Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue discolouration
Clinical narrative: Caller had the injection for the Modena shot on Wednesday and today they woke up in the morning and their tongue was black. Caller thought maybe they were bleeding from their mouth and it was all black.; Last night caller started feeling like they had a lot of heartburn and their throat was tightening up.; Last night caller started feeling like they had a lot of heartburn and their throat was tightening up; Caller said they were experiencing some shortness of breath yesterday when walking but it was not alarming.; Caller thought maybe they were bleeding from their mouth and it was all black; Caller also had bowels that were black; This spontaneous case was reported by a patient and describes the occurrence of MELAENA (Caller also had bowels that were black) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (Batch number:- 040A21A) on 23-Mar-2021, Moderna covid-19 vaccine (Batch number:- 025B21A) on 20-Apr-2021, Moderna covid-19 vaccine (Batch number: - 012F21A.) on 03-Dec-2021, MODERNA COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (Batch number: - 015H22A.) on 29-Jan-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), Moderna covid-19 vaccine, Moderna covid-19 vaccine and Moderna covid-19 vaccine. Concurrent medical conditions included Hay fever, Drug allergy (Morphine allergy), Drug allergy (Lisinopril allergy), Muscle spasm and reflux. Concomitant products included METHOCARBAMOL for Muscle spasm, FAMOTIDINE for Gastrooesophageal reflux disease, PARACETAMOL (TYLENOL EXTRA STRENGTH), GABAPENTIN, METFORMIN, LOVASTATIN, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), IRON, AMLODIPINE, LOSARTAN POTASSIUM and FOLIC ACID for an unknown indication.    On 17-Jan-2024, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In January 2024, the patient experienced MELAENA (Caller also had bowels that were black) (seriousness criterion medically significant). On 18-Jan-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced MOUTH HAEMORRHAGE (Caller thought maybe they were bleeding from their mouth and it was all black), DYSPEPSIA (Last night caller started feeling like they had a lot of heartburn and their throat was tightening up.), THROAT TIGHTNESS (Last night caller started feeling like they had a lot of heartburn and their throat was tightening up) and DYSPNOEA EXERTIONAL (Caller said they were experiencing some shortness of breath yesterday when walking but it was not alarming.). On 19-Jan-2024, the patient experienced TONGUE DISCOLOURATION (Caller had the injection for the Modena shot on Wednesday and today they woke up in the morning and their tongue was black. Caller thought maybe they were bleeding from their mouth and it was all black.). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at an unspecified dose and frequency. At the time of the report, MELAENA (Caller also had bowels that were black), MOUTH HAEMORRHAGE (Caller thought maybe they were bleeding from their mouth and it was all black), TONGUE DISCOLOURATION (Caller had the injection for the Modena shot on Wednesday and today they woke up in the morning and their tongue was black. Caller thought maybe they were bleeding from their mouth and it was all black.), DYSPEPSIA (Last night caller started feeling like they had a lot of heartburn and their throat was tightening up.), THROAT TIGHTNESS (Last night caller started feeling like they had a lot of heartburn and their throat was tightening up) and DYSPNOEA EXERTIONAL (Caller said they were experiencing some shortness of breath yesterday when walking but it was not alarming.) outcome was unknown.           It was reported that patient woke up in the morning and her tongue was black. She thought they were bleeding from their mouth and it was all black. Previous night she started feeling like they had a lot of heartburn and their throat was tightening up. So they took the equate Pepto Bismol tablets. She also experiencing some shortness of breath yesterday when walking but it was not alarming. Health care professional told her to brush her teeth and her tongue and she did that so it went away but it started to raise back up a little bit within few hours later. However she brushed it again and it looks better now but they see a fade tone. She also had bowels that were black.  Company Comment: This is a Spontaneous case reported by a patient, concerning a 66-year-old female patient, in treatment with famotidine for reflux, who experienced the unexpected and serious (due to medically significant) event of Melaena, which occurred after SPIKEVAX 2023-2024 vaccine, administered as fifth dose within COVID-19 vaccination schedule. As reported, patient started 1 day after vaccination with her tongue being black. She thought that maybe it was bleeding from her mouth, and it was all black. She then started feeling like she had a lot of heartburn and her throat was tightening up. So she took the equate Pepto Bismol tablets. She also experienced some shortness of breath when walking, but it was not alarming. Patient also had bowels that were black. No information disclosed about diagnostic tests performed. Underlying reflux could be a confounding factor for Melaena. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.