Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive for COVID on 30Apr; positive for COVID on 30Apr; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EK5730), on 08Jan2021 as dose 2, single (Lot number: EK9231), on 08Oct2021 as dose 3 (booster), single (Lot number: FF2580) and on 21Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 65 years for covid-19 immunisation; pneumococcal vaccine conj (PNEUMOCOCCAL CONJUGATE VACCINE), on 25Apr2022 as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Breast cancer", start date: 2015 (unspecified if ongoing), notes: Breast cancer; "Surgery", start date: 2020 (unspecified if ongoing), notes: I had surgery and radiation and in 2020 I had in the other breast, had surgery and radiation but otherwise no medical condition; "Radiation", start date: 2020 (unspecified if ongoing), notes: I had surgery and radiation and in 2020 I had in the other breast, had surgery and radiation but otherwise no medical condition. The patient took concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 30Apr2022, outcome "unknown" and all described as "positive for COVID on 30Apr". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Apr2022) Positive, notes: I did 3 rapid test 30Apr; (30Apr2022) Positive, notes: I did 3 rapid test 30Apr; (30Apr2022) Positive, notes: I did 3 rapid test 30Apr; (06May2022) Negative; (12May2022) Positive, notes: when I did the rapid test today about noon and it was positive within 2 minutes - 1 minutes."; (12May2022) Positive, notes: Date: Not Provided; Result: Positive; Unit: Not Provided. Therapeutic measures were taken as a result of covid-19, vaccination failure. Description of Product Complaint: She stated that she tested positive for COVID on 30Apr, started Paxlovid on 30Apr, she was symptom free by 03May and on 10May she began having rebound COVID. She noted that the symptoms were sinus, headache and running nose, no temperature. Last night she could not sleep and she took two Aleve and did not get any relief. She took a PCR test and it was also positive and she wanted to make report after complete the full course therapy for Paxlovid." Consumer stated, "Almost right, I did not have any temperature. So I took Paxlovid 30Apr through 04May My initial COVID rapid test was 30Apr  My symptoms approximately started 30Apr or perhaps 29Apr and official 430Apr, I was symptoms free on 03May I finished the Paxlovid on 04May and on 10May late in the day I began to have nasal sinus symptoms, 11May they become worse no pronounced, I tried Aleve with no relief and the morning on 12May today I also had a headache, sinus congestions, runny nose, headache and I took a rapid test repeated, rapid test today and it was positive and I also did a rapid test on 06May and it was negative and again I was symptom free in that period. when I did the rapid test today about noon and it was positive."  No follow-up attempts are possible. No further information is expected.