chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Off label use, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; vaccine dose number: 16; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), as dose 16 (booster), single (Lot number: GA6206) at the age of 72 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 5 (booster), single (Batch/Lot number: unknown), as dose 6 (booster), single (Batch/Lot number: unknown), as dose 7 (booster), single (Batch/Lot number: unknown), as dose 8 (booster), single (Batch/Lot number: unknown), as dose 9 (booster), single (Batch/Lot number: unknown), as dose 10 (booster), single (Batch/Lot number: unknown), as dose 11 (booster), single (Batch/Lot number: unknown), as dose 12 (booster), single (Batch/Lot number: unknown), as dose 13 (booster), single (Batch/Lot number: unknown), as dose 14 (booster), single (Batch/Lot number: unknown) and as dose 15 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (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"; OFF LABEL USE (medically significant), outcome "unknown", described as "vaccine dose number: 16"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid (Lot number: GA6206 ) from 10Jun2022 to 10Jun2022.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 11Jan2021 at 13:00 as dose 1, single (Lot number: EK9231), in left arm, on 01Feb2021 at 13:00 as dose 2, single (Lot number: EN9581), in left arm and on 28Sep2021 at 13:00 as dose 3 (booster), single (Lot number: FF2587) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "previous heart attack" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Known allergies: penecillin" (unspecified if ongoing); "Known allergies: buckwheat" (unspecified if ongoing). Concomitant medication(s) included: CARVEDILOL, start date: 01Feb2019, stop date: 10Jun2022. Past drug history included: Fentanyl, reaction(s): "Allergy". 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. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 26May022 to 31May2022 for treatment of COVID-19 in 2 weeks. Patient had rebound Covid 19 positive test with symptoms 9 days post Paxlovid treatment.  No follow-up attempts are needed. 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 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 14Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 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 and 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: Rebound symptoms of COVID-19 and positive test 10 days after original positive test. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: En6200), in left arm, on 15Mar2021 as dose 2, single (Lot number: Ep7534), in right arm, on 27Sep2021 as dose 3 (booster), single (Lot number: Ew0164), in right arm and on 13Apr2022 as dose 4 (booster), single (Lot number: Fm0698) at the age of 62 years, in left arm for Covid-19 immunization. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "slight high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 11May2022, stop date: 28May2022. Past drug history included: Aleve, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (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: home test said I was positive for the virus. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical information: Patient received Paxlovid as each packet exactly 12 hours apart (7 a.m. and 7 p.m.) for five days until gone. Four days later, Covid symptoms returned and a home test reported as positive for the virus. Symptoms were mild.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Depression" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Allergy:Amoxicillin". 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. The patient received Paxlovid from 07Jun2022 to 12Jun2022 for the treatment of COVID-19.   Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient. A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Feb2021 at 14:00 as dose 1, single  (Lot number: EL9264), in left arm, on 08Mar2021 at 14:00 as dose 2, single (Lot number: EN6203), in left arm, on 14Nov2021 at 14:00 as dose 3 (booster), single (Lot number: FH8030), in left arm and on 12Apr2022 at 15:00 as dose 4 (booster), single (Lot number: F24991) at the age of 61 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "SVT" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical information: No Other medication in 2 weeks. Paxlovid was taken as treatment, Start date was 30May2022,stop date was 03Jun2022. Recurrence of Covid approximately 5 days after finishing dose on 08Jun2022. Patient had no known allergies. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of LOE.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 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 took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (08Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid treatment started from 23May2022 to 28May2022.  Causality: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of LOE. Clinical information: Patient got COVID back test positive 10 days after taking paxlovid. No known allergies.   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 information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of LOE.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 17Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19", start date: Nov2020 (unspecified if ongoing), notes: Covid-19 positive 3 times (Nov2020, Dec2021, Jun2022). The patient had no known allergies. 