chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: White blood cell count increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act concerning a 16 year old female with low blood who on 23-MAY-2008 completed the series of GARDASIL (lot number 660391/0063X). Concomitant therapy included ORTHO EVRA and ZOMIG. The patient was hospitalized for 5 days, from 02-JUL-2008 to 07-JUL-2008, for severe, first-ever pancreatitis. The diagnosis was Acute pancreatitis possibly secondary to hypertriglyceridaemia. The patient also experienced mild iron deficiency anemia, obesity, protein malnutrition, fevers, elevated inflammatory markers, dyslipidaemia and complained of one day history of severe abdominal pain. On 04-AUG-2008 records received showed the following laboratory test, white blood cell count: 21.1, erythrocyte sedimentation rate: 55, f serum cholesterol test: 223, serum triglyceride test: 260, serum high-density lipoprotein cholesterol test: 62, serum low-density lipoprotein cholesterol test: 109, blood hemoglobin test: 12.5, blood chemistry: normal, hepatic function tests: elevated, serum amylase test: 112, white blood cell count: 20,000, pancreatic abdominal computed axial tomography consistent with pancreatitis. The patients was recovering from elevated inflammatory markers. The patient's older sister had pancreatitis at roughly the same age and was recently diagnosed with pancreatitis and diabetes mellitus. Mild iron deficiency anaemia, acute pancreatitis, severe abdominal pain, dyslipidaemia, hypertriglyceridaemia, elevated inflammatory markers, protein malnutrition, obesity and fever were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 319654-1. A standard lot check investigation was performed. All in-process quality checks for the lot # 660391/0063X were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements and was released. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Immediate post-injection reaction, Injection site atrophy, Injection site pain, Muscle atrophy
Clinical narrative: Information has been received from a nurse practitioner concerning a 13 year old female with no pertinent medical history or history of drug reactions or drug allergies who on 30-OCT-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast). On approximately 03-MAR-2008, "two days prior to" the second vaccination, the patient had received a steroid injection in the gluteal area, for the treatment of allergies. On 05-MAR-2008 the patient was vaccinated intramuscularly in the left arm with the first 0.5 ml dose of GARDASIL vaccine (yeast) (lot no. 655604/0052X). Concomitant therapy included YAZ, CLARITIN and ADDERALL TABLETS. On the same day, "after her second immunization", the patient developed pain and muscle tissue atrophy at the injection site. On 01-AUG-2008 the patient was vaccinated with the third dose of GARDASIL vaccine (yeast). At the time of this report, the patient was recovering from the symptoms. The patient sought unspecified medical attention via office visit. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site atrophy, Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 13 year old female with no pertinent medical history or history of drug reactions or drug allergies who on 30-OCT-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast). On approximately 03-MAR-2008, "two days prior to" the second vaccination, the patient had received a steroid injection in the gluteal area, for the treatment of allergies. On 05-MAR-2008 the patient was vaccinated intramuscularly in the left arm with the first 0.5 ml dose of GARDASIL vaccine (yeast) (lot no. 655604/0052X). Concomitant therapy included YAZ, CLARITIN and ADDERALL TABLETS. On the same day, "after her second immunization", the patient developed pain and muscle tissue atrophy at the injection site. On 01-AUG-2008 the patient was vaccinated with the third dose of GARDASIL vaccine (yeast). At the time of this report, the patient was recovering from the symptoms. The patient sought unspecified medical attention via office visit. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Culture stool negative, Diarrhoea, Rotavirus test negative
Clinical narrative: Information has been received from a physician concerning a 6 month old Asian male who on 29-JAN-2008 was vaccinated orally with his first dose of ROTATEQ vaccine live (human-bovine) (lot# 660379/0144X). On 28-MAR-2008 the patient was vaccinated orally with his second dose of ROTATEQ vaccine live (human-bovine) (lot# 660379/0144X). On 02-JUN-2008 the patient was vaccinated orally with his third dose of ROTATEQ vaccine live (human-bovine) (lot# 660379/0144X). Concomitant therapy included PREVNAR vaccine (CRM197) intramuscularly (lot# C49912), Hib conj vaccine (unspecified carrier) intramuscularly (lot# UF365AC) and diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (PEDIARIX) intramuscularly (lot# AC21156BA). On 09-JUN-2008 the patient experienced diarrhea "looser than usual" stools. Stool frequency increased to 4 times a day one week after administration. Some stools noted to be blood tinged. Stool culture, exam for O and P, and rotavirus antigen were all negative. Subsequently, the patient's symptoms resolved after three weeks. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Culture stool negative, Diarrhoea, Haematochezia, Rotavirus test negative
