chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, FLUX
Symptoms: COVID-19
Clinical narrative: Contracted Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Contracted Covid) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Contracted Covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) in December 2023 at an unspecified dose and frequency. At the time of the report, COVID-19 (Contracted Covid) outcome was unknown.            Concomitant medication was not provided.  Patient took Paxlovid by December and she had to wait 3 months from completion of Paxlovid to get the Booster shot. Patient took all Moderna vaccines that were required. She did not have last booster because had to have some procedures using steroid injections. She wanted to get Moderna again.
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Muscle disorder
Clinical narrative: Vaccine recipient described that after the first COVID vaccine (approximately spring 2021) she experienced muscle issues, and that after the booster (approximately December 2021) it got much worse and affected her mobility; Vaccine recipient described that after the first COVID vaccine (approximately spring 2021) she experienced muscle issues, and that after the booster (approximately December 2021) it got much worse and affected her mobility; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE DISORDER (Vaccine recipient described that after the first COVID vaccine (approximately spring 2021) she experienced muscle issues, and that after the booster (approximately December 2021) it got much worse and affected her mobility) and MOVEMENT DISORDER (Vaccine recipient described that after the first COVID vaccine (approximately spring 2021) she experienced muscle issues, and that after the booster (approximately December 2021) it got much worse and affected her mobility) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     She stated that she has a pre-existing autoimmune disease.  Concurrent medical conditions included Autoimmune disorder.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In 2021, the patient experienced MUSCLE DISORDER (Vaccine recipient described that after the first COVID vaccine (approximately spring 2021) she experienced muscle issues, and that after the booster (approximately December 2021) it got much worse and affected her mobility) and MOVEMENT DISORDER (Vaccine recipient described that after the first COVID vaccine (approximately spring 2021) she experienced muscle issues, and that after the booster (approximately December 2021) it got much worse and affected her mobility). At the time of the report, MUSCLE DISORDER (Vaccine recipient described that after the first COVID vaccine (approximately spring 2021) she experienced muscle issues, and that after the booster (approximately December 2021) it got much worse and affected her mobility) and MOVEMENT DISORDER (Vaccine recipient described that after the first COVID vaccine (approximately spring 2021) she experienced muscle issues, and that after the booster (approximately December 2021) it got much worse and affected her mobility) outcome was unknown.            No concomitant and treatment medication were provided
Age: 46.0
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 46-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 46 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient had not known allergies. The patient's 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. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "recovered" (Feb2024) and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was given nirmatrelvir, ritonavir (PAXLOVID) as treatment of COVID-19 starting on 01Feb2024 until 07Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 64.0
Sex: F
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 65-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Afib" (unspecified if ongoing); "Diabeties" (unspecified if ongoing). The patient had not known allergies. The patient's 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. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was given nirmatrelvir, ritonavir (PAXLOVID) as treatment of COVID-19 starting on 01Feb2024 until 06Feb2024. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Physician.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single) and as dose 4 (booster), single) 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 2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 03Feb2024 to 08Feb2024.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported event Drug ineffective , COVID-19  cannot be excluded.
Age: 75.0
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 from product quality group.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Apr2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 75 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Jan2021 as dose 1 , single (Lot number: 042L20A), in left arm, on 27Feb2021 as dose 2, single (Lot number: 002A21A), in left arm and on 17Nov2021 as dose 3 (booster), single (Lot number: 065F21A), 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 5 (booster), single (Lot number: AS7172B), in left arm for covid-19 immunisation; elasomeran (SPIKEVAX), on 20Oct2023 as dose 6 (booster), single), in left arm 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 2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient took anti viral treatment for covid-19 from 04Feb2024 to 08Feb2024.
Age: 69.0
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 an Other HCP.  A 70-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "kidney stones" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Septra, reaction(s): "Drug allergy". 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 2024, outcome "recovered" (05Feb2024) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Feb2024) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 02Feb2024 to 07Feb2024.  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: Based on the information provided, a causal relationship between the suspected drug and the reported events Vaccination failure , COVID-19 cannot be excluded.
