Received Mar 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM / RA |
injection site pain, after approximately one month, radiated to other parts of her upper body on the right side; Head pain; Migraine; Neck pain; upper back pain; pain went from her right wrist; stomach issues; can barely do anything/can barely move neck; limited in what she can do; lost 70 pounds; she was tested for lymes disease; Pain injection site; This serious case was reported by a consumer via call center representative and described the occurrence of lyme disease in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (diagnosed approximately 9 years ago), pinkeye (diagnosed approximately 9 years ago), migraine and gastrointestinal disorder. Previously administered products included Covid-19 vaccine with an associated reaction of no adverse event and Flu vaccine with an associated reaction of no adverse event. Concurrent medical conditions included fibromyalgia, diabetes, blood pressure high, blood cholesterol increased and depression. Additional patient notes included no past vaccine related illness. Concomitant products included oxycodone hydrochloride, paracetamol (Percocet) and dulaglutide (Trulicity). On 22-DEC-2025, the patient received the 1st dose of Shingrix (intramuscular, right arm). On 22-DEC-2025, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain injection site). On an unknown date, the patient experienced lyme disease (Verbatim: she was tested for lymes disease) (serious criteria GSK medically significant), radiating pain (Verbatim: injection site pain, after approximately one month, radiated to other parts of her upper body on the right side), headache (Verbatim: Head pain), migraine (Verbatim: Migraine), neck pain (Verbatim: Neck pain), upper back pain (Verbatim: upper back pain), wrist pain (Verbatim: pain went from her right wrist), gastric disorder (Verbatim: stomach issues), mobility decreased (Verbatim: can barely do anything/can barely move neck), decreased activity (Verbatim: limited in what she can do) and weight loss (Verbatim: lost 70 pounds). The patient was treated with lidocaine. The outcome of the lyme disease, injection site pain, radiating pain, headache, migraine, neck pain, upper back pain, wrist pain, gastric disorder, mobility decreased, decreased activity and weight loss were not resolved. It was unknown if the reporter considered the lyme disease, injection site pain, radiating pain, headache, migraine, neck pain, upper back pain, wrist pain, gastric disorder, mobility decreased, decreased activity and weight loss to be related to Shingrix. The company considered the lyme disease to be unrelated to Shingrix. It was unknown if the company considered the injection site pain, radiating pain, headache, migraine, neck pain, upper back pain, wrist pain, gastric disorder, mobility decreased, decreased activity and weight loss to be related to Shingrix. Additional Information: GSK Receipt Date: 18-MAR-2026 The patient had Shingrix and reported injection site pain for approximately one month. The patient reported the pain was at 8 or 9 on the pain scale all the time. The consumer stated that she also began experiencing daily migraines, which was abnormal for her. The patient reported that as a result of the migraines she was having stomach issues. The injection site pain, after approximately one month, radiated to other parts of her upper body on the right side. The consumer stated she had pain in her head, neck, upper back, and the pain went from her right wrist to the injection site. The customer reported she went to the emergency department (date not disclosed) for evaluation. At the emergency department visit, blood work was done, she was tested for Lyme disease, she was evaluated for dehydration, and she had an ultrasound of her upper right quadrant and x-rays taken of the upper right quadrant. The consumer did take Percocet (strength not disclosed) for fibromyalgia, which she was diagnosed with prior to the Shingrix vaccination. The emergency department did provide the consumer with a few pills of Percocet. The consumer stated she was referred to Rheumatology. She consulted with her primary care physician, who was perplexed by these ongoing issues. The consumer reported she had been applying lidocaine patches, heat, ice, and taking baths to relieve the pain. She had to resort to taking Percocet for the pain. The consumer reported that prior to having Shingrix administered she had an ongoing diagnosis of diabetes. The consumer reported her hemoglobin A1C was 5.9, she had lost 70 pounds, and she took Trulicity to control her diabetes. The patient reported her body was sensitive and it did take her longer to get over pain/illness. The batch number was not provided and a request for this information has been made.; Sender's Comments: A case of Lyme disease, unknown time after receiving 1st dose of Shingrix in a 59-year-old female patient. Based on the available information, a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
Blood cholesterol increased; Blood pressure high; Depression; Diabetes; Fibromyalgia
Medical History/Concurrent Conditions: Gastrointestinal disorder; Migraine; Pinkeye (diagnosed approximately 9 years ago); Shingles (diagnosed approximately 9 years ago); Comments: no past vaccine related illness
OXYCODONE;PARACETAMOL; TRULICITY
Test Name: blood test; Result Unstructured Data: (Test Result:tested for lymes disease,Unit:unknown,Normal Low:,Normal High:); Test Name: hemoglobin A1C; Result Unstructured Data: (Test Result:5.9,Unit:unknown,Normal Low:,Normal High:); Test Name: ultrasound; Result Unstructured Data: (Test Result:not reported,Unit:unknown,Normal Low:,Normal High:); Test Name: x-ray; Result Unstructured Data: (Test Result:not reported,Unit:unknown,Normal Low:,Normal High:)