Sex: U
Vaccine: COVID19, FLUX
Symptoms: Body temperature, Dry mouth, Feeling cold, Headache, Heart rate
Clinical narrative: heart rate is over 120 / tachycardic that I am over 120; started to feel a bit tremulous; Shaking all over which I could not control / violently shaking / shake violently, massive violently; Very bad headache/horrible headache; Dry mouth; Stuffiness in my head; Cannot remember how to do things; started to feel cold; running a fever; This is a spontaneous report received from an Other HCP.  An adult patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 30Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 30Sep2024 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRY MOUTH (non-serious) with onset 30Sep2024, outcome "unknown"; THINKING ABNORMAL (non-serious) with onset 30Sep2024, outcome "unknown", described as "Stuffiness in my head; Cannot remember how to do things"; HEADACHE (non-serious) with onset 30Sep2024, outcome "unknown", described as "Very bad headache/horrible headache"; TACHYCARDIA (medically significant) with onset 30Sep2024, outcome "unknown", described as "heart rate is over 120 / tachycardic that I am over 120"; PYREXIA (non-serious) with onset 30Sep2024, outcome "unknown", described as "running a fever"; TREMOR (non-serious) with onset 30Sep2024, outcome "recovering", described as "started to feel a bit tremulous; Shaking all over which I could not control / violently shaking / shake violently, massive violently"; FEELING COLD (non-serious) with onset 30Sep2024, outcome "unknown", described as "started to feel cold". The patient underwent the following laboratory tests and procedures: Body temperature: normal; Heart rate: over 120, notes: heart rate is over 120 / tachycardic. Therapeutic measures were taken as a result of headache, pyrexia.  Clinical course: Patient had the COVID vaccine this morning around 9 o'clock or so and also had the flu vaccine (Unspecified Flu Vaccine) and about two hours later, patient started to feel a bit tremulous and then became right out shaking all over which could not control. Patient stated, "Very bad headache, dry mouth and stuffiness in my head, it is like I cannot remember how to do things? And I am trying to figure out what is going on? Can you help me?" Patient was not cold but covered up on the blanket in case that is what it was. Later clarified that patient started to feel cold and then everything violently shaking; patient kept trying to stop. Described as shake violently, massive violently. The shaking has died down, patient went and laid down. Temperature was normal, took to the bed and wrapped up like patient could get warm and then took Tylenol; horrible headache. Patient thought he/she was running a fever. Reported that heart rate is over 120 and patient do not know what is going on. Patient was asking the possibility if it was from the vaccines. Patient stated, "also, my watch keeps telling me that I am tachycardic that I am over 120".  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: There is a reasonable possibility that the events headache, feeling cold, and pyrexia were related to COMIRNATY (2024-2025 FORMULA) based on known drug safety profile. Based on the close temporal relationship, the association between the rest of the other events with COMIRNATY (2024-2025 FORMULA) can not be fully excluded.  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.