Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, Off label use, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient via other company (Pfizer, Inc.) concerned a 63 year old  male. The patient's height, and weight were not reported. The patient's concurrent conditions included: lymphoma, and allergy (unspecified). The patient previously received first dose with non-company vaccine Pfizer Biontech Covid-19 Vaccine (tozinameran), (dose number in series 1), (batch number: EN6203 and expiry: UNKNOWN, form of admin, route of admin were not reported) dose was not reported, administered on 06-MAR-2021 at 16:00 to right arm for prophylactic vaccination (dose number in series 1). It was unknown whether patient had any adverse events following vaccination with first dose (dose number in series 1). The patient again received second dose with non-company vaccine Pfizer Biontech Covid-19 Vaccine (tozinameran), (dose number in series 1), (batch number: EN6207 and expiry: UNKNOWN, form of admin, route of admin were not reported) dose was not reported, administered on 27-MAR-2021 at 16:00 to left leg for prophylactic vaccination (dose number in series 1). It was unknown whether patient had any adverse events following vaccination with second dose (dose number in series 1). The patient received third dose with covid-19 vaccine ad26.cov2.s (dose number in series 2), (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: UNKNOWN) dose was not reported, 1 total administered on 08-JUL-2021 to left leg for prophylactic vaccination which was off label use, and inappropriate schedule of vaccine administered (Dose number in series 2). Age at time of vaccination 63 years old. The patient additional received fourth dose with non-company suspect vaccine Pfizer Biontech Covid-19 Vaccine (tozinameran), (dose number in series 3), (batch number: FL3197 and expiry: UNKNOWN, form of admin, route of admin were not reported) dose was not reported, administered on 27-DEC-2021 to left arm for prophylactic vaccination; and fifth dose with Moderna Covid-19 Vaccine (elasomeran), (dose number in series 4), (batch number: 001MZ1A and expiry: UNKNOWN, form of admin, route of admin were not reported) dose was not reported, administered on 20-APR-2022 at 12:00 to left arm for prophylactic vaccination. Concomitant medications included atorvastatin, finasteride, and zolpidem.  On 26-APR-2022, the patient experienced confirmed covid-19 infection and started treatment with Paxlovid. Patient took 5 days treatment with Paxlovid and felt all better and tested negative with covid-19 on day 7 (02-MAY-2022), then got congested on day 11 and tested positive again with covid-19 (06-MAY-2022). Paxlovid was also considered as suspect drug. The action taken with covid-19 vaccine ad26.cov2.s, Pfizer Biontech Covid-19 Vaccine (tozinameran), and Moderna Covid-19 Vaccine (elasomeran) was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.