Clinical narrative: Information has been received from a physician concerning a 6 month old Asian male who on 29-JAN-2008 was vaccinated orally with his first dose of ROTATEQ vaccine live (human-bovine) (lot# 660379/0144X). On 28-MAR-2008 the patient was vaccinated orally with his second dose of ROTATEQ vaccine live (human-bovine) (lot# 660379/0144X). On 02-JUN-2008 the patient was vaccinated orally with his third dose of ROTATEQ vaccine live (human-bovine) (lot# 660379/0144X). Concomitant therapy included PREVNAR vaccine (CRM197) intramuscularly (lot# C49912), Hib conj vaccine (unspecified carrier) intramuscularly (lot# UF365AC) and diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (PEDIARIX) intramuscularly (lot# AC21156BA). On 09-JUN-2008 the patient experienced diarrhea "looser than usual" stools. Stool frequency increased to 4 times a day one week after administration. Some stools noted to be blood tinged. Stool culture, exam for O and P, and rotavirus antigen were all negative. Subsequently, the patient's symptoms resolved after three weeks. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4
Symptoms: Activities of daily living impaired, Dizziness, Hypoaesthesia, Pallor, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 12 year old female with no pertinent medical history and no drug reactions or allergies, who on 22-APR-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 659657/1487U). Concomitant therapy included meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. After vaccination on an unspecified date in 2008, the patient was sick for 72 hours with fever and dizziness. The patient's arm also became numb and was tingling. The patient sought unspecified medical attention. It was noted that when the patient went for her second dose of GARDASIL vaccine (yeast) on 22-JUL-2008, she told the physician about what happened after the first dose and then, the second dose was not given. The GARDASIL vaccine (yeast) series was discontinued. At time of reporting, the patient was recovered. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 12 year old female with no pertinent medical history and no drug reactions or allergies, who on 22-APR-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 659657/1487U). Concomitant therapy included meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. After vaccination on an unspecified date in 2008, the patient was sick for 72 hours with fever and dizziness. The patient's arm also became numb and was tingling. The patient sought unspecified medical attention. It was noted that when the patient went for her second dose of GARDASIL vaccine (yeast) on 22-JUL-2008, she told the physician about what happened after the first dose and then, the second dose was not given. The GARDASIL vaccine (yeast) series was discontinued. At time of reporting, the patient was recovered. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4
Symptoms: Dizziness, Hypoaesthesia, Paraesthesia, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 12 year old female with no pertinent medical history and no drug reactions or allergies, who on 22-APR-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 659657/1487U). Concomitant therapy included meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. After vaccination on an unspecified date in 2008, the patient was sick for 72 hours with fever and dizziness. The patient's arm also became numb and was tingling. The patient sought unspecified medical attention. It was noted that when the patient went for her second dose of GARDASIL vaccine (yeast) on 22-JUL-2008, she told the physician about what happened after the first dose and then, the second dose was not given. The GARDASIL vaccine (yeast) series was discontinued. At time of reporting, the patient was recovered. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MNQ, HPV4
Symptoms: Drug exposure during pregnancy
Clinical narrative: Information has been received from the Merck pregnancy registry, a physician reported on a 19 year old female with no pertinent medical history and no known drug reactions/allergies who on 07-AUG-2008 was vaccinated with the first GARDASIL (lot # 660393/0067X), 0.5mL. IM. Concomitant therapy included MENACTRA and ORTHO EVRA contraceptive patch. The patient experienced abdominal pain and was evaluated in an emergency room but she was not admitted to the hospital. On an unspecified date, an urine test was positive for pregnancy (LMP 26-JUN-2008) (estimated delivery date 02-APR-2009). Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MNQ, HPV4
