Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Abdominal wall haematoma, COVID-19, Computerised tomogram, SARS-CoV-2 test
Clinical narrative: Positive for covid-19 after two series of Pfizer vaccine; Positive for covid-19 after two series of Pfizer vaccine; Development of severe right upper abdomen pain.; spontaneous rectus sheath hematoma; This is a spontaneous report from a contactable nurse (patient herself). A 40-year-old female non-pregnant patient received bnt162b2 (BNT162B2), dose 1 on 22Dec2020 (Lot Number: EJ1685; Expiration Date: 31Mar2021) at the age of  39-year-old and dose 2 on 12Jan2021(Lot Number: EL1283, Expiration Date: 30Apr2021) at the age of  39-year-old, both an via an unspecified route of administration as single dose for covid-19 immunisation. Medical history included HTN (hypertension), GERD (gastrooesophageal reflux disease), and known allergies: Latex. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks.  Patient has no covid prior vaccination. On 07Jul2021 09:30 PM, patient experienced positive for covid-19 after two series of Pfizer vaccine. Patient had development of severe right upper abdomen pain. Emergency room visit and CT verified a spontaneous rectus sheath Hematoma. Events resulted in doctor or other healthcare professional office/clinic visit. The patient received the IV medications, hydration, monitoring of lab work for events.  Outcome of events was not recovered.   Investigation results: 01) Product-Description: Compound Bnt162 Covid-19 Vaccine Suspension for Intramuscular 2ml Multiple Dose Vial X 1, Lot-#: EJ1685, Expiry date: 31Mar2021, Reasonably Suggest Device Malfunction was no. Severity of Harm was not applicable. Conclusion: For this lot Adverse Event Safety Request for Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot #. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS (Site name withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. 2) Product-Description: Compound BNT162 COVID-19 Vaccine Suspension for Intramuscular 2ml Multiple Dose Vial X 1, Lot-#: EL1283, Expiry date: 30Apr2021, Reasonably Suggest Device Malfunction was no. Severity of Harm was not applicable. This is a complaint for lack of effect of lot EL1283 of product PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE. The complaint and its classification have been reviewed. No immediate containment action is required. The complaint, its priority, and its classification have been reviewed and determined to be appropriate The initial scope of this investigation is limited to EL1283 pending review of lot genealogy to determine other in-scope lots. The investigation will include a include a review of the returned complaint sample (if received) and reserve samples, if necessary. A full investigation will be performed. Summary of Investigation: The initial scope of the investigation was limited to the reported finished goods lot. The final scope was expanded to include the reported finished goods lot EL1283, fill lot EL1281, and the formulated drug product lot EL1279. Manufacturing and packaging batch records were reviewed for the reported complaint lot. Pfizer QO did not receive photographs or a complaint sample for examination. The complaint was not confirmed. There were no planned or unplanned deviations recorded during the manufacture of the complaint lot and associated manufacturing lots that may have caused a complaint of this nature. A review of the manufacturing records confirmed processing steps were performed within pre-established parameters. All raw materials and amounts used in the manufacture of the batch were of the correct weight and identity. The results of all analytical tests performed at the time of lot release confirmed that the batch continues to meet potency specifications. The product requires storage in ultra-low temperature freezers. A review of the temperature log for the reported batch confirmed that all freezer temperatures were within allowable limits. Pfizer Quality Operations could not indicate a probable root cause for the complaint to be related to the production process of the involved batch. Review of the manufacturing and packaging batch records and release test results confirmed that the batch continues to meet potency specifications. It is unknown how the product was handled, stored, or administered after it left the Pfizer site. Impact Analysis: Based on the results of this investigation, the manufacturing and packaging batches remain acceptable and the reported complaint is not representative of the lot. No regulatory notification is needed. Corrective / Preventive Action: There were no corrective actions as a result of this complaint investigation. The results of all tests, inspections, and in-process controls have been reviewed and all results met the established requirements prior to the release of the reported batch for distribution. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL1283 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 EL1283, fill lot EL1281, and the formulated drug product lot EL1279. 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. The scope of this investigation included the reported finished goods lot EL1283, the filtration/fill/inspection lot EL1281, and the bulk formulated drug product lot EL1279. Acceptable review of manufacturing and packaging batch records of the complaint lot and associated lots, as well as examination of retained reference samples confirmed that were no issues that may have impacted product quality. Based on the results of this investigation, the scope was not expanded. There were no planned or unplanned deviations recorded during the manufacturing of the reported lot or associated batches that may have caused a complaint of this nature. The complaint history for the reported PFIZER-BIONTECH COVID-19 VACCINE lot EL1283 was reviewed. As of 15Feb2021, there are a total of five complaints for this lot and classification. No lot specific trend was identified that would require additional investigation. There were no lot trend actions taken as a result of this investigation.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events "Covid-19, Abdominal pain upper, abdominal wall haematoma" 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.