chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 07Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID.  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: Negative, notes: testing negative on day 6; Positive, notes: Tested positive for Covid on day 10; Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient received treatment for covid-19, treatment start date: 04may2022, treatment stop date: 08may2022. Patient took medication in 2 weeks and had no known allergies. Patient experienced runny nose sneezing on 13May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jun2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) (Vaccine lot unknown: True, Vaccine lot unknown reason: Misplaced/discarded, Vaccine dose number unknown: True, Vaccine dose number unknown reason: Unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 19Jan2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) (Vaccine brand unknown: False, Vaccine lot unknown: True, Vaccine lot unknown reason: Misplaced/discarded, Vaccine dose number unknown: True, Vaccine dose number unknown reason: unknown) in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). There were no concomitant medications in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". Anti-viral details: Product=COVID 19 Treatment, Brand=Paxlovid, Treatment start date: 04May2022, Treatment Stop date: 09May2022, Indication: Treatment of COVID-19. Adverse event: Relapse. Negative on 10May2022, positive again 13May2022 with cold symptoms. Adverse event country:, Adverse event start date: 13May2022, Adverse event start time: 12:00 PM. If patient was not Recovered. If treatment ae: No. Known allergies: No. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (10May2022) Negative; (13May2022) Positive. 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.  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: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Rebound symptoms of covid on day 16 from first positive test and 10 days after completing paxlovid.  Symptoms of side affects from ritonivir 18 days after completing 5 day dose; Rebound symptoms of covid on day 16 from first positive test and 10 days after completing paxlovid.  Symptoms of side affects from ritonivir 18 days after completing 5 day dose; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation. No known allergies.The patient's relevant medical history included: "environmental allergies" (unspecified if ongoing); "Elevated lipoprotein a" (unspecified if ongoing), notes: Other medical history: Elevated lipoprotein a and environmental allergies. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE]; SINGULAIR; MAGNESIUM; B12 [CYANOCOBALAMIN]; ALLEGRA. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Apr2022, outcome "unknown" and all described as "Rebound symptoms of covid on day 16 from first positive test and 10 days after completing paxlovid.  Symptoms of side affects from ritonivir 18 days after completing 5 day dose". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Apr2022) Positive, notes: Rebound symptoms of covid on day 16 from first positive test and 10 days after completing Paxlovid; (05May2022) Positive, notes: Rebound symptoms of covid on day 16 from first positive test and 10 days after completing Paxlovid. Therapeutic measures were taken as a result of covid-19. Anti-viral details: product COVID 19 Treatment, Paxlovid, Treatment start date: 22Apr2022, Treatment stop date: 26Apr2022, Indication: Treatment of COVID-19. Adverse event: Rebound symptoms of covid on day 16 from first positive test and 10 days after completing paxlovid. Symptoms of side affects from ritonivir 18 days after completing 5 day dose. Adverse event country: (name). Adverse event start date: 07May2022. Ae resulted in: None of the above. If patient recovered: Not recovered. If treatment ae: Yes. Ae treatment: Omeprazole and Pepcid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from 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 28Feb2021 as dose 1, single (Lot number: EN6203), in right arm, on 21Mar2021 as dose 2, single (Lot number: EP7534), in right arm and on 28Sep2021 as dose 3 (booster), single (Lot number: 301358a) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Heart palpitations" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: CORICIDIN [OXYMETAZOLINE HYDROCHLORIDE], start date: 05May2022, stop date: 07May2022; DAYQUIL, start date: 06May2022, stop date: 08May2022; SIMVASTATIN, start date: 04Jan2010, stop date: 04May2022; CALCIUM, start date: 03Jan2000; METOPROLOL, start date: 01Sep2008; BABY ASPIRIN; MAGNESIUM; POTASSIUM; VITAMIN C [ASCORBIC ACID], start date: 08Apr2020; ZINC, start date: 08Apr2020. Past drug history included: Cipro, reaction(s): "Allergy", notes: known allergies: Cipro. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti-viral details [product for COVID 19 Treatment, brand was Pfizer, treatment start date was 09May2022, treatment stop date was 13May2022, lot number was GA1188, indication for Treatment of COVID-19. The patient previously received a COVID-19 Vaccine. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Patient received Coricidin (brand: Bayer), DayQuil (brand: Vicks), Calcium & Multivitamin (brand: Equate) along with other concomitant medications.