Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate decreased, Suspected COVID-19, Vaccination failure
Clinical narrative: BEATS PER MINUTE HAD DROPPED BELOW 40; SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via other company (Pfizer) concerned a 60 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin was not reported, batch number: 1805022 and expiry: UNKNOWN) dose was not reported, 1 total administered on 16-MAR-2021 at 14:30 on right arm for prophylactic vaccination. Age at time of vaccination 59 years old. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194 and expiry: UNKNOWN) dose was not reported, 1 total administered on 28-OCT-2021 at 15:45 on right arm for prophylactic vaccination. No concomitant medications were reported. The patient received paxlovid (form of admin, route of admin not reported, batch number: GA8854 and expiry: unknown) dose was not reported, administered from 08-JUN-2022 to 12-JUN-2022 for treatment of COVID-19. On an unspecified date in 2022, the patient experienced suspected covid-19 infection which was suspected clinical vaccination failure (dose number in series 2). On 11-JUN-2022, the patient lwatch started giving her alerts in the middle of the night that her blood pressure per minute (blood pressure per minute) had dropped below 40 bpm (dose number in series 2). This happened while she was on the drug, Patient took all five days, when she stopped the drug it went away. Patient believe it only dropped her BPM about five points. Patient do not believe she was in any danger. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from beats per minute had dropped below 40 on 12-JUN-2022, and the outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint, and reference number requested.; Sender's Comments: V0:20220647189-COVID-19 VACCINE AD26.COV2.S-Suspected 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. 20220647189-COVID-19 VACCINE AD26.COV2.S-Beats per minute had dropped below 40. 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: CONMEDS-OTHER SUSPECT DRUGS. Therefore, this event(s) is considered not related.