Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Body temperature, Headache, Memory impairment, Pyrexia
Clinical narrative: The site got worse through Thursday and was red, hot; Weakness; woke up with 100.5 degrees temperature; Difficulty remembering things; Vomiting; Headache 10/10; developed a red area below injection site/The site got worse through Thursday and was red, hot; This is a spontaneous report from a contactable nurse. A 62-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular in right deltoid on 24Jan2021 at a single dose for prevention (COVID-19 immunization). Medical history included Low immunoglobulin/compromised immune status/Low immunoglobulin diagnosed 8 years ago, hereditary angioedema from 2010, asthma diagnosed in her 20's, Allergic to Thermarisol, diagnosed allergies, respiratory illness, and endocrine abnormalities (including diabetes) and obesity. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (LOT number: EJ1686) in right deltoid on 03Jan2021 for covid-19 immunization, and flu shot on Sep2020 without adverse event. She got second injection on 24Jan2021. On 25Jan2021, she woke up with 100.5 degrees temperature and could not stop vomiting.  She had to go to the ER.  They gave her Zofran, IV and also Toradol because she had a number 10 headache.  She continued with low grade temperature throughout week from 99.5-100.5 degrees Fahrenheit, and by Tuesday morning, she developed a red area below injection site. By Thursday, there was a red area growth to 13 cm x 15.5 cm on the injection site. She could not remember her email address and said her brain was not thinking. This started after the vaccine that she began having difficulty remember things. She never had a headache that bad.  It improved but she has a lingering headache still.  She continued to have a temperature from Monday to Saturday. Currently, she does not have an elevated temperature. Difficulty remembering things was reported as just irritating, but significant. The site got worse through Thursday and was red, hot and ended up measuring 13 cm x 15.5 cm. Regarding weakness, she could walk but medics had to help support from her seat to the ambulance. The outcome of the events red and hot injection site was not recovered; the outcome of the events vomiting, headache, weakness was recovering. The outcome of difficulty remembering things was unknown. The outcome of high temperature was recovered on an unknown date. The events was assessed as medically significant.; Sender's Comments: Based on the available information and known product profile, the causal relationship between  the reported events and the use of BNT162B2 cannot be excluded. The case will be assessed further upon receipt of additional 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 RAs, Ethics Committees, and investigators, as appropriate.