chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Dec2020 as dose 1, single (Lot number: EL0142), on 06Jan2021 as dose 2, single (Lot number: EL3302) and on 06Oct2021 as dose 3 (booster),single (Lot number: 301558A) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 06May2022 as dose 4 (booster), single (Lot number: 056M21A) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penicillins" (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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: COVID 19 Treatment; (17Jul2022) Negative; (21Jul2022) positive, notes: re-tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No Other medication in 2weeks. vaccine was received. Anti-viral details product was for COVID 19 Treatment, Brand=pfizer, Treatment start date was 11Jul2022 and stop date was 16Jul2022. Adverse event Rebound symptoms (sore throat, runny nose) and re-tested positive for COVID. This occurred 5 days after patient's last dose of Paxlovid and 4 days after patient had tested negative. No AE treatment was received.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective, covid-19.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician).  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Batch/Lot number: unknown), on 31Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 09Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: seafood" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (unspecified date) Negative, notes: tested negative after Paxlovid course; (19Jul2022) positive, notes: had return of cough/headache - repeat test Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 21.0
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 22-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: ER8729), on 06May2021 as dose 2, single (Lot number: EW0172) and on 13Jan2022 as dose 3 (booster), single (Lot number: FL3209) at the age of 21 years for covid-19 immunisation. The patient's relevant medical history included: "hashimotos hypothryroid" (unspecified if ongoing), notes: hashimotos hypothryroid; "Obesity" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. The patient received other medications in 2 weeks after vaccination. Past drug history included: Zithromax, reaction(s): "Known allergies: zithromax", notes: Known allergies: zithromax. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jun2022) Positive, notes: First day of Positive test; (Jul2022) Positive, notes: but still rapid positive; (20Jul2022) Positive, notes: Day-21 still showing positive rapid testing. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: First day of positive test, second day of bad symptoms. Took 5 days treatment. Around day 9-10 of COVID infection, symptoms returned serious head congestion, sinus pain. Day 21 and still showed positive rapid testing. Symptoms were much better, but still rapid positive. The patient received Paxlovid as treatment from 30Jun2022 to 04Jul2022 for COVID 19. Doxy antibiotic for sinus infection. Patient assumed this was rebound. Device Date reported on 21Jul2022.  No follow-up attempts possible. No further information expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 14Aug2021 as dose 2 (booster), single (Lot number: FC3180), in right arm, on 11Feb2022 as dose 3 (booster), single (Lot number: FM0698), in left arm and on 13Jun2022 as dose 4 (booster), single (Lot number: FJY991) at the age of 61 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 10Mar2021 as dose 1, single (Lot number: 1805025), in right arm for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing), notes: other medical history: RA; "Interchange of vaccine product" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Rituxin, notes: other medical history: Taking Rituxin twice a year. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jul2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jul2022) Positive, notes: Tested positive 09Jul2022; (16Jul2022) Negative, notes: Tested negative 16Jul2022; (21Jul2022) Positive, notes: tested positive 21Jul2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Tested positive 09Jul2022 started Paxlovid 10Jul2022 am. Tested negative 16Jul2022. Symptoms returned 21Jul2022 tested positive 21Jul2022. There was no other medication taken in 2 weeks. There were no known allergies  No follow-up attempts are possible. No further information is expected.
Age: 44.0
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 44-year-old male patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: ER8732), in left arm, on 13Apr2021 as dose 2, single (Lot number: EW0151), in left arm and on 25Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. No known allergies. Other medication in 2weeks was reported as No. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: positive pcr and rapid one full week; negative, notes: three consecutive days with negative pcr tests; Negative, notes: three consecutive days with negative pcr tests; Negative, notes: three consecutive days with negative pcr tests; Positive, notes: positive pcr and rapid one full week. Therapeutic measures were taken as a result of vaccination failure, covid-19 with anti viral paxlovid started on 07Jul2022 and stopped on 12Jul2022 with lot number 1910754A.
