chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ankylosing spondylitis, Memory impairment, Pneumonia
Clinical narrative: Spondylitis ankylosing flare up; Memory issues; Pneumonia; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4339879-00 (Agency).  A 48-year-old female patient received BNT162b2 (BNT162B2), on 20Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 20May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 47 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Batch/Lot number: unknown) and second regimen (ongoing) (Batch/Lot number: unknown), all subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PNEUMONIA (medically significant) with onset 2021, outcome "unknown"; ANKYLOSING SPONDYLITIS (medically significant), outcome "not recovered", described as "Spondylitis ankylosing flare up"; MEMORY IMPAIRMENT (non-serious), outcome "not recovered", described as "Memory issues". The action taken for adalimumab was dosage not changed.  The reporter's assessment of the causal relationship of "spondylitis ankylosing flare up" and "memory issues" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "pneumonia" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Sender's Comments: Based on the available information in the case, the causal association between the event Spondylitis ankylosing aggravated, Pneumonia, Memory impaired 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: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Illness, Near death experience
Clinical narrative: Thought I was going to die; sick; Sweating; Chills; serious fatigue/fatigue; Lungs hurt 24/7; have to take several naps everyday; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 20Nov2021 as dose 3 (booster), single (Lot number: FH 8030) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gallstones" (unspecified if ongoing); "Fatty liver" (unspecified if ongoing). None of Known allergies. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Batch/Lot number: EO7533, Location of injection: Arm Right), administration date: 26Mar2021, when the patient was 58-year-old, for Covid-19 Immunization; BNT162b2 (Dose 2, Batch/Lot number: EWO151, Location of injection: Arm Left), administration date: 16Apr2021, when the patient was 58-year-old, for Covid-19 Immunization. The following information was reported: CHILLS (life threatening) with onset 20Nov2021, outcome "not recovered"; PULMONARY PAIN (life threatening) with onset 20Nov2021, outcome "not recovered", described as "Lungs hurt 24/7"; HYPERHIDROSIS (life threatening) with onset 20Nov2021, outcome "not recovered", described as "Sweating"; NEAR DEATH EXPERIENCE (medically significant, life threatening) with onset 20Nov2021, outcome "not recovered", described as "Thought I was going to die"; SOMNOLENCE (life threatening) with onset 20Nov2021, outcome "not recovered", described as "have to take several naps everyday"; FATIGUE (life threatening) with onset 20Nov2021, outcome "not recovered", described as "serious fatigue/fatigue"; ILLNESS (life threatening) with onset 20Nov2021, outcome "not recovered", described as "sick". Nothing had been the same since getting booster. The patient did not have covid prior vaccination. The patient had been covid tested post vaccination. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Mar2022) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of near death experience, illness, hyperhidrosis, chills, fatigue, pulmonary pain, somnolence.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary pain, SARS-CoV-2 test, Somnolence
Clinical narrative: Thought I was going to die; sick; Sweating; Chills; serious fatigue/fatigue; Lungs hurt 24/7; have to take several naps everyday; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 20Nov2021 as dose 3 (booster), single (Lot number: FH 8030) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gallstones" (unspecified if ongoing); "Fatty liver" (unspecified if ongoing). None of Known allergies. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Batch/Lot number: EO7533, Location of injection: Arm Right), administration date: 26Mar2021, when the patient was 58-year-old, for Covid-19 Immunization; BNT162b2 (Dose 2, Batch/Lot number: EWO151, Location of injection: Arm Left), administration date: 16Apr2021, when the patient was 58-year-old, for Covid-19 Immunization. The following information was reported: CHILLS (life threatening) with onset 20Nov2021, outcome "not recovered"; PULMONARY PAIN (life threatening) with onset 20Nov2021, outcome "not recovered", described as "Lungs hurt 24/7"; HYPERHIDROSIS (life threatening) with onset 20Nov2021, outcome "not recovered", described as "Sweating"; NEAR DEATH EXPERIENCE (medically significant, life threatening) with onset 20Nov2021, outcome "not recovered", described as "Thought I was going to die"; SOMNOLENCE (life threatening) with onset 20Nov2021, outcome "not recovered", described as "have to take several naps everyday"; FATIGUE (life threatening) with onset 20Nov2021, outcome "not recovered", described as "serious fatigue/fatigue"; ILLNESS (life threatening) with onset 20Nov2021, outcome "not recovered", described as "sick". Nothing had been the same since getting booster. The patient did not have covid prior vaccination. The patient had been covid tested post vaccination. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Mar2022) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of near death experience, illness, hyperhidrosis, chills, fatigue, pulmonary pain, somnolence.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19; suspected COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Sep2021 at 12:00 as dose 3 (booster), single (Lot number: FF2588) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2), for COVID-19 immunization; Bnt162b2 (Dose Number: 1), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID 19"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "suspected COVID 19". No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chest discomfort, Dyspnoea, Fatigue
