Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Investigation, Malaise, Myalgia, Pain in extremity
Clinical narrative: Chills; moving slow and doesn't have any energy; Temp 101.1; injection site pain and tenderness, can barely touch it and it hurts; arm pain; injection site pain and tenderness, can barely touch it and it hurts; arm pain; Feeling unwell; Tiredness; sick; muscle pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Aug2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing), notes: Diabetes; "Pulmonary hypertension" (ongoing), notes: she was on high dose steroid for her Pulmonary Hypertension; "Arthritis" (ongoing), notes: Arthritis; "Overweight" (ongoing), notes: A little Overweight; "Hemolytic anemia" (ongoing); "Migraine" (ongoing); "Heart and Lung Disease" (ongoing); "Heart and Lung Disease" (ongoing); "Compromised Immune System" (ongoing); "Massive Blood Clots" (ongoing); "Pacemaker" (ongoing); "Lupus" (ongoing); "Oxygen 24 Hours" (ongoing). Concomitant medication(s) included: BENLYSTA intravenous taken for systemic lupus erythematosus, start date: 08Aug2023; COUMADIN taken for thrombosis; TYLENOL taken for migraine. Vaccination history included: BNT162b2 (Dose 1, single), administration date: 03Mar2021, when the patient was 60-year-old, for Covid-19 immunization, reaction(s): "it took her energy away", "her arm started hurting", "her legs got weak"; BNT162b2 (Dose 2, single), administration date: 25Mar2021, when the patient was 60-year-old, for Covid-19 immunization, reaction(s): "wanted to sleep", "tired"; BNT162b2 (Dose 3 (booster), single), administration date: 17Nov2021, when the patient was 61-year-old, for Covid-19 immunization; BNT162b2 (Dose 4 (booster), single), administration date: 09Aug2022, when the patient was 62-year-old, for Covid-19 immunization; BNT162b2 (Dose 5 (booster), single; Bivalent Booster, Lot number: GK1337), administration date: 12Jan2023, when the patient was 62-year-old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 14Aug2023, outcome "recovered" (15Aug2023); MALAISE (non-serious) with onset 14Aug2023, outcome "not recovered", described as "Feeling unwell"; PYREXIA (non-serious) with onset 14Aug2023, outcome "recovering", described as "Temp 101.1"; FATIGUE (non-serious) with onset 14Aug2023, outcome "not recovered", described as "Tiredness"; VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 14Aug2023, outcome "not recovered" and all described as "injection site pain and tenderness, can barely touch it and it hurts; arm pain"; ASTHENIA (non-serious) with onset 14Aug2023, outcome "recovering", described as "moving slow and doesn't have any energy"; MYALGIA (non-serious) with onset Aug2023, outcome "unknown", described as "muscle pain"; ILLNESS (non-serious) with onset Aug2023, outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Indication as Reported by the Primary Source was High Risk; Heart and Lung Disease Diabetes Pulmonary Hypertension, Lupus, Overweight and Arthritis. The reporter stated she called about the Pfizer Shot she got yesterday on 14Aug2023, the 6th one (as reported). She stated it threw her for a loop. AE with the First One included her arm started hurting the next day and her legs got weak and she almost could not get up on the bus. The social worker said patient needed to use a wheelchair for a while because it took her energy away. AE with the second one included she was really tired and she wanted to sleep a lot but with this one (sixth one) she feels weak and sick and when she saw her temperature went up, she thought as long as it went down she did not worry about it. She had injection site pain and tenderness. She stated will all of the other shots it never got sore so quick, and it is still sore. Patient has tiredness and she guesses muscle pain from the injection site, chills, a temperature of 101.1 and a feeling of being unwell and arm pain. She can barely touch the injection site it hurts so much and she is also moving slow and does not have any energy. She stated they took a nap and feels somewhat better but not all of the way better after the nap. She is still tired and does not have all her energy yet. She stated it is making her feel sick, like unwell. Moving slow and does not have any energy. Usually after eating, she gets her energy back, but her body said it is not giving her anything. Chills were intermittent, she would get the chills then they would stop, then she would get hot, then the chills. Temp 101.1, She stated she would start drinking water and ice to cool down. She reports the medication she takes for her Migraines has Tylenol in it so that helps to keep her Temperature down. Now it is running 99.7, 99.6, 99.5. She was trying to lose weight. She was on a high dose steroid for her Pulmonary Hypertension because it was really bad and the high dose steroids caused her to gain weight. She tries to take care of herself. She has a pacemaker, she is on 24-hour oxygen, she is on coumadin because she has massive blood clots, her Immune System is Compromised, Heart and Lung Disease, Diabetes, Pulmonary Hypertension, Lupus, Arthritis and she is told she is a little overweight. She also has Migraines. Investigations, The reporter stated they are always drawing PT/INR tests and running other tests such as CBC because her Red Blood Cells are too big. She had Hemolytic Anemia. Stated she has Macrocytic cells because they are so large. If her Hemoglobin and Hematocrit drop, she has to go back to the Cancer Doctor again.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.