chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 5 year old female with an allergy to Bactrim and no other pertinent medical history who on 01 Aug 2006 was vaccinated SC in the right posterior arm with a dose of Variavax (Lot# 653965/0591F). Concomitant therapy that day included a dose of Hepatitis A vaccine (inactive) (manufacturer unknown). On 02 Aug 2006 the patient developed a 2 and 3/4" x 2" red raised area at the injection site on her right posterior arm. There was local heat. The area was red with a purple center. It was tender to touch. Oral Benadryl and topical hydrocortisone creams were prescribed. There were no lab diagnostic studies performed. The outcome was recovering. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HIBV, PNC, VARCEL
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 12 month old female, with no medical history and no allergies, who on 12 Jul 2006, at 3:30pm, was vaccinated with a first subcutaneous dose in the right thigh of Variavax (Lot # 652803/0262F). Concomitant vaccines administered on the same day included a fourth intramuscular dose in the right thigh of Prevnar (Lot # A25969K) and a fourth intramuscular dose in the left thigh of ActHib (Lot # 6E766AA). Concomitant therapy included Tylenol. There was no illness at the time of vaccination. "A day after receiving Variavax", on 13 Jul 2006, the patient developed redness that had progressively gotten worse. It was noted that it was approximately the size of a half-dollar. The patient had a follow-up appointment on 23 Jul 2006 and was prescribed Keflex for the cellulitis. At the time of the report the patient had not recovered. There were no laboratory or diagnostic tests performed. Follow up information from a health professional indicated that the patient was seen in the office on 24 Jul 2006 with redness and warmth of the right thigh, 5x6 cm, that began on 12 Jul 2006. The patient was diagnosed with cellulitis and was treated with Keflex, 250/5, 1tsp, bid for 10 days. It was reported that the patient recovered. Additional information has been requested. The reporter requested a lot check. A lot check was requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency.
Age: 1.0
Sex: M
Vaccine: HEP, HIBV, PNC, VARCEL
Symptoms: Cellulitis, Erythema
Clinical narrative: Information has been received from a health professional concerning a 12 month old male, with an allergy to amoxicillin, who 07 Jul 2006 was vaccinated with a first subcutaneous dose in the right thigh of Variavax (Lot # 652803/0262F). Concomitant vaccines administered on the same day included a fourth intramusculaur dose in the left thigh of Act Hib (Lot # UE798AA), a third intramuscular dose in the left thigh of Recombvix (Lot # 648410/0499P) and a fourth intramuscular dose in the right thigh of Prevnar (Lot#A25969K). It was noted that the patient was experiencing congestion at the time of vaccination. After vaccination, in July 2006, the patient experienced cellulitis. It was noted that since receiving Variavax the patient's cellulitis has worsened each day. The patient had a follow up appointment on 21 Jul 2006 and was prescribed Keflex. At the time of the report the patient had not recovered. There were no laboratory or diagnostic tests performed. Follow up information indicated that on 21 Jul 2006 the patient was seen in the office with cellulits on the right leg beginning on 07 Jul 2006. It was reported that the patient had redness for two weeks. The patient was treated with Keflex, 250/5-3 cc, PO, BID, for 10 days. It was reported that the patient had recovered. The reported requested a lot check. A lot check was requested. The records of testing prior to release of the 1st in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site anaesthesia, Injection site hypersensitivity
Clinical narrative: Information has been received from a nurse practitioner/registered nurse concerning a 36 year old female with hereditary neuropathy and no drug reactions/allergies who on 11 Aug 2006 was vaccinated SC with a first dose of Variavax (Lot # 650232/0911R). Concomitant therapy included Ortho Tri-Cyclen and Echinacea. On 12 Aug 2006, 24 hours after the vaccination, the patient experienced numbness and increased skin sensitivity at the injection site. She received the injection in her left arm, and the numbness spread to the left neck and left calf. The patient was recovering (also reported as outcome unknown). The patient ha no history of similar reaction to other vaccines and numbness and increased skin sensitivity at the injection site. She received the injection in her left arm, and the numbness spread to the left neck and left calf. The patient was recovering ( also reported as outcome unknown). The patient had no history of similar reaction to other vaccines and no other notable symptoms. No additional information was available. There were no lab diagnostic studies performed. Unspecified medical attention was sought. There was no product quality complaint. No further information is expected.
