chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Decreased appetite, SARS-CoV-2 test, Vaccination failure
Clinical narrative: She had a knee replacement surgery on 03Oct2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Allergy to sulfa" (ongoing), notes: had to do with medication for knee replacement. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Batch/lot number: EP7533), administration date: 01Apr2021, when the patient was 65-year-old, for COVID-19 immunization; BNT162b2 (Dose: 2, Lot: EW0173), administration date: 29Apr2021, when the patient was 65-year-old, for COVID-19 immunization; BNT162b2 (Dose: 3, Lot: FF2593), administration date: 12Nov2021, when the patient was 66-year-old, for COVID-19 immunization; BNT162b2 (Dose: 4, Lot: Either FJ4489 or FJ4989), administration date: 12Apr2022, when the patient was 66-year-old, for COVID-19 immunization. The following information was reported: KNEE ARTHROPLASTY (hospitalization) with onset 03Oct2022, outcome "unknown", described as "She had a knee replacement surgery on 03Oct2022". The patient was hospitalized for knee arthroplasty (start date: 03Oct2022, discharge date: 05Oct2022, hospitalization duration: 3 day(s)). Therapeutic measures were taken as a result of knee arthroplasty. Clinical course included: The product was Comirnaty, Gray cap, Original/Omicron BA.4/BA.5 (Bivalent) She stated she had the Pfizer COVID vaccine in Apr2021 and never had a problem. Then Pfizer recommended that 5 months later it was recommended to get a booster so she had her boosters (all Pfizer) since 2021 and 2022. The last booster was 17Sep2022 (Lot# could be 6J2524 or GJ2524 but she thinks it is GJ2524 based on how they wrote other 6's on her card). She had a knee replacement surgery on 03Oct2022 and they were putting her in a nursing home after for 2 weeks because she had no help at home. Her doctor told them to stay home because this is a major surgery and she did exactly what he said. Patient was hospitalized for knee replacement surgery from 03Oct2022 to 05Oct2022 and sent to nursing home after hospital discharge for recovery, due to living situation.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300131331 same patient/drug, different dose number/event;
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Knee arthroplasty
Clinical narrative: She got COVID 19Nov2022 after she got out of the nursing home and it was severe, she could hardly eat, it was devastating.; She got COVID 19Nov2022 after she got out of the nursing home and it was severe, she could hardly eat, it was devastating.; could hardly eat; This is a spontaneous report received from contactable reporter (Consumer) from medical information team and product quality group. The reporter is the patient.  A 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 66 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: EP7533), on 29Apr2021 as dose 2, single (Lot number: EW0173), on 12Nov2021 as dose 3 (booster), single (Lot number: FF2593) and on 12Apr2022 as dose 4 (booster), single (Lot number: FJ4989) for covid-19 immunisation. The patient's relevant medical history included: "Allergy to sulfa", start date: 21Oct2022 (ongoing). The patient's concomitant medications were not reported. The patient reported that she got COVID 19Nov2022 after she got out of the nursing home and it was severe, she could hardly eat, it was devastating. She should have gone to hospital, she couldn't see her HCP and couldn't get anything done because they told her not to come into the office. She stated it scares her how bad off she got and that was even with the booster. The COVID was miserable, I can't tell you how terrible, it was not cool, it took 3 months for her to get better to start eating normally, it was devastating and stated she knows how bad it was. It was very scary. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she tested positive after she took the vaccine. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300130714 same patient/drug, different dose number/event;
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Decreased appetite, SARS-CoV-2 test, Vaccination failure
Clinical narrative: She got COVID 19Nov2022 after she got out of the nursing home and it was severe, she could hardly eat, it was devastating.; She got COVID 19Nov2022 after she got out of the nursing home and it was severe, she could hardly eat, it was devastating.; could hardly eat; This is a spontaneous report received from contactable reporter (Consumer) from medical information team and product quality group. The reporter is the patient.  A 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 66 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: EP7533), on 29Apr2021 as dose 2, single (Lot number: EW0173), on 12Nov2021 as dose 3 (booster), single (Lot number: FF2593) and on 12Apr2022 as dose 4 (booster), single (Lot number: FJ4989) for covid-19 immunisation. The patient's relevant medical history included: "Allergy to sulfa", start date: 21Oct2022 (ongoing). The patient's concomitant medications were not reported. The patient reported that she got COVID 19Nov2022 after she got out of the nursing home and it was severe, she could hardly eat, it was devastating. She should have gone to hospital, she couldn't see her HCP and couldn't get anything done because they told her not to come into the office. She stated it scares her how bad off she got and that was even with the booster. The COVID was miserable, I can't tell you how terrible, it was not cool, it took 3 months for her to get better to start eating normally, it was devastating and stated she knows how bad it was. It was very scary. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she tested positive after she took the vaccine. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300130714 same patient/drug, different dose number/event;
