Received Jun 10, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| YF | YELLOW FEVER (YF-VAX) | SANOFI PASTEUR | UNK | — | — |
off-label (intentional by hcp) use as per local labelling due to administration to a solid organ transplant recipient on an immunosuppressant medication with no reported adverse event; Initial information received on 02-Jun-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (health care professional). This case involves a 65-year-old female patient who had off-label (intentional by health care professional [HCP]) use of YELLOW FEVER VACCINE - (YF-VAX) as per local labelling due to administration to a solid organ transplant recipient on an immunosuppressant medication with no reported adverse event. The patient's past medical history included kidney transplant (start date: 1984). The patient's past medical treatment(s), past drugs, vaccination(s), family history were not provided. Concomitant medication(s) included prednisone. On an unspecified date, the patient received a dose of YELLOW FEVER VACCINE - [YF-VAX] solution for injection (batch/lot number: unknown, expiry date: unknown) (strength: unknown) via unknown route in an unknown administration site for immunization [Immunisation]. The patient was a 65-year-old female who would be traveling to an area where yellow fever was endemic. The patient had a kidney transplant in 1984, and at the time of reporting her only immunosuppressant therapy was low-dose prednisone, 5 mg per day. According to the Centers for Disease Control and Prevention (CDC) Yellow Book, having had a solid organ transplant was a contraindication to receiving live yellow fever vaccine. The RN assumed that was because transplant patients were usually on strong immunosuppressant therapy, but in this case it was just prednisone 5 mg daily. The patient's doctor had already approved the patient receiving the yellow fever vaccine. The RN asked if Sanofi was aware of any additional data or information in the literature that would assist in making a clinical decision whether or not to administer YF-VAX to this patient. The RN also stated that she was aware of the risks of administering YF-VAX in patients older than age 60. YF-VAX had not been administered to the patient yet. The off-label (intentional by HCP) use as per local labelling due to administration to a solid organ transplant recipient on an immunosuppressant medication with no reported adverse event (Off label use, onset date: unknown, latency: same day) was reported. There will be no information available on the batch number and expiration date corresponding to the one at time of event occurrence. Action taken: Not applicable.
Medical History/Concurrent Conditions: Kidney transplant; Comments: NONE
Prednisone