Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: REVACCINATION WITH DIFFERENT COVID-19 VACCINE; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: graves disease, and drug allergy (Vicodin, Doxycycline), and other pre-existing medical conditions included: Patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, 1 total administered on 12-MAR-2021 in left arm for covid-19 prophylaxis. Age at time of vaccination 32 years old. No concomitant medications were reported.  The patient received non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (dose number in series 2) (form of admin, and route of admin were not reported, batch number: 939904, expiry: UNKNOWN) dose was not reported, administered on 31-OCT-2021 in left 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 Pfizer Biontech covid-19 vaccine (tozinameran) (dose number in series 3) (form of admin, and route of admin were not reported, batch number: 6H9703, expiry: UNKNOWN) dose was not reported, administered on 01-OCT-2022 in right arm for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 3).  On an unspecified date in 2022, the patient had COVID-19 infection (dose number in series 3) for which patient received non-company suspect Paxlovid (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 13-NOV-2022 for covid-19 treatment. Date of last dose of administration was 18-NOV-2022. On NOV-2022, Laboratory data included: COVID-19 virus test Negative.  On 10-DEC-2022, the patient tested positive four weeks after testing negative following Paxlovid treatment (confirmed covid-19 infection) (dose number in series 3) which resulted to confirmed clinical vaccination failure (dose number in series 1). Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, tozinameran was not applicable and with Paxlovid was drug discontinued. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000264857.; Sender's Comments: V0-20221258545-Confirmed clinical vaccination failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.