chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MMRV, PNC
Symptoms: Body temperature increased, Coxsackie viral infection, Ear infection, Ear pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a male who on 29-JUN-2007 was vaccinated with a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # 656309/1393F).  Secondary suspect therapy on the same day included a dose of PREVNAR.  On 26-JUL-2007 the patient experienced fever and ear ache.  On 27-JUL-2007 the patient experienced another ear ache and had a fever of 101.8.  On 30-JUL-2007 the patient was diagnosed with coxsackie virus infection.  On 06-AUG-2007 the patient developed hives and was diagnosed with post-vaccination varicella.  On 24-AUG-2007 the patient experienced another ear infection and a fever of 101.  It was reported that no antibiotics were given.  Unspecified medical attention was sought.  At the time of report the patient had recovered.  A product quality complaint was not involved.  No further information is expected.
Sex: M
Vaccine: MMRV, PNC
Symptoms: Urticaria, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a male who on 29-JUN-2007 was vaccinated with a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # 656309/1393F).  Secondary suspect therapy on the same day included a dose of PREVNAR.  On 26-JUL-2007 the patient experienced fever and ear ache.  On 27-JUL-2007 the patient experienced another ear ache and had a fever of 101.8.  On 30-JUL-2007 the patient was diagnosed with coxsackie virus infection.  On 06-AUG-2007 the patient developed hives and was diagnosed with post-vaccination varicella.  On 24-AUG-2007 the patient experienced another ear infection and a fever of 101.  It was reported that no antibiotics were given.  Unspecified medical attention was sought.  At the time of report the patient had recovered.  A product quality complaint was not involved.  No further information is expected.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a "healthy" 4-year-old female who on 08-Aug-2007 was vaccinated with PROQUAD.  It was noted that the patient received a dose of varicella virus vaccine live (MSD) at the age of 1.  On 07-Sep-2007 the patient developed chicken pox.  Unspecified medical attention was sought.  No further information was provided.  There was no product quality complaint involved.  Additional information has been received from a physician stating that they did not know who the patient in question was and therefore had no further information.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 17 month old male with asthma and no known allergies who on 30-MAR-2007 was vaccinated SC in the right leg with a one time 0.5 ml dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot#656651/0143U).  Concomitant therapy included hepatitis A virus vaccine (manufacturer unknown) and PREVNAR.  On 02-SEP-2007 the patient developed shingles on the right leg where he received the vaccination.  The patient was seen by the physician on 05-SEP-2007.  No lab studies were performed.  Subsequently, on 09-SEP-2007, the patient recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 5 year old male who on 30-Aug-2007 was vaccinated with a dose of PROQUAD (Lot #658033/0986U).  On 08-Sep-2007, 9 days after vaccination, the patient developed a vaccine rash.  Unspecified medical attention was sought.  At the time of this 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: MMRV
Symptoms: Pyrexia, Varicella
Clinical narrative: Information has been received from a consumer concerning her 16 month old daughter who on 22-AUG-2007 was vaccinated with a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot#657780/0617U).  There was no concomitant medication.  On 29-AUG-2007, 7 days after vaccination, the patient developed a fever.  On 01-SEP-2007, 10 days after vaccination, the patient developed chicken pox.  Unspecified medical attention was sought.  No further information was provided.  There was no product quality complaint involved.  No further information is available.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Incorrect dose administered, Irritability, Teething
Clinical narrative: Information has been received from a physician concerning a 12 month old white female with no known allergies or pertinent medical history who on 10-SEP-2007 was vaccinated IM (previously reported as SC) with a 0.5 ml dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) and a dose of Varivax (Oka/Merck) (MSD).  The vaccines were given in separate syringes.  No adverse event was reported.  No further information was provided.  There was no product quality complaint involved.  Follow up information received from the medical assistant indicated that on 12-SEP-2007 the patient developed fussiness (it was noted the patient was also teething).  On 10-SEP-2007 the patient recovered.  Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Irritability, Teething
Clinical narrative: Information has been received from a physician concerning a 12 month old white female with no known allergies or pertinent medical history who on 10-SEP-2007 was vaccinated IM (previously reported as SC) with a 0.5 ml dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) and a dose of Varivax (Oka/Merck) (MSD).  The vaccines were given in separate syringes.  No adverse event was reported.  No further information was provided.  There was no product quality complaint involved.  Follow up information received from the medical assistant indicated that on 12-SEP-2007 the patient developed fussiness (it was noted the patient was also teething).  On 10-SEP-2007 the patient recovered.  Additional information is not expected.
