chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging brain, Paraparesis, Urinary incontinence
Clinical narrative: Information has been received from a physician concerning a female who on 26-JUL-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included MENACTRA. On 05-SEP-2007 the patient developed paraparesis and urinary incontinence. The patient was examined in the physician office on 06-SEP-2007 and is scheduled for a consultation with a neurologist on 07-SEP-2007. The physician reported that the patient had a magnetic resonance imaging performed on 06-SEP-2007 but the physician was unable to provided the results. The physician was unable to provide the lot number of Gardasil. The patient's paraparesis and urinary incontinence persisted. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 14 year old female patient, who was vaccinated IM (date not specified), with the second dose of GARDASIL (Lot # not provided). The following day (24 hours post vaccination), the patient developed swollen glands. After an unknown duration of time, the patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Skin discolouration
Clinical narrative: Information has been received from a certified medical assistant concerning a 27 year old female with no pertinent medical history or drug reactions/allergies who on 22-FEB-2007 was vaccinated with a first dose of Gardasil (lot# unknown) 0.5mL IM. Concomitant therapy included hormonal contraceptives (unspecified) for 5 years. On an unspecified date the patient developed brown spots on the face. There is one spot on each cheek. Medical attention was sought. The patient went to a dermatologist (unspecified) and is continuing to see the dermatologist for treatment. No further information was available. At the time of reporting the patient had not recovered. Additional information has been requested. Follow-up information was received. On 28-AUG-2007 the patient was vaccinated with a third dose of GARDASIL (lot# 654702/0011U) IM in the right gluteal. The patien stated that she has been using bleaching cream but the spots reappear if she stops using the cream. At the time of reporting it was unknown if the patient had recovered. Additonal information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a physician concerning a "few" female who were vaccinated with a 0.5 mL dose of Gardasil. The physician reported that she had a "few" patients complain that their menstrual system was irregular. The patients sought unspecified medical attention. The patient's outcome was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been recovered from a Registered Nurse (R.N.) concerning a 15 year old female patient who was vaccinated IM with a first dose of GARDASIL lot #658222/0927U. The nurse reported that the patient became dizzy and fainted, about ten minutes after being vaccinated with her first dose of GARDASIL. The patient recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site pain, Overdose
Clinical narrative: Information has been received from a nurse concerning a female between 11 and 12 years who in August 2007, "two weeks ago", was vaccinated with a dose of GARDASIL 0.5 ml injection. The nurse reported that the patient had received another dose of GARDASIL 5 days before at another clinic. The patient sought medical attention. The patient also experienced some injection site pain. The outcome of the events was not reported. The nurse felt that the event was an overdose. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a nurse concerning a female (age not reported) with a history of stomach virus earlier in the week who on an unspecified date was vaccinated with the first dose of Gardasil. Immediately after receiving the first dose of vaccine, the patient became dizzy, light headed, and had nausea. The patient did not eat breakfast the morning prior to be vaccinated. Medical attention was sought. On an unspecified date, the patient recovered. No further information is available.
Age: 1.9
Sex: U
Vaccine: MMRV
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with the first dose of PROQUAD SQ at 12 months of age. Subsequently, the patient experienced "a full blown case of the chicken pox at 21 months of age". The outcome was not reported. The patient sought unspecified medical attention. The physician is planning on giving the patient the second dose of PROQUAD. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: HEPA, HIBV, MMRV
Symptoms: Body temperature increased, Rash erythematous, Rash macular, Vomiting
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 13 month-old multi-racial female with no pre-existing allergies, birth defects or medical conditions, who on 13-JUN-2007 at 10AM was vaccinated subcutaneously in the left thigh with a first dose of PROQUAD (lot# reported as "4936"). Suspect vaccinations at 10 AM on 13-Jun-2007 included an intramuscular first dose in the right thigh of VAQTA (lot# 652294/0249U) (MSD). Concomitant therapy included an intramuscular fourth dose in the right thigh of ACTHIB (lot# UF067AA) (Sanofi Pasteur). On 22-Jun-2007, the patient had a temperature of 100.9 degrees. In the evening of 24-JUN-2007, the patient developed an erythematous, macular rash, on her face, neck, trunk and upper thighs. In the morning of 25-Jun-2007, the patient vomited once. On an unspecified day, the patient sought medical attention at the doctor's office. The outcome is reported an unknown. It is reported that the patient never had any adverse events following prior vaccinations. It is unknown if the patient's sibling had any adverse events following vaccinations. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Ataxia, Blood test normal, Computerised tomogram normal
Clinical narrative: Information has been received from a physician, (concerning information that a pediatrician consulted with her), concerning a 1-year-old patient who on 19-JUN-2007 was vaccinated with a dose of PROQUAD. On 26-JUN-2007 the patient was admitted to the emergency room with possible transient ataxia. Laboratory testing revealed a normal computed axial tomography (CAT scan) and "blood-work unspecified". It is reported that on an unspecified date the child recovered. No other information is available. No product quality complaint was involved. Follow up information indicates that the lot numbers are unavailable. No further is expected.
