the hospital or dead; this past week I came down with it and if it wasn't for this company and this vaccine that I got from this company, I may have ended up in the hospital or dead; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (003110). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose numbr 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 "this past week I came down with it and if it wasn't for this company and this vaccine that I got from this company, I may have ended up in the hospital or dead".  Clinical course: Description of Event Outcome, I know you probably get a lot of negative feedback but I want to personally thank the people who created the Covid 19 vaccine, this past week I came down with it and if it wasn't for this company and this vaccine that I got from this company, I may have ended up in the hospital or dead, I want to thank everyone involved in the hours and research it took to make this possible, I am great full. I know you probably get a lot of negative feedback but I want to personally thank the people who created the Covid 19 vaccine, this past week I came down with it and if it wasn't for this company and this vaccine that I got from this company, I may have ended up in the hospital or dead, I want to thank everyone involved in the hours and research it took to make this possible, I am great full. The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.  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: COVID-19, Drug ineffective, SARS-CoV-2 test, Tinnitus
Clinical narrative: I tested positive for covid this week; I tested positive for covid this week; bilateral tinnitus/ amplified; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Apr2021 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: TINNITUS (non-serious) with onset Apr2021, outcome "not recovered", described as "bilateral tinnitus/ amplified"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "I tested positive for covid this week". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: I tested positive for covid this week. I have confirmed the positive result with 3 tests.  Clinical course: From 13 hours after patient received 1st Pfizer covid vaccine, patient had bilateral tinnitus 24/7 nonstop for the past 14 months. patient tested positive for covid this week. patient ONLY symptom was that patient tinnitus has been amplified so markedly louder than ever, and on a whim, patient tested for covid because patient had no other explanation. patient had confirmed the positive result with 3 tests.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted when received.
Sex: U
Vaccine: COVID19
Symptoms: Throat cancer
Clinical narrative: throat cancer; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. 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 and concomitant medications were not reported. The following information was reported: THROAT CANCER (medically significant), outcome "unknown". Event took place after use of product. Patient, who is also a cardiologist, said the covid-19 vaccine gave him throat cancer.  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 available information and known product profile, the causal relationship of the reported events and the use of  Comirnaty is cannot be fully excluded. There is limited information available to make a meaningful assessment. The case will be assessed further once new information become 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis flare up in finger; deep cough; 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-163-4443530-00 (AbbVie).  A 65-year-old male 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), 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: RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "rheumatoid arthritis flare up in finger"; COUGH (non-serious), outcome "recovered", described as "deep cough". The action taken for upadacitinib was unknown.  Clinical Information: Solicited report from the USA by a consumer of an adult male with events of non-serious Rheumatoid arthritis flare up in finger and Deep cough with Rinvoq (Upadacitinib) . There was no reported medical history. On unknown dates, the patient experienced Rheumatoid arthritis flare up in finger and Deep cough. on unknown dates, Rheumatoid arthritis flare up in finger and deep cough resolved. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. It was unknown If patient was enrolled in a COVID-19 Vaccine Trial.   Causality for Rinvoq (Upadacitinib) The reporter's causality for the event (s) of Rheumatoid arthritis flare up in finger and Deep cough with Rinvoq (Upadacitinib) was no reasonable possibility.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neuropathy peripheral, SARS-CoV-2 test, Swelling, Trigger finger
Clinical narrative: feet neuropathy; more hand stiffness; trigger finger on the right hand; swelling in the armpit with the last two doses of booster vaccine; 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-163-4431030-00 (agency).  A 50-year-old female patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), from 03Dec2021 (Batch/Lot number: unknown) to 2022 at 40 mg (40 mg,1 in 2 week), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, unknown manufacturer), for COVID-19 Immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset Jun2022, outcome "unknown", described as "feet neuropathy"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Jun2022, outcome "unknown", described as "more hand stiffness"; SWELLING (non-serious) with onset Jun2022, outcome "unknown", described as "swelling in the armpit with the last two doses of booster vaccine"; TRIGGER FINGER (non-serious) with onset Jun2022, outcome "unknown", described as "trigger finger on the right hand". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jun2022) Positive. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "feet neuropathy", "more hand stiffness" and "trigger finger on the right hand" 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 "swelling in the armpit with the last two doses of booster vaccine" not related to BNT162b2. 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 available information in the case, the causal association between the events neuropathy peripheral, musculoskeletal stiffness, swelling, trigger finger and the suspect drug 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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Nerve conduction studies, Neuropathy peripheral
