Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Respiratory rate, Skin discolouration, Urticaria, Vision blurred, White blood cell count increased
Clinical narrative: Information has been received from a consumer concerning her 11 year old male child, born at 36 weeks, with a history of bronchiolitis, fever, cough, "bulge" in right groin, no drug reactions or allergies who on 04-JUN-2007 was vaccinated with VARIVAX (Oka/Merck) (lot # 657000/0339U). On 04-JUN-2007 the patient developed a localized rash over all his body that was extremely itchy. The rash reportedly turned dark red in color when exposed to the sun and faded when the patient was indoors. The patient was not recovered at the time of reporting. There was no concomitant therapy. Unspecified medical attention was sought. There was no product quality complaint. Follow up information was received from the patient's mother who reported that it has been over six weeks and her son has not yet recovered. it was further reported that on an undisclosed date the patient was rushed to Emergency Room (ER) due to difficulty breathing, where he was treated with steroids and released. There was no concomitant therapy. Unspecified medical attention was sought. There was no product quality complaint. There were no lab diagnostic studies performed. Follow up information was received from the patient's mother. On 05 JUN 2007 (previously reported as 04 JUN 2007) the patient received 0.5 ml of VARIVAX (Oka/Merck) into the right deltoid (lot number 657000/0339U). Upon departure from the physician's office, while in the parking lot, the patient developed pruritis, rash and welts on his face, neck, torso and extremities. The mother assumed the events were a transient reaction to the just administered vaccine, and therefore returned home with the patient. Once home the administering doctor was notified of the events, at which time the patient was prescribed BENADRYL prn. The patient consistently had similar outbreaks when exposed to the sun and heat, which resolved once oral BENADRYL, was administered. Once an outbreak occurred the patient needed to return indoors. The mother reported that on 18 JUL 2007 the patient was swimming for approximately one hour, when he returned to a shaded area, and was noted to have the same sequence of pruritis, rash, and welts. He subsequently complained of blurred vision, lethargy, shortness of breath and dyspnoea. The patient's mother observed extreme pallor, cyanotic nail beds and toenail beds, and cool, clammy skin. Emergency (911) was called. Upon arrival an IV was instituted with concomitant oxygen therapy via mask and the patient's vital signs were difficult to palpate, with a low blood pressure. The patient had "various" blood test performed, as well as a chest x-ray and EKG. The mother reports that the patient was evaluated by the ER physician and prednisone 30 mg orally was administered. The patient's condition stabilized, and he was subsequently discharged to be followed by a pediatrician. The patient was evaluated by a pediatrician who recommended CLARITIN anti histamine and ZYRTEC to follow, if the symptoms did not improve. He additionally recommended a follow-up with a pediatric allergist. The patient mother reported that the patient had no history of any allergic disorders or any abnormal reactions to direct sunlight or heat, until the aforementioned events transpired. Information has been received regarding a case in litigation, which included follow up information in the form of medical records. On 18 JUL 2007, Emergency Medical Services responded to a call for dizziness, and upon arrival, 13:22, found an 11 year old male supine on the ground, pale, cold and diaphoretic. The patient, initially ashen in color, was placed on oxygen via a non re-breather mask, after which the patient's skin color began to improve. Initial pulse rate was 88, thready, respiratory rate (RR) 16, BP was 82/p. The patient's pupils were equal and reactive to light; he was awake, alert and oriented, and following command. The mother admits that the patient had been playing in the sun and swimming since 10:30 that morning, and had not been drinking fluids. She also reported that the patient had a chickenpox vaccine 6 weeks prior, broke out in a rash, and was taking BENADRYL to help. Mother admits that the patient may have had the rash prior to the present symptoms. The patient denied loss of consciousness, chest pain, shortness