Age: 54.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pyrexia
Clinical narrative: CROHNS FLARE UP; NO SENSE OF TASTE; NO SENSE OF SMELL; FEVER 104 DEGREES; Shoulder injury; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (CROHNS FLARE UP) in a 55-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) for Crohn's disease.    The patient's past medical history included Anaphylactic reaction on 01-Jan-2020 and Shoulder injury (She had been on treatment since 2017) on 01-Jan-2021. Previously administered products included for Product used for unknown indication: flu vaccine. Past adverse reactions to the above products included Anaphylactic reaction with flu vaccine. Concurrent medical conditions included Crohn's disease (MODERATE TO SEVERE). Concomitant products included BUDESONIDE for Shoulder injury.   On 18-Jul-2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, citrate free. In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jan-2021, the patient experienced LIMB INJURY (Shoulder injury). On 01-Apr-2022, the patient experienced AGEUSIA (NO SENSE OF TASTE), ANOSMIA (NO SENSE OF SMELL) and PYREXIA (FEVER 104 DEGREES). On an unknown date, the patient experienced CROHN'S DISEASE (CROHNS FLARE UP) (seriousness criterion medically significant). In April 2022, AGEUSIA (NO SENSE OF TASTE), ANOSMIA (NO SENSE OF SMELL) and PYREXIA (FEVER 104 DEGREES) had resolved. At the time of the report, CROHN'S DISEASE (CROHNS FLARE UP) had resolved and LIMB INJURY (Shoulder injury) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2022, Body temperature: 104 degree Celsius.         No concomitant medications were reported.  It was reported patient took pneumonia vaccine and had anaphylactic reaction. It was reported that patient sustained shoulder injury when student in her class hit her with a metal chair. She had been on treatment since 2017 and felt that she was in remission but that she had occasional mild flares controlled easily with a short course of budesonide. She had covid booster and was sick afterwards for approx. She had Seven days with fever of 104 degrees and no sense of taste or smell. Daily dose of co suspect Humira was reported as citrate free.  Reporters causality for all events was not related with respect to Humira drug. Manufacture causality for all events was no reasonable possibility with respect to Humira drug.  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 is a spontaneous case, reported by a consumer, concerning a 54-year-old female patient with relevant medical condition of moderate to severe Crohn's disease, who experienced the unexpected serious (medically significant) event of Crohn's disease reported as Crohn's flare up, and unexpected non-serious adverse events of special interest Ageusia and Anosmia, in the context of the 3 doses of mRNA-1273 vaccine.  Latency cannot be properly assessed since the exact vaccination date nor event onset date of Crohn's disease were provided. Patient had received 2-dose primary series of mRNA-1273 vaccine, approximately 9 months prior to the third mRNA-1273 vaccination. The patient had fever of 104 degrees with no sense of taste or smell for 7 days after the booster dose of COVID-19 vaccine. No further details about the diagnostic procedures and treatments were provided. It was reported that the event Crohn's aggravated had resolved. The medical condition of moderate to severe Crohn's disease remains as a confounder for the event Crohn's aggravated. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 54-year-old female patient with relevant medical condition of moderate to severe Crohn's disease, who experienced the unexpected serious (medically significant) event of Crohn's disease reported as Crohn's flare up, and unexpected non-serious adverse events of special interest Ageusia and Anosmia, in the context of the 3 doses of mRNA-1273 vaccine.  Latency cannot be properly assessed since the exact vaccination date nor event onset date of Crohn's disease were provided. Patient had received 2-dose primary series of mRNA-1273 vaccine, approximately 9 months prior to the third mRNA-1273 vaccination. The patient had fever of 104 degrees with no sense of taste or smell for 7 days after the booster dose of COVID-19 vaccine. No further details about the diagnostic procedures and treatments were provided. It was reported that the event Crohn's aggravated had resolved. The medical condition of moderate to severe Crohn's disease remains as a confounder for the event Crohn's aggravated. The benefit-risk relationship of mRNA-1273 is not affected by this report.