chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid-19 after receiving Pfizer covid-19 vaccine; covid-19 after receiving Pfizer covid-19 vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6202), in right arm, on 17Mar2021 as dose 2, single (Lot number: ER2613), in right arm, on 20Oct2021 as dose 3 (booster), single (Lot number: FF8841), in right arm and on 22Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid - hypothyroid" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". 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 after receiving Pfizer covid-19 vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19 which include Paxlovid from 20Jul2022 to 24Jul2022.  Clinical course: The patient received Probiotic on 20Jul2022.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, 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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EH9899), in right arm, on 30Apr2021 as dose 2, single (Lot number: EL1284), in right arm and on 01Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: QVAR; NASONEX.  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: Body temperature: (unspecified date) 101, notes: Fever of 101; SARS-CoV-2 test: (2022) Positive, notes: Tested positive after being well for 5 days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti-viral details: Paxlovid indicated for Covid-19 treatment. Treatment start date was 22Jul2022 and stop date was 27Jul2022. Tested positive after being well for 5 days Fever of 101, stuffy and runny nose. No known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201025193 Same product, same patient, different event, different dose;
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: Blood in urine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jul2022 at 15:00 as dose 3 (booster), single (Lot number: FP7137) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "NHL Lymphoma" (unspecified if ongoing); "CVID" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer Biontech, Prev dose brand unknown=False, Prev dose lot unknown=True, Prev dose lot unknown reason=Unable to locate or read the details, Prev dose administration time=12:00 AM, Prev dose number=2, Prev dose vaccine location=Left arm), administration date: 28Apr2021, when the patient was 63-year-old, for COVID-19 immunization; BNT162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer Biontech, Prev dose brand unknown=False, Prev dose lot number=EW0151, Prev dose lot unknown=False, Prev dose administration time=12:00 AM, Prev dose number=1, Prev dose vaccine location=Left arm), administration date: 07Apr2021, when the patient was 63-year-old, for Covid-19 immunization. The following information was reported: BLOOD URINE PRESENT (medically significant) with onset 29Jul2022 at 19:00, outcome "unknown", described as "Blood in urine". The event "blood in urine" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood urine present: (29Jul2022) Blood in urine. It was unknown if therapeutic measures were taken as a result of blood urine present. The patient did not receive any other vaccines within four weeks prior to the vaccination. Other medications in two weeks were too long to list. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 at 13:00 as dose 1, single (Lot number: FN5318), in left arm, on 17Feb2021 at 13:00 as dose 2, single (Lot number: EN6200), in left arm, on 27Sep2021 at 13:00 as dose 3 (booster), single (Lot number: 301558A), in left arm and on 06Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). There were no 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". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Anti-viral details: product=covid 19 treatment, brand= pfizer, treatment start date= 22Jul2022, treatment stop date= 26Jul2022, indication= treatment of covid-19, known allergies: none.  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 the known safety profile and Limited information in the case report a casual association between reported LOE events and the suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment COVID-19; Treatment COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose 1, 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 or other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested positive after testing negative; Positive, notes: Tested positive after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 20Jul2022 to 24Jul2022. The patient tested positive after testing negative.  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 possible temporal association the causal association  of suspect  cannot be excluded for reported events .The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 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 was none. There were no concomitant medications. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Indication: Treatment of COVID-19; (2022) Negative, notes: an additional positive test after having tested negative a week prior; (2022) Positive, notes: an additional positive test after having tested negative a week prior. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not received other medication in 2weeks. The patient received COVID 19 Treatment, Brand  Paxlovid, Treatment start date - 21Jul2022, Treatment stop date - 26Jul2022. The patient other medical history was none. The patient did not had any Known allergies. Rebound of COVID 19 symptoms and an additional positive test after having tested negative a week prior.  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-202201025297 Same patient, different product and event;
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 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: "HTN" (unspecified if ongoing), notes: HTN; "prediabetes" (unspecified if ongoing); "intermittent asthma" (unspecified if ongoing), notes: intermittent; "ADHD" (unspecified if ongoing). No known allergies. The patient was not pregnant at the time of vaccination. 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". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received COVID 19 treatment with paxlovid from 25Jul2022 to 31Jul2022.  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 causal association between the reported event cannot be totally excluded, the case will be reassessed once new information becomes available.
