Received Mar 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Shingrix allergic reaction to first dose; Headache; Fatigue; Chills; Soreness at the injection site; Hardness at the injection site.; Bumpy rash five inches away of the injection site; Erythema five inches away of the injection site/Rubor five inches away of the injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (when she was 40 years prior to receipt of Shingrix). On 21-FEB-2025, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced allergic reaction (Verbatim: Shingrix allergic reaction to first dose), headache (Verbatim: Headache), fatigue (Verbatim: Fatigue), chills (Verbatim: Chills), injection site pain (Verbatim: Soreness at the injection site), injection site induration (Verbatim: Hardness at the injection site.), papular rash (Verbatim: Bumpy rash five inches away of the injection site) and erythema (Verbatim: Erythema five inches away of the injection site/Rubor five inches away of the injection site). The outcome of the allergic reaction, headache, fatigue, chills, injection site pain, injection site induration, papular rash and erythema were unknown. It was unknown if the reporter considered the allergic reaction, headache, fatigue, chills, injection site pain, injection site induration, papular rash and erythema to be related to Shingrix. It was unknown if the company considered the allergic reaction, headache, fatigue, chills, injection site pain, injection site induration, papular rash and erythema to be related to Shingrix. Additional Information: GSK receipt date: 07-MAR-2025, 10-MAR-2025 Pharmacist asked if she could get the second dose of Shingrix after presenting an allergic reaction to the first dose of this vaccine. The health care provider did not know the vaccine lot number and expiration date. Per follow up with Pharmacist, she states she had a prior history of shingles when she was 40 years prior to receipt of Shingrix. She states she was usually not sensitive to any vaccines in the past.
Medical History/Concurrent Conditions: Shingles (when she was 40 years prior to receipt of Shingrix)