Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: Burning Sensation; felt coolness all the way through the bone; Arm turned red where shot was given 11 days; Place was stinging; Place was itching; Soreness / very sore; Redness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), BURNING SENSATION (Burning Sensation), FEELING COLD (felt coolness all the way through the bone), MYALGIA (Soreness / very sore) and VACCINATION SITE ERYTHEMA (Arm turned red where shot was given 11 days) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Sulfa drugs), Drug allergy (Carbamazepine), Migraine, Degenerative arthritis spine, Chronic diastolic heart failure and Scoliosis. Concomitant products included OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for Back pain, TOPIRAMATE (TOPAMAX) for Migraine, ALPRAZOLAM (XANAX), GABAPENTIN (NEURONTIN) and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.    On 18-Jan-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced ERYTHEMA (Redness) and MYALGIA (Soreness / very sore). On 29-Jan-2021, the patient experienced FEELING COLD (felt coolness all the way through the bone), VACCINATION SITE ERYTHEMA (Arm turned red where shot was given 11 days), VACCINATION SITE PAIN (Place was stinging) and VACCINATION SITE PRURITUS (Place was itching). On 02-Feb-2021, the patient experienced BURNING SENSATION (Burning Sensation). On 15-Feb-2021, ERYTHEMA (Redness), BURNING SENSATION (Burning Sensation), FEELING COLD (felt coolness all the way through the bone), MYALGIA (Soreness / very sore), VACCINATION SITE ERYTHEMA (Arm turned red where shot was given 11 days), VACCINATION SITE PAIN (Place was stinging) and VACCINATION SITE PRURITUS (Place was itching) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient states that Arm turned red where shot was given 11 days after & was approximately 3" x 6" in size. Place was stinging, itching, felt coolness all the way through the bone, burning sensation & very sore. Finally went away after a little over 2 weeks.  No  treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up information received on 15-JUL-2021 contains significant information. Added  patient email address, Address, Patient demographic details like height, weight, Race information, Other relevant history, Concomitant medications ,Vaccine Facility Information, Events like vaccination site  erythema, Vaccination site pruritis , Feeling cold, Vaccination site pain, Event onset dates, Outcome of event.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.