Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: COVID-19; felt ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), MYALGIA (felt ache) and PYREXIA (fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B and 011L20A) for COVID-19 vaccination.     No allergies were reported.  Previously administered products included for Product used for unknown indication: Flu shot in October 2021. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Blood pressure high, Hypercholesterolaemia and Thyroid disorder.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced MYALGIA (felt ache) and PYREXIA (fever). On 09-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19), MYALGIA (felt ache) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medication included blood pressure medicine, cholesterol medicine and thyroid medicine. Treatment included Paxlovid from Pfizer, that contains nirmatrelvir and ritonavir. It was reported that after cruise on 08-Apr-2022 patient felt sick and on 09-Apr-2022 developed COVID-19, 5 months after first booster and went to urgent care. Patient wanted to know that how long to wait to get the second booster, and if someone had Pfizer could they take the Moderna Booster.  It was also reported that patient had no similar events in the past.  Company comment-This Spontaneous case concerns a 72-year-old, female patient with no relevant medical history reported, who experienced non serious unexpected AESI event of COVID 19 (with a positive SARS-CoV-2 test), 4 months 21 days after the first booster dose. She had fever and myalgia after the first booster. Patient reported that after a cruise, on 8th April she was sick, the next day she developed Covid -19. She went to the emergency treated with paxlovid (nirmatrelvir and ritonavir). At the time of the reporting, outcome of the event was resolved. The current pandemic situation of COVID 19 may remain a confounder, history of travel and elderly age of the patient could be risk factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report; Sender's Comments: This Spontaneous case concerns a 72-year-old, female patient with no relevant medical history reported, who experienced non serious unexpected AESI event of COVID 19 (with a positive SARS-CoV-2 test), 4 months 21 days after the first booster dose. She had fever and myalgia after the first booster. Patient reported that after a cruise, on 8th April she was sick, the next day she developed Covid -19. She went to the emergency treated with paxlovid (nirmatrelvir and ritonavir). At the time of the reporting, outcome of the event was resolved. The current pandemic situation of COVID 19 may remain a confounder, history of travel and elderly age of the patient could be risk factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report