Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Body mass index, Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 55 year old female. Initial information was processed along with additional information received from complaint vigilance department on 21-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: high BMI (Body mass index), and drug allergy (Sulpher based antibiotics). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, 01 total, administered at left arm on 19-MAR-2021 for prophylactic vaccination. Age at time of vaccination 54 years old. The patient received booster dose of non-company suspect vaccine Moderna Covid-19 Vaccine (Elasomeran) (Dose number in series 2) (form of admin, route of admin were not reported, batch number: 048C21A expiry: UNKNOWN, ) dose was not reported, administered at left arm on 09-NOV-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with booster dose of Moderna Covid-19 Vaccine (Elasomeran) (Dose number in series 2). The patient additionally received booster dose of non-company suspect vaccine Pfizer Biontech Covid-19 Vaccine (Tozinameran) (form of admin, route of admin were not reported, batch number: FP4554 expiry: UNKNOWN, ) dose was not reported, administered at left arm on 21-APR-2022 at 00:00 for prophylactic vaccination. Concomitant medications included atorvastatin, levothyroxine sodium and venlafaxine for unknown indication.  On an unspecified date in MAY-2022, patient started experiencing Covid-19 symptoms (confirmed Covid-19 infection) (Dose number in series 3) which was confirmed clinical vaccination failure (Dose number in series 1) and received non company suspect drug Paxlovid (Nirmatrelvir, Ritonavir) (form of administration and route of administration were not reported, batch number: unknown, expiry: unknown) dose was not reported, administered from 30-MAY-2022 till 03-JUN-2022 for covid-19 treatment. On 02-JUN-2022, Laboratory data included: COVID-19 PCR test Negative. On 03-JUN-2022, Laboratory data included: COVID-19 PCR test Negative. On 09-JUN-2022, Laboratory data included: COVID-19 PCR test positive. On 13-JUN-2022, Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and tozinameran was not applicable and treatment with paxlovid was withdrawn on 03-JUN-2022. The patient was recovering 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: 90000236618.; Sender's Comments: V0:20220640941-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.