Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Circumoral swelling, Dyspnoea, Lip swelling, Paraesthesia oral
Clinical narrative: a significant rash; her lips were both tingling and swollen; her lips were both tingling and swollen; swelling around her mouth like a thin rope; Throat tightness; Chest tightness; did not stop breathing; This is a spontaneous report from a contactable other healthcare professional (patient). A 71-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FF2588), via an unspecified route of administration, administered in right arm on 04Oct2021 20:00 (Age at vaccination: 71-years-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history included allergic to everything under the sun, allergy to antibiotic, lot of crazy allergies, migraine headaches all were from an unknown date and unknown if ongoing. Concomitant medication included erenumab aooe (AIMOVIG) taken for migraine headache from unspecified date in 2021 to an unspecified stop date (it was stated that about a month or six weeks before getting the Pfizer COVID-19 vaccine dose she started taking Aimovig in the beginning of Sep2021 or the end of Aug2021 for migraine headaches). The patient had previously received Pneumonia vaccine and Shingles vaccine both for immunization and experienced anaphylaxis. First and second dose of Hepatitis B vaccine for immunization and after second dose patient experienced allergy to vaccine. On 05Oct2021, the patient experienced her lips were both tingling and swollen, swelling around her mouth like a thin rope, throat tightness, chest tightness and a significant rash. On an unspecified date in 2021, the patient experienced did not stop breathing. It was reported patient is a nurse and she was behind on getting one but on 04Oct2021 she got her Pfizer COVID-19 vaccine first dose. She said she had not the Flu shot in 20 years. She said she was allergic to every antibiotic as well, so she had herself tested to see if she would be allergic to the Pfizer vaccine beforehand, and they said it would be all right to get it. She said she got her first dose at a pharmacy and stayed 30 minutes after getting it, and it was 8:30 at night so she went home and went to bed. She was woken up at 00:30 with a significant rash that was not as severe as the other anaphylaxis reactions she had in the past. Unable to clarify if she said significant rash or significant reaction as she continued speaking. she woke up because her lips were both tingling and swollen, she had swelling around her mouth like a thin rope, she had throat tightness that was very tight, and her chest got tight, but she did not stop breathing. She says she got a prescription for two EpiPens. she stayed up for 5 hours, then it finally started to get better. she went into the pharmacy when they opened and reported it thinking that was what she needed to do, and now that she was due for her second one, with her horrible history, so she spoke to the pharmacist and they said there was no place for them to document adverse events and for her to call Pfizer and another company. She says she has been a RN for 42 years, so she did not go to the emergency room or hospital, and she did not stop breathing but she did have a significant reaction and she wanted to make Pfizer aware. she did not know if this was a standard reaction, and she was due for her second dose this week. her health is good, she was still working, she wants to bring attention to it in case someone else has this kind of reaction. It was reported under the bottom of her lip was still swollen, which lasted for three days. she did not give herself a dose of the EpiPen, but she took Benadryl. she was guessing that dose was 25mg, and she also drank gallons of water to try to dilute it or something. her son called her and told her if she has a reaction to call him to take her to the ER, but since her son could not stay with her there if she was in the hospital she did not do that, because if she was going to die she did not want to die alone in the hospital she would rather die at home. The patient received treatment for the adverse events. The outcome for the event her lips were both tingling and swollen (swollen lips) was recovered on 08Oct2021, while other events outcome was reported as recovering at the time of this report.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Paraesthesia oral, Circumoral swelling, Throat tightness, Chest discomfort, Dyspnoea, Rash, and Lip swelling and BNT162B2.  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.