Age: 31.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report received from a Consumer or other non HCP. The patient is also the reporter.  A 31-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 03Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 03Oct2024 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Is the patient a smoker/former smoker?: No" (unspecified if ongoing); "suspicious that he had covid", start date: 2019, stop date: 2019, notes: in 2019 he was suspicious that he had covid but this is the first time he has ever tested positive for covid. The patient's concomitant medications were not reported. Vaccination history included: Moderna (DOSE 1, SINGLE, left arm and all were intramuscular), for COVID-19 immunization; Moderna (DOSE 2, SINGLE, left arm and all were intramuscular), for COVID-19 immunization; Moderna (DOSE 3 (BOOSTER), SINGLE, left arm and all were intramuscular), for COVID-19 immunization; Pfizer covid vaccines (DOSE 4 (BOOSTER), SINGLE, left arm and all were intramuscular), for COVID-19 immunization; Pfizer covid vaccines (DOSE 5 (BOOSTER), SINGLE, left arm and all were intramuscular), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jan2025, outcome "not recovered" and all described as "tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2025) Positive; Body temperature: (01Jan2025) he has not had a fever. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Indication as Reported by the Primary Source: just the annual vaccine to stay up with them. This report was not related to a study or programme. Investigations: Yes. A Pfizer colleague and verified he is reporting on himself as the patient. He is calling as he is required to call about adverse events or lack of effect and he is calling about the Pfizer Covid vaccine which is the MRNA one. He got his booster on 03Oct2024 he believed and on 01Jan2025 tested positive for covid and stated he felt definitely clinical. Caller confirmed his awareness date of these reported events as 01Jan2025. He believes his first three covid vaccines were Moderna and the rest he had were Pfizer covid vaccines but he does not have the dates of administration to provide and does not know how many covid vaccines he had and thinks the one he had in Oct2024 that that was his 6th dose of covid vaccine or somewhere around there. Treatment included (but reporter classified as concomitant medications): He took a Claritin the day before on 31Dec2024 and believes it is actually the generic version cetirizine and was 10mg orally and he started that on 31Dec2024 because he had sneezing and watery eyes; the sneezing and watery eyes are ongoing and are improved.   He did get all these free tests from work.  States there are no further testing or testing results to include and since he got the positive covid test he was taking Dayquil and Nyquil to help with the clinical signs and that includes more than the sneezing and watery eyes and he also has coughing, congestion and body aches. The coughing, congestion and body aches all began 01Jan2025 and are ongoing and he would say everything is improving except the coughing and the coughing is persisting.  For the outcome of taking the Dayquil and Nyquil he would say those are helping.  He is taking off from work. He thinks all of his vaccines for covid were in the left arm and all were intramuscular. States as far as he knows this is the only time he has had a positive test for covid and back when there were no tests, in 2019 he was suspicious that he had covid but this is the first time he has ever tested positive for covid. Vaccination Facility Type: nurse's office at work. Vaccine Administered at Military Facility? No. Prior Vaccinations (within 4 weeks): had a flu vaccine the same date on 03Oct2024. Family Medical History Relevant to Adverse Events (AEs): He has had other family members and in-laws from the Christmas and new years gathering test positive for covid as well and his awareness date for that event is the same day he took the test on 01Jan2025. Treatment: No other than Nyquil and Dayquil and generic for Claritin.  The patient was not hospitalized. The patient was not admitted to an Intensive Care Unit. Did the patient display clinical signs at rest indicative of severe systemic illness? checking his temperature and he has not had a fever and is also taking Dayquil and NyQuil also that is keeping it down so he will say no for that. The patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. Please provide information on any new or worsened symptoms/signs during the COVID-19 illness experienced(including date of/worsening): He would say the coughing. The patient was not a smoker/former smoker. Have no pre-existing diseases worsened during the SARS-CoV2 infection. Has the patient been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination?: Yes, he got the flu vaccine at the same time on 03Oct2024 and they put it in the opposite arm said that was their procedure; has no name or manufacturer name or lot number to provide for the flu vaccine. There was a product complaint to report. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.