Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling, Oropharyngeal discomfort, Pain, Pain in extremity
Clinical narrative: could not lift her left arm; throat felt funny; felt like she could barely swallow; full body aches,Felt achy; left arm sore; could not eat or drink; abdominal cramping; swelling at the injection site of left arm like a small mountain; pinkish red color spreading on her left arm and her abdominal cramping.; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 66-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 01-DEC-2023, the patient received Arexvy (left arm). On 01-DEC-2023, less than a day after receiving Arexvy, the patient experienced pharynx strange sensation of (Verbatim: throat felt funny) and swallowing difficult (Verbatim: felt like she could barely swallow). On 02-DEC-2023, the patient experienced injected limb mobility decreased (Verbatim: could not lift her left arm). In DEC-2023, the patient experienced injection site swelling (Verbatim: swelling at the injection site of left arm like a small mountain), injection site erythema (Verbatim: pinkish red color spreading on her left arm and her abdominal cramping.), generalized aching (Verbatim: full body aches,Felt achy), pain in arm (Verbatim: left arm sore), unable to eat (Verbatim: could not eat or drink) and abdominal cramp (Verbatim: abdominal cramping). The outcome of the injection site swelling, injection site erythema, swallowing difficult, unable to eat and abdominal cramp were unknown and the outcome of the injected limb mobility decreased, generalized aching and pain in arm were not resolved and the outcome of the pharynx strange sensation of was resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injected limb mobility decreased, pharynx strange sensation of, swallowing difficult, generalized aching, pain in arm, unable to eat and abdominal cramp to be related to Arexvy.     It was unknown if the company considered the injection site swelling, injection site erythema, injected limb mobility decreased, pharynx strange sensation of, swallowing difficult, generalized aching, pain in arm, unable to eat and abdominal cramp to be related to Arexvy.   Additional Information: GSK Receipt Date: 12-DEC-2023 The reporter was consumer. The reporter reported that she received the AREXVY vaccination on 01st December 2023 in her left arm. Consumer stated that after having the vaccine administered, she noticed on her drive home from the pharmacy that her throat began to feel funny. By the time she got home she states that she felt as if she could barely swallow. The next day she felt achy and could not lift her left arm. Then about 2 or 3 days later her left arm was pinkish red, and her arm was sore and began to swell at the injection site like a small mountain. She started experiencing full body aches and was unable to eat or drink and having abdominal cramping. On 06th December 2023 she went to the emergency department due to the pinkish red color spreading on her left arm and her abdominal cramping. She was observed and released the same day from the emergency department. Emergency department physician ruled out diverticulitis flair. Consumer reports that her throat no longer feels funny, but her arm is still sore, and she still cannot lift the left arm. Consented to follow up.