Received Apr 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | LA |
Pelvic pain/severe pain in the pelvic area; Back pain; incapacitated in bed all day; neck hurt badly; terrible headache; body aches; Hip pain/pain went down to her shoulder; Nausea/periodic nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Zostavax (received Zostavax in 2013 or 2014), Prednisone and Prolia with an associated reaction of bone pain (receive Prolia injections for Osteoporosis twice per year for 5 years). Concurrent medical conditions included leg cramps and osteoporosis. Concomitant products included calcium, magnesium and docusate sodium (Stool Softener). On 24-MAR-2025, the patient received the 1st dose of Shingrix (left arm). In MAR-2025, an unknown time after receiving Shingrix, the patient experienced nausea (Verbatim: Nausea/periodic nausea). On 24-MAR-2025, the patient experienced headache (Verbatim: terrible headache), general body pain (Verbatim: body aches), arthralgia (Verbatim: Hip pain/pain went down to her shoulder) and neck pain (Verbatim: neck hurt badly). On 25-MAR-2025, the patient experienced pelvic pain (Verbatim: Pelvic pain/severe pain in the pelvic area), back pain (Verbatim: Back pain) and bedridden (Verbatim: incapacitated in bed all day). The outcome of the headache, general body pain, nausea and neck pain were unknown and the outcome of the pelvic pain, back pain and arthralgia were not resolved and the outcome of the bedridden was resolved. It was unknown if the reporter considered the headache, general body pain, pelvic pain, back pain, arthralgia, nausea, neck pain and bedridden to be related to Shingrix. It was unknown if the company considered the headache, general body pain, pelvic pain, back pain, arthralgia, nausea, neck pain and bedridden to be related to Shingrix. Additional Information: GSK Receipt Date: 02-APR-2025 The patient received the first dose of Shingrix on Monday at a local pharmacy. The vaccine was injected into the left arm. Overnight, the patient began to experienced terrible headache and body aches. The patient was incapacitated in bed all day on the 25th and 26th March 2025. The patients stated her neck hurt badly and the pain went down to her shoulder. The patient was having severe pain in the pelvic area, in her back and hips, which was worse overnight and eases during the day. The pain in the pelvic area flares up after taking her Calcium and Multivitamin and then she goes to bed. The patient also experienced periodic nausea. The patient stated it was not the mattress that was causing her back and hip pain, because she had tried all 3 mattresses in her house without relief. The patient received Zostavax in 2013 or 2014. The patient took prednisone years ago. She had not taken prednisone since 2019. The patient used to receive Prolia injections for Osteoporosis twice per year for 5 years her last dose was May 2024. She experienced aching bones from Prolia.
Leg cramps; Osteoporosis
CALCIUM; MAGNESIUM; STOOL SOFTENER