Clinical narrative: fatigue; minimal chest discomfort; minimal  breathing issue; sore throat; complains of no energy/fatigue/low energy; Very sleepy; Aches all over; 2 patients tested positive for covid (corona virus) yesterday on rapid test; 2 patients tested positive for covid (corona virus) yesterday on rapid test; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "She had a breast augmentation done" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Apr2022, outcome "unknown" and all described as "2 patients tested positive for covid (corona virus) yesterday on rapid test"; FATIGUE (non-serious), outcome "unknown"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "minimal chest discomfort"; DYSPNOEA (non-serious), outcome "unknown", described as "minimal  breathing issue"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; ASTHENIA (non-serious), outcome "unknown", described as "complains of no energy/fatigue/low energy"; SOMNOLENCE (non-serious), outcome "unknown", described as "Very sleepy"; PAIN (non-serious), outcome "unknown", described as "Aches all over". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Apr2022) Positive. Therapeutic measures were not taken as a result of covid-19, fatigue, chest discomfort, dyspnoea, oropharyngeal pain, asthenia, somnolence, pain.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Covid-19,Vaccination failure.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, SARS-CoV-2 test, Somnolence, Vaccination failure
Clinical narrative: fatigue; minimal chest discomfort; minimal  breathing issue; sore throat; complains of no energy/fatigue/low energy; Very sleepy; Aches all over; 2 patients tested positive for covid (corona virus) yesterday on rapid test; 2 patients tested positive for covid (corona virus) yesterday on rapid test; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "She had a breast augmentation done" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Apr2022, outcome "unknown" and all described as "2 patients tested positive for covid (corona virus) yesterday on rapid test"; FATIGUE (non-serious), outcome "unknown"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "minimal chest discomfort"; DYSPNOEA (non-serious), outcome "unknown", described as "minimal  breathing issue"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; ASTHENIA (non-serious), outcome "unknown", described as "complains of no energy/fatigue/low energy"; SOMNOLENCE (non-serious), outcome "unknown", described as "Very sleepy"; PAIN (non-serious), outcome "unknown", described as "Aches all over". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Apr2022) Positive. Therapeutic measures were not taken as a result of covid-19, fatigue, chest discomfort, dyspnoea, oropharyngeal pain, asthenia, somnolence, pain.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Covid-19,Vaccination failure.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: felt sick after booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adolescent male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization.  The following information was reported: ILLNESS (non-serious) with onset Apr2022, outcome "unknown", described as "felt sick after booster shot". It was unknown if therapeutic measures were taken as a result of illness.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 26 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SPIRONOLACTONE, start date: 01Mar2022, stop date: 03Apr2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19. Clinical Information: The patient received COVID 19 Treatment with Paxlovid from 05Apr2022. Patient received vaccine. The patient received other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Following booster, patient reports that she developed psoriasis for the first time in her life; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Previous dose product: COVID 19, Previous dose Brand: Pfizer , Previous dose Brand unknown: False , Previous dose Lot number: Unknown, Previous dose Lot unknown: False, Previous dose number: 1), for COVID-19 immunization; Bnt162b2 (Previous dose details:, Previous dose product: COVID 19, Previous dose Brand: Pfizer , Previous dose Brand unknown: False , Previous dose Lot number: Unknown, Previous dose Lot unknown: False, Previous dose number: 2), for COVID-19 immunization.  The following information was reported: PSORIASIS (non-serious), outcome "not recovered", described as "Following booster, patient reports that she developed psoriasis for the first time in her life". The event "following booster, patient reports that she developed psoriasis for the first time in her life" required physician office visit. Therapeutic measures were taken as a result of psoriasis.  Additional Information: Following booster, patient reports that she developed psoriasis for the first time in her life. This happened about 3-4 weeks following the booster. It was unknown if she had any known allergies and other medical history. It was unknown if she had other vaccine in four weeks and other medications in two weeks. It was unknown if she had COVID-19 prior to vaccination and was tested for COVID-19 post the vaccination. She received Methotrexate as a treatment medication.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Back disorder, Crohn's disease, Fatigue, Vaccination site bruising, Vaccination site pain
