chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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 included: "Lyme's disease" (unspecified if ongoing); "Seafood" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: No other medication taken in 2 weeks. Treated with Paxlovid from 01Mar2023 to 05Mar2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 non-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 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. 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". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no known allergy. No other medication in 2weeks. Patient took treatment (Paxlovid) from 28Mar2023 to 01Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 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 38-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) 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); "Obesity" (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: (04Apr2023) Negative, notes: Tested negative for Covid on home rapid test on Tuesday 04Apr; (07Apr2023) Positive, notes: Tested positive again at home on Friday 07Apr. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: First symptom Tues 28Mar2023. Took Paxlovid as directed Wed on 29Mar2023 through that Sunday. Feeling better for a couple days. Tested negative for Covid on home rapid test on Tuesday 04Apr2023. Symptoms returned. Tested positive again at home on Friday 07Apr2023.  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.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, COVID-19, Investigation, Neutrophil count, Oxygen saturation
Clinical narrative: The lab results were significant for a positive COVID-19 PCR test/fatigue, malaise, myalgias and cough productive of clear sputum; The lab results were significant for a positive COVID-19 PCR test/fatigue, malaise, myalgias and cough productive of clear sputum; This is a literature report for the following literature source(s):   A 32-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single and on 30Mar2021 as dose 2, single for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes mellitus" (unspecified if ongoing); "end-stage renal disease (ESRD)" (unspecified if ongoing); "secondary to diabetic nephropathy" (unspecified if ongoing); "hemodialysis (HD)" (unspecified if ongoing); "SLE" (unspecified if ongoing); "antiphospholipid syndrome (APS)" (unspecified if ongoing); "peripheral arterial disease (PAD)" (unspecified if ongoing); "balloon angioplasty of right anterior and posterior tibial arteries" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE taken for systemic lupus erythematosus; PREDNISONE taken for systemic lupus erythematosus. Past drug history included: Insulin for type 1 diabetes mellitus; Warfarin, reaction(s): "splenic infarct on warfarin". The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 14Jan2022, outcome "unknown" and all described as "The lab results were significant for a positive COVID-19 PCR test/fatigue, malaise, myalgias and cough productive of clear sputum". The patient was hospitalized for vaccination failure, covid-19 (start date: 14Jan2022, discharge date: 2022). The patient underwent the following laboratory tests and procedures: Blood glucose: (Jan2022) 471 mg/dl, notes: hyperglycemia; SLEDAI-2 K scores: (Jan2022) 20; Neutrophil count: (Jan2022) 14.6 x10 9/l, notes: neutrophilic leukocytosis; Oxygen saturation: (Jan2022) 96 %, notes: on room air; Respiratory rate: (Jan2022) 14, notes: Unit: per min; SARS-CoV-2 antibody test: (Jan2022) greater than 250, notes: elevated; SARS-CoV-2 test: (Jan2022) Positive; Vital signs measurement: (Jan2022) Normal. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300148407 Same Article/drug/event; Different Patient;
Sex: M
Vaccine: COVID19
Symptoms: Respiratory rate, SARS-CoV-2 antibody test, SARS-CoV-2 test, Vaccination failure, Vital signs measurement
Clinical narrative: The lab results were significant for a positive COVID-19 PCR test/fatigue, malaise, myalgias and cough productive of clear sputum; The lab results were significant for a positive COVID-19 PCR test/fatigue, malaise, myalgias and cough productive of clear sputum; This is a literature report for the following literature source(s):   A 32-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single and on 30Mar2021 as dose 2, single for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes mellitus" (unspecified if ongoing); "end-stage renal disease (ESRD)" (unspecified if ongoing); "secondary to diabetic nephropathy" (unspecified if ongoing); "hemodialysis (HD)" (unspecified if ongoing); "SLE" (unspecified if ongoing); "antiphospholipid syndrome (APS)" (unspecified if ongoing); "peripheral arterial disease (PAD)" (unspecified if ongoing); "balloon angioplasty of right anterior and posterior tibial arteries" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE taken for systemic lupus erythematosus; PREDNISONE taken for systemic lupus erythematosus. Past drug history included: Insulin for type 1 diabetes mellitus; Warfarin, reaction(s): "splenic