Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eustachian tube dysfunction, Hyperacusis, Lumbar puncture, Magnetic resonance imaging head, SARS-CoV-2 test
Clinical narrative: tinnitus; severe hyperacusis after receiving the Pfizer Covid19 vaccines; she was going to start crying because she had forgotten how long event had lasted; she was going to start crying because she had forgotten how long event had lasted; MRI of the brain populated in formal field of testing/investigations was done in 2021/MRI of the brain showed inflammation; After lumbar puncture she developed a leak with a severe debilitating headache; she still has that inflammation in her brain that the neurologist told her will probably not go away; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose 2, single (Lot number: ER2613) at the age of 58 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "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; "Covid-19", start date: 11Jan2021, stop date: 11Jan2021. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE , Date administered: 02Mar2021:, Vaccine Lot Number: EN6205, Vaccine Lot Expire Date: Unknown, not on CDC vaccine record card., Time the Vaccination Was Given: around 21:30-22:00, Anatomical Location of Administration of Pfizer vaccine considered as suspect: Unknown arm), administration date: 02Mar2021, when the patient was 58-year-old, for COVID-19 Immunization, reaction(s): "severe hyperacusis", "tinnitus"; Flu vaccine, for Immunization. The following information was reported: TINNITUS (medically significant) with onset 25Mar2021, outcome "recovering"; POST LUMBAR PUNCTURE SYNDROME (non-serious) with onset 2021, outcome "unknown", described as "After lumbar puncture she developed a leak with a severe debilitating headache"; MAGNETIC RESONANCE IMAGING HEAD ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "MRI of the brain populated in formal field of testing/investigations was done in 2021/MRI of the brain showed inflammation"; HYPERACUSIS (medically significant) with onset 2021, outcome "recovered" (01Jun2021), described as "severe hyperacusis after receiving the Pfizer Covid19 vaccines"; INFLAMMATION (non-serious) with onset 2021, outcome "unknown", described as "she still has that inflammation in her brain that the neurologist told her will probably not go away"; CRYING (non-serious), MEMORY IMPAIRMENT (non-serious) all with onset 2021, outcome "unknown" and all described as "she was going to start crying because she had forgotten how long event had lasted". The events "tinnitus" and "severe hyperacusis after receiving the pfizer covid19 vaccines" required physician office visit. The patient underwent the following laboratory tests and procedures: Lumbar puncture: (unspecified date) Negative, notes: all results from lumbar puncture were negative; Magnetic resonance imaging: (26May2022) Unknown result; (2021) MRI of the brain showed inflammation, notes: Result: Inflammation; Unit: Not Provided; SARS-CoV-2 test: (unspecified date) positive; (unspecified date) positive; (11Jan2021) positive; (07Jan2022) positive. Therapeutic measures were taken as a result of tinnitus. Clinical course: Originating AE Request: REQ-799339. Caller was asking was there any research from Pfizer on adjustments in dosing for those who had adverse reactions to the Covid19 vaccine. Caller stated that she was desperate to get a Covid19 booster vaccine, but did not want to experience any adverse events again. Caller was asking "are there any recommendations from on getting the booster shot if they have experienced adverse events from the Covid19 vaccine primary series and does recommend getting a smaller dose of the booster for people who have had previous adverse events. 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 were not 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. She has not received a booster for fear of getting repeat of tinnitus and severe hyperacusis. She is just wondering if the recommendations, she knows recommendations for severe reactions is 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 is recommending she repeat the injection for the booster of Covid Vaccine; she made recommendation of either trying the Moderna or the J and J; although the J and J probably wouldn't provide as much protection. Caller 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. She saw in ENT doctor emergently on 06Apr2021. She reported event at this time was a little worse than it had been but reported event outcome overall as being improved since onset. There were so many things going on in her head. She contracted COVID with positive for COVID result on COVID test 07Jan2022. She can't remember when the onset of COVID symptoms started. She just had some very minimal cold-like symptoms. Acute symptoms weren't severe. She is scheduled for a repeat MRI of the brain on 26May2022. She is being followed by a neurologist. Vaccination Facility Type: Clinic, it was actually just a using whatever they could use, it was a lecture room within the University. Vaccine was not administered at Facility. No other vaccines administered on same date with the Pfizer vaccine considered as suspect. No AE(s) requires a visit to: Emergency Room. She was able to stave it off by forcing fluids. She still has headaches that are worse than normal; but does not know why. The neurologist thinks they are because she still has that inflammation in her brain that the neurologist told her will probably not go away. She will see the Neurologist in a couple of weeks. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). She had only had flu vaccine once in her life and has no history of ever having a reaction to a vaccine.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely 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.