Received Jul 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | RA |
still in constant pain on mainly her legs; getting stiff at the joints; lower lip is now swollen; hard time walking/Difficulty in walking; she had a large painful lump on her arm at the site of the injection; shot her blood sugar to over 400; many large lumps on both legs from her butt to her toes; high fever; she hurt everywhere including every joint/Joint pain; Pain injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included type ii diabetes mellitus (Existed prior to receiving the Shingrix vaccine) and osteoporosis (Existed prior to receiving the Shingrix vaccine). On 12-APR-2025, the patient received the 1st dose of Shingrix (right arm). On 12-APR-2025, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain injection site), fever (Verbatim: high fever) and joint pain (Verbatim: she hurt everywhere including every joint/Joint pain). On 19-APR-2025, the patient experienced injection site lump (Verbatim: she had a large painful lump on her arm at the site of the injection), blood sugar increased (Verbatim: shot her blood sugar to over 400), walking difficulty (Verbatim: hard time walking/Difficulty in walking) and lower extremity mass (Verbatim: many large lumps on both legs from her butt to her toes). On 15-JUN-2025, the patient experienced stiff joint (Verbatim: getting stiff at the joints) and lip swelling (Verbatim: lower lip is now swollen). On an unknown date, the patient experienced leg pain (Verbatim: still in constant pain on mainly her legs). The outcome of the injection site pain, injection site lump, joint pain, stiff joint, walking difficulty, lip swelling, leg pain and lower extremity mass were not resolved and the outcome of the blood sugar increased was not reported and the outcome of the fever was resolved. It was unknown if the reporter considered the injection site pain, injection site lump, blood sugar increased, fever, joint pain, stiff joint, walking difficulty, lip swelling, leg pain and lower extremity mass to be related to Shingrix. It was unknown if the company considered the injection site pain, injection site lump, blood sugar increased, fever, joint pain, stiff joint, walking difficulty, lip swelling, leg pain and lower extremity mass to be related to Shingrix. Additional Information: GSK Receipt Date: 17-JUN-2025 The patient reporting she received her first Shingrix vaccine. That evening vaccine, the patient said she hurt everywhere including every joint. She had a high fever the night of the injection. One week later the patient states she had a large painful lump on her arm at the site of the injection. The patient states she was having a hard time walking because of many large lumps on both legs from her butt to her toes. On 19-April-2025 the health care professional gave her a steroid that shot her blood sugar to over 400. The patient had to wait to see the health care professional for an appointment until 13-June-2025. The health care professional ordered a Magnetic Resonance Imaging that she took on 15-June-2025. The patient reports her hands were getting stiff at the joints, she was still in constant pain on mainly her legs that was making it hard for her to walk and the lumps were still present on both legs. The patient also mentioned her lower lip was now swollen.; Sender's Comments: US-GSK-US2025075741:SAME reporter
Osteoporosis (Existed prior to receiving the Shingrix vaccine); Type II diabetes mellitus (Existed prior to receiving the Shingrix vaccine)
Test Date: 20250419; Test Name: blood sugar; Result Unstructured Data: (Test Result:400,Unit:unknown,Normal Low:,Normal High:)