Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Condition aggravated, Injection site bruising, Mobility decreased, Musculoskeletal stiffness, Neck pain
Clinical narrative: Lot of pain on the neck/ it hurts a lot; Constrain muscle on the shoulder; Pain close to her neck; Pain in the arm; Difficulties moving her neck; The injection site is bruised, a little green in the injection site; This spontaneous case was received on 16-Oct-2020 from other health professional via Health Authority (reference number: SEQW20-03809) and concerned a 51-year-old female patient.  The patient had no relevant medical history. The patient's concomitant medications were not reported.  On 10-Oct-2020, the patient was vaccinated with Flucelvax QIV  (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml; route of administration: intramuscular; anatomical location: left arm) for influenza prophylaxis. The batch number reported was 279844 and expiry date: 30-Jun-2021.  On the same day, one hour after receiving Flucelvax QIV, the patient felt pain on the arm.    On 11-Oct-2020, one day after receiving Flucelvax QIV, patient felt constrain muscle on the shoulder and by afternoon she felt pain close to her neck.   On 12-Oct-2020, two days after receiving Flucelvax QIV, the patient felt a lot of pain on the neck.   On 13-Oct-2020, the patient waited 3 days, as advised by the pharmacy and symptoms got worse.  On an unknown date in Oct-2020, the patient had difficulties moving her neck, since it hurt a lot, also the injection site was bruised, a little green in the injection site. The patient took ibuprofen and Tylenol (paracetamol) as a treatment and also put heat cream for pain relief in the neck area. The patient scheduled an appointment for the doctor next Monday.   At the time of initial reporting on 16-Oct-2020, patient had not recovered from events and was getting worse, without improvement.   The reporter did not provide a causality assessment.  The reporter assessed the event as non-serious.  Company comment:The patient developed pain in extremity, musculoskeletal stiffness, pain and neck pain within two days after vaccination with the suspect product, Flucelvax QIV. The events of movement disorder and injection site bruising occurred on an unknown date within same month. According to narrative, chronology seems plausible. No information regarding medical history and concomitant medications was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed pain in extremity, musculoskeletal stiffness, pain and neck pain within two days after vaccination with the suspect product, Flucelvax QIV. The events of movement disorder and injection site bruising occurred on an unknown date within same month. According to narrative, chronology seems plausible. No information regarding medical history and concomitant medications was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).