Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: vertigo; dizziness; brain fog; Tinnitus; Bouts of fatigue; muscle aches occasionally; headache; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 10Aug2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable other healthcare professional (patient). A 49-year-old female patient received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6198), intramuscular, administered in Arm Left on 04Mar2021 (received at the age of 49-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks. Medical history included asthma from 1981 and ongoing, and depression from 1992 and ongoing. No known allergies. The patient was not pregnant at the time of vaccination and adverse events. The patient did not have COVID-19 prior to vaccination. Concomitant medication(s) included desvenlafaxine succinate monohydrate (PRISTIQ) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, Lot Number: EN9581), intramuscular, administered in Arm Right on 11Feb2021 (received at the age of 49-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient experienced tinnitus since the first day of the second dose, 04Mar2021 at 17:00. It is 24/7. The patient had bouts of fatigue, headache, muscle aches occasionally on 04Mar2021. She also experienced fatigue, dizziness, brain fog (intermittent) on 06Mar2021. The patient explained that starting the day of her second vaccine, she has had non-stop tinnitus. She also had bouts of dizziness, vertigo, fatigue and brain for every 2 weeks where she would need to take days off from work. 3 weeks ago, the bout came back, and she didn't feel better for week. The dizziness/ vertigo/ fatigue/ brain fog was intermittent, and tinnitus never stopped. Blood test in May2021 showed everything normal and her doctor could not further advise. The patient stated that she would have a full physical this month (Aug2021) in person to ask for a hearing test and to inquire on any medical advice. Relevant tests included: TSH on 18May2021: normal; BMP on 18May2021: normal; Hemograph on 18May2021: normal; Lipid panel on 18May2021: normal; FSH on 18May2021: normal, LH on 18May2021: normal; COVID-19 test on 01Feb2021: normal. The patient underwent nasal swab on 09Jul2021 with negative result. The patient did not receive any treatment for the events. Outcome of the events was not recovered. The events resulted into Doctor or other healthcare professional office/clinic visit. The event tinnitus was assessed as serious (Persistent/ Significant disability/ incapacity). The events fatigue, dizziness, brain fog were assessed as serious as well (Important medical event).; Sender's Comments: Based on the close temporal relationship the causal association between the events tinnitus, fatigue, dizziness and brain fog with the usage of the vaccine BNT162B2 cannot be excluded. The case will be reassessed if there is any new information reported. 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.