Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Back pain, Dysstasia, Gait disturbance, Hypoaesthesia, Muscular weakness
Clinical narrative: At night felt the left index finger was numb (the top of the finger); The pain got excruciating; Soreness of the arm/ Left arm was complete sore; Felt like I was paralyzed from the waist down from the back of my lower back down into the back of my legs/ legs were giving out/ very weak legs; This spontaneous case was received on 19-Oct-2022, from consumer via Communications (reference number: SEQW22-04712) with additional information (being processed together) received on the same day and on 25-Oct-2022 from Communications  and concerned a 71-year-old, female patient.  The patient's concurrent conditions included high blood pressure. The patient's concomitant medications included irbesartan, used for high blood pressure. The patient's historical vaccines included unspecified influenza vaccines, after which she experienced sore arm.   On 18-Oct-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 mL; route of administration: intramuscular and anatomical location: not reported) for prevention of influenza disease. The batch number reported was 346377.  On the same day, after receiving Fluad Quadrivalent, it was ok for a few minutes, as reported. Afterwards, the patient walked to her car and she sat down to start driving home. All of a sudden, the patient felt like she was paralyzed from the waist down from the back of her lower back down into the back of her legs. The pain got excruciating. The patient tried to get out of the car and stand up and her legs were giving out and she had to hang onto her car to keep from dropping to the ground. It subsided a little and the patient managed to limp back to the drug store, with v-ery weak legs, and told the pharmacist who administered the shot what had happened. The pharmacist told the patient to sit down for about ten minutes. It finally subsided to the point where the patient could walk properly. The pharmacist said that no one ever had this reaction before in that store. The patient has been getting flu shots for over 30 years and never had any reaction other than a sore arm where the shot was given to her.  On the same date, at night, the patient felt the left index finger was numb (the top of the finger) and all arm was sore and still was.  On the same date, the patient recovered from the events, 'lower extremities weakness of' and 'lower back pain'.   On an unspecified date in Oct-2022, the patient recovered from the event of 'numbness in fingers'.  At the time of the initial reporting, the patient had not recovered from the event 'pain in extremity'. As reported, the symptoms disappeared and just the left arm was complete sore.  The reporter assessed the events as related to Fluad Quadrivalent. The pharmacist said that no one ever had this reaction before in that store and the patient also has been getting flu shots for over 30 years and never had any reaction other than a sore arm where the shot was given to her.  The reproter assessed the events as non-serious.  This case is linked with the case 202205918 (the same patient and reporter).  Company comment: A 71-year-old, female patient was vaccinated with the suspect product Fluad Quadrivalent. On the same day after vaccination the patient developed muscular weakness of lower back and legs (also reported as felt like paralyzed). The patient also developed pain in extremity, pain and hypoesthesia. Based on plausible time relationship, causality is assessed as possibly related.; Reporter's Comments: The pharmacist said that no one ever had this reaction before in that store and the patient also  has been getting flu shots for over 30 years and never had any reaction other than a sore arm where the shot was given to her.; Sender's Comments: A 71-year-old, female patient was vaccinated with the suspect product Fluad Quadrivalent. On the same day after vaccination the patient developed muscular weakness of lower back and legs (also reported as felt like paralyzed). The patient also developed pain in extremity, pain and hypoesthesia. Based on plausible time relationship, causality is assessed as possibly related.