Received May 27, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | UNK | — | — |
IGA Nephropathy; IGA Nephropathy; flank pain; dark colored urine; This is a spontaneous report received from a Physician. A 34-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; meningococcal vaccine a/c/y/w conj (tet tox) (MENQUADFI), as dose number unknown, single for immunisation. The patient's relevant medical history included: "IGA Nephropathy" (ongoing). The patient's concomitant medications were not reported. The following information was reported: IGA NEPHROPATHY (medically significant), CONDITION AGGRAVATED (medically significant), outcome "unknown" and all described as "IGA Nephropathy"; FLANK PAIN (non-serious), outcome "unknown"; CHROMATURIA (non-serious), outcome "unknown", described as "dark colored urine". Additional Information: The patient had a potential adverse event to the vaccines he needed to receive prior to starting Fabhalta. After receiving the required vaccines, Prevnar and Menquadfi, the patient developed flank pain and dark-colored urine. The HCP was not sure whether it was caused specifically by the vaccines or represented a flare-up of the IgA nephropathy.; Sender's Comments: Based on plausible temporal association, there is reasonable possibility of causal association between the reported events IgA nephropathy and condition aggravated and the suspect drug. 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 given to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
IgA nephropathy