Received Aug 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | LA |
Posterior vitreous detachment/saw a bright flash/felt crummy/saw poppy seed like dots; Tiredness; vaccine was given too high on the shoulder/ it was given just below the shoulder bone; This serious case was reported by a consumer via call center representative and described the occurrence of posterior vitreous detachment in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Covid-19 vaccine (received a dose on an unknown date). Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and paracetamol (Tylenol). On 02-AUG-2025, the patient received the 2nd dose of Shingrix (left arm) .5 ml. On 02-AUG-2025, an unknown time after receiving Shingrix, the patient experienced vaccine administered at inappropriate site (Verbatim: vaccine was given too high on the shoulder/ it was given just below the shoulder bone). On 03-AUG-2025, the patient experienced tiredness (Verbatim: Tiredness). On 08-AUG-2025, the patient experienced posterior vitreous detachment (Verbatim: Posterior vitreous detachment/saw a bright flash/felt crummy/saw poppy seed like dots) (serious criteria GSK medically significant). The outcome of the posterior vitreous detachment and tiredness were unknown and the outcome of the vaccine administered at inappropriate site was not applicable. The reporter considered the posterior vitreous detachment to be possibly related to Shingrix. It was unknown if the reporter considered the tiredness to be related to Shingrix. The company considered the posterior vitreous detachment to be unrelated to Shingrix. It was unknown if the company considered the tiredness to be related to Shingrix. Additional Information: GSK Receipt Date: 11-AUG-2025 The patient self-reported this case for herself. The patient received the first dose of Shingrix on 31-MAY-2025. The patient further received the second dose of Shingrix on Saturday morning. The afternoon of Sunday 03-AUG-2025, 1 days after vaccination, the patient saw a bright flash on the right side of her right eye. The patient stated she felt crummy and tired. When asked to expand on felt crummy, the patient stated she felt like she did after a COVID vaccine. On Thursday, 07-AUG-2025, 5 days after vaccination, the patient saw 1000 poppy seed like dots in her right eye. The patient was seen by an eye physician on Friday 08-AUG-2025, 6 days after vaccination, and was diagnosed with posterior vitreous detachment (PVD). The patient was told by the physician that it was possible this (PVD) was related to the vaccine. The patient had no personal history or family history of eye problems, and the patient stated that the vaccine was given too high on the shoulder, it was given just below the shoulder bone, the placement of the vaccine seemed wrong to her, which led to vaccine administered at inappropriate site.; Sender's Comments: A case of Vitreous detachment, 6 days after receiving 2nd dose of Shingrix, in a 65-year-old female subject. and Report is inconsistent with causal relation to the vaccine product, considering implausible time to?onset and absence of biological plausibility and alternative risk factor(age)
SHINGRIX; TYLENOL