Symptoms: Abdominal pain, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from the Merck pregnancy registry, a physician reported on a 19 year old female with no pertinent medical history and no known drug reactions/allergies who on 07-AUG-2008 was vaccinated with the first GARDASIL (lot # 660393/0067X), 0.5mL. IM. Concomitant therapy included MENACTRA and ORTHO EVRA contraceptive patch. The patient experienced abdominal pain and was evaluated in an emergency room but she was not admitted to the hospital. On an unspecified date, an urine test was positive for pregnancy (LMP 26-JUN-2008) (estimated delivery date 02-APR-2009). Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, VARCEL, HEPA, HPV4, TTOX, VARCEL
Symptoms: Blood pressure, Immediate post-injection reaction, Nausea, Syncope
Clinical narrative: Information has been received from a consumer concerning her 12 year old daughter who on 04-AUG-2008 was vaccinated with GARDASIL (yeast). VARIVAX (dose not reported), VAQTA (inactive) (manufacturer unknown) and tetanus toxoid (manufacturer unknown). On 04-AUG-2008, after being vaccinated with GARDASIL her daughter reported the vaccination stung. Then, she felt dizzy, developed a blank expression on her face, her arms tightened, her head dropped forward and she fainted. She was pale and felt nauseated and her blood pressure was 90/50. She sat at the doctor's office for 10-15 minutes. The arm that had the vaccination for tetanus toxoid also hurt. The patient had eaten very little before vaccination. The patient sought medical attention at the clinic. On 04-AUG-2008, the patient recovered from the events.  Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, VARCEL, HEPA, HPV4, TTOX, VARCEL
Symptoms: Blood pressure, Dizziness, Immediate post-injection reaction, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Information has been received from a consumer concerning her 12 year old daughter who on 04-AUG-2008 was vaccinated with GARDASIL (yeast). VARIVAX (dose not reported), VAQTA (inactive) (manufacturer unknown) and tetanus toxoid (manufacturer unknown). On 04-AUG-2008, after being vaccinated with GARDASIL her daughter reported the vaccination stung. Then, she felt dizzy, developed a blank expression on her face, her arms tightened, her head dropped forward and she fainted. She was pale and felt nauseated and her blood pressure was 90/50. She sat at the doctor's office for 10-15 minutes. The arm that had the vaccination for tetanus toxoid also hurt. The patient had eaten very little before vaccination. The patient sought medical attention at the clinic. On 04-AUG-2008, the patient recovered from the events.  Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, VARCEL, HEPA, HPV4, TTOX, VARCEL
Symptoms: Nausea, Pallor, Syncope
Clinical narrative: Information has been received from a consumer concerning her 12 year old daughter who on 04-AUG-2008 was vaccinated with GARDASIL (yeast). VARIVAX (dose not reported), VAQTA (inactive) (manufacturer unknown) and tetanus toxoid (manufacturer unknown). On 04-AUG-2008, after being vaccinated with GARDASIL her daughter reported the vaccination stung. Then, she felt dizzy, developed a blank expression on her face, her arms tightened, her head dropped forward and she fainted. She was pale and felt nauseated and her blood pressure was 90/50. She sat at the doctor's office for 10-15 minutes. The arm that had the vaccination for tetanus toxoid also hurt. The patient had eaten very little before vaccination. The patient sought medical attention at the clinic. On 04-AUG-2008, the patient recovered from the events.  Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 03-JUN-2008 was vaccinated with the first dose of GARDASIL (lot # 659184/0843X) and no AE was reported. On 07-AUG-2008 the patient was vaccinated with the second dose of GARDASIL (lot # 659184/0843X). On 11-AUG-2008 the patient experienced an on going dizziness and faint feeling after getting the second does. The patient sought medical attention. The patient  was noted to be recovering. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 03-JUN-2008 was vaccinated with the first dose of GARDASIL (lot # 659184/0843X) and no AE was reported. On 07-AUG-2008 the patient was vaccinated with the second dose of GARDASIL (lot # 659184/0843X). On 11-AUG-2008 the patient experienced an on going dizziness and faint feeling after getting the second does. The patient sought medical attention. The patient  was noted to be recovering. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 14-AUG-2008 was vaccinated with the third dose of GARDASIL (lot no. 659964/1978U) and the second dose of VARIVAX (lot no. 659953/0329X). On 15-AUG-2008 the patient had a "quarter size rash" on her arm. Subsequently, on an unspecified date, the patient was recovered. The patient contacted the physician's office to seek unspecified medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 14-AUG-2008 was vaccinated with the third dose of GARDASIL (lot no. 659964/1978U) and the second dose of VARIVAX (lot no. 659953/0329X). On 15-AUG-2008 the patient had a "quarter size rash" on her arm. Subsequently, on an unspecified date, the patient was recovered. The patient contacted the physician's office to seek unspecified medical attention. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: C-reactive protein, Fatigue, Full blood count, Genital cyst, Metabolic function test
