Received Mar 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM / RA |
ended up having stroke like symptoms 2-3 weeks after shingrix, luckily it was not a stroke but thought was having one and thought was going to die; several headaches/severe headaches; neck issues; For several months I was not well; This serious case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 23-AUG-2024, the patient received the 1st dose of Shingrix (intramuscular, right deltoid). In SEP-2024, 2 weeks after receiving Shingrix, the patient experienced feeling abnormal (Verbatim: ended up having stroke like symptoms 2-3 weeks after shingrix, luckily it was not a stroke but thought was having one and thought was going to die) (serious criteria hospitalization), headache (Verbatim: several headaches/severe headaches) (serious criteria hospitalization), neck discomfort (Verbatim: neck issues) (serious criteria hospitalization) and feeling unwell (Verbatim: For several months I was not well) (serious criteria hospitalization). The patient was treated with vitamin b2 and ubidecarenone (Co Q10). The outcome of the feeling abnormal, headache, neck discomfort and feeling unwell were not resolved. The reporter considered the feeling abnormal, headache, neck discomfort and feeling unwell to be possibly related to Shingrix. The company considered the feeling abnormal, headache, neck discomfort and feeling unwell to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 10-MAR-2025 About 2 weeks after Shingrix the patien had stroke like symptoms, never have had any complications with vaccine until this Shingrix. As of March-2025 the patient still having symptoms of several headaches and neck issues have not been the same since. Back in September 2024, had a medical situation, 2 to 3 weeks prior to having this medical situation received Shingrix vaccine for shingles. The patient ended up having stroke-like symptoms 2 to 3 weeks after the injection, luckily it was not a stroke, but the patient thought she was having one and thought she was going to die. After having numerous tests, nerve injections, severe headaches a physician informed that it was due to receiving the shingle injections. For several months the patient was not well. Ever since received the Shingrix had issues that still dealing with today, and it's March 2025. The patient's issue was she was not aware that would be dealing with these issues this long after receiving the shingles vaccine. The patient did not have these issues until received the vaccine. All the symptoms actually listed and or complications that can occur actually known. The patient had other vaccines and never had any complications, so when received this shingles vaccine and had these medical issues was really concerned. The patient stated had never in life felt so scared that she really thought was dying. The worst feeling ever. The patient felt that she really needed to say something. She did not receive second Shingrix shot. Since he was the physician who thinks that that the events she was experiencing were related to the Shingrix. When asked her for concomitant medications she misunderstood the question and told about treatment medications. She indicated that she saw two neurologists and had two nerve blocks performed but they did not work. Then she went to see another neurologist, physician and he put her on two over-the-counter medications: 300 mg of Co-Q10 and 400 mg of Vitamin B2.; Sender's Comments: Feeling abnormal and Musculoskeletal discomfort are unlisted events which are considered unrelated to GSK vaccine Shingrix. Headache and Malaise are listed events which, due to the following criteria (insufficient information regarding medical history, concurrent conditions, concomitant medications) are considered unrelated to GSK vaccine Shingrix.