chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Oxygen saturation decreased, Reaction to preservatives, Urticaria
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 4 year old male with a pet allergy, syndactyly on toes and speech delay, who on 04-AUG-2008, was vaccinated IM into right thigh with the second dose of VARIVAX (Merck) (Lot # 660340/0315X). Concomitant vaccination included HAVRIX. Approximately 10-20 minutes after vaccination, the patient experienced an anaphylactic reaction (shortness of breath and trouble breathing), urticaria and decrease in saturation detected via pulse oximetry (90% during on set of event). The patient was given EPI subcutaneously and CLARITIN PO to treat the symptoms of the experience. Over 1-2 hour, the patient recovered. "The patient was fine now." The reporting physician considered the patient's anaphylactic reaction to be life threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center and was released. No further information is available.  This is in follow-up to report(s) previously submitted on 5/15/2009. Initial and follow-up information has been received from a physician concerning a 4 year old male with a pet allergy, syndactyly on toes and speech delay, who on 04-AUG-2008, was vaccinated IM into the right thigh with the second dose of VARIVAX (Merck) (Lot # 660340/0315X). Concomitant vaccination included HAVRIX. Approximately 10-20 minutes after vaccination, the patient experienced an anaphylactic reaction (shortness of breath and trouble breathing), urticaria and decrease in saturation detected via pulse oximetry (90% during on set of event). The patient was given EPI subcutaneously and CLARITIN PO to treat the symptoms of the experience. Over 1-2 hour, the patient recovered. "The patient was fine now." The reporting physician considered the patient's anaphylactic reaction to be life threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investiagation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information was received from a physician. The physician reported that bloodwork showed that this was a reaction to a gelatin in the vaccine. The physician also noted that the patient had no reaction with the first dose. No further information is available.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema multiforme, Injection site urticaria, Rash, Rash generalised, Rash maculo-papular
Clinical narrative: Information has been received from a physician's assistant student concerning a 12 month old male with no known drug reactions/allergies who on 04-AUG-2008 was vaccinated with a first dose of VARIVAX (Merck) (lot # 661443/0528X) subcutaneous into his right thigh, 0.5 mL, a first dose of MMR II (lot # 656864/0412U) into his left thigh and a dose of HAVRIX (lot # AHAVB245AA) given into his right thigh. There was no fever. On 05-AUG-2008 the patient had maculopapular rash on his legs and trunk. A half teaspoon of BENADRYL suspension 12.5 mg/5mL was given each 6 hours for 5 days. At time of reporting, the patient had not recovered. Follow-up information was received from the physician who reported that the rash was not maculopapular but rather an erythema multiforme. The rash was on the thigh and the covered all over the body except in the mouth. The rash is not Steven-Johnson syndrome. In follow-up, it was also reported that the patient's birth weight was 8 lb 11 oz. The patient also has iron deficiency anemia and no known drug allergies. At time of vaccination, the patient was being treated for otitis media and was being administered amoxicillin and was on day 9 or 10. It was reported that the patient developed a maculo papular-patchy rash that first started on abdomen and then extended to rest of torso and extremities. Patient also developed urticaria like lesions where vaccines were given. The patient's current outcome is unknown. This is one of two reports from the same source. No further information is available.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Anaphylactic reaction, Dysphagia, Orthostatic hypotension, Pruritus, Throat irritation
Clinical narrative: Information has been received from a physician concerning a 6 year old male with an unspecified hypersensitivity, attention deficit/hyperactivity disorder, asthma, enuresis and heart disease congenital who at 10:30 am on 05-AUG-2008 was vaccinated with a second dose of VARIVAX (Merck) (lot# 660322/0171X) 0.5 ml SQ in his right arm. Concomitant therapy included montelukast sodium and TOFRANIL. At 10:40 am on 05-AUG-2008, ten minutes after the vaccination, the patient started vomiting in the parking lot of the office and he continued to vomit. The patient developed generalized vasodilation, extensive pruritus, postural hypotension, itching in the throat and trouble swallowing. He was diagnosed with an anaphylactic reaction. The patient was treated with DECADRON 8 mg PO and BENADRYL 30 mg. Subsequently, the patient recovered from anaphylactic reaction. The patient sought medical attention in the office. The reporting physician considered the anaphylactic reaction to be an other important medical event and immediately life-threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. No further information is available.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Vasodilation procedure, Vomiting
Clinical narrative: Information has been received from a physician concerning a 6 year old male with an unspecified hypersensitivity, attention deficit/hyperactivity disorder, asthma, enuresis and heart disease congenital who at 10:30 am on 05-AUG-2008 was vaccinated with a second dose of VARIVAX (Merck) (lot# 660322/0171X) 0.5 ml SQ in his right arm. Concomitant therapy included montelukast sodium and TOFRANIL. At 10:40 am on 05-AUG-2008, ten minutes after the vaccination, the patient started vomiting in the parking lot of the office and he continued to vomit. The patient developed generalized vasodilation, extensive pruritus, postural hypotension, itching in the throat and trouble swallowing. He was diagnosed with an anaphylactic reaction. The patient was treated with DECADRON 8 mg PO and BENADRYL 30 mg. Subsequently, the patient recovered from anaphylactic reaction. The patient sought medical attention in the office. The reporting physician considered the anaphylactic reaction to be an other important medical event and immediately life-threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. No further information is available.
