chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 as dose 5 (booster), single (Lot number: GL0446) at the age of 75 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Mar2021 as dose 2, single (Lot number: ER2613), in left arm, on 09Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm and on 21Jul2022 as dose 4 (booster), single (Lot number: FP7139), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Demarol, reaction(s): "known allergies: DEMAROL". 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: (29Aug2023) Positive. Paxlovid was taken as therapeutic measures as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300290286 same patient, different drug/event;
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 as dose 5 (booster), single (Lot number: GL0446) at the age of 75 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Mar2021 as dose 2, single (Lot number: ER2613), in left arm, on 09Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm and on 21Jul2022 as dose 4 (booster), single (Lot number: FP7139), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Demarol, reaction(s): "known allergies: DEMAROL". 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: (29Aug2023) Positive. Paxlovid was taken as therapeutic measures as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300290286 same patient, different drug/event;
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: mild stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 as dose 5 (booster), single (Lot number: GL0446) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Demerol, reaction(s): "known allergies: Demerol". Vaccination history included: BNT162b2 (vaccine brand=Pfizer /BioNTech, vaccine brand unknown=False, vaccine lot number=FP7139, vaccine lot unknown=False, vaccine dose number=4, vaccine dose number unknown=False, vaccine location=Left arm), administration date: 21Jul2022, when the patient was 75-year-old, for Covid-19 Immunization; BNT162b2 (vaccine brand=Pfizer /BioNTech, vaccine brand unknown=False, vaccine lot number=30155BA, vaccine lot unknown=False, vaccine dose number=3, vaccine dose number unknown=False, vaccine location=Left arm), administration date: 09Oct2021, when the patient was 74-year-old, for Covid-19 Immunization; BNT162b2 (vaccine brand=Pfizer /BioNTech, vaccine brand unknown=False, vaccine lot number=ER2613, vaccine lot unknown=False, vaccine dose number=2, vaccine dose number unknown=False, vaccine location=Left arm), administration date: 20Mar2021, when the patient was 74-year-old, for Covid-19 Immunization; BNT162b2 (vaccine brand=Pfizer / BioNTech, vaccine brand unknown=False, vaccine lot unknown=True, vaccine lot unknown reason=Unable to locate or read the details, vaccine dose number=1, vaccine dose number unknown=False, vaccine location=Left arm), administration date: 27Feb2021, when the patient was 74-year-old, for Covid-19 Immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset Jun2023, outcome "unknown", described as "mild stroke".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300290774 same patient/product, different dose/event;
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: mild stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 as dose 5 (booster), single (Lot number: GL0446) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Demerol, reaction(s): "known allergies: Demerol". Vaccination history included: BNT162b2 (vaccine brand=Pfizer /BioNTech, vaccine brand unknown=False, vaccine lot number=FP7139, vaccine lot unknown=False, vaccine dose number=4, vaccine dose number unknown=False, vaccine location=Left arm), administration date: 21Jul2022, when the patient was 75-year-old, for Covid-19 Immunization; BNT162b2 (vaccine brand=Pfizer /BioNTech, vaccine brand unknown=False, vaccine lot number=30155BA, vaccine lot unknown=False, vaccine dose number=3, vaccine dose number unknown=False, vaccine location=Left arm), administration date: 09Oct2021, when the patient was 74-year-old, for Covid-19 Immunization; BNT162b2 (vaccine brand=Pfizer /BioNTech, vaccine brand unknown=False, vaccine lot number=ER2613, vaccine lot unknown=False, vaccine dose number=2, vaccine dose number unknown=False, vaccine location=Left arm), administration date: 20Mar2021, when the patient was 74-year-old, for Covid-19 Immunization; BNT162b2 (vaccine brand=Pfizer / BioNTech, vaccine brand unknown=False, vaccine lot unknown=True, vaccine lot unknown reason=Unable to locate or read the details, vaccine dose number=1, vaccine dose number unknown=False, vaccine location=Left arm), administration date: 27Feb2021, when the patient was 74-year-old, for Covid-19 Immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset Jun2023, outcome "unknown", described as "mild stroke".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300290774 same patient/product, different dose/event;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 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; 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), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: The patient was COVID positive and had symptoms and started Paxlovid. He was better and tested negative but is now sick with fever and congestion. The reporter thought this rebound COVID is much more prevalent than they initially thought.  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-202300291370 Same reporter/ drug/ event, different patient;
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 15Sep2022 as dose 1, single (Lot number: Gtt9693) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin and Codeine" (unspecified if ongoing). Concomitant medication(s) included: ESTROGEN, start date: May2013; PROGESTERONE, start date: May2013; BUSPIRONE HCL, start date: 19Aug2023, stop date: 22Aug2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (start date: 23Aug2023, stop date: 28Aug2023).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300291330 same patient, different drug/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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).  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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. The patient's relevant medical history included: "Thyroid cancer" (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 Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 14Aug2023 to 18Aug2023.  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-202300291425 Same patient, different event/drug;
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Nov2022 as dose 4 (booster), single (Lot number: fm0173) at the age of 76 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (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 Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "recovered" (Aug2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Negative; (Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 22Aug2023 to 27Aug2023.   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-202300291411 same patient/reporter; different drug/AE;
