Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Rebound, return of symptoms 5 days after dealing recovered, Still sick, pos test for Covid 12 days past start of illness, 11days after starting paxlovid; lack of drug effect; Interchange of vaccine products; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Rebound, return of symptoms 5 days after dealing recovered, Still sick, pos test for Covid 12 days past start of illness, 11days after starting paxlovid), DRUG INEFFECTIVE (lack of drug effect) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. O32f21a, O46a21a and O42b21a) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Diabetes. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) from an unknown date to 10-May-2022 and OMEPRAZOLE for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022 at 8:15 PM, the patient received fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Rebound, return of symptoms 5 days after dealing recovered, Still sick, pos test for Covid 12 days past start of illness, 11days after starting paxlovid), DRUG INEFFECTIVE (lack of drug effect) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 10-May-2022 to 14-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound, return of symptoms 5 days after dealing recovered, Still sick, pos test for Covid 12 days past start of illness, 11days after starting paxlovid) had not resolved and DRUG INEFFECTIVE (lack of drug effect) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.         Concomitant medication includes Mucenex. Device date: 22-May-2022. It was reported that, rebound, return of symptoms 5 days after dealing recovered, Still sick, positive test for COVID 12 days past start of illness, 11days after starting paxlovid).  Company comment: This case concerns an adult male patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown date after the third dose of mRNA-1273. The patient received doses 1, 2 and 3 of mRNA-1273 and dose 4 of BioNTech COVID-19 vaccine. The patient received treatment with NIRMATRELVIR, RITONAVIR and reports still feeling sick 12 days after COVID-19 diagnosis. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns an adult male patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown date after the third dose of mRNA-1273. The patient received doses 1, 2 and 3 of mRNA-1273 and dose 4 of BioNTech COVID-19 vaccine. The patient received treatment with NIRMATRELVIR, RITONAVIR and reports still feeling sick 12 days after COVID-19 diagnosis. The benefit-risk relationship of mRNA-1273 is not affected by this report.