Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: when the needle went it, she screamed and yelled because it hurt so bad,She did not attempt the 2nd pen for the loading dose; Syringe out of her refrigerator for her dose but put it back in refrigerator; Body temperature increased; Swelling, redness and itching at injection site; Fatigue; Injection site was also swollen/swelling, redness and itching at injection site; Swelling, redness and itching at injection site; This spontaneous case was reported by a patient and describes the occurrence of BODY TEMPERATURE INCREASED (Body temperature increased), VACCINATION SITE PRURITUS (Swelling, redness and itching at injection site), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Injection site was also swollen/swelling, redness and itching at injection site) and VACCINATION SITE ERYTHEMA (Swelling, redness and itching at injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    No Medical History information was reported.   On 28-May-2021, the patient received dose of DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. In July 2021, received dose of DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 600 milligram. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced BODY TEMPERATURE INCREASED (Body temperature increased), VACCINATION SITE PRURITUS (Swelling, redness and itching at injection site), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Injection site was also swollen/swelling, redness and itching at injection site), VACCINATION SITE ERYTHEMA (Swelling, redness and itching at injection site) and PRODUCT STORAGE ERROR (Syringe out of her refrigerator for her dose but put it back in refrigerator). On 29-May-2021, the patient experienced VACCINATION SITE PAIN (when the needle went it, she screamed and yelled because it hurt so bad,She did not attempt the 2nd pen for the loading dose). At the time of the report, BODY TEMPERATURE INCREASED (Body temperature increased), VACCINATION SITE PRURITUS (Swelling, redness and itching at injection site), FATIGUE (Fatigue), VACCINATION SITE ERYTHEMA (Swelling, redness and itching at injection site) and PRODUCT STORAGE ERROR (Syringe out of her refrigerator for her dose but put it back in refrigerator) outcome was unknown and VACCINATION SITE SWELLING (Injection site was also swollen/swelling, redness and itching at injection site) and VACCINATION SITE PAIN (when the needle went it, she screamed and yelled because it hurt so bad,She did not attempt the 2nd pen for the loading dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No concomitant medication was reported. No treatment medication was reported. It was reported that Injection site pain resolved on May-2021. On 28-May-2021, the patient attempted to do the initial injection using the autoinjector pen.