Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Drug intolerance, Hypotension, Mastication disorder, Pain
Clinical narrative: Body aches; Blood pressure dropped; He could barely talk or chew; He could barely talk or chew; He has a low tolerance to medication; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Body aches"; HYPOTENSION (non-serious), outcome "unknown", described as "Blood pressure dropped"; SPEECH DISORDER (non-serious), MASTICATION DISORDER (non-serious), outcome "unknown" and all described as "He could barely talk or chew"; DRUG INTOLERANCE (non-serious), outcome "unknown", described as "He has a low tolerance to medication". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain.  Additional information: The patient wanted to know as the Pfizer-BioNTech COVID-19 Vaccine was FDA approved on 23Aug2021 whether still an EUA. The patient had recieved both doses of the Pfizer Covid 19 Vaccine and was supposed to receive the Pfizer Booster Vaccine and whether the vaccine had been FDA approved. The agent thought the patient was asking if the booster had been FDA approved. The patient clarified that he was speaking on the two dose series of the Pfizer Covid 19 Vaccine. Response given to the patient was initially spoke from the Fact Sheet. "It was also authorized under EUA as a third primary series dose in individuals 12 years of age and older who had been determined to have certain kinds of immunocompromise. A single booster dose in individuals: 65 years of age and older."  After clarification from the patient, the agent spoke from the attached document. The patient asked if the Pfizer Covid 19 Vaccine had been approved in (Withheld) and the patient was advised that the agent didn't had information for (Withheld). Informed the patient that the agent would be happy to provide the information to reach out to Pfizer Medical for (Withheld) but patient declined the offer at that time. the patient asked why the Pfizer Covid 19 Vaccine had two different names. Response: Spoke from the attached document. "When the FDA approves a vaccine, it means they have determined, based on substantial evidence, that it is effective for its intended use, and that its benefits outweigh its risk when used according to the product's approved labeling. When the FDA approves a vaccine, it means they have determined, based on substantial evidence, that it is effective for its intended use, and that its benefits outweigh its risks when used according to the product's approved labeling." Per patient during his vaccination series he experienced body aches. He took Acetaminophen 1500mg within 1.5 hours. He had a low tolerance to medication. His blood pressure dropped, he could barely talk or chew. The ambulance was called out to his home. He spoke with his HCP who thought he possibly took to much medication along with his BP medication, causing his BP to drop. The patient asked if the dose for the Pfizer Covid 19 Booster is the same as the first vaccines.  E-TRANSMITNG, POTENTIAL AE NOTED (no age captured, AE noted after the caller had disconnected form the line) Response: Spoke from the attached document. "The booster dose described above is the same vaccine that is used for the primary series."  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.