chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, UNK
Symptoms: Night sweats, Pyrexia, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; bad headache; had loss of smell and taste; had loss of smell and taste; fever 101-102; night sweats; 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-163-4251995-00.  A 49 year-old female patient received bnt162b2 (BNT162B2), 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 immunization; upadacitinib (RINVOQ), oral (Lot number: 1150526) for rheumatoid arthritis. The patient's relevant medical history and 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 "recovering" and all described as "COVID-19"; HEADACHE (non-serious) with onset Jan2022, outcome "recovering", described as "bad headache"; ANOSMIA (non-serious), AGEUSIA (non-serious) all with onset Jan2022, outcome "recovering" and all described as "had loss of smell and taste"; PYREXIA (non-serious) with onset Jan2022, outcome "recovering", described as "fever 101-102"; NIGHT SWEATS (non-serious) with onset Jan2022, outcome "recovering", described as "night sweats". The patient underwent the following laboratory tests and procedures: body temperature: (Jan2022) 101-102, notes: fever. The action taken for upadacitinib was unknown. It was reported that, solicited report from the privacy by a consumer of a 49-year-old female with an event of non-serious COVID-19 with Rinvoq (upadacitinib). Pfizer biontech covid-19 vaccine (tozinameran) was also considered as suspect. On an unspecified date in Jan2022, two weeks ago the patient had loss of smell and taste, fever 101-102, night sweats and bad headache. It was unknown whether the patient was enrolled in a COVID-19 Vaccine trial.  Causality for Rinvoq (upadacitinib) The reporter's assessment of the causal relationship for the event(s) of COVID-19 with Rinvoq (upadacitinib) was no reasonable possibility. The reporter's assessment of the causal relationship for the event(s) of COVID-19 with Pfizer biontech covid-19 vaccine (tozinameran) was not reported.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, lack of efficacy ,anosmia, ageusia, headache, pyrexia, and night sweats of the suspected vaccine BNT162B2 cannot be completely excluded.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Palpitations, SARS-CoV-2 test, Urticaria
Clinical narrative: Chest pain; Palpitations; Intense hives; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Oct2021 13:45 (Lot number: FE3590) at the age of 34 years as dose 3 (booster), single, administered in arm left, administration date 08Apr2021 (Lot number: EW0158) as dose 2, single and administered in arm left, administration date 18Mar2021 (Lot number: EQ7534) as dose 1, single for covid-19 immunisation. Relevant medical history included: "I've had cocci meningitis" (unspecified if ongoing), notes: Other medical history: I've had cocci meningitis. The patient's concomitant medications were not reported. The following information was reported: CHEST PAIN (medically significant) with onset 2021, outcome "not recovered", described as "Chest pain"; PALPITATIONS (medically significant) with onset 2021, outcome "not recovered", described as "Palpitations"; URTICARIA (medically significant) with onset 2021, outcome "not recovered", described as "Intense hives". The events "chest pain", "palpitations" and "intense hives" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Feb2022) negative, notes: covid test type post vaccination: Nasal Swab. Therapeutic measures were taken as a result of chest pain, palpitations, urticaria.  Additional information: The patient was a reporter and Received 3 Doses with covid-19 vaccine of Pfizer. The patient had Previous doses . The patient did not  other vaccine in four weeks. The patient had adverse event  First  chest pain and palpitations. Went to ER and cardiologist for over a month. Intense hives also started and hasn't stopped since the booster shot. Then patient was consulted Doctor or other healthcare professional office/clinic visit, Emergency room/ department or urgent care. The patient was AE treatment with Trying to get a referral for allergist. The patient was prior covid tested post vaccination and known allergies  Was not before but now she got hives often.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Gingivitis, Myalgia, Rheumatoid arthritis
