chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 59-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Nov2023 at 16:30 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diagnosed with Epstein Barr", start date: 1987 (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: PROGESTERONE, start date: 01May2009; ESTRADIOL, start date: 15Jan2019. Vaccination history included: janssen covid-19 vaccine (Dose 1, Single, Administration Time: 11:00 am, Anatomical Location: Left Arm), administration date: 27May2020, for COVID-19 immunisation; bnt162b2 (Dose 2 (Booster), Single, Administration Time: 12:00 am, Anatomical Location: Left Arm), administration date: 11May2022, for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Nov2023, outcome "recovered" (18Nov2023) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Nov2023) Positive; (18Nov2023) Negative, notes: symptoms gone. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient tested negative on 18Nov2023 (symptoms gone) after initial positive Covid test (12Nov2023) and beginning Paxlovid treatment. This was her first time Covid infection. Symptoms were mild but similar to initial symptoms of congestion and diarrhea minus fever and body aches. Patient received Paxlovid treatment from 12Nov2023 to 17Nov2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300401046 same reporter/patient, different product/event;
Age: 57.0
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 a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 at 13:15 as dose 1, single (Lot number: HG4659) at the age of 57 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "Illness-induced asthma" (unspecified if ongoing); "Gluten allergy" (unspecified if ongoing); "Dairy allergy" (unspecified if ongoing); "bell peppers allergy" (unspecified if ongoing); "norco allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE), administration date: 20Mar2021, when the patient was 55-year-old, for COVID-19 immunization; bnt162b2 (DOSE 2, SINGLE), administration date: 11Apr2021, when the patient was 55-year-old, for COVID-19 immunization; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, vaccine lot number=30135BA), administration date: 10Oct2021, when the patient was 55-year-old, for COVID-19 immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, vaccine lot number=FM0698,, vaccine location=Left arm), administration date: 24Mar2022, when the patient was 56-year-old, for COVID-19 immunization; moderna (DOSE 5 (BOOSTER), SINGLE, vaccine lot number=049D22A,, vaccine location=Left arm), administration date: 16Oct2022, when the patient was 56-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Sep2023 at 13:15, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) positive, notes: but tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Unknown if patient had other medication in 2weeks; COVID 19 Treatment with Paxlovid, Treatment started on 06Nov2023 and Treatment stop date was 11Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "lung swelling and scarring from pneumonia" (unspecified if ongoing); "lung swelling and scarring from pneumonia" (unspecified if ongoing); "Pneumonia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Anatomical location: Right arm), for covid-19 immunisation; Bnt162b2 (DOSE 2, SINGLE, Anatomical location: Left arm), for covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 13Nov2023 to 17Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300404850 same patient, different drug/AE;
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos" (unspecified if ongoing); "Mango seasonal allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid start date 13Nov2023, stop date 18Nov2023).  The information on the batch/lot number for (BNT162B2 OMI XBB.1.5) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300404822 same patient different drug/ event;
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna/ vaccine brand=Pfizer; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 17Dec2020 as dose 1, single (Lot number: EH9899), in right arm, on 07Jan2021 as dose 2, single (Lot number: EK4176), in right arm and on 12Oct2021 as dose 3 (booster), single (Lot number: ER2613) at the age of 64 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Apr2022 as dose 4 (booster), single (Lot number: 986A22A), in left arm and on 20Oct2022 as dose 5 (booster), single (Lot number: 062P22A), in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 21Apr2023 as dose 6 (booster), single (Lot number: 067H22H), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "DJD" (unspecified if ongoing); "Known allergies: Adhesive" (unspecified if ongoing), notes: Known allergies: Adhesive; "Known allergies: shellfish" (unspecified if ongoing), notes: Known allergies: shellfish. Concomitant medication(s) included: ATORVASTATIN, stop date: 13Nov2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Apr2022, outcome "unknown", described as "vaccine brand other=Moderna/ vaccine brand=Pfizer"; 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: Negative, notes: positive test 48 hours after first negative test; Positive, notes: positive test 48 hours after first negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received paxlovid for COVID 19 treatment. The other medication in 2 weeks was atorvastatin.