Age: 1.1
Sex: M
Vaccine: MMRV
Symptoms: Skin lesion, Varicella
Clinical narrative: Information has been received from a physician concerning a 14-month-old male who on 24-July-2007 was vaccinated with a dose of PROQUAD (lot #657749/0616U).  On 11-Sep-2007 "the patient experienced a breakthrough case of chicken pox that was less than 50 lesions".  Unspecified medical attention was sought.  The outcome was reported as not recovered.  No product quality complaint was involved.  No further information is available.
Age: 1.1
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Urticaria
Clinical narrative: Information has been received from a physician and a registered nurse (R.N.) concerning a 13-month-old Caucasian male who on 06-APR-2007 was vaccinated subcutaneously in the left thigh with a first dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot # 657031/0231U).  Subsequently, it was reported that on "23-APR-2007" the patient developed an injection site reaction first reported as injection site induration which the physician was able to notice when the baby patient was brought to the clinic for follow up "3 weeks after administration" of the vaccine.  In follow-up, it was reported that the injection site reaction occurred 14 days after vaccination and was a red welt with dimensions of 20 x 25 mm on the left thigh.  It was reported that the patient was seen by a physician and that he recovered "within 2 weeks".  There was no product quality complaint involved.  Additional information is not expected.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Information has been received from a health professional concerning a 12 month old patient who was vaccinated with ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process).  Subsequently the patient experienced rash.  He sought unspecified medical attention.  Reportedly the patient recovered from the rash.  No product quality complaint was reported.  Additional information was not available.  This is one of two reports from the same source.  Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Exposure to communicable disease, Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old white male who on 29-Aug-2002 and 30-Oct-2006 was vaccinated with his first and second doses of PROQUAD (lot #653355/0301F) in the left deltoid.  On 23-Jul-2007 the patient developed varicella via exposure from his brother characterized by 2 lesions on the abdomen and 1 lesion on the upper leg.  Medical attention was sought and the patient was treated with ZOVIRAX 400mg TID for 5 days.  On 30-Aug-2007 the patient recovered.  The reporter considered the patient's experience to be an other important medical event since medication was prescribed.  This is one of several reports from the same source.  Additional information is not expected. Follow-up information from the reporting registered nurse indicated that the patient received the first dose of varicella virus vaccine live (oka/Merck) not measeles virus vaccine live (enders-Edmonston) (+) mumps virus live (Jeryl Lynn) (+) rubella virus live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) on 29-Aug-2002.  The patient developed 7 lesions on his abdomen and 1 lesion on his upper leg and the patient's brother (WAES#0789USA63364) was the first brother to experience the lesion on the mid right abdomen.  The reporter stated there was no mention of an exposure to VZV WILD TYPE STRAIN virus in the patient's chart.  The patient recovered.  It was noted that there were no reocurrences of the event.  This is one of several reports from the same source.
Age: 1.03
Sex: F
Vaccine: HIBV, MMRV, PNC
Symptoms: Herpes zoster, Rash, Rash vesicular
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 24-month-old female with a history of wheezing in 2006 and no allergies, who on 26-OCT-2006 was vaccinated subcutaneously in the left arm with a 0.5 milliliter dose of ProQuad (Oka/Merck upgrade process) (lot# 655624/1090F). Concomitant vaccination included ActHIB and Prevnar. On 25-Oct-2007, the patient was seen in the office and diagnosed with shingles. She had a rash on her back, chest and under her left arm that developed "4 days ago", on 21-Oct-2007. There were no laboratory or diagnostic tests performed. The patient's shingles persisted. It was noted that the physician was not interested in the VZV identification program. No product quality complaint was involved. Follow-up information received indicates that the patient was vaccinated at 9:20 AM with a first dose of MMR (Oka/Merck upgrade process). Concomitant vaccination at 9:20 AM included a fourth intramuscular dose in the right arm of Prevnar (lot# B08682A). It was reported that the patient had bilateral otitis media at the time of vaccination. On 21-Oct-2007, the patient developed a vesicular rash on the left back, chest and upper arm. The outcome was not reported. Additional information has been requested.  Follow-up information received indicated that the patient was recovered (date unspecified). Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: MMRV
Symptoms: Body temperature increased, Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 10 year old male with a history of measles post vaccine, chickenpox, possible acid reflux and no drug reactions/allergies, who on 27-OCT-2007 was vaccinated SC with a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process).  It was also noted that the patient had the flu at the time of the visit.  On 25-OCT-2007 the patient was seen in the office for an injection site reaction which included, redness, swelling, and itching at injection site.  On 26-OCT-2007 the reaction had become the size of a softball but the area around the reaction was less red and not painful.  The patient had a fever of 99.5F and had vomited once.  The injection site reaction had been treated with diphenhydramine hydrochloride and ice packs.  There were no lab diagnostics studies performed.  The outcome was reported as not recovered.  The physician was interested in the VZVID program.  Unspecified medical attention was sought.  There was no product quality complaint.  This is one report of several from the same source.  Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 10 year old male with a history of measles post vaccine, chickenpox, possible acid reflux and no drug reactions/allergies, who on 27-OCT-2007 was vaccinated SC with a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process).  It was also noted that the patient had the flu at the time of the visit.  On 25-OCT-2007 the patient was seen in the office for an injection site reaction which included, redness, swelling, and itching at injection site.  On 26-OCT-2007 the reaction had become the size of a softball but the area around the reaction was less red and not painful.  The patient had a fever of 99.5F and had vomited once.  The injection site reaction had been treated with diphenhydramine hydrochloride and ice packs.  There were no lab diagnostics studies performed.  The outcome was reported as not recovered.  The physician was interested in the VZVID program.  Unspecified medical attention was sought.  There was no product quality complaint.  This is one report of several from the same source.  Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Body temperature increased, Pharyngolaryngeal pain, Rash, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 4-year-old white female with no pre-existing allergies, birth defects or medical conditions who on 27-Apr-2007 was vaccinated subcutaneously at her current physician's office with a second dose PROQUAD (MSD).  There was no illness at the time of vaccination.  Previous vaccinations, that were done at another health providers office, included on 09-Mar-2004 a first dose of PROQUAD (MSD).  On 28-Oct-2007 the patient experienced a sore throat, a temperature of 101 and a rash on the trunk and arms.  She was seen at the physician's office on 30-Oct-2007 and diagnosed with probable chicken pox.  On 01-Nov-2007, the grandmother reported that the child was feeling better but continued to break out.  The patient recovered on 02-Nov-2007.  Additional information is not expected.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC, RV5
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 4 month old male who on 06-NOV-2007 was vaccinated SC with a 0.5 mL dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) instead of Rotateq due to error with the order.  Other concomitant therapy that day included PREVNAR, PEDIARIX, and PEDVAX HIB (OMPC) (MSD).  No adverse symptoms were noted.  No additional information was available at the time.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Underdose
Clinical narrative: Information has been received from a health professional concerning a 1 year old female who on 08-Nov-2007 received a dose of PROQUAD (lot #658032/0985U).  It was reported that while receiving the dose of vaccine the child jerked and may have received less than the recommended dose.  Medical attention sought and current patient status was not reported.  Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old patient who on 05-NOV-2007 was vaccinated with a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) instead of a dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (MSD).  Secondary suspect therapy on same day included a dose of Varivax (Oka/Merck).  It was reported that both the box and the description of the vaccine was similar.  The labeling was different on both the vaccines boxes but it was not enough to notice the difference.  It was reported that ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (MSD) was stored in the fridge for a least 5 months.  The patient did not experience any adverse symptom.  A product quality complaint was not involved.  Additional information has been requested. Follow-up information was received from concerning a 12-month-old female who was vaccinated with PROQUAD (Merck) (lot# 657265/0293U). The PROQUAD (Merck) was stored where the MMR II was supposed to be stored. Since there was no MMR II (Merck) left in the refrigerator, someone mistook the PROQUAD (Merck) for the MMR II. It was unknown who put the PROQUAD (Merck) in the MMR II spot. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 4 year old black female with no pre existing allergies or medical conditions who on 13-Aug-2007 was vaccinated subcutaneously into the right arm with a first dose of PROQUAD (Lot #658132/0775U).  Concomitant vaccine therapy that same day included a fifth dose of DAPTACEL (Lot #CZ655AA) administered intramuscularly into the right arm and a fifth dose of IPOL (Lot #20872), administered subcutaneously into the right arm.  There was no illness at the time of vaccination.  On 14-Aug-2007 the patient developed a local reaction on the right arm, that included swelling and a quarter size red area that was hot to touch.  Treatment included cool compresses and ibuprofen.  Subsequently, the patient recovered from the events on an unspecified date.  Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Herpes zoster, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 4-year-old female who on 15-MAY-2007 was vaccinated with a dose of ProQuad (Oka/Merck upgrade process) because she was due for her second dose of ProQuad (Oka/Merck). On 15-AUG-2003 the patient received her first subcutaneous 0.5 ml dose of Varivax (Oka/Merck). The physician reported that the patient was seen in the office on 17-AUG-2007 with her sister and was diagnosed with shingles. On an unspecified date the "patient cleared up fine". A product quality complaint was not involved. It was also reported the patient's sibling had an adverse experience WAES # 0711USA03386. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 15 month old female with no pertinent medical history and no drug reactions/allergies who on 07-Aug-2007 was vaccinated SC with a 0.5 mL dose of PROQUAD (lot number: 0478U).  Concomitant therapy included PREVNAR.  On 16-Nov-2007 the patient was seen in the office for a rash.  On 17-Nov-2007 the patient was seen again in the office because the rash had gotten worse.  The physician diagnosed the rash as shingles.  The rash developed on the patient's back, right buttock, and genital area.  There were no complications.  The patient was put on acyclovir therapy.  No further information was available.  