Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Nasal dryness, SARS-CoV-2 test, Tooth fracture
Clinical narrative: Developed multiple cracked teeth requiring dental care; 2-3 weeks post second Pfizer COVID vaccination developed severe dry mouth; severe dry nasal passages; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jan2021 at 12:00 as dose 2, single (Lot number: EL3248) at the age of 64 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing), notes: Other Medical History: hyperlipidemia; "LAD bridge" (unspecified if ongoing), notes: Other Medical History: LAD bridge; "Known allergies: yellow dye in medications" (unspecified if ongoing), notes: Known allergies: yellow dye in medications. Concomitant medication(s) included: PRAVASTATIN; EZETIMIBE; NEBIVOLOL. Vaccination history included: BNT162b2 (Dose number: 01, Lot Number: EL1284, Administrator route: Intramuscular, Administration date= 26Dec2020, Administration Time: 10:45 AM, Vaccine location= Left arm), administration date: 26Dec2020, when the patient was 64-year-old, for Covid-19 immunization. The following information was reported: DRY MOUTH (non-serious) with onset 02Feb2021 at 12:00, outcome "not recovered", described as "2-3 weeks post second Pfizer COVID vaccination developed severe dry mouth"; TOOTH FRACTURE (medically significant) with onset 02Feb2021 at 12:00, outcome "not recovered", described as "Developed multiple cracked teeth requiring dental care"; NASAL DRYNESS (non-serious) with onset 02Feb2021 at 12:00, outcome "not recovered", described as "severe dry nasal passages". The events "developed multiple cracked teeth requiring dental care", "2-3 weeks post second pfizer covid vaccination developed severe dry mouth" and "severe dry nasal passages" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jan2021) Negative, notes: Covid test type post vaccination: Blood test; (05May2021) Negative, notes: Covid test type post vaccination: Nasal swab. Therapeutic measures were taken as a result of tooth fracture, dry mouth, nasal dryness. Multiple dental treatments for cracked teeth, ENT visits for dry mouth and nose including Mucinex. It was reported that, ENT treatment over the past 18 months. Patient had not been diagnosed with COVID-19 prior to vaccination. The patient also received third dose of bnt162b2, Intramuscular, in Left arm on 03Oct2021 at 01:15 PM (Lot number: FF8841) and fourth dose of Moderna, Intramuscular, in Left arm on 10Apr2022 at 02:30 PM (Lot number: Q05M21A).; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely 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 response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.