Clinical narrative: Information has been received from a physician concerning an 11 year old female with no medical history who on an unspecified date was vaccinated with the first dose of GARDASIL and on 05-AUG-2008 was vaccinated with the second dose of GARDASIL IM. There was no illness at the time of vaccination. On 06-AUG-2008 the patient experienced rash on genital area and was noted to be tired all summer long. At the time of reporting, the outcome of the patient was unknown. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Mononucleosis heterophile test
Clinical narrative: Information has been received from a physician concerning an 11 year old female with no medical history who on an unspecified date was vaccinated with the first dose of GARDASIL and on 05-AUG-2008 was vaccinated with the second dose of GARDASIL IM. There was no illness at the time of vaccination. On 06-AUG-2008 the patient experienced rash on genital area and was noted to be tired all summer long. At the time of reporting, the outcome of the patient was unknown. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Genital rash, White blood cell count decreased
Clinical narrative: Information has been received from a physician concerning an 11 year old female with no medical history who on an unspecified date was vaccinated with the first dose of GARDASIL and on 05-AUG-2008 was vaccinated with the second dose of GARDASIL IM. There was no illness at the time of vaccination. On 06-AUG-2008 the patient experienced rash on genital area and was noted to be tired all summer long. At the time of reporting, the outcome of the patient was unknown. Additional information is not expected.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a nurse concerning a teenager female who was vaccinated with all 3 doses of GARDASIL vaccine (yeast) and contracted the high risk type of HPV. It is unknown if the patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a nurse concerning a teenager female who was vaccinated with all 3 doses of GARDASIL vaccine (yeast) and contracted the high risk type of HPV. It is unknown if the patient sought medical attention. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth, Musculoskeletal pain
Clinical narrative: Initial report was received 11 September 2008 from a health care professional.  A 21-year-old female patient had a past history of amoxicillin allergy, had received a first dose intramuscular right arm injection of ADACEL, lot number C2996AA and a first dose intramuscular left arm injection of GARDASIL (manufacturer Merck), lot number 0052X on 05 September 2008 and one day later, she developed a red raised 6cm diameter hot area at the injection site (arm not specified).  On 08 September 2008, three days post vaccination, the patient developed right arm pain from her shoulder to her hand.  She was evaluated by her physician on 11 September 2008 who diagnosed the patient with brachial neuritis.  Laboratory and diagnostic testing had not been performed.  The reporter stated that the patient had previously experienced a "swollen arm after TB test".  At the time of the report, the patient's recovery status was unknown.  No further information was provided.
Age: 21.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Pain in extremity, Radiculitis brachial
Clinical narrative: Initial report was received 11 September 2008 from a health care professional.  A 21-year-old female patient had a past history of amoxicillin allergy, had received a first dose intramuscular right arm injection of ADACEL, lot number C2996AA and a first dose intramuscular left arm injection of GARDASIL (manufacturer Merck), lot number 0052X on 05 September 2008 and one day later, she developed a red raised 6cm diameter hot area at the injection site (arm not specified).  On 08 September 2008, three days post vaccination, the patient developed right arm pain from her shoulder to her hand.  She was evaluated by her physician on 11 September 2008 who diagnosed the patient with brachial neuritis.  Laboratory and diagnostic testing had not been performed.  The reporter stated that the patient had previously experienced a "swollen arm after TB test".  At the time of the report, the patient's recovery status was unknown.  No further information was provided.
