Sex: U
Vaccine: COVID19
Symptoms: Hernia, Loss of consciousness
Clinical narrative: This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not have hernia before vaccination. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total administered, start therapy date were not reported for covid-19 prophylaxis. On an unspecified date, the patient was very sick for almost 18 months (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 was not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date (15 to 20 minutes after vaccination), the patient left and while walking down sidewalk out 10 feet patient passed out and was taken back into facility carried back and put on a chair. The patient was checked by the nurses and was told could leave had someone there to drive the patient home. The patient came in passed out and found a huge lump on pelvic area as big as a softball. It turned out as a pelvic floor hernia needed an operation and was sick for almost 18 months and now waiting for another surgery. The patient would never take another vaccine (Dose number in series 2). Reporter stated that, "I was excited to get my 2nd vaccine even though I was very sick from my first vaccine. Received my vaccine did the normal wait 15-20 min then left I left while walking down sidewalk out 10 feet I passed out I was taken back in to facility carried back and put on a chair. I was checked by the nurses and was told I could leave had someone there to drive me home. I came in passed out and found a huge lump on my pelvic area as big as a softball. It turned out as a pelvic floor hernia needed an operation. I have been sick for almost 18 months and now waiting for another surgery. I did not have a hernia before this vaccine I will never take another vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pelvic floor hernia and passed out was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220919467. Sender's Comments: V0- 20220925320-covid-19 vaccine ad26.cov2.s- Passed out. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220925320-covid-19 vaccine ad26.cov2.s- Pelvic floor hernia. The event(s) has an unknown/unclear 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: NATURE OF EVENT. Therefore, this event(s) is considered not related.