Age: 76.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 76 year old patient with a medical history of skin cancer, who on 11-JUL-2007 was vaccinated with a dose of PROQUAD (Lot # 657536/0475U) instead of zoster vaccine live (Oka/Merck). On 14-AUG-2007 the patient was administered zoster vaccine live (Oka/Merck) (Lot # 656859/0357U). The site reported that this was not product confusion. No adverse experience was related to this event. No further information was available. No product quality complaint was involved. Additional information has been requested. Follow-up received from a registered nurse stated that they have been very busy and have someone pull the vaccines for them. Normally the vaccines are checked twice but because it was so busy, it was not. The patient received zoster vaccine live (Oka/Merck) on 14-AUG-2007 and it was reported that "she was fine". There was nothing further to report. Additional is not expected.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC
Symptoms: Rash generalised
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 month old white male with no known allergies or pertinent medical history, who on 03-JUL-2007 at 10:27 was vaccinated SC in the right thigh with a first dose of PROQUAD (Lot#656647/0101U) (also reported as measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3) (MSD) and varicella virus vaccine live (Oka/Merck). Additional suspect vaccinations administered on 03-JUL-2007 at 10:26 included a third IM dose of PEDVAX HIB (Lot#654679/1126F) given in the left thigh. Additional concomitant therapy included a fourth IM dose of PREVNAR (Lot#608679h) given in the right thigh. There was no illness at the time of vaccination. On 09-JUL-2007 at 13:45 the patient developed a rash on his torso (also reported as entire body). Unspecified medical attention was sought. No lab studies were performed. No treatment was given. There was no adverse event following prior vaccinations. No further information was provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Age: 1.3
Sex: M
Vaccine: MMRV
Symptoms: Discomfort, Erythema, Herpes zoster, Pruritus, Rash papular
Clinical narrative: Initial and follow up information has been received from a physician concerning a 20 month old male patient, with no known allergies or pertinent medical history, who on 27-FEB-2007 was vaccinated subcutaneously with a 0.5 ml dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot#656444/1529F).  There was no concomitant therapy.  On 30-JUN-2007, while the patient was at the shore he developed a vesiculo-papular rash on his left arm following the dermatome pattern.  There was some redness at the base of the vesicles.  After one week (on approximately 07-JUL-2007) the patient was seen by the physician.  The physician noted that there was slight resolution, but the rash looked like zoster shingles.  The patient was prescribed hydroxyzine HCl for itch and discomfort.  The patient recovered.  The rash lasted ten days.  There was no product quality complaint involved.  No further information was provided.  No further information is expected.
Age: 1.3
Sex: M
Vaccine: MMRV
Symptoms: Rash vesicular
Clinical narrative: Initial and follow up information has been received from a physician concerning a 20 month old male patient, with no known allergies or pertinent medical history, who on 27-FEB-2007 was vaccinated subcutaneously with a 0.5 ml dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot#656444/1529F).  There was no concomitant therapy.  On 30-JUN-2007, while the patient was at the shore he developed a vesiculo-papular rash on his left arm following the dermatome pattern.  There was some redness at the base of the vesicles.  After one week (on approximately 07-JUL-2007) the patient was seen by the physician.  The physician noted that there was slight resolution, but the rash looked like zoster shingles.  The patient was prescribed hydroxyzine HCl for itch and discomfort.  The patient recovered.  The rash lasted ten days.  There was no product quality complaint involved.  No further information was provided.  No further information is expected.
