Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Had bad chills/shivering real bad; Her temperature was 100.5 and then it was 101; Her blood pressure was up; Runny nose; 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. Other Case identifier(s): US-PFIZER INC-202101409625 (Pfizer).  A 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 10:00 (Lot number: FC3184, Expiration Date: 30Oct2021) at the age of 77 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "allergy to vinegar" (unspecified if ongoing), notes: allergy to vinegar; "Anaemia" (unspecified if ongoing), notes: Anemic; "cold" (unspecified if ongoing); "she got an infection in her mouth" (unspecified if ongoing), notes: when they were putting gauze over the mouth she got an infection in her mouth; "she broke out in hives" (unspecified if ongoing); "swollen lips" (unspecified if ongoing), notes: swollen lips and rash are not fun.; "rash" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Allergy to erythromycin, reaction(s): "allergy to Erythromycin". Vaccination history included: Bnt162b2 (First dose Vaccine location: upper left arm lot EN9581), administration date: 03Feb2021, when the patient was 77 years old, for COVID-19 immunization, reaction(s): "light chills", "lower grade temperature"; Bnt162b2 (Second dose Vaccine location: upper left arm lot EL9266), administration date: 24Feb2021, when the patient was 77 years old, for COVID-19 immunization; Flu shot. The following information was reported: CHILLS (non-serious) with onset 01Oct2021, outcome "recovered with sequelae", described as "Had bad chills/shivering real bad"; BODY TEMPERATURE INCREASED (non-serious) with onset 01Oct2021, outcome "recovered" (2021), described as "Her temperature was 100.5 and then it was 101"; BLOOD PRESSURE INCREASED (non-serious) with onset Oct2021, outcome "unknown", described as "Her blood pressure was up"; RHINORRHOEA (non-serious) with onset Oct2021, outcome "unknown", described as "Runny nose". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of body temperature increased.  Additional information: States that about 1 month ago she had a virus and she went to the doctor and got a Covid test and it came back negative, but that so called virus she had seemed like it might have been the Delta. Caller relays she had the original shots in Feb2021 and it seems about the same as the side effects she had from the original shot. Stated she kept running a low grade temperature and they talked over quarantine as she hangs out at assistive living and with people her age and she quarantined for 2 weeks to be safe, she doesn't know but they are saying it's negative.  she got the shot at 10am last Friday 01Oct2021 and the symptoms started in the evening around 5-6pm. States that this came about and her temperature was 100.5 and then it was 101 and she thought ok fine that's enough and took 2 extra strength Tylenol and stayed up to make sure she was back to normal before she put down her book and called it a night. Caller relays her blood pressure was up and that might have been coincidental to her sitting there freezing a possibility. States the test was negative. Prior Vaccinations (within 4 weeks): unknown.  Brief Complaint Description: PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE  FC3184 - Lack Of Effect : Pfizer agrees with Investigation decision, classification, priority, and justification. The site assignment grid was reviewed and is accurate for this product. 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. A full investigation will be performed. This is a complaint for Lack of Effect related to lot FC3184 of PFIZER-BIONTECH COVID-19 VACCINE. The initial scope of this investigation is limited to the reported finished goods lot FC3184, fill lot EY0563 and the bulk formulated drug product EP8663.The investigation will include a include a review of the returned complaint sample (if received) and reserve samples, if necessary. Summary of Investigation: The initial scope of this investigation is limited to the reported finished goods lot FC3184, fill lot EY0563, and the bulk formulated drug product EP8663. Manufacturing and packaging batch records were reviewed for the reported complaint lot. Pfizer did not receive photographs or a complaint sample for examination. The complaint was not confirmed. No probable root cause for the complaint related to the manufacturing process of the reported lot was identified. There were no corrective actions taken as a result of this complaint investigation. No related quality issues were identified during the investigation. 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 drug product is stored at controlled refrigeration throughout the manufacturing process and a log is maintained documenting the elapsed time out of refrigeration. A review of the logs confirmed that all times were within allowable limits. The product also requires storage in ultra-low temperature freezers following the packaging of the product. A review of the freezer temperature log for the reported batch confirmed that all freezer temperatures were within allowable limits. The results of all analytical tests performed at the time of lot release confirmed that the batch meets potency specifications. There is no impact to the quality of the lot. It is unknown how the product was handled, stored, or administered after it left the manufacturing site.Root Cause Analysis/Identif: 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 meets potency specifications. It is unknown how the product was handled, stored, or administered after left the Pfizer manufacturing site. Impact Analysis: Based on the final scope of the investigation, which was limited to the reported finished goods lot and associated fill and formulated drug product lots, and that a root cause related to the production process was not identified, the reported issue is not representative of the lot and does not indicate a negative impact on product quality. No regulatory notification is required. 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 FC3184 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FC3184, fill lot EY0563, and the bulk formulated drug product lot EP8663. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No corrective or preventative actions were identified because it was determined that the controls currently in place are sufficient for preventing and removing any vial damage as observed in the complaint sample. All release testing performed prior to the release of the reported batch. Prior vaccinations within 4 weeks: None Thank you for contacting Pfizer. You indicated your Pfizer-Biontech Covid-19 Vaccine was not efficacious (not true that is not what I said. I said I was not too concerned about the side effect I experienced because I figured that meant it was working Booster) appreciate you-bringing-this to our attention: it is our mission provide the highest quality products to meet the health care needs of our customers. Prior to releasing any product to the market, strict regulations must be met including testing the product to ensure it contains the appropriate amount of active ingredient. Additionally, Pfizer conducts stability testing throughout the lifecycle of the product to ensure it continues to meet the registered specifications until the expiration date.  No follow-up attempts are possible. No further information is expected.