Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Autoimmune haemolytic anaemia, Dehydration, Full blood count abnormal, Gene mutation identification test negative, Haemoglobin decreased
Clinical narrative: Patient started to look jaundice on the night of May 29th.; extremely dehydrated; PCP stated his red blood cells were breaking down and to bring to ER. At this time patient was asleep and basically had no movement,; doctors/nurses tried to get blood and confirmed his HGB was at a 3; Diagnosis is Autoimmune Hemolytic Anemia; He had CBC testing per his whole admission twice a day levels were abnormal until June 2nd; Red Blood Cell Abnormality; Brought him to PCP on the 30th where he vomited; He was given a blood transfusion; Genetic testing was done and came back normal; This serious spontaneous safety report, with MSD reference number 2675610 (VAERS ID# 2675610-1), was received by a partner on 22-SEP-2023 and forwarded to company on 26-SEP-2023, from an HCP.  A 4-month-old male patient with unknown medical history had been vaccinated with Vaxelis (2nd dose and batch# U7535AA) intramuscularly (left leg) on 26-MAY-2023 for prophylaxis. Co-suspect vaccines included Vaxneuvance (2nd dose and batch# W036242) intramuscularly (right leg) and RotaTeq orally (2nd dose and batch # 1932212) also for prophylaxis.  No concomitant medication was reported.  On 26-MAY-2023, after receiving the vaccination with Vaxelis, the patient started to look jaundiced in the night of 29-MAY-2023.   On 30-MAY-2023, he was brought to the primary care provider (PCP) where he vomited. The PCP stated that his red bloods cells were breaking and he was moved to ER. At this time the patient was asleep and had no movement and was extremely dehydrated. In the ER they confirmed that the patient's hemoglobin (HGB) was 3. The patient received a blood transfusion of blood type A+; HGB went up to 5 and was given another blood transfusion and HGB went up to 7.9. He had been monitored and treated with a high dose of methylprednisolone.   On 01-JUN-2023, his HGB went down again to 6.3 and was given another transfusion and HGB went up to 11.4. The patient had been tested once every day.   On 07-JUN-2023, the patient was discharged. He was on prednisolone twice daily starting at 2.3 ml and presently taking 1.1 ml twice daily.  On 08-AUG-2023, the patient received his 6-month vaccines, since then his HGB dropped.  Steroids had been weaned up weekly until 15-AUG-2023.   On 16-AUG-2023, HGB was 10.8 and at 10.8 as well on 22-AUG-2023. Patient had been diagnosed with Autoimmune hemolytic anemia.   At the time of this report, the outcome of the events was reported as Not recovered/Not resolved.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the events "Patient started to look jaundice on the night of May 29th, "Extremely dehydrated", "PCP stated his red blood cells were breaking down and to bring to ER. At this time patient was asleep and basically had no movement, "doctors/nurses tried to get blood and confirmed his HGB was at a 3, "Diagnosis is Autoimmune Hemolytic Anemia," He had CBC testing per his whole admission twice a day levels were abnormal until June 2nd", "Red Blood Cell abnormality", "Brought him to PCP on the 30th where he vomited", "He was given a blood transfusion", "Genetic testing was done and came back normal".  Laboratory tests result includes CBC test twice daily results are abnormal and Genetic testing results were normal.   No further information is expected.  COMPANY COMMENT The events Jaundice, Dehydration, Mobility decreased, Haemoglobin decreased, Autoimmune haemolytic anaemia, Full blood count abnormal, Red blood cell abnormality, Vomiting, Transfusion, Gene mutation identification test negative were assessed as serious due to hospitalization.  Vomiting is listed whereas Jaundice, Dehydration, Mobility decreased, Haemoglobin decreased, Autoimmune haemolytic anaemia, Full blood count abnormal, Red blood cell abnormality, Transfusion, Gene mutation identification test negative are unlisted for Vaxelis as per the Reference Safety Information (CCDS).  Considering the current knowledge on Vaxelis (Vomiting is listed as per CCDS) and that these events occurred within three days of vaccination and despite the co-suspect vaccines as confounding factor and lack of medical history, the causal relationship between Vaxelis and the events Jaundice, Dehydration, Mobility decreased, Haemoglobin decreased, Autoimmune haemolytic anaemia, Full blood count abnormal, Red blood cell abnormality, Vomiting cannot be excluded and is assessed as related. However, an underlying predisposing condition needs to be taken into consideration in this case.  The causal relationship between Vaxelis and the events Transfusion, Gene mutation identification test negative is assessed as not applicable due to the nature of the events.  This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.; Sender's Comments: The events Jaundice, Dehydration, Mobility decreased, Haemoglobin decreased, Autoimmune haemolytic anaemia, Full blood count abnormal, Red blood cell abnormality, Vomiting, Transfusion, Gene mutation identification test negative were assessed as serious due to hospitalization.  Vomiting is listed whereas Jaundice, Dehydration, Mobility decreased, Haemoglobin decreased, Autoimmune haemolytic anaemia, Full blood count abnormal, Red blood cell abnormality, Transfusion, Gene mutation identification test negative are unlisted for Vaxelis as per the Reference Safety Information (CCDS).  Considering the current knowledge on Vaxelis (Vomiting is listed as per CCDS) and that these events occurred within three days of vaccination and despite the co-suspect vaccines as confounding factor and lack of medical history, the causal relationship between Vaxelis and the events Jaundice, Dehydration, Mobility decreased, Haemoglobin decreased, Autoimmune haemolytic anaemia, Full blood count abnormal, Red blood cell abnormality, Vomiting cannot be excluded and is assessed as related. However, an underlying predisposing condition needs to be taken into consideration in this case.  The causal relationship between Vaxelis and the events Transfusion, Gene mutation identification test negative is assessed as not applicable due to the nature of the events.  This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.