Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram abdomen, Drug ineffective, Gastrointestinal neoplasm, Intestinal obstruction
Clinical narrative: four COVID patients, three of four were fully vaccinated, she was fully vaccinated in Apr, her pre-op CT of abdomen picked up bottom of lungs which looked a little suspicious so COVID PCR was sent; four COVID patients, three of four were fully vaccinated, she was fully vaccinated in Apr, her pre-op CT of abdomen picked up bottom of lungs which looked a little suspicious so COVID PCR was sent; a small bowel obstruction that turned out to be due to a tumor; a small bowel obstruction that turned out to be due to a tumor; This is a spontaneous report from a contactable physician. The physician had four new COVID patients. Three of the four were fully vaccinated. This report corresponds to one of the three patients. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not provided), via an unspecified route of administration on an unknown date in 2021 as dose 2, single and received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not provided) via an unspecified route of administration on an unspecified date in 2021, as dose 1, single both for COVID-19 immunization. She was fully vaccinated in April. Medical history and concomitant medications were not reported. The physician reported that, the patient was presented with a small bowel obstruction that turned out to be due to a tumor on an unspecified date in 2021. Reportedly, COVID testing would not normally have been done on the patient since she was fully vaccinated and had no typical COVID symptoms; however, her pre-op CT of the abdomen picked up the bottom of the lungs which looked a little suspicious so the COVID PCR was sent, which was positive on an unknown date in 2021. Physician reported that they stopped pre-op COVID testing on fully vaccinated asymptomatic people a couple of weeks ago and wanted to know if Physician go back doing this. Physician thought that they should go back to the PCR- pre-hospitalisation PCR and a weekly PCR even in the vaccinated people. This will allow them to detect re-infection and to track transmission (better than Ig G anti-spike). Physician mentioned that vaccine efficacy was determined in the original trials against symptomatic COVID disease at a time when prevention of severe pneumonia was the goal but they really do not know for Moderna and Pfizer what is VE against atypical/asymptomatic infection. Physician wanted to know if these patients get sicker or have mild disease. Also, if their isolates be studied to determine if they are variant delta. And wanted to know if Pfizer checks baseline and convalescent NP and spike Ab. Physician was not sure this will help in any way other than to show that patients really have a second infectionand not just a + PCR. Physician mentioned that they have seen several patients also in (withheld) who have been vaccinated and are coming back with positive tests. Many of them have not been ill and had high cycle threshold which may reflect asymptomatic infection. Physician did have two immunocompromised hosts with severe infection and poor outcome. Physician reported that since 01Feb (somewhat arbitrary date when COVID vaccination was widely available in the community), 95% of our COVID admissions have been in individuals who were either unvaccinated or not fully vaccinated. Of those fully vaccinated patients who tested positive, nearly 50% were asymptomatic and tested positive for preprocedure screening or screening for placement in a congregate living facility. They have found fully vaccinated patients who are taking rituximab seem particularly vulnerable to break through infections, but otherwise the vaccine has been quite effective. (withheld) was hit particularly hard with Alpha variant surge this spring with high rates of COVID hospitalizations from mid-March to mid-June. Over the past month, COVID rates have remained low without any particular surprising break through cases. In March and April, they experienced a heavy surge of COVID in (withheld) primarily by B117 (AKA Alpha). During that surge, they did see some fully vaccinated individuals get sick with COVID. Few required hospitalization. Even fewer had disease severe enough to warrant ICU-level care. After looking at their data, their conclusion was that this was not out of step with what one might expect to see with a vaccine of 90-95% efficacy during a considerable surge with community positivity rates topping 20+%. Physician recommended developing a testing approach that not only looks at vaccination status, but also takes into consideration your community prevalence (either test positivity or # of new cases/100K, for example) and host factors (immunocompromised patients, those that live in congregate settings, persons with known close contact/household exposure, etc.). Physician's personal experience had been that most of the new cases are in unvaccinated individuals. Physician has seen about four or five cases over the last three months that were vaccinated but again one of them was on a biological and another patient was a renal transplant patient. For the most part, vaccination appears to be very effective but may allow breakthrough infections that are not very severe or critical. Data from (withheld) in the past week has shown that Pfizer vaccination is only about 60 to 70% effective in prevention of acquisition of infection. Data from the (withheld) and (withheld) data indicate a higher ability of the vaccine to prevent occurrence of the Delta variant in the 80-90% range. Physician personally did not see any reason to test asymptomatic individuals. Here in (withheld), in Physician's health care system, Physician dx 2-10 fully vax people per day w PCR, some w S&S of COVID, some w alternative dx, some pre-procedure testing and totally ASM. But Physician was seeing hospitalizations in vaccinated folks, many w predispositions/conditions to not respond to ANY vaccine, some w equivocal COVID pneumonia, meaning AECOPD, etc. But maybe one case in fully vax people every 3-5 days for the last 2 weeks w legit COVID PNA. Physician directs COVID outpatient clinic and monoclonal Ab infusion center and they have regularly seen breakthrough cases every week for months. Breakthroughs are to be expected, given that maximum vaccine efficacy in the trials were 66-95% (i.e., the breakthrough rates are not negligible). Physician mentioned that how well this is maintained with the delta variant is a matter of intense study, but if transmission in the community is rising (as it seems to be here), you don't necessarily need a decrease in vaccine efficacy to explain rising numbers of breakthrough cases. For that reason, Physician does think it is misleading when journalists and experts in media talk about breakthroughs as being "rare". Physician believed that there is overrepresentation of breakthrough cases in mAb clinic, since people who got vaccinated might be more likely to be aware of and accept mAb therapy. Also, the total number of patients in Physician's clinic these days is small fraction of what Physician saw during the January peak. The outcome of the events was unknown at the time of report.   Information about batch/lot number has been requested.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Drug ineffective, COVID-19, Intestinal obstruction cannot be completely excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.