Received Feb 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | IM / LA |
Fatigue; Nausea; weight loss; muscle weakness; diarrhea; swollen retina both eyes; Redness at injection site; Swelling at injection site; Fever; This serious case was reported by a other health professional via call center representative and described the occurrence of swelling of retina in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 07-JAN-2025, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) .5 ml. On 07-JAN-2025, immediately after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Redness at injection site) and injection site swelling (Verbatim: Swelling at injection site). On 08-JAN-2025, the patient experienced swelling of retina (Verbatim: swollen retina both eyes) (serious criteria GSK medically significant) and fever (Verbatim: Fever). On 09-JAN-2025, the patient experienced fatigue (Verbatim: Fatigue). In JAN-2025, the patient experienced nausea (Verbatim: Nausea), weight loss (Verbatim: weight loss), muscle weakness (Verbatim: muscle weakness) and diarrhea (Verbatim: diarrhea). The outcome of the swelling of retina was resolved (duration 5 days) and the outcome of the injection site erythema and injection site swelling were resolved (duration 1 week) and the outcome of the fever was resolved (duration 2 days) and the outcome of the fatigue, nausea and weight loss were not resolved and the outcome of the muscle weakness and diarrhea were not reported. It was unknown if the reporter considered the swelling of retina, injection site erythema, injection site swelling, fever, fatigue, nausea, weight loss, muscle weakness and diarrhea to be related to Shingrix. The company considered the swelling of retina to be unrelated to Shingrix. It was unknown if the company considered the injection site erythema, injection site swelling, fever, fatigue, nausea, weight loss, muscle weakness and diarrhea to be related to Shingrix. Additional Information: GSK receipt date: 30-JAN-2025 and 31-JAN-2025 The patient was an HCP (health care professional) and self-reported this case for herself. The reporter reported that she received Shingrix vaccine and experienced redness and swelling at the injection site that occurred immediately after the injection and lasted for a week in JAN-2025. The reporter reported that fever that occurred one day after injection that lasted two days and then resolved in JAN-2025. She had swollen retinas that occurred one day after injection that lasted 5 days and then resolved in JAN-2025. She reported that that she experienced fatigue that occurred 2 days after injection that was currently ongoing and had not resolved, nausea that occurred 9 days after injection that was still ongoing and had not resolved. The patient experienced weight loss that she noticed 3 weeks after the injection and had not resolved. The reporter did not have lot number or any identifying information for the vaccine. The reporter mentioned that nurse she spoke to was very kind, thorough, and she provided the information that was within her reach to help with some of the questions that she had. However, specific questions she had regarding side effects of the Guillain barre syndrome and how long it takes, were not provided to me because she was not allowed to give this information to a patient. She found this unacceptable she worked in the medical field. She worked with pharmaceutical companies, and she report side effects to the FDA, and she should have access to this information as a patient. The reporter mentioned that she had symptoms of muscle weakness, fatigue, nausea, diarrhea, among others and she was very concerned because it had been three weeks since her shot, and no one could provide information to her that was specific enough. The reporter reported that she was terrified, and she need information.; Sender's Comments: Retinal oedema is an unlisted event which is considered unrelated to GSK vaccine Shingrix.