Received Jun 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | LA |
she felt sleepy; she felt achy; This non-serious case was reported by a consumer via call center representative and described the occurrence of sleepiness in a 76-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included osteoporosis, hypothyroidism and asthma. Previously administered products included influenza vaccine with an associated reaction of pain in extremity (received in left arm in October 2017 and experienced increase in urination) and Prevnar 13 with an associated reaction of pain in extremity (received in left arm in October 2017 and experienced increase in urination). On 29-MAY-2025, the patient received the 1st dose of Shingles vaccine (left arm). On 29-MAY-2025, less than a day after receiving Shingles vaccine, the patient experienced sleepiness (Verbatim: she felt sleepy) and pain (Verbatim: she felt achy). The outcome of the sleepiness and pain were resolved (duration 2 days). It was unknown if the reporter considered the sleepiness and pain to be related to Shingles vaccine. It was unknown if the company considered the sleepiness and pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 06-JUN-2025 The reporter then reports that in October of 2017 She received the flu vaccine with the pneumonia vaccine called Prevnar 13 in the left arm at the same time. She states the night of the vaccines in 2017 her left arm had pain, and she had a hard time getting out of bed. The reporter states that getting bed was especially difficult due to have to urinate frequently. The reporter believes that the increase in urination was due to the Flu and Pneumonia vaccine. She states that she received her first Shingles vaccine. The reporter states that the day of her vaccine she felt sleepy and achy. This lasted 2 days and then resolved.
Medical History/Concurrent Conditions: Asthma; Hypothyroidism; Osteoporosis