Age: 67.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Swelling face, Urticaria, X-ray dental normal
Clinical narrative: big blisters in the stomach; Jaw swollen/face was swollen; swollen legs and arms; swollen back; jaw sore; swollen stomach; small blisters like small itchy bumps in legs, back and arms; his hands sore to the touch; hives; bad headache; This spontaneous case was reported by a patient and describes the occurrence of GASTRIC ULCER (big blisters in the stomach) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS714AB) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Patient had no allergies to medications, food and other products. Concurrent medical conditions included Diabetes (Start Date: 27 years ago), Kidney failure (Start Date: 27 years ago) and Blood pressure high (Start Date: 27 years ago). Concomitant products included INSULIN for Diabetes, AMLODIPINE, CLONIDINE, GUANFACINE, PRAVASTATIN, CALCITRIOL, LOSARTAN and SODIUM BICARBONATE for an unknown indication.  On 12-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Sep-2022, the patient experienced GASTRIC ULCER (big blisters in the stomach) (seriousness criterion medically significant), SWELLING FACE (Jaw swollen/face was swollen), PERIPHERAL SWELLING (swollen legs and arms), SWELLING (swollen back), PAIN IN JAW (jaw sore), ABDOMINAL DISTENSION (swollen stomach), BLISTER (small blisters like small itchy bumps in legs, back and arms), PAIN IN EXTREMITY (his hands sore to the touch), URTICARIA (hives) and HEADACHE (bad headache). At the time of the report, GASTRIC ULCER (big blisters in the stomach), SWELLING FACE (Jaw swollen/face was swollen), PERIPHERAL SWELLING (swollen legs and arms), SWELLING (swollen back), PAIN IN JAW (jaw sore), ABDOMINAL DISTENSION (swollen stomach), BLISTER (small blisters like small itchy bumps in legs, back and arms), PAIN IN EXTREMITY (his hands sore to the touch), URTICARIA (hives) and HEADACHE (bad headache) had not resolved.  For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.  Patient had no other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Symptoms come and go, they start over again every time at 3 o'clock. Patient had dose 1 of Moderna COVID-19 Vaccine (013M20A) on 02 Feb2021, dose 2 of Moderna COVID-19 Vaccine (013M20A) on 2Mar2021, first booster of Moderna COVID-19 Vaccine (007B21A) on 18Aug2021, second booster of Moderna COVID-19 Vaccine (048L21A) on 31Mar2022. No treatment had been given for his symptoms.  Company comment: This is a spontaneous case concerning a 67-year-old male patient, with medical history of diabetes, kidney failure and hypertension, who experienced the unexpected serious, medically significant AESI  of gastric ulcer and non-serious events of pain in jaw, swelling face, peripheral swelling, abdominal distension, swelling, blister, pain in extremity (all unexpected) and headache and urticaria (expected). All events occurred approximately one day after the administration of fifth dose of mRNA-1273 BIVALENT .222. The patient's previous vaccination series included 2 doses of mRNA-1273 (primary series) and two booster doses of mRNA-1273 vaccine. Outcome of all events was reported as ongoing ("symptoms come and go, they start over again every time at 3 o'clock"). No treatment was indicated for the events. The patient reported no similar events in the past; however, the patient also experienced a "sore arm for a couple days" after 4 previous vaccine shots. The patient had no reported allergies. Concurrent medical conditions of diabetes mellitus, kidney failure, hypertension, and multiple concomitant drugs remain as confounders for all events. The benefit-risk relationship of mRNA-1273 is not affected by this report.  This case was linked to MOD-2022-652295 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 67-year-old male patient, with medical history of diabetes, kidney failure and hypertension, who experienced the unexpected serious, medically significant AESI  of gastric ulcer and non-serious events of pain in jaw, swelling face, peripheral swelling, abdominal distension, swelling, blister, pain in extremity (all unexpected) and headache and urticaria (expected). All events occurred approximately one day after the administration of fifth dose of mRNA-1273 BIVALENT .222. The patient's previous vaccination series included 2 doses of mRNA-1273 (primary series) and two booster doses of mRNA-1273 vaccine. Outcome of all events was reported as ongoing ("symptoms come and go, they start over again every time at 3 o'clock"). No treatment was indicated for the events. The patient reported no similar events in the past; however, the patient also experienced a "sore arm for a couple days" after 4 previous vaccine shots. The patient had no reported allergies. Concurrent medical conditions of diabetes mellitus, kidney failure, hypertension, and multiple concomitant drugs remain as confounders for all events. The benefit-risk relationship of mRNA-1273 is not affected by this report.