chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old male patient received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 26 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: "Mild asthma" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jul2022, 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) Negative, notes: Tested positive on a rapid test after having tested negative for 9 days (7 days post finishing paxlovid treatment); (21Jul2022) Positive, notes: Tested positive on a rapid test after having tested negative for 9 days (7 days post finishing paxlovid treatment). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Product: COVID-19 Treatment, treatment start date: 11Jul2022, treatment stop date: 15Jul2022, indication: Treatment of COVID-19. No other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 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 included: "High blood pressure" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergy : Amoxicillin", notes: Known 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. Clinical course: Patient did not receive any other medication in 2 weeks. Antiviral treatment details: Patient received Paxlovid from 15Jul2022 to 20Jul2022 for the 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: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2022 as dose 4 (booster), single (Lot number: Ew0150) at the age of 47 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: "Chronic pain" (unspecified if ongoing). Concomitant medication(s) included: Venlafaxine; Gabapentin; Tramadol. 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: COVID-19 Treatment. Therapeutic measures were taken as a result of drug ineffective, Covid-19. No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID test result: Positive; COVID test result: Positive; 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 23Mar2021 as dose 1, single (Lot number: Er8730), in left arm, on 31Jul2021 as dose 2, single (Lot number: Er8731), in left arm and on 29Nov2021 as dose 3 (booster), single (Lot number: Ff2593) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Jun2022, outcome "unknown" and all described as "COVID test result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jun2022) Positive.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: En6205), in left arm and on 30Mar2021 as dose 2, single (Lot number: Er8730) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 27Oct2021 as dose number unknown, single (Lot number: 076c21a), in left arm and on 01Apr2022 as dose number unknown, single (Lot number: 002m21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Some fresh fruits" (unspecified if ongoing). Other medication in 2 weeks/Concomitant medication(s) included: ATORVASTATIN, stop date: 12Jul2022. 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: (unspecified date) Unknown results; (19Jul2022) Negative, notes: Covid rebound symptoms 4 days after final Paxlovid dose and positive test result 5 days after final Paxlovid dose. Had tested negative 2 days after final Paxlovid dose; (22Jul2022) Positive, notes: Covid rebound symptoms 4 days after final Paxlovid dose and positive test result 5 days after final Paxlovid dose. Had tested negative 2 days after final Paxlovid dose. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Anti-viral details: COVID 19 Treatment, brand=Paxlovid, started on 12Jul2022 and stopped on 17Jul2022.
Age: 67.0
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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17May2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Feb2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 11Mar2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 10Oct2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive, notes: Treatment of COVID-19. 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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EM9809), on 24Feb2021 as dose 2, single (Lot number: N6203) and on 08Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "penicillin" (unspecified if ongoing); "obesity" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "Drug ineffective "; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: test positive; negative, notes: negative on Days 5 & 6. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course included Rebound Covid- Symptoms mild, occurred 5 days after last dose of paxlovid, in home test positive on Day 1 of rebound and negative on Days 5 & 6. No other medication in 2weeks.  known allergies: penicillin; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2  to the reported events Vaccination failure and COVID-19 cannot be ruled out.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Dec2020 as dose 1, single (Lot number: EL0142), in left arm, on 21Jan2021 as dose 2, single (Lot number: EL9261), in left arm, on 21Oct2021 as dose 3 (booster), single (Lot number: FH8020), in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 56 years, in left arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient's relevant medical history included: "Restless leg syndrome" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included (Other medication in 2weeks): HORIZANT oral; ALENDRONATE oral; PRILOSEC [OMEPRAZOLE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative; (24Jul2022) Positive. Tested positive Antigen tests for Covid 6 days after finishing full dose, symptoms returned 5 days after finishing dose and after 2 negative antigen tests. Therapeutic measures were taken as a result of vaccination failure, covid-19 and treatment included Paxlovid from 13Jul2022 to 18Jul2022.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to vaccination failure and COVID-19 cannot be ruled out.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling
Clinical narrative: Swollen lower llip on left side
Age: 49.0
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 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2021 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19was Paxlovid. Treatment start date: 08Jul2022, Treatment stop date: 13Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 65-year-old female patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6199), in right arm, on 06Apr2021 as dose 2, single (Lot number: EW0150), in right arm, on 20Oct2021 as dose 3 (booster), single (Lot number: FF2590), in right arm and on 30Mar2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: No other medication was received in 2 weeks. The patient had an antiviral Paxlovid treatment for COVID 19 from 12Jul2022 to 17Jul2022. The patient had Runny nose, cough, chest congestion, and fever on 22Jul2022 from Paxlovid treatment.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, 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 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Feb2021 as dose 2, single (Lot number: EL9262), in right arm and on 16Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 56 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jul2022) Negative; (22Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received antiviral Paxlovid from 13Jul2022 to 17Jul2022 for treatment of COVID-19. Rebound Covid - tested positive again on 22Jul2022 after testing negative on 21Jul2022. Symptoms do appear milder that first time around.
