Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ACUTE KIDNEY INJURY (Shutdown renal), COVID-19 PNEUMONIA (COVID-19 pneumonia), VACCINATION SITE PAIN (Vaccination site pain), MOBILITY DECREASED (Mobility decreased), RASH (Rash trunk) and HIDRADENITIS (Hidradenitis suppurativa) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa. Concurrent medical conditions included Hidradenitis suppurativa. On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-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) Citrate free. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) (seriousness criterion hospitalization). On an unknown date, the patient experienced ACUTE KIDNEY INJURY (Shutdown renal) (seriousness criteria hospitalization and medically significant), COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criteria hospitalization and medically significant), MOBILITY DECREASED (Mobility decreased) (seriousness criterion hospitalization), RASH (Rash trunk) (seriousness criterion hospitalization) and HIDRADENITIS (Hidradenitis suppurativa) (seriousness criterion hospitalization). At the time of the report, ACUTE KIDNEY INJURY (Shutdown renal), COVID-19 PNEUMONIA (COVID-19 pneumonia), VACCINATION SITE PAIN (Vaccination site pain), MOBILITY DECREASED (Mobility decreased), RASH (Rash trunk) and HIDRADENITIS (Hidradenitis suppurativa) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications was reported. The patient's hidradenitis suppurativa had blown up and doctor gave him a antibiotics. 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 50-year-old male patient with medical history of hidradenitis suppurativa, who experienced the unexpected, serious (medically significant and hospitalization) adverse events of special interest of acute kidney injury and COVID-19, and other events such as rash and hidradenitis, among others. The events occurred an unknown time after the first and second dose of mRNA-1273. The patient experienced oropharyngeal pain and rhinorrhoea for which he was diagnosed with COVID-19 and admitted after developing pneumonia and acute kidney injury. He was also treated with antibiotics for a rash he had around his abdomen. Information regarding clinical evaluation, further diagnostic tests and treatment provided has not been disclosed. Hidradenitis suppurativa can present relapses as part of the natural history of disease, so that could be a contributory factor for the events rash and hidradenitis. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 50-year-old male patient with medical history of hidradenitis suppurativa, who experienced the unexpected, serious (medically significant and hospitalization) adverse events of special interest of acute kidney injury and COVID-19, and other events such as rash and hidradenitis, among others. The events occurred an unknown time after the first and second dose of mRNA-1273. The patient experienced oropharyngeal pain and rhinorrhoea for which he was diagnosed with COVID-19 and admitted after developing pneumonia and acute kidney injury. He was also treated with antibiotics for a rash he had around his abdomen. Information regarding clinical evaluation, further diagnostic tests and treatment provided has not been disclosed. Hidradenitis suppurativa can present relapses as part of the natural history of disease, so that could be a contributory factor for the events rash and hidradenitis. The benefit-risk relationship of mRNA-1273 is not affected by this report.