Clinical narrative: bleeding due to crohns; back felt like had a steel plate from ribs down; bruising of the vaccine area like it was sore, tender there; bruising of the vaccine area like it was sore, tender there; felt tired/heavy because of vaccine; MARKETING PROGRAM NAME NOT AVAILABLE.  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4344454-00 (Agency).  A 41-year-old male patient received BNT162b2 (BNT162B2), on 17Jun2021 as dose 1, single (Batch/Lot number: unknown) and on 03Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 40 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), at citrate free, subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE BRUISING (non-serious) all with onset 2021, outcome "recovered" and all described as "bruising of the vaccine area like it was sore, tender there"; FATIGUE (non-serious) with onset 2021, outcome "recovered", described as "felt tired/heavy because of vaccine"; CROHN'S DISEASE (medically significant), outcome "recovering", described as "bleeding due to crohns"; BACK DISORDER (non-serious), outcome "not recovered", described as "back felt like had a steel plate from ribs down". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "felt tired/heavy because of vaccine", "bleeding due to crohns", "back felt like had a steel plate from ribs down" and "bruising of the vaccine area like it was sore, tender there" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events crohn's disease, back disorder, vaccination site bruising and the use of suspect product BNT162B2 cannot be fully excluded. Based on known drug safety profile, the events of vaccination site pain and fatigue are assessed as related to BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Pain, Pyrexia, Vaccination site pain
Clinical narrative: body aches; pounding headache; medium grade fever; pain at injection sites; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 56-years-old male patient received BNT162b2 (BNT162B2), on 07Apr2022 at 11:00 as dose 4, single (Lot number: FL3197) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high LDL" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR. Vaccination history included: BNT162b2 (previous dose product=COVID 19, previous dose brand=PFIZER-BIONTECH, previous dose brand unknown= False, previous dose lot number=330308D, previous dose lot unknown=False, previous dose administration date=29Nov2021, previous dose administration time=07:00 PM, previous dose, dose number=3, previous dose vaccine location=Left arm), administration date: 29Nov2021, when the patient was 55-year-old, for COVID-19 immunization; BNT162b2 (previous dose product=COVID 19, previous dose brand=PFIZER-BIONTECH,, previous dose brand unknown=False, previous dose lot number= EL3247, previous dose lot unknown=False,, previous dose administration date=15Mar2021, previous dose administration time=02:00 PM, previous dose, dose number=2, previous dose vaccine location=Left arm), administration date: 15Mar2021, when the patient was 55-year-old, for COVID-19 immunization; BNT162b2 (previous dose product=COVID 19,, previous dose brand=PFIZER-BIONTECH, previous dose brand unknown=False, previous dose lot number= EL3247, previous dose lot unknown=False,, previous dose administration date=22Feb2021, previous dose administration time=01:00 PM, previous dose, dose number=1, previous dose vaccine location=Left arm), administration date: 22Feb2021, when the patient was 55-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 08Apr2022 at 01:00, outcome "recovering", described as "body aches"; PYREXIA (non-serious) with onset 08Apr2022 at 01:00, outcome "recovering", described as "medium grade fever"; VACCINATION SITE PAIN (non-serious) with onset 08Apr2022 at 01:00, outcome "recovering", described as "pain at injection sites"; HEADACHE (non-serious) with onset 08Apr2022 at 01:00, outcome "recovering", described as "pounding headache". Therapeutic measures were not taken as a result of pain, headache, pyrexia, vaccination site pain.  Additional Information: The patient experienced pounding headache, medium grade fever, pain at injection sites  and body aches. He had no known allergies. Other Medical history: high LDL. He had no other vaccines in 4 weeks. The other medications in two weeks: Lipitor 20mg and Multi vitamins. He did not have COVID-19 prior to vaccination and was not tested for COVID-19 post the vaccination. No treatment was received for the adverse events.