chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19-2
Symptoms: Respiratory arrest, Scan brain, Swelling, Swollen tongue
Clinical narrative: cardiomyopathy; anoxic brain damage; had trouble breathing stating she felt she had something in her throat/ loss of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 34-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 at 10:00 as dose 3 (booster), single (Lot number: GK1337) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "obesity" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: If COVID prior vaccination Yes; "Depression" (unspecified if ongoing), notes: Other medications in 2 weeks: :depression and anxiety medicine; "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN; OMEPRAZOLE. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0151, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 08Apr2021, when the patient was 32-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: ER8727, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 18Mar2021, when the patient was 32-year-old, for COVID-19 immunization. The following information was reported: BRAIN INJURY (death, hospitalization, life threatening) with onset 21Dec2022 at 04:30, outcome "fatal", described as "anoxic brain damage"; CARDIOMYOPATHY (death, hospitalization, life threatening) with onset 21Dec2022 at 04:30, outcome "fatal"; DYSPNOEA (death, hospitalization, life threatening) with onset 21Dec2022 at 04:30, outcome "fatal", described as " had trouble breathing stating she felt she had something in her throat/ loss of breath ". The patient was hospitalized for cardiomyopathy, brain injury, dyspnoea, (hospitalization duration: 2 day(s)). The events "cardiomyopathy", "anoxic brain damage" and "had trouble breathing stating she felt she had something in her throat/ loss of breath " required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Dec2022) Negative. Therapeutic measures were taken as a result of cardiomyopathy, brain injury, dyspnoea. The patient date of death was 22Dec2022. Reported cause of death: "Ischaemic cardiomyopathy". No autopsy was performed.  Additional information: 12 days after dose, had trouble breathing Stating she felt she had something in her throat. This led to loss of breath, cardiomyopathy, and anoxic brain damage which resulted in her death. Treatment includes: Ventilator and medications and will need to contact hospital.; Reported Cause(s) of Death: Ischaemic cardiomyopathy
Age: 34.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19-2
Symptoms: Brain injury, Cardiomyopathy, Dyspnoea, SARS-CoV-2 test
Clinical narrative: Week prior to vaccine, had upset stomach and diarrhea for 1 week. 4:30am on 12/21, had swelling in neck and under tongue. Call 911 at or around 5:30am due to unable to breathe. Was rushed to Health facility. She died from anoxic brain damage and Ischemic Cardiomyopathy.
Age: 34.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19-2
Symptoms: Brain injury, Death, Echocardiogram, Ischaemic cardiomyopathy, Mechanical ventilation
Clinical narrative: Week prior to vaccine, had upset stomach and diarrhea for 1 week. 4:30am on 12/21, had swelling in neck and under tongue. Call 911 at or around 5:30am due to unable to breathe. Was rushed to Health facility. She died from anoxic brain damage and Ischemic Cardiomyopathy.
Age: 34.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19, COVID19-2
Symptoms: Respiratory arrest, Scan brain, Swelling, Swollen tongue
Clinical narrative: Week prior to vaccine, had upset stomach and diarrhea for 1 week. 4:30am on 12/21, had swelling in neck and under tongue. Call 911 at or around 5:30am due to unable to breathe. Was rushed to Health facility. She died from anoxic brain damage and Ischemic Cardiomyopathy.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 at 14:00 as dose 5 (booster), single (Lot number: GJ6665) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EN6202), in left arm, on 22Mar2021 as dose 2, single (Lot number: ER2613), in left arm, on 29Sep2021 as dose 3 (booster), single (Lot number: EW0183), in left arm and on 21May2022 at 14:30 as dose 4 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Feb2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Feb2023) Positive; (17Feb2023) Negative; (20Feb2023) Positive. Clinical course: covid rebound, symptoms returned, tested positive again on 20Feb2023 after a negative test on 17Feb2023, first positive test was 11Feb2023. Therapeutic measures paxlovid were taken  from 12Feb2023 to 16Feb2023 as a result of vaccination failure, covid-19.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 17:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 16Apr2022 at 17:15 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: Sulfa" (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 "Covid-19". 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300077638 Same patient, different product and event;
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: EL3246) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: RASH (non-serious), outcome "recovered".  Additional information: The reporter was the patient's mother. Reported that her daughter, after receiving the second dose vaccine, developed a rash that lasted for 6 months. Stated that it was pretty bad. The patient's doctor told her to not get the booster. The patient could not go to work because she has to have the vaccine and booster in. Then, she got COVID and then she could go to work.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300078017 same reporter and patient, different AE;
Sex: F
