chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech 24Sep2022 / moderna 4Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "bronchiecstasis" (unspecified if ongoing); "known allergies: stone fruits, melons" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Sep2022, outcome "unknown", described as "Pfizer / BioNTech 24Sep2022 / moderna 4Apr2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received COVID 19 treatment with Paxlovid from 07Jan2023 to 11Jan2023.  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.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna, Date: 28Sep2022; Pfizer / BioNTech, Date: 05May2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 05May2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Sep2022 as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ROSUVASTATIN, start date: 01Oct2018, stop date: 03Jan2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Sep2022, outcome "not recovered", described as "Moderna, Date: 28Sep2022; Pfizer / BioNTech, Date: 05May2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (18Jan2023) Positive, notes: Positive antigen test 10 days after end of Paxlovid course. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 04Jan2023 to 08Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for COVID-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Brand was paxlovid, treatment start date at 06Jan2023, treatment stop date at 11Jan2023, indication was treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngeal swab
Clinical narrative: Covid - AG + test 18Jan; Covid - AG + test 18Jan; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 4 (booster), single (Lot number: gj6742) at the age of 49 years intramuscular, in left arm 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Jan2023, outcome "recovering" and all described as "Covid - AG + test 18Jan". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (18Jan2023) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events  drug ineffective/COVID 19 and the suspect drug BNT162B2 cannot be excluded.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: GS2524) at the age of 73 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Batch/Lot number: unknown), on 11Feb2021 as dose 2, single (Lot number: EM6201) and on 21Oct2021 as dose 3 (booster), single (Lot number: FE3590) for covid-19 immunisation. The patient's relevant medical history included: "Secondary Hypothyroidism" (unspecified if ongoing); "BPH" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (16Jan2023) Negative; (19Jan2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The patient received Paxlovid for treatment of COVID-19 from 09Jan2023 to 13Jan2023. He completed the 5-day Paxlovid treatment on 13Jan2022. He tested negative on 16Jan. He tested positive for Covid on 19Jan. He had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Seizure
Clinical narrative: seizures; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 at 10:30 as dose 2, single (Lot number: En6204) at the age of 22 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (prev. dose product COVID 19, prev. dose brand Pfizer, prev. dose brand unknown False, is bivalent False, prev. dose lot number En6202, prev. dose lot unknown False, prev. dose administration date 25Feb2021, prev. dose administration time 09:45 AM, prev. dose number 1, prev. dose vaccine location Left arm), administration date: 25Feb2021, when the patient was 22-year-old, for Covid-19 Immunization. The following information was reported: SEIZURE (hospitalization, disability, medically significant) with onset 27Jun2021 at 15:30, outcome "not recovered", described as "seizures". The patient was hospitalized for seizure (hospitalization duration: 1 day(s)). The event "seizures" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Electrocardiogram: Unknown Results, notes: AE treatment. Therapeutic measures were taken as a result of seizure.  Clinical course: Report about covid vaccine yes, Reporter type patient, Facility type vaccine military Base, no other vaccine in four weeks, About four months after having the covid-19 shot I started to have seizures. After having my first seizure I was put on seizure medication. The first medication was Keppra When on it I was suicidal moments and really depressed. I did not help with the seizure cause shortly after about three months later I had another seizure. After talking with doctors they put me on LaCosamide, with be on that medication it slowed down the seizures to every seven months. This effected my military career in the army. Now I'm being medically discharged. Ae resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage], No covid prior vaccination, no covid tested post vaccination.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose number unknown (booster), single (Lot number: GH9702) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jan2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jan2023) Positive, notes: I tested positive for Covid on 04Jan23; (12Jan2023) Negative, notes: I tested negative on 12Jan23 and 13Jan2023; (13Jan2023) Negative, notes: I tested negative on 12Jan23 and 13Jan2023; (15Jan2023) Positive, notes: I tested positive again on the morning of 15Jan2023. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not receive other medication in 2weeks. Patient had no known allergies and patient was extremely healthy. I tested positive for Covid on 04Jan23 and was prescribed Paxlovid. I tested negative on 12Jan23 and 13Jan2023 and then had a rebound on the evening of 14Jan2023 from taking Paxlovid. I tested positive again on the morning of 15Jan2023 with much more sever cold symptoms. Treatment start date was 04Jan2023 and stop date was 08Jan2023.  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: UNK
Symptoms: Death
