Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Wound infection
Clinical narrative: THIN SKIN; BANGED UP CHINS; THREE INCHES ABOVE ANKLES, AGAINST METAL RAILING ON FERRY AND IT WAS INFECTED; TOOK MODERNA BOOSTER/HAD SORE ARM; COVID; CONFUSED; This spontaneous case was reported by a consumer and describes the occurrence of SKIN ATROPHY (THIN SKIN), INJURY (BANGED UP CHINS), WOUND INFECTION (THREE INCHES ABOVE ANKLES, AGAINST METAL RAILING ON FERRY AND IT WAS INFECTED), CONFUSIONAL STATE (CONFUSED) and COVID-19 (COVID) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis and Plaque psoriasis.    Concurrent medical conditions included Psoriatic arthritis and Plaque psoriasis.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Aug-2022, received fourth 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) Citrate Free, Discontinued. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In 2020, the patient experienced CONFUSIONAL STATE (CONFUSED). On 19-May-2022, the patient experienced COVID-19 (COVID). On an unknown date, the patient experienced SKIN ATROPHY (THIN SKIN), INJURY (BANGED UP CHINS), WOUND INFECTION (THREE INCHES ABOVE ANKLES, AGAINST METAL RAILING ON FERRY AND IT WAS INFECTED) and VACCINATION SITE PAIN (TOOK MODERNA BOOSTER/HAD SORE ARM). At the time of the report, SKIN ATROPHY (THIN SKIN), WOUND INFECTION (THREE INCHES ABOVE ANKLES, AGAINST METAL RAILING ON FERRY AND IT WAS INFECTED) and COVID-19 (COVID) outcome was unknown, INJURY (BANGED UP CHINS) was resolving, CONFUSIONAL STATE (CONFUSED) had not resolved and VACCINATION SITE PAIN (TOOK MODERNA BOOSTER/HAD SORE ARM) had resolved.            Concomitant products were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The causality for Humira was reported as not provided for events thin skin, confused, COVID and banged up chins, three inches above ankles, against metal railing on ferry and it was infected. No reasonable possibility for events took Moderna booster/had sore arm and banged up chins, three inches above ankles, against metal railing on ferry and it was infected.  Treatment medications were not reported. Company Comment This spontaneous case concerns a 67-years-old female patient, with  medical history  of  Psoriatic arthritis and Plaque psoriasis under treatment with Co-suspect ADALIMUMAB who experienced the unexpected events of Covid-19 (AESI), skin atrophy, wound infection, injury, confusional state and other expected event In the context of  4th. dose of  mRNA-1273 vaccine.  The event Covid-19 occurred 5 months after 3rd. dose of moderna vaccine. The benefit-risk relationship of mrna-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.; Sender's Comments: Company Comment This spontaneous case concerns a 67-years-old female patient, with  medical history  of  Psoriatic arthritis and Plaque psoriasis under treatment with Co-suspect ADALIMUMAB who experienced the unexpected events of Covid-19 (AESI), skin atrophy, wound infection, injury, confusional state and other expected event In the context of  4th. dose of  mRNA-1273 vaccine.  The event Covid-19 occurred 5 months after 3rd. dose of moderna vaccine. The benefit-risk relationship of mrna-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.