Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bone disorder, Hyperaesthesia, Neuralgia
Clinical narrative: Bone disorder / Extra bone inside ankle moved around; Hyperaesthesia; Nerve pain; This spontaneous case was reported by a consumer and describes the occurrence of BONE DISORDER (Bone disorder / Extra bone inside ankle moved around), HYPERAESTHESIA (Hyperaesthesia) and NEURALGIA (Nerve pain) in a 55-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) injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis (Moderate to severe).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-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) Solution for injection in pre-filled pen. On an unknown date, the patient experienced BONE DISORDER (Bone disorder / Extra bone inside ankle moved around) (seriousness criterion hospitalization), HYPERAESTHESIA (Hyperaesthesia) (seriousness criterion hospitalization) and NEURALGIA (Nerve pain) (seriousness criterion hospitalization). The patient was treated with HYDROCORTISONE ACETATE (CORTIZONE [HYDROCORTISONE ACETATE]) at an unspecified dose and frequency and Surgery (Patient had ankle surgery in 2021 and the outcome of surgery was reported as recovered) for Bone disorder. At the time of the report, BONE DISORDER (Bone disorder / Extra bone inside ankle moved around), HYPERAESTHESIA (Hyperaesthesia) and NEURALGIA (Nerve pain) outcome was unknown.            No concomitant medications were reported.  The patient experienced nerve damage that happened during procedure was sore, pain and sensitivity sometimes. On unknown dates, the patient experienced extra bone inside ankle moved around and nerve damage that happened during procedure was sore, pain and sensitivity sometimes. The causality of ankle structure surgery was reported as no reasonable possibility with Humira and was unknown if the patient was enrolled in a COVID-19 vaccine trial. She was hospitalized for the surgery and causality for surgery was 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.  Company comment: This spontaneous case concerns a 55-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (hospitalization) events of bone disorder, neuralgia, and hyperaesthesia an unknown time after the first and second dose of mRNA-1273. The patient underwent an ankle procedure to remove an extra bone inside the ankle, which produced nerve damage (procedure complication). Treatment included hydrocortisone. The procedural complication could be a plausible alternative explanation for the events neuralgia and hyperaesthesia. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 28-Dec-2021: Follow up document was received. Updated the seriousness criteria and reporter causality of events. Event Procedural complication and neurological procedural complication were removed.; Sender's Comments: This spontaneous case concerns a 55-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (hospitalization) events of bone disorder, neuralgia, and hyperaesthesia an unknown time after the first and second dose of mRNA-1273. The patient underwent an ankle procedure to remove an extra bone inside the ankle, which produced nerve damage (procedure complication). Treatment included hydrocortisone. The procedural complication could be a plausible alternative explanation for the events neuralgia and hyperaesthesia. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.