chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Jan2021 at 10:00 as dose 1, single (Lot number: EL3302), in left arm, on 21Feb2021 at 08:00 as dose 2, single (Lot number: EL9261), in left arm, on 27Sep2021 at 09:00 as dose 3 (booster), single (Lot number: 13798), in left arm and on 03Apr2022 at 17:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Heart: left bundle block" (unspecified if ongoing), notes: Heart: left bundle block; "Osteoporosis" (unspecified if ongoing); "known allergies: Penicillins" (unspecified if ongoing); "known allergies: sulfate" (unspecified if ongoing), notes: known allergies: sulfate. Concomitant medication(s) included: ALENDRONATE SODIUM, start date: 17Jul2018, stop date: 15Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jul2022) Negative; (14Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Paxlovid for COVID-19 Treatment from 06Jul2022 to 10Jul2022. The patient previously receive a COVID-19 Vaccine. Reported Event: Finished last dose of Paxlovid 10Jul2022. Tested negative 12Jul2022. COVID symptoms came back 14Jul2022 at 09:00. Head cold, runny nose, feeling sick like bad cold. Positive COVID test 14Jul2022.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown), on 19Mar2021 as dose 2, single (Batch/Lot number: unknown), on 28Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 24Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto" (unspecified if ongoing). The patient took concomitant medications. 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". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: Anti viral details: Paxlovid, treatment start date is 08Jul2022, treatment stop date is 12Jul2022, other medication in 2 weeks product is Armour. Were you or Was the patient taking any other medications or products within 2 weeks of starting COVID-19 treatment was Yes. Did you the patient previously receive a COVID-19 Vaccine was Yes. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 09Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 66 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: "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. Concomitant medication(s) included: ROSUVASTATIN; EZETIMIBE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was given as treatment for covid-19 from 25Jun2022 to 29Jun2022.
Age: 65.0
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 65-year-old male patient received BNT162b2 (BNT162B2), on 03Jun2022 at 14:30 as dose 4 (booster), single (Lot number: FP4554) at the age of 65 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: "Pacemaker" (unspecified if ongoing), notes: Pacemaker. The patient's concomitant medications were not reported. There were no other medications received in 2weeks. There were no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jul2022, outcome "recovering" and all described as "COVID-19 Treatment". The patient experienced rebound Covid infection. The patient tested positive on 04Jul2022, started Paxlovid on 05Jul2022 and again tested positive with mild symptoms on 16Jul2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jul2022) Positive; (16Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EL8982), on 12Mar2021 as dose 2, single (Lot number: EN6108), in right arm, on 15Oct2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 22Apr2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: Sulfer drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (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: negative For seven day; (Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No any Seriousness criteria (results in death, Life threatening, prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect). Anti-viral product, brand was Paxlovid, started on 04Jul2022 and stopped on 08Jul2022 for treatment of COVID-19. Other medication in 2 weeks was famotidine, Claritin. The patient was take other medications/products within 2 weeks of starting COVID-19 treatment. She was previously received a COVID-19 Vaccine. She was positive and day 5 tested negative for seven days, now testing positive again. Device Date was reported as, 17Jul2022.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
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) (Physician). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2022 as dose 4 (booster), single (Lot number: fm9992) at the age of 52 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Dec2020 as dose 1, single (Lot number: 011j20a), on 29Jan2021 as dose 2, single (Lot number: 028l20a) and on 01Nov2021 as dose 3 (booster), single (Lot number: 071f21a) for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes" (unspecified if ongoing), notes: type 1 diabetes; "hypothyroidism" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa. 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: (09Jul2022) negative; (10Jul2022) negative; (14Jul2022) positive, notes: antigen home test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Age: 72.0
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 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 23Feb2021 at 15:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 24Sep2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "Ledderhose" (unspecified if ongoing), notes: Ledderhose; "Dupuytrens" (unspecified if ongoing), notes: Dupuytrens; "known allergies: just fragrances" (unspecified if ongoing), notes: known allergies: just fragrances. 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: (Jul2022) negative, notes: rebound lasted 6 days til testing negative again. 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: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: el5264), in left arm, on 28Feb2021 as dose 2, single (Lot number: en6200), in left arm, on 04Nov2021 as dose 3 (booster), single (Lot number: fh8028), in left arm and on 20Apr2022 as dose 4 (booster), single (Lot number: fk9894) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Gout" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL, start date: 04Jul2022(ACC221) .  