Unspecified medical attention was sought.  No lab diagnostics studies were performed.  The outcome was reported as recovering.  There was no product quality complaint.  Additional information has been requested. Information has been received froma registered nurse concerning a 15 month old female with no pertinent medical history and no drug reactions/allergies who on 07-AUG-2007 was vaccinated SC in the right thigh with a second 0.5 mL dose of MMR (Oka/Merck upgrade process) (lot number: 657032/04780). On 16-NOV-2007 the patient was seen in the office for a rash on her back and legs. The rash was lcoated on th elower back and genitalia. The rash was blister-like and raised. The rash was vesicular locatted on the lower back and right vulva. Her temperature that day was 97.6 F tympanic. On 17-NOV-2007 the patient was seen again in the office because the rash had gotten worse. The physician diagnosed the rash as shingles. The rash developed on the patient's back, right buttock, and genital area. There were no complications. The patient was pit on acyclovir therapy.Unspecified medical attention was sought. No lab diagnostics studies were performed. The outcome was reported as recovering. There was no product quality complaint. Follow up information indicated that on 08-NOV-2007 the patient was vaccinated in the right arm at 9:00 am with a third dose of HEPATITIS B vaccine (lot number 657180/0224U). The outcome was reported as recovered. No additional information is expected.
Age: 0.2
Sex: M
Vaccine: FLU3, HIBV, MMRV
Symptoms: Inappropriate schedule of drug administration, Irritability, Rash papular
Clinical narrative: Information has been received from a health professional concerning a 13 month old 25 lb. 13 oz. 33 1/2 inch male with an allergy to OMNICEF who on 24-OCT-2007 at 11:30 hours received his first subcutaneous dose in the right of ProQuad (Oka/Merck upgrade process) (lot#658314/0774U). Concomitant vaccinations included a first intramuscular dose in the left of Fluzone (lot#U2493AA) and a fourth intramuscular dose in Hib (unspecified carrier (lot# UF204PC). Illness reported at the time of vaccination included being fussy and a slight cough not accompanied by fever for 2 to 3 days. No adverse events were reported following prior vaccination. It was reported that on 31-OCT-2007, he was seen in the office by the physician after on 28-OCT-2007 he developed a rash that started on his face, and after 4 days new ones developed and spread. It was reported that the patient developed greater than 100 lesions that were diffuse papules with few tiny vesicles on a red base on the patient's trunk, face and extremities. It was reported that the patient was not ill, no fever and was pleasant. No diagnostic tests were reported. Current patient status was not reported. Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: MMRV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning an 18 month old patient who on 05-DEC-2007 was vaccinated with ProQuad (Oka/Merck upgrade process). Concomitant therapy included Recombivax. The physician reported that on 05-DEC-2007 the patient may have been given ProQuad (Oka/Merck upgrade process) given intramuscularly by mistake. The physician reported that the vials look similar for the two drugs both of the vials have AQUA blue tops. The nurse thought she was administered the ProQuad (Oka/Merck upgrade process) because it looked like the same vial. The patient did not seek medical attention. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Measles
Clinical narrative: Information has been received from a physician concerning a male patient with no drug reactions/allergies. The physician reported that the patient had a slight case of ProQuad as a baby. There was no product quality complaint. This is one report of several from the same souce. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a male patient. The patient may have had a case of chicken pox in 2002 although he received Varivax on 15-JUN-1008. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested
Age: 1.06
Sex: M
Vaccine: MMRV
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a approximate 49-month-old male who on 25-OCT-2006 was vaccinated with a dose of MMR (lot # 652328/0956R). On approximately 06-NOV-2007 ("within the last two weeks") the patient developed breakthrough chickenpox. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested. 02/10/2010 Follow up information received from a nurse on 12-DEC-2007 indicated the patient developed chickenpox on 10-JUL-2007 and has since recovered. She reported they were havign a lot of cases of chickenpos in thier office, sometimes 1-2 casses a week. Most of the cases were following VARIVAX. She thought the patient was the only case following MMR. The nurse explained they have been reporting the cases via the rmp and also to the state. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Local reaction
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a second dose of PROQUAD. The patient experienced a local non-systemic reaction. The patient's parent sought medical attention via a phone call to the child's physician. Subsequently, the patient recovered at an unspecified date per the nurse "because no parents called back after initial call". A product quality complaint was not involved. This is one of several reports from the same source. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Information has been received from a health professional concerning a 12 month old patient who was vaccinated with PROQUAD. Subsequently the patient experienced rash. He sought unspecified medical attention. Reportedly the patient recovered from the rash. No product quality complaint was reported. Additional information was not available. This is one of two reports from the same source. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a woman in a clinic concerning a patient who was vaccinated with ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) and had unspecified adverse experiences (also reported as cellulitis).  It was noted that "the experiences were not recent so she doesn't remember patient details".  Additional information has been requested.
