Received Jul 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
headaches; pain; swelling; arm was extremely swollen; heat/arm hot; itching; arm red; arm burning; Crying; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On 05-JUL-2025, less than a week after receiving Shingles vaccine, the patient experienced crying (Verbatim: Crying). On an unknown date, the patient experienced headache (Verbatim: headaches), pain (Verbatim: pain), swelling (Verbatim: swelling), swelling arm (Verbatim: arm was extremely swollen), extremities hot feeling of (Verbatim: heat/arm hot), pruritus (Verbatim: itching), erythema of extremities (Verbatim: arm red) and burning sensation (Verbatim: arm burning). The outcome of the headache, swelling, extremities hot feeling of and pruritus were not resolved and the outcome of the pain was resolved and the outcome of the swelling arm, erythema of extremities, burning sensation and crying were not reported. It was unknown if the reporter considered the headache, pain, swelling, swelling arm, extremities hot feeling of, pruritus, erythema of extremities, burning sensation and crying to be related to Shingles vaccine. It was unknown if the company considered the headache, pain, swelling, swelling arm, extremities hot feeling of, pruritus, erythema of extremities, burning sensation and crying to be related to Shingles vaccine. Additional Information: GSK receipt date: 04-JUL-2025 and 06-JUL-2025 The case was received from the patient via interactive digital media. The patient had first shingles vaccine six days ago and on the day of reporting the first time he/she was not in pain. The patient's arm was extremely swollen, hot, red and burning. One day before the reporting, it itched and burned so bad he/she was crying. The patient still struggling with headaches, pain, swelling, heat and itching. Praying tomorrow would be a better day. It's got to be better than shingles but it's not good and was not a baby. The patient did not think he/she would get the second vaccine.