Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 53 year old female of an unspecified race and ethnic origin. Initial information was processed with the additional information received on 19-JUL-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: brain cancer, and drug allergy (drug name not specified), and other pre-existing medical conditions included: The patient was not pregnant as the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 01 total, administered on 18-MAR-2021 to left arm for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 51 years old. No concomitant medications were reported.  The patient additionally received two doses of non-company suspect vaccine Moderna covid-19 vaccine (spikevax) (elasomeran) (Dose number in series 2) (form of admin and route of admin were not reported, batch number: unknown, expiry: unknown) dose was not reported, first dose administered on 18-NOV-2021 to left arm and second dose administered on 28-APR-2022 to left arm for covid-19 prophylaxis. On an unspecified date in 2022, patient started experiencing covid-19 symptoms (Dose number in series 2). Patient received non company suspect Paxlovid (form of administration and route of administration were not reported, batch number: unknown, expiry: unknown) dose was not reported, administered from 28-JUN-2022 till 02-JUL-2022 for covid-19 treatment.  On 02-JUL-2022, patient tested negative for Covid-19 test after Paxlovid treatment for 5 days as prescribed (Dose number in series 2). On an unspecified date in JUL-2022 (5 days after Paxlovid treatment), patient started experiencing symptoms of coughing, congestion and low grade fever (Dose number in series 2). On 08-JUL-2022 (6 days after negative test), patient tested positive for Covid-19 virus test (had confirmed covid-19 infection) (Dose number in series 2). Thus patient had confirmed clinical vaccination failure (Dose number in series 1). The patient was treated with guaifenesin (Mucinex) and cough medication (unspecified). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and action taken with Plaxlovid was treatment discontinued. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000242804. .; Sender's Comments: V0:20220736535 -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.