chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for 1 day, in left arm, as dose 2, single (Batch/Lot number: unknown) for 1 day, in left arm and on 27Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Occasional asthma" (unspecified if ongoing); "dairy" (unspecified if ongoing); "sulfa" (unspecified if ongoing); "history of pneumonia x2" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Fosamax, reaction(s): "Known allergies: Fosamax"; Erythromycin, reaction(s): "Known allergies: erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (13Jul2022) Positive, notes: + Covid 13Jul; (20Jul2022) Negative, notes: tested Negative 20Jul; (30Jul2022) Positive, notes: Tested Positive 30Jul. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid, + Covid 13Jul, took 5 days Paxlovid 15Jul to 19Jul, tested Negative 20Jul. Covid symptoms returned 28Jul. Tested Positive 730. Cough, sinus congestion, sore throat, fatigue. Other medication in 2weeks: No. Dose 1 and dose 2 were administered on 19Feb2021.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jun2022 as dose 4 (booster), single (Lot number: FP7135) at the age of 40 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (boster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). It was reported that the patient had no known allergies. Concomitant medication(s) included: DAYQUIL, start date: 25Jul2022, stop date: 27Jul2022; MUCINEX DM, start date: 27Jul2022, stop date: 29Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of covid-19. The COVID 19 Treatment received with Paxlovid with start date given as 28Jul2022 and stop date given as 30Jul2022.
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jun2021 as dose 1, single (Lot number: ew0186), on 13Aug2021 as dose 2, single (Lot number: ew0191), in right arm and on 04Mar2022 as dose 3 (booster), single (Lot number: fm0698), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2022) Positive, notes: Tested Positive at home 18Jul2022; (26Jul2022) Negative, notes: Tested Negative at home 26Jul2022; (30Jul2022) Positive, notes: Tested Positive at home 30Jul2022.Therapeutic measures were taken as a result of vaccination failure, covid-19 which included treatment with Paxlovid treatment start date was 18Jul2022 and stop date was 22Jul2022.  Clinical course: Patient vaccine received and no any Other medications in two weeks. No Known allergies  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested for covid; tested for covid; 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 01Apr2022 at 14:00 as dose 4 (booster), single at the age of 67 years, in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CLONAZEPAM, start date: 01Jan2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Jul2022, outcome "unknown" and all described as "tested for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jul2022) positive, notes: a positive test for covid; (30Jul2022) positive, notes: I tested for covid. My test was a solid clear positive result. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No known allergies. Yes patient received other medications with in 2 weeks. Patient took Plaxovid, full strength for 5 days starting first day of symptoms, and a positive test for covid. 9 day after starting Plaxovid a runny nose presented, and patient tested for covid and his test was a solid clear positive result. Took treatment on 22Jul2022 to 27Jul2022. Other medications include Clonazepam on 01Jan2022.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) 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: "gastrointestinal reflux" (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) in two weeks included: ASPIRIN LOW; OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jul2022) positive, notes: fatigue, chills- just like the symptoms he had the first day he tested positive and he developed a cough; (26Jul2022) Negative, notes: On the 2nd day post-treatment, I tested negative (at-home rapid test for Covid); (29Jul2022) positive, notes: On the 5th day I woke up feeling fatigued and had nasal congestion and tested positive for Covid 19 (at home rapid test). Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course reported as Patient tested positive for Covid-19 on 20Jul2022. That day he felt fatigued, feverish and had chills. He was prescribed Paxlovid that morning and began taking it immediately. Patient Covid-19 symptoms started to improve on the 2nd day of Paxlovid treatment, but he began to have a bad taste in his mouth. On subsequent days he would feel energetic upon waking and then fatigued after taking the morning dose of Paxlovid. Upon completing the 5 day treatment, treatment stop date was 24Jul2022, he felt normal and energetic for 3 days. On the 2nd day post-treatment, he tested negative (at-home rapid test for Covid). He continued to mask per CDC guidelines and distance from family, who also masked. On the 4th day post-treatment he experienced a runny nose. On the 5th day he woke up feeling fatigued and had nasal congestion and tested positive for Covid-19 (athome rapid test). He slept for most of that day, and the next day fatigue, chills- just like the symptoms he had the first day he tested positive and he developed a cough. Paxlovid rebound.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 25.0
Sex: M
