chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Echocardiogram, Heart valve incompetence, Rash
Clinical narrative: Full body rash covering 95% of my body.; 3 valve heart regurgitation.; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "HTN" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Ambien, reaction(s): "Known allergies: Ambien", notes: Known allergies: Ambien. Vaccination history included: BNT162b2 (Prev dose lot Number: LL8982, Prev dose administration date: 28Jan2021, Prev dose dose number: 2), administration date: 28Jan2021, when the patient was 36-year-old, for COVID-19 immunization; BNT162b2 (Prev dose lot Number: EJ1685, Prev dose administration date: 07Jan2021, Prev dose dose number:1), administration date: 07Jan2021, when the patient was 36-year-old, for COVID-19 immunization. The following information was reported: HEART VALVE INCOMPETENCE (disability) with onset 10Feb2022, outcome "recovered with sequelae" (2022), described as "3 valve heart regurgitation."; RASH (disability) with onset 10Feb2022, outcome "recovered with sequelae" (2022), described as "Full body rash covering 95% of my body.". The event "full body rash covering 95% of my body." required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy skin: Unknown results, notes: Multiple skin biopsies; Echocardiogram: Unknown results. Therapeutic measures were taken as a result of rash, heart valve incompetence.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug 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: Dementia
Clinical narrative: dementia; This is a spontaneous report received from a contactable reporter(s) (Physician).  An elderly male 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 Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: DEMENTIA (disability, medically significant), outcome "not recovered". It was unknown if therapeutic measures were taken as a result of dementia.  Clinical course: the patient age was 65+ Years. Patient was moved to a long term care facility. Patient healthy before mentally and physically. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknwon if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient has been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case narrative, a causal association between reported event dementia and suspect BNT162B2 cannot be excluded. Case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 71.0
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) from product quality group. The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 71 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: GR8730), in left arm, on 19Apr2021 as dose 2, single (Lot number: GW0161), in left arm, on 23Oct2021 as dose 3 (booster), single (Lot number: 320308D), in left arm and on 28Apr2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; FENOFIBRATE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient was taking Paxlovid from 19Oct2022 to 23Oct2022 for COVID 19 treatment.  On 31Oct2022, the group reported the following investigational results. Conclusion: The complaint for "PFIZERBIONTECH COVID-19 VACCINE" was investigated. The Investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lots GH9703 and FK9893. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or were identified as the complaint was not confirmed.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Glomerular filtration rate, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from a contactable reporter (Physician) from medical information team.  An 86-year-old male 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's relevant medical history included: "Parkinson's disease" (ongoing); "blood pressure" (unspecified if ongoing); "prostate" (unspecified if ongoing). Concomitant medication(s) included: SINEMET and medication for prostate and blood pressure. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: Glomerular filtration rate: (2022) 94; SARS-CoV-2 test: (2022) Positive, notes: tested positive for 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.; Sender's Comments: A contributory role of BNT162B2 to event Tested positive for COVID-19 cannot be excluded based on temporal association and available information.
Age: 82.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Interchange of vaccine products, Night sweats, Off label use, Product use issue, SARS-CoV-2 test
Clinical narrative: Prev dose brand= Johnson and Johnson, Prev dose administration date= 07Apr2021 / Prev dose brand= Pfizer Booster FH8027, Prev dose administration date=20Nov2021; Really bad night sweats; Other vaccine same date product=Flaurix; Other vaccine same date product=Flaurix; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Oct2022 at 13:00 as dose 3 (booster), single (Lot number: GH9702) at the age of 82 years, in left arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUARIX), on 29Oct2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: TRAZONE [TRAMADOL HYDROCHLORIDE]; VIT C; CALCIUM + MAGNESIUM; ARNICA EXTRACT. Vaccination history included: BNT162b2 (Dose 2 (Booster), Single; Administration site: Left arm; Batch/Lot No. FH8077), administration date: 20Nov2021, when the patient was 81-year-old, for COVID-19 immunization; johnson and johnson (Dose 1, Single; Administration site: Left arm; Batch/Lot No. 042A21A), administration date: 07Apr2021, when the patient was 80-year-old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 29Oct2022, outcome "unknown" and all described as "Other vaccine same date product=Flaurix"; NIGHT SWEATS (non-serious) with onset 30Oct2022 at 15:15, outcome "unknown", described as "Really bad night sweats"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Prev dose brand= Johnson and Johnson, Prev dose administration date= 07Apr2021 / Prev dose brand= Pfizer Booster FH8027, Prev dose administration date=20Nov2021". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of night sweats.  Additional information: Other medications in two weeks was reported as Trazone Vit C Calc-Mag 1 a day Homeopathic Arnica. Known allergies were reported as none.  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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer female, Condition aggravated
