chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 at 12:30 as dose 1, single (Lot number: EN6198), in left arm and on 23Mar2021 at 14:30 as dose 2, single (Lot number: EN6198) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Hyperparathyroidism" (unspecified if ongoing); "HTN" (unspecified if ongoing), notes: HTN; "Autoimmune MCTD" (unspecified if ongoing); "Anti-synthetase syndrome" (unspecified if ongoing); "Anti-phospholipid syndrome" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ, start date: 17Aug2022; LEFLUNOMIDE, start date: 13Jan2023; PREDNISONE; BISOPROLOL; SPIRONOLACTONE; LEVOTHYROXINE; VITAMIN D NOS; VITAMIN B12 NOS; IRBESARTAN; MAGNESIUM. Past drug history included: Diphenhydramine, reaction(s): "Allergy"; Statins, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Feb2023, outcome "unknown"; COVID-19 (medically significant) with onset Feb2023, outcome "unknown", described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: the patient received Paxlovid from 28Feb2023 to 05Mar2023 as treatment for COVID-19.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300107499 same patient, different product;US-PFIZER INC-202300108184 same patient and product, different dose and event;
Age: 67.0
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) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 at 09:45 as dose 1, single (Lot number: EM9809), in left arm, on 06Mar2021 as dose 2, single (Lot number: EN6199), in left arm, on 06Oct2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 09May2022 as dose 4 (booster), single (Lot number: 33036BD), in left arm for covid-19 immunisation; BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 16:15 as dose 5 (booster), single (Lot number: GH9702) at the age of 67 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient took Paxlovid from 23Feb2023 to 27Feb2023 for COVID 19 Treatment.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300107485 Same reporter/patient, different drug/event.;
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Aug2022 as dose 5 (booster), single (Lot number: Gj6739) at the age of 60 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Jul2022 as dose 4 (booster), single (Lot number: Fj4991) for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 09Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 01Feb2022 as dose 3 (booster), single (Lot number: Fg3527), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Nerve damage" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient was treated with Paxlovid from 22Dec2022 to 26Dec2022. 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-202300108245 same patient/vaccine, diff dose/event;
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Drug ineffective; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 76 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Jan2021 as dose 1, single (Lot number: 043L20A), on 25Feb2021 as dose 2, single (Lot number: 000A210), on 27Oct2021 as dose 3 (booster), single (Lot number: 014F21A) and on 07Apr2022 as dose 4 (booster), single (Lot number: 066K21A) for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "Stage 4 Prostate Cancer" (unspecified if ongoing); "Ambien allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Sep2022, outcome "unknown"; COVID-19 (medically significant) with onset Feb2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Feb2023, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 28Feb2023 05Mar2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300107490 Same patient, different drug and event;
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 13:30 as dose 5 (booster), single (Lot number: GJ5342) at the age of 67 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Sep2021 at 14:30 as dose 3 (booster), single (Lot number: FF2587) and on 02May2022 as dose 4 (booster), single (Lot number: FJ4991), 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: "hypothyroid" (unspecified if ongoing); "Hashimotos" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ampicillin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Mar2023, outcome "unknown"; COVID-19 (medically significant) with onset Mar2023, outcome "unknown", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Mar2023) Negative, notes: after 5 days negative Covid test on a Monday; (09Mar2023) Positive, notes: by Thursday I had a positive Covid test; (unspecified date) Negative, notes: at home tests have been negative; (10Mar2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Anti viral details: product=COVID-19 Treatment, Paxlovid, treatment start and stop date= 02Mar2023 and 05Mar2023,Treatment of COVID-19. After 5 days negative COVID test on a Monday by Thursday she had a positive COVID test and symptoms of stuffy nose. low grade fever today Saturday. Husband had been displaying COVID symptoms but his at home tests had been negative. He took a PCR test yesterday Friday 10Mar2023 so they will see this week if it comes out positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300107495 same patient, different drug/event;
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Apr2022 as dose 4 (booster), single (Lot number: FJ6369) at the age of 71 years, in right arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 21Sep2022 as dose 5 (booster), single (Lot number: AS71445B), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Jan2021 as dose 1, single (Lot number: 013L20A), in right arm, on 11Feb2021 as dose 2, single (Lot number: 039K20A), in right arm and on 10Sep2021 as dose 3 (booster), single (Lot number: 062E21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "cancer on chemo therapy" (unspecified if ongoing), notes: cancer on chemo therapy; "kidney disease" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Apr2022, outcome "unknown"; COVID-19 (medically significant) with onset 2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: Body temperature: 101 Fahrenheit; SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Treatment of Paxlovid started on 23Feb2023 an stopped on 28Feb2023.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events interchange of vaccine products, Covid-19, and drug ineffective are related to  BNT162b2 cannot be excluded. This case will be reassessed should additional information become available.,Linked Report(s) : US-PFIZER INC-202300107465 Same patient, different drug and event;
