chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
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) (Physician). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 23Apr2021 at 16:00 as dose 2, single (Batch/Lot number: unknown), in right arm, on 10Nov2021 at 09:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 16May2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension, controlled" (unspecified if ongoing); "History of depression" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM, start date: 09Apr2012; TELMISARTAN, start date: 10Jan2016. 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) Unknown result, notes: Treatment of COVID-19; (10Jul2022) Negative, notes: Test negative on July 10; (17Jul2022) Positive, notes: Rapid test positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information:  If vaccine received: Yes, other medication in 2weeks: Yes, if treatment ae: Yes and ae treatment: Paxlovid course 2 started. known allergies: No.  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 available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. ,Linked Report(s) : US-PFIZER INC-202200966836 same reporter/patient, different drug/event;
Sex: M
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) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Indication: Covid-19 treatment; Positive, notes: Positive rapid antigen test for COVID 19. Therapeutic measures were taken as a result of drug ineffective, covid-19.Clinical course: No other medication in 2weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  An 80-year-old male patient received BNT162b2 (BNT162B2), on 16Apr2022 as dose 4 (booster), single (Lot number: RA5797) at the age of 80 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive Ag test 4 days after completing 5-day course of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Recurrent Covid symptoms and positive Ag test 4 days after completing 5-day course of Paxlovid.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
Age: 54.0
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 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03May2021 at 15:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years, in right arm for COVID-19 immunization. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: 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: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. Patient had received anti-viral medication Paxlovid as of COVID-19 treatment. Treatment started on 02Jul2022 and stopped on 06Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 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: "ITP" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; AIRBORNE; CALCIUM; PROBIOTICS. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I finished Paxlovid then tested positive 5 days later. My cough and some symptom have returned. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received other medications in 2 weeks was Vitamin D, Airborne, One a day chewy, calcium and Probiotic. Patient did not have known allergies. Patient received Paxlovid (anti viral) from 06Jul2022 to 11Jul2022 for COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2022 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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, suspected covid-19 which included Paxlovid from 30Jun2022 to 05Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; Clinical courseThis is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: other medical history: No. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Adverse event Had COVID with symptoms; symptoms lasted for several days. Started feeling better. Then, had what I would call a relapse cough was nonstop, body aches, tired. No fever but a decline in overall.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 55-year-old female patient received BNT162b2 (BNT162B2), on 19Nov2021 as dose 2, single (Lot number: FH8030) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported and also reported that patient had other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Still testing positive for COVID; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, included Paxlovid (Lot number: GA2851) started on 07Jul2022 and stopped on 11Jul2022. Clinical course was reported as, Coughing and Phlegm returned. Still testing positive for COVID on 12Jul2022. No treatment received for symptoms and patient was recovering from symptoms.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Pfizer / BioNTech/ positive test result; Pfizer / BioNTech/ positive test result; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old male patient received BNT162b2 (BNT162B2), on 13Nov2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 24 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 15Jul2022, outcome "not recovered" and all described as "Pfizer / BioNTech/ positive test result". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jul2022) Positive, notes: A rapid antigen kit showed a positive test result. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.
Age: 48.0
Sex: M
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) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 27Oct2021 at 12:00 as dose 3 (booster), single (Lot number: 32030BD) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes Type 2" (unspecified if ongoing), notes: Other medical history: Diabetes Type 2. 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: 4 days after final dose of Paxlovid; (14Jul2022) Negative, notes: negative antigen test; (16Jul2022) Positive, notes: Positive test result 2 days after negative 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.
Age: 43.0
Sex: M
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 28Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CANNABIDIOL, start date: 09Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: On 05Jul2022 patient received paxlovid for COVID 19 Treatment and the stop date was 09Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
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 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 at 10:00 as dose 1, single (Lot number: EL1283), in right arm, on 09Feb2021 at 10:00 as dose 2, single (Lot number: EN5318), in right arm, on 08Oct2021 at 13:00 as dose 3 (booster),  single (Lot number: EW0191), in right arm and on 14Apr2022 at 09:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 74 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jul2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2022) Positive, notes: after having tested positive previously on 06Jul2022; (12Jul2022) Negative, notes: On 12Jul2022 I had tested negative from my first Covid experience; (17Jul2022) Positive, notes: Tested positive again on 17Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 treatment, Drug ineffective
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 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 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: "hbp" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient did not receive any other medication in 2weeks. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 TREATMENT (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 treatment.  Clinical Course: The patient received Paxlovid for COVID 19 treatment. The treatment start date was 06Jul2022 and stop date was 10Jul2022. The patient experienced diarrhea fairly severe, and burnt terrible taste in mouth to Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
