Received May 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Took the shot when I first saw the blisters and have had the 2nd shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug use for unapproved indication in a patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included rash, pain (Then the wrap around pain on the left side of my thorax was unbearable as well), pruritus (internal itching on the left side of my thorax), breast pain (I still feel it in my breast), skin pain (skin is very tender), nerve pain (Deep nerve pain starting in the armpit), breast lump (5 clusters on the left breast), knee replacement (I've had 2 knee replacements), cesarean section (I've had 2 knee replacements and 2 cesarean) and shingles (in July 2024 had shingles). On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug use for unapproved indication (Verbatim: Took the shot when I first saw the blisters and have had the 2nd shot). The patient was treated with pregabalin (Lyrica). The outcome of the drug use for unapproved indication was not applicable. Additional Information: GSK receipt date: 15-MAY-2025 This case was reported by a patient via interactive digital media. The reporter reported that it was meant to take out the nerve pain so at least she/he could sleep again. He had it in July 2024 it ran from deep in his/her armpit across his/her left breast and gave him/her five clusters on the left breast. Initially, he/she thought he/she was having a heart attack because of the intense, deep feeling he/she was experiencing. By morning, he/she had developed a rash. That rash felt like somebody had dragged me on a gravel road behind a truck. Then the wrap-around pain and internal itching on the left side of my thorax became unbearable as well. He/she still felt it in his/her breast, and his/her skin remained very tender at times, with the internal itching still present. He/she had not been vaccinated in time. He/she took the shot when he/she first saw the blisters and later received the second shot. The pain would take his/her breath away. It used to wake him/her up screaming in pain. His/her physician prescribed Lyrica, which helped tremendously. It was prescribed for shingles. The pain without Lyrica was the worst he/she had ever been through and he/she had undergone two knee replacements and two cesarean sections. He/she could only imagine what people went through before treatments like this existed.
Medical History/Concurrent Conditions: Breast lump (5 clusters on the left breast); Breast pain (I still feel it in my breast); Cesarean section (I've had 2 knee replacements and 2 cesarean); Knee replacement (I've had 2 knee replacements); Nerve pain (Deep nerve pain starting in the armpit); Pain (Then the wrap around pain on the left side of my thorax was unbearable as well); Pruritus (internal itching on the left side of my thorax); Rash; Shingles (in July 2024 had shingles); Skin pain (skin is very tender)