Age: 53.0
Sex: M
Vaccine: COVID19, HEPA
Symptoms: Haematemesis, Oesophageal ulcer, Rash, Rash pruritic
Clinical narrative: diagnosed with ulcers in his esophagus; Patient has been in the emergency room twice in the last 3 months for vomiting blood; The rash itched; rash in his legs and upper torso; This spontaneous case was reported by a consumer and describes the occurrence of OESOPHAGEAL ULCER (diagnosed with ulcers in his esophagus), HAEMATEMESIS (Patient has been in the emergency room twice in the last 3 months for vomiting blood), RASH PRURITIC (The rash itched) and RASH (rash in his legs and upper torso) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product HEPATITIS A VACCINE for an unknown indication.    Concomitant products included DULOXETINE, OLANZAPINE, FOLIC ACID, POTASSIUM, CHLORDIAZEPOXIDE, SUCRALFATE, OMEPRAZOLE, VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]), FEXOFENADINE and ONDANSETRON for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient received dose of HEPATITIS A VACCINE (unknown route) 1 dosage form. In April 2021, the patient experienced RASH PRURITIC (The rash itched) (seriousness criterion medically significant) and RASH (rash in his legs and upper torso) (seriousness criterion medically significant). On an unknown date, the patient experienced OESOPHAGEAL ULCER (diagnosed with ulcers in his esophagus) (seriousness criterion medically significant) and HAEMATEMESIS (Patient has been in the emergency room twice in the last 3 months for vomiting blood) (seriousness criterion medically significant). The patient was treated with TRIAMCINOLONE ACETONIDE for Rash and Itchy rash, at an unspecified dose and frequency and CETAPHIL [BUTYL HYDROXYBENZOATE;CETYL ALCOHOL;PROPYLENE GLYCOL;SODIUM LAURYL SULFATE;STEARYL ALCOHOL;WATER PURIFIED] for Rash, at an unspecified dose and frequency. At the time of the report, OESOPHAGEAL ULCER (diagnosed with ulcers in his esophagus) and HAEMATEMESIS (Patient has been in the emergency room twice in the last 3 months for vomiting blood) outcome was unknown and RASH PRURITIC (The rash itched) and RASH (rash in his legs and upper torso) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received second Moderna Covid-19 vaccine in April 2021. patient reported that sometime after the second Moderna Covid-19 vaccine, he developed a rash in his legs and upper torso. The rash itched.  The patient went to see his physician about the rash. Physician placed the patient on TRAMCINOLONE ACETONIDE cream. In addition to the TRIAMCINOLONE, his physician placed him on a lot of medication.  The medication seemed to make the rash worse except for the CETAPHIL cream. The physician did not think that the rash was related to the vaccine.   The CETAPHIL cream seemed to be making the rash better.    The patient had been in the emergency room twice in the last 3 months for vomiting blood. Patient was diagnosed with ulcers in his esophagus.  Company Comment: This spontaneous case concerns a 53 year old male with history of vaccination with Hepatitis A  ( April 2021) , who experienced serious  ( medically significant ) , unexpected events of  rash and rash pruritic which occurred on April 2021 after vaccination with the 2nd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) , On an unknown date after vaccination with the mRNA-1273 vaccine , he experienced Serious ( medically significant ) , unexpected events of hematemesis and esophageal ulcer. This patient was seen by his physician re the rash and was treated with Triamcinolone and cetaphil cream . The phyisician did not think that the rash was related to the vaccine. The re-challenge for this case is not applicable since the events ' outcome was  reported as unknown and just resolving. The history of vaccination with hepatitis A can be considered as a confounder for this case. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report   This case was linked to MOD22-003573 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2022: Follow-Up received on 19 Jan 2022-Dose description for all concomitant drugs added. HCP added as secondary reporter. Primary reporter's Contact number added.; Sender's Comments: This spontaneous case concerns a 53 year old male with history of vaccination with Hepatitis A  ( April 2021) , who experienced serious  ( medically significant ) , unexpected events of  rash and rash pruritic which occurred on April 2021 after vaccination with the 2nd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) , On an unknown date after vaccination with the mRNA-1273 vaccine , he experienced Serious ( medically significant ) , unexpected events of hematemesis and esophageal ulcer. This patient was seen by his physician re the rash and was treated with Triamcinolone and cetaphil cream . The phyisician did not think that the rash was related to the vaccine. The re-challenge for this case is not applicable since the events ' outcome was  reported as unknown and just resolving. The history of vaccination with hepatitis A can be considered as a confounder for this case. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.