Age: 64.0
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 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 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: "Ankylosing spondylitis" (unspecified if ongoing), notes: Ankylosing spondylitis and Crohn's disease; "Crohn's disease" (unspecified if ongoing), notes: Ankylosing spondylitis and Crohn's disease. There were no concomitant medications. No Known allergies. Other medication in 2 weeks was reported as No. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with antiviral Paxlovid started on 18Jul2022 with lot number GC8326.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 05May2021 as dose 1, single (Batch/Lot number: unknown) and on 08Dec2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "anorexia" (unspecified if ongoing), notes: nervosa; "osteoporosis" (unspecified if ongoing); "osteoarthritiss" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM; TRAZODON; ALENDRONATE; TERBINAFINE.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that patient was on medications within 2 weeks of starting COVID-19 treatment. Also patient previously had receive a COVID-19 Vaccine. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness, Investigation
Clinical narrative: sick; 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 received BNT162b2 (BNT162B2), on 11Mar2021 as dose 2, single (Lot number: EN0207) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "systemic lupus erythematosus nephritis", start date: 1980 (unspecified if ongoing), notes: she had SLE which is systemic lupus erythematosus nephritis with kidney involvement.; "stage three renal failure" (unspecified if ongoing); "hand surgery" (unspecified if ongoing), notes: Given oxycodone and tylenol. There were no concomitant medications. Past drug history included: Oxycodone, reaction(s): "liver levels", notes: Oxycodone and Tylenol: raised her liver levels/ Oxycodone caused her liver tests to go way up, which Tylenol does make her liver tests go up; Tylenol, reaction(s): "liver levels", notes: Oxycodone and Tylenol: raised her liver levels/ Oxycodone caused her liver tests to go way up, which Tylenol does make her liver tests go up. Vaccination history included: BNT162b2 (DOSE 1, SINGLE: Lot number: EN6198,), administration date: 19Feb2021, when the patient was 61-year-old, for COVID-19 immunization, reaction(s): "sick", "COVID-19", "Drug ineffective". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Glomerular filtration rate, Investigation, Vaccination failure
Clinical narrative: sick; 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 received BNT162b2 (BNT162B2), on 11Mar2021 as dose 2, single (Lot number: EN0207) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "systemic lupus erythematosus nephritis", start date: 1980 (unspecified if ongoing), notes: she had SLE which is systemic lupus erythematosus nephritis with kidney involvement.; "stage three renal failure" (unspecified if ongoing); "hand surgery" (unspecified if ongoing), notes: Given oxycodone and tylenol. There were no concomitant medications. Past drug history included: Oxycodone, reaction(s): "liver levels", notes: Oxycodone and Tylenol: raised her liver levels/ Oxycodone caused her liver tests to go way up, which Tylenol does make her liver tests go up; Tylenol, reaction(s): "liver levels", notes: Oxycodone and Tylenol: raised her liver levels/ Oxycodone caused her liver tests to go way up, which Tylenol does make her liver tests go up. Vaccination history included: BNT162b2 (DOSE 1, SINGLE: Lot number: EN6198,), administration date: 19Feb2021, when the patient was 61-year-old, for COVID-19 immunization, reaction(s): "sick", "COVID-19", "Drug ineffective". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Illness
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62-year-old female patient received BNT162b2 (BNT162B2), on 10Dec2021 as dose 3 (booster), single (Lot number: FJ8757, Expiration Date: 30Dec2021) at the age of 61 years for covid-19 immunization. The patient's relevant medical history included: "Stage 3 renal failure" (unspecified if ongoing); "Super sick in the fall" (unspecified if ongoing); "Fatigue" (unspecified if ongoing); "Intestinal issue" (unspecified if ongoing); "COVID-19", start date: Sep2021 (unspecified if ongoing), notes: The end of September last year. There were no concomitant medications. Past drug history included: Oxycodone for hand surgery, reaction(s): "Raised liver levels"; Tylenol for Hand surgery, reaction(s): "raised liver levels", notes: Lot number: P144565, Expiry date: Sep 2023. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6198), administration date: 19Feb2021, when the patient was 61-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: EN0207), administration date: 11Mar2021, when the patient was 61-year-old, for Covid-19 immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset Jan2022, outcome "unknown", described as "shingles"; ILLNESS (non-serious), outcome "unknown", described as "sick". Therapeutic measures were taken as a result of herpes zoster. Additional Information: Caller said all of the vaccine doses made her very sick, and then she had shingles a month after she had the booster. The reporter said that the treatment for shingles was Valacyclovir, which she also got sores in her mouth from her lupus so she had her Valacyclovir refilled so many times for the sores in her mouth, and she had also got something for the blisters on her back. Reporter stated she did not have medication with her at that time to provide NDC, Lot number and expiry date.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 15-year-old male patient received BNT162b2 (BNT162B2), on 14May2021 as dose 1, single (Lot number: EW0177), in left arm, on 05Jun2021 as dose 2, single (Lot number: EW0180), in left arm and on 03Dec2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 14 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Selective IgA immunodeficiency" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: We re-tested him for COVID using two at home test kits and he tested positive again for both; (unspecified date) Positive, notes: We re-tested him for COVID using two at home test kits and he tested positive again for both; (17Jul2022) Negative, notes: negative for COVID one day after completing his last Paxlovid dose. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Other medication in 2 weeks was reported as No. The patient received anti-viral COVID 19 Treatment (lot number= GA3595) via oral route, on 10Jul2022 and stopped on 15Jul2022. The patient tested negative for COVID one day after completing his last Paxlovid dose. All of his COVID symptoms resolved by day 4 of Paxlovid, but he had remained in quarantine until he tested negative using an at home test kit. Six days after his last Paxlovid dose, his COVID symptoms returned, including headache, runny nose, sneezing, and cough. It was reported that they have re-tested him for COVID using two at home test kits and he tested positive again for both and was re-isolating.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 04Apr2021 as dose 2, single (Lot number: EW0153), in left arm and on 07Dec2021 as dose 3 (booster), single (Lot number: 33130BQ) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Cardiac" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "obese" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound to Covid positive antigen and PCR after completing antiviral meds; Positive, notes: Rebound to Covid positive antigen and PCR after completing antiviral meds. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medical history: Diabetic, HTN, Cardiac, High Cholesterol, obese. Product: COVID 19 Treatment, start date: 06Jul2022, stop date: 10Jul2022. Other medication in 2weeks product: Too numerous to list Meds for Diabetes HTN high Cholesterol. Adverse event: Rebound to Covid positive antigen and PCR after completing antiviral meds. Adverse event start date: 14Jul2022, start time: 07:00 PM and outcome recovering. Treatment ae: No and known allergies: Yes.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2022 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 included: "T1 diabetes" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: HUMALOG; LEVEMIR; NP THYROID; ROSUVASTATIN; OMEPRAZOLE. Past drug history included: Urushiol, reaction(s): "Known allergies: anything containing Urushiol". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Anti viral from 17Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, C-reactive protein, C-reactive protein increased, Chest pain, Fatigue