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (09Jul2022) Negative; (12Jul2022) Positive; (15Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received other vaccines within 2 weeks and the patient had no known allergies.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 32-year-old female patient (not pregnant) 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's relevant medical history was not reported. Concomitant medication(s) included: PLAQUENIL S; LEVOTHYROXINE. Past drug history included: Minocycline, reaction(s): "known allergies: Minocycline", notes: known allergies: Minocycline. 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: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient received Anti-viral treatment of Paxlovid from 06Jul2022 to 11Jul2022 for the Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and the drug's known safety profile, a possible contribution of the drug to the Drug ineffective and COVID-19 cannot be excluded.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 09Jan2021 as dose 1, single (Lot number: EL3246), in left arm, on 31Jan2021 as dose 2, single (Lot number: E5318), in left arm, on 31Aug2021 as dose 3 (booster), single (Lot number: FC3183), in left arm and on 15Mar2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 71 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jul2022) Positive, notes: Recurrence of positive Covid antigen test 4 days after completing Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Recurrence of positive Covid antigen test 4 days after completing Paxlovid and new symptoms (bad nasal congestion, fluctuating fever up and down: normal, fever, normal, fever, sleepiness, headache, tinnitus). No other medication was received within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 at 12:00 as dose number 1, single (Lot number: EH9899), on 12Jan2021 at 10:00 as dose number 2, single (Lot number: EL1283), on 09Nov2021 at 10:00 as dose number 3 (booster), single (Lot number: FF2590) and on 06May2022 at 03:00 as dose number 4(booster), single (Lot number: FP4554) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "WPW" (unspecified if ongoing); "High BP" (unspecified if ongoing); "High Chol" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Nkma, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Lot number: ew0173), 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: "reactive airway" (unspecified if ongoing); "IBS" (unspecified if ongoing); "sulfa" (unspecified if ongoing); "known allergies: lactose" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of covid-19 and drug ineffective.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste immediately after both vaccines; extreme salt taste on tongue 2 days later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jun2021 at 10:00 as dose 2, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic migraines" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown., Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 11May2021, when the patient was 53-year-old, for COVID-19 immunization, reaction(s): "Metallic taste immediately after both vaccines", "extreme salt taste on tongue 2 days later". The following information was reported: DYSGEUSIA (medically significant), outcome "not recovered", described as "Metallic taste immediately after both vaccines"; DYSGEUSIA (medically significant), outcome "not recovered", described as "extreme salt taste on tongue 2 days later". The events "metallic taste immediately after both vaccines" and "extreme salt taste on tongue 2 days later" required physician office visit. Therapeutic measures were taken as a result of dysgeusia, dysgeusia. Clinical course: Patient was not having COVID prior to vaccination and Patient was not tested for COVID post vaccination. The patient has no known allergies. The patient has experienced Metallic taste immediately after both vaccines, then changed to extreme salt taste on tongue 2 days later. This has not improved at all (it's been over a year). He was told to take zinc on a daily basis.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. It was unknown if patient was pregnant at the time of vaccination. The patient's relevant medical history included: "migraines with aura" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Known allergies : penicillin" (unspecified if ongoing); "Known allergies: Sulfa/Clindamycin/Doxycycline" (unspecified if ongoing). Other medical history included migraines with aura, PCOS. Patient known allergies included allergies to penicillin, clindamycin, sulfa, doxycycline. Concomitant medication(s) included: SPIRONOLACTONE, start date: Jul2022, stop date: 07Jul2022. Other medication in 2 weeks included Spironolactone from Jul2022 to 07Jul2022.   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". 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. Patient received the vaccine. Patient received Paxlovid from 07Jul2022 to 13Jul2022 for the treatment of COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Nov2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 29 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: "Endometriosis" (unspecified if ongoing), notes: other medical history: Endometriosis; "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "Allergies" (unspecified if ongoing), notes: other medical history: Allergies; "known allergies: Cashews" (unspecified if ongoing), notes: known allergies Cashews and pistachios; "known allergies: pistachios" (unspecified if ongoing), notes: known allergies Cashews and pistachios. Concomitant medication(s) included: SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]; GUAIFENESIN; TYLENOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive Test on Day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19. Covid-19 treatment was done with paxlovid.  Additional information: Covid-19 treatment was done with paxlovid from 08Jul2022 to 12Jul2022.
