Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Malaise, Tremor
Clinical narrative: freezing and could not get warm; shaking; sick; Chills; tired; lightheadedness; Redness at injection site; Believe the vaccine was given subcutaneous; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EH9899 and expiration date: Mar2021, via subcutaneous route in the back of right arm where the fatty area far away from deltoid, first dose on 17Dec2020 18:15 at a single dose for routine vaccination. The patient's relevant medical history was none. There were no concomitant medications. The reporting nurse was reporting for herself for the covid vaccine. She received the vaccine and believed it was administered subcutaneously versus in her deltoid muscle on 17Dec2020. She had redness at injection site on 18Dec2020. She also reported chills, lightheadedness and was tired on 18Dec2020. She added that the symptoms did not happen until after Friday night (18Dec2020). She doesn't think she could have continued working as sick as she was that night. She did not know if it was medically significant though. She went between not serious and medically significant and then stated she guessed it would be medically significant. She was freezing and could not get warm and was shaking. She did not notice the redness until Friday night around 3pm. The redness has improved, but it was still there. Unknown time for when it first started, but the first that she noticed it was around 3pm. Lightheadedness started around 1pm on 18Dec2020. The tiredness started around 3pm on 18Dec2020. The chill started around 7pm on 18Dec2020. They all improved by Saturday, 19Dec2020. Part of this report is that the doctor said it was in her triceps muscle and she does not think it was. They pinched the skin and put it in. She said her muscle was not sore. As a nurse, she believed it was not in her triceps area.  It was not in the deltoid area and that was suggested from Pfizer. The reporting nurse's seriousness for 'believe the vaccine was given subcutaneous' was medically significant, while non-serious for 'Redness at injection site'. The patient had no ER nor physician visit required; she had no prior vaccines within 4 weeks. The patient does not have a positive test for SARS-CoV2. She does not have SARS-CoV2 antibodies at diagnosis as she has had blood test a couple of months ago, either end of Oct2020 or beginning of Nov2020, and there were No antibodies at that time. The patient was not hospitalized nor was she admitted to an Intensive Care Unit (ICU). The patient did not display clinical signs at rest indicative of severe systemic illness. She did not have supplemental oxygen (including high flow or ECMO) nor received mechanical ventilation. She did not receive any additional therapies for COVID-19. The events did not require the initiation of new medication nor other treatment or procedure. The outcome of the events chills, lightheadedness, tired and Redness at injection was recovering while unknown for believe the vaccine was given subcutaneous, freezing and could not get warm, shaking, and sick.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. 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.