Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Irritable bowel syndrome, Malaise, Motion sickness, Psoriasis
Clinical narrative: Clotting disorder; Irritable bowel syndrome; Fear of needles; Blood pressure high; Motion sickness; Rosacea; Injection site bruising; Vaccination site pain; Feeling unwell; increased tendency to bruise; vaccination site discomfort; Pulmonary hypertension; Psoriasis flare-up; Headache; Stress; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY HYPERTENSION (Pulmonary hypertension) and COAGULOPATHY (Clotting disorder) in a 50-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 RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) for Plaque psoriasis.    Concurrent medical conditions included Restless leg syndrome.   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient started RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) (Subcutaneous) at an unspecified dose. On 05-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2020, the patient experienced PULMONARY HYPERTENSION (Pulmonary hypertension) (seriousness criterion medically significant), STRESS (Stress), PSORIASIS (Psoriasis flare-up) and HEADACHE (Headache). On an unknown date, the patient experienced COAGULOPATHY (Clotting disorder) (seriousness criterion medically significant), IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome), FEAR OF INJECTION (Fear of needles), HYPERTENSION (Blood pressure high), MOTION SICKNESS (Motion sickness), ROSACEA (Rosacea), INJECTION SITE BRUISING (Injection site bruising), VACCINATION SITE PAIN (Vaccination site pain), MALAISE (Feeling unwell), INCREASED TENDENCY TO BRUISE (increased tendency to bruise) and VACCINATION SITE DISCOMFORT (vaccination site discomfort). At the time of the report, PULMONARY HYPERTENSION (Pulmonary hypertension), ROSACEA (Rosacea), INJECTION SITE BRUISING (Injection site bruising) and VACCINATION SITE PAIN (Vaccination site pain) was resolving, COAGULOPATHY (Clotting disorder), HYPERTENSION (Blood pressure high), MOTION SICKNESS (Motion sickness), STRESS (Stress), INCREASED TENDENCY TO BRUISE (increased tendency to bruise) and VACCINATION SITE DISCOMFORT (vaccination site discomfort) outcome was unknown, IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome) and FEAR OF INJECTION (Fear of needles) had not resolved and MALAISE (Feeling unwell), PSORIASIS (Psoriasis flare-up) and HEADACHE (Headache) had resolved.            No concomitant medication information was provided. 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. The patient was diagnosed with pulmonary hypertension in the end of last year 2020. She timed her SKYRIZI  treatments scheduled between Covid shots as per health care provider. She used Scopamine patch to prevent her motion sickness which she applied behind the ear and it gave her cotton dry mouth for a while and stayed in her system for three days. She had negative sick reactions with both Covid 19 Vaccines in 2021, and very sore from injections being jabbed in is uncomfortable during injection, considered it was booster shot. She had started new medication for pulmonary hypertension in January 2022. She administered last dose of Skyrizi for January 2022 but this was  administered a couple of weeks lately, in February 2022. On 23 February 2022, she administered her Skyrizi, and still had a bruise at inction site and where bandaid adhesive was. May 11 2022 is next injection at Health Care Providers office. Patient had 3 different blood clotting disorders and bruises easily. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unknown date patient experienced high blood pressure. No treatment medication was provided.   Company Comment- This spontaneous case concerns a 50-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of pulmonary hypertension and coagulopathy, among other non-serious events. The event pulmonary hypertension started the year before the first dose of mRNA-1273, and event coagulopathy started an unknown time after mRNA-1273 administration. Treatment for pulmonary hypertension was still ongoing at the time of the report, although specific information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Event coagulopathy could be a confounding factor for pulmonary hypertension. Outcome was reported as resolving for pulmonary hypertension and unknown for coagulopathy. The benefit-risk relationship of mRNA-1273 is not affected by this report.  Most recent FOLLOW-UP information incorporated above includes: On 02-Mar-2022: Significant follow up appended new event added..; Sender's Comments: This spontaneous case concerns a 50-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of pulmonary hypertension and coagulopathy, among other non-serious events. The event pulmonary hypertension started the year before the first dose of mRNA-1273, and event coagulopathy started an unknown time after mRNA-1273 administration. Treatment for pulmonary hypertension was still ongoing at the time of the report, although specific information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Event coagulopathy could be a confounding factor for pulmonary hypertension. Outcome was reported as resolving for pulmonary hypertension and unknown for coagulopathy. The benefit-risk relationship of mRNA-1273 is not affected by this report.