Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Groin pain, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: . Extreme difficulty getting in and out of tub and showering. Dressing couldn't lift arms over head.; lower left groin area with severe itching/itching lower left leg ankle; Extreme pain in upper arm; then paralysis; unable to move legs up; Started with pain in lower left groin area; bad pain in my buttocks; bad pain in my thighs; bad pain in my back; Unable to lift arms up; hard "knots" in deltoids both arms.; When I could move, had to use a cane to assist with mobility.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Aug2022 at 16:30 as dose 4 (booster), single (Lot number: FP7135) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Type II Diabetes" (unspecified if ongoing); "Diverticulosis" (unspecified if ongoing); "Bone Spur in Neck" (unspecified if ongoing); "Freckle in Left Eye" (unspecified if ongoing); "Cataracts" (unspecified if ongoing); "Eczema" (unspecified if ongoing); "Molds" (unspecified if ongoing); "she diagnosed with covid" (unspecified if ongoing); "Age-Related Macular Degeneration" (unspecified if ongoing); "Discs Issues in Lower Back" (unspecified if ongoing); "Bermuda Grass" (unspecified if ongoing); "Nickel" (unspecified if ongoing); "p-Phenylenediamine (in black hair dyes)" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM; HCTZ; ACETAZOLAMIDE; NIFEDIPINE; ATORVASTATIN; LEVOCETIRIZINE; TYLENOL EXTRA STRENGTH taken for pain; TYLENOL ARTHRITIS PAIN taken for arthritis, pain; ADVIL LIQUI GELS taken for pain; CENTRUM GENDER +50; VITAMIN D3; FISH OIL; COQ-10; METAMUCIL CITRON; FLUTICASONE PROPIONATE; AZELASTINE. Past drug history included: Ultram for Ultram makes me nauseated, reaction(s): "Known allergies: Ultram". Vaccination history included: BNT162b2 (Prev dose product= COVID 19, Prev dose brand=Pfizer Covid-19 Vaccine, Prev dose brand unknown= False, Is bivalent=False, Prev dose lot number=FE3590, Prev dose lot unknown= False, Prev dose administration date= 15Nov2021, Prev dose administration time=01:00 PM, Prev dose dose number= 3, Prev dose vaccine location= Left arm), administration date: 15Nov2021, when the patient was 68-year-old, for Covid-19 immunization; BNT162b2 (Prev dose product= COVID 19, Prev dose brand= Pfizer Covid-19 Vaccine, Prev dose brand unknown= False, Is bivalent=False, Prev dose lot number= EN6208, Prev dose lot unknown= False, Prev dose administration date= 15Mar2021, Prev dose administration time=02:45 PM, Prev dose dose number= 2, Prev dose vaccine location= Left arm), administration date: 15Mar2021, when the patient was 67-year-old, for Covid-19 immunization; BNT162b2 (Prev dose product= COVID 19, Prev dose brand= Pfizer Covid-19 Vaccine, Prev dose brand unknown= False, Is bivalent=False, Prev dose lot number= EN6200, Prev dose lot unknown= False, Prev dose administration date= 22Feb2021, Prev dose administration time=01:45 PM, Prev dose dose number= 1, Prev dose vaccine location= Left arm), administration date: 22Feb2021, when the patient was 67-year-old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Aug2022, outcome "recovered", described as "Extreme pain in upper arm"; GROIN PAIN (non-serious) with onset 08Aug2022, outcome "recovered", described as "Started with pain in lower left groin area"; MOVEMENT DISORDER (non-serious) with onset 08Aug2022, outcome "recovered", described as "Unable to lift arms up"; GAIT INABILITY (non-serious) with onset 08Aug2022, outcome "recovered", described as "When I could move, had to use a cane to assist with mobility."; BACK PAIN (non-serious) with onset 08Aug2022, outcome "recovered", described as "bad pain in my back"; MUSCULOSKELETAL PAIN (non-serious) with onset 08Aug2022, outcome "recovered", described as "bad pain in my buttocks"; PAIN IN EXTREMITY (non-serious) with onset 08Aug2022, outcome "recovered", described as "bad pain in my thighs"; NODULE (non-serious) with onset 08Aug2022, outcome "recovered", described as "hard "knots" in deltoids both arms."; PRURITUS (non-serious) with onset 08Aug2022, outcome "recovered", described as "lower left groin area with severe itching/itching lower left leg ankle"; PARALYSIS (medically significant) with onset 08Aug2022, outcome "recovered", described as "then paralysis"; MONOPLEGIA (medically significant) with onset 08Aug2022, outcome "recovered", described as "unable to move legs up"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as ". Extreme difficulty getting in and out of tub and showering. Dressing couldn't lift arms over head.". The events "then paralysis", "unable to move legs up", "started with pain in lower left groin area", "bad pain in my buttocks", "bad pain in my thighs", "bad