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 48-year-old male patient received BNT162b2 (BNT162B2), on 26Sep2021 as dose 3 (booster), single (Lot number: 3013087) at the age of 48 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: "hypertension" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Ag test positivity 11 days after initial positive test; Positive, notes: Ag test positivity 11 days after initial positive test. Therapeutic measures were taken as a result of covid-19.  Clinical course: The consumer started Paxlovid on 03May2022 for Treatment of COVID-19 till 07May2022. Adverse event: Recrudescence of symptoms and Ag test positivity 11 days after initial positive test and 6 days after completion of paxlovid therapy. Adverse event start date: 14May2022, If patient recovered: Recovering, If treatment ae: No (as reported). No other medication in 2 weeks.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 28 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: "crohns" (unspecified if ongoing); "Sulfa" (unspecified if ongoing), notes: known allergies: ibuprofen, sulfa. Concomitant medication(s) included: MERCAPTOPURINE; ALLOPURINOL. Past drug history included: Ibuprofen, reaction(s): "known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (12May2022) Positive, notes: rebound from paxlovid. The patient received paxlovid as other medication within in 2weeks for treatment of COVID-19 the treatment start date was 03May2022 and treatment stop date was 08May2022. The patient received Mercaptopurine and allopurinol as other medication in 2weeks product. The adverse event rebound from paxlovid, the adverse event start date was reported as 12May2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody 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 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Dec2021 as dose 3 (booster), single (Lot number: EW0175) at the age of 49 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: Yes" (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 antibody test: Relapse of mild symptoms/ positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received treatment with anti-viral product, brand paxlovid, treatment start date 05may2022, treatment stop date 09may2022. Patient experienced relapse of mild symptoms and positive test.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Indication for use in the case: Treatment of COVID-19; Indication for use in the case: 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 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 25Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "breast cancer" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "heart" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN HCT; METOPROLOL; TAMOXIFEN; TRAZODONE; LEVOTHYROXINE; ESCITALOPRAM. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Indication for use in the case: Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. No known allergies. The patient took other medication in 2 weeks. COVID-19 treatment was Paxlovid from 05May2022 to 09May2022. 9 days after onset of COVID, patient had symptoms again. Symptoms of stuffy nose, cough, fatigue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
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 64-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: EM9809), in left arm and on 05Mar2021 as dose 2, single (Lot number: EN6203) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 19Nov2021 at 17:15 as dose 3 (booster), single (Lot number: 035C21A), in left arm for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; HCTZ.  The following information was reported: VACCINATION FAILURE (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 antibody test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid (Lot number: FX8133) from 01May2022 to 06May2022.   Clinical course: And there was Rebound COVID Symptoms started on 12May2022 at 06:00 and patient was recovering. The patient had no Known allergies.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Maternal exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; is pregnant: Pregnant; 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 (pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 30 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: "Crohns disease" (unspecified if ongoing). Date of last menstrual period: 31Aug2021. The patient was 31 weeks pregnant at the time of exposure to BNT162b2. The patient was 31 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 10Jun2022. Concomitant medication(s) included: LOVENOX [ENOXAPARIN SODIUM], start date: 01Dec2021; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS], start date: 06Oct2021, stop date: 06Oct2021; REMICADE, start date: 01Nov2018. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 08Apr2022, outcome "unknown", described as "is pregnant: Pregnant"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered with sequelae" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I tested negative on day 8; Negative, notes: tested negative on day 11; Positive, notes: positive with no symptoms on day 14. Therapeutic measures were taken as a result of drug ineffective, covid-19, maternal exposure during pregnancy. Patient received Paxlovid from start date: 03May2022 to 07May2022 for the treatment of COVID-19. Patient woke up with a sore throat on days 8, 9, and 10 of infection. she was also accompanied by a runny nose and headache. The symptoms were about 50% of the severity of the original infection. Patient was tested negative on day 8 and 11, positive with no symptoms on day 14.