Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Investigation, Lethargy, Magnetic resonance imaging, Pain
Clinical narrative: pain / achy; paralyzed/couldn't move her legs or feet; couldn't walk; couldn't stand; whole body inflammatory response; extreme fatigue; very lethargic; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Dec2024 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "cervical myelopathy", start date: 2021 (unspecified if ongoing), notes: still had myelopathy compression in her neck for too long. MRI and radiology report done; one doctor said she didn't have it; "cervical myelopathy surgery", start date: 2021 (unspecified if ongoing), notes: Had the surgery probably 3 years ago; "Asthma" (ongoing); "Glaucoma" (ongoing); "Osteoporosis" (unspecified if ongoing), notes: Osteoporosis which she has; "Hip replacement", start date: 12Apr2024 (unspecified if ongoing). The patient's family history included: "osteoarthritis" (unspecified if ongoing), notes: osteoarthritis which she also has. Concomitant medication(s) included: TRAVOPROST taken for glaucoma (ongoing); DULERA taken for asthma (ongoing); INFLUENZA VACCINE taken for immunisation as dose number unknown single; PNEUMOCOCCAL VACCINE taken for immunisation as dose number unknown single; VARICELLA ZOSTER VACCINE taken for immunisation as dose 1, single as dose 2, single. The patient also took other concomitant therapy. Vaccination history included: Moderna (never had a side effect with Moderna Covid vaccines), for Covid-19 Immunization; Comirnaty (2023-2025 formula) (DOSE 1, SINGLE, doesn't recall which arm in Apr2024), administration date: Apr2024, when the patient was 79 years old, for Covid-19 Immunization, reaction(s): "paralyzed her the next day"; Comirnaty (2024-2025 formula) (DOSE 1, SINGLE, She was flat on her back for 2 days with a severe reaction.), administration date: Apr2024, when the patient was 79 years old, for Covid-19 Immunization, reaction(s): "had no strength in her body". The following information was reported: DYSSTASIA (non-serious) with onset 07Dec2024, outcome "unknown", described as "couldn't stand"; GAIT INABILITY (non-serious) with onset 07Dec2024, outcome "recovered" (08Dec2024), described as "couldn't walk"; FATIGUE (non-serious) with onset 07Dec2024, outcome "not recovered", described as "extreme fatigue"; PAIN (hospitalization) with onset 07Dec2024, outcome "not recovered", described as "pain / achy"; LETHARGY (non-serious) with onset 07Dec2024, outcome "not recovered", described as "very lethargic"; INFLAMMATION (non-serious) with onset 07Dec2024, outcome "unknown", described as "whole body inflammatory response"; PARALYSIS (hospitalization, medically significant) with onset Dec2024, outcome "not recovered", described as "paralyzed/couldn't move her legs or feet". The patient was hospitalized for paralysis, pain (start date: 07Dec2024, discharge date: 08Dec2024, hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: Blood test: (Dec2024) Unknown results; Computerised tomogram: (Dec2024) Unknown results; radiology report: (2021) Unknown results; Magnetic resonance imaging: (2021) Unknown results. Therapeutic measures were taken as a result of pain.  Clinical course: The patient was taking other concomitant medications (unspecified supplements). She got the Pfizer shot again 06Dec thinking it was just a reaction that time. She ended up on 07Dec and 08Dec she couldn't walk, couldn't stand. She had whole body inflammatory response and God awful pain. She was able to walk on the 8th. She was in hospital on the 7th. They carried her out of the house by emergency squad. Had terrible pain and paralyzed, she couldn't move her legs or feet. She finally got a room at 2:30am. She was able to walk later the next day but still not over the reaction to the shot. She has extreme fatigue, very lethargic and achy.  Clarifies 1st dose to Apr2024, doesn't have exact date to provide. It was before 12Apr2024. She had right hip replacement 12Apr2024. So it was a week before that. The next day she was paralyzed. She got up to go to the bathroom and couldn't get off her bed or on her bed. She slid to the floor and spent the day on the floor waiting to call someone to help her. It was an incredible experience. She thought if she slid to the floor, she could hoist herself, but she had no strength in her body. For the outcome - got over it rather completely she thinks doesn't know because she had hip surgery so not sure. It was states that this time, the pain was terrible. She got EMS because her friend couldn't get her off the floor. She couldn't move from the pain. She went to the hospital. Clarifies she got her 2nd shot on 06Dec2024. EMS carried her out of the house on 07Dec2024 because she couldn't get in a wheelchair the pain was so great. It was incredible inflammatory pain. She spent the afternoon in the ER. She got IV fluids and IV Tylenol and lidocaine patches. The next day she was still in (city withheld) and was still very weak. She came home on 08Dec2024. Clarifies she was admitted to the hospital. Rapid treatment unit. Extreme fatigue, very lethargic, and achy is just continuing from the 07Dec2024. Was pretty good on the 6th, she went shopping and came home went to bed and woke up a mess. Outcome: still has it, persisting. Has no get up and go. During investigations: They did a whole body CAT scan and a lot of blood work. This is in her records there. They called it a fall and she told them no, she didn't fall she let herself to the floor. After this happened and was sort of back and cognitive functioning level she googled side effects of covid vaccination and in the reading she did there was recommended for humans over certain age thinks 65 to get Moderna rather than Pfizer. That is on Google. When got the Moderna vaccinations she never had a side effect but had dramatic with both of Pfizer. Clarifies Moderna Covid vaccines.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400334628 same patient and vaccine, different dose and event;