Symptomtext
Tongue felt like it was swelling; Itching; Tickle in her throat; This is a spontaneous report from a contactable pharmacist. A 41-year-old not pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN3518), via intramuscular route of administration in left arm on 02Feb2021 at 11:45 AM at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: El1283), via intramuscular route of administration in left arm on 01Jan2021 at single dose for COVID-19 immunization and had no problem post 1st dose. Medical history and concomitant medications were not reported. The patient was allergic to shellfish anaphylaxis. On 02Feb2021 at 12:15 PM, the patient experienced tongue felt like it was swelling, tickle in her throat and itching. During observation period post second dose patient began itching and felt like she had a tickle in her throat. Patient began clearing her throat and asked for some water. RN noted she was rubbing throat and gave her water and benadryl 25 mg PO for itching. Patient noted that her throat was starting to feel funny like it might be closing up and her tongue felt like it was swelling. Epinephrine 0.3mg IM administered immediately after identifying these symptoms and patient wheeled down to ER for evaluation. Patient received IV benadryl in ER and famotidine. Observed for a couple of hours and then released. The outcome of the events was unknown.; Sender's Comments: A causal relationship between BNT162B2 and the reported events swollen tongue, pruritus and throat irritation cannot be excluded based on temporal association. 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 RAs, Ethics Committees, and Investigators, as appropriate .