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESTRADIOL; PROGESTERONE. Past drug history included: Lovenox, reaction(s): "Known Allergies: Lovenox". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown; Anatomical location: arm left; Administration time: 12:00 PM), administration date: Mar2021, when the patient was 46 years old, for Covid-19 immunization, reaction(s): "extreme fatigue", "fatigue", "listlessness", "101 fever"; Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown; Anatomical location: arm left; Administration time: 11:00 AM), administration date: Apr2021, when the patient was 46 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset Oct2021, outcome "recovered", described as "101-102 degree fever for 3 days"; C-REACTIVE PROTEIN INCREASED (non-serious) with onset Oct2021, outcome "recovered", described as "CRP as measure by doctor was elevated 3x normal."; CHEST PAIN (non-serious) with onset Oct2021, outcome "recovered"; FATIGUE (non-serious) with onset Oct2021, outcome "recovered", described as "extreme fatigue"; MYALGIA (non-serious) with onset Oct2021, outcome "recovered", described as "muscle aches". The events "extreme fatigue", "101-102 degree fever for 3 days", "muscle aches", "chest pain" and "crp as measure by doctor was elevated 3x normal." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, pyrexia, myalgia, chest pain, c-reactive protein increased. Additional information: It was reported that, prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESTRADIOL; PROGESTERONE. Past drug history included: Lovenox, reaction(s): "Known Allergies: Lovenox". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown; Anatomical location: arm left; Administration time: 12:00 PM), administration date: Mar2021, when the patient was 46 years old, for Covid-19 immunization, reaction(s): "extreme fatigue", "fatigue", "listlessness", "101 fever"; Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown; Anatomical location: arm left; Administration time: 11:00 AM), administration date: Apr2021, when the patient was 46 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset Oct2021, outcome "recovered", described as "101-102 degree fever for 3 days"; C-REACTIVE PROTEIN INCREASED (non-serious) with onset Oct2021, outcome "recovered", described as "CRP as measure by doctor was elevated 3x normal."; CHEST PAIN (non-serious) with onset Oct2021, outcome "recovered"; FATIGUE (non-serious) with onset Oct2021, outcome "recovered", described as "extreme fatigue"; MYALGIA (non-serious) with onset Oct2021, outcome "recovered", described as "muscle aches". The events "extreme fatigue", "101-102 degree fever for 3 days", "muscle aches", "chest pain" and "crp as measure by doctor was elevated 3x normal." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, pyrexia, myalgia, chest pain, c-reactive protein increased. Additional information: It was reported that, prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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. 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 for one week; (unspecified date) positive; (Jul2022) positive, notes: then COVID positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient has received palovid from 07Jul2022 to 11Jul2022 for the treatment of covid-19. Paxlovid rebound. After 5 day course, tested negative for one week, then COVID positive again and symptoms returned full force on 18Jul2022, the outcome was not recovered.  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
Symptoms: Blood test, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive for COVID; positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4035165-00.   A 53-year-old female patient received BNT162b2 (BNT162B2), on 04Aug2021 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years and on 25Aug2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.   The following information was reported: VACCINATION FAILURE (medically significant) with onset 16Sep2021, outcome "unknown", COVID-19 (medically significant) with onset 16Sep2021, outcome "recovered" and all described as "positive for COVID". The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) All good; SARS-CoV-2 test: (16Sep2021) Positive; (Nov2021) Positive.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 at 15:00 as dose 1, single (Lot number: EL3249), in left arm, on 11Feb2021 at 14:30 as dose 2, single (Lot number: EM9810), in left arm, on 24Nov2021 at 14:30 as dose 3 (booster), single (Lot number: 33026BD), in left arm and on 04Apr2022 at 15:00 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient's relevant medical history included: "mild HTN" (unspecified if ongoing); "osteo arthritis" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: Feb2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (14Jul2022) Positive; (16Jul2022) Negative; (18Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Paxlovid rebound. Started Rx 06Jul after developing a sore throat and testing positive. Completed Rx 10Jul. Still positive 14Jul, then negative on 16Jul. Sore throat returned again on 17Jul with positive test on the 18th. Symptoms were those of a bad cold. Sore throat>sinus issues>cough. No fever. Shall test again on 23Jul or after symptoms resolve.
