Age: 53.0
Sex: M
Vaccine: FLUC3
Symptoms: Discomfort, Frustration tolerance decreased, Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Pain in the arm; Uncomfortable and frustating; Can't really reach above my head a lot sometimes because it hurts really bad; Trouble sleeping; This spontaneous case was received on 09-Feb-2023 from other non-healthcare professional via Communications (reference number SEQW23-00552) and concerned a 53-year-old, male patient.  The patient's concurrent conditions included cholesterol, allergies (unspecified), and sleep disorder (unspecified).  The patient's concomitant medications included rosuvastatin and lisinopril, both used for unreported indications, and doxylamine used for allergies or for sleep, but most for allergies (as reported).  On 11-Nov-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.   On the same date, after receiving Flucelvax Quadrivalent, at night, the patient experienced pain in arm. It hurt pretty bad and was getting worse. The patient looked into product's Side Effects profile and 'it did not say anything' (as reported). The patient found information that there could be one or two days for any kind of pain (after vaccine), but that was too long (about three months). The pain was uncomfortable, and the patient did not know what to do about it anymore. The patient could not really reach above his head a lot sometimes because it hurt really bad, which was not normal and very awkward for the patient. It was very uncomfortable and very frustrating for the patient, and it bothered him, so he wanted to get of bottom of that. The patient expressed his concern for not finding similar adverse event in the package insert and wanted to see what was going on and how it could be fixed. The patient was referred to his healthcare professional, but he said he was not going to his doctor because he did not have health insurance. The patient insisted on information about adverse event (studies, other complaints regarding the same issue, compensation, possible problems regarding manufacturing processes and following Good Manufacturing Procedures, 483 Observation, and Warning Letters). The patient also reported that it was causing trouble sleeping, and that some days it was worse and some days it was not. The patient also added that he was not happy, and he wanted the pain to go away because it was very uncomfortable. The patient was informed about Vaccine Injury Compensation program (VICP), and that Seqirus did not have Patient Assistance Program for Flucelvax Quadrivalent, but the patient insisted manufacturer to be included in solving problem. The patient reported using acetaminophen, ibuprofen, and naproxen, sometimes if the pain was really bad. He had taken it multiple times, especially in the beginning because the pain was too high. At the time of reporting, the patient did not take much of it, but it was still bad, it was probably worst that was why the patient did not take medicines (as reported).  At the time of initial reporting, the patient had not recovered from the events. The pain in arm had not gone away, it hurt pretty bad, and it seemed it was getting worse.  The reporter assessed the events to be related to Flucelvax Quadrivalent. The patient was hundred percent confident that the events were happening because of the vaccine since it happened in the same day (when the vaccine was administered) and it had not gone away.  The case was assessed as non-serious.  Company comment: A 53-year-old male patient experienced pain in the extremity on the same date after vaccination with Flucelvax Quadrivalent vaccine. The patient also experienced discomfort, mobility decreased and sleep disorder. Information regarding the related diagnostic findings was not provided. Causality is assessed as possibly related for events pain in extremity, discomfort and mobility decreased based on plausible temporal relationship. Sleep disorder is assessed as not related to the suspect vaccine, considering that the pain caused it.; Reporter's Comments: The patient was hundred percent confident that the events were happening because of the vaccine since it happened in the same day (when the vaccine was administered) and it had not gone away.; Sender's Comments: A 53-year-old male patient experienced pain in the extremity on the same date after vaccination with Flucelvax Quadrivalent vaccine. The patient also experienced discomfort, mobility decreased and sleep disorder. Information regarding the related diagnostic findings was not provided. Causality is assessed as possibly related for events pain in extremity, discomfort and mobility decreased based on plausible temporal relationship. Sleep disorder is assessed as not related to the suspect vaccine, considering that the pain caused it.