Received Feb 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | IM / RA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | RA |
still has no energy; right arm was very swollen; right arm was about to "kill her" from the pain that she reports felt "like a baseball hit (her arm) at 100 miles per hour; pain caused her to start crying in the middle of the night; she is getting over the flu; she started not feeling good, feeling off; This non-serious case was reported by a consumer via call center representative and described the occurrence of loss of energy in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 08-FEB-2025 12:30, the patient received the 1st dose of Shingrix (right arm). On 08-FEB-2025, less than a day after receiving Shingrix, the patient experienced swelling arm (Verbatim: right arm was very swollen) and pain in arm (Verbatim: right arm was about to "kill her" from the pain that she reports felt "like a baseball hit (her arm) at 100 miles per hour). On 10-FEB-2025, the patient experienced loss of energy (Verbatim: still has no energy). In FEB-2025, the patient experienced feeling unwell (Verbatim: she started not feeling good, feeling off), crying (Verbatim: pain caused her to start crying in the middle of the night) and influenza-like symptoms (Verbatim: she is getting over the flu). The outcome of the loss of energy, feeling unwell, swelling arm and pain in arm were not resolved and the outcome of the crying was unknown and the outcome of the influenza-like symptoms was not reported. It was unknown if the reporter considered the loss of energy, feeling unwell, swelling arm, pain in arm, crying and influenza-like symptoms to be related to Shingrix. It was unknown if the company considered the loss of energy, feeling unwell, swelling arm, pain in arm, crying and influenza-like symptoms to be related to Shingrix. Additional Information: GSK Receipt Date: 10-FEB-2025 The patient received Shingrix and reported that by 6:30 to 7 PM that evening, her right arm was about to kill her from the pain that she reports felt like a baseball hit (her arm) at 100 miles per hour. The patient reports that she could not touch her right arm or lie on her right side, and still cannot lie on her right side today, 10-FEB-2025 because of the pain. This pain caused her to start crying in the middle of the night. The patient reports that the pain was not as bad on, 10-FEB-2025, as it was the first two nights. The patient also reports that her right arm was very swollen starting the day she received the Shingrix vaccine. The patient reports that she started not feeling good, feeling off. The patient reports it was day three after receiving the Shingrix first dose and she still has no energy like she was getting over the flu. The reporter consented to follow up.