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 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 03Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing). Concomitant medication(s) included: XYZAL. 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: (17Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The patient was treated with Paxlovid  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200966852 same reporter/patient, different drug/AE.;
Age: 41.0
Sex: U
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and on 20Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN; BUPROPION. 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.  Additional information: If vaccine received: Yes Other medication in 2weeks: Yes, Known allergies: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech/ Tested positive/ Covid symptoms; Pfizer / BioNTech/ Tested positive/ Covid symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 as dose 2, single (Lot number: EL9267) and on 19Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 72 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (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 05Jul2022, outcome "recovering", and all described as "Pfizer / BioNTech/ Tested positive/ Covid symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2022) positive, notes: Tested positive on antigen on 06Jul; (12Jul2022) positive, notes: on 12Jul Positive antigen; (15Jul2022) Negative, notes: on 15Jul Negative antigen; (16Jul2022) positive, notes: on 16Jul Tested positive on antigen 16Jul p.m. (5 days after completing Paxlovid and 36 hours after negative antigen). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Covid symptoms began on 05Jul Tested positive on antigen on 06Jul Began Paxlovid on 07Jul Completed Paxlovid on 11Jul Positive antigen on 12Jul Negative antigen on 15Jul in a.m. No symptoms Sore throat began 15Jul in p.m. Followed by minor cold symptoms. Sore throat, cough, sneezing, on 16Jul Tested positive on antigen 16Jul p.m. (5 days after completing Paxlovid and 36 hours after negative antigen)  Additional information: Anti-viral details: product=COVID 19 Treatment, brand=Paxlovid, treatment start date=07Jul2022, treatment stop date=11Jul2022, indication=Treatment of COVID-19. other medication in 2weeks product=L-Thyroxine (Synthroid)
Age: 67.0
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 contactable reporter(s) (Other HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL9264), in left arm, on 23Feb2021 as dose 2, single (Lot number: EN6200), in left arm, on 26Sep2021 as dose 3 (booster), single (Lot number: JOI5SRA), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION, start date: Dec2017; MELOXICAM, start date: Dec2019. 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 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that while taking Paxlovid, horrid taste for entire 5 day course of treatment; experienced horrific headaches in the middle of the night for the last 3 days of the 5 day course. Approximately 2 days after end of 5 day course, sore throat, increased congestion (head and chest), short of breath with exertion, fatigue, brain fog. Treatment start date 04Jul2022, treatment stop date 08Jul2022, indication was treatment of COVID-19. It was reported that none known allergies.  No follow-up attempts are possible. No further information was expected.; Sender's Comments: Based on the available information and the drug's known safety profile, a possible contribution of the drug to the vaccination failure and COVID-19 cannot be excluded.
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: ER8734) for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: Asthma" (unspecified if ongoing), notes: Other medical history: Asthma. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL] taken for asthma. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (30Jun2022) Positive, notes: Tested positive 30Jun; (05Jul2022) Negative, notes: Test negative 05Jul and 06Jul; (06Jul2022) Negative, notes: Test negative 05Jul and 06Jul; (14Jul2022) Positive, notes: Test positive 14Jul. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: After tested positive 30Jun2022, patient received treatment with Paxlovid from 01Jul2022 to 05Jul2022. Tested negative on 05Jul2022 and 06Jul2022. However, symptoms started again on 13Jul2022 and tested positive 14Jul2022. The patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Headache, SARS-CoV-2 test, Weight
Clinical narrative: intense headache; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EL9262) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing), notes: Osteoarthritis; "Hypertension" (unspecified if ongoing), notes: Hypertension; "Eczema" (unspecified if ongoing), notes: Eczema; "arthritis" (unspecified if ongoing); "EGR Reflux" (unspecified if ongoing); "heartburn" (unspecified if ongoing); "acidity" (unspecified if ongoing); "gas pain" (unspecified if ongoing). Concomitant medication(s) included: CELEBREX taken for arthritis; CENTRUM [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHLORINE;CHROMIUM;COPPER;CYANOCOBALAMIN;DL-ALPHA TOCOPHERYL ACETATE;FOLIC ACID;IODINE;IRON;MAGNESIUM;MANGANESE;MOLYBDENUM;NICKEL;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRI; LOSARTAN; HYDROCHLOROTHIAZIDE; PROTEX [ETHINYLESTRADIOL;MEDROXYPROGESTERONE ACETATE]; SIMETHICONE taken for flatulence; ALLEGRA taken for eczema; DEXILANT SOLUTAB taken for dyspepsia, gastric disorder. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "intense headache". Relevant laboratory tests and procedures are available in the appropriate section.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 42 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MUCINEX. 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: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treated with Paxlovid from 06Jul2022 to 10Jul2022. Other medication in 2 weeks: Yes. Other medication in 2weeks include Mucinex.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 24Jun2022 at 10:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose  1, single (Batch/Lot number: unknown), as dose  2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing); "Crohns" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment".  clinical source: Resurgence of symptoms. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. A 90-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 at 01:15 as dose 1, single (Lot number: EN6199), in right arm, on 25Mar2021 as dose 2, single (Lot number: ER8732), in right arm, on 29Oct2021 at 14:15 as dose 3 (booster), single (Lot number: 301308A), in right arm and on 16Jun2022 at 11:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 90 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). Concomitant medication included: Centrum [Minerals Nos; Vitamins Nos]; Nature Made Calcium Magnesium Zinc; Aspirin; Maxzide; Norvasc; Prinivil; Nature Made Super B Complex; Nature Made B12 Vitamin; Nature Made Vitamin C; Nature's Bounty Iron; Antihistamine Allergy Relief; Atorvastatin; Ocuvite [Ascorbic Acid; Beta carotene; Cupric Oxide; Sodium Selenate; Tocopheryl Acetate; Zinc Oxide]; Simethicone. Past drug history included: Prednisone, reaction: "Body rash"; Prednisone, reaction: "Allergies: Prednisone"; Toradol, reaction: "Nausea"; Toradol, reaction: "Allergies; Toradol". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, Covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Incorrect dose administered, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Dose Number: 5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 at 15:00 as dose 5 (booster), single (Lot number: FK9895) at the age of 69 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "Dose Number: 5". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results; (16Jul2022) Positive. Therapeutic measures were taken as a result of covid-19.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected 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) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Apr2021 at 00:15 as dose 1, single (Lot number: EW0171), in left arm, on 21May2021 at 00:30 as dose 2, single (Lot number: EW0186), in left arm and on 28Nov2021 at 12:15 as dose 3 (booster), single (Lot number: 330268D) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED 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 vaccination failure, suspected covid-19.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 15Apr2021 as dose 2, single (Lot number: EW0169), in left arm, on 03Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 02May2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Cipro, reaction(s): "Known allergies: cipro". 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: (13Jul2022) Negative, notes: Had two negative at home tests on 13Jul2022 and 14Jul2022; (14Jul2022) Negative, notes: Had two negative at home tests on 13Jul2022 and 14Jul2022; (16Jul2022) Positive, notes: Positive test occurred on 16Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Rebound symptoms beginning 6 days after completing Paxlovid treatment. Had two negative at home tests on 13Jul2022 and 14Jul2022. Symptoms increased and positive test occurred on 16Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "sinus allergy" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Dilaudid, reaction(s): "known allergies: dilaudid". The following information was reported: COVID-19 (medically significant) with onset Jun2022, outcome "not recovered", 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: (Jun2022) Positive, notes: I was positive with Covid-19 and I took the Paxlovid after the 4th day. The patient also reported that she was positive with Covid-19 and  took the Paxlovid after the 4th day  she still feel I have Covid and this time the symptoms was worse than the first one. She went to the Urgent Care and ER due to chest pain and they found T wave abnormality on my result.Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. 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; 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 20Mar2021 as dose 1, single (Lot number: EN6206), on 10Apr2021 as dose 2, single (Lot number: EW0158), in left arm, on 11Oct2021 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 02May2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Graves' disease" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti viral details: Paxlovid Treatment start date: 09Jul2022,  Treatment stop date: 13Jul2022, Indication: Treatment of covid-19
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) (Other HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cervical dystonia" (unspecified if ongoing); "Cillins Allergy" (unspecified if ongoing). There were no concomitant medications. 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. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient received Paxlovid for COVID 19 Treatment. The treatment start date was 07Jul2022 and stop date was 11Jul2022. The patient did not receive any other medication in 2weeks. Device timestamp was reported as 17Jul2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; 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 product to the reported drug ineffective 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 non-contactable reporter(s) (Nurse).  A 74-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history included: "Gout BPH" (unspecified if ongoing), notes: Goutm BPH; "Hyperlipidemia" (unspecified if ongoing); "Gout" (unspecified if ongoing), notes: Goutm BPH. 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: Unknown results, notes: Patient had rebound of COVID symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment (oral) from 30Jun2022 to 04Jul2022.  Clinical course: The patient received vaccine. and The patient did not received other medication in two weeks.  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 event Covid 19 and Drug Ineffective and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid 19 Treatment; Covid 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 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: "Penicillin allergy" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid 19 Treatment". Patient had not received any Other medication in 2 weeks. Patient had received Paxlovid from 01Jul2022 to 05Jul2022 as a treatment of Covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 67-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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) Unknown Results, notes: Treatment of COVID-19; (17Jul2022) positive, notes: 10 days after treatment still positive. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The Patient was treated with Paxlovid  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for first time with Covid 04Jul2022.; Tested positive for first time with Covid 04Jul2022.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Lot number: FL9266), in right arm, on 14Mar2021 as dose 2, single (Lot number: EN6205), in right arm, on 18Jul2021 as dose 3 (booster), single (Lot number: FF2590), in right arm and on 12Oct2021 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jul2022, outcome "not recovered" and all described as "Tested positive for first time with Covid 04Jul2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jul2021) Positive, notes: Tested positive for first time with Covid 04Jul2022; (10Jul2021) Negative, notes: Tested negative for Covid 10Jul2022; (12Jul2021) Positive, notes: Tested positive twice evening of 12Jul2022; (12Jul2021) Positive, notes: Tested positive twice evening of 12Jul2022; (17Jul2021) Positive, notes: As of 17Jul22 still positive and minor symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: If vaccine received: Yes, Other medication in 2weeks: No, Tested positive for first time with Covid 04Jul2022 was linked case Prescribed Paxlovid on 04Jul2022 and started taking as prescribed. Tested negative for Covid 10Jul2022. Felt good. 12Jul2022 starting have symptoms again. Tested positive twice evening of 12Jul2022. Got mildly sick / symptoms. As of 17Jul2022 still positive and minor symptoms. Other medical history was None.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.