chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Rebound COVID infection 4 days after finishing 5-day (300mg/100mg 2x/day) Paxlovid course. Mild symptoms so far. Began Paxlovid course one day after testing positive for COVID; Rebound COVID infection 4 days after finishing 5-day (300mg/100mg 2x/day) Paxlovid course. Mild symptoms so far. Began Paxlovid course one day after testing positive for COVID; 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)), on 13Sep2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "No" (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, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 4, manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jan2024, outcome "recovering" and all described as "Rebound COVID infection 4 days after finishing 5-day (300mg/100mg 2x/day) Paxlovid course. Mild symptoms so far. Began Paxlovid course one day after testing positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jan2024) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical information: Patient had no past drug allergies. Began Paxlovid course on 10Jan2024, one day after testing positive for COVID on 09Jan2024, 2 days after initial symptoms.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 62.0
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 62-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. No Known allergies. There were no concomitant medications. 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. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound Covid. 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.
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 from product quality group.  A 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Lot number: HG4628), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 5 (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 3 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19, with Paxlovid from 28Dec2023 to 01Jan2024
Age: 47.0
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 47-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound symptoms and new positive Covid test. Therapeutic measures were taken as a result of vaccination failure, covid-19, with Paxlovid from 09Jan2024 to 14Jan2024. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 53.0
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 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jul2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, 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 and 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.  Clinical information : The patient received the Paxlovid since 08Jan2024 till 13Jan2024 for COVID 19 Treatment. The patient received the vaccine. No other medication in 2 weeks.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Nurse.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 57 years, in right 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: "Known allergies: Wheat" (unspecified if ongoing); "Known allergies: milk" (unspecified if ongoing); "Known allergies: high fructose corn syrup" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I swabbed and was positive for Covid; Negative, notes: The previous week I swabbed twice for work andwas negative for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information : The patient received Paxlovid since 06Jan2024 to 10Jan2024 for the treatment of COVID-19. The patient received the vaccine. No other medication in 2 weeks.   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: 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, COVID-19 cannot be ruled out.
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 52-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Dec2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (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 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: 63.0
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 from product quality group.  A 63-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 at 13:30 as dose 1 (toppac), single (Lot number: HG4659) at the age of 63 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: 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 Jan2024, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Paxlovid (Lot# hg8238) administered from 12Jan2024 to 17Jan2024 for Treatment of COVID-19. No Known allergies. Felt fine until Saturday afternoon, 20Jan, when chills, sore throat, runny nose and mild headache returned, much milder than original symptoms.
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 49-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: "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. Concomitant medication included: WELLBUTRIN, start date: 01Sep2023, stop date: 21Jan2024. Past drug history included: Erythromycin, reaction: "Known allergies: Erythromycin", notes: Known allergies: Erythromycin. Vaccination history included: Covid-19 vaccine (DOSE 1; Unknown Manufacturer), for COVID-19 immunization. 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.  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, 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 52-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 52 years for covid-19 immunisation. The patient's relevant medical history included: "ear infection" (unspecified if ongoing), notes: Taking Augmentin. Concomitant medication(s) included: AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM] taken for ear infection, start date: 26Dec2023, stop date: 02Jan2024. Past drug history included: Rhinocort, reaction(s): "Allergies"; Chlorhexadine, reaction(s): "Allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Rebound of symptoms and positive home test; (18Jan2024) negative, notes: Tested negative on 18Jan; (21Jan2024) Positive, notes: Tested positive again on 21Jan. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 66.0
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 67-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 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: 2015 (unspecified if ongoing); "hypothyroidism" (ongoing); "hypertension" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing); "Allergy: fluoroquinolones" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 10Mar2021, when the patient was 64-year-old, for COVID-19 Immunization; moderna (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 08Apr2021, when the patient was 64-year-old, for COVID-19 immunization; moderna (Dose Number: 3, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 18Aug2021, when the patient was 64-year-old, for COVID-19 Immunization; moderna (Dose Number: 4, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 08Apr2022, when the patient was 65-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jan2024) Positive, notes: Tested positive at home. Daily positive tests still continuing; (11Jan2024) Negetive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was treated with Paxlovid. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 42.0
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. A 43-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Oct2023 as dose 1, single (lot number unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "known allergies: penicillins" (unspecified if ongoing); "depression" (unspecified if ongoing); "HPV" (unspecified if ongoing); "oral herpes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 5 (booster), unknown manufacturer), for covid-19 immunization; Covid-19 vaccine (dose 4 (booster), unknown manufacturer), for covid-19 immunization; Covid-19 vaccine (dose 3 (booster), unknown manufacturer), for covid-19 immunization; Covid-19 vaccine (dose 2, unknown manufacturer), for covid-19 immunization; Covid-19 vaccine (dose 1, unknown manufacturer), for covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid taken from 04Jan2024 to 08Jan2024.  Additional Information: Suspect vaccine dose was reported as "dose 6".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Confusional state, Drug ineffective, Feeding disorder
