chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 32 years for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". 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 with Paxlovid from 24Dec2022 to 28Dec2022.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech Dose Number: 3, Moderna Dose Number: 2; 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 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 40 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Apr2020 as dose 1, single (Lot number: 025B21A), in left arm and on 04May2020 as dose 2, single (Lot number: 006C21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "bipolar disorder" (unspecified if ongoing); "subclinical hypothyroidism" (unspecified if ongoing); "Antidepressant therapy" (unspecified if ongoing), notes: Other medication in 2weeks product=Antidepressant; "Mood stabiliser" (unspecified if ongoing), notes: Other medication in 2weeks product=Moodstabilizer. Concomitant medication(s) included: WELLBUTRIN taken for antidepressant therapy, start date: Feb2002; PRISTIQ taken for antidepressant therapy, start date: Jan2013; LAMICTAL taken for affective disorder, start date: Sep2004. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Dec2021, outcome "unknown", described as "Pfizer / BioNTech Dose Number: 3, Moderna Dose Number: 2"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid for COVID 19 Treatment from 24Dec2022 to 28Dec2022.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: 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 male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 5 (booster), single (Lot number: GJ6665) at the age of 66 years, in left arm for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 26May2022 as dose 4 (booster), single (Lot number: 037A22B), in left arm for covid-19 immunization; 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. Concomitant medication(s) included: SERTRALINE [SERTRALINE HYDROCHLORIDE], start date: 01Jan2022. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown"; COVID-19 (medically significant) with onset 2022, outcome "unknown", described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Oct2022, outcome "unknown", described as "Interchange of vaccine administered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (26Dec2022) Negative; (28Dec2022) Negative; (31Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment details Anti-viral details: product COVID 19 Treatment, brand Paxlovid, treatment start date 19Dec2022, treatment stop date 23Dec2022, indication Treatment of COVID-19.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Lot number: Gh9694) at the age of 41 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Dec2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2023) Positive, notes: positive antigen test occured on 01Jan2023; (20Dec2022) Positive, notes: twelve days after the initial day 0 for a positive Covid diagnosis using an at home antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300000696 Same patient, different product and event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient. A 34-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 and no known allergies. 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 "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 which included Paxlovid from 24Dec2022 to 30Dec2022. Then the patient had rebound symptoms on 31Dec2022 once she stopped Paxlovid. No treatment was received.   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: As there is limited information in the case provided, the causal association between the reported events with the suspect drugs BNT162B2 and BNT162b2, BNT162b2 omi ba.4-5 cannot be excluded. The case will be reassessed once new information is available.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) 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), 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: "Hyperlipidemia" (unspecified if ongoing); "asthma" (unspecified if ongoing); "highncholestrol" (unspecified if ongoing), notes: other medical history: highncholestrol. Concomitant medication(s) included: LIPITOR, start date: Jan2012; LANSOPRAZOLE, start date: Jan2012. Past drug history included: Ibuprofen, reaction(s): "known allergies Ibuprofen", notes: known allergies: Ibuprofen. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (unspecified date) positive, notes: COVID 19 Treatment; (02Jan2023) positive, notes: positive antibody test. Therapeutic measures 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2020 as dose 1, single (Batch/Lot number: unknown), in right arm, in Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm, in Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm, in Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm and in Aug2022 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sjogren's Syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine"; Augmentin, reaction(s): "Known allergies: augmentin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details indicated that COVID 19 Treatment was given from 22Dec2022 to 27Dec2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19, 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 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 12:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 64 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 included: "MAC" (unspecified if ongoing); "Known allergies: Noacin" (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. From 13Dec2022 to 18Dec2022, patient received Paxlovid for COVID-19 treatment.  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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 04Mar2021 as dose 2, single (Lot number: EN6199), in left arm, on 16Aug2021 as dose 3 (booster), single (Lot number: FA7485), in left arm and on 06Apr2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "hyperthyroidism" (unspecified if ongoing); "Hashimoto's disease" (unspecified if ongoing); "allergy to antibiotics" (unspecified if ongoing). The patient took concomitant medications which included medications for blood pressure and thyroid. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), all described as "COVID 19 Treatment". Therapeutic measures (paxlovid) were taken as a result of vaccination failure, covid-19. Outcome of the events was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid 19 Treatment; Covid 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). 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 08Oct2022 at 14:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 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) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SPIRONOLACTONE, start date: 10Dec2007. Past drug history included: Sentra, reaction(s): "Known allergies: Sentra", notes: Known allergies: Sentra; Minocycline, reaction(s): "Known allergies: Minocycline", notes: Known allergies: Minocycline. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Covid 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Negative, notes: Rebound of Covid 19 2 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 as patient received Paxlovid treatment on 21Dec2022 to 25Dec2022.  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 the information given in narrative, the causal relationship between the reported events  Drug ineffective and COVID 19 and the suspect drug BNT162B2 cannot be excluded.
