Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Diplopia, Dizziness, Headache, Injection site pain
Clinical narrative: headache; fever; L Arm (injection site) pain/severe left arm pain; dizziness; blurred double vision and couldn't function; eyes wouldn't focus, Couldn't function; blurred double vision and couldn't function; eyes wouldn't focus, Couldn't function; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 11Jan2021 15:00 at a single dose in the left arm for COVID-19 immunization. The patient received the vaccine in a skilled nursing facility or long term care facility. The patient received no other vaccinations recently. Medical history included attention deficit disorder diagnosed at least 5 years ago for which the patient was taking Ritalin; hypothyroidism diagnosed a long time ago, probably 10 years and depression diagnosed a long time ago, probably at least 25 year, she takes a cocktail of anti-depressants for this (no further details provided about her anti-depressants). The patient also had a similar reaction of blurred double vision and couldn't function/eyes could not focus before when her doctor put her on an antibiotic (unspecified). The patient was also very overweight. Concomitant medications included methylphenidate hydrochloride (RITALIN; lot: unknown, expiry: 28Jul2021) for attention deficit disorder and the patient takes a cocktail of anti-depressants (unspecified) for her depression. The patient received the first dose of the covid vaccine on 11Jan2021 at 3 PM and by 5PM she was experiencing bad headache, fever, L arm (injection site) pain that was severe. Later that evening she had blurred double vision and couldn't function. She also got a fever of about 100 degrees Fahrenheit, was dizzy and her eyes could not focus and were almost like double vision but not quite, it was hard to explain. She just remembered that she had a similar reaction with her eyes before, when her doctor put her on an antibiotic. She cannot recall what antibiotic that was. The patient also experienced dizziness on 11Jan2021. The patient treated her side effects with ibuprofen and most of these improved. The injection was given in her left arm, her non-dominate one. She says that the pain was so bad it woke her up, and she doesn't take any pain meds, but that was really bad. She says that she took some Ibuprofen (lot: P113671, exp: Jan2022), about a total of 800mg over a few hours. Her fever had started pretty fast, by 05:00PM on the 11th, and it was better after taking the Ibuprofen, as was her arm pain, and headache. She says that the dizziness went away probably around 02:00AM the following day (12Jan2021). She says her eyes can focus again as well. The patient thinks that these effects are medically significant, mostly that her eyes were not able to focus, it was very scary. The patient stated that the purpose of this call is to have this documented, and possibly find out if there are recommendations that she should not get the second dose, since she had to call out of work because she couldn't function. The outcome of the event "blurred double vision and couldn't function; eyes wouldn't focus, couldn't function" was recovered on an unspecified date and dizziness recovered on 12Jan2021 at 02:00. The outcome of the event "she had to call out of work because she couldn't function" was unknown while the other events were recovering.  Information on the lot/batch number has been requested.; Sender's Comments: The 56-year-old female patient had medical history included attention deficit disorder; hypothyroidism and depression and she takes a cocktail of anti-depressants for this. The patient also had a similar reaction of blurred double vision and couldn't function/eyes could not focus. Based on information reported, the reported double vision and difficulty focusing eyes were more likely due to pre-existing condition (s); and less likely causally related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The rest events fever, headache, vaccination site pain and dizziness were likely causally related to the use of vaccine due to plausible temporal relationship and known safety profile of this product.  The case will be reassessed should additional information become available.  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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.