Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Skin rash on his whole body; Urticaria; Right mouth swelling/left mouth swelling; Swelling face; Lower lip is swollen; Touches his face, the skin feels thicker; This is a spontaneous report from a contactable physician (patient). An 80-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 22Apr2021 as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that about 13 days ago, on 22Apr2021, he had the Pfizer Covid-19 Vaccine. He thinks that about one week or 8 days later he had a skin rash on his whole body. Treatment of skin rash on his whole body was applied. The patient added that he took Benadryl 25 mg only once and and a few hours later the rash faded. One day later, it was completely gone and was no more (as reported). Today, this morning (as reported), the patient woke up and his right mouth right below the chin to the mouth area to the lower lip is swollen. The patient adds that his body had urticaria. He took Benadryl, another one, 25 mg and one or two hours later his body urticaria disappeared. Right mouth swelling: the patient adds that his face was swollen below the cheek to lower the lip line and it is not disappearing but seems a little bit smaller. It used to be a bump and now it feels like skin is still thick but he feels better on the right side. Left mouth swelling: the patient adds that he thought probably he would caller interrupts statement  and says he does not know why but it turned to the left side, the left lower lip and it became swollen again (as reported). The right side has come down a little more but still feels like the inside of his mouth on the right side, he does not feel anything now, except when he touches his face, the skin feels thicker (as reported). Now, it has become to the left side left lower lip area, and lower chin. He does not know what to do. The patient confirms that this was his first dose of the Pfizer Covid-19 Vaccine. The outcome of the event "Skin rash on his whole body" and "Urticaria" was resolved, the outcome of the other events was unknown.   No follow up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Assuming a plausible drug-events temporal association and considering the nature of the reported events suggestive of a possible allergic reactions (the events urticaria and skin rash are also mentioned in the safety profile reported of the suspect product), the company deems there is a reasonable possibility that all the reported events are related to BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) administration. The impacts 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.