Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 infection) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0428B21A, 012M20A and 02BL20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Vibramycin and Arithromycin. Past adverse reactions to the above products included Allergy with Arithromycin and Vibramycin. Concurrent medical conditions included Diabetes and Cancer.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 infection). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 22-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19 infection) outcome was unknown.            No concomitant medication was provided by the reporter.  It was reported that on 31-May-2022 patient started  with nose stopping up and stuffy. Then patient had ulcers in mouth. Had trouble sleeping at night.The patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment. The device date was reported as 04-Jun-2022.  Company Comment: This is a spontaneous case concerning  a  67-year-old, female patient with concurrent medical conditions of Diabetes and Cancer, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred on an unknown day after the third dose of mRNA-1273 COVID 19 Vaccine which was administered on August28, 2021. Patient was treated with nirmatrelvir and ritonavir from 17-May-2022 to 22-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. It was reported that on May 31, 2022,started  with nose stopping up and stuffy. The event was reported as resolving. The concurrent medical conditions of Diabetes and Cancer remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  a  67-year-old, female patient with concurrent medical conditions of Diabetes and Cancer, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred on an unknown day after the third dose of mRNA-1273 COVID 19 Vaccine which was administered on August28, 2021. Patient was treated with nirmatrelvir and ritonavir from 17-May-2022 to 22-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. It was reported that on May 31, 2022,started  with nose stopping up and stuffy. The event was reported as resolving. The concurrent medical conditions of Diabetes and Cancer remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.