chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Fibrin D dimer, Pulmonary thrombosis
Clinical narrative: blood clots in both lungs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Feb2021 11:30 (Lot number: EL9264) at the age of 77 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: The patient experienced blood clots in both lungs on 01Mar2021, and resulted in hospitalization from 01Mar2021 to 02Mar2021. It was reported that the patient received first dose on 10Feb2021 and the second dose on 03Mar2021. Two days prior to the second dose he was admitted to hospital for blood clots in both lungs; they kept him over night. A CAT scan was done and determined he did have blood clots. At the time he was concerned or thought it was related to the vaccine. Then the day after getting out of the hospital got the second dose. On 02Sep2021 he had a second CAT scan and it was clear, it was a negative scan. The patient notes that the reason they kept him in the hospital over night was his D-dimer showed numbers that were over 800. He is calling to report his concern that possibly the vaccine may have had something to do with the blood clots, he is not sure but possibly and he wants it on record. The event resulted in Emergency Room visit. Treatment received for the event included he started Eliquis 5mg twice a day for the blood clots while in the hospital. The outcome of event was recovered on 02Sep2021.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Ear pain, Fatigue, Headache, Immunisation
Clinical narrative: ring in ears; headache; nausea; soreness; fatigue; shaking; breathing problems; painful needle-like ear-aches; rib and chest pain; rib and chest pain; unable to sleep; BOOSTER; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Nov2021 10:00 (Lot number: 3203080) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Intramuscular, lot#EW0164, expiry date: Aug2021), administration date: 14Apr2021, when the patient was 58 years old, for COVID-19 immunisation, reaction(s): "Ear pain", "Dizziness", "Chills", "Fever", "Soreness", "Haemoptysis", "Dyspnoea", "Tremor", "Headache", "Nausea", "Chest pain"; Comirnaty (Dose 2, Intramuscular, lot#EW0179), administration date: 05May2021, when the patient was 58 years old, for COVID-19 immunisation, reaction(s): "Ear pain", "Histamine level increased", "Dizziness", "Chills", "Fever", "Soreness", "Haemoptysis", "Dyspnoea", "Tremor", "Headache", "Nausea", "Chest pain", "Malaise", "Skin fissures", "Chapped lips". The following information was reported: On 06Nov2021, after 3rd jab of Pfizer patient experienced ringing in ears/headache within 24hrs and proceeded by nausea, soreness, fatigue, shaking, and breathing problems. Very painful needle-like ear-aches and extreme headaches. Rib and chest pain within 48 hrs and lasted approx. 27 days. unable to sleep due to standing position being only tolerable one. Seriousness Criteria for events: Important medical event. Treatment was not received for all events. The outcome of events was Recovering.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Musculoskeletal chest pain, Nausea, Pain, Respiratory disorder
Clinical narrative: ring in ears; headache; nausea; soreness; fatigue; shaking; breathing problems; painful needle-like ear-aches; rib and chest pain; rib and chest pain; unable to sleep; BOOSTER; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Nov2021 10:00 (Lot number: 3203080) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Intramuscular, lot#EW0164, expiry date: Aug2021), administration date: 14Apr2021, when the patient was 58 years old, for COVID-19 immunisation, reaction(s): "Ear pain", "Dizziness", "Chills", "Fever", "Soreness", "Haemoptysis", "Dyspnoea", "Tremor", "Headache", "Nausea", "Chest pain"; Comirnaty (Dose 2, Intramuscular, lot#EW0179), administration date: 05May2021, when the patient was 58 years old, for COVID-19 immunisation, reaction(s): "Ear pain", "Histamine level increased", "Dizziness", "Chills", "Fever", "Soreness", "Haemoptysis", "Dyspnoea", "Tremor", "Headache", "Nausea", "Chest pain", "Malaise", "Skin fissures", "Chapped lips". The following information was reported: On 06Nov2021, after 3rd jab of Pfizer patient experienced ringing in ears/headache within 24hrs and proceeded by nausea, soreness, fatigue, shaking, and breathing problems. Very painful needle-like ear-aches and extreme headaches. Rib and chest pain within 48 hrs and lasted approx. 27 days. unable to sleep due to standing position being only tolerable one. Seriousness Criteria for events: Important medical event. Treatment was not received for all events. The outcome of events was Recovering.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus, Tremor
