Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | IM / RL |
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | IM / RL |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | 2 | UNK | IM / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | IM / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | PO / MO |
Bronchiolitis; dehydration; Influenza-Like Illness; This 6-month-old female subject was enrolled in a blinded study. The subject received the 2nd dose of Bexsero vs Placebo (intramuscular) on 22nd August 2019, for prophylaxis. The subject received the 2nd dose of DTPa-HBV-IPV (intramuscular) on 22nd August 2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 22nd August 2019, for prophylaxis. The subject received the 2nd dose of Hiberix (intramuscular) on 22nd August 2019, for prophylaxis. The subject received the 2nd dose of Prevnar 13 (intramuscular) on 22nd August 2019, for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device injection syringe for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis. Concurrent medical conditions included upper respiratory tract infection. Concomitant products included influenza virus vaccine inactivated (Fluarix) and ciprofloxacin + dexamethasone (Ciprodex (Ciprofloxacin And Dexamethasone)). On 11th October 2019, 50 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix and Prevnar 13, the subject developed severe - grade 3 influenza like illness. Serious criteria included hospitalization. Additional event(s) included severe - grade 3 bronchiolitis on 18th October 2019 with serious criteria of hospitalization and severe - grade 3 dehydration on 18th October 2019 with serious criteria of hospitalization. The subject was treated with ibuprofen (Advil), ceftriaxone sodium (Rocephin), oseltamivir phosphate (Tamiflu), paracetamol (Tylenol), dextrose + saline infusion and sodium chloride 0.9% bolus. Bexsero vs Placebo was continued with no change. DTPa-HBV-IPV was continued with no change. Hiberix was continued with no change. Prevnar 13 was continued with no change. The outcome of influenza like illness was recovered/resolved on 23rd October 2019. The outcome(s) of the additional event(s) included dehydration (recovered/resolved on 23rd October 2019) and bronchiolitis (recovered/resolved on 31st October 2019). The investigator considered that there was no reasonable possibility that the influenza like illness, bronchiolitis and dehydration may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix and Prevnar 13. Relevant Tests: On 18 Oct 2019, RPP by PCR showed Parainfluenza 4 PCR detected RSV and Influenza A/B amplified probesRSV and Influenza A/B amplified probes. Diagnostic results (unless otherwise stated, normal values were not provided): On 18th October 2019, Culture urine result was No growth after 1 day of incubation, Influenza A virus test result was Neg, Influenza B virus test result was Neg, Polymerase chain reaction result was See text, Respiratory syncytial virus test result was neg and X-ray result was chest, bronchiolitis- no consolidative pneumonia. Investigator text 6 mo.term, healthy female presenting with 5 days of fever, with cough, congestion and decreased PO intake in the setting of a sibling who has confirmed influenza. On exam, she appears clinically dehydrated and extremely fussy. Given history of URI symptoms and no focal findings on CXR, presentation most consistent with dehydration secondary to decreased PO intake in setting of viral process. She has the clinical findings of bronchiolitis. UA with ketones also consistent with dehydration without UTI. Will treat prophylactically for flu given young age and sick contact, will continue supportive care, including fluid rehydration therapy. Respiratory Pathogen Panel by PCR -Parainfluenza 4 PCR detected (A) Patient admitted 18Oct2019. Diagnosis: Influenza-like illness in pediatric patient Primary, Dehydration. Bronchiolitis. Additional details: The suspect vaccine M-M-R II and Varivaxboth were administered after SAE onset date on 22Apr2020 via subcutaneous. Upon internal review the case was updated on 18-Mar-2025. Reported causality updated for devices updated. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of Influenza like illness, bronchiolitis and Dehydration, 50 days after receiving 2nd dose of Bexsero vs Placebo , DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix and Prevnar 13, in a 6 months old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility .
Upper respiratory tract infection
FLUARIX; CIPRODEAL
Test Date: 20191018; Test Name: Urine Culture; Result Unstructured Data: (Test Result:No growth after 1 day of incubation,Unit:unknown,Normal Low:,Normal High:); Test Date: 20191018; Test Name: Influ.A; Result Unstructured Data: (Test Result:Neg,Unit:unknown,Normal Low:,Normal High:); Test Date: 20191018; Test Name: Influ.B; Result Unstructured Data: (Test Result:Neg,Unit:unknown,Normal Low:,Normal High:); Test Date: 20191018; Test Name: RPP by PCR; Result Unstructured Data: (Test Result:See text,Unit:unknown,Normal Low:,Normal High:); Test Date: 20191018; Test Name: RSV; Result Unstructured Data: (Test Result:neg,Unit:unknown,Normal Low:,Normal High:); Test Date: 20191018; Test Name: X-ray; Result Unstructured Data: (Test Result:chest, bronchiolitis- no consolidative pneumonia,Unit:unknown,Normal Low:,Normal High:); Comments: On 18 Oct 2019, RPP by PCR showed Parainfluenza 4 PCR detected RSV and Influenza A/B amplified probesRSV and Influenza A/B amplified probes.