Sex: F
Vaccine: COVID19
Symptoms: Ataxia, Gait disturbance, Gait inability, Investigation, Speech disorder
Clinical narrative: problems with gait / unsteady unable to walk / issues with gait / unstable; unable to walk; not able to talk; ataxia; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 5 year-old female patient received bnt162b2 (BNT162B2), administration date 13Nov2021 (Batch/Lot number: Unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (hospitalization, medically significant) with onset 14Nov2021, outcome "unknown", described as "problems with gait / unsteady unable to walk / issues with gait / unstable"; GAIT INABILITY (hospitalization, medically significant) with onset 14Nov2021, outcome "not recovered", described as "unable to walk"; SPEECH DISORDER (hospitalization, medically significant) with onset 14Nov2021, outcome "not recovered", described as "not able to talk"; ATAXIA (non-serious) with onset 14Nov2021, outcome "not recovered", described as "ataxia". The patient was hospitalized for gait disturbance, gait inability, speech disorder (start date: 15Nov2021). The patient underwent the following laboratory tests and procedures: investigation: negative, notes: all the tests that they have done have been negative. Therapeutic measures were taken as a result of gait disturbance, gait inability, speech disorder, ataxia. Addition information: The report was not related to a study or programme. Investigation assessment was unknown. Agent states the caller on the line is actually calling on behalf of her colleague, the patient is her colleague's daughter. Caller states the child is getting worse not better. Agent states the caller wanted to know if there was any information on reports such as this and what to do. Caller states the patient's father is a physician as well and is currently seeing patients so she is calling on his behalf. States she originally had a hard time getting through. Caller states she is unsure what is going on or which direction the patient is going to go. States she believes the patient stopped talking yesterday, symptoms started with her gait being unstable on Sunday 14Nov2021. States the patient is currently not eating or anything, is only getting IV fluids. Patient was admitted to the hopsital yesterday, Monday 15Nov2021, at Hospital. Caller states she does not have specific details at this time but states the patient's father reported that all the tests that they have done have been negative and they are waiting to do an MRI. Caller states she does believe this event is serious or medically significant. Unsure how it is going to end up. States that is why she was calling, to see what treatments were given to other reported cases like this to turn it around. Caller reports the pediatric patient got the vaccine at a vaccine event at a church, address (Withheld). Phone number unknown. States the child had not received any other vaccines within 4 weeks of her first Pfizer dose on 13Nov2021. Caller states the patient's father has the vaccination record card with that information and will have him call back. Caller says that she has a report of a adverse event on a child, age 5. They had a community vaccine event and the child got the Pfizer vaccine and she is now in the hospital and the caller wanted to talk to Pfizer's physicians about on whether they have seen anything like she is having. The patient is having ataxia and is unable to talk and they are trying to figure out what is going on. Caller declined to complete the report and states that she just needs to get the information because this is happening in live time. If this agent wants to call her back then she already provided her phone number. She wants to move alone and speak with the other department. Reporter Type- Caller provided that she is a medical provider, confirmed and clarified to be a physician. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of Gait disturbance, Gait inability, Speech disorder. 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.