Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Condition aggravated, Hypoaesthesia
Clinical narrative: Pfizer BioNTech-numbness progressed halfway up to both feet; Pfizer BioNTech-sudden numbness in large toes that matched on left and right/Pfizer BioNTech-stated that all the toes on each foot became numb; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 59 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 26Apr2021 (Lot number: EP7933) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (ongoing), notes: Stated that it was diagnosed 10 years ago. Concomitant medication(s) included: COZAAR taken for hypertension (ongoing). Past drug history included: Losartan, start date: 29Jan2019, stop date: Mar2019, for Blood pressure high, reaction(s): "Dizziness", notes: Dosage Text: 100mg Once a day oral, Batch/lot number : OK1018132-A, Pharmaceutical form (Dosage form) : Tablet Form, NDC number of Losartan: 65862-203-90, Expiry Date of Losartan: Jun2021; Losartan, start date: 29Jan2019, stop date: Mar2019, for Blood pressure high, reaction(s): "Weakness", notes: Dosage Text: 100mg Once a day oral, Batch/lot number : OK1018132-A, Pharmaceutical form (Dosage form) : Tablet Form, NDC number of Losartan: 65862-203-90, Expiry Date of Losartan: Jun2021; Losartan, start date: 29Jan2019, stop date: Mar2019, for Blood pressure high, reaction(s): "it made him sick", notes: Dosage Text: 100mg Once a day oral, Batch/lot number : OK1018132-A, Pharmaceutical form (Dosage form) : Tablet Form, NDC number of Losartan: 65862-203-90, Expiry Date of Losartan: Jun2021. Vaccination history included: Bnt162b2 (Batch/lot number: EW0150, Route of administration: intramuscular, Anatomical location: unknown arm, administration date: 05Apr2021, when the patient was 59 years old, for Covid-19 Immunization. The following information was reported: HYPOAESTHESIA (medically significant) with onset 01Nov2021, outcome "not recovered", described as "Pfizer BioNTech-sudden numbness in large toes that matched on left and right/Pfizer BioNTech-stated that all the toes on each foot became numb"; CONDITION AGGRAVATED (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Pfizer BioNTech-numbness progressed halfway up to both feet". The patient underwent the following laboratory tests and procedures: blood pressure measurement: 120/70. Therapeutic measures were not taken as a result of hypoaesthesia, condition aggravated.  Losartan dosage was permanently discontinued. Pfizer BioNTech related sudden numbness in large toes that matched on left and right, all the toes on each foot became numb and numbness progressed halfway up to both feet was reported as worsened. On 15Nov2021 the patient experienced all the toes on each foot became numb which was still ongoing. The reporter seriousness for Pfizer BioNTech stated that all the toes on each foot became numb was medically significant. Cozaar was prescribed two years ago. The patient stated that when he changed to Cozaar that he went to 50mg because his blood pressure was doing so good. The patient's high blood pressure was diagnosed 10 years ago and was well controlled with Cozaar. Investigation assessment was not provided.  The reporter was calling for her husband who had the Pfizer BioNTech on 05Apr2021. The reporter stated that the second dose was on 26Apr2021. The reporter stated that on 01Nov that he had sudden numbness in his large toes that matched on his left and right. The reporter stated that on 15Nov that all the toes on each foot became numb and on 22Nov that the numbness progressed halfway up to both feet. The reporter stated that they saw other people had this reaction from Pfizer BioNTech. The reporter stated that there were thousands of people that had reactions to Losartan. The reporter stated that she was told this by the pharmacist. The reporter declined to complete reports about this.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the event Hypoesthesia 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.