Received Jun 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | IM / LA |
injected arm hurts; high blood pressure (bottom number); pulse high; Dizziness; body hurts / bones hurt making it hard to sleep and getting up to urinate, pain in hernia area; body hurts / bones hurt making it hard to sleep and getting up to urinate, pain in hernia area; body hurts / bones hurt making it hard to sleep and getting up to urinate, pain in hernia area; making it hard to sleep; he keeps getting up every 30 to 40 minutes to pee; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included hernia repair (Hernia surgery about 3 years ago). Previously administered products included Shingrix with an associated reaction of no adverse event (no problems with other vaccines, no side effects from Shingrix shot 1). Concomitant products included tamsulosin hydrochloride (Tamsulosin), enalapril maleate (Enalapril), pantoprazole sodium sesquihydrate (Pantoprazole) and Centrum. On 02-JUN-2025, the patient received the 2nd dose of Shingrix (intramuscular use, left deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: injected arm hurts), diastolic blood pressure increased (Verbatim: high blood pressure (bottom number)), pulse increased (Verbatim: pulse high), dizziness (Verbatim: Dizziness), hernia pain (Verbatim: body hurts / bones hurt making it hard to sleep and getting up to urinate, pain in hernia area), general body pain (Verbatim: body hurts / bones hurt making it hard to sleep and getting up to urinate, pain in hernia area), bone pain (Verbatim: body hurts / bones hurt making it hard to sleep and getting up to urinate, pain in hernia area), sleeplessness (Verbatim: making it hard to sleep) and nocturnal urinary frequency (Verbatim: he keeps getting up every 30 to 40 minutes to pee). The outcome of the pain in arm, diastolic blood pressure increased, hernia pain, general body pain, bone pain, sleeplessness and nocturnal urinary frequency were not resolved and the outcome of the pulse increased was resolved and the outcome of the dizziness was resolving. It was unknown if the reporter considered the pain in arm, diastolic blood pressure increased, pulse increased, dizziness, hernia pain, general body pain, bone pain, sleeplessness and nocturnal urinary frequency to be related to Shingrix. It was unknown if the company considered the pain in arm, diastolic blood pressure increased, pulse increased, dizziness, hernia pain, general body pain, bone pain, sleeplessness and nocturnal urinary frequency to be related to Shingrix. Additional Information: GSK receipt date: 03-JUN-2025 The reporter is the patient. Yesterday, patient made my second vaccine, and patient did not know I feel like my blood pressure 118/(unintelligible), pulse 110, and feel like dizzy and my body hurt. The voicemail did NOT include the name of the GSK vaccine. Outbound call made by GRC (GSK Response Center) on June 4th, 2025. Vaccine was confirmed as being Shingrix. Patient received Shingrix, on Monday June 2nd, 2025, dose 2, intramuscularly in the left upper arm deltoid. Patient states that the injected arm still hurts. High blood pressure: The patient reports that the bottom number (diastolic) of his blood pressure is higher than normal. Examples of recent readings: 118/93 and 120/94. Normally the bottom number is about 72. [Normally the top number is about 120]. Event not resolved "bottom number is still high." Pulse is high: the patient's pulse was 110 but normally his pulse is 75. (Event resolved) Dizziness. The patient is still a little dizzy but not as dizzy as yesterday. Body hurts: He states that his body is hurting, and he feels like his bones hurt and this is making it hard for him to sleep last night as also he keeps getting up every 30 to 40 minutes to pee. Also, he has noted that he has been experiencing pain in the hernia area. He does not know if this pain is connected to the Shingrix shot or not.
Medical History/Concurrent Conditions: Hernia repair (Hernia surgery about 3 years ago)
TAMSULOSIN; ENALAPRIL; PANTOPRAZOLE; MULTIVITAMINS WITH MINERALS
Test Name: blood pressure; Result Unstructured Data: (Test Result:118,Unit:unknown,Normal Low:,Normal High:); Test Name: blood pressure; Result Unstructured Data: (Test Result:118/93,Unit:unknown,Normal Low:,Normal High:); Test Name: blood pressure; Result Unstructured Data: (Test Result:120/94,Unit:unknown,Normal Low:,Normal High:); Test Name: pulse rate; Result Unstructured Data: (Test Result:110,Unit:unknown,Normal Low:,Normal High:)