Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Moderna arm; Felt hot at vaccination site; Itchy at vaccination site; A red spot about 2 inches by 4 inches on left arm midway between my shoulder and elbow where I got the vaccine; Sore at vaccination site; Back of her hand covered in red/ knuckles, face and neck were red down to my chest ,looked like a terrible sunburn; Her face was getting warm; Diarrhea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (Back of her hand covered in red/ knuckles, face and neck were red down to my chest ,looked like a terrible sunburn), HOT FLUSH (Her face was getting warm), DIARRHOEA (Diarrhea), VACCINATION SITE REACTION (Moderna arm) and VACCINATION SITE WARMTH (Felt hot at vaccination site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Drug allergy (Lisinipril). Concomitant products included ATENOLOL, LOSARTAN, PRAVASTATIN, OMEPRAZOLE, CALCIUM and VITAMIN D NOS for an unknown indication.   On 09-Feb-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021 at 2:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced ERYTHEMA (Back of her hand covered in red/ knuckles, face and neck were red down to my chest ,looked like a terrible sunburn), HOT FLUSH (Her face was getting warm) and DIARRHOEA (Diarrhea). On 21-Feb-2021, the patient experienced VACCINATION SITE REACTION (Moderna arm), VACCINATION SITE WARMTH (Felt hot at vaccination site), VACCINATION SITE PRURITUS (Itchy at vaccination site), VACCINATION SITE ERYTHEMA (A red spot about 2 inches by 4 inches on left arm midway between my shoulder and elbow where I got the vaccine) and VACCINATION SITE PAIN (Sore at vaccination site). On 09-Feb-2021, ERYTHEMA (Back of her hand covered in red/ knuckles, face and neck were red down to my chest ,looked like a terrible sunburn), HOT FLUSH (Her face was getting warm) and DIARRHOEA (Diarrhea) had resolved. At the time of the report, VACCINATION SITE REACTION (Moderna arm), VACCINATION SITE WARMTH (Felt hot at vaccination site), VACCINATION SITE PRURITUS (Itchy at vaccination site), VACCINATION SITE ERYTHEMA (A red spot about 2 inches by 4 inches on left arm midway between my shoulder and elbow where I got the vaccine) and VACCINATION SITE PAIN (Sore at vaccination site) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: increased (High) Temperature was way below normal 94.9 F/ temperature dropped/ temperature went down to 95.5 to 94.9 and increased (High) Temperature went upto 96.0 to 97.2/ temperature continued to rise overnight and was 97.6. On an unknown date, Heart rate: increased (High) Heart rate was elevated/ heart rate was 80-90 which was high and decreased (Low) Heart rate was down to 73 at 10:30 pm and 62 at 7:15 am.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included diphenhydramine (Benadryl), paracetamol (Tylenol) and cetirizine (Zyrtec).  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events are not applicable.   This case was linked to MOD-2021-089964 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow-up received on 23-APR-2021 included: Added  HCP contact details, patient demographics, patient medical history (allergies), details of 2nd dose of vaccine (start date/time, lot number, body site), concomitant medications, start date and stop date of all events, new events (Moderna arm, red spot at vaccination site, hot, sore and itchy at vaccination site) were added.