Age: 1.6
Sex: M
Vaccine: HIBV, MMRV
Symptoms: Expired drug administered, Injection site erythema, Injection site induration, Injection site pruritus, Injection site reaction
Clinical narrative: Information has been received from a pharmacist concerning a 19 month old male with no known allergies or pertinent medical history, who on 11-JUL-2007 was vaccinated with a 0.5 ml subcutaneous dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot # 654042/0663F) in the right thigh, which expired on 05-JUN-2007.  Concomitant therapy included PedvaxHIB (OMPC) (MSD) at another site.  On 11-JUL-2007 the patient developed an injection site reaction on the right thigh which was hard, red, scratchy, and the "size of a fist".  The patient sought unspecified medical attention.  There were no labs performed.  At the time of this repot the patient had not recovered.  There was no product quality complaint involved.  No further information was provided.  Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Diarrhoea, Inappropriate schedule of drug administration, Rash, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 12 month old male with no pertinent medical history who on 09-JUL-2007 was vaccinated with PROQUAD (Lot # 656547/1530F) IM and VARIVAX (Lot # 654750/1256F) IM. There was no concomitant medication. The patient was suppose to be vaccinated with MMR II and VARIVAX. No symptoms have been reported. The patient sought unspecified medical attention. This error was a result of product confusion in which the labeling for PROQUAD and MMR II appeared similar. No laboratory or diagnostic studies were performed. No symptoms have been reported. Follow-up information from the physician indicated that a medical assistant on her staff gave the incorrect vaccine. The physician was unaware of the error until she was reconciling some counts and found the PROQUAD lot # registered for the supposed MMR II vaccine. Disciplinary action was taken. The physician reported that this will not be an issue in the future as PROQUAD will not be available (details not ascertained). The physician further mentioned that the labels are much too similar for the vaccines. The physician also reported that on approximately 21-JUL-2007 (within 21 days of 09-JUL-2007 vaccination date) the patient developed a "few dots" rash and diarrhea. These events were concurrent with some dietary changes. The patient recovered on an unknown date July 2007. This is one of two reports concerning the same patient. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: 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 male with no drug allergies, and a vaccination history of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3 (MSD), Oka/Merck) (MSD) on 11-JUL-2003 with no other pertinent medical history, who on 27-APR-2007 was vaccinated with his first dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # 657034/0232U) into the left thigh.  There was no illness at the time of vaccination.  On 30-APR-2007 the patient developed injection site swelling, warmth, redness, and tenderness to the touch.  No medical attention was sought.  No diagnostic tests or labs were performed.  The patient was treated with AUGMENTIN ES 600mg and cool compresses.  The area was improved.  It was noted that injection site warmth and swelling took 3 to 4 days to go down.  There was no product quality complaint.  Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Listless, Parotitis, Rash morbilliform
Clinical narrative: Information has been received from a health professional concerning a male with no reported medical history and no allergies who on 05-JUN-2007 was vaccinated with ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # 656890/0152U).  There was no concomitant medication.  Sometime after vaccination, in approximately 2007, the patient developed a measles type reaction which required no treatment and has resolved.  On 16-JUL-200, the patient developed a parotiditis like reaction.  The left side of his face was swollen and tender and he was listless.  No treatment was required.  The mother of the patient called the office yesterday, on 17-JUL-2007, to report that the child is slightly better.  The patient is recovering.  Laboratory tests included an immunoglobulin G test (IgG) and an immunoglobulin M test (IgM).  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Swelling face, Tenderness
Clinical narrative: Information has been received from a health professional concerning a male with no reported medical history and no allergies who on 05-JUN-2007 was vaccinated with ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # 656890/0152U).  There was no concomitant medication.  Sometime after vaccination, in approximately 2007, the patient developed a measles type reaction which required no treatment and has resolved.  On 16-JUL-200, the patient developed a parotiditis like reaction.  The left side of his face was swollen and tender and he was listless.  No treatment was required.  The mother of the patient called the office yesterday, on 17-JUL-2007, to report that the child is slightly better.  The patient is recovering.  Laboratory tests included an immunoglobulin G test (IgG) and an immunoglobulin M test (IgM).  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: DTAPH, HEPA, MMRV
Symptoms: Rash morbilliform