Clinical narrative: Patient developed left breast cancer in Feb2022. Feels this is r/t the COVID injections.; Patient developed left breast cancer in Feb2022. Feels this is r/t the COVID injections.; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Aug2021 as dose 2, single (Lot number: FC3182) at the age of 60 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, Batch/Lot No: FB8448, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 10Aug2021, when the patient was 60-year-old, for COVID-19 Immunization. The following information was reported: BREAST CANCER FEMALE (medically significant), CONDITION AGGRAVATED (medically significant) all with onset 15Feb2022, outcome "recovering" and all described as "Patient developed left breast cancer in Feb2022. Feels this is r/t the COVID injections.". The event "patient developed left breast cancer in feb2022. feels this is r/t the covid injections." required physician office visit. Therapeutic measures were taken as a result of breast cancer female, condition aggravated.  Clinical course: Patient developed left breast cancer in Feb2022. Feels this is r/t the COVID injections. Patient had surgery for breast cancer as treatment. Patient did not received any other vaccines in four weeks. It is unknown that the patient had COVID prior vaccination and COVID tested post vaccination. Patient had no known allergies.    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 breast cancer female, condition aggravated and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Interchange of vaccine products, Quality of life decreased, Tinnitus
Clinical narrative: This is a spontaneous report received from a 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 28Sep2022 at 13:45 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing); "Known allergies: Statins" (unspecified if ongoing); "Known allergies: Contrast dye" (unspecified if ongoing); "Mild tinnitus (ringing) of 10+ years" (ongoing). The patient took concomitant medications. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin". Vaccination history included: moderna (Dose 1, Location of injection: Arm left), administration date: 01Feb2021, for COVID-19 immunization, reaction(s): "A day of body ache", "Arm pain", "Fatigue"; moderna (Dose 2, Location of injection: Arm left, Vaccine administration time: 16:00 pm), administration date: 15Mar2021, for COVID-19 immunization, reaction(s): "A day of body ache", "Arm pain", "Fatigue"; moderna (Dose 3, Location of injection: Arm left, Vaccine administration time: 16:00 pm), administration date: 12Nov2021, for COVID-19 immunization, reaction(s): "A day of body ache", "Arm pain", "Fatigue"; moderna (Dose 4, Location of injection: Arm left, Vaccine administration time: 02:30 am), administration date: 22Apr2022, for COVID-19 immunization, reaction(s): "A day of body ache", "Arm pain", "Fatigue".   Additional information: The patient received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. All previous shots were Moderna. All Moderna shots caused a day of body ache, arm pain, fatigue. The Pfizer shot did too but a day or two after the shot the patient noticed that her usually mild tinnitus (ringing) of 10+ years increased significantly. It was ongoing and very loud- loud enough to distract from all activities incl. TV, working outdoors, conversations, working indoors, reading, and writing this description. It decreased the quality of life. If she had known, she would have found the Moderna somewhere else. She emailed her primary who suggested seeing an audiologist which she declined b/c their remedies were few and were not very effective (counselling, masking devices). She knew educated older people who won't get latest booster b/c of severe tinnitus that appeared immediately following a COVID shot. The case was assessed as non-serious.  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: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Oropharyngeal pain, Pain, Somnolence
Clinical narrative: I started with aching; Chills; Sleeping all the time; Sore throat; I cannot hardly talk; I have never been this miserable in my whole life; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, 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 Vaccination. The following information was reported: CHILLS (non-serious) with onset Oct2022, outcome "unknown"; SPEECH DISORDER (non-serious) with onset Oct2022, outcome "unknown", described as "I cannot hardly talk"; FEELING ABNORMAL (non-serious) with onset Oct2022, outcome "unknown", described as "I have never been this miserable in my whole life"; PAIN (non-serious) with onset Oct2022, outcome "unknown", described as "I started with aching"; SOMNOLENCE (non-serious) with onset Oct2022, outcome "unknown", described as "Sleeping all the time"; OROPHARYNGEAL PAIN (non-serious) with onset Oct2022, outcome "unknown", described as "Sore throat".  