chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Lot number: GJ6665) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Mar2021 as dose 1, single (Lot number: FP7534), in left arm, on 18Apr2021 as dose 2, single (Lot number: ER8751), in left arm and on 23Apr2022 as dose 3 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholestrol" (unspecified if ongoing). Concomitant medication(s) included: LISOPRIL; ATORVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 23Apr2023 to 27Apr2023 for COVID-19 treatment.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300178266 same patient, different drug and event;
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Aplastic anaemia, SARS-CoV-2 test
Clinical narrative: Aplastic Anemia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Apr2022 at 15:15 as dose 4 (booster), single (Lot number: FK9894) at the age of 71 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE SODIUM]; FLONASE [MOMETASONE FUROATE]. Vaccination history included: Bnt162b2 (DOSE 3, SINGLE, Lot number: FC3181), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Lot number: EL9265), for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Lot number: EL3248), for COVID-19 immunization. The following information was reported: APLASTIC ANAEMIA (hospitalization, disability, medically significant, life threatening) with onset Apr2022, outcome "recovering", described as "Aplastic Anemia". The patient was hospitalized for aplastic anaemia (start date: 28Apr2022, discharge date: 08May2022, hospitalization duration: 11 day(s)). The event "aplastic anemia" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of aplastic anaemia from May2022 to present. Clinical course: Booster vaccine on 12Apr2022. Patient started bruising and getting tired with a fast heartbeat with minimal exertion that week. I was admitted to the hospital on 28Apr2022 and diagnosed with Aplastic Anemia on 06May2022.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: vitiligo; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2022 as dose 1, single (Lot number: FM0698) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VITILIGO (non-serious) with onset 2022, outcome "unknown".  Additional information: It was reported that patient wants to report an adverse event after first dose of the Pfizer covid shot, she got vitiligo. Upon further discussion, the patient stated she was interested in clinical trials with product since she developed vitiligo after receipt of the Pfizer Covid 19 vaccine. Patient had to get the Covid vaccine for work and ended up getting the Pfizer Covid 19 vaccine. Patient never had vitiligo in her life, and no family history of it. After the first dose, patient developed vitiligo, and it worsened after the second dose. Patient whole hand just turned white, then it spread all over to other hand and feet. After second shot, it went crazy. Patient developed depression due to these skin changes. Patient clarified that the vitiligo started on her neck and she got the first dose and had her skin right where the crease was on her shoulder to the neck where it was going up right around the neck line. She wore a necklace but thought all this was a reaction to the necklace as it was only on one side and then it started getting bigger bigger bigger. The vitiligo began about a week after 1st dose of the vaccine or it was 1.5 or 2 weeks after the dose. Her vaccine doses were administered in the afternoon. Patient had not received medication Prior Vaccinations (within 4 weeks).
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Depression, Skin discolouration, Vitiligo
Clinical narrative: I developed vitiligo, and it worsened after the second dose; I developed vitiligo, and it worsened after the second dose; My whole hand just turned white, then it spread all over to other hand and feet; developed depression due to these skin changes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), as dose 2, 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), for Covid-19 immunization, reaction(s): "vitiligo". The following information was reported: VITILIGO (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "I developed vitiligo, and it worsened after the second dose"; SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "My whole hand just turned white, then it spread all over to other hand and feet"; DEPRESSION (non-serious), outcome "unknown", described as "developed depression due to these skin changes".  Additional information: Th patient reported, she had to get the Covid vaccine for work and ended up getting the Pfizer Covid 19 vaccine. She never had vitiligo in her life, and no family history of it. After the first dose, she developed vitiligo, and it worsened after the second dose. Her whole hand just turned white, then it spread all over to other hand and feet. After second shot, it went crazy. She developed depression due to these skin changes. She was interested in clinical trials with product since she developed vitiligo after receipt of the Pfizer Covid 19 vaccine.  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: Body temperature, Local reaction, Pain in extremity, Pyrexia
