Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid and he has received 5 Pfizer Covid-19 vaccines; tested positive for Covid and he has received 5 Pfizer Covid-19 vaccines; This is a spontaneous report received from contactable reporter (Nurse).  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5, on 27Sep2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 71 years for covid-19 immunisation; BNT162b2 (PFIZER COVID-19 VACCINE), on 14Mar2021 as dose 1, single (Lot number: EN6207) intramuscular, on 11Apr2021 as dose 2, single (Lot number: ER8729) intramuscular, on 14Oct2021 as dose 3 (booster), single (Lot number: FF2587) intramuscular and on 13Jun2022 as dose 4 (booster), single (Lot number: F34991) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: INFLUENZA VACCINE taken for immunisation as dose number unknown, single. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Oct2022, outcome "unknown" and all described as "tested positive for Covid and he has received 5 Pfizer Covid-19 vaccines". The events "tested positive for covid and he has received 5 pfizer covid-19 vaccines" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Oct2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 and included treatment with Paxlovid (tablet, Lot number: 2692131, NDC number: 0069-1085-06, Expiry date: 03Mar2023). Clinical course: Calling about the bivalent vaccination Covid-19 vaccine. Caller said she was reporting on her husband. Patient was not on any medications and no risk factors and he was a perfectly healthy specimen in his 70s. Caller said with the last one they gave him the flu shot in his other arm. He received his bivalent on 27Sep2022 and on Monday (24Oct2022) of this week he tested positive for Covid and symptoms were scratchy throat on Saturday (22Oct2022) and Sunday (23Oct2022) he woke up with full blown sore throat and a fever started. On Monday and tested with an at home test and tested positive and having dysphagia and could not swallow. Caller said just the test demonstrating positive with two lines. Really between the fever and sore throat those were the only two symptoms and were not mild and he almost passed out and his throat was closing and thought was a laryngospasm spasm and he was swallowing water and throat closing and he almost passed out. Caller said she was a nurse and she told him to breathe through his nose and nasal passage was available and to keep his mouth closed and that held him until his 4:30 appointment in the afternoon with his doctor and was telehealth. Got through the day and was very trying. He was started on Paxlovid which was got for him and he took the first dose around 6 pm. The doctor called in immediately and had ready for her. He was able to the next morning to drink water and the temperature still affected his throat and after the third dose he was fine and she was able to introduce soft foods. He still had a raspy voice and a lingering cough from breathing and he was a mouth breather. The worst of all was in his throat. Caller said she worked in drug safety and she was a retiree of Pfizer. Caller said awareness date was Saturday 22Oct2022 and when started he thought was an allergy because he was on the lawnmower and that after started with swollen throat and slight cough and progressed to full blown throat issues and all concentrated there. Patient details: Caller said out of quarantine but staying in. CP details: The doctor had taken care of her husband for 25 years. He was quite surprised when he got it and he was vaccinated on 27Sep2022. Outcome: Improved that night after first dose and he was comfortable to lay down. She thought he might have slept for most of the night. He usually cleared his throat and not normally and he was clearing his throat a lot and irritating it more after fourth night and he still had a very sore throat and the Paxlovid worked right away. Caller said he fell asleep within an hour. Seriousness: Medically significant because his airway was compromised and he could not swallow and he had to hydrate and he could not do that and was concerned and the airway was the number one thing health care providers were concerned with. Caller said if he did not have Paxlovid she would have taken him to the Emergency Room. Caller confirmed he had received all of Covid-19 vaccines. He had the first two and the other one which was first booster and this one. Paxlovid: Caller said there is an S/N. Caller said was really tiny when reading from the Paxlovid packaging. Caller said there are two different doses 150 mg nirmatrelvir and 300 mg nirmatrelvir and 100 mg ritonavir. Two different tablets. 3 tablets a day. Two of those he took in one dose and two doses a day. 150 mg of nirmatrelvir and a total of 300 mg of nirmatrelvir and a third tablet 100 mg ritonavir.  and in evening same thing and was a different color on the package and he took twice daily for 5 days and he started on Monday morning and tested with an home test from the insurance company and was not expired. She thought was exposed by someone else and they were exposed and their test was expired.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "tested positive for COVID", which is considered as vaccination failure, and the administration of BNT162b2, BNT162b2 omi ba4-5 and BNT162B2, as the efficacy of a vaccine varies individually and may be affected by different factors including drug potency.