Sex: U
Vaccine: FLUA4
Symptoms: Pain, Pain in extremity
Clinical narrative: Dystonic drug reaction/Dystonic reaction to flu shot; Weird feeling in my head/ feeling strange; Tightness in my chest radiating to my back/ heaviness in my chest; Severe pain going up my legs, my arms; Unable to stand up; Every nerve in my body was attacking me/nerve pain; A feeling that lightning had struck my entire body / Couldnt believe the pain; This spontaneous case, initially received on 20-May-2024, was reported by a non-health professional and concerns a elderly patient (at the time of the report, the patient was a 80-year-old).  Past medical history included Flu and pregnancy. At the time of the event the patient had Allergy to sulfa drugs, allergy to penicillins and levofloxacin. The patient's historical vaccines included: Covid-19 Moderna vaccine on 21-Jan-2021 and 05-Aug-2023, Shingrix (zoster recombinant) on 04-Jan-2018, 07-Jan-2018, 03-May-2018 and 31-Jul-2018, Influenza vaccine (high dose, quadrivalent) on 10-May-2018 and 09-Jan-2021, Influenza vaccine (trivalent, adjuvanted) on 10-Oct-2019, and Fluad Quadrivalent on 28-Aug-2020 and 03-Oct-2022, all used for unreported indication.  Administration of company suspect drug(s): On 27-Sep-2023, the patient received Fluad Quadrivalent (influenza vaccine inact sag 4v) for unreported indication; dose, route of administration, and anatomical location: not reported; Lot number: 371632, expiry date: 30-Kin-2024.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 27-Sep-2023, the patient experienced Dystonic drug reaction/Dystonic reaction to flu shot (Medically Significant, outcome: Not Reported), Weird feeling in my head/ feeling strange (Medically Significant, outcome: Not Reported), Tightness in my chest radiating to my back/ heaviness in my chest (Medically Significant, outcome: Not recovered / Not resolved), Severe pain going up my legs, my arms (Medically Significant, outcome: Not Reported), Unable to stand up (Medically Significant, outcome: Not Reported), Every nerve in my body was attacking me/nerve pain (Medically Significant, outcome: Not Reported), A feeling that lightning had struck my entire body / Couldnt believe the pain (Medically Significant, outcome: Not Reported). On 28-Sep-2023, the patient experienced Dystonic drug reaction/Dystonic reaction to flu shot (Medically Significant, outcome: Not Reported). The patient reported few moments after receiving the vaccine, they felt strange and needed to sit down. The patient had heaviness in the chest and then, all of a sudden, starting from the legs up, every nerve in the body started attacking the patient, and the patient's entire body was in severe pain. The patient could not believe the pain and believed was going to die. Within five or six minutes, the patient was able to pull themselves up and with the aid of the cart left the store. The patient stated that they were a fool not to go to the emergency room.  On 28-Sep-2023, the patient went to the emergency room (ER), as the heaviness in the chest was still there. In the ER the patient's doctor did blood work and concluded it was a dystonic reaction to a flu shot.  Non-drug treatment/Other action taken:  Fluad Quadrivalent action taken: Not Applicable  Reporter's assessment: The reporter assessed the events as related to Fluad Quadrivalent. As reported, it was, without question, from the vaccination because it happened immediately after the patient received it. The emergency room doctor assessed the events as related to Fluad Quadrivalent. As reported, the emergency room doctor concluded that this was a dystonic reaction to flu shot.  The reporter did not provide a seriousness assessment.; Reporter's Comments: Causality is assessed as possibly related for pain, dysstasia, neuralgia, pain in extremity, chest discomfort, feeling abnormal and dystonia based on chronological plausibility.