Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling cold, Headache, Influenza like illness, Laboratory test
Clinical narrative: felt feverish; Slept most of the day and night; few scattered hives; flu like symptoms; Flu like symptoms-woke up freezing; Flu like symptoms-headache; Flu like symptoms- neck pain; Flu like symptoms- body aches; Flu like symptoms- restless; nausea; vomiting; fatigue; diagnosed with vestibular neuritis secondary to the vaccine; This is a spontaneous report from a contactable physician (patient). A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left arm on 08Jan2021 13:00 (Lot Number: EL3246) as single dose for covid-19 immunisation at age 34 years old. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. No concomitant medications. No other vaccine in four weeks and no other medications in two weeks. The patient previously received the first dose of BNT162B2 on 18Dec2020 (lot no: EJ1685) for COVID-19 immunization at 34 years old. After receiving the second dose of Pfizer vaccine on 08Jan2021, within 13 hours (09Jan2021 02:00) the patient was ill with flu like symptoms (woke up freezing, headache, neck pain, body aches, restless). Later that morning (09Jan2021), the patient had nausea, vomiting and fatigue. After 36 hours (09Jan2021), profound fatigue, intermittently dizzy, felt feverish but did not confirm; body aches had resolved. On 10Jan2021 01:00, slept most of the day and night, had a few scattered hives in the evening. On day 3 (11Jan2021), since this day the patient has had constant vertigo. She was hospitalized from 15Jan2021 to 16Jan2021, had extensive testing and saw different specialists, and was diagnosed with vestibular neuritis secondary to the vaccine. She never had CoVID before, healthy otherwise, and had negative CoVID antibody testing prior to receiving the vaccine. She was off work for 6 weeks, able to go back for 10 shifts but had worsening of vertigo symptoms and was unable to work x 3 weeks and ongoing; still working with vestibular rehab, still having daily significant vertigo. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability or permanent damage. Treatment received included medication and vestibular therapy. The patient underwent covid test (nasal swab) on 16Jan2021 with negative result. The patient recovered from body aches on an unspecified date in Jan2021; while not recovered from the rest of the events.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information. 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.