chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: her feel hot; like it she was closed in and claustrophobic; couldn't get air.; made her feel crazy; nauseated; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Jul2022 as dose 4 (booster), single (Lot number: FL3198) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious) with onset 2022, outcome "unknown", described as "couldn't get air."; FEELING HOT (non-serious) with onset 2022, outcome "unknown", described as "her feel hot"; CLAUSTROPHOBIA (non-serious) with onset 2022, outcome "unknown", described as "like it she was closed in and claustrophobic"; FEELING ABNORMAL (non-serious) with onset 2022, outcome "recovered", described as "made her feel crazy"; NAUSEA (non-serious) with onset 2022, outcome "unknown", described as "nauseated". The event "made her feel crazy" required emergency room visit. Therapeutic measures were taken as a result of nausea.  Additional information: The last shot she got made her feel crazy. The last Covid shot made her feel hot and like it she was closed in and claustrophobic. Felt like she couldn't ride in car and couldn't get air. That is why she hasn't got the next one.  When LOT queried caller states vaccine card says Pfizer Biontech FL3198. She was about to jump out of the car. It was making her crazy. Caller was at hospital within an hour for how she was feeling. She sat in emergency room for so long she just left. That feeling of crazy went away a month or so after the vaccine. Caller guesses it leaves the system. In the morning she felt nauseated and had to take ginger it was not a good feeling.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400026296 same patient,  same drug, same dose, different event;
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Claustrophobia, Dyspnoea, Feeling abnormal, Feeling hot, Nausea
Clinical narrative: her feel hot; like it she was closed in and claustrophobic; couldn't get air.; made her feel crazy; nauseated; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Jul2022 as dose 4 (booster), single (Lot number: FL3198) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious) with onset 2022, outcome "unknown", described as "couldn't get air."; FEELING HOT (non-serious) with onset 2022, outcome "unknown", described as "her feel hot"; CLAUSTROPHOBIA (non-serious) with onset 2022, outcome "unknown", described as "like it she was closed in and claustrophobic"; FEELING ABNORMAL (non-serious) with onset 2022, outcome "recovered", described as "made her feel crazy"; NAUSEA (non-serious) with onset 2022, outcome "unknown", described as "nauseated". The event "made her feel crazy" required emergency room visit. Therapeutic measures were taken as a result of nausea.  Additional information: The last shot she got made her feel crazy. The last Covid shot made her feel hot and like it she was closed in and claustrophobic. Felt like she couldn't ride in car and couldn't get air. That is why she hasn't got the next one.  When LOT queried caller states vaccine card says Pfizer Biontech FL3198. She was about to jump out of the car. It was making her crazy. Caller was at hospital within an hour for how she was feeling. She sat in emergency room for so long she just left. That feeling of crazy went away a month or so after the vaccine. Caller guesses it leaves the system. In the morning she felt nauseated and had to take ginger it was not a good feeling.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400026296 same patient,  same drug, same dose, different event;
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 59-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "prediabetes" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid treatment start date: 16Jan2024, stop date: 20Jan2024) were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events Vaccination failure and COVID-19 cannot be ruled out.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 38-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Mar2023 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "complete thyroidectomy", start date: Aug2014 (not ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 04Aug2014, stop date: 27Jan2024. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2024, 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 06Jan2024 to 10Jan2024. Clinical course: Patient was administered as dose number unknown (booster), single at 2:00 pm.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Pfizer - Dose Number: 5; Moderna - Dose Number: 4; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 5 (booster), single (Lot number: gh9693) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Mar2021 as dose 1, single (Lot number: 036a21a), in left arm, on 16Apr2021 as dose 2, single (Lot number: 026b21a), in left arm, on 08Dec2021 as dose 3 (booster), single (Lot number: 033h21a), in left arm and on 26Apr2022 as dose 4 (booster), single (Lot number: 001m21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: many food allergies" (unspecified if ongoing), notes: Known allergies: many food allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Oct2022, outcome "recovered", described as "Pfizer - Dose Number: 5; Moderna - Dose Number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" (Jan2024) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Positive, notes: then 5 day round of Paxlovid; (Jan2024) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes paxlovid from 17Jan2024 to 21Jan2024.  No follow-up attempts are possible.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Pfizer/BioNTech Dose Number: 5 /Moderna Dose Number: 6; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: Gh9702) at the age of 54 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Feb2021 as dose 1, single (Lot number: 030m20a), on 07Mar2021 as dose 2, single (Lot number: 036a21a), on 22Oct2021 as dose 3 (booster), single (Lot number: 017f21a), on 08May2023 as dose 6 (booster), single (Lot number: As7185b) and on 15Sep2023 as dose 7 (booster), single (Lot number: 3030368) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PRAVASTATIN, start date: 02Jul2018; LOSARTAN, start date: 03Aug2020; ADDERALL, start date: 01Jun2021; WEGOVY, start date: 10Jul2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Pfizer/BioNTech Dose Number: 5 /Moderna Dose Number: 6". Therapeutic measures (Paxlovid treatment start date: 15Jan2024, stop date: 20Jan2024) were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 51-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). The patient's concomitant medications were not reported. 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 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 12Jan2024 to 17Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 61.0
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 Nurse.  A 62-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "HLD/hyperlipidemia" (unspecified if ongoing); "PAF" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient had no known allergies. 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 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 18Jan2024 to 23Jan2024. Clinical course: Took 5 days of Paxlovid for symptomatic COVID with positive rapid home test. Began feeling well after 2nd day, felt nearly normal after 4th day, felt normal 5th day and 2 days after last dose.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events Vaccination failure and COVID-19 cannot be ruled out.