Age: 21.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Initial report was received 11 September 2008 from a health care professional.  A 21-year-old female patient had a past history of amoxicillin allergy, had received a first dose intramuscular right arm injection of ADACEL, lot number C2996AA and a first dose intramuscular left arm injection of GARDASIL (manufacturer Merck), lot number 0052X on 05 September 2008 and one day later, she developed a red raised 6cm diameter hot area at the injection site (arm not specified).  On 08 September 2008, three days post vaccination, the patient developed right arm pain from her shoulder to her hand.  She was evaluated by her physician on 11 September 2008 who diagnosed the patient with brachial neuritis.  Laboratory and diagnostic testing had not been performed.  The reporter stated that the patient had previously experienced a "swollen arm after TB test".  At the time of the report, the patient's recovery status was unknown.  No further information was provided.
Age: 21.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Radiculitis brachial
Clinical narrative: Initial report was received 11 September 2008 from a health care professional.  A 21-year-old female patient had a past history of amoxicillin allergy, had received a first dose intramuscular right arm injection of ADACEL, lot number C2996AA and a first dose intramuscular left arm injection of GARDASIL (manufacturer Merck), lot number 0052X on 05 September 2008 and one day later, she developed a red raised 6cm diameter hot area at the injection site (arm not specified).  On 08 September 2008, three days post vaccination, the patient developed right arm pain from her shoulder to her hand.  She was evaluated by her physician on 11 September 2008 who diagnosed the patient with brachial neuritis.  Laboratory and diagnostic testing had not been performed.  The reporter stated that the patient had previously experienced a "swollen arm after TB test".  At the time of the report, the patient's recovery status was unknown.  No further information was provided.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pyrexia, Rash generalised
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from a registered nurse concerning a 11 year old female who on 11-JUL-2008 was vaccinated with a dose of GARDASIL and MENACTRA. On 12-JUL-2008, the patient experienced fever and rash all over her body. The patient was also given a TB test On 10-JUL-2008 one day prior to getting GARDASIL, on 10-JUL-2008. No laboratory test was performed. The patient outcome was not reported. The patient sought medical attention by contacting the office. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Contraception
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with the first dose of GARDASIL IM and recently received the second dose of GARDASIL. The patient was also started on a new birth control pill, YAZ when the first dose of GARDASIL was given. After the first dose of GARDASIL, the patient experienced abdominal pain. The patient has had abdominal pain since the first dose of GARDASIL. At the time of the reporting, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a nurse practitioner in physician's office concerning a female who was vaccinated with GARDASIL IM, no Lot number was provided. Nurse practitioner reported that a patient experienced a widely disseminated rash all over her body 4 weeks after receiving the vaccine. No further information was provided. At the time of the report the patient symptoms were resolved. The patient sought medical attention. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from an office manager concerning a 12 year old female patient who on an unspecified date was vaccinated with the first dose of GARDASIL. On 14-NOV-2007, was vaccinated with the second dose of GARDASIL and is sick. Specific symptoms unspecified. Patient contacted the office by phone and is coming into the office tomorrow (18-JUL-2008). At the time of reporting the patient had not recovered. Follow-up information was received from the physician who reported that the sickness was allergies that were not relative to vaccine. The patient's sibling also had an adverse experienced after vaccination with GARDASIL. (WAES # 0807USA03685). No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Contraception, Dizziness, Headache
Clinical narrative: Information has been received from an office manager concerning a 20 year old female who was vaccinated with the first and second dose of GARDASIL and did not have any problems. In March 2008, the patient was vaccinated with the third dose of GARDASIL. Concomitant medication included birth control (unspecified). Following the third dose of GARDASIL, the patient experienced continued constant dizziness and headache. The time development of the dizziness and headache were unspecified. The patient went to her primary physician (name unspecified) for treatment of the dizziness and headaches. At the time of reporting, the patient had not yet recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Convulsion, Malaise, Muscle rigidity, Pallor