Age: 60.0
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 (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 18Oct2022 as dose 5 (booster), single (Lot number: AJ6739) at the age of 60 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: "Psoriatic arthritis" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Crohn's" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: sulfa. The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim"; Metformin, reaction(s): "Known allergies: Metformin". 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 included Paxlovid from 10Mar2023 to 14Mar2023.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 56 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: FP4554) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "high triglycerides" (unspecified if ongoing), notes: high triglycerides; "Known allergies:Mollusks" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Neosporin, reaction(s): "Known allergies: Neosporin". 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Mar2023) Negative, notes: On the evenings of 20Mar and 22Mar, at-home tests had shown negative results and patient had no symptoms; (22Mar2023) Negative, notes: On the evenings of 20Mar and 22Mar, at-home tests had shown negative results and patient had no symptoms; (23Mar2023) Positive, notes: Two at-home tests on the evening of 23Mar showed positive results for COVID-19; (23Mar2023) Positive, notes: Two at-home tests on the evening of 23Mar showed positive results for COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 10Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm and on 09Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Elevated cholesterol" (unspecified if ongoing). Concomitant medication(s) included: CIALIS, start date: Sep2022; ROSUVASTATIN, start date: May2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Positive; (15Mar2023) Positive; (20Mar2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Paxlovid.  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.
Age: 52.0
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). The reporter is the patient. A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Negative, notes: I tested negative on day 7 (of having COVID); (Mar2023) Positive, notes: I'm testing positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 13Mar2023 to 18Mar2023. Additional information: patient has no known allergies.  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: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: She received her first dose of the Moderna COVID-19 vaccines, bivalent, on 20Mar2023; Had COVID-19 in Dec2022; Had COVID-19 in Dec2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD-2023-716765 (Moderna).  A 68-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 20Mar2023 as dose 1 (booster), single (Batch/Lot number: unknown) for covid-19 prophylaxis. The patient's relevant medical history included: "bipolar disorder" (unspecified if ongoing), notes: Hx of bipolar disorder. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Had COVID-19 in Dec2022"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Mar2023, outcome "unknown", described as "She received her first dose of the Moderna COVID-19 vaccines, bivalent, on 20Mar2023".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2 NOS), on 04May2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", 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.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300130846 same patient, different drug/events;
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Dose 5: Pfizer/BioNTech; Dose 4: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 69 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Apr2022 as dose 4 (booster), single (Lot number: 001M21A), 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: "Generalized anxiety disorder" (unspecified if ongoing); "panic disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tramadol, reaction(s): "known allergies: Tramadol". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Sep2022, outcome "unknown", described as "Dose 5: Pfizer/BioNTech; Dose 4: Moderna"; 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 and COVID-19 and included treatment with PF-07321332/RItonvir (PAXLOVID).