Age: 1.6
Sex: U
Vaccine: MMRV
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician assistant concerning and 18 month old patient with no allergies and no pertinent medical history who on 14-Aug-2007, was vaccinated with a subcutaneous dose of PROQUAD (lot #0194U).  On 12-Sep-2007, the patient was seen in the office after developing a varicella-like rash of 50 lesions or less.  Specific treatment was not reported and the patient recovered.  No product quality complaint was reported.  No further information was available.  Additional information has been requested.
Sex: F
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Information has been received from a medical assistant concerning a female patient who was vaccinated with a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # 654998/0827F).  On an unspecified date the patient developed a rash (site unspecified).  The patient sought unspecified medical attention.  At the time of the report the patient's status was unknown.  A product quality complaint was not involved.  Follow-up information was received on 20-SEP-2007 via a telephone call.  Medical assistant confirmed that a female patient developed a rash following vaccination.  This is one of several reports from the same source.  Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Information has been received from a medica assistant concerning a patient who was vaccinated with a dose of PROQUAD.  On an unspecified date the patient developed a rash (site unspecified).  The patient sought unspecified medical attention.  At the time of the report the patient's status was unknown.  A product quality complaint was not involved.  Follow-up information was received on 20-Sep-2007 via a telephone call.  Medical assistant confirmed that an unknown patient developed a rash following vaccination.  This is one of several reports from the same source.  Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Information has been received from a medical assistant concerning a patient who was vaccinated with a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process).  On an unspecified date the patient developed a rash (site unspecified).  The patient sought unspecified medical attention.  The patient's status at the time of the report was unknown.  A product quality complaint was not involved.  Follow-up information was received on 20-SEP-2007 via a telephone call.  Medical assistant confirmed that an unknown patient developed a rash following vaccination.  This is one of several reports from the same source.  Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, MMRV, PNC
Symptoms: Blister, Dermatitis diaper, Erythema, Herpes zoster, Rash
Clinical narrative: Initial and follow up information has been received from a physician concerning a 22 month old white female with esophageal acid reflux and a history of bronchiolitis and incisional hernia repair, with no known food or drug allergies who on 02-OCT-2006 was vaccinated subcutaneously into the left arm with a first dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # 655140/0832F).  Concomitant vaccine therapy that same day included a fourth dose intramuscularly into the right thigh of PREVNAR (Lot #B08683C), a first dose of HAVRIX (Lot #U2174DA) intramuscularly into the right thigh, and a first dose of FLUZONE (lot #U2174DA) administered intramuscularly into the left thigh.  Concomitant therapy included: PREVACID and ATARAX, (also reported to have been treatment).  On 21 AUG 2007 the patient, presented for a sick visit with a rash to the left anterior chest, left axilla, and scattered hives throughout body.  The mother noted that the patient had had a paradoxical reaction to BENADRYL the day before.  The rash was described as red, raised, blistery and had been spreading for the last 4-5 days, with an onset of approximately 16 SEP 2007.  It was reported that the sibling had a few red lesions on her neck 2 weeks ago.  The patient was afebrile, 97 degrees, (tympanic), healthy appearing, alert and interactive and in no acute distress.  The physical examination was essentially unremarkable.  Pin-point vesicles on a red base in small clusters were present on the left side of the chest, axilla, arm, and back.  A few isolated similar lesions were present on the right shoulder and leg.  No super infection was present.  Final assessment was Varicella without mention Comp, also reported as shingles.  A non-specific mild/resolving diaper dermatitis was also noted at the time of examination.  There was no illness at the time of vaccination.  The patient has no reported adverse events with previous vaccines.  Polysporin was prescribed to treat "the rash".  At the time of reporting the patient was considered recovered, date unknown.  Symptoms reportedly persisted until "Labor Day" 03 SEP 2007.  It was also confirmed that the patient had only one episode of shingles.  There was no product quality complaint.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, MMRV, PNC