pain in my back", "unable to lift arms up", "hard "knots" in deltoids both arms.", "when i could move, had to use a cane to assist with mobility.", "lower left groin area with severe itching/itching lower left leg ankle" and "extreme pain in upper arm" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) Unknown Results; Computerised tomogram: (unspecified date) Unknown Results; Referral: (unspecified date) Unknown Results; Magnetic resonance imaging: (unspecified date) Unknown Results; SARS-CoV-2 test: (06Nov2022) Negative, notes: Nasal Swab; (30Nov2022) Negative, notes: Nasal Swab; X-ray: (unspecified date) Unknown Results. Therapeutic measures were taken as a result of paralysis, monoplegia, groin pain, musculoskeletal pain, pain in extremity, back pain, movement disorder, nodule, gait inability, pruritus, pain in extremity.  Clinical information: No other vaccine in four weeks. Patient received other products as well. Started with pain in lower left groin area with severe itching (no rash); then paralysis -unable to: raise my body up, roll to either side, move legs up. Excruciating pain in my left groin area with really bad pain in my buttocks, thighs, back. Later pain in right groin area and same type itching lower left leg ankle area with no rash. When I could finally move, unable to lift up legs to climb stairs, extreme difficulty getting in and out of tub, showering and putting on clothes. Unable to lift arms up over head to comb hair or reach for objects. Extreme pain in upper arm (left and right) with hard "knots" in deltoids both arms. When I could move, had to use a cane to assist with mobility. Concomitant, Medicinal Product Name as Reported by the Primary Source: Preservision Eye Vitamin, Dosage text: Takes 2 daily and Elderberry gummy 100mg; 2 gummies daily. Went online yesterday and filled out the information online to report an adverse event and underneath the drugs she was taking 2 weeks prior to the vaccination, it wouldn't let her list out all of her medications. She started to list them but couldn't list them all. Wants to add those medications to her original report.  Patient Details: She is 69 now because she has since had a birthday, but she was 68 when the adverse event happened. There were a lot of things that happened to her. She took vaccine on 05Aug2022 and late Friday evening she started the beginning of the side effects. Thinks the side effects are due to the vaccine and started on that following Monday. Got an itch in her lower left portion of her groin area and started hurting in her groin area. Couldn't get the itch to stop even when she scratched. Pain started in left groin area. No rash present and that was on the 08Aug2022. Went on that week. Itching would stop and start. Saturday night after 08Aug2022, she started experiencing paralysis. Was in the bed asleep at night, and woke up at night, couldn't move couldn't raise her body up, couldn't roll, couldn't raise legs up, had excruciating pain in left groin and buttocks thighs and back.  Finally subsided. Happened that Saturday and Sunday night. Went to her provider after that. Didn't go to emergency room. Was hurting bad enough to call 911. She thought about it but didn't. Waited until Monday and went to see her provider. Did X-rays and stuff. After that, several weeks passed and it started up again. Hurting in groin, hurting in left and right groin area. Has stairs in her house and couldn't lift legs to climb stairs. Extreme difficulty getting in and out of tub and showering. Dressing couldn't lift arms over head. Extreme pain in both arms in deltoid area. Muscles would get hard in both arms and when she could move around, she had to use a cane. Was a series of this going on for several week. Started 08Aug2022 and was referred to an ortho doctor. Went to two different doctors and finally went away. Didn't put any dates with it. All of this has been reported. Made one big paragraph of it and made it as thorough and brief as she could, but its all in there. The medications was the only area that concerned her because she wanted Pfizer to know everything she took and it wouldn't let her take the rest of the medications. She reported her cat scans, xrays, MRI, blood tests, and referrals. The previous report asked her prior to vaccination was she diagnosed with covid, and she said, no. Asked if she had been tested for covid, she said yes, but they were all home tests and she did them herself. She takes pictures of each home test she does, so she had the dates for those and was able to report that as well. Medications was the only area she wasn't able to fully report on. Doesn't wish to add anything else. If Pfizer wants anymore information, they can reach out and talk to her.