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 | 2 | UNK | PO / MO |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | UNK | IM / LL |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 1 | UNK | SC / LA |
Adenoidal hypertrophy; Obstructive sleep apnea syndrome; This 14-month-old male subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular, unknown deltoid) on 17-SEP-2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 09-JAN-2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular) on 05-MAR-2019, for prophylaxis. The subject received the 4th dose of Prevnar 13 (intramuscular) on 17-SEP-2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular) on 05-MAR-2019, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous) on 17-SEP-2019, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous) on 17-SEP-2019, for prophylaxis. The subject's past medical history included streptococcal pharyngitis and streptococcal pharyngitis. Concurrent medical conditions included snoring. On 30-NOV-2019, 74 days after receiving Bexsero vs Placebo, Prevnar 13, M-M-R II and Varivax, 325 days after receiving Rotarix lyophilized formulation and 270 days after receiving DTPa-HBV-IPV and Hiberix, the subject developed moderate - grade 2 adenoidal hypertrophy (Verbatim: Adenoidal hypertrophy). Serious criteria included hospitalization. Additional event(s) included moderate - grade 2 obstructive sleep apnea syndrome (Verbatim: Obstructive sleep apnea syndrome) on 04-AUG-2020 with serious criteria of hospitalization. The subject was treated with paracetamol (Tylenol). The outcome of adenoidal hypertrophy was resolved on 20-AUG-2020. The outcome(s) of the additional event(s) included obstructive sleep apnea syndrome (resolved on 20-AUG-2020). The investigator considered that there was no reasonable possibility that the adenoidal hypertrophy and obstructive sleep apnea syndrome may have been caused by Bexsero vs Placebo, Rotarix lyophilized formulation, DTPa-HBV-IPV, Prevnar 13, Hiberix, M-M-R II and Varivax. The company considered that there was no reasonable possibility that the adenoidal hypertrophy and obstructive sleep apnea syndrome may have been caused by Bexsero vs Placebo, Rotarix lyophilized formulation, DTPa-HBV-IPV, Prevnar 13, Hiberix, M-M-R II and Varivax. GSK Receipt date: 05-AUG-2020 Mom stated the child had planned adenoidectomy and tonsillectomy on 04Aug2020. The child was admitted overnight due to age per the mom. No complications. The child was discharged on 05Aug2020 at 13:00. subject was prescribed Tylenol with codeine. The parent stated she had not administered Tylenol with codeine but she did administer a pediatric Tylenol chewable tablet. The surgery was not planned prior to enrollment. The procedure normally does not require in-patient hospitalization. However, subject was admitted due to age. Subsequently site reported as SAE. Follow-up information received on 07-DEC-2022 Summary of changes : Frequency for treatment medication (Tylenol Chewable) has been updated. Follow-up information received on 12-JUN-2023 Summary of changes : Device products and narrative updated. Follow-up information received on 30-DEC-2024 The subject received treatment drug General anesthesia on 4/Aug/2020 to 4/Aug/2020 Once only via intravenous for Adenotonsillar hypertrophy. Summary of changes: General anesthesia unit updated unknown, Narrative updated. Upon internal review the case was updated on 07-FEB-2025. Authorization Number updated for Products Hiberix, Rotarix lyophilized formulation, DTPa-HBV-IPV-HIB from World-MKT to World-INV. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of Obstructive sleep apnoea syndrome and adenoidal hypertrophy, 322 days and 74 days respectively after receiving the 4th dose of Bexsero vs Placebo, the 4th dose of Prevnar 13, 1st dose of M-M-R II and 1st dose of Varivax, 518 days and 270 days respectively after receiving the 3rd dose of DTPa-HBV-IPV, the 3rd dose of Hiberix and 573 days and 325 days respectively after receiving 2nd dose of Rotarix lyophilized formulation, in a 14-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative etiology (adeno-tonsillar hypertrophy) for Obstructive sleep apnoea syndrome .
Snoring
Medical History/Concurrent Conditions: Streptococcal pharyngitis;