Age: 43.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 30Nov2021 as dose number unknown, single at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood preasure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 01Jul2022, stop date: 21Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral details: product: COVID 19 Treatment, brand: PAXLOVID Start date: 13Jul2022, stop date: 17Jul2022. No Known allergies.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if  and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: 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 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid disease" (unspecified if ongoing); "obese" (unspecified if ongoing); "past cancer" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; NEXIUM [ESOMEPRAZOLE SODIUM]; GABAPENTIN; BABY ASPIRIN; MAGNESIUM; CALCIUM; TURMERIC [CURCUMA LONGA RHIZOME]. Past drug history included: Amoxicillin, reaction(s): "known allergies; amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19".  Clinical course: Patient got COVID 19 and took Plaxlovid. Patient tested negative 6 days later and then three days after that patient had symptoms and tested positive again. Paxlovid treatment start date = 11Jul2022, Treatment stop date = 16Jul2022. Other medication in 2 weeks product include multi vitamin.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient. A male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Manufacturer: Unknown), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "memory loss", "terrible headaches". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "terribly sick". Additional Information: The reporter stated that he was experiencing terrible headaches and memory loss for two hours after the first booster shot and after the second booster he just became terribly sick. 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) :RA-PFIZER INC-PV202200028290 Same reporter/ drug, different patients/ events;RA-PFIZER INC-PV202200028309 Same reporter/ drug/patients/ different events;
Age: 78.0
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) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 78 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 was not reported. Concomitant medication(s) included: EZETIMIBE; HYDROCHLOROTHIAZIDE; LOSARTIN; MYRBETRIQ; ROSUVASTIN. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Thimerisol, reaction(s): "Known allergies:Thimerisol"; Sulfur, reaction(s): "Known allergies:Sulfur". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". 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. Treatment included antiviral product (start date:07Jul2022, stop date: 12Jul2022). When the patient appeared to be fully recovered and her Covid symptoms were mild cold and a little lethargy and when she was ready to end a 10 day quarantine, she had developed a bad cold.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 31-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 17Jul2022, outcome "recovering", DRUG INEFFECTIVE (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: vaccine received and Other medication in 2weeks product: Melatonin, Benzonatate and Acetaminophen start date 05Jul2022, stop date 09Jul2022.Treatment: Paxlovid start date 05Jul2022 and stop date 09Jul2022 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.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 78-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2022 at 11:00 as dose number unknown, single (Lot number: FK9893) at the age of 78 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 Paxlovid from 11Jul2022 to 15Jul2022. Recurrence of cough, sore throat, general malaise from 21Jul2022.
Age: 25.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient received BNT162b2 (BNT162B2), on 08Mar2022 as dose 2, single (Lot number: FM0698) at the age of 25 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADVIL [IBUPROFEN], start date: 18Jul2022, stop date: 20Jul2022; MUCINEX, start date: 19Jul2022, stop date: 20Jul2022. Past drug history included: Ceclor, reaction(s): "Drug allergy: Ceclor", notes: Known allergies: Ceclor; Zithromax, reaction(s): "Drug allergy: Zithromax", notes: Known allergies: Zithromax.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". 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.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "menopausal" (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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Symptoms returned 3 days after Paxlovid- much worse. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200998305 same reporter/patient, different drug/ 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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had other medication in 2 weeks. Anti-viral product Paxlovid, for Covid-19 treatment from 09Jul2022 and to 13Jul2022. The patient  had rebound Covid 7 days after completing Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Migraines" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received treatment with paxlovid from 12th Jul to 17th Jul2022. The patient had not received any other medication within 2 weeks. Device timestamp: 21Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: high fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "high fever". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The reporter reported that she knows someone who had high fever.  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: Illness
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non HCP, program ID: (172086). A female patient received the 1st, 2nd and 3rd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine); all single dose, for immunization. Medical history and concomitant medications not reported. The patient experienced illness/severe illness, with outcome of recovered. Therapeutic measures were taken as a result of illness. Additional information: The reporter's cousin and her daughter both received shots. They had a booster shot and were really severely ill. Caller stated the patient got over it with medicine within a week. The caller stated the patient brought the COVID-19 illness to first cousin and husband. It took about three weeks. They didn't have their shots and were afraid to take it. The information on the batch/lot number for BNT162B2 requested and will be submitted if/when received.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: they were really severely ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), 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: ILLNESS (non-serious), outcome "unknown", described as "they were really severely ill".  Additional information: Reporter's cousin and her daughter they had both shots and they had a booster shot and they were really severely ill.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.