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VAERS Report 2157093

Case Report Section

Vaer Report Details

Age: NA

Gender: Unknown

State: Outside US

Patient Died?
No
Vaccine information

Name: COVID19 (COVID19 (JANSSEN))

Type: Coronavirus 2019 vaccine

Manufacturer: JANSSEN

Lot: unknown


Date report was received
2022-03-04
Date form completed
Date Vaccinated
Date of Onset
0
Number of days (onset date – vaccination date)
0
Adverse Event Description

suspected clinical vaccination failure; suspected covid-19 infection; this spontaneous report was received from literature. this report concerned multiple patients of unspecified age, race and ethnicity. the objective of this study was to describe important role in suspected cases management, in treatment of confirmed patients with covid-19 and in vaccination program support. the extensive network of pulmonologists examined, diagnosed and monitored live and remotely a significant percentage of patients with covid-19, leading to a reduction in hospital referrals. in this study an attempt is made to capture this contribution. no past medical history or concurrent conditions were reported. the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number, expiry were not reported) dose, start therapy date were not reported, 01 in total, administered for prophylactic vaccination. the batch number was not reported. the company is unable to perform follow-up to request batch/lot numbers. no concomitant medications were reported. on an unspecified date, the patients had suspected coronavirus disease (suspected covid-19) infection and reported suspected clinical vaccination failure. on an unspecified date the patient's were hospitalized. the number of of days hospitalized and discharge information was not reported. the questionnaire was answered by 150 pulmonologists. 42.2 percent of the pulmonologists who participated in the research examined more than 50 suspicious cases in their office and 27 percent over 100. regarding the diagnosed with covid-19 disease, 50 percent of pulmonologists followed (live or remotely) over 50 patients, while over 100. 28.89 percent of pulmonologists. patients at the 1st diagnosis in 14 percent were examined in the pulmonologists' offices, 7 percent in their home and in 79 percent it was only remote treatment. in 28 percent of patients' blood tests and in 23 percent chest x-ray. 86 percent of the pulmonologists reported that less than 5 percentage of the patient's were fully vaccinated, while a significant 40 percent of the total patients (unclear if all were fully vaccinated) had admission criteria at initial diagnosis. the most common day of hospitalization is between the 6th and 10th with the main cause being hypoxemia at a rate of 72 percent. the action taken with covid-19 vaccine ad26.cov2.s was not applicable. the outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. the authors concluded that private pulmonologists' network supported the health authority by examining a significant number of suspected and confirmed cases of covid-19 in clinics, at home and remotely, requested and evaluated laboratory tests in positive patients and referred for possible admission. the instructions of the specialists. a significant percentage of vaccine information was provided individually by telephone. this report was serious (hospitalization caused / prolonged). this report was associated with product quality complaint. this case, from same literature article is linked to 20220255307, 20220255304, 20220255310 and 20220257203. it was determined that [20220255307, 20220255304, and 20220255310] were duplicate of this case. all relevant information regarding these cases will be submitted under [20220255303].; sender's comments: v0- 20220255303- covid-19 vaccine ad26.cov2.s - suspected clinical vaccination failure. the event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. there are other factors more likely to be associated with the event(s) than the drug. specifically: special situations. therefore, this event(s) is considered not related. 20220255303- covid-19 vaccine ad26.cov2.s - suspected covid-19 infection. the event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. there is no information on any other factors potentially associated with the event(s). therefore, this event(s) is considered unassessable

Lab Data
na
List of symptoms
vaccination failure suspected covid-19
Patient Died?
No
Date Died
NA
Birth defect
false
Vaccine Administered By:
Other
Vaccine Purchased By:
Unknown
Patient visit ER?
No
Patient Hospitalized?
Yes
Stay in hospital
No
Days in hospital
Unspecified
Permanent disability?
No
Allergies:
na
Current Illness
na