Age: 5.0
Sex: F
Vaccine: DTP, IPV, MMR
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: This case was reported by a nurse to a sales representative and described the occurrence of an arm swollen in a 5-year-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. Medical history included anemia and obesity. On 06 September 2006 the subject received 5th dose of Infanrix in left arm. On 06 September 200 the subject also received inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and measles, mumps and rubella  strain not specified (MMR II vaccine Merck). The injection sites for IPOL and MMRI vaccine were not provided. On 08 September 2006, 2 days after vaccination with Infanrix, the subject experienced elbow to shoulder swelling , elbow to shoulder redness and elbow to shoulder warmth. At the  time of initial reporting, 04 October 2006, the events were improved. The nurse considered the events were probably related to vaccination with Infanrix.
Age: 14.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Blister, Erythema, Pruritus, Rash, Rash pruritic
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 14-year-old male with a penicillin allergy and no other pertinent medical history, who on 13-JUL-2006 was vaccinated subcutaneous in the upper right arm with a single 0.5 ml dose of Varivax (lot# 646670/0627R). Concomitant therapy included clindamycin (CLEOCIN), minocycline HCl (MINOCIN) and a dose of ADACEL. On 17-JUL-2006 a rash was noticed on the patient's ankles and legs. It was described as red with some blisters and itchy. There was no fever. The physician recommended diphenhydramine hydrochloride (BENADRYL). The following day, on 18-JUL-2006, the patient was seen in the physician's office and the physician described the rash as pruritic vesicular eruptions to the legs and arms that were getting new lesions as the older ones crusted over. The skin had dew drop-like blisters. The physician's assessment was "varicella secondary to the vaccine". The patient was treated symptomatically and he recovered. The reporter considered the patient's adverse experience to be an other important medical event. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 14-year-old male with a penicillin allergy and no other pertinent medical history, who on 13-JUL-2006 was vaccinated subcutaneous in the upper right arm with a single 0.5 ml dose of Varivax (lot# 646670/0627R). Concomitant therapy included clindamycin (CLEOCIN), minocycline HCl (MINOCIN) and a dose of ADACEL. On 17-JUL-2006 a rash was noticed on the patient's ankles and legs. It was described as red with some blisters and itchy. There was no fever. The physician recommended diphenhydramine hydrochloride (BENADRYL). The following day, on 18-JUL-2006, the patient was seen in the physician's office and the physician described the rash as pruritic vesicular eruptions to the legs and arms that were getting new lesions as the older ones crusted over. The skin had dew drop-like blisters. The physician's assessment was "varicella secondary to the vaccine". The patient was treated symptomatically and he recovered. The reporter considered the patient's adverse experience to be an other important medical event. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse to a sales representative and described the occurrence of swelling injection site in a 40year-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline), live attenuated measles, mumps, (strain not specified), rubella vaccine (MMRII vaccine) and inactivated poliomyelitis vaccine (IPOL) for prophylaxis. The subject's medical history included possible anorexia. The subject was described as "really tiny physically." On 02 October 2006 the subject received 5th dose of Infanrix in the left arm and unspecified doses of MMRI II vaccine and IPOL. The injections sites for the MMR II vaccine and IPOL were not provided. On 04 October 2006, 2 days after vaccination with  IPOL, Infanrix and MMRI vaccine, the subject experienced swelling injection site, injection site redness and injection site warmth. At the time of initial reporting, 04 October 2006, the events were ongoing. The nurse considered the events were probably related to vaccination with Infanrix, IPOL and MMR II vaccine.