Age: 54.0
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 Consumer or other non HCP.  A 54-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 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing). Concomitant medication(s) included: OXCARBAZEPINE, start date: 01Jun2020. Vaccination history included: moderna COVID -19 vaccine (DOSE 1, SINGLE, Anatomical location: Right arm), administration date: 11Mar2021, when the patient was 51-year-old, for COVID-19 immunisation; moderna COVID -19 vaccine (DOSE 2, SINGLE, Anatomical location: Right arm), administration date: 03Apr2021, when the patient was 51-year-old, for COVID-19 immunisation; moderna COVID -19 vaccine (DOSE 3 (BOOSTER), SINGLE, Anatomical location: Right arm), administration date: 03Nov2021, when the patient was 52-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Anatomical location: Right arm), administration date: 01Apr2022, when the patient was 52-year-old, for COVID-19 immunisation. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, 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 17Jan2024 to 21Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: he is positive for COVID; he is positive for COVID; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 72-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 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: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), administration date: Aug2023, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Jan2024, outcome "not recovered" and all described as "he is positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jan2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. He was prescribed Paxlovid as treatment.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 32-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid treatment from 13Jan2024 to 17Jan2024).
Sex: M
Vaccine: 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 Consumer or other non HCP.  A 36-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Anatomical Location: Left arm), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE, Anatomical Location: Right arm), for COVID-19 immunisation. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" (23Jan2024) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jan2024) Negative; (25Jan2024) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 15Jan2024 to 21Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from an Other HCP.  A 55-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Jan2024 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in left arm 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. Th patient had no Known allergies. Vaccination history included: Bnt162b2 (Dose number unknown, single), for COVID-19 immunisation; Covid-19 vaccine (Dose number unknown, manufacturer unknown), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 17Jan2024 to 22Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events Vaccination failure and COVID-19 cannot be ruled out.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination failure; Covid-19; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Malarone, reaction(s): "Drug Allergies: Malarone"; Synvisc one, reaction(s): "Drug Allergies: Synvisc One". 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. The following information was reported: COVID-19 (medically significant) with onset Jan2024, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset Jan2024, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 19Jan2024 to 24Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Rebound COVID-19 infection after completion of Paxlovid series.; Treatment of COVID-19; Pfizer Dose Number: 4/ Moderna  Dose Number: 3; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Sep2023 at 11:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Jun2022 at 11:30 as dose 3 (booster), single), in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. Patient had no known allergies. 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 04Sep2023 at 11:30, outcome "unknown", described as "Pfizer Dose Number: 4/ Moderna  Dose Number: 3"; DRUG INEFFECTIVE (medically significant) with onset Jan2024, outcome "unknown", described as "Rebound COVID-19 infection after completion of Paxlovid series."; COVID-19 (medically significant) with onset Jan2024, outcome "unknown", described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 16Jan2024 to 20Jan2024.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 77.0
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 a Consumer or other non HCP.  A 77-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Nov2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "CAD 3 stents" (unspecified if ongoing); "CAD 3 stents" (not ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: latex" (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 Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 15Jan2024 to 20Jan2024.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old male patient received BNT162b2 (BNT162B2 NOS), on 21Oct2022 as dose nunber unknown, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Theophylline, reaction(s): "Drug allergy; theophylline". Patient received unspecified vaccine on 02Nov2023 in right arm. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures including Paxlovid from 04Jan2024 to 08Jan2024 were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 29.0
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 Consumer or other non HCP.  A 30-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 as dose 1, single (Lot number: HG2649) at the age of 29 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, lot number: GH9702), administration date: 20Sep2022, when the patient was 28-year-old, for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" (Jan2024) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Negative, notes: following end of paxlovid treatment /negative test. Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 20Jan2024 to 24Jan2024.  No follow-up attempts are possible.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19/Drug ineffective; Treatment of COVID-19/COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Sep2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 22Nov2022 as dose 2, single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "History of asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient had no known allergies. The following information was reported: COVID-19 (medically significant) with onset Jan2024, outcome "recovered" (Jan2024), described as "Treatment of COVID-19/COVID-19"; DRUG INEFFECTIVE (medically significant) with onset Jan2024, outcome "recovered" (Jan2024), described as "Treatment of COVID-19/Drug ineffective". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 17Jan2024 to 22Jan2024.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400026891 same patient/Vaccine, different dose/events (Dose 2);
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Nurse.  A 67-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 at 12:00 as dose 1 (toppac), single (Lot number: HG4628) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "alopecia" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). The patient had no known allergy. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE , Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE , Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE , Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE , Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE , Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 16Jan2024 to 21Jan2024.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Covid 19; Covid 19; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 31Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing); "early stage 2 ckd" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" and all described as "Covid 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 25Dec2023 to 29Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and 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 Consumer or other non HCP.  A 72-year-old male 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. Patient had no known allergies. 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" (Jan2024) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Negative. Therapeutic measures (Paxlovid treatment start date: 13Jan2024, stop date: 18Jan2024) were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; Covid-19; This is a spontaneous report received from a Pharmacist.  A 29-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 29 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Patient did not have known allergies. 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. The following information was reported: COVID-19 (medically significant) with onset Jan2024, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Jan2024, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid from 18Jan2024 to 22Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The efficacy of a vaccine varies individually and can be affected by different factors. However, a contributory role of BNT162b2 omi xbb.1.5 to the events Drug ineffective and Covid-19 cannot be ruled out.
