Received Jun 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | UNK | — |
tiredness; arm soreness; The patient received a 3rd dose; a new vaccine that protects against herpes simplex 2; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of fatigue (received first dose in 2018, refer case US2025AMR076267), Shingrix with an associated reaction of fatigue (received second dose in 2018, refer case US2025AMR076294) and Valtrex (patient had taken Valtrex). Concurrent medical conditions included herpes simplex type ii (about 20 years ago contracted genital herpes (herpes simplex 2)). Concomitant products included acyclovir. On 19-MAY-2025, the patient received the 3rd dose of Shingrix. On 19-MAY-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: The patient received a 3rd dose) and drug use for unapproved indication (Verbatim: a new vaccine that protects against herpes simplex 2). On an unknown date, the patient experienced tiredness (Verbatim: tiredness) and pain in arm (Verbatim: arm soreness). Rechallenge with Shingrix was positive. The outcome of the tiredness and pain in arm were unknown and the outcome of the extra dose administered and drug use for unapproved indication were not applicable. It was unknown if the reporter considered the tiredness and pain in arm to be related to Shingrix. It was unknown if the company considered the tiredness and pain in arm to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR076267, US2025AMR076294 Additional Information: GSK Receipt Date: 07-JUN-2025 and 09-JUN-2025 The reporter was the patient and lives part of the year in another country The doctor (gynecologist) that told the patient that there was a new vaccine that protects against herpes simplex 2, and she would no longer need to continue taking Acyclovir. The patient was thrilled and went ahead and got the first dose a few weeks ago. Upon checking out and seeing the name Shingrix, the patient realized they had previously received both doses but did not remember when. The patient checked with her Primary Care Professional who said that the patient had gotten the series in 2018 (in the US) and that no boosters are recommended. The patient received a 3rd dose of Shingrix vaccine from a doctor (gynecologist) on 19 May 2025 which led extra dose administered. The doctor proceeded to provide the Shingrix vaccine to the patient, which led to drug use for unapproved indication. The patient reported only side effects she experienced from any dose of Shingrix vaccine were arm soreness and tiredness. About 20 years ago, the patient contacted genital herpes. The patient had taken Valtrex, then went to Acyclovir for suppressive therapy. The patient stopped taking Acyclovir since receiving the 3rd dose of Shingrix vaccine. The patient mentioned that gynecologist did not respond to her questions, so she was reaching out to us. The patient enquired if Shingrix only protects against shingles, not herpes simplex 2 and if they should not get the second vaccine (what would be a 4th dose since patient received 2 doses in 2018). Further patient enquired if there are any positive or negative effects from having a third dose and is there anything else that patient should know.; Sender's Comments: US-GSK-US2025AMR076267:Same patient, 1st dose US-GSK-US2025AMR076294:Same patient, 2 nd dose
Herpes simplex type II (about 20 years ago contracted genital herpes (herpes simplex 2))
ACYCLOVIR