Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Bronchospasm, COVID-19, Chills
Clinical narrative: chills; difficulty breathing; bronchospasms; fatigue; weakness; COVID infection; COVID infection; fever; This is a spontaneous report from a contactable consumer (patient). A 48 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at age of 48 years old, dose 1 via an unspecified route of administration, administered in Arm Left on 24Mar2021 15:00 (Batch/Lot Number: ER 8727) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in Arm Left on 16Apr2021 15:00 (Batch/Lot Number: EW 0161; Expiration Date: 31Jul2021) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included multiple sclerosis. Patient is not pregnant at time of vaccination. Concomitant medications included fingolimod hydrochloride (GILENYA); colecalciferol (VIT D [COLECALCIFEROL]); and cyanocobalamin (VIT B12) and multivitamins. The patient previously took erythromycin and acetaminophen and experienced allergies. The patient experienced COVID infection: chills, difficulty breathing, bronchospasms, fatigue, weakness and all on 06Jul2021 14:00 with outcome of not recovered. While reporting she said her fever began 25Mar2021 it was 99.3 and that is ongoing, its gotten higher. She took Tylenol about 2 hours ago when it was 101.7. She would say the fever had worsened because it went up to 101.7. No further information provided. Adverse events resulted in Emergency room/department or urgent care. No other vaccine in four weeks. Treatment was received for adverse events. AE treatment includes albuterol, oxygen, monoclonal antibodies, prednisone. No Covid prior vaccination. Covid tested post vaccination. The patient underwent lab tests and procedures which included SARS-COV-2 AD Test (Nasal Swab): positive on 13Jul2021.  The outcomes of events were not recovered.   The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 vaccine lot ER8727 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot ER8727, fill lot EP8679, and the formulated drug product lot EP8566. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. 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. The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EW0161 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EW0161, fill lot EP8694, and the formulated drug product lot EP8591. 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.  Follow-up attempts are completed. No further information is expected.