Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging brain
Clinical narrative: cranial nerve 3 palsy. Ptosis of the left eye, it was completely shut; cannot hear; This is a spontaneous report from a contactable physician. A 93-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. Medical history included atrial fibrillation, hypertension, hyperlipidaemia, diabetes, and chronic kidney disease. Concomitant medications were not reported. No additional vaccines administered on the same date of the vaccine and no prior vaccinations within 4 weeks. The reporter is the family's physician, who stated that the patient received the first dose of the Pfizer COVID vaccine on 22Jan2021 and three days later (25Jan2021), his left eye had ptosis - he was unable to open his left eye and it was completely shut. The patient came to him and when he would try to lift the eyelid up, it would just drop down. He then called a neuro ophthalmologist, he thought to himself that the patient could be having a stroke. The patient was sent to the Emergency Room and kept overnight to do CT of brain, MRI of brain, CT of orbits and MRI of neck. All tests came back normal, there was no stroke. The patient was discharged and was told to go see an ophthalmologist; the eye doctor diagnosed him with Cranial Nerve 3 Palsy. The reporter had read the consultation notes; the eye doctor "wrote 1-2 days after he had COVID and had this happen". The reporter clarified that the patient never had COVID, maybe this was a misunderstanding or typo with the doctor, but the patient just had the vaccine. The point is that the patient was diagnosed. The reporter further added that the patient can't hear, and so he will provide the patient's son's phone number. The reporter would like to know if this is a possible side effect of the vaccine and if he should receive the second dose of the vaccine as he is due in two days (Friday at 8:30AM on 12Feb2021). It was also reported that the ptosis has not gotten worse and has not resolved. The reporter added that the patient was admitted to the hospital for a full day. The patient underwent lab tests and procedures which included computerized tomography (CT) of the brain, CT of the neck, magnetic resonance imaging (MRI) of the brain and MRI of the orbits-all of which resulted normal in Feb2021. The events cranial nerve 3 palsy and 'Ptosis of the left eye, it was completely shut' had not resolved while the outcome of the rest of the events was unknown.   Information on the batch/lot number has been requested.; Sender's Comments: By close temporal relationship, the company cannot completely exclude that the reported cranial nerve 3 palsy' is related to BNT162b2 administration, even though medical history including atrial fibrillation, hypertension, hyperlipidemia, diabetes, and chronic kidney disease, in the setting of elderly age, can be considered confounding factors in the overall clinical evaluation of this event occurred three days after the vaccination. Conversely, even though cannot be excluded as reportable event based on the information provided, the company deems there is not a reasonable possibility that the reported deafness is related to BNT162b2 administration, but, at the present time, evaluated as an intercurrent condition that cannot be also excluded as already present before the vaccination. The impacts 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.