Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Underdose
Clinical narrative: Low fill of 2 Shingrix vials after reconstitution/ only able to withdraw 0.3 mL /swabbed the top of the adjuvant / withdraw 0.5 mL of liquid / able to withdraw only 0.3 mL total solution / unsure if the adjuvant or antigen are the affected component; withdraw only 0.3 mL total solution / administered to a patient / notified the patient of the low fill of the dose; only able to withdraw 0.3 mL after reconstitution; This case was reported by a pharmacist and described the occurrence of underdose in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 9472F, expiry date 14th October 2022) and (batch number MM59F, expiry date 14th October 2022) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included Herpes zoster (Shingrix) (batch number 9472F, expiry date 14th October 2022) and (batch number MM59F, expiry date 14th October 2022) for prophylaxis.   On 29th April 2021, the patient received Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. On 29th April 2021, the patient received Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. On 29th April 2021, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced underdose and package volume underfill. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the underdose, package volume underfill and pharmaceutical product complaint were unknown.  Additional details were provided as follows: The patient herself was the reporter. She reported low fill of two Shingrix vials after reconstitution.  Both vials came out of the same box and the total reconstituted volume was between 0.3 and 0.4 mL for both.  When preparing the first injection, the reporter swabbed the top of the adjuvant vial and injected 0.5mL of air into the vial. She then withdrew 0.5 mL of liquid. She swabbed the top of the antigen vial, then inserted the liquid adjuvant and was only able to withdraw 0.3 mL. This dose was not administered and was discarded. There was no patient involvement.  With the second vial, the pharmacist swabbed the top of the adjuvant and did not inject air into the vial. She was able to withdraw 0.5 mL of liquid. She swabbed the top of the antigen, inserted the needle to reconstitute and was able to withdraw only 0.3 mL total solution. This dose was administered to the patient which led to underdose and package volume underfill. The pharmacist notified the patient of the low fill of the dose.  No resulting patient symptoms were noted.  The reporter was unsure if the adjuvant or antigen were the affected component. A picture of the defect product was taken and emailed.  Suspect product was not available for return as it had been discarded.  It was unknown if other vials in that particular box were affected.  The vial after reconstitution were swirled laterally for about 15 seconds, it was held upside-down when the vaccine was being withdrawn.  The reporter was able to withdraw between 0.3 and 0.4 mL for both vials and 3 ml syringe was used with 0.1 ml interval hash marks. The reporter had not experienced a low fill problem with this product before. No leaks or cracks were observed in vial. The reporter consented to follow up via email.