Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Tenderness, Urticaria, Vaccination site pain, Vaccination site swelling
Clinical narrative: left arm tender; put ice on her left arm; fever; sore, like a "cold sore" under her middle of lower lip /another "cold sore" was present on the left side of her lower lip; laid down and slept; two hives on chest; Felt worse; itchy; felt sick; hives on chest better but still presenredt and; left arm hurting; bad chills; headache; the site of injection,the consumer endorsed pain, swelling, tenderness and /left arm swollen like a grapefruit; At the site of injection, the consumer endorsed pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt sick), TENDERNESS (left arm tender), URTICARIA (two hives on chest), FEELING ABNORMAL (Felt worse) and ERYTHEMA (hives on chest better but still presenredt and) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SIMVASTATIN for Hypercholesterolaemia, AMLODIPINE for Hypertension, MELOXICAM and TRAMADOL for Pain, METHOTREXATE, TOFACITINIB CITRATE (XELJANZ XR), TIZANIDINE and DULOXETINE for Rheumatoid arthritis, SERTRALINE HYDROCHLORIDE (ZOLOFT) and FOLIC ACID for an unknown indication.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced MALAISE (felt sick), ERYTHEMA (hives on chest better but still presenredt and), PAIN IN EXTREMITY (left arm hurting), CHILLS (bad chills), HEADACHE (headache), VACCINATION SITE SWELLING (the site of injection,the consumer endorsed pain, swelling, tenderness and /left arm swollen like a grapefruit) and VACCINATION SITE PAIN (At the site of injection, the consumer endorsed pain). On 21-May-2021, the patient experienced URTICARIA (two hives on chest), FEELING ABNORMAL (Felt worse), PRURITUS (itchy) and SOMNOLENCE (laid down and slept). On 23-May-2021, the patient experienced ORAL HERPES (sore, like a "cold sore" under her middle of lower lip /another "cold sore" was present on the left side of her lower lip). On an unknown date, the patient experienced TENDERNESS (left arm tender), LIMB DISCOMFORT (put ice on her left arm) and PYREXIA (fever). On 22-May-2021, MALAISE (felt sick), FEELING ABNORMAL (Felt worse), SOMNOLENCE (laid down and slept) and CHILLS (bad chills) outcome was unknown. On 24-May-2021, ERYTHEMA (hives on chest better but still presenredt and) outcome was unknown. At the time of the report, TENDERNESS (left arm tender), URTICARIA (two hives on chest), LIMB DISCOMFORT (put ice on her left arm), PRURITUS (itchy), ORAL HERPES (sore, like a "cold sore" under her middle of lower lip /another "cold sore" was present on the left side of her lower lip), PAIN IN EXTREMITY (left arm hurting), HEADACHE (headache), VACCINATION SITE SWELLING (the site of injection,the consumer endorsed pain, swelling, tenderness and /left arm swollen like a grapefruit), VACCINATION SITE PAIN (At the site of injection, the consumer endorsed pain) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received Dose 1 of the COVID-19 vaccine on 20May2021 in the left, upper arm around 12 noon. By the evening, she began to feel sick. She endorsed having a headache, bad chills and a painful left arm. She woke up in the morning of 21May2021 ( around 3am -4am) and noticed the hives on her chest and put hydrocortisone on it as it was also itchy. She stated she felt tired and slept. Then on 23May2021, she saw that she developed a sore, like a "cold sore" under her middle of lower lip. Then this morning today, 24May2021, another "cold sore" was present on the left side of her lower lip. She began to take Benadryl, 25mg tablet. Consumer also stated that the hives are improved but still present; hives are still red. Lastly, consumer stated that her left arm has been sore since the day of injection, 20May2021. At the site of injection, the consumer endorsed pain, swelling, tenderness and stated that the swelling is the size of a grapefruit. She tried placing ice on her arm but the swelling and pain is still present; her arm signs and symptoms are still persistent today and she has been taking Advil, every 6-8hrs since Friday. Of note, patient stated she has a history of Rheumatoid Arthritis and her rheumatologist advised her to hold off on her Rheumatoid Arthritis medications until her COVID-19 vaccination is complete. She also has a history of penicillin allergy