of breath, nausea, vomiting, vision problems, numbness, tingling in extremities, or recent trauma. The patient does admit to dizziness. A review of symptoms was unremarkable. The general impression was dehydration (r/o medical). The patient was placed on a cardiac monitor, and found to be in normal sinus rhythm with occasional PAC, that later went away after a 800 cc bolus of NSS, via a 20 gauge IV catheter in the left anticubital. The patient admitted to feeling much better. At 13:35, after receiving 400 cc IV fluid, BP 90/p and pulse 78 regular RR 16. EMS reported, that at the requested of the mother, the patient was transported without incident, as a Code 2 (non life threatening) to the local emergency room (ER) 13:54 BP 104/p, pulse 68 regular and RR 14 regular. Upon arrival to ER the patient's mother reported that the patient had been playing outside today, and swimming, when he began to complain of hives, itching, that was followed by some shortness of breath and dizziness. The mother states the patient was somewhat disoriented when EMS arrived. The patient admits to having a rash, and then began having some shortness of breath followed by some mild dizziness. The patient is an 11 year old male with a negative medical history except for the rash, the presents when exposed to the sun. The patient is on BENADRYL as needed for the rash. Review of systems were unremarkable. It was noted mucous membranes were slightly dry. The patient awake, alert, and nontoxic and answering questions appropriately. Lungs clear, with no increased work of breathing. An erythematous rash was present on the arms, chest and abdomen, stopping at the waistband, where the patient would not have been exposed to the sun, and reported as being consistent with an allergic reaction. A chest X-ray on 18 JUL 2007 did not reveal any acute process. AN EKG on that same day, showed normal sinus rhythm, without ST elevations, T-wave inversion, QT prolongation or delta wave. An initial potassium was 2.7, glucose 116. The CBC revealed a mild leukocytosis at 13.9 Hemoglobin was 17.2, hematocrit 51.2. Platelet were slightly elevated at 405. A repeat potassium was 4.0, at which time the patient had no further symptomatology. Oxygen saturation was normal. The rash on his arms and chest had resolved. The patient was completely non toxic in appearance. The patient was discharged to home following an allergic reaction which had resolved. Steroids were not required. It was noted that the patient symptoms appear to have been caused only by exposure to the sun. Instructions at discharge included use of BENADRYL, and an Epi Pen Jr. was supplied to the father, a physician, along with prescription, to be used if the patient develops shortness of breath or throat swelling. The patient was seen by his Primary Care Physician (PCP) on 19 JUL 2007. The patient's mother reports that the previous day the patient had become pale and dizzy, 911 was called and the patient was taken to the ER, where we was given 30 mg prednisone IV and BENADRYL, from which he recovered within two hours. A review of symptoms at this time was unremarkable. It was noted that the patient exhibited urticaria due to cold/heat. The patient was prescribed ZYRTEC for solar urticaria. On 19 JUL 2007 the patient's mother called the office for her son's PCP reporting that she would like to change physicians, and requested all information concerning the vaccine her son was given. The mother reported to the office staff that the patient, her son, had been seen in the ER the previous evening for an "anaphylactic reaction" that she was positive was from VARIVAX he received on 05 JUN 2007. Prior vaccinations include: VARIVAX (Oka/Merck) 20-Jan-1997; Hib conj vaccine (unspecified carrier) 20-Jan-1997, 21-May-1996, 09-Aug-1996, 18-Apr-1997; pertussis acellular vaccine (unspecified) (+) tetanus toxoid 19-May-1996, 21-May-1996, 09-Aug-1996, 07-Jul-2007, 16-Jul-2007; hepatitis B virus vaccine 07-Jan-1996, 13-Feb-1996, 02-Oct-1996; MMR II 08-Apr-1997, 16-Jul-2007; and poliovirus vaccine inactivated (unspecified) 19-Mar-1996, 02-May-2006, 07-Jul-2007, 16-Jul-2007. On 07 FEB 2008 the patient's mother called to report that the patient is "now seeing an allergist". On 03 MAR 2008 the patient's mother called and communicated that "it is almost summer time and even now I can only play catch with my son in the shade because of the reaction he had with VARIVAX. No further information is expected.