chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.3
Sex: M
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, Rash generalised
Clinical narrative: Information has been received from a physician concerning a 15 month old male who was vaccinated with a dose of Proquad. Subsequently the patient experienced a rash all over. The patient returned to the office after 2 weeks with a rash all over. It appears that it is resolving on it's own. No medications or treatment were given for this experience. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Pruritus, Rash vesicular, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 13 month old female with no medical history and no allergies who on 13-MAR-2007 was vaccinated with a 0.5ml subcutaneous dose of Proquad (Lot#655845/1350F). There were no concomitant medications. On 01-MAY-2007 the patient developed two itchy varicella like lesions, one lesion on the left side of her chest and one lesion on the left side of her back. There were no laboratory or diagnostic tests performed. No further information was available at the time of this report. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 1.38
Sex: M
Vaccine: DTAP, HIBV, MMRV, PNC
Symptoms: Rash vesicular, Varicella post vaccine
Clinical narrative: Information was received from a registered nurse concerning a 12 month old male, with an unspecified medical history, who on 24-APR-2007 was vaccinated with a dose of ProQuad (lot number 656170/1400F). It was reported that on 29-APR-2007 the patient experienced a chicken pox like rash in the diaper area, five days after receiving the vaccination. Unspecified medical attention was sought. The patient's status was unknown. No laboratory tests were performed. No product quality complaint was involved. Additional information has been requested.  10/06/2007 This is in follow-up to report(s) previously submitted on 7/6/2007. Initial and follow-up information was received from a registered nurse concerning a 16 month old male, with no pertinent medical history, who on the morning of 24-APR-2007 was vaccinated subcutaneously into the left thigh with a dose of PROQUAD (Oka/Merck upgrade process) (Lot # 656170/1400F). Concomitant therapy included IM TRIPEDIA (Lot # 1813AB), administered into the right thigh IM, ACTHIB (Lot # UE868AA), administered into the right thigh IM, and PREVNAR (Lot # B08674H), administered into the left thigh IM. It was reported that on 29-APR-2007, five days after receiving the vaccination, the patient experienced chickenpox-like "rash" lesions in the diaper area and a low-grade temperature. Unspecified medical attention was sought. The lesions continued and were present for about ten days. The patient recovered. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: MMRV
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a physician concerning a female patient whose daughter on 24-APR-2007 was SC vaccinated with a dose of Proquad (Lot # 657190/0349U). It was reported that patient's mother developed shingles before 02-MAY02007. Unspecified medical attention was sought. No diagnostic laboratory procedures were undertaken. A product quality complaint was not involved. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: MMRV
Symptoms: Rash morbilliform
Clinical narrative: Information has been received from a physician concerning a 12 month old female, with no pertinent medical history, who on 24-APR-2007 was vaccinated with 0.5 ml of ProQuad (Lot # 656548/0095U). Concomitant therapy that same day included tuberculin purified protein derivative (PPD) tuberculin test. Twelve to thirteen days after immunization with ProQuad, on approximately 06-MAY-2007, the patient developed a generalized "measles like rash". The patient was treated with diphenhydramine hydrochloride. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Cold compress therapy, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning a child between the age of 4-6 years who in first week of May 2007 was vaccinated SC with second dose of ProQuad (Lot # 657262/0259U). It was reported that within 5 minutes to 12 hours after vaccination, the patient developed swelling, redness and warmth at injection site. The child was treated with cool compress. At the time of report the patient recovering. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female child with no medical history or allergies who on 30-APR-2007 at 4:00 PM was vaccinated SC on left arm with a dose of ProQuad (Lot# 656313/0298U). At the time of vaccination the patient did not have any illness. One day after vaccination, on 01-MAY-2007 the patient developed red, painful, swollen arm that was warm to touch. No medical attention was sought and no diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been received from the registered nurse who reconfirmed that the patient experienced a red, painful, swollen arm that was warm to the touch in the AM of 01-MAY-2007. It was reported that the patient recovered on 03-MAY-2007. No further information is expected. This is one of several reports received from same source.