Received Feb 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
shingles was seen on the patient's lower back, right light knee, and right shin; shingles in addition to her groin and pelvis; stopped being able to void her bladder; unable to defecate; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included intervertebral disc protrusion (mentioned nerve dissection at L5 and herniated disk at L3, L4, and L5). Concomitant products included methylprednisolone sodium succinate (Methylprednisolone), pregabalin, methocarbamol, ibuprofen and valaciclovir hydrochloride (Valacyclovir). On 26-DEC-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: shingles was seen on the patient's lower back, right light knee, and right shin), genital herpes zoster (Verbatim: shingles in addition to her groin and pelvis), urine output decreased (Verbatim: stopped being able to void her bladder) and decreased stool volume (Verbatim: unable to defecate). The outcome of the shingles and decreased stool volume were unknown and the outcome of the genital herpes zoster was not reported and the outcome of the urine output decreased was resolved. It was unknown if the reporter considered the shingles, genital herpes zoster, urine output decreased and decreased stool volume to be related to Shingrix. It was unknown if the company considered the shingles, genital herpes zoster, urine output decreased and decreased stool volume to be related to Shingrix. Additional Information: GSK Receipt Date: 10-JAN-2025 The reporter was the patient who reported receiving her first dose of Shingrix vaccine on 26th December 2024. On 2nd January 2024 she went to a neurosurgeon for back pain and got an Magnetic resonance imaging which showed a herniated disk at L3, L4, and L5. She also mentioned nerve dissection at L5. It was on this day that disseminated shingles was seen on the patient's lower back, right light knee and right shin it crossed multiple dermatomes. She also experienced pain in the areas of the shingles in addition to her groin and pelvis. She started valacyclovir on 4th January 2024. Recently she stopped being able to void her bladder and unable to defecate. She stopped taking all her medications except for valacyclovir and she was able to urinate and defecate.
Medical History/Concurrent Conditions: Intervertebral disc protrusion (mentioned nerve dissection at L5 and herniated disk at L3, L4, and L5)
METHYLPREDNISOLONE; PREGABALIN; METHOCARBAMOL; Ibuprofen; VALACYCLOVIR
Test Name: MRI; Result Unstructured Data: (Test Result:not reported,Unit:unknown,Normal Low:,Normal High:) showed herniated disk at L3, L4, and L5