Age: 1.1
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Body temperature increased, Full blood count normal, Otitis media, Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 15 months male with eczema, global delay, allergies and strabismus who on 08-APR-2008 was vaccinated with a first dose of VARIVAX (Merck) (lot# 660078/1849U). Suspect therapy included a first dose of MMR (Lot number 654985/1181F). Concomitant therapy included a fourth dose of DAPTACEL (Lot number U2354CA). Within one week post vaccination, the patient developed a varicella rash. On 11-APR-2008 complete blood cell count was performed. The result was normal. On 14-APR-2008 the patient developed fever. The patient sought unspecified medical attention. On 18-APR-2008 the patient was seen. The patient's temperature was 101.9 F and had vesicles in various stages. Some were super infected. The patient was also with a left otitis media. On an unspecified date the patient recovered. No further information is available.
Age: 1.1
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Skin infection
Clinical narrative: Information has been received from a physician concerning a 15 months male with eczema, global delay, allergies and strabismus who on 08-APR-2008 was vaccinated with a first dose of VARIVAX (Merck) (lot# 660078/1849U). Suspect therapy included a first dose of MMR (Lot number 654985/1181F). Concomitant therapy included a fourth dose of DAPTACEL (Lot number U2354CA). Within one week post vaccination, the patient developed a varicella rash. On 11-APR-2008 complete blood cell count was performed. The result was normal. On 14-APR-2008 the patient developed fever. The patient sought unspecified medical attention. On 18-APR-2008 the patient was seen. The patient's temperature was 101.9 F and had vesicles in various stages. Some were super infected. The patient was also with a left otitis media. On an unspecified date the patient recovered. No further information is available.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 10 year old female who on 04-AUG-2008 was vaccinated with the second dose of VARIVAX (Merck) (LOT#: 660826/0424X). Concomitant therapy included amoxicillin. On 05-AUG-2008 the patient developed an 11 by 13 centimeter spot on injection site that was red, warm, firm and itchy. The patient sought unspecified medical attention. The patient's outcome was not reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Oedema peripheral
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 4 year old male with a history of methicillin-resistant staphylococcal aureus infection, eczema and oesophageal stricture who on 06-AUG-2008 at 11:00 AM was vaccinated subcutaneously into the right thigh with the second 0.5 ml dose of VARIVAX (Merck) (lot # 659944/1796U). Suspect therapy included the second dose of MMR II (lot # 655269/0747U) given subcutaneously into the left thigh, the fourth dose of IPOL (lot # A0169) given intramuscularly into the right thigh and the fifth dose of INFANRIX (lot # AC14B062AA) given intramuscularly into the left thigh. Concomitant therapy included albuterol and ELIDEL. On 07-AUG-2008 at 07:00 AM the patient developed 3cm area erythema with very mild induration at the right posterior thigh, no warmth, not tender to palpation. Otherwise, the patient's skin had no rash or lesion except edema to arms and legs bilaterally. The symptoms required emergency room/ doctor visit. Subsequently, the patient recovered from the symptoms. This is one of several reports received from the same source. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 5 year old male who on 11-AUG-2008 at 9:00 am was vaccinated subcutaneously into the right thigh with the second 0.5 ml dose of VARIVAX (Oka/Merck) (lot # 660342/0318X).  Concomitant therapy included the second dose of M-M-R II (lot # 659414/0240X) given subcutaneously into the left thigh, the fifth dose of INFANRIX (lot # AC14B085AA) given intramuscularly into the left thigh and ALBUTEROL.  On 12-AUG-2008 the patient developed erythema and induration at the right posterior thigh.  The symptoms required emergency room/ doctor visit.  Subsequently, the patient recovered from the symptoms.  This is one of several reports received from the same source.  Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 13 -year-old female who on 14 - Aug-2008 was vaccinated with the second dose of VARIVAX  (Oka/Merck)(lot#659953/0329X, site not reported) and on the same day the patient was vaccinated with the second dose of GARDASIL (lot# 659052/1984U) (site not reported). Subsequently, the patient experienced quarter sized rash on her arm near the injection site (site not reported).No further information available from the caller. Follow up information was recovered from the physician's office who reported that the patient with no known allergic or pertinent medical history who on 14-Aug-2008 was vaccinated with the second dose of VARIVAX (Oka/Merck) (lot#659953/0329X) subcutaneously, into the left arm, and on the same day the patient was vaccinated with the third dose of GARDASIL (lot# 659052/1984U), intramuscularly into left deltoid. On 15-Aug-2008, the patient developed a quarter size ring around injection site, and was warm to touch. No treatment was done. There was no illness at the time of vaccination. The patient's sister also experienced and adverse event after receiving her second dose of GARDASIL refer to WAES No 0808USA04087. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on 14-Aug-2008 was vaccinated with the second dose of VARIVAX (Oka/Merck) (lot#659953/0329X) and a dose of DTAP (unspecified). Concomitant therapy included ALLEGRA. On 15-Aug-2008 the patient experienced tennis ball size rash and the patient was sent to the emergency room but was not admitted. The reporter also reported that no reaction occurred after the first dose of VARIVAX (Oka/Merck). No further information available from caller. Follow up information was received from the physician's office who reported that on 14 Aug 2008, the patient was vaccinated with the second dose of VARIVAX (Oka/Merck) (lot# 659953/0329X) subcutaneously, into the left arm and a dose of DTAP (lot# C2997AA), intramuscularly, into the left deltoid. On 15-Aug-2008 the patient developed a tennis ball sized red reaction to VARIVAX (Oka/Merck). The patient also had a low grade of fever. The patient's experienced required an ER / doctor's visit. At the time of the report the outcome was unknown. No further information is available.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 12 month old male who on 19-AUG-2008 was vaccinated with a dose of VARIVAX (lot # 661443/0528X) 0.5 mL, subcutaneously into his right arm and a dose of MMR II (lot # 656864/0412U) 0.5 mL, subcutaneously into his left arm. On 22-AUG-2008 the patient experienced a small itchy papular rash on his arms chest and legs. At time of reporting the patient was recovered. The patient did not seek medical attention. There were no lab diagnostics studies performed. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV, PPV, VARCEL
Symptoms: Varicella
Clinical narrative: Initial and follow-up information has been received from a consumer and a registered nurse concerning a 30 month old female (birth weight 6 pounds, 14 ounces), who on 12-FEB-2007 was vaccinated with a dose of VARIVAX (Merck) at another practice. The patient was also vaccinated with a dose of PNEUMOCOCCAL vaccine (unspecified) on the same day. In follow-up information the registered nurse reported that the patient was also vaccinated with the first dose of PROQUAD (MSD), Lot # 656547/1530F (site and route unknown). On 16-AUG-2008 the patient experienced chicken pox. The responsible physician was not sure if the patient had chickenpox or not. The patient had 10 spots in total. In follow-up information, the nurse reported that the patient experienced varicella breakthrough on 16-AUG-2008. Patient was diagnosed with varicella at the physician's office on 17-AUG-2008. The nurse also reported that the patient had 8-10 lesions and had no fever. At the time of the report the patient's outcome was unknown. Further information is not available.
Age: 4.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Pruritus
Clinical narrative: Initial and follow-up information has been received from a physician and a health care professional, concerning a 4 year old female (birth weight 6 pounds, 2.3 ounces with one sister, who on 05-SEP-2008 at 11:00 am, was vaccinated with her second dose of VARIVAX (Merck) (lot# 659953/0329X) subcutaneously, on left thigh.  In follow-up information it was reported that the patient was also vaccinated on 05-SEP-2008 at 11:00 am, with HAVRIX (Lot # AHAVB245AA), intramuscularly in left thigh and MMR II (MSD), (Lot # 660401/0907X), subcutaneously, into right thigh. On 06-NOV-2008, "within 36 hours of receiving shot", the patient developed a rash, after being vaccinated, a 6 cm deep red erythematous reaction surround by a pink halo of 2 cm and total induration of 15 cm, at site of VARIVAX booster. She was treated with OTC BENADRYL for itching and cool compresses. It was also reported that the patient required emergency room/doctor visit. At the time of the report the patient's outcome was unknown. No further information is available.