Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Sciatica
Clinical narrative: Myalgia/muscle soreness; Neurological sciatic discomfort in right leg/pain is along the sciatic area, close to his thigh, hamstring area/feels neuropathic in origin/discomfort in his right leg; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 44-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Nov2022 as dose 4 (booster), single (Lot number: GL0446, Expiration Date: 31Jul2023) at the age of 44 years intramuscular, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), administration date: 2020, for COVID-19 immunization; Bnt162b2 (Dose 2), administration date: 2020, for COVID-19 immunization; Bnt162b2 (Dose 3 (booster)), administration date: 2021, for COVID-19 immunization. The following information was reported: MYALGIA (medically significant) with onset 10Nov2022, outcome "recovered" (12Nov2022), described as "Myalgia/muscle soreness"; SCIATICA (medically significant) with onset 10Nov2022, outcome "not recovered", described as "Neurological sciatic discomfort in right leg/pain is along the sciatic area, close to his thigh, hamstring area/feels neuropathic in origin/discomfort in his right leg". Therapeutic measures were not taken as a result of myalgia, sciatica.  Additional information: The reporter stated that he called about the Pfizer product bivalent Covid booster. He called to report a side effect and wanted more information about the side effects. He received the original 2 doses of the vaccine about 2 years ago and a booster of that vaccine about a year ago. He received the bivalent Covid booster last Wednesday. After the bivalent Covid booster, he had myalgia, described as muscle soreness, then that went away.  He has also had this almost neurological sciatic discomfort in his right leg. He was wondering if anyone else has reported side effects of that. The myalgia, described as muscle soreness, that he experienced started the Thursday after the vaccine, verified as 10Nov2022. It went away on Saturday 12Nov2022, and he has recovered completely from that particular symptom. Neurological sciatic discomfort in right leg also began on 10Nov2022. The pain was along the sciatic area, close to his thigh, hamstring area. It felt neuropathic in origin. Once the myalgia went away, the discomfort in his right leg worsened. It was now persisting. Seriousness: He has not been to the hospital or the doctor yet, but his symptoms were significant, if they persist, he will have to see a medical professional. Causality: He did feel the bivalent Covid booster was the cause of his symptoms. Stated that you can never be 100% on causes, but the timing of this is suspicious. History and Investigations: He denied any other medications, medical conditions, labs, testing, or treatments relevant to these events. No prior vaccinations (within 4 weeks), no concomitant drugs, no medical history, and no relevant tests.  Relatedness of drug to reaction(s)/event(s) Myalgia/muscle soreness and Neurological sciatic discomfort in right leg/pain is along the sciatic area, close to his thigh, hamstring area/feels neuropathic in origin/discomfort in his right leg Source of assessment: Primary Source Reporter   Method of assessment: Agency   Result of Assessment: yes; Sender's Comments: Based on the available information in the case, the causal association between the event Myalgia,Sciatic neuralgia and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.