Clinical narrative: sore arm; little fever; Just a local reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "digestive problems" (unspecified if ongoing), notes: digestive problems. Concomitant medication(s) included: MIRALAX taken for functional gastrointestinal disorder. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PYREXIA (non-serious), outcome "unknown", described as "little fever"; LOCAL REACTION (non-serious), outcome "unknown", described as "Just a local reaction". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated my wife and I took four regular doses of the Pfizer BioNTech COVID-19 monovalent vaccine. We also had one bivalent booster. We experienced nothing more than a sore arm and a little fever maybe but no rash or no breathing problems. Just a local reaction. We are eligible for the second bivalent booster however, my wife started taking Miralax for digestive problems one or two 17 gram capsules a day and it is pure polyethylene glycol. She might have developed a rash with itching with it, because it started when she started taking it and went away after she quit taking it. We think there is a risk of rash with the Pfizer BioNTech COVID-19 bivalent vaccine, does it contain Polyethylene glycol?.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300180051 same reporter/patient/product/AE, different dose;US-PFIZER INC-202300180052 same reporter/patient/product/AE, different dose;US-PFIZER INC-202300180053 same reporter/patient/product/AE, different dose;US-PFIZER INC-202300180055 same reporter/product/AE, different patient;US-PFIZER INC-202300180056 same reporter/product/AE, different patient;US-PFIZER INC-202300180057 same reporter/product/AE, different patient;US-PFIZER INC-202300180058 same reporter/product/AE, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Local reaction, Pain in extremity, Pyrexia
Clinical narrative: sore arm; little fever; local reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MIRALAX. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Just a Local reaction", "sore arm", "little fever". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PYREXIA (non-serious), outcome "unknown", described as "little fever"; LOCAL REACTION (non-serious), outcome "unknown".  Additional information: Reporter's wife and patient took four regular doses of the Pfizer BioNTech COVID-19 monovalent vaccine. They also had one bivalent booster. They experienced nothing more than a sore arm and a little fever maybe but no rash or no breathing problems. Just a local reaction. They were eligible for the second bivalent booster however, His wife started taking Miralax for digestive problems one or two 17 gram capsules a day and it was pure polyethylene glycol. She might have developed a rash with itching with it, because it started when she started taking it and went away after she quit taking it. They think there was a risk of rash with the Pfizer BioNTech COVID-19 bivalent vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300180008 same reporter/patient/product/AE, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sore arm; little fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 75-year-old 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 (Dose 1), for Covid-19 immunization, reaction(s): "sore arm", "little fever"; Bnt162b2 (Dose 2), for Covid-19 immunization, reaction(s): "sore arm", "little fever". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PYREXIA (non-serious), outcome "unknown", described as "little fever".  Additional information: My wife and I took four regular doses of the Pfizer BioNTech COVID-19 monovalent vaccine. We also had one bivalent booster. We experienced nothing more than a sore arm and a little fever maybe but no rash or no breathing problems. Just a local reaction. We are eligible for the second bivalent booster however, my wife started taking Miralax for digestive problems one or two 17gram capsules a day and it is pure polyethylene glycol. She might have developed a rash with itching with it, because it started when she started taking it and went away after she quit taking it. We think there is a risk of rash with the Pfizer BioNTech COVID-19 bivalent vaccine, does it contain Polyethylene glycol?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300180008 same reporter/patient/product/AE, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sore arm; little fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MIRALAX. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization, reaction(s): "Sore arm", "Little fever"; Bnt162b2 (Dose: 02), for COVID-19 Immunization, reaction(s): "Sore arm", "Little fever"; Bnt162b2 (Dose: 03), for COVID-19 Immunization, reaction(s): "Sore arm", "Little fever". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PYREXIA (non-serious), outcome "unknown", described as "little fever".  Additional information: My wife and I took four regular doses of the Pfizer BioNTech COVID-19 monovalent vaccine. We also had one bivalent booster. We experienced nothing more than a sore arm and a little fever maybe but no rash or no breathing problems. Just a local reaction. We are eligible for the second bivalent booster however, my wife started taking Miralax for digestive problems one or two 17gram capsules a day and it is pure polyethylene glycol. She might have developed a rash with itching with it, because it started when she started taking it and went away after she quit taking it. We think there is a risk of rash with the Pfizer BioNTech COVID-19 bivalent vaccine, does it contain Polyethylene glycol?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300180008 same reporter/patient/product/AE, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Local reaction, Pain in extremity, Pyrexia
