Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Feeling of body temperature change, Headache, Malaise, Myalgia
Clinical narrative: feeling very unwell/sick; Muscle pain; Vomiting; dry heaves; Dizziness; Nausea; hot and cold chills; Heart muscle inflammation; Tiredness; Fever; joint pain; she is just weak; chills; headaches; she was not able to eat for three days; 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 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 as dose 1, single (Lot number: BT6456520) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hysterectomy" (not ongoing), notes: at age 40; "stroke that was in her right eye", start date: Jun2022 (unspecified if ongoing); "cancer" (unspecified if ongoing); "heart failed", start date: 2012 (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Antidepressants; Carvedilol, start date: 2012, notes: 12.5mg twice per day; Diltiazem, start date: 2012, notes: 250mg once per day; Zofran, reaction(s): "cardiac arrest", notes: Zofran was the only one they could conclude was related to the cardiac arrest. Vaccination history included: Moderna (Dose number unknown, single), for COVID-19 immunisation; Fluvaccin (Dose number unknown, single), for Influenza immunisation. The following information was reported: PYREXIA (non-serious) with onset Oct2023, outcome "unknown", described as "Fever"; MYOCARDITIS (medically significant) with onset Oct2023, outcome "unknown", described as "Heart muscle inflammation"; FATIGUE (non-serious) with onset Oct2023, outcome "unknown", described as "Tiredness"; CHILLS (non-serious) with onset Oct2023, outcome "unknown"; HEADACHE (non-serious) with onset Oct2023, outcome "unknown", described as "headaches"; ARTHRALGIA (non-serious) with onset Oct2023, outcome "unknown", described as "joint pain"; ASTHENIA (non-serious) with onset Oct2023, outcome "unknown", described as "she is just weak"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 26Oct2023, outcome "not recovered", described as "hot and cold chills"; DIZZINESS (non-serious) with onset 27Oct2023, outcome "recovered" (31Oct2023); NAUSEA (non-serious) with onset 27Oct2023, outcome "recovered" (31Oct2023); RETCHING (non-serious) with onset 28Oct2023, outcome "recovering", described as "dry heaves"; MALAISE (non-serious), outcome "unknown", described as "feeling very unwell/sick"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; VOMITING (non-serious), outcome "unknown"; FEEDING DISORDER (non-serious), outcome "recovered", described as "she was not able to eat for three days". Therapeutic measures were taken as a result of myocarditis. Clinical course: Patient was calling about the Pfizer vaccine and usually got Moderna and got the Pfizer on 23Oct and started getting hot and cold chills by 25Oct2023 and she was sick as a dog in bed since. She was a heart patient and there had been nothing but problems and she had been taking her heart medication double with an aspirin like her cardiologist told her to. She had dry heaves and name it and she had it; she had heart muscle inflammation, fever, joint pain, fever, pain, nausea, feeling very unwell, muscle pain, headache, tiredness, dry heaves that were the worst, vomiting and dizziness. This was very concerning and she had always gotten the Moderna and her pharmacy said they were out of that and gave her the Pfizer and said it was compatible and her mother and the caller went and her mother was age 80 and they got the flu shots and did the Moderna shots too and the caller was so sick. The caller had been a customer for years of Pfizer and had taken antidepressants for many many years. She was not a healthcare professional but was a registered dental assistant and did oral surgeries. She has had reactions to three different drugs but not Moderna which she never had a problem with; she took three drugs that killed her and literally put her in cardiac arrest and those caller states later in the call were Zofran, Iodine and contrast. She had cardiac arrest and they put in a defibrillator in her heart when she was only age 40 and the Zofran was the only one they could conclude was related to the cardiac arrest. She did an Magnetic resonance imaging for her cancer and her eyes shot out like egg yokes and clarified that she does not know the date that occurred but will say that was in Sep2000 and the drugs that she referred to that killed her regarding giving her cardiac arrest earlier in the call were Zofran, Iodine, and contrast and states she had no information to provide for those including the lot numbers or manufacturer names.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300356618 same reporter/drug, different patient/AE;