chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: 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) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2021 at 10:30 as dose 1, single (Lot number: EK4176), in right arm, on 28Jan2021 at 15:30 as dose 2, single (Lot number: EL3249), in right arm and on 02Jul2021 at 10:30 as dose 3 (booster), single (Lot number: EW0181) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: INDOLE-3-CARBINOL, start date: 06May2017, stop date: 19Jun2022; SUPER B COMPLEX [VITAMIN B COMPLEX], start date: 24Apr2017, stop date: 19Jun2022; VITAMIN D 3, start date: 08Sep2016, stop date: 19Jun2022; MAGNESIUM, start date: 08Sep2016, stop date: 19Jun2022; FISH OIL, start date: 24Apr2016, stop date: 19Jun2022; CALCIUM, start date: 08Sep2016, stop date: 19Jun2022; 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, start date: 24Apr2017, stop date: 19Jun2022. 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 antibody test: (unspecified date) Positive, notes: COVID 19 Treatment; (11Jul2022) Negative, notes: Tested negative twice. Therapeutic measures were taken as a result of drug ineffective, covid-19 of Paxlovid with lot number: GC4800.  Clinical course: the patient received other medication in 2weeks.   No follow-up attempts were possible. No further information was expected.
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 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Lot number: FN9992) 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 colitis" (unspecified if ongoing); "recovered breast cancer" (unspecified if ongoing), notes: other medical history: recovered breast cancer; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jul2022) Negative, notes: I tested negative daily 25Jul -29Jul; (26Jul2022) Negative, notes: I tested negative daily 25Jul -29Jul; (27Jul2022) Negative, notes: I tested negative daily 25Jul -29Jul; (28Jul2022) Negative, notes: I tested negative daily 25Jul -29Jul; (29Jul2022) Negative, notes: I tested negative daily 25Jul -29Jul; (30Jul2022) Positive, notes: tested positive 30Jul; (unspecified date) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received vaccine. The patient received other medication in 2weeks.  No follow-up attempts are possible. No information is necessary.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Result Unknown. Therapeutic measures were taken as a result of drug ineffective, covid-19.Clinical course: Anti viral details COVID 19 Treatment, Paxlovid, Treatment start date 19Jul2022, Treatment stop date 23Jul2022. Admitted for chest pain for first booster. Had rebound covid from paxlovid.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 72.0
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 a 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 03Jul2021 at 14:30 as dose number unknown, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Jul2022, outcome "recovering" 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 drug ineffective, covid-19.  Clinical Course: Patient received other medication in 2 weeks. Anti-viral details: Product: COVID 19 Treatment, Brand was Paxlovid. Treatment start date was 27Jul2022 and treatment stop date was 30Jul2022, Lot number: GD8744, Indication was Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
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 patient (no qualifiers provided) 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 was not reported. There were no concomitant medications.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: The patient did not receive other medication in 2weeks. Paxlovid Treatment start date: 19Jul2022 and stop date: 23Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, 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 24-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 at 12:00 as dose 1, single (Lot number: EN6207), in left arm, on 31Mar2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 30Sep2021 at 16:00 as dose 3 (booster) single (Lot number: F2589) at the age of 23 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Allergic Rhinitis" (unspecified if ongoing); "Inverse Psoriasis" (unspecified if ongoing); "Eczema" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST SODIUM, start date: 01Jul2021; FLUTICASONE PROPIONATE, start date: 01Jul2021; CETIRIZINE HYDROCHLORIDE, start date: 01Jul2021; PANTOPRAZOLE SODIUM, start date: 01Dec2021.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Body temperature: 100 Fahrenheit; 102 Fahrenheit; SARS-CoV-2 test: Positive.  Additional information: Anti-viral Paxlovid was given from 20Jul2022 to 24Jul2022 for treatment of COVID-19. Patient experienced COVID rebound after taking the Paxlovid anti-viral drug as prescribed. Paxlovid was administered within the first 24-hours of symptoms onset. The patient took his last dose of Paxlovid on the evening of Sunday, 24Jul. His symptoms improved during the day Monday and were nearly gone by Tuesday. He returned to work on Wednesday and noticed that symptoms began to return Thursday night. By Friday, symptoms including fever, sore throat, congestion, and body aches returned albeit with perhaps less vigor than before. For example, his maximum fever during initial treatment was 102F whereas his maximum fever during the rebound was 100F. His sore throat was severe during the first round and is minor to moderate during the rebound. His body aches were painful during the first round and are best described as somewhat uncomfortable during the rebound. He made this report on Saturday, 30Jul with all rebound symptoms continuing.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Glomerular filtration rate
