Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Gastric ulcer, Hyperkeratosis, Memory impairment, Nail hypertrophy, Pruritus
Clinical narrative: psoriasis to the head, face, arm, leg, back and stomach; Due to psoriasis, the patient had sepsis; attacked the heart valve and required a valve replacement/infected heart valve; ulcer repair of stomach; itching and scratching every 3-4 days; itching and scratching every 3-4 days; grown double layers of toenails; bottom of feet and hand became callous and thick; lost the hair; The patient cannot walk without support; depressed; memory issues; bottom of the feet are scaly; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (psoriasis to the head, face, arm, leg, back and stomach), SEPSIS (Due to psoriasis, the patient had sepsis), ENDOCARDITIS (attacked the heart valve and required a valve replacement/infected heart valve) and GASTRIC ULCER (ulcer repair of stomach) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PSORIASIS (psoriasis to the head, face, arm, leg, back and stomach), (seriousness criterion medically significant) ,SEPSIS (Due to psoriasis, the patient had sepsis) (seriousness criterion medically significant), ENDOCARDITIS (attacked the heart valve and required a valve replacement/infected heart valve) (seriousness criterion medically significant), GASTRIC ULCER (ulcer repair of stomach) (seriousness criterion medically significant), SCRATCH (itching and scratching every 3-4 days), PRURITUS (itching and scratching every 3-4 days), NAIL HYPERTROPHY (grown double layers of toenails), HYPERKERATOSIS (bottom of feet and hand became callous and thick), ALOPECIA (lost the hair), GAIT DISTURBANCE (The patient cannot walk without support), DEPRESSION (depressed), MEMORY IMPAIRMENT (memory issues) and SKIN EXFOLIATION (bottom of the feet are scaly). The patient was treated with ACETAMINOPHEN at a dose of 600 milligram every four hours; ACITRETIN at a dose of 10 milligram once a day; AMOXICILLIN at a dose of 2000 milligram once a day; ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 81 milligram once a day; DILTIAZEM HYDROCHLORIDE (DILTIAZEM AN) at a dose of 300 milligram once a day; SALICYLIC ACID (CERAVE PSORIASIS) (topical) at an unspecified dose and frequency; SALICYLIC ACID (EUCERIN [SALICYLIC ACID]) at a dose of UNK, bid; MACROGOL, PROPYLENE GLYCOL, SIMETICONE, SORBIC ACID, SORBITOL, WHITE SOFT PARAFFIN (VANICREAM) at a dose of UNK, bid; FAMOTIDINE at a dose of 20 milligram twice a day; FERROUS SULFATE HEPTAHYDRATE (FERROUS SULFATE [FERROUS SULFATE HEPTAHYDRATE]) at a dose of 325 milligram twice a day; FOLIC ACID at a dose of 1 milligram once a day; HYDROXYZINE HCL at a dose of UNK, tid; INFLIXIMAB at a dose of 100 mg; LEVOTHYROXINE at a dose of 88 microgram once a day; METHOTREXATE at a dose of 10 milligram four times per day; PANTOPRAZOLE at a dose of 40 milligram once a day; POTASSIUM CHLORIDE at a dose of 40 milliequivalent twice a day; SERTRALINE HYDROCHLORIDE (ZOLOFT) at a dose of 50 milligram once a day; TORSEMIDE at a dose of 40 milligram twice a day; APREMILAST (OTEZLA) for Psoriasis, at a dose of 25 pills, qd; Surgery (valve replacement) for Sepsis; Surgery (valve replacement, open heart surgery) for Endocarditis and Surgery (ulcer repair of stomach) for Gastric ulcer. At the time of the report, PSORIASIS (psoriasis to the head, face, arm, leg, back and stomach), SEPSIS (Due to psoriasis, the patient had sepsis), ENDOCARDITIS (attacked the heart valve and required a valve replacement/infected heart valve), GASTRIC ULCER (ulcer repair of stomach), NAIL HYPERTROPHY (grown double layers of toenails), HYPERKERATOSIS (bottom of feet and hand became callous and thick), ALOPECIA (lost the hair), GAIT DISTURBANCE (The patient cannot walk without support), DEPRESSION (depressed), MEMORY IMPAIRMENT (memory issues) and SKIN EXFOLIATION (bottom of the feet are scaly) outcome was unknown and SCRATCH (itching and scratching every 3-4 days) and PRURITUS (itching and scratching every 3-4 days) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy: drug related events (inconclusive) found out to be drug related. In 2021, Weight: lost 240 lb to 160 lb (Low) lost 240 pounds to 160 pounds.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was reported.  The patient's sister reported that a week after receiving the second dose of Moderna vaccine, the patient had a severe case of psoriasis. The patient was receiving infusion for treatment of psoriasis and 25 pills a day (one was Otezla). The patient had undergone two biopsies that turned out to be drug-related. It was reported that since vaccination, patient had sepsis, and open-heart surgery because of the infected heart valve. The patient was feeling like dying, and the patient's sister could not do anything about it. The patient was very healthy prior to vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 29-Dec-2021: Significant Follow up received : Suspect vaccine start date, lot number of vaccine, anatomical location and route of administration of vaccine were updated.  Company comment: This spontaneous case concerns a 73-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Psoriasis, Endocarditis, Sepsis and Gastric ulcer after mRNA- 1273 vaccine. The onset of the event Psoriasis occurred approximately 1 week after the second dose of mRNA- 1273 vaccine and Endocarditis, Sepsis and Gastric ulcer occurred at an unknown later date. Psoriasis was reported as severe and involved the head, face, arm, leg, back and stomach. It is noted that skin biopsy was performed and reported the lesion as drug-related. Treatment with Infliximab infusion, methotrexate, apremilast, Acitretin were prescribed, among other drugs. Sepsis secondary to psoriasis occurred, which lead to Endocarditis. Valve replacement intervention was required. Additionally, Gastric ulcer repair was reported. Very limited information is available regarding these events. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 73-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Psoriasis, Endocarditis, Sepsis and Gastric ulcer after mRNA- 1273 vaccine. The onset of the event Psoriasis occurred approximately 1 week after the second dose of mRNA- 1273 vaccine and Endocarditis, Sepsis and Gastric ulcer occurred at an unknown later date. Psoriasis was reported as severe and involved the head, face, arm, leg, back and stomach. It is noted that skin biopsy was performed and reported the lesion as drug-related. Treatment with Infliximab infusion, methotrexate,  and Apremilast, Acitretin was prescribed, among other drugs. Sepsis secondary to psoriasis occurred, which lead to Endocarditis. Valve replacement intervention was required. Additionally, Gastric ulcer repair was reported. Very limited information is available regarding these events. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.