Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Impaired work ability
Clinical narrative: arm pain during the injection; swelling (of the injected arm); pain (of the injected arm); shivering; body aches (including neck) flu-like; body aches; neck aches; fatigue (went to bed 4 hours earlier than normal); dizziness/think I am going to fall down; inability to work/cannot go out to work; I almost fell flat on my face; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (Shingrix shot 1 administered (at same pharmacy) in Feb 2023). Concurrent medical conditions included diabetes (she was diabetic but that is probably the case).   On 01-AUG-2023, the patient received the 2nd dose of Shingrix (intramuscular, right deltoid). On 01-AUG-2023, immediately after receiving Shingrix, the patient experienced injection site pain (Verbatim: arm pain during the injection), swelling arm (Verbatim: swelling (of the injected arm)), pain in arm (Verbatim: pain (of the injected arm)), shivering (Verbatim: shivering), influenza-like symptoms (Verbatim: body aches (including neck) flu-like), general body pain (Verbatim: body aches), neck pain (Verbatim: neck aches) and fatigue (Verbatim: fatigue (went to bed 4 hours earlier than normal)). In AUG-2023, the patient experienced dizziness (Verbatim: dizziness/think I am going to fall down), inability to work (Verbatim: inability to work/cannot go out to work) and fall (Verbatim: I almost fell flat on my face). The outcome of the injection site pain and shivering were resolved and the outcome of the swelling arm and fatigue were unknown and the outcome of the pain in arm, influenza-like symptoms, general body pain, neck pain, dizziness and inability to work were not resolved and the outcome of the fall was not reported.   The reporter considered the injection site pain, swelling arm, pain in arm, shivering, influenza-like symptoms, general body pain, neck pain, fatigue, dizziness and inability to work to be related to Shingrix. It was unknown if the reporter considered the fall to be related to Shingrix.     The company considered the injection site pain, swelling arm, pain in arm, shivering, influenza-like symptoms, general body pain, neck pain, fatigue, dizziness and inability to work to be related to Shingrix. It was unknown if the company considered the fall to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-AUG-2023 The reporter was the patient. She received 2nd dose of Shingrix in the afternoon.  She reported that the injection itself hurt and also, she was experiencing pain in the right arm.   She did not have the lot number of the Shingrix which was administered but did provide her pharmacy's contact information where the shot was administered.  She reported that within a matter of a couple hours after the shot she began to experience side effects which were really terrible, and she wanted to know how long they would last.  She stated, at around 7:00 pm last night (on vaccination day) told her husband that she had to go to bed. Any which way moved, she was shivering, it felt like she had the flu, my neck, body aches, all of that, and if she would have known this then she would not have taken the second shot. She stated that she just felt so achy, but it was not just in the arm site.  Yesterday afternoon the patient was like, look at her arm it was swollen, then progressively by like 7:00 at night she said, she got to go to sleep which was not like her as usually she got to sleep at 11:00. She stated, last night she woke up in middle of night to go the restroom, almost fell flat on her face, so she guessed dizziness was one of the side effects. She thought that she was going to fall down. she was started to get better, a little bit, but she knew she could not go out to work. The reporter consented to follow up.