Received Dec 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER LIVE (ZOSTAVAX) | MERCK & CO. INC. | 1 | — | — |
Email received to Inbox on 01DEC2025 at 4:28pm with subject "FW: 12/1/25 Pharmacovigilance-sanofi/Rotateg & Pedvaxhib-2025SA315865 & Varicella Vaccine-2024SA156882/ 493850332" containing a scanned document sent from Sanofi r; Email received to Inbox on 01DEC2025 at 4:28pm with subject "FW: 12/1/25 Pharmacovigilance-sanofi/Rotateg & Pedvaxhib-2025SA315865 & Varicella Vaccine-2024SA156882/ 493850332" containing a scanned document sent from Sanofi r; Email received to Inbox on 01DEC2025 at 4:28pm with subject "FW: 12/1/25 Pharmacovigilance-sanofi/Rotateg & Pedvaxhib-2025SA315865 & Varicella Vaccine-2024SA156882/493850332" containing a scanned document sent from Sanofi r; This spontaneous report was received from a consumer, referring himself a 53-year-old male patient. The patient's pertinent medical history, risk factor, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided. In November 2023, the patient started taking the first dose of dupilumab (DUPIXENT) solution for injection (strength: 300 mg/2ml) at a dose of 300 mg every other week (qow) (lot number and expiration date not reported) (latency: 2 months approximately), subcutaneously for the treatment of nasal polyps delivered via dupilumab (DUPIXENT) single dose prefilled pen. In January 2024, the patient was vaccinated with the first dose of Zoster Vaccine Live (manufacturer unknown) (strength, dose, route, anatomical location lot # and expiration date were not reported) as prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date not reported). It was reported that the vaccine was recommended by his primary care Doctor of Medicine (md) with no adverse event directly linked to the product (product prescribing issue and contraindicated product administered). It was unknown if there were lab data/results available On unknown date, the patient experienced some burning when injection (vaccination site burning) following the first dose intake of dupilumab (DUPIXENT) and Zoster Vaccine Live (manufacturer unknown). Therefore, he was treated with lidocaine cream. At the reporting time, the outcome of the event was unknown. The action taken with dupilumab (DUPIXENT) was unknown (conflicting also ongoing) The causality was not provided. Lot # is being requested and will be submitted if received. This is one of the two cases created from the same source.
Sterile diluent; DUPIXENT