Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Auditory disorder
Clinical narrative: her left ear it sounds like she is talking underwater; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 16Sep2024 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 76 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUPROPION taken for depression (ongoing); FOSAMAX taken for osteoporosis (ongoing); TORSEMIDE taken for oedema (ongoing); LIOTHYRONINE taken for hypothyroidism (ongoing); LEVOTHYROXINE taken for hypothyroidism (ongoing); ELIQUIS taken for atrial fibrillation (ongoing); CARVEDILOL taken for hypertension (ongoing); GABAPENTIN taken for restless legs syndrome (ongoing); SIMVASTATIN taken for blood cholesterol increased (ongoing); OLMESARTAN taken for hypertension (ongoing); AMLODIPINE taken for hypertension (ongoing). The patient also took other concomitant therapy. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed; unknown manufacturer), for COVID-19 Immunization. The following information was reported: AUDITORY DISORDER (non-serious) with onset 16Sep2024, outcome "not recovered", described as "her left ear it sounds like she is talking underwater". Therapeutic measures were not taken as a result of auditory disorder.  Additional Information: Called about the Pfizer Covid booster and she just got this and this just happened where her left ear it sounds like she was talking underwater and she just had the covid booster and this happened after that and she was wondering if that was related to the vaccine and was it serious and does she need to go to the emergency room or urgent care. Stated her weight was about 100 pounds. The vaccine was administered 16Sep2024 and her left ear sounding like she was talking underwater occurred about three hours after the vaccine was administered occur about 3 hours after the vaccine ongoing and persisting Has no lot number or expiry date for the vaccine on the printed information from her pharmacy. The vaccine was administered to her right arm shoulder area and the printed information that the caller verified was from the pharmacy printed information, she has a magnifying glass for as the pharmacy information was awfully tiny print and states it was the Comirnaty 30 mcg/0.3mL intramuscular vaccine. She taken a lot of Concomitant medications. No treatment required for the reported event. She just not want to go to the emergency room if this was something that was going to go away. BUPROPION: Additional Information for Other med Bupropion: began it maybe a year and a half ago. FOSAMAX: Additional Information for Other meds Fosamax: began taking it probably 9 months ago but she was not really sure. TORSEMIDE: Additional Information for Other meds Torsemide: began taking it about a yr ago. LIOTHYRONINE: Additional Information for Other meds Liothyronine: began taking it probably about 3 yrs ago. LEVOTHYROXINE: add info for Other meds Levothyroxine:she does not know when she began this, was probably 25 yrs ago. ELIQUIS: add info for Other meds Eliquis: began that probably 5 yrs ago maybe longer. CARVEDILOL: Additional Information for Other medicines Carvedilol: initially states it was 6.5mg twice a day and clarified she thinks that was wrong and thinks she takes that as 20mg once a day and began taking it probably about a year ago. GABAPENTIN: add info for Other medicines Gabapentin: began that 2 years ago. SIMVASTATIN: Additional Information for Other medicines Simvastatin: began that probably 20 years ago. OLMESARTA: Additional Information for Other medicines Olmesartan: began that probably 10 years ago. AMLODIPINE: Additional Information for Other medicines Amlodipine: began that probably but does not know but it was 15 years ago  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.