Clinical narrative: Information has been received from a nurse practitioner concerning a female in her early 20's who on 09-SEP-2008 was vaccinated with the first dose of GARDASIL and experienced a vaso vascular episode or seizure following administration of vaccine. There was no concomitant medication. The patient received the vaccination and stated that she did not feel well. The patient was assisted to a chair and laid her head back against the wall. The patient called a nurse and had placed her head on the desk. Effort was made to have the patient sit up and placed her between her knees. She became rigid and made snorting noises. The patient was lowered to the floor and woke up in a few seconds. She was pale and clammy, blood pressure was 108/72. Patient was treated with an ice pack to the back of the neck. Within 15 minutes the patient reported feeling better and went home. the events were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Leukaemia, Malaise
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL (lot number, injection site and route not reported).  The patient "not long after began to not feel well".  The patient was then diagnosed with leukemia.  The physician heard this information from another source.  The physician is not the patient's physician.  The physician also mentioned that the patient and her parents will be moving soon.  Unspecified medical attention was sought.  The patient's outcome was unspecified.  Upon internal review, leukemia is considered to be an other important medical event.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Hypersensitivity
Clinical narrative: Information has been received from a 19 year old female patient, who on 30-JAN-2008, was vaccinated with the first dose of GARDASIL. On 02-APR-2008, the patient was vaccinated with the second dose of GARDASIL ((Lot # 655327/1287U). Concomitant therapy included birth control pills. The consumer reported that after received the second dose of GARDASIL and within 24 hours on 04-APR-2008 she was admitted to the ER. The consumer reported that the hospital releasing statement was that she had an allergic reaction. She complained that she couldn't walk. She was given BENADRYL in the hospital I.V. At the time of the report the patient had recovered. Not being able to walk was considered disabling. Additional information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Alkalosis, Drug exposure during pregnancy, Human papilloma virus test negative, Premature labour, Renal failure
Clinical narrative: Information has been received through the Merck pregnancy registry from a physician concerning a 17 year old female with a history of a pap smear on 01-DEC-2006 that was positive for HPV and showed ASCUS, and a colposcopy on 11-JAN-2007 which showed LGSIL, who on approximately 03-JUN-2008 was vaccinated with a first dose of GARDASIL (route and administrating site not reported) at her primary care provider's office. The patient found out she was pregnant about 3 or 4 weeks after receiving the GARDASIL. The patient has a follow up exam scheduled with the physician. The patient sought medical attention by calling the office. The patient's last menstrual period was approximately 21-JAN-2008. The estimated due date is 24-OCT-2008. An ultrasound test perform on 11-JUN-2008 indicated a SIUP at 20 weeks and 3 days. On 26-JUN-2008 a pap smear was negative for HPV. Follow-up information was received from a registered nurse indicating that on 26-JUN-2008 a toxoplasma IgG and IgM was performed with a positive result. Spiramycin was used from 18-JUL-2008 to 11-AUG-2008 for the treatment of toxoplasmosis. The patient's complications during pregnancy included renal failure and alkalosis. On 26-AUG-2008 the patient gave birth prematurely at 31 weeks. The birth weight of the female infant was 1630 gm. Upon internal review the premature birth and the mother's renal failure were determined to be other important medical events. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Toxoplasma serology positive, Toxoplasmosis, Ultrasound scan
