Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: COVID-19; Medicinal taste that lasted until the day after the last; Severe inflammation of the anus leading to painful defecation and bleeding; Severe inflammation of the anus leading to painful defecation and bleeding; Severe inflammation of the anus leading to painful defecation and bleeding; Diarrhea for the first 2 days; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), TASTE DISORDER (Medicinal taste that lasted until the day after the last), ANAL INFLAMMATION (Severe inflammation of the anus leading to painful defecation and bleeding), ANAL HAEMORRHAGE (Severe inflammation of the anus leading to painful defecation and bleeding) and DYSCHEZIA (Severe inflammation of the anus leading to painful defecation and bleeding) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine and Drug allergy.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2022 at 8:00 PM, the patient experienced TASTE DISORDER (Medicinal taste that lasted until the day after the last), ANAL INFLAMMATION (Severe inflammation of the anus leading to painful defecation and bleeding), ANAL HAEMORRHAGE (Severe inflammation of the anus leading to painful defecation and bleeding), DYSCHEZIA (Severe inflammation of the anus leading to painful defecation and bleeding) and DIARRHOEA (Diarrhea for the first 2 days). On an unknown date, the patient experienced COVID-19 (COVID-19). On 13-May-2022, DIARRHOEA (Diarrhea for the first 2 days) had resolved. On 17-May-2022, TASTE DISORDER (Medicinal taste that lasted until the day after the last), ANAL INFLAMMATION (Severe inflammation of the anus leading to painful defecation and bleeding), ANAL HAEMORRHAGE (Severe inflammation of the anus leading to painful defecation and bleeding) and DYSCHEZIA (Severe inflammation of the anus leading to painful defecation and bleeding) had resolved. At the time of the report, COVID-19 (COVID-19) outcome was unknown.            Co-suspect product included non-company product COVID-19 treatment for Treatment of COVID-19; started on 11-May-2022 and last dose taken on 16-May-2022.  No concomitant medication was reported. Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  No treatment medication was reported.  Company Comment: This spontaneous case concerns a 69-year-old female patient, with a relevant medical history of Drug allergy, who experienced the unexpected AESI of COVID-19, The unexpected events of Taste disorder, Anal inflammation, Anal hemorrhage, Dyschezia and Diarrhea. The events occurred approximately 6 months after receiving the third dose of mRNA-1273 Vaccine. The patient was treated with an unspecified drug for COVID-19 on the same day of occurrence of the events. The outcome of the event was reported as unknown. Due to its temporal relationship, the unspecified drug for COVID-19, remain as a confounder for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69-year-old female patient, with a relevant medical history of Drug allergy, who experienced the unexpected AESI of COVID-19, The unexpected events of Taste disorder, Anal inflammation, Anal hemorrhage, Dyschezia and Diarrhea. The events occurred approximately 6 months after receiving the third dose of mRNA-1273 Vaccine. The patient was treated with an unspecified drug for COVID-19 on the same day of occurrence of the events. The outcome of the event was reported as unknown. Due to its temporal relationship, the unspecified drug for COVID-19, remain as a confounder for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.