Clinical narrative: States she has Covid; she has symptoms; fever; shortness of breath; States she has Covid; she has symptoms; fever; shortness of breath; sounds confused; can't eat, she is hungry; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 85-year-old female patient received BNT162b2 (BNT162B2 NOS), in Feb2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "States she has Covid; she has symptoms; fever; shortness of breath"; CONFUSIONAL STATE (non-serious), outcome "unknown", described as "sounds confused"; FEEDING DISORDER (non-serious), outcome "unknown", described as "can't eat, she is hungry". Caller wants to know the COVID 19 symptoms since caller is having fever, caller recalls having the Covid vaccine on Feb2022 and attributes this symptoms to the covid vaccine. During call caller sounds confused and with shortness of breath, states that she wants medical advice, caller keeps asking, "Am I going to die?" and states, "I can't eat" several times. Thinks she has Covid. States she gets flu shot and after they started to say it didn't do it and so 215 Twin 3. Captured as heard on call. Caller states she has symptoms and can't eat, she is hungry. Never get any shots. Flu shots it's a big strapping guys go down. She thinks has it though what are symptoms. States she has Covid and wondering what symptoms are. She took the Pfizer Covid shot. Asked can she get medicine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 70.0
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 70-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 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine"; Codeine, reaction(s): "Known allergies: Codeine". 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The Patient took Paxlovid (Pfizer anti-viral) from 10Jan2024 to 15Jan2024 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: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood pressure measurement, 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 74-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Nov2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "afib" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: TRESIBA; HUMALOG; FINASTERIDE; TAMSULOSIN; BUMEX; POTASSIUM; GABAPENTIN; SIMVASTATIN. Past drug history included: Amoxicillin, reaction(s): "Allergies:amoxicillin", notes: Allergies:amoxicillin. 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: Blood cholesterol: High; Blood pressure measurement: High. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information : The patient received Paxlovid since 11Jan2024 to 15Jan2024 for COVID 19 Treatment. The patient received the vaccine. Other medication in 2 weeks were treseba, humilog, finesteride, tamsolosin, Bumex, Potassium, Gabapentin and simvastatin.  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, 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 53-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose 1, single (Lot number: HD9876) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE;  MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE;  MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE;  MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid from 09Jan2024.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech, dose 1 and 2 then Moderna Dose 3-5; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8730), in left arm and on 19Apr2021 as dose 2, single (Lot number: EW0169) at the age of 34 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Sep2023 as dose 4 (booster), single), on 08Dec2021 as dose 3 (booster), single), in left arm and on 22Sep2023 as dose 5 (booster), single), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: PRISTIQ taken for antidepressant therapy, start date: 08Aug2023; REXULTI taken for antidepressant therapy, start date: 01Nov2023; NOW VITAMIN D3, start date: 01Feb2021. The patient also took other concomitant therapy. Past drug history included: Tetracycline, reaction(s): "Allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Dec2021, outcome "unknown", described as "Pfizer / BioNTech, dose 1 and 2 then Moderna Dose 3-5"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) very bold positive; (Jan2024) very faint; (Jan2024) very faint. Therapeutic measures were taken which was Paxlovid as a result of vaccination failure, covid-19.
Sex: F
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.  An 80-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 had no relevant medical history. Concomitant medication(s) included: LOSARTIN; ATORVASTIN. 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: DRUG INEFFECTIVE (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 drug ineffective, covid-19.  Clinical course: The patient received Anti-viral Paxlovid on an unknown date in Jan2024 for COVID-19. Other medication in 2 weeks were losartan and atorvastin. 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.
Age: 68.0
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 69-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 12:15 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: ACE inhibitors" (unspecified if ongoing); "Known allergies: Tomatoes" (unspecified if ongoing); "Known allergies: Shrimp" (unspecified if ongoing); "known allergies: sulpha meds" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, in Jan2014. 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. 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.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 09:00 as dose 3 (booster), single (Lot number: GJ3277) at the age of 31 years, in right 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: "Adhd combined type" (unspecified if ongoing); "IBS" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid taken from 11Jan2024 to 16Jan2024.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. 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: MYOCARDITIS (hospitalization), outcome "unknown". The patient was hospitalized with myocarditis several days after booster. Therapeutic measures were taken as a result of myocarditis.   The lot number for BNT162b2, BNT162b2 omi ba.4-5, was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: RSV
Symptoms: Abdominal discomfort, Diarrhoea, Exposure during pregnancy, Headache, Myalgia
Clinical narrative: mild muscle aches; headache; GI upset (nausea and diarrhea).; GI upset (nausea and diarrhea).; GI upset (nausea and diarrhea).; This is a spontaneous report received from a Pharmacist. A 34-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 21Jan2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 34 years for immunisation. The patient's relevant medical history was not reported. Date of last menstrual period: Jun2023. The patient was 32 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 16Mar2024. Concomitant medication(s) included: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; FERROUS SULFATE; VITAMIN D [COLECALCIFEROL]; VITAMIN B-12; VITAMIN C [ASCORBIC ACID]; TDAP, on 08Jan2024 as dose number unknown, single. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), DIARRHOEA (non-serious), NAUSEA (non-serious) all with onset 22Jan2024, outcome "recovering" and all described as "GI upset (nausea and diarrhea)."; HEADACHE (non-serious) with onset 22Jan2024, outcome "recovering"; MYALGIA (non-serious) with onset 22Jan2024, outcome "recovering", described as "mild muscle aches". Therapeutic measures were not taken as a result of myalgia, headache, abdominal discomfort, diarrhoea, nausea. Batch/lot number is not provided, and it cannot be obtained.