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 at 14:00 as dose 5 (booster), single (Lot number: GJ3277) at the age of 74 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 06Feb2021 at 10:00 as dose 1, single (Lot number: 004M20A), in left arm, on 06Mar2021 at 10:00 as dose 2, single (Lot number: 013A21A), in left arm, on 26Oct2021 at 17:00 as dose 3 (booster), single (Lot number: 017F21A), in left arm and on 21Apr2022 at 16:00 as dose 4 (booster), single (Lot number: 057M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "Allergy to sulfa" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 16Jan2017; HCTZ, start date: 16Jan2017; ATENOLOL, start date: 16Jan2017; TERAZOSIN, start date: 13May2020; GABAPENTIN, start date: 12May2022, stop date: 12May2022; JARDIANCE, start date: 12May2022, stop date: 12May2022; AMITRIPTYLINE, start date: 04Jan2010; TURMERIC [CURCUMA LONGA RHIZOME], start date: 16Jan2017; CINNAMON, start date: 12May2022. Past drug history included: Norvasc, reaction(s): "drug allergy"; Clonidine patch, reaction(s): "drug allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Oct2022, outcome "unknown"; COVID-19 (medically significant) with onset 16Mar2023, outcome "not recovered"; DRUG INEFFECTIVE (medically significant) with onset 16Mar2023, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Mar2023) Positive; (26Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Adverse Event: Covid symptoms 14Mar2023, tested positive 16Mar2023, Paxlovid 150-100 16Mar2023 -20Mar2023. Felt good, no symptoms 19Mar2023. On 24Mar2023, had Covid symptoms again; runny nose, sneezing, congested, tested positive 26Mar2023. Covid rebound symptoms not as severe as original Covid, also no fever and fatigue with rebound.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300130848 same patient different drug /event;
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as DOSE 5 (BOOSTER), SINGLE (batch/lot number: unknown) at the age of 74 years old 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), as DOSE 3 (BOOSTER), SINGLE (batch/lot number: unknown) and as DOSE 4 (BOOSTER), SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "high BP" (unspecified if ongoing), notes: Other medical conditions. The patient had no known allergies. 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, notes: COVID-19 Treatment. 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: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Nov2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 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: "High blood pressure" (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 "unknown" and all described as "COVID-19". 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.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing). Allergies were not known. Concomitant medication(s) included: EXEMESTANE, start date: 01Nov2022, stop date: 25Mar2023. 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, notes: after stopping tested positive and had covid 19 symptoms again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Pfizer COVID 19 treatment was received from 06Mar2023 to 11Mar2023. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
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 non-contactable reporter (Consumer). The reporter is the patient.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 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: "Type 1 Diabetes" (unspecified if ongoing), notes: other medical history: Type 1 Diabetes; "Hypertension" (unspecified if ongoing), notes: other medical history: Hypertension; "Kidney Disease" (unspecified if ongoing), notes: other medical history: Kidney Disease; "Anemia" (unspecified if ongoing), notes: other medical history: Anemia; "Gastroparesis" (unspecified if ongoing), notes: other medical history: Gastroparesis. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (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, notes: after 2 days. Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine_brand_other=Moderna, Vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Lot number: Gh9703) at the age of 65 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Apr2022 as dose 4 (booster), single (Lot number: Fj4989) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Feb2021 as dose 1, single (Lot number: 031mzoa), on 23Mar2021 as dose 2, single (Lot number: 030a21a) and on 10Nov2021 as dose 3 (booster), single (Lot number: 034F21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "Known allergies: Sulpha" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Apr2022, outcome "unknown", described as "Vaccine_brand_other=Moderna, Vaccine brand=Pfizer / BioNTech"; 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 included Paxlovid (COVID 19 Treatment) from 15Mar2023 to 19Mar2023.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 46-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Childhood asthma" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Facial nerve pain" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medications included: PREGABALIN; CLONAZEPAM, stop date: 14Mar2023. Past drug history included: Wellbutrin, reaction: "Known allergies: Wellbutrin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 15Mar2023 to 19Mar2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 14:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "asthma" (unspecified if ongoing). 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". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 08Mar2023 to 13Mar2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure. 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. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 10:30 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 69 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), 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); "hypothyroid" (unspecified if ongoing); "Latex sensitivity" (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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Mar2023) Positive, notes: First Positive (home test) Wed 15Mar2023 am; (18Mar2023) Positive, notes: faint positive; (21Mar2023) Negative; (23Mar2023) Negative; (25Mar2023) Positive, notes: strongly. 