Received Mar 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | IM / LA |
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | IM / LA |
right hand pain; right thumb joint pain/right shoulder joint pain/knee pain reported as worsened; muscle pain on right and left arm; Hands unable to grasp things; lower back pain; trouble moving and walking/"I could not walk; difficulty moving knee/trouble moving with rignt knee; she started having nausea (AE: nausea),; This non-serious case was reported by a consumer via call center representative and described the occurrence of nausea in a 87-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. The patient's past medical history included knee pain (had knee pain). On 30-JAN-2025, the patient received Arexvy (intramuscular, left arm) .5 ml. On 30-JAN-2025, 15 min after receiving Arexvy, the patient experienced nausea (Verbatim: she started having nausea (AE: nausea),), unable to walk (Verbatim: trouble moving and walking/"I could not walk) and mobility decreased (Verbatim: difficulty moving knee/trouble moving with rignt knee). On an unknown date, the patient experienced pain in hand (Verbatim: right hand pain), arthralgia (Verbatim: right thumb joint pain/right shoulder joint pain/knee pain reported as worsened), myalgia (Verbatim: muscle pain on right and left arm), decreased ability to grasp (Verbatim: Hands unable to grasp things) and low back pain (Verbatim: lower back pain). The patient was treated with paracetamol (Tylenol). The outcome of the nausea was resolving and the outcome of the pain in hand, arthralgia, myalgia, decreased ability to grasp, low back pain, unable to walk and mobility decreased were not resolved. It was unknown if the reporter considered the nausea, pain in hand, arthralgia, myalgia, decreased ability to grasp, low back pain, unable to walk and mobility decreased to be related to Arexvy. It was unknown if the company considered the nausea, pain in hand, arthralgia, myalgia, decreased ability to grasp, low back pain, unable to walk and mobility decreased to be related to Arexvy. Additional Information: GSK Receipt Date: 26-FEB-2025 The reporter reported that a patient received Arexvy vaccine and had right hand pain, right thumb joint pain, muscle pain on right and left arm, hands unable to grasp things, knee pain, knee pain was reported as worsened, difficulty moving knee and could not walk. The patient reports that almost immediately after administering the vaccine (15 to 20 minutes) she started having nausea, and great trouble moving and walking with her right knee, it got worse and had to use a cane to walk. The patient reports having right hand pain, and right thumb joint pain. The patient reports that she would go to bed and the next morning like nothing had happened. The patient reports she could not grasp things then had muscle pain from left arm and now was in the right arm and right shoulder joint pain. The patient could not take Advil because of possible issues in the abdomen area and taking Tylenol only but did not help. The patient reports she had a full blood count test, and the results showed no indication of anything. The patient reports these side effects recurred and had not resolved since the day of vaccination. The patient inquired was there a direct correlation of this to the vaccine. The patient did not provide any additional medical history or medication treatments.
Medical History/Concurrent Conditions: Knee pain (had knee pain)
Test Name: CBC; Result Unstructured Data: (Test Result:Normal,Unit:unknown,Normal Low:,Normal High:)