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Vaccine brand other=Moderna (Dose1,2,3)/Vaccine brand=Pfizer/BioNTech (Dose4, 5); 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 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 04Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 17Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Aug2023, outcome "recovered" (27Aug2023) and all described as "COVID-19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovered", described as "Vaccine brand other=Moderna (Dose1,2,3)/Vaccine brand=Pfizer/BioNTech (Dose4, 5)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Aug2023) Positive; (27Aug2023) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 18Aug2023 to 22Aug2023. Clinical course: Patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300291415 same patient/reporter; different drug/event;
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Thyroid (graves)" (unspecified if ongoing), notes: Thyroid (graves); "Severe pre-eclampsia" (unspecified if ongoing), notes: Severe pre-eclampsia; "HBP" (unspecified if ongoing), notes: HBP. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures: Paxlovid from 07Aug2023 to 11Aug2023 were taken as a result of drug ineffective, covid-19.  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-202300291426 same patient/reporter; different drug/AE;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other=Moderna (Dose1,2)/Vaccine brand=Pfizer/BioNTech (Dose 3, 4); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 4 (booster), single (Lot number: GT2524), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Nov2021 as dose 3 (booster), single (Lot number: FJ1620), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Jan2021 at 09:00 as dose 1, single (Lot number: 011L20H), in left arm and on 17Feb2021 at 09:00 as dose 2, single (Lot number: 032620A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cancers" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "known allergies: sulfas" (unspecified if ongoing), notes: known allergies: sulfas. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Nov2021, outcome "unknown", described as "Vaccine brand other=Moderna (Dose1,2)/Vaccine brand=Pfizer/BioNTech (Dose 3, 4)"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) 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 48 years, in left arm 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. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 21Aug2023 to 25Aug2023.  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-202300291520 Same patient, different event/drug;
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 30 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 15Apr2021 as dose 2, single (Lot number: EN6207), in left arm and on 03Nov2021 as dose 3 (booster), single (Lot number: 30135BA), in left arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "pre-diabetic" (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 "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid from 22Aug2023 to 27Aug2023 as treatment for the events.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Nov2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 59 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Jul2022 as dose 4 (booster), single (Lot number: FP7138), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6203), in right arm, on 20Mar2021 as dose 2, single (Lot number: ER8730), in right arm and on 11Oct2021 as dose 3 (booster), single (Lot number: FF8839), in right 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 "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Nov2022 as dose number unknown (booster), single (Lot number: GJ6742) at the age of 53 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04May2022 as dose number unknown, single (Lot number: FL3197), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "allergies: IV contrast dye" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Colazol, reaction(s): "known allergies: Colazol". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID from 29Aug2023 to 02Sep2023.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 63 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EL9267), in left arm, on 17Mar2021 as dose 2, single (Lot number: EP7534), in left arm, on 09Oct2021 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 28May2022 as dose 4 (booster), single (Lot number: FJ4989), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19 from 09Aug2023 to 14Aug2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300292179 same patient, different event/ drug;
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  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-202300291334 same patient, different drug/event;
Age: 65.0
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) from product quality group. The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 4 (booster), single (Lot number: 027E22A) 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: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: patient received COVID 19 Treatment (Brand: Pfizer) from 23Aug2023 to 28Aug2023.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (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), 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: "asthma" (unspecified if ongoing); "sarcoidosis" (unspecified if ongoing). The patient's concomitant medications were not reported. No Known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (2023) negative; (2023) Negative; (2023) Positive, notes: Tested positive for covid after 2 days of testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment Paxlovid from 25Aug2023 to 29Aug2023.  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, Maternal exposure during pregnancy
Clinical narrative: 16 weeks pregnant; 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 30-year-old female patient (pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing). Date of last menstrual period: 08May2023. The patient was 16 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 12Feb2024. The patient's concomitant medications were not reported. Past drug history included: Known allergies: clindamycin, reaction(s): "Known allergies: clindamycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "16 weeks pregnant". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid was given as treatment. It was reported that the treatment start date was 01Sep2023 and the treatment stop date was Sep2023.  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.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 4, single (Lot number: GJ5342) at the age of 69 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "BPH" (unspecified if ongoing); "Coronary artery calcification" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing); "Penicillin Allergy" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: Jan2012, stop date: 26Aug2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19, treatment was Paxlovid from 26Aug2023 to 30Aug2023.
