Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Gingival bleeding, Injection site bruising, Malaise, Pain, Pain in extremity
Clinical narrative: no energy; Difficulty falling and staying asleep; sleeping cycle changed; poor sleep; Joint pain in her hands; painful burning sensation in hand; Bleeding gums; sinus pressure, feels fluid behind her ears; problems with injected arm; increase in PMS symptoms/tender breasts; feeling unwell; experienced side effects as fatigue; Bruise at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 5454X, expiry date 25th October 2022) for prophylaxis.   Previously administered products included Zostavax (received on 27th February 2017).   On 7th June 2021, the patient received the 1st dose of Shingrix (intramuscular). On 7th June 2021, immediately after receiving Shingrix, the patient experienced feeling unwell and fatigue. In August 2021, the patient experienced premenstrual breast pain. On an unknown date, the patient experienced injection site bruising, loss of energy, difficulty sleeping, change in sleep pattern, poor sleep, pain in joint involving hand, pain burning, gingival bleeding, sinus pressure and pain in arm. The patient was treated with decongestant nos (Decongestant). On an unknown date, the outcome of the injection site bruising and pain in arm were recovered/resolved and the outcome of the feeling unwell and pain burning were unknown and the outcome of the fatigue, loss of energy, difficulty sleeping, change in sleep pattern, poor sleep, pain in joint involving hand, premenstrual breast pain, gingival bleeding and sinus pressure were not recovered/not resolved.   It was unknown if the reporter considered the injection site bruising, feeling unwell, fatigue, loss of energy, difficulty sleeping, change in sleep pattern, poor sleep, pain in joint involving hand, pain burning, premenstrual breast pain, gingival bleeding, sinus pressure and pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient said she has excellent dental care and just saw her physician right before the Shingrix shot and everything was fine. The patient's right hand was her dominant hand. There was no history of sinus issues. The patient received Shingrix in the left deltoid. The patient states she has experienced side effects which are affecting her adversely and has been feeling unwell since shortly after receiving the Shingrix vaccine. The patient elaborated side effects, horrible fatigue or no energy (due to) not being able to sleep. She said her sleeping (cycle) totally changed [and nothing else (in her life) changed]. Difficulty falling asleep and difficulty staying asleep, poor sleep, not sleeping. Joint pain in her hands. The ring finger of each hand has a horribly painful burning sensation. The left hand was worse than the right. This flared up overnight with no explanation, no injury. Increase in PMS (Premenstrual symptoms) symptoms which were not going away: 7 days ago, she had tender breasts which was not alleviated with her usual menstrual cycle. Bleeding gums for no reason. The patient had horrible sinus pressure feels like she has fluid behind her ears and switches between ears. The patient has begun using a decongestant. The patient experienced bruise at the injection site which lasted 3 weeks. The patient had problems with arm (problems with the injected arm) which have since resolved. The reporter did not consent to follow-up.