Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Relapse of COVID-19 symptoms after apparently having recovered; Lack of Drug Effect; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Relapse of COVID-19 symptoms after apparently having recovered) and DRUG INEFFECTIVE (Lack of Drug Effect) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L21A, 939905, 038A21A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Obstructive sleep apnea syndrome and Drug allergy. Concomitant products included LISINOPRIL (LISINOPRIL LUPIN), CHLORTHALIDONE, DOXAZOSIN MESYLATE, OMEPRAZOLE, EMTRICITABINE, TENOFOVIR DISOPROXIL PHOSPHATE (EMTRICITABINE/TENOFOVIR DISOPROXIL TEVA) and FEXOFENADINE HYDROCHLORIDE for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-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 (Relapse of COVID-19 symptoms after apparently having recovered) and DRUG INEFFECTIVE (Lack of Drug Effect). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-Apr-2022 to 22-Apr-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, COVID-19 (Relapse of COVID-19 symptoms after apparently having recovered) was resolving and DRUG INEFFECTIVE (Lack of Drug Effect) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was taking other medications or products within 2 weeks of starting COVID-19 treatment and also received a COVID-19 Vaccine previously.  It was reported as relapse of COVID-19 symptoms after apparently having recovered, 5 days after end of treatment with Paxlovid.   The patient had received a second 5-day course of Paxlovid and Device Date was reported as 01 May 2022.  Company Comment: This spontaneous case concerns a 56-year-old, male patient with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred on unknown days after receiving the fourth dose of mRNA-1273 vaccine. Drug ineffective was also considered (COVID-19 occurred more than 15 days post-completion of primary vaccination of mRNA-1273 within recommended interval). It was reported that patient developed COVID-19 and was treated with Nirmatrelvir/Ritonavir (Paxlovid) for four days. He recovered from the infection however developed relapse of unspecified COVID-19 symptoms on the 5th day after recovery. He was treated with another 5 days course of Nirmatrelvir/Ritonavir (Paxlovid). The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 56-year-old, male patient with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred on unknown days after receiving the fourth dose of mRNA-1273 vaccine. Drug ineffective was also considered (COVID-19 occurred more than 15 days post-completion of primary vaccination of mRNA-1273 within recommended interval). It was reported that patient developed COVID-19 and was treated with Nirmatrelvir/Ritonavir (Paxlovid) for four days. He recovered from the infection however developed relapse of unspecified COVID-19 symptoms on the 5th day after recovery. He was treated with another 5 days course of Nirmatrelvir/Ritonavir (Paxlovid). The benefit-risk relationship of mRNA-1273 is not affected by this report.