Age: 36.0
Sex: F
Vaccine: COVID19, FLU4, PPV
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Pyrexia
Clinical narrative: Joint pain; Fatigue; Dizziness; Headache; Fever; This spontaneous case was retrieved on 13-Nov-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2697070-1) reported by other healthcare professional and concerned a 36-year-old female patient.  The patient's medical history included history of falls. The patient's concurrent conditions included allergy to mint. The patient's concomitant medication was not reported.  On 13-Oct-2023, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; dose: reported as '1'; route of administration: intramuscular (IM); anatomical location: right arm (RA)) for active immunization against influenza disease caused by influenza virus subtypes A and B. The batch number was not reported.  On the same date, the patient was vaccinated with non-company co-suspect Novavax (COVID-19 vaccine prot. subunit (NVX CoV 2373); dose: 0.5 ml; route of administration: intramuscular (IM); anatomical location: left arm (LA); indication: not reported). The batch number was not reported.  On the same date, the patient was vaccinated with non-company co-suspect Pneumovax (pneumococcal vaccine polysacch 23v; dose: reported as '1'; route of administration: intramuscular (IM); anatomical location: left arm (LA); indication: not reported). The batch number was not reported.  On 15-Oct-2023, two days after receiving Afluria Quadrivalent and non-company co-suspects Novavax and Pneumovax, the patient experienced fever, severe fatigue, dizziness, joint pain and headache.  At the time of initial reporting, the patient had not recovered from the event of fever, 'fatigue', dizziness, joint pain and headache.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Additional information received on 21-Nov-2023 from Med Communications (reference number: SEQW23-04431): Two additional reporters added. Indication updated for suspect vaccine Afluria Quadrivalent. Dose added for non-company co-suspect Novavax. Narrative amended accordingly.  Case correction (19-Apr-2024): After internal review of information Report Sent to Regulatory Authority by Reporter? and Intermediary were removed on General tab so report to FDA can be generated. No changes in the narrative.  Company comment: A 36-year-old female patient was vaccinated on the same day with the suspect product Afluria Quadrivalent and non-company co-suspect Novavax and Pneumovax vaccines. Two days after vaccination the patient experienced fever, severe fatigue, dizziness, joint pain and headache. Information regarding the related diagnostic findings has not been provided. Causality is confounded by concurrently administered co-suspect vaccines. Based on plausible time relationship, causality is assessed as possibly related for the events arthralgia, fatigue, dizziness, headache and pyrexia.; Reporter's Comments: A 36-year-old female patient was vaccinated on the same day with the suspect product Afluria Quadrivalent and non-company co-suspect Novavax and Pneumovax vaccines. Two days after vaccination the patient experienced fever, severe fatigue, dizziness, joint pain and headache. Information regarding the related diagnostic findings has not been provided. Causality is confounded by concurrently administered co-suspect vaccines. Based on plausible time relationship, causality is assessed as possibly related for the events arthralgia, fatigue, dizziness, headache and pyrexia.