Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Diagnosed on 18May2022 with COVID-19 on at home test; Diagnosed on 18May2022 with COVID-19 on at home test; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EL9261), on 01Mar2021 as dose 2, single (Lot number: EN6202) and on 26Sep2021 as dose 3 (booster), single (Lot number: FC3182) at the age of 71 years for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient had no family medical history relevant to adverse event. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18May2022, outcome "recovering" and all described as "Diagnosed on 18May2022 with COVID-19 on at home test". The event "diagnosed on 18may2022 with covid-19 on at home test" required emergency room visit on 19May2022, not admitted to hospital. The events did not require Physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) Positive, notes: Diagnosed on 18May2022 with COVID-19 at home test; (27May2022) Positive, notes: COVID-19 at home test; (31May2022) Positive, notes: COVID-19 at home test. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid. No additional vaccines were administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18May2022, the patient was diagnosed with COVID-19 and had positive COVID-19 at home test. On 19May2022, the patient started Paxlovid and completed 5 day course. She took 5 days course of Paxlovid and it was standard, normal dose. She took it twelve hours apart. Symptoms quickly abated. Then it wasn't even a couple days after she stopped taking Paxlovid, she felt symptoms were coming back. Definitely was on day 5 of symptoms. On 26May2022, the patient had rebound COVID-19 and symptom. Improved a little, but not a lot. COVID-19 test remained positive entire time, tested twice, 27May2022 and 31May2022. She was still positive for COVID-19 and back in isolation. She didn't have scary symptoms, had stuffy/runny nose, headache and off-on sore throat, sinuses didn't feel quite as bad. She had pain in the neck. At first, she had pressure and pain in the sinuses. Was better than 4-5 days ago. It was nothing more than an upper respiratory head cold. She knew when the Paxlovid studies were done it was the delta variant, which was different. She had the Pfizer vaccines two doses and had been boosted twice. She was disappointed because she already did isolation. She tested twice and was positive both times. She should have gone and stayed the course of COVID-19 without medicine. She should have not taken Paxlovid. She didn't know how long to isolate for rebound COVID-19. If she wouldn't have taken Paxlovid, she would have been over it at this time and not experienced it twice. The primary infection site was unknown. There was no secondary site. There were no predisposing factors. No culture was performed. There was no Antipyretic use. There was a Product complaint.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of covid-19 and vaccination failure.