Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Loss of personal independence in daily activities, Muscular weakness, Myalgia, Nausea
Clinical narrative: potassium a little low at 3.4; urine mucus was 3 plus and abnormal; urine blood was abnormal; urine bacteria was abnormal; infection; BNT162B2, BNT162B2 OMI BA.4-5 as dose 1; dizziness; white blood cell count was a little high at 11.1; absolute basophils were high as well at 0.110; cannot stand or walk; cannot stand or walk; patient then fell; muscles were on fire; urine albumin was abnormal at 30.0; muscle weakness; numbness, from shoulders to hips/ her whole left side was numb/ she did not feel either one of her legs; nausea; threw up; weakness; being assisted by her sister in the shower; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  An 18-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2023 at 12:48 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 18 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (ongoing); "PTSD" (unspecified if ongoing). There were no concomitant medications. The following information was reported: BASOPHIL COUNT INCREASED (non-serious) with onset 11Sep2023, outcome "unknown", described as "absolute basophils were high as well at 0.110"; DYSSTASIA (non-serious), GAIT INABILITY (non-serious) all with onset 11Sep2023, outcome "not recovered" and all described as "cannot stand or walk"; DIZZINESS (non-serious) with onset 11Sep2023, outcome "recovered" (11Sep2023); MYALGIA (non-serious) with onset 11Sep2023, outcome "unknown", described as "muscles were on fire"; FALL (non-serious) with onset 11Sep2023, outcome "unknown", described as "patient then fell"; ALBUMIN URINE PRESENT (non-serious) with onset 11Sep2023, outcome "unknown", described as "urine albumin was abnormal at 30.0"; WHITE BLOOD CELL COUNT INCREASED (non-serious) with onset 11Sep2023, outcome "unknown", described as "white blood cell count was a little high at 11.1"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 11Sep2023 at 12:48, outcome "unknown", described as "BNT162B2, BNT162B2 OMI BA.4-5 as dose 1"; INFECTION (non-serious) with onset 12Sep2023, outcome "unknown"; BLOOD POTASSIUM DECREASED (non-serious) with onset 12Sep2023, outcome "unknown", described as "potassium a little low at 3.4"; BACTERIAL TEST POSITIVE (non-serious) with onset 12Sep2023, outcome "unknown", described as "urine bacteria was abnormal"; BLOOD URINE PRESENT (non-serious) with onset 12Sep2023, outcome "unknown", described as "urine blood was abnormal"; URINE ABNORMALITY (non-serious) with onset 12Sep2023, outcome "unknown", described as "urine mucus was 3 plus and abnormal"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Sep2023, outcome "unknown", described as "being assisted by her sister in the shower"; MUSCULAR WEAKNESS (medically significant) with onset Sep2023, outcome "unknown", described as "muscle weakness"; NAUSEA (non-serious) with onset Sep2023, outcome "recovered" (Sep2023); HYPOAESTHESIA (medically significant) with onset Sep2023, outcome "recovering", described as "numbness, from shoulders to hips/ her whole left side was numb/ she did not feel either one of her legs"; VOMITING (non-serious) with onset Sep2023, outcome "recovered" (Sep2023), described as "threw up"; ASTHENIA (non-serious) with onset Sep2023, outcome "unknown", described as "weakness". The event "numbness, from shoulders to hips/ her whole left side was numb/ she did not feel either one of her legs" required emergency room visit.  Clinical course: Caller stated "in a sense of she's having now, is that muscle weakness. She could stand with help and that's just barely. She tries to walk by herself and she falls down.". Caller stated that they instructed her to take her daughter back to a different ER. Caller was instructed to file a report about this incident. Caller added that the patient is currently being assisted by her sister in the shower. The patient went and got her vaccination for clinicals on Monday at 12:48pm and 30 minutes or so after getting the vaccine, the patient started getting nauseous and went to the bathroom and threw up and all that and then started having numbness from her shoulder to her hip and the patient was fixing to come home and could get home to see if she would feel better. The caller left work and went home with the patient and the patient was really dizzy and the caller took her home to lay down. The caller went back to work but 20 minutes later checked on the patient and the patient was weak, could not hold the phone and her whole left side was numb at this point so the caller took her to the emergency room and they ran all the tests and said that is just the side effects of the vaccine. The caller brought the patient back home and the patient was getting ready to get in the bathtub but she could not walk by herself and the patient's sister had to help the patient to the bathroom and sat her on the toilet to get her into the bathtub and transfer the patient from the toilet to the bathtub and the patient then fell. The patient took a bath and got out of the bath and can't stand by herself now and they got her out of bed, let her eat and she then went to sleep and was complaining about her muscles were on fire. Caller wanted to know has this happened before and what can they do for recovery of the patient and what do they need to do. Right now, the patient can't walk and can't hold herself and is like jello and her legs are like spaghetti noodles. Nausea: resolved immediately after she got sick and threw up some red jelly like stuff and she had not eaten prior to taking the vaccine but had a couple of packets of crackers they made her eat as she had not eaten before that and so the patient probably almost immediately after she threw up felt better as far as the nausea. Numbness: This began about that same time as the nausea started; her arms and hands were tingly and it was very mild and complete movement of the arms and hands; her arms and hands have gotten better and the patient can hold things now. Dizziness: began probably maybe 15 minutes after she threw up which was on 11Sep2023 and these side effects are like stair stepped there together; dizziness is not ongoing and resolved maybe later that evening on 11Sep2023. The caller took the patient to the emergency room on Monday night and the doctor then did not give any diagnosis or anything or a report and no heart levels that were high or low; the caller took the patient back to the emergency room on Tuesday as she did not feel either one of her legs and they ran all kinds of tests on her and the emergency room doctor said this was side effects of the vaccine. They did saline and flushed it out but she has all the labs and all the findings. Investigations: The paperwork she has says clinical impression is that this is vaccine side effects. Reporter stated she has all the labs done and these were on 11Sep2023 and she has no units of measure to provide for the lab results: The white blood cell count was a little high at 11.1; absolute basophils were high as well at 0.110; creatine was low at 0.6; they did chest xrays and all those were normal. They did some more tests on 12Sep2023 and these are as follows: whole blood and everything was normal; Urinalysis, glucose, bilirubin and keytones were negative; urine blood was abnormal; urine albumin was abnormal at 30.0; urine mucus was 3 plus and abnormal; urine bacteria was abnormal; potassium a little low at 3.4 and they said this was because of the virus and the infection; caller was asked if the patient was diagnosed with a virus or infection and caller clarified and states they have on there that this is a side effect of the vaccine. Stated everything else was normal. Therapeutic measures were taken as a result of hypoaesthesia.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.