Sex: F
Vaccine: 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 health care professional via another manufacturer (Pfizer) concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: left ventricle dysfunction, tricuspid regurgitation, mitral regurgitation, aortic regurgitation, hyperparathyroidism, hypercholesterolemia, thyroid nodule, obstructive sleep apnea, colon polyps, seizure disorder, post-traumatic stress disorder, depressive disorder, osteopenia, sulfa drugs allergy, iodinated agents allergy, and drug allergy (Morphine). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included acetylsalicylic acid, ascorbic acid, calcium/colecalciferol, escitalopram, gabapentin, ibuprofen, lactobacillus rhamnosus, magnesium citrate, melatonin, metoprolol tartrate, rosuvastatin, ubidecarenone, vitamin b complex and multivitamins. The patient received additional 2 dosage of non-company suspect vaccine of pfizer (tozinameran) (dose number in series 2) (form of admin, route of admin, and batch number and expiry date were not reported) dose was not reported, administered on 16-NOV-2021 and 10-MAY-2022 for prophylactic vaccination.  On 17-MAY-2022, the patient developed symptoms of covid-19 (coded as confirmed covid-19 infection) (dose number in series 2). On 19-MAY-2022, the patient tested positive at home (confirmed clinical vaccination failure) (dose number in series 1). The patient was prescribed with non-company drug Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered first dose on 20-MAY-2022 and last dose on 24-MAY-2022 for treatment of covid 19 and was recovered. On 28-MAY-2022, tested negative on rapid antigen test and on 31-MAY-2022, the patient developed fatigue, headache and increased congestion (dose number in series 2). On 01-JUN-2022, Laboratory data included: COVID-19 virus test Positive (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran 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 product quality complaint number: 90000235164.; Sender's Comments: V0: 20220617400-Covid-19 vaccine ad26.cov2.s-confirmed 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.