Age: 67.0
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; Pfizer 4 th dose: 15Apr2022/ Moderna 5 th dose: 09Sep2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Oct2021 as dose 3 (booster), single (Lot number: FF2593), in right arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 67 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Jan2021 as dose 1, single (Lot number: 032L2dA), in right arm, on 27Feb2021 as dose 2, single (Lot number: 022M2dA), in right arm and on 09Sep2022 as dose 5 (booster), single (Lot number: AS7145B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "mild asthma" (unspecified if ongoing); "lumpectomy for breast cancer Jan2019", start date: Jan2019 (unspecified if ongoing), notes: lumpectomy for breast cancer Jan2019; "Known allergies: Sulfa drugs" (unspecified if ongoing); "lumpectomy for breast cancer Jan2019", start date: Jan2019 (unspecified if ongoing), notes: lumpectomy for breast cancer Jan2019. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Pfizer 4 th dose: 15Apr2022/ Moderna 5 th dose: 09Sep2022". Patient first felt ill the evening of 15Dec22. Presented with strong gastrointestinal symptoms and the following day, started having a runny nose and cough. Tested negative 2x until Monday, 19Dec when patient tested positive at home. Patient called the doctor and put her on Paxlovid starting that evening. All symptoms were completely gone after the first 2 doses of Paxlovid. Patient felt great during the entire 5 days. However, the day following last dose (24Dec), nose began running again, and upper respiratory symptoms all came back including a cough. On the 5th day after completing treatment (29Dec), again was Covid positive. It was now 02Jan2023 and cold symptoms are still not improving. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (unspecified date) negative, notes: Tested negative 2x until Monday; (unspecified date) negative, notes: Tested negative 2x until Monday; (19Dec2022) Positive, notes: 19Dec when I tested positive at home; (29Dec2022) Positive, notes: On the 5th day after completing treatment (29Dec), I again was Covid positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Did you/the patient previously receive a COVID-19 Vaccine?: Yes; COVID rebound; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 75 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart attack", start date: 2016 (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; HYDROCHLOROTHIAZIDE; METFORMIN; TRULICITY; ATORVASTATIN, stop date: 22Dec2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes"; COVID-19 (medically significant), outcome "unknown", described as "COVID rebound". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid was used for Covid-19 treatment. Treatment start date was 22Dec2022 and treatment stop date was 27Dec2022. Patient had received other medications in two weeks.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose 1, 2, 3 of BNT162B2 and Dose 4: Moderna Vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 16Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Jun2022 as dose 4 (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: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Jun2022, outcome "not recovered", described as "Dose 1, 2, 3 of BNT162B2 and Dose 4: Moderna Vaccine"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Dec2022) Negative, notes: Negative COVID test 26Dec2022; (29Dec2022) Positive, notes: Positive COVID test and return of symptoms 29Dec2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient took Paxlovid as treatment, start date was 20Dec2022 and stop date was 25Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events interchange of vaccine products, vaccination failure , COVID 19 and the suspect drug BNT162B2 cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, COVID-19, Drug ineffective, Influenza virus test, Oxygen saturation
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 15:00 as dose 5 (booster), single (Lot number: GJ5342) at the age of 70 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EL3248), in left arm, on 15Mar2021 as dose 2, single (Lot number: EN6205), in left arm, on 03Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 05Apr2022 as dose 4 (booster), single (Lot number: FM0698), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "pre diabetic" (unspecified if ongoing); "fatty liver" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR, start date: 01Jan2018; PRINIVIL, start date: 01Jan2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Blood cholesterol: (unspecified date) high; Influenza virus test: (unspecified date) Negative, notes: Flu swab negative; Oxygen saturation: (unspecified date) remained normal throughout; SARS-CoV-2 test: (unspecified date) Positive; (25Dec2022) Negative, notes: Took 5 days of Paxlovid, last dose am of 25Dec. Tested negative that evening; (28Dec2022) Positive, notes: Tested mildly positive on 28Dec; (30Dec2022) Positive, notes: Tested positive at Dr(s) office on 30Dec22, fatigue, chills, sx; (31Dec2022) Positive, notes: Symptoms worsened over next few days, tested strong positive on 31Dec. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid on 20Dec2022 to 25Dec2022. Clinical course: the patient had other medication in 2 weeks which includes Lisinopril, and Rosuvastatin. She has no known allergies.