Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Dehydration, Drug ineffective, Electrocardiogram
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes/Positive; Since the vaccination, has the patient been tested for COVID-19?:Yes/Positive; sore arm; sinus pain; sinus pain; dehydration; Booster; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in Arm Left on 10Oct2021 12:00 (Batch/Lot Number: FE3590) at the age of 66-year-old as dose 3 (booster), single; via an unspecified route of administration administered in Arm Left on 06Mar2021 17:00 PM (Batch/Lot Number: EN6205) at the age of 65-year-old as dose 2, single, via an unspecified route of administration administered in Arm Left on 17Feb2021 17:00PM at the age of 65-year-old (Batch/Lot Number: EM9809) as dose 1, single for covid-19 immunisation. Medical history included enlarged prostate, kidney stones from an unknown date and unknown if ongoing. Concomitant medications included influenza vaccine (FLU) taken for immunisation on 24Sep2021 in Left arm; rosuvastatin calcium (CRESTOR, 10 miligrans) taken for an unspecified indication, start and stop date were not reported. The patient experienced since the vaccination, has the patient been tested for covid-19:yes/positive on 19Oct2021, The events was reported as serious per medically significant. The patient also experienced headache, sore arm, 100 fever, scratchy throat, excessive cough, sneezing, heavy phlegm, sinus pain, excessive urination, dehydration on 12Oct2021 07:00. Therapeutic measures were taken as a result of these events, outpatient clinic visit, outpatient hospital visit for IV fluids, Xray, EKG (Electrocardiogram). The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab test which included fever: 100 on 12Oct2021, EKG: unknown results on 12Oct2021, Sars Cov 2, NAA: positive on 19Oct2021 (Nasal Swab, NAA; Positive CoronavirusOC43), x-ray: unknown results on 12Oct2021. The outcome of events since the vaccination, has the patient been tested for covid-19:yes/positive was unknown, for other events was resolving. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Not known allergies.   Investigation results of BNT162B2 for lot EN6205: BNT162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial x 1. Lot number: EN6205. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EN6205 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 and product type. The final scope included the reported finished goods lot EN6205, fill lot EN5337, and the formulated drug product lot EN5326. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Investigation results of BNT162B2 for lot EM9809: Compound BNT162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial x 1; Lot number: EM9809. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EM9809 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 EM9809, fill lot EM9807, and the formulated drug product lot EM9805.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.