Age: 32.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Constipation, Fatigue, Pain
Clinical narrative: constipation; general body pain; tiredness; This spontaneous case was reported by a physician and describes the occurrence of CONSTIPATION (constipation), PAIN (general body pain) and FATIGUE (tiredness) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 003A21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Crohn's disease.    The patient's past medical history included Fibromyalgia in November 2020 and Clostridium difficile infection in December 2020. Concurrent medical conditions included Sulfonamide allergy (manifested by hives), Allergy to antibiotic (flagyl allergy manifested by diarrhea), Ankylosing spondylitis, Blood pressure high, Anxiety, Bloating, Insomnia, Depression, Restless leg syndrome, Asthma, Food allergy (apple juice), Crohn's disease and Rheumatoid arthritis. Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and FLUTICASONE for Allergy, GABAPENTIN for Ankylosing spondylitis, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, ETHINYLESTRADIOL, NORGESTIMATE (SPRINTEC) for Birth control, SIMETICONE (GAS X) for Bloating, PROPRANOLOL (PROPANOLOL [PROPRANOLOL]) for Blood pressure high and Anxiety, ARIPIPRAZOLE (ABILIFY) for Depression, CELECOXIB for Fibromyalgia, TRAZODONE for Insomnia, LACTOBACILLUS ACIDOPHILUS (FLORASTOR [LACTOBACILLUS ACIDOPHILUS]) for Probiotic therapy, ROPINIROLE HYDROCHLORIDE (REQUIP) for Restless leg syndrome.   In March 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced CONSTIPATION (constipation), PAIN (general body pain) and FATIGUE (tiredness). On 01-Apr-2021, PAIN (general body pain) and FATIGUE (tiredness) had resolved. At the time of the report, CONSTIPATION (constipation) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN (general body pain) and FATIGUE (tiredness) to be probably related. No further causality assessment was provided for CONSTIPATION (constipation).    The patient had clostridioides difficile manifested by extreme diarrhea, a very bad abdominal pain in Dec 2020. She had a fecal transplant on 26 Mar 2021, started having stomach pain a few days later that got worse on 12 Apr 2021. The causality for diarrhea and abdominal pain for Humira was not related and for COVID-19 vaccine not applicable. It was unknown if patient was enrolled I a COVID-19 vaccine trial. Patient is a non smoker and abstains from alcohol.  Action taken with the drug is not applicable. Dechallenge and rechallenge results are not applicable. The patient was treated with Cefpodoxime.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The medical history of  Fibromyalgia is a confounder.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The medical history of  Fibromyalgia is a confounder.