Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Colitis ulcerative, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: I have Idiopathic Ulcerative Rectocolitis; Patient missed the second dose; Shoulder pain in left arm, still ongoing, coming and going; Patient was diagnosed with COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (I have Idiopathic Ulcerative Rectocolitis), PRODUCT DOSE OMISSION ISSUE (Patient missed the second dose), COVID-19 (Patient was diagnosed with COVID-19) and ARTHRALGIA (Shoulder pain in left arm, still ongoing, coming and going) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Ulcerative colitis. Concomitant products included LOSARTAN, ACETYLSALICYLIC ACID (ASPIRIN 81), MESALAZINE (MESALAMINE) and METOPROLOL for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced COVID-19 (Patient was diagnosed with COVID-19). On 02-Feb-2021, the patient experienced ARTHRALGIA (Shoulder pain in left arm, still ongoing, coming and going). On 16-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed the second dose). On 29-Apr-2021, the patient experienced COLITIS ULCERATIVE (I have Idiopathic Ulcerative Rectocolitis). On 16-Feb-2021, PRODUCT DOSE OMISSION ISSUE (Patient missed the second dose) had resolved. At the time of the report, COLITIS ULCERATIVE (I have Idiopathic Ulcerative Rectocolitis) and COVID-19 (Patient was diagnosed with COVID-19) outcome was unknown and ARTHRALGIA (Shoulder pain in left arm, still ongoing, coming and going) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 19Jan2021, she received the Moderna COVID-19  vaccine in her left upper, non dominant arm. Patient was diagnosed with COVID-19 on 27Jan2021. The patient reported the onset of symptoms occurred two weeks after the first dose of the Moderna COVID-19  vaccine, on or around 02Feb2021. These symptoms included shoulder pain in left arm, still ongoing, coming and going. The patient missed her second dose of the Moderna COVID-19 vaccine that had been scheduled  on 16 Feb 2021. On 29Apr2021, she experienced idiopathic ulcerative rectocolitis.  Treatment information was included acetaminophen 400 grams one tablet by mouth (PO) a day (OD) to try alleviate the symptoms.  Action taken with mRNA-1273 in response to the event was unknown.  company comment: Very limited information regarding these events has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine, the ulcerative colitis event may not be unrelated to the patient's medical history.; Sender's Comments: Very limited information regarding these events has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine, the ulcerative colitis event may not be unrelated to the patient's medical history.