Age: 34.0
Sex: F
Vaccine: RSV
Symptoms: Nausea
Clinical narrative: mild muscle aches; headache; GI upset (nausea and diarrhea).; GI upset (nausea and diarrhea).; GI upset (nausea and diarrhea).; This is a spontaneous report received from a Pharmacist. A 34-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 21Jan2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 34 years for immunisation. The patient's relevant medical history was not reported. Date of last menstrual period: Jun2023. The patient was 32 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 16Mar2024. Concomitant medication(s) included: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; FERROUS SULFATE; VITAMIN D [COLECALCIFEROL]; VITAMIN B-12; VITAMIN C [ASCORBIC ACID]; TDAP, on 08Jan2024 as dose number unknown, single. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), DIARRHOEA (non-serious), NAUSEA (non-serious) all with onset 22Jan2024, outcome "recovering" and all described as "GI upset (nausea and diarrhea)."; HEADACHE (non-serious) with onset 22Jan2024, outcome "recovering"; MYALGIA (non-serious) with onset 22Jan2024, outcome "recovering", described as "mild muscle aches". Therapeutic measures were not taken as a result of myalgia, headache, abdominal discomfort, diarrhoea, nausea. Batch/lot number is not provided, and it cannot be obtained.
Age: 71.0
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 Consumer or other non HCP.  A 72-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 at 13:15 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "celiacs disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 01, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 02, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 03 (Booster), Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 04 (Booster), Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 05 (Booster), Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 06 (Booster), Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 07 (Booster), Manufacturer Unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient has 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.
Age: 80.0
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. An 81-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), 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 which was treated 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: 48.0
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 an Other HCP.  A 48-year-old male 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 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacture Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Manufacture Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); Manufacture Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); Manufacture Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovering" 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 which was Paxlovid 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: 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: 62.0
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 62-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Dec2023 at 09:00 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history and 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 which included Paxlovid taken from 10Jan2024 to 14Jan2024.  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: Muscle spasms
Clinical narrative: another nurse had to give up her job because of muscle spasms.; This is a spontaneous report received from a Consumer or other non HCP.  A female patient (unknown if 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. The following information was reported: MUSCLE SPASMS (non-serious), outcome "unknown", described as "another nurse had to give up her job because of muscle spasms.".  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: paralyse fully; This is a spontaneous report received from a consumer. A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARALYSIS (medically significant), outcome "unknown", described as "paralyse fully". Clinical course: The reporter stated that the patient who worked in the blood lab was all for taking the shot, now paralyse fully with 2 children.  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: F
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 70-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 06Oct2022 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: "known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 18Jan2024 to 19Jan2024. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 60.0
Sex: M
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 60-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 13:15 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies Pencillin" (unspecified if ongoing); "known allergies Sulfa drugs" (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.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid taken from 18Jan2024 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: 60.0
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 Consumer or other non HCP.  A 63-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Nov2023 as dose 1, 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: "Take prophylactic medicine for gout. Haven't had gout in 6+ years." (unspecified if ongoing). 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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: rapid test line was darkest, notes: rapid test line was darkest. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid taken from 11Jan2024 to 16Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: sx (symptoms) of COVID 12Jan Friday late night then Positive PCR  lucira test 13Jan; sx (symptoms) of COVID 12Jan Friday late night then Positive PCR  lucira test 13Jan; This is a spontaneous report received from a Nurse.  A 44-year-old female patient (unknown if pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Lot number: HF9275) at the age of 44 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, start date: 13Sep2023, stop date: 13Sep2023. Vaccination history included: 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) all with onset 12Jan2024, outcome "recovered" and all described as "sx (symptoms) of COVID 12Jan Friday late night then Positive PCR  lucira test 13Jan". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jan2024) Positive, notes: Nasal Swab; (13Jan2024) Positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course:  (Symptoms) of COVID on 12Jan2024 (Friday late night as reported) then Positive PCR lucira test on  13Jan2024.  No follow-up attempts are possible.; 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.