Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Colonoscopy, Headache, Nasopharyngeal swab, Nasopharyngitis, Nervousness
Clinical narrative: Nervousness; Common cold; headache; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (Nervousness), NASOPHARYNGITIS (Common cold), HEADACHE (headache) and PAIN IN EXTREMITY (Pain in arm) in a 60-year-old female 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.    The patient's past medical history included Bowel obstruction in 2019, Proctectomy in 2003 and Supplementation therapy since an unknown date. Concurrent medical conditions included Stricture intestinal since 2010, Alcohol use, Neuropathy, Dust allergy (manifested by sinus reaction), Indigestion, Acid reflux (esophageal), Crohn's disease, Pulse rate and Stricture intestinal in 2010. Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), FOLIC ACID and MERCAPTOPURINE for Crohn's disease, PANCREATIN (CREON) for Digestion impaired, PROPRANOLOL for Pulse rate, VITAMIN D3 and POTASSIUM for Supplementation therapy.   In 2013, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced NASOPHARYNGITIS (Common cold), HEADACHE (headache) and PAIN IN EXTREMITY (Pain in arm). On an unknown date, the patient experienced NERVOUSNESS (Nervousness). The patient was treated with RIVAROXABAN (XARELTO) at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency and ZINC at an unspecified dose and frequency. On 22-Feb-2021, HEADACHE (headache) and PAIN IN EXTREMITY (Pain in arm) had resolved. At the time of the report, NERVOUSNESS (Nervousness) and NASOPHARYNGITIS (Common cold) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Nov-2020, Nasopharyngeal swab: (Positive) Covid 19 Positive. In July 2021, Colonoscopy: Narrowing of the colon.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had the stricture or narrowing of her bowel since 2010. In 2015, patient had a deep vein thrombosis on right leg. Patient was hospitalized for one to two days. Patient had a bowel obstruction in 2019 and was hospitalized for one week. There was a stent and the physician opened up the ileum. Patient discontinued HUMIRA  when patient was in the hospital but could not provide the exact dates. In Nov 2020, patient had chill, headache and cough. In Dec 2020, the loss of smell, chill, headache, loss of smell and cough were recovered in Dec 2020. From 18 Mar 2021 to 23 Mar 2021, patient had recurred headache. Patient tested positive for Covid 19 but was not hospitalized and just does not the fourteen days quarantine. Patient recently had more stricture or narrowing of patient bowel frequent and had to do the surgery monthly stretch colon. The most recent surgery was last Jul 2021. On 10 Aug 2021, patient removed cap one first straight off in an upright position then removed second cap in order. Patient looked at the window to check the solution and saw that was empty. HUMIRA Pens were not dropped. Patient does not pushed the button on both pens. No injection attempted. Patient accidentally fell in morning as of 12 Aug 2021 and hit hip and stated that hurts. That occurred because patient stepped into something while getting the lot number of her HUMIRA Pen and tried to informed to report product quality. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the events of Nervousness, common cold and pain in arm was not related for Humira.  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.   This case was linked to MOD-2021-624661 (Patient Link).