Sex: M
Vaccine: COVID19
Symptoms: Malaise, Tinnitus
Clinical narrative: malaise; tinnitus; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team for a Pfizer sponsored program.   A 68 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MALAISE (non-serious), outcome "recovered", described as "malaise"; TINNITUS (non-serious), outcome "not recovered", described as "tinnitus".   Additional information: Physician calling on behalf of 68 year old male patient who reportedly experienced tinnitus and malaise after receiving the first two doses of Comirnaty. Caller stated patients malaise resolved but tinnitus did not. Caller asking for information on tinnitus experienced after Comirnaty vaccination, and whether his patient should receive a booster dose of Comirnaty after experiencing this adverse event. "As of 29Jun2021, a search of the published medical literature has identified limited information regarding reports of tinnitus following the administration of the Pfizer-BioNTech COVID-19 Vaccine (also known as BNT162b2). A summary of available information follows." "A search of adverse events reported at 1 month after Dose 2 in the Pfizer-BioNTech COVID-19 Vaccine trial, which included 21,926 individuals who received vaccine and 21,921 individuals who received placebo, did not identify a safety signal. There were similar rates of tinnitus in those individuals who received the vaccine as those who received placebo injection (0.04% each). "Withheld reported sudden unilateral tinnitus in a 37-year-old female patient and a 63-year-old male patient 7 and 20 hours after dose 1 of the Pfizer-BioNTech COVID-19 Vaccine, respectively, and in a 30-year old male patient 6 days after dose 2 of the vaccine. None of the patients had previously been diagnosed with COVID-19. Otoscopy examination was normal in the 3 patients; 2 patients underwent MRI of the internal auditory meatus and cerebellopontine angle that revealed no abnormalities. The female patient reported tinnitus with short term dizziness and no hearing loss. She had a medical history of glaucoma and undifferentiated connective tissue disease. She was treated with corticosteroids for 10 days with no improvement at a follow-up visit on day 13. In addition to the tinnitus, both men presented with hyperacusis and dysacusis. The 63-year-old patient had a history of bilateral symmetrical mild high frequencies sensorineural hearing loss, chronic gastritis, extrinsic asthma and depression. In this 63-year-old male, the authors noticed a slight worsening in Pure Tone audiometry (PTa) threshold compared to results obtained 6-months before with spontaneous improvement 7 days later. The 30-year-old patient presented with nausea and fever as side effects of the vaccine treated with acetaminophen. He had no prior history of audio-vestibular symptoms; comorbidities included Hashimoto thyroiditis. PTa did not reveal hearing abnormalities. The patient significantly improved after 10 days on prednisone. The authors hypothesized that history of atopy and autoimmune disorders in these patients could have triggered an abnormal autoimmune response that affected the cochlea-vestibular system. They also considered immunization anxiety-related reaction and a coincidental event as other possible causes of the tinnitus and concluded that larger well-designed studies are needed to establish if tinnitus is an adverse effect of the COVID-19 vaccine. "Pfizer is unable to make any recommendations regarding the treatment of tinnitus following administration of Pfizer/BioNTech COVID-19 Vaccine; clinical judgment based on the medical history and the clinical status of a specific patient should dictate the appropriate actions to be taken. The Centers for Disease Control and Prevention (CDC) has established a project comprised of a team of vaccine safety experts who can be consulted on complex COVID-19 vaccine safety questions. More complete information is available on their website, which is Withheld. If interested, please be sure to follow the CDCs detailed instructions on making a request (either online or by phone)." The reporter seriousness, start date of event tinnitus was reported as unspecified. Dates for Pfizer COVID vaccine: (Start: Unspecified Stop: Unspecified). NDC number of Pfizer COVID vaccine: Not Provided. Reason for no lot number: of Pfizer COVID vaccine: Caller unwilling to complete the report. Expiry Date of Pfizer COVID vaccine: Not Provided. Investigation Assessment: Not Provided. He had a healthcare professional on the line who reports that a patient claims to have experienced tinnitus after receiving Pfizer COVID vaccine. He would like to know if they should proceed with getting booster shot. He did not wish to create report. He did not wish to be contacted or provide any other contact details and requested to be transferred to have his question answered. No further details provided.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.