Sex: U
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Tested Negative; (unspecified date) Positive, notes: COVID 19 Treatment; (27Jul2022) Positive, notes: then 3 days later tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no known allergies. Treatment included anti viral drug PAXLOVID was taken from 20Jul2022 to 24Jul2022 for COVID 19 treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201025324 Same patient, different product and event;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Reappearance of symptoms and positive COVID at home antigen test after day 10; Reappearance of symptoms and positive COVID at home antigen test after day 10; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfas" (unspecified if ongoing), notes: Known allergies: Sulfas. Concomitant medication(s) included: LISINOPRIL; OMEPRAZOLE; FLUOXETINE; ROSUVASTATIN; TESTOSTERONE; RED YEAST RICE; FISH OIL; NIACIN; IMODIUM; ALLERTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Reappearance of symptoms and positive COVID at home antigen test after day 10". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: indication: Treatment of COVID-19; (Jul2022) Positive, notes: positive COVID at home antigen test after day 10. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Treatment was initiated with Paxlovid from 22Jul2022 to 26Jul 2022. All concomitants were taken in time period of 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid rebound, Positive antigen tests, 10 days after completion of Paxlovid regimen; Covid rebound, Positive antigen tests, 10 days after completion of Paxlovid regimen; 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 01Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 22Mar2021 as dose 2, single (Lot number: ER2613), in left arm and on 21Sep2021 as dose 3 (booster), single (Lot number: 303308A) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 01Apr2022 as dose 4 (booster), single (Lot number: 002M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes II" (unspecified if ongoing); "High BP" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: Known allergies: sulfa. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Jul2022, outcome "not recovered" and all described as "Covid rebound, Positive antigen tests, 10 days after completion of Paxlovid regimen". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive antigen tests. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient took anti-viral medication Paxlovid for covid 19, starting on 16Jul2022 and stopped on 20Jul2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201025436 Same patient, different product and event;
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Batch/Lot number: unknown), on 06Mar2021 as dose 2, single (Batch/Lot number: unknown), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "Allergy", notes: Allergy to: Morphine. The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered", described as "SARS-CoV-2 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (29Jul2022) Unknown results, notes: Rebound symptoms of COVID - return of dry cough, congestion, fatigue and headache 5 days after resolution. Had not completed antigen retest. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was unknown if patient received any other medication in 2 weeks. Known allergies to morphine. Other medical history reported as none. The patient received Paxlovid (route of administration: oral) as a treatment of COVID-19 from 18Jul2022 to 22Jul2022. After taking Paxlovid, Rebound symptoms of COVID - return of dry cough, congestion, fatigue and headache, 5 days after resolution. Had not completed antigen retest.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Vaccination failure and covid 19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Rebound mild symptoms of fever, congestion malaise starting  approximately 1 week after completing paxlovid.; Rebound mild symptoms of fever, congestion malaise starting  approximately 1 week after completing paxlovid.; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 65-year-old female patient (not pregnant) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Rebound mild symptoms of fever, congestion malaise starting  approximately 1 week after completing paxlovid.". 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 vaccination failure, covid-19.  Additional Information: Rebound mild symptoms of fever, congestion malaise starting approximately 1 week after completing paxlovid  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on available information , there is reasonable possibility of causal association between the events Vaccination Failure and COVID 19  and the suspect drug BNT162b2 .
