Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Laboratory test, Pain in extremity, SARS-CoV-2 test, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; SORE ARM; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's past medical history included: confirmed covid-19 infection, and other pre-existing medical conditions included: On 05-JAN-2021 (one year ago), the patient had PCR (polymerase chain reaction) test and was confirmed with Covid-19 prior to receiving the Janssen Covid-19 vaccine. The patient received covid-19 vaccine ad26.cov2.s (dose number in series was 1) (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 26-JUL-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 26-JUL-2021, after vaccination the patient experienced sore arm for a day and no other side effects. On 02-JAN-2022, the patient experienced congestion, runny nose, and intermittent cough (subsumed under suspected Covid-19 infection). She noted that she thought her symptoms were consistent with a cold. On 05-JAN-2022, the patient took Abbott Binax now home rapid test and was tested positive, hence Suspected clinical vaccination failure (dose number in series 1). The patient reported, she followed up with the county for confirmation of the rapid test result with another 4872-hour test (PCR (polymerase chain reaction) Covid-19 test) performed on 05-JAN-2022, the result was pending. The patient reported, she went to the new year weekend with her husband, and they were exposed to many other people in number of social settings. The patient reported, she received confirmation on same day that one of those settings she might have come into contact with 3 people who now have confirmed positive covid-19. The patient said she let her employer and work know she had an exposure to someone who tested positive. The patient noted she tested herself before attending these social gatherings to be safe and ensure she was not the source of any infection for others. The patient also reported, she performed a rapid home test for covid-19 today, along with her husband. The patient reported her husband tested negative, but that she tested positive on the rapid test.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 27-JUL-2021, had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220107289. This report was associated with product quality complaint: 90000210423.; Sender's Comments: V0: 20220107982-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Suspected clinical vaccination failure. This event(s) is considered not related. 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.