Reporte zur Charge 059U21A

Symptomtext

CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer from other company (Pfizer) concerned a 64 year old female. Initial information was processed along with the additional information received from on 10-AUG-2022. The patient's height and weight were not reported. The patient's concurrent conditions included: elevated blood pressure (managed) and neomycin allergy (triple antibiotic). The patient was not pregnant at the time of vaccination. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, dose 1, 1 total administered to the left arm on 11-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 63 years old. Concomitant medications included vitamin D (ergocalciferol) and metoprolol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient also received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (dose number in series 2) (form of administration, route of administration were not reported, batch number: 077C21B and expiry: unknown) dose was not reported, dose 2 administered to the left arm on 30-OCT-2021 for covid-19 prophylaxis. Age at time of vaccination 63 years old. The patient also additionally received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (dose number in series 3) (form of administration, route of administration were not reported, batch number: 059U21A and expiry: unknown) dose was not reported, dose 3 administered to the left arm on 02-JUN-2022 for covid-19 prophylaxis. Age at time of vaccination 64 years old. 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 12-JUL-2022 to 17-JUL-2022 for treatment of COVID-19. It was reported that on 19-JUL-2022, after taking Paxlovid the patient tested negative. It was also mentioned that on 22-JUL-2022, evening the symptoms came back (coded as confirmed covid-19 infection) (dose number in series 3) which led to confirmed clinical vaccination failure (dose number in series 1). On 23-JUL-2022, patient tested positive. On 28-JUL-2022, the patient was positive with symptoms. On 19-JUL-2022, Laboratory data included: COVID-19 virus test Negative. On 23-JUL-2022, Laboratory data included: COVID-19 virus test Positive. On 28-JUL-2022, Laboratory data included: COVID-19 virus test Positive. Laboratory data (dates unspecified) included: Blood pressure elevated. The action taken with Moderna covid-19 vaccine (elasomeran) was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000245895.; Sender's Comments: V0:20220820200-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.