Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthrodesis, Fatigue, Food poisoning, Headache, Illness
Clinical narrative: left ankle/fusion was coming loose (screws and rods) due to either fibromyalgia or diabetes; sick; Migraine headache; felt food poisoning; bad reaction to first Moderna injection; nauseousness; fatigued; bad headache; left foot surgery/fusion on left ankle/fusion was coming loose (screws and rods) due to either fibromyalgia or diabetes; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRODESIS (left foot surgery/fusion on left ankle/fusion was coming loose (screws and rods) due to either fibromyalgia or diabetes) and POST PROCEDURAL COMPLICATION (left ankle/fusion was coming loose (screws and rods) due to either fibromyalgia or diabetes) in a 52-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 products included non-company products RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis and DULOXETINE HYDROCHLORIDE (CYMBALTA) for Fibromyalgia.    The patient's past medical history included Surgery (reconstructive surgery on her left foot ankle, fusion on left ankle, nine screws, big plate, and pins placed.) in July 2021. Previously administered products included for Fibromyalgia: Abilify since an unknown date. Past adverse reactions to the above products included No adverse event with Abilify. Concurrent medical conditions included Fibromyalgia and Diabetes mellitus.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram and DULOXETINE HYDROCHLORIDE (CYMBALTA) (unknown route) at an unspecified dose. In July 2021, the patient experienced ARTHRODESIS (left foot surgery/fusion on left ankle/fusion was coming loose (screws and rods) due to either fibromyalgia or diabetes) (seriousness criterion medically significant). On an unknown date, the patient experienced POST PROCEDURAL COMPLICATION (left ankle/fusion was coming loose (screws and rods) due to either fibromyalgia or diabetes) (seriousness criterion medically significant), ILLNESS (sick), MIGRAINE (Migraine headache), FOOD POISONING (felt food poisoning), IMMUNISATION REACTION (bad reaction to first Moderna injection), NAUSEA (nauseousness), FATIGUE (fatigued) and HEADACHE (bad headache). At the time of the report, ARTHRODESIS (left foot surgery/fusion on left ankle/fusion was coming loose (screws and rods) due to either fibromyalgia or diabetes), MIGRAINE (Migraine headache), FOOD POISONING (felt food poisoning), NAUSEA (nauseousness) and FATIGUE (fatigued) was resolving, POST PROCEDURAL COMPLICATION (left ankle/fusion was coming loose (screws and rods) due to either fibromyalgia or diabetes) and ILLNESS (sick) outcome was unknown and IMMUNISATION REACTION (bad reaction to first Moderna injection) and HEADACHE (bad headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient had to wear the cam boot again and had to nose and toes to ceiling this weekend. Patient was fatigued due to the pain medication. Patient was stuck in the bed for few days.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Patient was recovering from the reconstructive surgery. patient surgeon was happy with the results, but patient was unsure with previous adverse event. patient had to wear the cam boot again and had to nose and toes to ceiling this weekend. patient was fatigued due to the pain medication. patient was stuck in the bed for few days. patient switched patient medication from abilify to Cymbalta for patient fibro and patient had bad reaction and switched back. Patient remembered her bad reaction to the first Moderna injection when questioned about the vaccine.  The reporter's causality for the events of left foot surgery/fusion on left ankle/fusion was coming loose (screws and rods) due to either fibromyalgia or diabetes onset in July 2021, bad reaction to Cymbalta and vaccine reaction/bad reaction to the first Moderna injection with skyrizi was no reasonable possibility. The reporter's causality for the events of left foot surgery/fusion on left ankle/fusion was coming loose (screws and rods) due to either fibromyalgia or diabetes unknown onset, sick, migraine headache, felt food poisoning, nauseousness, fatigued, bad headache, left foot surgery/fusion on left ankle/fusion was coming loose (screws and rods) due to either fibromyalgia or diabetes unknown onset and left foot surgery/fusion on left ankle/fusion was coming loose (screws and rods) due to either fibromyalgia or diabetes unknown onset 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 spontaneous case concerns a 52-year-old, female patient with medical history of Fibromyalgia and Diabetes Mellitus, status post Reconstructive surgery on Left foot ankle (Jul2021), history of co-suspect intake of Cymbalta (duloxetine hydrochloride) for Fibromyalgia and co-suspect intake of an unspecified pain medication, and history of co-suspect administration of Skyrizi (risankizumab) for Moderate-to-severe Chronic Plaque