Sex: U
Vaccine: COVID19, UNK
Symptoms: COVID-19, Diarrhoea, Drug ineffective, Dysgeusia, SARS-CoV-2 test
Clinical narrative: COVID-19; Lack of effect; Significant dysgeusia (metallic taste); Moderate diarrhea; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (COVID-19), DYSGEUSIA (Significant dysgeusia (metallic taste)), DIARRHOEA (Moderate diarrhea) and DRUG INEFFECTIVE (Lack of effect) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A, 031L20A and 013L20A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    Previously administered products included for Product used for unknown indication: Telithromycin. Past adverse reactions to the above products included Allergy with Telithromycin. Concurrent medical conditions included Sleep apnea, Morbid obesity and Obsessive-compulsive disorder. Concomitant products included SERTRALINE, TRAZODONE, ETHINYLESTRADIOL, NORETHISTERONE (NORTREL [ETHINYLESTRADIOL;NORETHISTERONE]), ERGOCALCIFEROL (VITAMIN D [ERGOCALCIFEROL]) and IVERMECTIN (SOOLANTRA) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021 at 10:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (Oral) at an unspecified dose. On 12-May-2022, the patient experienced DYSGEUSIA (Significant dysgeusia (metallic taste)) and DIARRHOEA (Moderate diarrhea). On an unknown date, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of effect). On 17-May-2022, DYSGEUSIA (Significant dysgeusia (metallic taste)) and DIARRHOEA (Moderate diarrhea) had resolved. At the time of the report, COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.         The patient did not receive any treatment for the events moderate diarrhea and significant dysgeusia (metallic taste). The patient received nirmatrelvir, ritonavir (Paxlovid) as treatment for COVID-19.  Company Comment: This spontaneous case of Lack of effect concerns a  patient of an unknown age and gender, with co-suspect product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, who experienced the unexpected AESI of COVID-19, and the unexpected events Dysgeusia and Diarrhea. The event occurred approximately 7 months after completing the primary and booster doses of mRNA-1273 Vaccine. The patient was given NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment and on the same day, Dysgeusia and Diarrhea occurred. The outcome of the events was reported as unknown. The patient's treatment with Paxlovid, remain as a confounder for the occurrence of the events Dysgeusia and Diarrhea. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case of Lack of effect concerns a  patient of an unknown age and gender, with co-suspect product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, who experienced the unexpected AESI of COVID-19, and the unexpected events Dysgeusia and Diarrhea. The event occurred approximately 7 months after completing the primary and booster doses of mRNA-1273 Vaccine. The patient was given NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment and on the same day, Dysgeusia and Diarrhea occurred. The outcome of the events was reported as unknown. The patient's treatment with Paxlovid, remain as a confounder for the occurrence of the events Dysgeusia and Diarrhea. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.