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Dose 1,2,3: Moderna and Dose 4: Pfizer; 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 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), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Chronic fatigue syndrome" (unspecified if ongoing); "Chronic migraines" (unspecified if ongoing); "herpes simplex type ii" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Known allergies: Corn (mild)" (unspecified if ongoing). Concomitant medication(s) included: NORTRIPTYLINE, start date: 01Jan2013; CYMBALTA, start date: 01Jan2014; VERAPAMIL, start date: 01Jan2015; CLONIDINE, start date: 01Dec2022, stop date: 18Mar2023; MIRTAZAPINE, start date: 01Oct2017, stop date: 18Mar2023; NEUPRO, start date: 01Jan2015. 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"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose 1,2,3: Moderna and Dose 4: Pfizer". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 19Mar2023.  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: 64.0
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; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 13Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 26Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Jun2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Mar2023) Positive; (08Mar2023) Negative; (10Mar2023) Positive, notes: weak positive sign; (16Mar2023) Positive; (18Mar2023) Negative; (22Mar2023) Negative. 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: 68.0
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) (Physician). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2 NOS), on 06Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient had no known allergies. 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 which included paxlovid received from 11Mar2023 to 15Mar2023.  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 available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Vaccine dose number=4; Pfizer/ Vaccine dose number=5; Moderna; COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer). The reporter is the patient. A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right arm for COVID-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 16Sep2022 at 11:00 as dose 5 (booster), single (Batch/Lot number: unknown), in right 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 immunization. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: codeine".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Vaccine dose number=4; Pfizer/ Vaccine dose number=5; Moderna". Therapeutic measures were taken as a result of drug ineffective and COVID-19. Clinical information: It was reported that the patient had COVID-19 in 2023 and received PAXLOVID as treatment from 28Feb2023 until 04Mar2023.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Aug2022 as dose 5 (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) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. 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. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had mild symptoms, tested positive, started Paxlovid for COVID-19 Treatment from 14Mar2023 to 18Mar2023.  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: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Jan2023 as dose 4 (booster), single (Lot number: GJ3274) at the age of 34 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), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 18Mar2023 to 23Mar2023 as Treatment of COVID-19.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and COvid-19 are  related to BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) cannot be excluded.  This case will be reassessed should additional information become available.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer- 22Oct2021/ Moderna- 18Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 at 13:00 as dose 1, single (Lot number: El3248), in left arm, on 12Feb2021 at 13:00 as dose 2, single (Lot number: El3249), in left arm and on 22Oct2021 at 13:00 as dose 3 (booster), single (Lot number: Ff2590) at the age of 76 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Apr2022 at 13:00 as dose 4 (booster), single (Lot number: Ouzm21A), in left arm and on 21Sep2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Iodine dye" (unspecified if ongoing); "Known allergies: NSAIDS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Apr2022 at 13:00, outcome "unknown", described as "Pfizer- 22Oct2021/ Moderna- 18Apr2022"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received Paxlovid from 13Mar2023 to 20Mar2023 for treatment of COVID-19. On 26Mar2023 at 13:00 pm, ten days after negative test, chills and aches, positive test.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown), 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), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken with Paxlovid from 13Mar2023 to 18Mar2023 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.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: GH9894) at the age of 35 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "anxiety/depression" (unspecified if ongoing); "anxiety/depression" (unspecified if ongoing); "adhd" (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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.