Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Erythema, Pyrexia, Tenderness, Vaccination site swelling
Clinical narrative: left arm hurt like crazy/My arm was so sore that I could not put my arm over my head.; Arm was red hot raised and swollen; feverish; at the injection site the arm was swollen to the size of a baseball.; at the injection site the arm was swollen to the size of a baseball.; feverish; Arm was red hot raised and swollen; left arm hurt like crazy/My arm was so sore that I could not put my arm over my head.; weakness in both of her legs. The leg weakness was very poor. The patient associated her leg weakness with her spinal stenosis however at times the patient thought that her leg weakness maybe due to the vaccine.; left arm hurt like crazy/My arm was so sore that I could not put my arm over my head.; Arm was red hot raised and swollen; feverish; at the injection site the arm was swollen to the size of a baseball.; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness in both of her legs. The leg weakness was very poor. The patient associated her leg weakness with her spinal stenosis however at times the patient thought that her leg weakness maybe due to the vaccine.), the first episode of TENDERNESS (left arm hurt like crazy/My arm was so sore that I could not put my arm over my head.), the first episode of ERYTHEMA (Arm was red hot raised and swollen), the third episode of TENDERNESS (left arm hurt like crazy/My arm was so sore that I could not put my arm over my head.) and the second episode of TENDERNESS (left arm hurt like crazy/My arm was so sore that I could not put my arm over my head.) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7171B and 251F21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Spinal stenosis (patient had lost 3&1/2 inches in height since May of 2018.) since May 2018.   On 08-Nov-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-May-2023, received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced the first episode of TENDERNESS (left arm hurt like crazy/My arm was so sore that I could not put my arm over my head.), the first episode of ERYTHEMA (Arm was red hot raised and swollen), the first episode of PYREXIA (feverish) and the first episode of VACCINATION SITE SWELLING (at the injection site the arm was swollen to the size of a baseball.). On 31-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced ASTHENIA (weakness in both of her legs. The leg weakness was very poor. The patient associated her leg weakness with her spinal stenosis however at times the patient thought that her leg weakness maybe due to the vaccine.), the second episode of TENDERNESS (left arm hurt like crazy/My arm was so sore that I could not put my arm over my head.), the second episode of ERYTHEMA (Arm was red hot raised and swollen), the second episode of PYREXIA (feverish) and the second episode of VACCINATION SITE SWELLING (at the injection site the arm was swollen to the size of a baseball.). On an unknown date, the patient experienced the third episode of TENDERNESS (left arm hurt like crazy/My arm was so sore that I could not put my arm over my head.), the third episode of ERYTHEMA (Arm was red hot raised and swollen), the third episode of PYREXIA (feverish) and the third episode of VACCINATION SITE SWELLING (at the injection site the arm was swollen to the size of a baseball.). At the time of the report, ASTHENIA (weakness in both of her legs. The leg weakness was very poor. The patient associated her leg weakness with her spinal stenosis however at times the patient thought that her leg weakness maybe due to the vaccine.), the last episode of TENDERNESS (left arm hurt like crazy/My arm was so sore that I could not put my arm over my head.), the last episode of ERYTHEMA (Arm was red hot raised and swollen), the last episode of PYREXIA (feverish) and the last episode of VACCINATION SITE SWELLING (at the injection site the arm was swollen to the size of a baseball.) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered ASTHENIA (weakness in both of her legs. The leg weakness was very poor. The patient associated her leg weakness with her spinal stenosis however at times the patient thought that her leg weakness maybe due to the vaccine.) to be related. No further causality assessments were provided for TENDERNESS (left arm hurt like crazy/My arm was so sore that I could not put my arm over my head.), ERYTHEMA (Arm was red hot raised and swollen), TENDERNESS (left arm hurt like crazy/My arm was so sore that I could not put my arm over my head.), TENDERNESS (left arm hurt like crazy/My arm was so sore that I could not put my arm over my head.), ERYTHEMA (Arm was red hot raised and swollen), ERYTHEMA (Arm was red hot raised and swollen), PYREXIA (feverish), PYREXIA (feverish), PYREXIA (feverish), VACCINATION SITE SWELLING (at the injection site the arm was swollen to the size of a baseball.), VACCINATION SITE SWELLING (at the injection site the arm was swollen to the size of a baseball.) and VACCINATION SITE SWELLING (at the injection site the arm was swollen to the size of a baseball.).    No relevant concomitant medications were reported. The patient received her second Moderna Covid-19 booster vaccine on September 26. The events left arm hurt like crazy, injection site the arm was swollen to the size of a baseball, arm was red hot raised and swollen, feverish were all ended after a week of each vaccination. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-053248 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-053248:Same patient, different dose (MODERNA COVID-19 VACCINE, BIVALENT)