Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Anxiety, Cerebrovascular accident, Electroencephalogram, Fatigue
Clinical narrative: some lingering fatigue; impending doom; he was numb, like he was paralyzed on his left side of his body; neurological episodes; normal anaphylactic reactions; I think I had a TIA; mild stroke; This is a spontaneous report from a contactable other health care professional (Nurse). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 19Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 25Apr2021 caller is calling on behalf of her son who received the first dose of the Pfizer COVID-19 vaccine on 19Apr2021. She states that 6 days later he experienced neurological episodes. She states that she has already reported the adverse events but does not have a reference number to provide. The caller is wondering if her son is still eligible to receive the second dose because his school is requiring proof of vaccination. She also wants to know what the efficacy is with the vaccine given after 42 days. She states that he had an appointment with a neurologist, and he had an EEG (Electroencephalogram) and an MRI (Magnetic resonance imaging), and everything came back negative. She states that she heard on the news that school as requiring proof of vaccination before they go back, and her son wants to get the second shot, but she wanted him to wait until they met with the neurologist. She states that her son has symptoms that were associated with anaphylactic reaction. She states that normal anaphylactic reactions happen right after but not 3-5 days after. She states that 6 days after getting the covid-19 vaccine her son had symptoms associated with anaphylactic reaction such as impending doom, confusion, and he felt like he was dizzy. She states that her son said that he was numb, like he was paralyzed on his left side of his body. She states that he is still having some lingering fatigue. She states she didn't know if he was hypertensive because he didn't tell her until a couple days later when he stated " I think I had a mild stroke, I think I had a TIA (transient ischemic attack), I googled it. She states oh you had the vaccine on Monday, and she correlated the symptoms with getting the vaccine. Caller states that she guesses she must have faith in God and in Pfizer that everything will be okay if he takes the second shot because he wants to get it and the school requires it. Caller wants to know if any of the symptoms he experienced were reported, she states that when she called before they only gave general symptoms, but none matched what her son experienced. Caller wanted to know if there would be a certain level of efficacy if her son would only get one dose of the Pfizer BIONTECH Covid-19 Vaccine. Caller wanted to know if there would be a need to restart the entire vaccination series if the patient missed to get the 2nd dose of the Pfizer BIONTECH covid-19 Vaccine after 42 days. Caller stated that her son experienced a series of neurological episodes after a few days of receiving the Pfizer BIONTECH Covid-19 Vaccine. Her son got the first dose on 19Apr2021. They are hesitant to get the second dose because their HCP is against it, but her son wants to get it because vaccination is a requirement of their school. Unable to obtain age information. The patient underwent lab tests and procedures which included EEG (Electroencephalogram) and an MRI (Magnetic resonance imaging) and everything came back negative. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Anaphylaxis reaction, Transient Ischaemic attack, and stroke and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.