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VAERS Report 2157415

Case Report Section

Vaer Report Details

Age: NA

Gender: Male

State: Outside US

Patient Died?
No
Vaccine information

Name: PNEUMO (PREVNAR13)

Type: Pneumococcal 13-valent conjugate vaccine

Manufacturer: PFIZER

Lot: ew2017


Name: ROTAVIRUS (ROTATEQ)

Type: Rotavirus vaccine, live, oral, pentavalent

Manufacturer: MERCK & CO

Lot: u018821


Name: DTAP+IPV+HIB+HEPB (VAXELIS)

Type: DTAP+IPV+HIB+HEPB (VAXELIS) / MSP, Diphtheria, Haemophilus, Hepatitis B, Polio

Manufacturer: MSP VACCINE COMPANY

Lot: u017895


Date report was received
2022-03-04
Date form completed
Date Vaccinated
2022-01-13
Date of Onset
1
Number of days (onset date – vaccination date)
1
Adverse Event Description

breathing difficulties with evident and severe episodes of respiratory failure and episodes of asthma; breathing difficulties with evident and severe episodes of respiratory failure and episodes of asthma; breathing difficulties with evident and severe episodes of respiratory failure and episodes of asthma; this case was retrieved during the monitoring in regulatory agency 28-feb-2022 with the following reference number: it-minisal02-846776. the original narrative from the sender is as below: actions taken (he was taken several times to the hospital where they suspected bronchiolitis, so we treated with a bronchodilator and cortisone. there was no improvement and after bringing him back to hospital we were told that it is not possible to do anything else and that in any case it was not even bronchiolitis). impact on quality of life (8/10) pneumococcal vaccine: administration site (right thigh) booster dose number (2). follow-up of 23-feb-2021. the report is updated with new information: the child was vaccinated on 13-jan-2022 with prevenar (2nd dose), vaxelis (2nd dose) and rotateq (3rd dose). company comment:� asthma, respiratory failure and dyspnoea are assessed as serious due to the events causing hospitalization. asthma, respiratory failure and dyspnoea are unlisted for vaxelis as per the safety information the patient did not have any historical conditions but considering the events appeared one day after the vaccination, and despite the co-suspect vaccines as confounding factors and the limited information provided, the causal relationship between vaxelis and asthma, respiratory failure and dyspnoea cannot be excluded and is assessed as related. this single individual case safety report does not modify the benefit/risk balance of this product. therefore, no change in the label or other measures is recommended at this time. however, the company will continue to monitor all respective reports received and, based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.; sender's comments: asthma, respiratory failure and dyspnoea are assessed as serious due to the events causing hospitalization. asthma, respiratory failure and dyspnoea are unlisted for vaxelis as per the safety information the patient did not have any historical conditions but considering the events appeared one day after the vaccination, and despite the co-suspect vaccines as confounding factors and the limited information provided, the causal relationship between vaxelis and asthma, respiratory failure and dyspnoea cannot be excluded and is assessed as related. this single individual case safety report does not modify the benefit/risk balance of this product. therefore, no change in the label or other measures is recommended at this time. however, the company will continue to monitor all respective reports received and, based on cumulative experience, will re-evaluate the available evidence on an ongoing basis

Lab Data
na
List of symptoms
bronchiolitis
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
prophylaxis