Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Guillain-Barre syndrome, Heart rate, Heart rate increased, Hypoaesthesia
Clinical narrative: Guillain-Barre; Her "throat was tight"; had numbness inside her mouth; numbness on the legs; had palpitations or severe tachycardia with heart rate from 110-120 per minute when she walks from family room to kitchen and also when sitting; had palpitations or severe tachycardia with heart rate from 110-120 per minute when she walks from family room to kitchen and also when sitting; had palpitations or severe tachycardia with heart rate from 110-120 per minute when she walks from family room to kitchen and also when sitting; it was very hard for her to walk; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 31Jan2021 (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: GUILLAIN-BARRE SYNDROME (medically significant) with onset 03Feb2021, outcome "recovered" (2021), described as "Guillain-Barre"; THROAT TIGHTNESS (medically significant) with onset 2021, outcome "recovered" (2021), described as "Her "throat was tight""; HYPOAESTHESIA ORAL (medically significant) with onset 2021, outcome "recovered" (2021), described as "had numbness inside her mouth"; HYPOAESTHESIA (medically significant) with onset 2021, outcome "recovered" (2021), described as "numbness on the legs"; HEART RATE INCREASED (non-serious), PALPITATIONS (non-serious), TACHYCARDIA (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "had palpitations or severe tachycardia with heart rate from 110-120 per minute when she walks from family room to kitchen and also when sitting"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "recovered" (2021), described as "it was very hard for her to walk". The events "her "throat was tight"", "had numbness inside her mouth" and "numbness on the legs" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: heart rate: (2021) 110-120, notes: heart rate from 110-120 per minute. Therapeutic measures were taken as a result of throat tightness, hypoaesthesia oral, hypoaesthesia.  Reporter stated that she had the first dose of the Pfizer BioNTech COVID-19 vaccines last 31Jan2021 and "after receiving the first dose, she experienced a reaction". Her "throat was tight". She "had numbness inside her mouth, numbness on the legs and was brought to the Emergency Room where she was given Claritin and More Benadryl". Reporter mentioned that she "took Benadryl before going to the Emergency Room". Reporter also stated that she "came home with and Epinephrine Pen which she never had before". Reporter also mentioned that she "had palpitations or severe tachycardia with heart rate from 110-120 per minute when she walks from family room to kitchen and also when sitting but her heart rate was not that high". "On the third day, reporter had Guillain-Barre and it was very hard for her to walk but all that resolved". Reporter wanted to ask if she can take the second dose of the Pfizer COVID-19 vaccine considering her experience with the first dose. In reponse to the reporter with regards to off label use and treatment disclaimers it had been reported that do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine. Contraindications and precautions to COVID-19 vaccines are described below. For the purposes of this guidance, regarding timing of allergic reactions, an immediate allergic reaction to a vaccine or injectable therapy is de?ned as any hypersensitivity-related signs or symptoms such as urticaria, angioedema, respiratory distress (e.g., wheezing, stridor), or anaphylaxis that occur within four hours following administration. For the purposes of this guidance, regarding severity of allergic reactions Severe allergic reactions include that Possible anaphylaxis, a progressive life-threatening reaction that typically includes urticaria but also with other symptoms such as wheezing, di?culty breathing, or low blood pressure (see Appendix D) Any angioedema a?ecting the airway (i.e., tongue, uvula or larynx) Di?use rash which also involves mucosal surfaces (e.g., Stevens-Johnson Syndrome), Non-severe allergic reactions may include: Urticaria (hives) beyond the injection site Angioedema (visible swelling) involving lips, skin of face or skin in other locations. NOTE: Any angioedema a?ecting the airway (i.e., tongue, uvula, or larynx) is considered a severe allergic reaction. Reporter was upset because the Government was mandating the vaccine and she is hesitant to take it because of her experience. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and a possible contributory role of suspect product BNT162B2 to the development of events Guillain barre syndrome, throat tightness, hypoaesthesia oral, hypoaesthesia cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.