Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, COVID-19, Incomplete course of vaccination
Clinical narrative: COVID-19; Incomplete course of vaccination; ANAPHYLACTIC REACTION AFTER MODERNA VACCINE.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) and ANAPHYLACTIC REACTION (ANAPHYLACTIC REACTION AFTER MODERNA VACCINE.) in a 77-year-old male 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 ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. In 2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization) and ANAPHYLACTIC REACTION (ANAPHYLACTIC REACTION AFTER MODERNA VACCINE.) (seriousness criterion medically significant). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (Incomplete course of vaccination). The patient was hospitalized for 40 days due to COVID-19. At the time of the report, COVID-19 (COVID-19), ANAPHYLACTIC REACTION (ANAPHYLACTIC REACTION AFTER MODERNA VACCINE.) and INCOMPLETE COURSE OF VACCINATION (Incomplete course of vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant drugs were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient reported after he took his first dose and 13 days later he was experiencing sharp pain in the middle of his back which sent him to the hospital. He also had blood clots and was hospitalized for about 40 days. Patient also had COVID while he was in the hospital. The reporter's causality for the event of BLOOD CLOTS, COVID-19, ANAPHYLACTIC REACTION AFTER MODERNA VACCINE and BACK PAIN with humira was not provided.  Opinion is that there is no reasonable possibility that the events of BLOOD CLOTS, COVID-19, ANAPHYLACTIC REACTION AFTER MODERNA VACCINE and BACK PAIN are related to HUMIRA.  Treatment medication were not given.  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  CC: This spontaneous concerns a 77-year-old, male patient with a concurrent condition of rheumatoid arthritis treated with adalimumab, who experienced an expected, medically significant event of Anaphylactic reaction and an unexpected, serious AESI COVID-19 in association with a 1st dose of mRNA-1273 vaccine. Exact onset latency of the event Anaphylactic reaction relative to vaccination cannot be determined with an unknown event's onset date. Approximately 6 months after receiving a 1st dose of mRNA-1273 vaccine, patient took a first dose of adalimumab. He experienced a sharp pain in the middle of his back that led to hospitalization 13 days later. Blood clots were found. Patient had COVID-19 during his 40-day hospital stay. Vaccination history included only one dose of mRNA-1273 as the 2nd dose was deferred due to anaphylactic reaction post vaccination with the 1st dose. Patient's elderly age, underlying rheumatoid arthritis, and treatment with adalimumab remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this repor; Sender's Comments: This spontaneous concerns a 77-year-old, male patient with a concurrent condition of rheumatoid arthritis treated with adalimumab, who experienced an expected, medically significant event of Anaphylactic reaction and an unexpected, serious AESI COVID-19 in association with a 1st dose of mRNA-1273 vaccine. Exact onset latency of the event Anaphylactic reaction relative to vaccination cannot be determined with an unknown event's onset date. Approximately 6 months after receiving a 1st dose of mRNA-1273 vaccine, patient took a first dose of adalimumab. He experienced a sharp pain in the middle of his back that led to hospitalization 13 days later. Blood clots were found. Patient had COVID-19 during his 40-day hospital stay. Vaccination history included only one dose of mRNA-1273 as the 2nd dose was deferred due to anaphylactic reaction post vaccination with the 1st dose. Patient's elderly age, underlying rheumatoid arthritis, and treatment with adalimumab remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement and the available information.