Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Lyme disease, Psoriasis, Vaccination site pain
Clinical narrative: Lyme disease; Psoriasis of scalp; Vaccination site pain; weakness; This spontaneous case was reported by a consumer and describes the occurrence of LYME DISEASE (Lyme disease) in a 55-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 Psoriatic arthritis and Plaque psoriasis.    Concurrent medical conditions included Psoriatic arthritis and Plaque psoriasis (chronic plaque psoriasis).   On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-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 2019, the patient experienced ASTHENIA (weakness). On an unknown date, the patient experienced LYME DISEASE (Lyme disease) (seriousness criterion medically significant), PSORIASIS (Psoriasis of scalp) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, (Lyme disease), PSORIASIS (Psoriasis of scalp), ASTHENIA (weakness) and VACCINATION SITE PAIN (Vaccination site pain) had resolved.            No concomitant medications were reported.  It was reported that the patient had soreness at the injection site.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   No treatment medications were reported.  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 55-year-old, male patient with concurrent conditions of psoriatic arthritis and chronic plaque psoriasis treated with adalimumab, who experienced an unexpected, medically significant event of Lyme disease in association with a dose of mRNA-1273 vaccine. Exact onset latency of the event Lyme disease relative to vaccination cannot be determined with an unknown event's onset date. Outcome of the event was reported as resolved. Vaccination history included a 2-dose primary series of mRNA-1273 vaccine, given 33 days apart. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying conditions and treatment with adalimumab remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.; Sender's Comments: This spontaneous case concerns a 55-year-old, male patient with concurrent conditions of psoriatic arthritis and chronic plaque psoriasis treated with adalimumab, who experienced an unexpected, medically significant event of Lyme disease in association with a dose of mRNA-1273 vaccine. Exact onset latency of the event Lyme disease relative to vaccination cannot be determined with an unknown event's onset date. Outcome of the event was reported as resolved. Vaccination history included a 2-dose primary series of mRNA-1273 vaccine, given 33 days apart. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying conditions and treatment with adalimumab remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.