Age: 24.0
Sex: F
Vaccine: FLUC3
Symptoms: Product administered at inappropriate site, Rotator cuff syndrome, Tendon rupture
Clinical narrative: Inflammes bursa; Torn biceps tendon/rotator cuff tendon; Torn biceps tendon/rotator cuff tendon; The injection might have been given a little high; This spontaneous case was retrieved on 06-Sep-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1233003-1), reported by other healthcare professional and concerned a 24-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 07-Dec-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular, anatomical location: left arm, dose and indication: not reported). The patient was told that the injection might had been given a little high (explicitly coded as 'Vaccine administered at inappropriate site'). The batch number reported was 279841 (reported batch number was identified by Seqirus to be linked to suspect product Flucelvax Quadrivalent instead of reported suspect product Fluad Quadrivalent).  On the same date, after receiving Flucelvax Quadrivalent, the patient experienced left arm pain, described as a dull soreness with sharp pain when moving the arm. The patient tried to take ibuprofen for the pain, without relief, along with heat and ice.   On 10-Dec-2020, the patient came to see physician assistant (PA). It felt like pain had spread to her left upper back. The patient was prescribed Mobic (meloxicam) for the pain.  On an unspecified date, the patient underwent a magnetic resonance imaging (MRI) scan, which showed inflamed bursa, torn biceps tendon/rotator cuff tendon. The patient started with physical therapy.  On 07-Apr-2021, the patient came back to office and reported an MRI results. As stated, the patient had been doing physical therapy and was seeing hand and shoulder specialist.   The outcome of the events was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 24-year old female patient experienced left arm pain on the same date after receiving the suspect Flucelvax Quadrivalent vaccine. On unspecified date the patient was diagnosed with bursitis and torn biceps tendon/rotator cuff tendon. The patient was told that vaccine might had been given a little high (explicitly coded as 'Vaccine administered at inappropriate site'). Administration error may have contributed to development of the events. However, based on plausible temporal relationship, causality is assessed as possibly related. Vaccine administered at inappropriate site is assessed as not related as per the Company's conventions.; Sender's Comments: A 24-year old female patient experienced left arm pain on the same date after receiving the suspect Flucelvax Quadrivalent vaccine. On unspecified date the patient was diagnosed with bursitis and torn biceps tendon/rotator cuff tendon. The patient was told that vaccine might had been given a little high (explicitly coded as 'Vaccine administered at inappropriate site'). Administration error may have contributed to development of the events. However, based on plausible temporal relationship, causality is assessed as possibly related. Vaccine administered at inappropriate site is assessed as not related as per the Company's conventions.