Clinical narrative: muscle soreness following the covid-19 vaccine; gum infection with HUMIRA; Rheumatoid 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-163-4256243-00 (AbbVie).  A 63 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 08Dec2021 (Batch/Lot number: unknown) at the age of 62 years as dose number unknown (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for rheumatoid arthritis. Relevant medical history included: "Rheumatoid arthritis flare", start date: Nov2021 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine janssen (Daily Dose: , 1st dose (1 in 1 Once), Route of Admin: Intra-muscular, Indication for use: Covid-19 Vaccination, Therapy Dates/Duration: 20May2021 - 20May2021), administration date: 20May2021, when the patient was 62 years old, for Covid-19 immunization; Covid-19 vaccine janssen (2nd dose (1 in 1 Once), Route of Admin: Intra-muscular, Therapy Dates/Duration: 2021 - 2021), administration date: 2021, for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset Nov2021, outcome "not recovered", described as "Rheumatoid arthritis flare up"; MYALGIA (non-serious) with onset Dec2021, outcome "unknown", described as "muscle soreness following the covid-19 vaccine"; GINGIVITIS (non-serious) with onset Nov2021, outcome "unknown", described as "gum infection with HUMIRA". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for humira (ADALIMUMAB): The reporter's causality for the event(s) of rheumatoid arthritis flare, muscle soreness following the covid-19 vaccine and gum infection was not provided.  Causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran): The reporter's causality for the event(s) of muscle soreness was possible; rheumatoid arthritis flare and gum infection was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and RHEUMATOID ARTHRITIS , MYALGIA, GINGIVITIS ,cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Cough, Nausea
Clinical narrative: elevated blood pressure; fever (102.4); cough; nausea; rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (non-serious), outcome "recovered", described as "elevated blood pressure"; PYREXIA (non-serious), outcome "recovered", described as "fever (102.4)"; COUGH (non-serious), outcome "recovered", described as "cough"; NAUSEA (non-serious), outcome "recovered", described as "nausea"; RASH (non-serious), outcome "recovered", described as "rash". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The symptoms lasted approximately 7 days first time and lasted approximately 4 days most recently. The patient underwent lab tests and procedures on an unspecified date which included: blood pressure measurement: elevated; body temperature: 102.4.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: elevated blood pressure; fever (102.4); cough; nausea; rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (non-serious), outcome "recovered", described as "elevated blood pressure"; PYREXIA (non-serious), outcome "recovered", described as "fever (102.4)"; COUGH (non-serious), outcome "recovered", described as "cough"; NAUSEA (non-serious), outcome "recovered", described as "nausea"; RASH (non-serious), outcome "recovered", described as "rash". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The symptoms lasted approximately 7 days first time and lasted approximately 4 days most recently. The patient underwent lab tests and procedures on an unspecified date which included: blood pressure measurement: elevated; body temperature: 102.4.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia eye, Maternal exposure during pregnancy
Clinical narrative: went numb/the upper half of my face from my eyes up into my scalp; went numb/the upper half of my face from my eyes up into my scalp; Vaccine exposure during pregnancy; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient (pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14May2021 10:30 (Lot number: EW0172) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraines", start date: 1995 (ongoing), notes: Preventative meds imitrez 100 mg, Maxalt 10 mg. The patient was 15 weeks pregnant at the time of exposure to bnt162b2. The patient was 15 weeks pregnant at the event onset. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01, Time: 10:30 AM, Site and route of injection: , Anatomical site if injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EW0153), administration date: 23Apr2021, when the patient was 34 years old, for COVID-19 Immunization, reaction(s): "Lower part of my face and lips went numb", "Lower part of my face and lips went numb", "Vaccine exposure during pregnancy". The following information was reported: HYPOAESTHESIA (medically significant) with onset 15May2021 10:30, outcome "recovered" (22May2021), HYPOAESTHESIA EYE (medically significant) with onset 15May2021, outcome "recovered" (22May2021) and all described as "went numb/the upper half of my face from my eyes up into my scalp"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 14May2021 10:30, outcome "unknown", described as "Vaccine exposure during pregnancy". Therapeutic measures were not taken as a result of hypoaesthesia, hypoaesthesia eye.  Clinical course: The reporter considered the Pfizer product (BNT162B2) had a casual effect to the adverse event.  The reporter stated that, a little over 24 hours after my first vaccine my lower part of my face and lips went numb + stayed that way for several hours. After my 2nd vaccine the next day the same thing. Only it was the upper half o my face from my eyes up in to my scalp. It came and went for about a week.