Sex: F
Vaccine: FLUA4
Symptoms: Asthenia, Blood pressure decreased, Dizziness, Fatigue, Gait inability
Clinical narrative: The patient became very weak; Blood pressure 70/35; The patient was having problems moving; The patient felt like her leg from the knee down has a brick tied to it; Leg was painful, stiff; Leg was painful, stiff; Fatigue / fatigued; Blurry vision; Dizziness; This spontaneous case from the Regulatory Authority was received on 03-Nov-2021 from other non-health care professional (consumer) (reference number: SEQW21-05035) and concerned an elderly female patient of unspecified age, she was maybe 83-year-old.  The patient's medical history and concomitant medications were not reported.  On an unspecified date in Oct-2021, about two weeks ago as reported, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported. The reporter stated that she was unsure of which vaccine her grandmother received - it was either Fluzone (influenza vaccine) or Fluad Quadrivalent.   On the same day, right after receiving Fluad Quadrivalent, the patient experienced blurry vision, dizziness and fatigue. The reporter was unsure whether or not these issues continued longer than the day of administration.   On 02-Nov-2021, on the afternoon, the patient was exercising, and she became very weak, fatigued and was having problems moving. The patient was not able to walk because her leg was painful, stiff and it felt like her leg from the knee down had a brick tied to it. She was also experiencing blurry vision and dizziness during this time. The patient's blood pressure was taken during this episode and it was 70/35. She was rushed to the hospital on the same day.   On an unspecified date in Nov-2021, during hospitalisation, the stroke was ruled out.   On an unspecified date in Nov-2021, everything was resolved except for her issue with her leg.   At the time of this report on 03-Nov-2021, the patient was still in hospital and had not recovered from 'leg pain', 'limbs stiffness', 'mobility decreased' and 'heaviness in leg'.   The reporter did not provide a causality assessment. The reporter believed that the vaccine may have contributed to these issues and had questions about whether her grandmother was experiencing, but she did not want to report an adverse event.   The events were assessed as serious due to the seriousness criterion of hospitalisation.  Company comment: A 83-year-old patient experienced blurry vision, dizziness, asthenia, decreased blood pressure, decreased mobility, heaviness, stiffness, and pain in leg, as well as fatigue after receiving Fluad Quadrivalent. The patient's medical history and concomitant drugs were not reported. Advance age of patient contributed to the development of the events. Due to suggestive time relationship (reportedly, on the same day, right after receiving Fluad Quadrivalent), causality for the events blurry vision, dizziness, and fatigue is assessed as possibly related, and for all other events, it is unassessable, due to unclear chronology.; Sender's Comments: A 83-year-old patient experienced blurry vision, dizziness, asthenia, decreased blood pressure, decreased mobility, heaviness, stiffness, and pain in leg, as well as fatigue after receiving Fluad Quadrivalent. The patient's medical history and concomitant drugs were not reported. Advance age of patient contributed to the development of the events. Due to suggestive time relationship (reportedly, on the same day, right after receiving Fluad Quadrivalent), causality for the events blurry vision, dizziness, and fatigue is assessed as possibly related, and for all other events, it is unassessable, due to unclear chronology.