Clinical narrative: Information has been received from a male reporter concerning a 14-month-old male with no pre-existing allergies, birth defects, or medical conditions who on 26-JUN-2007 was vaccinated with a first dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot# 657265/0293U).  Concomitant therapy included TRIHIBIT (lot# UFUOAA) and a first dose of Vaqta (MSD) (lot# 656993/0001U).  There was no illness at the time of vaccination.  On 05-JUL-2007 the patient experienced a measles-like rash that began behind his ears and progressed to neck then face, arms, back and legs.  The patient sought medical attention, he saw a physician who gave a visual diagnosis.  No outcome was reported.  Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Biopsy skin, Blister, Body temperature, Injection site erythema, Injection site vesicles
Clinical narrative: Information has been received from a nurse concerning a 12 month old male with a drug allergy to CEFZIL who on 18-JUL-2007 was vaccinated with a 0.5ml subcutaneous dose of PROQUAD (Lot # 657536/0475U) in the right thigh. There was no concomitant medication. On 23-JUL-2007 the patient developed redness and vesicles around the injection site with fever. The rash spread over the body to the areas of the chest, arms, head and a couple of areas on the lower extremities. On 26-JUL-2007, the patient had a sample of the lesion and vesicle sent for VZV identification and the results showed that the specimen was inadequate, negative for B-Globin and there was no strain ID. Subsequently the patient recovered. Unspecified medical attention was sought. No further information was available. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash, Skin lesion
Clinical narrative: Information has been received from a nurse concerning a 12 month old male with a drug allergy to CEFZIL who on 18-JUL-2007 was vaccinated with a 0.5ml subcutaneous dose of PROQUAD (Lot # 657536/0475U) in the right thigh. There was no concomitant medication. On 23-JUL-2007 the patient developed redness and vesicles around the injection site with fever. The rash spread over the body to the areas of the chest, arms, head and a couple of areas on the lower extremities. On 26-JUL-2007, the patient had a sample of the lesion and vesicle sent for VZV identification and the results showed that the specimen was inadequate, negative for B-Globin and there was no strain ID. Subsequently the patient recovered. Unspecified medical attention was sought. No further information was available. No product quality complaint was involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 4-year-old male who on approximately 05-JUL-2007 was vaccinated with a 0.5 milliliter dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot# 657188/0431U).  On approximately 06-JUL-2007, the patient experienced redness and swelling at injection site.  Unspecified medical attention was sought.  The outcome is reported as recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site vesicles
Clinical narrative: Information has been received from a physician concerning a 12 month old male who was vaccinated with a first dose of PROQUAD. It was reported that the patient developed light vesicles around injection site. The patient was advised by the physician to apply hydrocortisone cream at the injection site. A product quality complaint was not involved. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: Rash, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 6-year-old male with no pertinent medical history and no drug reactions/allergies who on 30-OCT-2006 was vaccinated SC with a 0.5mL dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # 653465/0465F).  Concomitant therapy included ZYRTEC.  It was noted that the patient was vaccinated with Varivax (MSD) on 03-APR-2002 (lot number not reported).  The patient developed a skin rash on the lower extremity on 02-AUG-2007 which spread to the entire body.  The rash presented as dew drops on rose petals consistent with varicella.  On 03-AUG-2007 the patient was diagnosed with chickenpox by the physician.  No other details were provided.  There were no lab diagnostic studies performed.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
Age: 0.97
Sex: M
Vaccine: MMRV
Symptoms: Decreased appetite, Diarrhoea, Pyrexia, Rash generalised, Varicella
Clinical narrative: This is in follow-up to report(s) previously submitted on 10/6/2007. Information has been received from a licensed practical nurse reporting on her child, a 1 year old male, who was vaccinated with PROQUAD (Lot #656310/1394F). A month and a half after being vaccinated with PROQUAD, the patient experienced "for approximately three days", 100-150 chickenpox, decreased appetite and vomiting. The patient had no fever as well as no scabs. Unspecified medical attention was sought. The patient recovered. No further information was provided. No product quality was involved. Additional information has been requested. Follow-up information on 27-AUG-2007. During a follow-up phone call the patient's mother (licensed practical nurse) provided the lot number for the administered vaccine Lot #656310/1394F. Informatin has been received from a licensed practical nurse concerning a 14-month-old also reported as 16-month-old male with otitis media chronic who on 13-JUN-2007 was vaccinated in his left leg with his first dose of MMR II (+) VARIVAX (Merck) (Lot # 656310/1394F) at 09:00 hours. There were no illnesses at the time of vaccination. On 27-JUL-2007 at 16:40 hours the patient experienced 100-250 chickenpox and broke out in rash all over body, decreased appetite, vomiting, diarrhea and fever up to 102.5. The patient sought unspecified medical attention. On 06-AUG-2007 the patient recovered. Additional information is not expected.