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 17:00 as dose 5 (booster), single (Lot number: GHQ703) at the age of 77 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Feb2021 at 11:00 as dose 1, single (Lot number: EL9266), in left arm and on 11Apr2022 at 03:00 as dose 2, single (Lot number: FJ4991), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies and is healthy no diabetes, Hypertension etc. The patient received Paxlovid from 08Mar2023. No other medication in 2 weeks.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300108400 same patient, different drug/event;US-PFIZER INC-202300108419 same patient/vaccine, different dose/event;
Age: 63.0
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) (Nurse). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 at 16:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 63 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: "Age related osteoporosis" (unspecified if ongoing); "Protein C deficiency" (unspecified if ongoing); "known allergies: PCN" (unspecified if ongoing); "known allergies: cauliflower, broccoli" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetanus toxoid, reaction(s): "known allergies tetanus toxoid". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Feb2023, outcome "recovered" (09Mar2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Mar2023) Positive, notes: 1st positive COVID test; (09Mar2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient did not receive other medication in 2 weeks. The patient was treated with Paxlovid from 01Mar2023 to 05Mar2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a vaccine varies individually and can be affected by different factors including product potency; however, a contributory role of BNT162B2 to the events COVID-19 and drug ineffective cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300108336 same patient, different drug and event.;
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Vaccination failure; Covid-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EJ1685), in left arm, on 12Jan2021 as dose 2, single (Lot number: 1685), in left arm and on 08Oct2021 as dose 3 (booster), single (Lot number: ff8839) at the age of 75 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Apr2022 as dose 4 (booster), single (Lot number: 033K2124), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of covid-19. Clinical course: Patient treated COVID-19 with Paxlovid from 02Mar2023 till 07Mar2023. Patient had no allergies.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product BNT162B2 to the reported events vaccination failure and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300108517 same patient, diff drug/event;
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination failure; 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 61--old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Lot number: FP&141) at the age of 60 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6203), in left arm, on 15Mar2021 as dose 2, single (Lot number: EN6207), in left arm, on 15Oct2021 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa drugs and ampicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "recovered" (Mar2023), described as "COVID 19"; VACCINATION FAILURE (medically significant) with onset 2023, outcome "recovered" (Mar2023). Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received Paxlovid 150(x2) from 03Mar2023 to 08Mar2023 for treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300108567 same patient, different product;
Age: 32.0
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 32-year-old female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 32 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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 included: "Ulcerative colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ceclor, reaction(s): "Allergy"; Tylenol, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (Mar2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Negative, notes: two negative tests 48 hours apart on Day 6 and Day 8. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid from 04Mar2023 to 09Mar2023 for COVID 19 Treatment. Lot number of Comirnaty was unknown since it was misplaced/ discarded.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300107925 Same reporter/patient, different drug/event.;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 39-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sulpha allergy" (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", described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 28Feb2023 to 06Mar2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300108669 same patient, different drug and event.;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 01May2021 as dose 2, single (Lot number: ER8732), in left arm, on 30Oct2021 as dose 3 (booster), single (Lot number: 301SSBA), in left arm and on 30Aug2022 as dose 4 (booster), single (Lot number: FP7150), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing); "COPD" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: Aug2009. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for covid again after after being treated with paxlovid and testing negative; Negative, notes: Tested positive for covid again after after being treated with paxlovid and testing negative. Therapeutic measures were taken as a result of covid-19. Clinical course: Anti-viral details: Product: COVID 19 Treatment: Paxlovid. Treatment start and stop date: 03Mar2023 and 07Mar2023. Indication= Treatment of COVID-19. Adverse event: Tested positive for covid again after after being treated with paxlovid and testing negative. No exposure to anyone with covid.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300107503 same patient, different drug/event;US-PFIZER INC-202300108848 same patient, different dose and event;
