Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, 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 company (pfizer) concerned a 67 year old female.  Initial information was processed along with the additional information received on 15-JUL-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: migraines, rheumatoid arthritis, fibromyalgia, osteoporosis, herpes, and hypothyroidism, and other pre-existing medical conditions included: Patient was not pregnant at the time of vaccination, Patient was not having any allergy. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered 1 in total to the left arm on 06-MAR-2021 for prophylactic vaccination. Age at time of vaccination 66 years old. On 20-JUN-2022, the patient experienced confirmed clinical vaccination failure following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). Latency 471 days. Patient received second dose of non-company suspect vaccine included: elasomeran (Moderna vaccine) (Dose number in series 2) (batch number: 054G21A expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose was not reported, administered to the left arm on 08-AUG-2021 for prophylactic vaccination. Age at time of vaccination 66 years old. It was unknown whether patient had any adverse events following vaccination with elasomeran  (Dose number in series 2).  Patient received third dose of non-company suspect vaccine included: elasomeran (Moderna vaccine) (Dose number in series 3) (batch number: 066D21A expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose was not reported, administered to the left arm on 05-SEP-2021 for prophylactic vaccination. Age at time of vaccination 66 years old. It was unknown whether patient had any adverse events following vaccination with elasomeran  (Dose number in series 3).  Patient received fourth dose of non-company suspect vaccine included: elasomeran (Moderna vaccine) (Dose number in series 4) (batch number: 025L21 expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose was not reported, administered to the left arm on 09-FEB-2022 12:00 for prophylactic vaccination. Age at time of vaccination 67 years old. Concomitant medications included duloxetine, gabapentin, hydroxychloroquine, levothyroxine sodium, meloxicam, and valaciclovir hydrochloride.  On 20-JUN-2022, the patient tested positive with home test (confirmed covid-19 infection), duration 13 days. Patient began isolating at home. On 22-JUN-2022 patient started Paxlovid. On 26-JUN-2022 patient tested negative. On 27-JUN-2022 patient completed prescribed course of Paxlovid and continued isolating at home but observed social distancing and wore mask when out of the home. On 30-JUN-2022 patient again tested positive and continued isolation at home. On 03-JUL-2022 patient tested negative following vaccination with elasomeran (Dose number in series 4). Laboratory data included: COVID-19 virus test Positive. On 26-JUN-2022, Laboratory data included: COVID-19 virus test Negative. On 30-JUN-2022, Laboratory data included: COVID-19 virus test Positive. On 03-JUL-2022, Laboratory data included: COVID-19 virus test Negative. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, elasomeran, and elasomeran was not applicable. The patient recovered from confirmed covid-19 infection on 03-JUL-2022, 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: 90000242598; Sender's Comments: V0: 20220729860-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.