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 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 at 13:00 as dose 1, single (Lot number: 012MO2A), in left arm and on 06Nov2021 at 12:45 as dose 2, single (Lot number: 012A21A) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "allergies Sulfa" (unspecified if ongoing), notes: allergies Sulfa. 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 "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Glomerular filtration rate: (2021) 60. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 15Jul2022 to 20Jul2022.  Clinical course: patient received other medications within 2 weeks. Following first case of Covid-19 patient took paxlovid for 5 days. She tested Negative the 10th day. Also, the Pharmacy gave her the lesser dose Paxlovid because of a GFR test in 2021 that value was 60. Paxlovid 2 pills two times per day for 5 days she did not understand why; she had kidney disease.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 04Mar2021 as dose 2, single (Lot number: EN6198), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: 301485A), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: other medical history: Hypertension; "hyperlipidemia" (unspecified if ongoing), notes: other medical history: hyperlipidemia; "Benign Prostatic Hypertrophy" (unspecified if ongoing), notes: other medical history: Benign Prostatic Hypertrophy. Concomitant medication(s) included: LISINOPRIL; ROSUVASTATIN GLENMARK; TAMSULOSIN AUROBINDO; FINASTERIDE ACCORD. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti-viral details: Product: COVID 19 Treatment, Brand: Pfizer, Treatment start date: 21Jul2022, Treatment stop date: 26Jul2022, Lot number = GC4800, Indication: Treatment of COVID-19
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
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 33-year-old female patient (not pregnant) 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. 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 "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 vaccination failure, suspected covid-19.  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
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 non-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 28Feb2021 as dose 1, single (Batch/Lot number: unknown), on 18Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 24Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 22Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "immune-compromised" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported:VACCINATION FAILURE (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: (21Jul2022) negative, notes: positive covid with symptoms 7 days after completing Paxlovid, and after 2 negative tests; (23Jul2022) positive, notes: positive covid with symptoms 7 days after completing Paxlovid, and after 2 negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19. Adverse event: Rebound infection of positive covid with symptoms 7 days after completing Paxlovid, and after 2 negative tests  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Jan2021 as dose 1, single (Batch/Lot number: unknown), on 15Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood cholesterol increased" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin, and apparently paxlovid. Concomitant medication(s) included: ROSUVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: 5 days of testing negative; Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral details: Product:COVID 19 Treatment,  Brand: Paxlovid  treatment start date: 19Jul2022  treatment stop date: 23Jul2022  indication: Treatment of COVID-19   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 64.0
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) (Physician).  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 at 14:15 as dose 1, single (Lot number: EN6199), in left arm, on 13Apr2021 at 15:30 as dose 2, single (Lot number: ER8729), in left arm, on 17Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 10Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "htn" (unspecified if ongoing); "GERD" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing); "history hsv" (unspecified if ongoing); "hx of nonmelanoma skin cancer" (unspecified if ongoing); "Allergies: sulfa" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" (19Jul2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Still positive on day 5 of illness; (06Jul2022) Positive, notes: Tested positive 06Jul2022; (14Jul2022) Negative, notes: Tested positive 14Jul2022 (day 11). Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Treatment received as Paxlovid, Treatment start date: 06Jul2022, Treatment stop date: 10Jul2022  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 BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
Age: 47.0
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 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 at 15:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Apr2021 at 15:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 17Dec2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 19Jul2022 at 15:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies Penecillin" (unspecified if ongoing), notes: known allergies Penicillin. There were no concomitant medications. Past drug history included: Vicodin, reaction(s): "known allergy: Vicodin"; Vallum, reaction(s): "known allergy: valium". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (19Jul2022) Negative, notes: Paxlovid rebound 3 days after testing negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Report about covid treatment was Yes. if vaccine received reported as Yes. other medication in 2weeks reported as No. anti viral details was product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 22Jul2022, treatment stop date: 27Jul2022, indication: Treatment of COVID-19. Adverse event reported as Paxlovid rebound 3 days after testing negative.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: indication: Treatment of COVID-19; indication: 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 28Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 25Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovering" and all described as "indication: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative, notes: Tested Negative for 3 days after finishing 5 day TX. But symptoms returned and Tested positive on day 4, 5 6. Post Paxlovid TX; (Jul2022) positive, notes: Tested Negative for 3 days after finishing 5 day TX. But symptoms returned and Tested positive on day 4, 5 6. Post Paxlovid TX; (Jul2022) positive; (Jul2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes treatment with Paxlovid from 17Jul2022 to 22Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
