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 | 3 | UNK | IM / RL |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | 3 | 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 |
anaphylaxis; This 7-month-old male subject was enrolled in a blinded study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular, right thigh) on 28-FEB-2023, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 28-FEB-2023, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 28-FEB-2023, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 10-JAN-2023, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. Concurrent medical conditions included peanut allergy. On 23-APR-2023, 54 days after receiving Bexsero vs Placebo, Hiberix and DTPa-HBV-IPV and 103 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 anaphylaxis (Verbatim: anaphylaxis). Serious criteria included hospitalization. The subject was treated with cetirizine hydrochloride (Zyrtec), acrivastine (Benadryl) and epinephrine (Epipen). The outcome of anaphylaxis was resolved on 24-APR-2023. The investigator considered that there was no reasonable possibility that the anaphylaxis may have been caused by Bexsero vs Placebo, Hiberix, DTPa-HBV-IPV and Rotarix lyophilized formulation. The company considered that there was no reasonable possibility that the anaphylaxis may have been caused by Bexsero vs Placebo, Hiberix, DTPa-HBV-IPV and Rotarix lyophilized formulation. GSK Receipt Date: 25-APR-2023 Subject hospitalized due to anaphylaxic reaction to peanut butter. Medical records pending. The subject had no medical history at randomization. The discharge diagnosis for subject was "anaphylaxis". He was treated withepipen x 2, benadryl x 1, and zyrtec x 1. He has been diagnosed with eczema, which has been reported as an AE. He does take benadryl prn for itchy rash. He went to the ED on 23APR2023, admitted for observation and discharged on 24APR2023. His symptoms were hives and swelling of face, improved post 2nd EpiPen. Monitored overnight, without requiring any further epinephrine. Rash and swelling improving throughout admission. Meds given were epipen x2, one hour apart, 1st for respitory, 2nd for hives. Also received Benadryl x1, and Zyrtec x1. Has eczema which has been recorded. He takes hydrocortisone 2% ointment prn for eczema. He was prescribed Benadryl 2.5 ml prn for allergies. Follow-up information received on 23-MAY-2023. Summary of changes: Narrative updated. Follow-up information received on 06-JUN-2023. Summary of changes: Event outcome and narrative updated. Follow-up information received on 15-JUN-2023. Summary of changes: Narrative updated, SAE peanut allergy added Follow-up information received on 29-JUN-2023 and 04-jul-2023. Summary of changes: Event term updated from anaphylaxis from peanut butter to anaphylaxis, additional event peanut allergy deleted, treatment drugs added Follow up information received on 13-JAN-2025 and 16-JAN-2025 Medication name was reported as Epipen (NOS) Summary of changes: Medication name was updated from Epinephrine to Epipen (NOS) Upon internal review case was updated on 20-JAN-2025 Suspect vaccine coding was updated from DTPa-HBV-IPV to Pediarix. Medication Benadryl was coded with generic name acrivastine Follow-up information received on 06-Feb-2025. Summary of changes: Medical condition peanut allergy added. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of Anaphylactic reaction, 54 days after receiving 3rd dose of Bexsero, DTPa-HBV-IPV, Prevenar 13 and Hiberix and 103 days after receiving 2nd dose of Rotarix lyophilized formulation, in a 7-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative etiology (anaphylaxic reaction to peanut butter).
Peanut allergy