chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient had 1st dose of Pfizer (05May2021), 2nd dose was Moderna Covid-19 booster (monovalent) (02Dec2021); Patient had 1st dose of Pfizer (05May2021), 2nd dose was Moderna Covid-19 booster (monovalent) (02Dec2021); 2nd dose was Moderna Covid-19 booster (monovalent); This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient had 1st dose of Pfizer (05May2021), 2nd dose was Moderna Covid-19 booster (monovalent) (02Dec2021)), COVID-19 IMMUNISATION (Patient had 1st dose of Pfizer (05May2021), 2nd dose was Moderna Covid-19 booster (monovalent) (02Dec2021)), WRONG PRODUCT ADMINISTERED (2nd dose was Moderna Covid-19 booster (monovalent)) and NO ADVERSE EVENT (No adverse event) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer (1st dose) on 05-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer.    On 02-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient had 1st dose of Pfizer (05May2021), 2nd dose was Moderna Covid-19 booster (monovalent) (02Dec2021)), COVID-19 IMMUNISATION (Patient had 1st dose of Pfizer (05May2021), 2nd dose was Moderna Covid-19 booster (monovalent) (02Dec2021)) and WRONG PRODUCT ADMINISTERED (2nd dose was Moderna Covid-19 booster (monovalent)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient had 1st dose of Pfizer (05May2021), 2nd dose was Moderna Covid-19 booster (monovalent) (02Dec2021)), COVID-19 IMMUNISATION (Patient had 1st dose of Pfizer (05May2021), 2nd dose was Moderna Covid-19 booster (monovalent) (02Dec2021)), WRONG PRODUCT ADMINISTERED (2nd dose was Moderna Covid-19 booster (monovalent)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (Patient had 1st dose of Pfizer (05May2021), 2nd dose was Moderna Covid-19 booster (monovalent) (02Dec2021)), COVID-19 IMMUNISATION (Patient had 1st dose of Pfizer (05May2021), 2nd dose was Moderna Covid-19 booster (monovalent) (02Dec2021)) and WRONG PRODUCT ADMINISTERED (2nd dose was Moderna Covid-19 booster (monovalent)).    No concomitant medications were reported.  No treatment medications were reported.
Age: 5.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products
Clinical narrative: old patient received a Bivalent booster of Moderna COVID-19 vaccine on 27JAN2023 instead of Pfizer; Revaccination with different COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (old patient received a Bivalent booster of Moderna COVID-19 vaccine on 27JAN2023 instead of Pfizer) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) in a 5-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE on 05-Aug-2022 and PFIZER BIONTECH COVID-19 VACCINE on 02-Sep-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 27-Jan-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Jan-2023, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (old patient received a Bivalent booster of Moderna COVID-19 vaccine on 27JAN2023 instead of Pfizer) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (old patient received a Bivalent booster of Moderna COVID-19 vaccine on 27JAN2023 instead of Pfizer) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: after the first three doses everything was ok, aside from headache and chills.; after the first three doses everything was ok, aside from headache and chills.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15-year-old female patient received BNT162b2 (BNT162B2), on 19May2021 as dose 1, single (Lot number: EW0164) at the age of 14 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), CHILLS (non-serious), outcome "unknown" and all described as "after the first three doses everything was ok, aside from headache and chills.".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300039544 same product and patient, different dose;US-PFIZER INC-202300039545 same product and patient, different dose;US-PFIZER INC-202300039546 same product and patient, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: severe illness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  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: ILLNESS (non-serious), outcome "unknown", described as "severe illness".  Additional information: Calling about the Pfizer COVID-19 vaccine. The reporter added that she lost her nephew due to a severe side effect and a heart attack after getting the vaccine and her niece got a severe illness from taking bad shots of the vaccine. The reporter also said why we are giving this to people and it's having side effects because it was not tested.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke after first Covid vaccine; 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 58-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "recovered", described as "Stroke after first Covid vaccine". The event "stroke after first covid vaccine" required physician office visit.  Clinical course: Caller stated that he had refused to get the Covid booster. No other condition, no investigations performed and no other product used. Caller asked if Pfizer had a compensation program from his Oct shot. Agent does not provide a year. Later in report, Caller corrected some of this information. Patient stated that had six strokes since got the Covid 19 shot. Later in report, Caller corrected this information provided by agent. He had been unable to work for 18 months. The patient can provide the information of hcp later and declined to provide this time. Onset time: first stroke mid-afternoon; second stroke and blood clot mid-afternoon. Patient stated a date but then when clarified later on stated as unknown, he does not have his vaccine card with him at the time of call to provide dates. He went to see his doctor; was not hospitalized, told to stop work. Route of administration reported as left arm maybe. No other prior vaccinations within 4 weeks and no details provided on family medical history relevant to adverse events.  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-202300039677 same product, patient, different AEs, different dose;
