Received May 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Eye itching; mast cell reaction; shingles type rash; Head to toe itching; nausea; vomiting; Unable to eat; This serious case was reported by a consumer and described the occurrence of mast cell activation syndrome in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included anxiety, insomnia, cholecystectomy, hysterectomy, tubal ligation, post herpetic neuralgia (post herpetic neuralgia from shingles 2 years ago.) and shingles (shingles 2 years ago). Concurrent medical conditions included diabetes mellitus, hypothyroidism, migraine (Migraines, neuralgic) and neuropathy. Concomitant products included amitriptyline and lidocaine. On 11-SEP-2025, the patient received Shingrix. On 12-SEP-2025, 1 days after receiving Shingrix, the patient experienced mast cell activation syndrome (Verbatim: mast cell reaction) (serious criteria GSK medically significant), vesicular rash (Verbatim: shingles type rash), generalized pruritus (Verbatim: Head to toe itching), nausea (Verbatim: nausea), vomiting (Verbatim: vomiting) and unable to eat (Verbatim: Unable to eat). On an unknown date, the patient experienced eye pruritus (Verbatim: Eye itching). The patient was treated with diphenhydramine hydrochloride (Benadryl). The outcome of the mast cell activation syndrome, vesicular rash, generalized pruritus, nausea, vomiting, unable to eat and eye pruritus were not resolved. It was unknown if the reporter considered the mast cell activation syndrome, vesicular rash, generalized pruritus, nausea, vomiting, unable to eat and eye pruritus to be related to Shingrix. The company considered the mast cell activation syndrome to be unrelated to Shingrix. It was unknown if the company considered the vesicular rash, generalized pruritus, nausea, vomiting, unable to eat and eye pruritus to be related to Shingrix. Additional Information: GSK Receipt Date: 02-MAY-2026 The patient presented to clinic with possible allergic reaction to the Shingrix vaccine she got back in AUG-2025. The patient stated that she itches from head to toe, did not start all the itching till she had vaccine. The patient had even talked to the company who makes the vaccine for recommendations to why she would have a reaction. The allergic reaction was a new problem. The current episode started more than 1 week ago and the problem occurs constantly. The problem was unchanged and moderate which was associated symptoms included eye itching and itching. Pertinent negatives included no coughing, diarrhea eye redness, eye watering or rash. The treatment provided with no relief. The batch number was not provided upon follow- up with the reporter.; Sender's Comments: A case of Mast cell activation syndrome, 1 day after receiving Shingrix in a 56-year-old female patient.Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factors (medical history of anxiety, and concomitant amitriptyline). US-GSK-US2026AMR062137:Original Case Number : US2026059893
Diabetes mellitus; Hypothyroidism; Migraine (Migraines, neuralgic); Neuropathy
Medical History/Concurrent Conditions: Anxiety; Cholecystectomy; Hysterectomy; Insomnia; Post herpetic neuralgia (post herpetic neuralgia from shingles 2 years ago.); Shingles (shingles 2 years ago); Tubal ligation
AMITRIPTYLINE; LIDOCAINE
Comments: Review of Systems included: Constitutional: Negative for appetite change, fatigue and fever. HENT: Negative for congestion. Eyes: Positive for itching. Negative to redness. Respiratory: Negative for cough. Gastrointestinal: Negative for diarrhe Skin: Positive for itching. Negative for color change and rash. Diagnosis was Pruritus (Primary) and following were orders for patient to this visit: Lactate Dehydrogenase Basic Metabolic Panel CBC with Differential SED Rate (ESR) C-Reactive Protein Hepatic Function Panel Tryptase Anti-Nuclear ABS