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) (Other HCP). The reporter is the patient.  A 25-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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 "recovered" (16Feb2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (16Feb2023) Negative. Patient received Paxlovid for COVID 19 Treatment from 09Feb2023 to 14Feb2023. 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 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300079648 Same product and event, different patient;
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: got headache; kind of ached like she had the flu but not too bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 29Jul2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetic" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing), notes: She also takes supplements due to her osteoporosis. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/lot number: EL3246, Administered Location: left arm), administration date: 21Jan2021, when the patient was 74-year-old, for Covid-19 immunization, reaction(s): "bone pain", "Bad headache", "Dizzy"; BNT162b2 (DOSE 2, SINGLE, LOT: EL9265, NDC, EXP: Unknown), administration date: 11Feb2021, when the patient was 74-year-old, for Covid-19 immunization, reaction(s): "just ached all over", "Bad headache", "Dizzy"; BNT162b2 (DOSE 3, SINGLE, LOT: FF2589, NDC, EXP: Unknown), administration date: 08Oct2021, when the patient was 75-year-old, for COVID-19 Immunization, reaction(s): "pain was terrible", "Headache was awful", "sick", "hardly eat". The following information was reported: HEADACHE (non-serious) with onset 29Jul2022, outcome "recovered" (29Jul2022), described as "got headache"; PAIN (non-serious) with onset 29Jul2022, outcome "recovered" (29Jul2022), described as "kind of ached like she had the flu but not too bad". Therapeutic measures were taken as a result of headache, pain.  Additional information: Concomitant drugs include medication for blood pressure and diabetes, and supplements due to her osteoporosis. She received a booster on 29Jan2022. The patient informed that the doctor really encouraged her to get it and just block out couple of days. She was going on a cruise, that is why they wanted her to have the next booster. With that one, got headache, kind of ached like she had the flu but not too bad. Took Tylenol, took a nap, got up, felt fine.  Clarified later that same day, 29Jul2022, she felt fine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300077890 same product, patient, different AEs, different dose;
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "headaches".  Additional information: A patient called in and said since he get the Pfizer covid-19 vaccine booster shot 10 months ago he was still having headaches (at the time of report). Caller said he talked to 200 people who have a headaches from that booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Neuropathy peripheral, Sensory loss
Clinical narrative: Neuropathy in fingertips of both hands, did not pass first knuckle. Started two days after vaccination, lasted about two weeks. Occasionally happens in middle and ring fingers. Consistent loss of sens; Neuropathy in fingertips of both hands, did not pass first knuckle. Started two days after vaccination, lasted about two weeks. Occasionally happens in middle and ring fingers. Consistent loss of sens; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 at 17:30 as dose 4 (booster), single (Lot number: GL0446) at the age of 53 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUAD), on 10Nov2022 as dose number unknown, single (Lot number: 942395), in left arm for immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "Prior carpal tunnel release in both hands." (unspecified if ongoing). The patient had no allergy. Concomitant medication(s) included: ADDERALL. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization. The patient had no covid prior vaccination. The patient didn't have covid tested post vaccination.  The following information was reported: NEUROPATHY PERIPHERAL (medically significant), SENSORY LOSS (non-serious) all with onset 12Nov2022, outcome "recovered with sequelae" and all described as "Neuropathy in fingertips of both hands, did not pass first knuckle. Started two days after vaccination, lasted about two weeks. Occasionally happens in middle and ring fingers. Consistent loss of sens". Therapeutic measures were not taken as a result of neuropathy peripheral, sensory loss.  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: 47.0
Sex: M
Vaccine: 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) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2 NOS), on 29Sep2022 at 14:30 as dose number unknown, single (Batch/Lot number: unknown) at the age of 47 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient had no known allergies.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 for which patient received PF-07321332, ritonavir (PAXLOVID) from to 09Feb2023 to 14Feb2023. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 as dose 5 (booster), single (Lot number: Gh9703) at the age of 75 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Dec2020 as dose 1, single (Lot number: 025j2da), in left arm, on 26Jan2021 as dose 2, single (Lot number: 029k20a), in left arm, on 22Oct2021 as dose 3 (booster), single (Lot number: 012f21a), in left arm and on 15Apr2022 as dose 4 (booster), single (Lot number: 002m21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Chronic rhinitis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Lumbar spinal stenosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Oct2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Feb2023) Positive; (12Feb2023) Negative; (13Feb2023) Positive; (16Feb2023) Negative; (17Feb2023) Negative; (18Feb2023) Negative; (20Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received PF-07321332, ritonavir (PAXLOVID), from 12Feb2023 (Lot number: Unknown) to 17Feb2023 for covid-19 treatment.; Sender's Comments: The efficacy of a vaccine varies from patient to patient and may be influenced by multiple factors, including the inherent disease condition, concurrent medical conditions, and concomitant medications; however, a contributory role of BNT162B2, BNT162B2 OMI BA.4-5 to the reported events cannot  be excluded.  Case will be reassessed if additional information is received
