Age: 60.0
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Peripheral swelling, Pharyngeal erythema, Pharyngeal swelling, Throat irritation
Clinical narrative: COVID (disease); she could not raise or move her left arm (she could not pick up a cup of coffee) / she still has problems using her left arm but is better than it was; hearing loss in her left ear; swollen left hand/ swollen left arm; throat redness; throat burning; throat swelling; hair loss; shingles; This spontaneous report was received from a consumer referring to herself, a 74-year-old female patient with penicillin allergy and on hospice care. No information regarding the patient's medical history or concomitant medications was provided.  On an unknown date, reported as 12 years ago, when "the patient turned 60", she was first vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date in 2020, reported as last year, the patient received a new double shot vaccine (not otherwise specified) (dose, frequency, route of administration, lot# and expiration date were not reported).  On 19-OCT-2021, she was vaccinated with a dose of varicella zoster vaccine rge (cho) (SHINGRIX), solution for injection, probably on left arm (dose, frequency, route of administration were not reported), lot # 7742Z, expiration date: 25-MAR-2023, and with a dose of influenza vaccine (manufacturer unknown), reported as flu vaccine, in right arm (dose, frequency, route of administration, lot# and expiration date were not reported), both for prophylaxis.  On an unknown date in October 2021, the patient experienced multiple reactions: hearing loss in her left ear, swollen left hand and swollen left arm, throat redness, throat burning, throat swelling and hair loss. She stated that she could not raise or move her left arm (she stated that she could not pick up a cup of coffee) starting on 20-OCT-2021. She admitted that she still had problems using her left arm but it seemed better than it was on 20-OCT-2021 and 21-OCT-2021. On an unknown date, the patient experienced Coronavirus disease 2019 (COVID-19) disease. On an unknown date, reported as now, she had shingles and "she would not say, it was a mild case", additionally, shingles (disease) was also reported as the patient's medical history (clarification regarding discrepancies pending).  The outcome of hearing loss in her left ear, swollen left hand and swollen left arm, COVID-19 disease, hair loss, throat redness, throat burning, throat swelling and shingles was unknown. The outcome of peripheral swelling was reported as recovering/resolving.  The causality assessment between the events and zoster vaccine live (ZOSTAVAX) and influenza vaccine (manufacturer unknown) was not provided. The relatedness between zoster vaccine rge (cho) (SHINGRIX) and hearing loss in her left ear, swollen left hand swollen left arm, could not raise or move her left arm,  throat redness, throat burning, throat swelling, and hair loss was related. The causality assessment between zoster vaccine rge (cho) (SHINGRIX) and COVID-19 disease and shingles was not reported.  Upon internal review, the event of hearing loss in her left ear was considered to be medically significant.