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 12 month old patient who was vaccinated with a dose of Proquad. It was reported that the patient developed a severe rash about 14 days after vaccination that was not measles like. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old male patient with no medical history or allergies who on 30-APR-2007 was vaccinated SC with 0.5 ml dose of Proquad (Lot # 656642/1556F). There was no concomitant medication. On 07-MAY-2007 the patient started experiencing an "on and off" fever of 100 F for about 1 week. The patient also developed a rash on the left thigh that looks like a group formation of 5 red bumps together. Unspecified medical attention was sought. No diagnostic laboratory procedures were performed. At the time of report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Dehydration, Fluid replacement, Pyrexia, Rash, Vomiting
Clinical narrative: Information has been received from a physician concerning a 5 year old patient with no history who on 10-MAY-2007 was vaccinated with 0.5 ml dose of ProQuad (Lot # 657297/0429U). There were no concomitant medication. On approximately 10-MAY-2007 the patient experienced fever, vomiting and rash. It was reported the patient had symptoms the night after vaccination and was seen in the office on approximately 11-MAY-2007 and received IV fluids due to dehydration. At the time of report, the patient was not recovered. No diagnostic laboratory procedures were undertaken. A product quality complaint was not involved. Additional information will be provided if available. This is one of several reports received from the same source.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning an approximately 4 to 6 year old female patient who on 13-APR-2007 was vaccinated with 0.5 ml dose of Proquad (Lot # 656312/0297U).Concomitant therapy included TB test on the forearm. It was reported that "within 24 hours of injection" on approximately 13-APR-2007, the patient developed redness, swelling, tenderness and induration at injection site. The reaction was reported to be 5x5 cm in area. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 12 month old female who on 01-MAY-2007 was vaccinated with "one dose" Proquad. On 11-MAY-2007 the patient developed a rash on her forehead. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.  10/06/2007 This is in follor-up to report(s) previously submitted on 7/6/2007. Follow up information was received from a physician who reported "not sure if it was a vaccine reaction. No case". Additional information is not expected.  Follow up information was received from a physician who reported "not sure if it was a vaccine reaction. No case. Follow up information was received from a health care provider who indicated "we do not have any patient, you are wrong", previously reported as a 12 month old female. No further information is expected.
Sex: U
Vaccine: MMRV
Symptoms: Body temperature increased, Pyrexia, Rash morbilliform
Clinical narrative: Information has been received from a nurse practitioner concerning a child who was vaccinated with a dose of Proquad. Subsequently the patient developed a fever over 101 and a measle-like rash 10 days post vaccine. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 12 month old male who on 24-APR-2007 was vaccinated with ProQuad (Lot #657264/0294U). On 03-MAY-2007 the patient experienced a fever over 101F. Medical attention was sought. The patient's outcome was not reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Diarrhoea, Pyrexia, Rash
Clinical narrative: Information has been received from a nurse concerning a 12 month old female who on 24-APR-2007 was vaccinated SC with a 0.5 mL of Proquad (Lot # 657264/0294U). On 03-MAY-2007 the patient experienced rash, diarrhea and fever of 102F. Medical attention was sought. The patient's outcome was not reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash macular
Clinical narrative: Information has been received from a health professional concerning a 12-month-old male who on 30-APR-2007 was vaccinated SC with 0.5 ml of ProQuad (Lot #657264/0294U). On 10-MAY-2007 the patient experienced fever and rash with macules on the torso and face. Medical attention was sought. The patient's outcome was not reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 12 month old male with no previous medical history and no drug reactions/allergies who on 25-APR-2007 was vaccinated subcutaneously with a 0.5 mL dose of Proquad (lot# 657264/0294U). There was no concomitant medication. On 08-MAY-2007 the patient developed a fever of 1010 F and a rash on his torso. The patient sought unspecified medical attention. The patient's outcome was not reported. There was no product quality complaint involved. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: MMRV