Sex: F
Vaccine: COVID19
Symptoms: Near death experience
Clinical narrative: almost really killed her after taking the shot of the booster shot of the Pfizer (Unspecified Vaccine); nearly died after getting the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing), notes: The caller would like to report that his wife who has Lupus. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer.), for COVID-19 Immunization. The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "almost really killed her after taking the shot of the booster shot of the Pfizer (Unspecified Vaccine); nearly died after getting the shot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), 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), 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: "Psoriatic arthritis" (unspecified if ongoing). Concomitant medication(s) included: ENBREL, start date: 01Feb2017. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19; negative, notes: negative antigen test; Positive, notes: positive antigen test. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Additional information: Return of Covid symptoms and positive antigen test after completing Paxlovid and having negative antigen test. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID 02Jul2022.; Tested positive for COVID 02Jul2022.; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 04Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Nexium, start date: 01Mar2018. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jul2022, outcome "not recovered" and all described as "Tested positive for COVID 02Jul2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jul2022) Positive; (10Jul2022) Negative; (15Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical courses: Tested positive for COVID 02Jul22022. Began Paxlovid evening of 02Jul2022 and took last dose morning of 07Jul2022. On 10Jul2022 tested negative for COVID (the patient had gone due to blisters on tongue and white patches so they tested her again). On 14Jun2022 began having head and chest congestion, headache, body aches. 15Jul2022 symptoms of headache and body aches increased and began chest congestion, and head congestion, feeling fatigued. Took COVID test and tested positive.  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 current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Arthralgia/ joint pain; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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: ARTHRALGIA (non-serious), outcome "unknown", described as "Arthralgia/ joint pain".  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) : US-PFIZER INC-202200967151 same reporter/drug/AE, different patient;
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: This is a spontaneous report received from a contactable physician. A male patient received unknown dose number of  BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. The patient experienced arthralgia/joint pain, with outcome of unknown. The information on the batch/lot number for BNT162B2 requested and will be submitted if/when received. Sender's comments: Linked report: US-PFIZER INC-202200967150 (same reporter/drug/AE, different patient).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: took, both of the vaccines Pfizer one, two, we also took both of the boosters/contracted Covid; took, both of the vaccines Pfizer one, two, we also took both of the boosters/contracted Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "took, both of the vaccines Pfizer one, two, we also took both of the boosters/contracted Covid". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical information: Consumer stated, she was 71 years old, diabetic (Intent: Medical Condition). She and her husband both took, both of the vaccines (Further not clarified hence suspect captured as Unspecified Vaccine) Pfizer one, two, they also took both of the boosters. Her husband contracted Covid which before last but he was able to get his infusion with antibodies but she did not qualify for that (Further clarifications unknown), so her doctor put her on Paxlovid (Further clarifications unknown hence event captured as per verbatim; she and her husband both took, both of the vaccines; so her doctor put her on Paxlovid), the 5 day treatment. she had been feeling better however she had noticed she was retaining some fluid in her left leg, puffiness in ankle and puffiness on 'right' (Further not clarified) but one of her concern was that her left calf that's between her knee and ankle, that's calf right? she had noticed difference in her leg to left one was wider. Then the right one and when we push down it does kind of have a in tension, it finally popped back out (Event captured as per verbatim), so if retaining fluid a side effect of Paxlovid?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 24Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 08Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: took, both of the vaccines Pfizer one, two, we also took both of the boosters/contracted Covid; took, both of the vaccines Pfizer one, two, we also took both of the boosters/contracted Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (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 "took, both of the vaccines Pfizer one, two, we also took both of the boosters/contracted Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took, both of the vaccines Pfizer one, two. Patient also took both of the boosters. Patient contracted Covid which before last but he was able to get his infusion with antibodies.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
