Received Aug 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | IM |
osteopenia; bilateral nerve pain; Pain at injection site; early morning headaches/Headache; Body ache; Painful arm; Burning sensation at the front of her legs; intermittent bilateral ankle burning at night ankle to the mid part of the shin.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included thyroid disorder and diabetes. Additional patient notes included She was not hypotensive, not on any blood control medication, not on metformin or insulin. Concomitant products included levothyroxine and dapagliflozin propanediol monohydrate (Farxiga). On 09-JUL-2025, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On 09-JUL-2025, less than a day after receiving Shingrix, the patient experienced headache (Verbatim: early morning headaches/Headache), pain in arm (Verbatim: Painful arm) and general body pain (Verbatim: Body ache). In JUL-2025, the patient experienced burning sensation in joints (Verbatim: intermittent bilateral ankle burning at night ankle to the mid part of the shin.) and burning leg (Verbatim: Burning sensation at the front of her legs). On an unknown date, the patient experienced injection site pain (Verbatim: Pain at injection site), osteopenia (Verbatim: osteopenia) and nerve pain (Verbatim: bilateral nerve pain). The outcome of the injection site pain was not reported and the outcome of the burning sensation in joints, headache, pain in arm, burning leg and general body pain were not resolved and the outcome of the osteopenia and nerve pain were unknown. It was unknown if the reporter considered the injection site pain, burning sensation in joints, headache, osteopenia, nerve pain, pain in arm, burning leg and general body pain to be related to Shingrix. It was unknown if the company considered the injection site pain, burning sensation in joints, headache, osteopenia, nerve pain, pain in arm, burning leg and general body pain to be related to Shingrix. Additional Information: GSK Receipt Date: 01-AUG-2025 The patient had a Shingrix shot and since she has been having early morning headaches, when she gets up in the morning, she claims she has a headache and gets a cup of coffee and middle of the night she has been experiencing bilateral ankle burning, up from the ankle to the mid part of the shin. She said it's also weather related, if its damp or raining weather it gets worse and the frequency of it was intermittent. The patient was on thyroid medication 75 MCG of levothyroxine. She was still experiencing it. She called in reporting morning she was a friend of the family and told her that the symptoms that she described to did not line up with what would expect from Shingrix vaccine. The reporter cannot find anything related to bilateral ankle neuralgia, its sounds more to like a disc issue. She has no disc issue or osteoporosis but has osteopenia. She just got bone density test done and it showed up as osteopenia not osteoporosis. She walks and exercise but pain she gets in the middle of the night with the ankle and to me its sounds more like neuralgia, not disc related, the reporter stated he/she could be wrong but the issue with her was that she never had it until she took the Shingrix injection. Did not know if its temporal relationship or not, did not know but it's interesting now she took the injection and she has now bilateral nerve pain. She states that she has been experiencing headache, painful injection site, body aches, and a burning sensation at the front of her legs. She states that these symptoms were ongoing intermittently. The burning sensation began a few days ago and was ongoing. The reporter would like to know if there were any reports of this, because the issue here was this, she was pending a 2nd injection. So, if she developing some neuralgia was this a form of Guillain-Barre syndrome. The reporter did not think so, but think about it, it usually affects the back. Covid vaccine from Aztra Zeneca pulled out the vaccine because of that and people end up getting paralysis. So, the reporter not going to recommend that she gets a 2nd dose if this was preamble to potentially to be paralysis for her. The reporter also aware physician for example did not pay attention to black box warning for example ciprofloxacin and they prescribe it has candy drops. She said he had spoken to her primary, and he said he was not aware of any issues happening to other patients, so the reporter did not know if this was a one off or a unique circumstance for her. The reporter did not know if it's indicative of delayed hypersensitivity reaction and might get worse at a 2nd dose. Right now, the reporter told her did not take a 2nd dose and she can wait it out, she has been exposed to chicken pox before and not had any eruption or 2nd occurrence of it since she was a kid. The reporter asked her if she had herniated disc, she said she does not and one feature she never had this neuralgia prior to injection. Did not know if Shingrix activated something in her system she got a small inflammation at the nerve root that gets inflamed at nighttime. She said it was intermittent to me if it was inflamed it would be chronic constant.
Diabetes; Thyroid disorder
Comments: She was not hypotensive, not on any blood control medication, not on metformin or insulin
LEVOTHYROXINE; FARXIGA
Test Date: 2025; Test Name: bone density test; Result Unstructured Data: (Test Result:osteopenia,Unit:unknown,Normal Low:,Normal High:)