chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
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 a contactable reporter(s) (Physician) from product quality. The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 17Dec2020 at 08:00 as dose 1, single (Lot number: EH9899), in left arm, on 07Jan2021 at 08:00 as dose 2, single (Lot number: EL1284), in left arm and on 09Nov2021 at 15:00 as dose 3 (booster), single (Lot number: FH8030) at the age of 66 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19 incuded Paxlovid from 11Jul2022 to 15Jul2022.; Sender's Comments: As per available information the causality of the event Vaccination failure and covid-19 with suspect product BNT162B2 can not be ruled out.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: still testing positive; still testing positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: ER8727), in left arm, on 13Apr2021 as dose 2, single (Lot number: ER8731), in left arm, on 13Oct2021 as dose 3 (booster), single (Lot number: 320308D), in left arm and on 25Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 66 years, in left arm for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient's relevant medical history included: "Obesity" (unspecified if ongoing), notes: Other medical history: Obesity until recent weight loss (dieting); "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. The patient took 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 "still testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: My first "negative" test had a very faint line; positive, notes: I am still testing positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: The patient received Paxlovid from 18Jul2022 to 23Jul2022 as COVID 19 treatment. Bounce-back after Paxlovid. Her first "negative" test had a very faint line, and now on day 14 of her infection (first symptom was day 0) The patient still testing positive. Original symptoms were runny nose and sore throat, only symptom now is sore throat, mild. From 17Jul2022 to 19Jul2022, the patient received other medication in 2 weeks product Cold and Flu, brand= Up & Up start date=17Jul2022 stop date=19Jul2022 and lot number was P108452. The patient known allergies: sulfa drugs and other medical history: obesity until recent weight loss (dieting).  No follow-up attempts are possible. No further information is expected.
Age: 36.0
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) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), 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: "Autoimmune disease" (unspecified if ongoing), notes: Autoimmune disease; "B12 deficiency" (unspecified if ongoing), notes: B12 deficiency. Concomitant medication(s) included: HYDROXYCHLOROQUINE, start date: 21Mar2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: 4 days after my first negative test; (26Jul2022) negative. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient received Paxlovid anti-viral COVID 19 Treatment which start date was 18Jul2022 and stop date was 23Jul2022. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine. After completing her Paxlovid prescription she tested negative about 3 days later, felt better for about 4 or 5 days and then woke up with symptoms again and tested positive 4 days after her first negative test. Have a slight fever, congestion and feel run down. AE start date was 29Jul2022. It was recovering. No treatment received for AE. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 03Apr2021 as dose 2, single (Lot number: ER8734), in left arm and on 12Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin; "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "known allergies: Compazine", notes: known allergies: Compazine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2022) Negative; (20Jul2022) Positive, notes: Did not test negative again until 27Jul2022 in the morning; (27Jul2022) Negative. Therapeutic measures were taken as a result of covid-19.  Clinical Course: The patient had anti-viral Paxlovid (Lot number: GA9630) treatment for COVID-19 from 11Jul2022 and treatment was stopped on 16Jul2022. The patient had COVID symptom relapse after completing Paxlovid. Last Paxlovid dose was on 16Jul2022 in the morning. Negative COVID test on 18Jul2022 in the morning. Positive COVID test and return of symptoms on 20Jul2022 in the morning. The patient did not test negative again until 27Jul2022 in the morning. The patient had some lingering COVID symptoms. The patient had adverse event which stated on 20Jul2022 06:00 am of which outcome was recovering. The device date was 30Jul2022. The patient also had other medications within 2 weeks of starting COVID-19 treatment - Humalog (Insulin), Humulin N (Insulin), Sertraline, Simvastatin, Levothyroxine, Losartin, Multivitamin, Probiotics, and Vitamin C.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on possible temporal association and lack of effect 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: 48.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 11Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 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: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative; (30Jul2022) Positive. Therapeutic measures were taken as a result of covid-19 from 20Jul2022 to 24Jul2022.  Clinical course: It was reported that Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. patient previously received a COVID-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
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 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 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 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) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient was not taking any other medications/products within 2 weeks of starting COVID-19 and patient previously received covid 19 vaccine.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID positive on 30Jul2022 via antigen testing; COVID positive on 30Jul2022 via antigen testing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Batch/Lot number: unknown), on 25Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 02Dec2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 30Jul2022, outcome "unknown", COVID-19 (medically significant) with onset 30Jul2022, outcome "recovering" and all described as "COVID positive on 30Jul2022 via antigen testing". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jul2022) Positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
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 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 22May2022 as dose 4 (booster), single (Lot number: FM0173) 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), 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: "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative; (18Jul2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Horrid taste while taking Paxlovid,went away when course was done. Covid recurrence (positive test) 7 days after previously negative test on last day of course. Still positive at present.
