Reporte zur Charge 025J00/NA

Symptomtext

Blooded stools; Eyes are a little bit itchy; Right eye swollen; A spontaneous report was received from a consumer who was an 83-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blooded stools, eyes are a little bit itchy, and right eye swollen. The patient's medical history was not provided. Concomitant medications reported included magnesium. On 04 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J00/NA) intramuscularly for prophylaxis of COVID-19 infection. On the evening of 04 Jan 2021, the patient experienced blooded stools, eyes are a little bit itchy, and right eye swollen. The patient reported having blooded stools that were not diarrhea, but had occurred three or four times. Treatment for the events included non specified allergy medicine for the eyes. On 06 Jan 2021, the patient reported feeling better in regard to the blooded stools and was unsure if it was actually blood or not in her stools and she had ate spicy and red food. Action taken with mRNA-1273 in response to the events was not provided. The event, blooded stools, was considered resolved. The outcome for the events, eyes are a little bit itchy and right eye swollen was unknown.; Reporter's Comments: This case concerns an 83-year-old female patient with unknown medical history, who received their first of two planned doses of mRNA-1273 (Lot 025J00/NA), and who experienced the unlisted serious event of Haematochezia and the unlisted non-serious events of Eye pruritus and Eye swelling. Based on the current available information and temporal association between the use of the product and the start date of the event on the day of vaccination, a causal relationship cannot be excluded making the events possibly related to the vaccine.