Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Blood pressure increased, Discomfort, Extra dose administered, Headache
Clinical narrative: Elevated blood pressure; Weakness; Headache; fever; was uncomfortable for the patient; whole body pain for 1 week; Extra dose administered/got 3 Shingrix vaccines instead of 2; This non-serious case was reported by a consumer via call center representative and described the occurrence of increased blood pressure in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of discomfort (On 5th June 2023, 1st dose was received and experienced discomfort). Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX), irbesartan and nifedipine.   On 31-AUG-2023, the patient received the 3rd dose of Shingrix. On 31-AUG-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Extra dose administered/got 3 Shingrix vaccines instead of 2). On 01-SEP-2023, the patient experienced increased blood pressure (Verbatim: Elevated blood pressure), weakness (Verbatim: Weakness), headache (Verbatim: Headache), fever (Verbatim: fever), discomfort (Verbatim: was uncomfortable for the patient) and pain (Verbatim: whole body pain for 1 week).  Rechallenge with Shingrix was positive. The outcome of the increased blood pressure, headache, fever, discomfort and pain were resolved and the outcome of the weakness was not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the increased blood pressure, weakness, headache, fever, discomfort and pain to be related to Shingrix.     It was unknown if the company considered the increased blood pressure, weakness, headache, fever, discomfort and pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR139971   Additional Information: GSK Receipt Date: 03-OCT-2023 Reporter was the daughter calling on behalf of her father who was a male patient that received Shingrix vaccine. The reporter informed about Shingrix vaccine and went ahead and told this agent about various adverse events. The reporter stated they had got 3 Shingrix vaccines instead of 2, which led to extra dose administered. The 2nd vaccine was given on 22-AUG-2023 and 3rd one was on 31-AUG-2023. These vaccinations were given at 3 different pharmacies and there was only one pharmacy that was known. Reporter had no information about lot, expiry, location of administration, route of administration to provide. The patient felt very weak after the 3rd dose starting the day after the vaccine, 1-SEP-2023, and was still experiencing weakness The patient had a headache, fever, was sore, and had uncomfortable, whole body pain for 1 week after the 3rd dose that started the day after the vaccine. The patient's blood pressure was higher (increased) than before (no time frame provided) and had to double his Nifedipine daily dose from 60MG to 120MG. The patient also took Irbesartan 12.5MG daily for blood pressure (unknown product information). The reporter also stated that the 1st dose of Shingrix was received 5-JUN-2023 and it was uncomfortable for the patient. No information was provided about this dose. The reporter did not consent to follow up. The consent to follow up with healthcare professional was declined per a phone. The reporter was advised to contact his healthcare professional for further instructions. For the tolerance of previous dose, refer case - US2023AMR139971.; Sender's Comments:  US-GSK-US2023AMR139971:1st dose, same reporter