Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 2 patients tested positive for covid (corona virus) yesterday on rapid test; 2 patients tested positive for covid (corona virus) yesterday on rapid test; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 53-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Apr2022, outcome "unknown" and all described as "2 patients tested positive for covid (corona virus) yesterday on rapid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Apr2022) positive, notes: rapid test. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Reporter stated his 2 patients tested positive for covid (corona virus) yesterday on rapid test. He stated that PAXLOVID was for mild to moderate symptoms patient one (Husband , 53-year-old) does not had any symptoms. There was no emergency and both patients are on quarantined now for 5 days. reporter did stated that both patients (husband and wife) received the Pfizer covid vaccine 2 doses and one booster dose also. Agent stated, "had a doctor on the line. He was calling for Paxlovid, he stated that two patients, husband and wife, husband is 53-year-old and wife is 54-year-old, they both received the Pfizer COVID vaccine (clarified as Pfizer COVID-19 Vaccine) and a booster shot and yesterday tested positive for COVID so he wanted to know about can they receive Paxlovid. Agent provide that information to him. Now the husband tested positive on rapid test but does not had any symptoms. Thats all the information that he provided to agent, agent are filing because they received the Pfizer COVID Vaccine as well and one booster shot and then after developed the COVID. When paraphrased the above concern, reporter (Doctor) stated, "No, their age is not 54, 74 and the husband 73 reporter believe. They had the rapid testing and it was positive for corona virus. Patient was not having any real symptoms, does not had any real renal problems, no heart problems, she still had her sense of smell and taste. Like reporter said they had the regular Pfizer two test and then they had one booster so they had a total of three, they had not done the fourth treatment, in other way the second booster. Reporter stated that reporter was not sure had all that, these are reporter ex-wife and her husband and reporter friends with both of them. They live about four blocks from reporter house. Not sure, the wife was reporter think it was 04Dec. Reporter don't have them in front of me right now can get them. Reporter was in home right now, was not in the office, they both came to the same place. They are not heavy reporter can't tell their exact weight, the husband plan to lose weight so reporter can't give the exact weight. They are both on the thinner size, they are not heavy or obese. When queried for lot number reporter stated that don't had any numbers or anything. They were both given these standard vaccines with the appropriate times in between them and the same way with the booster. The booster reporter think was just given about a month ago may be, little more than a month but they were at the usual time given. Reporter stated, No, they havent taken any other treatment till this time. When queried for medical history it was stated that reporter don't think they are on any major medication. When queried for prior vaccinations it was reported that , think they only got, reporter was noy aware they got the usual shot.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Vaccination failure", "COVID-19" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.