Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Product administered at inappropriate site
Clinical narrative: Pain in shoulder; RSV vaccine given to high shoulder bone; The initial case was missing the following minimum criteria: [No adverse effect]. Upon receipt of follow-up information on [08Mar2024], this case now contains all required information to be considered valid. This is a spontaneous report and received from Pharmacists from medical information team.  A 64-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 06Jan2024 at 11:08 as dose number unknown, 0.5ml single (Lot number: HM7643, Expiration Date: Mar2025) at the age of 64 years intramuscular for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious) with onset 06Jan2024 at 11:08, outcome "unknown", described as "Pain in shoulder"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 06Jan2024 at 11:08, outcome "unknown", described as "RSV vaccine given to high shoulder bone". Therapeutic measures were not taken as a result of arthralgia. Additional information: Caller inquired whether patient would have to be revaccinated, since Abrysvo dose was administered to an elderly patient on Saturday (06Jan2024), but on shoulder, since "patient was cold and had several layers of clothing, which she did not want to remove" and also "shoulder was puffy". Caller states a colleague administered the vaccine to a patient last Saturday and explained the patient who received the vaccine was cold and did not want to remove all the layers of clothing so the patient exposed her shoulder and the shoulder was puffy and they did not really have the proper section to administer the vaccine to so the vaccine was administered in the shoulder. Caller verified the information provided and clarified that the shoulder being puffy was during the vaccine being administered but by puffy they mean that the layers of clothing that the patient did not take off and those layers of the clothing were like bunching on the top of the clothing and that was what was puffy. Seriousness criteria: She is not sure about seriousness criteria and the patient was ok and the patient said she was ok; the caller was supposed to follow up with the patient this morning but the caller got side tracked and was so busy so did not follow up with the patient but the colleague that administered the vaccine was concerned about shoulder injury because as known it should be 2 inches below the shoulder in the deltoid and because there were too many layers regarding the patient's clothing, they could not gauge this so that is why the vaccine was administered and the colleague of the caller was more concerned about shoulder injury. Causality: states the event of the patient being administered the vaccine in the shoulder is vaccine related for causality. No treatment required for the reported event yet. The Pfizer product had a causal effect to the adverse event pain in shoulder. RSV vaccine given to high shoulder bone. Gave to high an bundled up and cold, could not See top of arm and accidentally gave to high. Realized when tried to put on bandaid.