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Hypo aesthesia, Hypo aesthesia eye and the suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid and is fully vaccinated; Tested positive for Covid and is fully vaccinated; feeling really terrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A 9 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Dec2021 14:00 (Lot number: FL0007) at the age of 8 years as dose 2 (tris), single and administered in arm left, administration date 01Dec2021 14:00 (Lot number: FL0007) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Feb2022, outcome "unknown" and all described as "Tested positive for Covid and is fully vaccinated"; FEELING ABNORMAL (non-serious) with onset Feb2022, outcome "unknown", described as "feeling really terrible". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Feb2022) positive, notes: A rapid test at home test was done, called doctor, took three tests; (07Feb2022) positive; (07Feb2022) positive.  No follow-up attempts are possible. No further information is expected.  Follow-up attempts completed. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Interchange of vaccine products, Off label use
Clinical narrative: Moderna Covid-19 Vaccine as dose1, dose2 and dose 3 of BNT16B2 vaccine; covid; high level of fatigue; Moderna Covid-19 Vaccine as dose1, dose2 and dose 3 of BNT16B2 vaccine; covid; 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-163-4256621-00.  A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Jan2022 (Batch/Lot number: unknown) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation; risankizumab rzaa (SKYRIZI [RISANKIZUMAB RZAA]), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, SINGLE, Route of Administration: Intra Muscular, MANUFACTURER: MODERNA), for Covid-19 immunization; Moderna covid-19 vaccine (DOSE 2, SINGLE, Route of Administration: Intra Muscular, MANUFACTURER: MODERNA), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset Jan2022, outcome "unknown", INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown" and all described as "Moderna Covid-19 Vaccine as dose1, dose2 and dose 3 of BNT16B2 vaccine"; DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset Jan2022, outcome "unknown" and all described as "covid"; FATIGUE (non-serious), outcome "unknown", described as "high level of fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive.  It was unknown if patient was enrolled in a covid-19 vaccine trial.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, lack of efficacy, Fatigue , Off label use and interchange of vaccine products of the suspected vaccine BNT162B2 cannot be completely excluded.The case will be reevaluated should additional 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Moderna Covid-19 Vaccine as dose1, dose2 and dose 3 of BNT16B2 vaccine; covid; high level of fatigue; Moderna Covid-19 Vaccine as dose1, dose2 and dose 3 of BNT16B2 vaccine; covid; 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-163-4256621-00.  A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Jan2022 (Batch/Lot number: unknown) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation; risankizumab rzaa (SKYRIZI [RISANKIZUMAB RZAA]), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, SINGLE, Route of Administration: Intra Muscular, MANUFACTURER: MODERNA), for Covid-19 immunization; Moderna covid-19 vaccine (DOSE 2, SINGLE, Route of Administration: Intra Muscular, MANUFACTURER: MODERNA), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset Jan2022, outcome "unknown", INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown" and all described as "Moderna Covid-19 Vaccine as dose1, dose2 and dose 3 of BNT16B2 vaccine"; DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset Jan2022, outcome "unknown" and all described as "covid"; FATIGUE (non-serious), outcome "unknown", described as "high level of fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive.  It was unknown if patient was enrolled in a covid-19 vaccine trial.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, lack of efficacy, Fatigue , Off label use and interchange of vaccine products of the suspected vaccine BNT162B2 cannot be completely excluded.The case will be reevaluated should additional 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID finally got to my vessels I'm trying to deal with that; COVID finally got to my vessels I'm trying to deal with that; This is a spontaneous report received from a contactable reporter(s) (Other 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 number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: REVATIO. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID finally got to my vessels I'm trying to deal with that". Clinical course: Caller called in seeking assistance with the medication Revatio. During the call caller stated. Patient was just trying to get well he have had 2 major heart surgeries since patient talked last time. The COVID finally got to patient vessels patient was trying to deal with that. Caller later stated on the call." When we took the Pfizer shot that's what we went with, you guys have helped us.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events drug ineffective and COVID-19 cannot be totally excluded.
