Received Apr 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | LA |
Hard time talking; Chest pain/she woke up during the night Tuesday morning, 8-APR-2025 with pain in her chest; Back pain/pain in lower back and is still experiencing these events today, 10-APR-2025.; Can not Breathe/she cannot breathe and it hurts to breathe, which also started 8-APR-2025 and continues today, 10-APR-2025; Hurts; This non-serious case was reported by a consumer via call center representative and described the occurrence of chest pain in a 93-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 07-APR-2025 15:00, the patient received the 1st dose of Shingrix (left arm). On 08-APR-2025, 1 days after receiving Shingrix, the patient experienced chest pain (Verbatim: Chest pain/she woke up during the night Tuesday morning, 8-APR-2025 with pain in her chest), back pain (Verbatim: Back pain/pain in lower back and is still experiencing these events today, 10-APR-2025.), difficulty breathing (Verbatim: Can not Breathe/she cannot breathe and it hurts to breathe, which also started 8-APR-2025 and continues today, 10-APR-2025) and pain (Verbatim: Hurts). On an unknown date, the patient experienced speech disorder (Verbatim: Hard time talking). The outcome of the chest pain, back pain, difficulty breathing, pain and speech disorder were not resolved. It was unknown if the reporter considered the chest pain, back pain, difficulty breathing, pain and speech disorder to be related to Shingrix. It was unknown if the company considered the chest pain, back pain, difficulty breathing, pain and speech disorder to be related to Shingrix. Additional Information: GSK Receipt Date: 10-APR-2025 The reporter reported that a patient that received the first dose of Shingrix and reports that she woke up during the night Tuesday morning, 8-APR-2025 with pain in her chest and lower back and was still experiencing these events. The patient also reports that she cannot breathe and it hurts to breathe, which also started 8-APR-2025 and continues. The patient reports that she is having a hard time talking. The patient went to the emergency room on 9-APR-2025, and they did a Cat Scan, Lung Scan, Lab Work, and Imaging (no further information provided), and did not find anything wrong with the patient. The patient was sent home the same day (unclear if ante meridiem or post meridiem), with pain medication to take every six hours (unknown product information).
Test Name: Cat Scan; Result Unstructured Data: (Test Result:Not reported,Unit:unknown,Normal Low:,Normal High:); Test Name: Lung Scan; Result Unstructured Data: (Test Result:Not reported,Unit:unknown,Normal Low:,Normal High:)