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: (Nov2020) Positive, notes: Covid-19 positive 3 times (Nov2020, Dec2021, Jun2022); (Dec2021) Positive, notes: Covid-19 positive 3 times (Nov2020, Dec2021, Jun2022); (Jun2022) Positive, notes: Covid-19 positive 3 times (Nov2020, Dec2021, Jun2022). Therapeutic measures were taken as a result of covid-19 which include Paxlovid from 01Jun2022 to 05Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment/Proprietary medicinal product name: Paxlovid/testing positive; COVID 19 Treatment/Proprietary medicinal product name: Paxlovid/testing positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 at 08:00 as dose 1, single (Lot number: EK9231), in left arm, on 12Feb2021 at 08:00 as dose 2, single (Lot number: EL9261), in left arm, on 23Aug2021 as dose 3 (booster), single (Lot number: FC3180), in right arm and on 22Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "primary immunodeficiency (Hypogammaglobulinemia)" (unspecified if ongoing), notes: I have primary immunodeficiency (Hypogammaglobulinemia) and asthma; "asthma" (unspecified if ongoing), notes: I have primary immunodeficiency (Hypogammaglobulinemia) and asthma. Concomitant medication(s) included: PREDNISONE, start date: 31May2022, stop date: 05Jun2022; TESSALON, start date: 31May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment/Proprietary medicinal product name: Paxlovid/testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: testing positive and finishing paxlovid. Therapeutic measures were not taken as a result of drug ineffective. Clinical course information: No known allergies reported. Patient received Anti viral treatment of Covid 19 from 30May2022 to 03Jun2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 18Mar2021 as dose 2, single (Lot number: ER2613), in left arm and on 01Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Known allergies: Soy" (unspecified if ongoing); "Known allergies: walnuts" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Msg, reaction(s): "Known allergies: msg". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid course and did not test positive.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Lot number: FF8831) 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: "type 1 diabetes" (unspecified if ongoing); "hashimoto's thyroiditis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin, Sulfa Drugs; "Known allergies: SUlfa drugs" (unspecified if ongoing), notes: Known allergies: Penicillin, Sulfa Drugs. Concomitant medication(s) included: INSULIN; LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) Positive; (29May2022) Negative; (10Jun2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks. Product- COVID 19 Treatment, Brand: Paxlovid, Treatment start date- 25May2022, Treatment stop date- 30May2022; Novolog. I tested positive for COVID19 on an at home test on 25May2022. I have Type 1 diabetes and consulted with endocrinologist who prescribed Paxlovid. I took the full course and followed CDC guidelines on masking/isolation. I recovered, and tested negative on 29May (Day 4). I remained negative on subsequent tests through Day 12 (the last day I had tested prior to 10Jun2022). On Day 16 or 10Jun2022, symptoms returned and I tested positive for COVID19 again.  No follow-up attempts are possible. No further information is expected.; 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.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2022 as dose number unknown, single (Lot number: Fj4989) at the age of 58 years 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 "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Became antigen test negative; (unspecified date) Positive, notes: positive testing again; (06Jun2022) Positive, notes: positive testing again. Therapeutic measures were taken as a result of drug ineffective, covid-19. treatment received was no, known allergies was no.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Vaccination failure; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 19Aug2021 as dose 3 (booster), single (Lot number: FC3180) at the age of 52 years for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "overweight" (unspecified if ongoing); "motorcycle accident injuries" (unspecified if ongoing); "Known allergies: Opiates" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Vaccination failure"; 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: (03Jun2022) Positive, notes: Had a positive Covid test on 03Jun2022; (12Jun2022) Positive, notes: Woke up with a sore throat on 12Jun, tested, and was positive for COVID.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
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) from product quality. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2022 as dose 4 (booster), single (Lot number: FL3198) at the age of 49 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: "Ankylosing Spondylitis" (unspecified if ongoing); "Type II Diabetes" (unspecified if ongoing), notes: Type II Diabetes. Concomitant medication(s) included: RELAFEN, start date: 19Aug2011; METHOTREXATE, start date: 19Aug2011; METFORMIN, start date: 01Jun2018. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results; (Jun2022) Negative, notes: day 8; (Jun2022) positive, notes: on Day 12. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional information: Other medication in 2 weeks was reported as yes. She had taken Paxlovid for 1-5 days, tested negative day 8, sore throat, cough & nasal congestion returned day 10-still testing positive on Day 12. If treatment ae was no. Known allergies was reported as no.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral details, Paxlovid, treatment start date: 01Jun2022 and treatment stop date: 05Jun2022. Indication: Treatment of COVID-19. Rebound covid after taking paxlovid dose. The patient reported inhaler as treatment for the event. The patient has no known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: EN5318), in left arm, on 13Feb2021 as dose 2, single (Lot number: EN6201), in left arm, on 13Sep2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 29Mar2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 71 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "known allergies: Walnuts" (unspecified if ongoing), notes: known allergies: Walnuts. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive Covid19 result". The patient underwent the following laboratory tests and procedures: Chest X-ray: Unknown Results, notes: Chest x-ray, consult with Doctor; SARS-CoV-2 test: positive, notes: Paxlovid was taken for 5 days per instructions for positive Covid-19 result; positive, notes: rebounded 2 days after the 5 day treatment. I had fever, facial discomfort, full throat, runny nose, cough, fatigue - full symptoms experienced with positive test results just days prior. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: Patient had no other medication in 2weeks reported. Paxlovid used as treatment drug for COVID 19 started on 30May2022 and stopped on 03Jun2022. Paxlovid was taken for 5 days per instructions for positive Covid19 result. I responded well to its benefits but rebounded 2 days after the 5 day treatment. I had fever, facial discomfort, full throat, runny nose, cough, fatigue - full symptoms experienced with positive test results just days prior.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive in rapid Antigen test; I tested positive in rapid Antigen test; 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), on 05Oct2021 at 13:30 as dose 3 (booster), single (Lot number: FF2589) at the age of 53 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: "High BP" (unspecified if ongoing), notes: High BP; "High triglycerides" (unspecified if ongoing), notes: High triglycerides; "Moya moya disease (middle cerebral artery" (unspecified if ongoing), notes: Moyamoya disease (middle cerebral artery block). Concomitant medication(s) included: AMLODIPINE oral; METOPROLOL oral; ATORVASTATIN oral; BABY ASPIRIN oral. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "I tested positive in rapid Antigen test". Clinical course: Other medication details: other medication in 2weeks product: amlodipine, other medication in 2weeks brand: generic, other medication in 2weeks administrator route: oral, other medication in 2weeks product: metoprolol, other medication in 2weeks brand: generic, other medication in 2weeks administrator route: oral, other medication in 2weeks product: atorvastatin, other medication in 2weeks brand: generic, other medication in 2weeks administrator route: oral, other medication in 2weeks product: baby aspirin, other medication in 2weeks brand: (name Withheld), other medication in 2weeks administrator route: oral. Adverse event: Pt suddenly felt sick (cough, chills, congested nose and throar). Pt tested positive in rapid Antigen test. Pt had finished full 5 day course of Paxlovid last Sunday (today was day 7) and tested negative last Tuesday. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: tested positive in rapid Antigen test; negative, notes: tested negative last Tuesday. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional information: The patient had received other medications within 2 weeks. Antiviral details, Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 31May2022, Treatment stop date: 05Jun2022, Indication Treatment of COVID-19, Administrator route: Oral. Other medical history: High BP, High triglycerides, Moya moya disease (middle cerebral artery block).  Follow-Up (15Jun2022): Follow-up attempts are completed. No further information is expected.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 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: "Pancreatitis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Additional information: Patient administered anti viral drug for COVID 19 Treatment with Paxlovid, treatment start date: 11Jun2022, lot number: GC4027. Patient experienced metal mouth, Everything tastes like metal, adverse event start date: 11Jun2022 07:00 am, Not recovered. The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 57.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 23Mar2021 as dose 1, single (Lot number: 031A21A), in left arm, on 20Apr2021 as dose 2, single (Lot number: 039A21A), in left arm and on 18Nov2021 as dose 3 (booster), single (Lot number: 004F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Discoid lupus erythmatosis" (unspecified if ongoing), notes: Discoid lupus erythmatosis; "Menieres Disease" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: tested positive again; (08Jun2022) Unknown results, notes: tested on Wednesday, 08Jun2022 and the line was barely visible; (11Jun2022) Positive, notes: tested positive again the morning of 11Jun2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Completed 10 prescribed doses of Paxlovid from 02Jun2022 to 07Jun2022, for Treatment of COVID-19. Patient tested on Wednesday, 08Jun2022 and the line was barely visible. On Friday, 10Jun2022 patient felt the symptoms returning in the evening. Patient tested positive again the morning of 11Jun2022.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: A direct report of mine notified me that he tested positive for covid. He also reported; A direct report of mine notified me that he tested positive for covid. He also reported; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Jun2022 at 14:15, outcome "unknown" and all described as "A direct report of mine notified me that he tested positive for covid. He also reported". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Jun2022) positive, notes: A direct report of mine notified me that he tested positive for covid. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: suspected COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 30Oct2021 at 09:30 as dose 3 (booster), single (Lot number: FH8020) at the age of 35 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: "Chronic Kidney stones" (unspecified if ongoing), notes: Chronic Kidney stones; "higher than normal blood pressure" (unspecified if ongoing), notes: higher than normal blood pressure. The patient's concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), outcome "unknown"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID-19". Therapeutic measures were taken as a result of suspected covid-19, drug ineffective.  