Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysphagia, Swollen tongue, Throat irritation
Clinical narrative: Chills; Irritation in throat; Swelling of tongue; Unable to swallow solids; This is a spontaneous report from a contactable nurse (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), dose 2 via an unspecified route of administration, administered in the right arm on 25Feb2021 for covid-19 immunization.  The patient's medical history was not reported; She takes other unspecified medications, though declined to provide details. The patient previously took BNT162B2 (Lot EM9809) on 04Feb2021 as first single dose for covid-19 immunization and hydrochlorothiazide and experienced anaphylactic reaction on an unspecified date (reported as years ago).   The patient experienced the following medically significant events:  irritation in throat on 27Feb2021 with outcome of recovered; swelling of tongue on 27Feb2021 with outcome of not recovered; unable to swallow solids on 27Feb2021 with outcome of not recovered; chills on an unspecified date with outcome of unknown. Details were as follows: the reporting nurse received both doses of the Covid-19 vaccine. She received the first dose on 04Feb2021. She received the second dose on 25Feb2021. 48 hours after the second dose she developed a really sore throat way down in the back of her throat. Her tongue also started swelling. She took diphenhydramine (ASSURED) 50mg. Her tongue was swollen the next day and she was unable to swallow solids.  She went to a Covid clinic and was prescribed a diphenhydramine mouthwash. She was still unable to swallow. She has been taking diphenhydramine and Ibuprofen. It waxes and wanes.  She had to take diphenhydramine to go to sleep. She thinks it is a reaction to the vaccine. She read about the ingredients and is not allergic to anything in the vaccine. She clarified that she did not have a sore throat. Her throat was irritated. It felt like pop rocks in the back of her throat. She saw a provider on 01Mar2021. She thinks her histamine level is too high. She also had chills last night, date unspecified. She had them once since 27Feb2021 and again last night. She was unable to confirm if they are ongoing or resolved. She had to turn up her electric blanket to 8. She was not shaking but just had chills.  Years ago she had an anaphylactic reaction to hydrochlorothiazide. This felt similar to that. She was walking around fine and then started having swelling. She did not have difficulty breathing. She hoped it was not anaphylaxis. The diphenhydramine mouthwash was a compound of lidocaine, diphenhydramine and Maalox. The ratio was 1:1:1. The diphenhydramine 50 mg was a liquid children's allergy relief medication. Therapeutic measures were taken as a result of the events as aforementioned. Relatedness of drug to reaction for irritation in throat, swelling of tongue, unable to swallow solids and chills per primary source reporter  of assessment was reported as related. The outcome of irritation in throat was recovered on 28Feb2021; the outcome of swelling of tongue  and unable to swallow solids was not recovered; the outcome of chills was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of  irritation in throat, swelling of tongue, unable to swallow solids  due to temporal relationship and the known product safety profile.  The clinical presentation is suggestive of a severe allergic reaction, involving the tongue and throat.  There is limited information provided in this report.  This case will be reassessed once additional information is available.  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.