Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: itching in the area of injection; swelling as if there is almost a ball under the injection site; soreness in the injection arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (soreness in the injection arm), INJECTION SITE PRURITUS (itching in the area of injection) and INJECTION SITE SWELLING (swelling as if there is almost a ball under the injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history reported).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PAIN IN EXTREMITY (soreness in the injection arm). On 07-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itching in the area of injection) and INJECTION SITE SWELLING (swelling as if there is almost a ball under the injection site). At the time of the report, PAIN IN EXTREMITY (soreness in the injection arm) was resolving and INJECTION SITE PRURITUS (itching in the area of injection) and INJECTION SITE SWELLING (swelling as if there is almost a ball under the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (soreness in the injection arm), INJECTION SITE PRURITUS (itching in the area of injection) and INJECTION SITE SWELLING (swelling as if there is almost a ball under the injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history reported).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PAIN IN EXTREMITY (soreness in the injection arm). On 07-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itching in the area of injection) and INJECTION SITE SWELLING (swelling as if there is almost a ball under the injection site). At the time of the report, PAIN IN EXTREMITY (soreness in the injection arm) was resolving and INJECTION SITE PRURITUS (itching in the area of injection) and INJECTION SITE SWELLING (swelling as if there is almost a ball under the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  For the first two days since injection patient experienced minor soreness. It got gradually lessened in the next few days. On 07 Jan 2021, the patient developed itching and swelling around the area of injection. The patient reported that swelling was almost like a ball under the injection site.  No treatment information was provided.  Company comment: Based on a temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported event and the product use cannot be excluded.  Injection site swelling and injection site pruritus are consistent with the known safety profile of the vaccine.; Reporter's Comments: Based on a temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported event and the product use cannot be excluded.  Injection site swelling and injection site pruritus are consistent with the known safety profile of the vaccine.