Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sluggishness, Tremor
Clinical narrative: kidney failure; I am nervous; I am shaking so much; I would say stomach distress like I don't know if I was constipated or what but I had a pain.; nausea; feeling chills; fever; sluggish; achy/pain; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 79-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Mar2024 at 15:30 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history included: "I have some serious heart conditions, heart failure among them" (unspecified if ongoing); "I have a defibrillator" (unspecified if ongoing); "I have some serious heart conditions, heart failure among them" (unspecified if ongoing); "Hypothyroidism" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism. The patient also took other concomitant therapy. Vaccination history included: Bnt162b2 (Dose 6(Booster), Single), for COVID-19 Immunization; Bnt162b2 (Dose 5(Booster), Single), for COVID-19 Immunization; Bnt162b2 (Dose 4(Booster), Single), for COVID-19 Immunization; Bnt162b2 (Dose 3 (Booster), Single), for COVID-19 Immunization; Bnt162b2 (Dose 2, Single), for COVID-19 Immunization; Bnt162b2 (Dose 1, Single), for COVID-19 Immunization, reaction(s): "heart attack".  The following information was reported: PAIN (non-serious) with onset 02Mar2024 at 19:30, outcome "unknown", described as "achy/pain"; CHILLS (non-serious) with onset 02Mar2024 at 19:30, outcome "unknown", described as "feeling chills"; PYREXIA (non-serious) with onset 02Mar2024 at 19:30, outcome "recovered", described as "fever"; SLUGGISHNESS (non-serious) with onset 02Mar2024 at 19:30, outcome "unknown", described as "sluggish"; ABDOMINAL DISCOMFORT (non-serious) with onset 04Mar2024, outcome "recovering", described as "I would say stomach distress like I don't know if I was constipated or what but I had a pain."; NAUSEA (non-serious) with onset 04Mar2024, outcome "unknown"; RENAL FAILURE (medically significant), outcome "unknown", described as "kidney failure"; NERVOUSNESS (non-serious), outcome "unknown", described as "I am nervous"; TREMOR (non-serious), outcome "unknown", described as "I am shaking so much". The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) I did have blood work for my kidney doctor. It was, notes: for renal function; Body temperature: (05Mar2024) 101, notes: this morning it was 101 and I did take Tylenol, I took it and now it's normal like 97.6; (Mar2024) 101.7; (Mar2024) 97.6; SARS-CoV-2 test: (05Mar2024) Negative. Therapeutic measures were taken as a result of renal failure, chills, pyrexia.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.  Clinical course: The caller got Pfizer covid booster shot Saturday since then she is feeling chills, fever, nausea wants to know if its immune response. The Caller stated she has high fever, chills are bad, she had 7 covid vaccination and have not had any reactions, stated " something is wrong with her." The caller stated she will go to the hospital and did not proceed with the call. Consumer stated, she had the COVID bivalent booster on Saturday at 3:30. It's her sixth or seventh, she started at the very beginning, and she had a booster whenever a new one was available, or the CDC approved it. So, this is what she wants to ask about. So, at 3:30 she had the injection, by 7:30 she felt very sluggish and then she had fever and chills and achy, so that has continued off and on even today. Now her fever would go up to 101.7, it would fluctuate. Now, today this morning it was 101 and she did take Tylenol, she took it and now it was normal like 97.6 but she also had last night, she would say stomach distress like she does not know if she was constipated or what, but she had a pain. She finally did go to the bathroom a bit and she felt better but she has also had slight nausea. Now, this morning her husband got a fresh COVID test. He said she should take the test to make sure she had not caught COVID contemporaneously and the COVID test was negative. Just for your information, she is 79. She has some serious heart conditions, heart failure among them. She has a defibrillator. she had a heart attack right after she had first COVID shot (Suspect captured as COVID Vaccine). She knows that's not related. She also has some kidney failure. She has hypothyroidism, she takes Levothyroxine. So, what do you think. Did she mention chills, she also has chills like now she does not have a fever, but she does have chills. May be the chills are because she is nervous. Is this her immune response and will it end soon. " When asked if took the Pfizer COVID Booster shot, the consumer stated, "Yes, the Bivalent. The most recent." When paraphrased the concern, consumer confirmed the same. The consumer stated, "she wants to stay hydrated because she has such bad chills." "Her symptoms came by 7:30, 4 hours after she had the shot. She was shaking so much. she might have to go to the hospital." Consumer was requested to call their healthcare provider in case of emergency. Other medical history and concomitant medications stated, "she does take lot of other medication for heart and kidney and things." The consumer stated, "Yes, she did have blood work for her kidney doctor. It was for renal function." Treatment: Consumer stated, "she has taken 2 or 3 at the most Tylenol a day and she was having drinking water."  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] will be requested and submitted if and when received.