Age: 0.97
Sex: M
Vaccine: MMRV
Symptoms: Varicella post vaccine, Vomiting
Clinical narrative: This is in follow-up to report(s) previously submitted on 10/6/2007. Information has been received from a licensed practical nurse reporting on her child, a 1 year old male, who was vaccinated with PROQUAD (Lot #656310/1394F). A month and a half after being vaccinated with PROQUAD, the patient experienced "for approximately three days", 100-150 chickenpox, decreased appetite and vomiting. The patient had no fever as well as no scabs. Unspecified medical attention was sought. The patient recovered. No further information was provided. No product quality was involved. Additional information has been requested. Follow-up information on 27-AUG-2007. During a follow-up phone call the patient's mother (licensed practical nurse) provided the lot number for the administered vaccine Lot #656310/1394F. Informatin has been received from a licensed practical nurse concerning a 14-month-old also reported as 16-month-old male with otitis media chronic who on 13-JUN-2007 was vaccinated in his left leg with his first dose of MMR II (+) VARIVAX (Merck) (Lot # 656310/1394F) at 09:00 hours. There were no illnesses at the time of vaccination. On 27-JUL-2007 at 16:40 hours the patient experienced 100-250 chickenpox and broke out in rash all over body, decreased appetite, vomiting, diarrhea and fever up to 102.5. The patient sought unspecified medical attention. On 06-AUG-2007 the patient recovered. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 4 year old female who on 03-AUG-2007 was vaccinated with a second single subcutaneous dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # 658133/0773U) in her leg.  Concomitant vaccine administered on the same day included DTaP.  Within 24 hours post-vaccination, on approximately 04-AUG-2007, the patient developed a large hive at the site of injection.  The next day, the patient was covered with hives all over her body.  The patient was treated with a long acting antihistamine at the office visit on 06-AUG-2007.  The office has not heard from the patient's mother and is unaware of the patient's present status.  No further information was provided.  Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Skin lesion, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male who on 05-JUN-2007 was vaccinated with a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process).  There was no concomitant medication.  On approximately 05-JUL-2007 the patient developed moderate chicken pox, about 50 lesions on his legs and torso with a high fever.  Unspecified medical attention was sought.  No diagnostic studies or labs were performed.  It was noted that the patient was not recovered.  There was no product quality complaint.  This is one of several reports from the same source.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a 12-month-old patient who was inadvertently vaccinated with a dose of PROQUAD instead of MMR II. It is reported that there were no adverse symptoms and no product confusion. It is unspecified if medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 86 year old patient who on 11-JUL-2007 was vaccinated with ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot # 6587536/0475U) instead of Zostavax (Oka/Merck).  On 24-AUG-2007 the patient was administered Zostavax (Oka/Merck) (lot # 656859/0357U).  Concomitant therapy included TOPROL XL TABLETS, losartan potassium (MSD), PERMIRAN, and "cloredine".  The site reported that this was not product confusion.  No adverse experience was related to this event.  No further information was available.  No product quality complaint was involved.  Additional information has been requested.  Follow-up information received from a registered nurse stated that they have been very busy and have someone pull the vaccines for them.  Normally the vaccines are checked twice but because it was so busy, it was not.  There was nothing further to report.  Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female with no medical history and no allergies who on 03-AUG-2007 was vaccinated with a first 0.5ml subcutaneous dose of PROQUAD (Lot #
Age: 4.0
Sex: U
Vaccine: HEPA, MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 5 year old patient who on 13-AUG-2007 was vaccinated with a second dose of PROQUAD (Lot # 658187/0790U) in the left leg. Concomitant vaccine administered on the same location, left leg, included hepatitis A virus vaccine (manufacturer unspecified). The left leg became swollen, red and itchy at the injection site and the area measured approximately 5-6 centimeters. The physician reported that the reaction was most likely due to the PROQUAD. The patient was given ATARAX syrup, manufacturer unknown. No further information was available. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Decreased appetite, Varicella, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a child who was vaccinated on an unspecified date with ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process).  A month and a half after being vaccinated with ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process), the patient experienced "for approximately three days", 100-150 chickenpox, decreased appetite and vomiting.  The patient had no fever as well as no scabs.  It is reported that the patient attends daycare where a lot of children have gotten chickenpox.  It is unspecified if medical attention was sought.  No further information was provided.  No product quality complaint was involved.  This is one of several reports from the same reporter.  Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 5 year old female who on an unspecified date was vaccinated with PROQUAD (Lot # 657878/0651U). Subsequently the patient experienced redness and swelling at injection site. The dimension  of the swelling was about 7 cm in diameter. The patient was given MOTRIN and BENADRYL. At the time of reporting the outcome was unknown. Unspecified medical attention was sought. There was no product quality complaint. This is two of three reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: MMRV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning her 14 year old son who on 17-AUG-2007 was vaccinated with a dose of ProQuad (Merck) instead of a dose of VARIVAX (Merck) (MSD).  It was reported that the office did not had Varivax (Merck) (MSD) vaccine on 17-AUG-2007.  It was reported that the patient had a dose of VARIVAX (Merck) (MSD) in 1995.  The reporter stated that the this was patient's third dose of MMR  (MSD).  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested. Thi is in follow-up to report (s) previously submitted on 10/6/2007. Additional information has been received from the physician who stated that the patient was vaccinated in a health clinic in other city. It was reported that no adverse reaction was noted. No further information is expected.