infarct on warfarin". The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 14Jan2022, outcome "unknown" and all described as "The lab results were significant for a positive COVID-19 PCR test/fatigue, malaise, myalgias and cough productive of clear sputum". The patient was hospitalized for vaccination failure, covid-19 (start date: 14Jan2022, discharge date: 2022). The patient underwent the following laboratory tests and procedures: Blood glucose: (Jan2022) 471 mg/dl, notes: hyperglycemia; SLEDAI-2 K scores: (Jan2022) 20; Neutrophil count: (Jan2022) 14.6 x10 9/l, notes: neutrophilic leukocytosis; Oxygen saturation: (Jan2022) 96 %, notes: on room air; Respiratory rate: (Jan2022) 14, notes: Unit: per min; SARS-CoV-2 antibody test: (Jan2022) greater than 250, notes: elevated; SARS-CoV-2 test: (Jan2022) Positive; Vital signs measurement: (Jan2022) Normal. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300148407 Same Article/drug/event; Different Patient;
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Granuloma annulare, SARS-CoV-2 test, Vaccination site mass
Clinical narrative: granuloma annulare on hands; Bump at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 02Nov2021 at 12:00 as dose 3 (booster), single (Lot number: Ff2593) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PTSD" (unspecified if ongoing); "liver and gallbladder disease" (unspecified if ongoing); "liver and gallbladder disease" (unspecified if ongoing). Concomitant medication(s) included: BUSPAR; WELLBUTRIN; XANAX. Past drug history included: Flagyl, reaction(s): "Known allergies: Sensitivity to flagyl"; Cipro, reaction(s): "Known allergies: Cipro". Vaccination history included: BNT162b2 (Dose 2, Single, Batch/Lot No: En8727, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 06Apr2021, when the patient was 50-year-old, for Covid-19 immunization; BNT162b2 (Dose 1, Single, Batch/Lot No: En6205, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 19Mar2021, when the patient was 50-year-old, for Covid-19 immunization. The following information was reported: GRANULOMA ANNULARE (hospitalization), outcome "recovered with sequelae", described as "granuloma annulare on hands"; VACCINATION SITE MASS (hospitalization), outcome "recovered with sequelae", described as "Bump at injection site". The events "granuloma annulare on hands" and "bump at injection site" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of granuloma annulare, vaccination site mass.  Clinical course: No other vaccine in four weeks.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 61 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Lot number: FM0698), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: ER8730), on 17Apr2021 as dose 2, single (Lot number: EW0153), in left arm and as dose 3 (booster), single (Lot number: 30155BA), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure and covid-19 with Paxlovid from 25Mar2023 to 29Mar2023.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: After they took the bivalent six months or five months later they got covid again; After they took the bivalent six months or five months later they got covid again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A patient (no qualifiers provided) 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 included: "Suspected COVID-19" (unspecified if ongoing), notes: Had COVID-19 three times. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "After they took the bivalent six months or five months later they got covid again".  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-PV202300063579 Same patient, same product, different event;
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 50 years 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 Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication taken in 2 weeks. Patient treated with Paxlovid (nirmatrelvir tablets; ritonavir tablets), co-pa (from 17Feb2023 to 22Feb2023)  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative, notes: Paxlovid was great but 3 days after I tested negative. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Patient had no known allergies. Patients did not receive other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Mar2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 58 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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (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 Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated with paxlovid and treatment start date: 30Mar2023 and treatment stop date: 03Apr2023.  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: 65.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 at 14:00 as dose 4 (booster), single (Lot number: GH9703) at the age of 65 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Oct2021 at 12:30 as dose 3 (booster), single (Lot number: FF2587), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications within 2 weeks. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 29Mar2023 to 02Apr2023.
