Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 11Nov2023; COVID-19 11Nov2023; The initial case was previously missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 17Jun2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Physician and a Consumer or other non HCP, Program ID.  A 65-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose 1 (toppac); single (Lot number: HG4677) at the age of 65 years for covid-19 immunisation, Device Lot Number: HG4677. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: COPD with intermittent O2 use; "Asthma" (unspecified if ongoing); "slightly blood pressure" (unspecified if ongoing); "Alcohol use disorder" (unspecified if ongoing), notes: She has been sober for 8 years; "Long term smoking history" (unspecified if ongoing), notes: Long term smoking history/active smoking of Cigarette. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number 1, Date: 26Feb2021, Batch/Lot Number: EN6203), administration date: 26Feb2021, when the patient was 62-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number 2, Date: 18Mar2021, Batch/Lot Number: ER2613), administration date: 18Mar2021, when the patient was 62-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number 3, Date: 12Oct2021, Batch/Lot Number: FF2587), administration date: 12Oct2021, when the patient was 63-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number 4, Date: 20Apr2022, Batch/Lot Number: FF4984), administration date: 20Apr2022, when the patient was 63-year-old, for Covid-19 Immunization, reaction(s): "Covid-19"; moderna (Dose Number 5, Date: 24Sep2022, Manufacturer: Moderna, Batch/Lot Number: AS7143C), administration date: 24Sep2022, when the patient was 64-year-old, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Nov2023, outcome "unknown" and all described as "COVID-19 11Nov2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Nov2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid was given on 11Nov2023 or 12Nov2023 (as reported). Clinical course: It was stated that this is her third time having COVID she had COVID Feb2023 and Nov2023 and today she tested again positive and she has other underlined condition, medical condition. They called for a 5 day course of Paxlovid for each of her 3 episode of covid-19. In spite of this she has experienced covid-19 on 3 separate occasions (diagnosed with mailed RAT tests). However, it seems likely that vaccination may have provided some level of protection from progression to more severe disease such as hospitalization, in conjugation with timely initiation of treatment with Paxlovid.; 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,Linked Report(s) : US-PFIZER INC-202400096881 same patient/event, different vaccine dose;US-PFIZER INC-202400195239 same patient/event, different vaccine dose;