Received Feb 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | IM |
redness - injection site; swelling - injection site; pain - injection site; infection - injection site; eyelid cyst; lung pain; cough; stuffy nose; runny nose; sneezing; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concomitant products included pregabalin (Lyrica). On 09-DEC-2024, the patient received Arexvy (intramuscular, unknown deltoid). In DEC-2024, less than a month after receiving Arexvy, the patient experienced injection site erythema (Verbatim: redness - injection site), injection site swelling (Verbatim: swelling - injection site), injection site pain (Verbatim: pain - injection site) and injection site infection (Verbatim: infection - injection site). On an unknown date, the patient experienced eyelid cyst (Verbatim: eyelid cyst), pulmonary pain (Verbatim: lung pain), cough (Verbatim: cough), nasal stuffiness (Verbatim: stuffy nose), runny nose (Verbatim: runny nose) and sneezing (Verbatim: sneezing). In DEC-2024, the outcome of the injection site erythema, injection site swelling, injection site pain and injection site infection were not resolved. The outcome of the eyelid cyst, pulmonary pain, cough, nasal stuffiness, runny nose and sneezing were not resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain and injection site infection to be related to Arexvy. The reporter considered the eyelid cyst, pulmonary pain, cough, nasal stuffiness, runny nose and sneezing to be related to Arexvy. It was unknown if the company considered the injection site erythema, injection site swelling, injection site pain and injection site infection to be related to Arexvy. The company considered the eyelid cyst, pulmonary pain, cough, nasal stuffiness, runny nose and sneezing to be related to Arexvy. Additional Information: GSK Receipt Date: 17-JAN-2025 The reporter reported that a patient received Arexvy on 9th December 2024. About two weeks later the vaccination, she developed injection site redness, swelling and pain. The area was about the size of a fifty cent piece. She believed the injection site was infected but not diagnosed by Healthcare professional. The local or injection site effects had not resolved. About three weeks after the vaccine, she developed sneezing, runny nose, stuffy nose, cough, and lung pain. At first, she thought the sneezing, runny nose, stuffy nose, cough and lung pain were due to environmental allergies. After reading about the potential side effects of Arexvy, she believed all these effects were due to the vaccine. She saw her physician a day before reporting. The physician prescribed an unknown topical treatment for the cyst on her eyelid. The patient would see a dermatologist in two weeks regarding the injection site effects. Nothing else was reported.
LYRICA