Clinical narrative: ring in ears; headache; nausea; soreness; fatigue; shaking; breathing problems; painful needle-like ear-aches; rib and chest pain; rib and chest pain; unable to sleep; BOOSTER; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Nov2021 10:00 (Lot number: 3203080) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Intramuscular, lot#EW0164, expiry date: Aug2021), administration date: 14Apr2021, when the patient was 58 years old, for COVID-19 immunisation, reaction(s): "Ear pain", "Dizziness", "Chills", "Fever", "Soreness", "Haemoptysis", "Dyspnoea", "Tremor", "Headache", "Nausea", "Chest pain"; Comirnaty (Dose 2, Intramuscular, lot#EW0179), administration date: 05May2021, when the patient was 58 years old, for COVID-19 immunisation, reaction(s): "Ear pain", "Histamine level increased", "Dizziness", "Chills", "Fever", "Soreness", "Haemoptysis", "Dyspnoea", "Tremor", "Headache", "Nausea", "Chest pain", "Malaise", "Skin fissures", "Chapped lips". The following information was reported: On 06Nov2021, after 3rd jab of Pfizer patient experienced ringing in ears/headache within 24hrs and proceeded by nausea, soreness, fatigue, shaking, and breathing problems. Very painful needle-like ear-aches and extreme headaches. Rib and chest pain within 48 hrs and lasted approx. 27 days. unable to sleep due to standing position being only tolerable one. Seriousness Criteria for events: Important medical event. Treatment was not received for all events. The outcome of events was Recovering.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dry mouth
Clinical narrative: a flare up; Dry mouth; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 55 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), oral (Batch/Lot number: unknown) at 11 mg daily. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Hydrocodone, reaction(s): "Allergies: HYDROCODONE". The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "a flare up"; DRY MOUTH (non-serious), outcome "unknown", described as "Dry mouth". The action taken for tofacitinib citrate was temporarily withdrawn.  Additional information: Patient states had to go off Xeljanz for a week when she got her covid vaccine (Pfizer) and had a flare up while she was on vacation it was miserable. Doctor aware.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: my son was tested positive recently after having received Pfizer vaccine  2 doses in April of this year.; my son was tested positive recently after having received Pfizer vaccine  2 doses in April of this year.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Apr2021 (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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Dec2021, outcome "unknown" and all described as "my son was tested positive recently after having received Pfizer vaccine  2 doses in April of this year.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Dec2021) positive. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Immunisation, Pruritus
Clinical narrative: booster; itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2021US186639. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; omalizumab (XOLAIR) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTUERER UNKNOWN), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster "; PRURITUS (non-serious), outcome "unknown", described as "itching".  Additional information: Patient stated she took her Xolair Medication three days after receiving her Covid booster shot. The patient advised that after this she began to experience itching and that it felt as though her shot did nothing for her.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage
Clinical narrative: Eye hemorrhage with airplane take off, lasting several weeks; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Jan2021 (Batch/Lot number: unknown) at the age of 36 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown.), administration date: 31Dec2020, when the patient was 36 years old, for COVID-19 immunization. The following information was reported: On 31Aug2021, the patient experienced Eye hemorrhage with airplane take off, lasting several weeks. The event was evaluated at the physician office visit. Therapeutic measures were taken as a result of eye haemorrhage. Outcome of event was recovering. Patient received dose 3 of bnt162b2 on 31Oct2021. Patient did not have covid prior vaccination, and did not have covid tested post vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on temporal relationship the possibility of causal association between the reported events Eye hemorrhage and the suspect drug BNT162B2 cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she tested positive for COVID Dec. 7, 2021 after receiving 2 doses back in June 2021.; she tested positive for COVID Dec. 7, 2021 after receiving 2 doses back in June 2021.