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 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), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: after 4 negative,antigen tests 4 different days; Negative, notes: after 4 negative, antigen tests 4 different days; Negative, notes: after 4 negative, antigen tests 4 different days; Negative, notes: after 4 negative, antigen tests 4 different days; positive, notes: new positive test with moderate symptoms Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: No, other medication in 2 weeks. Rebound in six days, after 4 negative antigen tests 4 different days, new positive test with moderate symptoms covid. No known allergies.  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.; Sender's Comments: Based on the available information in the case, the causal association between the events  drug ineffective, covid-19 and the suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Transient ischaemic attack
Clinical narrative: Transient ischemic attack (TIA) - Mini Stroke; Dose Number: 1, Date: Jan2022 / Dose Number: 2, Date: Aug2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Aug2022 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 Number: 1, product=COVID 19,, brand=Pfizer-BioNTech COVID-19 vaccine,, lot unknown reason=Not available/provided to reporter at the time of report completion,, administration date=Jan2022,, administration time=01:15 PM), administration date: Jan2022, for COVID-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset Aug2022, outcome "unknown", described as "Dose Number: 1, Date: Jan2022 / Dose Number: 2, Date: Aug2022"; TRANSIENT ISCHAEMIC ATTACK (hospitalization, disability, medically significant) with onset Nov2022, outcome "not recovered", described as "Transient ischemic attack (TIA) - Mini Stroke". The patient was hospitalized for transient ischaemic attack (hospitalization duration: 2 day(s)). The event "transient ischemic attack (tia) - mini stroke" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of transient ischaemic attack treated with blood thinner and physical therapy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
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 contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 55 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), 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: "Thyroidectomy" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Neggram, reaction(s): "know allergies: Neggram", notes: know allergies: Neggram. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, 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 the Paxlovid from 17Jan2023 to 21Jan2023, for treatment of covid-19. Vaccine lot number unknown as unable to locate or read the details.  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: Illness
Clinical narrative: I got sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  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: ILLNESS (non-serious), outcome "unknown", described as "I got sick". Additional information: My family took this (the vaccine). My family got sick. My neighbor took this. I got sick. And my sister told me they're getting sick from COVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in right 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), 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: "Coronary artery disease" (unspecified if ongoing); "Tree nuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19; The patient received Paxlovid from 08Jan2023 to 13Jan2023. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 51 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20May2022 as dose 4 (booster), single (Lot number: FM7553), 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 had no relevant medical history. Concomitant medication(s) included: VITAMIN D3; PROBIOTIC [BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM LACTIS;BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: took home Ag test, Covid +; took home Ag test, Covid +; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 26-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 07Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 25 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 26Jan2023, outcome "recovering" and all described as "took home Ag test, Covid +". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jan2023) Positive, notes: home Ag test. Therapeutic measures were not taken as a result of covid-19, drug ineffective. Clinical course: patient developed symptoms - headache, body chills, soreness on 26Jan2023, took home Ag test (Nasal swab), Covid + on 27Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, a causal relationship between BNT162b2, and the reported events covid-19, drug ineffective cannot be excluded.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Cardiac function test, Confusional state, SARS-CoV-2 test, Transient ischaemic attack
Clinical narrative: Subject had a TIA; memory loss; confusion/trouble telling time; This is a spontaneous report received from contactable reporter(s) (Other HCP).  An 84-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Lot number: 301558A) at the age of 84 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "aneurysm" (unspecified if ongoing). Patient had no known allergies and didn't have COVID-19 prior to vaccination. Concomitant medication(s) included: INFLUENZA VACCINE (Seqirus), on 19Oct2021 as unk, single. Patient was on BP meds. Vaccination history included: BNT162b2 (Dose 2, lot number: EN6205, administrator route: Intramuscular), administration date: 16Mar2021, when the patient was 83-year-old, for COVID-19 immunization; BNT162b2 (Dose 1, lot number: EL9267, administrator route: Intramuscular), administration date: 21Feb2021, when the patient was 83-year-old, for COVID-19 immunization. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (hospitalization, medically significant) with onset 24Oct2021, outcome "recovered with sequelae", described as "Subject had a TIA"; CONFUSIONAL STATE (hospitalization) with onset 24Oct2021, outcome "recovered with sequelae", described as "confusion/trouble telling time"; AMNESIA (hospitalization) with onset 24Oct2021, outcome "recovered with sequelae", described as "memory loss". The patient was hospitalized for transient ischaemic attack, amnesia, confusional state (hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jul2022) Negative, notes: Blood Test, covid test name post vaccination PCR; Cardiac function test: (unspecified date) unremarkable. Therapeutic measures were taken as a result of transient ischaemic attack, amnesia, confusional state, which included Diagnostic workup (as reported). Clinical course: patient had a TIA and was hospitalized. History includes brain aneurysm noted on Diagnostics but patient was asymptomatic requiring no treatment. Patient had memory Loss, confusion trouble telling time. No motor Weakness. Cardiac workup was unremarkable.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported events Transient ischaemic attack, Amnesia, Confusion cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I have the covid, and I have Pfizer covid shots, the vaccine; I have the covid, and I have Pfizer covid shots, the vaccine; 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 78-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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I have the covid, and I have Pfizer covid shots, the vaccine". Additional information: Serious was reported No.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna Dose Number: 5 ... Pfizer / BioNTech  Dose Number: 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6203), in left arm, on 25Mar2021 as dose 2, single (Lot number: EN6207), in left arm and on 19Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 47 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Nov2021 as dose 3 (booster), single (Lot number: 033F), in right arm and on 14Oct2022 as dose 5 (booster), single (Lot number: 049D22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: seasonal allergies" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Raynaud's" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: Jan2019, stop date: 18Jan2023. Past drug history included: Known allergies: codeine, reaction(s): "Known allergies: codeine". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 14Oct2022, outcome "unknown", described as "Moderna Dose Number: 5 ... Pfizer / BioNTech  Dose Number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Brain injury, Cerebrovascular accident, Gait inability
Clinical narrative: I had a stroke 20 days after my Pfizer shot.; I have damage on the left side of my Brain, but I have damage on the left side of my Brain; I just woke up in the morning and couldn't walk; 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 53-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: "thyroid issues" (unspecified if ongoing), notes: But have thyroid issues and have an autoimmune hasimoto; "autoimmune hasimoto" (unspecified if ongoing), notes: But have thyroid issues and have an autoimmune hasimoto. The patient's concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "I had a stroke 20 days after my Pfizer shot."; BRAIN INJURY (medically significant), outcome "unknown", described as "I have damage on the left side of my Brain, but I have damage on the left side of my Brain"; GAIT INABILITY (non-serious), outcome "unknown", described as "I just woke up in the morning and couldn't walk".  Clinical course: I had a stroke 20 days after my Pfizer shot. I was 53 at the time. I made it in time for major damage to my brain, but I have damage on the left side of my Brain. I want my age added to the stroke victims as I am not 65 or older. But have thyroid issues and have an autoimmune hasimoto. Please respond how I do that be included in that age bracket being lowered. I think autoimmune diseases also have to be considered with the stroke victims because I just woke up in the morning and couldn't walk.  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: Investigation, Neuropathy peripheral
Clinical narrative: Non diabetic neuropathy; 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 68-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1), administration date: 2021, for covid-19 immunization. The following information was reported: NEUROPATHY PERIPHERAL (disability) with onset 2022, outcome "not recovered", described as "Non diabetic neuropathy". The event "non diabetic neuropathy" required physician office visit. The patient was looking to find information, to see if there is any connection between the COVID vaccine and non diabetic neuropathy. He had 2 vaccines towards the end of 2021 and did not get the 3rd one when it became available. He received them both within a few weeks a part of each other, not quite sure when but, was towards end of 2021.  He had each vaccine in opposite shoulder. He has experienced non diabetic neuropathy pretty much in the beginning of last year, 2022. The event has rapidly gotten worse, was not getting any better. It was in his arms, legs, feet, hands and chest. He had neuropathy test results, maybe Mar2022. Therapeutic measures were taken as a result of neuropathy peripheral. Right now, the only thing they knew to do was vitamins.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: A contributory role of BNT162B2 to event non diabetic neuropathy cannot be excluded based on temporal association and available information. 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, COVID19, COVID19
Symptoms: Atrial fibrillation, Cardiac disorder, Chest pain, Hyperhidrosis, Interchange of vaccine products