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 65-year-old male patient received BNT162b2 (BNT162B2), on 17Sep2021 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 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: "Psoriatic Arthritis" (unspecified if ongoing), notes: Other medical history: Moderate to severe Psoriatic & Rheumatoid Arthritis; "Rheumatoid Arthritis" (unspecified if ongoing), notes: Other medical history: Moderate to severe Psoriatic & Rheumatoid Arthritis; "Allergy" (unspecified if ongoing), notes: Statins. Concomitant medication(s) included: HUMERA, start date: 01Jan2018, stop date: 02Jul2022. 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: Negative, notes: Tested negative on 6th day with rapid test; Positive, notes: On day 8 took PCR test that was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Anti-viral Paxlovid was used for COVID 19 treatment from 06Jul2022 to 12Jul2022. Covid Rebound. 5 Days after symptom onset, symptoms: Fever, aches cough: subsided and tested negative on 6th day with rapid test. On day 8 took PCR test that was positive. Somewhat different symptoms: scratchy throat, sneezing, lethargy and sinus congestion set in on evening of day 8. Symptoms persist today: Day 11. Continued to isolate. Adverse event start date: 14Jul2022, Adverse event start time: 08:00 PM, If patient recovered: Recovering, If treatment ae: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL1283), in right arm and on 23Aug2021 as dose 3 (booster), single (Lot number: FA6780) at the age of 69 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Other medical history: Hypothyroidism, high cholesterol, osteopenia; "high cholesterol" (unspecified if ongoing), notes: Other medical history: Hypothyroidism, high cholesterol, osteopenia; "osteopenia" (unspecified if ongoing), notes: Other medical history: Hypothyroidism, high cholesterol, osteopenia. There were no concomitant medications. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Erythromycin. 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: Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical Course: The patient vaccine received. The patient took other medication in 2weeks. The patient received Antiviral for COVID 19 Treatment. The treatment start date was reported as 02Jul2022 and stop date was 07Jul2022. It was reported that the patient finished full course of Paxlovid on 07Jul2022 (a.m.). Had been symptom-free since 05Jul2022. Symptoms returned 11Jul2022.
Age: 54.0
Sex: M
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 55-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 at 10:00 as dose 1, single (Lot number: EN6202), in right arm, on 25Mar2021 at 11:00 as dose 2, single (Lot number: EP7534), in right arm and on 03Oct2021 at 09:00 as dose 3 (booster), single (Lot number: FC3184) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "cardiac disease (4 previous heart attacks)" (unspecified if ongoing), notes: other medical history: cardiac disease (4 previous heart attacks); "cardiac disease (4 previous heart attacks)" (unspecified if ongoing), notes: other medical history: cardiac disease (4 previous heart attacks); "known allergies: sulpha based antibiotics" (unspecified if ongoing), notes: known allergies: sulpha based antibiotics; "known allergies: sulpha based antibiotics" (unspecified if ongoing), notes: known allergies: sulpha based antibiotics. Concomitant medication(s) included: ATORVASTATIN, start date: 05Jul2019; DILTIAZEM, start date: 01Oct2021; PRASUGREL, start date: 05Feb2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Completed treatment of Paxlovid after testing positive for Covid; (11Jul2022) Negative, notes: Performed rapid tests 3 consequtive days (11Jul, 12Jul, and 13Jul) testing negative; (12Jul2022) Negative, notes: Performed rapid tests 3 consequtive days (11Jul, 12Jul, and 13Jul) testing negative; (13Jul2022) Negative, notes: Performed rapid tests 3 consequtive days (11Jul, 12Jul, and 13Jul) testing negative; (17Jul2022) Positive, notes: On Sunday 17Jul, woke up with runny nose and scratchy throat. Took rapid test at home and tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The patient completed treatment with Paxlovid  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Indication: Treatment of COVID-19; Indication: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 04Feb2021 at 10:00 as dose 1, single (Lot number: EL9264), in left arm and on 25Feb2021 at 10:00 as dose 2, single (Lot number: EN6198) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Jan2022 at 14:00 as dose 3 (booster), single (Lot number: 084J21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications in 2weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Indication: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (16Jul2022) Positive, notes: 10 days after taking Paxlovid tested positive for Covid 19 and symptoms returned. Patient received treatment of Paxlovid for COVID-19  from 01Jul2022 to 06Jul2022.10 days after taking Paxlovid tested positive for Covid 19 and symptoms returned.Adverse event started on 14Jul2022 at 06:00 PM with outcome not recovered. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid symptoms started Weds evening. Positive test Thursday afternoon.; Covid symptoms started Weds evening. Positive test Thursday afternoon.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 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. Concomitant medications in 2weeks included: YAZ taken for contraception, start date: 13Jul2022; MUCINEX, start date: 13Jul2022. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Jul2022, outcome "not recovered" and all described as "Covid symptoms started Weds evening. Positive test Thursday afternoon.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2022) Positive, notes: Positive test Thursday afternoon. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid (start date: 15Jul2022). Covid symptoms started Wednesday evening. Positive test Thursday afternoon. Started Paxlovid Friday afternoon. Loss of smell and taste noted same day. Could just be Covid and drug will clear but thought I'd let you know.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.