Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Product dose omission issue, Seizure, Therapeutic product effect decreased
Clinical narrative: seizure like activity; it was very frightening for her; slurred speech and could not talk; more she started to talk the more slurred her speech got; slurred speech and could not talk; more she started to talk the more slurred her speech got; her tongue started feeling funny; On 19Mar2021 I had weakness in left arm radiating up to left side of neck on left side; went back to get the second one and they wouldn't give it to her; told to seek medical advice; he seizure activity occurred and it was like she had not taken her medicine.; This is a spontaneous report from a contactable consumer.   This 65-year-old non-pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6205, Expiry date: Unknown) via unspecified route of administration in left arm on 19Mar2021 at 13:15 (at age of 65-year-old) as a single dose for COVID-19 immunisation. Patient's Medical History (including any illness at time of vaccination; Provide other relevant medical history including but not limited to these conditions:  diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity): history of partial seizures and migraine headaches since 1996. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Any other medications the patient received within 2 weeks of vaccination: Yes (Topomax). Prior to vaccination, the patient was not  diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had known allergies (but not specified). The patient not received other vaccine in 4 weeks. Concomitant medication include Topomax 50 mg one tablet twice daily for partial seizures and migraine headaches (Batch number: 20EG075 and expiry date Mar2022). No further details provided. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in past. On 19Mar2021, at 13:15, the patient experienced seizure like activity, patient was very frightened, slurred speech and could not talk, more she started to talk the more slurred her speech got, her tongue started feeling funny, weakness in left arm radiating up to left side of neck on left side. The patient took her medication that morning and it was like she hadn't taken it. The patient went back to get the second one and they wouldn't give it to her and said to seek medical advice. After vaccination, immediately after the injection she felt the medication radiating in the arm and going up the left side of the neck and then her tongue started feeling funny. On 19Mar2021, the patient had weakness in left arm radiating up to left side of neck on left side, and slurred speech and could not speak immediately after getting Pfizer Covid 19 vaccine. She told nurse and they had waited another 15 min, and when it was over she felt like she had woke up refreshed and awake but it bothered me. The patient took medication to help and after getting the Pfizer Covid 19 vaccine 1st dose my medicine did not seem to be working on 19Mar2021 and continue to date. The patient received the first dose of the Covid vaccine and it appears to had given her seizure like activity and had explained all of that on the application. It was very frightening for her. Her doctor sent her for MRI/MRA testing and she does not know why she went into this as soon as she was given the Covid vaccine. She does take an anticonvulsant for partial seizures as well as migraine headaches and takes that everyday. Took her medicine that morning and it was just like she hadn't taken it. When she takes the anticonvulsant she doesn't have a problem, but after given the Covid vaccine immediately afterwards the seizure activity occurred and it was like she had not taken her medicine. Does not know what to do, she went back to get the second one and they wouldn't give it to her and advised her to get medical advice and then she would have to wait 30 minutes instead of the 15 minutes since having that reaction. The patient wanted to know if she should get second dose. That day she was observed and told to wait 30 minutes instead of the 15minutes until everything subsided. Immediately afterwards she had slurred speech and could not talk and was told if she was not okay they would send her to the emergency room. Had the seizure immediately afterwards before she could get to the waiting area. Went to see the neurologist yesterday and they want to see her back in 4 months. Does not provide manufacture and states she has been on Topamax for years and has had this condition since 1996. Also mentions on bottle she saw a S/N and GTIN, but does not provide any further details. The patient had gotten the results from the MRI/MRI and had the testing done on 30Apr2021. Again mentioned that immediately after the injection she could feel the medication radiating in her arm and going up the left side of her neck and then her tongue started feeling funny. The more she started to talk the more slurred her speech got. Caller stated she has already completed a vaccine adverse event application online on 09Apr2021 and provides reference: DFB2A40A-8C82-4220-B77E-F0A0F1C1F89E. The Outcome of the event weakness in left arm radiating up to left side of neck on left side was unknown and went back to get the second one and they wouldn't give it to her; told to seek medical advice was not recovered, feel the medication radiating in the arm and going up the left side of the neck and then her tongue started feeling funny/took her medication that morning and it was like she hadn't taken it, slurred speech and could not talk; more she started to talk the more slurred her speech got, it was very frightening for her and seizure like activity was recovering.   Follow up needed, further information has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of Seizures , dysarthria, Aphasia and other event cannot be excluded. But also consider medical history of partial seizure. however, the reported event of fear is consider as a consequence of seizure that patient experienced and not related to the suspect vaccine.  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.