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Pfizer / BioNTech: Dose Number: 1, Dose Number: 2, Dose Number: 3; Paxlovid: Treatment of COVID-19; Pfizer / BioNTech: Dose Number: 1, Dose Number: 2, Dose Number: 3; Paxlovid: Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 at 15:00 as dose 1, single (Lot number: EK9231), on 19Feb2021 at 10:00 as dose 2, single (Lot number: EN9581) and on 11Oct2021 at 15:00 as dose 3 (booster), single (Lot number: FE3590) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mitral valve with liver congestion" (unspecified if ongoing); "Mitral valve with liver congestion" (unspecified if ongoing). Concomitant medication(s) included: CHLORTHIAZIDE, start date: 10Feb2021; ROBITUSSIN DM, start date: 09May2022; TYLENOL, start date: 09May2022; IBUPROFEN, start date: 09May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech: Dose Number: 1, Dose Number: 2, Dose Number: 3; Paxlovid: 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 covid-19.  Clinical course: The patient had no known allergies. On 12May2022, the patient received Paxlovid for treatment of Covid-19.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 59.0
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 non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 17Nov2021 at 13:00 as dose 3 (booster), single (Lot number: FF8841), 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", 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: (unspecified date) Unknown results; (13May2022) Negative with antigen; (15May2022) Positive on antigen test. Therapeutic measures were taken as a result of covid-19. Clinical course: No other medication in 2weeks. COVID 19 Treatment: Paxlovid. Treatment start date: 05May2022 and stop date: 10May2022. Finished 5 day course of Paxlovid, felt fine and tested negative with an antigen test on Day 8. On Day 10 (on 14May2022), tested positive on antigen test. Have a mild cough and minor congestion like mild allergy symptoms.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive 04May; Tested positive May 4.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 07Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease" (unspecified if ongoing); "Polycystic ovarian syndrome" (unspecified if ongoing); "Psoriatic arthritis" (unspecified if ongoing); "IGA" (unspecified if ongoing); "Depleted Blood" (unspecified if ongoing); "Known allergies: sulpha drugs" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE, start date: 31Jan2009; LEVOTHYROXINE SODIUM, start date: 17Aug2005; SPIRONOLACTONE, start date: 01Aug2017; LEXAPRO, start date: 22Aug2005; LORATADINE, start date: 04Feb2019; VITAMIN D3, start date: 09Aug2016; CIMZIA, start date: 05Jul2021; PREDNISONE, start date: 09Mar2022; AZATHIOPRINE, start date: 07Mar2022. The following information was reported: VACCINATION FAILURE (medically significant) with onset 04May2022, outcome "unknown", described as "Tested positive 04May"; COVID-19 (medically significant) with onset 04May2022, outcome "not recovered", described as "Tested positive May 4.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04May2022) Positive; (10May2022) Negative; (13May2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Tested positive 04May2022. Started Paxlovid 04May2022 in evening. Finished Monday morning 09May2022. Tested negative and only symptom left was exhaustion 10May2022. 13May2022 woke up with symptoms tested positive again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 67 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Jan2021 as dose 1, single (Lot number: 032L20A), on 25Feb2021 as dose 2, single (Lot number: 001A21A) and on 08Oct2021 as dose 3 (booster), single (Lot number: 058E21A) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "peripheral neuropathy" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "situational anxiety" (unspecified if ongoing); "reactive airway disease" (unspecified if ongoing); "Known allergy:Sulfanomides" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE; FAMOTIDINE; CELECOXIB; AZELASTINE; GABAPENTIN; DULOXETINE; MONTELUKAST; ADVAIR; XANAX; PREMARIN; ESTRADIOL; PROLIA. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Additional information: Report about covid treatment was yes. If vaccine received reported as Yes. Other medication in 2weeks reported as Yes. Anti viral details product: COVID 19 Treatment, Brand: Paxlovid, treatment start date: 06May2022, treatment stop date: 11May2022, indication: Treatment of COVID-19.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: ER8734), on 28Apr2021 as dose 2, single (Lot number: EW0171) and on 22Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 40 years, all intramuscular 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 15May2022 at 10:00, outcome "recovering" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15May2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Nov2021 as dose 3 (booster) , single (Batch/Lot number: unknown) at the age of 56 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "graves disease" (unspecified if ongoing); "arrythmia" (unspecified if ongoing); "allergic to apple and peach skins" (unspecified if ongoing). There were no concomitant medications. Patient had no other medications in two weeks. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 01May2022, outcome "not recovered", described as "tested positive for COVID"; COVID-19 (medically significant) with onset 01May2022, outcome "not recovered", described as "tested positive for COVID ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Negative; (01May2022) Positive; (15May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient started to feel sick on 28Apr2022 and tested negative for COVID on 29Apr2022. On 01May2022, she tested positive for COVID and took Paxlovid for 5 full days. She began Paxlovid on the evening of 01May2022 and finished the treatment on the morning of 06May2022. She started to feel better about one or two days after finishing the treatment. Then, about a week later (on Friday, 13May2022), she started to feel sick again with very similar symptoms (sore throat, congestion, mucous, sneezing, etc.). She took a COVID test this morning on 15May2022 (it was now 2.5 weeks from the initial onset of her COVID symptoms) and it was positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: drug ineffective; Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 10Sep2020 at 12:15 as dose 1, single (Batch/Lot number: unknown), in left arm, on 10Apr2021 at 12:15 as dose 2, single (Batch/Lot number: unknown), in left arm, on 20Oct2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 29Apr2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "BMI = 30" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19. Additional information: There was no other medications in two weeks. Still l testing positive on rapid assay as of 14May Diarrhea, bad taste in mouth.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Lot number: FJ8757), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: WELLBUTRIN; VYVANSE; LAMOTRIGINE. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course of the events: If vaccine received: Yes. Other medications in two weeks: Yes. Anti-viral details: Paxlovid treatment start date= 06May2022.Treatment stop date= 11May2022. Adverse event: Symptoms reappeared 3 days after treatment ended. Adverse event start date: 13May2022. No Known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Illness, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: sore throat; felt sick again; 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 22Mar2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 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: "she'll fish" (unspecified if ongoing), notes: known allergies: Penicillin she'll fish. Concomitant medication(s) included: HORIZANT. Past drug history included: Penicillin, reaction(s): "known allergies: Penicillin", notes: known allergies: Penicillin. The following information was reported: ILLNESS (non-serious) with onset 14May2022, outcome "recovering", described as "felt sick again"; OROPHARYNGEAL PAIN (non-serious) with onset 14May2022, outcome "recovering", described as "sore throat"; 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: COVID 19 Treatment. Therapeutic measures were taken as a result of covid-19. Therapeutic measures were not taken as a result of oropharyngeal pain, illness.  Clinical Information: Other medication in 2weeks was yes. Anti-viral details was, Product=COVID 19 Treatment, Brand was paxlovid, Treatment start date was  05May2022. Treatment stop date was 09May2022. Other medication in 2weeks product was Horizant. After a few days sore throat and felt sick again. Adverse event start date was 14May2022.If patient recovered was Recovering. If treatment ae was no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
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 consumer or other non HCP. The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Apr2022 at 14:30 as dose 4 (booster), single (Lot number: FJ4991) at the age of 50 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: "Hashimoto's Thyroiditis" (unspecified if ongoing); "IBS" (unspecified if ongoing). There were no concomitant medications. 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 includes that SARS-CoV-2 test on an unspecified date positive and on 06May2022 positive, about 5 days after ending the paxlovid patient covid symptoms returned and patient began testing positive again. patient have been sicker than she was the first time, and a week later she still testing positive. Paxlovid has resulted in her being sick and in quarantine for 3 full weeks now, with no end in sight. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient had no Known allergies. Patient had no other medication in 2weeks of vaccination. Anti viral details includes tat product of COVID 19 Treatment. Brand was paxlovid. treatment start date was 27Apr2022 and treatment stop date was 01May2022.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Rebound after completing paxlovid. Tested positive with sx 27Apr, started 5 day rx with paxlovid, improved and began testing negative. Symptoms returned and started testing positive again 9May. Sympto; Rebound after completing paxlovid. Tested positive with sx 27Apr, started 5 day rx with paxlovid, improved and began testing negative. Symptoms returned and started testing positive again 9May. Sympto; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EK4176), on 12Feb2021 as dose 2, single (Lot number: EL9264) and on 24Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history included: "Pregnancy" (unspecified if ongoing). Concomitant medication(s)/other medication in 2 weeks product included: ASPIRIN [ACETYLSALICYLIC ACID]; LEVOTHYROXINE. Other medication details: other medication in 2 weeks product: Prenatal vitamins. Past drug history included: Cefotetan, reaction(s): "known allergies Cefotetan", notes: known allergies Cefotetan. