Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody positive, Biopsy skin, Blood test normal, COVID-19, Chest discomfort
Clinical narrative: home test-covid test result=Positive; home test-covid test result=Positive; experienced coolness in my legs/ cold feeling spread to my buttocks. My buttocks feel icy. My legs and buttocks feel cool to the touch but extremely cold to me; It is difficult to concentrate on my work and my life because of the cold feeling in my legs and my buttocks.; I am very uncomfortable; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 (Lot number: Fd7218) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Essential tremor" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: known allergies: Erythromycin. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 047B21A, Location of injection: Arm Left), administration date: 14Apr2021, when the patient was 52 years old, for COVID-19 Immunization; Moderna (Dose Number: 1, Batch/Lot No: 046A21A, Location of injection: Arm Left), administration date: 17Mar2021, when the patient was 52 years old, for COVID-19 Immunization. The patient did not had other vaccine in four weeks and other medications in two weeks.The patient did not have covid prior vaccination. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Dec2021, outcome "unknown", described as "Interchange of vaccine products"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "unknown" and all described as "home test-covid test result=Positive"; FEELING COLD (disability, medically significant) with onset 18Dec2021 17:00, outcome "not recovered", described as "experienced coolness in my legs/ cold feeling spread to my buttocks. My buttocks feel icy. My legs and buttocks feel cool to the touch but extremely cold to me"; DISTURBANCE IN ATTENTION (disability, medically significant) with onset 18Dec2021 17:00, outcome "not recovered", described as "It is difficult to concentrate on my work and my life because of the cold feeling in my legs and my buttocks."; DISCOMFORT (disability, medically significant) with onset 18Dec2021 17:00, outcome "not recovered", described as "I am very uncomfortable". The events "experienced coolness in my legs/ cold feeling spread to my buttocks. my buttocks feel icy. my legs and buttocks feel cool to the touch but extremely cold to me", "it is difficult to concentrate on my work and my life because of the cold feeling in my legs and my buttocks." and "i am very uncomfortable" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive, notes: covid test type post vaccination=Nasal Swab; (19Dec2021) negative, notes: covid test type post vaccination=Nasal Swab; (21Dec2021) negative, notes: covid test type post vaccination=Nasal Swab. Therapeutic measures were not taken as a result of feeling cold, disturbance in attention, discomfort.  Clinical course: 2 days after the Pfizer vaccine booster (3rd shot), Patient experienced coolness in her legs. About 2 weeks later the cold feeling spread to her buttocks. Her buttocks feel icy. Her legs and buttocks feel cool to the touch but extremely cold to me. She have had to wear outdoor lined running pants 24/7. She put a heating pad on her desk chair to sit on and drape a blanket over her lap. She was very uncomfortable. It was difficult to concentrate on work and her life because of the cold feeling in her legs and buttocks. It was persistent, relentless and does not let up.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.  Amendment (DSU): to allow successful HA submission.