Age: 1.2
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 14 month old patient who on 21-AUG-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, MSD).  On that same day, the patient was also given a dose of Varivax (Oka/Merck) (MSD).  No adverse events were reported.  It was unknown whether medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Body temperature decreased, Rash erythematous
Clinical narrative: Information has been received from a licensed practical nurse concerning a 5 year old female with no allergies or pertinent medical history who on 17-AUG-2007 was vaccinated SC with a 0.5 ml dose of PROQUAD (Lot#656891/0914U). There was no concomitant therapy. On 26-AUG-2007 the patient developed a rash described as 12 papules. Unspecified medical attention was sought over the phone by the patient's mother. No lab studies were performed. The nurse was not interested in VZV analysis by PCR. The patient has no other symptoms. At the time of this report the patient had not recovered. It was noted that the patient's vaccination history included VARIVAX given 15-JUL-2003. No further information was provided. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/6/2007.  Information has been received from a licensed practicall nurse concerning a 5 year old 42 lb.  42 1/2 in. female who was 9 lb.  12 oz. at birth with no allergies or pertinent medical history who on 13-AUG-2007 was vaccinated SC with a 0.5 dose of PROQUAD (Lot#656891/0914U).  There was no reported illness at the time of vaccination and no adverse events following  prior vaccination.  There was no concomitant therapy.  On 26-AUG-2007 the patient developed a rash described as 12 papules and was itchy.  Unspecified medical attention was sought over the phone by the patient's mother.  No lab studies were performed.  The nurse was not interested in VZV analysis by PCR.  The patient had no other symptoms.  At the time of the initial report the patient had not recovered.  It was noted that the patient's vaccination history included VARIVAX (Merck) given 15-JUL-2003.  No further information was provided.  There was no product quality complaint involved.  Follow-up information from a licensed practical nurse indicated that the patient had recovered.  Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Abscess drainage, Erythema, Incorrect route of drug administration, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning an otherwise healthy 4 year old female who on 30-AUG-2007 was vaccinated with an IM dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) instead of a subcutaneous dose in the left arm.  Concomitant vaccinations that day included an IM dose of DTaP in the left arm and an IM dose of IPV (unspecified) in the left arm.  On 31-AUG-2007 the patient may have developed possible cellulitis characterized by the arm that swollen, red and draining.  The child had no fever.  Medical attention was sought via doctor visit the next day following vaccination.  The patient was treated with KEFLEX 1.5 teaspoonfuls twice a day in addition to a needed follow-up in a couple of days.  It was unknown if there has been any improvement since treatment with KEFLEX.  There was no product quality complaint.  Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: MMRV
Symptoms: Accidental exposure, Eye irritation
Clinical narrative: Information has been received from a registered nurse concerning a 30-year-old (also reported as 28) female with a history of chickenpox and two prior doses of MMR (MSD) who on 04-SEP-2007 was inadvertently exposed to ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process).  On the 04-SEP-2007 the patient was administering ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) to a child who was kicking and the vaccine splashed into her eyes causing a slight burning, but no redness.  The patient rinsed her eye with water but not immediately.  It was reported the patient did not have any further problems beyond the initial splash sensation.  The patient sought unspecified medical attention.  The patient recovered from the adverse experience.  A product quality complaint was not involved.  It is not clear of the child received a full dose because of the splash (WAES # 0709USA00294).  Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Decreased appetite, Exposure to communicable disease, Varicella, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a child who was vaccinated with PROQUAD. A month and a half after being vaccinated with PROQUAD, the patient experienced "for approximately three days", 100-150 chickenpox, decreased appetite and vomiting. The patient had no fever as well as no scabs. It is reported that the child is in daycare where a lot children have gotten chickenpox. It is unspecified if medical attention was sought. No further information was provided. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female who on an unspecified date was vaccinated with a second dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process).  It was noted that the patient received the first dose at 18 months of age.  Subsequently about 12 hours after receiving the vaccination the patient developed injection site redness, warmth and raised area about 4 1/2 inches in circumference.  The patient had no fever, but the red warm area at the injection site lasted and diminished in a 4 day period.  Unspecified medical attention was sought.  The nurse reported that the patient was fighting the injection so the red warm area may be linked to the behavior of the child while giving the injection.  The patient had recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested. Follow-up information form the licensed practical nurse indicated that the patient was vaccinated IM with a first (previously reported as second) dose of MMR II (Oka/Merck upgrade process) (Lot # 655747/1117F) at 13:20 on 27-AUG-2007. Subsequently the patient developed redness, swelling and itching at the injection site for four days. The patient recovered. No further information was provided. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: IPV, MMRV
Symptoms: Blister, Rash papular, Scab, Skin lesion, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female with a history of cleft palate repair on August 2004, who on 08-SEP-2006 was vaccinated subcutaneously in the left arm with a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot # 652679/1137R).  Concomitant vaccination included IPV (unspecified) (lot# 40991).  On 07-JUN-2007 the patient was diagnosed with a case of breakthrough chicken pox after receiving a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process).  It was reported that no medical attention was sought.  Approximately 20 to 30 vesicular and papular lesions and few crusted lesions on trunk and legs.  On an unspecified date the patient recovered.  It was also reported that the patient received a first dose of Varivax (Oka/Merck) (MSD) (lot# 645045/0208N) subcutaneously in the left thigh on 22-AUG-2003.  No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Culture throat positive, Dyspnoea, Electrocardiogram QT prolonged, Hyperhidrosis
Clinical narrative: Information has been received from a registered nurse and a medical record concerning a 19 year old white female patient with no family history of sudden death or syncope who on 27-AUG-2007 at 12:00 (also reported as 11:30), was vaccinated IM with a first dose of GARDASIL (Lot# 658222/0927U). Around 12:20, the patient became pale, sweaty, and felt short of breath. The patient used her albuterol inhaler and her symptoms got worse. The patient then went to the emergency room. It was reported that in the emergency room the patient felt weak. The patient had a normal exam and was afebrile. After an observation period, the patient developed bilateral axillary "LAD" and some anterior cervical "LAD" also. No neck pain, stiffness, headache, fever, signs of pyelo or other infection was reported. Patient now has left tonsillitis with exudate. She was diagnosed with acute pharyngitis. Pregnancy test was negative. A throat culture was taken and strep test results were not reported at this time. On arrival to the emergency room, the patient had "QTc" of 495 on electrocardiogram (ECG). The patient was treated with a dose of prednisolone and was improving, ambulating, stable and afebrile. On 27-AUG-2007, the patient recovered. Discharge medications were penicillin v potassium 500 mg, one tablet by mouth four times a day for 10 days and prednisolone 20 mg tablets, 3 by mouth every day for 2 days. The patient should recheck her ECG and follow up with her primary medical doctor. It was reported that the physician was unclear if the patient had symptom's of allergy from GARDASIL or pharyngitis. On 29-AUG-2007, the patient began YASMIN. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Pallor, Pharyngitis, Pharyngitis streptococcal, Pregnancy test negative
