Age: 0.17
Sex: F
Vaccine: HEP, PNC, UNK
Symptoms: Irritability, Pyrexia, Screaming
Clinical narrative: was laid supine, she would scream, which to her indicated a neurological problem; developed a fever of 100.9F; After 30 minutes she became fussy which is no normal for her; was inconsolable for 6 hours and this has never happened; her daughter became dehydrated and and could not drink for 6 hours; could not eat for 6 hours; had a flat effect for 5 days; Initial information received on 01-Mar-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 4 months old female patient who after 30 minutes she became fussy which is no normal for her and was inconsolable for 6 hours and this has never happened, developed a fever of 100.9F, If she was laid supine she would scream, which to her indicated a neurological problem daughter became dehydrated and could not eat and drink for 6 hours, had flat effect for 5 days after receiving vaccines pneumococcal vaccine conj 7V (CRM197) (Prevnar), Hepatitis B vaccine and diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)].  The patient's past medical history included Infant premature (daughter was premature at 33 weeks) The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 11-Aug-2022, the patient received a  dose of suspect Hepatitis B vaccine not produced by Sanofi Pasteur (dose, strength, formulation, batch number and expiry date not reported) via unknown route in unknown administration site and on same day the patient also  received a dose 1 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection (strength, batch number and expiry date) not reported via unknown route in unknown administration site and on same day she also received a dose 1 of the suspect pneumococcal vaccine conj 7V (CRM197) not produced by Sanofi Pasteur (dose, strength, formulation, batch number and expiry date not reported) via unknown route in unknown administration site all for Immunization.   On 11-Oct-2022 she also received a dose 2 of the suspect pneumococcal vaccine conj 7V (CRM197) not produced by Sanofi Pasteur (dose, strength, formulation, batch number and expiry date not reported) via unknown route in unknown administration site and on same day she also received a dose 2 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection (strength, batch number and expiry date) not reported via unknown route in unknown administration site both for Immunization.  On Unknown date in December 2022, the patient received a  dose of suspect pneumococcal vaccine conj 7V (CRM197) not produced by Sanofi Pasteur (dose, strength, formulation, batch number and expiry date not reported) via unknown route in unknown administration site for Immunization.  On 11-Oct-2022  (latency; same day) after the second dose 30 minutes she became fussy which is no normal for her (irritability) and was inconsolable for 6 hours and this has never happened (restlessness) (latency: 2 months) first dose of vaccines.  On an unknown date the patient became dehydrated and and could not drink for 6 hours (dehydration), could not eat for 6 hours (decreased appetite) if she was laid supine, she would scream, which to her indicated a neurological problem (screaming), developed a fever of 100.9f (pyrexia) and had a flat effect for 5 days (flat affect) (unknown latency).  Relevant laboratory test results included: Body temperature - On an unknown date: 100.9 F [fever]   Action taken : not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events and was Recovered / Resolved on an unknown date for the event had a flat effect for 5 days.