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 Physician.  A 67-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Chronic microscopic colitis" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Recurrent syncope" (unspecified if ongoing); "known allergies: Adhesive tape" (unspecified if ongoing); "known allergies: skin reaction" (unspecified if ongoing). Concomitant medication(s) included: TOPIRAMATE, start date: 06Feb2019; BUDESONIDE, start date: 06Feb2019; LOMAIRA, start date: 06Feb2019; LEVOTHYROXINE. Vaccination history included: COVID-19 vaccine (DOSE 6 (BOOSTER); MANUFACTURER UNKNOWN), administration date: 09Aug2023, when the patient was 67-year-old, for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Anatomical location=Left arm), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE, Anatomical location=Left arm), for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), 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 2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 02Feb2024 to 06Feb2024.  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: Based on the information provided, a causal relationship between the suspected drug and the reported events Vaccination failure , COVID-19 cannot be excluded.
Age: 49.0
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 a Consumer or other non HCP.  A 49-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose 1 , single (Batch/Lot number: unknown) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune hepatitis" (unspecified if ongoing); "Allergy: sulfa antibiotics" (unspecified if ongoing). Concomitant medication(s) included: BUDESONIDE, start date: 17Dec2016. Past drug history included: Codeine, reaction(s): "Allergy". 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; Covid-19 vaccine (DOSE 6 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Jan2024, outcome "recovered" (03Feb2024) and all described as "COVID-19". The clinical course was reported as follows: The patient started nirmatrelvir, ritonavir (PAXLOVID) as treatment of COVID-19 on day 1 (30Jan2024) after testing, until 04Feb2024. Had moderate symptoms from day 1-3. On day 5 (03Feb2024) the patient felt fine, no symptoms, negative antigen test. The patient underwent laboratory tests and procedures as aforementioned. Therapeutic measures 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.
Age: 53.0
Sex: F
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 54-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 as dose 1, single (Lot number: HG4665) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Colitis ulcerative" (unspecified if ongoing). Concomitant medication(s) included: LIALDA. Vaccination history included: pfizer / biontech (DOSE NUMBER UNKNOWN; lot number: GJ6743; in left arm), administration date: 05Jun2023, when the patient was 53-year-old, for COVID-19 immunization; Typhoid vaccine, for Typhoid immunisation, reaction(s): "known allergies"; Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received PAXLOVID as directed for COVID-19 treatment from 05Feb2024 to 09Feb2024.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400042620 Same patient, different drug and event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Maternal exposure timing unspecified
Clinical narrative: Pregnant; COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 31-year-old female patient (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 had no relevant medical history. The patient had no known allergies. The patient is expected to deliver a baby(s) on 26May2024. Concomitant medication(s) included: TYLENOL. 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "not recovered" and all described as "COVID-19"; MATERNAL EXPOSURE TIMING UNSPECIFIED (non-serious), outcome "unknown", described as "Pregnant". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received PAXLOVID as COVID-19 treatment from 05Feb2024 to 10Feb2024  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-202400042663 Same patient, different drug and event;
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 46-year-old female patient received BNT162b2 (BNT162B2), on 29Nov2023 as dose 5 (booster), single (Lot number: FM9992) at the age of 45 years, in left arm for covid-19 immunisation; BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (Lot number: GJ5342), 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: "Rheumatoid arthritis" (unspecified if ongoing); "known allergies: iodine" (unspecified if ongoing); "known allergies: Bees" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 30Jan2024 to 04Feb2024.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400043230 same patient/drug, different dose/events;
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 an Other HCP.  A 33-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown), 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. The patient's relevant medical history included: "Gallstone pancreatitis" (unspecified if ongoing); "gallbladder surgery" (unspecified if ongoing); "sepsis" (unspecified if ongoing); "Known allergies: NSAIDS" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing); "Known allergies: banana" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Feb2024) Negative, notes: Tested negative Day 2 and Day 4 after taking Paxlovid; (07Feb2024) Negative, notes: Tested negative Day 2 and Day 4 after taking Paxlovid; (09Feb2024) Positive, notes: Tested positive Day 6 after taking Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 04Feb2024 to 09Feb2024 as treatment of 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 causal association of reported drug ineffectiveness in relation to suspected vaccine BNT162b2 omi xbb.1.5  cannot be totally excluded based on observe clinical outcome after vaccine administration. Case is for reassessment once new information becomes available.