Psoriasis, who experienced the unexpected, serious (medically significant) events of arthrodesis (ankle arthrodesis) and post procedural complication, and other unexpected and expected, non-serious events. The event arthrodesis occurred unknown number of days after intake of Cymbalta, unknown number of days after receiving Skyrizi, and unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the date of intake of Cymbalta and administration dates of Skyrizi and the mRNA-1273 vaccine were not reported while the event onset date was reported as unspecified date in Jul2021, hence, the onset latency could not be assessed. The start dates of the other events were not provided, hence, the onset latency also could not be assessed. For an unknown indication, the patient underwent a reconstructive surgery on her left foot ankle which involved fusion on the left ankle and placement of nine screws, big plate and pins. It was reported that the patient was recovering from the surgery. On an unknown date, the fusion came loose (screws and rods) and, as per the patient's Orthopedic surgeon, was due to either her Fibromyalgia or Diabetes. The patient had to wear the cam boot again and had to 'nose and toes to ceiling'. She was also fatigued due to the pain medication (unspecified). The patient was also sick and suffered from a migrane headache. She was stuck in bed for a few days, and felt it was food poisoning at the beginning but transitioned into nausea and bad headaches. The patient was feeling better at the time of the report. It was also reported that the patient had a bad reaction (unspecified) after receiving the first dose of the mRNA-1273 vaccine. Treatment information was not provided. The history of Reconstructive surgery on Left foot ankle remains a confounder for the events arthrodesis and post procedural complication. The history of Fibromyalgia and Diabetes Mellitus remains a confounder for the event post procedural complication. The co-suspect intake of Cymbalta remains a confounder for the non-serious events nausea and fatigue which are common side effects of the medication. The co-suspect intake of an unspecified pain medication remains a confounder for the event fatigue. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 52-year-old, female patient with medical history of Fibromyalgia and Diabetes Mellitus, status post Reconstructive surgery on Left foot ankle (Jul2021), history of co-suspect intake of Cymbalta (duloxetine hydrochloride) for Fibromyalgia and co-suspect intake of an unspecified pain medication, and history of co-suspect administration of Skyrizi (risankizumab) for Moderate-to-severe Chronic Plaque Psoriasis, who experienced the unexpected, serious (medically significant) events of arthrodesis (ankle arthrodesis) and post procedural complication, and other unexpected and expected, non-serious events. The event arthrodesis occurred unknown number of days after intake of Cymbalta, unknown number of days after receiving Skyrizi, and unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the date of intake of Cymbalta and administration dates of Skyrizi and the mRNA-1273 vaccine were not reported while the event onset date was reported as unspecified date in Jul2021, hence, the onset latency could not be assessed. The start dates of the other events were not provided, hence, the onset latency also could not be assessed. For an unknown indication, the patient underwent a reconstructive surgery on her left foot ankle which involved fusion on the left ankle and placement of nine screws, big plate and pins. It was reported that the patient was recovering from the surgery. On an unknown date, the fusion came loose (screws and rods) and, as per the patient's Orthopedic surgeon, was due to either her Fibromyalgia or Diabetes. The patient had to wear the cam boot again and had to 'nose and toes to ceiling'. She was also fatigued due to the pain medication (unspecified). The patient was also sick and suffered from a migrane headache. She was stuck in bed for a few days, and felt it was food poisoning at the beginning but transitioned into nausea and bad headaches. The patient was feeling better at the time of the report. It was also reported that the patient had a bad reaction (unspecified) after receiving the first dose of the mRNA-1273 vaccine. Treatment information was not provided. The history of Reconstructive surgery on Left foot ankle remains a confounder for the events arthrodesis and post procedural complication. The history of Fibromyalgia and Diabetes Mellitus remains a confounder for the event post procedural complication. The co-suspect intake of Cymbalta remains a confounder for the non-serious events nausea and fatigue which are common side effects of the medication. The co-suspect intake of an unspecified pain medication remains a confounder for the event fatigue. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.