Received Sep 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | IM |
Bad headaches; Tightening in the chest; Heart palpitations; Hot flashes; Cold flash; anxiety; Broke out in hives; Shingles like rash; Feeling sick; Feeling stressed; Panicked; Mental confusion; Allergic reaction; This non-serious case was reported by a consumer via call center representative and described the occurrence of palpitation in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Vitamin B12 with an associated reaction of hot flush (Vitamin B12 supplement caused her hot and cold flashes). Concurrent medical conditions included anxiety (Anxiety) and hypertension (The patient was on other medicines antihypertensive, on low dose). On 11-AUG-2025, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid). On 11-AUG-2025, less than a day after receiving Shingrix, the patient experienced palpitation (Verbatim: Heart palpitations), hot flashes (Verbatim: Hot flashes) and cold flash (Verbatim: Cold flash). On 12-AUG-2025, the patient experienced headache (Verbatim: Bad headaches) and chest tightness (Verbatim: Tightening in the chest). In AUG-2025, the patient experienced anxiety (Verbatim: anxiety), hives (Verbatim: Broke out in hives), vesicular rash (Verbatim: Shingles like rash), feeling unwell (Verbatim: Feeling sick), stress (Verbatim: Feeling stressed), panic reaction (Verbatim: Panicked), mental confusion (Verbatim: Mental confusion) and allergic reaction (Verbatim: Allergic reaction). The outcome of the palpitation, hot flashes, cold flash, anxiety, headache, chest tightness, hives, vesicular rash, feeling unwell, stress, panic reaction, mental confusion and allergic reaction were not resolved. It was unknown if the reporter considered the palpitation, hot flashes, cold flash, anxiety, headache, chest tightness, hives, vesicular rash, feeling unwell, stress, panic reaction, mental confusion and allergic reaction to be related to Shingrix. It was unknown if the company considered the palpitation, hot flashes, cold flash, anxiety, headache, chest tightness, hives, vesicular rash, feeling unwell, stress, panic reaction, mental confusion and allergic reaction to be related to Shingrix. Additional Information: GSK Receipt Date: 18-AUG-2025 and 28-AUG-2025 The patient received her second Shingrix dose on 11-Aug-2025, that evening she began experiencing hot and cold flashes and heart palpitations. They were ongoing 7 days later. She reported that some time before taking the Shingrix vaccine, she was taking a B12 supplement, which her doctor informed her caused hot and cold flashes several times per day. She discontinued the supplement well before receiving Shingrix, and the flashes reduced to 2 times per day. After having the Shingrix vaccine, the hot/cold flashes were back to about every 1-2 hours. She had not resumed the B12 supplement. She also reported that she suffered from anxiety and indicated that could be the cause for these symptoms. About 24 hours after receiving the second dose of Shingrix, the patient began to develop really bad headaches, hot flashes, tightening in the chest and heart palpitations. Those events had been happening every day. After about a week, the patient went to the emergency room. A couple days ago, the patient broke out in hives. Yesterday morning, the patient woke up with which looks like a shingles rash under her arm. The patient went to her doctor, and the doctor said it looks like a mosquito bite. The patient disagrees that it was a mosquito bite, and that it looked like Shingles. The patient was feeling really sick, having anxiety, feeling stressed, panicked, and having mental confusion as to what was going on with her body. The patient was up all night with hot flashes. The patient believed she was having an allergic reaction to the vaccine.
Anxiety (Anxiety); Hypertension (The patient was on other medicines antihypertensive, on low dose)