Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Pharyngeal swelling, Swollen tongue, Tongue paralysis
Clinical narrative: tongue swelled in her throat, deep in her throat; throat swelled/swelling throat on the right side; swelling of her throat and tongue/ dealt with this reaction in the past; her tongue is paralyzed; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 02Sep2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer (patient) and from a Pfizer-sponsored program. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 07Feb2021 (Lot Number: EM9809) as single dose (at the age of 71-years-old) for COVID-19 immunization. Medical history included angioedema, she does have allergies to some medications. She says they are just simple things like Aspirin, NSAIDs don't ever take them want more, allergic IVP dye, allergy to corn, and 'swelling of throat and tongue'. There were no concomitant medications. The patient previously took aspirin (e.c.) and experienced allergy, and Epipen. The patient experienced her tongue is paralyzed on 2021, tongue swelled in her throat, deep in her throat on 07Feb2021, and throat swelled/swelling throat on the right side on 07Feb2021. Patient received Pfizer-BioNTech COVID-19 Vaccine first dose on 07Feb2021, experienced 'swelling of her throat and tongue' within 30 minutes of getting vaccinated. She stated 'I dealt with this reaction in the past and haven't had it in like maybe... 15 years.. I used to carry an EpiPen. I think it was because it was snowing. My Allergist said if I could swallow something to gargle with antihistamines, but I had fear to do that and I didn't.' She further reported that her throat swelled and her tongue swelling in her throat, like deep in her throat. She continued to have that problem during the night. That is something she deals with she has suffered from angioedema, her doctor said, she is not sure whether or not should take the second dose. She is sorry she did do this before. She confirms she got the first dose 07Feb2021 and the throat swelling began the same day about 15 minutes after the dose was given (as reported, also reported as 30 minutes). She says it has resolved, she had it through the night but she was able to sleep so she probably felt it until about midnight that night and then it was resolved. She confirms it has resolved completely (as reported). Patient was advised not to receive the 2nd dose yet. She has been calling because of her side effects since then. She said that she had reported this condition to VSAFE and asked if there is a way to follow up. She is still experiencing a swelling throat on the right side and her tongue is paralyzed. Patient is asking if she can undergo a treatment and proceed with the 2nd dose of our COVID-19 vaccine. The final outcome of the event, tongue swelled in her throat, deep in her throat was recovered on an unspecified date, while for the rest of the events was not recovered. The event "her tongue is paralyzed" is serious (medically significant).