Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, Fall, Pain, Urinary incontinence
Clinical narrative: His balance is poor that he fell down his backyard; he fell down in his backyard; due to potentially administering an expired vaccine; experiencing chills such as his teeth were chattering for 3 hours; he couldn't get up with his arms and knees; Until the call, he's still feeling very weak; his upper body muscles were shivering; He lost appetite in which he couldn't finish his breakfast for 2 days; back ache; wetted the bed at midnight; Initial information received on 29-Oct-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 78 years old male patient who had back ache, wetted the bed at midnight, his balance is poor that he fell down his backyard, he fell down in his backyard, his upper body muscles were shivering, he lost appetite in which he couldn't finish his breakfast for 2 days, due to potentially administering an expired vaccine, experiencing chills such as his teeth were chattering for 3 hours, he couldn't get up with his arms and knees and until the call, he's still feeling very weak after receiving influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), Concomitant medications, vaccination(s) and family history were not provided.   On 24-Oct-2024, the patient received unknown dose of suspect influenza quadrival A-B high dose HV vaccine (unknown strength, formulation, lot and expiry date) via unknown route in unknown administration site for influenza.  On an unknown date in Oct-2024 the patient developed a non-serious back ache (back pain), wetted the bed at midnight (enuresis), his upper body muscles were shivering (tremor), he lost appetite in which he couldn't finish his breakfast for 2 days (decreased appetite), experiencing chills such as his teeth were chattering for 3 hours (chills), he couldn't get up with his arms and knees (muscular weakness), until the call, he's still feeling very weak (asthenia) (unknown latency) due to potentially administering an expired vaccine (expired product administered) (Latency same day) following the administration of influenza quadrival A-B high dose HV vaccine.   On 28-Oct-2024 the patient developed his balance is poor that he fell down his backyard (balance disorder) and he fell down in his backyard (fall) (Latency 4 days) following the administration of influenza quadrival A-B high dose HV vaccine.  Information on the batch number was requested corresponding to the one at time of event occurrence  Reportedly, Upon verifying with the patient, he was told in the pharmacy when he's getting his dose that it's the quadrivalent version. He said that he's experiencing severe adverse reactions after getting his dose. In our documentation, it only talks about the most common reactions. It also talks about fatal reactions such as Guillain-Barre Syndrome, but he wants to know what are the least or uncommon reactions. Patient initially declined to provide information about the reactions he's experiencing. The vaccine threw him on the ground for 11-hours. The consumer reported that he was outside in his yard and on his own; that he had to sleep in the backyard after spending hours crawling across the yard; that he got to the porch was unable to get up on the porch; that the strength of the arms and legs were gone; that he slept in the backyard from sundown to midnight; that he needed to restore his strength; that he would take naps in an effort to build up strength to be able to get in the house; that he eventually got inside.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Additional information was received on 31-Oct-2024: case was degraded to non-serious, clinical course updated. Text amended accordingly.