Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Post procedural infection, Vaccination site erythema, Vaccination site nodule, Vaccination site pain
Clinical narrative: Ankylosing spondylitis flare; Back surgery and got infected/ Back surgeries developed an infection; Knot at vaccine site; Extremely sore arm and ring around arm after second covid vaccine; Red spot at vaccine site; This spontaneous case was reported by a consumer and describes the occurrence of POST PROCEDURAL INFECTION (Back surgery and got infected/ Back surgeries developed an infection) and ANKYLOSING SPONDYLITIS (Ankylosing spondylitis flare) in a 53-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 Crohn's disease and Ankylosing spondylitis.    Concurrent medical conditions included Overweight, Hypertension, Asthma, Crohn's disease and Ankylosing spondylitis.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jan-2022, received third 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) CF. On 23-Feb-2021, the patient experienced VACCINATION SITE NODULE (Knot at vaccine site), VACCINATION SITE PAIN (Extremely sore arm and ring around arm after second covid vaccine) and VACCINATION SITE ERYTHEMA (Red spot at vaccine site). On 09-Apr-2021, the patient experienced POST PROCEDURAL INFECTION (Back surgery and got infected/ Back surgeries developed an infection) (seriousness criterion medically significant). On an unknown date, the patient experienced ANKYLOSING SPONDYLITIS (Ankylosing spondylitis flare) (seriousness criterion medically significant). The patient was treated with Surgery for Post procedural infection. On 05-Mar-2021, VACCINATION SITE NODULE (Knot at vaccine site) and VACCINATION SITE ERYTHEMA (Red spot at vaccine site) had resolved. At the time of the report, POST PROCEDURAL INFECTION (Back surgery and got infected/ Back surgeries developed an infection), ANKYLOSING SPONDYLITIS (Ankylosing spondylitis flare) and VACCINATION SITE PAIN (Extremely sore arm and ring around arm after second covid vaccine) outcome was unknown. Not Provided          No concomitant medication was reported.  The co-suspect Humira formulation was reported as solution for injection in pre-filled pen. On 23-Feb-2021, patient had knot and red spot at vaccination site that lasted for about 10 days. On 20-May-2021, the patient had surgery to clean out infection. On 07-Jan-2022, the patient received the booster dose of Moderna COVID-19 vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was reported.  The reporter causality for the events of back surgery and got infected/ back surgeries developed an infection, extremely sore arm and ring around arm after second COVID vaccine, extremely sore arm and ring around arm after second COVID vaccine, ankylosing spondylitis flare, knot at vaccine site and red spot at vaccine site co-suspect Humira was not provided.  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 is a spontaneous case, reported by a consumer, concerning a 53-year-old female patient with relevant medical condition of Ankylosing spondylitis treated with Adalimumab, who experienced the unexpected serious (medically significant) adverse event of special interest Ankylosing spondylitis reported as Ankylosing spondylitis flare, and unexpected serious (medically significant) event of Post procedural infection reported as infection after back surgery. Ankylosing spondylitis occurred on an unknown date, while the event Post procedural infection occurred 73 days after receiving the first dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 28 days which falls within the recommended vaccine dosing schedule, approximately 10 months and 2 weeks prior to third mRNA-1273 vaccination. It was reported that the patient experienced extremely sore arm with redness, knot and ring around her arm after second vaccine. Patient underwent back surgery and got infected and subsequently underwent another surgery to clean out infection. No further details about the diagnostic procedures and treatment medication were provided. Outcome of the events Ankylosing spondylitis and Post procedural infection were unknown. The medical condition of Ankylosing spondylitis remains as a confounder for Ankylosing spondylitis flare, and the co-suspect drug Adalimumab, which is an immunosuppressant, increases the susceptibility of patient to acquire infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.  Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2022: Follow up includes medical history updated and new events added.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 53-year-old female patient with relevant medical condition of Ankylosing spondylitis treated with Adalimumab, who experienced the unexpected serious (medically significant) adverse event of special interest Ankylosing spondylitis reported as Ankylosing spondylitis flare, and unexpected serious (medically significant) event of Post procedural infection reported as infection after back surgery. Ankylosing spondylitis occurred on an unknown date, while the event Post procedural infection occurred 73 days after receiving the first dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 28 days which falls within the recommended vaccine dosing schedule, approximately 10 months and 2 weeks prior to third mRNA-1273 vaccination. It was reported that the patient experienced extremely sore arm with redness, knot and ring around her arm after second vaccine. Patient underwent back surgery and got infected and subsequently underwent another surgery to clean out infection. No further details about the diagnostic procedures and treatment medication were provided. Outcome of the events Ankylosing spondylitis and Post procedural infection were unknown. The medical condition of Ankylosing spondylitis remains as a confounder for Ankylosing spondylitis flare, and the co-suspect drug Adalimumab, which is an immunosuppressant, increases the susceptibility of patient to acquire infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.