Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Prostatic specific antigen, Pruritus, Pyrexia, Swelling, Vaccination site erythema
Clinical narrative: Groin swelling, itching difficulty walking; groin itching; groin swelling itching and pain; Malaise; Difficulty walking; Redness at injection site, round swelling; Had slight fever and malaise; I had lymph node inflammation, lymphadenopathy it was painful; Axillary lymph nodes both sides inflammed; Redness at injection site, round swelling; This spontaneous case was reported by a pharmacist and describes the occurrence of SWELLING (Groin swelling, itching difficulty walking), PRURITUS (groin itching), GROIN PAIN (groin swelling itching and pain), MALAISE (Malaise) and GAIT DISTURBANCE (Difficulty walking) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A, 015M20A and 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, METFORMIN, AMLODIPINE, ATORVASTATIN, LOSARTAN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (Groin swelling, itching difficulty walking), PRURITUS (groin itching), GROIN PAIN (groin swelling itching and pain), MALAISE (Malaise), GAIT DISTURBANCE (Difficulty walking), VACCINATION SITE ERYTHEMA (Redness at injection site, round swelling), PYREXIA (Had slight fever and malaise), LYMPH NODE PAIN (I had lymph node inflammation, lymphadenopathy it was painful), LYMPHADENOPATHY (Axillary lymph nodes both sides inflammed) and VACCINATION SITE SWELLING (Redness at injection site, round swelling). At the time of the report, SWELLING (Groin swelling, itching difficulty walking), PRURITUS (groin itching), GROIN PAIN (groin swelling itching and pain), MALAISE (Malaise), GAIT DISTURBANCE (Difficulty walking), VACCINATION SITE ERYTHEMA (Redness at injection site, round swelling), PYREXIA (Had slight fever and malaise), LYMPH NODE PAIN (I had lymph node inflammation, lymphadenopathy it was painful), LYMPHADENOPATHY (Axillary lymph nodes both sides inflammed) and VACCINATION SITE SWELLING (Redness at injection site, round swelling) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Oct-2021, Prostatic specific antigen: 8.9 (High) elevated PSA levels (seen 10 days after the third dose, level 8.9.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The pharmacist received his first dose of the Moderna COVID-19 vaccine on 23 JAN 2021 in the left nondominant arm while the second dose was given on 16 FEB 2021 and the third dose was given on 03OCT2021. The pharmacist had events-  redness at the injection site,  fever and elevated PSA levels (seen 10 days after the third dose, level 8.9), he also experienced malaise lymph node inflammation groin swelling itching and pain.  No treatment information was provided.