Age: 0.33
Sex: M
Vaccine: PNC13, RV1
Symptoms: Breath holding, Crying, Musculoskeletal stiffness, Seizure
Clinical narrative: might be a seizure/possible seizure; stiffening of his arms/stiffening of the body; hold his breath; This case was reported by a physician via other manufacturer and described the occurrence of seizure in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVENAR 13) for prophylaxis.   Concomitant products included PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVENAR 13).   On an unknown date, the patient received Rotarix lyophilized formulation, Rotarix Oral Applicator Device and the 2nd dose of PREVENAR 13. On an unknown date, less than 2 weeks after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced seizure (serious criteria GSK medically significant), limbs stiffness and breath holding. On an unknown date, the outcome of the seizure, limbs stiffness and breath holding were recovered/resolved.   The reporter considered the seizure, limbs stiffness and breath holding to be possibly related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-July-2022 Reporter's comment:  The reporter had a patient this past week, from date of reporting who was 4 months old, that had gotten the Prevnar 13 at 2 months old as well, and received the vaccines including the Prevnar 13 and Rotarix. The Rotarix was given first and the second vaccine given was Prevnar 13. The 3rd vaccine that the patient was to receive was the Pentacel for DTaP-IPV/HIB for diphtheria, tetanus, whooping cough and polio. Following the injection of Prevnar 13, the baby, which was reported by the mother and medical assistant, seemed to hold his breath and did not turn cyanotic but had stiffening of his arms outward. The mother came in alerted the reporter and the caller found the baby to be stable and not cyanotic with no seizure. The medical assistant had picked the baby up and gave the injections and the baby started crying. The reporter thought the episode was a breath holding spell but after reading literature on the product insert, he thought this might be a seizure and be reported as a possible vaccine reaction. The medical assistant was very qualified, but the mother panicked and alerted the caller. The medical assistant reported the stiffening of the body and the baby's arms out. No tonic clonic jerking but not certain if this was a breath holding spell. According to the reporter, breathing holding was normally seen in babies 9 to 10 months to a 1 to 1.5 years but could have seizure like activity for breath holding. He had not been able to reach the mother and assumed the mother might had taken the baby elsewhere. He had the packet insert and sees seizure as an adverse effect and mentioned seizures. He was wondering if baby could have had a seizure following the vaccine. He wanted to talk with Pfizer for possible seizures following the Prevnar 13 vaccine and see if the baby was at risk. He asked what the experiences with babies was having seizures after the Prevnar 13 vaccine. The reporter reported the patient got the same vaccine at 2 months of age and this was the second Prevnar 13 vaccine. The reporter declined to complete a report. The reporter consented to follow-up.