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 13 year-old female patient received bnt162b2 (COMIRNATY), administration date Jun2021 (Batch/Lot number: unknown) as dose 2, single and administration date Jun2021 (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) all with onset 07Dec2021, outcome "unknown" and all described as "she tested positive for COVID Dec. 7, 2021 after receiving 2 doses back in June 2021.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Dec2021) positive. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 7 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Dec2021 13:00 (Lot number: FK5127) at the age of 7 years as dose 2 (tris), single for covid-19 immunisation. Relevant medical history included: "type I diabetes" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: INSULIN. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5618, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM, Route of Administration: Intramuscular), administration date: 08Nov2021, when the patient was 7 years old, for COVID-19 Immunization. The following information was reported: URTICARIA (non-serious) with onset 05Dec2021, outcome "recovering", described as "Hives". Therapeutic measures were taken as a result of urticaria. Additional information: the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Antihistamines received for the adverse event.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: After three Pfizer shots; I got the dreaded "Positive" on a COVID test last night and have some mild symptoms; I got the dreaded "Positive" on a COVID test last night and have some mild symptoms; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). 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: IMMUNISATION (medically significant), outcome "unknown", described as "After three Pfizer shots"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 07Dec2021, outcome "unknown" and all described as "I got the dreaded "Positive" on a COVID test last night and have some mild symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Dec2021) positive, notes: got the dreaded Positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Chest pain, Dyspnoea, Gait disturbance, Mass
Clinical narrative: heart arrhythmia; severe tachycardia; chest pain on the left side; shortness of breath; I have painful hard lumps behind my knee and down my calf; fevers; body aches/ painful hard lumps; now cannot walk up stairs or reasonable distances without my heart acting up; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Dec2021 12:00 (Batch/Lot number: unknown) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hypothyroid" (unspecified if ongoing), notes: hypothyroid; "sulfa allergy" (unspecified if ongoing), notes: sulfa allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications. Past drug history included: Nitrofurantoin, reaction(s): "nitrofurantoin: Drug Allergy". Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The following information was reported: ARRHYTHMIA (medically significant) with onset 05Dec2021 20:00, outcome "not recovered", described as "heart arrhythmia"; TACHYCARDIA (non-serious) with onset 05Dec2021 20:00, outcome "not recovered", described as "severe tachycardia"; CHEST PAIN (non-serious) with onset 05Dec2021 20:00, outcome "not recovered", described as "chest pain on the left side"; DYSPNOEA (non-serious) with onset 05Dec2021 20:00, outcome "not recovered", described as "shortness of breath"; MASS (non-serious) with onset 05Dec2021 20:00, outcome "not recovered", described as "I have painful hard lumps behind my knee and down my calf"; PYREXIA (non-serious) with onset 05Dec2021 20:00, outcome "not recovered", described as "fevers"; PAIN (non-serious) with onset 05Dec2021 20:00, outcome "not recovered", described as "body aches/ painful hard lumps"; GAIT DISTURBANCE (non-serious) with onset 05Dec2021 20:00, outcome "not recovered", described as "now cannot walk up stairs or reasonable distances without my heart acting up". The events "heart arrhythmia", "severe tachycardia", "chest pain on the left side", "shortness of breath", "i have painful hard lumps behind my knee and down my calf", "fevers", "body aches/ painful hard lumps" and "now cannot walk up stairs or reasonable distances without my heart acting up" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of arrhythmia, tachycardia, chest pain, dyspnoea, mass, pyrexia, pain, gait disturbance. The patient had fevers and body aches for four days so far. The events were reported as non-serious.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tachycardia