Age: 50.0
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 Consumer or other non HCP.  A 51-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (DOSE 4 (BOOSTER),SINGLE), administration date: 08Apr2023, when the patient was 50-year-old, for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 04Feb2024 to 09Feb2024.  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: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Nurse.  A 29-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 29 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penicillin" (unspecified if ongoing). 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 08Feb2024 to 13Feb2024.  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 causal association of reported drug ineffectiveness and COVID 19 I relation to suspected vaccine BNT162b2 omi xbb.1.5  cannot be totally excluded based on observed clinical outcome after vaccine administration. Case will be reassess once new information becomes available.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Sep2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Sulfar allergy" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: Jan2023, stop date: 12Feb2024; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: Feb2008, stop date: 12Feb2024. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 for which paxlovid treatment was taken from 13Feb2024 and 15Feb2024.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
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 Consumer or other non HCP.  An 88-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Oct2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: DULOXETINE, start date: 01Feb2019, stop date: 16Feb2024. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "recovered" (Feb2024) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2024) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 07Feb2024 to 12Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 64.0
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 64-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: moderna COVID-19 vaccine (Dose 1, single, Batch/Lot No: 025B21A), administration date: 17Mar2021, when the patient was 61-year-old, for Covid-19 immunization; moderna COVID-19 vaccine (Dose 2, single, Batch/Lot No: 025B21A), administration date: 14Apr2021, when the patient was 61-year-old, for Covid-19 immunization; moderna COVID-19 vaccine (Dose 3 (Booster), single, Batch/Lot No: 013f21A), administration date: 02Dec2021, when the patient was 62-year-old, for Covid-19 immunization; moderna COVID-19 vaccine (Dose 4 (Booster), single, Batch/Lot No: 016B22A), administration date: 13Jul2022, when the patient was 62-year-old, for Covid-19 immunization; BNT162b2, BNT162b2 omi ba.4-5 (Dose 5 (Booster), single, Batch/Lot No: GH9697), administration date: 01Nov2022, when the patient was 63-year-old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Paxlovid from 04Feb2024 to 08Feb2024. Clinical course: The 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: PNC20
Symptoms: Arthralgia, Blood test normal, Pain
Clinical narrative: chronic, diffuse joint pain; This is a spontaneous report received from a Physician from a sales representative and medical information team.  A male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (disability) with onset Sep2023, outcome "not recovered", described as "chronic, diffuse joint pain". The patient underwent the following laboratory tests and procedures: Blood test: clear. It was unknown if therapeutic measures were taken as a result of arthralgia.  Clinical course: Reported as, After Prevnar 20 vaccination in Sep2023 patient has complained to (withheld) of chronic, diffuse joint pain that wasn't a problem before vaccination. (withheld) reports clear bloodwork and an otherwise healthy patient. Adverse event start date: Sep2023 and resulted in: [Disability or permanent damage].  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: Based on known drug safety profile, the event arthralgia is assessed as related to the suspect drug pneumococcal 20-val conj vac. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Physician.  A 76-year-old female patient (not pregnant) 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: "Hypothyroidism" (unspecified if ongoing), notes: other medical history: hypothyroidism. The patient's 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (07Feb2024) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid (Oral) started on 05Feb2024 and stopped on 06Feb2024.  Clinical information: Patient had no known allergy. Patient received vaccine. Patient tested negative on 07Feb2024. Symptom free until 16Feb2024. Now COVID positive.  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 drug varies from patient to patient and can be affected by varied factors; however, a contributory role of the suspect product to the reported Drug ineffective and COVID-19 cannot be ruled out.