Clinical course: Covid treatment received Yes. No other medication in 2 weeks . Adverse event Bitter, at times metallic, taste in mouth. Especially bad at night and during the day the taste comes and goes. At times mouth feels like it is coated in a film. Rinsing with water helps, but taste comes back. While disgusting, I am not willing to stop taking the medication as it absolutely makes me feel better. Adverse events start date: 10Jun2022. Adverse events start time: 06:00 PM.  .Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm, on 26Mar2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 07Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ACETAMINOPHEN, start date: 30May2022, stop date: 03Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19. Antiviral treatment was administered with Paxlovid. The therapy duration was from 30May2022 to 05Jun2022.  Clinical course: Adverse events are noted as nasal congestion, sneezing and body aches. No fever was reported. Event start date denoted as 07Jun2022, 08:00 AM. Outcome reported as recovering. No treatment was administered. Product COVID 19 Treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 25Mar2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 27Dec2021 at 18:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "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: Treatment of COVID-19; (07Jun2022) Negative, notes: Tested negative on day 8; (09Jun2022) Positive, notes: Day 10 felt much worse coughing and congestion tested positive again for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had other medication in 2 weeks. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 09Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 31Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 27Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos Thyroiditis" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE; SYNTHROID; WELLBUTRIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Negative, notes: tested negative as of 01Jun2022; (11Jun2022) Positive, notes: I took a test today and tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 28May2022 to 02Jun2022. Patient took the full course of Paxlovid and tested negative as of 01Jun2022. Starting around the 6th, patient felt heavy fatigue. The cough returned on the 9th and the night of the 10th she barely slept due to cough and inability to breathe well. Patient took a test today (11Jun2022) and tested positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
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) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: Er2613), in left arm, on 10Apr2021 as dose 2, single (Lot number: Er8729), in left arm and on 11Nov2021 at 14:30 as dose 3 (booster), single (Lot number: Ff2593) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Have a susceptibility to chest infections if i get a cold" (unspecified if ongoing), notes: Used a rescue inhaler albuterol and alvesco when these episodes happen.; "Have a susceptibility to chest infections if i get a cold" (unspecified if ongoing), notes: Used a rescue inhaler albuterol and alvesco when these episodes happen. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24May2022, outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) positive; (29May2022) negative; (08Jun2022) positive.  Clinical course: The patient did not take any other medication in 2 weeks. The patient had no allergies. Reported, 24 may tested positive, and took Pablo in. 29th negative and played sport. 06June chest started to tighten and didnt feel well. 08June tested positive again. Tight chest, headache, unable to lie down, very tired. Patient had Paxlovid from 25May2022 to 31May2022 for Treatment of COVID-19. Patient had treatment for adverse event (Antibiotics and over the counter relief).  No follow up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech: Dose Number: 4; Paxlovid: COVID 19 Treatment; Pfizer / BioNTech: Dose Number: 4; Paxlovid: COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2022 as dose 4 (booster), single (Lot number: FM9992) 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: "Diabetes" (unspecified if ongoing); "Obese" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Sulfa allery, reaction(s): "Known allergies: Sulfa"; Penicillin allergy, reaction(s): "Known allergies:penicillin" .The following information was reported: COVID-19 (medically significant) with onset 10Jun2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech: Dose Number: 4; Paxlovid: COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and covid-19 and BNT162B2.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID infection per rapid test; COVID infection per rapid test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EL3247), in left arm, on 31Mar2021 as dose 2, single (Lot number: EL3247), in left arm and on 11Dec2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 40 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jun2022 at 10:00, outcome "recovering" and all described as "COVID infection per rapid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Additional information: No covid prior vaccination. No treatment AE  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: er2613), in left arm and on 16Mar2021 as dose 2, single (Lot number: er8737) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Apr2022 as dose 3 (booster), single (Lot number: 069h21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sullfa drugs" (unspecified if ongoing); "asthma" (unspecified if ongoing); "arthritis" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID], start date: 01Nov2020, stop date: 12Jun2022; ACETAMINOPHEN, start date: 03Jan2021, stop date: 12Jun2022.  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: (31May2022) Positive, notes: Day 1: symptom onset,(runny nose, fever, sore throat) positive antigen test; (04Jun2022) Negative, notes: Day 4,5,6: negative antigen test; (05Jun2022) Negative, notes: Day 4,5,6: negative antigen test; (06Jun2022) Negative, notes: Day 4,5,6: negative antigen test; (12Jun2022) Positive, notes: Day 12: new symptoms (NO fever, very sore throat with swollen, raw uvula, mild cough) positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.