Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pyrexia, Tremor
Clinical narrative: advised by her HCP not to get second vaccine; exhaustion is more than debilitating; She has MS; She is exhausted,  and it is more than being tired/  This exhaustion is more than debilitating; still dizzy since the vaccine in April; Face is burning hot; Spasm; Flu; Body twists so hard; Shaking/ her entire body shakes after the first vaccine; hypothermia; Chills/ she is waking up with chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (She has MS) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 8482374) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pain NOS and Allergy to vaccine (ingredient PEG that was in the vaccine). Concomitant products included OXYCODONE HYDROCHLORIDE, PARACETAMOL (OXYCODONE AND ACETAMINOPHEN) for Pain, GABAPENTIN and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 15-Apr-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced BURNING SENSATION (Face is burning hot), MUSCLE SPASMS (Spasm), INFLUENZA (Flu), MUSCLE TWITCHING (Body twists so hard), TREMOR (Shaking/ her entire body shakes after the first vaccine) and CHILLS (Chills/ she is waking up with chills). 17-Apr-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (hypothermia) and PYREXIA (Fever). On an unknown date, the patient experienced MULTIPLE SCLEROSIS (She has MS) (seriousness criterion medically significant), OFF LABEL USE (advised by her HCP not to get second vaccine), ASTHENIA (exhaustion is more than debilitating), FATIGUE (She is exhausted,  and it is more than being tired/  This exhaustion is more than debilitating) and DIZZINESS (still dizzy since the vaccine in April). At the time of the report, MULTIPLE SCLEROSIS (She has MS), BURNING SENSATION (Face is burning hot), MUSCLE SPASMS (Spasm), INFLUENZA (Flu), MUSCLE TWITCHING (Body twists so hard), FEELING OF BODY TEMPERATURE CHANGE (hypothermia) and PYREXIA (Fever) outcome was unknown, TREMOR (Shaking/ her entire body shakes after the first vaccine), ASTHENIA (exhaustion is more than debilitating), CHILLS (Chills/ she is waking up with chills), FATIGUE (She is exhausted,  and it is more than being tired/  This exhaustion is more than debilitating) and DIZZINESS (still dizzy since the vaccine in April) had not resolved and OFF LABEL USE (advised by her HCP not to get second vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included maintenance medicines.  On an unspecified date the patient had blood work with results listed as normal.  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.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow-up included updates to address, allergies, events, and tests.; 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.