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Recurrence of Covid symptoms; Recurrence of Covid symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 at 10:00 as dose 1, single (Lot number: EN6203), in left arm and on 18Mar2021 at 11:00 as dose 2, single (Lot number: EN6207), in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Breast Cancer" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN CITRATE, start date: Oct2015; OMEPRAZOLE, start date: Jun2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "Recurrence of Covid symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid from 19Jul2022 to 23Jul2022 for the treatment of COVID-19. Patient had recurrence of Covid symptoms (cough and sinus congestion) and positive PCR test 5 days after completing Paxlovid treatment on 28Jul2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201025686 Same patient, different product and event;
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, 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) for covid-19 immunisation. The patient's relevant medical history included: "Mitral valve prolapse" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing); "known allergies: Tree nuts" (unspecified if ongoing). Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE], start date: 23May2022; CLARITIN [CLARITHROMYCIN]; VITAMIN B COMPLEX. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had COVID-19 treatment with anti-viral drug. Treatment start date was 29Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201025696 Same patient, different product and event;
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, 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 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 at 10:00 as dose 1, single (Lot number: EL9262), in right arm, on 19Feb2021 at 13:00 as dose 2, single (Lot number: EN6201), in right arm and on 29Oct2021 at 14:30 as dose 3 (booster), single (Lot number: FE3590) at the age of 77 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE; METOPROLOL; HYDROCHLOROTHIAZIDE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jul2022 at 21:00, outcome "recovering" and all described as "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 vaccination failure, covid-19. Clinical course: Patient received Paxlovid for treatment of COVID-19. Treatment start date: 12Jul2022 and stop date: 15Jul2022. Lot number: FX8140. No known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201025685 Same patient, different product and event;
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Did you/the patient previously receive a COVID-19 Vaccine?: Yes; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Lot number: EP6955), in right arm and on 06Apr2021 as dose 2, single (Lot number: ER8727) at the age of 41 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 18Dec2021 as dose 3 (booster), single (Lot number: 032H21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Appendectomy" (unspecified if ongoing); "Cesarean section" (unspecified if ongoing); "Ramsay Hunt syndrome" (unspecified if ongoing); "cholecystectomy" (unspecified if ongoing); "known allergies: Possible shellfish allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered", described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes"; 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: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not received any other medication in 2 weeks of vaccine. Antiviral details included COVID 19 Treatment, Brand was Paxlovid started on  22Jul2022 to 26Jul2022 (Lot number: Gd8819). It was reported as rebound symptoms 2 days after completing Paxlovid including fatigue, sore throat, congestion, body aches, headache.
Age: 52.0
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 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 2, single (Lot number: ep7534) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CYMBALTA, start date: 01Dec2018, stop date: 01Aug2022; OTEZLA, start date: 01May2020, stop date: 01Aug2022; MAGNESIUM, start date: 01Nov2021, stop date: 01Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jul2022) Negative, notes: Tested negative on Thursday 28Jul2022; (29Jul2022) Positive, notes: woke up Saturday the 29Jul2022 with Covid symptoms and a positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient has taken Paxlovid for the treatment of COVID-19 from 23Jul2022 to 27Jul2022. The patient has experienced the adverse event on 30Jul2022 at 01:00 AM and the outcome was recovering, treatment received was unknown.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), on 05May2022 at 01:00 as dose 4 (booster), single (Lot number: fm9992) 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 included: "High blood pressure" (unspecified if ongoing); "High blood pressure and cholesterol" (unspecified if ongoing); "known allergies: Shrimp" (unspecified if ongoing); "known allergies: Shrimp and some grasses" (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 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.  Follow-Up (03Aug2022): Follow-up attempts are completed. No further information is expected.
Age: 48.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 48 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: "Idiopathic thrombocytopenic purpura" (unspecified if ongoing); "Graves Disease" (unspecified if ongoing); "Asplenia" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID; PROZAC; WELLBUTRIN and SPIROLACTONE. 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: Positive, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine was received and Other medication in 2 weeks were received. For covid-19 Treatment Paxlovid was received on 19Jul2022 to 23Jul2022. Patient had no known allergies.
