Age: 0.17
Sex: F
Vaccine: PNC13
Symptoms: Fluid intake reduced, Infant irritability, Nervous system disorder, Pyrexia, Restlessness
Clinical narrative: inconsolable for 6 hours; fever of 100.9F; If she was laid supine she would scream, which to her indicated a neurological problem; her daughter became dehydrated; could not eat and drink for 6 hours; had a flat effect for 5 days; neurological problem; restlessness; After 30 minules she became fussy which is no normal for her; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023SA070193.  A 10-month-old female patient (not pregnant) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 11Aug2022 as dose 1, single (Batch/Lot number: unknown), on 11Oct2022 as dose 2, single (Batch/Lot number: unknown) and in Dec2022 as dose 3, single (Batch/Lot number: unknown) at the age of 2 months for immunisation; diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), on 11Aug2022 as dose 1, single (Batch/Lot number: unknown) and on 11Oct2022 as dose 2, single (Batch/Lot number: unknown) for immunisation; hepatitis B vaccine (HEPATITIS B VACCIN), on 11Aug2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Infant Premature" (unspecified if ongoing), notes: premature at 33 weeks. The patient's concomitant medications were not reported. The following information was reported: INFANT IRRITABILITY (non-serious) with onset 11Oct2022, outcome "unknown", described as "After 30 minules she became fussy which is no normal for her"; CRYING (non-serious), outcome "unknown", described as "inconsolable for 6 hours"; PYREXIA (non-serious), outcome "unknown", described as "fever of 100.9F"; SCREAMING (non-serious), outcome "unknown", described as "If she was laid supine she would scream, which to her indicated a neurological problem"; DEHYDRATION (non-serious), outcome "unknown", described as "her daughter became dehydrated"; DECREASED APPETITE (non-serious), outcome "unknown", described as "could not eat and drink for 6 hours"; FLAT AFFECT (non-serious), outcome "recovered", described as "had a flat effect for 5 days"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "neurological problem"; RESTLESSNESS (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: On 11Aug2022, the patient received a dose of suspect Hepatitis B vaccine, dose 1 of suspect diphtheria/tetanus/5 hybrid AC pertussis / IPV (Vero)/ HIB (PRP/T) vaccine, and she also received a dose 1 of the suspect pneumococcal vaccine. On 11Oct2022, she received a dose 2 of pneumococcal vaccine, and dose 2 of suspect diphtheria/tetanus/5 hybrid AC pertussis / IPV (Vero)/ HIB (PRP/T) vaccine. It was reported that after the dose 2, 30 minutes, she became fussy which was not normal for her and was inconsolable for 6 hours and this has never happened during the first dose of vaccines (restlessness) with latency of 2 months. In Dec2022, the patient received a dose 3 of pneumococcal vaccine. It was reported that she developed a fever of 100.9F. If she was laid supine she would scream, which to her indicated a neurological problem and daughter became dehydrated and could not eat and drink for 6 hours. She had a flat effect for 5 days after receiving vaccines pneumococcal vaccine conj 7V (CRM 197) (Prevnar), Hepatitis B vaccine and diphtheria/tetanus/5 hybrid pertussis / IPV (Vero)/ HIB (PRP/T) AC vaccine [(Pentacel (Vero)]. It was not reported if the patient received a corrective treatment for all the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.