Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth, Vitamin D
Clinical narrative: Postmenopausal spotting; Pancreatic duct dilatation; Condition aggravated; Back arthritis; Curvature of spine; Vaccination site warmth; Skin injury; Increased tendency to bruise; Anemic; Abdominal pain; Vaccination site pruritus; Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Postmenopausal spotting) and PANCREATIC DUCT DILATATION (Pancreatic duct dilatation) in a 53-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 and Ankylosing spondylitis.    Concurrent medical conditions included Crohn's disease (ADULT CROHN'S DISEASE) and Ankylosing spondylitis.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Postmenopausal spotting) (seriousness criterion medically significant), PANCREATIC DUCT DILATATION (Pancreatic duct dilatation) (seriousness criterion medically significant), CONDITION AGGRAVATED (Condition aggravated), SPONDYLITIS (Back arthritis), SPINAL DEFORMITY (Curvature of spine), VACCINATION SITE WARMTH (Vaccination site warmth), SKIN INJURY (Skin injury), INCREASED TENDENCY TO BRUISE (Increased tendency to bruise), ANAEMIA (Anemic), ABDOMINAL PAIN (Abdominal pain), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (Postmenopausal spotting), SPONDYLITIS (Back arthritis), SPINAL DEFORMITY (Curvature of spine), ANAEMIA (Anemic) and ABDOMINAL PAIN (Abdominal pain) outcome was unknown, PANCREATIC DUCT DILATATION (Pancreatic duct dilatation), CONDITION AGGRAVATED (Condition aggravated), SKIN INJURY (Skin injury) and INCREASED TENDENCY TO BRUISE (Increased tendency to bruise) had not resolved and VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vitamin D: Low.         No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The humira drug was available as solution for injection in pre-filled pen. The causality as per reporter for humira for event condition aggravated was reported as reasonable possibility. The causality as per reporter for humira for rest of the events was reported as No reasonable possibility. No treatment medications were reported. 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 female patient aged 53 years with concurrent condition of CROHN'S and ANKYLOSING SPONDYLITIS reported, experienced unexpected serious (medically significant) events of Postmenopausal haemorrhage and Pancreatic duct dilatation on unknown dates in the context of mRNA-1273 vaccination. Additionally Condition aggravated was reported. She also experienced non serious events of Spondylitis, Spinal deformity. Patient received the first and second doses at an interval of 31 days. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Vitamin D done on an unknown date was low. Outcome of the event Postmenopausal haemorrhage was unknown and Pancreatic duct dilatation was not resolved at the time of report. Concurrent condition of ANKYLOSING SPONDYLITIS could be confounder to nonserious events Spondylitis, Spinal deformity. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient aged 53 years with concurrent condition of CROHN'S and ANKYLOSING SPONDYLITIS reported, experienced unexpected serious (medically significant) events of Postmenopausal haemorrhage and Pancreatic duct dilatation on unknown dates in the context of mRNA-1273 vaccination. Additionally Condition aggravated was reported. She also experienced non serious events of Spondylitis, Spinal deformity. Patient received the first and second doses at an interval of 31 days. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Vitamin D done on an unknown date was low. Outcome of the event Postmenopausal haemorrhage was unknown and Pancreatic duct dilatation was not resolved at the time of report. Concurrent condition of ANKYLOSING SPONDYLITIS could be confounder to nonserious events Spondylitis, Spinal deformity. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.