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Life Threatening? No
Write-up: felt like ears had popped ( like when on a plane ) the evening of vaccine; felt like ears had popped ( like when on a plane ) the evening of vaccine/Hives; Earache; Ringing in ears; Fatigue; Sounds are distorted.; Headache; This is a spontaneous report from a contactable other hcp received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106042027548930-R2IUR. Safety Report Unique Identifier GB-MHRA-ADR 25423839. A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 03Jun2021 (Lot Number: EW3143) as single dose for covid-19 immunisation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not pregnant. Patient is not currently breastfeeding. Medical history included Lactation decreased, Hay fever, contraception, Anemia B12 deficiency, Depression, all from unknown date and unknown if ongoing. Concomitant medications included amoxicillin taken for an unspecified indication from 20Apr2021 to 27Apr2021; loratadine (NON-DROWSY HAYFEVER AND ALLERGY RELIEF) taken for Hay fever, start and stop date were not reported; desogestrel, ethinylestradiol (GEDAREL) taken for contraception, start and stop date were not reported; hydroxocobalamin taken for Anemia B12 deficiency, start and stop date were not reported; sertraline taken for depression, start and stop date were not reported. The patient experienced felt like ears had popped (like when on a plane) the evening of vaccine/Hives on an unspecified date, earache on 04Jun2021, ringing in ears on 04Jun2021, headache on 03Jun2021 and reported with the time between suspect drug administration and start of the event of 1 day, fatigue on 04Jun2021, all reported as serious due to medically significant. Felt like ears had popped (like when on a plane) the evening of vaccine, and then continued with ringing and heavy earache feeling still the day after. Sounds are distorted. The reporter did not think that the report related to possible blood clots or low platelet counts. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event felt like ears had popped (like when on a plane) the evening of vaccine/Hives was recovering, of the event headache was recovered with sequelae, of the others was not recovered. No follow-up attempts are possible. No further information is expected.
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