Clinical narrative: didn't want to go to the hospital because of Covid; didn't want to go to the hospital because of Covid; 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. This report only refers to lack of efficacy for BNT162B2, other events reported.  A 43-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "didn't want to go to the hospital because of Covid". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging heart: Unknown results. Clinical course: He received the booster in the beginning or middle of Dec2021, then on 10Jan2022, 3 or 4 weeks after the booster, he had serious cardiac issues and events that developed in 10Jan2022 and had to go through 6 months of testing and he still have premature atrial contractions (PACs) what they call pre atrial contractions all the time, and other weird stuff. He was not too concerned about it what it really was this mess with one of the females, his daughter had an event. And his father had a heart attached a week after his booster, so he was thinking genetically something may not be jiving. Father had heart attack. His last thing He was talking about in Dec2022, had adverse things, and also migraines terrible for about 3 months. They went away. It was 3 - 4 months after he had the booster, that he had the cardiac events that scared the heck out of me that sent him down the path of troubleshooting route, all the way up to cardiac MRI. He had an episode of atrial fibrillation (Afib), which he had never had. His heart stopped beating for a second and he started passing out. And he started with chest pains. He almost passed out; he went to the ground. There were sweats, chest pain, and he was this close to going to the ER, didn't go because he started feeling okay, didn't want to go to the hospital because of COVID, he wound up going to see his cardiologist the next day. That's when they went down the path of starting to test him for what was going on, with halter monitors, and things of that nature, then in all the halter monitors and studies they found the PACs, supraventricular tachycardia (SVTs), and one episode captured of Afib on one of the devices.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Loss of consciousness, Magnetic resonance imaging heart, Migraine, Myocardial infarction
Clinical narrative: didn't want to go to the hospital because of Covid; didn't want to go to the hospital because of Covid; 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. This report only refers to lack of efficacy for BNT162B2, other events reported.  A 43-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "didn't want to go to the hospital because of Covid". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging heart: Unknown results. Clinical course: He received the booster in the beginning or middle of Dec2021, then on 10Jan2022, 3 or 4 weeks after the booster, he had serious cardiac issues and events that developed in 10Jan2022 and had to go through 6 months of testing and he still have premature atrial contractions (PACs) what they call pre atrial contractions all the time, and other weird stuff. He was not too concerned about it what it really was this mess with one of the females, his daughter had an event. And his father had a heart attached a week after his booster, so he was thinking genetically something may not be jiving. Father had heart attack. His last thing He was talking about in Dec2022, had adverse things, and also migraines terrible for about 3 months. They went away. It was 3 - 4 months after he had the booster, that he had the cardiac events that scared the heck out of me that sent him down the path of troubleshooting route, all the way up to cardiac MRI. He had an episode of atrial fibrillation (Afib), which he had never had. His heart stopped beating for a second and he started passing out. And he started with chest pains. He almost passed out; he went to the ground. There were sweats, chest pain, and he was this close to going to the ER, didn't go because he started feeling okay, didn't want to go to the hospital because of COVID, he wound up going to see his cardiologist the next day. That's when they went down the path of starting to test him for what was going on, with halter monitors, and things of that nature, then in all the halter monitors and studies they found the PACs, supraventricular tachycardia (SVTs), and one episode captured of Afib on one of the devices.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Magnetic resonance imaging heart, Suspected COVID-19
Clinical narrative: didn't want to go to the hospital because of Covid; didn't want to go to the hospital because of Covid; 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. This report only refers to lack of efficacy for BNT162B2, other events reported.  A 43-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "didn't want to go to the hospital because of Covid". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging heart: Unknown results. Clinical course: He received the booster in the beginning or middle of Dec2021, then on 10Jan2022, 3 or 4 weeks after the booster, he had serious cardiac issues and events that developed in 10Jan2022 and had to go through 6 months of testing and he still have premature atrial contractions (PACs) what they call pre atrial contractions all the time, and other weird stuff. He was not too concerned about it what it really was this mess with one of the females, his daughter had an event. And his father had a heart attached a week after his booster, so he was thinking genetically something may not be jiving. Father had heart attack. His last thing He was talking about in Dec2022, had adverse things, and also migraines terrible for about 3 months. They went away. It was 3 - 4 months after he had the booster, that he had the cardiac events that scared the heck out of me that sent him down the path of troubleshooting route, all the way up to cardiac MRI. He had an episode of atrial fibrillation (Afib), which he had never had. His heart stopped beating for a second and he started passing out. And he started with chest pains. He almost passed out; he went to the ground. There were sweats, chest pain, and he was this close to going to the ER, didn't go because he started feeling okay, didn't want to go to the hospital because of COVID, he wound up going to see his cardiologist the next day. That's when they went down the path of starting to test him for what was going on, with halter monitors, and things of that nature, then in all the halter monitors and studies they found the PACs, supraventricular tachycardia (SVTs), and one episode captured of Afib on one of the devices.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dystonia, Limb discomfort, Muscle spasms, Muscle twitching