Clinical narrative: nerve conduction abnormal; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 71-year-old female patient received BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Onset date: Long term. Concomitant medication(s) included: SINGULAIR oral taken for asthma (ongoing); DULERA nasal taken for asthma (ongoing). Vaccination history included: BNT162b2 (Dose: 1st, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EM9809), administration date: 07Feb2021, when the patient was 70-year-old, for COVID-19 immunisation; BNT162b2 (Dose:2, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EN6203), administration date: 27Feb2021, when the patient was 70-year-old, for COVID-19 immunisation, reaction(s): "right after second vaccine severe left upper arm pain and also decreased range of motion", "right after second vaccine severe left upper arm pain and also decreased range of motion", "left arm and weakness/ severe weakness of left arm and hand/ weakness on left leg", "frozen shoulder", "trouble walking", "hand atrophy", "suggest ALS". The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 18Nov2021, outcome "unknown", described as "nerve conduction abnormal". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (24Oct2021) normal, notes: brachial plexus; (11Sep2021) Mild C5-C6, moderate degenerative changes,moderat, notes: Mild C5-C6, moderate degenerative changes, moderate canal stenosis, C5-C6, right greaterv than left, mild stenosis/C4, C45 neuroforaminol; (24Oct2021) L3-4, L4-5 dics, L4 and L5 bilaterally; Nerve conduction studies: (18Nov2021) abnormal, notes: Moderate right, mild left median nerve neuropathy, C7 root disease.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event peripheral neuropathy and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Sex: U
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: painful arthritis in my right hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (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 (Primary immunization series completed but unknown manufacturer), for COVID-19 immunization. The following information was reported: ARTHRITIS (non-serious), outcome "not recovered", described as "painful arthritis in my right hand".  Additional information: It was reported that side effects of final Pfizer booster gave the patient painful arthritis in their right hand that remained daily.  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: Basedow's disease
Clinical narrative: Graves Disease; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  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 (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: BASEDOW'S DISEASE (medically significant), outcome "unknown", described as "Graves Disease".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: His heart disease was a side effect of the covid vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US146170_OS.  A 68-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "His heart disease was a side effect of the covid vaccine.".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: sore arm; slight flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 16Mar2021 at 09:30 as dose 1, single (Lot number: EN6208) at the age of 69 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Hysterectomy", start date: 1978 (unspecified if ongoing); "Depression" (unspecified if ongoing); "B/P" (unspecified if ongoing); "Hormones" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL TARTRATE oral taken for blood pressure measurement, start date: 2012 (ongoing); CITALOPRAM oral taken for depression, start date: 2019 (ongoing); ESTRADIOL oral taken for hormone therapy, start date: 1999 (ongoing); WELLBUTRIN oral taken for depression, start date: 2012 (ongoing); ATORVASTATIN oral taken for blood cholesterol, start date: 2020 (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "slight flu like symptoms".
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Upper respiratory tract infection
Clinical narrative: I test positive for COVID on 02May2022 with severe URI symptoms; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 50-year-old male patient received BNT162b2 (BNT162B2), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "Is the patient a smoker/former smoker? No" (unspecified if ongoing), notes: Is the patient a smoker/former smoker? No. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 01), administration date: Dec2020, when the patient was 49 years old, for COVID-19 immunization, reaction(s): "Covid-19"; Bnt162b2 (DOSE: 02), administration date: Jan2021, when the patient was 49 years old, for Covid-19 Immunization, reaction(s): "Covid-19". The following information was reported: UPPER RESPIRATORY TRACT INFECTION (non-serious), outcome "unknown", described as "I test positive for COVID on 02May2022 with severe URI symptoms".  Additional information: The patient did not have a positive test for SARS-CoV2. The patient have SARS-CoV2 antibodies at diagnosis. The patient was not hospitalized. Patient was not admitted to an Intensive Care Unit. The patient did not display clinical signs at rest indicative of severe systemic illness. The patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. The patient was not smoker/former smoker. The patient was not taking any medications routinely prior to the event being reported. The patient did not have pre-existing diseases worsened during the SARS-CoV2 infection (please specify). The patient had not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The patient think this was report worthy, as The patient Had clear documentation of negative tests, and subsequent days of positive testing with new symptoms occurring.  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: Asthenia, Pyrexia
