Age: 42.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Feeling abnormal, Flatulence, Frequent bowel movements, Gastrointestinal sounds abnormal, Gastrooesophageal reflux disease
Clinical narrative: Foggy head; Acid reflux; Cramps right hand; Occasional headache; Heart burn; Felt anxious; Felt tired; Stomach growling/making gurgling sounds; Felt scared; Unable to do things peers or friends can do; Lacked energy; More frequent bowel movement than usual; Gas more than usual; Trouble sleeping; Felt sad/blue; Diarrhea worsened; Loss of appetite; Abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL SOUNDS ABNORMAL (Stomach growling/making gurgling sounds), FEAR (Felt scared), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to do things peers or friends can do), ASTHENIA (Lacked energy) and FREQUENT BOWEL MOVEMENTS (More frequent bowel movement than usual) in a 42-year-old female 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) solution for injection for Crohn's disease and ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    The patient's past medical history included Joint pain.   On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Aug-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 160 milligram once a day. On 20-Aug-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 80 milligram once a day. On 03-Sep-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced DECREASED APPETITE (Loss of appetite) and ABDOMINAL PAIN (Abdominal pain). On 07-Aug-2021, the patient experienced DYSPEPSIA (Heart burn). In August 2021, the patient experienced GASTROINTESTINAL SOUNDS ABNORMAL (Stomach growling/making gurgling sounds), FEAR (Felt scared), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to do things peers or friends can do), ASTHENIA (Lacked energy), FREQUENT BOWEL MOVEMENTS (More frequent bowel movement than usual), FLATULENCE (Gas more than usual), INSOMNIA (Trouble sleeping), DEPRESSED MOOD (Felt sad/blue), ANXIETY (Felt anxious), DIARRHOEA (Diarrhea worsened) and FATIGUE (Felt tired). On 28-Dec-2021, the patient experienced FEELING ABNORMAL (Foggy head), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), MUSCLE SPASMS (Cramps right hand) and HEADACHE (Occasional headache). At the time of the report, GASTROINTESTINAL SOUNDS ABNORMAL (Stomach growling/making gurgling sounds), FEAR (Felt scared), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to do things peers or friends can do), ASTHENIA (Lacked energy), FREQUENT BOWEL MOVEMENTS (More frequent bowel movement than usual), FLATULENCE (Gas more than usual), INSOMNIA (Trouble sleeping), DEPRESSED MOOD (Felt sad/blue), DYSPEPSIA (Heart burn), ANXIETY (Felt anxious), DECREASED APPETITE (Loss of appetite), ABDOMINAL PAIN (Abdominal pain), DIARRHOEA (Diarrhea worsened) and FATIGUE (Felt tired) outcome was unknown and FEELING ABNORMAL (Foggy head), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), MUSCLE SPASMS (Cramps right hand) and HEADACHE (Occasional headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Clostridium test: (Negative) Negative.         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.  The dose of co-suspect drug Humira was reported as 160 mg for day 1, 80 mg for days 15 and 40 mg for days 29.   No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported.  The reporter's causality for the events of felt tired, stomach growling/making gurgling sounds, felt scared, unable to do things peers or friends can do, foggy head, lacked energy, more frequent bowel movement than usual, loss of appetite, gas more than usual, trouble sleeping, felt sad/blue, heart burn, felt anxious, acid reflux, diarrhea worsened, abdominal pain, did not feel humira was helping, nausea, cramps right hand and occasional headache was not provided for Humira 80mg/0.8ml.  The reporter's causality for the events of felt tired, stomach growling/making gurgling sounds, felt scared, unable to do things peers or friends can do, foggy head, lacked energy, more frequent bowel movement than usual, loss of appetite, gas more than usual, trouble sleeping, felt sad/blue, heart burn, felt anxious, acid reflux, diarrhea worsened, abdominal pain, did not feel humira was helping, nausea, cramps right hand and occasional headache was not provided for Humira 40mg/0.4ml.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Significant follow-up: Event removed and updated. On 10-Jan-2022: Significant follow-up appended: Event information, medical history and narrative description updated.