Received May 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MNP | MENINGOCOCCAL CONJUGATE (PENBRAYA) | PFIZER\WYETH | 1 | LJ0077 | IM / LL |
| MNP | MENINGOCOCCAL CONJUGATE (PENBRAYA) | PFIZER\WYETH | 1 | LJ0077 | OT |
Fever; Joint Pain; Body ache; fatigue; The initial case was missing the following minimum criteria: Unspecified number of patients. Upon receipt of follow-up information on 27May2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Physician from a sales representative. A 16-year-old female patient received meningococcal group abcwy vaccine (PENBRAYA), on 23Apr2025 as dose 1, single (Lot number: LJ0077) at the age of 16 years intramuscular for immunisation, Device Lot Number: LJ0077. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN (hospitalization, medically significant) with onset 23Apr2025, outcome "recovered" (2025), described as "Body ache"; PYREXIA (hospitalization, medically significant) with onset 23Apr2025, outcome "recovered" (2025), described as "Fever"; ARTHRALGIA (hospitalization, medically significant) with onset 23Apr2025, outcome "recovered" (2025), described as "Joint Pain"; FATIGUE (hospitalization, medically significant) with onset 23Apr2025, outcome "recovered" (2025). The patient was hospitalized for pyrexia, arthralgia, pain, fatigue (start date: 2025, discharge date: 2025, hospitalization duration: 1 day(s)). Therapeutic measures were taken as a result of pyrexia, arthralgia, pain, fatigue (IV fluid). Additional information: The office has been using Penbraya since last summer. Doctor said she was seeing a lot more adverse events since using Penbraya verses individual separate vaccines: Fever (one adolescent went to hospital along with other symptoms), joint pain, muscle pain, pain at injection site, and body aches (reported as a general observation). As a general practice, doctor was advising patients to take Tylenol after vaccination.; Sender's Comments: There is a reasonable possibility that the events pyrexia, arthralgia, and fatigue were related to PENBRAYA based on known drugs safety profile and temporal relationship. The association between the event pain with PENBRAYA can not be fully excluded with the currently available information. 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