Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Histamine level, Lip swelling, Swelling face
Clinical narrative: facial swelling; mothers lip blew up; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 43-year-old female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported) via an unspecified route of administration on an unspecified date (age at vaccination 43 years) as dose 1, single for COVID-19 immunization. Medical history included covid-19 (her family all contracting COVID-19 virus in December), Mast Cell Syndrome (she has since she was 20 years old) and inflammation from an unknown date and ongoing. The patient's concomitant medications were not reported. On an unspecified date in 2021 patient experienced facial swelling and mothers lip blew up. Patient questions if her or her daughter's reactions following dose one of the vaccine would be considered severe allergic reactions/anaphylaxis. Patient was advised that the risks of BNT162B2 (Covid-19 vaccine, mRNA) and the PFIZER-BIONTECH COVID-19 VACCINE include that there was a remote chance that the vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include: difficulty breathing, swelling of your face and throat, a fast heartbeat, a bad rash all over your body, dizziness and weakness. Strongly encouraged her to work with her provider in determining if they felt that her reaction was severe but reiterated that swelling of the face was noted as a severe allergic reaction here as stated. Patient stated that her, age 43 years old, and her daughter, age 16 years old, both received the Pfizer vaccine 1st dose 3 weeks ago. Their second dose was supposed to be received tomorrow. Mother reported her family all contracting COVID-19 virus in December. She also reported they have Mast Cell Syndrome that she had since she was 20 years old. She stated this was when her immune system overpowers itself and she expected this to happen, it was how their systems were. She also stated that they both have inflammation going on. The patient's daughter had seizures from COVID in december and they had just now gotten those under control and she continued to had ongoing inflammation problems. After receiving the 1st dose of the Pfizer vaccine, both the mother and the daughter, experienced facial swelling. Mother reported she was still dealing with side effects from the vaccine. The reactions did not occur immediately or within minutes of receiving the vaccine, but later that day. Patient's daughter's reaction occurred a few hours after the vaccination she stated. The daughters face swelled from her eye down to the mouth area on the left side and the mothers lip blew up. Mother did have her histamine levels checked by her HCP and they were noted to be high. Patient stated that what she was trying to figure out at that time was whether or not she/her daughter should receive the 2nd dose of the vaccine after a reaction from the 1st dose. Mother stated that she had received no guidance/direction from her provider or the health department regarding this concern. She stated she did not know what to do and stated it was their immune system going wonkey. This was great, she didn't know what to do. Dern if you do and dern if you didn't. Patient understood that an allergic reaction was something that happens fast after the vaccine but questions could it happen later. She stated that she knows the vaccine caused the swelling but only because their systems were overpowering themselves. The 16-year-old daughter wanted to get her 2nd dose because she was tired of getting quarantined due to close contact in HS. She was tired of having her life uprooted because of it. Patient advised that as noted in the fact sheet for recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision also advised the patient per the fact sheet: Contraindications: Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine. Consumer stated: Mother fine for second vaccine, just a little swelling of her arm. Daughter second vaccination around 02Sep2021, she took birth control because of seizures around ovulation. She ovulated after second vaccine, causing her birth control to not work properly. Seriousness of the events was non serious. The patient underwent lab tests and procedures which included histamine level: high on an unspecified date. The outcome of the events was not recovered.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.