Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Peripheral coldness
Clinical narrative: the patient was presenting with Guillain-Barre syndrome; numbness in her extremities bilaterally, mid-arm that extended distally to her lower extremities, and mid-thigh bilaterally that extended distally.; Difficulty walking/gait changes; Cool extremities; weakness; This is a spontaneous report from a contactable Physician reporting for a patient. A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, time the vaccination was given, anatomical location of administration, Batch/lot number, NDC number and Expiry date were unknown), via an unspecified route of administration on 05Aug2021 at the age of 38-years-old as dose 1, single for covid-19 immunisation. Patient's medical History including any illness at time of vaccination was none. Family medical history relevant to AE(s) included maternal aunt had a history of Gillian-Barre. There were no concomitant medications. Relevant Tests were none. Vaccination facility type was unknown. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): this was the patient's first dose. Additional vaccines administered on same date of the pfizer suspect if applicable, list all vaccines administered on same date with the pfizer vaccine considered as suspect were none. Prior Vaccinations within four weeks prior to the first administration date of the suspect vaccine were none. AE(s) following prior vaccinations were none. There was no investigation assessment. The Reporter was calling in regard to Pfizer's COVID vaccine. The reporter stated that she had a patient, a 38-year-old female, who had numbness in her extremities bilaterally, mid-arm that extended distally to her lower extremities, and mid-thigh bilaterally that extended distally on an unspecified date in Aug2021. She stated that the patient received their first dose on 05Aug2021, and her symptoms started 10 days later. The reporter wanted to gain clarification in regard to the incidences of this type of reaction occurring with the Pfizer COVID-19 vaccine. Her symptoms presented for 3 days and were self-limiting, but because of her weakness and gait changes on an unspecified date in Aug2021, the vaccine facility where she received her first dose had concerns the patient was presenting with Guillain-Barre syndrome on an unspecified date in Aug2021. The reporter explains the patient was never formally assessed when she was symptomatic. The symptoms began 10 days after receiving her first dose and presented for 3 days. The reporter confirmed the patient was not assessed by any provider while she was symptomatic. The reporter confirms the patient had said she had some weakness on an unspecified date in Aug2021, but this cannot be confirmed objectively. Per the patient, the patient had difficulty walking the first day she became symptomatic on an unspecified date in Aug2021, but this was unverified in terms of any cooperation with a medical professional. The reporter confirms the symptoms resolved after 3 days but the diagnosis were unverified. She said the vaccine facility from where she the patient received the vaccine believes it may be GBS. The patient also reported cool extremes of her extremities at the time she was symptomatic on an unspecified date in Aug2021. The Reporter stated that the patient had a physical before her appointment and no new medications were initiated for the patient. The patient did no test after this episode but mentioned her maternal aunt had a history of (name). The reporter states the patient was asymptomatic when they discussed her symptoms today. She is setting the patient up to see neurology for further assessment, however the patient didn't have any acute symptoms at the time she was assessed today. There were no initial diagnoses other than an exam. Adverse events did not require a visit to Emergency Room or Physician Office. The patient didn't seek any acute care. HCP wanted to know if there have been reports of numbness after receiving the 1st dose. Physician wanted to know if they should still give the patient a 2nd dose after having a reaction with the 1st dose. The reporter was a healthcare provider and would like to discuss how to treat an adverse event that occurred in one of her patients. Reporter assessed seriousness for numbness in her extremities bilaterally, mid-arm that extended distally to her lower extremities, and mid-thigh bilaterally that extended distally, cool extremities and difficulty walking as medically significant. Causality: Due to the time frame (the patient having symptoms within 10 days of the vaccine), the reporter believes the symptoms are related. Relatedness of drug to reaction(s)/event(s): Reactions assessed: numbness in her extremities bilaterally, mid-arm that extended distally to her lower extremities, and midthigh bilaterally that extended distally and cool extremities. Drug result: Related. The outcome of the events was recovered on an unspecified date in Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on temporal relationship there is reasonable possibility of causal association between the reported events Gullian Barre Syndrome, Hypoaesthesia, gait disturbance, peripheral coldness, asthenia,  and the suspect drug BNT162B2.   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.