Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Rash
Clinical narrative: Covid arm bright red from their shoulder to below the elbow in both arms; Very very brighter in color on the arm of the injection/starting a little on the other arm; Quite sick/had a extensive response; Could barely sleep; Felt weak; Rash; A slight rash on the other non shot arm; Body aches all over; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Covid arm bright red from their shoulder to below the elbow in both arms), ERYTHEMA (Very very brighter in color on the arm of the injection/starting a little on the other arm), ILLNESS (Quite sick/had a extensive response), INSOMNIA (Could barely sleep) and ASTHENIA (Felt weak) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu shot (Flu shot years ago and was not able to use arm for 3days.). Past adverse reactions to the above products included Movements reduced with Flu shot. Concomitant products included LISINOPRIL, PANTOPRAZOLE, FAMOTIDINE, FISH OIL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced ERYTHEMA (Covid arm bright red from their shoulder to below the elbow in both arms), ERYTHEMA (Very very brighter in color on the arm of the injection/starting a little on the other arm), ILLNESS (Quite sick/had a extensive response), INSOMNIA (Could barely sleep), ASTHENIA (Felt weak), RASH (Rash), RASH (A slight rash on the other non shot arm) and MYALGIA (Body aches all over). In 2021, the patient experienced CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Covid arm bright red from their shoulder to below the elbow in both arms), ERYTHEMA (Very very brighter in color on the arm of the injection/starting a little on the other arm), RASH (Rash), RASH (A slight rash on the other non shot arm) and CHILLS (Chills) outcome was unknown and ILLNESS (Quite sick/had a extensive response), INSOMNIA (Could barely sleep), ASTHENIA (Felt weak) and MYALGIA (Body aches all over) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: high (High) 100.1 F (normal temperature is under 98.6°F).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient had rash but not all over body. It was reported after the 2nd shot it was brighter and went from shoulder down to elbow and patient think a little below.  A slight rash on the other non shot arm but that was in March, was reported. Patient reported she could sleep, felt weak, just to correct so that she not confirming that she could not sleep.   This case was linked to MOD-2021-372470 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Significant follow up appended on 04-NOV-2021 and event updated with correction.