Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Gastroenteritis viral, Stent placement
Clinical narrative: Stent placement a few weeks ago; Sick with a stomach virus; This spontaneous case was reported by a nurse and describes the occurrence of STENT PLACEMENT (Stent placement a few weeks ago) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stent placement (A few weeks ago) in November 2021. Concurrent medical conditions included Osteoporosis. Concomitant products included DENOSUMAB (PROLIA) for Osteoporosis, MINOXIDIL, CARBIDOPA MONOHYDRATE, LEVODOPA (SINEMET), PROPRANOLOL, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), ACETYLSALICYLIC ACID (ASPIRIN 81), COENZYME Q10 [UBIDECARENONE] and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced STENT PLACEMENT (Stent placement a few weeks ago) (seriousness criterion medically significant) and GASTROENTERITIS VIRAL (Sick with a stomach virus). The patient was treated with Transplant for Stent placement. At the time of the report, STENT PLACEMENT (Stent placement a few weeks ago) and GASTROENTERITIS VIRAL (Sick with a stomach virus) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included Essient 10mg once a day. The patient had a stent placement a feweeks ago and will be starting on another blood thinners next week: Lovalo. The patient need to know how far apart she needs to wait to get booster separated from the Prolia so did not interact. Patient was scheduled for the booster on 09-Dec-2021. Pharmacist said she can receive booster 1 week after Prolia and primary care physician said 2 weeks apart. Patient reported that she received the last Prolia injection on 03-Jun-2021.  Company comment: This spontaneous case concerns a 68-year-old female patient undergoing treatment with Acetylsalicylic acid, who experienced the unexpected serious (medically significant) event of Stent placement after mRNA- 1273 Moderna vaccine. The event occurred approximately 7 months after the second dose of mRNA- 1273 vaccine. Very limited information is available regarding the underlying diagnosis, site of stent and clinical course. The rechallenge is not applicable, since the event occurred exclusively after the second dose. Chronic treatment with Acetylsalicylic acid was reported for an unknown indication, which could be confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report   This case was linked to MOD-2021-054640 (Patient Link).; Sender's Comments: This spontaneous case concerns a 68-year-old female patient undergoing treatment with Acetylsalicylic acid, who experienced the unexpected serious (medically significant) event of Stent placement after mRNA- 1273 Moderna vaccine. The event occurred approximately 7 months after the second dose of mRNA- 1273 vaccine. Very limited information is available regarding the underlying diagnosis, site of stent and clinical course. The rechallenge is not applicable, since the event occurred exclusively after the second dose. Chronic treatment with Acetylsalicylic acid was reported for an unknown indication, which could be confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report