Age: 73.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Impaired work ability, Injected limb mobility decreased, Injection site reaction
Clinical narrative: Had not been able to use the right arm correctly for work/limited use of right arm & unable to do my work; Limited use of Arm- Pain radiates down arm at times; Injection site has not healed; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 73-year-old female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 01Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years intramuscular, in right arm for immunisation. The patient's relevant medical history included: "Blood thinner" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN taken for anticoagulant therapy. The patient also took other concomitant therapy. The following information was reported: IMPAIRED HEALING (disability) with onset 14Sep2023, outcome "not recovered", described as "Injection site has not healed"; VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious), outcome "not recovered", described as "Had not been able to use the right arm correctly for work/limited use of right arm & unable to do my work"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Limited use of Arm- Pain radiates down arm at times". The events "injection site has not healed" and "had not been able to use the right arm correctly for work/limited use of right arm & unable to do my work" required physician office visit. The patient underwent the following laboratory tests and procedures: Weight: 196. Therapeutic measures were taken as a result of impaired healing.  Additional Information: The patient received the RSV vaccine from a pharmacy and to-date, the injection site has not healed, and the patient had not been able to use the right arm correctly for work since then. The patient stopped at the pharmacy and filled out their paperwork, and also went to a physician. This not being a fault of the patient's own felt that the company needs to be aware of these interactions and what other steps the patient can do to be able to work properly again.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.  Follow-up (23Jul2024): This is a spontaneous follow-up report received from the same consumer (patient) in response to Non-HCP letter sent. Updated information included: reporter details, patient details (medical history, height and lab test), suspect drug details (dosage regimen, route of administration), concomitant medication, reaction data (new event: limited use of Arm- Pain radiates down arm at times), seriousness assessment, and clinical course. Verbatim of "Had not been able to use the right arm correctly for work" updated. Case upgraded to serious.  Follow-up (22Aug2024): This is a spontaneous follow-up report received from a Other-HCP.  Updated Information: reporter details, Best Doctor / Health Care Professional Information added.   The information on the batch/lot number for [RSV VACCINE PROT.SUBUNIT PREF 2V] has been requested and will be submitted if and when received.