Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Neurological examination, Papilloedema, Photophobia, Red blood cell sedimentation rate normal, SARS-CoV-2 test negative
Clinical narrative: migraines; dizziness off and on; Severe chronic headaches; fatigue; little lethargic/feeling lethargic; sensitivity to light; balance is off/was going left and right trying to stay in balance; hypersomnia; not been able to work or drive since being vaccinated; vision impairment; This is a spontaneous report from contactable other HCP. A 37-years-old (current age of 37-38 when the reported events began) male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Batch/Lot Number: EW0I58; expiration: not reported), intramuscular, administered in arm right on 12Apr2021 16:00 as single for Covid-19 immunisation/covid precautions, not wanting to get covid at pharmacy or drug store. The patient medical history was none. Concomitant medication(s) included vortioxetine hydrobromide (TRINTELLIX; received within 2 weeks of vaccination). No additional vaccines administered on same date of the Pfizer suspect, no other prior vaccinations (within 4 weeks prior to the COVID vaccine), no relevant family medical history. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination. No other products and no investigation assessment. On 13Apr2021, the patient had headache, sensitivity to light, was feeling lethargic, balance was off, fatigue, and hypersomnia. The headache and vision impairment (start date: 13Apr2021) were ongoing and began the very next day after the 1st dose of the Pfizer COVID Vaccine and at first the headache was very severe and now was just different and his headache kind of moved around and was always constant and persistent and got better and then boom it came back. The patient had been a little lethargic (start date: 13Apr2021) and that began the same day as the headache and vision impairment which was the very next day after the 1st dose of the vaccine. Dizziness (start date: 13Apr2021) began the very next day after the vaccine and was almost like an imbalance of whenever he was walking, he noticed he was kind of not walking a straight line almost and was going left and right trying to stay in balance (start date: 13Apr2021) and this was a little bit better. After the 1st dose the patient was getting a little concerned right now because he got the vaccine about three weeks ago and ever since he had been having severe chronic headaches and vision impairment that was ongoing and began the very next day after the 1st dose of the vaccine; the patient was a little lethargic, kind of had dizziness off and on and went to his PCP, had an MRI, and was sent to a neurologist. The patient was taking Advil, Motrin and Tylenol that were not helping his migraines (start date: unspecified) and nothing from the bunch of medications the neurologist gave him were working to help and stated Nurtec ODT (lot 3990840, expiry date Oct2022 and NDC 72618-3001-1) 75mg once daily and Nortriptyline 10mg (orange pharmacy bottle with no lot, expiry date or NDC) supposed to be one capsule the 1st week and then two capsules after that by mouth. Motrin, Advil and Tylenol (no lot numbers, expiry dates or UPC numbers to provide because he ran out of those and threw the bottles away when he was done and has been meaning to get more but has not). Unspecified medicines, Toradol IV were given as therapeutic measure. The patient was not sure about the dates regarding his MRI (MRI was maybe a week and a half after this all started and then maybe a week after that he saw the neurologist). Headaches kept him up to night also and the patient had been to neurology, ophthalmology consultation, and received an MRI. The adverse events resulted in disability or permanent. The patient had not been able to work or drive since being vaccinated. The patient had no further treatment and had not gone to the ER but was under advisement that he was to go to the ER, but he could not afford to go to the ER. The patient had not had the 2nd dose of the Pfizer COVID Vaccine yet and his PCP and neurologist both agree that he would not be getting the 2nd dose of the vaccine due to the reactions he has had. The patient was calling to see if Pfizer offered help as he was without insurance and his PCP said he might need to send the patient to the hospital which might be out of the question and he was calling to see if Pfizer could help him with anything as he has not been at work for three weeks and the headache was not going away. The patient underwent lab tests and procedures which included magnetic resonance imaging with no results on unspecified date and nasal swab (sars-cov-2 test) was negative on 15Apr2021. The outcome for little lethargic/feeling lethargic was not recovered, severe chronic headaches was not recovered, sensitivity to light was not recovered, balance is off was not recovered, fatigue was not recovered, hypersomnia was not recovered, not been able to work or drive since being vaccinated was not recovered, vision impairment was not recovered, kind of has dizziness off and on was recovering and for migraine was not recovered.     Information on Lot/Batch number was available. Additional information has been requested; Sender's Comments: The events was considered related to suspect drug based on Compatable temporal association and known safety profile of the drug.   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 RAs, Ethics Committees, and Investigators, as appropriate.