Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test, Sinusitis, Vaccination failure
Clinical narrative: tested positive for covid on 16Jul; tested positive for covid on 16Jul while her husband, 17Jul; she thought she had a sinus infection; having trouble breathing; coughing up of green stuff and worsened coughing; flu/cold; she got real sick; flu/cold; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6207; Expiration Date: Jul2021), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 09:45 (at the age of 64-years-old) as single dose and dose 2 via an unspecified route of administration, administered in Arm Left on 31Mar2021 09:45 (at the age of 64-years-old) (Batch/Lot Number: ER8734; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation. The patient's medical history included obesity. No other medical history reported. There were no concomitant medications and other products reported. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). There were no predisposing factors (e.g. immunosuppression, contact with other infected persons). The patient and her husband got their first dose of the Pfizer Covid 19 vaccine last 11Mar2021 and their second dose was on 31Mar2021. Caller stated the covid 19 vaccination record. She got real sick, like with a flu/cold and she took some over the counter medicine, pain medicine but caller states on Wednesday, 21Apr2021, she had to go to the emergency room because she was having trouble breathing and has continued coughing up of green stuff and worsened coughing. Albuterol Nebulizer. She has been doing the nebulizer, the albuterol nebulizer machine. Caller states that's only if she's having an attack, but she hasn't had one prior to this. Caller verifies she hasn't had an attack prior to getting the shots. Caller provides Albuterol Nebulizer LOT: 021331, Expiry Date: Apr2022. Caller provides over the counter medicine she was taking: Alka-Seltzer Plus, Severe Cold and Flu. She doesn't have the box anywhere; she usually throws them away. Caller provides with LOT: X24AD9 EXP: Jun2022. Product strength and count size dispensed: Caller states they are 250 mg each tablet, she takes two usually by mouth. She was unsure of the quantity in the package since she threw both away. Albuterol Nebulizer: Not provided. The patient tested and diagnosed with positive for covid on 16Jul2021 while her husband, 17Jul2021. Asked why they got covid since they already got both doses of the vaccine. The patient asked if the vaccine they got was effective. The patient wanted to make sure the vaccine that was given to them is really from Pfizer. No prescribing doctor. On 16Jul2021, she visited physician office: urgent care, as she thought she had a sinus infection. What she is looking for is they both had the vaccine and they are positive with covid. Was this any good, and are there other people who are now positive, were the lot numbers any good. They did what the world said and now they have covid 19 and she was missing 14 days of work. She spoke with Medical information and they can't give any information. She wants to know why they got covid. Is it a hoax and in fourteen she will have been healed and can go back to work. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot ER8734 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 was determined to be the reported finished goods lot ER8734, fill lot EP8686, and the formulated drug product lot EP8573. 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. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6207 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 EN6207, fill lot EN5340, and the formulated drug product lot EN5328. 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. The result of the assessment concluded there was no microbiological impact to Lot EP8573. The batch remains acceptable for use. The outcome of the events was unknown.