Clinical narrative: heart arrhythmia; severe tachycardia; chest pain on the left side; shortness of breath; I have painful hard lumps behind my knee and down my calf; fevers; body aches/ painful hard lumps; now cannot walk up stairs or reasonable distances without my heart acting up; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Dec2021 12:00 (Batch/Lot number: unknown) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hypothyroid" (unspecified if ongoing), notes: hypothyroid; "sulfa allergy" (unspecified if ongoing), notes: sulfa allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications. Past drug history included: Nitrofurantoin, reaction(s): "nitrofurantoin: Drug Allergy". Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The following information was reported: ARRHYTHMIA (medically significant) with onset 05Dec2021 20:00, outcome "not recovered", described as "heart arrhythmia"; TACHYCARDIA (non-serious) with onset 05Dec2021 20:00, outcome "not recovered", described as "severe tachycardia"; CHEST PAIN (non-serious) with onset 05Dec2021 20:00, outcome "not recovered", described as "chest pain on the left side"; DYSPNOEA (non-serious) with onset 05Dec2021 20:00, outcome "not recovered", described as "shortness of breath"; MASS (non-serious) with onset 05Dec2021 20:00, outcome "not recovered", described as "I have painful hard lumps behind my knee and down my calf"; PYREXIA (non-serious) with onset 05Dec2021 20:00, outcome "not recovered", described as "fevers"; PAIN (non-serious) with onset 05Dec2021 20:00, outcome "not recovered", described as "body aches/ painful hard lumps"; GAIT DISTURBANCE (non-serious) with onset 05Dec2021 20:00, outcome "not recovered", described as "now cannot walk up stairs or reasonable distances without my heart acting up". The events "heart arrhythmia", "severe tachycardia", "chest pain on the left side", "shortness of breath", "i have painful hard lumps behind my knee and down my calf", "fevers", "body aches/ painful hard lumps" and "now cannot walk up stairs or reasonable distances without my heart acting up" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of arrhythmia, tachycardia, chest pain, dyspnoea, mass, pyrexia, pain, gait disturbance. The patient had fevers and body aches for four days so far. The events were reported as non-serious.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Device issue, Drug ineffective, SARS-CoV-2 test, Vaccination site induration
Clinical narrative: drug ineffective; COVID-19; Device issue; Injection site papule; Injection site induration; This is a solicited report received from contactable Consumer (the patient)  for a sponsored program. Other Case identifier(s): 21K-163-4186569-00 (Abbvie).  A 35 year-old female patient received the first dose of bnt162b2 (BNT162B2), intramuscularly, on 05Apr2021 (Batch/Lot number: unknown) at the age of 34 years as a single dose  and received the second dose of  bnt162b2 (BNT162B2), intramuscularly, on  26Apr2021 (Batch/Lot number: unknown) at the age of 34 years old as a single dose, both for COVID-19 immuniz ation; unspecified adalimumab (HUMIRA) (Batch/Lot number: unknown) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE with onset 2021, outcome "recovered", described as "drug ineffective"; COVID-19  with onset 2021, outcome "recovered", described as "COVID-19"; DEVICE ISSUE (non-serious) with onset 2021, outcome "not recovered", described as "Device issue"; VACCINATION SITE PAPULE (non-serious) with onset 2021, outcome "not recovered", described as "Vaccination site papule"; VACCINATION SITE INDURATION  with onset 2021, outcome "not recovered", described as "Vaccination site induration". The patient underwent the following laboratory tests and procedures: SARS-COV-2 test: (2021) positive. The reporter stated that it was possible that the events device issue, COVID-19, injection site papule and Injection site induration were related to the Pfizer BioNTech Covid-19 Vaccine. The reporter's causality for the event(s) of PEN MISFIRE with HUMIRA (ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of COVID-19, RAISED AT INJECTION SITE and HARD AT INJECTION SITE was not provided.  The The action taken for adalimumab was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided a possible causal association between the reported events drug ineffective, Covid 19, vaccination site induration vaccination site papule are assessed as related to the suspect BNT162B2. Device issue may not be related to BNT162b2.
