chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: But I contacted the Virus on Tuesday, the Wednesday and I tested positive on Thursday at the clinic we have here and I got tested again, I was positive; But I contacted the Virus on Tuesday, the Wednesday and I tested positive on Thursday at the clinic we have here and I got tested again, I was positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old male 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) all with onset 2022, outcome "unknown" and all described as "But I contacted the Virus on Tuesday, the Wednesday and I tested positive on Thursday at the clinic we have here and I got tested again, I was positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive on Thursday at the clinic; Positive, notes: I got tested again, I was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 19Aug2022.  Clinical Information: Reporter stated he had all the Pfizer shots (Pfizer COVID-19 Vaccine). Stated he contacted the virus on Tuesday, the Wednesday and tested positive on Thursday at the clinic and he got tested again, he was positive. He was given Paxlovid and have taken for two and a half days and now he got very severe sore throat, very severe, like almost felt like slit throat.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
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 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN 6199), in left arm, on 26Mar2021 as dose 2, single (Lot number: ER 8732), in left arm, on 29Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 20May2022 as dose 4 (booster), single (Lot number: 038A22A) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Celiac disease" (unspecified if ongoing). Concomitant medication(s) included: VIT D3, start date: 01Jan2022; VIT B12, start date: 01Jan2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: The patient had no known allergies. The patient received vaccine. The patient received Paxlovid for COVID 19 Treatment as other medication in 2weeks. The start date for paxlovid was 11Aug2022 and stop date was 16Aug2022. The patient took Multi vitamin (Vita fusion) as other medication in 2weeks; lot: YY20695090) with start date as 01Jan2022. The patient took Ibuprofen (lot: 2BE2284A) 200mg as needed as other medication in 2weeks product with start date as 01Aug2022 and stop date as 22Aug2022. The brand name for vit B12 was reported as Nature Made and brand name for Vit D3 was reported Vita fusion.
Age: 67.0
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 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications/No Other medication in 2weeks. Past drug history included: Macrodantin, reaction(s): "Known allergies: Macrodantin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Paxlovid rebound Test negative but symptoms returned after 5 days after last dose. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Antiviral treatment and details included: product: COVID 19 Treatment, Brand: Pfizer, Treatment Start date: 12Aug2022, Treatment Stop date: 16Aug2022, indication=Treatment of COVID-19, lot number=Unknown.  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: Cough, Dizziness, Dyspnoea, Fatigue
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (003110). The reporter is the patient. A 79-year-old female patient received BNT162b2 (BNT162B2), on 18May2022 as dose 4 (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 3 (BOOSTER), SINGLE), administration date: 13Oct2021, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 16Mar2021, for COVID-19 Immunization; BNT162b2 (DOSE 1, SINGLE), administration date: 16Feb2021, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset Aug2022, outcome "unknown", described as "extreme fatigue"; DIZZINESS (non-serious) with onset Aug2022, outcome "unknown", described as "light headedness"; DYSPNOEA (non-serious) with onset Aug2022, outcome "unknown", described as "shortness of breath"; COUGH (non-serious) with onset Aug2022, outcome "unknown", described as "terrible cough". Additional information: It was reported that, the patient had 4 Pfizer COVID vaccines, the last one in May of this year. For the past 3 weeks she had a terrible cough, shortness of breath, light headedness and extreme fatigue. She thought these symptoms were related to the vaccines. She wanted to know the remedy and the time till how long it will last The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
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) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), 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 was not reported. Concomitant medication(s) included: DAYQUIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Dayquil in 2 weeks. The patient started treatment with paxlovid for COVID-19 from 11Aug2022 to 15Aug2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Dyspnoea, Gait disturbance, Palpitations
Clinical narrative: couldn´t even walk six feet without having to gasp for breath for a couple of seconds; heart palpitations; Unable to walk 6 feet without stopping; Racing Heart; Sand paper in her heart; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 20Apr2021 as dose 2, 0.3 ml single (Lot number: ER8732, Expiration Date: Jul2021) at the age of 56 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (ongoing), notes: She was diagnosed in 2002, it may have been 2001, She was diagnosed at the time of 11Sep.; "Acid reflux" (ongoing), notes: acid reflux She doesn't know when she was diagnosed but doctor mentioned it to her. She was diagnosed probably a few years ago when it flared up and she had to get on medicine for it. It still effects her very much. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1, LOT: ER2613, EXPIRY: Jul2021, formulation of: vaccine 30mcg/0.3mL intramuscular suspension. Both of the doses she received are the same.), administration date: 30Mar2021, when the patient was 56-year-old, for COVID-19 Immunisation. The following information was reported: PALPITATIONS (hospitalization) with onset May2021, outcome "recovered" (Jun2021), described as "Racing Heart"; CARDIAC DISORDER (hospitalization) with onset May2021, outcome "recovered" (May2021), described as "Sand paper in her heart"; GAIT DISTURBANCE (hospitalization) with onset May2021, outcome "recovered", described as "Unable to walk 6 feet without stopping"; DYSPNOEA (hospitalization) with onset May2021, outcome "recovered", described as "couldn´t even walk six feet without having to gasp for breath for a couple of seconds"; PALPITATIONS (hospitalization) with onset May2021, outcome "recovered", described as "heart palpitations".