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Headache, Pruritus, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old female with penicillin allergy and no pertinent medical history, who on 11-SEP-2008 was vaccinated with a second dose of VARIVAX (lot # 661534/0952X) 0.5 mL subcutaneously. Concomitant vaccination included a dose of BOOSTRIX. On 12-SEP-2008 the patient had 2 or 3 wheals on her body. On 13-SEP-2008 only, the patient had a headache. The same day, she had "a lot" of wheals. On 15-SEP-2008, the patient had more than 50 itchy wheals. There were no wheals on her trunk or back. They were present on her extremities, between her fingers, the base of her neck and the top of her toes. Other than the itchy wheals, the patient was asymptomatic. The patient was instructed to take oral Benadryl and use an ice pack for the itching. Dose 1 of VARIVAX was administered at a different office and did not have any symptoms. There were no lab diagnostics studies performed. The patient sought medical attention with the nurse. At time of reporting, the patient had not recovered from wheals on her body. Follow-up information was received from the registered nurse who reported that the patient had previously received a dose of BOOSTRIX on 30-OCT-2002. The nurse reported that the patient received a first dose of VARIVAX 0.5 mL SQ on 14-JUL-2005. It was reported that the second dose of VARIVAX was given into her right arm. It was also reported that the patient's concomitant vaccination included a dose of BOOSTRIX. The patient recovered on 22-SEP-2008. There was no illness at time of vaccination. No further information is available.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning a 12 month old male who at 11:00 am, on 12-SEP-2008 was vaccinated SC with her first dose of VARIVAX (Oka/Merck) (lot number 659602/1910U). Concomitant therapy included PREVNAR (lot number C86142). On 18-SEP-2008 the patient experienced break through chicken pox. The outcome of the event was not reported. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Herpes simplex, Herpes zoster, Rash vesicular, Scab, Varicella zoster serology negative
Clinical narrative: Information has been received from a physician and a nurse concerning an approximately 34 month old female who on 26-MAY-2007 was vaccinated with a dose of VARIVAX (Oka/Merck). On 25-SEP-2008, the patient developed a small bump on her right thigh that had spread to a 3 inch rash hot to the touch. The child was examined at the emergency room on 27-SEP-2008 and the rash was described as weeping, asymmetrical vesicular with some crusting. The emergency room physician diagnosed it as herpetic whitlow. The patient was seen by family physician on 29-SEP-2008. The area of the rash had "dried up", due to treatment with ZOVIRAX. The family physician diagnosed the rash as Zoster on 29-SEP-2008. At time of reporting, the patient was recovering. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 12 month old male with no medical history who on 29-SEP-2008 was vaccinated with the first dose of VARIVAX (Oka/Merck) (lot # 661660/0994X). Vaccine received the same day included MMR II. On approximately 29-SEP-2008, after vaccination, the patient experienced large 4 to 5 inch red spots at the injection site. The site was swollen and painful to touch. The patient received BENADRYL and recovered. It was reported that the patient did not seek medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: FLUN3, MNQ, TDAP, VARCEL, FLUN3, MNQ, TDAP, VARCEL, FLUN3, HEPA, MNQ, TDAP
Symptoms: Dizziness, Heart rate normal, Nausea, Oxygen saturation normal, Vomiting
Clinical narrative: Information has been received from a physician concerning a 12 year old male who on 13-OCT-2008 was vaccinated with a second dose of VARIVAX (Merck) (lot #661653/1140X) SC into the right arm, a dose  of ADACEL (lot # C2767AA) IM into the right deltoid, a first dose of MENACTRA (lot # U2618AA) IM into the left deltoid and a second dose of FLUMIST (lot #500545P) via nasal route. The vaccines were given as instructed by the physician, followed by lead test (capillary phlebotomy) at the patient's mom's request. After lead test completed and bandaid applied, the patient complained of dizziness, light headedness and nausea. The episode resolved approximately 30-45 seconds after an emesis. Laboratory data and diagnostic test included pulse oximetry (POX) at 98% and heart rate (HR) at 78. No further information is available.
Age: 12.0
Sex: M
Vaccine: FLUN3, MNQ, TDAP, VARCEL, FLUN3, MNQ, TDAP, VARCEL, FLUN3, HEPA, MNQ, TDAP
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 12 year old male who on 13-OCT-2008 was vaccinated with a second dose of VARIVAX (Merck) (lot #661653/1140X) SC into the right arm, a dose  of ADACEL (lot # C2767AA) IM into the right deltoid, a first dose of MENACTRA (lot # U2618AA) IM into the left deltoid and a second dose of FLUMIST (lot #500545P) via nasal route. The vaccines were given as instructed by the physician, followed by lead test (capillary phlebotomy) at the patient's mom's request. After lead test completed and bandaid applied, the patient complained of dizziness, light headedness and nausea. The episode resolved approximately 30-45 seconds after an emesis. Laboratory data and diagnostic test included pulse oximetry (POX) at 98% and heart rate (HR) at 78. No further information is available.
