Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. 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, the patient experienced suspected clinical vaccination failure, suspected covid-19 infection. The reporter stated that "I caught it from my vaccinated wife who caught it at a party where everyone was vaccinated. 8 of them caught it. My son and I both caught it and had mild symptoms. No loss of taste or smell or even a cough. No vaccines, and I have multiple issues that probably should have made me very ill at least. My vaccinated wife got very sick and lost taste and smell for 4 months. I see vaccinated people every day coming down with covid. Most tell me they were at least very ill. They're not telling you the whole truth. I was definitely less sick than most people tell me about their personal experience with vaccine side effects." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint: 90000217213. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the RA evaluation/investigation performed. This case, from the same reporter is linked to 20220230277 and 20220230299.  Additional information received from Regulatory authority 24-FEB-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result added. Upon review following information was amended: case is considered as valid since it was received from website (identifiable reporter).; Sender's Comments: V1: This version followup updates the information regarding Product quality complaint investigation result and information was amended: case is considered as valid since it was received from website (identifiable reporter). This updated information does not change the causality of the previously reported events. 20220230393-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.