Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Bone densitometry, Bone density abnormal, Headache, Illness
Clinical narrative: Bone density was not good; Loss weight; Feeling sick to my stomach; Headache; Psoriatic arthritis inflammation was high; Therapeutic product effect incomplete; Uterine cancer; Patient got sick with Moderna vaccination/Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of UTERINE CANCER (Uterine cancer), ILLNESS (Patient got sick with Moderna vaccination/Booster), BONE DENSITY ABNORMAL (Bone density was not good), WEIGHT DECREASED (Loss weight), ABDOMINAL DISCOMFORT (Feeling sick to my stomach), HEADACHE (Headache) and PSORIATIC ARTHROPATHY (Psoriatic arthritis inflammation was high) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product APREMILAST (OTEZLA) tablet for Psoriasis.    The patient's past medical history included Urinary tract infection and Surgery (The patient had uterine cancer and had surgery.) in 2019. Previously administered products included for Product used for unknown indication: Humira. Past adverse reactions to the above products included Urinary tract infection with Humira. Concurrent medical conditions included Allergy to chemicals, Drug hypersensitivity and Psoriatic arthropathy. Concomitant products included FISH OIL, CALCIUM, COLECALCIFEROL (CALCIUM + D3 [CALCIUM;COLECALCIFEROL]), CENTRUM JR [ASCORBIC ACID;BIOTIN;CALCIUM;CALCIUM CARBONATE;CALCIUM PANTOTHENATE;CHROMIUM;COPPER;CYANOCOBALAMIN;ERGOCALCIFEROL;FOLIC ACID;IODINE;IRON;MAGNESIUM;MANGANESE;MOLYBDENUM;NICOTINAMIDE;PHOSPHORUS;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;TH and ALENDRONATE SODIUM for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and APREMILAST (OTEZLA) (Oral) 30 milligram twice a day. In 2019, the patient experienced UTERINE CANCER (Uterine cancer) (seriousness criterion medically significant) and ILLNESS (Patient got sick with Moderna vaccination/Booster) (seriousness criterion medically significant). On an unknown date, the patient experienced BONE DENSITY ABNORMAL (Bone density was not good) (seriousness criterion medically significant), WEIGHT DECREASED (Loss weight) (seriousness criterion medically significant), ABDOMINAL DISCOMFORT (Feeling sick to my stomach) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PSORIATIC ARTHROPATHY (Psoriatic arthritis inflammation was high) (seriousness criterion medically significant) and THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete). The patient was treated with Surgery for Uterine cancer. At the time of the report, UTERINE CANCER (Uterine cancer), ILLNESS (Patient got sick with Moderna vaccination/Booster), BONE DENSITY ABNORMAL (Bone density was not good), WEIGHT DECREASED (Loss weight), ABDOMINAL DISCOMFORT (Feeling sick to my stomach), HEADACHE (Headache), PSORIATIC ARTHROPATHY (Psoriatic arthritis inflammation was high) and THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Bone densitometry: Abnormal.     The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided. Patient thought Otezla worked part time, not worked much for arthritis. patient psoriatic arthritis inflammation was high. Patient physician wanted to add another medication, but did not started due to potential side effects. The other health care professional reported that event drug ineffective was possibly related to Otezla and for other events, causality was not provided for Otezla. Company comment This spontaneous case concerns a female patient of patient of an unknown age, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of uterine cancer, illness, bone density abnormal, weight decreased, abdominal discomfort, headache and psoriatic arthropathy aggravated. She received a dose of mRNA-1273.222 (BA.4/BA.5) vaccine (Spikevax Bivalent Original/Omicron BA.4-5). Latency cannot be assessed since exact vaccination date and event onset date were not disclosed. It was reported that the patient began Apremilast (Otezla) and experienced that it was not meeting treatment expectations because it did not have much effect on her arthritis, she was losing weight, feeling sick to her stomach and having headaches. Other health professional reported that the event therapeutic product effect incomplete was possibly related to Otezla. No further clinical information was available for review. The benefit-risk relationship of mRNA-1273.222 (BA.4/BA.5) Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of patient of an unknown age, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of uterine cancer, illness, bone density abnormal, weight decreased, abdominal discomfort, headache and psoriatic arthropathy aggravated. She received a dose of mRNA-1273.222 (BA.4/BA.5) vaccine (Spikevax Bivalent Original/Omicron BA.4-5). Latency cannot be assessed since exact vaccination date and event onset date were not disclosed. It was reported that the patient began Apremilast (Otezla) and experienced that it was not meeting treatment expectations because it did not have much effect on her arthritis, she was losing weight, feeling sick to her stomach and having headaches. Other health professional reported that the event therapeutic product effect incomplete was possibly related to Otezla. No further clinical information was available for review. The benefit-risk relationship of mRNA-1273.222 (BA.4/BA.5) Vaccine is not affected by this report.