Age: 39.0
Sex: F
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 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: EW1053), in left arm, on 01May2021 as dose 2, single (Lot number: EW0167), in right arm and on 31Oct2021 as dose 3 (booster), single (Lot number: 330268D) at the age of 39 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "history of subarachnoid hemorrhage" (unspecified if ongoing); "chronic Epstein Barr" (unspecified if ongoing); "overweight" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ceclor, reaction(s): "Known allergies: Ceclor". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: After 4 days testing negative (August 9th-12th); (unspecified date) Positive, notes: COVID 19 Treatment; (19Aug2022) Positive, notes: received a positive test result on 19Aug. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not receive other medications in two weeks. Anti viral details: brand: Paxlovid for Treatment of COVID-19; Treatment start date 29Jul2022; treatment end date= 03Aug2022. Known allergies: Penicillin, Ceclor. Other medical history: history of subarachnoid hemorrhage; chronic Epstein Barr and overweight (not severe).  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, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech / Treatment of COVID-19  Start date: 9Aug2022; Pfizer / BioNTech / Treatment of COVID-19  Start date: 9Aug2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing), notes: other medical history: Heart disease; "in treatment for breast cancer" (unspecified if ongoing), notes: other medical history: in treatment for breast cancer. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "Pfizer / BioNTech / Treatment of COVID-19 Start date: 9Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive, notes: Treatment of COVID-19; (Aug2022) Negative, notes: Had Covid rebound 3 days after negative test; (17Aug2022) Positive, notes: Had Covid rebound 3 days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no other medication in 2 weeks reported. Patient was treated with anti viral drug for COVID 19 Paxlovid, treatment start date was 09Aug2022 and treatment stop date was 14Aug2022.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid19 infection with mild, cold-like symptoms; Covid19 infection with mild, cold-like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 28-year-old male patient received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Lot number: EN6199), on 05Apr2021 as dose 2, single (Lot number: EP7533) and on 15Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Aug2022 at 17:30, outcome "recovering" and all described as "Covid19 infection with mild, cold-like symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Covid19 infection with mild cold-like symptoms. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: Other vaccine in four weeks and other medications in two weeks was unknown. Covid prior vaccination and covid tested post vaccination was unknown
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 25Jun2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Celiac" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing). There were no concomitant medications. 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: (unspecified date) Negative, notes: Tested negative last week a couple of times including PCR test; (22Aug2022) Positive, notes: Tested positive again on 22Aug22. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient did not receive any other medication in 2 weeks. Patient was received Paxlovid dated from 12Aug2022 to 16Aug2022 for Treatment of COVID-19. Patient had COVID Rebound. Tested positive again on 22Aug22. Tested negative last week a couple of times including PCR test. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Maternal exposure timing unspecified, Neuritis, Pain, Paraesthesia
Clinical narrative: 30 y/o pregnant female developed left sided facial numbness and slight painful tingling (neuritis) 4-5 weeks after second vaccine dose; 30 y/o pregnant female developed left sided facial numbness and slight painful tingling (neuritis) 4-5 weeks after second vaccine dose; 30 y/o pregnant female developed left sided facial numbness and slight painful tingling (neuritis) 4-5 weeks after second vaccine dose; 30 y/o pregnant female developed left sided facial numbness and slight painful tingling (neuritis) 4-5 weeks after second vaccine dose; 30 y/o pregnant female developed left sided facial numbness and slight painful tingling (neuritis) 4-5 weeks after second vaccine dose; This is a spontaneous report received from contactable reporter(s) (Physician).  A 30-year-old female patient (pregnant) received BNT162b2 (COMIRNATY), on 17May2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient was 22 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 05Dec2022. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: MATERNAL EXPOSURE TIMING UNSPECIFIED (non-serious) with onset 17May2022, outcome "unknown", HYPOAESTHESIA (non-serious), NEURITIS (non-serious), PARAESTHESIA (non-serious), PAIN (non-serious) all with onset Jun2022, outcome "unknown" and all described as "30 y/o pregnant female developed left sided facial numbness and slight painful tingling (neuritis) 4-5 weeks after second vaccine dose". The events "30 y/o pregnant female developed left sided facial numbness and slight painful tingling (neuritis) 4-5 weeks after second vaccine dose" required physician office visit. Additional information: 30 y/o pregnant female developed left sided facial numbness and slight painful tingling (neuritis) 4-5 weeks after second vaccine dose. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: die; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "die". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Patient died in the first day of trials. One died instantly.  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-PV202200047905 Same reporter, event, drug, different patient;; Reported Cause(s) of Death: die
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Die; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Die". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: it was reported patient died in the first day of trials. One died instantly.  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-PV202200047905 Same reporter, event, drug, different patient;; Reported Cause(s) of Death: Die
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Die; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Die". The patient date of death was unknown. Reported cause of death: "Die". It was not reported if an autopsy was performed. Clinical course: it was reported patient died in the first day of trials. One died instantly.  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-PV202200047905 Same reporter, event, drug, different patient;; Reported Cause(s) of Death: Die
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Die; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Die". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Patient died in the first day of trials. One died instantly.  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-PV202200047905 Same reporter, event, drug, different patient;; Reported Cause(s) of Death: die
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, SARS-CoV-2 test, Thrombosis
Clinical narrative: Blood clot on brain area causing brain accident (stroke); Blood clot on brain area causing brain accident (stroke); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Sep2021 at 18:00 as dose 2, single (Lot number: FE3592) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Loosing volume Brain" (unspecified if ongoing); "cyst on right side of brain" (unspecified if ongoing); "cardiovascular problems" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose lot number=FD8448, Prev dose administration date=26Aug2021, Prev dose administration time=06:00 PM, Prev dose dose number=1, Prev dose vaccine location=Right arm), administration date: 26Aug2021, when the patient was 44-year-old, for Covid-19 Immunisation. The following information was reported: CEREBROVASCULAR ACCIDENT (disability, medically significant), THROMBOSIS (disability, medically significant) all with onset 30Sep2021, outcome "not recovered" and all described as "Blood clot on brain area causing brain accident (stroke)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of cerebrovascular accident, thrombosis.  Clinical course: Patient did not any other vaccine in four weeks. Patient not had any known allergies.  Follow-up (24Aug2022): Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is patient. A 43-year-old male patient received BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Lot number: EK9231), on 25Jan2021 as dose 2, single (Lot number: EL8982) and on 28Sep2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "Dysthymia" (unspecified if ongoing). Concomitant medication(s) included: Rosuvastatin; Escitalopram. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Aug2022) Negative, notes: asymptomatic; (22Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: Other medication was received in 2 weeks. Rebound COVID: tested negative 16Aug2022 and was asymptomatic; tested positive 22Aug2022 with mild congestion and fatigue. Device date was 22Aug2022. Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and vaccination failure, Covid 19 cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: in the emergency room with A-Fib; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male 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: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "in the emergency room with A-Fib". The event "in the emergency room with a-fib" required emergency room visit. Clinical course: Patient took the vaccine and was in the emergency room with A-Fib the same day. His mom took the vaccine and ended up sick for weeks now after receiving the vaccine. His uncle took the vaccine as well and forgot who he is. He would like us to explain the bait and switch. We advertise to the people that the vaccine is approved and it's not. Comirnaty, but not everyone was taking that. A judge said that and how can we account for how that is ok. Reporter sated it was a blatant bait and switch. On advertisements even while he was on hold it says about the vaccine blah blah blah and it prevents infections and that was a lie, it does not prevent infections, people that got the vaccine are the ones getting sick and people like him that are not vaccinated are ok. It's because the vaccine is fighting your own immune system and that is why the vaccinated people have reinfection and that is a fact. The reporter stated that third thing is he hoped we realized that in a sane world that everyone that works in Pfizer should be in jail. Stated you troubled his family forever and messed with their DNA.