Sex: U
Vaccine: COVID19, FLUX
Symptoms: Ultrasound Doppler, Vaccination site discomfort, Vaccination site movement impairment, X-ray
Clinical narrative: left arm began not be able to move and it was very heavy; my left arm began not be able to move/could not lift my arm at all; left arm was stiff; Nauseous; shivering like out of control; I am extremely cold/ chills; shivering like out of control; I am extremely cold/ chills; sick; Left leg underneath the knee swelled up/ leg is at least 2-3 times the size of my right leg; ankle is swollen; leg right now is beyond 10/ very painful and it is so swollen; felt like I was going to passed out; not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), in Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "immunosuppressed" (unspecified if ongoing); "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid 19 vaccine (Primary immunization series completed, Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset Oct2023, outcome "unknown", described as "Left leg underneath the knee swelled up/ leg is at least 2-3 times the size of my right leg"; NAUSEA (non-serious) with onset Oct2023, outcome "unknown", described as "Nauseous"; JOINT SWELLING (non-serious) with onset Oct2023, outcome "unknown", described as "ankle is swollen"; PRESYNCOPE (non-serious) with onset Oct2023, outcome "unknown", described as "felt like I was going to passed out"; VACCINATION SITE DISCOMFORT (non-serious) with onset Oct2023, outcome "unknown", described as "left arm began not be able to move and it was very heavy"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Oct2023, outcome "unknown", described as "left arm was stiff"; PAIN IN EXTREMITY (non-serious) with onset Oct2023, outcome "unknown", described as "leg right now is beyond 10/ very painful and it is so swollen"; VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious) with onset Oct2023, outcome "unknown", described as "my left arm began not be able to move/could not lift my arm at all"; MALAISE (non-serious) with onset Oct2023, outcome "unknown", described as "not feeling well"; CHILLS (non-serious), FEELING COLD (non-serious) all with onset Oct2023, outcome "unknown" and all described as "shivering like out of control; I am extremely cold/ chills"; ILLNESS (non-serious) with onset Oct2023, outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient called because he/she needed to talk about the adverse effects of this new COVID booster that the patient took one week ago, Friday and the patient has been sick. The patient stated that he/she was an immunosuppressed and immunocompromised patient. The patient was a post transfer patient oncology and bunch of other stuff (as reported). The patient reported that on that day, the same day he/she took the flu shot. The patient had the flu shot on the patient's right arm and had the Covid booster in the left arm. The patient stated, " Just to let you know for the record, I have taken Pfizer Covid booster, you know when they first came out with the shot, no adverse effects ever, never." This one had been unbelievably bad for the patient. The patient took it a week ago, Friday, at his/her pharmacy and the first effect was the patient kept moving his/her arms. The patient's right arm had no affect from the flu shot. The patient's left arm was stiff but also the left arm began not be able to move and it was very heavy, that part was not great but then the patient takes exercise class at a gym. The patient had to cancel on Saturday because the patient just could not lift his/her arm at all. So then by Sunday, the patient was back to taking that exercise class at a studio. The patient was fine and took classes at his/her gym. On Monday, Tuesday, Wednesday, this past week, all of a sudden the patient ran out the gym and went into, the patient was nauseous, shivering like out of control and was dressed with sweatshirt on, put a hood on, couldn't stop shivering. The patient felt like he/she was going to passed out, chills beyond anything he/she has experienced. The patient got home, put on his/her heat so like 75 degrees couldn't get warm. The patient was under blankets everything. The patient was supposed to go see his/her 'vasp pulmonary value' people and transfer people and the patient could not go because the patient was so sick. The patient did not go anywhere on Thursday and on Friday. He/she was able to just get out and off to do his/her laundry and on Saturday he/she could not go to the gym again Sunday the patient really and truly just did really well. Today the patient went back to the gym, the patient didn't feel good. Now, the last two and a half days the patient just, the shot was given on the left arm, two and a half days ago all of a sudden his/her left leg underneath the knee swelled up and the patient is right now elevating which he/she does normally. The patient's leg, he/she just told people here. The patient had a nurse come from part of his/her health insurance, they came out yesterday last night in fact, took a look at the leg. There was not warning any fever, he/she was extremely cold. The leg was at least 2-3 times the size of the patient's right leg and the ankle was swollen. They have taken a doppler ultrasound, they also took a regular x-ray of the entire leg. The patient didn't have the results yet but to the patient there was something wrong and it turned out, he/she talked with his/her pharmacist people are getting these laid reactions but people are getting all kinds of reaction like terrible adverse effects. The patient asked if this was normal. The patient stated that he/she never had a problem with Pfizer vaccines before. The patient stated, "Why this one? Are you getting people calling with these kind of things and why are these symptoms so severe? Is there a different formulary that they are using on this one? Is it affecting people that are difficult to the new system, what is the situation?". When confirmed if it is a Pfizer Covid booster shot, consumer stated, "Yes, it is. I stayed with Pfizer Completely because I never had a problem, it's a first time and here's a thing One of my physician assistant, she took the same Pfizer Covid shot also was down for 3 days with fever, chill like she said she has had all Pfizer boosters and vaccines and never had a problem until this one and the murphy that I keep talking to everybody is experiencing the same thing and a lot of them is very delayed like they are not experiencing in the first 24-48 hours, I mean they might have arm soreness which not a big deal and little stiffness, little pain. My leg right now is beyond 10, I mean its very painful and it is so swollen but I am saying. So I am trying to find out are you guys finding people calling with these symptoms? What's going on? What make these booster so different?". When paraphrased the concern, consumer stated, "No, I am not. I have had all signs and problem. Are you getting people calling these adverse effects? Are you getting any similarities or let me ask you a question, when you guys do the clinical trial before you actually released it how long do you use the clinical trial I mean how long did you do the research and did you have actual people that took these. Like when you do clinical trial you usually have people that have the actual vaccine and then others that are taking up for 'civil' so were their clinical studies done, how long did you do it I mean are you getting calls with these adverse effects, So I have several questions." Reporter was informed about the role of Pfizer Drug Safety and also informed that Pfizer Medical Information is the concerned department to answer the question. The patient stated, "Before we do that you are a pharmacist, you should be able to tell me what if any adverse effect you are getting calls about is what I am experiencing is this, are you getting calls related, similar related, I am trying to figure it out. I also think it is important that you document what I am telling you which is I am an immunocompromised and immunosuppressive patient and this is supposed to be according to my pharmacy, my head pharmacist advised that this is going to be a really tight like the flu shot, So I wanted to know I have to prepare myself, am I going to experience this continuously the other, but this is a concern in mind because I am not feeling well and this is a week later."  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300341520 Same reporter and drug, similar events, different patient;