chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Illness, Pain, Pyrexia, Respiratory arrest
Clinical narrative: stopped breathing; "every bone in my body had been hit by a truck to the site of the road"; low grade fever; she received her booster dose last Friday and got extremely sick again from that; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose: 1, Caller stated she "became extremely sick" from her first 2 shots of the Comirnaty vaccine), for Covid-19 Immunization, reaction(s): "Extremeely sick"; Comirnaty (Dose: 2, Caller stated she "became extremely sick" from her first 2 shots of the Comirnaty vaccine), for Covid-19 Immunization, reaction(s): "Extremeely sick". The following information was reported: RESPIRATORY ARREST (medically significant), outcome "unknown", described as "stopped breathing"; PAIN (non-serious), outcome "unknown", described as ""every bone in my body had been hit by a truck to the site of the road""; PYREXIA (non-serious), outcome "unknown", described as "low grade fever"; ILLNESS (non-serious), outcome "unknown", described as "she received her booster dose last Friday and got extremely sick again from that". The patient underwent the following laboratory tests and procedures: body temperature: low, notes: She also had low grade fever. Therapeutic measures were taken as a result of respiratory arrest, pain. Clinical Course: The patient wanted to know "how long the booster dose is good for after its manufacturing date on the vial." The patient said the date on the Comirnaty vial was 21Sep2021 and she just wanted to make sure that what she received isn't expired. The patient also said she isn't sure what formulation she received but it should be the grey cap as it does not need to be mixed. The patient reported that she "became extremely sick" from her first 2 shots of the Comirnaty vaccine. The patient said she received her booster dose last Friday and got extremely sick again from that. The patient mentioned she had stopped breathing but good thing she had an EpiPen. She mentioned that she felt like "every bone in my body had been hit by a truck to the site of the road" and that she also had low grade fever. The patient also mentioned she wasn't aware that she can get the booster dose after 5 months from her last dose so she waited for 6 months. She said yesterday would have been 6 months from her last shot. The patient also said that she took Advil after getting the booster dose and said that the "pain was bad this time but not as bad as before because of the Advil."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Body temperature increased, Fatigue
Clinical narrative: After both injections, my blood pressure was elevated for approx 21 days at 180''s to 190''s over 140''s.; increased fatigue; muscle aches; I ran a consistent temp of 99.8 to 100.3; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Jan2021 17:15 (Lot number: EL3247) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Morphine, reaction(s): "Drug Allergy". The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 23Jan2021, outcome "recovered with sequelae", described as "After both injections, my blood pressure was elevated for approx 21 days at 180''s to 190''s over 140''s."; FATIGUE (non-serious) with onset 23Jan2021, outcome "recovered with sequelae", described as "increased fatigue"; MYALGIA (non-serious) with onset 23Jan2021, outcome "recovered with sequelae", described as "muscle aches"; BODY TEMPERATURE INCREASED (non-serious) with onset 23Jan2021, outcome "recovered with sequelae", described as "I ran a consistent temp of 99.8 to 100.3". The patient underwent the following laboratory tests and procedures: blood pressure measurement: elevated, notes: blood pressure was elevated for approx 21 days at 180's to 190's over 140's; body temperature: 99.8 to 100.3, notes: I ran a consistent temp of 99.8 to 100.3; sars-cov-2 test: negative. Therapeutic measures were not taken as a result of blood pressure increased.  Clinical information: The patient has received Dose 2. The patient has not receive any other vaccine in four weeks. No Other medications were received within in two weeks .No treatment was received No prior COVID vaccination. No Other medical history. COVID tested post vaccination was Yes.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event blood pressure increased 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, SARS-CoV-2 test