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). A 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: ILLNESS (non-serious), outcome "unknown", described as "ended up sick for weeks now". Additional information: Reported stated some of his family took the Pfizer COVID 19 vaccine. His mom took the vaccine and ended up sick for weeks now after receiving the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cognitive disorder
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). A male 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: COGNITIVE DISORDER (non-serious), outcome "unknown", described as "Forgot who he was". Additional information: This report is related to a study or program. Reporter's family took the Pfizer Covid 19 vaccine. His uncle took the vaccine as well and forgot who he was. Reporter confirmed above and stated that was for about a 24-hour period. Unable to clarify further. Also stated those are just antidotal family things. On advertisements even while he was on hold it says about the vaccine and it prevented infections and that was a lie, it doesn't prevent infections, people that got the vaccine were the ones getting sick and people like him that are not vaccinated are ok. It's because the vaccine was fighting your own immune system and that was why the vaccinated people have reinfection and that was a fact. Reporter stated vaccine messed with his family's DNA. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
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 a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 at 10:00 as dose 1, single (Lot number: ER2613), in left arm, on 19Aug2021 at 16:15 as dose 2, single (Lot number: EW0158), in left arm and on 01Nov2021 at 13:30 as dose 3 (booster), single (Lot number: 33026BD) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Known allergies: ceftin, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: The patient had not taken any other medication in 2 weeks. Patient was treated with Paxlovid from 28Apr2022 to 01May2022.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 24Mar2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 05Sep2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 05Mar2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received treatment for events with antiviral Paxlovid from 08Aug2022 to 13Aug2022.  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, 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) (Nurse).  A female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 13Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "migraine" (unspecified if ongoing); "uti" (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"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid was given for the treatment of COVID-19 through oral route with start date 04Aug2022 and stop date 08Aug2022,11 days after completing paxlovid on 18 Aug2022 patient experienced chest and head cold, Cough mild sore throat and stomach cramping. Vertigo, fatigue and outcome for these events was recovering.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 55 years for COVID-19 immunization; 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 immunization. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Chronic allergic rhinitis" (unspecified if ongoing), notes: Chronic allergic rhinitis. Concomitant medication(s) included: SINGULAIR; LOSARTAN; FLOVENT. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19.  Clinical course: Patient started Paxlovid (Lot number: GF4424)treatment on 12Aug2022 and stopped on 16Aug2022 via oral route for COVID-19. Patient received other medications in 2 weeks. No known allergies were reported.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID-19 and BNT162B2.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Pfizer / BioNTech Dose Number: 1/Dose Number: 2 and Evusheld Dose Number: 1; 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 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6203), in left arm and on 01Apr2021 as dose 2, single (Lot number: EN5318) at the age of 67 years, in left arm for covid-19 immunisation; cilgavimab, tixagevimab (EVUSHELD), on 08Apr2022 as dose 3 (booster), single (Lot number: AZ210060), in left gluteus medius for covid-19 immunisation. The patient's relevant medical history included: "lymphoma in remission" (unspecified if ongoing), notes: lymphoma in remission; "hypertension" (unspecified if ongoing); "depression" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing); "psoriasis" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "intussusception" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE; LISINOPRIL; FOLIC ACID; LEXAPRO; TYLENOL PM. 