Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | UNK | IM / RL |
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | 4 | UNK | IM / RL |
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | 1 | UNK | SC / RA |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | 4 | UNK | IM / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | UNK | IM / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | PO / MO |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 1 | UNK | SC / LA |
ASTHMA, UNSPECIFIED WITH ACUTE EXACERBATION; This 2-year-old male subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular, right thigh) on 07-OCT-2020, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 08-APR-2020, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 17-JAN-2020, for prophylaxis. The subject received the 4th dose of Prevnar 13 (intramuscular, left thigh) on 07-OCT-2020, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 08-APR-2020, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous, right arm) on 07-OCT-2020, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous, left arm) on 07-OCT-2020, for prophylaxis. Concomitant products included influenza vaccine inact split 3v (Flulaval). On 30-SEP-2021, 358 days after receiving Bexsero vs Placebo, Prevnar 13, M-M-R II and Varivax, 540 days after receiving DTPa-HBV-IPV and Hiberix and 622 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 asthma aggravated (Verbatim: ASTHMA, UNSPECIFIED WITH ACUTE EXACERBATION). Serious criteria included hospitalization. The subject was treated with salbutamol (Ventolin), fluticasone propionate (Flovent), diphenhydramine hydrochloride (Benadryl), dexamethasone (Decadron), albuterol and paracetamol (Tylenol). The outcome of asthma aggravated was resolved on 03-OCT-2021. Relevant Tests: Labs CBC and DIFF was drawn in ER. However no results were obtained due to blood clotted in lab. X-ray of chest not remarkable. Covid 19 test was done, Covid not detected.. The investigator considered that there was no reasonable possibility that the asthma aggravated may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Prevnar 13, Hiberix, M-M-R II and Varivax. The company considered that there was no reasonable possibility that the asthma aggravated may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Prevnar 13, Hiberix, M-M-R II and Varivax. Subject who had history of wheezing developed cough on 30SEP2021. Mom gave albuterol twice overnight but child continued to have to work for breathing so brought to ER on 01oct2021 AT 1114 AM. In the ER subject was initially tachypenic with respiratory distress and poor air entry so given Decadron and started on continuous Albuterol. High flow nasal cannula was added with improvement. Admitted to Hospital on 01OCT2021 at 1745 continued on continuous Albuterol, Respiratory status slowly improved. Given second dose Decadron. Stable on room air prior to discharge, vitals otherwise stable. Eating well without any need for IV fluids. Decision made to start on controller inhaler Flovent 2 puffs BID. Asthma education given. Discharged home on 02OCT2021 at 1318. Phoned mom on 13OCT2021. She said child was back to his normal self on 03OCT2021 Follow-up information received on 01-JUN-2022 this follow-up was consider significant. Summary of changes: Suspect drug Bexsero vs Placebo vaccination date updated, hospital admission date and discharge date updated, treatment drug updated. Follow-up information received on 16-JUN-2022. This follow-up was consider significant. Summary of changes: The treatment medicine were updated. Follow-up information received on 20-Sep-2022. This follow-up was consider significant. Summary of changes: Suspect product updated. Follow-up information received on 06-AUG-2024 Summary of changes: Frequency of ALBUTEROL (PROVENTIL/VENTOLIN) updated as QH Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of asthma aggravated, 358 days after receiving the 4th doses of Bexsero vs Placebo, Prevnar 13 and 1st doses of M-M-R II, Varivax, 540 days after receiving the 3rd doses of DTPa-HBV-IPV with dtpa-hbv-ipv vaccine pre-filled syringe device and Hiberix and 622 days after receiving the 2nd dose of Rotarix lyophilized formulation with rotavirus vaccine oral applicator device in a 2-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility.
FLULAVAL
Comments: Labs CBC and DIFF was drawn in ER. However no results were obtained due to blood clotted in lab. X-ray of chest not remarkable. Covid 19 test was done, Covid not detected.