Age: 53.0
Sex: F
Vaccine: FLUA4, FLU4
Symptoms: Injection site swelling, Peripheral swelling, Pyrexia, Sensitive skin
Clinical narrative: Stomach was unsettled; Had no appetite; Skin sensitivity; Felt pretty miserable; Fever (99.1); Very significant chills; This spontaneous case was retrieved on 26-Oct-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2471845-1), reported by other non-healthcare professional and concerned a 53-year-old, female patient.  The patient's concurrent conditions included hypothyroidism (reported as 'hypothyroid'), Covid-19, cough, mucus and allergy to ampicillin ('rash', reported in addition). The patient's past medical history included 101.9 fever, and heavy congestion. The patient's concomitant medications included benzonatate, used to address remaining cough from covid, Mucinex DM (dextromethorphan hydrobromide, guaifenesin), used to address mucus, levothyroxine, QVAR 40 inhaler, and Singulair (montelukast sodium), all used for an unreported indication. The patient's historical vaccines included Pneumococcal vaccine (brand not specified; reported as 'pneumonia shot'), received on an unspecified date in Oct-2019, after which the patient experienced unusual swelling moving down the arm from the injection site.  It was reported that on 04-Oct-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular, anatomical location: left arm, dose and indication: not reported). The batch number reported was AS3612B. The reported batch number was identified by Seqirus to be linked to suspect product Afluria Quadrivalent (Influenza vaccine inact split 4v) instead of reported suspect Fluad Quadrivalent. Based on the reported batch number, the suspect product was changed to Afluria Quadrivalent.  On the same date, after receiving Afluria Quadrivalent, the patient experienced a mild fever (99.1) and very significant chills. The patient felt pretty miserable with skin sensitivity. Regarding gastrointestinal (GI) symptoms - stomach was unsettled and the patient had not appetite.  On 05-Oct-2022, the next morning, on Wednesday (reported as 'Wed.'), the patient recovered from the events of fever and chills. As reported, the temperature was normal and the chills were gone, but stomach was still unsettled, and the patient had little appetite. Around 8 pm the patient started feeling better.  At the time of initial reporting, the patient was recovering from the events of 'stomach upset', 'appetite lost', 'sensitive skin' and 'feeling miserable'.   The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 53-year-old patient experienced abdominal discomfort, loss of appetite, sensitive skin, miserable feeling, fever, and chills on the same day, after receiving the suspect product Afluria Quadrivalent. Based on suggestive temporal relationship, causality for the reported events is assessed as possibly related.; Sender's Comments: A 53-year-old patient experienced abdominal discomfort, loss of appetite, sensitive skin, miserable feeling, fever, and chills on the same day, after receiving the suspect product Afluria Quadrivalent. Based on suggestive temporal relationship, causality for the reported events is assessed as possibly related.