Clinical narrative: Information has been received through the Merck pregnancy registry from a physician concerning a 17 year old female with a history of a pap smear on 01-DEC-2006 that was positive for HPV and showed ASCUS, and a colposcopy on 11-JAN-2007 which showed LGSIL, who on approximately 03-JUN-2008 was vaccinated with a first dose of GARDASIL (route and administrating site not reported) at her primary care provider's office. The patient found out she was pregnant about 3 or 4 weeks after receiving the GARDASIL. The patient has a follow up exam scheduled with the physician. The patient sought medical attention by calling the office. The patient's last menstrual period was approximately 21-JAN-2008. The estimated due date is 24-OCT-2008. An ultrasound test perform on 11-JUN-2008 indicated a SIUP at 20 weeks and 3 days. On 26-JUN-2008 a pap smear was negative for HPV. Follow-up information was received from a registered nurse indicating that on 26-JUN-2008 a toxoplasma IgG and IgM was performed with a positive result. Spiramycin was used from 18-JUL-2008 to 11-AUG-2008 for the treatment of toxoplasmosis. The patient's complications during pregnancy included renal failure and alkalosis. On 26-AUG-2008 the patient gave birth prematurely at 31 weeks. The birth weight of the female infant was 1630 gm. Upon internal review the premature birth and the mother's renal failure were determined to be other important medical events. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a certified medical assistant for the pregnancy registry for GARDASIL, concerning a 16 year old female who on 27-JUL-2007 was vaccinated with the first dose of GARDASIL, 0.5 mL, I.M. and on 05-OCT-2007 with the second dose of GARDASIL. On 14-MAR-2008, the patient was scheduled to receive a third dose of the series, but the patient had a positive pregnancy test and the third dose was not given. On 17-MAR-2008, the patient had a miscarriage of the pregnancy. The reporter stated that the patient has since become pregnant again. On an unspecified date, positive pregnancy test since having miscarriage was performed (WAES # 0809USA01854). The patient sought unspecified medical attention. Upon internal review, miscarriage of the pregnancy was determined to be an other important medical event. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: HEP
Symptoms: Abdominal distension, Gastrointestinal tube insertion, Hepatomegaly, Incorrect dose administered, Laboratory test normal
Clinical narrative: Information has been received from a consumer concerning her friend's daughter, a 7 week old female patient who in July 2008 "about 7 weeks ago", was vaccinated with 1 mL of RECOMBIVAX HB (lot # not reported).  On approximately 31-AUG-2008, "9 days ago, the patient experienced a high fever and was taken to the emergency room.  She had tests done which showed that her platelets were low and she was admitted to the hospital.  The patient's platelets continued to go down.  The lowest the platelets got were 5000.  The consumer reported that the doctors continued to do test and everything came back normal. The consumer also reported that in addition to having low platelets, the patient also experienced an enlarged liver and spleen as well as a bloated belly.  The patient was subsequently put on a feeding tube"  Therapy with RECOMBIVAX HB was discontinued.  At the time of the report the patient had not recovered from high fever, low platelets, enlarged liver, enlarged spleen and bloated belly.  Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: HEP
Symptoms: Platelet count decreased, Pyrexia, Splenomegaly
Clinical narrative: Information has been received from a consumer concerning her friend's daughter, a 7 week old female patient who in July 2008 "about 7 weeks ago", was vaccinated with 1 mL of RECOMBIVAX HB (lot # not reported).  On approximately 31-AUG-2008, "9 days ago, the patient experienced a high fever and was taken to the emergency room.  She had tests done which showed that her platelets were low and she was admitted to the hospital.  The patient's platelets continued to go down.  The lowest the platelets got were 5000.  The consumer reported that the doctors continued to do test and everything came back normal. The consumer also reported that in addition to having low platelets, the patient also experienced an enlarged liver and spleen as well as a bloated belly.  The patient was subsequently put on a feeding tube"  Therapy with RECOMBIVAX HB was discontinued.  At the time of the report the patient had not recovered from high fever, low platelets, enlarged liver, enlarged spleen and bloated belly.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Blood sodium decreased, Convulsion, Diarrhoea, Enterocolitis, Sepsis
