Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: numbness and tingling in both right and left arm from elbow down; numbness and tingling in both right and left arm from elbow down; weakness in right arm; This is a spontaneous report from a Pfizer Sponsored Program. A contactable pharmacist reported that a 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FC3180; Expiration Date: 31Oct2021), intramuscular, administered in deltoid right on 30Jul2021 (age at vaccination: 30-years-old) as dose 1, 0.3 ml, single for COVID-19 immunisation. Medical history included ongoing Lupus, Covid virus from Nov2020. The patient was immunosuppressed. Concomitant medication included ongoing chloroquine taken for Lupus. Historical vaccine included Hepatitis B, as dose 1, single and Second dose of Hepatitis B Series that was not administered at their location was given 10 days prior to Covid vaccine. The patient was received first dose of Pfizer Covid 19 vaccine on 30Jul2021 and no second dose to date. On an unknown date in Aug2021, within 5 to 7 Days she developed numbness and tingling in both right and left arm from elbow down. It was less in left arm and experiencing weakness in right arm. No weakness in her left arm. This was bilateral from the elbow down and not involving the shoulder. The patient experienced side effects after dose 1 of Pfizer Covid 19 vaccine but not the second dose as to date. During conversation between agent and Pharmacist timing of second dose noted. Pharmacist noted that he would refer to HCP and was aware that second dose could be given as late as 42 days. The patient was also immunosuppressed and the patient would like to get the second and third dose. The events of numbness and tingling in both right and left arm from elbow down and weakness in right arm were considered as serious (Medically significant) by reporter (pharmacist). The pharmacist has chosen medical significant since weakness was a part of it. The patient was not visited emergency Room and Physician Office. Relevant tests were none. The outcome of the all events was recovered on an unknown date in Aug2021. Causality was unknown.  Post marketing reports for paresthesia as of 31Dec2020, a search of our safety surveillance database for Pfizer-BioNTech COVID-19 vaccine revealed that we have received spontaneous reports of dental paresthesia, paresthesia, paresthesia oral, paresthesia mucosal, intranasal paresthesia, pharyngeal paresthesia, paresthesia ear and vaccination site paresthesia since the market introduction (including emergency use authorization) of Pfizer-BioNTech COVID-19 vaccine.  "Please note, however, that accumulated case reports cannot be used to calculate incidence or estimates of drug risk for the following reasons: 1) the number of reports received may not be reflective of the actual number of cases that have occurred, 2) the actual number of patients receiving Pfizer-BioNTech COVID-19 vaccine at any time point is not known, and 3) a causal relationship between Pfizer-BioNTech COVID-19 vaccine and these cases has not been established. Pfizer is unable to make any recommendations regarding the treatment of paresthesia following administration of Pfizer/BioNTech COVID-19 Vaccine; clinical judgment based on the medical history and the clinical status of a specific patient should dictate the appropriate actions to be taken."  Post marketing reports for paresthesia as of 02Jul2021, a search of our safety surveillance database for Pfizer-BioNTech COVID-19 Vaccine revealed that we have received spontaneous reports of Guillain-Barre syndrome since the market introduction (including conditional marketing authorization and/or emergency use authorization) of Pfizer-BioNTech COVID-19 Vaccine. Please note, however, that accumulated case reports cannot be used to calculate incidence or estimates of drug risk for the following reasons: 1) the number of reports received may not be reflective of the actual number of cases that have occurred, 2) the actual number of patients receiving for Pfizer-BioNTech COVID-19 Vaccine at any time point is not known, and 3) a causal relationship between for Pfizer-BioNTech COVID-19 Vaccine and these cases has not been established.  MANAGEMENT GUIDELINES: Pfizer does not have any recommendations regarding the management of Guillain-Barre syndrome in patients who have received Pfizer-BioNTech COVID-19 Vaccine. Clinical judgement based on the medical history and the clinical status of a specific patient should dictate the appropriate actions to be taken".; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the events tingling, numbness and weakness of arm 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.