Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) and concerned a 48 year old  female. Initial information was processed along with the additional information received on 11-OCT-2022. The patient's height and weight were not reported. The patient's concurrent conditions included: hypothyroid (subclinical), pre-diabetic, chronic sciatica and drug allergy. The 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: 1808978 and expiry: Unknown) dose was not reported, 1 total administered to the left arm on 28-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 47 years old. Concomitant medications included gabapentin (drug start on 01-DEC-2019) and levothyroxine (drug start on 01-SEP-2021). The patient additional 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: 017E21H, expiry: Unknown) dose was not reported, administered to the left arm on 25-OCT-2021 for covid-19 prophylaxis (coded as revaccination with different covid-19 vaccine). Age at time of vaccination 47 years old. The patient also additional received non-company suspect vaccine, Moderna covid-19 vaccine (elasomeran) (dose number in series 3) (form of admin and route of admin were not reported, batch number: 013B22A and expiry: Unknown) dose was not reported, administered to the right arm on 14-JUL-2022 for covid-19 prophylaxis. Age at time of vaccination 48 years old. On an unspecified date, the patient experienced covid-19 infection for which patient received Paxlovid as a treatment (confirmed covid-19 infection) (dose number in series 3) which led to confirmed clinical vaccination failure (dose number in series 1). The patient received non-company co-suspect drug Paxlovid (form of administration, route of administration, batch number and expiry were not reported) dose was not reported, administered from 20-SEP-2022 to 25-SEP-2022 for treatment of COVID-19.  It was reported that on an unspecified date, the patient was rebounded in COVID symptoms and two positive test done through eight days after finishing Paxlovid doses. It was also mentioned that the patient still tested positive after 2 week of first symptoms and positive test. On an unspecified date in 2022, Laboratory data included: COVID-19 virus test Positive, COVID-19 virus test Positive. On an unspecified date in OCT-2022, Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran 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: 90000254858.; Sender's Comments: V0:20221016490-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.