Age: 61.0
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 non-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 13Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 61 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: "Ovarian cancer in remission" (unspecified if ongoing), notes: Ovarian cancer in remission; "follicular Lymphoma" (unspecified if ongoing); "known allergies : Fish" (unspecified if ongoing), notes: Known allergies : Fish. Concomitant medication(s) included: ALIGN, start date: 01Dec2021; MELATONIN, start date: 01Dec2020; NYQUIL, start date: 14Jul2022. Past drug history included: Erythromycin, reaction(s): "Known allergies : erythromycin", notes: Known allergies : erythromycin; Bactrim, reaction(s): "Known allergies : Bactrim", notes: Known allergies : Bactrim; Pyridine, reaction(s): "Known allergies:pyridine", notes: Known allergies : Pyridine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, 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=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti viral details: product COVID 19 Treatment (Brand: Paxlovid) was given from 13Jul2022 to 17Jul2022 for indication treatment of COVID-19. Adverse event: rebound of symptoms. Dry cough, fatigue, sore throat (Adverse event start date: 20Jul2022, Not recovered, If treatment ae: No).  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: ER2613), in right arm, on 16Apr2021 as dose 2, single (Lot number: EW0158), in right arm and on 10Nov2021 at 12:00 as dose 3 (booster), single (Lot number: FH8028) at the age of 30 years for Covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE. 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: (unspecified date) Positive; (unspecified date) Negative; (Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Patient took Paxlovid from 13Jul2022 to 18Jul2022 for treatment of COVID-19. Rebound two days after testing negative and finishing a round of Paxlovid. No follow up attempts possible. No further information is required.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive rapid test, 7 days after negative rapid test.; Positive rapid test, 7 days after negative rapid test.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 08Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE. Past drug history included: Dicloxicillin, reaction(s): "Known allergies: Dicloxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Positive rapid test, 7 days after negative rapid test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive rapid test, 7 days after negative rapid test; Negative, notes: Positive rapid test, 7 days after negative rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
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 contactable reporter(s) (Other HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: Fc3184) and on 31Mar2022 as dose 4 (booster), single (Lot number: Fk9893) at the age of 72 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: "Usually stable moderate severe asthma on maintenance meds" (unspecified if ongoing), notes: Usually stable moderate severe, asthma on maintenance meds. Concomitant medication(s) included: PREDNISONE, start date: 09Jul2022, stop date: 20Jul2022; MONTELUKAST; LISINOPRIL; OMEPRAZOLE; ASA; SYMBICORT; INCRUSE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (Jul2022) Positive, notes: Now on day 14 since Covid I am still testing positive on home test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Covid-19 treatment was with paxlovid on 09Jul2022 and stopped on 13Jul2022. Reported that the started 5 days of Paxlovid. On day 1 patient's expected URI viral induced asthmatic bronchitis was the mildest ever compared to other URI induced asthmatic bronchitis he had. Prednisone was also started from 09Jul2022 to 20Jul2022 as usual early in URI because of patient's experience with asthmatic bronchitis exacerbations. Within 2 days of finishing 5th day of Paxlovid, patient's asthmatic bronchitis worsened requiring rescue inhaler/ nebulizer. Now on day 14 since Covid patient still testing positive on home test and the bronchitis is pretty typical of any other post URI asthmatic bronchitis. As per patient Paxlovid effectively minimized the effect of the virus on his asthma for 6 to 7 days but without it now, his bronchitis was worse, though it was a typical post URI. The patient has no known allergies.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 at 16:00 as dose 1, single (Lot number: EP6955), in right arm, on 20Apr2021 at 16:00 as dose 2, single (Lot number: EV8731), in right arm and on 22Nov2021 at 16:00 as dose 3 (booster) single (Lot number: FH8027) at the age of 34 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), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid (start date=14Jul2022, stop date=18Jul2022). Clinical course: On Jul2022, the patient experienced new covid symptoms after symptoms had almost completely ended. New symptoms included heavy congestion, fatigue, and minor loss of taste and smell. Adverse event start date: 22Jul2022 at 06:00.  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 antibody 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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "severe sleep apnea" (unspecified if ongoing); "allergies" (unspecified if ongoing); "thyroid insufficiency" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. 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 antibody test: Positive, notes: tested positive 7 days after stopping Paxlovid; Negative, notes: 5 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 11Jul2022 to 15Jul2022.  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 plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Age: 71.0