Symptoms: Skin lesion, Urticaria, Varicella
Clinical narrative: Initial and follow up information has been received from a physician concerning a 22 month old white female with esophageal acid reflux and a history of bronchiolitis and incisional hernia repair, with no known food or drug allergies who on 02-OCT-2006 was vaccinated subcutaneously into the left arm with a first dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # 655140/0832F).  Concomitant vaccine therapy that same day included a fourth dose intramuscularly into the right thigh of PREVNAR (Lot #B08683C), a first dose of HAVRIX (Lot #U2174DA) intramuscularly into the right thigh, and a first dose of FLUZONE (lot #U2174DA) administered intramuscularly into the left thigh.  Concomitant therapy included: PREVACID and ATARAX, (also reported to have been treatment).  On 21 AUG 2007 the patient, presented for a sick visit with a rash to the left anterior chest, left axilla, and scattered hives throughout body.  The mother noted that the patient had had a paradoxical reaction to BENADRYL the day before.  The rash was described as red, raised, blistery and had been spreading for the last 4-5 days, with an onset of approximately 16 SEP 2007.  It was reported that the sibling had a few red lesions on her neck 2 weeks ago.  The patient was afebrile, 97 degrees, (tympanic), healthy appearing, alert and interactive and in no acute distress.  The physical examination was essentially unremarkable.  Pin-point vesicles on a red base in small clusters were present on the left side of the chest, axilla, arm, and back.  A few isolated similar lesions were present on the right shoulder and leg.  No super infection was present.  Final assessment was Varicella without mention Comp, also reported as shingles.  A non-specific mild/resolving diaper dermatitis was also noted at the time of examination.  There was no illness at the time of vaccination.  The patient has no reported adverse events with previous vaccines.  Polysporin was prescribed to treat "the rash".  At the time of reporting the patient was considered recovered, date unknown.  Symptoms reportedly persisted until "Labor Day" 03 SEP 2007.  It was also confirmed that the patient had only one episode of shingles.  There was no product quality complaint.
Age: 1.1
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Body temperature increased, Irritability, Rash maculo-papular
Clinical narrative: Information has been received from a physician's assistant concerning her 13-month-old Caucasian, birth twin son with no pre-existing allergies, birth defects or medical conditions, who, on 17-Jul-2006 was vaccinated with a first dose of PROQUAD (lot #652234/0951R).  Concomitant vaccination given on the same day included a first dose of HAVRIX (lot #AHAVB105CA).  There was no illness at the time of vaccination.  On 25-Jul-2006, the patient developed a fever of 101-103 degrees Fahrenheit.  The patient also experienced fussiness and a scattered rash described as macular-papular rash that appeared on 28-Jul-2006 at 7:00 am.  No medical attention was sought.  The patient was treated with diphenhydramine hydrochloride (BENADRYL) for the rash and acetaminophen (TYLENOL) for the fever.  Subsequently, the patient recovered on 01-Aug-2006.  The patient's vaccination history included: PEDIARIX given in the right thigh on 30-Aug-2005 (lot #AC21BC15DA), 02-Nov-2005 (lot #AC21B022BA) and 21-Dec-2005 (lot #AC21B053AA); PEDVAXHIB given in the left thigh on 30-Aug-2005 (lot #651250/0186R), 02-Nov-2005 (lot #651897/0529R) and 21-Dec-2005 (lot #652026/0541R); and PNU-IMUNE 23 given in the left thigh on 30-Aug-2005 (lot #A85856F), 02-Nov-2005 (lot #B10637E), and 21-Dec-2005 (lot #B08686).  The patient's sister had the same symptoms, however, the lesions were more severe (WAES #0608USA00904).  Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV, PNC
Symptoms: Biopsy skin abnormal, Herpes virus infection, Injection site rash, Injection site vesicles, Rash
Clinical narrative: Information has been received from a physician concerning an approximately 17 month old male who in May 2007 (five months ago), was vaccinated with the first dose of 0.5 ml ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process).  On approximately 03-OCT-2007 (about a week ago) the patient experienced vesicles were formed around the injection sight and dermatome rash that traveled from patients head up to injection sight.  The physician believes  that it may be "something like shingles".  The patient was referred to a dermatologist and is waiting to hear from him with a diagnosis.  The dermatologist did a test to determine the diagnosis and results were pending.  Follow-up was received from the physician.  On 24-APR-2007, the patient was vaccinated with the first dose ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # "97586D1", invalid) SQ.  Concomitant vaccination included the fourth dose of PREVNAR (Lot # 808692F) IM.  