Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Headache, Myalgia, Ocular discomfort
Clinical narrative: Stomach upset; got booster shot and had a reaction; eyes didn't look great/looked bad; body ached; headache; arm hurt where injected, Arm was sore; temperature of 102°F; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset), VACCINATION COMPLICATION (got booster shot and had a reaction), OCULAR DISCOMFORT (eyes didn't look great/looked bad), MYALGIA (body ached) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: FLU (The vaccination (FLU WALGREENS) Performed on 10-2021 on left arm.) in 2021. Past adverse reactions to the above products included No adverse event with FLU. Concomitant products included VILAZODONE HYDROCHLORIDE (VIIBRYD) from 2021 to an unknown date and ROSUVASTATIN from 2010 to an unknown date for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-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 ABDOMINAL DISCOMFORT (Stomach upset), VACCINATION COMPLICATION (got booster shot and had a reaction), OCULAR DISCOMFORT (eyes didn't look great/looked bad), MYALGIA (body ached), HEADACHE (headache), VACCINATION SITE PAIN (arm hurt where injected, Arm was sore) and PYREXIA (temperature of 102°F). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Stomach upset) had not resolved and VACCINATION COMPLICATION (got booster shot and had a reaction), OCULAR DISCOMFORT (eyes didn't look great/looked bad), MYALGIA (body ached), HEADACHE (headache), VACCINATION SITE PAIN (arm hurt where injected, Arm was sore) and PYREXIA (temperature of 102°F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102°F.         This is a Spontaneous case concerning a 65-year-old, female patient with non reported medical history,  who experienced the unexpected non serious events of abdominal discomfort, vaccination complication, ocular discomfort and the expected non serious event of myalgia, pyrexia, headache and vaccination site pain. The event occurred after the third dose of mRNA 1273 vaccine. The Benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow up received. added patient demographic (height and weight), medical history. added concomitant medications. New event added.; Sender's Comments: This is a Spontaneous case concerning a 65-year-old, female patient with non reported medical history,  who experienced the unexpected non serious events of abdominal discomfort, vaccination complication, ocular discomfort and the expected non serious event of myalgia, pyrexia, headache and vaccination site pain. The event occurred after the third dose of mRNA 1273 vaccine. The Benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.