Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, COVID-19, Drug ineffective, Lip erythema, Lip pain
Clinical narrative: she had Covid; she had Covid; she woke up with extreme mouth swelling; mouth and lips started hurting again; She had redness and swelling of her mouth and lips.; mouth and lips started hurting again; She had redness and swelling of her mouth and lips.; She had redness and swelling of her mouth and lips.; Anaphylaxis/numbness and tingling in her mouth and lips/Hypoaesthesia oral/Paraesthesia oral; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. Other Case identifier(s): GL-021422-3848 (Agency).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "she had Covid"; ANAPHYLACTIC REACTION (medically significant) with onset Dec2021, outcome "unknown", described as "Anaphylaxis/numbness and tingling in her mouth and lips/Hypoaesthesia oral/Paraesthesia oral"; MOUTH SWELLING (non-serious) with onset Dec2021, outcome "unknown", described as "she woke up with extreme mouth swelling"; LIP PAIN (non-serious), ORAL PAIN (non-serious) all with onset 13Feb2022, outcome "unknown" and all described as "mouth and lips started hurting again"; LIP ERYTHEMA (non-serious), ORAL MUCOSAL ERYTHEMA (non-serious), LIP SWELLING (non-serious), all with onset 13Feb2022, outcome "unknown" and all described as "She had redness and swelling of her mouth and lips." The event "she woke up with extreme mouth swelling" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of anaphylactic reaction.  Clinical course: The patient was injected with Kysse 4 months ago. And had the normal response after the injection with minimal swelling. It subsided after 1 week. In Dec2021, she started experiencing numbness and tingling in her mouth and lips. She took Benadryl and it only got worse. By the night time she woke up with extreme mouth swelling and went to the ER. They treated her for anaphylaxis and thought maybe it was due to her blood pressure medication. She stopped the blood pressure medication and the symptoms subsided. Yesterday (13Feb2022) her mouth and lips started hurting again. She had redness and swelling of her mouth and lips. They hurt but they were numb if that makes sense. On unknow dates, she had 2 Pfizer shots and she had Covid.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.  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