Age: 55.0
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 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 4 (booster), single (Lot number: GH9U93) at the age of 55 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8734), in left arm, on 23Apr2021 as dose 2, single (Lot number: EW0151), in left arm and on 02Dec2021 as dose 3 (booster), single (Lot number: FJ8757), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "obesity" (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 Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19: Paxlovid from 29Mar2023 to 03Apr2023.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand=Other, vaccine brand other=Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Sep2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 04Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Mar2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 06Apr2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 02Sep2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Heart condition" (unspecified if ongoing), notes: Heart condition. Concomitant medication(s) included: LIPITOR, start date: 01Aug2008, stop date: 27Mar2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Sep2022 at 12:00, outcome "unknown", described as "vaccine brand=Other, vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. COVID symptoms returned 4 days after completion of antiviral medication. Tested positive for COVID. Symptoms include fever, runny nose.  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: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: acute COVID; acute COVID; This is a spontaneous report received from a contactable reporter(s) (Physician). 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 12Nov2022 as dose 5 (booster), single (Lot number: GH9697) at the age of 67 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: "Inflammatory proctitis" (unspecified if ongoing); "Known allergies: Sulpha" (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 Mar2023, outcome "not recovered" and all described as "acute COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Apr2023) Positive, notes: 3 days after first negative test; (Mar2023) Positive; (Apr2023) Negative, notes: day 8. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 29Mar2023 to 03Apr2023.  Clinical course: Had acute COVID, and became negative day8 and symptoms resolved. Symptoms returned 3 days after first negative test and antigen test became positive again.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Age: 34.0
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 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 34 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 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 Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Positive; (01Apr2023) Positive, notes: Previous positive test was on Saturday, 01Apr; (03Apr2023) Negative, notes: A negative test was performed on Monday, 03Apr and again on Wednesday 05Apr; (05Apr2023) Negative, notes: A negative test was performed on Monday, 03Apr and again on Wednesday 05Apr. Therapeutic measures were taken as a result of drug ineffective, 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.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Dec2022 as dose 4 (booster), single (Lot number: GL0446) at the age of 22 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: "Lupus" (unspecified if ongoing), notes: Other medical history: Lupus, immunocompromised; "immunocompromised" (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 25Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Mar2023) Positive, notes: first tested positive on 25Mar2023; (30Mar2023) Negative, notes: I tested negative the following day (30Mar2023); (02Apr2023) Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: She had a rebound. She had symptoms starting on 24Mar2023, first tested positive on 25Mar2023, started Paxlovid that day, finished 29Mar2023. She tested negative the following day (30Mar2023). Two days later, on the night of 01Apr2023, she started feeling sick again. She woke up the next morning and tested positive again.
Age: 64.0
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 (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose number unknown (booster), single (Lot number: GJ6665) at the age of 64 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 included: "Known allergies: penicillins" (unspecified if ongoing); "Known allergies: tree nuts" (unspecified if ongoing). Concomitant medication included: ESTRADIOL, start date: Dec2014, stop date: Apr2023. Past drug history included: Toradol, reaction: "Known allergies: Toradol". 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: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 29Mar2023 to 03Apr2023. Clinical course: The patient's symptoms had abated on Day 5 with end of Paxlovid course and felt recovered on morning of Day 9, but by afternoon runny nose developed.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 35 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Dec2021 as dose 3 (booster), single (Lot number: FJ8762) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Feb2021 as dose 1, single (Lot number: 041L20A) and on 27Mar2021 as dose 2, single (Lot number: 031A21A) 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 "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: The patient is treated with Paxlovid for covid-19 from 29Mar2023 to 03April2023. Patient had a bitter taste in her mouth the entire time she took Paxlovid. She also had diarrhea intermittently.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 2, 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, single; manufacturer unknown), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headaches". Additional information: The reporter (patient's spouse) stated that her husband (patient) has headaches since having the 2nd dose and her husband will not be getting any more.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myelitis transverse
Clinical narrative: Transverse myelitis/idiopathic; This is a literature report for the following literature source(s):   A 39-year-old female patient received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, 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: MYELITIS TRANSVERSE (medically significant) with onset 06Jan2021, outcome "unknown", described as "Transverse myelitis/idiopathic".; Sender's Comments: Based on available information and temporal relationship, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the event Myelitis transverse. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Myelitis transverse
Clinical narrative: Transverse myelitis/idiopathic; This is a literature report.  A 37-year-old female patient received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, 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: MYELITIS TRANSVERSE (medically significant) with onset 27Dec2021, outcome "unknown", described as "Transverse myelitis/idiopathic".; Sender's Comments: Based on the information currently available, a possible contribution of the suspect drug administration to the reported event cannot be excluded, due to a plausible temporal relationship. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article;drug/different patient;
Sex: M
Vaccine: COVID19
Symptoms: CSF test, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Myelitis transverse