Age: 14.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 14 year old male with drug reactions or allergies to penicillin and no pertinent medical history, who on 15-OCT-2008 was vaccinated with VARIVAX (Oka/Merck), 0.5ml subcutaneous injection. Concomitant therapy included poliovirus vaccine, MMR and DTaP. On 18-OCT-2008 the patient experienced chicken pox rash after receiving VARIVAX (Oka/Merck). The patient experienced the rash from head to toe. The patient sought unspecified medical attention by the physician. No lab diagnostics studies performed. The patient did not recover from chicken pox rash. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Respiratory disorder, Varicella
Clinical narrative: Information has been received from a physician concerning a 16 month old female patient with who approximately September 2008 "about a month ago" was vaccinated with VARIVAX(Oka/Merck), the patient came back to the office because the patient had developed a rash at the injection site. The physician reported that he looked at the rash and it looked like the patient was developing chickenpox marks. The physician reported that he believed that the patient had recovered since he did not hear back form the patient's mother. Follow up information was received from a certified medical assistant who reported that on 07-Oct-2008 the female patient with no known medical history, and no known allergies, was vaccinated with the first dose of VARIVAX (Oka/Merck) (lot# No 661063/1134X). There was no concomitant medication. On 17-Oct-2008, the patient was seen by her pediatrician for upper respiratory symptoms and there was no testing was performed regarding the "rash" incident. Additional information is requested.
Sex: U
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a patient who on 20-OCT-2008 was vaccinated with VARIVAX (Oka/Merck) ( Lot # 661660/0994X). Vaccine received the same day included MMR II. Other vaccines received the same day included PREVNAR and DTAP (manufacturer unknown). After vaccination (approximately 20-OCT-2008), the patient experienced large 4 to 5 inch red spots at the injection site. The site was site swollen and painful to the touch. Subsequently, the patient received BENADRYL and recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Viral infection
Clinical narrative: Information has been received from a 48 year old male pharmacy technician with gout, hypertension and type 2 diabetes mellitus, no drug reactions/allergies, who on 01-OCT-2008 was vaccinated subcutaneously with the first 0.5 mL dose of VARIVAX (Oka/Merck) and on 29-OCT-2008 was vaccinated subcutaneously with the second 0.5 mL dose of VARIVAX. Concomitant therapy included VIBRAMYCIN, allopurinol, metformin hydrochloride (+) sitagliptin phosphate, LOPID, simvastatin, colchicine, lisinopril (manufacturer unknown), and NORCO. On 04-NOV-2008 the patient developed a "rash" on his chest and he stated he had a fever of 100.9 in the beginning. He was seen by the physician and was told that he had a "viral reaction". The patient was required to receive the vaccine for employment and had been out of work since the development of the rash. He was not allowed to return to work until the rash resolved. He worked in a hospital pharmacy. At the time of reporting, the patient was recovering. Rash was considered to be a disabling event. Follow-up information was received from a physician. The patient had no illness at the time of being vaccinated. The patient was vaccinated subcutaneously in the right arm deltoid with the second dose of VARIVAX (Oka/Merck) (lot # 3131 per patient) on 28-OCT-2008 at 9:00 pm. The patient visited doctor's office for medical attention. On 23-NOV-2008 the patient recovered from the adverse events. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Varicella zoster virus serology positive, Viral rash
Clinical narrative: Information has been received from a healthcare worker concerning a 4 month old male who on 19-NOV-2008 was vaccinated with a dose of VARIVAX (Merck) and MMRII.  The patient has not experienced any known symptoms.  It was unknown if the patient sought medical attention.  Follow-up information was received on 11-DEC-2008 from a certified assistant C.M.A. indicating that the patient developed mumps following the administration of MMRII and VARIVAX (Merck) on 19-NOV-2008.  The patient also received DTaP and HAVRIX on 19-NOV-2008.  At the time of the report, 11-DEC-2008, the patient had not recovered from the mumps.  The patient was returning to the office on 15-DEC-2008 for follow-up.  Follow-up information was received on 05-FEB-2009 from the C.M.A. and the physician via medical records indicating that on 19-NOV-2008, at 16:25, the patient with a history of bronchitis (onset 31-OCT-2008) was vaccinated with a first dose of VARIVAX (Merck) (Lot #661664/1187X) in the right leg and a first dose of MMRII (Lot #656526/0284U) in the left leg.  It was reported that the patient was followed "the next day and then in a week" and there was no medical problem.  On 03-DEC-2008, in the morning, the patient developed a rash suddenly found by the mother.  The child was taken to a clinic and at this point, the mother reported that the child had had only the rash, but no fever, a little bit of decreased appetite, but taking orally.  His reflex seemed to be a little bit more present, but there was no vomiting.  According to the mother there was normal neurologic activity.  The child was playful, making good eye contacts, smiling and there were no other constitutional symptoms.  He was again taking his oral formula and he was just without any problems  having his normal bowel movements.  It was reported that the child had not had any contact with any other sick child.  Physical examination showed a macular papular rash over the patient's abdominal area more prominent in the trunk and the upper chest and upper back, some of these are tracking up to the skull in the back very little on the face and some of this was on the upper extremities all the way to the distal portion of the lower extremities to the distal portion.  It was blanching, it was not vesicular and there were no other abnormalities on the skin.  The physician's assessment was viral exanthem.  The physician highly suspected that it was related to MMRII and VARIVAX immunization that the child received.  The physician planned to obtain IgG and IgM titers and gave the patient's mother instructions of signs or symptoms to look for that may indicate a more serious/severe problem.  Laboratory testing was performed (Varicella Zoster Abs, IgG/IgM) on 03-DEC-2008 and results on 10-DEC-2008 indicated Varicella Zoster IgG = 2.14 which was indicative of a positive test.  The test results for the same test on 05-DEC-2008 had been negative <0.90.  At the time of the report, the patient had recovered.  Additional information is not expected.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis diaper, Rash vesicular