Age: 33.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 04Dec2021 as dose 2, single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid fluctuations" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergies.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 for which patient received PF-07321332, ritonavir (PAXLOVID) from to 10Feb2023 to 15Feb2023. 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-202300078241 same reporter/patient/product, different dose/event.;
Age: 61.0
Sex: F
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 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 25Oct2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: hyperlipidemia, history of breast cancer with chemotherapy and radiation. The patient's concomitant medications were not reported. Past drug history included: PCN (Penicillin), reaction(s): "known allergies: PCN", notes: known allergies: PCN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 for which patient received PF-07321332, ritonavir (PAXLOVID) from to 11Feb2023 to 15Feb2023.  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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: exposed at the gym to COVID and sx 18Feb and positive AG test 20Feb2023; exposed at the gym to COVID and sx 18Feb and positive AG test 20Feb2023; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 46-year-old female patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL3247), on 17Feb2021 as dose 2, single (Lot number: EL3247), on 29Oct2021 as dose 3 (booster), single (Lot number: FF2589) and on 26Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Feb2023, outcome "unknown" and all described as "exposed at the gym to COVID and sx 18Feb and positive AG test 20Feb2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Feb2023) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Whatever the efficacy of a product, lack of effect can occur and it is an expected finding. Based on the information provided by the reporter, the reported events most likely were due to the pandemic.,Linked Report(s) : US-PFIZER INC-202300078340 Same patient/vaccine, different event and dose;US-PFIZER INC-202200511012 Same patient/vaccine, different event and dose;
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got covid and was sick bad; got covid and was sick bad; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got covid and was sick bad".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She tested positive for covid and this is the 2nd time; She tested positive for covid and this is the 2nd time; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID: (172086). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: EN6207), on 30Apr2021 as dose 2, single (Lot number: EP7534) and on 03Nov2021 as dose 3 (booster), 0.3ml single (Lot number: FF2587) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing); "less memory" (unspecified if ongoing); "lost all that weight" (unspecified if ongoing); "had no appetite" (unspecified if ongoing); "weaker" (unspecified if ongoing). The patient took concomitant medications. When she first got diagnosed, she was getting weaker and had less sensitivity and had less memory like she was aging so fast and she has always been very sharp and was working and then felt like she was not in control of what she was thinking and lost all that weight and had no appetite whatsoever and all different things but did not tie anything together; clarified she was diagnosed with covid disease. Her doctor brought all the seniors in his practice as they had all been out being tested and told her that her husband was positive and to go get shots at the hospital and she was told she was negative but then tested positive and they both went and got all the shots and nothing made any difference in terms of testing positive and clarified they both had the Pfizer Covid vaccines that were a series of three vaccines. She stated she is getting older by the minute. She tested positive for covid and this is the 2nd time they said she was positive and she is a little confused. On Friday 18Feb2023, stated she has to get her wits about her, and on that date she tested positive that afternoon for covid the 2nd time. She received PAXLOVID as treatment. Outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300078557 same product/event, different patients;