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; FACILITATED COLLECT  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-163-4252543-00 (Agency).  A 28 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 18Aug2021 (Batch/Lot number: unknown) at the age of 27  as dose 3 (booster), single, intramuscular, administration date 29Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 08Apr2021 (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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "not recovered" and all described as "COVID-19". The action taken for adalimumab was unknown.  Causality: Causality of : PFIZER BIONTECH COVID-19 VACCINE and events were reported as Possible and causality of HUMIRA and events were not reported.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE  and covid-19 and BNT162B2.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 tested positive; COVID-19 tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20220146089 (Janssen).  A male patient received bnt162b2 (BNT162B2), administration date 03Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE), administered in arm left, administration date 14Mar2021 (Lot number: 1805029, Expiration Date: 23Aug2021) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Jan2022, outcome "unknown" and all described as "COVID-19 tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Jan2022) positive, notes: tested positive with Bi Nax Now antigen test (NR: not provided) positive.  Clinical information: The patient received Covid-19 vaccine ad2 6.cov2.s, dose number in series was 1 administered. On 14Mar2021 to left arm for prophylactic vaccination. No adverse events were reported following with Covid-19 vaccine ad26.cov2.s. The patient additionally received non-company suspect vaccine included: BNT162 (Pfizer), patient received unspecified concomitant medications. On 23Jan2022, following vaccination with BNT 162, the patient tested positive with Bi Nax Now antigen test positive. The outcome of covid-19 teste positive was not reported (dose number in series was 2). Causality as per reporter (Drug/Vaccine): Possible Causality as per Mfg. (Drug/Vaccine): Possible for JANSSEN COVID-19 VACCINE.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Pneumonia, Pulmonary thrombosis, Suspected COVID-19
Clinical narrative: He came down with covid-19 and was hospitalized; He came down with covid-19 and was hospitalized; pneumonia in both lungs; he had 3 blood clots in his lungs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, DOSE NUMBER UNKNOWN, primary series completed.), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), SUSPECTED COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "He came down with covid-19 and was hospitalized"; PNEUMONIA (medically significant), outcome "unknown", described as "pneumonia in both lungs"; PULMONARY THROMBOSIS (medically significant), outcome "unknown", described as "he had 3 blood clots in his lungs". Clinical course: Caller knows of 2 cases: one was a cardiologist who had his primary series and was boostered. He came down with covid-19 and was hospitalized, pneumonia in both lungs and also he had 3 blood clots in his lungs." Caller also says she knows people who had the booster who got very sick and some people didn't get sick at all.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain, Psoriatic arthropathy, Pyrexia, Therapeutic product effect incomplete
Clinical narrative: psoriatic arthritis flare; Uveitis was a lot better but not fully healed on humira; Fever; achy body; FACILITATED COLLECT  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-163-4253187-00 (Agency).  A 71 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Aug2021 (Batch/Lot number: unknown) at the age of 70 years as dose 3 (booster), single, intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 04Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriatic arthropathy. The patient's relevant medical history was not reported. Concomitant medication(s) included: METHOTREXATE. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "recovered", described as "psoriatic arthritis flare"; THERAPEUTIC PRODUCT EFFECT INCOMPLETE (non-serious), outcome "recovering", described as "Uveitis was a lot better but not fully healed on humira"; PYREXIA (non-serious), outcome "recovered", described as "Fever"; PAIN (non-serious), outcome "recovered", described as "achy body". The action taken for adalimumab was unknown. Clinical course was reported as, the patient had events of non-serious uveitis was a lot better but not fully healed on HUMIRA, psoriatic arthritis flare, fever and achy body with HUMIRA (ADALIMUMAB). 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 HUMIRA(ADALIMUMAB); The reporter's causality for the event(s) of uveitis was a lot better but not fully healed on HUMIRA, psoriatic arthritis flare, fever and achy body was not provided. Causality as per reporter (Drug/Vaccine) for all the events were 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 provided the causal association of the events with the suspect product BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Passed away; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) The patient is the reporter's mother.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DEATH (death, hospitalization) with onset 2021, outcome "fatal", described as "Passed away". The patient date of death was unknown. The reported cause of death was "Passed away". No autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Passed away
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Aphonia, Pneumonia, SARS-CoV-2 test, Sinusitis
