Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Flushing, Heart rate increased, Hyperhidrosis, Malaise
Clinical narrative: allergic reaction to the vaccine; difficulty clearing throat; increased pulse rate; dizziness; headache; weakness; Feeling hot; flushed; nauseousness; decreased RR; increase in SBP/DBP; increase in SBP/DBP; This is a spontaneous report from a contactable nurse (patient herself). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 26Dec2020 17:45 (at the age of 52-years-old) at a single dose for COVID-19 immunization. Medical history included asthma, migraines, sulfa allergy, and shellfish allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included estradiol (MANUFACTURER UNKNOWN) and galcanezumab (EMGALITY). Other concomitant medications, taken within two weeks of vaccination, included unspecified multivitamin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced allergic reaction to the vaccine, difficulty clearing throat, increased pulse rate, dizziness, headache, weakness, feeling hot, flushed, nauseousness, decreased respiratory rate (RR), and increase in systolic blood pressure (SBP)/diastolic blood pressure (DBP) on 26Dec2020 at 18:00. The event, allergic reaction to the vaccine, was reported as life-threatening. The events were described as: The patient was feeling hot and flushed after injection, that progressed to difficulty clearing throat, increased pulse rate, dizziness, headache, and weakness. The patient was taken to the emergency room (ER) for treatment for an allergic reaction to the vaccine. The symptoms continued and new ones developed including nauseousness, decreased RR, and increase in SBP/DBP. The patient underwent lab tests and procedures, all on an unspecified date, which included blood pressure: increased, pulse rate: increased, and respiratory rate: decreased. Therapeutic measures were taken in the ER as a result of the events, which included methylprednisolone sodium succinate (SOLU-MEDROL), diphenhydramine hydrochloride (BENADRYL), and famotidine (PEPCID). The clinical outcome of allergic reaction to the vaccine, difficulty clearing throat, increased pulse rate, dizziness, headache, weakness, feeling hot, flushed, nauseousness, decreased RR, and increase in SBP/DBP was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Sender's Comments: Based on a plausible chronological relationship,  there is a reasonable possibility of an association between the events and the study product. The underlying predisposing condition of positive medical history for allergy may have played a contributory role toward the cascade of events. 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.