Reporte zur Charge FN6198/EN6198

Symptomtext

allergic reaction; swelling and numbness to her mouth, lips, and tongue; swelling and numbness to her mouth, lips, and tongue; swelling and numbness to her mouth, lips, and tongue; swelling and numbness to her mouth, lips, and tongue; face was numb and heavy; face was numb and heavy; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, NDC number: 59267100002), via an unspecified route of administration, administered in the left arm on 09Mar2021 at 15:00 at the age of 47 years old (Batch/Lot number: FN6198/EN6198, and Expiration date: unknown) as the 1st dose, single dose for COVID-19 immunization, to protect herself from getting COVID-19. The patient had no medical history. There were no concomitant medications. The patient reportedly experienced swelling and numbness to her mouth, lips, and tongue on an unspecified date in Mar2021. The patient was asking if there was any research to determine what she might have reacted to in the vaccine and also if there was any information about the kind of reaction she had and if that would relate to a specific ingredient. It was further reported that the patient had an allergic reaction to the first dose of the COVID vaccine and did not provide specifics. The patient wanted to know if there were studies on allergic reactions and if there had been any follow ups and would love to know what she was allergic to, since she had never had an anaphylactic reaction and if there had been any research. The patient stated she was seen at the emergency room and did not know if she should share the doctor's information that had seen her in the emergency room or her primary care doctor. She had mouth, tongue, lip swelling and numbness and so she went right away to the emergency room. She never had breathing distress and was given an intravenous (IV) steroid and also a medication to bring down the swelling. The patient stated she had the vaccine around 3pm in the afternoon and she woke up around 3am during the night on an unspecified date in Mar2021 and her face was numb and heavy and her lips were huge and she realized she was breathing ok, but she went to the emergency room. The patient stated she wanted to get the second dose of the vaccine, but the emergency room doctor did not recommend it. She clarified that the symptom of her mouth tongue lip swelling and numbness had actually occurred sometime in Mar2021, and not Feb2021, since she got the vaccine on 09Mar2021. It lasted for about two days until it went down. The patient stated there had been no changes and she had not had anything different to eat. Therapeutic measures were taken as a result of all the events, which included IV steroid and a medication to bring down the swelling. The patient recovered from all the events on an unspecified date in Mar2021.