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: body aches; pounding headache; medium grade fever; pain at injection sites; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 56-years-old male patient received BNT162b2 (BNT162B2), on 07Apr2022 at 11:00 as dose 4, single (Lot number: FL3197) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high LDL" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR. Vaccination history included: BNT162b2 (previous dose product=COVID 19, previous dose brand=PFIZER-BIONTECH, previous dose brand unknown= False, previous dose lot number=330308D, previous dose lot unknown=False, previous dose administration date=29Nov2021, previous dose administration time=07:00 PM, previous dose, dose number=3, previous dose vaccine location=Left arm), administration date: 29Nov2021, when the patient was 55-year-old, for COVID-19 immunization; BNT162b2 (previous dose product=COVID 19, previous dose brand=PFIZER-BIONTECH,, previous dose brand unknown=False, previous dose lot number= EL3247, previous dose lot unknown=False,, previous dose administration date=15Mar2021, previous dose administration time=02:00 PM, previous dose, dose number=2, previous dose vaccine location=Left arm), administration date: 15Mar2021, when the patient was 55-year-old, for COVID-19 immunization; BNT162b2 (previous dose product=COVID 19,, previous dose brand=PFIZER-BIONTECH, previous dose brand unknown=False, previous dose lot number= EL3247, previous dose lot unknown=False,, previous dose administration date=22Feb2021, previous dose administration time=01:00 PM, previous dose, dose number=1, previous dose vaccine location=Left arm), administration date: 22Feb2021, when the patient was 55-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 08Apr2022 at 01:00, outcome "recovering", described as "body aches"; PYREXIA (non-serious) with onset 08Apr2022 at 01:00, outcome "recovering", described as "medium grade fever"; VACCINATION SITE PAIN (non-serious) with onset 08Apr2022 at 01:00, outcome "recovering", described as "pain at injection sites"; HEADACHE (non-serious) with onset 08Apr2022 at 01:00, outcome "recovering", described as "pounding headache". Therapeutic measures were not taken as a result of pain, headache, pyrexia, vaccination site pain.  Additional Information: The patient experienced pounding headache, medium grade fever, pain at injection sites  and body aches. He had no known allergies. Other Medical history: high LDL. He had no other vaccines in 4 weeks. The other medications in two weeks: Lipitor 20mg and Multi vitamins. He did not have COVID-19 prior to vaccination and was not tested for COVID-19 post the vaccination. No treatment was received for the adverse events.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  An adult male patient received BNT162b2 (BNT162B2), as dose number unknown, single for covid-19 immunization. The patient's relevant medical history included: "Chronic obstructive pulmonary disease" (unspecified if ongoing). The patient's 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-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19 which included oral Paxolovid, which was started on 31Mar2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Screaming
Clinical narrative: woke up screaming several times; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. Other Case identifier(s): MOD22-010540 (Moderna case), 137265 (Moderna AE#), U1075497 (Moderna).  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, She mentioned her daughter got 3 Pfizer vaccines and had really bad reactions.), for Covid-19 immunization, reaction(s): "Covid"; Bnt162b2 (2nd Dose, She mentioned her daughter got 3 Pfizer vaccines and had really bad reactions.), for Covid-19 immunization, reaction(s): "Covid". The following information was reported: SCREAMING (non-serious), outcome "unknown", described as "woke up screaming several times".  Additional information: The reporter called and indicated that she had 5 fractures in her shoulder and her humerus bone was turned. She stated that her doctor told her to let it heal and the reporter is asking if we had any information on if this would affect her ability to get the booster. During the call the reporter stated that she is immunocompromised and also had reactions to the previous doses. She said after the first 2 doses she was really achy and tired; it was hard for her to turn head "it must having affected the little joints in my head/neck (10 days). She also mentioned joint aches. For the third dose she had more reactions like fever, body aches, nausea (3 days). She stated that the third dose was worse than the first two. In addition, she mentioned her daughter got 3 Pfizer vaccines and had really bad reactions. She woke up screaming several times and got COVID shortly after. (Non-Moderna AE) Moderna 1st dose: 6Mar2021, 027A21A. Moderna. 2nd dose: 3Apr2021,036B21A. Moderna 3rd dose: 24Oct2021, 012F21A  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Joint range of motion decreased, Pain in extremity, Rheumatoid arthritis
Clinical narrative: right hand was immobile and can not write; rheumatoid arthritis flare ups; pain in right hand; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4344885-00.  A 57-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), as citrate free (Batch/Lot number: unknown) subcutaneous for rheumatoid arthritis. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: JOINT RANGE OF MOTION DECREASED (medically significant), outcome "unknown", described as "right hand was immobile and can not write"; RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "rheumatoid arthritis flare ups"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "pain in right hand". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "right hand was immobile and can not write", "rheumatoid arthritis flare ups" and "pain in right hand" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of Joint range of motion decreased was Not reported. The reporter's causality for the event(s) of rheumatoid arthritis flare ups and pain in right hand with Humira (Adalimumab) was no reasonable possibility.   