Age: 64.0
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 64-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Oct2023 at 17:45 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Barrett's sophomore" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "Allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Levoquin, reaction(s): "Allergies: Levoquin". Vaccination history included: BNT162b2 (Dose 1, single, Vaccine administration time: 11:00 AM, Vaccine location: Left arm), administration date: 10Feb2021, when the patient was 61-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2, single, Vaccine administration time: 02:00 PM, Vaccine location: Left arm), administration date: 25Mar2021, when the patient was 61-year-old, for COVID-19 Immunization; BNT162b2 (Dose 3 (booster), single, Vaccine administration time: 05:45 PM, Vaccine location: Left arm), administration date: 28Nov2021, when the patient was 62-year-old, for COVID-19 Immunization; BNT162b2;BNT162b2 omi ba.4-5 (Dose 4 (booster), single, Vaccine administration time: 05:45 PM, Vaccine location: Left arm), administration date: 20Oct2022, when the patient was 63-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received Paxlovid from 08Feb2024 to 13Feb2024 for the treatment of 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: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 40-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose number unknown (booster), single (Lot number: GJ3277) at the age of 39 years, in right 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: "High blood pressure" (unspecified if ongoing); "Type 2 diabetic" (unspecified if ongoing); "HIV (Human Immunodeficiency Virus)-1" (unspecified if ongoing). Patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "recovered" (Feb2024) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2024) Negative. Therapeutic measures were taken as a result of drug ineffective, Covid-19 with Paxlovid from 06Feb2024 to 11Feb2024.  No follow-up attempts are possible.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Physician.  A 32-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose1 unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose2 unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose3 unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19, treatment was Paxlovid from 07Feb2024 to 11Feb2024.  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: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccination failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Age: 68.0
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 69-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Dec2023 at 11:30 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Light Chain Amyloidosis" (unspecified if ongoing); "known allergies: Yes" (unspecified if ongoing). The patient's 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. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Paxlovid received from 07Feb2024 to 12Feb2024 for the treatment of 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: 57.0
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 58-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 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: "asthma" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (booster); unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (booster); unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 5 (booster); unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Paxlovid received from 07Feb2024 to 11Feb2024 for the treatment of COVID-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 79.0
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 Physician.  A 79-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "mild hypertension" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN, start date: 11Oct2023; AMLODIPINE BESYLATE, start date: 12Dec2023. Past drug history included: Lisinopril, reaction(s): "Allergy"; Lyrica, reaction(s): "Allergy"; Hydrochlorothiazide, reaction(s): "Allergy". 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 2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient previously received a COVID-19 Vaccine. Patient received Paxlovid (Batch/lot number: HK3277) from 03Feb2024 to 07Feb2024 for treatment of 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 drug varies from patient to patient and can be affected by varied factors; however, a contributory role of the suspect product to the reported Vaccination failure / COVID-19 cannot be ruled out.
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 Consumer or other non HCP.  A 57-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's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures 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: 52.0
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 53-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Dec2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "ocular shingles" (unspecified if ongoing), notes: Tx (treatment) for ocular shingles 1+ yr from acute; "Breast cancer", start date: Dec2020 (unspecified if ongoing), notes: breast cancer Dec2020. The patient's concomitant medications were not reported. Past drug history included: Neosporin, reaction(s): "Known allergies:Neosporin", notes: Known allergies: Neosporin products. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Paxlovid (LOT: GK9346) received from 06Feb2024 to 11Feb2024 for the treatment of 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; Vaccine brand other=Moderna/ vaccine brand=Pfizer/BioNTech; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 17:00 as dose 5 (booster), single (Lot number: GH9702) at the age of 55 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Jan2021 as dose 1, single (Lot number: 012120A), in left arm, on 11Feb2021 as dose 2, single (Lot number: 016M204), in left arm, on 26Nov2021 as dose 3 (booster), single (Lot number: 034F21A), in left arm and on 27Apr2022 at 17:00 as dose 4 (booster), single (Lot number: 056M21A), in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), on 09Oct2023 at 17:00 as dose 6 (booster), single), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa drugs (bactrum, septrum), tetracycline" (unspecified if ongoing). Concomitant medication(s) included: CONCERTA, start date: 03Jan2022, stop date: 18Feb2024; CALCIUM, start date: 03Jan2022, stop date: 18Feb2024; MULTIVITAMIN [VITAMINS NOS], start date: 03Jan2022, stop date: 18Feb2024. The patient also took other concomitant therapy. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Sep2022 at 17:00, outcome "unknown", described as "Vaccine brand other=Moderna/ vaccine brand=Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Other medication in 2 weeks included nature's Sunshine.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Physician.  A 72-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 at 13:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. No known allergy. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Feb2024, outcome "unknown" and all described as "COVID-19 ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Feb2024) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 including paxlovid.  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: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccination failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.