Clinical narrative: Information has been received from a registered nurse and a medical record concerning a 19 year old white female patient with no family history of sudden death or syncope who on 27-AUG-2007 at 12:00 (also reported as 11:30), was vaccinated IM with a first dose of GARDASIL (Lot# 658222/0927U). Around 12:20, the patient became pale, sweaty, and felt short of breath. The patient used her albuterol inhaler and her symptoms got worse. The patient then went to the emergency room. It was reported that in the emergency room the patient felt weak. The patient had a normal exam and was afebrile. After an observation period, the patient developed bilateral axillary "LAD" and some anterior cervical "LAD" also. No neck pain, stiffness, headache, fever, signs of pyelo or other infection was reported. Patient now has left tonsillitis with exudate. She was diagnosed with acute pharyngitis. Pregnancy test was negative. A throat culture was taken and strep test results were not reported at this time. On arrival to the emergency room, the patient had "QTc" of 495 on electrocardiogram (ECG). The patient was treated with a dose of prednisolone and was improving, ambulating, stable and afebrile. On 27-AUG-2007, the patient recovered. Discharge medications were penicillin v potassium 500 mg, one tablet by mouth four times a day for 10 days and prednisolone 20 mg tablets, 3 by mouth every day for 2 days. The patient should recheck her ECG and follow up with her primary medical doctor. It was reported that the physician was unclear if the patient had symptom's of allergy from GARDASIL or pharyngitis. On 29-AUG-2007, the patient began YASMIN. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Tonsillitis
Clinical narrative: Information has been received from a registered nurse and a medical record concerning a 19 year old white female patient with no family history of sudden death or syncope who on 27-AUG-2007 at 12:00 (also reported as 11:30), was vaccinated IM with a first dose of GARDASIL (Lot# 658222/0927U). Around 12:20, the patient became pale, sweaty, and felt short of breath. The patient used her albuterol inhaler and her symptoms got worse. The patient then went to the emergency room. It was reported that in the emergency room the patient felt weak. The patient had a normal exam and was afebrile. After an observation period, the patient developed bilateral axillary "LAD" and some anterior cervical "LAD" also. No neck pain, stiffness, headache, fever, signs of pyelo or other infection was reported. Patient now has left tonsillitis with exudate. She was diagnosed with acute pharyngitis. Pregnancy test was negative. A throat culture was taken and strep test results were not reported at this time. On arrival to the emergency room, the patient had "QTc" of 495 on electrocardiogram (ECG). The patient was treated with a dose of prednisolone and was improving, ambulating, stable and afebrile. On 27-AUG-2007, the patient recovered. Discharge medications were penicillin v potassium 500 mg, one tablet by mouth four times a day for 10 days and prednisolone 20 mg tablets, 3 by mouth every day for 2 days. The patient should recheck her ECG and follow up with her primary medical doctor. It was reported that the physician was unclear if the patient had symptom's of allergy from GARDASIL or pharyngitis. On 29-AUG-2007, the patient began YASMIN. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Congenital naevus, Drug exposure during pregnancy, Jaundice neonatal, Pelvic pain, Torticollis
Clinical narrative: Initial and follow-up information has been received from the Merck Pregnancy Registry concerning an 18 year old female with no pertinent medical history who on 05-JUL-2007 was vaccinated with a first dose of Gardasil (Lot # 657868/0523U).  Concomitant therapy included ORTHO TRI-CYCLEN LO.  On 12-JUL-2007 an ultrasound was performed due to pelvic pain and the patient was found to be pregnant.  The patient's last menstrual period was on 06-JUN-2007 and the estimated date of delivery is 12-MAR-2008.  Unspecified medical attention was sought.  At the time of the report the patient's outcome was unknown.  Additional information has been requested. Medical records were received from the physician's office on 03-MAR-2008 the baby was in for a well child visit and was 5 days old. The baby was born full term by spontaneous vaginal delivery, no complications during pregnancy/delivery. The birth weight was 5 pounds 11 ounces, length was 18 inches. The patient had a black spot on the left foor and was diagnosed witht mongolian spots on legs. The baby also experienced newborn jaundice down to the face. On 28-FEB-2008 the baby also tilts head to the left with tightness on the left and was diagnosed with torticollis. The parents were instructed in stretching techniques while feeding, changing diapers and at play. On 28-FEB-2008, the patient was vaccinated with Hepatitis B virus vaccine (manufactiurer unknown). On 13-MAR-2008 the bab was seen and there was no jaundice. Upon internal review, mongplian spots wre considered to be a congenital anomaly. Subsequently the patient experienced adverse events after vaccination with hepatitis B virus vaccine (manufacturer unknown). Additional information has been requested.