Age: 68.0
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 an Other HCP.  A 68-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 at 19:45 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: "Allergic rhinitis" (unspecified if ongoing); "ulnar neuropathy" (unspecified if ongoing); "chronic pain" (unspecified if ongoing), notes: chronic pain secondary to ulnar neuropathy; "known allergies: sulfonamides" (unspecified if ongoing), notes: Known allergies: Sulphur, sulfonamides; "known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN, start date: 20Sep2023; FLUTICASONE PROPIONATE, start date: 20Sep2023. Past drug history included: Morphine sulfate, reaction(s): "known allergies: Morphine sulfate". Vaccination history included: moderna (DOSE 1, SINGLE, Batch/ Lot number: Unknown, Vaccine administration time: 12:45 PM, Anatomical location: left arm), administration date: 25Feb2021, when the patient was 65-year-old, for COVID-19 Immunization; moderna (DOSE 2, SINGLE, Batch/ Lot number: Unknown, Vaccine administration time: 02:30 PM, Anatomical location: left arm), administration date: 26Mar2021, when the patient was 66-year-old, for COVID-19 Immunization; moderna (DOSE 3 (BOOSTER), SINGLE, Batch/ Lot number: Unknown, Vaccine administration time: 12:30 PM, Anatomical location: left arm), administration date: 17Nov2021, when the patient was 66-year-old, for COVID-19 Immunization; moderna (DOSE 4 (BOOSTER), SINGLE, Batch/ Lot number: Unknown, Vaccine administration time: 11: 15 AM, Anatomical location: left arm), administration date: 29Apr2022, when the patient was 67-year-old, for COVID-19 immunization; moderna (DOSE 5 (BOOSTER), SINGLE, Batch/ Lot number: Unknown, Vaccine administration time: 02:00 PM, Anatomical location: left arm), administration date: 19Sep2022, when the patient was 67-year-old, for COVID-19 immunization; moderna (DOSE 6 (BOOSTER), SINGLE, Batch/ Lot number: Unknown, Vaccine administration time: 01:15 PM, Anatomical location: left arm), administration date: 28Apr2023, when the patient was 68-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Dec2023, outcome "recovered" (Dec2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Negative, notes: tested neg. at 24, 48, 72 hrs; (Dec2023) Negative, notes: tested neg. at 24, 48, 72 hrs; (Dec2023) Negative, notes: tested neg. at 24, 48, 72 hrs; (15Dec2023) Positive, notes: COVID-19 was detected on 15Dec / Treatment of Covid-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid treatment from 15Dec2023 to 20Dec2023. Clinical course: COVID-19 was detected on 15Dec during Phys. OV (1st infection ever). I finished a 5-day PAXLOVID regimen and tested neg. at 24, 48, 72 hrs.  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 vaccine failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.