Sex: U
Vaccine: RVX
Symptoms: Back pain, Dyspnoea, Injected limb mobility decreased, Insomnia, Musculoskeletal disorder
Clinical narrative: Oral surgery; could not lift his/her right arm/lost the use of his/her right arm; My hands were trembling like an earthquake; Severe pain in the back of my back; Trouble breathing; Destroyed my sleep patterns completely; I was up 24 hours straight nonstop; wreaked my sleep; Neurological attack to my brain; thoughts were racing;trying to control my thought process, could not do it; Neurological attack to my brain; thoughts were racing;trying to control my thought process, could not do it; Neurological attack to my brain; thoughts were racing;trying to control my thought process, could not do it; Destroyed my sleep patterns completeley; Destroyed my sleep patterns completeley, I was up 24 hours straight non-stop/wreaked my sleep; This serious case was reported by a consumer via other manufacturer and described the occurrence of oral surgery in a adult patient who received RSVPreF3 adjuvanted (RSV vaccine) (batch number NX577, expiry date 18-AUG-2025) for prophylaxis.   The patient's past medical history included chronic kidney disease (stage 3b), obesity (too obese), heart attack and finger amputation (20 years ago). Concurrent medical conditions included blood pressure high, nocturnal frequency, type ii diabetes mellitus, bipolar disorder (bipolar manic) and triglycerides high. Concomitant products included tamsulosin, dapagliflozin propanediol monohydrate (Farxiga), eplerenone, carvedilol, acetylsalicylic acid (Baby Aspirin), ubidecarenone (Coq-10), polycarbophil calcium (Fibercon), lithium carbonate, omega-3-acid ethyl ester (Lovaza), etoricoxib (Acadia) and chondroitin sulfate, glucosamine hydrochloride (Osteo Bi-Flex).   On 27-MAR-2024, the patient received RSV vaccine (right arm). On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced oral surgery (Verbatim: Oral surgery) (serious criteria clinically significant/intervention required and other: Serious as per reporter), injected limb mobility decreased (Verbatim: could not lift his/her right arm/lost the use of his/her right arm), tremor of hands (Verbatim: My hands were trembling like an earthquake), back pain (Verbatim: Severe pain in the back of my back), difficulty breathing (Verbatim: Trouble breathing), difficulty sleeping (Verbatim: Destroyed my sleep patterns completely; I was up 24 hours straight nonstop; wreaked my sleep), neurological symptom (Verbatim: Neurological attack to my brain; thoughts were racing;trying to control my thought process, could not do it), racing thoughts (Verbatim: Neurological attack to my brain; thoughts were racing;trying to control my thought process, could not do it), abnormal thinking (Verbatim: Neurological attack to my brain; thoughts were racing;trying to control my thought process, could not do it), change in sleep pattern (Verbatim: Destroyed my sleep patterns completeley) and sleep apnea (Verbatim: Destroyed my sleep patterns completeley, I was up 24 hours straight non-stop/wreaked my sleep). The outcome of the oral surgery was unknown and the outcome of the injected limb mobility decreased, tremor of hands, back pain, difficulty breathing, difficulty sleeping, neurological symptom, racing thoughts, abnormal thinking, change in sleep pattern and sleep apnea were resolved.   It was unknown if the reporter considered the oral surgery, injected limb mobility decreased, tremor of hands, back pain, difficulty breathing, difficulty sleeping, neurological symptom, racing thoughts, abnormal thinking, change in sleep pattern and sleep apnea to be related to RSV vaccine.     It was unknown if the company considered the oral surgery, injected limb mobility decreased, tremor of hands, back pain, difficulty breathing, difficulty sleeping, neurological symptom, racing thoughts, abnormal thinking, change in sleep pattern and sleep apnea to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 29-APR-2024 The reporter was retired and his/her physician who was an Endo-Kinesiologist(not clarified) that specialized in diabetes and chronic kidney disease recommended this new vaccine that everybody was pushing, the RSV respiratory (Clarified as Abrysvo), he/she thought physical vaccine and he/she had to call up and told what was going on.  The reporter just received RSV vaccine and it was so deadly.  The reporter was asked if got the Arexvy vaccine or the Abrysvo vaccine and caller stated that when originally got the vaccine for the respiratory syncytial virus vaccine, they gave this paper and read it but they did not tell assumed got the RSV but on the paper and when looked it up, it meant the same thing.  Due to reporter stated that he/she got the respiratory syncytial virus vaccine and paper said was Arexvy but was calling about Abrysvo, this report was filed for suspect product as respiratory syncytial virus vaccine despite attempts at clarification of which vaccine the caller was administered, details were captured as stated by the caller and respiratory syncytial virus vaccine was populated into formal suspect product field.  The reporter was not sure if he/she was to come out of or land in the hospital.  