Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Computerised tomogram, Dysphagia, Feeling hot, Lymphadenopathy
Clinical narrative: angioedema; lymphadenopathy, described as "very impressive swelling" at the base of neck that got inflamed when she got hot or stressed out, causing impacts on her swallowing; lymphadenopathy, described as "very impressive swelling" at the base of neck that got inflamed when she got hot or stressed out, causing impacts on her swallowing; lymphadenopathy, described as "very impressive swelling" at the base of neck that got inflamed when she got hot or stressed out, causing impacts on her swallowing; lymphadenopathy, described as "very impressive swelling" at the base of neck that got inflamed when she got hot or stressed out, causing impacts on her swallowing; This is a spontaneous report from a contactable pharmacist via Medical Information team. A 39-year-old female patient (nurse) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown, NDC number), via an unspecified route of administration at the age of 38 years on 18Jan2021 as a single dose for COVID-19 immunization. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date were not reported) on an unspecified date for COVID-19 immunization. Relevant medical history included acute lymphatic leukemia (ALL) when she was 8 years old, but had been in remission since she was 13. The patient's concomitant medications were not reported. The pharmacy manager reported that the patient, who was one of her employees at the hospital, received her second dose of the Pfizer BioNTech COVID-19 vaccine on 18Jan2021 and on an unspecified date had experienced lymphadenopathy afterwards that was still ongoing. The reporter described it as "very impressive swelling" at the base of neck that got inflamed when the patient got hot or stressed out, causing impacts on her swallowing. The reporter stated that the patient had gone to the emergency room twice, where it had been described as angioedema on an unspecified date and had also seen an allergist, who described it as a "robust immune response." The reporter was concerned about the ongoing nature of this lymphadenopathy and would like any information that would help to treat this. The reporter also stated that the patient had gone through "medical procedures and computerized tomography (CT) scans" with unknown results on an unspecified date and would like to know if the patient would be eligible for the Program because of the event. The patient was in the group that got the vaccine first. The patient still had impressive lymphadenopathy and it was persisting. At first it was interfering with the patient's swallowing, but it was still occasionally interfering with her swallowing. The reporter was wondering if there was any more in house data that had been reported on this. The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of angioedema, which included that the patient had been prescribed antihistamines, such as cetirizine (ZYRTEC), fexofenadine (ALLEGRA), hydroxyzine, famotidine (PEPCID), and methylprednisolone (MEDROL) dose packs. The patient was not recovered from the event "lymphadenopathy," while the outcome of the rest of the events 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 event of angioedema, lymphadenopathy and other events  due to temporal relationship.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   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.