Age: 69.0
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) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 at 13:00 as dose 1, single (Lot number: EN6198), in right arm and on 15Jul2022 at 11:00 as dose 2, single (Lot number: FP7139) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast Cancer" (unspecified if ongoing); "Type 2 Diabetes" (unspecified if ongoing), notes: Type 2 Diabetes. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Jul2022) negative; (30Jul2022) positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Had extreme exhaustion that never improved. 4 days after I finished Paxlovid the sniffles and sneezing started again and feeling run down. Had a negative Covid test on 26Jul2022 and had another positive test on 30Jul2022.
Sex: F
Vaccine: COVID19, COVID19, 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 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Nov2021 as dose number unkown, single (Lot number: 330268D) and on 28Apr2022 as dose number unkown, single (Lot number: FJ4989), in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 09Apr2021 as dose number unkown, single (Lot number: 1805018), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer history" (unspecified if ongoing), notes: Cancer history, but normal mammograms since; "known allergies: Penicillin, oral" (unspecified if ongoing), notes: known allergies: Penicillin, oral. Concomitant medication(s) included: GABAPENTIN, start date: Jun2018; ALENDRONATE, start date: Nov2020; CALCIUM, start date: Nov2020; IBUPROFEN, start date: Jan1983; PROPRANOLOL, start date: Jan2003; SUMATRIPTAN, start date: Jan2000; ESTRADIOL, start date: Jan2017; REFRESH OPTIVE, start date: Jan2003; ACETAMINOPHEN, start date: Jan1960; FEXOFENADINE HYDROCHLORIDE, start date: Jan1974; LANSOPRAZOLE, start date: Jan2003.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive; (20Jul2022) Positive. Therapeutic measures were taken as a result of covid-19.  clinical course: In last 2 week patient took several other medication like Multi for her,(Nature made nutritional products; start date=Jan1985; lot number=2457281)  rest of additional info given was already captured in linked case  202201021866same patient and reporter, different drug and event.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Pharyngeal erythema, 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 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Nov2021 as dose number unkown, single (Lot number: 330268D) and on 28Apr2022 as dose number unkown, single (Lot number: FJ4989), in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 09Apr2021 as dose number unkown, single (Lot number: 1805018), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer history" (unspecified if ongoing), notes: Cancer history, but normal mammograms since; "known allergies: Penicillin, oral" (unspecified if ongoing), notes: known allergies: Penicillin, oral. Concomitant medication(s) included: GABAPENTIN, start date: Jun2018; ALENDRONATE, start date: Nov2020; CALCIUM, start date: Nov2020; IBUPROFEN, start date: Jan1983; PROPRANOLOL, start date: Jan2003; SUMATRIPTAN, start date: Jan2000; ESTRADIOL, start date: Jan2017; REFRESH OPTIVE, start date: Jan2003; ACETAMINOPHEN, start date: Jan1960; FEXOFENADINE HYDROCHLORIDE, start date: Jan1974; LANSOPRAZOLE, start date: Jan2003.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive; (20Jul2022) Positive. Therapeutic measures were taken as a result of covid-19.  clinical course: In last 2 week patient took several other medication like Multi for her,(Nature made nutritional products; start date=Jan1985; lot number=2457281)  rest of additional info given was already captured in linked case  202201021866same patient and reporter, different drug and event.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
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 61-year-old female patient received BNT162b2 (BNT162B2), on 24May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. Concomitant medication(s) included: NORVASC, start date: 01Feb2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; positive, notes: 4 days after testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Positive test result for COVID 4 days after testing positive. Patient had a home rapid test. Patient had a runny nose, sneezing, fatigue. Treatment included Amlodipine tab 2.5 mg.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
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) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 08Apr2021 as dose 2, single (Lot number: EW0150), in left arm, on 17Nov2021 as dose 3 (booster), single (Lot number: FJ1611), in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 55 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Doxycycline, reaction(s): "Allergy:Doxycycline", notes: Known allergies: Doxycycline. The following information was reported: VACCINATION FAILURE (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 vaccination failure, covid-19.  Clinical course: Patient took Anti-viral product Paxlovid indicated for COVID 19, and treatment started on 14Jul2022, Treatment stopped on 19Jul2022. Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine. It was reported that patient had a rebound case of covid, and the symptoms were far more severe than his initial case. Adverse events start date was reported as17Jul2022. Patient was Recovering. No treatment ae was reported. In other medical history was reported as None. Possible undiagnosed autoimmune disease. Device Date was reported as 30Jul2022.
