Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: COVID-19; Congestion fatigue muscle and joint pain; Congestion fatigue muscle and joint pain; Congestion fatigue muscle and joint pain; Congestion fatigue muscle and joint pain; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19), NASAL CONGESTION (Congestion fatigue muscle and joint pain), FATIGUE (Congestion fatigue muscle and joint pain), MYALGIA (Congestion fatigue muscle and joint pain) and ARTHRALGIA (Congestion fatigue muscle and joint pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056M21A, 032F21A, 040A21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's thyroiditis and Drug allergy (unspecified drug).   On 12-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021 at 3:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022 at 3:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022 at 2:00 PM, the patient experienced NASAL CONGESTION (Congestion fatigue muscle and joint pain), FATIGUE (Congestion fatigue muscle and joint pain), MYALGIA (Congestion fatigue muscle and joint pain) and ARTHRALGIA (Congestion fatigue muscle and joint pain). On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 08-May-2022 to 10-May-2022 for COVID-19, at a dose of 1 dosage form. At the time of the report, COVID-19 (COVID-19) outcome was unknown and NASAL CONGESTION (Congestion fatigue muscle and joint pain), FATIGUE (Congestion fatigue muscle and joint pain), MYALGIA (Congestion fatigue muscle and joint pain) and ARTHRALGIA (Congestion fatigue muscle and joint pain) had not resolved.            No concomitant medication was reported.  Company Comment: This is a spontaneous case concerning a 69-year-old female patient with no relevant medical history, who experienced the unexpected non-serious events of COVID-19(AESI) and Nasal congestion and the expected non-serious events of Fatigue, Myalgia, and Arthralgia. Event Covid-19 occurred unknown number of days in relation to dose 4 of mRNA-1273 while all the other events occurred 9 days after vaccination. The first 3 doses of mRNA-1273 vaccine were given 1 year 2 months 22 days, 1 year 2 months 2 days, and 6 months 3 days before the dose 4, respectively. Patient was treated for COVID-19 with Nirmatrelvir, Ritonavir (Paxlovid). The associated clinical manifestations of COVID-19, date of the initial diagnosis of COVID-19, and date of the initial COVID-19 test were not provided in this report. The patient's age remains a confounder for events COVID-19, Fatigue, Myalgia, and Arthralgia, as these have a higher incidence in patient's elderly age group. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-574031 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 69-year-old female patient with no relevant medical history, who experienced the unexpected non-serious events of COVID-19(AESI) and Nasal congestion and the expected non-serious events of Fatigue, Myalgia, and Arthralgia. Event Covid-19 occurred unknown number of days in relation to dose 4 of mRNA-1273 while all the other events occurred 9 days after vaccination. The first 3 doses of mRNA-1273 vaccine were given 1 year 2 months 22 days, 1 year 2 months 2 days, and 6 months 3 days before the dose 4, respectively. Patient was treated for COVID-19 with Nirmatrelvir, Ritonavir (Paxlovid). The associated clinical manifestations of COVID-19, date of the initial diagnosis of COVID-19, and date of the initial COVID-19 test were not provided in this report. The patient's age remains a confounder for events COVID-19, Fatigue, Myalgia, and Arthralgia, as these have a higher incidence in patient's elderly age group. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.