Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Feeling hot, Flushing, Hypertensive urgency, Muscle tightness
Clinical narrative: hypertensive emergency; felt like the swelling was progressing into the back of her throat; swallowed harder; she felt like she was hot in her face and felt like something was squeezing her neck like a tight collar on her shirt; she felt like she was hot in her face and felt like something was squeezing her neck like a tight collar on her shirt; shivering on and off; This is a spontaneous report from a contactable pharmacist.  This pharmacist reported similar events for two patients.  This is the first of two reports.  A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH9899), intramuscularly in an unspecified arm on 21Dec2020 14:30 at 0.3 mL single for COVID-19 immunization.  Medical history included sulfa allergy.  The patient's concomitant medications were not reported. There were no prior vaccinations within 4 weeks prior to the first administration of the suspect vaccine. The patient did not have a history of reactions to any other vaccines.  On 21Dec2020, the patient experienced hypertensive emergency, which was reported as being medically significant.  On 21Dec2020, the patient also felt like she was hot in her face and felt like something was squeezing her neck like a tight collar on her shirt, shivering on and off, felt like the swelling was progressing into the back of her throat and she swallowed harder.  Clinical details were reported as follows: the patient received the vaccine on 21Dec2020 at 14:30 and fairly quickly the patient started saying she felt like she was hot in her face and felt like something was squeezing her neck like a tight collar on her shirt. She was given 25mg of diphenhydramine hydrochloride (BENADRYL), orally. The patient was shivering on and off and patient said she felt like the swelling was progressing into the back of her throat. She was having to clear her throat and swallow harder. She was taken to the emergency department around 15:11 and given intravenous (IV) famotidine (PEPCID) 20mg at 15:27.   The patient did not have issues oxygenating. It was noticed that the patient's blood pressure was 232/100 on 21Dec2020 and they started treating her for the hypertensive emergency with amlodipine (MANUFACTURER UNKNOWN) 5mg orally, one time of IV labetalol (MANUFACTURER UNKNOWN), 10mg , IV labetalol (MANUFACTURER UNKNOWN) 20mg once, Clonidine (MANUFACTURER UNKNOWN) 0.1mg, orally. The patient was sent home around midnight and was not admitted to the hospital. The outcome of hypertensive emergency was recovering and of patient also felt like she was hot in her face and felt like something was squeezing her neck like a tight collar on her shirt, shivering on and off, felt like the swelling was progressing into the back of her throat and she swallowed harder was unknown.  When querying causality, the reporter stated this patient did not have a history of hypertension, so she thinks it is suspicious.; Sender's Comments: The 67-year-old female patient had sulfa allergy medical history. Throat swelling and hypertensive emergency were possibly related to the BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), considering temporal relationship and clinical course.  This case will be reassessed should additional information become available.  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.,Linked Report(s) : US-PFIZER INC-2020510772 Same reporter/different patient/similar events