Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Abdominal pain upper, COVID-19, Flatulence
Clinical narrative: in feb 2021, patient had second dose of moderna and in Dec 2021, Patient had COVID.; Stomach pain; Swelling abdomen; Gas; Acid reflux (esophageal); Abdominal cramp; in feb 2021, patient had second dose of moderna and in Dec 2021, Patient had COVID.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (in feb 2021, patient had second dose of moderna and in Dec 2021, Patient had COVID.), VACCINATION FAILURE (in feb 2021, patient had second dose of moderna and in Dec 2021, Patient had COVID.), ABDOMINAL PAIN UPPER (Stomach pain), ABDOMINAL DISTENSION (Swelling abdomen) and FLATULENCE (Gas) in a 31-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 products included non-company products ADALIMUMAB (HUMIRA) injection for Crohn's disease and ADALIMUMAB (HUMIRA) injection for Crohn's disease.    The patient's past medical history included Crohn's disease (MODERATE TO SEVERE ADULT CROHN'S DISEASE).   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jan-2022, 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) 40 milligram and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In December 2021, the patient experienced COVID-19 (in feb 2021, patient had second dose of moderna and in Dec 2021, Patient had COVID.). On an unknown date, the patient experienced VACCINATION FAILURE (in feb 2021, patient had second dose of moderna and in Dec 2021, Patient had COVID.), ABDOMINAL PAIN UPPER (Stomach pain), ABDOMINAL DISTENSION (Swelling abdomen), FLATULENCE (Gas), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux (esophageal)) and ABDOMINAL PAIN (Abdominal cramp). At the time of the report, COVID-19 (in feb 2021, patient had second dose of moderna and in Dec 2021, Patient had COVID.) was resolving, VACCINATION FAILURE (in feb 2021, patient had second dose of moderna and in Dec 2021, Patient had COVID.), ABDOMINAL DISTENSION (Swelling abdomen) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux (esophageal)) outcome was unknown and ABDOMINAL PAIN UPPER (Stomach pain), FLATULENCE (Gas) and ABDOMINAL PAIN (Abdominal cramp) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: (Positive) Positive.         Humira was not working (LOE). In December 2021, the patient experienced had COVID. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the reporter. The reporter's causality for the event(s) of HAD COVID with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of STOMACH PAIN with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of HUMIRA WAS NOT WORKING, ABDOMINAL CRAMPING, ABDOMINAL SWELLING, ABDOMINAL GAS and ACID REFLUX was not 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 a male patient aged 31 years with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19 (with positive SARS-CoV-2 test) that occurred on an unknown date approximately 10 months after the second dose of mRNA-1273 vaccination. Additionally, Vaccination failure was also noted. The time interval between first and second dose of mRNA-1273 vaccine was 31 days. Outcome of the event was resolving at the time of report. Current pandemic situation of COVID 19 may remain as confounder to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness(non-serious) assessed as per medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Follow-up received include Suspect (Spikevax) dosage details added, Suspect Humira added, Event (Abdominal pain upper) added. On 31-Mar-2022: Follow-up received include event onset date added. On 04-Apr-2022: Follow-up received include Event (Abdominal pain upper) outcome updated and suspect product details updated; Sender's Comments: This spontaneous case concerns a male patient aged 31 years with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19 (with positive SARS-CoV-2 test) that occurred on an unknown date approximately 10 months after the second dose of mRNA-1273 vaccination. Additionally, Vaccination failure was also noted. The time interval between first and second dose of mRNA-1273 vaccine was 31 days. Outcome of the event was resolving at the time of report. Current pandemic situation of COVID 19 may remain as confounder to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness(non-serious) assessed as per medical judgement.