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 26-year-old male patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 27Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 25 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "shrimp" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ciproflaxin, reaction(s): "Drug Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive on day 9 after original symptoms; Negative, notes: testing negative for several days. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid started on 20Jul2022 and stop date 25Jul2022. Clinical course: Paxlovid rebound. Tested positive on day 9 after original symptoms (4 days after completion of Paxlovid) after testing negative for several days. Experiencing mild symptoms during rebound.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of 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.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
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 49-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 at 13:00 as dose 1, single (Lot number: EN6208), in left arm, on 06Apr2021 at 13:00 as dose 2, single (Lot number: EW0151), in left arm and on 30Nov2021 at 13:00 as dose 3 (booster), single (Lot number: FF2589) at the age of 48 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: Patient had no known allergies. No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, 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 31-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: En6200), on 17Mar2021 as dose 2, single (Lot number: En6207) and on 26Oct2021 as dose 3 (booster), single (Lot number: 3203080) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history included: "Reoccurring pericarditis" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "gerd" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; PANTOPRAZOLE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jul2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) High; SARS-CoV-2 test: (20Jul2022) Positive; (26Jul2022) Negative; (28Jul2022) Positive; (30Jul2022) Positive, notes: Still testing positive with head cold like symptoms on 30Jul. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received Paxlovid for covid-19 treatment from 20Jul2022 to 25Jul2022.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 02May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 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: "Arthritis" (unspecified if ongoing); "Seizure disorder" (unspecified if ongoing). Concomitant medication(s) included: PHENYTOIN; SULFASALAZINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported other medication in 2weeks: Yes. Treatment for COVID-19, start date: 21Jul2022, stop date: 25Jul2022. Other AE's reported Nasal congestion. Tired. Sneezing. Known allergies: NKDA.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Rebound covid after taking 5 days of paxlovid Jul2022; Rebound covid after taking 5 days of paxlovid Jul2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Lot number: EN6200), in left arm and on 18Mar2021 at 13:00 as dose 2, single (Lot number: EN6207) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Paxlovid for covid-19 immnization, notes: Antiviral treatment, Treatment start date: 13Jul2022, Treatment stop date: 17Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Rebound covid after taking 5 days of paxlovid Jul2022". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information included as Patient had taken other medication in 2weeks. Patient had Known allergies.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID -19 Treatment; COVID -19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 at 12:00 as dose 3 (booster), single (Lot number: ff2593) at the age of 63 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: "Known allergies: Sulfa medication" (unspecified if ongoing), notes: Known allergies: Sulfa medication. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, 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: Positive covid test with full covid symptoms returning. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Anti viral start date: 15Jul2022 and Treatment stop date: 19Jul2022  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 06Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "GERD" (unspecified if ongoing); "migraine" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: PROZAC, start date: Aug1989; PEPCID [FAMOTIDINE], start date: Aug2017.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that Paxlovid with lot no 2815223 was given as COVID-19 treatment from 25Jul2022 to 30Jul2022. It was reported that the other medications used by the patient in 2 weeks of vaccination are Fluoxetine (Generic Prozac) with start date as Aug 1989 and Famotidine (Generic Pepcid) with start date as Aug2017.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 27Dec2021 as dose 3, (booster) single (Lot number: 33036bd) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Iga nephropathy" (unspecified if ongoing); "essential thrombocytopenia" (unspecified if ongoing); "Gout" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE, start date: 04Oct2021; ALLOPURINOL; ECOTRIN; VITAMIN D3; GUAIFENESIN. 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: COVID-19: (unspecified date) positive, notes: Treatment of COVID-19; (27Jul2022) positive, notes: Verified Covid positive with test 2 days later. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: If vaccine received: Yes. Other medication in 2 weeks: Yes. Patient received Paxlovid from 20Jul2022 to 25Jul2022 for Covid 19 treatment. Patient received her medication in 2weeks product: Farxiga (lot no Pa0051) from 01Mar2022. On 04Oct2021 Metoprolol succ er 25 mg tab, Allopurinol 300 mg tablet, Asprin 325mg, Ecotrin, Vitamin D3 50 mcg, Guaifenesin 400 mg. Acetaminophen 500mg, on 22Jul2022, started Diphenhydramine HCL 25mg, 22Jul2022, Pseudoephedrine HCL 30mg. Covid symptoms returned 3 days after last dose of Paxlovid. Verified Covid positive with test 2 days later. Eevnt onset is 28Jul2022 at 03:00 PM and no treatment and no known allergy reported.