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Oct2023 at 09:30 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: erythromycin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Time of vaccine administration: 12:00 PM, Batch/Lot number: ER8729), administration date: 06Apr2021, when the patient was 54-year-old, for COVID-19 immunisation; bnt162b2 (DOSE 2, SINGLE, Time of vaccine administration: 12:00 PM, Batch/Lot number: EW0182), administration date: 04May2021, when the patient was 54-year-old, for COVID-19 immunisation; moderna (DOSE 3 (BOOSTER), SINGLE, Time of vaccine administration: 12:00 PM, Batch/Lot number: 066F21A), administration date: 20Nov2021, when the patient was 55-year-old, for COVID-19 immunisation; moderna (DOSE 4 (BOOSTER), SINGLE, Time of vaccine administration: 12:00 PM, Batch/Lot number: 038A22A), administration date: 20May2022, when the patient was 55-year-old, for COVID-19 immunisation; bnt162b2 (DOSE 5 (BOOSTER), SINGLE, Time of vaccine administration: 12:00 PM, Batch/Lot number: GJ6665), administration date: 22Oct2022, when the patient was 56-year-old, for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of Covid-19; (Nov2023) Negative, notes: 2 days following a negative COVID test result. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 13Nov2023 to 17Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300404827 same patient, different drug/ event;
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 67-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had no known allergies. Patient received Paxlovid treatment from 11Nov2023 to 16Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300404916 same reporter/patient, different product/event.;
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Jan2023 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic Arthritis" (unspecified if ongoing); "Sarcoidosis" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing). There were no concomitant medications.  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". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID from 02Nov2023 to 07Nov2023.  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: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 16Nov2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01May2015. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro"; Bactrim, reaction(s): "Known allergies: Bactrim". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: testing positive again; (2023) Negative, notes: after taking Paxlovid and testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID from 13Nov2023 to 18Nov2023.  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, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech/Moderna; COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 11May2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 62 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Jan2021 as dose 1, single (Lot number: 025J20A), in left arm and on 05Feb2021 as dose 2, single (Lot number: 028L20A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: ZESTORETIC, start date: 27Jan2020; MAGNESIUM, start date: 27Jan2020. Past drug history included: Clindamycin, reaction(s): "Allergies". Vaccination history included: Hepatitis b vaccine, for Immunisation, reaction(s): "Allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Nov2023, outcome "recovering" and all described as "COVID 19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Pfizer / BioNTech/Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Nov2023) Positive; (16Nov2023) Negative; (20Nov2023) Positive; (23Nov2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 09Nov2023 to 14Nov2023.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 10Nov2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "allergies to tree nuts" (unspecified if ongoing); "Thyroid cancer" (unspecified if ongoing); "May Thurner syndrome" (unspecified if ongoing); "Sulfa allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Pectin, reaction(s): "allergies"; Cipro, reaction(s): "allergies"; Erythromycin, reaction(s): "allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment form 14Nov2023 to 18Nov2023  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Moderna (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (20Nov2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Nov2023) Negative. Therapeutic measures were taken as a result of drug ineffective, Covid-19 with Paxlovid from 14Nov2023 to 18Nov2023. Clinical course: The patient had no known allergies. Reportedly, symptoms were gone and test was negative on 20Nov2023, minor symptoms returned with positive Covid test on 22Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300405421 same patient, different drug and AE;
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: High heart rate between 110-126 all day while resting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Nov2023 as dose 1, single (Lot number: 00069236210) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: RSV VACCINE taken for immunisation, on 08Nov2023; INFLUENZA VACCINE taken for immunisation, on 25Oct2023; CITALOPRAM. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (dose 2, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (dose 3, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (dose 4, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (dose 5, manufacturer unknown), for COVID-19 immunisation. The following information was reported: HEART RATE INCREASED (non-serious) with onset 23Nov2023 at 05:15, outcome "recovering", described as "High heart rate between 110-126 all day while resting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased.