Age: 34.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site papule
Clinical narrative: drug ineffective; COVID-19; Device issue; Injection site papule; Injection site induration; This is a solicited report received from contactable Consumer (the patient)  for a sponsored program. Other Case identifier(s): 21K-163-4186569-00 (Abbvie).  A 35 year-old female patient received the first dose of bnt162b2 (BNT162B2), intramuscularly, on 05Apr2021 (Batch/Lot number: unknown) at the age of 34 years as a single dose  and received the second dose of  bnt162b2 (BNT162B2), intramuscularly, on  26Apr2021 (Batch/Lot number: unknown) at the age of 34 years old as a single dose, both for COVID-19 immuniz ation; unspecified adalimumab (HUMIRA) (Batch/Lot number: unknown) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE with onset 2021, outcome "recovered", described as "drug ineffective"; COVID-19  with onset 2021, outcome "recovered", described as "COVID-19"; DEVICE ISSUE (non-serious) with onset 2021, outcome "not recovered", described as "Device issue"; VACCINATION SITE PAPULE (non-serious) with onset 2021, outcome "not recovered", described as "Vaccination site papule"; VACCINATION SITE INDURATION  with onset 2021, outcome "not recovered", described as "Vaccination site induration". The patient underwent the following laboratory tests and procedures: SARS-COV-2 test: (2021) positive. The reporter stated that it was possible that the events device issue, COVID-19, injection site papule and Injection site induration were related to the Pfizer BioNTech Covid-19 Vaccine. The reporter's causality for the event(s) of PEN MISFIRE with HUMIRA (ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of COVID-19, RAISED AT INJECTION SITE and HARD AT INJECTION SITE was not provided.  The The action taken for adalimumab was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided a possible causal association between the reported events drug ineffective, Covid 19, vaccination site induration vaccination site papule are assessed as related to the suspect BNT162B2. Device issue may not be related to BNT162b2.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Fatigue, SARS-CoV-2 test, Suspected COVID-19, Vaccination site discomfort
Clinical narrative: COVID-19; COVID-19; fatigue; Injection site itching; Injection site burning; Injection site discomfort; This is a solicited report received from contactable reporter (Consumer) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4186948-00 (Abbvie). The reporter is the patient.  A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administration date 01May2021 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single and intramuscular, administration date 30May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for uveitis. The patient's relevant medical history and concomitant medications were not reported. On unknown dates, the patient experienced injection site for humira had been itchy and burning and uncomfortable for a few days and Covid. In 2021, the patient experienced fatigued. In 2021, the fatigued resolved. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. The outcome of event Covid-19 was recovering; drug ineffective was unknown; outcome of event fatigue was recovered on an unspecified date in 2021; outcome of other events was not recovered.  The reporter's assessment of the causal relationship of the events with 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 available information in the case provided, the causal association between the events Suspected COVID-19, Drug ineffective, Fatigue, Vaccination site pruritus, Vaccination site pain, Vaccination site discomfort and the suspect drug BNT162B2 cannot be excluded considering drug-event temporal relationship.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: COVID-19; COVID-19; fatigue; Injection site itching; Injection site burning; Injection site discomfort; This is a solicited report received from contactable reporter (Consumer) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4186948-00 (Abbvie). The reporter is the patient.  A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administration date 01May2021 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single and intramuscular, administration date 30May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for uveitis. The patient's relevant medical history and concomitant medications were not reported. On unknown dates, the patient experienced injection site for humira had been itchy and burning and uncomfortable for a few days and Covid. In 2021, the patient experienced fatigued. In 2021, the fatigued resolved. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. The outcome of event Covid-19 was recovering; drug ineffective was unknown; outcome of event fatigue was recovered on an unspecified date in 2021; outcome of other events was not recovered.  The reporter's assessment of the causal relationship of the events with 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 available information in the case provided, the causal association between the events Suspected COVID-19, Drug ineffective, Fatigue, Vaccination site pruritus, Vaccination site pain, Vaccination site discomfort and the suspect drug BNT162B2 cannot be excluded considering drug-event temporal relationship.
