Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Chills, Full blood count, Inflammation, Muscle spasms
Clinical narrative: I had muscle spasms in both thighs, I couldn't even move.; terrible pain all over my body; My blood work showed that my inflammation level is elevated.; I have a little arthritis.; terrible pain in my neck; muscle pain in my thighs/in my hips/upper arms; I couldn't clinch my fists, because it was very painful; chills; muscle pain in my thighs,hips/muscle pain in my upper arms; I couldn't clinch my fists, because it was very painful/terrible pain all over my body; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (muscle pain in my thighs,hips/muscle pain in my upper arms), PAIN (I couldn't clinch my fists, because it was very painful/terrible pain all over my body), MYALGIA (muscle pain in my thighs/in my hips/upper arms), PAIN (I couldn't clinch my fists, because it was very painful), NECK PAIN (terrible pain in my neck), PAIN (terrible pain all over my body), MUSCLE SPASMS (I had muscle spasms in both thighs, I couldn't even move.), INFLAMMATION (My blood work showed that my inflammation level is elevated.) and ARTHRITIS (I have a little arthritis.) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 003B21A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN from an unknown date to 21-Jun-2021 for Cholesterol.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced CHILLS (chills) (seriousness criterion medically significant), MYALGIA (muscle pain in my thighs,hips/muscle pain in my upper arms) (seriousness criterion medically significant) and PAIN (I couldn't clinch my fists, because it was very painful/terrible pain all over my body) (seriousness criterion medically significant). On 02-Apr-2021, the patient experienced MYALGIA (muscle pain in my thighs/in my hips/upper arms) (seriousness criterion medically significant) and PAIN (I couldn't clinch my fists, because it was very painful) (seriousness criterion medically significant). On 19-Jul-2021, the patient experienced NECK PAIN (terrible pain in my neck) (seriousness criterion medically significant). On 15-Sep-2021, the patient experienced INFLAMMATION (My blood work showed that my inflammation level is elevated.) (seriousness criterion medically significant) and ARTHRITIS (I have a little arthritis.) (seriousness criterion medically significant). On 08-Oct-2021, the patient experienced PAIN (terrible pain all over my body) (seriousness criterion medically significant). On 16-Oct-2021, the patient experienced MUSCLE SPASMS (I had muscle spasms in both thighs, I couldn't even move.) (seriousness criterion medically significant). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, CHILLS (chills), MYALGIA (muscle pain in my thighs,hips/muscle pain in my upper arms), PAIN (I couldn't clinch my fists, because it was very painful/terrible pain all over my body), MYALGIA (muscle pain in my thighs/in my hips/upper arms), PAIN (I couldn't clinch my fists, because it was very painful), NECK PAIN (terrible pain in my neck), PAIN (terrible pain all over my body), MUSCLE SPASMS (I had muscle spasms in both thighs, I couldn't even move.), INFLAMMATION (My blood work showed that my inflammation level is elevated.) and ARTHRITIS (I have a little arthritis.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Full blood count: inflammation level is elevated.. In September 2021, X-ray: . No results were reported.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company Comment: This RA case concerns a 78 year old female with no reported history who experienced the serious unlisted events of Arthritis, Myalgia, Pain and inflammation beginning a week after the second dose of mRNA-1273. Re-challenge is not applicable as no events occurred with dose and this is dose 2. Benefit-risk relationship of mRNA-1273 is not affected by this report. The events are all assessed as serious by the RA; however, no information in the source documents supports serious criteria being met.; Sender's Comments: This RA case concerns a 78 year old female with no reported history who experienced the serious unlisted events of Arthritis, Myalgia, Pain and inflammation beginning a week after the second dose of mRNA-1273. Re-challenge is not applicable as no events occurred with dose and this is dose 2. Benefit-risk relationship of mRNA-1273 is not affected by this report. The events are all assessed as serious by the RA; however, no information in the source documents supports serious criteria being met.