Age: 59.0
Sex: U
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 contactable reporter(s) (Other HCP). The reporter is the patient.  A 59-year-old patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Nov2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 13Nov2023 to 18Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy (vaccination failure and Covid-19) with the suspect vaccine bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)) in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300405573 Same patient, different drug/event;
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 06Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID from 17Nov2023 to 21Nov2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Oct2023 at 12:15 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 16Nov2023 to 21Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300405782 same reporter/patient, different product/AE;
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine dose number=6; vaccine brand other=Moderna/ vaccine dose number=1 to vaccine dose number=5; vaccine brand=Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 75 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 03May2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EN5318), in left arm, on 24Feb2021 as dose 2, single (Lot number: EN6201), in left arm and on 29Sep2021 as dose 3 (booster), single (Lot number: 30130BA), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Sep2023 as dose 6 (booster), single (Lot number: 8079685) for covid-19 immunisation. The patient's relevant medical history included: "Blood cholesterol increased" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR, stop date: 06Nov2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Sep2023, outcome "unknown", described as "vaccine dose number=6; vaccine brand other=Moderna/ vaccine dose number=1 to vaccine dose number=5; vaccine brand=Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information : The patient received Paxlovid for COVID 19 treatment since 06Nov2023 till 11Nov2023. The other medication in 2 week was crestor.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 1, single (Lot number: HG4629) at the age of 61 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "obesity, over 60" (unspecified if ongoing), notes: over 60. The patient's concomitant medications were not reported. Past drug history included: Nubain, reaction(s): "Known allergies: Nubain", notes: Known allergies: Nubain. Vaccination history included: bnt162b2 (DOSE 1, lot number:EN6208, vaccine location: Left arm), administration date: 11Mar2021, when the patient was 59-year-old, for COVID-19 immunization; bnt162b2 (DOSE 2, lot number:EP1533, vaccine location: Left arm), administration date: 01Apr2021, when the patient was 59-year-old, for COVID-19 immunization; bnt162b2 (DOSE 3, lot number: FG3527, vaccine location: Left arm), administration date: 08Nov2021, when the patient was 59-year-old, for COVID-19 immunization; bnt162b2 (DOSE 4, lot number: FP7138, vaccine location: Left arm), administration date: 11Aug2022, when the patient was 60-year-old, for COVID-19 immunization; bnt162b2, bnt162b2 omi ba.4-5 (DOSE 5, lot number: GH9702, vaccine location: Left arm), administration date: 17Oct2022, when the patient was 60-year-old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 15Apr2021 at 16:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 18Jul2022 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DICYCLOMINE, start date: 01Feb2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: Rebound COVID tested positive; (2023) Negative, notes: testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Rebound Covid tested positive again 3 days after testing negative. Same symptoms runny nose and sore throat but no fever. The event onset date was reported as 11Nov2023 08:00 AM. Patient had other medication in 2 weeks. COVID 19 Treatment with Paxlovid on 13Nov2023 till 18Nov2023. No Known allergies.  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: Erythema, Skin discolouration, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: never had reaction at all to the injection site and this time, it was swollen, slightly painful and itchy for several days; never had reaction at all to the injection site and this time, it was swollen, slightly painful and itchy for several days; never had reaction at all to the injection site and this time, it was swollen, slightly painful and itchy for several days; the swelling has almost gone down but it is still discolored.; the swelling has almost gone down but it is still discolored./And red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, Manufacturer unknown), for COVID-19 immunisation. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE PRURITUS (non-serious), outcome "unknown" and all described as "never had reaction at all to the injection site and this time, it was swollen, slightly painful and itchy for several days"; SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "the swelling has almost gone down but it is still discolored."; ERYTHEMA (non-serious), outcome "unknown", described as "the swelling has almost gone down but it is still discolored./And red".  Additional information: Patient stated "I had the latest COVID shot (Pfizer COVID-19 Vaccine) on the 21st and I have had all my previous injection, never had reaction at all to the injection site and this time, it was swollen, slightly painful and itchy for several days and it is still, it is not so swollen. It is almost, the swelling has almost gone down but it is still discolored."