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she had no symptoms but tested positive; she had no symptoms but tested positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 4 (booster), single (Lot number: Gj6742) at the age of 33 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 16Feb2021 as dose 2, single (Lot number: EL3247) and as dose 3 (booster), single (Lot number: FF2589) 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), ASYMPTOMATIC COVID-19 (medically significant) all with onset 16Feb2023, outcome "recovering" and all described as "she had no symptoms but tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Feb2023) Positive, notes: post vaccination. There was no other vaccine in four weeks. Child with COVID first then she had no symptoms but tested positive 16Feb2023 PM.  It was unknown if therapeutic measures were taken as a result of drug ineffective, asymptomatic covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 27-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Jan2023 as dose 4 (booster), single (Lot number: GH9697) at the age of 27 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6199), in left arm and on 31Mar2021 as dose 2, single (Lot number: ER8732), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Lot number: 3303080), in right arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "depression" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "generalized anxiety" (unspecified if ongoing); "acne" (unspecified if ongoing); "eczema" (unspecified if ongoing); "benign breast tumors" (unspecified if ongoing); "ankle arthroscopy surgery" (unspecified if ongoing). Concomitant medication(s) included: DAYQUIL, start date: 15Feb2023, stop date: 17Feb2023; SERTRALINE, start date: 02Feb2023, stop date: 21Feb2023; MINOCYCLINE, start date: 02Feb2023, stop date: 21Feb2023; CETIRIZINE, start date: 02Feb2023, stop date: 21Feb2023; ACETAMINOPHEN, start date: 13Feb2023, stop date: 13Feb2023. Past drug history included: Known allergies chorhexidine, reaction(s): "Known allergies chorhexidine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Dayquil (brand: Kroger CO), Sertaline (brand: Aurobindo pharma), Minocyline 100mg (Sun pharmaceuticals), cetirizine (brand: Kroger Co), Acetaminophen 500mg (brand: Kroger CO). The patient received Paxlovid from 16Feb2023 to 20Feb2023 for treatment of COVID-19.
Age: 74.0
Sex: F
Vaccine: 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) (Consumer or other non HCP). The reporter is the patient. A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Aug2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Patient did not have known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 11Feb2023 to 16Feb2023 for Treatment of COVID-19.   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
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; tested positive; This is a spontaneous report received from a contactable reporter Consumer (wife of the patient) from product quality group.  A 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "tested positive". The doctor told her that her husband was positive (unspecified date in 2023) and to go get shots at the hospital and she was told she was negative but then tested positive and they both went and got all the shots and nothing made any difference in terms of testing positive and clarified they both had the Pfizer COVID vaccines that were a series of three vaccines.  Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  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-202300078472 same product/event, different patients;
Age: 36.0
Sex: F
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 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Dec2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "IgA Nephropathy" (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. From 14Feb2023 to 19Feb2023, the patient took nirmatrelvir; ritonavir (PAXLOVID) for COVID-19 treatment. The patient's known allergies was no nsaids.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19-2
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 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 10:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 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: "Mild high blood pressure" (unspecified if ongoing); "Known allergies: Iodine" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM, start date: 02May2019. 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 including Paxlovid from 09Feb2023.  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: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: COVID-19, Chills, Cough, Feeling abnormal, Pyrexia
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 10:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 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: "Mild high blood pressure" (unspecified if ongoing); "Known allergies: Iodine" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM, start date: 02May2019. 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 including Paxlovid from 09Feb2023.  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: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 10:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 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: "Mild high blood pressure" (unspecified if ongoing); "Known allergies: Iodine" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM, start date: 02May2019. 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 including Paxlovid from 09Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Arthralgia, Impaired work ability, Malaise, Peripheral swelling