Age: 76.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Lower respiratory tract infection, Shoulder arthroplasty
Clinical narrative: Shoulder replacement; Chest cold; 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): 21K-163-4187943-00.  A 76 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 76 years as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SHOULDER ARTHROPLASTY (medically significant), outcome "recovering", described as "Shoulder replacement"; LOWER RESPIRATORY TRACT INFECTION (non-serious), outcome "recovered", described as "Chest cold". On unknown dates, the patient experienced SHOULDER REPLACEMENT and CHEST COLD. On an unknown date, CHEST COLD resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient reported that he had shoulder replacement surgery and contracted chest cold. It was unknown if she was enrolled in a Covid-19 Vaccine Trial. She received COVID-19 Vaccine manufactured by Pfizer/BioNTech. The action taken for adalimumab was unknown. Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of SHOULDER REPLACEMENT and CHEST COLD was not provided.  opinion is that there is no reasonable possibility that the event of SHOULDER REPLACEMENT is related to HUMIRA(ADALIMUMAB).  opinion is that the event of CHEST COLD is not assessable. Causality for BNT162B2: Shoulder replacement (Shoulder arthroplasty), Causality as per reporter (Drug/Vaccine): Possible; Chest cold (Lower respiratory tract infection), Causality as per reporter(Drug/Vaccine): 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 available and 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   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood pressure measurement, Diabetes mellitus, Hypersensitivity, Hypertension, Lethargy
Clinical narrative: 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. A 65 year-old male patient received BNT162B2, intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; upadacitinib (RINVOQ), oral (ongoing) (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE DOSE, Intramuscular), administration date: 01Feb2021, when the patient was 64 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE DOSE, Intramuscular), administration date: 28Feb2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: DIABETES MELLITUS (medically significant), outcome "not recovered", described as "Diabetic"; HYPERTENSION (non-serious), outcome "not recovered", described as "Blood pressure high"; HYPERSENSITIVITY (non-serious), outcome "not recovered", described as "allergy"; LETHARGY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Lethargic." Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient had high blood pressure. He had allergies. He was diabetic. He was lethargic for a week after receiving the booster shot of Pfizer in 2021. The patient underwent the following laboratory tests and procedures: blood pressure measurement: high. The action taken for upadacitinib was dosage not changed.  The reporter's causality for the events of high blood pressure, allergies, diabetic and lethargic with Rinvoq (Upadacitinib) was: no reasonable possibility. Causality as per reporter for the suspect vaccine to the event lethargy was assessed as possible. The reporter's assessment of the causal relationship of the other events 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 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   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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypogeusia, Immunisation
Clinical narrative: The patient received third dose; Taste further diminished with booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "osteopenia" (unspecified if ongoing); "Known allergies:sulfonamide abx allergy" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; ATENOLOL; CALCIUM+D3. Vaccination history included: Bnt162b2 (Lot number unknown, Dose:1), for COVID-19 immunization, reaction(s): "Diminished taste"; Bnt162b2 (Lot number unknown, Dose:2), for COVID-19 immunization, reaction(s): "Diminished taste". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "The patient received third dose"; HYPOGEUSIA (non-serious) with onset 2021, outcome "not recovered", described as "Taste further diminished with booster". Therapeutic measures were not taken as a result of hypogeusia.  Additional information: Prior to vaccination, the patient was not diagnosed with covid-19. Since vaccination, the patient had not been tested for covid-19. Device date was reported as 22Oct2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Immune system disorder, Immunisation, Limb discomfort, Rash