Clinical narrative: After both injections, my blood pressure was elevated for approx 21 days at 180''s to 190''s over 140''s.; increased fatigue; muscle aches; I ran a consistent temp of 99.8 to 100.3; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Jan2021 17:15 (Lot number: EL3247) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Morphine, reaction(s): "Drug Allergy". The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 23Jan2021, outcome "recovered with sequelae", described as "After both injections, my blood pressure was elevated for approx 21 days at 180''s to 190''s over 140''s."; FATIGUE (non-serious) with onset 23Jan2021, outcome "recovered with sequelae", described as "increased fatigue"; MYALGIA (non-serious) with onset 23Jan2021, outcome "recovered with sequelae", described as "muscle aches"; BODY TEMPERATURE INCREASED (non-serious) with onset 23Jan2021, outcome "recovered with sequelae", described as "I ran a consistent temp of 99.8 to 100.3". The patient underwent the following laboratory tests and procedures: blood pressure measurement: elevated, notes: blood pressure was elevated for approx 21 days at 180's to 190's over 140's; body temperature: 99.8 to 100.3, notes: I ran a consistent temp of 99.8 to 100.3; sars-cov-2 test: negative. Therapeutic measures were not taken as a result of blood pressure increased.  Clinical information: The patient has received Dose 2. The patient has not receive any other vaccine in four weeks. No Other medications were received within in two weeks .No treatment was received No prior COVID vaccination. No Other medical history. COVID tested post vaccination was Yes.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event blood pressure increased 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hip surgery, Hypoaesthesia
Clinical narrative: Hip surgery; Numbness in hand;   This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 73 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Aug2021 (Batch/Lot number: unknown) at the age of 72 years as dose1, single for covid-19 immunisation. Relevant medical history included: "MODERATE TO SEVERE RHEUMATOID ARTHRITIS" (ongoing). Concomitant medication(s) included: HUMIRA taken for rheumatoid arthritis. The following information was reported: HIP SURGERY (medically significant), outcome "recovered", described as "Hip surgery"; HYPOAESTHESIA (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "Numbness in hand".  Clinical course: The patient had a hip surgery which was successful. The vaccine caused her hand to lose feeling for about two to three months. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Company's opinion is that there is no reasonable possibility that the events of hip surgery and vaccine caused Hand to lose feeling are related to Humira (adalimumab).  The reporter considered "hip surgery" and "numbness in hand" 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 a positive temporal relationship, causal relationship between the reported events the suspect BNT162B2 cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Rheumatoid arthritis, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; rheumatoid arthritis symptoms flared up; FACILITATED COLLECTED  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (NOT AVAILABLE). The reporter is the patient. Other Case identifier(s): 22K-163-4289039-00.  A 49 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 05Oct2021 (Batch/Lot number: unknown) at the age of 49 years as dose 3 (booster), single, intramuscular, administration date 17Mar2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 24Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), first regimen oral (Batch/Lot number: unknown) and second regimen oral since Feb2022 (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), outcome "recovered", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19"; RHEUMATOID ARTHRITIS (medically significant), outcome "recovering", described as "rheumatoid arthritis symptoms flared up". The action taken for upadacitinib was unknown. Therapeutic measures were taken as a result of rheumatoid arthritis.  The reporter causality of BNT162B2 in respect to the event Covid-19 and Rheumatoid arthritis flare up (Rheumatoid arthritis) was not reported, Vaccination adverse reaction (Vaccination complication), and Sleepy (Somnolence) was probable. The reporter causality for Rinovaq COVID-19 (COVID-19) was No reasonable possibility, Vaccination adverse reaction (Vaccination complication) and Sleepy (Somnolence) was not reported and Rheumatoid arthritis flare up (Rheumatoid arthritis) was not applicable.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes 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.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Immunisation
Clinical narrative: has been experiencing extreme dry mouth; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 (Lot number: FH8028) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing); "Enlarged prostate" (ongoing); "Hashimoto's disease" (ongoing); "Blood pressure" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder (ongoing); TAMSULOSIN taken for prostatomegaly (ongoing); FINASTERIDE AN taken for prostatomegaly (ongoing); LOSARTAN taken for blood pressure abnormal (ongoing); AMLODIPINE BESILATE taken for blood pressure abnormal (ongoing). Vaccination history included: Bnt162b2 (Dose 2, LOT-ER8732), administration date: 31Mar2021, when the patient was 73 years old, for Covid-19 immunization; Bnt162b2 (Dose 1, LOT-EN6202), administration date: 05Mar2021, when the patient was 73 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021, outcome "unknown", described as "booster"; DRY MOUTH (non-serious) with onset Jan2022, outcome "not recovered", described as "has been experiencing extreme dry mouth". The events "booster" and "has been experiencing extreme dry mouth" were evaluated at the physician office visit.
