Received Sep 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | IM |
heart deviation; Thyroid up; thyroid down; congested chest; abdominal discomfort; Urine abnormal; Short of breath; low electrolytes; drug dose administration interval too long; This non-serious case was reported by a consumer via call center representative and described the occurrence of urine analysis abnormal in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis. Previously administered products included Shingrix with an associated reaction of oral herpes (received first dose on 12-DEC-2024). On 30-JUL-2025, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the patient received Hepatitis B vaccine. On 30-JUL-2025, an unknown time after receiving Shingrix and not applicable after receiving Hepatitis B vaccine, the patient experienced drug dose administration interval too long (Verbatim: drug dose administration interval too long). On 15-AUG-2025, the patient experienced urine analysis abnormal (Verbatim: Urine abnormal), shortness of breath (Verbatim: Short of breath), blood electrolytes decreased (Verbatim: low electrolytes), chest fullness (Verbatim: congested chest) and abdominal discomfort (Verbatim: abdominal discomfort). On an unknown date, the patient experienced heart disorder (Verbatim: heart deviation), thyroid hormones decreased (Verbatim: Thyroid up) and thyroid hormones decreased (Verbatim: thyroid down). The outcome of the urine analysis abnormal, shortness of breath, blood electrolytes decreased, chest fullness and abdominal discomfort were unknown and the outcome of the heart disorder, thyroid hormones decreased and thyroid hormones decreased were not resolved and the outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the urine analysis abnormal, shortness of breath, blood electrolytes decreased, heart disorder, thyroid hormones decreased, thyroid hormones decreased, chest fullness and abdominal discomfort to be related to Shingrix and Hepatitis B vaccine. It was unknown if the company considered the urine analysis abnormal, shortness of breath, blood electrolytes decreased, heart disorder, thyroid hormones decreased, thyroid hormones decreased, chest fullness and abdominal discomfort to be related to Shingrix and Hepatitis B vaccine. Additional Information: GSK Receipt Date: 22-AUG-2025 The patient reported that she had to visit the ER for several complaints. She was not hospitalized, and the CT with contrast was within normal limits, she was told that she has abnormal blood, abnormal urine, low electrolytes, a deviation with her heart and her thyroid was going up and down. She had difficulty providing the history, the details and dates of the vaccinations and the dates of the miscellaneous disorders. The outcome date of events Urine analysis abnormal, Shortness of breath, Blood electrolytes decreased, Chest fullness and abdominal discomfort was provided as 15-AUG-2025.
Test Date: 20250815; Test Name: Electrolytes; Result Unstructured Data: (Test Result:Decreased,Unit:unknown,Normal Low:,Normal High:); Test Name: Blood test; Result Unstructured Data: (Test Result:Abnormal,Unit:unknown,Normal Low:,Normal High:); Test Name: CT scan; Result Unstructured Data: (Test Result:Normal,Unit:unknown,Normal Low:,Normal High:); Test Name: Thyroid test; Result Unstructured Data: (Test Result:up and down,Unit:unknown,Normal Low:,Normal High:); Test Date: 20250815; Test Name: urine analysis; Result Unstructured Data: (Test Result:Abnormal,Unit:unknown,Normal Low:,Normal High:)