Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Muscle rigidity, Myalgia
Clinical narrative: Really hard; Bodyache; Chills; Headaches; Really swollen today/Has been swollen/Swelling; Really tired/Tired; Heart palpitations; site of the shot got hot last night; premature ventricular contractions; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (site of the shot got hot last night), VENTRICULAR EXTRASYSTOLES (premature ventricular contractions), MUSCLE RIGIDITY (Really hard), PALPITATIONS (Heart palpitations) and MYALGIA (Bodyache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Stent placement and Premature ventricular contractions. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.   On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced VENTRICULAR EXTRASYSTOLES (premature ventricular contractions). On 25-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE WARMTH (site of the shot got hot last night), PALPITATIONS (Heart palpitations) and FATIGUE (Really tired/Tired). On 26-Sep-2021, the patient experienced VACCINATION SITE SWELLING (Really swollen today/Has been swollen/Swelling). On 27-Sep-2021, the patient experienced MUSCLE RIGIDITY (Really hard), CHILLS (Chills) and HEADACHE (Headaches). 27-Sep-2021, the patient experienced MYALGIA (Bodyache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (site of the shot got hot last night), MUSCLE RIGIDITY (Really hard), PALPITATIONS (Heart palpitations), MYALGIA (Bodyache), FATIGUE (Really tired/Tired), CHILLS (Chills) and HEADACHE (Headaches) outcome was unknown, VENTRICULAR EXTRASYSTOLES (premature ventricular contractions) had resolved and VACCINATION SITE SWELLING (Really swollen today/Has been swollen/Swelling) had not resolved.            Tylenol was given as treatment medication for adverse event.   This case was linked to MOD-2021-333788 (Patient Link).; Sender's Comments: This case concerns a 61-year-old, female patient with relevant medical history of Premature ventricular contractions, who experienced the unexpected non serious events of vaccination site warmth, swelling, palpitations, pain in extremity, premature ventricular contractions and condition aggravated and expected events of fatigue, chills, headache, vaccination site swelling and myalgia. The events occurred approximately 1  to 2 days after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as events occurred after second dose and no further dosing was reported or planned, based on information provided.  The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.