Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Fibromyalgia, Joint injury, Tooth fracture
Clinical narrative: Fall; Knocked two teeth out and knees; Fell on face and knocked two teeth out; Fibromyalgia; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fall) in a 69-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) for Rheumatoid arthritis.    The patient's past medical history included Stroke in 2017. Concomitant products included TRAMADOL, PARACETAMOL (TYLENOL) and HYDROCODONE for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 16-Jul-2021, the patient experienced FIBROMYALGIA (Fibromyalgia). In August 2021, the patient experienced FALL (Fall) (seriousness criterion medically significant), JOINT INJURY (Knocked two teeth out and knees) and TOOTH FRACTURE (Fell on face and knocked two teeth out). In July 2021, FIBROMYALGIA (Fibromyalgia) had resolved. At the time of the report, FALL (Fall) was resolving and JOINT INJURY (Knocked two teeth out and knees) and TOOTH FRACTURE (Fell on face and knocked two teeth out) outcome was unknown.            No treatment information mentioned.  Patient had a stroke in 2017 that made it harder for her to think when talking. She had hard of hearing and also speech was slightly distorted. Stroke also affected her right leg, was weak but could walk on it. She was hard of hearing and speech was slightly distorted too. Was diagnosed with fibromyalgia by physician. In AUG2021, she fell on face and knocked two teeth out and knees. She fell on the good leg. Had difficulty walking. Falls quite a bit, but this was worst one.  The reporters causality for fibromyalgia and fell on face and knocked two teeth out and knees in AUG2021 with Humira was no reasonable possibility. The reporters causality for the events of hard of hearing, fell on face and knocked two teeth out and knees in AUG2021, and fell on good leg was not provided. Reporter provided that the events fibromyalgia and fell on face and knocked two teeth out and knees in AUG2021 are not related to Humira.  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   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Significant Follow Up. Onset date for events and events updated.  Company comment: This spontaneous case concerns a 69-year-old female patient, with relevant medical history of cerebrovascular accident with weak right leg and difficulty walking, treated with co-suspect Adalimumab for moderate to severe rheumatoid arthritis (start date not reported and no medical history of arthritis reported), with concomitant medications Tramadol and Hydrocodone, who experienced the unexpected serious (medically significant) event of Fall and unexpected non-serious AESI Fibromyalgia after receiving the 2nd dose of mRNA-1273 vaccine. Fibromyalgia occurred 3 months and 18 days, and fall approximately 5 months, respectively, post vaccination. Patient was diagnosed with fibromyalgia.  Patient fell hitting her face causing two teeth out and knee injury. Clinical course and treatment details were not reported. The outcome of fibromyalgia was reported as resolved and fall resolving. The medical history of cerebrovascular accident with weak right leg and difficulty walking could be considered as a risk factor and concomitant Tramadol and Hydrocodone can cause dizziness and sedation which may affect the normal function that may lead to fall could be considered as confounders, and co-suspect Adalimumab for  rheumatoid arthritis which could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.; Sender's Comments: This spontaneous case concerns a 69-year-old female patient, with relevant medical history of cerebrovascular accident with weak right leg and difficulty walking, treated with co-suspect Adalimumab for moderate to severe rheumatoid arthritis (start date not reported and no medical history of arthritis reported), with concomitant medications Tramadol and Hydrocodone, who experienced the unexpected serious (medically significant) event of Fall and unexpected non-serious AESI Fibromyalgia after receiving the 2nd dose of mRNA-1273 vaccine. Fibromyalgia occurred 3 months and 18 days, and fall approximately 5 months, respectively, post vaccination.Patient was diagnosed with fibromyalgia.  Patient fell hitting her face causing two teeth out and knee injury. Clinical course and treatment details were not reported. The outcome of fibromyalgia was reported as resolved and fall resolving. The medical history of cerebrovascular accident with weak right leg and difficulty walking could be considered as a risk factor and concomitant Tramadol and Hydrocodone can cause dizziness and sedation which may affect the normal function that may lead to fall could be considered as confounders, and co-suspect Adalimumab for rheumatoid arthritis  could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.