Clinical narrative: booster; booster messed up system; terrible red rash, kind of hot & a little painful; terrible red rash, kind of hot & a little painful; terrible red rash, kind of hot & a little painful; covid arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (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): "No reaction". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "booster messed up system"; RASH ERYTHEMATOUS (non-serious), FEELING HOT (non-serious), RASH (non-serious), outcome "unknown" and all described as "terrible red rash, kind of hot & a little painful"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "covid arm". It was unknown if therapeutic measures were taken as a result of immune system disorder, rash erythematous, feeling hot, rash, limb discomfort.  Additional information: patient reported that booster messed up her system; covid arm; terrible red rash, kind of hot & a little painful; showed up 5 days after getting the booster. No reaction to either first or second dose at all.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: booster; booster messed up system; terrible red rash, kind of hot & a little painful; terrible red rash, kind of hot & a little painful; terrible red rash, kind of hot & a little painful; covid arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (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): "No reaction". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "booster messed up system"; RASH ERYTHEMATOUS (non-serious), FEELING HOT (non-serious), RASH (non-serious), outcome "unknown" and all described as "terrible red rash, kind of hot & a little painful"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "covid arm". It was unknown if therapeutic measures were taken as a result of immune system disorder, rash erythematous, feeling hot, rash, limb discomfort.  Additional information: patient reported that booster messed up her system; covid arm; terrible red rash, kind of hot & a little painful; showed up 5 days after getting the booster. No reaction to either first or second dose at all.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: have a break through Covid infection after having both dosage of the Pfizer vaccine plus the booster; have a break through Covid infection after having both dosage of the Pfizer vaccine plus the booster; This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (batch/lot number: unknown) as DOSE 2, SINGLE and (Batch/Lot number: unknown) as DOSE 1, SINGLE for COVID-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Cirrhosis" (unspecified if ongoing). Concomitant medication included: LEXAPRO. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "have a break through Covid infection after having both dosage of the Pfizer vaccine plus the booster". The patient underwent the following laboratory tests and procedures: Covid-test: unknown result.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Inflammation, Oral surgery, Pain
Clinical narrative: Fatigue; Inflammation; pain; headache; Oral Surgery; This is a solicited report received from contactable reporter Consumer for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4185276-00.  A 44 year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation; HUMIRA, citrate free, subcutaneous (Batch/Lot number: unknown) for uveitis, psoriasis. The patient had no relevant medical history and no Known Allergies. There were no concomitant medications. Vaccination history included: Covid-19 vaccine manufactured by johnson & johnson (Route of Administration: Intramuscular), for Covid-19 Immunization. The following information was reported: ORAL SURGERY (medically significant) with onset 2021, outcome "recovering", described as "Oral Surgery"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; INFLAMMATION (non-serious), outcome "recovering", described as "Inflammation"; PAIN (non-serious), outcome "recovering", described as "pain"; HEADACHE (non-serious), outcome "unknown", described as "headache". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of oral surgery.  The reporter's causality for the events of oral surgery, inflammation and pain with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the events of fatigue and headaches was not provided. The reporter's assessment of the causal relationship of the events with 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.  Opinion is that there is no reasonable possibility that the events of oral surgery, fatigue, inflammation, pain and headaches are related to Humira (Adalimumab).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events (except oral surgery)  and suspect drug BNT162B2 cannot be excluded. Based on the  information in the case report oral surgery may not be related to suspect drug BNT162B2 .
Sex: F
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure, Inappropriate schedule of product administration
Clinical narrative: Grand Mal seizures; Dose 1 on 25Mar2021, Dose 2 on 08Apr2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 14:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient was not pregnant when administration. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, lot number unknown, administration time=02:00 PM), administration date: 25Mar2021, for Covid-19 immunization. The patient didn't receive other vaccines in 4 weeks. The patient was not diagnosed with COVID-19 prior to vaccination and she has not been tested for COVID-19 post vaccination. The following information was reported: GENERALISED TONIC-CLONIC SEIZURE (hospitalization) with onset 08Apr2021, outcome "not recovered", described as "Grand Mal seizures"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 08Apr2021 14:00, outcome "unknown", described as "Dose 1 on 25Mar2021, Dose 2 on 08Apr2021". The patient was hospitalized for generalised tonic-clonic seizure (hospitalization duration: 3 day(s)). Levitrecem was taken as a result of generalised tonic-clonic seizure.  The lot number for bnt162b2 was not provided and will be requested during follow up.