Received Apr 5, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | LA |
rash at the injection site; Flu like symptoms; Inside the rash, she sees dark red spots.; Body odor; Fever; Diarrhea; Nausea; Left side headache; conjunctivitis; ringing in the left ear; swollen; Body aches; pain at the injection site; Injection site warmth; erythematous at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included atorvastatin calcium propylene glycol solvate (Atorvastatin) and levothyroxine sodium (Synthroid). On 23-MAR-2026, the patient received the 2nd dose of Shingrix (left deltoid) .5 ml. In MAR-2026, less than a week after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at the injection site), injection site warmth (Verbatim: Injection site warmth), injection site erythema (Verbatim: erythematous at the injection site), fever (Verbatim: Fever), diarrhea (Verbatim: Diarrhea), nausea (Verbatim: Nausea), headache (Verbatim: Left side headache), conjunctivitis (Verbatim: conjunctivitis), ringing in ears (Verbatim: ringing in the left ear), swelling (Verbatim: swollen) and general body pain (Verbatim: Body aches). On 23-MAR-2026, the patient experienced injection site rash (Verbatim: rash at the injection site), influenza-like symptoms (Verbatim: Flu like symptoms), red rash (Verbatim: Inside the rash, she sees dark red spots.) and body odor (Verbatim: Body odor). The outcome of the injection site pain, injection site warmth, injection site erythema, injection site rash, fever, diarrhea, nausea, headache, conjunctivitis, ringing in ears, swelling and general body pain were unknown and the outcome of the influenza-like symptoms, red rash and body odor were not resolved. It was unknown if the reporter considered the injection site pain, injection site warmth, injection site erythema, injection site rash, influenza-like symptoms, red rash, body odor, fever, diarrhea, nausea, headache, conjunctivitis, ringing in ears, swelling and general body pain to be related to Shingrix. It was unknown if the company considered the injection site pain, injection site warmth, injection site erythema, injection site rash, influenza-like symptoms, red rash, body odor, fever, diarrhea, nausea, headache, conjunctivitis, ringing in ears, swelling and general body pain to be related to Shingrix. Additional Information: GSK Receipt Date: 26-MAR-2026 and 27-MAR-2026 The reporter stated that rash started 2.5 days ago at the injection site and had moved/grown distally and medially. It was warm, erythematous, painful, especially with palpation. There were darker red lesions in the rash. She initially experienced flu symptoms, body aches, fever, pain at the injection site and body odor. She had experienced new symptoms. She was experiencing diarrhea, nausea, left sided headache, sensitivity to light, conjunctivitis and ringing in the left ear. She believes the left side symptoms were nerve related. She also had a rash that was on her left arm that was about 6 inches by 3 inches. Inside the rash, she sees dark red spots. The rash was red and swollen although today, she states that it seems to be resolving. She has been taking Advil and Tylenol for the rash. The batch number was not provided upon follow up with the reporter.
Atorvastatin; Synthroid