Symptoms: Body temperature increased, Pyrexia, Rash erythematous
Clinical narrative: Information has been received from a nurse concerning a 13 month old male with no medical history and no allergies who on 04-MAY-2007 was vaccinated with a 0.5 ml subcutaneous dose of ProQuad (Lot # 657264/0294U). There were no concomitant medications. On 14-MAY-2007, the patient developed a fever of 101 degrees fahrenheit and a roseola type rash on his face and torso. Unspecified medical attention was sought. No product quality complaint was sought. This is one of five reports received from the same source. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: MMRV
Symptoms: Rash papular, Rash vesicular
Clinical narrative: Information has been received from a health professional concerning a 16 month old female with no medical history and no allergies who on 05-JAN-2007 was vaccinated with a 0.5ml subcutaneous dose of ProQuad (Lot # 655845/1350F) in the left leg. There was no concomitant medication. On 13-MAY-2007 the patient experienced a couple of varicella spots on the left buttock. On 17-MAY-2007, the child's mother informed the prescriber that several clusters of papules spread down the posterior of the child's leg. No treatment was given. At the time of this report, the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 1.15
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC
Symptoms: Rash, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 13 month old female with no allergies or medical history who on 17-MAY-2007 was vaccinated SC on left thigh with 0.5 ml dose of ProQuad (Lot# 656446/1483F). Concomitant therapy included a dose of DTaP (+) tetanus toxoid, a dose of Vaqta, a dose of Pedvaxhib and a dose of Prevnar. There was no other concomitant medication. On 20-MAY-2007, the patient developed a rash which was described as six inches from the injection site on the left thigh. It was reported that less than 50 lesions were noted. Unspecified medical attention was sought. At the time of report the patient was recovering. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/6/2007. Information has been received from a registered nurse concerning a 13 month old female with no allergies or medical history who on 17-MAY-2007 was vaccinated SC on left thigh with the first dose of 0.5 ml dose of MMR II (Merck upgrade process) (Lot #656446/1483F). On 17-MAY-2007, concomitant vaccinations included the second dose of INFANRIX (Lot # AC148036AA) IM in the right thigh, a dose of HEP A (inactive), the second dose of PEDVAXHIB (Lot # 652222/1189R) IM in the right thigh and a second dose of PREVNAR (Lot #B086744) IM in the left thigh. There was no other concomitant medication. On 15-MAY-2007 also reported as 2-3 days following immunization, the patient had an "onset rash in diaper area" which resolvedin 4-5 days (recovery date also reported as 23-MAY-2007). The patient did not require medical care. On 20-MAY-2007, the patient developed a rash which was described as six inches from the injection site on the left thigh. It was reported that less than 50 lesions were noted. Unspecified medical attention was sought. At the time of report the patient was recovering. A product quality complaint was not involved. The patient's mother was expecting a baby and was concerned about chickenpox. Additional information has been requested.
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a male patient who on 13-APR-2007 was vaccinated with a dose of Proquad (Lot # 656312/0297U). It was reported that the patient developed redness, swelling, tenderness and induration at injection site on an unspecified date after vaccination, approximately April 2007. Additional information has been requested. This is one of several reports received from the same source.
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female patient who on 17-APR-2007 was vaccinated with a dose of ProQuad (Lot # 656312/0297U). It was reported that the patient developed redness, swelling, tenderness and induration at injection site on an unspecified date after vaccination, approximately April 2007. Additional information has been requested. This is one of several reports received from the same source.
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: It has been received from a physician concerning a female patient who on 17-APR-2007 was vaccinated with a dose of ProQuad (Lot # 656312/0297U). It was reported that the patient developed redness, swelling, tenderness and induration at injection site on an unspecified date after vaccination, approximately April 2007. Additional information has been requested. This is one of several reports received from the same source.