Additional information: It was reported that patient felt perfectly fine and got this COVID -19 (confirmed as Pfizer COVID-19 vaccine) on Tuesday and Wednesday started with aching, chills and sleeping all the time for 2 days. Patient stated, this was the 3rd day and started, well started yesterday afternoon with the worst, patient thought was getting better and then got the worse sore throat that ever had. When asked if had any questions regarding the concern patient stated, no just wanted to report these symptoms because had the other COVID shots and have not had anything, had all this. Patient thought will never have another one. Patient never had COVID (general statement). When asked to proceed with the question patient stated no cannot, hardly talk. Patient had never been this miserable in whole life.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: I started with aching; Chills; Sleeping all the time; Sore throat; I cannot hardly talk; I have never been this miserable in my whole life; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, 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 Vaccination. The following information was reported: CHILLS (non-serious) with onset Oct2022, outcome "unknown"; SPEECH DISORDER (non-serious) with onset Oct2022, outcome "unknown", described as "I cannot hardly talk"; FEELING ABNORMAL (non-serious) with onset Oct2022, outcome "unknown", described as "I have never been this miserable in my whole life"; PAIN (non-serious) with onset Oct2022, outcome "unknown", described as "I started with aching"; SOMNOLENCE (non-serious) with onset Oct2022, outcome "unknown", described as "Sleeping all the time"; OROPHARYNGEAL PAIN (non-serious) with onset Oct2022, outcome "unknown", described as "Sore throat".  Additional information: It was reported that patient felt perfectly fine and got this COVID -19 (confirmed as Pfizer COVID-19 vaccine) on Tuesday and Wednesday started with aching, chills and sleeping all the time for 2 days. Patient stated, this was the 3rd day and started, well started yesterday afternoon with the worst, patient thought was getting better and then got the worse sore throat that ever had. When asked if had any questions regarding the concern patient stated, no just wanted to report these symptoms because had the other COVID shots and have not had anything, had all this. Patient thought will never have another one. Patient never had COVID (general statement). When asked to proceed with the question patient stated no cannot, hardly talk. Patient had never been this miserable in whole life.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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.  An 85-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 84 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 21Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: HTN; "Arthritis" (unspecified if ongoing); "Cervical dystonia" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing), notes: Known allergies: Shellfish. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti-viral details: Product: COVID-19 Treatment, Brand: Paxlovid, Treatment start date: 14Oct2022, Treatment stop date: 19Oct2022, Indication: Treatment of COVID-19. Adverse event: Headache, fatigue, cough, tight chest, runny nose, decreased sense of smell and taste.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 test positive; COVID-19 test positive; received Moderna as dose 4; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 22Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 22Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESTRADIOL, start date: 01Feb2015; PROGESTERONE, start date: 01Feb2015. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 15Apr2022, outcome "unknown", described as "received Moderna as dose 4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Oct2022, outcome "not recovered" and all described as "COVID-19 test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive; (18Oct2022) Negative; (19Oct2022) Negative; (20Oct2022) Negative; (21Oct2022) Negative; (22Oct2022) Negative; (24Oct2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: The patient tested negative on an antigen rapid test from 18Oct2022 - 22Oct2022. Returned home and tested positive on a rapid antigen test on 24Oct2022. Still testing positive. Symptoms were mild for initial infection. Symptoms were slightly worse on the rebound.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201265273 same patient and reporter, different product and event;
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Gait disturbance, Loss of personal independence in daily activities, Pruritus