Clinical narrative: killed my mother and my father; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient 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: DEATH (death, medically significant), outcome "fatal", described as "killed my mother and my father". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical Course: Caller received an email from Pfizer. It was asking her to take a Covid vaccine. She wants to know how we got her email address. She states I am just really upset. You dont have any business having my email address. I am going to tell you right now; your vaccination killed my mother and my father. I became an orphan in 14 days. useless vaccination. (Name withheld) needs to burn in hell. He knew.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300030989 same reporter/product/AE, different patient;; Reported Cause(s) of Death: killed my mother and my father
Sex: F
Vaccine: COVID19
Symptoms: Injection site nodule, Interchange of vaccine products, Lymphadenopathy, Off label use
Clinical narrative: swollen lymph node in collarbone; 3-4 nodules in her left bicep, the same arm where vaccine was given; Off label use; interchange of vaccine products; 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), in Nov2021 as dose 2 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (1st vaccine was J&J), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious) with onset Nov2021, outcome "unknown"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset Nov2021, outcome "unknown"; LYMPHADENOPATHY (non-serious), outcome "recovered", described as "swollen lymph node in collarbone"; INJECTION SITE NODULE (non-serious), outcome "not recovered", described as "3-4 nodules in her left bicep, the same arm where vaccine was given". The event "3-4 nodules in her left bicep, the same arm where vaccine was given" required physician office visit. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Additional information: Pfizer COVID 19 Vaccine - Adult formulation, booster in Nov2021, Not Omicron formulation per patient. Purple or Gray cap formulation not confirmed by patient other than date of vaccination. Patient noted that this would be her 2nd dose total, but also referred to as her booster dose. 1st vaccine was J&J. The patient was told that where these nodules were not her lymph nodes. She was looking for guidance outside of lymph node concerns following the vaccination. Doctors didn't know she stated so she then spoke with her pharmacist who told her to call Pfizer to see if they have seen other issues. She did have a swollen lymph node in collarbone, that has since went down. She now reported having 3-4 nodules in her left bicep, the same arm where vaccine was given. That is where her concern is at this time she stated. It has been over one year and now she had at least 3 and she verbalized concerns of not getting answers.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Diagnosed with covid after getting pfizer covid bivalent booster/ covid symptomatic; Diagnosed with covid after getting pfizer covid bivalent booster/ covid symptomatic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Jan2023 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cardiac arrhythmia", start date: 1985 (ongoing). Concomitant medication(s) included: ELIQUIS taken for arrhythmia.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Jan2023, outcome "unknown" and all described as "Diagnosed with covid after getting pfizer covid bivalent booster/ covid symptomatic". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jan2023) positive, notes: Result: positive; Unit: Not Provided; (16Jan2023) positive, notes: She did her first self test on 16Jan2023 and that was a strong positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: It was reported that, patient had other medications that are prescribed for other problems. One medication had to be modified since it is an anticoagulant for a cardiac arrhythmia, clarifies the medication is Eliquis. Manufacturers bottle is mainly covered by pharmacy label and unable to provide lot, ndc, or expiration. She has taken Eliquis for several years. Cardiac arrhythmia with any other treatment other than beta blockers which she has been taking since the mid 80s. She had an antigen rapid test this morning, it was self administered, which still shows positive for covid. She is a little spacy here, she became covid symptomatic on Saturday 14Jan2023. On the 06Jan2023 she had the Pfizer bivalent booster. She does not have vaccine card handy to provide further details. She did her first self test on 16Jan2023 and that was a strong positive. Paxlovid was started on 17Jan2023.   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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; 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 27Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Mar2021 as dose 2, single (Lot number: EN6798), in left arm, on 02Oct2021 as dose 3 (booster), single (Lot number: FE3592), in left arm, on 02Feb2021 as dose 1, single (Lot number: EL9266), in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FK9896), in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "glaucoma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer Dose 5 14Sep2022, Moderna Dose 4 18Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (bootser), single (Lot number: GH9702) at the age of 53 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Apr2021 as dose 1, single (Lot number: 002C21A), in left arm, on 17May2021 as dose 2, single (Lot number: 034C21A), on 24Nov2021 as dose 3 (booster) single (Lot number: O31H21A) and on 18Apr2022 as dose 4 (booster), single (Lot number: 056A22A) for covid-19 immunisation. The patient's relevant medical history included: "Reactive airway" (unspecified if ongoing); "known allergies: many foods, but not life-threatening" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 14Sep2022, outcome "unknown", described as "Pfizer Dose 5 14Sep2022, Moderna Dose 4 18Apr2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Report about covid treatment was reported as yes. Reporter type patient. Vaccine received was reported as yes. Other medication in 2weeks was reported as no. Patient received Paxlovid treatment from 10Jan2023 to 15Jan2023 for Covid-19.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I tested negative for several days; Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medication in 2 weeks.   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.
