Age: 21.0
Sex: F
Vaccine: FLUC3
Symptoms: Arthralgia, Expired product administered, Headache, Incorrect product formulation administered, Injection site pain
Clinical narrative: Body hurts; The arm where I got the expired dose hurts; Headache; Joint pain; Received an expired flu shot; Received an expired flu shot; This spontaneous case was received on 11-Oct-2022 from other healthcare professional via Communications (reference number: SEQW22-04343) and concerned a 21-year-old, female patient.   The patient's concurrent conditions included lupus with chest pain and trouble breathing as consequence of this condition. The patient was not taking any concomitant medications.    On 10-Sep-2022, the patient was vaccinated with expired Flucelvax Quadrivalent (influenza vaccine inact sag 4v, dose: 0.5 ml, anatomical location: arm and route of administration: not reported) for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and B contained in the vaccine. The batch number was not reported, and expiry date was 30-May-2022. As reported, healthcare professional (HCP) who administrated the expired vaccine which he counted as not valid and additionally administrated what they deemed to be valid, non-expired, a second dose of Flucelvax Quadrivalent on the other arm (explicitly coded as 'Expired vaccine used' and 'Inappropriate formulation of vaccine').  On the same day, after receiving Flucelvax Quadrivalent, the patient's arm where she got the expired dose hurt, her body hurt, and she had a headache. The patient also claimed to be suffering from joint pain. As reported, the arm where the valid dose was administered did not hurt.  At the time of reporting, the patient had not recovered from the events of 'general body pain', 'pain in the arm', headache and joint pain.  The reporter assessed the events of 'general body pain', 'pain in the arm', headache and joint pain to be possible related to Flucelvax Quadrivalent. As reported, the patient suspected that she was suffering from side-effects from the immunization process.  The case was assessed as non-serious.  Company comment: A 21-year-old, female patient was vaccinated with the suspect product Flucelvax Quadrivalent. As reported the patient got administered an expired vaccine (explicitly coded as 'Expired vaccine used' and 'Inappropriate formulation of vaccine'). On the same day after vaccination the patient developed pain in extremity (where the expired dose was administered), general body pain, headache and arthralgia. Causality for expired vaccine used and inappropriate formulation of vaccine is assessed as not related based on company specific guidelines. Based on plausible time relationship causality for the remaining events is assessed as possibly related.; Reporter's Comments: As reported, the patient suspected that she was suffering from side-effects from the immunization process.; Sender's Comments: A 21-year-old, female patient was vaccinated with the suspect product Flucelvax Quadrivalent. As reported the patient got administered an expired vaccine (explicitly coded as 'Expired vaccine used' and 'Inappropriate formulation of vaccine'). On the same day after vaccination the patient developed pain in extremity (where the expired dose was administered), pain, headache and arthralgia. Causality for expired vaccine used and inappropriate formulation of vaccine is assessed as not related based on company specific guidelines. Based on plausible time relationship causality for the remaining events is assessed as possibly related.