Age: 79.0
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.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 27Sep2021 at 01:15 as dose 4 (booster), single (Lot number: 301458A) at the age of 79 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: "meningioma left side" (unspecified if ongoing); "Known allergies: Sulfur drugs" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Opioids, reaction(s): "known Allergy: opioids". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment for COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had Paxlovid (Lot no: 608744) from 26Jul2022 to 28Jul2022 for COVID 19 Treatment.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody 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 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Nov2021 at 12:00 as dose 3 (booster),single (Lot number: Ff2589), in right arm and on 21May2022 at 12:00 as dose 4 (booster), single (Lot number: Fm9992) at the age of 64 years, in right 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (15Jul2022) positive; (20Jul2022) Negative; (28Jul2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No other medication within 2 weeks. Patient received COVID 19 Treatment of paxlovid from 15Jul2022 to 20Jul2022. There was no Known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 09Jul2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Jul2022, 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. Clinical course: COVID 19 treatment with Anti viral Paxlovid (Lot: GC4800) from 13Jul2022 to 17Jul2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Did you/the patient previously receive a COVID-19 Vaccine?: Yes; 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 40-year-old male patient received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in right 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. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovered", described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes"; COVID-19 (medically significant), outcome "recovered", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid rebound. Tested positive and mild symptoms returned 7 days after finishing paxlovid; Negative, notes: Tested positive and mild symptoms returned 7 days after finishing paxlovid, testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received anti-viral as COVID-19 treatment from 29Jun2022 to 04Jul2022. Patient had no known allergies and did not received other medication in 2 weeks. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-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 was not reported. There were no concomitant medications. 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: (unspecified date) Positive, notes: COVID 19 Treatment; (Jul2022) Negative, notes: Symptoms went away a few days later and tested negative; (15Jul2022) Positive, notes: A few days later, experienced new symptoms and tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was not received other medication in two weeks. Paxlovid (anti viral) treatment started on 08Jul2022 and stopped on 12Jul2022. Patient was infected with covid19. Completed course of Paxlovid. Symptoms went away a few days later and tested negative. A few days later, experienced new symptoms and tested positive again. He experienced Paxlovid rebound. Patient did not receive treatment for AE but recovered with lasting effects.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 68 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: Other medical history: HTN. Concomitant medication(s) included: LEVOTHYROXINE; BISOPROLOL; SIMVASTATIN; PAROXETINE; ASA; OMEPRAZOLE. 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: Negative, notes: positive test after testing negative after Paxlovid treatment; Positive, notes: positive test after testing negative after Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective and covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2 (BNT162B2), on 03Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 28 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. There were no concomitant medications (No other medication received in 2weeks). 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 and treatment included Paxlovid from 22Jul2022 to 27Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 75-year-old male patient received BNT162b2 (BNT162B2, Vaccine brand unknown, Vaccine lot unknown, Vaccine dose number unknown: False), on 25Jan2021 at 08:30 as dose 1, single (Lot number: EL9262), in left arm, on 18Feb2021 at 14:30 as dose 2, single (Lot number: EN6201), in left arm and on 28Sep2021 at 14:30 as dose 3 (booster), single (Lot number: 30135BA) at the age of 74 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) with onset 2022, outcome "unknown", COVID-19 (medically significant) 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: (23Jul2022) Positive; (24Jul2022) Positive; (25Jul2022) Positive; (26Jul2022) Positive; (27Jul2022) Positive; (28Jul2022) Positive; (29Jul2022) Positive; (30Jul2022) Positive; (31Jul2022) Positive; (01Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 17Jul2022. Treatment stop date: 17Jul2022, Indication: Treatment of COVID-19 (Adverse Event: Rebound infection after taking Paxlovid. Testing positive from 23Jul to 01Aug. Adverse event start date: 23Jul2022, 08:00AM, If patient recovered: Recovering. Other medication details: Other medication in 2 weeks product: Lisinopril-Hctz 20-25 mg tab. Other medication in 2 weeks product: Allopurinal).  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 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 was not reported. Concomitant medication(s) included: METOPROLOL. 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: Negative, notes: After completing the medication and testing negative two full days of feeling good; Positive, notes: tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: After completing the medication and testing negative two full days of feeling good. Started a fever 101.8 tested positive sneezing, coughing and very stuffy.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
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 contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: EWD185) at the age of 58 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: "CAD" (unspecified if ongoing); "PPM" (unspecified if ongoing); "AICD" (unspecified if ongoing); "Afib" (unspecified if ongoing); "coagulopathy" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN; PLAVIX; ECASA; COREG; ENTRESTO; ATORVASTATIN; WELLBUTRIN; METHIMAZOLE; HCTZ; OMEGA 3 [FISH OIL;VITAMIN E NOS]. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "recovering" and all described as "covid-19". The patient was hospitalized for drug ineffective, covid-19 (hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Received Paxlovid 3 days after + COVID testing. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks: Anti viral details: start date=26Jul2022, stop date=30Jul2022, Indication=Treatment of COVID-19. Received Paxlovid 3 days after positive COVID testing. 3 days after completion of paxlovid went into refractory requiring 5 defibrillation attempts to convert to normal sinus rhythm. Ae treatment: Defibrillation x5, amiodorone drip & po.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE) and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202201026024 Same patient, different product and event;