Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: had ringing in her head 24/7, and gave her tinnitus in her right ear; headache; The initial case was invalid due to Other-duplicate case. Upon receipt of follow-up information on 07Nov2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Physician), Program ID. The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001362 (Novavax).  A 70-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (ongoing); "GERD" (ongoing); "Seasonal allergies" (ongoing); "Blood cholesterol increased" (ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE] oral taken for hypersensitivity, start date: 2005 (ongoing); IRBESARTAN oral taken for hypertension, start date: 2012 (ongoing); OMEPRAZOLE oral taken for gastrooesophageal reflux disease, start date: 2012 (ongoing); ROSUVASTATIN oral taken for blood cholesterol increased, start date: 2012 (ongoing). Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Anatomical site of Injection: Right deltoid, Route of administration: Intramuscular, Batch/Lot number: EN6198), administration date: 12Mar2021, for Covid-19 immunization, reaction(s): "Headache", "tinnitus on right after"; bnt162b2 (DOSE 2, SINGLE, Anatomical site of Injection: Right deltoid, Route of administration: Intramuscular, Batch/Lot number: ER18727), administration date: 02Apr2021, for Covid-19 immunization, reaction(s): "Headache"; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Anatomical site of Injection: Right deltoid, Route of administration: Intramuscular, Batch/Lot number: 33026BD), administration date: 29Nov2021, for Covid-19 immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Anatomical site of Injection: Right deltoid, Route of administration: Intramuscular, Batch/Lot number: FJ4991), administration date: 07Apr2022, for Covid-19 immunization; bnt162b2, bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Anatomical site of Injection: Right deltoid, Route of administration: Intramuscular, Batch/Lot number: RAH4915), administration date: 15Oct2022, for Covid-19 immunization. The following information was reported: TINNITUS (medically significant), outcome "not recovered", described as "had ringing in her head 24/7, and gave her tinnitus in her right ear"; HEADACHE (non-serious), outcome "recovered". Therapeutic measures were not taken as a result of tinnitus, headache.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.  Follow-up (07Nov2023): This is a spontaneous follow up report received from same contactable physician. Updated information included: Reporter type in slider#01, reporter added in slider#02, date of birth, age, gender and seriousness criteria of new event (had ringing in her head 24/7, and gave her tinnitus in her right ear), Reporter suffix in slider#01, historical vaccine, relevant medical history, dosage regimen, Vaccine facility information, Concomitant medication added.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.The impact of this report on the benefit/risk profile of the Pfizer drug 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.,Linked Report(s) : US-PFIZER INC-PV202300176335 same patient, different dose number/event;US-PFIZER INC-202300347676 same patient/event, different dose number;