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 15:00 as dose 5 (booster), single (Lot number: GJ5342) at the age of 70 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EL3248), in left arm, on 15Mar2021 as dose 2, single (Lot number: EN6205), in left arm, on 03Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 05Apr2022 as dose 4 (booster), single (Lot number: FM0698), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "pre diabetic" (unspecified if ongoing); "fatty liver" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR, start date: 01Jan2018; PRINIVIL, start date: 01Jan2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Blood cholesterol: (unspecified date) high; Influenza virus test: (unspecified date) Negative, notes: Flu swab negative; Oxygen saturation: (unspecified date) remained normal throughout; SARS-CoV-2 test: (unspecified date) Positive; (25Dec2022) Negative, notes: Took 5 days of Paxlovid, last dose am of 25Dec. Tested negative that evening; (28Dec2022) Positive, notes: Tested mildly positive on 28Dec; (30Dec2022) Positive, notes: Tested positive at Dr(s) office on 30Dec22, fatigue, chills, sx; (31Dec2022) Positive, notes: Symptoms worsened over next few days, tested strong positive on 31Dec. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid on 20Dec2022 to 25Dec2022. Clinical course: the patient had other medication in 2 weeks which includes Lisinopril, and Rosuvastatin. She has no known allergies.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable consumer. 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 12Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Dec2022, outcome "recovered" (29Dec2022) and all described as "Positive COVID-19 test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Dec2022) Positive; (29Dec2022) Negative. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included ritonavir/ nirmatrelvir from 20Dec2022 to 24Dec2022.  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: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from 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), on 11Sep2022 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), 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 included: "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), outcome "not recovered" and all described as "COVID 19". 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 (paxlovid)  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 29Mar2021 as dose 2, single (Lot number: EP6955), in left arm, on 29Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 04May2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "IBS/IBD" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN, start date: Jan2010; CYMBALTA, start date: Jan2018; TROKENDI XR, start date: Jan2012; OMEPRAZOLE, start date: Apr2012; FISH OIL, start date: Jan2018; MAGNESIUM, start date: Jan2018; ALIGN, start date: Jan2000.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment/tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (21Dec2022) Positive, notes: 1st tested positive 21Dec with symptoms; (24Dec2022) negative, notes: Tested negative on 24Dec; (31Dec2022) Positive, notes: 31Dec - Tested positive again; (02Jan2023) Positive, notes: 02Jan still positive. Therapeutic measures were taken 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.
Age: 51.0
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) (Physician). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Lot number: EK5730), in left arm, on 11Jan2021 as dose 2, single (Lot number: ELO142), in left arm and on 19Sep2021 as dose 3 (booster), single (Lot number: 301358a) at the age of 51 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Sep2022 as dose 4 (booster), single (Lot number: AS7163B), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESTRADIOL, start date: 01Apr2021; VIT D3, start date: 01Apr2021. Past drug history included: Bactrim, reaction(s): "Known Allergy: Bactrim". 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, which includes: Mucinex and Paxlovid.  Clinical course: The reporter was the patient herself.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. 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.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 75 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 was not reported. Concomitant medication(s) included: SYNTHROID; LOSARTAN. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.  Clinical course: It was reported that patient had Other medications in two weeks (Synthroid, Losartan). Patient was treated for covid-19 with Paxlovid.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 16Nov2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Contrast dye" (unspecified if ongoing), notes: known allergies: Contrast dye. 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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Encephalitis, Mental status changes
