Reporte zur Charge CUS17394

Symptomtext

CANKER SORE UNDER THE LEFT SIDE OF THE TONGUE; SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy to coating in canned food. The patient previously received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total first dose administered on unspecified date for covid-19 prophylaxis. Concomitant medications included lisinopril, and pantoprazole. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received 2 doses with non-company suspect vaccine moderna (elasomeran) (Dose number in series 2) second dose (form of admin, route of admin, and were not reported, batch number: 027H21B, expiry: UNKNOWN) dose was not reported, and third dose (form of admin, route of admin, and were not reported, batch number: 065H22A, expiry: UNKNOWN) dose was not reported, administered on unspecified date for covid-19 prophylaxis (dose number in series 2). It was unknown whether the patient had any adverse events following two doses of moderna (elasomeran) (dose number in series 2). The patient received fourth dose of non-company suspect vaccine moderna (elasomeran) (Dose number in series 3) (form of admin, route of admin were not reported, batch number: CUS17394, expiry: UNKNOWN) dose was not reported, fourth dose administered on right arm on 09-APR-2021 date for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 3). On unspecified date in 2023, the patient experienced suspected covid-19 infection (dose number in series 3) and received non-company suspect drug Paxlovid (nirmatrelvir/ritonavir) (form of admin, route of admin were not reported, batch number: GD8819, expiry: UNKNOWN) from 03-SEP-2023 to 07-SEP-2023 for covid-19 treatment. On 03-SEP-2023, the patient experienced canker sore under the left side of the tongue and inside of the lower mouth cavity, also experienced bitter mouth during the entire time (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran (dose number in series 2), and elasomeran (dose number in series 3) was not applicable, and action taken with nirmatrelvir/ritonavir was not reported. The patient was recovering from canker sore under the left side of the tongue, and suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.