Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Gastric ulcer, Nausea, Pain, Pneumonia
Clinical narrative: Stomach ulcers; Pneumonia; Soreness with Booster COVID-19 vaccine; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of GASTRIC ULCER (Stomach ulcers) and PNEUMONIA (Pneumonia) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. In December 2021, the patient experienced GASTRIC ULCER (Stomach ulcers) (seriousness criteria hospitalization and medically significant) and PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PAIN (Soreness with Booster COVID-19 vaccine) and NAUSEA (Nausea). At the time of the report, GASTRIC ULCER (Stomach ulcers), PNEUMONIA (Pneumonia), PAIN (Soreness with Booster COVID-19 vaccine) and NAUSEA (Nausea) was resolving.            No concomitant medication was reported.  The Humira formulation was reported as Solution for injection in pre-filled pen. On an unknown date, patient received booster dose of Moderna COVID-19 Vaccine. Patient was hospitalized due to he had stomach ulcers and pneumonia in the beginning of Dec-2021. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment information was reported.  The reporter causality for all events with co-suspect Humira was reported as no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment  This spontaneous case reported by a consumer, concerns a 79 year old male patient, with no relevant medical history, who experienced the unexpected, serious (Hospitalization, medically significant) events of Gastric Ulcer and Pneumonia unknown days after receiving the 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with other non serious events. Patient had previously received 2 primary doses with Moderna vaccines without any adverse events reported. On an unknown date patient also received Adalimumab for chronic plaque psoriasis. Patient was hospitalized due to stomach ulcers and pneumonia in the beginning of Dec-2021. The events were resolving.  No further clinical information on other comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment were reported. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns a 79 year old male patient, with no relevant medical history, who experienced the unexpected, serious (Hospitalization, medically significant) events of Gastric Ulcer and Pneumonia unknown days after receiving the 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with other non serious events. Patient had previously received 2 primary doses with Moderna vaccines without any adverse events reported. On an unknown date patient also received Adalimumab for chronic plaque psoriasis. Patient was hospitalized due to stomach ulcers and pneumonia in the beginning of Dec-2021. The events were resolving.  No further clinical information on other comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment were reported. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.