Clinical course: Solicited report by a consumer of an adult female with an event of non-serious right hand was immobile and cannot write, rheumatoid arthritis flare ups and pain in right hand with HUMIRA (ADALIMUMAB). There was no reported medical history. On unknown dates, the patient experienced right hand was immobile and cannot write, rheumatoid arthritis flare ups and pain in right hand. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided there is a reasonable possibility of causal association between the events with the suspect product bnt162b2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: injection pain; Diarrhea; nausea; weakness; trembling; light headed; loss of appetite; headache; tiredness; loss of balance; feeling unwell; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 07Apr2022 at 13:00 as dose 1, single (Lot number: Fk9894) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; ATORVASTATIN; GLIPIZIDE; FAMOTIDINE; BENTYL. The following information was reported: DIARRHOEA (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering", described as "Diarrhea"; MALAISE (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering", described as "feeling unwell"; HEADACHE (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering"; VACCINATION SITE PAIN (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering", described as "injection pain"; DIZZINESS (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering", described as "light headed"; DECREASED APPETITE (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering", described as "loss of appetite"; BALANCE DISORDER (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering", described as "loss of balance"; NAUSEA (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering"; FATIGUE (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering", described as "tiredness"; TREMOR (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering", described as "trembling"; ASTHENIA (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering", described as "weakness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, diarrhoea, nausea, asthenia, tremor, dizziness, decreased appetite, headache, fatigue, balance disorder, malaise.  Additional information: The clinical course was reported as the patient had not other vaccine in 4 weeks. Patient had other medication in 2 weeks with metformin, atorvastatin, glipizide, famotidine and bentyl. Patient had covid prior to vaccination and had covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Nausea, SARS-CoV-2 test
Clinical narrative: injection pain; Diarrhea; nausea; weakness; trembling; light headed; loss of appetite; headache; tiredness; loss of balance; feeling unwell; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 07Apr2022 at 13:00 as dose 1, single (Lot number: Fk9894) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; ATORVASTATIN; GLIPIZIDE; FAMOTIDINE; BENTYL. The following information was reported: DIARRHOEA (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering", described as "Diarrhea"; MALAISE (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering", described as "feeling unwell"; HEADACHE (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering"; VACCINATION SITE PAIN (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering", described as "injection pain"; DIZZINESS (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering", described as "light headed"; DECREASED APPETITE (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering", described as "loss of appetite"; BALANCE DISORDER (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering", described as "loss of balance"; NAUSEA (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering"; FATIGUE (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering", described as "tiredness"; TREMOR (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering", described as "trembling"; ASTHENIA (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering", described as "weakness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, diarrhoea, nausea, asthenia, tremor, dizziness, decreased appetite, headache, fatigue, balance disorder, malaise.  Additional information: The clinical course was reported as the patient had not other vaccine in 4 weeks. Patient had other medication in 2 weeks with metformin, atorvastatin, glipizide, famotidine and bentyl. Patient had covid prior to vaccination and had covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vaccination site pain
Clinical narrative: injection pain; Diarrhea; nausea; weakness; trembling; light headed; loss of appetite; headache; tiredness; loss of balance; feeling unwell; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 07Apr2022 at 13:00 as dose 1, single (Lot number: Fk9894) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; ATORVASTATIN; GLIPIZIDE; FAMOTIDINE; BENTYL. The following information was reported: DIARRHOEA (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering", described as "Diarrhea"; MALAISE (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering", described as "feeling unwell"; HEADACHE (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering"; VACCINATION SITE PAIN (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering", described as "injection pain"; DIZZINESS (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering", described as "light headed"; DECREASED APPETITE (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering", described as "loss of appetite"; BALANCE DISORDER (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering", described as "loss of balance"; NAUSEA (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering"; FATIGUE (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering", described as "tiredness"; TREMOR (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering", described as "trembling"; ASTHENIA (non-serious) with onset 07Apr2022 at 16:00, outcome "recovering", described as "weakness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, diarrhoea, nausea, asthenia, tremor, dizziness, decreased appetite, headache, fatigue, balance disorder, malaise.  