Clinical narrative: Information has been received from a licensed practical nurse concerning an approximately 15 month old female, with no pertinent medical history and no known drug allergies, who on 09-SEP-2008 was vaccinated with VARIVAX (Oka/Merck) 0.5ml subcutaneously on the left thigh. There was no concomitant medication. On 29-NOV-2008 the patient experienced diaper rash in the groin area. Later the patient also developed a zoster-like vesicular rash on her right midline forehead. There were 4 to 5 clusters of blisters. HCP was not interested in VZV analysis by PCR. Varicella Virus Culture not able to get an accurate result due to specimen. Patient sought medical attention by going to an office visit. At the time of the report the patient was recovering. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DPP, HEPA, VARCEL
Symptoms: Allergy to vaccine, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old female who on 02-AUG-1999 was vaccinated SQ with the first 0.5 ml dose of VARIVAX and on 30-JAN-2009 was vaccinated SQ with the second 0.5 ml dose of VARIVAX (lot #: 662149/1529X). There was no concomitant medication. On 31-JAN-2009, "2 days ago", the patient experienced a reaction. The patient went to the emergency room. She complained of redness, swelling and pain of the vaccinated arm. She had huge red erythema-like rashes all over the body that felt hot and looked red. She also had a fever. The ER treated her with Benadryl, Keflex. She was diagnosed with an allergic reaction to the chickenpox vaccine. The patient was seen on 02-FEB-2009 and still had an allergic reaction (rash). The fever has resolved but the redness, swelling and pain at the injection site was not resolved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DPP, HEPA, VARCEL
Symptoms: Rash generalised
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old female who on 02-AUG-1999 was vaccinated SQ with the first 0.5 ml dose of VARIVAX and on 30-JAN-2009 was vaccinated SQ with the second 0.5 ml dose of VARIVAX (lot #: 662149/1529X). There was no concomitant medication. On 31-JAN-2009, "2 days ago", the patient experienced a reaction. The patient went to the emergency room. She complained of redness, swelling and pain of the vaccinated arm. She had huge red erythema-like rashes all over the body that felt hot and looked red. She also had a fever. The ER treated her with Benadryl, Keflex. She was diagnosed with an allergic reaction to the chickenpox vaccine. The patient was seen on 02-FEB-2009 and still had an allergic reaction (rash). The fever has resolved but the redness, swelling and pain at the injection site was not resolved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DPP, HEPA, VARCEL
Symptoms: Pyrexia, Skin warm
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old female who on 02-AUG-1999 was vaccinated SQ with the first 0.5 ml dose of VARIVAX and on 30-JAN-2009 was vaccinated SQ with the second 0.5 ml dose of VARIVAX (lot #: 662149/1529X). There was no concomitant medication. On 31-JAN-2009, "2 days ago", the patient experienced a reaction. The patient went to the emergency room. She complained of redness, swelling and pain of the vaccinated arm. She had huge red erythema-like rashes all over the body that felt hot and looked red. She also had a fever. The ER treated her with Benadryl, Keflex. She was diagnosed with an allergic reaction to the chickenpox vaccine. The patient was seen on 02-FEB-2009 and still had an allergic reaction (rash). The fever has resolved but the redness, swelling and pain at the injection site was not resolved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL, VARCEL
Symptoms: Ear infection, Erythema, Hypersensitivity, Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 month old male patient with no known drug reactions/allergies and medical history who on 21-JAN-2009 was vaccinated subcutaneously with the first 0.5ml dose of VARIVAX (Oka/Merck) (Lot # 661848/1006X). There was no concomitant medication. On 10-FEB-2009 after receiving the vaccine the patient developed chickenpox lesions. The patient developed 5 lesions on 10-FEB-2009 and 5 more lesions on 11-FEB-2009 for the total of 10 lesions. The lesions are found on his head, neck and chest. The patient sought medical attention by the physician. At the time of reporting the patient was recovering. Follow up information has been received from the licensed practical nurse who reported that there was no new information. Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Abnormal behaviour, Disturbance in attention, Oppositional defiant disorder
Clinical narrative: Information has been received from a mother concerning her 8 year old son with a history of attention deficit disorder and environmental allergy who was vaccinated with his second dose of VARIVAX (lot # 661970/1393X). His "first dose of VARIVAX was given years back." Concomitant therapy included Strattera. On evening on 23-JAN-2009 the patient had "a very distinct change of personality " after receiving the second dose of VARIVAX. The patient had sought medical attention from the physician and was recovering from the adverse event. Follow-up information has been received from physician that the patient with attention deficit disorder, rhinitis allergic, asthma and no known previous events with first dose was vaccinated with his first dose of VARIVAX IM on 14-JAN-2002 and was vaccinated with his second dose of VARIVAX (lot # 661970/1393X) on approximately 4:00 PM 23-JAN-2009. Concomitant therapy included Stratter and Albuterol (manufacturer unspecified). The patient's mother reported that post the second dose of vaccination the patient's behavior changed and became more oppositional and inattentive after receiving vaccine. No relevant diagnostic test or laboratory test was performed. The patient had recovered from the adverse event. No further information is available.
