chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02May2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (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: "Asthma" (unspecified if ongoing); "HTN" (unspecified if ongoing), notes: HTN; "UC with ileostomy" (unspecified if ongoing); "UC with ileostomy" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 02Jan2015. Past drug history included: Prilosec, reaction(s): "Allergy: Prilosec". 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". Therapeutic measures were taken as a result of covid-19 with Paxlovid and treatment start date was 20Jul2022 and stop date was 25Jul2022.  Clinical information: Paxlovid treatment start date 20Jul2022, treatment stop date 25Jul2022. Device Date 30Jul2022.  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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jan2022 as dose 3 (booster), single (Lot number: FJ8757) 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 included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jul2022, outcome "unknown", COVID-19 (medically significant) with onset Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) positive; (Jul2022) Negative, notes: Finished the antivirals and tested negative for COVID; (Jul2022) Negative, notes: Tested negative Tuesday to make sure; (28Jul2022) positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: It was reported that took the antivirals after testing positive for COVID. Finished the antivirals and tested negative for COVID that Monday (about 2 days after finishing). Tested negative Tuesday to make sure. Thursday 28July started having a runny nose. Woke up 29th feeling terrible, tested for COVID again and tested positive. Rebound into COVID not even a week after finishing the treatment and testing negative.  No follow-up attempts are possible. No further information is expected.
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 29-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 26Jul2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 22Oct2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes" (unspecified if ongoing). Concomitant medication(s) included: FIASP. 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; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course information: Patient received the vaccine and other medication in 2 weeks brand.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 86.0
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Oxygen saturation, 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.  An 86-year-old patient received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 20Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 24Oct2021 as dose 3 (booster), single (Lot number: FD8448), in right arm and on 10May2022 as dose 4 (booster), single (Lot number: EN6200) at the age of 86 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Resistant to penicillin" (unspecified if ongoing), notes: Resistant to penicillin. Concomitant medication(s) included: AMLODIPINE BESYLATE, start date: Sep2021, stop date: Jul2022. The following information was reported: VACCINATION FAILURE (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: Blood pressure measurement: (Jul2022) 110/72, notes: The lowest BP reading was 110/72 during the entire episode; Oxygen saturation: (Jul2022) was above 93%. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient had Other medication in 2 weeks.Other medication in 2 weeks product :Amlodipine Besylate 5mg.Other medication in 2 weeks brand :Lupin. Anti viral details product=COVID 19 Treatment, brand=Paxlovid, treatment start date=11Jul2022, treatment stop date=15Jul2022, indication=Treatment of COVID-19. Adverse event: Reduced to half dosage by the doctor during and three days after taking. Paxlovid to avoid an excessive drop in blood pressure. The lowest BP reading was 110/72 during the entire episode. Oxygen saturation was above 93% during the entire episode. Paxlovid did its job. Ae treatment: Reduced Amlodipine to 1/2 dosage.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Apr2021 as dose 1, single (Lot number: EW0164), in left arm, on 22May2021 as dose 2, single (Lot number: EW0185), in right arm and on 22Nov2021 as dose 3 (booster), single (Lot number: 330268D) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 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) Negative, notes: I had a negative COVID test after 4 days on Paxlovid; (Jul2022) positive, notes: But my symptoms returned and I tested positive a week and a half later. Therapeutic measures were taken as a result of covid-19.  Clinical course: Paxlovid rebound. Patient had a negative COVID test after 4 days on Paxlovid. But her symptoms returned and tested positive a week and a half later.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 04Oct2021 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Afib" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 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 covid-19. Clinical course: Patient did not take other medication in 2 weeks. He had no known allergies. He took Paxlovid for COVID-19 treatment (treatment start date: 21Jul2022 and stop date: 26Jul2022). He was feeling normal after completing Paxlovid and 6 days later woke up feeling ill, took at home COVID test resulting in positive test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 77.0
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 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Aug2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 10Feb2022 at 12:00 as dose 2, single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Garlic" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL, start date: 12Jul2022; MELOXICAM, start date: 12Jul2022; SENOKOT; TYLENOL; VITAMIN B 12 [CYANOCOBALAMIN]; VITAMINS C; VITAMINS D3.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID-19 Treatment. 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: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 25-year-old male patient received BNT162b2 (BNT162B2), on 11Dec2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 24 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" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative; (26Jun2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical Course: The patient underwent COVID-19 Treatment with Paxlovid, treatment start date=17Jun2022, treatment stop date=22Jun2022. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient reported that he experienced COVID-19 rebound, where his symptoms went away and he tested negative with an at home test, completed the Paxlovid course, and on 26Jun experienced some symptoms and tested positive again. The symptoms ended up worse overall than before treatment (as the treatment was effective in the first place).
