Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Lethargy, Loss of consciousness, Pain, Pallor, Vomiting
Clinical narrative: From initial information received on 11/24/03 from a health care professional regarding an adverse event occurring in the USA, it was reported that a four year old male patient received his fourth dose of IPOL, lot number W1156-2, administered SC in the left arm, a fifth dose of DTaP, lot number 610A2, administered IM in the left deltoid, and his second dose of MMR, lot number 0273N, administered SC in the right deltoid on 11/21/03 at approximately 3:30 PM. Ten minutes after immunization, the patient developed abdominal pain, paleness, cool diaphoresis, and lost consciousness at times. He also had emesis. The child was given oxygen and epinephrine at the doctor's office and was sent to the emergency room for further evaluation and treatment. Pulse oximetry and vital signs were taken several times while the patient was at the medical office during the event, but no readings were provided. Reportedly, the patient recovered from these events Further data are awaited. (OMIC). From additional information received on 12/26/03 from another manufacturer, it was reported by a health care professional that the patient received his fifth dose of INFANRIX, lot number 610A2, administered IM in the left deltoid, not DTaP, as previously stated. On 11/21/03 the patient's heart rate (total heartbeat count) was low (measurements not reported). Reportedly, in addition to the symptoms previously provided, the patient also became lethargic. The patient was diagnosed with unresponsive episode usually seen with whole cell vaccine. A nurse reported that the patient did not have any problems with past immunizations. The reporter considered the patient's abdominal pain, vomiting, and unresponsive episode to be disabling events and to be other important medical event (OMIC). Reportedly, the physician was concerned about the MMR vaccine lot number, however the records of testing by the other manufacturer prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. On 12/26/03, additional information was also received from a second manufacturer. Reportedly, the patient received a 0.5ml single dose of INFANRIX, lot number DTPA610A2 on 11/21/03. The reporter stated that upon regaining consciousness, the patient was unresponsive to verbal commands and lethargic. No other information was provided.  From additonal information received on 26/Dec/2003 from another manufacturer, reference number WAES0311USA02713 , it was reported by a health care professional that the patient received his fifth dose of INFANRIX, lot number 610A2, manufacturer SKB, administered intra-muscularly in the left deltoid, not DTaP, as previously stated. On 21/NOV/2003 the patient's heart rate (total heartbeat count) was low (measurements not reported). Reportedly, in addition to the symptoms previously provided, the patient also became lethargic. The patient was diagnosed with "unresponsive episode usually seen with whole cell vaccine". A nurse reported that the patient did not have any problems with past immunizations. The reporter considered the patient's abdominal pain, vomiting and unresponsive episode to be disabling events and to be other important medical event. Reportedly, the physician was concerned about the measles virus vaccine live (Moraten ) (+) mumps virus vaccine live + rubella virus vaccine live lot, however the records of testing by the other manufacturer prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. On 25/Dec/2003, additional information was also received from a second manufacturer, reference number WAES0311USA2713 it was reported that ten minutes after receiving the vaccinations "the child's eyes rolled up into his head, he would look at you if you called his name but he did not respond verbally". Thepatient was taken to the emergency room. The patient then became responsive and was "treated and released". No other informaiton was provided. No further information is anticipated, this case is considered closed. From additional information received on 20/JAN/2004 from another manufacturer, it was reported that ten minutes after receiving the vaccinations "the child's eyes rolled up into hishead, he would look at you if you called his name but did not respond verbally". The pt was taken to the ER. The patient then became  responsive and was "treated and released". No other information was provided. No further information is anticipated, this case is considered closed.