Age: 70.0
Sex: F
Vaccine: RSV, FLUX, RSV
Symptoms: Depressed mood, Discouragement, Fatigue, Frustration tolerance decreased, Gait disturbance
Clinical narrative: she developed pain in her left knee that worsen the pain in the right knee/Knee pain; pain in her ankles and down the legs sometimes/ pain in right arm/feet pain; back pain is back; the vaccine is affecting my mentality; I'm having trouble in my daily basis/RSV (AREXVY) vaccine has totally ruined my quality of life; knee lock; neurological issue; nauseous nearly every, single morning and after eating; headaches; fatigue; body aches/bizarre pains coming out of nowhere all over my body; Although I still tried to walk, several times on each walk, I would nearly collapse from the pain; sometimes tingling; I was in the absolute best health I had been in for a very long time/Your RSV (AREXVY) vaccine has totally ruined my quality of life/My life has been awful; I am depressed; angry; Confused; disappointed/I feel like breaking the television every time I see your AREXVY ads of the seniors bragging about your vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of knee pain in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5 AN52, expiry date 20-OCT-2024) for prophylaxis.   Co-suspect products included Influenza vaccine (batch number UT8043CA) for prophylaxis.   The patient's past medical history included back pain. Concurrent medical conditions included cholesterol. Concomitant products included simvastatin.   On 25-AUG-2023, the patient received Arexvy and Influenza vaccine. On 26-AUG-2023, 1 days after receiving Arexvy, the patient experienced knee pain (Verbatim: she developed pain in her left knee that worsen the pain in the right knee/Knee pain), leg pain (Verbatim: pain in her ankles and down the legs sometimes/ pain in right arm/feet pain), back pain (Verbatim: back pain is back), mental state abnormal (Verbatim: the vaccine is affecting my mentality), activities of daily living impaired (Verbatim: I'm having trouble in my daily basis/RSV (AREXVY) vaccine has totally ruined my quality of life), knee lock (Verbatim: knee lock), neurological disorder nos (Verbatim: neurological issue), postprandial nausea (Verbatim: nauseous nearly every, single morning and after eating), headache (Verbatim: headaches), fatigue (Verbatim: fatigue), general body pain (Verbatim: body aches/bizarre pains coming out of nowhere all over my body), gait disturbance (Verbatim: Although I still tried to walk, several times on each walk, I would nearly collapse from the pain), tingling (Verbatim: sometimes tingling), general physical condition decreased (Verbatim: I was in the absolute best health I had been in for a very long time/Your RSV (AREXVY) vaccine has totally ruined my quality of life/My life has been awful), depression (Verbatim: I am depressed), anger (Verbatim: angry), confusion (Verbatim: Confused) and frustration (Verbatim: disappointed/I feel like breaking the television every time I see your AREXVY ads of the seniors bragging about your vaccine). The patient was treated with cortisone. The outcome of the knee pain, leg pain, back pain, mental state abnormal, activities of daily living impaired, neurological disorder nos, postprandial nausea, headache, fatigue, general body pain, gait disturbance, tingling, general physical condition decreased, depression, anger, confusion and frustration were not resolved and the outcome of the knee lock was not reported.   It was unknown if the reporter considered the knee pain, leg pain, back pain, mental state abnormal, activities of daily living impaired, knee lock, neurological disorder nos, postprandial nausea, headache, fatigue, general body pain, gait disturbance, tingling, general physical condition decreased, depression, anger, confusion and frustration to be related to Arexvy.     It was unknown if the company considered the knee pain, leg pain, back pain, mental state abnormal, activities of daily living impaired, knee lock, neurological disorder nos, postprandial nausea, headache, fatigue, general body pain, gait disturbance, tingling, general physical condition decreased, depression, anger, confusion and frustration to be related to Arexvy.   Additional Information: GSK Receipt Date: 06-NOV-2023 The reporter was the patient who states she received Arexvy and she was having the worse side effects.  According to the reporter the morning after receiving the vaccine she got up with right knee locked up, the pain was very intense, terrible pain and got better after a walk but increased during the week.  The reporter states the pain was constant and after month she developed pain in her left knee that worsen the pain in the right knee.  The patient also reported pain in her ankles and down the legs sometimes, and yesterday she developed pain in her right arm.  The reporter stated she had been on 3 different doctors and they did not had an explanation for the pain. The patient had no history of arthralgia, and doctors believed the pain was more a neurological issue.  The reporter stated she tried Cortisone for a week without relief of the pain, also had X-rays and nothing showed there.  The patient stated that her life was dramatic after she received the vaccine, my back pain was back. The reporter stated she received a Flu shot the same day she received Arexvy, lot UT8043CA (not a match in system).  The patient stated that the vaccine was affecting her mentality, and she had trouble in daily basis. It was unknown if the reporter considered the knee pain, leg pain, back pain, mental state abnormal, activities of daily living impaired, knee lock and neurological disorder nos to be related to Flu vaccine. The reporter consented to follow up.   Follow-up information received on 14-NOV-2023. The patient mentioned that GSK RSV (Arexvy) vaccine had totally ruined her quality of life.  Since August 26, the day after she got the vaccine, her body had not been the same. The patient was in the absolute best health, she had been in for a very long time. In fact, for nearly 96 days in a row, she was walking from two to six miles. The GSK vaccine attacked patient's knees in a horrible way as the next day she had terrible knee pain in her right knee which would dissipate in a few minutes once she moved around. However, within a few weeks, that pain got worse and stuck around. Although, the patient still tried to walk, several times on each walk, she would nearly collapse from the pain. Then it let up a little, only to go to my left knee which was in so much more pain than the right one. In addition, the patient was nauseous nearly every, single morning and after eating, headaches, body aches, fatigue and bizarre pains coming out of nowhere all over her body. The patient had strange body pain, sometimes sharp, sometimes tingling. None of this was happening prior to getting the vaccine. The patient was depressed, angry, confused and disappointed that none of the doctors she had seen had been able to help her yet. The patient got this terrible vaccine. Even steroids did nothing. The patient's life had been awful and she felt like breaking the television every time she was GSK Arexvy ads of the seniors bragging about GSK vaccine. The reporter hoped that, others were not experiencing the horrible consequences from GSK vaccine that she had been experiencing. It was unknown if the company considered the knee pain, leg pain, back pain, mental state abnormal, activities of daily living impaired, knee lock, neurological disorder, postprandial nausea, headache, fatigue, general body pain, gait disturbance, tingling, general physical condition decreased, depression, anger, confusion and frustration to be related to Influenza vaccine. Summary of Changes: Patient initials, current condition, concomitant products, Arexvy vaccine batch number, Flu vaccine batch number and vaccination date updated. New events added postprandial nausea, headache, fatigue, general body pain, gait disturbance, tingling, general physical condition decreased, depression, anger, confusion and frustration with time to onset for all events 1 day and narrative updated.