Age: 8.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Attention deficit/hyperactivity disorder, Condition aggravated, Personality change
Clinical narrative: Information has been received from a mother concerning her 8 year old son with a history of attention deficit disorder and environmental allergy who was vaccinated with his second dose of VARIVAX (lot # 661970/1393X). His "first dose of VARIVAX was given years back." Concomitant therapy included Strattera. On evening on 23-JAN-2009 the patient had "a very distinct change of personality " after receiving the second dose of VARIVAX. The patient had sought medical attention from the physician and was recovering from the adverse event. Follow-up information has been received from physician that the patient with attention deficit disorder, rhinitis allergic, asthma and no known previous events with first dose was vaccinated with his first dose of VARIVAX IM on 14-JAN-2002 and was vaccinated with his second dose of VARIVAX (lot # 661970/1393X) on approximately 4:00 PM 23-JAN-2009. Concomitant therapy included Stratter and Albuterol (manufacturer unspecified). The patient's mother reported that post the second dose of vaccination the patient's behavior changed and became more oppositional and inattentive after receiving vaccine. No relevant diagnostic test or laboratory test was performed. The patient had recovered from the adverse event. No further information is available.
Age: 15.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Feeling hot
Clinical narrative: Information has been received from a registered nurse, via health department, concerning a patient who was vaccinated with VARIVAX (Merck). "Within the last 2 weeks" the patient developed erythema at the injection site after receiving VARIVAX (Merck). The patient also experienced swelling at the injection site after receiving VARIVAX (Merck). The patient had sought medical attention. The outcome of the patient's adverse effect was not reported. In follow-up the registered nurse did not provide specific identifying information as she reported that information was already sent. This is one of several reports from the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/15/2009. Follow-up information has been received from the registered nurse that the 15 year old male patient with no illness at the time of vaccination and allergy to AUGMENTIN and CELOR, Objective Sleep Apnea, asthma, constipation and esophageal reflux was vaccinated with his second dose of VARIVAX (Merck) (lot # 661970/1392X) SQ into his left arm on 28-JAN-2009. The patient complained of arm hurting and generally not feeling well "last night". On PM 29-JAN-2009 the patient experienced erythema 50 cent sized and afebrile. The patient was prescribed BENADRYL and ibuprofen. This is one of several reports from the same source. No further information is available.
