Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Acoustic stimulation tests abnormal, Asthenia, Computerised tomogram normal, Deafness neurosensory, Deafness unilateral
Clinical narrative: couldn't hear, lost hearing in right ear; stated had to be neurological; felt sick, congestion in head, low grade fever, lethargic, didn't feel had energy to work, and sore throat, clarified tonsils were inflamed, put on antibiotic; subcutaneous; This is a spontaneous report received from a Nurse.  A 65-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 15May2024 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years subcutaneous, in left arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 15May2024, outcome "unknown", described as "subcutaneous"; DEAFNESS UNILATERAL (disability) with onset 16May2024, outcome "not recovered", described as "couldn't hear, lost hearing in right ear"; TONSILLITIS (non-serious) with onset 16May2024, outcome "unknown", described as "felt sick, congestion in head, low grade fever, lethargic, didn't feel had energy to work, and sore throat, clarified tonsils were inflamed, put on antibiotic"; DEAFNESS NEUROSENSORY (disability) with onset 16May2024, outcome "not recovered", described as "stated had to be neurological". The events "couldn't hear, lost hearing in right ear", "stated had to be neurological" and "felt sick, congestion in head, low grade fever, lethargic, didn't feel had energy to work, and sore throat, clarified tonsils were inflamed, put on antibiotic" required physician office visit. Therapeutic measures were taken as a result of tonsillitis. Clinical course: Caller (reporter/patient) went to doctor and was told caller should have Pfizer shot, clarified and confirmed Prevnar 20 (preventative reasons, preventing getting sick). Caller went that evening to (Withheld) on 15May2024, a Wednesday, and got Prevnar 20. Then the next day, 16May2024, couldn't hear, lost hearing in right ear. Caller was at work, caller is a Registered Nurse in (Withheld), and a monitoring was going on, another nurse told caller to turn off monitor, caller didn't hear it, caller was facing on right side. Caller was blocking one ear trying to figure it out. 16May2024, felt sick, congestion in head, low grade fever, lethargic, didn't feel had energy to work, and sore throat. Not sure what is going on, then went to doctor on Monday, throat was, clarified tonsils were inflamed, put caller on antibiotic. Was told wasn't hearing, doctor did quick hearing test, clarified doctor flicked finger and caller didn't hear, no idea why. Not sure if someone else reported this or if something to do with Prevnar 20 or nothing to do with Prevnar 20. Clarified calling reporting what happened after the injection, when have a drug, needs feedback. Caller was sent to ENT doctor. Couldn't hear, lost hearing in right ear was ongoing, can't hear television, if puts phone to ear can hear a little bit. Caller is working as a nurse, and other nurse had to say to caller that the monitor was on because caller didn't know. Caller was fine until that day. Did a hearing test, the ENT doctor caller saw did hearing test, and had do CT scan. CT scan showed normal findings, remarkable, no degeneration of bones, caller stated had to be neurological. When caller did hearing test, it showed some diminished hearing, could be age or degeneration. Relatedness of drug to reaction was related per reporter. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: There is not a reasonable possibility that the reported event was related to the suspect product event most likely due to patient underlying contributory factors.