Age: 24.0
Sex: U
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) for a Pfizer sponsored program (NOT AVAILABLE). The reporter is the patient. Regulatory number: 22K-163-4292770-00 (AbbVie).  A 24 year-old patient received bnt162b2 (BNT162B2), intramuscular, administration date 15Nov2021 (Batch/Lot number: unknown) at the age of 24 years as dose 3 (booster), single, intramuscular, administration date 10Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 25Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at cf for crohn's disease. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jan2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset Jan2022, outcome "recovered" (2022) and all described as "Covid-19". The action taken for adalimumab was unknown.  Causality for HUMIRA (ADALIMUMAB)  The reporter's causality for the event(s) of COVID with HUMIRA (ADALIMUMAB) was no reasonable possibility.  Causality for COVID-19 (COVID-19) Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Possible, De challenge: N/A  The reporter's assessment of the causal relationship of the (drug ineffective, Suspected covid-19) with the suspect product 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 lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 75.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Cardiac operation
Clinical narrative: Cardiac operation; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4290526-00.  A 75 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 23Aug2021 (Batch/Lot number: unknown) at the age of 75 years as dose 3 (booster), single, intramuscular, administration date 16Mar2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 23Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: CARDIAC OPERATION (medically significant), outcome "recovering", described as "Cardiac operation". The action taken for adalimumab was unknown.  Causality for Humira (Adalimumab)The reporter's causality for the event(s) of heart surgery with Humira(Adalimumab) was no reasonable possibility. (Company name) opinion is that there is no reasonable possibility that the event of heart surgery is related to Humira(Adalimumab).Drug:   PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) (TOZINAMERAN), Causality: Cardiac operation (Cardiac operation), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Possible, De challenge: N/A  The reporter's assessment of the causal relationship of the (CARDIAC OPERATION) with the suspect product 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 information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Peripheral venous disease, Swelling
Clinical narrative: swelling in both legs; pain; venous insufficiency; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING (disability), outcome "unknown", described as "swelling in both legs"; PAIN (disability), outcome "unknown", described as "pain"; PERIPHERAL VENOUS DISEASE (disability), outcome "unknown", described as "venous insufficiency". Clinical course: I want you to know that I had two vaccine shots plus a booster. All Pfizer. As a result I wound up with venous insufficiency, pain and swelling in both legs with permanent disability.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Psoriatic arthropathy
Clinical narrative: psoriatic arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4290156-00 (Agency).  A 37 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 28Sep2021 (Batch/Lot number: unknown) at the age of 37 years as dose 2, single and intramuscular, administration date 07Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) as unk (citrate free) for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "recovering", described as "psoriatic arthritis flare up". The action taken for adalimumab was dosage not changed.The reporter's causality for the event(s) of psoriatic arthritis flare up with HUMIRA (ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of psoriatic arthritis flare up with Covid-19 Vaccine (Tozinameran) was a possible. 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 and a plausible temporal relationship, a possible causal association between the event 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, UNK
Symptoms: Drug ineffective, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Humira not working; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk, (citrate free) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis flare up"; DRUG INEFFECTIVE (non-serious), outcome "unknown", described as "Humira not working". The action taken for adalimumab was dosage permanently withdrawn.  The reporter causality of BNT162B2 for the event Rheumatoid arthritis flare-up was reported as possible and lack of drug effect was not reported and the reported causality of the event Humira for the events Rheumatoid arthritis flare-up and lack of drug effect was not reported. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events RHEUMATOID ARTHRITIS and DRUG INEFFECTIVE and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Meningitis aseptic
Clinical narrative: Aseptic meningitis; This is a spontaneous report received from contactable reporter(s) (Other HCP and Physician) from medical information team. Other Case identifier(s): US-PFIZER INC-202200348390 (Pfizer).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 03Feb2022 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE1, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: MENINGITIS ASEPTIC (medically significant), outcome "unknown", described as "Aseptic meningitis". The doctor doesn't think it was correlated, but reporter just wanted to cover all basis.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Meningitis aseptic  cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: pericarditis; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "pericarditis".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Eye paraesthesia, Insomnia, Paraesthesia, Paraesthesia oral
