Received May 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | TS525 | SC / LA |
Potential wrong route of administration/subcutaneous administration instead of intramuscular; Vaccine leaked from skin at injection site/vaccine came out of the injection site onto her arm; the patient feels she may not have received the full dose Vaccine leaked from skin at injection site/Underdose; swelling at the injection site; she has lump at the injection site; she has redness at the injection site; she has lump at the injection site describing it sounded like induration; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number TS525, expiry date 10-MAR-2027) for prophylaxis. The patient's past medical history included shingles (The patient developed Shingles in 2020). Concurrent medical conditions included overweight. On 25-APR-2025, the patient received the 1st dose of Shingrix (subcutaneous, left arm). In APR-2025, less than a week after receiving Shingrix, the patient experienced injection site swelling (Verbatim: swelling at the injection site), injection site lump (Verbatim: she has lump at the injection site), injection site erythema (Verbatim: she has redness at the injection site) and injection site induration (Verbatim: she has lump at the injection site describing it sounded like induration). On 25-APR-2025, the patient experienced intramuscular formulation administered by other route (Verbatim: Potential wrong route of administration/subcutaneous administration instead of intramuscular), exposure via skin contact (Verbatim: Vaccine leaked from skin at injection site/vaccine came out of the injection site onto her arm) and accidental underdose (Verbatim: the patient feels she may not have received the full dose Vaccine leaked from skin at injection site/Underdose). The outcome of the injection site swelling, injection site lump, injection site erythema and injection site induration were unknown and the outcome of the intramuscular formulation administered by other route, exposure via skin contact and accidental underdose were not applicable. It was unknown if the reporter considered the injection site swelling, injection site lump, injection site erythema and injection site induration to be related to Shingrix. It was unknown if the company considered the injection site swelling, injection site lump, injection site erythema and injection site induration to be related to Shingrix. Additional Information: GSK Receipt Date: 28-APR-2025 Nurse was calling as a patient since she got first dose of Shingrix on 25th April 2025, but when administering, some of the vaccine leaked on the skin from the injection site, and she had a large lump with redness at the site, easily about 3 inches in diameter. Caller thought it might be subcutaneous administration instead of intramuscular, but she was not sure which led to Intramuscular formulation administered by other route. Caller did not have lot number or expiration date for the vaccine on hand. Details provided from nurse to second line agent when second line agent was asking details of the lump, the way caller was describing it sounded like induration, so agent asked if she thought it could be induration, and nurse said yes it was probably induration. Caller mentioned she was overweight, and it was possible she could have received the vaccine subcutaneously as a result, due to her size and the size of the needle. After the pharmacist removed the needle from the patient's Left arm, the vaccine came out of the injection site onto her arm (Vaccine contact with skin). Because of this, the patient feels she might not have received the full dose had Underdose. The patient stated that she had redness and swelling at the injection site (Left arm). The paperwork provided to the patient by the pharmacy, reads the dose of SHINGRIX as 1ml. The patient believed that this was incorrect and that it should read 0.5ml. The patient did not believe that a dose of 1ml was attempted.
Overweight
Medical History/Concurrent Conditions: Shingles (The patient developed Shingles in 2020)