Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, COVID-19, Drug ineffective, Energy increased
Clinical narrative: lack of drug effect; Felt like ankylosing spondylitis developed as result of COVID; More energy; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of ANKYLOSING SPONDYLITIS (Felt like ankylosing spondylitis developed as result of COVID) in a 50-year-old female 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 Ankylosing spondylitis.    No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-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) at an unspecified dose. On 17-Aug-2021, the patient experienced ANKYLOSING SPONDYLITIS (Felt like ankylosing spondylitis developed as result of COVID) (seriousness criterion medically significant), ENERGY INCREASED (More energy) and COVID-19 (COVID-19). On an unknown date, the patient experienced DRUG INEFFECTIVE (lack of drug effect). At the time of the report, ANKYLOSING SPONDYLITIS (Felt like ankylosing spondylitis developed as result of COVID), ENERGY INCREASED (More energy), COVID-19 (COVID-19) and DRUG INEFFECTIVE (lack of drug effect) outcome was unknown.            No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The formulation for Humira was reported as Solution for injection in pre-filled pen. 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 female patient with no reported medical history, who experienced the unexpected, serious (medically significant) adverse events of special interest of ankylosing spondylitis and COVID-19 (non-serious) 6 months after the second dose of mRNA-1273. Additionally, lack of drug effect was also captured as an event. The patient reports that ankylosing spondylitis developed due to COVID-19 infection. It is unclear whether the patient was diagnosed with ankylosing spondylitis after mRNA-1273 administration or if the patient experienced a flare up episode after vaccine administration. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 50-year-old female patient with no reported medical history, who experienced the unexpected, serious (medically significant) adverse events of special interest of ankylosing spondylitis and COVID-19 (non-serious) 6 months after the second dose of mRNA-1273. Additionally, lack of drug effect was also captured as an event. The patient reports that ankylosing spondylitis developed due to COVID-19 infection. It is unclear whether the patient was diagnosed with ankylosing spondylitis after mRNA-1273 administration or if the patient experienced a flare up episode after vaccine administration. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.