Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan, X-ray
Clinical narrative: swelling of left toe and foot/swelling in his distal left lower extremity, including the MTP joint of the first digit of his left foot as well as the dorsal and plantar aspects of his left foot; Excruciating pain in my left big toe that spread to the instep and sole of my foot; Gout; I had a blood pressure of 180/100; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE INCREASED (I had a blood pressure of 180/100), PERIPHERAL SWELLING (swelling of left toe and foot/swelling in his distal left lower extremity, including the MTP joint of the first digit of his left foot as well as the dorsal and plantar aspects of his left foot), PAIN IN EXTREMITY (Excruciating pain in my left big toe that spread to the instep and sole of my foot) and GOUT (Gout) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Knee replacement in 2017. Concurrent medical conditions included Hypertension since 2014, Hypercholesterolemia and BPH since 2000. Concomitant products included TAMSULOSIN, NIFEDIPINE (NIFEDIPINE EG), LOSARTAN, ATORVASTATIN, VITAMIN D3 and VITAMIN E NOS for an unknown indication.    On 04-Mar-2021 at 12:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Excruciating pain in my left big toe that spread to the instep and sole of my foot). On 09-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling of left toe and foot/swelling in his distal left lower extremity, including the MTP joint of the first digit of his left foot as well as the dorsal and plantar aspects of his left foot). In March 2021, the patient experienced BLOOD PRESSURE INCREASED (I had a blood pressure of 180/100) and GOUT (Gout). On 11-Mar-2021, PERIPHERAL SWELLING (swelling of left toe and foot/swelling in his distal left lower extremity, including the MTP joint of the first digit of his left foot as well as the dorsal and plantar aspects of his left foot) had resolved. In March 2021, BLOOD PRESSURE INCREASED (I had a blood pressure of 180/100) had resolved. In 2021, PAIN IN EXTREMITY (Excruciating pain in my left big toe that spread to the instep and sole of my foot) had resolved. At the time of the report, GOUT (Gout) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood uric acid: increased (High) Blood tests showed uric acid levels in the high end of the normal range.. In 2021, Ultrasound scan: normal (normal) did not show any damage to the toe, foot or leg. In 2021, X-ray: normal (normal) did not show any damage to the toe, foot or leg.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient stated that his Primary care physician believed the left lower extremity swelling and pain to have been an episode of gout.  Treatment included an injection (unknown type) by the doctor.  Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.  Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events.   This case was linked to MOD-2021-235138 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up received updated patient demographics, new event gout added, updated outcome of the events, start date of the vaccine updated, treatment information updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.  Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events.