Received Jun 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LY8609 | OT / LA |
has limited range of motion in the abduction and he cannot go past 90 degrees abduction; severe muscle twitching in his deltoid and forearm region; Shoulder pain; This is a spontaneous report received from an Other HCP from medical information team. A 61-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 14May2025 as dose number unknown, 0.5 ml single (Lot number: LY8609, Expiration Date: 31Aug2026) at the age of 61 years intramuscular, in left deltoid for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ARTHRALGIA (medically significant) with onset May2025, outcome "recovering", described as "Shoulder pain"; MUSCLE TWITCHING (medically significant) with onset May2025, outcome "not recovered", described as "severe muscle twitching in his deltoid and forearm region"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "has limited range of motion in the abduction and he cannot go past 90 degrees abduction". Therapeutic measures were not taken as a result of muscle twitching, arthralgia, joint range of motion decreased. The patient that was given Prevnar 20 vaccine about to two weeks ago in his left deltoid. The patient returned having shoulder pain and having severe muscle twitching in his deltoid and forearm region. He has limited range of motion in the abduction, and he cannot go past 90 degrees abduction. The reporter is calling for advice on treatment and if this has been seen before. The reporter stated while performing passive range of motion on the patient the caller can get the patient's arm to go up to 180 degrees.; Sender's Comments: There is a reasonable possibility that the event arthralgia was related to PREVNAR 20 based on known drug safety profile. Based on the temporal relationship, the association between the event muscle twitching with PREVNAR20 can not be fully 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.
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Other Conditions: No