Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Temperature intolerance, Throat irritation, Tinnitus, Upper respiratory tract congestion
Clinical narrative: fatigue; feeling dizzy/lightheaded; ringing in her ears; head feels stuffy/ head feeling stuffy; feeling like she can't regulate heat well; Dry throat; throat itching; voice change/Hoarse voice; skin itch; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 17Sep2021 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (medically significant) with onset 17Sep2021, outcome "unknown", described as "skin itch"; THROAT IRRITATION (medically significant) with onset 17Sep2021, outcome "not recovered", described as "throat itching"; DYSPHONIA (medically significant) with onset 17Sep2021, outcome "not recovered", described as "voice change/Hoarse voice"; DRY THROAT (non-serious) with onset 2022, outcome "unknown"; FATIGUE (non-serious) with onset 2022, outcome "unknown"; DIZZINESS (non-serious) with onset 2022, outcome "not recovered", described as "feeling dizzy/lightheaded"; TEMPERATURE INTOLERANCE (non-serious) with onset 2022, outcome "unknown", described as "feeling like she can't regulate heat well"; UPPER RESPIRATORY TRACT CONGESTION (non-serious) with onset 2022, outcome "unknown", described as "head feels stuffy/ head feeling stuffy"; TINNITUS (non-serious) with onset 2022, outcome "unknown", described as "ringing in her ears". The events "throat itching", "voice change/hoarse voice" and "skin itch" required emergency room visit. Therapeutic measures were taken as a result of throat irritation, dysphonia, pruritus.   Clinical course included, 63-year-old female patient who after having her Pfizer vaccinations has experienced throat itching, voice change, skin itch, head feeling stuffy, fatigue, and feeling like she could not regulate heat well for more than one year after vaccination. The doctor was calling, because her patient insisted her to, to know if there was additional information about this side effects that could be provided to her patient. Her first and only vaccine was on 17Sep2021 and a few hours after the vaccine she went to the Emergency Department for some and was a few hours and noted throat itching, voice change and skin itching and was treated like an allergic reaction at the Emergency Room and not anaphylaxis and she was treated with Epi (epinephrine) and prednisone and followed up with her in office. A year later she was still having hoarse voice and dry itchy throat, feeling dizzy and for her was lightheaded, ringing in her ears, head feels stuffy, feeling like she could not regulate heat well, and fatigue. Reporter said kind of persisting non specific symptoms and a not true allergic reaction and timing was concerning and the patient has not gone forward with any other COVID vaccines or other vaccines since then. she checked a bunch of labs that were unrevealing and recommended her to see Ear Nose Throat for her chronic hoarseness and she was declining before. patient tried to call Pfizer and felt like there is something Pfizer could tell a medical professional. She did not and said she thought was an odd case and not like a thing. Reporter told her she would call. Reporter said to send her to the other department and see if recommend any test when asked to complete report.   The lot number for the BNT162b2 was not provided and will be requested during follow up. Sender's Comments: Based on the available information in the case, the causal association between the event's 'pruritus', 'throat irritation', 'dysphonia' and the suspect drug BNT162B2 cannot be 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.