Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeding disorder, Gait disturbance, Mobility decreased, Night sweats
Clinical narrative: she was frozen on the sofa she could not move/ tried getting up so many times and she could not; did not eat for those two days; unable to do anything/very weak; Fever; cannot walk straight/not steady on her feet; the first two nights she was soaking wet/ all sweating, whole body; lost a lot of weight; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 03Dec2024 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "COPD" (ongoing); "blood pressure" (unspecified if ongoing); "Heart disorder" (unspecified if ongoing), notes: her heart, there's little bit of clog, very little; "cancer" (unspecified if ongoing); "shingles" (unspecified if ongoing); "Non-Hodgkin's lymphoma" (ongoing); "immune compromised" (ongoing). The patient's family history included: "heart condition" (unspecified if ongoing), notes: elder sister has heart condition, she is 81 years old. Concomitant medication(s) included: WIXELA INHUB taken for asthma; SPIRIVA taken for asthma; LOSARTAN taken for blood pressure abnormal; MONTELUKAST taken for asthma, chronic obstructive pulmonary disease; VALACYCLOVIR [VALACICLOVIR]; ROSUVASTATIN taken for cardiac disorder; GABAPENTIN taken for herpes zoster; ENTECAVIR. The patient also took other concomitant therapy. Patient stated she is taking a lot of medications. She has asthma, so she has two inhalers. Vaccination history included: Bnt162b2 (Primary immunization series completed), for Covid-19 immunization, reaction(s): "no adverse effect"; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "no adverse effect"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "no adverse effect"; Bnt162b2 omi xbb.1.5 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "no adverse effect". The following information was reported: FEEDING DISORDER (medically significant) with onset 04Dec2024, outcome "unknown", described as "did not eat for those two days"; MOBILITY DECREASED (medically significant) with onset 04Dec2024 at 08:30, outcome "unknown", described as "she was frozen on the sofa she could not move/ tried getting up so many times and she could not"; ASTHENIA (medically significant) with onset 04Dec2024, outcome "not recovered", described as "unable to do anything/very weak"; PYREXIA (medically significant) with onset Dec2024, outcome "unknown", described as "Fever"; GAIT DISTURBANCE (medically significant) with onset Dec2024, outcome "not recovered", described as "cannot walk straight/not steady on her feet"; WEIGHT DECREASED (medically significant) with onset Dec2024, outcome "recovering", described as "lost a lot of weight"; NIGHT SWEATS (medically significant) with onset Dec2024, outcome "unknown", described as "the first two nights she was soaking wet/ all sweating, whole body". The patient underwent the following laboratory tests and procedures: Weight: (Dec2024) below100, notes: probably 90; (Dec2024) lost, notes: 20 pounds; (Dec2024) gained about 15 pounds; (Dec2024) 97.2 lbs, notes: pounds. Therapeutic measures were taken as a result of weight decreased, asthenia, pyrexia. Clinical details: On 03Dec2024, patient received a Covid Shot (Pfizer Covid-19 Shot). The first day of Tuesday everything was fine, then on Wednesday morning she got up for breakfast and then she sat in the sofa waiting for withheld to send the technician scheduled for 8:30 to 9:30 AM that day. Unfortunately, this is on Wednesday, 04Dec2024 in the morning at 8:30, she could not get up from the sofa, she was frozen and the intercom in her apartment get calling and calling because withheld was downstairs and she could not get to it. That day she could get up and she slept on the sofa which is where she was sitting. The next day (05Dec2024), lucky for her, withheld sent another technician and the manager of the building came to her apartment, yelled her name and she yelled back to go get a security key because she can't get up, which she did. Then the withheld people came in and the manger was very nice, he extended his arms, help patient get up from the sofa, so she could go to the bathroom and then she sat again on the sofa and she asked something to eat, she has not eaten anything and he went and got her soup. That day she did not eat anything else. Patient's sister called her later in the afternoon, patient told her what happened and she came to help the patient and she cooked for patient for five days because patient was unable to do anything. Patient lost 20 pounds and she was receiving treatment for Non-Hodgkin's lymphoma and she was on the IVG (unspecified medication, patient stated it's called 'IVG'. This is her doctor that's all she knows. It has vitamins or something to help her recover from the chemo treatment. This is done at the hospital, it's intravenous through her vein.). She was doing IVG once a month. She was very weak, of course, she did not eat for those two days and it was a big setback for her and she is trying to recover her weight. She has to go back to her 'card' just to have an appointment in January to get another IVG too and explain to her oncologist what happened to her. That's the reason she lost all that weight. Patient has to start all over again to recover. She had Covid shots and never had much reaction. This one (Covid-19 Shot) destroyed her and that's where she stand. She is still weak. She is eating more than three meals. She is eating everything she possibly can to gain back her weight and it's going to take time and she is also still weak. Patient stated she was frozen on the sofa she could not move. She tried getting up so many times and she could not. She started getting the symptoms the following morning. She ate breakfast, sat on the sofa waiting for withheld and when they came, she could not get up. She started getting all these on the next morning. Patient was retired. She has been treated for Non-Hodgkin's lymphoma. The treatment was going well and she was at place where she would get the IVG which has helped her to recover, but this is a setback for her now because she lost a lot of weight and she is trying to get it back. Patient's weight is below100 currently, it's probably 90. She found lucky and she is usually 100 but as she said she lost 20 pounds and she is trying to recover. When patient was not able to get up and her sister helped her, she cooked for patient. Patient went to check her weight and went down to 78 which was frightening. So, patient's sister cooks everything, she possibly cooked for her and patient was able to gain some more. She thinks she has gained about 15 pounds. She has to weigh herself again. She has to reach at least 98 pounds. Patient is going to need physical therapy because she cannot walk straight. Her weight right now is 97.2 (pounds). So, she gained some weight. She is eating cake in order to gain weight because she just eat food, she does not gain weight. She needs physical therapy so she can walk straight because she is still weak. Patient stated every year that she had the Covid shot, the Pfizer Covid Shot, she did not have any significant, there is no significant anything. Her sister took it and patient did not think she had a fever or anything. This is the first time that patient have a reaction to Covid Shot. These medications are the same medications she has had for many years. When she had a Covid Shot all these medications she was getting just like she is currently. So, she does not think it's her medications that did that. Patient is eating as much as she can and she has vitamins that she takes to help her. She takes one a day vitamin, she takes B12, she takes D3 but these are normal vitamins that she has taken over the years there is nothing unusual. Patient had a fever, a high fever and the first two nights she was soaking wet, all her sheets, blanket and her mattress was soaking wet. Her sister gave her Tylenol for fever. That was two nights. This is her reaction to it. First patient was frozen, she could not move and then she was all sweating, whole body and her sheets were wet, everything was wet. She stopped taking Tylenol. She only took Tylenol for two days when she was experiencing a fever and she was wet. Her whole body, her face everything was wet. That was the reaction to the Covid Shot (Covid-19 shot). Patient get one shot a year. She even took the 'RS' something (Further not clarified) but it obviously her doctor tells her what to take and she has to take this shot (COVID-19 shot) because she is immune compromised. That's the only reason she took the Covid shot. Her doctor said she has to take it because she is immune compromised, but she had one shot every year and she has no reaction whatsoever and all the medication that she has listed, she has been taking that all along when she has been taking the Covid shot and had no reaction, nothing significant anyway.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.