Clinical narrative: right foot began twisting and clenching uncontrollably; right foot began twisting and clenching uncontrollably; Subtle Twitching of toes on right foot following second inj.; DX'd with Dystonia of the right foot; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 at 11:00 as dose 2, single (Lot number: EP7533) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Bees" (unspecified if ongoing), notes: known allergies: Bees & Custaceans; "known allergies: Custaceans" (unspecified if ongoing), notes: known allergies: Bees & Custaceans. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Right, Vaccine Administration Time: 02:30 PM), administration date: 18Mar2021, when the patient was 60-year-old, for COVID-19 Immunization. The following information was reported: DYSTONIA (disability) with onset May2021, outcome "not recovered", described as "DX'd with Dystonia of the right foot"; MUSCLE SPASMS (disability) with onset May2021, outcome "not recovered", described as "Subtle Twitching of toes on right foot following second inj."; MUSCLE TWITCHING (disability), LIMB DISCOMFORT (disability) all with onset Aug2021, outcome "not recovered" and all described as "right foot began twisting and clenching uncontrollably". The events "subtle twitching of toes on right foot following second inj.", "dx'd with dystonia of the right foot" and "right foot began twisting and clenching uncontrollably" required physician office visit. BNT162b2 (Lot#: FF2590) dose 3 was received on 08Dec2021 at 12:00 AM in left arm. There was no other vaccine in four weeks. Other medications in two weeks was none. Patient had subtle twitching of toes on right foot following second inj. By Aug2021, right foot began twisting and clenching uncontrollably. Patient saw primary care followed by numerous tests and specialist consults. DXd with dystonia of the right foot. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Events treatment including Botox injections foot/leg every 3 months. There was no COVID-19 prior vaccination. COVID-19 was not tested post vaccination.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Her Husband also had the Pfizer COVID Vaccines and he got COVID/ his was like a bad cold; Her Husband also had the Pfizer COVID Vaccines and he got COVID/ his was like a bad cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient's spouse. 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. Caller stated her husband also had the Pfizer COVID Vaccines and he got COVID but he didn't get PAXLOVID, his was like a bad cold.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Her Husband also had the Pfizer COVID Vaccines and he got COVID/ his was like a bad cold". Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: She had the Pfizer COVID Vaccines and the Booster and she still got COVID; She had the Pfizer COVID Vaccines and the Booster and she still got COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 78-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; 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. There were no concomitant medications. Caller stated she had the Pfizer COVID Vaccines and the booster and she still got COVID (in the middle of Sep2022). Stated she had gotten the vaccines way previously but she was surprised she still got COVID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "She had the Pfizer COVID Vaccines and the Booster and she still got COVID". Therapeutic measures were taken as a result of drug ineffective, 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.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: This genocide this bioweapon; My father and my cousin had died so far; This is a spontaneous report received from a non-contactable reporter (Nurse).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as DOSE NUMBER UNKNOWN, SINGLE (batch/ot number: unknown) for COVID-19 immunization. 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 "This genocide this bioweapon; My father and my cousin had died so far." The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Additional information: The reporter (Registered Nurse) stated, "I am not worrying about getting disconnected. Are you involved in this genocide this bioweapon COVID 19 jab (COVID-19 Vaccine)? Do you know it is a withheld violation? You are a pharmacist you know what is going on. Yes, I am a registered nurse and I know what is going on to the violation. I have known for two years why you knew 6 months after Pfizer did, that is what going to happen to Pfizer. Where you located are you in (country)?" Reporter further stated, "I hope you are not involved in this Genocide because you know what they did with other people (not clarified) and knowingly or just say I was doing my job getting proud of it either then people also bring violation. You know about (withheld) do you not? You are educated you are a Pharmacist. What about this fake protein mRNA's that's making people 'creates' by protein? Did you have any family members died yet? My father and my cousin had died so far. Did you have anyone died in (country) or do they ban it in (country)?" Reporter also stated, "Can you have false information? Who would believe Pfizer. You are part of that plan. (withheld) 2.0 study up on that, you know they hung people (further clarifications unknown)." The Reporter hung up the call abruptly. Thus, further probing was not done.   No follow-up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information. 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-202300043076 same reporter/drug/event, different patient;; Reported Cause(s) of Death: This genocide this bioweapon; My father and my cousin had died so far