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Covid 19; Covid 19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 5 (booster), single (Lot number: 656665) at the age of 64 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: ENG208), on 19Apr2021 as dose 2, single (Lot number: EW0150) and on 24May2022 as dose 4 (booster), single (Lot number: FM7553) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Dec2021 as dose 3 (booster), single (Lot number: 058H21A) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Dec2021, outcome "unknown"; 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: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid, Treatment start date was 24Feb2023 and stop date was 28Feb2023.  Clinical course: Patient had no Known allergies. Other medication in 2weeks: Yes  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events INTERCHANGE OF VACCINE PRODUCTS, DRUG INEFFECTIVE, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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: COVID-19 (medically significant) with onset 2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Treatment of Paxlovid started on 04Mar2023, stopped on 8Mar2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300108730 same patient, different drug and event.;
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 at 16:00 as dose 4 (booster), single (Lot number: GJ3277) at the age of 43 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 and concomitant medications were not reported. Past drug history included: Panelist, reaction(s): "Known allergies: Panelist". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: negative results for the past 6 days. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No other medication in 2 weeks. The patient received Paxlovid from 27Feb2023 to 02Mar2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300108759 same patient, different drug and event;
Age: 79.0
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 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 5 (booster), single (Lot number: GJ6665) at the age of 79 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: EL3249), in left arm, on 04Feb2021 as dose 2, single (Lot number: EL9261), in left arm, on 30Sep2021 as dose 3 (booster), single (Lot number: FC3183), in left arm and on 11Apr2022 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic obstructive pulmonary disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfur, reaction(s): "Known allergies: sulfur". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient did not receive other medication in 2 weeks. The patient was treated with Paxlovid from 28Feb2023 to 04Mar2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300107504 same patient, different drug/event;US-PFIZER INC-202300108795 same reporter, different patient, product, and event;
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 20Jan2021 as dose 2, single (Lot number: EI1283), in left arm, on 18Sep2021 as dose 3 (booster), single (Lot number: 301458A), in right arm and on 22Apr2022 as dose 4 (booster), single (Lot number: IK9894), in right arm for covid-19 immunisation; BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Morbid Obesity" (unspecified if ongoing); "Breast Cancer" (unspecified if ongoing); "Pre Diabetes" (unspecified if ongoing); "Hypercalcemia" (unspecified if ongoing); "Parathyroid Disease" (unspecified if ongoing); "Sensitive to penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" (Mar2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Mar2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient took Paxolovid from 02Mar2023 to 06Mar2023 for COVID 19 Treatment.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300108870 Same reporter/patient, different drug/event.;
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 at 10:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 35 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: "Salmon allergy" (unspecified if ongoing). Concomitant medication(s) included: SUDAFED 12 HOUR, start date: 01Mar2023, stop date: 03Mar2023. Past drug history included: Sulfa, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovered"; COVID-19 (medically significant), outcome "recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid taken from 01Mar2023 to 06Mar2023 as treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300109069 same patient, different drug and event.;
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Jan2023 at 10:00 as dose 5 (booster), single (Lot number: GL0087) at the age of 52 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), 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 included: "Rheumatoid arthritis" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Hot flashes" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; EFFEXOR taken for hot flush, start date: 01Aug2022; METFORMIN; SINGULAIR; NASACORT; VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS; MULTIVITAMINS [VITAMINS NOS]. Past drug history included: Macrobid, reaction(s): "Allergy", notes: Known allergies: macrobid; Sulfonamide, reaction(s): "Allergy", notes: Known allergies: Sulfa. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid from 09Mar2023 to 13Mar2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300109526 Same reporter/patient, different drug/event.;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Htn" (unspecified if ongoing), notes: Other medical history: Htn obesity; "obesity" (unspecified if ongoing); "allergy" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN, start date: Nov2003. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19. Clinical course: Anti-viral details: Product: COVID 19 Treatment, brand: Paxlovid. Treatment start and stop date 01Mar2023 and 06Mar2023 for Indication: Treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product BNT162b2 vaccine, cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.,Linked Report(s) : US-PFIZER INC-202300109616 Same patient, different product/ event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 12:00 as dose 5 (booster), single (Lot number: As7164c), 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), 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 included: "Sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION, stop date: 11Mar2023. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Treatment of Paxlovid started on 12Mar2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300109642 Same patient, different drug, different event;
