Report #2883702

Overview

Sex

Female

Age

Age unknown

State

VA

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (3)

Symptom narrative

missed her dose of Shingrix; it leaked out while the needle was inserted into the vial; Pharmaceutical product complaint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) (batch number 92M54, expiry date 06-FEB-2021) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: missed her dose of Shingrix), product leakage (Verbatim: it leaked out while the needle was inserted into the vial) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the incomplete course of vaccination, product leakage and pharmaceutical product complaint were not applicable. Additional Information: GSK Receipt Date: 16-MAY-2019 and 04-JUN-2019 A female patient had missed her dose of Shingrix on 11-MAY due to a suspected vial and had consented to follow-up. Call notes indicated that the pharmacist had been the reporter. It was stated that an experienced pharmacist had reported that while preparing a vial for administration, it had leaked out while the needle was inserted into the vial. The pharmacist had withdrawn the liquid from the liquid vial without issue. The syringe had then been inserted into the powder vial to be mixed. When the pharmacist had injected the liquid, it had spat back out and leaked from the hole where the needle had been inserted. The needle had still been in the vial when it leaked out. No air had been injected. There had been no evidence of any leakage in the packaging. A BD 23-gauge one-inch safety needle had been used. A customer had reported a complaint that fell within the following product technical complaint category, leak vial at needle puncture. An investigation had been performed, including a review of the reported defect trends, the reference samples, and the production records. No root cause for the reported complaints had been identified at the level of the manufacturing processes under GlaxoSmithKline Vaccines control. Furthermore, no atypical finding had been detected during practical testing of the reference samples. According to the procedure, as there had been no supporting proof or evidence that the root cause of the complaints had taken place within GlaxoSmithKline Vaccines, these complaints had been considered unsubstantiated.