Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, COVID-19, SARS-CoV-2 test
Clinical narrative: Patient was treated with Paxlovid for COVID-19/ tested positive for Covid on rapid test post Paxlovid treatment; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient was treated with Paxlovid for COVID-19/ tested positive for Covid on rapid test post Paxlovid treatment) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 076C21A, 012M20A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included Kidney donor (Kidney donation) in March 2020. Concurrent medical conditions included Acid reflux (oesophageal), Hypertension, Drug allergy (Unspecified drug) and Hypercholesterolemia. Concomitant products included AMLODIPINE from May 2020 to an unknown date, ATORVASTATIN from March 2021 to 10-May-2022, MESO ZEAXANTHIN, XANTOFYL, ZEAXANTHIN (MACUHEALTH WITH LMZ3) from May 2019 to an unknown date and OMEPRAZOLE from April 2019 to an unknown date for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient was treated with Paxlovid for COVID-19/ tested positive for Covid on rapid test post Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 10-May-2022 to 15-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient was treated with Paxlovid for COVID-19/ tested positive for Covid on rapid test post Paxlovid treatment) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2022, SARS-CoV-2 test: negative (Negative) Negative PCR test. On 20-May-2022, SARS-CoV-2 test: negative (Negative) negative rapid test. On 27-May-2022, SARS-CoV-2 test: positive (Positive) positive for Covid on rapid test. On an unknown date, Blood cholesterol: elevated (High) elevated.         Patient's race was reported as Caucasian. Concomitant product was reported as MacuHealth (Lutein/Meso-Zeaxanthin/Zeaxanthin) and Dexcel Pharma (Omeprazole). The patient was treated with Paxlovid for COVID-19. After completing 5 day course of Paxlovid on 10-May-2022, the symptoms resolved. On 19-May-2022, the patient had negative PCR test and negative rapid test on 20-May-2022. On 25-May2022, patient experienced sneezing and tested positive for COVID on rapid test on 27-May-2022. No treatment medication given for COVID re-infection post treatment with Paxlovid. Company comment This is a spontaneous case concerning a 72-year-old male patient with no relevant medical history reported, who experienced the non-serious, unexpected AESI event of COVID-19, which occurred on an unknown date after the fourth dose of mRNA-1273. It was reported that the patient experienced COVID-19, completed treatment with Paxlovid for 5 days, symptoms resolved. After 9 days the patient tested negative for 2 days. 5 days later, the patient began sneezing and tested positive again 2 days after. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 72-year-old male patient with no relevant medical history reported, who experienced the non-serious, unexpected AESI event of COVID-19, which occurred on an unknown date after the fourth dose of mRNA-1273. It was reported that the patient experienced COVID-19, completed treatment with Paxlovid for 5 days, symptoms resolved. After 9 days the patient tested negative for 2 days. 5 days later, the patient began sneezing and tested positive again 2 days after. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.