Age: 56.0
Sex: M
Vaccine: COVID19, 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 57-year-old male patient received BNT162b2 (BNT162B2), on 01Jun2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure"; "Known allergies: sulfa based antibiotics". Concomitant medication(s) included: LISINOPRIL, start date: 01Feb2019. Past drug history included: Vicodin, reaction(s): "Known allergies: Vicodin". 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 drug ineffective, covid-19 and included treatment with Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CKD" (unspecified if ongoing); "acid reflux" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; NEXIUM [ESOMEPRAZOLE SODIUM]; ROSUVASTATIN. The patient has no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (14Jan2023) negative, notes: Tested negative for COVID on day 4 and day 6; (16Jan2023) negative, notes: Tested negative for COVID on day 4 and day 6; (19Jan2023) positive, notes: tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 11Jan2023 to 15Jan2023. Clinical course: COVID symptoms were gone by day 3 after starting paxlovid. Tested negative for COVID on day 4 and day 6. Symptoms returned on day 9 and tested positive again.  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: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral thrombosis, Memory impairment
Clinical narrative: cerebral blood clot three months after the Pfizer Covid Booster.; memory fog; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 48-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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), for Covid-19 Immunization, reaction(s): "memory fog"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "memory fog". The following information was reported: CEREBRAL THROMBOSIS (medically significant), 3 months after the suspect product(s) administration, outcome "unknown", described as "cerebral blood clot three months after the Pfizer Covid Booster."; MEMORY IMPAIRMENT (non-serious), outcome "recovered", described as "memory fog".  Clinical course: Patient had three Pfizer shots and no issues except some memory fog that lasted 6 weeks and then was gone. The patient developed a cerebral blood clot three months after the Pfizer Covid Booster. Stroke team of cardiologists and neurologists narrowed down the cause of the blood clot to the mRNA 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: Linked Report(s) : US-PFIZER INC-PV202300013179 Same reporter, same patient, same product, different dose, different event.;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral thrombosis
Clinical narrative: cerebral blood clot three months after the Pfizer Covid Booster.; memory fog; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 48-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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), for Covid-19 Immunization, reaction(s): "memory fog"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "memory fog". The following information was reported: CEREBRAL THROMBOSIS (medically significant), 3 months after the suspect product(s) administration, outcome "unknown", described as "cerebral blood clot three months after the Pfizer Covid Booster."; MEMORY IMPAIRMENT (non-serious), outcome "recovered", described as "memory fog".  Clinical course: Patient had three Pfizer shots and no issues except some memory fog that lasted 6 weeks and then was gone. The patient developed a cerebral blood clot three months after the Pfizer Covid Booster. Stroke team of cardiologists and neurologists narrowed down the cause of the blood clot to the mRNA 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: Linked Report(s) : US-PFIZER INC-PV202300013179 Same reporter, same patient, same product, different dose, different event.;
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; 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 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 3 (booster), single at the age of 61 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" 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 drug ineffective, covid-19 and included treatment with Paxlovid.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: UNK
Symptoms: Death
Clinical narrative: vaccination killed my mother and my father; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient 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: DEATH (death, medically significant), outcome "fatal", described as "vaccination killed my mother and my father". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300029178 same reporter/product/AE, different patient;; Reported Cause(s) of Death: killed my mother and my father
Sex: M
Vaccine: UNK
Symptoms: Blood cholesterol normal, Cerebrovascular accident
