Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Culture, Culture urine, Dizziness, Electroencephalogram, Loss of consciousness
Clinical narrative: Neurological reaction; she felt like her chest was caving in like she was drowning and she was very lightheaded; She was very lightheaded; she was unconscious for a period of time; strength was now 4 out of 5 in her upper and lower extremities; This is a spontaneous report from a contactable physician (patient husband). A 32-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), first dose via an unspecified route of administration, administered in Arm Left at 24May2021 11:30 (Batch/Lot number was not reported) as single dose (it was the full shot) for covid-19 immunisation at age of 32-year-old. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. Patient mother had high blood pressure. Concomitant medication included azithromycin for sinusitis (took it for 5 days before she had the vaccine). The patient had never had a reaction before. She got her yearly flu vaccine and her Pneumovax vaccine. She had no drug allergies. The patient was hospitalized from 24May2021 to 26May2021 after a neurological reaction at 24May2021 11:35 from the first dose of the Pfizer-BioNTech COVID-19 vaccine. The reporter stated he had to attend to a patient and cannot stay on the line. The patient was in the hospital in the neurological ICU for 72 hours. Afterwards her effects seemed like they had worn off. She was just discharged. Her neurological reaction happened on Monday. About 11:30 was the time of the vaccine, and it happened about 5 minutes after she had the vaccine. This was her first dose. It has mostly resolved now. He would say her strength was now 4 out of 5 in her upper and lower extremities. The physician confirmed due to events patient was not taken to the Emergency Room or had to go to physician office. He went on to state, it was a good time for him to tell the sequence from when she got the vaccine. Her mom got it first, and it was her second dose. Her mom got the jab in her left arm and had no issues and sat down and waited for his wife. They explained the risks and benefits and gave her the vaccine. Immediately when they finished they put a band-aid on and gave them cards and that was it. She started walking to the front of the store, and by the time, the patient got to the front of the store she felt like her chest was caving in like she was drowning and she was very lightheaded. They told the clerk at the store to call 911, and she slowly sat down. Soon after she passed out. An ambulance came, and when the EMTs assessed her they said she was unconscious for a period of time then she came back. They got her loaded onto the stretcher, and when she was supine on the stretcher she had another episode of unresponsiveness. They went to the nearest hospital. The patient had blood tests, cerebro-spinal fluid culture, pleural fluid culture, urine culture, MRI, a chest X-ray, a CT scan of her head, and a 24 hour video EEG done while she was in the hospital in May2021. The doctors at the hospital were at a loss, but they were glad it resolved. They wanted him to do this and maybe as a second try to get more information on anything else that has happened like this and what they might be able to watch out for or treatment she might need. He asks if Pfizer recommends that she get the second dose of the vaccine. The neurologists at the hospital said they might not recommend the second dose in light of what happened. The outcome of the event was recovering.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information in the case report and a close temporal relationship, A possible causal relationship between the events neurological symptom, chest discomfort, dizziness, loss of consciousness,muscular weakness and suspect drug BNT162B2 Cannot be excluded. 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 Committees, and Investigators, as appropriate.