The reporter had all chronic condition (History) in the research that he/she studied and he/she would tell what happened to him/her.  Because of this vaccine, he/she would never ever get another vaccine of any kind again in his/her life, never ever.  It was that bad and everywhere, he/she went, they were pushing this vaccine doctors, pharmacists and he/she saw 10 different doctors of different specialties because he/she had life threatening diseases that he/she was battling with and company had published articles and when and different companies and when asked Pfizer to comment they refused but they need to know. The reporter was just trying to let them know. So, nobody else went through what he/she went through.  It was unbelievable and he/she was not blaming because vaccines affect people different ways and his/her physician were honorable, he took it, nothing happened but he did not had any chronic issues but he/she need to know because you were advertising or Pfizer advertising to study applicants to be guinea pigs for the adverse effects and that was the reason he/she was calling.  The reporter was not looking for any compensation anything.  The reporter just wanted to document this and did more research, that was all.  The reporter stated that in the article published that he/she had read, if they had chronic conditions, you were over 60 years old the side effects were 6.5 times worse than normal side effects.  The patient wished if he/she did research before he/she took this vaccine.  The problem was with physicians now in the medical industry and he/she was sure aware of this, whether it was specific country, whether it was any part of globe the physicians today in the medical industry it was saturated with patients, the physicians were very limited other time when they had seen the patients, they did not have enough time to even discuss things with the patients during their appointments they left information out.  They did not discuss it, it was very upsetting and it was having an adverse reaction.  One of his/her physicians, he/she knew from 25 years was retiring because he/she was fed up what the quality of care and the way it was come out and physician did not return calls. The patient had landed in the hospital twice, he/she was almost died because they did not return calls.  It was really bad.  The reporter just found out he/she had chronic kidney disease, stage 3b(History) last December in the hospital. They put it in his/her discharge papers.  The patient had a diabetic fall injury (History) that went into the hospital but nobody discussed those condition.  The reporter did his/her research, his/her side effects match.  The patient got several physicians to verify it, he/she had the condition but nobody said anything.  They said his/her condition elevated but never specifically chronic kidney disease.  The patient went back 3 years in his/her records.  The patient had evidence that nobody said anything, this was what he/she was taking about.  The side effects with this new RSV vaccine was as follows: If you had chronic kidney disease and diabetic type, it was IQ-fold, not 6 and a half.  So, because of these conditions his/her hands were trembling like an earthquake, severe pain in the back of his/her back, like the graft when you come out of the shower, you got a draft in your back but it would not stop. Trouble breathing, have difficulty in breathing.  The patient lost the use of his/her right arm.  The patient could not lift his/her right arm up at all and then the most scariest part, he/she had a neurological attack to his brain.  The patient thought that he/she would never get out of this, his/her thoughts were racing. It destroyed his/her sleep patterns completely, he/she had sleep apnea.  The patients physician just put him/her through a sleep study and they shipped him/her a sleep facial mask.  The patient was going to use.  The patient had not even started it and this thing totally destroyed his/her sleep.  The patient was up 24 hours straight nonstop pacing in the living room trying to control his/her thought process, could not do it.  It wreaked his/her sleep.  The patient was trying to think there was one other evidence.  The patient was not sure if he/she was going to come out of this again but he/she did.  It took several days for him/her to re bounce back.  The patient just wanted you to know they need to do more studies with people with chronic conditions. The patient had no prior vaccination within weeks. The patient's next blood work appointment was in April but he/she received the shot. The patient did not get hospitalized.  The patient said that he/she was in verge of going to the hospital if he/she could not take this and he/she was right at the point of going.  The patient waited out in his/her house.  The patient was also taking for bipolar, it was weaning him/her off of Lithium because he/she had chronic kidney disease, it was Divalproex it, they called it Depakote ERN, the same thing with different name. It was also 500 milligrams (Further not clarified if the consumer was taking Divalproex or Depakote, hence not captured in tab). The reporter stated recently had a serious oral surgery and the surgeon was the same way, was no nonsense but extremely bright.