Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Crohn's disease, Intestinal obstruction, Vaccination site bruising, Vaccination site nodule
Clinical narrative: Crohn's disease aggravated / Crohn's disease flare up; Weight gain / gained 50 pounds; recurred knot at injection site; took second Covid-19 vaccine recurred bruising on the arm; recurred abdominal pain; Abdominal pain; Took covid-19 vaccine had bruised arm; Knot at injection site; Ate corn and peas at the same time and caused a blockage in intestine; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohn's disease aggravated / Crohn's disease flare up) and INTESTINAL OBSTRUCTION (Ate corn and peas at the same time and caused a blockage in intestine) in a 52-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 product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    The patient's past medical history included Ex-smoker (she smoked for just a month when she was 18 years old.) and Alcohol abuse (1 or 2 drinks a year bourbon in mid 20s). Previously administered products included for Product used for unknown indication: ASPIRIN, CODEINE, MORPHINE and TYLENOL. Past adverse reactions to the above products included No adverse event with ASPIRIN, CODEINE, MORPHINE and TYLENOL. Concurrent medical conditions included Allergic reaction to analgesics, Swelling of tongue (Aspirin allergy manifested by tongue Swelling), Difficulty breathing (Aspirin allergy manifested by difficulty in breathing), Alcohol allergy, Topical adhesive allergy, Rash (Isopropyl alcohol and adhesives allergy manifested by Rash), Skin inflammation (Isopropyl alcohol and adhesives allergy manifested by inflamed skin), Bleeding (Isopropyl alcohol and adhesives allergy manifested by openly bleed to the pores), Allergy to metals, Swelling (metals/jewelry allergy manifested by swelling), Redness (metals/jewelry allergy manifested by redness), Sensation of warmth (metals/jewelry allergy manifested by heat at the site where the metal was), Drug allergy, Drug allergy, Vomiting (morphine and codeine allergy manifested by vomiting), Migraine (morphine and codeine allergy manifested by migraine), Drug allergy, Sickness (Tylenol allergy manifested by violently sick), Vomiting (Tylenol allergy manifested by vomiting), Headache (Tylenol allergy manifested by headache) and Crohn's disease. Concomitant products included CELECOXIB (CELEBREX) for Arthritis, AZATHIOPRINE (IMURAN [AZATHIOPRINE]) for Crohn's disease, ESOMEPRAZOLE for Gastroesophageal reflux disease, RIZATRIPTAN for Migraine, TIZANIDINE for Muscle spasm, PROMETHAZINE (PHENERGAN [PROMETHAZINE]) for Nausea, CLONAZEPAM for Restless leg syndrome, BIOTIN and GINSENG [GINSENG NOS] for Supplementation therapy.    In 2014, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In 2017, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate free. On 03-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jul-2021, the patient experienced VACCINATION SITE BRUISING (Took covid-19 vaccine had bruised arm), VACCINATION SITE NODULE (Knot at injection site) and ABDOMINAL PAIN (Abdominal pain). In July 2021, the patient experienced INTESTINAL OBSTRUCTION (Ate corn and peas at the same time and caused a blockage in intestine) (seriousness criterion medically significant). On 28-Jul-2021, the patient experienced VACCINATION SITE NODULE (recurred knot at injection site), VACCINATION SITE BRUISING (took second Covid-19 vaccine recurred bruising on the arm) and ABDOMINAL PAIN (recurred abdominal pain). On an unknown date, the patient experienced CROHN'S DISEASE (Crohn's disease aggravated / Crohn's disease flare up) (seriousness criterion medically significant) and WEIGHT INCREASED (Weight gain / gained 50 pounds). The patient was treated with HYDROMORPHONE HYDROCHLORIDE (DILAUDID) at an unspecified dose and frequency. In July 2021, INTESTINAL OBSTRUCTION (Ate corn and peas at the same time and caused a blockage in intestine), VACCINATION SITE BRUISING (Took covid-19 vaccine had bruised arm), VACCINATION SITE NODULE (Knot at injection site), VACCINATION SITE NODULE (recurred knot at injection site), VACCINATION SITE BRUISING (took second Covid-19 vaccine recurred bruising on the arm), ABDOMINAL PAIN (Abdominal pain) and ABDOMINAL PAIN (recurred abdominal pain) had resolved. At the time of the report, CROHN'S DISEASE (Crohn's disease aggravated / Crohn's disease flare up) and WEIGHT INCREASED (Weight gain / gained 50 pounds) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: Gain 50 Pounds.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   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 52-year-old female patient with relevant medical history of Crohn's disease, who experienced the unexpected, serious  (medically significant ) events of Crohn's disease (Crohn's disease aggravated / Crohn's disease flare up), and Intestinal obstruction on unknown dates in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency cannot be determined as date of onset of events were not provided. The event intestinal obstruction occurred during  the same month of vaccination of both doses as the two doses were given within the same month. Patient received a 2-dose primary series of mRNA-1273 vaccine given 25 days apart. The relevant medical history of Crohn's disease  remains a confounder as the disease itself is known to result in flares, and with intestinal obstruction as the most common complication.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Follow-up received include medical history added, Drug allergy added, Concomitant added, Event Abdominal pain, Vaccination site nodule added.; Sender's Comments: This spontaneous case concerns a 52-year-old female patient with relevant medical history of Crohn's disease, who experienced the unexpected, serious  (medically significant ) events of Crohn's disease (Crohn's disease aggravated / Crohn's disease flare up), and Intestinal obstruction on unknown dates in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency cannot be determined as date of onset of events were not provided. The event intestinal obstruction occurred during  the same month of vaccination of both doses as the two doses were given within the same month. Patient received a 2-dose primary series of mRNA-1273 vaccine given 25 days apart. The relevant medical history of Crohn's disease  remains a confounder as the disease itself is known to result in flares, and with intestinal obstruction as the most common complication.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.