Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, SARS-CoV-2 test
Clinical narrative: Within 1 week after my second dose I began to have very bad and very frequent heart palpitations. They continued for months following the second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20May2021 (Lot number: EW0185) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypothyroid" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: ARMOUR THYROID. Past drug history included: Ceftin, reaction(s): "Known allergies: ceftin", notes: Known allergies:ceftin. Vaccination history included: Bnt162b2 (Dose1, Lot number:EW0173, Vaccine location:Left arm), administration date: 29Apr2021, when the patient was 41 years old, for Covid-19 Immunization. The following information was reported: PALPITATIONS (non-serious) with onset 27May2021, outcome "recovered", described as "Within 1 week after my second dose I began to have very bad and very frequent heart palpitations. They continued for months following the second dose". The event "within 1 week after my second dose i began to have very bad and very frequent heart palpitations. they continued for months following the second dose" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of palpitations.  Additional information: Adverse event: Within 1 week after my second dose I began to have very bad and very frequent heart palpitations. They continued for months following the second dose. Patient didn't had other vaccine within four weeks of vaccination. Other medication in two weeks reported as Armour thyroid. Prior vaccination patient didn't had covid. Post vaccination patient was tested for COVID.This is a notification generated from the RA system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process. Refer to the below table for details: RA ID: 6881121. Product Description: COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCUL AR 2ML MULTIPLE DOSE VIAL X 1. Lot-#: EW0185. Conclusion of Previously Completed Investigation (RA): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EW0185 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, an analysis of complaint history for the reported lot and analytical release test results. The final scope included the reported finished goods lot EW0185, fill lot EP8735, and the formulated drug product lot EP8616. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. RA ID of Previously Completed Inv: 6065591.   No follow-up attempts are possible. No further information is expected.