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female patient who on 17-APR-2007 was vaccinated with a dose of Proquad (Lot # 656312/0297U). It was reported that the patient developed redness, swelling, tenderness and induration at injection site on an unspecified date after vaccination, approximately April 2007. Additional information has been requested. This is one of several reports received from the same source,
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female patient who on 17-APR-2007 was vaccinated with a dose of ProQuad (Lot# 656312/0297U). It was reported that the patient developed redness. Swelling, tenderness and induration at injection site on an unspecified date after vaccination, approximately April 2007. Additional information has been requested. This is one of several reports received from the same source.
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a male patient who on 19-APR02007 was vaccinated with a dose of Proquad (Lot # 656312/0297U). It was reported that the patient developed redness, swelling, tenderness and induration at injection site on an unspecified date after vaccination approximately April 2007. Additional information has been requested. This is one of several reports received from the same source.
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a male patient who on 03-MAY-2007 was vaccinated with a dose of ProQuad (Lot # 657190/0349U). It was reported that the patient developed redness, swelling, tenderness and induration at injection site on an unspecified date after vaccination, approximately May 2007. Additional information has been requested. This is one of several reports received from the same source.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Vaccination failure, Varicella
Clinical narrative: Information has been received from a nurse concerning an approximately 12 month old male who "11 or 12" days ago", on approximately 12-May-2007 was vaccinated with Proquad. The patient developed breakthrough disease after receiving the vaccine. No further information was provided at the time of this report. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Information has been received from a physician concerning a 5 year old patient with no medical history who on 10-MAY-2007 was vaccinated with 0.5 ml dose of ProQuad (Lot # 657297/0429U). There were no concomitant medication. On approximately 10-MAY-2007 the patient experienced fever, vomiting and rash. It was reported that the patient had symptoms the night after vaccination and was seen in the office the next day on approximately 11-MAY-2007. At the time of report, the patient was not recovered. No diagnostic laboratory procedures were undertaken. A product quality complaint was not involved. Additional information will be provided if available. This is one of several reports received from the same source.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 12 month old patient who was vaccinated with a 0.5ml subcutaneous dose of ProQuad. About one week post vaccination, the patient developed chickenpox. No other information was available. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 5 year old male who on 23-MAY-2007 was vaccinated with Proquad. After receiving the vaccine, in May 2007, the patient developed swelling, erythema, induration and discoloration of the injection site. The area was "silver dollar sized". At the time of this report, the patient had not recovered. No further information was provided. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a patient who on 23-MAY-2007 was vaccinated with a dose of ProQuad. Concomitant vaccines administered the same day included a dose of Varivax. It was reported that the patient was vaccinated inadvertently with ProQuad instead of a dose of MMR II. There was no product confusion, it was a mistake on the part of the medical assistant. The patient is not experiencing any known symptoms. No product quality complaint was involved. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: MMRV
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 12 month old male with no allergies who on 19-APR-2007 was vaccinated with a subcutaneous dose of ProQuad Lot # 656941/0227U) in the right thigh. There was no concomitant medication. On 30-APR-2007 the patient developed a varicella-like rash at the injection site. There were no laboratory or diagnostic tests performed. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: DTAP, HEPAB, MMRV
Symptoms: Dizziness, Medication error, Nausea, Pregnancy