Clinical narrative: Loss of voice; Pneumonia; Sinus infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20220138480 (Janssen).  A 30 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (Batch/Lot number: unknown) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE), intramuscular, administration date 24May2021 (Batch/Lot number: unknown) as dose 1, single and intramuscular (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous (Batch/Lot number: unknown). Relevant medical history was not reported. Concomitant medication(s) included: DOXYCYCLINE. The following information was reported: PNEUMONIA (medically significant) with onset Dec2021, outcome "recovering", described as "Pneumonia"; APHONIA (medically significant), outcome "not recovered", described as "Loss of voice"; SINUSITIS (medically significant) with onset 2021, outcome "unknown", described as "Sinus infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. The action taken for risankizumab was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Fatigue, Feeling abnormal, Immunisation
Clinical narrative: Booster; interchange of vaccine admnstered; Off label use; Feeling bad; Fever; Tiredness; COVID positive; COVID positive; MARKETING PROGRAM 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-163-4226788-00 (Agency).  A 31 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Oct2021 (Batch/Lot number: unknown) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE), first regimen intramuscular from 2021 (Batch/Lot number: unknown) to 2021 at single (dose 2, single) and second regimen intramuscular from 01Apr2021 (Batch/Lot number: unknown) to 01Apr2021 at single (dose 1, single); adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) till 20Dec2021 for colitis ulcerative. Relevant medical history included: "first and second dose COVID-19 Vaccine manufactured by Johnson and Johnson" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "recovered" (Jan2022) and all described as "COVID positive"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "interchange of vaccine admnstered"; OFF LABEL USE (non-serious), outcome "unknown", described as "Off label use"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "Feeling bad"; PYREXIA (non-serious), outcome "recovered", described as "Fever"; FATIGUE (non-serious), outcome "recovered", described as "Tiredness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive. The action taken for adalimumab was unknown.  Clinical comment: The reporter's causality for the event(s) of covid-19 positive with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of feeling bad, fever and feeling tired was not provided.     The lot number for bnt162b2 was not provided and will be requested during follow up.; 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 ineffective,covid19,interchange of vaccine admnstered,booster,off label use, feeling bad, fever and feeling tired.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Interchange of vaccine products, Off label use, Pyrexia, SARS-CoV-2 test
Clinical narrative: Booster; interchange of vaccine admnstered; Off label use; Feeling bad; Fever; Tiredness; COVID positive; COVID positive; MARKETING PROGRAM 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-163-4226788-00 (Agency).  A 31 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Oct2021 (Batch/Lot number: unknown) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE), first regimen intramuscular from 2021 (Batch/Lot number: unknown) to 2021 at single (dose 2, single) and second regimen intramuscular from 01Apr2021 (Batch/Lot number: unknown) to 01Apr2021 at single (dose 1, single); adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) till 20Dec2021 for colitis ulcerative. Relevant medical history included: "first and second dose COVID-19 Vaccine manufactured by Johnson and Johnson" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "recovered" (Jan2022) and all described as "COVID positive"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "interchange of vaccine admnstered"; OFF LABEL USE (non-serious), outcome "unknown", described as "Off label use"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "Feeling bad"; PYREXIA (non-serious), outcome "recovered", described as "Fever"; FATIGUE (non-serious), outcome "recovered", described as "Tiredness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive. The action taken for adalimumab was unknown.  Clinical comment: The reporter's causality for the event(s) of covid-19 positive with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of feeling bad, fever and feeling tired was not provided.     The lot number for bnt162b2 was not provided and will be requested during follow up.; 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 ineffective,covid19,interchange of vaccine admnstered,booster,off label use, feeling bad, fever and feeling tired.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Investigation
Clinical narrative: Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the parent.  A 11 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 (tris), single and (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: investigation: positive, notes: got COVID.  Additional information: My family (children and husband) got COVID. They had previously received the Pfizer vaccine. Their COVID is mild.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; 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: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Investigation
