Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | NDC: 58160-0823 | IM / LA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM / LA |
Loss of voice/ her voice was completely gone; Eyelid edema; Red face; entire right eye was red/ left eye was grossly red; entire right eye was swollen/ left eye was grossly swollen; This non-serious case was reported by a consumer via call center representative and described the occurrence of loss of voice in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included gastroesophageal reflux disease. Concomitant products included famotidine (Pepcid). On 18-MAR-2025, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 19-MAR-2025, 1 days after receiving Shingrix, the patient experienced loss of voice (Verbatim: Loss of voice/ her voice was completely gone), eyelid edema (Verbatim: Eyelid edema), red face (Verbatim: Red face), eye red (Verbatim: entire right eye was red/ left eye was grossly red) and eye swelling (Verbatim: entire right eye was swollen/ left eye was grossly swollen). The patient was treated with diphenhydramine hydrochloride (Benadryl), prednisone, cetirizine hydrochloride (Zyrtec) and famotidine. On 20-MAR-2025, the outcome of the loss of voice was resolved. The outcome of the eyelid edema, red face and eye red were resolving and the outcome of the eye swelling was not reported. It was unknown if the reporter considered the loss of voice, eyelid edema, red face, eye red and eye swelling to be related to Shingrix. It was unknown if the company considered the loss of voice, eyelid edema, red face, eye red and eye swelling to be related to Shingrix. Additional Information: GSK Receipt Date: 24-MAR-2025 The patient self-reported this case for herself. The patient called and stated that she had a severe reaction to her first Shingrix vaccine. She received the Shingrix vaccine in her left arm on 18th March 2025 and noticed within the first 24 hours that her entire right eye was swollen and red. She placed ice on it, thinking it might help. Within an hour, she noticed her left eye was grossly swollen and red as well. The patient stated that she called an on call healthcare professional and waited for a call back for one hour before noticing her voice was completely gone. She texted a neighbor, who contacted the patient's healthcare professional and was advised to go to the emergency room. When the patient arrived at the emergency room, she was given Benadryl 50 milligram, Prednisone 40 milligram, and Zyrtec 10 milligram, and was monitored for 4 hours before being sent home. Once at home, she continued Benadryl 50 milligram every 6 hours and Zyrtec 10 milligram once a day. The patient later had a visit with her healthcare professional, who adjusted her medications to Prednisone 40 milligram for 5 days and then 10 milligram for one month. She was also instructed to take Benadryl 25 to 50 milligram as needed for the reaction, Famotidine 20 milligram once daily, and Zyrtec 10 milligram once daily. Her voice completely returned within the first 24 hours, and there was improvement in the redness and swelling of her eyelids, though they had not fully resolved.
Gastroesophageal reflux disease
Pepcid