Clinical narrative: Joint pain/In pain; Doesn't feel well; Hands and feet swollen; Alopecia/lost just about all of her hair/bald; Rash/have a rash on my face all of the time; she can't work; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "not recovered", described as "Joint pain/In pain"; MALAISE (non-serious), outcome "unknown", described as "Doesn't feel well"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Hands and feet swollen"; ALOPECIA (non-serious), outcome "unknown", described as "Alopecia/lost just about all of her hair/bald"; RASH (non-serious), outcome "not recovered", described as "Rash/have a rash on my face all of the time"; IMPAIRED WORK ABILITY (non-serious), outcome "not recovered", described as "she can't work".  Additional information: Patient had the first a second dose and doesn't feel well. Reported joint pain, hands and feet swollen, alopecia and rash. Querying if there is anything Pfizer could suggest for her symptoms. She said she had lost just about all of her hair and was about to shave her head. This had become a nightmare and she can't work because she was in pain, bald, and had a rash on her face all the time. She said she went from a thriving, spry person to a not leaving the house person. She doesn't want this to happen to anyone else. She was a healthy, exercising, vegan, organic person and now she doesn't leave her house. She connected the dots because she had read the side effect information already. She doesn't know how this can keep happening. She doesn't want to spend another 30 years like this. This was awful. Caller stated the side effects were not published until a court order forced them to be published and that Pfizer wanted to keep them secret for 75 years.  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-202300079948 Same patient/vaccine, different dose and event;
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Joint pain/In pain; Doesn't feel well; Hands and feet swollen; Alopecia/lost just about all of her hair/bald; Rash/have a rash on my face all of the time; she can't work; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "not recovered", described as "Joint pain/In pain"; MALAISE (non-serious), outcome "unknown", described as "Doesn't feel well"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Hands and feet swollen"; ALOPECIA (non-serious), outcome "unknown", described as "Alopecia/lost just about all of her hair/bald"; RASH (non-serious), outcome "not recovered", described as "Rash/have a rash on my face all of the time"; IMPAIRED WORK ABILITY (non-serious), outcome "not recovered", described as "she can't work".  Additional information: Patient had the first a second dose and doesn't feel well. Reported joint pain, hands and feet swollen, alopecia and rash. Querying if there is anything Pfizer could suggest for her symptoms. She said she had lost just about all of her hair and was about to shave her head. This had become a nightmare and she can't work because she was in pain, bald, and had a rash on her face all the time. She said she went from a thriving, spry person to a not leaving the house person. She doesn't want this to happen to anyone else. She was a healthy, exercising, vegan, organic person and now she doesn't leave her house. She connected the dots because she had read the side effect information already. She doesn't know how this can keep happening. She doesn't want to spend another 30 years like this. This was awful. Caller stated the side effects were not published until a court order forced them to be published and that Pfizer wanted to keep them secret for 75 years.  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-202300079948 Same patient/vaccine, different dose and event;
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Still get sharp pain at the vaccination sites as of 05Feb2023 in both arms at different times, not continuous!; 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 male patient received BNT162b2 (BNT162B2), on 04May2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Anatomical location: Right arm), for COVID-19 immunization, reaction(s): "Still get sharp pain at the vaccination sites as of 05Feb2023 in both arms at different times, not continuous!", "Vertigo". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "Still get sharp pain at the vaccination sites as of 05Feb2023 in both arms at different times, not continuous!".  Additional information: Patient stated "I looked into the VAERS list and seen there is many that are also getting pain at the injection site. I also reported mine to the VAERS list. With all the many vaccinations I have had over the many years this is the only one that has done this! What is it?"  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-202300079655 Same reporter/patient/drug/AE, different dose of vaccine;
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Arthralgia, Malaise, Nightmare, Peripheral swelling
Clinical narrative: Joint pain/In pain; Doesn't feel well; Hands and feet swollen; Alopecia/ Lost just about all of her hair/Baldness/about to shave her head; Rash/have a rash on the face all of the time; Nightmare; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Vegan" (unspecified if ongoing), notes: a healthy, exercising, vegan, organic person and now patient doesn't leave her house. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization, reaction(s): "Alopecia/ Lost just about all of her hair/Baldness/about to shave her head", "Joint pain/In pain", "Doesn't feel well", "Nightmare", "Hands and feet swollen", "Rash/ Rash on the face all of the time". The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain/In pain"; MALAISE (non-serious), outcome "unknown", described as "Doesn't feel well"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Hands and feet swollen"; ALOPECIA (non-serious), outcome "unknown", described as "Alopecia/ Lost just about all of her hair/Baldness/about to shave her head"; RASH (non-serious), outcome "unknown", described as "Rash/have a rash on the face all of the time"; NIGHTMARE (non-serious), outcome "unknown". Additional information: Patient can't work because she was in pain, bald, and had a rash on the face all of the time. She said she went from a thriving, spry person to a not leaving the house person. She didn't want this to happen to anyone else.  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-202300079801 Same patient/vaccine, different dose and event;