Sex: F
Vaccine: 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 Consumer or other non HCP.  A 69-year-old female patient (not pregnant) 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 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" (Jan2024) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Negative, notes: took Paxlovid and completed round and tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 17Jan2024 to 22Jan2024.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 84.0
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 Consumer or other non HCP.  An 84-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 as dose 1, single (Lot number: HD9876) at the age of 84 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "removal of cancerous tumor in colon", start date: 01Sep2023 (not ongoing), notes: Have been recovering (very well); "cancerous tumor in colon" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" (Jan2024) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 21Jan2024 to 25Jan2024.
Sex: M
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 Consumer or other non HCP.  A 79-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "BPH" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "heart attack", start date: 12May2023 (unspecified if ongoing). Concomitant medication(s) included: FINASTERIDE, start date: 02Aug2012; ALFUZOSIN, start date: 02Jan2018, stop date: 18Jan2024; TADALAFIL, start date: 18Jan2018; MULTIVITAMIN [VITAMINS NOS], start date: 10Oct2018; CYANOCOBALAMIN, start date: 17May2023; MAGNESIUM OXIDE, start date: 03Aug2023. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical location: Left arm), administration date: 02Feb2021, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE), administration date: 26Sep2021, for COVID-19 immunisation; BNT162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 08Oct2022, for COVID-19 immunisation. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" (Jan2024) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Negative, notes: day 7; (Jan2024) Negative, notes: day 8. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 18Jan2024 to 23Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 70.0
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 Consumer or other non HCP.  A 71-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "TB" (unspecified if ongoing); "Lyme disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna (DOSE 1, SINGLE , Batch/Lot No: 043L20A), administration date: 04Feb2021, when the patient was 68-year-old, for COVID-19 immunisation; moderna (DOSE 2, SINGLE , Batch/Lot No: 023m20a), administration date: 03Mar2021, when the patient was 68-year-old, for COVID-19 immunisation; moderna (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: 030h21b, Anatomical Location: Arm Left), administration date: 30Nov2021, when the patient was 69-year-old, for COVID-19 immunisation; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: 6h903, Anatomical Location: Arm Left), administration date: 10Dec2022, when the patient was 70-year-old, for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 13Jan2024 to 18Jan2024. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and 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 Consumer or other non HCP.  A 39-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Long COVID" (unspecified if ongoing). The patient's concomitant medications were not reported. 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 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" (Jan2024) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Negative, notes: Positive Covid test after initially testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 18Jan2024 to 23Jan2024.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 67.0
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 an Other HCP.  A 67-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Controlled hypertension" (unspecified if ongoing); "bronchial asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. 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. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" (Jan2024) and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 10Jan2024 to 15Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events Vaccination failure and COVID-19 cannot be ruled out.
Age: 34.0
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 a Consumer or other non HCP.  A 34-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Oct2023 as dose 1 (toppac), single (Lot number: HG4664) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes, Type 2" (unspecified if ongoing). The patient had no known allergy. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer unknown,), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for Covid-19 immunization. The following information was reported: 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 with Paxlovid from 18Jan2024 to 23Jan2024.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna Dose Number 4; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Jul2022 as dose 4 (booster), single), in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Gillian Barre syndrome at age 22" (unspecified if ongoing). Patient had no known allergies. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Nov2022, outcome "recovered", described as "Moderna Dose Number 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" (Jan2024) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Negative, notes: testing negative for 3 days in a row. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes paxlovid from 18Jan2024 till 22Jan2024.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 37 years 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 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 15Jan2024 to 20Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.