Clinical narrative: extremely itchy palms/extremely itchy bottoms of our feet; Pretty exhausted/Worn out/tried the other day; unable to actually walk my dogs around the block because I am so worn out; Couldn't even finish the walk; Off and on shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 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: PRURITUS (non-serious), outcome "unknown", described as "extremely itchy palms/extremely itchy bottoms of our feet"; FATIGUE (non-serious), outcome "unknown", described as "Pretty exhausted/Worn out/tried the other day"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "unable to actually walk my dogs around the block because I am so worn out"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Couldn't even finish the walk"; DYSPNOEA (non-serious), outcome "unknown", described as "Off and on shortness of breath".  Additional information: Consumer stated, her husband and patient both got the Pfizer Bivalent Shot (Clarified as: COVID-19 Vaccine Bivalent). They got that on Wednesday and both of them ended up within 24 hours, of extremely itchy palms and extremely itchy bottoms of their feet, last for couple of hours, kind of weird, never had that before. They are both pretty exhausted and this was now Sunday, patient had been unable to actually walk her dogs around the block because she so worn out. She tried the other day and she couldn't even yesterday and she couldn't even finish the walk barely and she had off and on shortness of breath and she do not know how long these side effects are going to last, But this was the fourth day now, the third day actually. They had the shot (COVID-19 Vaccine Bivalent) on Wednesday. So, she just a little concerned. Consumer stated, her husband had the same effects. Consumer was informed about the Role of Pfizer Drug Safety. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, COVID-19, Delirium, Dizziness
Clinical narrative: sore arm; Fatigue; Kind of delirious; dizzy; Temperature 102. 9; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), in morning on 28Jan2022 as dose 4 (booster), single (Lot number: FJ5683) at the age of 62 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arrhythmia" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL oral taken for arrhythmia (ongoing); MELOXICAM oral taken for arthritis, start date 05Sep and stop date 06Sep. Vaccination history included: BNT162b2 (Dose: 3rd, Date/time:, Date: 31Aug2021, Time: morning, Site and route of injection:, Anatomical site of injection: arm (Left), Route of administration: Intramuscular, Batch/lot number: FA6780), administration date: 31Aug2021, when the patient was 62-year-old, for Covid-19 immunization, reaction(s): "sore arm", "Fatigue"; BNT162b2 (Dose: 2nd, Date/time:, Date: 15Apr2021, Time: morning, Site and route of injection:, Anatomical site of injection: arm (Left), Route of administration: Intramuscular, Batch/lot number: EW0161), administration date: 15Apr2021, when the patient was 62-year-old, for Covid-19 immunization, reaction(s): "sore arm", "Fatigue"; BNT162b2 (Dose: 1st, Date/time:, Date: 05Mar2021, Time: Morning , Site and route of injection:, Anatomical site of injection: arm (Left), Route of administration: Intramuscular, Batch/lot number: EN6207), administration date: 05Mar2021, when the patient was 62-year-old, for Covid-19 immunization, reaction(s): "sore arm", "Fatigue". The following information was reported: DELIRIUM (medically significant) with onset 28Sep2022, outcome "unknown", described as "Kind of delirious"; BODY TEMPERATURE INCREASED (non-serious) with onset 28Sep2022, outcome "unknown", described as "Temperature 102. 9"; DIZZINESS (non-serious) with onset 28Sep2022, outcome "unknown", described as "dizzy"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Body temperature: (28Sep2022) 102. 9 Fahrenheit, notes: Norm Low: 98.6, Norm High: 98.6, Kind of delirious, dizzy; COVID-19: (08Sep2022) positive, notes: I continue to test positive. Clinical course: The patient stated she had no adverse events associated with any of my vaccine, just sore arm plus fatigue for one day.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; Fatigue; Kind of delirious; dizzy; Temperature 102. 9; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), in morning on 28Jan2022 as dose 4 (booster), single (Lot number: FJ5683) at the age of 62 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arrhythmia" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL oral taken for arrhythmia (ongoing); MELOXICAM oral taken for arthritis, start date 05Sep and stop date 06Sep. Vaccination history included: BNT162b2 (Dose: 3rd, Date/time:, Date: 31Aug2021, Time: morning, Site and route of injection:, Anatomical site of injection: arm (Left), Route of administration: Intramuscular, Batch/lot number: FA6780), administration date: 31Aug2021, when the patient was 62-year-old, for Covid-19 immunization, reaction(s): "sore arm", "Fatigue"; BNT162b2 (Dose: 2nd, Date/time:, Date: 15Apr2021, Time: morning, Site and route of injection:, Anatomical site of injection: arm (Left), Route of administration: Intramuscular, Batch/lot number: EW0161), administration date: 15Apr2021, when the patient was 62-year-old, for Covid-19 immunization, reaction(s): "sore arm", "Fatigue"; BNT162b2 (Dose: 1st, Date/time:, Date: 05Mar2021, Time: Morning , Site and route of injection:, Anatomical site of injection: arm (Left), Route of administration: Intramuscular, Batch/lot number: EN6207), administration date: 05Mar2021, when the patient was 62-year-old, for Covid-19 immunization, reaction(s): "sore arm", "Fatigue". The following information was reported: DELIRIUM (medically significant) with onset 28Sep2022, outcome "unknown", described as "Kind of delirious"; BODY TEMPERATURE INCREASED (non-serious) with onset 28Sep2022, outcome "unknown", described as "Temperature 102. 9"; DIZZINESS (non-serious) with onset 28Sep2022, outcome "unknown", described as "dizzy"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Body temperature: (28Sep2022) 102. 9 Fahrenheit, notes: Norm Low: 98.6, Norm High: 98.6, Kind of delirious, dizzy; COVID-19: (08Sep2022) positive, notes: I continue to test positive. Clinical course: The patient stated she had no adverse events associated with any of my vaccine, just sore arm plus fatigue for one day.
