Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain, Pain in extremity, Periarthritis, Product administration error
Clinical narrative: Cannot lift her arm/ Cannot reach a certain height; Frozen shoulder; Scar tissue; Swelling; Arm was hurting/ Arm was "killing" her/ When I move a certain way, it hurts/ Feels like something is crumbling in there; This spontaneous case was received on 18-Jan-2023 from a pharmacist via Agency (reference number: SEQW23-00260), with additional information received on 19-Jan-2023 from other non-healthcare professional (consumer) (reference number: SEQW23-00275) (being processed together) and concerned a 50-year-old female patient.  The patient's concurrent medical condition included several chronic issues, disability and a depressive disorder, according to the patient's health care provider (HCP), based on the different psychotropic drug medications the patient was taking. The patient's concomitant medications included Abilify (Aripiprazole), mirtazapine, and Cymbalta (duloxetine hydrochloride), all used for unreported indications. The patient's historical vaccine included an influenza vaccine (brand not specified), administered on an unknown date, for unreported indication, after which the patient experienced swelling. The patient had no previous problems with her arm. The reporter stated how he initially dismissed the reports as he has known the patient for 40 years, and she "has a tendency for drama" and is whiny ("a whiny baby").  On 24-Oct-2022, the patient was vaccinated with Afluria Quadrivalent vaccine (influenza vaccine inact split 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for immunization against influenza disease caused by influenza virus subtypes A and B present in the vaccine. The batch number was P100464789, and the expiration date was 30-May-2023.  On the same date, during the administration of Afluria Quadrivalent, the patient immediately felt something was wrong because the pharmacist "jabbed" her hard, believing it may have hit a bone and a nerve. After receiving  Afluria Quadrivalent vaccine, the patient experienced swelling and pain.   On an unspecified date in 2022, the patient went to the pharmacy to complain about the arm that was 'killing' her. As per the reporter/pharmacist, there was no swelling or heat in the arm. The patient was advised to take Benadryl and Tylenol and to use an ice pack. The pharmacist, when comparing one arm to the other, initially treated it as something allergic, although the patient disagreed based on her own experience.   On an unspecified date, a few weeks later, the patient was still complaining about her arm. Consequently, she was advised to go to the doctor.   On an unspecified date, the patient went to an emergency department of the hospital, but was not hospitalized. The patient did an X-ray and was referred to a specialist, and the results revealed that the patient had a frozen shoulder and she had scar tissue, hence the cortisone shot. The specialist referred the patient to a therapist after administering a cortisone shot. After which she complained that the cortisone shot made it worse. The patient further claimed when she moved a certain way, it hurt, and it felt like something was crumbling in there, and she could not reach a certain height.  On an unspecified date, the patient was subsequently put in physical therapy by her healthcare provider (HCP). The HCP reported that the patient could not lift her arm and that is still was very painful to the point that, when the patient was grabbed and manipulation wit her arm was attempted she almost started screaming. The patient had one physiotherapy session and claimed she could barely put on her jacket.  At the time of follow up reporting, on 19-Jan-2023, the patient had not recovered from the events.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  This case is linked with 202300800 (the same reporter).  Company comment: A 50-year-old female patient experienced swelling and pain in the extremity on the same date, after vaccination with Afluria Quadrivalent vaccine. Reportedly, on an unspecified date the X-ray was performed and the results revealed that patient had a frozen shoulder and scar tissue. The patient also had mobility decreased. Causality is assessed as possibly related to the suspect vaccine for all events, based on plausible temporal relationship.; Sender's Comments: A 50-year-old female patient experienced swelling and pain in the extremity on the same date, after vaccination with Afluria Quadrivalent vaccine. Reportedly, on an unspecified date the X-ray was performed and the results revealed that patient had a frozen shoulder and scar tissue. The patient also had mobility decreased. Causality is assessed as possibly related to the suspect vaccine for all events, based on plausible temporal relationship.