Illness at the time of vaccination included left otitis media and was being treated with AUGMENTIN.  The patient had no pre-existing allergies, birth defects, or medical conditions.  On 05-OCT-2007, the patient had a rash on her left arm vesicular lesions in clusters following dermatomes C6-C8 and T1-T2.  The physician reported that the rash consistent with herpes zoster in same arm as MMR-V given 5 1/2 months earlier.  On 20-OCT-2007, the patient was seen by the dermatologist for initial consultation who stated "our impression of his dermatomal cutaneous eruption was herpes zoster vs. an allergic reaction dermatitis".  The patient's parent were advised to continue acyclovir, AUGMENTIN and ELCON ointment.  A punch biopsy and confirmed a diagnosis of herpes infection.  Unfortunately, we could not prove this viral culture as he was already on appropriate antiviral therapy when this test was obtained on 12-OCT-2007.  Given the linear distribution and histologic findings we favored a diagnosis of herpes zoster as opposed to cutaneous herpes simplex or primary varicella.  On 16-OCT-2007, his eruption was resolving well.  The patient's parents were advised to discontinue mometasone furoate and complete the acyclovir.  No further information was available.
Age: 1.0
Sex: M
Vaccine: MMRV, PNC
Symptoms: Virus culture
Clinical narrative: Information has been received from a physician concerning an approximately 17 month old male who in May 2007 (five months ago), was vaccinated with the first dose of 0.5 ml ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process).  On approximately 03-OCT-2007 (about a week ago) the patient experienced vesicles were formed around the injection sight and dermatome rash that traveled from patients head up to injection sight.  The physician believes  that it may be "something like shingles".  The patient was referred to a dermatologist and is waiting to hear from him with a diagnosis.  The dermatologist did a test to determine the diagnosis and results were pending.  Follow-up was received from the physician.  On 24-APR-2007, the patient was vaccinated with the first dose ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # "97586D1", invalid) SQ.  Concomitant vaccination included the fourth dose of PREVNAR (Lot # 808692F) IM.  Illness at the time of vaccination included left otitis media and was being treated with AUGMENTIN.  The patient had no pre-existing allergies, birth defects, or medical conditions.  On 05-OCT-2007, the patient had a rash on her left arm vesicular lesions in clusters following dermatomes C6-C8 and T1-T2.  The physician reported that the rash consistent with herpes zoster in same arm as MMR-V given 5 1/2 months earlier.  On 20-OCT-2007, the patient was seen by the dermatologist for initial consultation who stated "our impression of his dermatomal cutaneous eruption was herpes zoster vs. an allergic reaction dermatitis".  The patient's parent were advised to continue acyclovir, AUGMENTIN and ELCON ointment.  A punch biopsy and confirmed a diagnosis of herpes infection.  Unfortunately, we could not prove this viral culture as he was already on appropriate antiviral therapy when this test was obtained on 12-OCT-2007.  Given the linear distribution and histologic findings we favored a diagnosis of herpes zoster as opposed to cutaneous herpes simplex or primary varicella.  On 16-OCT-2007, his eruption was resolving well.  The patient's parents were advised to discontinue mometasone furoate and complete the acyclovir.  No further information was available.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Blister, Culture wound negative, Tenderness, Viral DNA test positive
Clinical narrative: Information has been received from a physician concerning an 18 month old female with no pre-existing allergies, birth defects, or medical conditions who in the P.M. of 12-Mar-2007, received a subcutaneous first dose in her right thigh of PROQUAD (lot #656307/1391).  It was reported that she had no illness at the time of the vaccination and had not experienced any adverse events from previous vaccinations.  It was reported that on 22-Sep-2007, she developed vesicles and blister cluster erupted to her right thigh inner aspect.  On 28-Sep-2007, she presented to the physician for evaluation.  The doctor reported that the vesicles and blister cluster were tender to touch and looked like classic shingles.  Diagnostics obtained on 28-Sep-2007, included varicella-zoster virus culture (positive) and a superficial wound culture of the right inner thigh (negative).  It was reported that as of 04-Oct-2007, she had recovered with all drying lesions.  A product quality complaint was not reported.  No further information was available.  Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: Information has been received from a physician concerning her 4 year old son with allergies to amoxicillin and no pertinent medical history who on 28-Sep-2007 was vaccinated with PROQUAD.  The patient's vaccination history included 0.5 ml subcutaneous of VARIVAX on 25-Aug-2004, and a 0.5 ml subcutaneous of MSD.  On 07-Oct-2007, the patient developed maculo-pular rash that started on his hands and feet and then became widespread over the next few days.  The rash was erythematous and slightly itchy.  The patient was seen in the physician's office and therapy was prescribed with Benadryl.  It was reported that the rash was resolving.  No product quality complaint was reported.  No further information was available.  Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: MMRV, PNC
