Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Post procedural complication, Speech disorder
Clinical narrative: Speech disorder; Postoperative complication; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of POST PROCEDURAL COMPLICATION (Postoperative complication), FATIGUE (Fatigue) and SPEECH DISORDER (Speech disorder) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    There was no reported medical history.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 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) CF. In April 2021, the patient experienced SPEECH DISORDER (Speech disorder) (seriousness criterion medically significant). In 2021, the patient experienced POST PROCEDURAL COMPLICATION (Postoperative complication) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). The patient was treated with Surgery (Anterior cervical discectomy with fusion) for Speech disorder. At the time of the report, POST PROCEDURAL COMPLICATION (Postoperative complication), FATIGUE (Fatigue) and SPEECH DISORDER (Speech disorder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  It was reported that, the patient had fatigue for a few days after covid and flu vaccines.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   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 66 year old male patient with no reported medical history, who experienced the unexpected, serious (medically significant) events of Post procedural complication, Fatigue and Speech disorder, unknown days after receiving the second dose of mRNA-1273 vaccine. The patient received the first dose with the same vaccine on the first of the same month, with no reported adverse events. He underwent anterior cervical discectomy with fusion on an unknown date. No information on risk factors, detailed clinical course, relevant investigations, treatment and outcome of the events was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 66 year old male patient with no reported medical history, who experienced the unexpected, serious (medically significant) events of Post procedural complication, Fatigue and Speech disorder, unknown days after receiving the second dose of mRNA-1273 vaccine. The patient received the first dose with the same vaccine on the first of the same month, with no reported adverse events. He underwent anterior cervical discectomy with fusion on an unknown date. No information on risk factors, detailed clinical course, relevant investigations, treatment and outcome of the events was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.