Clinical narrative: Encephalitis; Sudden onset altered mental statues; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team and a sales representative.  An 82-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: ENCEPHALITIS (medically significant), outcome "unknown"; MENTAL STATUS CHANGES (non-serious), outcome "unknown", described as "Sudden onset altered mental statues".  Clinical course: Age 82 otherwise fully functioning. Event took place after use of product.  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 the temporal relation, the association between the event of encephalitis and the suspect product cannot be completely ruled out.  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.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Moderna/Dose number 4; 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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2021 at 10:30 as dose 1, single (Lot number: EL3247), in left arm, on 20Feb2021 at 15:00 as dose 2, single (Lot number: EN6201), in right arm and on 31Dec2021 at 15:00 as dose 3 (booster), single (Lot number: FF8841) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Sep2022 at 09:45 as dose 4 (booster), single (Lot number: 054A22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mitro Valve prolapse" (unspecified if ongoing), notes: Mitro Valve prolapse; "Known allergies: Opioids" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL, start date: 17Jun2020. Past drug history included: Macrobid, reaction(s): "Known allergies: Macrobid", notes: Macrobid. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Sep2022 at 09:45, outcome "unknown", described as "Moderna/Dose number 4". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Dec2022) Negative, notes: Tested negative on the 1st day and 3rd day after completing the Paxlovid; (30Dec2022) Negative, notes: Tested negative on the 1st day and 3rd day after completing the Paxlovid; (02Jan2023) Positive, notes: I tested and was positive for COVID once again. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient was treated with Paxlovid from 23Dec2022 to 28Dec2022. Patient took other medication in 2 weeks.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Oropharyngeal pain
Clinical narrative: Suddenly sick; Sore throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2022US285221_OS (Novartis).  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Kidney Disease Stage 3B" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 2022, outcome "unknown", described as "Sore throat"; MALAISE (non-serious) with onset 2022, outcome "unknown", described as "Suddenly sick".  Additional information: Patient had all Covid vaccines, including the 5th booster. Patient received 5th booster on 14Nov2022, and then took monthly injection on 30Nov and was suddenly sick. The next day, patient developed a sore throat and on 03Dec2022 tested positive for Covid. Patient Covid was fairly bad with a high fever. On Covid Day 4, Patient received a half-dose of Paxlovid, as the patient also has Kidney Disease Stage 3B. Patient started feeling better on Covid Day 10 and tested negative on Day 11 and Day 12. On Day 13 patient began to feel badly again and tested positive for Covid.  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: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Suddenly sick; Sore throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2022US285221_OS (Novartis).  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Kidney Disease Stage 3B" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 2022, outcome "unknown", described as "Sore throat"; MALAISE (non-serious) with onset 2022, outcome "unknown", described as "Suddenly sick".  Additional information: Patient had all Covid vaccines, including the 5th booster. Patient received 5th booster on 14Nov2022, and then took monthly injection on 30Nov and was suddenly sick. The next day, patient developed a sore throat and on 03Dec2022 tested positive for Covid. Patient Covid was fairly bad with a high fever. On Covid Day 4, Patient received a half-dose of Paxlovid, as the patient also has Kidney Disease Stage 3B. Patient started feeling better on Covid Day 10 and tested negative on Day 11 and Day 12. On Day 13 patient began to feel badly again and tested positive for Covid.  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: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Oropharyngeal pain
Clinical narrative: had all Covid vaccines, including the 5th booster/All vaccines were Pfizer/ tested positive for Covid; had all Covid vaccines, including the 5th booster/All vaccines were Pfizer/ tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2022US285221_OS.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 75 years for COVID-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Kidney Disease Stage 3B" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Dec2022, outcome "not recovered" and all described as "had all Covid vaccines, including the 5th booster/All vaccines were Pfizer/ tested positive for Covid". The patient underwent the following laboratory tests and procedures: Covid-19 test: (unspecified date) Positive, notes: On Day 13 patient began to feel badly again and tested positive for Covid; (unspecified date) Negative, notes: tested negative on Day 11 and Day 12; (unspecified date) Negative, notes: tested negative on Day 11 and Day 12; (03Dec2022) Positive, notes: on 03Dec tested positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient is 75 years old and has had all Covid vaccines, including the 5th booster. All vaccines were Pfizer. Patient received 5th booster on 14Nov of this year, and then took monthly injection on 30Nov and was suddenly sick. The next day, patient developed a sore throat and on 03Dec tested positive for Covid. Patient's Covid was fairly bad with a high fever. On Covid Day 4, Patient received a half-dose of Paxlovid, as the patient also has Kidney Disease Stage 3B. Patient started feeling better on Covid Day 10 and tested negative on Day 11 and Day 12. On Day 13 patient began to feel badly again and tested positive for Covid.  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.