Clinical narrative: fever; weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: pfizer 4176) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Epstein barr virus", start date: 03May2019, stop date: 10May2019, notes: Pertinent details: hospitalized 5 days (Name) hospital; "sciatica", start date: Feb2010, stop date: 03Aug2010, notes: Pertinent details: spinal injection; "vagina haemorrhage", start date: 1982, stop date: 1994, notes: Pertinent details: hysterectomy Dr (name withheld) 1996; "Miscarriage", start date: 1979, stop date: 1979; "hysterectomy", start date: 1996 (unspecified if ongoing), notes: Pertinent details: hysterectomy Dr (name withheld)  1996. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 22Jan2021, outcome "unknown", described as "fever"; ASTHENIA (non-serious) with onset 22Jan2021, outcome "unknown", described as "weakness". Therapeutic measures were taken as a result of pyrexia, asthenia.  Additional information: Prior vaccinations: None. Therapeutic measures were taken as a result of pyrexia, asthenia includes Tylenol
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: contracted COVID-19/Bad sore throat/Stuffy nose/loss of taste/Loss of smell; contracted COVID-19/Bad sore throat/Stuffy nose/loss of taste/Loss of smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (003110). The reporter is the patient.  A patient (no qualifiers provided) 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), SUSPECTED COVID-19 (medically significant) all with onset 28Jun2022, outcome "unknown" and all described as "contracted COVID-19/Bad sore throat/Stuffy nose/loss of taste/Loss of smell". The patient reported he/she contracted COVID-19 however because he/she received the Pfizer vaccines and booster, he/she did not die. He/she had bad sore throat for a few days, stuffy nose, loss of taste and smell. 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: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis 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-163-4447026-00.  A 59-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine trial. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovered with sequelae", described as "Rheumatoid arthritis flare up". The action taken for adalimumab was unknown.  The reporter considered "rheumatoid arthritis flare up" related to BNT162b2. The reporter's causality for the event(s) of Rheumatoid arthritis flare up with Humira (Adalimumab) was a reasonable possibility.  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 in the case report, a possible causal relationship between 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
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort, Swelling face, Urticaria
Clinical narrative: hives were everywhere including her eyes and mouth; pressure on her right eye; jawline was swollen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4302776 (Genentech, Inc.).  A 64-year-old female patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Idiopathic urticaria" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "high cholesterol" (unspecified if ongoing); "underactive thyroid" (unspecified if ongoing), notes: underactive thyroid; "diabetes type 1" (unspecified if ongoing), notes: diabetes type 1; "hives" (unspecified if ongoing); "diabetic nerve pain" (unspecified if ongoing), notes: diabetic nerve pain; "anxiety" (unspecified if ongoing); "COVID" (unspecified if ongoing); "influenza A" (unspecified if ongoing); "pneumonia" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; CARVEDILOL; PRAVASTATIN; AMLODIPINE; HYDROCHLOROTHIAZIDE; LEVOTHYROXINE; PEPCID [FAMOTIDINE]; ALLEGRA; CYMBALTA; TRESIBA; NOVOLOG; FINASTERIDE; METOCLOPRAMIDE; MINOXIDIL; PREDNISONE; ASPIRIN [ACETYLSALICYLIC ACID]; CLOBETASOL; TRIAMCINOLONE; BENADRYL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: URTICARIA (non-serious) with onset Apr2021, outcome "recovered", described as "hives were everywhere including her eyes and mouth"; SWELLING FACE (non-serious) with onset Apr2021, outcome "recovered", described as "jawline was swollen"; OCULAR DISCOMFORT (non-serious) with onset Apr2021, outcome "recovered", described as "pressure on her right eye".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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-163-4447196-00.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 25Jul2021 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; adalimumab (HUMIRA), (Lot number: 1162124), subcutaneous for rheumatoid arthritis, uveitis. 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 "recovered" and all described as "Covid-19". The action taken for adalimumab was dosage permanently withdrawn.  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.  Additional information: Causality for HUMIRA(ADALIMUMAB)-The reporter's causality for the event(s) of COVID-19 with HUMIRA(ADALIMUMAB) was no reasonable possibility. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective  (LOE) cannot be ruled out
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Incorrect product storage (unknown if vaccine was administered); This case has been considered invalid-Unspecified AE.  COVID-19 Vaccine temperature related enquiry by a costumer  Product and costumer information:  Product description: Pfizer BioNTech COVID-19 gray cap Batch/LOT number: FP7135 Expiry date: Nov2021 Date of shipment arrived at costumer and reference number for shipment (If applicable): 09May2022 Number of product unit impacted: 30 vials Costumer type: Pharmacy Temperature excursion information:  Is the product diluted or undiluted: Undiluted Where the product stored when excursion occurred?: Freezer  Maximum and minimum temperature reported/Measured during excursion: -5 to -6degree F Duration of excursion: 49 Provide the completed temperature data during storage at costumer location: Attached If Pfizer has not delivered product o the costumer location where excursion has occurred, provide the temperature data for the transport to this location to confirm this stock has not experienced any other /previous excursion: Pfizer delivered to this location  Follow-Up (30Jun2022): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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-163-4445222-00.  A 55-year-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), all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI), (ongoing) (Lot number: 1160234), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "COVID-19". The action taken for risankizumab was unknown. Clinical course: During early week of 15Jun2022, the patient got COVID-19. She had cough due to COVID-19 symptoms. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter considered "covid-19" related to BNT162b2.   The reporter's causality for Skyrizi (Risankizumab) for event COVID-19 was not provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective  (LOE) cannot be ruled out