Symptoms: Irritability, Pyrexia, Rash generalised
Clinical narrative: Information has been received from a physician concerning his 7 year old daughter who on 10-Oct-2007, was vaccinated with PROQUAD (lot #657186/0302U).  Concomitant vaccination included PREVNAR (batch 3 B26510D.  On 14-Oct-2007, developed a rash all over, low grade fever, and was cranky.  It was reported that the vaccinating pediatrician was aware and the patient recovered.  A product quality complaint was not reported.  Further information was not available.  Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: HEPA, MMR, MMRV, VARCEL
Symptoms: Incorrect route of drug administration, Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant concerning a 3 year old male who was inadvertently vaccinated SC with a 0.5 mL dose of PROQUAD (lot number: 657264/0294U) instead of VAQTA. The patient was inadvertently administered the wrong vaccine. The reporter stated that this was a staff error; the patient's sibling was suppose to get vaccinated with PROQUAD. The medical assistant stated that the patient was vaccinated with one dose of MMR and one dose of VARIVAX in 2005. No other information reported. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Blister, Rash papular, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 24 month old female who on 20-Oct-2006 was vaccinated with a "standard dose" of PROQUAD (655625/1091F).  Other vaccinations received the same day included influenza virus vaccine (unspecified) and Vitamin B 12 injection.  On 18-Oct-2007 the patient experienced chickenpox.  The patient had multiple papules and vesicles on her toe, back, arms and legs.  The patient sought medical attention via an office visit on 18-Oct-2007.  At the time of the report, the patient was recovering.  There was no product quality complaint.  Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RVX
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a 4-month-old male subject who was vaccinated with Pediarix for prophylaxis. Concurrent vaccinations given the same day included Haemophilus influenzae type B vaccine; pneumococcal vaccine and rotavirus vaccine. On 14 June 2007 at 17:30 the subject received 2nd dose of Pediarix (unknown). On 14 June 2007, within 24 hours after vaccination with Pediarix, the subject experienced fever of 102 degrees Fahrenheit. The fever increased to 103.6 degrees Fahrenheit. The subject was hospitalized overnight. At the time of reporting the outcome of the event was unspecified.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Blood culture positive, Crying, Gram stain positive, Pain, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a child of unspecified gender who was vaccinated with Pediarix (GlaxoSmithKline) for prophylaxis.  On an unspecified date on or before 18 December 2006, the subject received unspecified dose of Pediarix.  At an unspecified time after vaccination with Pediarix, on an unspecified date on or before 18 December 2006, the subject experienced fever, pain and crying. The subject was seen at a physician's office.  The subject was hospitalized.  The healthcare professional considered the events were clinically significant (or requiring intervention).  The outcome of the events was not reported.  The healthcare professional considered the events were probably related to vaccination with Pediarix.  Follow-up information was received on 13 April 2007 via a registered nurse, who reported that the subject was 2 months old (gender unspecified).  On 28 November 2006, the subject received a .5 ml dose of Pediarix.  The subject also received Prevnar and PedvaxHIB intramuscularly on 28 November 2006.  On 28 November 2006, the subject experienced fever, pain and crying.  On an unspecified date, the subject had a blood culture result of gram positive cocci.  The reporting nurse questioned the positive test result as possibly being due to poor venous collection technique.  As of 03 December 2006, the events were resolved.  At the time of reporting, Pediarix had been reintroduced to the subject and the symptoms did not recur.  The reporting nurse considered the events were possibly related to vaccination with Pediarix.  The reporting nurse also indicated that the events could have been associated with a blood culture result of gram positive cocci.