Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Crying, Hyperacusis, Inflammation, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: tinnitus; Tinnitus: Initial onset was 04Mar2021. Described as having the ringing, kind of like a eustachian tube dysfunction; Tinnitus: Initial onset was 04Mar2021. Described as having the ringing, kind of like a eustachian tube dysfunction; severe hyperacusis after receiving the Pfizer Covid19 vaccines; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6205) at the age of 58 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: 07Jan2021 (unspecified if ongoing), notes: Symptom onset 07Jan2021. Positive for COVID on 11Jan2021.She took 2 or 3 COVID tests that were all positive; "Seasonal Allergies" (ongoing), notes: Illness/AE: Seasonal Allergies, Onset Date: Childhood, Stop Date: Ongoing; "Seasonal Asthma" (ongoing), notes: Illness/AE: Seasonal Asthma, Onset Date: Childhood, Stop Date: Ongoing; "tinnitus" (unspecified if ongoing), notes: Family Medical History Relevant to AE(s): Dad has tinnitus. There were no concomitant medications. Vaccination history included: Flu vaccine (She has only had flu vaccine once in her life, and has no history of ever having a reaction to a vaccine), for immunization. The following information was reported: EUSTACHIAN TUBE DYSFUNCTION (medically significant), TINNITUS (medically significant) all with onset 04Mar2021, outcome "recovered" (Mar2021) and all described as "Tinnitus: Initial onset was 04Mar2021. Described as having the ringing, kind of like a eustachian tube dysfunction"; TINNITUS (medically significant) with onset 04Mar2021, outcome "recovering"; HYPERACUSIS (medically significant) with onset Mar2021, outcome "recovered" (Mar2021), described as "severe hyperacusis after receiving the Pfizer Covid19 vaccines". The patient underwent the following laboratory tests and procedures: Lumbar puncture: (2021) All negative; Magnetic resonance imaging head: (2021) Inflammation; SARS-CoV-2 test: (unspecified date) Positive, notes: ook 2 or 3 COVID tests that were all positive for COVID; (11Jan2021) positive; (07Jan2022) Positive, notes: Positive for COVID. Therapeutic measures were not taken as a result of tinnitus, eustachian tube dysfunction, tinnitus.  Additional information: Reporter was a 58 year old female RN and stated that she developed tinnitus and severe hyperacusis after receiving the Pfizer Covid19 vaccines. Reporter stated she got her Pfizer Covid19 vaccines on 02Mar2021 and 23Mar2021. Reporter was asking are these known severe adverse reactions to the vaccines. Reporter was asking was there any research from Pfizer on adjustments in dosing for those who had adverse reactions to the Pfizer Covid19 vaccine. Reporter stated that she was desperate to get a Pfizer Covid19 booster vaccine but does not want to experience any adverse events again. Reporter was asking are there any recommendations from Pfizer on getting the booster shot if they have experienced adverse events from the Pfizer Covid19 vaccine primary series. and does Pfizer recommend getting a smaller dose of the booster for people who have had previous adverse events. Relevant Medical History and Concurrent Conditions: COVID. Symptom onset 07Jan2021.Tested positive for COVID on COVID test on 11Jan2021.She took 2 or 3 COVID tests that were all positive for COVID. Husband took COVID test and he was negative for COVID. Acute symptoms weren't severe, was mild case of COVID. When developed COVID she was given a week of Prednisone because she developed headaches. It had to have been she would call it mid Jan2021 that she did the Prednisone. This Nurse was also the patient who called regarding her 2 doses of Pfizer product: Covid Vaccine. She reported having tinnitus and severe hyperacusis after both doses of Covid Vaccine. She additionally reported she contracted COVID in Jan2022. She has not received a booster for fear of getting repeat of tinnitus and severe hyperacusis. She was just wondering if the recommendations, she knows recommendations for severe reactions was not to take another one of the Covid Vaccines. She does not know if the tinnitus and severe hyperacusis fall in the category of severe adverse events or reactions. She discussed this with her primary care doctor. Primary care doctor was recommending she repeat the injection for the booster of Covid Vaccine; she made recommendation of either trying the Moderna or the J&J; although the J&J probably wouldn't provide as much protection. Reporter knows there's been reports to VAERS; she did report these events to VAERS. She just wanted to see if these events are considered to be serious adverse events or reactions; and if there are recommendations on additional doses such as the booster doses if patient has experienced these events with prior Covid Vaccines. Tinnitus: Initial onset was 04Mar2021. Described as having the ringing, kind of like a eustachian tube dysfunction. Event lasted for about a week before she had recovered completely from event, so around 11Mar2021. She does not think she went on steroids for that initial event. Recurrence of event occurred after second dose of the Covid Vaccine, she thinks on 25Mar2021 her life pretty much spiraled down pretty quickly. She was started on steroid: Prednisone for this event on 27Mar2021 which she continued taking for a good month. Severe hyperacusis onset time/date: Unknown other than in 2021. There were so many things going on in her head. She mentioned she was going to start crying because she had forgotten how long event had lasted. First dose: Date administered: 02Mar2021; Lot: EN6205; Dose: Unknown volume/strength/dose injection in unknown arm around 21:30-22:00. MRI of the brain populated in formal field of testing/investigations was done in 2021, unknown if Jun2021 or Jul2021. Lumbar puncture populated in formal field of testing/investigations was done because MRI of the brain showed inflammation; all results from lumbar puncture were negative. She was scheduled for a repeat MRI of the brain on 26May2022. She was being followed by a neurologist. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. AE(s) following prior vaccinations: None. She has only had flu vaccine once in her life, and has no history of ever having a reaction to a vaccine. Illness/AE: Seasonal Allergies; Onset Date: Childhood; Stop Date: Ongoing; Illness/AE: Seasonal Asthma; Onset Date: Childhood; Stop Date: Ongoing. Family Medical History Relevant to AE(s): Dad has tinnitus.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Tinnitus , eustachian tube dysfunction , hyperacusis and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.