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 |
Left Finger Cellulitis; This 11-month-old male subject was enrolled in a blinded study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular, right thigh) on 16-MAR-2023, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 16-MAR-2023, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 22-DEC-2022, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 16-MAR-2023, for prophylaxis. Co-suspect products included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylaxis. On 22-JUL-2023, 128 days after receiving Bexsero vs Placebo, Hiberix and DTPa-HBV-IPV and 212 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 cellulitis of finger (Verbatim: Left Finger Cellulitis). Serious criteria included hospitalization. The subject was treated with clindamycin, lidocaine;prilocaine (Emla), vancomycin hydrochloride (Vancocin), ceftriaxone sodium (Rocephin), cefalexin (Keflex), ibuprofen (Motrin) and paracetamol (Tylenol). Bexsero vs Placebo was continued with no change. The outcome of cellulitis of finger was resolved on 04-AUG-2023. Relevant Tests: On 25JUL2023, Methicillin-Resistant Staphylococcus Test Data showed Positive (heavy growth Methicillin-Resistant Staphylococcus Aureus (Normal Range: Negative, No Growth). On 24JUL2023, Erythrocyte Sedimentation rate-Test done showed 31 (normal range 0-15). On 24JUL2023, Lymphocytes-Test done showed 94 (normal range 20-70).. The investigator considered that there was no reasonable possibility that the cellulitis of finger may have been caused by Bexsero vs Placebo, Hiberix, Rotarix lyophilized formulation and DTPa-HBV-IPV. The company considered that there was no reasonable possibility that the cellulitis of finger may have been caused by Bexsero vs Placebo, Hiberix, Rotarix lyophilized formulation and DTPa-HBV-IPV. GSK receipt date: 15-SEP-2023 Admit to hospital 25JUL2023 at 0014. Discharge from hospital 26JUL2023 at 0958. 11 Month old mail, born at term with no ongoing medical concerns, presenting with increasing erythema and swelling of his left third finger. A small area of erythema was first noticed on 22JUL2023, also had fever up to 104.0F (axillary), (fever noted 22JUL2023 to 23JUL2023). Pediatrician started Cephalexin and swabbed for Herpes Simplex Virus (which was negative). The erythema and swelling continued to spread so child was admitted to hospital for antibiotics and monitoring of left finger cellulitis. There was household contact with active/recent MRSA (Methicillin-Resistant Staphylococcus Aureus) infection. Child discharged home on oral antibiotics. Follow up information received on 15-NOV-2024 Summary of changes: The frequency of treatment medication Cleocin (Clindamycin) was updated from blank to tid, Narrative updated Upon internal review on 26-NOV-2024 The Study Center ID was added./ Follow up information received on 11-Mar-2025. End of study Unblinding completed.; Sender's Comments: A case of Cellulitis,128 days after receiving 3rd dose of Bexsero vs Placebo, 3rd dose of Prevnar 13, 3rd dose of Hiberix and 3rd dose of DTPa-HBV-IPV and 212 days after receiving 2nd dose of Rotarix lyophilized formulation, in 11-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factor (household contact with active/recent MRSA infection).
Comments: On 25JUL2023, Methicillin-Resistant Staphylococcus Test Data showed Positive (heavy growth Methicillin-Resistant Staphylococcus Aureus (Normal Range: Negative, No Growth). On 24JUL2023, Erythrocyte Sedimentation rate-Test done showed 31 (normal range 0-15). On 24JUL2023, Lymphocytes-Test done showed 94 (normal range 20-70).