Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Malaise, Myalgia
Clinical narrative: was not feeling so good; chills; body was achy; running a temperature/broke a fever; sweat; shaking; muscle soreness; tired; sore arm; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 78-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 as dose 7 (booster), 0.3 ml single (Batch/Lot number: unknown) at the age of 78 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "blood thinner" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "atrial fibrillation" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for hypertension; ELIQUIS taken for blood disorder, hypertension, atrial fibrillation; ATORVASTATIN taken for blood cholesterol increased; METOPROLOL taken for atrial fibrillation. Vaccination history included: bnt162b2 (Dose 1), administration date: 27Sep2022, when the patient was 77-year-old, for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization; Bnt162b2 (Dose 3), for COVID-19 immunization; Bnt162b2 (Dose 4), for COVID-19 immunization; Bnt162b2 (Dose 5), for COVID-19 immunization; Bnt162b2 (Dose 6), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset Sep2023, outcome "unknown", described as "body was achy"; CHILLS (non-serious) with onset Sep2023, outcome "unknown"; MYALGIA (non-serious) with onset Sep2023, outcome "unknown", described as "muscle soreness"; PYREXIA (non-serious) with onset Sep2023, outcome "unknown", described as "running a temperature/broke a fever"; TREMOR (non-serious) with onset Sep2023, outcome "unknown", described as "shaking "; PAIN IN EXTREMITY (non-serious) with onset Sep2023, outcome "unknown", described as "sore arm"; HYPERHIDROSIS (non-serious) with onset Sep2023, outcome "unknown", described as "sweat"; FATIGUE (non-serious) with onset Sep2023, outcome "unknown", described as "tired"; MALAISE (non-serious) with onset Sep2023, outcome "unknown", described as "was not feeling so good". Therapeutic measures were taken as a result of pain, pyrexia.  Additional information: An adult female patient stated she had the Pfizer COVID vaccine Comirnaty yesterday. She got chills, body was achy and all of the stuff. She's asking can she take the vaccine next year like half of the medication or half of the vaccine? She had 7 shots of the Pfizer vaccines. Per patient, she had not a really bad reaction last year but did react to it. And this year, she knows it's probably a different vaccine but it was really kind of miserable. During the night it was severe chills, and probably was running a temperature but she was not feeling so good and she didn't take her temperature. She took Ibuprofen. And when she woke up in the morning she was just covered .with sweat. So she thought she might have run a temperature but has no proof of it. She's wondering next year if she gets the flu shot, is it going to escalate the reaction. I clarified the half vaccine she was asking about if that is regarding a flu vaccine or Pfizer COVID vaccine. She said it's the COVID. She said she's kind of worried about it already if it's going to be a worst reaction than what she had last night. Advised her that we only recommend 1 dose of the Comirnaty 2023-2024 formula for those 12 years and older and the dose is really 30 mcg for 0.3ml. Consumer stated, "I had the vaccine yesterday and I had a lot of chills last night, during the night for about 3 hours and I did not know if I wanted to report it or not. When paraphrased the concern, consumer stated, "I mean I am okay today, but I was just really shaking. It was probably almost 12 hours after the vaccine, I was fine and it woke me up at night and I was shaking in bed and I couldn't control it and I finally got up and took some ibuprofen because I was achy and finally went to sleep and when I woke up about 6 o'clock in the morning, I was really profusely sweating, so I thought maybe I broke a fever but I did not take a temperature because I was not feeling too low."  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.