Age: 2.0
Sex: M
Vaccine: HEPA, VARCEL, HEPA, VARCEL
Symptoms: Alopecia, Alopecia effluvium
Clinical narrative: Information has been received from a nurse and also from a consumer concerning her approximately 25 month old native American son with eczema who on 31-AUG-2006 was vaccinated SC in the left arm with a first dose of Varivax (lot # 650235/1110R). Concomitant vaccination included a dose of HAVRIX (lot # AHAVB113AA). There was no other concomitant medication. Subsequently "about a month later", in approximately September 2006, the patient started losing his hair. The hair loss occurred mostly on the top of the patient's head. It was also reported that the hair on the back of her son's head looked almost "fried", kind of like when you get a "bad perm". Medical attention was sought, "a liver test, CBC, urine test, blood tests, and a thyroid test" were performed, results were not reported. The patient was diagnosed with telogen effluvium. The patient's mother was told that the patient's hair should start growing back within 3-4 months. At the time of the report the patient had not recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HEPA, VARCEL, HEPA, VARCEL
Symptoms: Alopecia, Blood test, Full blood count, Liver function test, Thyroid function test
Clinical narrative: Information has been received from a nurse and also from a consumer concerning her approximately 25 month old native American son with eczema who on 31-AUG-2006 was vaccinated SC in the left arm with a first dose of Varivax (lot # 650235/1110R). Concomitant vaccination included a dose of HAVRIX (lot # AHAVB113AA). There was no other concomitant medication. Subsequently "about a month later", in approximately September 2006, the patient started losing his hair. The hair loss occurred mostly on the top of the patient's head. It was also reported that the hair on the back of her son's head looked almost "fried", kind of like when you get a "bad perm". Medical attention was sought, "a liver test, CBC, urine test, blood tests, and a thyroid test" were performed, results were not reported. The patient was diagnosed with telogen effluvium. The patient's mother was told that the patient's hair should start growing back within 3-4 months. At the time of the report the patient had not recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HEPA, VARCEL, HEPA, VARCEL
Symptoms: Urine analysis
Clinical narrative: Information has been received from a nurse and also from a consumer concerning her approximately 25 month old native American son with eczema who on 31-AUG-2006 was vaccinated SC in the left arm with a first dose of Varivax (lot # 650235/1110R). Concomitant vaccination included a dose of HAVRIX (lot # AHAVB113AA). There was no other concomitant medication. Subsequently "about a month later", in approximately September 2006, the patient started losing his hair. The hair loss occurred mostly on the top of the patient's head. It was also reported that the hair on the back of her son's head looked almost "fried", kind of like when you get a "bad perm". Medical attention was sought, "a liver test, CBC, urine test, blood tests, and a thyroid test" were performed, results were not reported. The patient was diagnosed with telogen effluvium. The patient's mother was told that the patient's hair should start growing back within 3-4 months. At the time of the report the patient had not recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Rash papular, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 15 month old Hispanic female with a history of eczema on 03-Oct-2006 was vaccinated with a SC first dose in the left thigh of varicella virus vaccine live (Oka-Merck) (lot# B08642H). Concomitant vaccination administered that day included an IM first dose in the left thigh of hepatitis A vaccine (inactive ) (MSD) (lot #654337/0510of). Concomitant therapy included cyproheptadine hydrochloride (MSD) and isopropyl myristate (+) mineral oil (Eucerin Lotion). On 10-Oct-2006 the patient developed papular, papulo-vesicular lesions over her face, arms, trunk and legs. The patient's lesions increase in number from the time the mother noticed them to the time the patient was seen at the office. No laboratory tests were performed. There was no product quality complaint involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Pain in extremity
Clinical narrative: Information has been received from a medical assistant concerning a 5 year old white male with no known allergies or pertinent medical history who on 11-Oct-2006 was vaccinated SC in the right arm with a first 0.5ml dose of varicella virus live (Oka/Merck) (lot#646814/0629R). Concomitant vaccination included a second dose of hepatitis A virus vaccine inactivated (MSD) (lot#655090/0651F) given in the left arm. After vaccination, the patient developed immediate erythema and edema at the varicella virus vaccine live Oka/Merck) (lot#646814/0629R) injection site. The patient also had increased and persistent pain in the right arm, reported to be more than what the medical assistant was accustomed to seeing. Medical attention was sought, ice was applied to the site and patient received ibuprofen (MOTRIN) and chlorpheniramine maleate (+) phenylpropanolamine hydrochloride (TRIAMINIC COLD AND ALLERGY). There were no lab studies performed. It was reported that the patient improved on therapy. On 11-Oct-2006 the patient recovered. No further information was available. There was not product quality complaint involved. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning an 11-year-old female who on 20-OCT-2006 was vaccinated subcutaneously with a 0.5ml dose of varicella virus vaccine live (Oka/Merck) (lot #654609/1048F). Several days post vaccination, on approximately 23-OCT-2006, the patient developed redness, swelling, induration and pain at the injection site. Unspecified medical attention was sought and she was treated with antibiotics. At the time of this report the patient was recovering. No product quality complain was involved. