Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Pain in extremity, Vaccination site injury, Vaccination site pain
Clinical narrative: this last shot hurt badly when administered; Red round sores on the front of their legs on their thigs; Are painful/red marks hurt/lesions hurt; This last shot hurt badly when administered and the patient feels it hit the bone; Afterwards it developed a really huge rash at injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red round sores on the front of their legs on their thigs), PAIN IN EXTREMITY (Are painful/red marks hurt/lesions hurt), VACCINATION SITE INJURY (This last shot hurt badly when administered and the patient feels it hit the bone), VACCINATION SITE RASH (Afterwards it developed a really huge rash at injection site) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0161321A and 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia (diagnosed 6 months ago). Concurrent medical conditions included Osteoarthritis (diagnosed 6 months ago) and Osteoporosis (diagnosed 6 months ago). Concomitant products included TRAMADOL for Pain.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced ERYTHEMA (Red round sores on the front of their legs on their thigs), PAIN IN EXTREMITY (Are painful/red marks hurt/lesions hurt), VACCINATION SITE INJURY (This last shot hurt badly when administered and the patient feels it hit the bone), VACCINATION SITE RASH (Afterwards it developed a really huge rash at injection site) and HEADACHE (Headache). On 29-May-2021, the patient experienced VACCINATION SITE PAIN (this last shot hurt badly when administered). At the time of the report, ERYTHEMA (Red round sores on the front of their legs on their thigs) and PAIN IN EXTREMITY (Are painful/red marks hurt/lesions hurt) had not resolved and VACCINATION SITE INJURY (This last shot hurt badly when administered and the patient feels it hit the bone), VACCINATION SITE RASH (Afterwards it developed a really huge rash at injection site), HEADACHE (Headache) and VACCINATION SITE PAIN (this last shot hurt badly when administered) outcome was unknown.            Treatment medications ointment Q10.  Patient states they have fibromyalgia, osteoarthritis, and osteoporosis, diagnosed 6 months ago.  This is a spontaneous case concerning a 70-year-old female patient with medical history of Fibromyalgia, osteoporosis and osteoarthritis, who experienced the non-serious  unexpected events pain in extremity and erythema and expected vaccination site pain, vaccination site rash and headache. The events occurred approximately between one and three days after the second  dose of mRNA-1273 Moderna vaccine.  The medical history of Fibromyalgia and osteoarthritis  could be a potentially confounder for events pain in extremity and vaccination site pain. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.Sender's Comments: This is a spontaneous case concerning a 70-year-old female patient with medical history of Fibromyalgia, osteoporosis and osteoarthritis, who experienced the non-serious  unexpected events pain in extremity and erythema and expected vaccination site pain, vaccination site rash and headache. The events occurred approximately between one and three days after the second  dose of mRNA-1273 Moderna vaccine.  The medical history of Fibromyalgia and osteoarthritis  could be a potentially confounder for events pain in extremity and vaccination site pain. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.