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"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 2022, outcome "unknown", described as "Pfizer / BioNTech Dose Number: 1/Dose Number: 2 and Evusheld Dose Number: 1". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient has no known allergies. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Patient took Paxlovid for COVID 19 Treatment from 12Aug2022 to 16Aug2022 for COVID. The vaccine Cilgavimab & Tixagevimab (Evusheld) location was administered Left buttocks.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; Pfizer / BioNTech: Dose Number: 1-3 and Moderna: Dose Number: 4; 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 79-year-old female patient received BNT162b2 (BNT162B2), on 20Jan2021 at 15:00 as dose 1, single (Lot number: EL3302), in left arm, on 08Feb2021 at 16:00 as dose 2, single (Lot number: EM9810), in left arm and on 30Sep2021 at 14:45 as dose 3 (booster), single (Lot number: FE3592) at the age of 78 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Apr2022 at 12:30 as dose 4 (booster), single (Lot number: PT0538), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Known allergies: Iron" (unspecified if ongoing). Concomitant medication(s) included: SYNTHYROID, start date: 05Sep1994; LISINOPRIL, start date: 05Mar2018; PRAVASTATIN, start date: 02Nov2020, stop date: 05Aug2022.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13Apr2022 at 12:30, outcome "unknown", described as "Pfizer / BioNTech: Dose Number: 1-3 and Moderna: Dose Number: 4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Aug2022, outcome "recovered" (20Aug2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Aug2022) Negative; (13Aug2022) Negative; (14Aug2022) Negative; (15Aug2022) Negative; (16Aug2022) Negative; (17Aug2022) Positive; (22Aug2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Other medication in 2 weeks was Yes. Anti-viral details: Product: COVID 19 Treatment, Brand: Pfizer Paxlovid, Treatment start date: 06Aug2022, Treatment stop date: 11Aug2022, Indication: Treatment of COVID-19. Tested negative 12Aug to 16Aug. On 17Aug tested positive after symptom started again. Became very congested, lost her voice, got a severe headache. Finally tested negative today 22Aug2022. Known Allergies was Iron. Other medical history was High blood pressure. Device Date : 22Aug2022.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; J&J,moderna and Pfizer / BioNTech; J&J,moderna and Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Aug2021 as dose 2 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 13Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), OFF LABEL USE (medically significant), outcome "unknown" and all described as "J&J,moderna and Pfizer / BioNTech". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (unspecified date) Positive, notes: after day 8 of negative result, positive result; (15Aug2022) Negative, notes: after day 8 of negative result; (19Aug2022) Positive, notes: Rapid antigen tests showed positives on Day 12 and Day 16; (23Aug2022) Positive, notes: Rapid antigen tests showed positives on Day 12 and Day 16. Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid from 08Aug2022 to 14Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 26.0
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 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 26 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Had collapsed lungs 9 years ago" (unspecified if ongoing), notes: Had collapsed lungs 9 years ago. There were no concomitant medications.  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; (Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not took any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. Anti-viral details: Paxlovid from 10Aug2022 to 14Aug2022. After taking paxlovod she recovered and got back to normal. Then she suddenly got congested. Exhausted. And a sore throat. Her cough returned and she tested positive again. Device Date: 22Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19, 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) (Nurse). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 31May2022 at 16:30 as dose 4 (booster), single (Lot number: FM79992) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Rheumatoid Arthritis" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "seizure disorder" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "TBI" (unspecified if ongoing); "Shrimp" (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 "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: anti-viral details. Product: COVID 19 Treatment. Brand: Paxlovid. Treatment start date=19Aug2022. Lot number=G05198. Indication: Treatment of COVID-19. Other medication in 2weeks was Unknown. Patient was prescribed 5 days of Paxlovid. She was immunosuppressed. After the second dose, she got a sore throat and strong metallic taste in the back of her throat. she tried almost everything to stop it but can't get rid of it.; Sender's Comments: The reported COVID-19 positive after BNT162b2 COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.