Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Off label use, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 60 year old female of an unspecified ethnicity. Initial information was processed along with additional information on 09-OCT-2022. The patient's height, and weight were not reported. The patient's past medical history included: stem cell transplant recipient, and relapse/lost graft, and concurrent conditions included: myelofibrosis (Currently diagnosed with myelofibrosis again), and the patient was not pregnant at the time of reporting. Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered first dose on 05-MAR-2021 in left arm and second dose on 26-AUG-2021 in right arm for covid-19 prophylaxis. The batch number was not reported and has been requested. The drug was associated with Off label use (off label dosing frequency, dose number in series 1). Age at time of vaccination 60 years old. Concomitant medications included hydrocortisone.  The patient additionally received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 27-MAY-2022 15:00 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 2). The patient additionally received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (dose number in series 3) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 08-SEP-2022 14:00 in right arm for covid-19 prophylaxis.  On 16-SEP-2022, the patient first tested positive for covid-19, contacted physician and was prescribed Paxlovid, which she started on same date (confirmed covid-19 infection, dose number in series 3).  The patient received non-company suspect vaccine included: Paxlovid (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 16-SEP-2022 for covid-19 treatment. Patient took last dose of Paxlovid on 20-SEP-2022. On 20-SEP-2022, all symptoms were abated. On 22-SEP-2022, patient self-tested negative for covid-19 and again on 25-SEP-2022. On 26-SEP-2022, in evening, patient had nasal congestion, which worsened overnight. On 27-SEP-2022 at 08:30 (morning), patient tested positive for covid-19, contacted doctor, who stated she likely had rebound infection, post-Paxlovid. Patient was not receiving further treatment at this time. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and elasomeran was not applicable and with paxlovid was discontinued. The patient had not recovered from confirmed covid-19 infection, and the outcome of off label dosing frequency was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000254663.