Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Erythema, Feeling hot, Headache, Nausea
Clinical narrative: shot reaction; arm itchy; redness and rash spread out up above the elbow, to the top of shoulder; left arm was swollen up; totally red, redness spread out up above the elbow, to the top of the shoulder; hot arm; had a rash on left arm; nausea; headache; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 26-May-2021. The most recent information was received on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm was swollen up), ERYTHEMA (totally red, redness spread out up above the elbow, to the top of the shoulder), FEELING HOT (hot arm), VACCINATION SITE REACTION (shot reaction) and PRURITUS (arm itchy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO) for an unknown indication.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced NAUSEA (nausea) and HEADACHE (headache). On 25-May-2021, the patient experienced PERIPHERAL SWELLING (left arm was swollen up), ERYTHEMA (totally red, redness spread out up above the elbow, to the top of the shoulder), FEELING HOT (hot arm), PRURITUS (arm itchy), RASH (redness and rash spread out up above the elbow, to the top of shoulder) and VACCINATION SITE RASH (had a rash on left arm). On an unknown date, the patient experienced VACCINATION SITE REACTION (shot reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 25-May-2021 for Peripheral swelling, at a dose of 1 dosage form and Manual therapy (Applied ice packs) for Peripheral swelling. On 15-May-2021, NAUSEA (nausea) and HEADACHE (headache) had resolved. At the time of the report, PERIPHERAL SWELLING (left arm was swollen up), ERYTHEMA (totally red, redness spread out up above the elbow, to the top of the shoulder), RASH (redness and rash spread out up above the elbow, to the top of shoulder) and VACCINATION SITE RASH (had a rash on left arm) had not resolved and FEELING HOT (hot arm), VACCINATION SITE REACTION (shot reaction) and PRURITUS (arm itchy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jul-2021, Body temperature increased: 101 F temperature.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.     Preferred mode of contact for follow up is email. Patient used ice packs to treat the swelling that started on 25 May 2021.  After receiving the second dose of the Moderna vaccine, on 01 Jul 2021, the patient almost had a seizure, and her body was shaking from head to feet. She also had 101F temperature, and her left arm was swollen up and itched from the inside out. The patient also had a rash on her left arm, but the itch now is not as severe, but she still has it. The patient's second dose also deviated, as it was 49 days later.   This case was linked to MOD-2021-249209 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Non-significant follow-up appended to AER On 02-Jun-2021: Non significant follow-up appended On 06-Jul-2021: Significant Follow-up information received: Additional reporter information and Patient information.