Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, Off label use, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; OFF LABEL DOSING FREQUENCY; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 64 year old  male of an unspecified ethnicity. Initial information was processed along with additional information on 16-MAR-2023. The patient's height, and weight were not reported. The patient's concurrent conditions included: one coronary artery partially blocked, and drug allergy (not specified), and other pre-existing medical conditions included: Patient was old age. The patient previously received two doses of covid-19 vaccine (dose number in series 1, unspecified manufacturer) (form of admin, and route of admin was not reported, batch number: unknown expiry: unknown) dose was not reported, administered on an unspecified date for covid-19 prophylaxis.  It was unknown whether patient had any adverse event following vaccination with two doses of covid-19 vaccine (dose number in series 1, unspecified manufacturer). The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 2, unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis.  It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2, unspecified manufacturer). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin not reported, batch number: 210021A, expiry: unknown) dose was not reported, 1 total, fourth dose, administered on 15-DEC-2021 in right arm for covid-19 prophylaxis which was associated with off label dosing frequency (off label use) and revaccination with different covid-19 vaccine (dose number in series 3). Age at time of vaccination 64 years old. Concomitant medications included acetylsalicylic acid, allium sativum, clopidogrel bisulfate, ergocalciferol, ezetimibe, fish oil, linum usitatissimum seed oil, omeprazole, rosuvastatin calcium, serenoa repens, withania somnifera and multivitamin.  The patient received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (dose number in series 4) (form of admin, and route of admin were not reported, batch number: 005M21A expiry: unknown) dose was not reported, fifth dose, administered on 14-APR-2022 in right arm for covid-19 prophylaxis. It was unknown whether patient had any adverse event following vaccination with Moderna covid-19 vaccine (elasomeran) (dose number in series 4). The patient received non-company suspect vaccine included: Pfizer Biontech covid-19 vaccine (tozinameran ) (dose number in series 5) (form of admin, and route of admin were not reported, batch number: GH9694 expiry: unknown) dose was not reported, sixth dose administered on 12-SEP-2022 in left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse event following vaccination with Pfizer Biontech covid-19 vaccine (tozinameran) (dose number in series 5). The patient additionally received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (dose number in series 6) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, seventh dose administered on 12-JAN-2023 in right arm for covid-19 prophylaxis. On an unspecified date in 2023, the patient experienced covid-19 infection (confirmed covid-19 infection, dose number in series 6) for which the patient received non company suspect drug: Pfizer (unspecified medication) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, first dose administered on 24-FEB-2023 and last dose was administered on 28-FEB-2023 for treatment of covid-19. Patient had daily covid self tests (using both BinaxNOW and FlowFlex). On 01-MAR-2023, 02-MAR-2023, 03-MAR-2023, and 04-MAR-2023, Laboratory data included: COVID-19 virus test Negative. On 05-MAR-2023, they both showed very weak positive. On 06-MAR-2023, they both showed stronger positive. On 07-MAR-2023, they both showed very positive (strongly colored bars). No fever, no coughing, no other symptoms except maybe a slight headache in the morning, but he sometimes had that anyway. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran (dose number in series 4), tozinameran (dose number in series 5), and elasomeran (dose number in series 6) was not applicable and with pfizer (unspecified medication) was not reported. The patient had not recovered from confirmed covid-19 infection, and the outcome of off label dosing frequency and revaccination with different covid-19 vaccine was not reported. This report was non-serious. This report was associated with product quality complaint: Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case assessed as non serious.