Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Leukaemia, Limb injury, Muscular weakness, Musculoskeletal stiffness, Nasal congestion
Clinical narrative: weakness/upper body weakness/Extreme bilateral upper body weakness; leg weakness; congestion; extreme allergy like runny nose and sneezing; exhaustions/Tiredness/total exhaustion; Runny nose; Sneezing; minor pain at the shot site; pain in the shoulder and the other shoulder; trouble keeping his head up/Could not do more than lift my head; Local arm holding; Arm hurting; nausea; Leukemia; anemia; tightening of the arm; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 79-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23May2024 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Parkinson's" (unspecified if ongoing); "Chronic lymphocytic leukemia" (unspecified if ongoing); "Anemia" (unspecified if ongoing). Concomitant medication(s) included: LEVODOPA; CARBIDOPA. The patient also took other concomitant therapy. Past drug history included: Iron infusion for CLL (Chronic lymphocytic leukemia), notes: I have had two of those for the CLL, for the anemia; Iron infusion for anemia. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization, reaction(s): "Tiredness", "typical local arm holding or may be arm hurting". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 23May2024, outcome "recovering", described as "minor pain at the shot site"; ARTHRALGIA (non-serious) with onset 23May2024, outcome "recovering", described as "pain in the shoulder and the other shoulder"; RHINORRHOEA (non-serious) with onset 24May2024, outcome "recovering", described as "Runny nose"; SNEEZING (non-serious) with onset 24May2024, outcome "recovering"; NASAL CONGESTION (non-serious) with onset 24May2024, outcome "recovering", described as "congestion"; FATIGUE (non-serious) with onset 24May2024, outcome "recovering", described as "exhaustions/Tiredness/total exhaustion"; RHINITIS ALLERGIC (non-serious) with onset 24May2024, outcome "recovering", described as "extreme allergy like runny nose and sneezing"; MUSCULAR WEAKNESS (non-serious) with onset 24May2024, outcome "recovering", described as "leg weakness"; ASTHENIA (non-serious) with onset 24May2024, outcome "recovering", described as "weakness/upper body weakness/Extreme bilateral upper body weakness"; LEUKAEMIA (medically significant) with onset 2024, outcome "recovering", described as "Leukemia"; LIMB INJURY (non-serious) with onset 2024, outcome "recovering", described as "Local arm holding; Arm hurting"; ANAEMIA (medically significant) with onset 2024, outcome "recovering", described as "anemia"; NAUSEA (non-serious) with onset 2024, outcome "recovering"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2024, outcome "recovering", described as "tightening of the arm"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 2024, outcome "recovering", described as "trouble keeping his head up/Could not do more than lift my head". Therapeutic measures were taken as a result of leukaemia, anaemia. Therapeutic measures were not taken as a result of musculoskeletal stiffness, asthenia, nausea, fatigue, vaccination site pain, arthralgia, muscular weakness, nasal congestion, rhinitis allergic, joint range of motion decreased, limb injury, rhinorrhoea, sneezing. Clinical course: Caller had the Covid 19 vaccine shot 2023-2024 formula on 23May2024, and after this he experienced some current side effects like holding the tightening of the arm, minor pain in the shoulder, upper body weakness, like weakness, nausea, exhaustions, trouble keeping his head up. After this he has been taking iron shots for his Leukemia and anemia, he has been feeling gradually relieved, however he wants to know if it would be safe to take another shot. Consumer stated, "He was 79 years old and he had current, with all my COVID shots until the current one that was just been released and he have not had any reaction except the typical local arm holding or may be arm hurting or tiredness or whatever, until the last one she had which was Thursday on the 23May2024). About 9:15 he received his latest COVID booster (Later clarified as covid-19 vaccine), which is Pfizer, a Pfizer vaccine and again he was current, up to that point he had no side effects except the local ones. Thursday afternoon and evening he experienced minor pain at the shot site and some pain in the shoulder and the other shoulder, but the next morning he woke up with the extreme bilateral, especially upper body weakness and later leg weakness, like congestion, extreme allergy like runny nose and sneezing and total exhaustion. He really could not do more than lift his head and that was barely, but the symptoms gradually improved on Saturday and Sunday before seeming to go away on Sunday morning now. He never had anything like that before or since and he called his pharmacist to report it, his pharmacist reported it to the FDA side effects web site. He wanted to call them because he tried to figure out what happened and whether he would dare risk another covid shot, because the new ones are out, or the flu shot or what the heck was going on there.". Consumer stated. He did not see anything; it says 12 plus LC4370. Time of vaccination: Consumer stated, "No, approximate time he would guess it would be 10am, but he could not be sure of that.". Vaccination facility name: Consumer stated, "(Pharmacy name withheld)". Consumer stated, all the doses have the same thing 12 plus and then it has 056M21A. He said was that a Lot# or that something else. Consumer was informed that they cannot confirm that and informed that the same will be mentioned in the report. Route of administration: Consumer stated, "He did not know, it was the usual thing." Anatomical site: Consumer stated, "he thought it was the right arm. He thought but not sure." Treatment: Consumer stated, "No.". Consumer stated, "Several medications, several conditions. Parkinson's for one. CLL (Chronic lymphocytic leukemia), and there was no medication for that. Chronic lymphocytic leukemia, he thought." (Further not clarified appropriately, hence not captured). Consumer stated, "he was really had one thing. He have been getting Iron infusions. He have had two of those for the CLL, for the anemia and he had that before the last COVID shot." When probed for the manufacturer and Lot# of Iron infusions, consumer stated, "No, there was no way he did not know that."  When probed if the consumer was getting Iron infusions in hospital, consumer stated, "No. When probed if there are any other vaccinations within four weeks prior taking the COVID-19 vaccine, Consumer stated, "No. He always wait at least a month." Reassurance: Consumer stated, "No, he means that was the big thing he was trying to figure out if he could safely take a flu shot, the COVID shot or whether he could get more iron infusions. He also wanted to make sure that Pfizer knew about these reactions because it looks more and more like a side effect from the vaccine."  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.