Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle contractions involuntary, Neuropathy peripheral, Paraesthesia, Thyroid function test, Vitamin B12
Clinical narrative: Peripheral Neuropathy; fasciculations in both legs; Inappropriate dose of Vaccine administered; tingling in both feet/paresthesias had spread upwards into both legs, fingers on both hands were tingling and also noticed tingling in face; numbness in both feet; This is a spontaneous report received from a contactable other hcp. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 29Jan2022 14:30 (Lot number: FK9896) at the age of 68 years as dose 4, single for covid-19 immunisation. Relevant medical history included: "stage 3 breast cancer", start date: Feb2003 (unspecified if ongoing), notes: in remission; "HLA B27 positive w/history of iritis" (ongoing); "Tachycardia" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medications included: METOPROLOL taken for tachycardia, start date: 2000 (ongoing); ALDACTONE 50 HCT taken for hypertension, start date: 2021 (ongoing). The patient has history of high dose breast cancer therapy. Vaccination history included: BNT162B2 (dose 1), administration date: 30Jan2021, when the patient was 67 years old, for Covid-19 Immunization, reaction: "no side effects"; BNT162B2 (dose 2), administration date: 20Feb2021, when the patient was 67 years old, for Covid-19 Immunization, reaction: "no side effects"; BNT162B2 (dose 3), administration date: 17Aug2021, when the patient was 67 years old, for Covid-19 Immunization, reaction: "no side effects".  The following information was reported: NEUROPATHY PERIPHERAL (disability, medically significant), outcome "not recovered", described as "Peripheral Neuropathy"; PARAESTHESIA (medically significant) with onset 29Jan2022, outcome "unknown", described as "tingling in both feet/paresthesias had spread upwards into both legs, fingers on both hands were tingling and also noticed tingling in face"; HYPOAESTHESIA (non-serious) with onset 29Jan2022, outcome "unknown", described as "numbness in both feet"; MUSCLE CONTRACTIONS INVOLUNTARY (non-serious), outcome "unknown", described as "fasciculations in both legs"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 29Jan2022 14:30, outcome "unknown", described as "Inappropriate dose of Vaccine administered". The nurse reported that she had no issues, no side effects with the first 3 vaccinations. 5 hours after the 4th vaccination, she experienced numbness and tingling in both feet. By the next morning the paresthesias had spread upwards into her both legs, fingers on both hands were tingling and also noticed tingling in her face. She was also experiencing fasciculations in both legs. She had seen that the Regulatory Authority has recommended that paresthesias should be added to the list of side effects from the Comirnaty mRNA covid vaccine due to the large numbers of reports they are receiving. This was fourth dose, was advised by physician to obtain 4th dose. The patient provided information to the nurse regarding the reported adverse event(s) with the use of the product and if yes above, the nurse considered the Pfizer product had a casual effect to the adverse event. Then the nurse also reported that peripheral neuropathy continues 12 days after dose 4 which resulted in physician office visit and subsequent blood tests: CRP, thyroid pane1, HGgA1c and B12. Physician feels that neuropathy is direct result of vaccine. The nurse received gabapentin to the event peripheral neuropathy. The event "peripheral neuropathy" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: unknown results; CRP: unknown results; HGgA1c: unknown results; thyroid panel: unknown results; B12: unknown results. Therapeutic measures were taken as a result of neuropathy peripheral.  Follow-up attempts are completed. No further information is expected; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely 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.