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) (Other HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 18Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jul2022) Negative, notes: Negative antigen on 28Jul; (unspecified date) Positive, notes: indication: Covid-19 treatment; (29Jul2022) Positive, notes: Then tested on 29Jul which was positive and return of symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was unknown if patient had received any other medication in two weeks. Patient had received paxlovid from 13Jul2022 as a COVID 19 Treatment. After 2 days post Paxlovid, symptoms back and worse. Started 2nd pack of Paxlovid which finished on 25Jul2022. Negative antigen on 28Jul. Then tested on 29Jul which was positive and return of symptoms. 2nd rebound. This was causing Covid to last now over 20 days of loss of work and health.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of LOE.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 05May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Mar2021 as dose 1, single (Lot number: 044A21A), on 15Apr2021 as dose 2, single (Lot number: 041B21A) and on 19Nov2021 as dose 3 (booster), single (Lot number: 020F21A) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: TAMSULOSIN; FINASTERIDE; OMEPRAZOLE. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex", notes: Known allergies: Keflex. 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: Positive, notes: Treatment of COVID-19; Positive, notes: strongly positive test. Therapeutic measures were taken (Paxlovid) as a result of drug ineffective, covid-19.  Clinical information: Rebound of symptoms, congestion/throat/sick feeling/weakness/fatigue and a strongly positive test.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID-19; This is a spontaneous report received from a non-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 14May2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 16Dec2021 at 16:00 as dose number unknown, (booster), single (Batch/Lot number: unknown) at the age of 67 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID 19"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. No other medication in 2 weeks. : Paxlovid treatment started on 19Jul2022 to 23Jul2022. Patient had no known allergies.  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: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: 11122) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Dairy" (unspecified if ongoing), notes: Known allergies: Dairy. 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, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that COVID 19 Treatment with Paxlovid. Treatment start date was 23Jul2022 and stop date was 26Jul2022, Indication: Treatment of COVID-19  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 events Covid 19 and Drug Ineffective and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Physician).  An 86-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 04May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteopenia" (unspecified if ongoing); "Mixed hyperlipidemia" (unspecified if ongoing); "CAD" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Raynaud disease" (unspecified if ongoing); "STEMI" (unspecified if ongoing); "a fib" (unspecified if ongoing); "HTN" (unspecified if ongoing); "CVA" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Thiazides, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 13Jul2022, outcome "recovered" (29Jul2022), COVID-19 (medically significant) with onset 13Jul2022, outcome "recovered" (29Jul2022) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Symptom onset on 13Jul022. Treated with monoclonal antibody infusion and paxlovid. Recovered. Symptoms recurred 23Jul (day 10 of illness). Home antigen test positive 7/24. Recovered without further therapy (noted 29Jul 5 days after positive test). Patient was treated for COVID-19 with Paxlovid via oral route from 13Jul2022 to 17Jul2022.   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: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2022 as dose 4 (booster), single (Lot number: FM0698) 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), 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: "MS" (unspecified if ongoing), notes: Other medical history: MS, POTS, Fibromyalgia, Hypothyroidism, sleep apnea, obesity; "POTS" (unspecified if ongoing), notes: Other medical history: MS, POTS, Fibromyalgia, Hypothyroidism, sleep apnea, obesity; "Fibromyalgia" (unspecified if ongoing), notes: Other medical history: MS, POTS, Fibromyalgia, Hypothyroidism, sleep apnea, obesity; "Hypothyroidism" (unspecified if ongoing), notes: Other medical history: MS, POTS, Fibromyalgia, Hypothyroidism, sleep apnea, obesity; "sleep apnea" (unspecified if ongoing), notes: Other medical history: MS, POTS, Fibromyalgia, Hypothyroidism, sleep apnea, obesity; "obesity" (unspecified if ongoing), notes: Other medical history: MS, POTS, Fibromyalgia, Hypothyroidism, sleep apnea, obesity. Concomitant medication(s) included: EVUSHELD, start date: 12Jul2022, stop date: 12Jul2022. The following information was reported: DRUG INEFFECTIVE (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: (unspecified date) positive, notes: testing positive again; (17Jul2022) positive, notes: tested positive for Covid on 17Jul2022; (24Jul2022) negative, notes: tested negative after Paxlovid on 24Jul; (28Jul2022) positive, notes: testing positive again (before it even reached the C line, so very strong). Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Patient reported that she tested positive for Covid on 17Jul2022, then tested negative after Paxlovid on 24Jul. Symptoms got significantly worse again on 28Jul and after she learned about rebound infections she just retested myself and am testing positive again (before it even reached the C line, so very strong). Adverse event start date was 28Jul2022 and patient was recovering.  No follow-up attempts are possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Investigation, Optical coherence tomography, Papilloedema, Visual acuity tests
