Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye swelling, Laboratory test, Pruritus, Rash
Clinical narrative: redness; lumps on her head; swelling of the face/swelling on the side of her face; swelling of her eye; swelling of the back; rash/rash all over the body; itching; This is a spontaneous report from a contactable Physician. A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) at the age of 69 years via unspecified route of administration in the right arm on 28Jan2021 13:00 (lot number EL6982 and expiry date unknown) at single dose for Covid-19 immunization in a facility. Medical history included drug allergic to penicillin, liver problems 17 or 18 years ago and has fully recovered from the liver problems. The patient was admitted to the hospital because her liver enzymes were high; ongoing high blood pressure, ongoing cholesterol (blood cholesterol abnormal), ongoing blood pressure (blood pressure abnormal). Concomitant medication included ongoing atenolol for blood pressure, ongoing lovastatin for cholesterol, ongoing losartan for high blood pressure, ongoing vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) for unspecified indication, aminobenzoic acid, biotin, choline bitartrate, folic acid, inositol, nicotinamide, pantothenic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, vitamin b12 nos (B COMPLEX [AMINOBENZOIC ACID;BIOTIN;CHOLINE BITARTRATE;FOLIC ACID;INOSITOL;NICOTINAMIDE;PANTOTHENIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;VITAMIN B12 NOS]) from unspecified date for unspecified indication. The patient received first dose of BNT162B2 at the age of 69 years on 07Jan2021 13:00 (lot number EL3246) in the right arm for Covid-19 immunization and had no side effects. The patient has no prior vaccinations within 4 weeks. On 31Jan2021, the patient experienced swelling of the face, swelling of her eye, swelling of the back, rash and itching. The reporter (a retired physician/husband) was calling regarding his wife who received the second dose on 28Jan2021 and on Sunday 31Jan2021 she got swelling of the face and eyes and went to the ER for 5 or 6 hours. The patient received cortisone and Benadryl and she was some improved. Today (unspecified date) she was still getting more swelling of the face and redness. The reporter clarified that the patient received the second dose on 28Jan2021 at 13:00 in the right arm. The patient noticed 31Jan2021 in the evening swelling of her face, swelling on the side of her face, swelling of the eyes and swelling on her back, also some lumps on her head. The patient was a little improved at the ER, but today there was more rash all over the body and itching and it was getting worse. The reporter added that the rash appears on one side and then disappears and went to another part of the body. The patient underwent lab tests and procedures which included lab tests: normal on unspecified date, neck x-ray: showed no significant, it was normal except for degeneration of C5-C6 on unspecified date. The patient received treatment with the events swelling of the face/swelling on the side of her face, swelling of her eye, swelling of the back, rash/rash all over the body, itching, lumps on her head. The outcome of the events was not recovered. The events swelling of the face/swelling on the side of her face, swelling of her eye, swelling of the back, rash/rash all over the body, itching was reported medically significant.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of all reported events cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  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.