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VAERS Report 2157094

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

respiratory failure; covid-19 pneumonia; suspected vaccination failure; this spontaneous report was received from literature. this report concerned multiple patients (number unspecified) of unspecified sex, age, race and ethnicity. the objective of this study is to highlight the epidemiological characteristics and clinical outcome of patients with covid19 who were hospitalized in the pulmonology clinics of our hospital for the period of time in question, while highlighting the history of vaccination history. the patient's weight, height, and medical history were not reported. the patient's concurrent conditions included: critical illness. the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported , 1 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 experienced covid-19 pneumonia with concomitant respiratory failure, suspected vaccination failure and was hospitalized (date unspecified) in lung clinics. 182 patients with a mean age of 55.99 years (sd:16.25), predominantly male (60%), were registered. 79 % of them had severe or critical disease, 81 % of all patients were not vaccinated. 25 % of all were admitted to the icu (5 were vaccinated and with critical illness). the duration of hospitalization was unspecified. the action taken with covid-19 vaccine ad26.cov2.s was not applicable. the outcome of the suspected vaccination failure, covid-19 pneumonia and respiratory failure was not reported. the authors concluded that, the hospitalized patients with covid-19 disease in the pulmonology clinics of the hospital for the period in question were mostly suffering from severe and critical disease. the comparison of hospitalization outcomes between vaccinated and non-vaccinated patients confirms the international literature data and underlines the need for universal vaccination of the population. this report was serious (hospitalization caused / prolonged, and life threatening). this case was associated with product quality complaint, and reference number requested. this case, from same literature article is linked to 20220255303, 20220258394 and 20220258762.; sender's comments: v0: 20220257203-covid-19 vaccine ad26.cov2.s-covid-19 pneumonia, respiratory failure. the event(s) has a compatible/suggestive 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. v0: 20220257203-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. the event(s) has a compatible/suggestive 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

Lab Data
na
List of symptoms
respiratory failure vaccination failure covid-19 pneumonia
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
critical illness