Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea
Clinical narrative: COVID-19; Diarrhea after taking Paxlovid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and DIARRHOEA (Diarrhea after taking Paxlovid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Type 2 diabetes mellitus, Hypertension and Allergy (Name of drug reported as unknown). Concomitant products included LISINOPRIL, METOPROLOL, AMLODIPINE, TORSEMIDE, ACETYLSALICYLIC ACID (ASPRIN), DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) and ROSUVASTATIN for an unknown indication.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (Oral) at an unspecified dose. On 18-May-2022, the patient experienced DIARRHOEA (Diarrhea after taking Paxlovid). On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. On 18-May-2022, DIARRHOEA (Diarrhea after taking Paxlovid) had resolved. At the time of the report, COVID-19 (COVID-19) outcome was unknown.            It was reported that the patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  Treatment medications also included fluids.  Awareness date was reported as 18-May-2022.  Company Comment: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred approximately 6 months after receiving the third dose of mRNA-1273 vaccine. Patient has completed the primary vaccination with mRNA-1273 with the last dose taken approximately 9 months prior to the third dose. It was reported that patient developed COVID-19 on unspecified date and was treated with Nirmatrelvir, Ritonavir (Paxlovid). Treatment was discontinued after the first dose of Paxlovid due to diarrhea. Patient was given fluid replacement and antidiarrheal. The clinical course, diagnostic investigations, and further treatment details of COVID-19 were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred approximately 6 months after receiving the third dose of mRNA-1273 vaccine. Patient has completed the primary vaccination with mRNA-1273 with the last dose taken approximately 9 months prior to the third dose. It was reported that patient developed COVID-19 on unspecified date and was treated with Nirmatrelvir, Ritonavir (Paxlovid). Treatment was discontinued after the first dose of Paxlovid due to diarrhea. Patient was given fluid replacement and antidiarrheal. The clinical course, diagnostic investigations, and further treatment details of COVID-19 were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.