Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation
Clinical narrative: Swollen lips; Burning lips; the inside of her cheeks were swollen; Swelling of tongue; throat and the inside of her nose was burning; the inside of her nose was burning; This is a spontaneous report from a non-contactable consumer (patient). A 83-Year-Old female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EN6206, Expiration Date: 30Jun2021 and NDC number was unknown) via an unspecified route of administration, administered in left arm on 11Mar2021 at 17:30 hours as dose 1, single (at the age of 83-years-old) for COVID-19 immunisation. Medical history included nasal congestion (during the winter when the heat was on and she was not getting outside for fresh air), had very bad sinuses & used a humidifier in her room & the humidifier seems to help, lot of sinus allergies, had a condition where she was shrinking and bending over, and her current weight did not help. Patient said everyone keeps telling her that she has to lose weight. Patient does not take any medication, as she was very sensitive to medications and does not take any. She said the humidifier helps her. She said if she didn't use the humidifier, she would be so stuffed up that no one would be able to understand her when she talked. Patient previously took amoxicillin, at a dose of 500mg, three times a day, 2-3 years ago and experienced allergic reaction to amoxicillin. Patient stated that she had the exactly the same reaction in the past to amoxicillin (2-3 years ago). Patient stated that she never reported her reaction to the Amoxicillin manufacturer but told her doctor. She said her doctor took her right off of the amoxicillin and told her to not take amoxicillin anymore. She said at the time she was prescribed amoxicillin 500mg three times a day. Historical vaccine included patient received flu shot in Dec2020 for immunisation. Patient had no additional vaccines administered on same date of the Pfizer suspect. Patient had no prior vaccinations (within 4 weeks). Patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. Patient stated that her husband had not let her out of the house since the pandemic started. On 12Mar2021, patient found that this morning, about 12 hours later, that her lips were swollen and burning, and the inside of her cheeks and tongue were swollen. Patient said her throat and the inside of her nose was burning. Patient stated that her tongue and cheek swelling had gone down, but she still had the burning sensation, especially inside her nose. She said the inside of her nose was very tender and felt raw. She said the burning sensation was like if she had eaten a lot of cinnamon or hot sauce. She said her lip swelling had improved. Patient had no emergency room and physician office visit for all the events. No relevant tests were performed. Patient felt she had a very mild reaction to the COVID-19 Vaccine, but that her COVID-19 Vaccine reaction was a different kind of reaction. Patient stated that she was going to just wait a couple days, and her COVID-19 Vaccine reaction symptoms should be gone. Patient clarified that was what her doctor had told her to do with the amoxicillin reaction she had, and the amoxicillin reaction symptoms went away on their own. Patient said when she goes back for her second COVID-19 Vaccine, the COVID-19 vaccination facility will probably decide if they want to give her the second COVID-19 Vaccine or not. She said the COVID-19 vaccination facility seemed pretty fussy. The outcome of all the events was recovering.  No follow-up attempts are possible. No further information is expected.