Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Cough, Fatigue, Feeling abnormal, Headache
Clinical narrative: vomiting; Nausea; extreme fatigue; Sore throat; coughing; Sneezing; heart rate over 100; body aches; Joint pain; Has had headaches, since before taking the vaccine. Had gotten notably worse, after taking it.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Nov2023 at 09:00 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 57 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing), notes: Crohn's disease; "Diabetes" (unspecified if ongoing), notes: Diabetes; "Anemia" (unspecified if ongoing), notes: Anemia; "Gastritis" (unspecified if ongoing), notes: Gastritis; "Osteopetrosis" (unspecified if ongoing), notes: Osteopetrosis; "Pancreatitis" (unspecified if ongoing), notes: Has problems with Pancreatitis; "Colitis" (unspecified if ongoing), notes: Has problems with Colitis; "Sicca syndrome" (unspecified if ongoing), notes: Has dry eyes, dry mouth, everything; "Cataracts" (unspecified if ongoing), notes: Cataracts; "reflux disease" (unspecified if ongoing); "low thyroid" (unspecified if ongoing); "Squamous skin cancer" (unspecified if ongoing), notes: Squamous skin cancer Has history of Squamous skin cancer; "kidney stones" (unspecified if ongoing), notes: History of kidney stones; "headaches" (unspecified if ongoing), notes: Has had headaches, since before taking the vaccine; "severe illnesses" (unspecified if ongoing), notes: does not have real good health either; "high blood pressure" (unspecified if ongoing), notes: In past year, doctor took her off blood pressure medicine, it seemed to have gone back to regular. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (1st dose: , Anatomical Site of injection:  rm unknown which one, Batch/Lot number: EN5318, guessing that is LOT), administration date: 25Feb2021, when the patient was 54-year-old, for Covid-19 Immunization; bnt162b2 (2nd dose: , Anatomical Site of injection: Unknown, Batch/Lot number: EN5318), administration date: 16Mar2021, when the patient was 54-year-old, for Covid-19 Immunization; bnt162b2 (3rd dose, Anatomical Site of injection: Unknown, Batch/Lot number: 30145BA or 301458A), administration date: 15Oct2021, when the patient was 55-year-old, for Covid-19 Immunization; bnt162b2 (4th dose, Anatomical Site of injection: Unknown, Batch/Lot number: F55683), administration date: 27Apr2022, when the patient was 56-year-old, for Covid-19 Immunization; bnt162b2, bnt162b2 omi ba.4-5 (5th dose, Bivalent booster, Anatomical Site of injection: Unknown, Batch/Lot number: looks like 6219694 or 649694), administration date: 07Oct2022, when the patient was 56-year-old, for Covid-19 Immunization, reaction(s): "throw up"; flucelvax (Vaccine Name: Flucelvax, NDC: 70461-0323-03, Expiry Date: 19Oct2024, Route, Anatomical Location: PF injection 2023-24 .5ml, administered to right arm), administration date: 20Oct2023, when the patient was 57-year-old, for Immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 04Nov2023, outcome "unknown", described as "Joint pain"; SNEEZING (non-serious) with onset 04Nov2023, outcome "recovered"; OROPHARYNGEAL PAIN (non-serious) with onset 04Nov2023, outcome "recovering", described as "Sore throat"; PAIN (non-serious) with onset 04Nov2023, outcome "unknown", described as "body aches"; COUGH (non-serious) with onset 04Nov2023, outcome "recovering", described as "coughing"; FATIGUE (non-serious) with onset 04Nov2023, outcome "not recovered", described as "extreme fatigue"; HEART RATE INCREASED (non-serious) with onset 04Nov2023, outcome "unknown", described as "heart rate over 100"; NAUSEA (non-serious) with onset 04Nov2023 at 09:00, outcome "recovering"; VOMITING (non-serious) with onset 04Nov2023 at 09:00, outcome "recovered" (04Nov2023 at 20:00); HEADACHE (non-serious) with onset Nov2023, outcome "unknown", described as "Has had headaches, since before taking the vaccine. Had gotten notably worse, after taking it.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vomiting, nausea, oropharyngeal pain, cough, headache. Therapeutic measures were not taken as a result of heart rate increased. Additional information: The patient called regarding Comirnaty vaccine for Covid. She wanted to report some side effects she had with that. When asked about the indication of the vaccine, the patient stated her husband has brain cancer and she does not have real good health either. She tried to get all vaccines, to cut down on severe illnesses. She took the vaccine on Friday (03Nov2023), about 9 am, she thinks it was. First part of the day was fine. The next morning (04Nov2023) about 9 am, started having nausea, ended up vomiting 11 hours, that was really, really bad. She had extreme fatigue, sore throat of course and coughing and sneezing. The patient clarified that nausea and vomiting started 04Nov2023, the day after vaccine, starting at 9AM. She clarified she was vomiting for 11 hours. After 11 hours and 4mg Zofran, from her husband, she stopped vomiting. She still feels nauseas, vomiting stopped. Nausea was still lasting, she was just taking Pepto Bismol. Nausea has gotten a little better than it was the first day but, still not good. There was no other treatment for nausea and vomiting other than Zofran and Pepto Bismol she previously mentioned. Extreme fatigue started the same day, on 04Nov2023. She basically laid on bathroom floor, pretty much all day, couldn't make it to toilet from bedroom. Sore throat got better after Sunday (05Nov2023). The patient took Tylenol and a couple cough drops for her sore throat. She stopped sneezing probably after Sunday (05Nov2023). She stated she was still coughing intermittently but slowly getting better. She did take some Sudafed one day, to see if it would help any, seemed to help some. She was having was having real bad headaches too. She took Tylenol but didn't seem to be touching it. She made sure she took Sudafed. Has had headaches, since before taking the vaccine. Had gotten notably worse, after taking it; this started on Saturday, 04Nov2023 or Sunday, 05Nov2023. When asked if adverse events required a visit to the physician office or emergency room, the patient stated she called ger doctor that night. If she thought she could have made it to emergency room, she would have. She went on patient portal. Without throwing up and other things, she would have gone. She simply couldn't stop long enough to go. The patient also had a heart rate over 100, for like 24 hours, maybe not 24, more like 12 hours. This occurred on the same date, 04Nov2023. This was happening even though she wasn't throwing up. At times, she could rest, calm down from vomiting, it was still going fast. She got watch alerts that were going off, until she finally took watch off. The patient did not receive treatment for this. She has had problems with high blood pressure. In past year, her doctor took her off blood pressure medicine, it seemed to have gone back to regular. She had body aches and joint pain really bad which started around same time, 04Nov2023. She still experienced these after then. It probably took until Monday (06Nov2023) or Tuesday(07Nov2023)  for her to start feeling better, that way. At the time of report, the patient stated she was still very tired and was still having nausea issues. Her doctor told her she should report this.   The information on the batch/lot number for (BNT162B2 OMI XBB.1.5), has been requested and will be submitted if and when received.