Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea, Pain, Pain in extremity, Syncope
Clinical narrative: Fainted; Swelling at injection site, round as a soft ball, raised; Headache; Patient was foggy; Felt nauseated; Thinking was not ok; Foot dead while parking the car; Sore body, feels like Jell-O; Pain in both arms; Backache; Redness at injection site, size of a soft ball; This serious case was reported by a consumer via call center representative and described the occurrence of fainting in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included covid-19 (had COVID last year in September 2022).   On 20-MAR-2023 17:00, the patient received the 1st dose of Shingrix (intramuscular, right arm). In MAR-2023, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Redness at injection site, size of a soft ball), pain in arm (Verbatim: Pain in both arms), back ache (Verbatim: Backache), nauseated (Verbatim: Felt nauseated), abnormal thinking (Verbatim: Thinking was not ok), numbness in feet (Verbatim: Foot dead while parking the car) and general body pain (Verbatim: Sore body, feels like Jell-O). On 21-MAR-2023, the patient experienced fainting (Verbatim: Fainted) (serious criteria GSK medically significant), injection site swelling (Verbatim: Swelling at injection site, round as a soft ball, raised), headache (Verbatim: Headache) and foggy feeling in head (Verbatim: Patient was foggy). The patient was treated with ibuprofen (Advil). The outcome of the fainting, nauseated, abnormal thinking, numbness in feet and general body pain were not reported and the outcome of the injection site swelling, injection site erythema, headache, pain in arm, back ache and foggy feeling in head were not recovered/not resolved.   It was unknown if the reporter considered the fainting, injection site swelling, injection site erythema, headache, pain in arm, back ache, foggy feeling in head, nauseated, abnormal thinking, numbness in feet and general body pain to be related to Shingrix.     It was unknown if the company considered the fainting, injection site swelling, injection site erythema, headache, pain in arm, back ache, foggy feeling in head, nauseated, abnormal thinking, numbness in feet and general body pain to be related to Shingrix.   Additional Information: GSK receipt date: 21-MAR-2023 The patient herself reported this case.  The patient reported that she got her 1st dose of Shingrix vaccine in her right arm yesterday 20-Mar-2023 at 5 pm.  The patient reported she got the injection at her doctor's office.  Customer did not have the lot and expiry date information.   The patient reported that on 21-Mar-2023, the injection site was swelling up and was round as a soft ball. The patient reported that she had a headache since morning.  The patient reported that she took Advil for the headache.  The patient reported that the area was red like the size of a soft ball.  The patient reported that the area was raised. The patient reported having pain in both arms and backache.  The patient reported that she was foggy, felt nauseated and fainted.  The patient reported that her my thinking was not ok.  The patient reported while parking and backing my car in the parking at work, I had my foot dead stuck on the gas pedal. The patient reported that her body was sore and it felt like Jell-O.  The patient reported that she had COVID last year in September 2022. The reporter consented to follow up.