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 10-year-old male who on 23-OCT-2006 was vaccinated subcutaneously with a 0.5ml dose of varicella virus vaccine live (Oka/Merck) (lot #65428/1055F. Several days post vaccination, on approximately 26-OCT-2006, the patient developed redness, swelling, induration and pain at the injection site. Unspecified medical attention was sought and he was treated with antibiotics. At the time of this report the patient was recovering. No product quality complaint was involved. Additional informed has been requested.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 28-year-old female with no medical history, who on 06-NOV-2006 was vaccinated subcutaneously with a 0.5ml dose of varicella virus vaccine live (Oka/Merck) (lot #653360/0361F). Concomitant therapy included motelukast sodium (MSD) and sertraline HCL (ZOLOFT). The next day on 07-NOV02996, the injection site was red and warm to touch. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 46.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Malaise, Pain, Rash maculo-papular, Rash pruritic, Skin ulcer
Clinical narrative: Information was received from a 46 year old female consumer, with no drug reactions or allergies, and no pertinent medical history reported, who was vaccinated with her first dose of Varivax in "November." In approximately November 2006 the patient developed an outbreak of chickenpox 13 days subsequent to being vaccinated with Varivax. The consumer reported she had the "infection in her eye and broke out into little bumps without the blister." There was no concomitant therapy. Unspecified medical attention was sought. The patient was recovering from the reported event at the time of this report. The consumer is uncertain if she should receive the booster dose of Varivax. There was no product quality complaint. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Eye infection, Varicella
Clinical narrative: Information was received from a 46 year old female consumer, with no drug reactions or allergies, and no pertinent medical history reported, who was vaccinated with her first dose of Varivax in "November." In approximately November 2006 the patient developed an outbreak of chickenpox 13 days subsequent to being vaccinated with Varivax. The consumer reported she had the "infection in her eye and broke out into little bumps without the blister." There was no concomitant therapy. Unspecified medical attention was sought. The patient was recovering from the reported event at the time of this report. The consumer is uncertain if she should receive the booster dose of Varivax. There was no product quality complaint. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 6 year old male with no medical history or allergies who  on 18-MAY-2001 was vaccinated "on the left" with a dose of varicella virus vaccine live (Oka/Merck) (lot #638568/1888K). There was no concomitant medication. On 06-JAN-2007 the patient developed a rash and fever and was sent to the emergency room. The emergency room physician diagnosed the rash as zoster and treated him with aycyclovir. The physician examined the patient on 08-JAN-2007 and described the rash as covering the left lower back, left buttock, and down the left leg to the knee. The patient was referred to a dermatologist who reaffirmed the diagnosis of zoster. Testing was done on locally on the rash, the results were not reported. On 11-JAN-2007 the patient recovered. It was reported that the patient's brother (WAES# 0701USA044261) experienced varicella after exposure to this patient. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Herpes zoster, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 6 year old male with no medical history or allergies who  on 18-MAY-2001 was vaccinated "on the left" with a dose of varicella virus vaccine live (Oka/Merck) (lot #638568/1888K). There was no concomitant medication. On 06-JAN-2007 the patient developed a rash and fever and was sent to the emergency room. The emergency room physician diagnosed the rash as zoster and treated him with aycyclovir. The physician examined the patient on 08-JAN-2007 and described the rash as covering the left lower back, left buttock, and down the left leg to the knee. The patient was referred to a dermatologist who reaffirmed the diagnosis of zoster. Testing was done on locally on the rash, the results were not reported. On 11-JAN-2007 the patient recovered. It was reported that the patient's brother (WAES# 0701USA044261) experienced varicella after exposure to this patient. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: TDAP, DTAP, HEP
Symptoms: Autism, Autism spectrum disorder
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of developmental delay in an 4 year old male subject who was vaccinated with Infanrix for prophylaxis and Engerix-B. Concurrent vaccinations given at the same time included inactivated IPV; pneumococcal vaccine (manufacturer unspecified); varicella virus vaccine (manufacturer unspecified); and combination haemophilus influenzae type b conjugate/hepatitis B vaccine (manufacturer unspecified). On 08 March 2002 the subject received the first dose of Infanrix (lot number DTaP538A2). The nurse reported that the subject received 2 other additional doses of Infanrix on 06 May 2002 and 25 July 2002. He received the first vaccination of Engerix-B on 20 July 2003 and the third dose on 07 May 2004. The second dose (unspecified manufacturer) was given on an unspecified date. Approximately three years later (after the first dose of Infanrix) on an unspecified date in June 2005, the subject experienced developmental disorders and autism was being ruled out. According to the mother of the subject, he experienced "autism and PDD (pervasive developmental disorder). "At the time of reporting, on 21 July 2006, the events were unresolved.