Clinical narrative: Just a local reaction; sore arm; little fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "digestive problems" (unspecified if ongoing), notes: started taking Miralax for digestive problems one or two 17gram capsules a day. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "sore arm", "little fever"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "sore arm", "little fever"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "sore arm", "little fever"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "sore arm", "little fever". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PYREXIA (non-serious), outcome "unknown", described as "little fever"; LOCAL REACTION (non-serious), outcome "unknown", described as "Just a local reaction".  Additional information: The reporter was asking if there were any components in the Covid 19 vaccine that was in complication with another medication Miralax. (Id withheld) Reporter's wife and reporter took four regular doses of the Pfizer BioNTech COVID-19 monovalent vaccine. They also had one bivalent booster. They experienced nothing more than a sore arm and a little fever maybe but no rash or no breathing problems. Just a local reaction. They were eligible for the second bivalent booster however, reporters' wife started taking Miralax for digestive problems one or two 17gram capsules a day and it was pure polyethylene glycol. She might had developed a rash with itching with it, because it started when she started taking it and went away after she quit taking it. They thought there was a risk of rash with the Pfizer BioNTech COVID-19 bivalent vaccine, did it contain Polyethylene glycol.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Local reaction, Pain in extremity, Pyrexia
Clinical narrative: sore arm; little fever; local reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PYREXIA (non-serious), outcome "unknown", described as "little fever"; LOCAL REACTION (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information : The patient's wife and he took four regular doses of the Pfizer BioNTech COVID-19 monovalent vaccine. They also had one bivalent booster. They experienced nothing more than a sore arm and a little fever maybe but no rash or no breathing problems. Just a local reaction. They were eligible for the second bivalent booster however, his wife started taking Miralax for digestive problems one or two 17gram capsules a day and it was pure polyethylene glycol. She might have developed a rash with itching with it, because it started when she started taking it and went away after she quit taking it. They think there was a risk of rash with the Pfizer BioNTech COVID-19 bivalent vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300180008 same reporter/product/AE, different patient;
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Little fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), as dose 2, 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), for COVID-19 immunization, reaction(s): "Sore arm", "Little fever". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; PYREXIA (non-serious), outcome "unknown", described as "Little fever".  Additional information included patient took four regular doses of the Pfizer BioNTech COVID-19 monovalent vaccine. Patient had one bivalent booster. We experienced nothing more than a sore arm and a little fever maybe but no rash or no breathing problems.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300180008 same reporter/product/AE, different patient;
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sore arm; little fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (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), for Covid-19 immunization, reaction(s): "sore arm", "little fever"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "sore arm", "little fever"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "sore arm", "little fever"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "sore arm", "little fever".  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PYREXIA (non-serious), outcome "unknown", described as "little fever".  Additional information: Patients wife and patient took four regular doses of the Pfizer BioNTech COVID-19 monovalent vaccine. They also had one bivalent booster. They experienced nothing more than a sore arm and a little fever maybe but no rash or no breathing problems. Just a local reaction. They were eligible for the second bivalent booster.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: The patient mentioned that he and his wife took the initial Pfizer COVID vaccine and the bivalent COVID vaccine last Oct and had a sore arm. His wife started taking Miralax (propylene glycol) and possibly had a reaction to it. He wants to know if vaccines have the same product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: minor body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 14Feb2021 as dose 2, single (Lot number: EM9809) at the age of 50 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (ongoing). Concomitant medication(s) included: ZOLOFT oral taken for anxiety, start date: 2003 (ongoing). Vaccination history included: BNT162b2 (DOSE 1, Time: 12 PM, Anatomical site: Left arm, Route of administration: Intramuscular, Batch/Lot number: EL8982), administration date: 24Jan2021, when the patient was 50-year-old, for COVID-19 Immunization, reaction(s): "minor body aches". The following information was reported: PAIN (non-serious) with onset 14Feb2021, outcome "recovered" (15Feb2021), described as "minor body aches".  Additional information: Vaccination facility information for dose 1, Vaccination facility type: School/Student health clinic. Vaccination was not administered at Military Facility. Specific relevant test for thromboembolic events with thrombocytopenia was none. The first 2 vaccines resulted in minor body aches that lasted about 24 hours. Not serious, no medical attention was required. Lack of Effect details: No lack of effect-product reduced disease/symptoms to expected level. The patient did not experience any adverse event(s) as a consequence of the error.
