Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Gastrointestinal pain, Therapeutic response shortened
Clinical narrative: Wearing off effect; Gut pain; Fatigue; Pain stomach; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE SHORTENED (Wearing off effect), ABDOMINAL PAIN UPPER (Pain stomach), GASTROINTESTINAL PAIN (Gut pain) and FATIGUE (Fatigue) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate Free. On an unknown date, the patient experienced THERAPEUTIC RESPONSE SHORTENED (Wearing off effect), ABDOMINAL PAIN UPPER (Pain stomach), GASTROINTESTINAL PAIN (Gut pain) and FATIGUE (Fatigue). At the time of the report, THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) and GASTROINTESTINAL PAIN (Gut pain) outcome was unknown and ABDOMINAL PAIN UPPER (Pain stomach) and FATIGUE (Fatigue) had resolved.            There was no reported medical history.   Concomitant drugs not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial.  The reporter's causality for the events of Fatigue, pain stomach and gut pain was not provided. The reporter's causality for the events of effect of Humira wearing off effect with Humira (adalimumab) was a reasonable possibility.  No treatment medication were provided. 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 concerns an adult male patient with concurrent condition of Crohn s disease and reported non serious event of Therapeutic response shortened (reported as Wearing off effect) along with the non serious events of upper abdominal pain and gastrointestinal pain, unknown days after receiving the first dose of mRNA-1273 vaccine. The patient received the second dose about 1 month later. No information on detailed clinical course including whether the patient was diagnosed with COVID 19 was available in the report.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient with concurrent condition of Crohn s disease and reported non serious event of Therapeutic response shortened (reported as Wearing off effect) along with the non serious events of upper abdominal pain and gastrointestinal pain, unknown days after receiving the first dose of mRNA-1273 vaccine. The patient received the second dose about 1 month later. No information on detailed clinical course including whether the patient was diagnosed with COVID 19 was available in the report.  The benefit-risk relationship of mRNA-1273 is not affected by this report.