Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Return of COVID symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Return of COVID symptoms) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039f21a) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Allergic reaction to antibiotics. Concomitant products included GUAIFENESIN (MUCINEX) from 10-May-2022 to 16-May-2022 and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) from 11-May-2022 to 16-May-2022 for an unknown indication.   On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 17-May-2022, the patient experienced COVID-19 (Return of COVID symptoms). At the time of the report, COVID-19 (Return of COVID symptoms) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient  was taking other medications/products within 2 weeks of starting COVID-19 treatment. Device Date was reported as 24-May-2022. No treatment medications were provided.  Company Comment: This spontaneous case concerns a 35-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 approximately 7 months after receiving the third dose of mRNA-1273 vaccine. There was no information regarding the first three doses of COVID-19 vaccine. Patient developed COVID-19 on unspecified date and was treated with 6-day course of Nirmatrelvir, Ritonavir (Paxlovid). He was also given Guaifenesin and Dextromethorphan Hydrobromide, Guaifenesin, Paracetamol, Pseudoephedrine Hydrochloride. A day after completion of antiviral treatment, patient reported recurrence of COVID-19 symptoms. The clinical course, COVID-19 test results, and treatment details after recurrence of symptoms were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 35-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 approximately 7 months after receiving the third dose of mRNA-1273 vaccine. There was no information regarding the first three doses of COVID-19 vaccine. Patient developed COVID-19 on unspecified date and was treated with 6-day course of Nirmatrelvir, Ritonavir (Paxlovid). He was also given Guaifenesin and Dextromethorphan Hydrobromide, Guaifenesin, Paracetamol, Pseudoephedrine Hydrochloride. A day after completion of antiviral treatment, patient reported recurrence of COVID-19 symptoms. The clinical course, COVID-19 test results, and treatment details after recurrence of symptoms were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.