Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Diarrhoea, Feeling hot, Illness, Pain in extremity
Clinical narrative: Shooting pain down to her fingers; There is a knot at the injection site; had a fever; arm is very sore around the injection site; had a fever, I was a little warm, I could feel my body was heating up"; "had diarrhea real bad"; "something's not right, felt like, when she put the needle in, something broke off"; Became very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Became very sick), PAIN IN EXTREMITY (Shooting pain down to her fingers), VACCINATION SITE NODULE (There is a knot at the injection site), DEVICE CONNECTION ISSUE ("something's not right, felt like, when she put the needle in, something broke off") and FEELING HOT (had a fever, I was a little warm, I could feel my body was heating up") in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Diarrhea.    Concurrent medical conditions included Restless leg syndrome. Concomitant products included ROPINIROLE for Restless leg syndrome, AMITRIPTYLINE for Sleep loss, CLONAZEPAM and DIAZEPAM (VALIUM) for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced ILLNESS (Became very sick) and DEVICE CONNECTION ISSUE ("something's not right, felt like, when she put the needle in, something broke off"). On 30-Apr-2021, the patient experienced FEELING HOT (had a fever, I was a little warm, I could feel my body was heating up") and DIARRHOEA ("had diarrhea real bad"). On 06-May-2021, the patient experienced VACCINATION SITE PAIN (arm is very sore around the injection site). On an unknown date, the patient experienced PAIN IN EXTREMITY (Shooting pain down to her fingers) and VACCINATION SITE NODULE (There is a knot at the injection site). an unknown date, the patient experienced PYREXIA (had a fever). On 01-May-2021, FEELING HOT (had a fever, I was a little warm, I could feel my body was heating up") had resolved. At the time of the report, ILLNESS (Became very sick), PAIN IN EXTREMITY (Shooting pain down to her fingers), VACCINATION SITE NODULE (There is a knot at the injection site), DEVICE CONNECTION ISSUE ("something's not right, felt like, when she put the needle in, something broke off"), DIARRHOEA ("had diarrhea real bad"), VACCINATION SITE PAIN (arm is very sore around the injection site) and PYREXIA (had a fever) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the drug was not applicable. The patient reported that the  diarrhea started on 30APR2021 at "2 or 3 in the morning" and lasted about 2 days.