Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Bradyphrenia, Fatigue, Feeling abnormal, Incorrect route of product administration, Injection site erythema
Clinical narrative: Hot to the touch; Hives on the back; Very large, red (2.5/3in circle) allergic reaction at the injection site; Didn't feel good; Couldn't process things well; Lack of correct administration, injection appears to be lower than where normally given, was injected in the fat and not in the muscle; Swollen arm/hardness; Tired; A spontaneous report was received from a other healthcare professional, concerning a 37-year-old, female patient, who received Moderna's Covid-19 vaccine (mRNA-1273) and didn't feel good, couldn't process things well, hot to the touch, hives on the back, lack of correct administration/injection appears to be lower than where normally given/was injected in the fat and not in the muscle, swollen arm/hardness, tired and very large, red (2.5/3in circle) allergic reaction at the injection site.  No relevant medical history and concomitant medications were reported.  On 08-Jan-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number: 011L20A) in the left non-dominant arm for prophylaxis of COVID-19 infection.   On 08-Jan-2020, the patient received vaccine, which was of lack of correct administration as it was injected in the fat and not in the muscle and injection which was appears to be lower than where normally given. On the same date, after administration of vaccine, the patient had experienced swollen arm (swelling), hives on the back, 2.5in red circle, didn't feel good, was tired and couldn't process things well. On 18-Jan-2021, 10 days after the administration of vaccine, the patient had developed very large-red allergic reaction at the injection site with perfect circle and was hot to the touch. Treatment for the event included paracetamol (acetaminophen) and loratadine.   Action taken with mRNA-1273 in response to the events were not provided.   The outcome of events didn't feel good, hot to the touch, hives on the back, tired and very large, red (2.5/3in circle) allergic reaction at the injection site was unknown. The event lack of correct administration, injection appears to be lower than where normally given, was injected in the fat and not in the muscle was considered to be resolved on 08-Jan-2021. The event swollen arm/hardness was considered to be resolved on 09-Jan-2021. The event couldn't process things well was considered to be resolved on 15-Jan-2021.; Reporter's Comments: This spontaneous report refers to a case of a 37-year-old female patient who experienced non-serious events of lack of correct administration/injection appears to be lower than where normally given/was injected in the fat and not in the muscle ( inappropriate route of vaccine administered), didn't feel good, couldn't process things well, hot to the touch, hives on the back, swollen arm/hardness, tired and very large, red (2.5/3in circle) allergic reaction at the injection site..  All events excluding (large-red allergic reaction at the injection site with perfect circle hot to the touch) developed on the same day after the administration of the mRNA-1273 vaccine (lot # 011L20A, expiration date-unknown). The event of large-red allergic reaction at the injection site with perfect circle which was hot to the touch developed 10 days after the vaccine administration. Based on the information provided which includes a temporal association, a causal association between the administration of the vaccine and the other reported events cannot be excluded. Tiredness, redness and hives are consistent with the safety profile of the vaccine. The event of inappropriate route of vaccine administered is considered not applicable.