Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Product dose omission issue, Swelling, Tinnitus
Clinical narrative: Left ear felt blocked, tinnitus was acting up; Tingling in her earlobe; Swollen eardrum on the left side; Second shot, which was supposed to be on 02Jul2021, but she is holding off/she skipped the 2nd dose for fear it would cause hearing loss; This is a spontaneous report from a contactable consumer or other non-HCP (Patient herself).  A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left (left upper arm) on 28May2021 14:22 (at the age of 40-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included temporomandibular joint syndrome (TMJ) from 2020, the patient had it over a year now. The patient's concomitant medications were not reported and no other products reported. The patient had no history of previous immunization with the Pfizer vaccine. No additional vaccines administered on same date of the Pfizer suspect. The patient had no prior vaccinations (within 4 weeks). The patient had all prior vaccines and can't remember any adverse reactions. The patient had first shot was on 28May2021, and she came home, took a shower, within a couple of hours her left ear felt blocked and her tinnitus was acting up. She felt like something was poking in her ear, on the left side, she was unsure if it was related, but then she had the tingling sensation/felt tingling in her ear lobes later that night, and that started for the next couple weeks, and she still had it until 02Jul2021, but she did not do that shot yet, as she was nervous why that would happen, and she did research, and she thought some people reported tinnitus, hearing loss, and she still had tingling, which was now gone. The tingling stopped, so that's good. But she would like to get the second dose to be fully vaccinated, but she was unsure if something worse may happen. But because of the ear tingling she skipped the 2nd dose for fear it would cause hearing loss. Caller reports that she can't remember the exact date that the tingling to her ear lobes stopped but reports that it eventually went away. She went to Doctor Sunday, she can't remember when, but it was recent, as she had a swollen eardrum on the left side, she was unsure if it's related to the vaccine, but the tingling did stop, but she has TMJ, and she had the swollen eardrum, she was unsure if its vaccine related, or both, but it's gone now and it's not swollen, and she wondered if the tingling of the earlobe could be worse with the second shot or affect the hearing. She called the pharmacy, they said they had no side effects like that, and caller researched and it said some people had side effects with ears, and at the ENT visit yesterday she thinks, it was someday this week, she was so tired, she cannot confirm if it's related to the vaccine, it was a follow up from urgent care, where she was diagnosed with a swollen ear drum in the left ear, and they said everything was fine, that it could be related to TMJ or could or could not be related to the vaccine, but the doctor's opinion was it would be ok to get the vaccine because her ears looked fine. She was wondering if there are any reports of Tinnitus or ear tingling from the vaccine and if so, did those people lose their hearing. She was asking, if the second dose was administered later than the recommended time interval does that change the efficacy, it's been more than 6 weeks since her first dose. Alternative dosing regimens of Pfizer-BioNTech COVID-19 Vaccine have not been evaluated. The decision to implement alternative dosing regimens resides with health authorities; however, we at Pfizer believe that it was critical for health authorities to conduct surveillance on implemented alternative dosing schedules to ensure that vaccines provide the maximum possible protection. The adverse events not required visit to emergency room. No relevant test done. The outcome of the events Tingling in her earlobe and Swollen eardrum on the left side was recovered on an unspecified date in 2021 and outcome of other events was unknown.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.