Clinical narrative: Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the parent.  A 45 year-old male patient received bnt162b2 (BNT162B2, solution for injection) (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: investigation: positive, notes: Got Covid.  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 and a possible contributory role of suspect product BNT162B2 to the development of events drug ineffective, covid19 cannot be totally excluded.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Pain in extremity, Suspected COVID-19, Vaccination complication
Clinical narrative: patient husband had covid and thought patient also had it but was not tested, first dose of covid vaccine had a really bad reaction; patient husband had covid and thought patient also had it but was not tested, first dose of covid vaccine had a really bad reaction; Achy Arms; patient husband had covid and thought patient also had it but was not tested, first dose of covid vaccine had a really bad reaction; 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 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), VACCINATION COMPLICATION (non-serious), outcome "unknown" and all described as "patient husband had covid and thought patient also had it but was not tested, first dose of covid vaccine had a really bad reaction"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Achy Arms". The action taken for adalimumab was unknown.  Clinical course: It was unknown if patient was enrolled in a covid-19 vaccine trial. The reporter's causality for the event(s) of patient husband had covid and thought patient also had it but was not tested, first dose of covid vaccine had a really bad reaction and achy arms related with humira was not provided. The reporter's causality for the event(s) related with Pfizer BioNTech Covid-19 Vaccine for patient husband had covid and thought patient also had it but was not tested and first dose of covid vaccine had achy arms was not provided and for the events first dose of covid vaccine had a really bad reaction was not related.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective, Suspected COVID-19, Pain in extremity and Vaccination complication and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Knee arthroplasty
Clinical narrative: Knee replacement surgery; FACILITATED COLLECT  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-163-4114081-00 (Agency).  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Oct2021 (Batch/Lot number: unknown) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation; upadacitinib (RINVOQ), first regimen oral (Lot number: 1150526) and second regimen oral (Lot number: 1154506) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Second dose. (1 in 1 Once), Route of admin:  Intra-muscular), administration date: 22Mar2021, when the patient was 57 years old, for Covid-19 immunization, reaction(s): "Urinary tract infection", "Patient cut knuckles", "had knot in arm", "vacine caused a sore arm", "feels pain when the temperature was cold", "Sinus infection"; Bnt162b2 (Dose 1, First dose. (1 in 1 Once), Route of admin:  Intra-muscular), administration date: 27Feb2021, when the patient was 57 years old, for Covid-19 immunization, reaction(s): "Urinary tract infection", "Patient cut knuckles", "had knot in arm", "vacine caused a sore arm", "feels pain when the temperature was cold", "Sinus infection". The following information was reported: KNEE ARTHROPLASTY (medically significant) with onset 14Oct2021, outcome "recovering", described as "Knee replacement surgery". The action taken for upadacitinib was unknown.  Additional information: On 02Dec2021, received updates to event information, reporter opinion of causality and narrative description. The events of "Laceration of Finger" and "Vaccination Site Nodule" were added. On 30Dec2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The event of "Vaccine Injection Site Was Sore" was added. On 27Jan2022, received updates to patient demographics, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The events of "Feels Pain When the Temperature Was Cold" and "Sinus Infection" were added. The event of "Vaccine Injection Site Was Sore" was amended to "Vaccine Caused a Sore Arm".  Causality Reaction: Total knee replacement (Knee arthroplasty) Action(s) taken with drug: Unknown; Causality as per reporter (Drug/Vaccine): Not reported; Dechallenge: N/A  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 and close temporal association there is a reasonable possibility of causal association between the events with the suspect product bnt162b2.
Sex: U
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: My arm is hurting/its hurting me bad; I am losing use of my arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 08Feb2022 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Feb2022, outcome "unknown", described as "My arm is hurting/its hurting me bad"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 08Feb2022, outcome "unknown", described as "I am losing use of my arm".  COVID-19  Vaccine is a Pfizer product, unspecified COVID-19 Vaccine manufacturer, Dates for COVID-19 Vaccine: (Start: Unspecified Stop: Unspecified. Additional information; The  patient gonna call, we are gonna call back, we can call back we got a bad connection because she is breaking up, I just don't think I understand, just hang up." Further probing could not be done as consumer hung up abruptly. Hence, product details (LOT, expiration date, NDC, UPC), purchase details and other details were unknown and limited information was available over the call. reporter type captured as consumer or other non health professional by default.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.