Clinical narrative: Third dose: eyes feel like they're going to die from all the pins and needles; Third dose: feeling like millions of pins and needles coming out of her body- her eyes, nose, tongue, she can feel it in her chest and in her colon; Third dose: feeling like millions of pins and needles coming out of her body- her eyes, nose, tongue, she can feel it in her chest and in her colon; Third Dose: 3 nights where she didn't sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200348380 (pfizer).  A female patient received bnt162b2 (BNT162B2), administration date 23Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization, reaction(s): "no reaction"; Bnt162b2 (Dose: 2), for Covid-19 immunization, reaction(s): "Second Dose: on the very end of it she had a slight reaction of like pins and needles but then it went away and she got rid of that". The following information was reported: EYE PARAESTHESIA (medically significant) with onset 25Sep2021, outcome "unknown", described as "Third dose: eyes feel like they're going to die from all the pins and needles"; PARAESTHESIA ORAL (medically significant), PARAESTHESIA (medically significant) all with onset 25Sep2021, outcome "unknown" and all described as "Third dose: feeling like millions of pins and needles coming out of her body- her eyes, nose, tongue, she can feel it in her chest and in her colon"; INSOMNIA (non-serious) with onset 25Sep2021, outcome "unknown", described as "Third Dose: 3 nights where she didn't sleep". After 2 days the caller started to feel like there are a million pins and needles internal, in her stomach and her body and she was in terrible shape. Usually if the patient has a reaction to something she gets a steroid injection. The patient generally doesn't like to take the steroid injections. Therapeutic measures were taken with steroid injection as a result of eye paraesthesia, paraesthesia oral, paraesthesia, insomnia.  Clinical information: The patient got a steroid injection yesterday against her doctor's better judgement. The doctor didn't want to give it to her because it would work so hard against something. But the patient has got to have some relief because she had 3 nights where she didn't sleep. The patient lays down and it was like a million pins and needles coming out her head, it was so painful and powerful she would rub her head to make sure the pins weren't actually there and its horrible. This has happened really severe.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, COVID-19, Drug ineffective, Joint stiffness, Mobility decreased
Clinical narrative: Joint stiffness; Joint pain; Mobility decreased; COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (Not applicable). The reporter is the patient. Other Case identifier(s): 22K-163-4257540-00 (Agency).  A 57 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at daily (unknown, daily (cf)) for rheumatoid arthritis. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "recovering" and all described as "COVID-19"; MOBILITY DECREASED (non-serious) with onset 17Feb2022, outcome "recovering", described as "Mobility decreased"; JOINT STIFFNESS (non-serious), outcome "recovering", described as "Joint stiffness"; ARTHRALGIA (non-serious), outcome "recovering", described as "Joint pain". It was reported that events of non-serious difficulty to move in the morning when it was cloudy and cold outside, Joint stiffness, Joint pain and COVID-19 with Humira (Adalimumab). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken for adalimumab was unknown.  Causality for Humira (adalimumab): The reporter's causality for the event(s) of Difficulty to move in the morning when it was cloudy and cold outside, Joint stiffness, Joint pain and COVID-19 with Humira (Adalimumab) was no reasonable possibility.  Causality for Pfizer BioNTech COVID-19 Vaccine: The reporter's causality for the event(s) of Difficulty to move in the morning when it was cloudy and cold outside, Joint stiffness, Joint pain and COVID-19 with Pfizer BioNTech COVID-19 Vaccine was not reported.  The reporter's assessment of the causal relationship of the covid-19, vaccination failure, Joint stiffness, Joint pain and Mobility decreased 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 lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded.
Age: 59.0
Sex: M
Vaccine: COVID19, UNK
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) for a sponsored program. The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 21Jan2022 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ) (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), outcome "recovered", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19".  Causality for Rinvoq (Upadacitinib) The reporter's causality for the event(s) of contracted Covid with Rinvoq (Upadacitinib) was no reasonable possibility.   Causality PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN) for event COVID-19 (COVID-19) Causality as per reporter (Drug/Vaccine): Probable De challenge: N/A  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: cine BNT162B2 cannot be ruled out.  Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However,  case will be reevaluated should additional information become available.
