Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Illness, Nausea, Oxygen saturation, Pain
Clinical narrative: short of breath/figured it was an issue asthma attack/pulse oximeter 92%; heart rate 125/Heart rate 91; severe chills; nausea; diarrhea; Feel sick this morning; Exhausted and sore from high heart rate; total body aches; This is a spontaneous report received from a Nurse.  A 66-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 13Sep2024 at 12:30 as dose 1, single (Lot number: CM2223) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma-controlled" (unspecified if ongoing); "chronic iron deficiency" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "UGI bleed x3" (unspecified if ongoing); "Gastric bypass surgery", start date: 2001, stop date: 2001; "pericarditis", start date: 2008 (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "Known allergies: Benzene" (unspecified if ongoing); "Known allergies: NSAIDS" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 omi xbb.1.5 (dose number: 1, in right arm), administration date: 15Aug2024, when the patient was 66-year-old, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 19Sep2024 at 02:30, outcome "unknown", described as "Exhausted and sore from high heart rate"; ILLNESS (non-serious) with onset 19Sep2024 at 02:30, outcome "unknown", described as "Feel sick this morning"; DIARRHOEA (non-serious) with onset 19Sep2024 at 02:30, outcome "unknown", described as "diarrhea"; HEART RATE INCREASED (non-serious) with onset 19Sep2024 at 02:30, outcome "recovered" (19Sep2024), described as "heart rate 125/Heart rate 91"; NAUSEA (non-serious) with onset 19Sep2024 at 02:30, outcome "unknown"; CHILLS (non-serious) with onset 19Sep2024 at 02:30, outcome "unknown", described as "severe chills"; ASTHMA (medically significant) with onset 19Sep2024 at 02:30, outcome "unknown", described as "short of breath/figured it was an issue asthma attack/pulse oximeter 92%"; PAIN (non-serious) with onset 19Sep2024 at 02:30, outcome "unknown", described as "total body aches". The patient underwent the following laboratory tests and procedures: Heart rate: (19Sep2024) 125; (19Sep2024) 91; Oxygen saturation: (19Sep2024) 92 %. Therapeutic measures were taken as a result of asthma. Therapeutic measures were not taken as a result of heart rate increased, chills, nausea, diarrhoea, illness, fatigue, pain.  Clinical course: On 19Sep2024, woke up short of breath, heart rate 125, severe chills, nausea, diarrhea. Figured it was an issue asthma attack used albuterol inhaler x2. Feel sick this morning. Exhausted and sore from high heart rate and total body aches/chills. Heart rate 91. Pulse oximeter 92%. No chest pain or diaphoresis. The remaining events did not receive treatment.; Sender's Comments: The event asthma is conservatively assessed as related to the suspect drug BNT162B2 OMICRON (KP.2) based on plausible temporal association but consider also possible contributory effects from medical history of the patient (with relevant medical history of asthma) and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.