Age: 8.0
Sex: U
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a licensed practical nurse concerning an 8 year old patient with no pre existing allergies, birth defects, or medical conditions who on 24 Sep 1999 was vaccinated SC in the left arm with a first dose of Variavax (Lot# 630678/0426J). There was no illness at the time of vaccination. Concomitant therapy that day included a first dose of MMR (Lot # 05475) administered SC in the right arm. On 21 Feb 2007 at bedtime, the patient experienced chicken pox, noted to be clinical varicella. There were no relevant diagnostic tests or laboratory data. Unspecified medical attention was sought. The status of the patient was unknown at the time of this report. There was no product quality complaint. No additional information is expected.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 4-year-old male with no pre-existing allergies, birth defects, or medical conditions who on 01-MAR-2007 at 9:00 AM was vaccinated SC in the right arm with a second dose of Varivax (Lot # 656079/1306F). Suspect therapy that day at 9:00AM included a second dose of MMR II (Lot # "D697F"). There was no illness at the time of vaccination. Concomitant therapy that day at 9:00AM included a fifth dose of Infanrix (Lot # AC14B042BA) administered in the left deltoid and a forth dose of IPOL (Lot # 20306) administered SC in the left arm. On 01-MAR-2007 at 9:00AM the patient experienced urticaria. It was noted that the urticaria was first at the right arm, at the site of both the Varivax and MMR II. However, the event occurred immediately after the Varivax administration. Within a 1/2 hour, urticaria expanded to the anterior and posterior trunk. Diphenhydramine hydrochloride (BENADRYL) 19mg was administered, and the patient was observed in the office for 1 hour. He was discharged from the office to continue diphenhydramine hydrochloride (BENADRYL) 1 and 1/2 tsp q6hours for hives and itching. Subsequently, on 07-MAR-2007, the patient recovered. There were no adverse events following prior vaccinations. The event was considered an other important medical event by the reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Injection site urticaria, Pruritus, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 4-year-old male with no pre-existing allergies, birth defects, or medical conditions who on 01-MAR-2007 at 9:00 AM was vaccinated SC in the right arm with a second dose of Varivax (Lot # 656079/1306F). Suspect therapy that day at 9:00AM included a second dose of MMR II (Lot # "D697F"). There was no illness at the time of vaccination. Concomitant therapy that day at 9:00AM included a fifth dose of Infanrix (Lot # AC14B042BA) administered in the left deltoid and a forth dose of IPOL (Lot # 20306) administered SC in the left arm. On 01-MAR-2007 at 9:00AM the patient experienced urticaria. It was noted that the urticaria was first at the right arm, at the site of both the Varivax and MMR II. However, the event occurred immediately after the Varivax administration. Within a 1/2 hour, urticaria expanded to the anterior and posterior trunk. Diphenhydramine hydrochloride (BENADRYL) 19mg was administered, and the patient was observed in the office for 1 hour. He was discharged from the office to continue diphenhydramine hydrochloride (BENADRYL) 1 and 1/2 tsp q6hours for hives and itching. Subsequently, on 07-MAR-2007, the patient recovered. There were no adverse events following prior vaccinations. The event was considered an other important medical event by the reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 4-year-old male with no pre-existing allergies, birth defects, or medical conditions who on 01-MAR-2007 at 9:00 AM was vaccinated SC in the right arm with a second dose of Varivax (Lot # 656079/1306F). Suspect therapy that day at 9:00AM included a second dose of MMR II (Lot # "D697F"). There was no illness at the time of vaccination. Concomitant therapy that day at 9:00AM included a fifth dose of Infanrix (Lot # AC14B042BA) administered in the left deltoid and a forth dose of IPOL (Lot # 20306) administered SC in the left arm. On 01-MAR-2007 at 9:00AM the patient experienced urticaria. It was noted that the urticaria was first at the right arm, at the site of both the Varivax and MMR II. However, the event occurred immediately after the Varivax administration. Within a 1/2 hour, urticaria expanded to the anterior and posterior trunk. Diphenhydramine hydrochloride (BENADRYL) 19mg was administered, and the patient was observed in the office for 1 hour. He was discharged from the office to continue diphenhydramine hydrochloride (BENADRYL) 1 and 1/2 tsp q6hours for hives and itching. Subsequently, on 07-MAR-2007, the patient recovered. There were no adverse events following prior vaccinations. The event was considered an other important medical event by the reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, HPV4, FLU3, HPV4
Symptoms: Electroencephalogram, Nuclear magnetic resonance imaging
Clinical narrative: Initial report received on 14 May 2007 from another manufacturer, report# WAES0703USA01477. The initial reporter to this manufacturer had been a health care professional . Verbatim from the report:"Initial and follow up information has been received from a physician concerning a 12 year old adolescent female with a history of a developmental delay (NOS) who on 11-DEC-2006 was vaccinated intramuscularly in the right deltoid with the first dose of Gardasil (Lot# 654540/1163F). Concomitant therapy included mefloquine and Fluzone. Subsequently, on 21-DEC-2006 the patient had a seizure while at school. The seizure was described to include both eye rolling and loss of consciousness lasting than one minute. The patient went to the emergency room where a electroencephalography, magnetic resonance imaging and unspecified labs were completed. Results of all testing were normal/negative. On 21-DEC-2006 therapy with mefloquine was discontinued. On 19-FEB-2007 the patient received the second intramuscular vaccination of Gardasil (Lot# 655503/0012U) in the left deltoid. It was also reported that on 07-MAR-2007 while at home at the breakfast table the patient had a second seizure which lasted less than one or two minutes. It was reported by a physician that the patient did not have any illness at the time of vaccination and had no prior history of seizures. The physician reported that the patient had recovered from both seizures. Upon internal medical review, the seizures were felt to be other medical events. Additional information has been requested."
