Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Inflammation, Laboratory test, Oesophageal injury
Clinical narrative: Inflammation in organs; Difficulty eating; Allergic reaction; Esophagus looks as if it was cut by razor blades; Scratchy throat; Injection site was really red; Headache; Fever; Had trouble breathing/Couldn't breathe/Can't lie flat and can't breathe properly; Swollen throat/Throat became so swollen that it was closed off; Injection site really hot; Injection site was swollen; This spontaneous case was reported by a consumer and describes the occurrence of OESOPHAGEAL INJURY (Esophagus looks as if it was cut by razor blades) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included INDOMETHACIN [INDOMETACIN] and DEXLANSOPRAZOLE (DEXILANT) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced THROAT IRRITATION (Scratchy throat), DYSPNOEA (Had trouble breathing/Couldn't breathe/Can't lie flat and can't breathe properly), PHARYNGEAL SWELLING (Swollen throat/Throat became so swollen that it was closed off), VACCINATION SITE WARMTH (Injection site really hot), VACCINATION SITE SWELLING (Injection site was swollen), VACCINATION SITE ERYTHEMA (Injection site was really red), HEADACHE (Headache) and PYREXIA (Fever). On an unknown date, the patient experienced OESOPHAGEAL INJURY (Esophagus looks as if it was cut by razor blades) (seriousness criterion medically significant), INFLAMMATION (Inflammation in organs), FEEDING DISORDER (Difficulty eating) and HYPERSENSITIVITY (Allergic reaction). The patient was treated with EPINEPHRINE (EPIPEN) for Throat swelling, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, OESOPHAGEAL INJURY (Esophagus looks as if it was cut by razor blades), THROAT IRRITATION (Scratchy throat), INFLAMMATION (Inflammation in organs), FEEDING DISORDER (Difficulty eating), DYSPNOEA (Had trouble breathing/Couldn't breathe/Can't lie flat and can't breathe properly), PHARYNGEAL SWELLING (Swollen throat/Throat became so swollen that it was closed off), VACCINATION SITE WARMTH (Injection site really hot), VACCINATION SITE SWELLING (Injection site was swollen), HYPERSENSITIVITY (Allergic reaction), VACCINATION SITE ERYTHEMA (Injection site was really red), HEADACHE (Headache) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: abnormal (abnormal) Damage to esophagus. Inflammation in organs.. On an unknown date, Endoscopy: abnormal (abnormal) Damage to esophagus. Inflammation in organs.. On an unknown date, Fibrin D dimer: abnormal (abnormal) Abnormal. On an unknown date, Laboratory test: abnormal (abnormal) Inflammation level in lab work is off the charts..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patients symptoms have grown in severity, with internal damage to her organs from an allergic reaction .   Patient treatment information includes Dexilant and unspecified steroids.  Company Comment: This case concerns a 33-year-old, female patient on concomitant treatment with indomethacin and Dexilant for unknown indication with no other reported relevant medical history, who experienced the unexpected event of esophageal injury. The event occurred 1 day after the first dose of the mRNA-1273 (Moderna CoviD-19 Vaccine). The re-challenge was unknown since no information about the second dose was disclosed.  The benefit-risk relationship of mRNA-1273 (Moderna CoviD-19 Vaccine) is not affected by this report. Event was considered medically significant.; Sender's Comments: This case concerns a 33-year-old, female patient on concomitant treatment with indomethacin and Dexilant for unknown indication with no other reported relevant medical history, who experienced the unexpected event of esophageal injury. The event occurred 1 day after the first dose of the mRNA-1273 (Moderna CoviD-19 Vaccine). The re-challenge was unknown since no information about the second dose was disclosed.  The benefit-risk relationship of mRNA-1273 (Moderna CoviD-19 Vaccine) is not affected by this report. Event was considered medically significant