Clinical narrative: Information has been received through a Merck pregnancy registry concerning a female patient with no medical history or allergies who on 14-FEB-2007 was vaccinated SC with a 0.5mL dose of Proquad (lot number 655847/1386F). Concomitant vaccines given that day included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a dose of hepatitis A virus vaccine (unspecified (+) hepatitis B virus vaccine (unspecified) (lot number AHABB050AA). It was reported that the patient is now 6 weeks pregnant. The nurse stated that the vaccination record lists "MMRV" and she believes that the name of the vaccine was Proquad. Subsequently, about six weeks ago the patient experienced nausea, queasiness and dizziness related to her pregnancy. Unspecified medical attention was sought. The patient's status is not recovered. No diagnostic laboratory tests were performed. No product quality complaint was involved. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a 4 year old patient who was vaccinated with a single dose of Proquad. Subsequently the patient developed a rash which did not appear to be wild-type chicken pox. No additional information regarding the nature of the rash was provided. The prior vaccine history of the patient was not provided. Unspecified medical attention was sought. No product quality complaint was involved. The patient's six month old sibling also broke out with the same type of rash which did not appear to be wild-type chicken pox following this vaccination with Proquad. (WAES0706USA02678). Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 12-month-old female who was vaccinated with a dose of Varivax. Subsequently the patient developed fever. Subsequently, the patient recovered. Medical attention was sought. There was no product quality complaint involved. It was reported that this patient had a similar experience after vaccination with Proquad (WAES0704USA02190). Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Local reaction
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of Proquad. It was reported that the patient developed a local reaction after vaccination. Unspecified medical attention was sought. At the time of report, the patient had recovered. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Sex: U
Vaccine: MMRV
Symptoms: Local reaction
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of Proquad. It was reported that the patient developed a local reaction after vaccination. Unspecified medical attention was sought. At the time of report, the patient had recovered. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning a child between the age of 4-6 years who in first week of May 2007 was vaccinated SC with second dose of Proquad (Lot # 657262/0295U). It was reported that within 5 minutes to 12 hours after vaccination, the patient developed swelling, redness and warmth at injection site. The child was treated with cool compresses. At the time of report the patient recovering. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning a child between the age of 4-6 years who in first week of May 2007 was vaccinated SC with second dose of Proquad (Lot # 657262/0295U). It was reported that within 5 minutes to 12 hours after vaccination, the patient developed swelling, redness and warmth at injection site. The child was treated with KEFLEX. At the time of report the patient recovering. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Age: 0.5
Sex: U
Vaccine: MMRV
Symptoms: Rash, Secondary transmission
Clinical narrative: Information has been received from a nurse practitioner concerning a 6 month old whose sibling was vaccinated with a single dose of Proquad. It was reported that the patient broke out with the same type of rash which did not appear to be wild-type chicken pox. The patient's sibling developed a rash following vaccination with Proquad. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with Proquad. Subsequently, the patient experienced fever. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Injection site mass, Injection site pain
Clinical narrative: Information has been received from a health professional concerning over 150 patients who were vaccinated with Gardasil in the hip instead of the deltoid area. Many of the patient reported pain at the injection site and a lump forming at the injection site. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor
Clinical narrative: Information has been received from a physician concerning an 18 year old female who was vaccinated with Gardasil. After receiving her second dose of vaccine, the patient from turned "ghost white." The patient sought unspecified medical attention. On an unspecified date, the patient recovered with turning "ghost white." This is one of several reports received from the same source. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Incorrect route of drug administration
Clinical narrative: Information has been received from a LPN concerning an 18year old female with no pertinent medical history and no prior drug reactions who on 21-FEB-2007 was vaccinated with second dose Gardasil (Lot#653978/955F). Concomitant therapy included ORTHO TRI-CYCLEN and BENADRYL as needed for rash/itch. The patient was administered her first and second dose of Gardasil via the gluteus. The first dose was administered at another practice (not administered by the reporting nurse's practice). On 12-FEB_2007, the patient received her second dose of Gardasil and within minutes of vaccination, she experienced dizziness. Subsequently, after a few minutes, the patient recovered from dizziness. The patient sought unspecified medical attention. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Haemorrhage, Ultrasound abdomen, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a physician for the Pregnancy Registry of Gardasil concerning a 25 year old female with Von Willebrand's disease with a history of 0 pregnancies and 0 live births and a history of left retinoblastoma who on 13-DEC-2006 was vaccinated with Gardasil, lot # 654389/0961F. On 13-FEB-2007 she was vaccinated with Gardasil, lot # 656049/0187U expiration 29-SEP-2009. On 20-MAR-07 the patient went to the health clinic and a urine pregnancy test was performed and the results were positive (6 weeks gestation, LMP= approximately 23-JAN-2007). On 21-MAR-2007 the patient went to the hospital due to bleeding. A sonogram was performed and HCG levels were monitored. The patient was not hospitalized and she did not miscarry. The patient's HCG levels are being monitored. The patient was not hospitalized and she did not miscarry. The patient's HCG levels are being monitored. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Influenza like illness
Clinical narrative: Information has been received from a physician concerning a patient (age and gender not reported) who on unspecified dates was vaccinated with the first and second doses of Gardasil. Concomitant medication was not reported. Subsequently on an unspecified date, the patient experienced flu-like symptoms after receiving the first and second doses of Gardasil. The patient sought unspecified medical attention. The outcome and causality of the events were not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female with an empty stomach who was vaccinated with Gardasil. Subsequently the patient fainted immediately after receiving the Gardasil. Subsequently, the patient recovered from fainting. This is one of several reports received from the same source. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 17 year old female with an empty stomach who was vaccinated with Gardasil. Subsequently the patient fainted immediately after receiving the Gardasil. Subsequently, the patient recovered from fainting. This is one of several reports received from the same source. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Eye pruritus, Eye swelling
Clinical narrative: Initial and follow up information has been received from a physician concerning a 14 year old female student with possible penicillin allergy who on 02-APR-2007 was vaccinated IM with a first dose 0.5 mL of Gardasil lot # 655205/1426F. On 02-APR-2007 the patient developed swollen eyes after receiving the injection. On 03-APR-2007 the patient was seen in the emergency room (E.R.) for swollen eyes and itching and was given BENADRYL intravenous (IV) and ATERAX by mouth (PO). No abnormality of the eye found. On 05-APR-2007 the patient recovered. In follow up it was indicated that on 03-APR-2007, at AM patient developed swollen eyes and itching. She was seen in the emergency room (E.R.) on 03 APR-2007 and no abnormality of the eyes found. She was given treatment of BENADRYL intravenous (IV) and ATERAX by mouth. On 05-APR-2007 patient recovered. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Initial and follow up information has been received from the nursing staff and practice manager of a pediatric practice concerning patients who were vaccinated with a dose of Gardasil and experienced injection site pain routinely when the Gardasil was given. The number of patients experiencing the injection site pain was unreported, and it was unknown if medical attention was sought. The outcome was unknown. The reporter reported that one other pediatric office and another physician reported patient experiencing pain after receiving the Gardasil. In follow up it was indicated by the practice manager that the pain was a generalization that the girls were reporting a tenderness after the shot of Gardasil, but they were coming back for the second and third dose. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Metrorrhagia, Nausea, Pregnancy, Ultrasound abdomen
Clinical narrative: Initial and follow up information has been received for a Merck Pregnancy Registry via a health professional concerning a female who on 06-SEP-2006 was vaccinated with the first dose of Gardasil (lot not reported). On 08-NOV-2006, the patient was vaccinated with the second dose of Gardasil (lot reported as "9725101"). The patient was found to be pregnant after receiving her second dose, and it was noted as "second trimester". Routine vital signs were noted to be performed. The patient sought unspecified medical attention. Additional information has been received concerning the 24 year old female who had her last menstrual period on 27-FEB-2007 (estimated date of delivery, 04-NOV-2007). From 23-MAR-2007 to 03-MAY-2007 the patient was treated with PROMETRIUM, 200 mg BID, for low progesterone. From 23-MAR-2007 to the present she was treated with PHENERGAN, 25 mg PRN for nausea. On 26-MAR-2007 an ultrasound was performed due to "spotting". The results of test were "Early IOP". Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of Gardasil (lot number unknown). The physician reported that the patient experienced pain at the injection site after receiving the Gardasil routinely; however she had not had any issues with patients coming back for the second and third injections. The outcome was unknown. Additional information was received from the office manager via phone call who reported that the pain did not linger. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from the nursing staff of a pediatric practice concerning patients who were vaccinated with a dose of Gardasil (lot number unknown) and experienced pain at the injection site after receiving Gardasil. The pain was worse than the pain with other vaccines. The outcome was unknown. Additional information was received from a registered nurse via phone call who reported that there were too many patients to quantify who complained about the pain of the injection. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Chest pain, Electrocardiogram normal, Ultrasound scan normal
Clinical narrative: Information has been received from a physician concerning a 22 year old female with no pertinent medical history and no history of drug reaction/allergies who in January 2007, was vaccinated with a first dose of Gardasil (lot # not reported) 0.5 ml IM. Concomitant therapy included hormonal contraceptives (unspecified). In March 2007, the patient experienced left sided chest pain. Medical attention was sought. There was no radiation and treatment prescribed. In March 2007, the patient had an electrocardiogram, blood work and ultrasound performed; all results were negative. The patient was taking birth control but was discontinued in march 2007. The pain resolved on its own. When the patient was seen again by the physician at the end of April 2007, the pain had resolved completely. The physician restarted the birth control after the patient's visit in April, 2007. The patient was requesting the second dose of Gardasil. No additional information was available at the time of reporting. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old white female who on 25-APR-2007 was vaccinated IM into the right deltoid with a 0.5 ml first dose of Gardasil (lot# 657621/0387U). On 25-APR-2007 the patient experienced pain at the injection site for three to four weeks after her injection. The patient obtained relief with MOTRIN. The patient has occasional discomfort at the injection site with movement currently. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Epstein-Barr virus antibody negative, Epstein-Barr virus infection, Rash generalised, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 13 year old female with penicillin allergy who on 29-MAY-2007 was vaccinated IM with 0.5 ml of the first dose of Gardasil (Lot #654702/0011U). There was no concomitant medication. On 30-MAY-2007 the patient experienced an all over body rash with itching. Prior to the injection, the patient complained of her eyes hurting, an upper respiratory infection, and fatigue. The patient did not have a fever. The physician performed an Epstein-Barr titer that came back with a result of "convalescencing". The patient was given Depo-Medrol on 30-MAY-2007 and Garamycin ointment for her eye. As of 01-JUN-2007, the patient was recovering. Medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Dizziness, Nausea, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female patient who on 31-MAY-2007 was vaccinated IM with a first 0.5ml dose of Gardasil (Lot# 657005/0314U). On 31-MAY-2007, the patient experienced a fever of 102 deg F along with dizziness and nausea. Unspecified medical attention was sought. At the time of this report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Abdominal pain lower, Computerised tomogram normal
Clinical narrative: Information has been received from a physician concerning an "18 year old" female who on 18-MAY-2007 who on 18-MAY-2007 was vaccinated IM in her left arm with Gardasil. Concomitant therapy included VAQTA and BOOSTRIX. On 19-MAY-2007 the patient experienced severe lower right abdominal pain. The patient sought medical attention at the hospital and had a CT Scan performed. It was reported the CT Scan was normal and the patient was not admitted to the hospital. Subsequently, the patient recovered from severe lower right abdominal pain. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal chest pain
