Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | 483-636-765 | IM |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | 523-292-473 | IM / LA |
Injection site erythema left arm; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of injection site erythema in a 51-year-old female patient who received Herpes zoster (Shingles vaccine) (batch number 523-292-473) for prophylaxis. Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) (batch number 483-636-765) for prophylaxis. Previously administered products included Shingles vaccine (Received 1st dose of Shingles vaccine on 04-APR-2025 at 09:46, Lot number 487-083-242, intramuscularly in left deltoid.). On 02-JUN-2025 10:47, the patient received the 2nd dose of Shingles vaccine (intramuscular use, left arm). On 05-MAY-2025 10:10, the patient received the 1st dose of RSV vaccine (intramuscular use). On 04-JUN-2025, 2 days after receiving Shingles vaccine and 30 days after receiving RSV vaccine, the patient experienced injection site erythema (Verbatim: Injection site erythema left arm). The outcome of the injection site erythema was resolving. The reporter considered the injection site erythema to be related to Shingles vaccine. The reporter considered the injection site erythema to be unrelated to RSV vaccine. The company considered the injection site erythema to be related to Shingles vaccine. The company considered the injection site erythema to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 20-JUN-2025 This is a Pfizer sponsored interventional study report. A female patient received varicella zoster vaccine rge (cho), powder for suspension for injection (VARICELLA ZOSTER VACCINE RGE (CHO)), on 02Jun2025 and received rsv vaccine prot.subunit pref 2v, powder for solution for injection (RSV Vaccine Prot.Subunit Pref 2V), on 05May2025. The patient had no relevant medical history. There were no concomitant medications. The patient reported no concomitant vaccine or prior vaccination. The following information was reported: erythema at injection site (medically significant) with onset 04Jun2025, described as erythema at injection site left arm. Clinical course: Site was requesting for this serious adverse event (SAE) report to be retracted. On 04 June 2025, the patient reported a severe reaction of redness reaction via the e-diary measuring 21 cm. The site scheduled patient to come into the site to be assessed by the sub-investigator. The site assessed this as a Grade 3 reaction and, in error, submitted an SAE report. However, as this reaction occurred within the 7 day post-vaccination window, it was classified as a reactogenicity event per protocol and does not meet the criteria for a true SAE. The adverse event was being downgraded to grade 2. The patient had not withdrawn and had not experience any life-threatening events. Inform had already been updated accordingly. The action taken in response to the event was not applicable. The outcome of the event was recovering. The investigator considered there was a reasonable possibility that the event erythema at injection site left arm was related to varicella zoster vaccine rge (cho), powder for suspension for injection. The investigator considered there was not a reasonable possibility that the event erythema at injection site left arm was related to rsv vaccine prot.subunit pref 2v, powder for solution for injection. The event erythema at injection site left arm was reported as unrelated to concomitant medications or to any clinical trial procedures.