Age: 58.0
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 59-year-old male patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: en6199), in left arm and on 11Apr2021 as dose 2, single (Lot number: ew0158) at the age of 58 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Dec2021 as dose 3 (booster), single (Lot number: 045j21a) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST, start date: Jan2021; LOSARTAN, start date: Jan2021.  The following information was reported: VACCINATION FAILURE (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: (31Jul2022) Positive, notes: Recurrence of covid 19 from home test kit on 31Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: It was reported that, treatment drug Paxlovid was received from 21Jul2022 to 25Jul2022 for the treatment of COVID-19.
Age: 56.0
Sex: F
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) (Physician). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2021 at 13:00 as dose 1, single (Lot number: EL0142), in left arm, on 23Jan2021 at 13:00 as dose 2, single (Lot number: EL3248), in left arm and on 18Aug2021 at 13:00 as dose 3 (booster), single (Lot number: EW0168) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Jun2022 at 13:00 as dose 4 (booster), single (Lot number: 004M21A), in left arm for covid-19 immunisation; cilgavimab, tixagevimab (EVUSHELD), on 27Apr2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "Vit D deficiency" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", 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: have continued to test positive 3 additional times by rapid antigen test; (unspecified date) Positive, notes: have continued to test positive 3 additional times by rapid antigen test; (unspecified date) Positive, notes: have continued to test positive 3 additional times by rapid antigen test; (18Jul2022) Positive, notes: I tested positive for Covid 18Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The patient had no known allergies. I am an immunocompromised physician due to treatment for MS (Gilenya). I am vaccinated with 2 boosters (Pfizer and Moderna), resulting in no significant antibody response, proven by participation in a multistate study. I underwent prophylactic Evusheld administration, with last dose given 27Apr2022. I contracted Covid-19 with symptoms starting 08Jul2022. I began Paxlovid on day 4, and took it 12Jul2022 to 17Jul2022. I tested positive for Covid 18Jul2022, and have continued to test positive 3 additional times by rapid antigen test. I believe that my case falls into the category of treatment failure rather than Paxlovid rebound, since I never had a negative test following cessation of treatment.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 to the reported events Vaccination failure and COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: RM7553) 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: SPIRIVA. (Other medication in 2 weeks). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound after taking Paxlovid. Tested negative 3 days after full 5 days of Paxlovid; Positive, notes: Texted positive 3 days later with very mild sympotoms; Negative, notes: Tested negative again (and have remained negative) 4 days after positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment paxlovid started from 09Jul2022 and treatment stopped on 14Jul2022.   Follow-Up (02Aug2022): Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 received BNT162b2 (BNT162B2), on 05Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabestes 2" (unspecified if ongoing); "myasthenia Gracie" (unspecified if ongoing), notes: myasthenia Gracie. The patient's concomitant medications were not reported. Past drug history included: Scopolamine patch, reaction(s): "known allergies: Scopolamine patch", notes: Scopolamine patch; Zantac, reaction(s): "known allergies: Zantac"; Prevacid, reaction(s): "known allergies: Prevacid"; Codeine, reaction(s): "known allergies: codeine".  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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient was not taking any other medications, products within 2 weeks of starting COVID-19 treatment.  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, SARS-CoV-2 antibody test, Vaccination failure
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 78-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL1263), in left arm, on 16Feb2021 as dose 2, single (Lot number: EI9267), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 01Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FM0698) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteopenia" (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 "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (25Jul2022) Negative; (30Jul2022) Positive; (unspecified date) Unknown results; (28Jul2022) Negative; (30Jul2022) Positive. From 18Jul2022 to 23Jul2022, Paxlovid (Lot number: 2692127) as therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 69.0
Sex: M
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 70-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 at 14:00 as dose 1, single (Lot number: EN6199), in left arm, on 07Apr2021 at 14:00 as dose 2, single (Lot number: EB8737), in left arm and on 05Nov2021 at 14:00 as dose 3 (booster), single (Lot number: 30155BA) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "prostate cancer" (unspecified if ongoing); "Known allergies: Shrimp" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Meperidine, reaction(s): "Known allergies: meperidine class"; Lisinopril, reaction(s): "Known allergies: Lisinopril". The following information was reported: COVID-19 (medically significant) with onset Jul2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had not received other medication in 2 weeks. Patient received of COVID 19  treatment Paxlovid from 18Jul2022 till 23Jul2022.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
