Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: almost like she also had some mild hearing loss; nausea; exacerbation of migraine with paresthesia and tinnitus/ headaches/migraines; exacerbation of migraine with paresthesia and tinnitus; exacerbation of migraine with paresthesia and tinnitus/ increased tinnitus; some abdominal tightness; This is a spontaneous report from a contactable pharmacist (patient herself) via Medical Information team.  A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3302, NDC number/expiration date was unknown), via an unspecified route of administration on the left arm (also reported as upper left arm) on 13Jan2021 at 09:00 at a single dose for COVID-19 immunization; the patient was a healthcare worker and was trying to protect herself. The vaccination facility type was reported as a drive thru site. Relevant medical history included previous neurological problems, which included history of underlying migraine with paresthesia/chronic paresthesia (ongoing) and tinnitus. The patient had no family medical history relevant to the adverse events (AEs). There were no concomitant medications. The patient had no other vaccine received on the same day of the Pfizer suspect or 4 weeks prior. She never had any problems with vaccines in the past. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Initially, the patient was asking if there were any reports of paresthesia, serious neurologic adverse events, tinnitus, hearing loss, or abdominal tightness in the studies for the Pfizer-Biontech Covid-19 vaccine. After the patient received the first dose of the Pfizer-BioNTech COVID-19 vaccine on 13Jan2021, she experienced an exacerbation of migraine with paresthesia and tinnitus. She also reported experiencing some abdominal tightness on an unspecified date in Jan2021. The patient reported she was scheduled for her second dose of the Pfizer COVID-19 vaccine, but had concerns because she was still experiencing tinnitus and it was "almost like she also had some mild hearing loss" on an unspecified date. The patient further reported that she was due for the next dose the following day at the time of the report (03Feb2021). She had previous neurological problems and did not know if this did exacerbate things or not. She had migraines, tinnitus, and paresthesia and was wondering how many other patients with neurological problems reported this and was this a common side effect or adverse event reported. One doctor told her not to get the second dose and another one told her to get it and she wanted to know what she should do. The patient had headaches/migraines on the evening of vaccination on 13Jan2021 that were fairly mild and 3 days after that on 16Jan2021, they got bad and was accompanied with nausea with increased tinnitus. The migraines and nausea had gone, and the chronic paresthesia was the same as she always had, but the tinnitus was a lot louder and worse. The patient also mentioned that her migraines usually go away, but this one had lingered. The AEs did not require any visit to an emergency room or a physician office. There were no investigation assessment. The patient recovered from the event "nausea" on an unspecified date, she was recovering from the event "exacerbation of migraine/ headaches/migraines," she was not recovered from the events "exacerbation of paresthesia and tinnitus/increased tinnitus, while the outcome of the events "almost like she also had some mild hearing loss and some abdominal tightness" was unknown. The reporter assessed the events "migraine, tinnitus, paresthesia, and nausea" as serious, other medically important conditions. The relatedness of drug to the reactions/events "migraine, tinnitus, paresthesia, and nausea" was unknown as per the reporting pharmacist (Method of assessment: Global Introspection).; Sender's Comments: The 61-year-old female had relevant medical history included previous neurological problems. The reported neurological events and partial hearing loss were more likely due to pre-existing conditions, and less likely related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).  Event nausea was likely due to the first dose of bnt162b2.  The case will be reassessed should additional information become available.  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.