Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Muscle spasms, Pain, Tinnitus, Walking aid user
Clinical narrative: back pain and body aches and have continued to become worse each day; severe shortness of breath; Worsening fatigue; fatigue; did not intend to receive any high dose products and that it was an error by the pharmacy for administering this product to her; wheeze; joint pain; body ache; currently having to use her cane; Leg cramps in her upper thighs; worsening tinnitus in left ear; stomach pain; loss of appetite; multiple bowel movements daily; anxiety; insomnia; Arm soreness at the injection site; Initial information received on 05-Dec-2023 regarding an unsolicited valid  non-serious case received from a Patient with live follow up.  This case is linked to case 2023SA380929(CLUSTER).  This case involves a 66 years old female patient who experienced leg cramps in her upper thighs, worsening tinnitus in left ear, stomach pain, loss of appetite, multiple bowel movements daily, anxiety, insomnia, arm soreness at the injection site, fatigue, severe shortness of breath, wheeze, joint pain, body ache and did not intend to receive any high dose products and that it was an error by the pharmacy for administering this product to her after receiving vaccine influenza quadrival A-B high dose HV vaccine [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Asthma, Chronic back pain, Pollen allergy, Egg allergy with she is able to eat egg once a week and Food allergy.   On 29-Nov-2023, the patient received a dose of suspect influenza quadrival A-B high dose HV vaccine (lot number, strength, dose, expiry date, form not reported) via unknown route in the right arm as immunization.  On 29-NOV-2023 the patient did not intend to receive any high dose products and that it was an error by the pharmacy for administering this product to her (vaccination error) same day following the administration of influenza quadrival A-B high dose HV vaccine. On 29-NOV-2023 the patient developed a non-serious leg cramps in her upper thighs (muscle spasms), worsening tinnitus in left ear (tinnitus), stomach pain (abdominal pain upper), loss of appetite (decreased appetite), multiple bowel movements daily (bowel movement irregularity), anxiety, insomnia, arm soreness at the injection site (injection site pain), wheeze (wheezing), joint pain (arthralgia), body ache (pain) for which the patient had currently having to use her cane (walking aid user) and on an unknown date the back pain and body aches and have continued to become worse each day (condition aggravated) same day following the administration of influenza quadrival A-B high dose HV vaccine. On 30-NOV-2023 the patient developed a non-serious fatigue 1 day following the administration of influenza quadrival A-B high dose HV vaccine which On 01-DEC-2023 the patient had worsening fatigue (fatigue) (Latency: 3 days). On 02-DEC-2023 the patient developed severe shortness of breath (dyspnoea) 3 days following the administration of influenza quadrival A-B high dose HV vaccine.  It was reported "Shortness of breath is more manageable, continues to wheeze at night will see her pulmonologist on 08DEC2023. Has messaged her primary care provider and they instructed her to increase her fluids and take Tylenol. She contacted the pharmacist, and they informed her that she may have symptoms for 10-14 days."  Action taken: not applicable.  The patient currently taking Tylenol and plan on taking her narcotic pain medication prescribed for chronic back pain. Also, Patient reports using her inhalers (history of asthma).  At time of reporting, the outcome was Recovered / Resolved on an unknown date in 2023 for the event arm soreness at the injection site, was Not Recovered / Not Resolved for the other events and was Unknown for the event did not intend to receive any high dose products and that it was an error by the pharmacy for administering this product to her.   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.