Clinical narrative: developed acute, unilateral vision loss; superior sectoral optic disc edema; This is a literature report for the following literature source(s):   A 64-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLINDNESS UNILATERAL (medically significant), 6 days after the suspect product(s) administration, outcome "unknown", described as "developed acute, unilateral vision loss"; PAPILLOEDEMA (medically significant), 6 days after the suspect product(s) administration, outcome "unknown", described as "superior sectoral optic disc edema". The patient underwent the following laboratory tests and procedures: All examination findings: normal OD; revealed superior sectoral optic disc edema; revealed peripapillary splinter hemorrhages in the, notes: optic nerve OS; Optical coherence tomography: showed diffuse thickening of the retinal nerve fib, notes: fiber layer OS; Visual acuity tests: 20/80; 20/100, notes: OS; Visual field tests: revealed dense constriction OS.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available reported information, the causal association between the events blindness unilateral and pappilloedema and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200034068 Same patient/drug, events occurred in different time;
Sex: F
Vaccine: COVID19
Symptoms: Visual field tests
Clinical narrative: developed acute, unilateral vision loss; superior sectoral optic disc edema; This is a literature report for the following literature source(s):   A 64-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLINDNESS UNILATERAL (medically significant), 6 days after the suspect product(s) administration, outcome "unknown", described as "developed acute, unilateral vision loss"; PAPILLOEDEMA (medically significant), 6 days after the suspect product(s) administration, outcome "unknown", described as "superior sectoral optic disc edema". The patient underwent the following laboratory tests and procedures: All examination findings: normal OD; revealed superior sectoral optic disc edema; revealed peripapillary splinter hemorrhages in the, notes: optic nerve OS; Optical coherence tomography: showed diffuse thickening of the retinal nerve fib, notes: fiber layer OS; Visual acuity tests: 20/80; 20/100, notes: OS; Visual field tests: revealed dense constriction OS.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available reported information, the causal association between the events blindness unilateral and pappilloedema and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200034068 Same patient/drug, events occurred in different time;
Age: 52.0
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 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Mar2021 as dose 1, single (Lot number: 006B21A), in left arm, on 17Apr2021 as dose 2, single (Lot number: 040B2119), in left arm and on 14Jun2022 as dose 4 (booster), single (Lot number: 058A22-2A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing), notes: Other medical history: Type 2 Diabetes; "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; LISINOPRIL; ATORVASTATIN.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: I tested for covid and was prescribed paxlovid; (19Jul2022) Negative, notes: I tested negative on days 4 & 7; (22Jul2022) Negative, notes: I tested negative on days 4 & 7; (26Jul2022) Positive, notes: Then on day 11 my symptoms returned and I tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient tested positive for Covid and was prescribed Paxlovid (patient had T2 diabetes) which patient took for the full five days. Her symptoms had disappeared, and she tested negative on days 4 and 7. Then on day 11 her symptoms returned and she tested positive. She was suffering worse symptoms than the previous event and she was on day 6 of the new event.
Age: 74.0
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 75-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 17Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 74 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 24Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. 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: Positive, notes: COVID 19 Treatment; Positive, notes: mild symptoms positive at home test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. 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. Clinical course: Rebound Covid after taxing full course of Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: EP7534), in left arm and on 22Apr2021 as dose 2, single (Lot number: EW0170) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 06Dec2021 as dose 3 (booster),single (Lot number: 013F21A), in left arm and on 21May2022 as dose 4 (booster), single (Lot number: 049L21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN, start date: 25Jul2022, stop date: 28Jul2022; TERBINAFINE, start date: 01Mar2022; BUPROPION, start date: 01May2022; LEVOTHYROXINE, start date: 06Jun2022; FLUOXETINE, start date: 17Apr2022; LORATADINE, start date: 01Jan2022; CALCIUM CITRATE, start date: 01Jan2022; PREGABALIN, start date: 01Aug2021. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergy: Codeine. 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: (01Aug2022) Positive, notes: Positive test 10 days after completing Paxlovid (01Aug2022). Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received COVID 19 treatment with Paxlovid on 25Jul2022 and stop date was 29Jul2022.  No follow-up attempts are possible. No further information is expected.