Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Crying, Disability, Emotional distress, Impaired work ability, Loss of personal independence in daily activities
Clinical narrative: This is a spontaneous case, initially received from other non-health professional (consumer) on 15-Mar-2019, concerning an adult female patient of an unspecified age. On unspecified dates in previous years, the patient had flu shots for unknown indications and did not experience any adverse event. The current condition of the patient included kidney cancer since an unspecified date in Nov-2017 and the patient was currently trying to book surgery for it. The concomitant medications of the patient included an antibiotic (not specified, patient could not remember the name and start/stop date), Eliquis (apixaban), Ambien (zolpidem tartrate), Xanax (alprazolam), hydromorphone, Cymbalta (duloxetine hydrochloride) and some more medicines for several years. Patient could not name all the medicines she takes nor the start date, because she was taking those medications for several years. On an unspecified date in Sep-2018 (patient could not remember exact date), the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, anatomical location: right arm, dose, route of administration, batch number, expiry date, trade name and manufacturer: not reported) for influenza prophylaxis. On an unknown date in Oct-2018 after the vaccination, the patient experienced muscle pain, extreme pain in shoulder blade and left arm (as reported), then the pain was from the shoulder into fingers, and she could not move her arm. The patient was disabled and could not work or even perform her daily activities for several months. The patient went to several doctors and at the beginning, she was not sure why it happened until one of the healthcare professional (HCP) mentioned it might be related with the flu shot. This was first time the patient had a reaction to a flu shot (causality: related). On an unspecified date after the vaccination, the patient was hospitalized for 2 nights with pain, but she could not remember the exact date of hospitalization. The treatment measures associated with the events was that the patient was administered a cortisone shot in the shoulder and unspecified pain medication on unspecified dates. The patient was also very emotional stating she could not do anything for several months, because of her arm and shoulder, she had a very bad time with horrible pain. The patient started crying because she could not visit her grandmother, who passed away while the patient was experiencing the adverse events from the flu shot. The patient was now afraid of getting flu shot next seasons. The outcome of the events (shoulder blade pain, joint range of motion decreased, painful left arm, radiating pain, activities of daily living impaired) was recovered on an unknown date in Feb-2019 (patient could not remember exact date). The outcome of the events (emotional disturbance NOS and crying) was not reported. The reporter assessed this case as serious (disability and hospitalization).; Reporter's Comments: A female patient of unspecified age experienced musculoskeletal pain, pain in extremity, joint range of motion decreased, pain, loss of personal independence in daily activities and myalgia, unspecified period of time after receipt of INN flu vaccine seasonal. Due to the lack of information important for the causality assessment, such as onset latency between the vaccination and reported events, company assessed the causality of all the events as unassessable except loss of personal independence in daily activities. The patient also experienced emotional disturbance and crying, unspecified period of time. The events loss of personal independence in daily activities, crying and emotional disturbance assessed as not related to suspect vaccine as they can be alternately explained by the underlying events associated with pain rather than the suspect vaccine.