Age: 72.0
Sex: M
Vaccine: FLUX, RSV
Symptoms: Coating in mouth, Electric shock sensation, Fatigue, Iliotibial band syndrome, Inflammatory marker increased
Clinical narrative: Night sweats; swollen left testicle (inflammation of the spermadic cord); spermadic cord was tender; Mouth feels filmy; blood work: Inflammatory markers high; achy lower left side of back; extreme fatigue; muscle pain primarily in his legs, but that it travels around; bone on bone pain increased left hand/aching from his hips; inflammation of the iliotibial band; chills; fever/low grade fever; body aches/aching lower body/sharp pain left thigh from hip to knee; severe pain in his left foot like an electric shock/pain in his left hand/pain in his right hand; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 72-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   On 29-SEP-2023, the patient received Arexvy (intramuscular) and Influenza vaccine. On 30-SEP-2023, 1 days after receiving Arexvy, the patient experienced chills (Verbatim: chills), fever (Verbatim: fever/low grade fever) and general body pain (Verbatim: body aches/aching lower body/sharp pain left thigh from hip to knee). In OCT-2023, the patient experienced pain in extremity (Verbatim: severe pain in his left foot like an electric shock/pain in his left hand/pain in his right hand), muscle pain (Verbatim: muscle pain primarily in his legs, but that it travels around), arthritic pains (Verbatim: bone on bone pain increased left hand/aching from his hips) and iliotibial band syndrome (Verbatim: inflammation of the iliotibial band). On 17-OCT-2023, the patient experienced fatigue (Verbatim: extreme fatigue). On 14-NOV-2023, the patient experienced low back pain (Verbatim: achy lower left side of back). On 16-NOV-2023, the patient experienced oral disorder (Verbatim: Mouth feels filmy) and inflammatory marker increased (Verbatim: blood work: Inflammatory markers high). On an unknown date, the patient experienced night sweat (Verbatim: Night sweats), testicular swelling (Verbatim: swollen left testicle (inflammation of the spermadic cord)) and testicular pain (Verbatim: spermadic cord was tender). The outcome of the chills, fever and general body pain were resolved (duration 2 days) and the outcome of the pain in extremity was resolved (duration 10 min) and the outcome of the night sweat, oral disorder, muscle pain, fatigue, inflammatory marker increased, testicular swelling, testicular pain, arthritic pains, iliotibial band syndrome and low back pain were unknown.   The reporter considered the chills, fever, general body pain, pain in extremity, night sweat, oral disorder, muscle pain, fatigue, inflammatory marker increased, testicular swelling, testicular pain, arthritic pains, iliotibial band syndrome and low back pain to be related to Arexvy.     The company considered the chills, fever, general body pain, pain in extremity, night sweat, oral disorder, muscle pain, fatigue, inflammatory marker increased, testicular swelling, testicular pain, arthritic pains, iliotibial band syndrome and low back pain to be related to Arexvy.   Additional Information: GSK receipt date:20-NOV-2023 The reporter reported that the patient experienced the usual fever, chills and body aches for two days. The following week he had a severe pain in his left foot like an electric shock that was lasted about ten minutes.  Later that week he was awakened in the night with aching from his hips down. The patient was began running a low grade fever again, at approximately 99.6 degrees Fahrenheit, along with muscle pain primarily in his legs, but states that it travels around. The patient was hiking and had a sharp pain in his left thigh from hip to knee.  The patient said that the iliotibial band was inflamed and also experienced pain in his left hand at about that same time.  About one or two weeks ago he also had pain in his right hand which only lasted a short amount of time.  The patient thought he had pulled something in his left thigh, but also was having swelling of his left testicle. The spermadic cord was tender. The physician was ordered basic blood work which came back normal, then ordered inflammatory markers which were elevated.  The patient stated that when he awakes for the day his temperature was normal. It rose in late afternoon into the evening to low-grade fever of 99.5.  The theory of patient was that the vaccines put his immune system into overdrive and caused the symptoms. On 30-SEP-2023, 1 days after receiving Influenza vaccine, the patient experienced chills, fever and general body pain. In OCT-2023, after receiving Influenza vaccine, the patient experienced pain in extremity, muscle pain, arthritic pains and iliotibial band syndrome. On 17-OCT-2023, after receiving Influenza vaccine, the patient experienced fatigue. On 14-NOV-2023, after receiving Influenza vaccine, the patient experienced low back pain. On 16-NOV-2023, after receiving Influenza vaccine, the patient experienced oral disorder and inflammatory marker increased. On an unknown date, after receiving Influenza vaccine, the patient experienced night sweat, testicular swelling and testicular pain. The reporter considered the chills, fever, general body pain, pain in extremity, night sweat, oral disorder, muscle pain, fatigue, inflammatory marker increased, testicular swelling, testicular pain, arthritic pains, iliotibial band syndrome and low back pain to be related to Influenza vaccine. The reporter consented to follow up.