Age: 32.0
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 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EL9267), in left arm, on 16Mar2021 as dose 2, single (Lot number: EP7534), in left arm and on 13Nov2021 as dose 3 (booster), single (Lot number: FF2593), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Reactive airway disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 from 12Jan2023 to 16Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 15Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Jan2019. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 25Aug2023 to 31Aug2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; brand=Pfizer / BioNTech, brand other=Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Jun2023 as dose 6 (booster), single (Lot number: gl2042) at the age of 71 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Nov2022 as dose 5 (booster), single (Lot number: 052d22a) 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: "glaucoma" (unspecified if ongoing), notes: other medical history: glaucoma; "prostatectomy" (unspecified if ongoing), notes: other medical history: prostatectomy. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Jun2023, outcome "unknown", described as "brand=Pfizer / BioNTech, brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other vaccination and did not receive any other medication in 2 weeks. Paxlovid was given as treatment for COVID-19 from 24Aug2023 to 29Aug2023. The event was reported as Covid rebound. Positive covid test, very runny nose, persistent cough. No fever or achey leg muscles like the first go-around. Patient did not have any known allergies
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; brand other=Moderna bivalent, brand=Pfizer / BioNTech; 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 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 11Oct2022 as dose 5 (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: "Asthma" (unspecified if ongoing); "crohn's disease" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Aspirin, reaction(s): "Drug allergies:Aspirin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Oct2022, outcome "unknown", described as "brand other=Moderna bivalent, brand=Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 67-year-old female patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: ER8727), in right arm and on 05Oct2021 as dose 3 (booster), single (Lot number: EN6203) at the age of 65 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Oct2021 as dose 2, single (Lot number: 30155BA), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31May2022 as dose 4 (booster), single (Lot number: 037A22B), in right arm and on 24Jan2023 as dose 5 (booster), single (Lot number: 042H22A), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31May2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (09Sep2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid as treatment for covid-19.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Skin cancer
Clinical narrative: 03Apr or 04Apr2021 had first surgery to remove the skin cancer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 71-year-old female patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EN6199) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "Cancer", start date: Feb2021 (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "allergies: bactrim"; Ativan, reaction(s): "allergies: ativan". The following information was reported: SKIN CANCER (hospitalization, medically significant), outcome "unknown", described as "03Apr or 04Apr2021 had first surgery to remove the skin cancer". The event "03apr or 04apr2021 had first surgery to remove the skin cancer" required physician office visit. Therapeutic measures were taken as a result of skin cancer. Clinical course included on 03Apr or 04Apr2021, patient had first surgery to remove the skin cancer at doctors.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300139170 same patient/drug/reporter, different dose;US-PFIZER INC-202300293267 same patient/drug/reporter, different dose;US-PFIZER INC-PV202300150867 same patient/drug/reporter, different dose;
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenectomy, Skin graft
Clinical narrative: lymph nodes removed; graft at hospital; This is a spontaneous report received from a contactable Consumer. A 72-year-old female patient received BNT162b2 (BNT162B2), on 05Apr2021 as dose 2, single (Lot number: EP7533) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "Cancer", start date: Feb2021 (unspecified if ongoing); "first surgery to remove the skin cancer", start date: Apr2021, stop date: Apr2021, notes: 03Apr2021 or 04Apr2021 had first surgery to remove the skin cancer; "wheelchair" (unspecified if ongoing), notes: Durable medical equipment company brings wheelchair, nebulizer; "nebulizer" (unspecified if ongoing), notes: Durable medical equipment company brings wheelchair, nebulizer. The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Allergies: Bactrim"; Ativan, reaction(s): "Allergies: Ativan". Vaccination history included: BNT162b2 (Dose 1, Manufacturer: Pfizer , Lot number: EN6199), administration date: 15Mar2021, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "Skin cancer". The patient underwent graft at hospital on 20May2021 and lymph nodes removed on 22May2021 at medical center (name withheld). Patient was hospitalized on 20May2021. Outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300139170 same patient/drug/reporter, different dose and event.;US-PFIZER INC-202300293266 same patient/drug/reporter, different dose and event.;US-PFIZER INC-PV202300150867 same patient/drug/reporter, different dose and event.;
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 (Other HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive; (unspecified date) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included nirmatrelvir; ritonavir (PAXLOVID) oral from 23Aug2023 to 27Aug2023. 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: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from 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 21Jul2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hayfever" (unspecified if ongoing); "lactose intolerance" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 10Aug2023 to 14Aug2023.  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.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable consumer. The reporter is the patient. A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Feb2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: codeine"; Demerol, reaction(s): "Known allergies: demerol". Patient received PAXLOVID for COVID-19 treatment in Sep2023. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.