Age: 82.0
Sex: F
Vaccine: FLUA4
Symptoms: Anxiety, Erythema, Pain in extremity, Product administered at inappropriate site
Clinical narrative: The vaccine was administered a little lower than the deltoid muscle, between the deltoid and the biceps muscles; Redness and pain on arm; Redness and pain on arm; Concerned about whether she will be protected for this season; This spontaneous case was received on 02-Sep-2020 from pharmacist and consumer via Agency (reference number: SEQW20-01152) and concerned a 82-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 30-Aug-2020, the patient was vaccinated with Fluad Quadrivalent [Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, route of administration: intramuscular, anatomical location: arm (little lower than the deltoid muscle, between the deltoid and the biceps muscles), dose: 0.5 ml] (explicitly coded as 'Vaccine administered at inappropriate site') for influenza prophylaxis. The batch number reported was 279794 and expiry date 29-May-2020.  On an unspecified date in 2020, between 30-Aug-202 and 02-Sep-2020 after receiving Fluad Quadrivalent vaccine, the patient experienced redness and slight pain on her arm. The patient was not concerned about these effects but more about whether she will be protected for this season.  On an unspecified date in 2020, the patient recovered from the event 'pain in arm'.  At the time of initial reporting on 02-Sep-2020, the patient was recovering from the event of 'erythema of extremities'.  The outcome of the event 'worry' was not reported.  The reporter assessed the event 'pain in arm' and 'erythema of extremities' to be related to Fluad Quadrivalent vaccine. The reporter believed that the reason for the side effects that the patient experienced might was due to vaccine administered a little below the deltoid muscle, maybe between the deltoid and biceps muscle. The reporter did not provide a causality assessment of the event 'worry'.  Company comment:The patient developed erythema, pain in extremity and anxiety within next three days after vaccination with the suspect product, Fluad Quadrivalent. Chronology is plausible. Reportedly, the vaccine was administered a little lower than the deltoid muscle, between the deltoid and the biceps muscles, suggesting that product was administered at inappropriate site. No information about medical history and concomitant medications was provided. Based on provided information, causal relationship between the suspect product and the event product administered at inappropriate site is assessed as not related per company conventions, while for all other all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).; Reporter's Comments: The reporter believed that the reason for the side effects that the patient experienced might was due to vaccine administered a little below the deltoid muscle, maybe between the deltoid and biceps muscle.; Sender's Comments: The patient developed erythema, pain in extremity and anxiety within next three days after vaccination with the suspect product, Fluad Quadrivalent. Chronology is plausible. Reportedly, the vaccine was administered a little lower than the deltoid muscle, between the deltoid and the biceps muscles, suggesting that product was administered at inappropriate site. No information about medical history and concomitant medications was provided. Based on provided information, causal relationship between the suspect product and the event product administered at inappropriate site is assessed as not related per company conventions, while for all other all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).