Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Injection site cellulitis, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Inflamed area noted to left arm that is warm to touch, tender, and lumpy; Inflamed area noted to left arm that is warm to touch, tender, and lumpy; Inflamed area noted to left arm that is warm to touch, tender, and lumpy; Inflamed area noted to left arm that is warm to touch, tender, and lumpy; 100.0 temp; Possible cellulitis; It appears that the injection was given too low that muscle may have been missed; May not have received the full dose of the Moderna vaccine; A spontaneous report  was received from a nurse, concerning a 91-year-old male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced inflamed area noted to left arm that is warm to touch, tender, and lumpy, 100.0 temp, may not have received the full dose of the Moderna vaccine, it appears that the injection was given too low that muscle may have been missed, and possible cellulitis.   The patient's medical history was not provided. Concomitant medications were not reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Batch number: 039K208) intramuscularly in the left arm for the prophylaxis of COVID-19 infection. On 26 Jan 2021, at the time of the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly in the left deltoid for the prophylaxis of COVID-19 infection.   On 26 Jan 2021, the patient may not have received the full dose of the Moderna vaccine as it appeared that the injection was given too low that muscle may have been missed.    On 28 Jan 2021, the patient experienced an inflamed area to the left arm, that was warm to touch, tender, and lumpy. The patient also had fever of 100.0 Fahrenheit (F). He was being evaluated for concerns of possible cellulitis Treatment for the events included paracetamol and diphenhydramine.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of events, inflamed area noted to left arm that is warm to touch, tender, and lumpy, 100.0 temp, may not have received the full dose of the Moderna vaccine, and possible cellulitis, were considered unknown. The events, it appears that the injection was given too low that muscle may have been missed and may not have received the full dose of the Moderna vaccine, were considered resolved on 26 Jan 2021.; Reporter's Comments: This case concerns a 91-year-old, White, male, who experienced a Product administration error, Incorrect dose administered, and non-serious unexpected event of injection site cellulitis, injection site warmth, and non-serious expected events of injection site swelling, injection site pain, and pyrexia. There were no reported AEs associated with this case of a Product administration error and incorrect dose administered.  The events occurred  2 days after mRNA-1273 (Lot# 039k208). Treatment included Tylenol and Benadryl. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.