Age: 28.0
Sex: F
Vaccine: COVID19, FLU4, COVID19
Symptoms: Nystagmus, Off label use, Product use issue, Vertigo, Vestibular neuronitis
Clinical narrative: moderna 1st&2nd dose, pfizer booster dose; moderna 1st&2nd dose, pfizer booster dose; vestibular neuritis; could not walk to the bathroom without losing my balance; I was diagnosed with Vertigo in the ED; developed nystagmus; feeling dizzy it lasted for about 10  minutes; booster; Location of injection for vaccine received same date: Influenza: AFLURIA QUAD 2021-22 (3YR UP) - right deltoid; Initially after that vaccination I just had generalized fatigue for two days; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Oct2021 14:00 (Lot number: 320308d) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient no known allergies. Concomitant medication(s) included: AFLURIA QUAD, start date: 31Oct2021, stop date: 31Oct2021. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Vaccine Administration Time: 09:00 AM), administration date: 08Feb2021, when the patient was 27 years old, for Covid-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Vaccine Administration Time: 09:00 AM), administration date: 09Jan2021, when the patient was 27 years old, for Covid-19 immunization. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown" and all described as "moderna 1st&2nd dose, pfizer booster dose"; IMMUNISATION (medically significant) with onset 31Oct2021 14:00, outcome "unknown", described as "booster"; VESTIBULAR NEURONITIS (medically significant) with onset 21Nov2021, outcome "recovering", described as "vestibular neuritis"; PRODUCT USE ISSUE (non-serious) with onset 31Oct2021, outcome "unknown", described as "Location of injection for vaccine received same date: Influenza: AFLURIA QUAD 2021-22 (3YR UP) - right deltoid"; FATIGUE (non-serious) with onset 31Oct2021, outcome "recovered" (02Nov2021), described as "Initially after that vaccination I just had generalized fatigue for two days"; DIZZINESS (non-serious) with onset 16Nov2021 05:00, outcome "recovered" (16Nov2021 05:10), described as "feeling dizzy it lasted for about 10  minutes", On 20Nov2021 she had another episode of dizziness that lasted about 20-30 minutes and then went away; BALANCE DISORDER (non-serious) with onset 21Nov2021, outcome "recovering", described as "could not walk to the bathroom without losing my balance"; VERTIGO (non-serious) with onset 21Nov2021, outcome "recovering", described as "I was diagnosed with Vertigo in the ED", The neurologist said it could be from vestibular neuritis; NYSTAGMUS (non-serious) with onset 21Nov2021, outcome "recovering", described as "developed nystagmus". The events "vestibular neuritis", "initially after that vaccination i just had generalized fatigue for two days", "feeling dizzy it lasted for about 10  minutes", "could not walk to the bathroom without losing my balance", "i was diagnosed with vertigo in the ed" and "developed nystagmus" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of vestibular neuronitis, fatigue, dizziness, balance disorder, vertigo, nystagmus included Meclazine, zofran, and vestibular exercises. Initially after receiving the booster vaccination she did not develop a fever, ear pain, or ear pressure, was very active, healthy and rarely get sick. The patient did not have any medical problems. The patient had no prior vaccination, not tested for covid post vaccination. No other vaccine administered in four weeks and no other medications in two weeks.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the reported events Off label use, Interchange of vaccine products, Immunisation, Vestibular neuronitis and suspect drug BNT162B2 cannot be excluded.  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 re-sponse, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.