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 contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 09:30 as dose 5 (booster), single (Lot number: GH9693), 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 had no relevant medical history. There were no concomitant medications. 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: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 34.0
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; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "overweight" (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 "not recovered" and all described as "Treatment of Covid-19"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown". 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 which included Paxlovid from 07Oct2022 to 12Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: She is experiencing lot of vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent.  A child female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed, unknown manufacturer), for COVID-19 immunization. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "She is experiencing lot of vomiting".  Additional information: Reporter stated, "I gave my child the Bivalent booster shot (Clarified as Pfizer Covid-19 Vaccine Bivalent) on Thursday afternoon. She is experiencing lot of vomiting and I would like to report it and I'd like to know where I can find the information or speak to someone about what to do about her symptoms." Reporter was suggested to contact nearest emergency room or any of the health care providers like a Nurse, Physician or a Pharmacist.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 11:00 as dose 4 (booster), single (Lot number: gh9703), 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INSULIN. 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.  Investigational results for Lot # GH9703: Batch and lot tested and found within specification was checked. Product Description (CR): COMPOUND BNT162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1. Lot-# (CR): GH9703. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for "PFIZER BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9703. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. (Name withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "glaucoma" (unspecified if ongoing); "migraine" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "known allergies: Erythromycin", notes: known allergies: Erythromycin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with onset 27Oct2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (28Oct2022) Positive, notes: Tested positive again for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: It was reported that the patient tested positive again for Covid on 28Oct2022. Event start date reported was 27Oct2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: product=COVID 19 Treatment; patient on paxlovid; product=COVID 19 Treatment; patient on paxlovid; 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 female patient 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "product=COVID 19 Treatment; patient on paxlovid".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
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 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 33 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: "Birth control" (unspecified if ongoing). The patient took concomitant medications: birth control from 01Oct2022 to 20Oct2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (Oct2022) Positive, notes: Positive test. Therapeutic measures taken because of the events included PAXLOVID from 20Oct2022 to 24Oct2022.  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: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 10:30 as dose 5 (booster), single (Lot number: 59267-0304-01) 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), 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: "high blood pressure" (unspecified if ongoing); "Known allergy: Shellfish" (unspecified if ongoing); "low thyroid" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pruritus
Clinical narrative: extremely itchy palms/bottoms of our feet; pretty exhausted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 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: PRURITUS (non-serious) with onset Oct2022, outcome "recovered" (Oct2022), described as "extremely itchy palms/bottoms of our feet"; FATIGUE (non-serious) with onset Oct2022, outcome "unknown", described as "pretty exhausted".  Additional information: Reporter stated, her husband and reporter both got the Pfizer Bivalent Shot (Clarified as: COVID-19 Vaccine Bivalent). They got that on Wednesday and both of them ended up within 24 hours, of extremely itchy palms and extremely itchy bottoms of there feet, last for couple of hours, kind of weird, never had that before. They were both pretty exhausted.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
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 (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 21Jun2022 at 14:00 as dose 2, single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. There were no concomitant medications. The patient had no other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 17Oct2022, outcome "unknown", COVID-19 (medically significant) with onset 17Oct2022, outcome "recovered" (23Oct2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive, notes: been testing positive for last week; (17Oct2022) Positive (POS); (23Oct2022) Negative (NEG); (24Oct2022) Positive, notes: Positive again. Therapeutic measures were taken as a result of COVID-19, which included Paxlovid from 17Oct2022 to 22Oct2022. Clinical course: The patient was positive (POS) on 17Oct2022, negative (NEG) on 23Oct2022, positive again on 24Oct2022, and had been testing positive for last week. It was further reported that the patient had COVID rebound after Paxlovid on 24Oct2022 at 09:00 AM and was recovering with no treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.