Sex: M
Vaccine: COVID19
Symptoms: Dyskinesia
Clinical narrative: developed oral mandibular dyskinesis; This is a spontaneous report received from contactable reporter(s) (Physician).  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: DYSKINESIA (non-serious), outcome "not recovered", described as "developed oral mandibular dyskinesis".  Additional information: It was reported that the product was the Pfizer COVID vaccine, and she did not know the formulation or cap color and stated that after the patient got 1st booster of the Pfizer COVID vaccine, he developed oral mandibular dyskinesis within a day and it still had not resolved and it had been several weeks. Her awareness date was 02May2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Thrombosis
Clinical narrative: Developed a blood clot in his arm; Had afib; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A male patient in his 50's received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Developed a blood clot in his arm"; ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "Had afib". Therapeutic measures were taken as a result of thrombosis. Clinical Course: The doctor himself was sharing his own personal story; the physician who reported this was the patient also and stated he had developed a blood clot in his arm so he was being treated for that and about three weeks later he had afib and these events occurred after his Pfizer COVID vaccine. Reporter had no patient details to provide but stated that she guessed about his height and weight as she saw him every week. The patient was probably in his 50s and was otherwise healthy. The reporter did not had had the lot number at the time of reporting to provide.  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 known drug safety profile, there is reasonable possibility of causal association between the events (THROMBOSIS, ATRIAL FIBRILLATION) and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300180253 Same product, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in her ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: TINNITUS (non-serious), outcome "unknown", described as "ringing in her ears". The event "ringing in her ears" required physician office visit. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.  Additional information: caller reported has already spoken with an ENT doctor regarding the ringing in her ears.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Rebound infection; Rebound infection; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 at 14:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 01Aug2022 at 11:30 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing); "Asperger's syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Macrobid, reaction(s): "Drug allergy"; Demerol, reaction(s): "Drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Rebound infection". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 09:00 as dose 4 (booster), single (Lot number: GH09702) at the age of 64 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: "pulmonary fibrous" (unspecified if ongoing). There were no concomitant medications. There was no known drug allergy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19; patient received Paxlovid.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I have tinnitus. One day after I received my COVID booster my tinnitus disappeared; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Tinnitus" (unspecified if ongoing). The patient's 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: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I have tinnitus. One day after I received my COVID booster my tinnitus disappeared".  Additional Information: It was reported that the second day after receiving the booster, the tinnitus came back and the reporter wanted to know if there could be anything that the COVID booster helped the tinnitus.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; Confirmed COVID-19 respiratory Infection; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 43-year-old male patient received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Batch/Lot number: unknown), on 06Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 01Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis", start date: 2009 (ongoing); "CMV colitis", start date: 2021 (unspecified if ongoing); "hypertension", start date: 2014 (unspecified if ongoing); "Diabetes mellitus", start date: 2014 (ongoing); "prior smoker" (unspecified if ongoing); "fatty liver disease", start date: 2014 (unspecified if ongoing); "colonoscopy", start date: 2017 (unspecified if ongoing); "vitamin D deficiency" (unspecified if ongoing). Concomitant medication(s) included: ENTYVIO intravenous, start date: Jun2021, stop date: Dec2021; METHYLPREDNISOLONE oral, start date: 30Jul2021 (ongoing); PHENERGAN [PROMETHAZINE] oral (ongoing); ALBUTEROL [SALBUTAMOL] resp inhalation (ongoing); METFORMIN, start date: 01Jun2021, stop date: 19Jul2022; TYLENOL (ongoing). The following information was reported: COVID-19 (medically significant) with onset 02Apr2022, outcome "recovered" (12Apr2022), described as "Confirmed COVID-19 respiratory Infection"; VACCINATION FAILURE (medically significant) with onset 02Apr2022, outcome "recovered" (12Apr2022). The events "vaccination failure" and "confirmed covid-19 respiratory infection" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Apr2022) Positive, notes: COVID-19 (SARS-CoV-2) infection (confirmed), coronavirus. Clinical course: This patient had an upper respiratory infection then was evaluated in an emergency room on 02Apr2022, and was diagnosed with coronavirus. This did not involve prolonged in patient hospitalized. The infection was confirmed via an unknown COVID-19 test this patient described having flu-like symptoms. Event outcome was indicated as recovered. Recovery date 12Apr2022. The investigator was unable to confirm disease activity prior and at the time of the event. Patient also received BNT162b2 (BNT162B2), as dose 4 (Booster) on 14Apr2022 for covid-19 immunisation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The contributory role of the suspect product to the reported Vaccination failure and COVID-19 cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency. ,Linked Report(s) : US-PFIZER INC-PV202300079420 same patient, different drug/ event;
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis, Pain
Clinical narrative: Myocarditis; Body aches; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Body aches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, a possible contributory role of the suspect product cannot be excluded for the reported events 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
