Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Contusion, Fatigue
Clinical narrative: Bruise; Felt fatigue/ fatigue flares ups; Spondylitis ankylosing aggravated; This spontaneous case was reported by a consumer and describes the occurrence of ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated), CONTUSION (Bruise) and FATIGUE (Felt fatigue/ fatigue flares ups) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   In August 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free, Solution for injection in pre-filled pen. On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, the patient experienced CONTUSION (Bruise) (seriousness criterion hospitalization) and FATIGUE (Felt fatigue/ fatigue flares ups) (seriousness criterion hospitalization). On an unknown date, the patient experienced ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) (seriousness criterion medically significant). The patient was hospitalized on sometime in September 2021 due to CONTUSION. At the time of the report, ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated), CONTUSION (Bruise) and FATIGUE (Felt fatigue/ fatigue flares ups) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. On 18 Aug 2021 patient took first dose of Moderna COVID-19 vaccine a week after vaccination with Humira. Patient noticed her skin started to bruise, patient felt fatigue and was struggling with symptoms for a month during September for which patient was hospitalized. Patient stated that Humira was wearing off causing fatigue and her joint pain levels to 9-10 flares ups. Patient became sick more frequently than normal. Patient visited to rheumatology physician. Patient explained she started noticing an increase in pain and flare ups in middle of December which may possibly increase often on bed rest. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication reported.   The reporter's causality for the event(s) in aspect of Humira of felt fatigue/ fatigue flares ups and ankylosing spondylitis flare ups with Humira(adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of struggling with symptoms, skin started to bruise, Humira wearing off sooner than next and sick was not provided. Agency's opinion was that there was no reasonable possibility that the events of felt fatigue/ fatigue flares ups, struggling with symptoms, skin started to bruise, Humira wearing off sooner than next, sick and ankylosing spondylitis flare ups were related to Humira(adalimumab).  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 36-year-old female patient with concurrent Ankylosing spondylitis on Adalimumab which was administered a week prior to mRNA-1273 vaccination, who experienced the unexpected, serious  (medically significant) adverse event of special interest Ankylosing spondylitis (Spondylitis ankylosing aggravated), and (Hospitalization) events of Fatigue (Felt fatigue/ fatigue flares ups), and Contusion. The events Fatigue and Contusion occurred on unspecified dates in the following month after receiving the first dose of mRNA-1273 vaccine, while the event Ankylosing spondylitis occurred on an unspecified date approximately 4 months after administration with the same mRNA-1273 vaccine.  Exact onset latency cannot be determined as the events were not reported with start dates. Patient experienced fatigue along with bruising on her skin that occurred for a month and led to hospitalization. Patient also sought consultation with a rheumatology physician with undisclosed clinical management. The increase in pain and flare ups were noticed 3 months after hospitalization. The concurrent Ankylosing spondylitis is a chronic, progressive inflammatory disease, thus remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 36-year-old female patient with concurrent Ankylosing spondylitis on Adalimumab which was administered a week prior to mRNA-1273 vaccination, who experienced the unexpected, serious  (medically significant) adverse event of special interest Ankylosing spondylitis (Spondylitis ankylosing aggravated), and (Hospitalization) events of Fatigue (Felt fatigue/ fatigue flares ups), and Contusion. The events Fatigue and Contusion occurred on unspecified dates in the following month after receiving the first dose of mRNA-1273 vaccine, while the event Ankylosing spondylitis occurred on an unspecified date approximately 4 months after administration with the same mRNA-1273 vaccine.  Exact onset latency cannot be determined as the events were not reported with start dates. Patient experienced fatigue along with bruising on her skin that occurred for a month and led to hospitalization. Patient also sought consultation with a rheumatology physician with undisclosed clinical management. The increase in pain and flare ups were noticed 3 months after hospitalization. The concurrent Ankylosing spondylitis is a chronic, progressive inflammatory disease, thus remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.