Received May 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM / RA |
patient had itching all over; Pain injection site; swollen 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 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (episode of Shingrix sometime around February and March of 2025), rash and scab. Concurrent medical conditions included disability. On 15-MAY-2025, the patient received the 1st dose of Shingrix (intramuscular, right arm) .5 ml. In MAY-2025, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain injection site) and injection site swelling (Verbatim: swollen at the injection site). On an unknown date, the patient experienced generalized pruritus (Verbatim: patient had itching all over). The outcome of the injection site pain and injection site swelling were unknown and the outcome of the generalized pruritus was not resolved. It was unknown if the reporter considered the injection site pain, injection site swelling and generalized pruritus to be related to Shingrix. It was unknown if the company considered the injection site pain, injection site swelling and generalized pruritus to be related to Shingrix. Additional Information: GSK Receipt Date: 15-MAY-2025 The reporter was the patient. The patient reported on 15th May 2025, that he received the 1st dose of Shingrix vaccine at the beginning of May 2025 at a local pharmacy. The patient reported the vaccine was administered in the right arm. The patient reported that for the first 3 days he had pain at the injection site, and it was swollen. The patient reported that he had a previous episode of Shingrix sometime around February and March of 2025. The patient reported that he got the vaccine after his rash and scabbing was gone. The patient reported that after receiving the vaccine the patient had itching on the back, arm, chin, neck, head. The patient had itching all over. The patient reported that it had not improved. The patient described it was like welts or swelling spots. The reporter stated it was still happening and had not improved. The reporter reported that the patient did not see any rash, it was just itching. No additional information was reported. The patient declined to provide demographics and disconnected from the call abruptly. The agent was unable to obtain any additional information.
Disability
Medical History/Concurrent Conditions: Rash; Scab; Shingles (episode of Shingrix sometime around February and March of 2025)