Additional information: The clinical course was reported as the patient had not other vaccine in 4 weeks. Patient had other medication in 2 weeks with metformin, atorvastatin, glipizide, famotidine and bentyl. Patient had covid prior to vaccination and had covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: extremely dizzy/light headsd; sweats; extremely dizzy/light headsd; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose Number Unknown, Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 3 (Booster), Single, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious), DIZZINESS (non-serious) all with onset 07Apr2022 at 12:00, outcome "not recovered" and all described as "extremely dizzy/light headsd"; HYPERHIDROSIS (non-serious) with onset 07Apr2022 at 12:00, outcome "not recovered", described as "sweats". Therapeutic measures were not taken as a result of dizziness, hyperhidrosis, dizziness.  Additional information: The clinical course was reported as patient had received more than 3 doses. The patient had not received other vaccine in 4 weeks. Patient had not other medications in 2 weeks. Patient had not covid prior to vaccination and had not covid tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: I don't feel good, I feel like I have enough now; 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 (Pfizer-COVID-19 Vaccine- Solution for injection), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I don't feel good, I feel like I have enough now".  Additional information: Reaction/Event as Reported: gave me a Pfizer shot the first time and when I went in to get my second one they gave me Moderna, I got two different kinds. Consumer stated, "I need to ask some questions, (Name Withheld)." Name of medication: Consumer stated, "Pfizer (COVID-19 Vaccine) and Moderna (COVID-19 Vaccine), I was calling about the Pfizer Vaccine."  Consumer stated, "What will happen if my shot was of Pfizer and second dose was of Moderna?" When paraphrased, Consumer stated, "No, they gave me a Pfizer shot the first time and when I went in to get my second one they gave me Moderna, I got two different kinds." Consumer further stated, "Correct and I don't feel good, I feel like I have enough now."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got COVID shortly after; got COVID shortly after; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. Other Case identifier(s): MOD22-010540 (Moderna case), 137265 (Moderna AE#), U1075497 (Moderna).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got COVID shortly after". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeding disorder, Nausea
Clinical narrative: felt nauseated; had stomach pain; cannot keep her food down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization.  The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "felt nauseated"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "had stomach pain"; FEEDING DISORDER (non-serious), outcome "unknown", described as "cannot keep her food down".  Additional information: Patient was already received the Pfizer covid-19 vaccine shot and the booster shot. She mentioned that after a couple of months of having the booster shot she experienced events. She wanted to know if that was part of the long term side effects of the covid-19 vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (Not Aplicable). The reporter is the patient. Other Case identifier(s): 22K-163-4344558-00 (Agency).  A 47-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 08Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 46 years, all intramuscular for covid-19 immunisation; risankizumab rzaa (SKYRIZI [RISANKIZUMAB RZAA]), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2022, outcome "recovering" and all described as "COVID-19". The action taken for risankizumab rzaa was unknown.  The reporter considered "covid-19" related to BNT162b2. Additional information- It was reported that the reporter's causality for the event(s) of COVID with SKYRIZI (RISANKIZUMAB) was a reasonable possibility. In Mar2022, patient had covid and had a lingering cough. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events COVID-19 and drug ineffective cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: testing positive for Covid 19; testing positive for Covid 19; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "psoriasis" (unspecified if ongoing), notes: Patient had psoriasis and was on tremfya. Concomitant medication(s) included: TREMFYA taken for psoriasis. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "testing positive for Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.Clinical course:Patient reported she tested positive for Covid 19. After symptom resolution, patient received Covid -19 booster shot and again tested positive for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.