Age: 15.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Malaise, Pain in extremity
Clinical narrative: Information has been received from a registered nurse, via health department, concerning a patient who was vaccinated with VARIVAX (Merck). "Within the last 2 weeks" the patient developed erythema at the injection site after receiving VARIVAX (Merck). The patient also experienced swelling at the injection site after receiving VARIVAX (Merck). The patient had sought medical attention. The outcome of the patient's adverse effect was not reported. In follow-up the registered nurse did not provide specific identifying information as she reported that information was already sent. This is one of several reports from the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/15/2009. Follow-up information has been received from the registered nurse that the 15 year old male patient with no illness at the time of vaccination and allergy to AUGMENTIN and CELOR, Objective Sleep Apnea, asthma, constipation and esophageal reflux was vaccinated with his second dose of VARIVAX (Merck) (lot # 661970/1392X) SQ into his left arm on 28-JAN-2009. The patient complained of arm hurting and generally not feeling well "last night". On PM 29-JAN-2009 the patient experienced erythema 50 cent sized and afebrile. The patient was prescribed BENADRYL and ibuprofen. This is one of several reports from the same source. No further information is available.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 15 month old male with no pertinent medical history and no allergies who on 05-MAR-2009 was vaccinated with the first dose of VARIVAX (Oka/Merck) (lot # 660668/1380X). Other suspect vaccine received on 05-MAR-2009 included MMR II (lot #661675/1505X). There was no concomitant medication. Within four hours after receiving the vaccinations the patient experienced vomiting and decreased appetite. The patient recovered from vomiting and decreased appetite within 8 hours of vaccination. Lot checks have been requested. This is one of several reports from the same source. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Decreased appetite, Vomiting
Clinical narrative: Information has been received from a physician concerning a 15 month old male with no pertinent medical history and no allergies who on 05-MAR-2009 was vaccinated with the first dose of VARIVAX (Oka/Merck) (lot # 660668/1380X). Other suspect vaccine received on 05-MAR-2009 included MMR II (lot #661675/1505X). There was no concomitant medication. Within four hours after receiving the vaccinations the patient experienced vomiting and decreased appetite. The patient recovered from vomiting and decreased appetite within 8 hours of vaccination. Lot checks have been requested. This is one of several reports from the same source. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Basedow's disease, Blood test, Computerised tomogram, Dizziness, Fibromyalgia
Clinical narrative: Information has been received from a registered pharmacist concerning a 33 year old female with diabetes and no known drug allergies who on 23-JUN-2008 was vaccinated with the first dose of VARIVAX (Oka/Merck) (LOT# 658408/1177U). There was no concomitant medication. On 30-JUN-2008 the patient developed zoster. The patient had also been exposed to zoster. Subsequently the patient recovered from zoster. The patient sought medical attention via occupational health department. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and it is present to identify if it is associated with the wild-type VZV strain or with the Oka/Merck vaccine VZV strain. The sample of the lesion was collected on 09-JUL-2008. The sample was taken from a vesicular lesion in the mid back. The PCR results for the specimen from the vesicular lesion was negative. The VZV DNA was not amplified and B-globin DNA was amplified. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Heart rate increased, Immediate post-injection reaction, Lumbar puncture, Migraine, Multiple sclerosis
Clinical narrative: Information has been received from a registered pharmacist concerning a 33 year old female with diabetes and no known drug allergies who on 23-JUN-2008 was vaccinated with the first dose of VARIVAX (Oka/Merck) (LOT# 658408/1177U). There was no concomitant medication. On 30-JUN-2008 the patient developed zoster. The patient had also been exposed to zoster. Subsequently the patient recovered from zoster. The patient sought medical attention via occupational health department. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and it is present to identify if it is associated with the wild-type VZV strain or with the Oka/Merck vaccine VZV strain. The sample of the lesion was collected on 09-JUL-2008. The sample was taken from a vesicular lesion in the mid back. The PCR results for the specimen from the vesicular lesion was negative. The VZV DNA was not amplified and B-globin DNA was amplified. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Nuclear magnetic resonance imaging, Presyncope, Rash, Rash vesicular, Respiratory disorder
Clinical narrative: Information has been received from a registered pharmacist concerning a 33 year old female with diabetes and no known drug allergies who on 23-JUN-2008 was vaccinated with the first dose of VARIVAX (Oka/Merck) (LOT# 658408/1177U). There was no concomitant medication. On 30-JUN-2008 the patient developed zoster. The patient had also been exposed to zoster. Subsequently the patient recovered from zoster. The patient sought medical attention via occupational health department. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and it is present to identify if it is associated with the wild-type VZV strain or with the Oka/Merck vaccine VZV strain. The sample of the lesion was collected on 09-JUL-2008. The sample was taken from a vesicular lesion in the mid back. The PCR results for the specimen from the vesicular lesion was negative. The VZV DNA was not amplified and B-globin DNA was amplified. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: X-ray
Clinical narrative: Information has been received from a registered pharmacist concerning a 33 year old female with diabetes and no known drug allergies who on 23-JUN-2008 was vaccinated with the first dose of VARIVAX (Oka/Merck) (LOT# 658408/1177U). There was no concomitant medication. On 30-JUN-2008 the patient developed zoster. The patient had also been exposed to zoster. Subsequently the patient recovered from zoster. The patient sought medical attention via occupational health department. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and it is present to identify if it is associated with the wild-type VZV strain or with the Oka/Merck vaccine VZV strain. The sample of the lesion was collected on 09-JUL-2008. The sample was taken from a vesicular lesion in the mid back. The PCR results for the specimen from the vesicular lesion was negative. The VZV DNA was not amplified and B-globin DNA was amplified. Additional information has been requested.