Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Thyroid function test
Clinical narrative: has no energy what so ever; has been feeling lousy and feels like everything is being drained out of her/ it is driving her nuts.; it was weird; Ear has been blocked and cannot hear anything after receiving the first dose; Ear has been blocked and cannot hear anything after receiving the first dose/ left ear is blocked; constantly tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2, solution for injection), administered in arm right, administration date 28Nov2021 10:00 (Batch/Lot number: unknown) at the age of 52 years as dose 1, single and administered in arm right, administration date 12Dec2021 10:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hyperthyroidism" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID taken for hyperthyroidism (ongoing); VITAMINS A & D. The following information was reported: DEAFNESS (medically significant) with onset 28Nov2021, outcome "unknown", described as "Ear has been blocked and cannot hear anything after receiving the first dose"; EAR DISCOMFORT (non-serious) with onset 28Nov2021, outcome "not recovered", described as "Ear has been blocked and cannot hear anything after receiving the first dose/ left ear is blocked"; FATIGUE (non-serious) with onset 28Nov2021, outcome "unknown", described as "constantly tired"; ASTHENIA (non-serious), outcome "unknown", described as "has no energy what so ever"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "has been feeling lousy and feels like everything is being drained out of her/ it is driving her nuts."; FEELING ABNORMAL (non-serious) with onset 28Nov2021, outcome "not recovered", described as "it was weird". The patient underwent the following laboratory tests and procedures: blood test: unknown results; thyroid function test: unknown results. Therapeutic measures were taken as a result of deafness, ear discomfort, fatigue, asthenia, feeling abnormal, feeling abnormal. Clinical course: Patient was warm transferred by DSU Agent withheld, NT ID #, Rep. no. # and was calling about the Pfizer Covid19 vaccine. She stated that she received her first dose of the vaccine last 28Nov2021 and her second dose on 12Dec2021, but she stated that her ear has been blocked and cannot hear anything after receiving the first dose. She wanted to know if this is a commonly reported side-effect of the vaccine and how to unblock it Response: Reviewed the PI/Fact Sheet for purple cap, LAB-# Revised: 09Dec2021. Spoke from CONS-reports of tinnitus (v2.0) as reported SE in the ear, similar to her concern: In a review of the Comirnaty (also known as Pfizer-BioNTech COVID-19 Vaccine) Phase 3 study at 1 month after the second dose of the vaccine (or placebo injection), the rate of  tinnitus (or ringing in the ears) was reported in a similar number of people who received the vaccine as those who received a placebo injection.1Pfizer has received voluntary reports of tinnitus (ringing in the ears) since the authorization of the Pfizer-BioNTech COVID-19 vaccine. A link between the vaccine and these reports has not been established. Please call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away. Emphasized that no link has been established between tinnitus and ear blockage with the vaccine as this needs to be further investigated or studied. Referred caller to her HCP for clinical recommendations. She asked as a follow up question, "did she receive the dose too early" as she received her 2nd dose 14 days after her 1st dose. Response: Spoke from FACT SHEET/FULL EUA PI FOR HCPs ADMINISTERING (PURPLE CAP) PFIZER-BIONTECH COVID-19 VACCINE FOR 12 YEARS OF AGE AND OLDER - DILUTE BEFORE USE (v2.0); LAB-#, Revised: 09Dec2021: The Pfizer-BioNTech COVID-19 Vaccine is administered as a primary series of 2 doses (0.3 mL each) 3 weeks apart in individuals 12 years of age or older. Referred to her HCP and CDC for clinical recommendations. Additional Information for Concomitant Products Armour Thyroid: Patient states it is a form of Synthroid that she takes, over the counter. She h has never had issues with this and has been on it for years. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Treatment: She was just taking Advil that went with her side effects or whatever but that was not going to affect her ear.  The lot number for bnt162b2 was not provided and will be requested during follow up.