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Pharmacist). A 48-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: EP6955), on 13Apr2021 as dose 2, single (Lot number: EP6955) and on 16Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin. The following information was reported: COVID-19 (medically significant) with onset 24Jul2022, outcome "not recovered", VACCINATION FAILURE (medically significant) with onset 24Jul2022, outcome "unknown" and all described as "On 28Jul2022 patient tested positive for COVID-19". The event "on 28jul2022 patient tested positive for covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Jul2022) Negative, notes: home rapid test [Antigen rapid test]; (28Jul2022) Positive, notes: Nasal swab; rapid antigen test at doctor's office. Therapeutic measures were taken as a result of covid-19. Additional information: on Sunday night 24Jul2022 or on Monday 25Jul2022 [was unsure exactly when started]. At home rapid test [withheld Antigen rapid test] was negative evening of 26Jul2022. Then on 28Jul2022 patient tested positive for COVID-19 on rapid antigen test at doctor's office. Paxlovid prescribed by doctor to treat COVID-19 and started evening of 28Jul2022. Event is ongoing as of this report submission on 29Jul2022.; Sender's Comments: Based on the information given in narrative, the causal relationship between the events COVID-19 and vaccination failure and the suspect vaccine BNT162B2 cannot be excluded.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 62-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 01Apr2021 as dose 2, single (Lot number: EW01503), in left arm and on 02Dec2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "enlarged prostate" (unspecified if ongoing); "boarder line diabetes" (unspecified if ongoing), notes: boarder line diabetes; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: FAMOTIDINE, start date: Jan2009; ATORVASTATIN, start date: Jan2010, stop date: 18Jul2022; MYRBETRIQ, start date: Jan2016, stop date: 18Jul2022; TAMSULOSIN, start date: Jan2016, stop date: 18Jul2022. 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". Therapeutic measures were taken as a result of covid-19.  Clinical Course: Patient received other medication in 2 weeks. Anti viral details product=COVID 19 Treatment, brand=Plaxovid, Treatment start date=19Jul2022, Treatment stop date=24Jul2022, Indication=Treatment of COVID-19.Device timestamp: 29Jul2022.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61-year-old male patient received BNT162b2 (BNT162B2), on 30Jun2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) 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) 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) Negative; (Jul2022) Positive, notes: positive indication After 3 days. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Patient received treatment with Paxlovid from 19Jul2022 till 23Jul2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 46-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2021 at 16:00 as dose 3 (booster), single (Lot number: FE3590) at the age of 46 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jul2022) faint line; (28Jul2022) faint line got darker; (29Jul2022) line is darker. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid, treatment start date=22Jul2022, treatment stop date=27Jul2022.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound Covid 1 week after completing antiviral; Rebound Covid 1 week after completing antiviral; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jul2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SYNTHYROID; T3. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Rebound Covid 1 week after completing antiviral". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown results, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: other medication in 2 weeks product: Synthyroid and T3. other medication in 2 weeks brand; Compounded  drugs. Adverse event - Rebound Covid 1 week after completing antiviral.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
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 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1,single (Batch/Lot number: unknown), in left arm, on 04Apr2021 as dose 2,single (Batch/Lot number: unknown), in left arm and on 12Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "asthma" (unspecified if ongoing); "polycistic ovaries" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: ACETAMINOPHEN; BUSPIRONE; ENALAPRIL; HYDROCHLOROTHIAZIDE; MONTELUKAST; NATURE'S BOUNTY OPTIMAL SOLUTIONS HAIR, SKIN & NAILS; PANTOPRAZOLE; VITAMIN C [ASCORBIC ACID]; VITAMIN D3; VITAFUSION WOMEN'S; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: high; SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 40-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient had no known allergies, no other medications in two weeks. Patient was treated with Paxlovid form 15Jun2022 to 21Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Lot number: Fc3184) at the age of 36 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: "Reactive airway disease" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; BUPROPION. Past drug history included: Sulfonamides, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (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: (unspecified date) Positive; (24Jul2022) Negative, notes: I was negative on a home antigen test on July 24 or 25th. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical information: The patient received other medication in two weeks. She was negative on a home antigen test on 24Jul2022 or 25Jul2022. She started having congestion on 28Jul2022. On 30Jul2022 she felt fatigued and had a cough. She took another home antigen test that came back positive. Treatment details: Anti viral details, product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 18Jul2022, treatment stop date: 23Jul2022, Indication: Treatment of COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: First tested positive 20Jul.; First tested positive 20Jul.; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Batch/Lot number: unknown), on 17Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 02Dec2021 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: LOSARTAN, start date: 01Nov2021; ATORVASTATIN, start date: 01May2018, stop date: 20Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jul2022, outcome "not recovered" and all described as "First tested positive 20Jul.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jul2022) First tested positive; (26Jul2022) Positive; (28Jul2022) Negative; (29Jul2022) Weakly positive; (30Jul2022) Clearly positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No known allergies. The patient received Paxlovid from 20Jul2022 to 25Jul2022 for the treatment of COVID-19. First tested positive 20Jul. Fatigue/aches/no fever. Started Paxlovid evening of 20Jul after atorvastatin washout. Felt much better by 5 am. Still positive 26Jul.Tested negative 28Jul. Weakly positive 29Jul slight sore throat. Clearly positive on 30Jul. Very slight congestion.  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 drug BNT162B2 to the reported events Vaccination failure and COVID-19 cannot be ruled out.
Age: 69.0
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 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14May2022 at 13:00 as dose 4 (booster), single (Lot number: FMO173) at the age of 69 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: BENADRYL, start date: 15Jul2022, stop date: 20Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jul2022) Negative; (25Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Anti viral Paxlovid treatment from 15Jul2022 to 19Jul2022).  Clinical course: Patient received other medication within 2 weeks. Patient does not have any known allergy. Anti viral details: Product: COVID 19 Treatment, brand: Pfizer, treatment start date: 15Jul2022, treatment stop date: 19Jul2022.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 59 years, in right arm and as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: Tested positive again after course of med. 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive test again; Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not received any other medication in 2weeks of vaccine. Anti viral details included COVID 19 Treatment, brand was Paxlovid, started on 21Jul2022 to 25Jul2022, (lot number: Gd2995). Rebound symptoms and positive test again was reported. No known allergies were reported.   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 limited information in the case , a possible causal association between   the reported  events and the suspect drug cannot be excluded.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 71-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose number unknown, single (Lot number: EN6198) at the age of 69 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "IPF" (unspecified if ongoing); "HTN" (unspecified if ongoing). Concomitant medication(s) included: Pirfenidone; Gabapentin; Valsartan; Indapamide; Omeprazole; Nifedipine; NAC [Acetylcysteine]; Quercetin; Ezetimibe; Diazepam; Pravastatin. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin", notes: known allergies: Levaquin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Jul2022) Negative, notes: positive test 4 days after testing negative following a full 5 day course of Paxlovid; (28Jul2022) Positive, notes: positive test 4 days after testing negative following a full 5 day course of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Treatment included Paxlovid.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. 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: The patient did not receive any medication in two weeks. The patient has received Paxlovid for the treatment of COVID-19 from 19Jul2022 to 24Jul2022. The patient has experienced covid-19 rebound on 29Jul2022 and was recovering, the patient did not receive any treatment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jun2022 at 13:30 as dose 4 (booster), single (Lot number: FK9893) at the age of 66 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: "Osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". 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. No Other medication in 2 weeks. No If treatment ae, No Known Allergies