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "recovering" and all described as "Rebound after completing paxlovid. Tested positive with sx 27Apr, started 5 day rx with paxlovid, improved and began testing negative. Symptoms returned and started testing positive again 9May. Sympto". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14May2022) POSITIVE, notes: Still sx and antigen positive 14May; (unspecified date) NEGATIVE, notes: began testing negative; (27Apr2022) POSITIVE, notes: Tested positive with sx 27Apr, started 5 day rx with Paxlovid; (09May2022) POSITIVE, notes: Symptoms returned and started testing positive again 9May; (14May2022) POSITIVE, notes: Still sx and antigen positive 14May. Therapeutic measures were taken as a result of covid-19, vaccination failure. Antiviral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 27Apr2022, Treatment stop date: 02May2022, Indication: Treatment of COVID-19. Adverse event: Rebound after completing Paxlovid. Tested positive with sx 27Apr, started 5 day rx with Paxlovid, improved and began testing negative. Symptoms returned and started testing positive again 9May. Symptoms worse than the first time. Still sx and antigen positive 14May.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Pfizer / BioNTech: Dose Number: 4; Paxlovid: Treatment of COVID-19; Pfizer / BioNTech: Dose Number: 4; Paxlovid: 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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 71 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. No known allergies. The patient's relevant medical history included: "atrial fibrillation" (unspecified if ongoing), notes: Very rare instances (less than 1 per year) of atrial fibrillation. Concomitant medication(s) included: VALACYCLOVIR [VALACICLOVIR], start date: 20Jan2022, stop date: 12May2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech: Dose Number: 4; Paxlovid: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of suspected covid-19 included Paxlovid.  Clinical course: Treatment: Paxlovid, on 13May2022 to 14May2022.  Follow-up attempts completed. No further information is expected.
Age: 60.0
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) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: er8727), on 08Apr2021 as dose 2, single (Lot number: ew0162), on 14Oct2021 as dose 3 (booster), single (Lot number: 301558a) and on 19Apr2022 as dose 4 (booster), single (Lot number: fk9894) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "seasonal allergies" (unspecified if ongoing), notes: seasonal allergies; "sulfa" (unspecified if ongoing), notes: sulfa; "HTN" (unspecified if ongoing), notes: HTN; "Hx TIA" (unspecified if ongoing), notes: Hx TIA; "endometrosis" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: HCTZ; OMEPRAZOLE; AMLODIPINE; FISH OIL; CALCIUM + MAGNESIUM + ZINK; VIT D3; VITAMIN B12 [CYANOCOBALAMIN]; ASPIRIN 81. Past drug history included: Levaquin, reaction(s): "known allergies Levaquin", notes: known allergies Levaquin; Methoprednsolne, reaction(s): "known allergies methoprednsolne", notes: known allergies methoprednsolne. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) negative; (03May2022) positive, notes: day of positive test; (09May2022) negative; (11May2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient received treatment with Paxlovid from 03May2022 (day of positive test) to 07May2022 for treatment of COVID-19.
Age: 44.0
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 44-year-old male patient received BNT162b2 (BNT162B2), on 04Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 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 was not reported. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient did not take other medication in 2 weeks and did not know allergies. He did not have other medical history. He took as antiviral for Covid-19 as Paxlovid treatment start since 13May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Pfizer / BioNTech: Mar2021, Apr2021, Moderna Dec2021; Paxlovid: Treatment of COVID-19; Pfizer / BioNTech: Mar2021, Apr2021, Moderna Dec2021; Paxlovid: Treatment of COVID-19; The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm and in Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: ALKA SELTZER PLUS [ACETYLSALICYLIC ACID], start date: 04May2022, stop date: 07May2022; THERAFLU [PARACETAMOL;PHENIRAMINE MALEATE;PHENYLEPHRINE HYDROCHLORIDE], start date: 08May2022, stop date: 09May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Pfizer / BioNTech: Mar2021, Apr2021, Moderna Dec2021; Paxlovid: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details: product=COVID 19 Treatment, Brand=Paxlovid, Treatment start date= 06May2022, Treatment stop date= 10May2022. Indication=Treatment of COVID-19, Adverse event: Rebound Covid after taking Paxlovid, Adverse event start date: 14May2022, Ae resulted in: Not recovered, If patient recovered: Not recovered.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.