Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Erythema, Pruritus allergic, Rash, Urticaria
Clinical narrative: Allergic reaction on leg/ patch of hives which were red and itchy; COVID; Allergic reaction on leg/ patch of hives which were red and itchy; Allergic reaction on leg/ patch of hives which were red and itchy; Rash on arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Allergic reaction on leg/ patch of hives which were red and itchy), COVID-19 (COVID), PRURITUS ALLERGIC (Allergic reaction on leg/ patch of hives which were red and itchy), URTICARIA (Allergic reaction on leg/ patch of hives which were red and itchy) and RASH (Rash on arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, citrate free. On an unknown date, the patient experienced ERYTHEMA (Allergic reaction on leg/ patch of hives which were red and itchy), COVID-19 (COVID), PRURITUS ALLERGIC (Allergic reaction on leg/ patch of hives which were red and itchy), URTICARIA (Allergic reaction on leg/ patch of hives which were red and itchy) and RASH (Rash on arm). At the time of the report, ERYTHEMA (Allergic reaction on leg/ patch of hives which were red and itchy), COVID-19 (COVID), PRURITUS ALLERGIC (Allergic reaction on leg/ patch of hives which were red and itchy) and URTICARIA (Allergic reaction on leg/ patch of hives which were red and itchy) outcome was unknown and RASH (Rash on arm) had resolved.            No concomitant medications information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded. No treatment medications were provided.  Company comment-This spontaneous case concerns a female patient of unknown age with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination dates were not disclosed. Patient had received 3 doses of vaccination with mRNA-1273 on unknown dates.   No further details on clinical course, lab test and treatment received were reported. Outcome of the event was not known at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination dates were not disclosed. Patient had received 3 doses of vaccination with mRNA-1273 on unknown dates.   No further details on clinical course, lab test and treatment received were reported. Outcome of the event was not known at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.