Received Jul 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | EK225 | IM / LA |
Back pain; excruciating sciatica pain; Leg pain; I can't even walk due to the pain; Injection site pain; Injection site warmth; Injection site swelling; I can't even walk due to the pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number EK225, expiry date 03-OCT-2027) for prophylaxis. Concurrent medical conditions included sciatic nerve injury. Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix), gabapentin and ibuprofen sodium (Ibuprofen). On 27-JUN-2025, the patient received the 2nd dose of Shingrix (intramuscular, left arm) .5 ml. In JUN-2025, an unknown time 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), pain (Verbatim: I can't even walk due to the pain) and unable to walk (Verbatim: I can't even walk due to the pain). On 28-JUN-2025, the patient experienced back pain (Verbatim: Back pain), sciatica aggravated (Verbatim: excruciating sciatica pain) and leg pain (Verbatim: Leg pain). Rechallenge with Shingrix was positive. The outcome of the injection site pain, injection site warmth, injection site swelling, pain, back pain, sciatica aggravated, leg pain and unable to walk were not resolved. It was unknown if the reporter considered the injection site pain, injection site warmth, injection site swelling, pain, back pain, sciatica aggravated, leg pain and unable to walk to be related to Shingrix. It was unknown if the company considered the injection site pain, injection site warmth, injection site swelling, pain, back pain, sciatica aggravated, leg pain and unable to walk to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR082131 Additional Information: GSK Receipt Date: 30-JUN-2025 The reporter was the patient. The patient reports that she received the 2nd dose of Shingrix vaccine at a local pharmacy and were administered in the left arm. The patient reports that she has sciatic nerve issues and gets treatment with a chiropractor and her condition was under control. The patient states she had just left the chiropractor office when she went to get the 2nd dose of Shingrix. The patient reports that on Saturday June 28th 2025 in the morning she had excruciating sciatica pain on her back and right leg. The patient reports with the 1st dose she had pain and swollen of the injection site. She reports that with the second dose she has the same but also it was warm. The patient reports could not even walk due to the pain. The patient reports she has applied ice and has taken Ibuprofen for the pain. No additional event was reported.; Sender's Comments: US-GSK-US2025AMR082131:Same patient/Dose 1
Sciatic nerve injury
SHINGRIX; GABAPENTIN; IBUPROFEN