Symptoms: Thrombosis
Clinical narrative: Patient developed blood clot after vaccine booster shot; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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; Manufacturer unknown), for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "recovered", described as "Patient developed blood clot after vaccine booster shot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, a possible contributory role of the suspect product cannot be excluded for the reported events 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
Symptoms: Thrombosis
Clinical narrative: Blood clot that started in leg went down to foot; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A male patient received BNT162b2 (BNT162B2), as dose 2, 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), for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Blood clot that started in leg went down to foot". Therapeutic measures were taken as a result of thrombosis. Clinical course: The patient had blood clot that started in leg went down to foot and had to have a portion of his foot and 2 smallest toes amputated. The patient had no family history of blood clots.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, a possible contributory role of the suspect product cannot be excluded for the reported events 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
Symptoms: Deafness unilateral
Clinical narrative: Developed hearing loss in one ear; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DEAFNESS UNILATERAL (medically significant), outcome "unknown", described as "Developed hearing loss in one ear ". Clinical Course: Developed hearing loss in one ear after receiving vaccine. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event (DEAFNESS UNILATERAL) and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 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), for COVID-19 immunization, reaction(s): "Sore arm"; Bnt162b2 (Dose: 2), for COVID-19 immunization, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: It was reported that, he and his wife took the initial Pfizer COVID vaccine and the bivalent COVID vaccine last Oct and had a sore arm. His wife started taking Miralax (propylene glycol) and possibly had a reaction to it. He wanted to know if vaccines have the same product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: minor body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old patient received BNT162b2 (BNT162B2), on 24Jan2021 at 12:00 as dose 1, single (Lot number: EL8982) at the age of 50 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (ongoing). Concomitant medication(s) included: ZOLOFT oral taken for anxiety, start date: 2003 (ongoing). The following information was reported: PAIN (non-serious) with onset 24Jan2021, outcome "recovered" (25Jan2021), described as "minor body aches". Therapeutic measures were not taken as a result of pain.  Additional information: The first 2 vaccines resulted in minor body aches that lasted about 24 hours. Not serious, no medical attention was required. Relevant tests and specific relevant tests for thromboembolic events with thrombocytopenia were none.
Age: 43.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Vaccination site erythema, Vaccination site induration
Clinical narrative: Injection site redness and induration; Injection site redness and induration; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 at 10:15 as dose 4 (booster), single (Lot number: GJ6742) at the age of 43 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 01Nov2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: prior to vaccination; "chronic autoimmune hives" (unspecified if ongoing); "ocular migraines" (unspecified if ongoing). Concomitant medication(s) included: ALLI; MVI [VITAMINS NOS]; CULTURELLE; CETIRIZINE; TYLENOL. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE INDURATION (non-serious) all with onset 02Nov2022 at 12:00, outcome "recovering" and all described as "Injection site redness and induration". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site induration.  Additional information: The patient had no known allergies. The patient first noticed the redness and induration at the injection site on left arm around noon on 02Nov2022. She can see it and feel the induration when touched. It is tender to the touch but did not feel the redness or induration prior to that. It is currently ongoing. There is mild sensitivity at the injection site only. The patient was not tested for COVID-19 post-vaccination.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Vertigo
Clinical narrative: Extreme vertigo lasting more than one month; brain fog; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 14:00 as dose 4 (booster), single (Lot number: FiH9694) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "atrial flutter" (unspecified if ongoing); "GERD" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hx breast CA" (unspecified if ongoing); "known allergies: sulpha" (unspecified if ongoing). Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE MAGNESIUM]; FAMOTIDINE; METOPROLOL; XARELTO; ATORVASTATIN. Past drug history included: Iodine, reaction(s): "known allergies: Iodine". Vaccination history included: moderna covid-19 vaccine (Dose 1,, lot number: 026L20A, administration time: 07:00 PM, vaccine location: Left arm, ), administration date: 13Jan2021, when the patient was 67-year-old, for COVID-19 immunization; moderna covid-19 vaccine (Dose 2,, lot number: 010M20A, administration time: 12:00 PM, vaccine location: Left arm), administration date: 26Feb2021, when the patient was 67-year-old, for COVID-19 immunization; moderna covid-19 vaccine (Dose 3,, lot number: 939905, administration time: 03:00 PM, vaccine location: Left arm), administration date: 01Nov2021, when the patient was 68-year-old, for COVID-19 immunization. The following information was reported: VERTIGO (non-serious) with onset 29Sep2022 at 06:00, outcome "recovering", described as "Extreme vertigo lasting more than one month"; BRAIN FOG (non-serious) with onset 29Sep2022 at 06:00, outcome "recovering". The events "extreme vertigo lasting more than one month" and "brain fog" required physician office visit. Therapeutic measures were taken as a result of vertigo, brain fog. Additional information: the patient had no other vaccine in four weeks. The patient had no been diagnosed with COVID-19 prior to vaccination, didn't tested for COVID-19 after vaccination. Treatment: Physical therapy, medication, home exercises.