Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Pruritus, Pyrexia, Seizure, Swelling face
Clinical narrative: cause or causes of death were unknown; seizures; wasn't able to breathe; Severe adverse reaction including vomiting that ended in death/ throwing up; spiking fevers; itchiness; swelling of the lips, tongue, cheeks and throat; swelling of the lips, tongue, cheeks and throat/ tongue had swollen and blocked her airway; sore throat; swelling of the lips, tongue, cheeks and throat; swelling of the lips; swelling of the lips, tongue, cheeks and throat; This is a spontaneous report from a contactable consumer on behalf of the patient who was a member of her own family. A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 05Apr2021 08:15 at the age of 69-years-old (Lot Number: ER8733) as single dose for covid-19 immunisation. Medical history included obesity, for her height she was probably considered obese; asthma from 2010, patient was wheezing before 2011, onset probably around 2010 and patient had had an inhaler for years, the reporter's mother (the patient's next of kin) had asthma since she was born extremely prematurely in the 1940s, asthma ran in the family; lip swelling from 2019 to 2019, patient had reaction of lip swelling, nothing else to what they think may have been lisinopril she was taking as blood pressure medication, they were never certain it was from lisinopril but took her off of lisinopril in 2019 in response. She took herself to the doctor at that point, was fully able to speak to them and everything; lip swelling from Feb2021 to Feb2021, patient ate something that just made her lips swell, they are unsure what it was she ate but it just made her lips swell, no throat swelling, tongue swelling or face swelling, she was able to drive herself to the hospital where she received primary care, primarily able to speak and do everything else with this event; antidepressant.  Concomitant medications included vitamin D; famotidine from 14Feb2021 for unknown indication, it was started right after she had lips swelling reaction in Feb2021; hydrochlorothiazide; diltiazem hydrochloride (DILTIAZEM CD); sertraline; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) taken for asthma. The historical vaccine included 1st dose of BNT162B2 (Lot: EN6207) on 14Mar2021 for covid-19 immunisation, injection to right arm at around 15:00-16:00. The reporter thouht the 6 was the numeral six on the CDC vaccine record card. The patient had a severe adverse reaction including vomiting that ended in death after being administered that second dose of Pfizer-BioNTech COVID-19 Vaccine. This reporter was advised by a family physician to ask for Pfizer to perform the autopsy on the deceased patient because she was unable to do so herself. The patient experienced vomiting and sore throat. She also then experienced swelling of the lips, tongue, cheeks and throat. They came home around 17:00 that day and the patient began throwing up around 19:00 that night of 05Apr2021. The patient took some Benadryl without telling them maybe around 00:00 or a little before 01:00 on 06Apr2021 because she was experiencing itchiness and swelling of the throat hoping that the Benadryl would help with those events. When the Benadryl didn't help those events and her tongue really started to swell and patient wasn't able to breathe on her own they called EMS. EMS came around 01:00 on 06Apr2021 and took the patient to the emergency room at the hospital. On the way to the hospital in the ambulance they were unable to intubate patient to place an airway and she flat-lined in the ambulance. They performed 2 rounds of CPR in the ambulance and were able to finally revive her. Once they got the patient to the emergency room at the hospital they performed 3 more rounds of CPR. After that she began having seizures throughout the early morning hours of 06Apr2021. Throughout that next morning of 06Apr2021 she was given Ativan to try to stop the seizures. Seizures continued into the next day, 07Apr2021 and they finally did get her intubated and then had her on the ventilator. Then she began spiking fevers and they kept her sedated throughout that day, 07Apr2021 and the next day, 08Apr2021. Then they took her off of sedation and after 36 hours they advised them that the patient wouldn't wake again. They wanted to pursue aggressive treatment to see if they could maybe give her brain a chance to wake up. On Sunday morning, 11Apr2021 around 04:00 the patient flat-lined again. They used the paddles but they were unable to resuscitate the patient. The official time of death was around 08:00 on 11Apr2021. Reporter provided information that the cause or causes of death were unknown. The reporter described death as untimely death. These events were the first time the patient's tongue had swollen and blocked her airway, and her cheeks swelling; they had not seen that before with patient's medical history. The patient was hospitalized from 06Apr2021 to 11Apr2021. The event outcome of vomiting was fatal, of the other events was unknown. The patient died on 11Apr2021.  An autopsy was not performed.; Reported Cause(s) of Death: Severe adverse reaction including vomiting that ended in death