Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient. A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EN9581), on 26Feb2021 as dose 2, single (Lot number: EN6202), on 17Aug2021 as dose 3 (booster), single (Lot number: FC3181) and on 15Jan2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 66 years for Covid-19 immunisation. The patient's relevant medical history included: "Giant Cell Arteritis" (unspecified if ongoing); "Polymyalgia Rheumatica" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Enlarged Thoracic Aorta" (unspecified if ongoing); "Mild Aortic Murmur-Sclerosis" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing); "Allergic Rhinitis" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing); "Cataracts" (unspecified if ongoing). Concomitant medication(s) included: ACTEMRA intravenous; PREDNISONE; FAMOTIDINE; FLUOXETINE; ASPIRIN [ACETYLSALICYLIC ACID]; ROSUVASTATIN, stop date: 24Apr2022; CALCIUM; VITAMIN D3. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Apr2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Apr2022) negative, notes: Day 0 (23Apr2022)-Started with symptoms similar to Day 10 with a negative Antigen Rapid Test; (24Apr2022) positive, notes: Day 1; (28Apr2022) Tested faintly positive on Antigen Rapid Test, notes: Day 6; (02May2022) Tested very faintly positive on Antigen Rapid Test. Therapeutic measures were taken as a result of Covid-19. Clinical course: The patient received other medication in 2 weeks. Anti-viral details: product included COVID-19 Treatment, brand Paxlovid 300-100 mg. Pack/Pfizer, treatment start date was 24Apr2022, treatment stop date was 29Apr2022, indication was treatment of COVID-19. Other medication in 2 weeks products included: Actemra 400mg IV Monthly, prednisone 6mg, Famotidine 40mg, Fluoxetine 30mg, Aspirin 81mg, Rosuvastatin 5mg (stop date: 24Apr2022), Calcium 1200mg, Vitamin D3 2000 IU. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. The reported event included: On the evening of Day 9 (02May2022) the patient started feeling nasal congestion again and developed a mild, intermittent, throat clearing cough that was productive. The patient awoke on Day 10 (03May2022) with a sore throat, headache, nasal congestion, achy upper back and neck, and clearing throat cough. No fever or chest symptoms present. The patient tested with an Antigen Rapid Test that quickly turned darkly positive. Previously: Day 0 (23Apr2022)- Started with symptoms similar to Day 10 with a negative Antigen Rapid Test. Day 1- The patient tested positive and started the Paxlovid in the PM. Day 2- No increase in symptoms. The patient did develop a constant, very bitter taste in the mouth that didn't resolve until after finishing the medication. Day 3- Symptoms resolving Day 4 and 5- No upper respiratory symptoms, just mild fatigue. Day 6- Feel good. Tested faintly positive on Antigen Rapid Test. Day 8- Feel fully recovered. Tested very faintly positive on Antigen Rapid Test. Adverse event start date was 02MAy2022 at 06:00 PM. It was unknown if patient recovered and if patient received treatment AE. The patient had no Known allergies. No follow-up attempts are possible. No further information is expected.