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, HPV4, FLU3, HPV4
Symptoms: Convulsion, Vaccine positive rechallenge
Clinical narrative: Initial report received on 14 May 2007 from another manufacturer, report# WAES0703USA01477. The initial reporter to this manufacturer had been a health care professional . Verbatim from the report:"Initial and follow up information has been received from a physician concerning a 12 year old adolescent female with a history of a developmental delay (NOS) who on 11-DEC-2006 was vaccinated intramuscularly in the right deltoid with the first dose of Gardasil (Lot# 654540/1163F). Concomitant therapy included mefloquine and Fluzone. Subsequently, on 21-DEC-2006 the patient had a seizure while at school. The seizure was described to include both eye rolling and loss of consciousness lasting than one minute. The patient went to the emergency room where a electroencephalography, magnetic resonance imaging and unspecified labs were completed. Results of all testing were normal/negative. On 21-DEC-2006 therapy with mefloquine was discontinued. On 19-FEB-2007 the patient received the second intramuscular vaccination of Gardasil (Lot# 655503/0012U) in the left deltoid. It was also reported that on 07-MAR-2007 while at home at the breakfast table the patient had a second seizure which lasted less than one or two minutes. It was reported by a physician that the patient did not have any illness at the time of vaccination and had no prior history of seizures. The physician reported that the patient had recovered from both seizures. Upon internal medical review, the seizures were felt to be other medical events. Additional information has been requested."
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, HPV4, FLU3, HPV4
Symptoms: Convulsion, Electroencephalogram normal, Gaze palsy, Laboratory test, Loss of consciousness
Clinical narrative: Initial report received on 14 May 2007 from another manufacturer, report# WAES0703USA01477. The initial reporter to this manufacturer had been a health care professional . Verbatim from the report:"Initial and follow up information has been received from a physician concerning a 12 year old adolescent female with a history of a developmental delay (NOS) who on 11-DEC-2006 was vaccinated intramuscularly in the right deltoid with the first dose of Gardasil (Lot# 654540/1163F). Concomitant therapy included mefloquine and Fluzone. Subsequently, on 21-DEC-2006 the patient had a seizure while at school. The seizure was described to include both eye rolling and loss of consciousness lasting than one minute. The patient went to the emergency room where a electroencephalography, magnetic resonance imaging and unspecified labs were completed. Results of all testing were normal/negative. On 21-DEC-2006 therapy with mefloquine was discontinued. On 19-FEB-2007 the patient received the second intramuscular vaccination of Gardasil (Lot# 655503/0012U) in the left deltoid. It was also reported that on 07-MAR-2007 while at home at the breakfast table the patient had a second seizure which lasted less than one or two minutes. It was reported by a physician that the patient did not have any illness at the time of vaccination and had no prior history of seizures. The physician reported that the patient had recovered from both seizures. Upon internal medical review, the seizures were felt to be other medical events. Additional information has been requested."
