Received May 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | IM / LA |
had trouble lifting her arm/range of motion is not there/decreased range of motion; Injection site pain; Injection site warmth; Injection site swelling; deltoid muscle was very sore; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 08-MAY-2025, the patient received Shingrix (intramuscular, left deltoid). On 08-MAY-2025, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain), injection site warmth (Verbatim: Injection site warmth), injection site swelling (Verbatim: Injection site swelling) and muscle soreness (Verbatim: deltoid muscle was very sore). On 09-MAY-2025, the patient experienced mobility decreased (Verbatim: had trouble lifting her arm/range of motion is not there/decreased range of motion). The outcome of the injection site pain, injection site warmth, injection site swelling, muscle soreness and mobility decreased were not resolved. It was unknown if the reporter considered the injection site pain, injection site warmth, injection site swelling, muscle soreness and mobility decreased to be related to Shingrix. It was unknown if the company considered the injection site pain, injection site warmth, injection site swelling, muscle soreness and mobility decreased to be related to Shingrix. Additional Information: GSK Receipt Date: 12-MAY-2025 The patient reports that she received her Shingrix dose. That evening of vaccination she noticed pain, swelling and warmth at the injection site. The following day her left deltoid muscle was very sore and she had trouble lifting her arm. States that the range of motion was not there. She states that all symptoms were ongoing. She states that there was no other activity or medication that could have contributed to the symptoms.