Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Heart rate, Human rhinovirus test, Muscle fatigue
Clinical narrative: seizures; muscle fatigue; hives; rash from head to toe; sore muscles; wrap around headache; This is a spontaneous report received from a contactable healthcare professional (patient herself). A 66 -year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: EN6208; Expiration Date: 30Jun2021) as a single dose for COVID-19 immunisation. She provided a brief history from 2017. She was walking her dog and she fell and suffered a concussion, she had a seizure, then she developed bipolar disorder. She's been taking sodium valproate (DEPAKOTE) for her seizures since 2017. She reports she's very active. She's not an old lady. She can run circles around some 22 year old's. In September of 2017, she had a concussion and had seizures. She's been on sodium valproate (DEPAKOTE) since that time. She's not mentally ill, the concussion she got in 2017 caused her brain to turn bipolar. It's hard for people to understand that. Sodium valproate (DEPAKOTE) was 500mg. She takes 1 tablet in the morning and 2 tablets at night because it can make you sleepy. She reports she was recently hospitalized in Feb2021 for atrial fibrillation with rapid ventricular rate (RVR). Her heartrate was 181 beats per minute, her blood pressure was dropping, she tested positive for rhinovirus and the doctor thinks the atrial fibrillation with RVR was caused from the rhinovirus. She was allergic to bee venom and carries an EPI PEN. Medical history also included ongoing high blood pressure from an unspecified date (controlled with medication). Concomitant medications included ongoing metoprolol tartrate (LOPRESSOR) taken for blood pressure; ongoing lisinopril; ongoing valproate semisodium (DEPAKOTE) taken for seizure from 2017; ongoing hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) taken for blood pressure; paracetamol (TYLENOL) from an unspecified date in 2021. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Mar2021 (Batch/Lot Number: EM9810; Expiration Date: 30Jun2021). The patient did not receive any recent vaccines for any other conditions or any recent vaccines for any other conditions prior to the event being reported; or any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient reported that with the second Covid 19 vaccine she had two seizures on 27Mar2021. The seizures were back to back. The seizures resolved within 2 minutes. She had fatigue from an unspecified date, sore muscles and a wrap around headache on 26Mar2021. The wrap around headache felt like she was going to have a stroke even though her blood pressure was fine. She monitored her blood pressure at her home. She feels it's weird that they publish that the second Covid 19 vaccine is going to be worse. She thought she'd have muscle soreness and fatigue but not seizures. She looked it up and the wrap around headache and seizure are the rarest things that can happen after receiving the Covid 19 vaccine. She stayed in bed from Friday afternoon after she received the second Covid 19 vaccine on 26Mar2021 and started to feel better Sunday afternoon, 28Mar2021. Her blood pressure and pulse were both fine with her wrap around headache. She had fatigue with both Covid 19 vaccines. She also developed hives, which she still has. She has a rash from her head to her toes. It looked like she rolled around in an ant bed. The hives were clearing up. She was using an anti-itch cream. The hives and the rash started midday on Saturday, 27Mar2021. She only has around 5 hives now on her chest. She hasn't taken Benadryl. She doesn't like to take it. Her doctor didn't want her to open the hives and cause impetigo. She never had any soreness in her arm. She doesn't think the headache was serious because she had a blood pressure cuff at home. She just knew the hives and the rash were a reaction to the Covid 19 vaccine. She didn't go to the hospital for her seizures. She was not seen in the Emergency Department, hospitalized, or admitted to an Intensive Care Unit. She tries to do holistic medicines and treatments. She doesn't run to the hospital every time something happens. She tries to stay out of the hospital. She's fine now and she loves Pfizer. If she can get a medicine she needs that Pfizer makes she tries to get it. She tries to see every side of things. Outcome of seizures was recovered on 27Mar2021 and sore muscles was recovered on 28Mar2021; of remaining events was recovering.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and seizure cannot be excluded based on a compatible temporal relation.  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.