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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: En6201), on 10Mar2021 as dose 2 , single (Lot number: En6205), in left arm, on 29Nov2021 as dose 3 (booster) , single (Lot number: Fe3592), in left arm and on 14Apr2022 as dose 4 (booster) , single (Lot number: FK9896) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CENTRUM SILVER +50; MUCINEX, start date: 09Jul2022; SUDAFED 12 HOUR, start date: 09Jul2022; TYLENOL; VENLAFAXINE; XYZAL, start date: 09Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jul2022) Positive; (18Jul2022) Negative; (21Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had received Paxlovid, treatment from 09Jul2022 to 13Jul2022 for treatment of COVID-19.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 11Feb2021 at 00:30 as dose 2, single (Batch/Lot number: unknown), in right arm, on 09Nov2021 at 13:30 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 20Apr2022 at 14:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing), notes: Other medical history: Type 1 diabetes as of 3 years. The patient had no Known allergies. There were no concomitant medications/no Other medication in 2weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jul2022) Negative, notes: After having been tested negative for COVID on Sunday 17Jul and Monday 18Jul; (18Jul2022) Negative, notes: After having been tested negative for COVID on Sunday 17Jul and Monday 18Jul; (24Jul2022) Positive, notes: tested myself again today on 24Jul and was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient started treatment with Anti-viral details included: Brand: Paxlovid, Treatment start date: 14Jul2022, Treatment stop date: 18Jul2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-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 patient received no other medication in 2 weeks. 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: product=COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31May2021 as dose 1, single (Lot number: EL9262), in right arm, on 30Jun2021 as dose 2, single (Lot number: EN6201), in right arm, on 08Oct2021 as dose 3 (booster), single (Lot number: 301358A), in right arm and on 09Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" , notes: other medical history: Depression; "herpes" , notes: other medical history: herpes; "high cholesterol" , notes: other medical history: high cholesterol; "obesity" , notes: other medical history: obesity; "asthma" , notes: other medical history: asthma. Concomitant medication(s) included: BUPROPION; ZETIA; NALTREXONE; VALCLOVIR; VITAMIN C [ASCORBIC ACID]; CRANBERRY; ASPIRIN (E.C.); VITAMIN D [COLECALCIFEROL]; FISH OIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Jul2022 at 09:00, outcome "recovering" and all described as "COVID-19".  The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jul2022) Negative, notes: Tested negative for Covid four days after the Paxlovid; (21Jul2022) Positive, notes: then tested positive again for Covid four days after testing negative. I have continued to test positive for the last three days. Therapeutic measures were taken as a result of covid-19. Treatment included Paxlovid. No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 05Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "Known allergies: Ivp dye" (unspecified if ongoing); "Known allergies: Pcn" (unspecified if ongoing). The patient's concomitant medications were not reported. 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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid).   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Considering the nature of the reported events and product profile, a causal role of the suspect BNT162B2 cannot be denied for the reported events.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Oct2021 at 13:00 as dose 3 (booster), single (Lot number: FF0590) at the age of 56 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 included: "sciatic pain" (unspecified if ongoing), notes: I had sciatic pain on right only healed completely; "breast cancer" (unspecified if ongoing), notes: I am 2 time breast cancer survivor; "microdiscectomy", start date: 30May2022 (unspecified if ongoing), notes: on my right side which is very successful no pain at all. The patient's concomitant medications were not reported. No Known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jul2022, outcome "not recovered" and all described as "COVID 19". Patient was 2 times breast cancer survivor and her oncologist advised her to start Paxlovid immediately after she got positive. started by itching on throat and had very aggressive symptoms. In 12 Hours her Oxygen was 84, took 2 dose of pills for shortness of breath getting worse so quickly and was ready to go to ER. From hour 13 her Covid got reversed as quickly as it got worse. Oxygen got improved after 7 H Back to 90. On day 8 she was negative. Day 9 woke up Not being able to walk due to severe left leg pain 10/10 Went to ER after 2 Morphine pain was 5/10 still she can survive only with strong pain medicine. She had bulging disc on left but never any symptoms. She heard about rebound and checked on day 10 strongly Positive, started body ache (mild) and congestion. For few days her leg pain was killing her hip and shin no sleep, walking with cane and recently had spine surgery microdiscectomy on 30May2022 on her right side which was very successful no pain at all. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Jul2022) Negative, notes: On day 8 I was negative; (Jul2022) Positive, notes: day 10 strongly Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with anti viral Paxlovid started on 06Jul2022 and stopped on 10Jul2022.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the suspect and cannot be excluded. The case will be reassessed once new information is available.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). 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 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, suspected covid-19. Clinical course: Other medication in 2weeks: No. The patient received COVID 19 Treatment of Anti-Viral from 13Jul2022 to 18Jul2022. It was reported that patient had covid again on 23Jul2022 and for which no treatment was received with outcome as not recovered. The patient had no Known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
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) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 04May2022 as dose 4 (booster), single (Lot number: FX9893) 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), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. 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. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive other medications in two weeks. The patient had no known allergies. The patient receive Paxlovid for Treatment of COVID-19 on 16Jul2022 and stopped on 21Jul2022. On 23Jul2022 at 05:00 PM, the patient have a sore throat, runny nose, cough, body aches, very tired, and did not receive treatment for this.
Age: 74.0
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) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Aug2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "A Fib" (unspecified if ongoing); "pine nuts" (unspecified if ongoing), notes: known allergies pine nuts. The patient's concomitant medications were not reported. Past drug history included: Ampicillin, reaction(s): "known allergies ampicillin"; Statins, reaction(s): "known allergies statins". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of covid-1 for Paxlovid, Treatment Start Date: 22Jul2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
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 62-year-old male patient received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 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 had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: Tested positive again after testing negative; (2022) Positive, notes: Tested positive again after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: patient had no Known allergies. Patient has no other medical history. Other medication in 2weeks was no. Patient received COVID 19 Treatment with Paxlovid. Treatment start date was 12Jul2022 and stop date was 16Jul2022. Indication of the treatment was COVID-19. Tested positive again after testing negative for several days. Fever, cough, congestion returned also. event start date was 22Jul2022. The patient received no treatment for tested positive again after testing negative for several days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient. A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in right arm and on 09Feb2021 at 12:00 as dose 2, single (Batch/Lot number: unknown) at the age of 68 years, in right arm for Covid-19 immunisation; CoviD-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE), on 23Mar2022 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: LEVOXYL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19/ Paxlovid COVID rebound". Therapeutic measures were taken as a result of vaccination failure, Covid-19. The patient received Paxlovid from 16Jul2022 to 21Jul2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
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 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EH16208), on 02Apr2021 as dose 2, single (Lot number: ER8732) and on 21Dec2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: Other medical history: HTN; "GERD" (unspecified if ongoing), notes: Other medical history: GERD; "Known allergies: Pesticides" (unspecified if ongoing), notes: Known allergies: Pesticides; "Known allergies: nuts" (unspecified if ongoing), notes: Known allergies:  nuts. Concomitant medication(s) included: AMLODIPINE BESILATE, start date: 01May2000; BENAZEPRIL, start date: 01May2000; OMEPRAZOLE, start date: 01Jan2019. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jul2022) Negative, notes: Tested Negative for Covid 15Jul2022; (19Jul2022) Positive, notes: Tested Positive for Covid 19Jul2022; (23Jul2022) Positive, notes: Still testing positive 23Jul2022; (09Jul2022) Positive, notes: Tested Positive with a home test for the first time on 09Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient took other medication in 2 weeks. Patient took Paxlovid for COVID 19 Treatment, drug started on 09Jul2022 stopped on 14Jul2022.