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient. A 67-year-old patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) 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 immunization. The patient's relevant medical history was not reported. The patient took concomitant medications, also reported as Patient took other medication in 2weeks (Unspecified). 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: unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, Covid-19 included Paxlovid from 16Jul2022 to 21Jul2022. Clinical course: Patient had rebound of symptoms. If treatment received for symptoms was unknown and patient was recovering from symptoms. 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: 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 28Feb2021 at 15:45 as dose 1, single (Lot number: EN6206), in right arm, on 21Mar2021 at 12:00 as dose 2, single (Lot number: EN6208), in left arm and on 05Oct2021 at 10:45 as dose 3 (booster), single (Lot number: 30135BA) at the age of 60 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Apr2022 at 13:00 as dose 4 (booster), single (Lot number: 056MZIA), in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "Type 2 Diabetes" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Gastroparesis" (unspecified if ongoing); "enlarged prostate" (unspecified if ongoing); "low testosterone" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: Jan2018; ATORVASTATIN, start date: Jan2018, stop date: 18Jul2022; TESTOSTERONE, start date: Jan2018. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: I tested negative for one day; (unspecified date) Positive, notes: The next day I tested positive; (unspecified date) Positive, notes: Day 2 I also tested positive; (unspecified date) Positive, notes: On day 3 I tested positive; (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Received treatment with Paxlovid. Clinical course: The patient tested negative for one day. The next day, he tested positive and felt a little tired. He was positive on day 2 also. On day 3 he tested positive and he woke up with worse symptoms than in the first round of covid. He was exhausted, had sore throat, slight fever, sinus congestion, headache, very sore muscles including his jaw, and the beginning of an acute bronchitis episode which happened often but did not happen with the original covid round.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 79-year-old male patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6198), in left arm and on 15Mar2021 as dose 2, single (Lot number: EN6204) at the age of 77 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Nov2021 as dose 3 (booster), single (Lot number: 051F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Graves diagnosed", start date: May1977 (unspecified if ongoing), notes: Other medical history: Graves diagnosed May1977. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2022) Positive; (22Jul2022) Negative; (27Jul2022) Positive. Therapeutic measures were taken as a result of covid-19. Clinical information received on 29Jul2022: Reported that I tested positive for Covid-19 on 18Jul2022 and began the Paxlovid series on that date, with symptoms of very runny nose, body aches & general weakness. Quick recovery with negative covid test on 22Jul2022. However retested positive for Covid on 27Jul2022 with symptoms of very runny nose, light fever, cough, general weakness. I do not like this paxlovid rebound. I'm still suffering symptoms on day 3 of the re-bound and would probably been over it if I hadn't taken the Paxlovid. I was happy with Paxlovid at first, but not now.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown), on 21Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VAGIFEM; METROGEL; CALCIUM; VITAMIN D3; BIOTIN; CHROMIUM PICOLINATE; TURMERIC [CURCUMA LONGA]. 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: (27Jul2022) Positive; (unspecified date) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other medication in 2 weeks: Vagifem, Metrogel, Calcium, Vitamin D3, Biotin, Chromium Picolinate and Turmeric. Patient had no known allergies. Patient received Paxlovid (anti-viral) from 18Jul2022 to 23Jul2022 for COVID-19 treatment. On 27Jul2022 tested positive for COVID again. The next day developed a runny nose. Patient did not receive treatment for AE but recovering from the symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) and in Sep2021 as dose number unknown (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 "unknown" and all described as "my brother got sick first, he got sick first and then I got sick couple days after tested positive/We didn't get sick for two years, now get covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: We didn't get sick for two years, now get covid. Clinical course: It was reported that reporter's brother also had all the vaccine and booster shot we all had Pfizer and Pfizer booster and took booster in September it been about 5 months or 4 month, we had our vaccine last year. It was also reported that reporter's brother also had all the vaccine and booster shot we all have Pfizer and Pfizer booster. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : PFIZER INC-202201020871 same reporter/drug/event, different patient;
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EK5730), in left arm, on 24Feb2021 as dose 2, single (Lot number: EL9269), in right arm and on 28Sep2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Probable autoimmune disorder" (unspecified if ongoing), notes: Other medical history: Probable autoimmune disorder (under review by rheumatologist); "Known allergies: PCN" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Mobic, reaction(s): "Known allergies: Mobic", notes: Known allergies: Mobic; Keflex, reaction(s): "Known allergies: Keflex", notes: Known allergies: Keflex. 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, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on known drug safety profile and temporal association, there is reasonable possibility of causal association reported between the events and the suspect drug BNT162B2