Clinical narrative: Stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient 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: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Stroke". The patient underwent the following laboratory tests and procedures: Blood cholesterol: 139.  Clinical course: Reporter stated I just want you to know that my husband suffered a stroke and I'm coming after you ! I'm filling a lawsuit against pfizer for this vaccine you made! I'm not going to give up till the public knows your vaccines are causing strokes and heart attacks. The dr even said to us that it was the vaccine. My husband is super healthy, cholesterol of 139 . Works out everyday. Shame on you , you will pay for this. See you in court.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes with all 3 Pfizer shots. Swollen lymph nodes on collar, neck, groin,bone/ Went to urgent care and side swollen lymph nodes were due to vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A 49-year-old female patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Swollen lymph nodes with all 3 Pfizer shots. Swollen lymph nodes on collar, neck, groin, bone/ Went to urgent care and side swollen lymph nodes were due to vaccine". The events "swollen lymph nodes with all 3 Pfizer shots. swollen lymph nodes on collar, neck, groin, bone/ went to urgent care and side swollen lymph nodes were due to vaccine" required emergency room visit.  Additional Information: It was reported that swollen lymph nodes with all 3 Pfizer shots. Swollen lymph nodes on collar, neck, groin, bone. Went away after a week each time. Went to urgent care and said swollen lymph nodes were due to vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Head discomfort, Headache, Tinnitus
Clinical narrative: tinnitus, more apparent in one ear but in both; mild headache; pressure in head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 54-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 included: "Slightly overweight" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing), notes: High cholesterol managed by meds; "spontaneous tinnitus" (unspecified if ongoing). The patient's 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: TINNITUS (non-serious), outcome "unknown", described as "tinnitus, more apparent in one ear but in both"; HEADACHE (non-serious), outcome "unknown", described as "mild headache"; HEAD DISCOMFORT (non-serious), outcome "unknown", described as "pressure in head". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Experienced tinnitus, more apparent in one ear but in both. Also a mild headache and pressure in head. Both symptoms started a few hours after receiving booster dose.  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: UNK
Symptoms: Deafness neurosensory
Clinical narrative: lost partial hearing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient 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: DEAFNESS NEUROSENSORY (medically significant), outcome "unknown", described as "lost partial hearing".  Clinical course: My brother, who lost partial hearing post vaccine; my son's ear doctor says he too was witnessing this post vaccine ("Neurosensory" hearing loss) in several of his patients.  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: Cardiac disorder
Clinical narrative: one has documented heart changes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: CARDIAC DISORDER (non-serious), outcome "unknown", described as "one has documented heart changes".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: UNK
Symptoms: Computerised tomogram normal, Electrocardiogram normal, Hypertension, Myocardial infarction, Myocardial necrosis marker increased
Clinical narrative: elevated cardiac enzymes; Heart attack; extreme hypertension; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 73-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "TAVR" (unspecified if ongoing), notes: TAVR patient. The patient's concomitant medications were not reported. The following information was reported: MYOCARDIAL NECROSIS MARKER INCREASED (medically significant), outcome "unknown", described as "elevated cardiac enzymes"; MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "Heart attack"; HYPERTENSION (non-serious), outcome "unknown", described as "extreme hypertension". The patient underwent the following laboratory tests and procedures: Computerised tomogram: Normal; Electrocardiogram: Normal; Myocardial necrosis marker: Elevated. Clinical course: Optional Information: TAVR (Transcatheter aortic valve replacement) patient, heart in great condition, no visible signs of damage of obstruction. EKG normal, CT scan normal, only elevated cardia enzymes and extreme hypertension scan normal, only elevated cardia enzymes and extreme hypertension. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: cardiac event; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 21-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: CARDIAC DISORDER (death), outcome "fatal", described as "cardiac event". The patient date of death was unknown. Reported cause of death: "Cardiac event".  Clinical information: Caller was a doctor and would like to know how many boosters shots Pfizer wanted to give out because he had seen devastation from these shots with his patients and mentioned that these shots didn't work. They did more harm than good. MRNA was dangerous to humans. He also mentioned that he had a 21-year-old boy die after a booster from a cardiac event. He also mentioned that it was going to be a lawsuit of epic proportion because this booster and this vaccine was killing people.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the event cardiac disorder  and the suspect drug 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.; Reported Cause(s) of Death: Cardiac event
