Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Faeces discoloured, Gout, Inappropriate schedule of product administration, Peripheral swelling
Clinical narrative: tarry black diarrhea; swollen foot; vomiting; possible gout attack; possible cellulitis; shceduled to receive the second dose after 58 days; Runny nose; hard area at injection site; tender to touch the injection site; left arm swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GOUT (possible gout attack), CELLULITIS (possible cellulitis), FAECES DISCOLOURED (tarry black diarrhea), PERIPHERAL SWELLING (swollen foot) and VOMITING (vomiting) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CITALOPRAM, RIVASTIGMINE (EXELON [RIVASTIGMINE]), FAMOTIDINE, ASPIRIN [ACETYLSALICYLIC ACID], ZOLPIDEM TARTRATE (AMBIEN), XANTOFYL (LUTEIN OPT), KRILL OIL, CALCIUM, VITAMIN B3, VITAMIN C [ASCORBIC ACID], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), TOCOPHEROL (VITAMIN E [TOCOPHEROL]), CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and EVOLOCUMAB (REPATHA) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced RHINORRHOEA (Runny nose), VACCINATION SITE INDURATION (hard area at injection site), VACCINATION SITE PAIN (tender to touch the injection site) and VACCINATION SITE SWELLING (left arm swelling). On 15-Feb-2021, the patient experienced FAECES DISCOLOURED (tarry black diarrhea) (seriousness criterion hospitalization), PERIPHERAL SWELLING (swollen foot) (seriousness criterion hospitalization) and VOMITING (vomiting) (seriousness criterion hospitalization). On an unknown date, the patient experienced GOUT (possible gout attack) (seriousness criterion hospitalization), CELLULITIS (possible cellulitis) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (shceduled to receive the second dose after 58 days). The patient was hospitalized for 8 days due to CELLULITIS, FAECES DISCOLOURED, GOUT, PERIPHERAL SWELLING and VOMITING. On 03-Feb-2021, RHINORRHOEA (Runny nose), VACCINATION SITE INDURATION (hard area at injection site), VACCINATION SITE PAIN (tender to touch the injection site) and VACCINATION SITE SWELLING (left arm swelling) had resolved. At the time of the report, GOUT (possible gout attack), CELLULITIS (possible cellulitis), FAECES DISCOLOURED (tarry black diarrhea), PERIPHERAL SWELLING (swollen foot) and VOMITING (vomiting) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (shceduled to receive the second dose after 58 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was started on antibiotics and prednisone treatment for possible gout attack or cellulitis. No treatment information regarding other events was available.; Sender's Comments: This case of an 83-year-old female patient who experienced inappropriate schedule of vaccine administered after first dose of mRNA-1273 (58 days). Based on temporal association between mRNA-1273 use and onset of the events of runny nose, vaccination site induration, pain and swelling, a causal relationship cannot be excluded.  There is not enough information to assess the other events due to lack of critical details in patient's medical history. Additional information is being requested.