Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via Pfizer (other manufacturer) concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, fibromyalgia, asthma, idiopathic anaphylaxis, systemic cold urticaria, and drug allergy (Nsaids), and other pre-existing medical conditions included: The patient was not pregnant. The patient was taking any other medications or products within 2 weeks of starting COVID-19 treatment. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose,1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. The patient additionally received booster dose of non-company suspect vaccine elasomeran (moderna vaccine) (spikevax) (Dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 20-NOV-2021 for prophylactic vaccination. Concomitant medications included adalimumab, doxepin, hydroxychloroquine phosphate, and methotrexate. On 07-MAY-2022, covid symptoms first appeared ((confirmed covid-19 infection (Dose number in series 2) and confirmed clinical vaccination failure (Dose number in series 1)). On 09-MAY-2022, after receiving a positive PCR test and she was placed on Paxlovid and it was finished on 13-MAY-2022. The patient was pretty much symptom free except for occasion bouts of tiredness and an occasional cough. The last necessary dose of cough medicine was taken by her was on 14-MAY-2022. On 18-MAY-2022, 12 days after first symptoms her cough started to come back. After a telehealth appointment on 19-MAY-2022, her doctor put her on Penicillin, as he said it was either a secondary infection or what will eventually be considered long Covid and not once did he mentioned the post Paxlovid rebound. And physician told her if it continues into next week, he will do a chest X-ray. The patient talked to a second medical professional and she informed the patient of it and felt that was what was going on. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran (spikevax) was not applicable. The patient had not recovered from confirmed covid-19 infection and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.; Sender's Comments: V0: 20220557265-COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. 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: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.