Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site inflammation, Injection site nodule, Injection site reaction, Injection site swelling
Clinical narrative: Injection site had two nodules,nodules 2.5 inches then nodules became 4 inches; Injection site inflamed; Injection site raised; Lot of arm pain; Arm warm to touch; Headache; Vaccine given subcutaneously; Extreme fatigue; Joint pain; Muscle aches; Swelling at the injection site; Redness at the injection site; Red mark down the arm; A spontaneous report  was received from a 50-year old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) was given subcutaneously by the pharmacist resulting in the event and also experienced redness and swelling on the injection site, headache, fatigue, joint pain, red mark down the arm, lot of arm pain, arm was warm to touch, muscle aches, injection site had 2 nodules which got really red, injection site raised and inflamed.  The patient's current medical history was reported as allergic to Penicillin and Sulfa drugs. Concomitant medications were Vitamins.  On 13 Jan 2021, the patient received their first dose of two planned doses of MRNA-1273 (Lot Number: 041L20A) subcutaneously for prophylaxis of COVID-19 infection.  On 13th Jan 2021, the patient received the mRNA-1273 vaccine subcutaneously, which was told by another pharmacist. No treatment for the event was provided.  On an unknown date, she experienced redness and swelling on the injection site, headache, fatigue, joint pain, red mark down the arm, and muscle aches. By Day 7 these symptoms subsided. Treatment for the events were Ciprofloxacin, Benadryl and ice.  On 21st Jan 2021, she started to experience a lot of arm pain and arm was warm to touch. The injection site had 2 nodules, got red (a quarter of an inch). The nodules became 2.5 Inches after 8 hours which were raised and inflamed.   On 23rd Jan 2021, the area became 4 inches. Treatment for the event was Ciprofloxacin, Benadryl and ice.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, Vaccine given subcutaneously was considered resolved.  The outcome of the events, redness and swelling on the injection site, headache, fatigue, joint pain, red mark down the arm were recovering/resolving.  The outcome of the events, lot of arm pain, arm was warm to touch, the injection site had 2 nodules, got red (a quarter of an inch), 8 hours later it was 2.5 Inches, raised and inflamed then the area became 4 inches was unknown.; Reporter's Comments: This case concerns a 50-year-old female patient with relevant medical history of allergy to Penicillin and Sulfa drugs. The patient reported Incorrect route of product administration and experienced non-serious expected events of Injection site swelling, Injection site erythema, Injection site pain, Erythema, Headache, Fatigue, Arthralgia, Myalgia, and non-serious unexpected events of Injection site warmth, Injection site nodule, Injection site inflammation, and Injection site reaction. The events of Injection site swelling, Injection site erythema, Erythema, Fatigue, Headache, Myalgia and Arthralgia occurred on an unknown date after receiving their first of two planned doses of mRNA-1273 (Lot #041L20A).  The events of Injection site pain, Injection site warmth, Injection site nodule, Injection site inflammation, and Injection site reaction occurred approximately eight days after receiving their first of two planned doses of mRNA-1273 (Lot #041L20A). Treatment for the events were Ciprofloxacin, Benadryl and ice. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. Of note, patient's medical history of allergy to Penicillin and Sulfa drugs is considered a risk factor.