Age: 33.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4287870-00 (Agency).  A 33 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Jul2021 (Batch/Lot number: unknown) at the age of 33 years as dose 2, single and intramuscular, administration date Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Lot number: 1154508) for rheumatoid arthritis. The patient had no relevant medical history. The patient's concomitant medications were not reported. he following information was reported: COVID-19 (medically significant) with onset Dec2021, outcome "recovered", DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive. The action taken for upadacitinib was unknown.  Causality for Rinvoq (Upadacitinib): The reporter's causality for the event(s) of covid and drug ineffective with Rinvoq (Upadacitinib) was no reasonable possibility.  Causality for Pfizer BIONTECH covid-19 vaccine (Tozinameran): The reporter's causality for the event(s) of covid and drug ineffective with Pfizer BIONTECH covid-19 vaccine (Tozinameran) was possible  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 11.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Crohn's disease
Clinical narrative: Crohn's aggravated; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 11 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 18Feb2022 (Batch/Lot number: unknown) at the age of 11 years as dose 2 (tris), single and intramuscular, administration date 21Jan2022 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) as unk (cf) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant), outcome "not recovered", described as "Crohn's aggravated".  The reporter considered "crohn's aggravated" not 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 event and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 12.0
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) for a sponsored program. The reporter is the patient.  A 12 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 09Sep2021 (Batch/Lot number: unknown) at the age of 12 years as dose 2, single and intramuscular, administration date 14Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset Jan2022, outcome "recovering", DRUG INEFFECTIVE (medically significant) with onset Jan2022, outcome "unknown" and all described as "COVID-19". The action taken for adalimumab was unknown.  The reporter's causality for the event(s) of COVID-19 and Drug ineffective with PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN) was Possible. The reporter's causality for the event(s) of COVID-19 and Drug ineffective with HUMIRA (ADALIMUMAB) was no reasonable possibility.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a causal  relationship between reported events drug ineffective, suspected Covid-19 and suspect BNt162B2 cannot be excluded.
Age: 15.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Bowel movement irregularity, COVID-19, Drug ineffective, Faeces hard, SARS-CoV-2 test
Clinical narrative: Covid-19 right after getting second vaccine but mild symptoms; Covid-19 right after getting second vaccine but mild symptoms; the patient experienced some problems with bowel movements, hard stools; the patient experienced some problems with bowel movements, hard stools; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 15 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 15 years as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", described as "Covid-19 right after getting second vaccine but mild symptoms"; COVID-19 (medically significant) with onset 2022, outcome "recovered", described as "Covid-19 right after getting second vaccine but mild symptoms "; FAECES HARD (non-serious) with onset 2022, outcome "recovering", BOWEL MOVEMENT IRREGULARITY (non-serious) with onset 2022, outcome "unknown" and all described as "the patient experienced some problems with bowel movements, hard stools". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The action taken for adalimumab was unknown.  Clinical course: The reporter's causality for the event(s) of some problems with bowel movements, hard stools with Humira (Adalimumab) was a reasonable possibility whereas no reasonable possibility for the event(s) of Covid-19 right after getting second vaccine but mild symptoms and patient had omicron variant. The reporter considered the event covid-19 right after getting second vaccine but mild symptoms as related to Pfizer Biontech covid-19 vaccine whereas not reported for the events some problems with bowel movements, hard stools.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.Based on the current available limited information in the case provided, the causal association between the events faeces hard and bowel movement irregularity and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Hidradenitis
Clinical narrative: COVID-19; COVID-19; hidradenitis Suppurativa breakout; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4281671-00 (RA).  A 60 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 19Mar2021 (Batch/Lot number: unknown) at the age of 59 years as dose 2, single and intramuscular, administration date 26Feb2021 (Batch/Lot number: unknown) as dose 1 , single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) for hidradenitis. 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"; HIDRADENITIS (non-serious), outcome "unknown", described as "hidradenitis Suppurativa breakout". The action taken for adalimumab was unknown. Clinical information: No known allergies.  The reporter's assessment of the causal relationship of the event 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 lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded.
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; MARKETING PROGRAM NAME IS NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4233376-00 (Agency).  A 48 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous since 24Feb2021 (ongoing) (Batch/Lot number: unknown) at unk, citrate free for ankylosing spondylitis. 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: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 01Jan2022, outcome "recovered" (2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) positive. The action taken for adalimumab was dosage not changed.  The reporter considered "covid-19" related to bnt162b2. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of COVID-19 with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of COVID-19 with bnt162b2 (BNT162B2) was possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure, Vaccination site pain
Clinical narrative: COVID-19; COVID-19; Vaccination site pain/sore arm with all three doses; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4042085-00 (AbbVie).  A 59 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 21Oct2021 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single, intramuscular, administration date 20Feb2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 20Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Lot number: 1151978) at citrate free and second regimen subcutaneous (Lot number: 1155481) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Vaccination site pain/sore arm with all three doses". The action taken for adalimumab was dosage permanently withdrawn. Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the events Vaccination site pain/ sore arm with all three doses and COVID-19 with Humira (Adalimumab) was no reasonable possibility.   Causality for Pfizer Biontech Covid-19 Vaccine: The reporter's causality for the events Vaccination site pain/ sore arm with all three doses was probable and for COVID-19 was not reported.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event. The case will be reassessed once new information is available.