Age: 47.0
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 47-year-old male patient received BNT162b2 (BNT162B2), on 30Nov2021 as dose 3 (booster), single (Lot number: FK5618) 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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma, but mild and under control" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Montelukast, start date: 01Oct2018, for Drug allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jul2022) positive, notes: first day of symptoms and positive covid test; (28Jul2022) negative, notes: On Day 9 I tested negative on the antigen test; (30Jul2022) positive, notes: Day 11 I took the antigen test and got positive results (immediate and bright red on the test). Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Apparent rebound of COVID infection. Mild symptoms.; Apparent rebound of COVID infection. Mild symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: EN6205), on 20Apr2021 as dose 2, single (Lot number: EN0150), on 01Dec2021 as dose 3 (booster), single (Lot number: FJ8757) and on 20Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL; PANTOPRAZOLE; BUPROPION [BUPROPION HYDROCHLORIDE]. The following information was reported: COVID-19 (medically significant) with onset 29Jul2022, outcome "recovering", described as "Apparent rebound of COVID infection. Mild symptoms"; VACCINATION FAILURE (medically significant) with onset 29Jul2022, outcome "recovering", described as "Apparent rebound of COVID infection. Mild symptoms.". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Treatment of Paxlovid, Treatment start date-20Jul2022, Treatment stop date-25Jul2022, lot number- GC8123, indication: Treatment of COVID-19. No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2022 as dose 4 (booster), single (Lot number: FM9492) at the age of 74 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high BP" (unspecified if ongoing), notes: high BP; "Demylenating disease of CNS" (unspecified if ongoing), notes: Demylenating disease of CNS; "wheat" (unspecified if ongoing), notes: known allergies wheat. Concomitant medication(s) included: NIFEDIPINE, start date: 03Apr2021. Past drug history included: Dilaudid, reaction(s): "known allergy: dilaudid", notes: known allergies dilaudid. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment for COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received treatment with Paxlovid for the treatment of COVID-19. 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 drug ineffective and COVID-19 cannot be ruled out.
Age: 44.0
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 a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Lot number: EL1284), in left arm, on 25Jan2021 as dose 2, single (Lot number: EL9262), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: FF8893), in left arm and on 02Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 44 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Ibuprofen, reaction(s): "known allergies: Ibuprofen", notes: known allergies: Ibuprofen.  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: (27Jul2022) Negative, notes: after testing negative on day 8; (30Jul2022) Positive, notes: Retested positive on day 11. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had received vaccine. Had not received other medication in 2 weeks. Reported anti viral details regarding product COVID 19 Treatment, brand name was reported as plaxovid, treatment started on 19Jul2022, and treatment stopped on 123ul2022, lot number reported was GC9416. The treatment received for the indication COVID-19. The adverse event reported that retested positive on day 11 after testing negative on day 8 on 29Jul2022. Used of Paxlovid as recommended. The event was not recovered. Therapeutic measures was not taken for the event.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, the causal association  between the events Vaccination failure, Covid-19 and suspect drug BNT162b2 cannot be excluded completely.
Age: 29.0
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 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Lot number: EN5318), in left arm, on 20Feb2021 as dose 2, single (Lot number: EN5318), in left arm, on 15Oct2021 as dose 3 (booster), single (Lot number: EW0217), in left arm and on 19Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 29 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Down syndrome" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Gastric reflux" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "Eczema" (unspecified if ongoing); "Birth control" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN taken for contraception. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: Patient received treatment of Paxlovid from 14Jul2022 to 19Jul2022 for COVID 19 Treatment. Positive home rapid test on 28Jul2022 at 11.00 PM. Patient was recovering.
Age: 60.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6199), on 29Mar2021 as dose 2, single (Lot number: ER8732), on 02Oct2021 as dose 3 (booster), single (Lot number: FF2589) and on 30Mar2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension under treatment/control" (unspecified if ongoing); "Hyperlipedemia under treatment/control" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE; WILD ALASKAN FISH OIL PEAK EPA; COQ10 [UBIDECARENONE]; D3; ASPIRIN [ACETYLSALICYLIC ACID]; GLUCOSAMINE/CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE]. The following information was reported: VACCINATION FAILURE (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: (unspecified date) Positive, notes: COVID 19 Treatment; (26Jul2022) Negative, notes: I tested negative by quick antigen test 3 days after Paxlovid regimen; (28Jul2022) Positive, notes: five days after Paxlovid regimen I tested definite positive with Abbott BinaxNow and Acon FlowFlex quick antigen tests; (30Jul2022) Positive, notes: Am still positive by FlowFlex 7 days after Paxlovid regimen. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received anti-viral drug Paxlovid (Lot number: 607762) from 19Jul2022 to 23Jul2022 for treatment of COVID-19. Patient stated that I tested negative by quick antigen test 3 days after Paxlovid regimen, with gradual reduction in test line to negative, five days after Paxlovid regimen I tested definite positive with Abbott BinaxNow and Acon FlowFlex quick antigen tests. Am still positive by FlowFlex 7 days after Paxlovid regimen (mild congestion, cough, sneezing). Patient did not have any known allergies.
Age: 68.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EN6198), in left arm, on 22Sep2021 as dose 2, single (Lot number: EN6204), in left arm, on 13Nov2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 02Mar2022 at 02:30 as dose 4 (booster), single (Lot number: FJ9943) at the age of 68 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 Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: No known allergies. Patient received no other medication in 2 weeks.