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand=Pfizer/BioNTech/vaccine brand=Other, vaccine brand other=Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm and in May2021 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "ASCVD (Atherosclerotic cardiovascular disease)" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Aug2022, stop date: 14Nov2023; EZETIMIBE, start date: Mar2023, stop date: 14Nov2023; ESTROGEN, start date: Jul2019, stop date: 14Nov2023; PROGESTERONE, start date: Jul2019, stop date: 14Nov2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Nov2021, outcome "unknown", described as "vaccine brand=Pfizer/BioNTech/vaccine brand=Other, vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received paxlovid treatment since 14Nov2023 till 19Nov2023 for COVID-19. The patient received other medication in 2 weeks.  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: 54.0
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; Vaccine brand other= Moderna; Vaccine brand=Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 54 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Jan2021 as dose 1, single (Lot number: 025L20A), in left arm, on 12Feb2021 as dose 2, single (Lot number: 031M20A), in right arm and on 02Dec2021 as dose 3 (booster), single (Lot number: 045J21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin, Doxicycline" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Sep2022, outcome "recovered", described as "Vaccine brand other= Moderna; Vaccine brand=Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (22Nov2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Nov2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (start date 16Nov2023, stop date 21Nov2023). Clinical course: Tested negative and felt fine on 22Nov2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300409548 same reporter/patient; different drug/AE;
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: barely walk after she got vaccinated with Pfizer booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "barely walk after she got vaccinated with Pfizer booster".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she have had all five Pfizer vaccine; she have had all five Pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 75-year-old female patient received 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Nov2023, outcome "recovering" and all described as "she have had all five Pfizer vaccine". Specifically, it was reported that she had COVID about a week from now. Caller wants to know how soon she can get the updated Pfizer COVID vaccine after recently having COVID. Caller mentions that her COVID symptoms were turned around within 24 hours. Caller added that she came down with it (COVID) on Sunday night, Monday afternoon, and her temperature was at 101 and she started feeling poorly as her fever wouldn't come down. Caller took Paxlovid the next morning and by that evening her temperature was normal, her sinus pressure went away and she is on day 8 after having COVID and the effects were dramatic. Caller states that Paxlovid is a miracle drug. The patient underwent the following laboratory tests and procedures: Body temperature: (Nov2023) 101; SARS-CoV-2 test: (Nov2023) positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Malaise, Pain
Clinical narrative: coughing; aches, pain; tiredness; felt bad, terrible, like he had been run over by a truck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 24Nov2023, outcome "not recovered", described as "aches, pain"; COUGH (non-serious) with onset 24Nov2023, outcome "not recovered", described as "coughing"; MALAISE (non-serious) with onset 24Nov2023, outcome "not recovered", described as "felt bad, terrible, like he had been run over by a truck"; FATIGUE (non-serious) with onset 24Nov2023, outcome "not recovered", described as "tiredness". Additional information: the patient was feeling as bad on 27Nov2023 as he did on 24Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300414160 Same reporter/drug,, similar events, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Menstruation irregular
Clinical narrative: irregular periods ever since / this vaccine has really messed up her menses; Amenorrhea; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "irregular periods ever since / this vaccine has really messed up her menses"; AMENORRHOEA (non-serious), outcome "unknown", described as "Amenorrhea". Additional information: the patient was not overweight.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hot flush, Pyrexia, Rash erythematous
Clinical narrative: chills; light fever; fatigue; hot flashes; itchy, raised, red with light halo rash on arms, legs and torso; itchy, raised, red with light halo rash on arms, legs and torso; itchy, raised, red with light halo rash on arms, legs and torso; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Nov2023 as dose 1, single (Lot number: H69498) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (Dose Number: 1, Batch/Lot No: FM0173, Location of injection: Arm Left), administration date: 02Aug2022, for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 24Nov2023, outcome "recovering"; FATIGUE (non-serious) with onset 24Nov2023, outcome "recovering"; HOT FLUSH (non-serious) with onset 24Nov2023, outcome "recovering", described as "hot flashes"; RASH ERYTHEMATOUS (non-serious), RASH PRURITIC (non-serious), RASH PAPULAR (non-serious) all with onset 24Nov2023, outcome "recovering" and all described as "itchy, raised, red with light halo rash on arms, legs and torso"; PYREXIA (non-serious) with onset 24Nov2023, outcome "recovering", described as "light fever". Therapeutic measures were taken as a result of chills, pyrexia, fatigue, hot flush, rash erythematous, rash pruritic, rash papular.  Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not have been tested for COVID-19. Treatment received for the adverse event included antihistamine.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Rash pruritic
Clinical narrative: chills; light fever; fatigue; hot flashes; itchy, raised, red with light halo rash on arms, legs and torso; itchy, raised, red with light halo rash on arms, legs and torso; itchy, raised, red with light halo rash on arms, legs and torso; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Nov2023 as dose 1, single (Lot number: H69498) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (Dose Number: 1, Batch/Lot No: FM0173, Location of injection: Arm Left), administration date: 02Aug2022, for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 24Nov2023, outcome "recovering"; FATIGUE (non-serious) with onset 24Nov2023, outcome "recovering"; HOT FLUSH (non-serious) with onset 24Nov2023, outcome "recovering", described as "hot flashes"; RASH ERYTHEMATOUS (non-serious), RASH PRURITIC (non-serious), RASH PAPULAR (non-serious) all with onset 24Nov2023, outcome "recovering" and all described as "itchy, raised, red with light halo rash on arms, legs and torso"; PYREXIA (non-serious) with onset 24Nov2023, outcome "recovering", described as "light fever". Therapeutic measures were taken as a result of chills, pyrexia, fatigue, hot flush, rash erythematous, rash pruritic, rash papular.  Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not have been tested for COVID-19. Treatment received for the adverse event included antihistamine.