Clinical narrative: Transverse Myelitis (idiopathic); This is a literature report.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 17Dec2020 as dose 1, 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: MYELITIS TRANSVERSE (medically significant) with onset 24Dec2020, outcome "unknown", described as "Transverse Myelitis (idiopathic)". The patient underwent the following laboratory tests and procedures: CSF test: Unknown result; Magnetic resonance imaging head: Unknown result; Magnetic resonance imaging spinal: transverse myelitis. Therapeutic measures were taken as a result of myelitis transverse.  Clinical course: Tingling in both hands following 1st dose. After 2nd dose, paresthesias in feet, weakness in left arm and both legs. Difficulty climbing ladder and fell in his home. Underwent L3-4 fusion, but paresthesia and weakness worsened. Uncontrolled twitching in both thighs and loss of function of left hand. Improved on corticosteroid therapy.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Transverse myelitis and the use of suspect product BNT162b2  cannot be fully excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article;drug/different patient;
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Lumbar puncture, Magnetic resonance imaging, Multiple sclerosis, Myelitis transverse
Clinical narrative: multiple sclerosis; Transverse Myelitis; seizures; This is a literature report.  A 34-year-old female patient received BNT162b2 (BNT162B2), on 06Jan2021 as dose 1, 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: SEIZURE (medically significant) with onset 25Jan2021, outcome "unknown", described as "seizures"; MYELITIS TRANSVERSE (medically significant) with onset 05Feb2021, outcome "unknown", described as "Transverse Myelitis"; MULTIPLE SCLEROSIS (medically significant), outcome "unknown".  Adverse event summary: new onset seizures starting 25Jan2021. Dx transverse myelitis on 05Feb2021 and, later, multiple sclerosis with an atypical presentation. Diagnosis was reported as multiple sclerosis. The patient underwent the following laboratory tests and procedures: Blood test: Unknown result; Lumbar puncture: Unknown result, notes: twice; Magnetic resonance imaging: Unknown result.  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 and temporal relationship, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and all events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article/ drug/event and different patient;
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: multiple sclerosis; Transverse Myelitis; seizures; This is a literature report.  A 34-year-old female patient received BNT162b2 (BNT162B2), on 06Jan2021 as dose 1, 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: SEIZURE (medically significant) with onset 25Jan2021, outcome "unknown", described as "seizures"; MYELITIS TRANSVERSE (medically significant) with onset 05Feb2021, outcome "unknown", described as "Transverse Myelitis"; MULTIPLE SCLEROSIS (medically significant), outcome "unknown".  Adverse event summary: new onset seizures starting 25Jan2021. Dx transverse myelitis on 05Feb2021 and, later, multiple sclerosis with an atypical presentation. Diagnosis was reported as multiple sclerosis. The patient underwent the following laboratory tests and procedures: Blood test: Unknown result; Lumbar puncture: Unknown result, notes: twice; Magnetic resonance imaging: Unknown result.  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 and temporal relationship, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and all events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article/ drug/event and different patient;
Sex: M
Vaccine: COVID19
Symptoms: Myelitis transverse
Clinical narrative: idiopathic Transverse Myelitis; This is a literature report.  A male patient received BNT162b2 (BNT162B2), on 01Jan2021 as dose 1, 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: MYELITIS TRANSVERSE (medically significant), outcome "recovering", described as "idiopathic Transverse Myelitis". Therapeutic measures were taken as a result of myelitis transverse. Clinical courses: the patient experienced left side numb, gait unsteady, left hand dysfunction over weeks. Treated with corticosteroids with recovery. Diagnosed as idiopathic.  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 causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the event Myelitis transverse. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article/drug, similar event and different patient;
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging spinal, Myelitis transverse
Clinical narrative: idiopathic transverse myelitis; This is a literature report. This is a literature report based on a Health Authority database analysis.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, 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: MYELITIS TRANSVERSE (medically significant) with onset 10Jan2021, outcome "unknown", described as "idiopathic transverse myelitis". Adverse event summary reported as left side numb three days after vaccination in the left arm; right side weak three days after 2nd vaccine (unknown manufacturer) injected in the right arm. Diagnosed as idiopathic transverse myelitis. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging spinal: T2 signal abnormalities.  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 and temporal relationship, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the event Myelitis transverse. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article/ drug/event and different patient;
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging spinal, Myelitis transverse
Clinical narrative: idiopathic Transverse Myelitis; This is a literature report for the following literature source(s):   A 71-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2, administration date: 12Feb2021, for COVID-19 immunisation. The following information was reported: MYELITIS TRANSVERSE (medically significant) with onset 05Mar2021, outcome "unknown", described as "idiopathic Transverse Myelitis". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging spinal: Normal. Clinical courses: Headache, cramping after 2nd injection; chills, fatigue, leg pain and difficulty walking by the second day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of event transverse myelitis  cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article/drug, similar event and different patient;
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Gait disturbance, Headache, Magnetic resonance imaging spinal normal
Clinical narrative: idiopathic Transverse Myelitis; This is a literature report for the following literature source(s):   A 71-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2, administration date: 12Feb2021, for COVID-19 immunisation. The following information was reported: MYELITIS TRANSVERSE (medically significant) with onset 05Mar2021, outcome "unknown", described as "idiopathic Transverse Myelitis". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging spinal: Normal. Clinical courses: Headache, cramping after 2nd injection; chills, fatigue, leg pain and difficulty walking by the second day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of event transverse myelitis  cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article/drug, similar event and different patient;