Age: 60.0
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 61-year-old male patient received BNT162b2 (BNT162B2), on 26Mar2021 at 19:00 as dose 1, single (Lot number: ENG207), in right arm, on 23Apr2021 at 19:00 as dose 2, single (Lot number: EIN0172), in right arm and on 24Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF2587) at the age of 60 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Mar2022 at 12:30 as dose 4 (booster), single (Lot number: 002M21A7/22), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Spina Bifida" (unspecified if ongoing); "neurogenic bladder" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE, start date: 01Oct2017, stop date: 30Jul2022; METOPROLOL, start date: 01Jan2012, stop date: 30Jul2022; METHENAMINE HIPPURATE, start date: 01Jan2019, stop date: 30Jul2022.  The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", 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: Today is day 18 since symptoms first began, pt. still testing positive on rapid antigen test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: COVID rebound, felt like a bad cold, lasted three days. Today was day 18 since symptoms first began, pt. still testing positive on rapid antigen test. Treatment of covid-19 was done with antiviral medication with start date on 15Jul2022 and stop date on 20Jul2022.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 09Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 21Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 18May2021 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), outcome "unknown" and all described as "COVID 19 Treatment". 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. patient received Treatment as Paxlovid.    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, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: Ej1685), in left arm, on 12Jan2021 as dose 2, single (Lot number: El3249), in left arm and on 14Oct2021 as dose 3 (booster), single (Lot number: Ew0217) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Apr2022 at 10:30 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 04Aug2015; METOPROLOL, start date: 04Aug2014; HYDROCHLOROTHIAZIDE, start date: 04Nov2014. 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 antibody test: (27Jul2022) negative, notes: Two days after finish treatment tested negative; (30Jul2022) positive, notes: tested positive on day 5 after treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient took Paxlovid(LOT NO: Gd7762) (Pfizer ) from 20Jul2022 to 25Jul2022 For the Treatment of COVID-19, Two days after finish treatment tested negative . Day 3 Covid symptom worsened diarrhea congestion. Low grade fever and tested positive on day 5 after treatment last day. Patient had no Known allergies.; Sender's Comments: Based on the information in the case, an association between the reported non events covid 19 and Vaccination failure and the suspect product bnt162b2 cannot be ruled out
Age: 72.0
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 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: El3248), in right arm, on 06Mar2021 as dose 2, single (Lot number: EN6205), in right arm, on 19Aug2021 as dose 3 (booster), single (Lot number: FA7485), in right arm and on 16Feb2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic lymphocytic leukaemia" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: shrimp" (unspecified if ongoing), notes: Known allergies: shrimp; "Known allergies: lobster" (unspecified if ongoing), notes: Known allergies: lobster, Ciprofloxacin. Concomitant medication(s) included: IMBRUVICA, start date: 09Dec2020, stop date: 07Jul2022. Past drug history included: Ciprofloxacin, reaction(s): "Known allergies: Ciprofloxacin", notes: Known allergies: Ciprofloxacin. 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: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (13Jul2022) Negative; (16Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Second round of Paxlovid was given as AE treatment from 07Jul2022 to 11Jul2022. After testing negative on 13Jul2022, the patient tested positive on 16Jul because the patient was coughing and felt new head congestion. The patient received other medication in 2 weeks.
Age: 40.0
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 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: Er2613) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Age group reported as (18-64 Years). No other medication in two weeks. It was reported that anti viral Paxlovid stated on 20Jul2022 and stopped on 25Jul2022 for COVID 19 Treatment.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Started taking Paxlovid 18Jul for 5 days. Tested negative 25Jul Tested positive 28Jul; Started taking Paxlovid 18Jul for 5 days. Tested negative 25Jul Tested positive 28Jul; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 20Feb2021 as dose number unknown, single (Lot number: EL9264) and on 07Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mitral valve repair" (unspecified if ongoing), notes: Other medical history: Mitral valve repair 20 years ago.; "High BP" (unspecified if ongoing), notes: Other medical history: High BP. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Started taking Paxlovid 18Jul for 5 days. Tested negative 25Jul Tested positive 28Jul". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (25Jul2022) Negative, notes: Tested negative 25Jul; (28Jul2022) Positive, notes: Tested positive 28Jul. 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2021 at 13:30 as dose number unknown (booster), single (Lot number: FE3594) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing); "vitamin D deficiency" (unspecified if ongoing); "overweight" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN; WELLBUTRIN; OMEPRAZOLE; VITAMIN D [COLECALCIFEROL]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; MIRALAX. Past drug history included: Dilaudid, reaction(s): "Known allergies: Dilaudid". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient received COVID 19 treatment with Paxlovid on 17Jul2022 and stopped on 22Jul2022 (Lot number: 2815223). It was reported that, covid symptoms returned 2-3 days after completing 5-day Paxlovid. coughing, scratchy throat, deep voice, body aches, runny nose. Not as severe as before. No follow-up attempts are possible. No further information is expected.