Clinical narrative: Information has been received from a 22 year old female nurse who on 23-MAY-2007 was vaccinated with the first dose of Gardasil. On 24-MAY-2007 the patient experienced pain in her oblique muscles of her rib area. Subsequently, the patient recovered from pain in her oblique muscles of her rib area. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a nurse concerning a 21 year old female patient who on 24-MAY-2007 was vaccinated with Gardasil. On 25-MAY-2007 the patient experienced dizziness and nausea. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/6/2007. Initial and follow-up information has been received from a nurse practitioner and a licensed practical nurse concerning a 21 year old female student, who on 24-MAY-2007 in the am, was vaccinated IM in the deltoid with a second dose of GARDASIL (lot # 654272/0319U). On 25-MAY-2007 the patient experienced dizziness and nausea. The patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who on 25-MAY-2007 was vaccinated with the second dose of GARDASIL (Lot #657736/0389U). Concomitant therapy included medroxyprogesterone acetate (DEPO-PROVERA). On 25-MAY-2007 the patient fainted after receiving the vaccination. The patient recovered that day and plans to receive the third injection of the vaccine. Medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Leukopenia, Platelet count decreased, Pyrexia, White blood cell count decreased
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who was vaccinated with a dose of Gardasil. The physician reported that "the patient was not pregnant but had miscarried three weeks prior" to vaccination. "Weeks of gestation was not known." The patient was seeing again by the physician on 07-JUN-2007. It was reported that two days after the patient received her dose of Gardasil, she was sent to the emergency room because she had developed a fever, leucopenia, and a lower platelet count of 80,000 (also reported as 86,000). The patient was treated with ciprofloxacin hydrochloride (CIPROFLOXACIN) and was sent home. The physician reported that "she has done well" but has a "big knot at the injection site, outer later quad in her leg (specific leg not specified)" which was "red before, no longer red now, just a knot, a fibrinous deposition there." The patient was told by her hematologist that "it was the vaccine and that this can happen in an immunization situation and not to take it again." The physician stated that "they need to find out what exactly caused this reaction in her." It was reported that "she has no other significant allergies but a family history of allergies, specifically a strong history of allergy to iodine dye used in radiology procedures." The patient "never wants to attempt any dye after all this." There was no product quality complaint. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose normal, Blood pressure decreased, Computerised tomogram normal, Dyskinesia, Electrocardiogram normal
Clinical narrative: Information has been received from a nurse concerning her 20 year old daughter with a history of sulfonamide allergy who on 15-MAY-2007 was vaccinated with the second dose of GARDASIL (lot number not provided). Concomitant therapy included hormonal contraceptive (unspecified). On 24-MAY-2007 the patient fainted under the hair dryer at a beauty salon. The patient reported feeling hot then slumped forward unconscious. She was  sweaty, her lips were white, and her right side was jerking. The paramedics were called and they could not find a pulse but her blood pressure was low and her blood sugar was 65. She came to before being transported to the emergency clinic and had blurred vision. At the hospital her left side began jerking, her left arm was rigid, and she had a severe headache and nausea. She had many lab tests in the clinic including an electrocardiogram which was normal, a CT scan that was normal except for sinusitis. She had no fever her pulse ox was 99, pulse 80 on arrival then 64 later, her blood pressure was 78/50 on arrival then 90/60 later, and her blood sugar was 85. She was not admitted. Subsequently, the patient recovered from fainted, sinusitis, left arm rigid, left side jerking, blurred vision, right side jerking, right side jerking, loss of consciousness, severe headache and nausea. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Headache, Heart rate normal, Hyperhidrosis, Loss of consciousness
Clinical narrative: Information has been received from a nurse concerning her 20 year old daughter with a history of sulfonamide allergy who on 15-MAY-2007 was vaccinated with the second dose of GARDASIL (lot number not provided). Concomitant therapy included hormonal contraceptive (unspecified). On 24-MAY-2007 the patient fainted under the hair dryer at a beauty salon. The patient reported feeling hot then slumped forward unconscious. She was  sweaty, her lips were white, and her right side was jerking. The paramedics were called and they could not find a pulse but her blood pressure was low and her blood sugar was 65. She came to before being transported to the emergency clinic and had blurred vision. At the hospital her left side began jerking, her left arm was rigid, and she had a severe headache and nausea. She had many lab tests in the clinic including an electrocardiogram which was normal, a CT scan that was normal except for sinusitis. She had no fever her pulse ox was 99, pulse 80 on arrival then 64 later, her blood pressure was 78/50 on arrival then 90/60 later, and her blood sugar was 85. She was not admitted. Subsequently, the patient recovered from fainted, sinusitis, left arm rigid, left side jerking, blurred vision, right side jerking, right side jerking, loss of consciousness, severe headache and nausea. Additional information has been requested.