Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antibody test, Blood test, COVID-19, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient (other healthcare professional) via other manufacturer (Pfizer) concerned a 56 year old female of unspecified race. Initial information was processed along with the additional information received on 29-APR-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: borderline type II diabetes, genetic hyperlipidemia, and unknown drug allergy, and other pre-existing medical conditions included: Patient is virologist (Other Health care professional). Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient received with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: unknown) dose was not reported, 1 total administered at right arm on 08-APR-2021 for prophylactic vaccination. Age at time of vaccination 55 years old.  The patient additionally received booster of non-company suspect vaccine included: Pfizer biontech Covid-19 vaccine (tozinameran) (Dose number in series 2) (Form of admin and route of admin were not reported, batch number: 301458A and expiry: unknown) dose was not reported, administered at left arm on 08-NOV-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 03-APR-2022, the patient was infected and on 07-APR-202, tested positive by one rapid test. On 05-APR-2022 the patient had clinical signs (symptoms) of sore throat, fatigue, muscle aches, cough, and no fever (Covid-19 infections) which were lasted till 08-APR-2022. On 07-APR-2022, the patient took first dose of non-company suspect drugs Paxlovid for covid-19 treatment. On 09-APR-2022, it was reported that these symptoms were improved. On 11-APR-2022. the patient took last dose of Paxlovid. On 18-APR-2022 the patient saw that these symptoms were progressed and at home done covid-19 test which was positive (Dose number in series 2). Since the patient was a virologist and NIAID program officer, and she contacted her colleagues for further tests. On 19-APR-2022, they arranged to have samples taken for analyses. On 20-APR-2022, Laboratory data included: Antibody test (NR: not provided) not reported, and other test included T cell, virus titer, confirmation infection and virus sequencing were performed. Laboratory data included: COVID-19 PCR test (NR: not provided) positive and it was reported that polymer chain reaction (PCR) confirmatory test results was cycle threshold (Ct) of 20.6, which led to confirmed clinical vaccination failure (dose number in series 1). The patient stated that she had other signs of disease include heavy, frequent, nonproductive coughing with some mucus, heavy rhinorrhea, headache. The patient had no fever. On APR-2022, Laboratory data included: Blood test (NR: not provided) and clinical chemistry were normal. The patient taken over-the-counter day quill during relapse. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient had not recovered 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: 90000228793.; Sender's Comments: V0: 20220457713-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.