Received Oct 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 3273h | IM / LA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 3273H | LA |
his left arm is still numb today/arm that I got to shingle vaccine in is numb; has had a tooth ache back and forth; he is afraid to fall asleep; his blood pressure has been out of control/ his blood pressure being so high; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site numbness in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 3273H, expiry date 31-MAR-2027) for prophylaxis. Co-suspect products included Influenza vaccine for prophylaxis. The patient's past medical history included cancer (was a cancer survivor, with chemo and radiation, 10 years ago, prior to receiving Shingrix). In AUG-2025, the patient received the 1st dose of Shingrix (left arm) and Influenza vaccine (right arm). In AUG-2025, less than 3 weeks after receiving Shingrix and Influenza vaccine, the patient experienced increased blood pressure (Verbatim: his blood pressure has been out of control/ his blood pressure being so high). On an unknown date, the patient experienced injection site numbness (Verbatim: his left arm is still numb today/arm that I got to shingle vaccine in is numb), toothache (Verbatim: has had a tooth ache back and forth) and fear (Verbatim: he is afraid to fall asleep). The patient was treated with paracetamol (Tylenol). The outcome of the injection site numbness, increased blood pressure, toothache and fear were not resolved. It was unknown if the reporter considered the injection site numbness, increased blood pressure, toothache and fear to be related to Shingrix. It was unknown if the reporter considered the increased blood pressure, toothache and fear to be related to Influenza vaccine. It was unknown if the company considered the injection site numbness, increased blood pressure, toothache and fear to be related to Shingrix. It was unknown if the company considered the increased blood pressure, toothache and fear to be related to Influenza vaccine. Additional Information: GSK Receipt Date: 02-SEP-2025 and 03-SEP-2025 A patient received the first dose of the Shingrix vaccine in his left arm approximately three weeks prior to the reporting date (exact date not provided). As of the reporting date, the patient continued to experience numbness at the injection site, describing the sensation as similar to having a heart attack, although he confirmed he was not experiencing one. The patient reported that his blood pressure had been significantly elevated since receiving the Shingrix vaccine, with the highest recorded reading being 220/161. Due to this, a stress test scheduled for 13-AUG-2025 was cancelled. On the morning of reporting date, his blood pressure measured 186/122, and during a phone call on the same day, it was 184/111. The patient expressed fear of falling asleep and stated that he was unable to perform daily activities due to his uncontrolled blood pressure, describing himself as a prisoner of his bed. The patient 's physicians had attempted to adjust his medications, but these interventions had not been effective (specific products not disclosed). Additionally, the patient had received a flu vaccine in his right arm at the same time as the Shingrix dose. No product details (lot number, expiry date, NDC, or product name) were available for the flu vaccine. The patient also reported experiencing intermittent toothache (no specific dates provided) and was taking Tylenol (500 mg, one tablet by mouth, six times daily) for pain management. The batch number was not provided and a request for this information has been made.
Medical History/Concurrent Conditions: Cancer (was a cancer survivor, with chemo and radiation, 10 years ago, prior to receiving Shingrix)
Test Date: 20250902; Test Name: Blood pressure; Result Unstructured Data: (Test Result:220/161,Unit:unknown,Normal Low:,Normal High:); Comments: blood pressure being so high; Test Date: 20250902; Test Name: Blood pressure; Result Unstructured Data: (Test Result:186/122,Unit:unknown,Normal Low:,Normal High:); Comments: his blood pressure was 186/122 this morning, 2-SEP-2025; Test Date: 20250902; Test Name: Blood pressure; Result Unstructured Data: (Test Result:184/111,Unit:unknown,Normal Low:,Normal High:); Comments: his blood pressure was 184/111 while on the phone with me today, 2-SEP-2025; Comments: LabComments: Blood pressure 02-SEP-25: blood pressure being so high, Blood pressure 02-SEP-25: his blood pressure was 186/122 this morning, 2-SEP-2025, Blood pressure 02-SEP-25: his blood pressure was 184/111 while on the phone with me today, 2-SEP-2025