Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain
Clinical narrative: tested COVID-19 positive on Jan2022; 1st booster she felt aches a lot for about a week; This spontaneous case was reported by a patient and describes the occurrence of PAIN (1st booster she felt aches a lot for about a week) and COVID-19 (tested COVID-19 positive on Jan2022) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Flu vaccination (flu shot on 2021 before the first booster) in 2021. Concurrent medical conditions included Bee sting hypersensitivity (Bumblebees).   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 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 PAIN (1st booster she felt aches a lot for about a week). In January 2022, the patient experienced COVID-19 (tested COVID-19 positive on Jan2022). In November 2021, PAIN (1st booster she felt aches a lot for about a week) had resolved. At the time of the report, COVID-19 (tested COVID-19 positive on Jan2022) outcome was unknown.            The patient was under a lot of concomitant and regular medications, but not provided names.  Patient didn't had any history of myocarditis or pericarditis.  Treatment and hospitalization due to COVID-19 was unknown.  Company comment: This is a spontaneous case concerning a 81-year-old, female patient with no relevant medical history. The patient has vaccination history of receiving first and second dose of mRNA-1273 vaccine with unknown dosage interval. It was reported that the patient experienced pain (a few aches) after the first and second dose of mRNA-1273 vaccine administration. The patient experienced the unexpected non-serious AESI event of Covid-19, and the unexpected non-serious event of pain. The event Covid-19 occurred approximately 2 months after the third dose (first booster) of mRNA-1273 vaccine administration. The event pain occurred the same month after the third dose (first booster) of mRNA-1273 vaccine administration. The rechallenge was reported as positive for the event pain. No further clinical information was available for medical review. The outcome of the event Covid-19 was unknown, while the event pain the outcome was reported as resolved. The current Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-635781, MOD-2022-635787 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 81-year-old, female patient with no relevant medical history. The patient has vaccination history of receiving first and second dose of mRNA-1273 vaccine with unknown dosage interval. It was reported that the patient experienced pain (a few aches) after the first and second dose of mRNA-1273 vaccine administration. The patient experienced the unexpected non-serious AESI event of Covid-19, and the unexpected non-serious event of pain. The event Covid-19 occurred approximately 2 months after the third dose (first booster) of mRNA-1273 vaccine administration. The event pain occurred the same month after the third dose (first booster) of mRNA-1273 vaccine administration. The rechallenge was reported as positive for the event pain. No further clinical information was available for medical review. The outcome of the event Covid-19 was unknown, while the event pain the outcome was reported as resolved. The current Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.