Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches from head to toe which made her barely able to walk and really painful even to seat on the toilet), HEART RATE DECREASED (low heart pulse of 43bpm), PAIN IN EXTREMITY (a very very sore arm not only at the injection site but also her entire upper arm), CHEST DISCOMFORT (a little bit of pressure on her chest) and BREAST PAIN (pain on both breasts) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Liver fatty deposit (NASH Contribution due to birth control pills) on 01-Jan-2010, Asthma on 01-Jan-1995, Polycystic ovarian syndrome on 05-Jan-2018, Ovarian abscess on 15-Dec-2020, Irregular menstruation on 03-Jan-1996 and Hormone level abnormal on 01-Jan-2005. Concurrent medical conditions included Anaemia since 01-Jun-2020. Concomitant products included MULTI VITAMIN & MINERAL from 01-Jan-2020 to an unknown date for Healthcare associated pneumonia. On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced MYALGIA (body aches from head to toe which made her barely able to walk and really painful even to seat on the toilet), HEART RATE DECREASED (low heart pulse of 43bpm), PAIN IN EXTREMITY (a very very sore arm not only at the injection site but also her entire upper arm), CHEST DISCOMFORT (a little bit of pressure on her chest), BREAST PAIN (pain on both breasts), BALANCE DISORDER (Loss of balance), FEELING HOT (very very hot body even though the fever was not that high), CHILLS (chills), PYREXIA (a fluctuating fever from 99.1-100°F) and FATIGUE (extreme fatigue). On an unknown date, the patient experienced CHEST PAIN (chest hurts). On 01-Feb-2021, MYALGIA (body aches from head to toe which made her barely able to walk and really painful even to seat on the toilet), HEART RATE DECREASED (low heart pulse of 43bpm), PAIN IN EXTREMITY (a very very sore arm not only at the injection site but also her entire upper arm), CHEST DISCOMFORT (a little bit of pressure on her chest), BREAST PAIN (pain on both breasts), BALANCE DISORDER (Loss of balance), FEELING HOT (very very hot body even though the fever was not that high), CHILLS (chills), PYREXIA (a fluctuating fever from 99.1-100°F) and FATIGUE (extreme fatigue) had resolved. At the time of the report, CHEST PAIN (chest hurts) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.1-100 Fahrenheit. On an unknown date, Heart rate: 43 43 bpm. No treatment product information was provided. Action taken with mRNA-1273 in response to the event was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2021: Upon internal Review on 20-Sept-2022, non-significant correction was  performed to update case level seriousness. On 20-Apr-2021: Follow up information included patient demographic details, medical history and outcome of the events. On 25-Jun-2021: Follow up information included additional event and seriousness criteria were updated. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.