Sex: U
Vaccine: UNK, UNK
Symptoms: Cerebrovascular accident, Chest pain, Laboratory test, Multiple sclerosis
Clinical narrative: After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS.; After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS.; After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old patient received BNT162b2 (BNT162B2 NOS), 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: Covid-19 vaccine (Dose: 01; Unknown manufacturer, Lot number: unknown), for Covid-19 immunization.  The following information was reported: MULTIPLE SCLEROSIS (medically significant), CEREBROVASCULAR ACCIDENT (medically significant), CHEST PAIN (non-serious), outcome "unknown" and all described as "After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS.". The event "after 2nd vaccine, chest pain felt like stroke while driving. er. redid lab work. bad. ms." required emergency room visit. The patient underwent the following laboratory tests and procedures: Lab test: Unknown results, notes: Redid lab work.  Clinical course: Patient injured by 2nd Pfizer vaccine, needed for employment. Super healthy 58 years; only go to doctor for annual physical. After lab work each year my doctor says, "You are the healthiest person I have ever seen in my life!" After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS. Now, 5 years to live and ruined Patient's life.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: UNK, UNK
Symptoms: Biopsy skin abnormal, Cardiac monitoring, Chest X-ray, Chest pain, Differential white blood cell count
Clinical narrative: After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS.; After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS.; After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old patient received BNT162b2 (BNT162B2 NOS), 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: Covid-19 vaccine (Dose: 01; Unknown manufacturer, Lot number: unknown), for Covid-19 immunization.  The following information was reported: MULTIPLE SCLEROSIS (medically significant), CEREBROVASCULAR ACCIDENT (medically significant), CHEST PAIN (non-serious), outcome "unknown" and all described as "After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS.". The event "after 2nd vaccine, chest pain felt like stroke while driving. er. redid lab work. bad. ms." required emergency room visit. The patient underwent the following laboratory tests and procedures: Lab test: Unknown results, notes: Redid lab work.  Clinical course: Patient injured by 2nd Pfizer vaccine, needed for employment. Super healthy 58 years; only go to doctor for annual physical. After lab work each year my doctor says, "You are the healthiest person I have ever seen in my life!" After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS. Now, 5 years to live and ruined Patient's life.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: UNK, UNK
Symptoms: Electric shock sensation, Electrocardiogram, Epstein-Barr virus test positive, Fatigue, Fibrin D dimer
Clinical narrative: After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS.; After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS.; After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old patient received BNT162b2 (BNT162B2 NOS), 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: Covid-19 vaccine (Dose: 01; Unknown manufacturer, Lot number: unknown), for Covid-19 immunization.  The following information was reported: MULTIPLE SCLEROSIS (medically significant), CEREBROVASCULAR ACCIDENT (medically significant), CHEST PAIN (non-serious), outcome "unknown" and all described as "After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS.". The event "after 2nd vaccine, chest pain felt like stroke while driving. er. redid lab work. bad. ms." required emergency room visit. The patient underwent the following laboratory tests and procedures: Lab test: Unknown results, notes: Redid lab work.  Clinical course: Patient injured by 2nd Pfizer vaccine, needed for employment. Super healthy 58 years; only go to doctor for annual physical. After lab work each year my doctor says, "You are the healthiest person I have ever seen in my life!" After 2nd vaccine, chest pain felt like stroke while driving. ER. Redid lab work. Bad. MS. Now, 5 years to live and ruined Patient's life.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.