Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Giant cell arteritis, Inflammation, Off label use, Swelling face
Clinical narrative: Swelling on left and right side of temporal areas of the face; High levels of inflammation in hid body, was admitted in the hospital for four days regarding this condition; Diagnosed him with temporal arthritis; Double vision in both eyes; Did not receive my second dose of the Moderna COVID-19 Vaccination per health care provider's recommendation due to; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLAMMATION (High levels of inflammation in hid body, was admitted in the hospital for four days regarding this condition), GIANT CELL ARTERITIS (Diagnosed him with temporal arthritis), SWELLING FACE (Swelling on left and right side of temporal areas of the face) and DIPLOPIA (Double vision in both eyes) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol total abnormal NOS (Patient takes Lipitor for cholesterol). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced SWELLING FACE (Swelling on left and right side of temporal areas of the face) (seriousness criterion hospitalization) and DIPLOPIA (Double vision in both eyes) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INFLAMMATION (High levels of inflammation in hid body, was admitted in the hospital for four days regarding this condition) (seriousness criterion hospitalization), GIANT CELL ARTERITIS (Diagnosed him with temporal arthritis) (seriousness criterion hospitalization) and OFF LABEL USE (Did not receive my second dose of the Moderna COVID-19 Vaccination per health care provider's recommendation due to). The patient was hospitalized from 16-Apr-2021 to 19-Apr-2021 due to DIPLOPIA, GIANT CELL ARTERITIS and INFLAMMATION. The patient was treated with PREDNISONE at a dose of 60 mg and PREDNISONE on 25-May-2021 at a dose of 40 milligram. At the time of the report, INFLAMMATION (High levels of inflammation in hid body, was admitted in the hospital for four days regarding this condition), GIANT CELL ARTERITIS (Diagnosed him with temporal arthritis), SWELLING FACE (Swelling on left and right side of temporal areas of the face), DIPLOPIA (Double vision in both eyes) and OFF LABEL USE (Did not receive my second dose of the Moderna COVID-19 Vaccination per health care provider's recommendation due to) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       On 17Mar2021, the patient began to experience double vision in both eyes as well as swelling on the left and right side of the temporal areas of the face.  The patient underwent a biopsy of both sides of the face, results were not provided.  Ultimately, the patient was diagnosed with "temporal arthritis" along with "having high levels of inflammation in his body" by his rheumatologist.  On 16Apr2021, the patient was admitted in the hospital for four days until 19Apr2021 for observation. The patient received high doses of steroids/prednisone for treatment including 60 milligrams for one month and then 40 milligrams starting 25May2021.  It was recommended by the patient's physician that he not receive his second Moderna COVID-19 vaccination which was originally scheduled for 07Apr2021.  Further clinical course is unknown/not reported at this time.  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.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant follow-up received. Follow-up contained no new information.; 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.