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: My body has broke out from head to toe, when it first started breaking out/It  start first as a rash, it's all over my entire body; itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1), administration date: 2021, for COVID-19 Immunization; Covid-19 vaccine (Primary immunization completed; unknown manufacturer), for COVID-19 Immunization. The following information was reported: RASH (medically significant), outcome "not recovered", described as "My body has broke out from head to toe, when it first started breaking out/It  start first as a rash, it's all over my entire body"; PRURITUS (non-serious), outcome "not recovered", described as "itching". Therapeutic measures were taken as a result of rash, pruritus.  Clinical information: Patient stated "My body has broke out from head to toe, when it first started breaking out, I started itching but you couldn't see anything but in about 3, 4, 5 weeks later, It start first as a rash, it's all over my entire body. I tried Prednisone, Steroids, I've got kind of cream that you could possibly imagine and nothing, absolutely nothing." Patient was asked if he has consulted a health care provider and he responded, "I have been to two dermatologist, doctor and I was going to another medical doctor on Wednesday, but I was telling you I was in a bad shape." Caller added "The doctors for whatever reason, I didn't know whatever reason, but the doctor should have reported this to CDC." Patient stated, "I would say if I had the shot in Feb2021 and this Mar2023, would say this rash would went away." Caller additionally asked if there was a way to reverse the effect he was currently experiencing. Caller confirmed that he received the Pfizer BioNTech covid-19 bivalent vaccine for ages 12 and older and he mentioned that he was 71. Already took Prednisone, steroids, and applied cream but absolutely nothing helped caller. Transfer agent thinks caller mentioned caller received the 1st shot in 2021 but transfer agent was not able to get additional information. Caller mentioned something about Mar2023, transfer agent thinks that was when caller started experiencing the rash, but transfer agent was not sure. Is there a product complaint to report? Yes. Description of Product Complaint: PC was not on suspect product. Body has broken out from head to toe and started itching, already took Prednisone, steroids, and applied cream but absolutely nothing helped. No additional information provided due to caller disconnecting prior to completion of transfer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Feb2021 as dose 1, single (Lot number: 024M20A), on 17Mar2021 as dose 2, single (Lot number: 001B21A) and on 01Nov2021 as dose 3 (booster), single (Lot number: 048C21A) for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Apr2022 as dose 4 (booster), single (Lot number: PK9893) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: no other medical history. The patient took Paxlovid from 02Mar2023 to 07Mar2023. Other medication in 2 weeks product calcium; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300109918 Same patient, different drug/event;
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Dry skin, Pruritus, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; Itching; Dry skin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown"; PRURITUS (non-serious), outcome "unknown", described as "Itching"; DRY SKIN (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Postive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Originating AE Request: REQ-1093092. PQC Details: Request Name: REQ-1093092. Question: Caller mentioned she is just getting over covid and was given Paxlovid. She mentioned she did not have any side effects mentioned in the information she got. She stated she had been "exposed to a lot of people in her job and did not how long she get it (covid). She mentioned she was vomiting, had headache, severe nausea a long time before taking paxlovid, and she also have itching from dry skin before (Paxlovid). She wanted to compare Paxlovid's effects to another treatment option for mild to moderate covid which is Remdesivir (Veklury) (see response REQ-1093101). She got the Pfizer booster shot and wanted to know why she got had it (covid) so bad even though she got the shot (addressed in this REQ-1093092). DSU: Adverse event warm transferred to RA NTID: (ID woithheld), Reportum. Documenting additional AE details captured after listening to the call. Request Name: REQ-1093136. Product: NO PRODUCT. Question: Caller said she did not have anymore tests left to check Covid. She wanted to know who she should reach out to. Request Name: REQ-1093101. Product: PAXLOVID. Question: Caller was getting over covid and was given Paxlovid.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300112793 Same patient/product, different dose/events;
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 21Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Gastro reflux" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Augmenting, reaction(s): "Known allergies: Augmenting"; Lisinopril, reaction(s): "Known allergies: lisinopril". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received other medication in 2 weeks. The patient was treated with Paxlovid from 01Mar2023 to 06Mar2023.  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-202300109702 Same patient, different product, different event;
Age: 38.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 38 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. The patient was treated with Paxlovid from 05Mar2023 to 09Mar2023.