Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Pain in extremity
Clinical narrative: Couldn't move/can't move her hips, legs, hands/can't move arm or her legs; Reaction on both shoulders; Pain; Pain in every joints/pain goes from the arm, hips, legs and knees; She can't do anything; Pain in every joints/pain goes from the arm, hips, legs and knees; This spontaneous case was received on 29-Oct-2020 from other non-health professional (consumer) with additional information (being processed together) received on 03-Nov-2020 and 05-Nov-2020 via Health Authority (reference number: SEQW20-04501) and concerned a 70-year-old, female patient.  The patient's medical history was not reported.  The patient's concomitant medications included amlodipine, Brintellix (vortioxetine hydrobromide) and levothyroxine, all used for an unreported indication.  On 16-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 ml, route of administration: intramuscular and anatomical location: right arm) for flu prevention. The batch number reported was 279819, expiration date: 30-Jun-2021.  In the morning on 17-Oct-2020, after receiving Fluad Quadrivalent, the patient had a severe reaction on both shoulders, she could not move, and was getting worse and worse. The patient could not move her hips, legs, hands. The patient was treated with methylprednisolone, however, after four days of treatment, she was not better.  On an unspecified date in Oct-2020, the patient was in pain.  On an unspecified date in 2020, the patient developed pain in every joint, and the pain was going to the arm, hips, legs and knees. The patient could not move her arms and legs and could not do anything. As reported, since the past three days her symptoms got worse and worse.   On 03-Nov-2020, the patient was admitted to hospital.  At the time of initial reporting, the patient had not recovered from the events of 'movement disorder', pain, 'joint pain', 'pain in extremity' and 'loss of personal independence in daily activities'.  The outcome of the event 'reaction on both shoulders' was not reported.  All the events were assessed as serious due to the criteria of hospitalisation.   The reporter did not provide causality assessment.  Company comment: Movement disorder, adverse event ('reaction on both shoulders'), pain, pain in extremity ('pain in every joints/pain goes from the arm, hips, legs and knees'), loss of personal independence in daily activities and arthralgia were associated with Fluad Quadrivalent. The events emerged the day post vaccination and reoccurred, making chronology plausible. The patient's concomitant medication - amlodipine could explain pain, pain in extremity and arthralgia making causality unlikely related. Movement disorder and loss of personal independence in daily activities could be result of pain/ extremity pain/ arthralgia in combination with the patient's advanced age and presumable hypothireoidim, making them not related to vaccine. Reaction to both shoulders is undefined and assessed as not related per company conventions. (unlikely related defaults to related for reporting purposes); Sender's Comments: Movement disorder, adverse event ('reaction on both shoulders'), pain, pain in extremity ('pain in every joints/pain goes from the arm, hips, legs and knees'), loss of personal independence in daily activities and arthralgia were associated with Fluad Quadrivalent. The events emerged the day post vaccination and reoccurred, making chronology plausible. The patient's concomitant medication - amlodipine could explain pain, pain in extremity and arthralgia making causality unlikely related. Movement disorder and loss of personal independence in daily activities could be result of pain/ extremity pain/ arthralgia in combination with the patient's advanced age and presumable hypothireoidim, making them not related to vaccine. Reaction to both shoulders is undefined and assessed as not related per company conventions. (unlikely related defaults to related for reporting purposes)