Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Immunisation, Injection site pain, Off label use, Pyrexia
Clinical narrative: This is a spontaneous report from a Contactable Consumer (patient) and also from Pfizer Product Quality Group. A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3183), third dose via an unspecified route of administration, administered in right arm on 14Oct2021 at 09:00 (at the age of 79-year-old) as dose 3 (booster), single for COVID-19 immunisation at hospital. Medical history included, back pain from an unknown date and unknown if ongoing, nerve compression from an unknown date and unknown if ongoing, COVID-19 from an unknown date and unknown if ongoing If Covid prior vaccination: Yes. Concomitant medications included influenza vaccine (INFLUENZA) administered in left arm for immunisation from 30Sep2021 to 30Sep2021; tramadol (TRAMADOL) taken for an unspecified indication, start and stop date were not reported; lidocaine (LIDOCAINE) taken for an unspecified indication, start and stop date were not reported; menthol (BIOFREEZE PAIN RELIEVING) taken for an unspecified indication, start and stop date were not reported. Historical vaccine given to patient previously was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9810), second dose via an unspecified route of administration, administered in Left arm on 08Feb2021 at 13:00 (at the age of 79-year-old) as dose 2, single for COVID-19 immunisation and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3183), first dose via an unspecified route of administration, administered in left arm on 16Jan2021 at 13:00 (at the age of 79-year-old) as dose 1, single for COVID-19 immunisation. Other medications in two weeks were tramadol, Tylenol, lidocaine patch, Biofreeze. The patient previously took iodine, and experienced iodine allergy, Levitra/Plaquenil, and experienced drug hypersensitivity. On 14Oct2021 the patient received third booster dose of bnt162b2. The patient experienced injection site pain and temperature 99.2 on 15Oct2021 at 08:00. The patient was treated with Tylenol. The patient underwent lab tests and procedures which included body temperature: 99.2 on 15Oct2021. Therapeutic measures were taken as a result of temperature 99.2 (pyrexia), injection site pain (injection site pain). The patient had not been tested for COVID-19 since the vaccination. The outcome of the events (injection site pain and temperature 99.2) was recovering. Product Description (CR): compound BNT 162 COVID-19 vaccine suspension for intramuscular 2ml multiple dose vial x 1 Lot-# (CR): EM9810. Conclusion of Previously Completed Investigation (FCI/SI/Official): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EM9810 was investigated in (withheld). 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 EM9810, fill lot EM9806, and the formulated drug product lot EM9808. 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. Product Description (CR): Compound BNT 162 COVID-19 vaccine suspension for intramuscular 2ml multiple dose vial x 1 Lot-# (CR): EL3302. Conclusion of Previously Completed Investigation (FCI/SI/Official): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EL3302 as 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 EL3302, fill lot EL3300, and the formulated drug product lot EL3299. 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. Product Description (CR): Compound BNT 162 COVID-19 vaccine suspension for intramuscular 2ml multiple dose vial x 1 Lot-# (CR):FC3183. Conclusion of Previously Completed Investigation (FCI/SI/Official): The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot FC3183 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FC3183, fill lot EY0555, and the bulk formulated drug product lot EP8657. 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. No follow-up attempts are needed. No further information is expected.