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) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 04May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02Dec2021 as dose 3 (booster), single (Lot number: 066F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Adhesives" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies Amoxicillin", notes: known allergies Amoxicillin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jul2022) Positive, notes: Recurrence of covid symptoms and a positive antigen test 9 days after last Paxlovid dose; (unspecified date) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 20Nov2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm 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 test: (29Jul2022) Negative, notes: COVID test (PCR and home kit) tested negative on 29Jul2022; (30Jul2022) Positive, notes: But 30Jul2022, the home kit shows positive; (31Jul2022) Positive, notes: 31Jul2022 still shows positive with darker positive line. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course was reported as patient had COVID test (PCR and home kit) tested negative on 29Jul2022. But 30Jul2022, the home kit showed positive and on 31Jul2022 still showed positive with darker positive line. On 31Jul2022, patient started to have running nose and coarse throat and treatment of COVID-19 was given with Paxlovid. treatment start date=22Jul2022, treatment stop date=26Jul2022, lot number=1916517A.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; Treatment of 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 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 21 years, in right 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 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that the patient was treated with Paxlovid from 18Jul2022 to 23Jul2022 for Covid-19. It was unknown if other medications the patient received within 2 weeks of vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. This is second report of the total two reports. A female patient received BNT162b2 (BNT162B2), on 29Jul2022 at 16:00 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation complete, unknown manufacturer), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "I just have slight headaches". Additional information: The patient had received COVID-19 booster shot the previous day at 4 pm. The patient just had slight headaches. The patient did not know if they had to isolate. The patients husband's mother was supposed to come over that night and she was immunocompromised cancer patient. There was nothing in the fact sheet that stated after vaccine if you were just suppose to do not run but then tell you, if you were needing to stay away from people. The patient did not know, that was the question. The patient could not get it on any website or paper. The patient was not worried about herself. She knew it was not allowed for her sake. It was in mRNA so, she did not think it was body responding. The patient responded that she was close to find out and just need to be clearer but that was fine, she would figure it out and hung the phone abruptly. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Drug ineffective, Pyrexia, Suspected COVID-19
Clinical narrative: He had COVID and he is also had, like being fully vaccinated and now he has both boosters; He had COVID and he is also had, like being fully vaccinated and now he has both boosters; He is running a 101.5 after the shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), on 29Jul2022 at 16:00 as dose number unknown (booster), single (Batch/Lot number: unknown), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "His COVID was in 2020", start date: 2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset Jul2022, outcome "unknown", described as "He is running a 101.5 after the shot"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "He have had COVID and he is also had, like being fully vaccinated and now he has both boosters". The patient underwent the following laboratory tests and procedures: Body temperature: 101.5.  Clinical course: Reporter reported that, she and her husband had the COVID-19 booster shots and her husband tested positive for COVID (Later reporter clarified that husband does not have active COVID right now). So, she would like to know, if they need to isolate because (Incomplete sentence). Reporter stated, "No. He did not test for COVID, no. Both took the vaccine yesterday at 4 pm. Reported said, patient was just doing well. He had COVID and he also had, like being fully vaccinated and now he has both boosters. His COVID was in 2020. So, no he did not have active COVID right now. Reporter question was, patient is running a 101.5 after the shot. I just have slight headaches.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 03Mar2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 27Sep2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm 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: positive, notes: now on day 17 testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: No other medication in 2 weeks and No known allergies: No  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 57-year-old male patient received BNT162b2 (BNT162B2), on 01Jul2022 as dose 4 (booster), single (Lot number: FP7135), 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 relevant medical history included: "Known allergies: CT contrast dye" (unspecified if ongoing). Concomitant medication(s) included: VIT C, start date: Jul2022; VIT D [VITAMIN D NOS], start date: Jul2022, ZINC, start date: Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering'', 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, (25Jul2022) Negative, (31Jul2022) Positive. Therapeutic measures were taken because of drug ineffective, covid-19. The patient received treatment of Paxlovid for COVID-19 from 18Jul2022 to 23Jul2022.  Clinical course: Patient Tested Covid negative 25Jul after treatment, and tested Covid positive 31Jul. Rebound Covid and patient experienced hardly any symptoms second time.
Age: 39.0
Sex: F
Vaccine: 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 contactable reporter(s) (Nurse). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jun2021 as dose 1, single (Lot number: EW0173) and on 14Jul2021 as dose 2, single (Lot number: EW0186) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "mvp" (unspecified if ongoing); "svt" (unspecified if ongoing); "migraines" (unspecified if ongoing); "h/o Lyme disease" (unspecified if ongoing); "Epstein Barr" (unspecified if ongoing). Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE].  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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Treatment included was :Anti-viral details: COVID 19 Treatment, brand: Paxlovid, treatment started on 09Jul2022, treatment stopped on 11Jul2022. Patient took Other medication in 2weeks was Plaquenil. Other Known allergies was not reported. Other medical history reported were Lupus, mvp, svt, migraines , h/o Lyme disease and Epstein Barr.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug ineffective  and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.