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, HPV4, FLU3, HPV4
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: Initial report received on 14 May 2007 from another manufacturer, report# WAES0703USA01477. The initial reporter to this manufacturer had been a health care professional . Verbatim from the report:"Initial and follow up information has been received from a physician concerning a 12 year old adolescent female with a history of a developmental delay (NOS) who on 11-DEC-2006 was vaccinated intramuscularly in the right deltoid with the first dose of Gardasil (Lot# 654540/1163F). Concomitant therapy included mefloquine and Fluzone. Subsequently, on 21-DEC-2006 the patient had a seizure while at school. The seizure was described to include both eye rolling and loss of consciousness lasting than one minute. The patient went to the emergency room where a electroencephalography, magnetic resonance imaging and unspecified labs were completed. Results of all testing were normal/negative. On 21-DEC-2006 therapy with mefloquine was discontinued. On 19-FEB-2007 the patient received the second intramuscular vaccination of Gardasil (Lot# 655503/0012U) in the left deltoid. It was also reported that on 07-MAR-2007 while at home at the breakfast table the patient had a second seizure which lasted less than one or two minutes. It was reported by a physician that the patient did not have any illness at the time of vaccination and had no prior history of seizures. The physician reported that the patient had recovered from both seizures. Upon internal medical review, the seizures were felt to be other medical events. Additional information has been requested."
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Barium enema, Haematochezia, Intussusception, Vomiting
Clinical narrative: Information received on 14 May 2007 from another manufacturer, report# WAES0704USA04525. Verbatim from the report: "Information has been received concerning a 6 month old patient who on 15-Jan-2007 was vaccinated with the third dose of Rotateq. On 25-JAN-2007 the patient developed intussusception which required a barium enema. Upon internal review, intussusception which required an enema was considered an other important medical event. Further information has been received concerning this 6 month old patient with no medical history and no known allergies who was vaccinated with the third dose of Rotateq (Lot# 655866/1110F). Other vaccines administered on the same date included Pediarix AC 21B084CA third dose, ActHib UF0588AA third dose and Prevnar 2B08670B third dose. There were no other concomitant medications. The patient was hospitalized for a two night stay due to a history of vomiting for several days followed by bloody stools, Over the course of the admission the infant developed bloody stools x 2 as well as billous vomiting. Review of systems on admission were positive for vomiting and lethargy. Physical examination was within normal limits except it was noted the patient was mildly difficult to arrouse. Laboratory data reported included abdominal xrays and barium enema. Labs and diagnostic: KUB reveals an abnormal gas pattern which may have reflected a mild paralytic ileus or small bowel obstruction. Contrast barium enema revealed an intussusception distal to the hepatic field. The intussusception was reduced with air enema. It was revealed that the onset of the patient's experience was 25-JAN-2007 and that the patient recovered on 09-MAR-2007." "The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and released." The lot number for ActHib that was reported in the structured field of the report was UF058AA which corresponds to, lot number Z1077-2.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Barium double contrast, Barium enema, Depressed level of consciousness, Haematochezia
Clinical narrative: Information received on 14 May 2007 from another manufacturer, report# WAES0704USA04525. Verbatim from the report: "Information has been received concerning a 6 month old patient who on 15-Jan-2007 was vaccinated with the third dose of Rotateq. On 25-JAN-2007 the patient developed intussusception which required a barium enema. Upon internal review, intussusception which required an enema was considered an other important medical event. Further information has been received concerning this 6 month old patient with no medical history and no known allergies who was vaccinated with the third dose of Rotateq (Lot# 655866/1110F). Other vaccines administered on the same date included Pediarix AC 21B084CA third dose, ActHib UF0588AA third dose and Prevnar 2B08670B third dose. There were no other concomitant medications. The patient was hospitalized for a two night stay due to a history of vomiting for several days followed by bloody stools, Over the course of the admission the infant developed bloody stools x 2 as well as billous vomiting. Review of systems on admission were positive for vomiting and lethargy. Physical examination was within normal limits except it was noted the patient was mildly difficult to arrouse. Laboratory data reported included abdominal xrays and barium enema. Labs and diagnostic: KUB reveals an abnormal gas pattern which may have reflected a mild paralytic ileus or small bowel obstruction. Contrast barium enema revealed an intussusception distal to the hepatic field. The intussusception was reduced with air enema. It was revealed that the onset of the patient's experience was 25-JAN-2007 and that the patient recovered on 09-MAR-2007." "The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and released." The lot number for ActHib that was reported in the structured field of the report was UF058AA which corresponds to, lot number Z1077-2.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Ileus paralytic, Intussusception, Lethargy, Small intestinal obstruction, Urinary system X-ray
