Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Off label use, Pain, Pain in extremity
Clinical narrative: weak; Still don't feel back to normal, just feeling so terrible; had some depression; Cough issues; bruise on injection arm; temperatures of 99.1 after the second Covid Vaccine.; stomach flora was distrubed; His wife has a immunodeficiency; His wife has a immunodeficiency; Feeling Very Sick; Chills; Headache; body aches; Nausea; Diarrhea; Sore Arm; This is a spontaneous report from two contactable consumers. A 71-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EL9267, Expiration Date: 31May2021) via an unspecified route of administration administered in left arm on 17Feb2021 at 13:15 as single dose and first dose (Lot number :EL3302 or EL330Z) (at the age of 71-year-old) for COVID-19 immunization. The patient's medical history included immunodeficiency common variable from 2004 and ongoing. The patient's concomitant medications included immunoglobulin human normal (GAMMAGARD SD) taken for immunodeficiency common variable from 2004 and ongoing. Patient had a significant reaction a few days after the vaccine. Patient had second Covid Vaccine on 17Feb2021, which was a Wednesday. Patient got a very sore arm on 17Feb2021. And then Friday evening, patient was feeling very sick, had chills, headache, body aches, diarrhea, nausea. Patient stated she has not had an actual fever since diagnosis of COVID in 2004 and started Gammagard.  Patient stated her temperature usually runs 97.4 to 97.7.  Patient stated she had temperatures of 99.1 after the second Covid Vaccine. Patient continued through the weekend feeling sick. Thought she was feeling better on Monday but stated it all returned and lasted for about 10 days. It was reported that, second dose was about 2 inches to 2 1/2 inches further down and towards the back of her arm.  Patient has bruise on injection arm, left arm. Patient stated she went to see her primary care provider when experiencing symptoms and was told her stomach flora was disturbed. Patient was struggling with intermittent nausea, and weak. Patient stated she was still not one hundred percent. Still did not felt back to normal, just feeling so terrible, and had some depression. It was really not a fun experience. Patient was having cough issues, but did not provide further details. Patient stated chills, headache, and body aches lasted about 10 days. Patient stated still having some nausea and diarrhea but that it was getting a lot better.  It was a 10 day battle including Friday, about 9-10 days.The outcome of sore arm was not resolved and feeling very sick was recovering. The outcome of his wife has a immunodeficiency, chills, headache, body aches, nausea, diarrhea, weak, still don't feel back to normal, just feeling so terrible, had some depression, cough issues, bruise on injection arm, temperatures of 99.1 after the second covid vaccine, stomach flora was disturbed was unknown. Brief Complaint Description: PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE - EL9267- Lack Of Effect. No reasonably suggest device malfunction. Severity of harm not applicable. Suggest Device. IDC - Level 1: Quality. IDC - Level 2: Product Complaint. IDC - Level 3: Complaint - Complaint - Function / Therapeutic Properties. (Parent) Complaint Class: Product Use Attributes. (Parent) Complaint Sub-Class: Lack of Effect. (Parent) Brand/Trade-Name: Pfizer-Biontech Covid-19 Vaccine Injectable. (Parent) Product Family-API: BNT162B2. (Parent) Product-Description: Compound Bnt 162 Covid-19 Vaccine Suspension For Intramuscular 2ml. (Parent) Product-Type: RX. (Parent) Product-Category: Injectable. (Parent) Sterile-Product: Yes. (Parent) Combination-Product: No. (Parent) Medical-Device: No. (Parent) Combination-Product-Type: N/A. (Parent) Lot-: EL9267. (Parent) UDI-(if appl): N/A. (Parent) Batch-Expiry Year: 2021 (Parent) Batch-Expiry Month: May. (Parent) Batch-Expiry Day: 31. Fill Date: This is the date the formulation product is filled into the primary container 29Dec2020. Package Date: This is the start date when the finished product is packaged into the commercial presentation 31Dec2020.  Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL9267 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 EL9267, fill lot EL9258, and the formulated drug product lot EL9249. 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.  No follow-up attempts are possible. No further information is expected.