Clinical narrative: Information received on 14 May 2007 from another manufacturer, report# WAES0704USA04525. Verbatim from the report: "Information has been received concerning a 6 month old patient who on 15-Jan-2007 was vaccinated with the third dose of Rotateq. On 25-JAN-2007 the patient developed intussusception which required a barium enema. Upon internal review, intussusception which required an enema was considered an other important medical event. Further information has been received concerning this 6 month old patient with no medical history and no known allergies who was vaccinated with the third dose of Rotateq (Lot# 655866/1110F). Other vaccines administered on the same date included Pediarix AC 21B084CA third dose, ActHib UF0588AA third dose and Prevnar 2B08670B third dose. There were no other concomitant medications. The patient was hospitalized for a two night stay due to a history of vomiting for several days followed by bloody stools, Over the course of the admission the infant developed bloody stools x 2 as well as billous vomiting. Review of systems on admission were positive for vomiting and lethargy. Physical examination was within normal limits except it was noted the patient was mildly difficult to arrouse. Laboratory data reported included abdominal xrays and barium enema. Labs and diagnostic: KUB reveals an abnormal gas pattern which may have reflected a mild paralytic ileus or small bowel obstruction. Contrast barium enema revealed an intussusception distal to the hepatic field. The intussusception was reduced with air enema. It was revealed that the onset of the patient's experience was 25-JAN-2007 and that the patient recovered on 09-MAR-2007." "The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and released." The lot number for ActHib that was reported in the structured field of the report was UF058AA which corresponds to, lot number Z1077-2.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information received on 14 May 2007 from another manufacturer, report# WAES0704USA04525. Verbatim from the report: "Information has been received concerning a 6 month old patient who on 15-Jan-2007 was vaccinated with the third dose of Rotateq. On 25-JAN-2007 the patient developed intussusception which required a barium enema. Upon internal review, intussusception which required an enema was considered an other important medical event. Further information has been received concerning this 6 month old patient with no medical history and no known allergies who was vaccinated with the third dose of Rotateq (Lot# 655866/1110F). Other vaccines administered on the same date included Pediarix AC 21B084CA third dose, ActHib UF0588AA third dose and Prevnar 2B08670B third dose. There were no other concomitant medications. The patient was hospitalized for a two night stay due to a history of vomiting for several days followed by bloody stools, Over the course of the admission the infant developed bloody stools x 2 as well as billous vomiting. Review of systems on admission were positive for vomiting and lethargy. Physical examination was within normal limits except it was noted the patient was mildly difficult to arrouse. Laboratory data reported included abdominal xrays and barium enema. Labs and diagnostic: KUB reveals an abnormal gas pattern which may have reflected a mild paralytic ileus or small bowel obstruction. Contrast barium enema revealed an intussusception distal to the hepatic field. The intussusception was reduced with air enema. It was revealed that the onset of the patient's experience was 25-JAN-2007 and that the patient recovered on 09-MAR-2007." "The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and released." The lot number for ActHib that was reported in the structured field of the report was UF058AA which corresponds to, lot number Z1077-2.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Barium double contrast, Depressed level of consciousness, Haematochezia, Ileus paralytic
Clinical narrative: Information received on 14 May 2007 from another manufacturer, report# WAES0704USA04525. Verbatim from the report: "Information has been received concerning a 6 month old patient who on 15-Jan-2007 was vaccinated with the third dose of Rotateq. On 25-JAN-2007 the patient developed intussusception which required a barium enema. Upon internal review, intussusception which required an enema was considered an other important medical event. Further information has been received concerning this 6 month old patient with no medical history and no known allergies who was vaccinated with the third dose of Rotateq (Lot# 655866/1110F). Other vaccines administered on the same date included Pediarix AC 21B084CA third dose, ActHib UF0588AA third dose and Prevnar 2B08670B third dose. There were no other concomitant medications. The patient was hospitalized for a two night stay due to a history of vomiting for several days followed by bloody stools, Over the course of the admission the infant developed bloody stools x 2 as well as billous vomiting. Review of systems on admission were positive for vomiting and lethargy. Physical examination was within normal limits except it was noted the patient was mildly difficult to arrouse. Laboratory data reported included abdominal xrays and barium enema. Labs and diagnostic: KUB reveals an abnormal gas pattern which may have reflected a mild paralytic ileus or small bowel obstruction. Contrast barium enema revealed an intussusception distal to the hepatic field. The intussusception was reduced with air enema. It was revealed that the onset of the patient's experience was 25-JAN-2007 and that the patient recovered on 09-MAR-2007." "The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and released." The lot number for ActHib that was reported in the structured field of the report was UF058AA which corresponds to, lot number Z1077-2.