Clinical narrative: Information has been received from a physician concerning an approximately 2 month old male who on approximately 25-AUG-2008 was vaccinated PO with the first dose of ROTATEQ. Concomitant suspect vaccine therapy included a dose of PEDVAXHIB (manufacturer unknown). Other concomitant vaccine therapy included a dose of poliovirus vaccine, a dose of DTaP (unspecified) and a dose of PREVNAR. The physician reported that approximately 4-5 days after vaccination the patient started to have loose stools. On approximately 29-AUG-2008, the patient came into the office still having diarrhea and now vomiting. The patient went home that day and had a seizure. The patient was taken by ambulance to the hospital. The patient is now septic, with low sodium and also has enterocolitis. The physician reported that unspecified lab diagnostics and studies were performed. It was noted that the patient was hospitalized for two weeks and at the time of this report remained in the hospital. The patient was reported as not recovered. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning an approximately 2 month old male who on approximately 25-AUG-2008 was vaccinated PO with the first dose of ROTATEQ. Concomitant suspect vaccine therapy included a dose of PEDVAXHIB (manufacturer unknown). Other concomitant vaccine therapy included a dose of poliovirus vaccine, a dose of DTaP (unspecified) and a dose of PREVNAR. The physician reported that approximately 4-5 days after vaccination the patient started to have loose stools. On approximately 29-AUG-2008, the patient came into the office still having diarrhea and now vomiting. The patient went home that day and had a seizure. The patient was taken by ambulance to the hospital. The patient is now septic, with low sodium and also has enterocolitis. The physician reported that unspecified lab diagnostics and studies were performed. It was noted that the patient was hospitalized for two weeks and at the time of this report remained in the hospital. The patient was reported as not recovered. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 68 year old female who "2 months ago", in July 2008, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Oka/Merck). "A week ago", on approximately 03-SEP-2008 the patient developed a severe case of shingles. Unspecified medical attention was sought. The patient was given FAMVIR within 48 hours to slow the progression of the rash. At the time of this report, the outcome was unknown. The nurse felt that the patient's shingles were an other important medical event. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Retinal pigment epitheliopathy
Clinical narrative: Information has been received via a literature citation, title as stated above, concerning a child who on an unknown date was vaccinated with VARIVAX (Oka/Merck).  Subsequently, the patient developed acute posterior multifocal placoid pigment epitheliopathy.  Upon internal review, the patient's acute posterior multifocal placoid pigment epitheliopathy was considered an other important medical event.  Additional information has been requested.  A copy of the published literature article will be provided when available.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Rash maculo-papular, Rash pruritic
Clinical narrative: Information has been received by the contract pharmacy from the prescriber concerning a 52 year old male patient with asthma and multiple myeloma, started on REVLIMID 10 mg orally daily for 21 days of a 28 day cycle in January 2008, and he received 2 cycles.  The dose was increased to 15 mg for 3 cycles, and then increased to 20 mg for cycle 6.  In approximately June 2008 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number not provided).  Concomitant medications included ADVAIR, ATROVENT, azithromycin, and albuterol.  In the middle of the REVLIMID cycle 6 in June 2008, the patient had to stop the REVLIMID for 2 weeks due to a pruritic rash with diffuse maculopapular eruption and confluent erythema over the trunk and lower extremities.  Treatment included BENADRYL and prednisone.  The rash resolved after 2 weeks.  The REVLIMID 20 mg was restarted on 30-JUN-2008 with no rash or lesions noted as of the progress note of 24-JUL-2008.  On 28-JUL-2008 the patient continued cycle 8 of REVLIMID 25 mg daily for 21 days of a 28 day cycle.  The prescriber reported that the rash was likely due to PNEUMOVAX 23 since this patient was continued on a higher dose of REVLIMID 25 mg daily.  A causal relationship between therapy and pruritic rash (Diffuse maculopapular eruption, erythema) is considered unlikely due to confounding by co-suspect PNEUMOVAX 23.  There was negative rechallenge after REVLIMID was re-introduced and REVLIMID continued on a higher dose.  The reporter considered pruritic rash to be an other important medical event.  No further information was provided.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Anorexia, Dizziness, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning an 86 year old female with "no important medical history to report beside normal health problems associated with age" and allergies to penicillin, sulfonamide, indomethacine sodium (MSD), (WAES# 0808USA04821), CELEBREX, rofecoxib (MSD) (WAES# 0808USA04820), and BEXTRA. Concomitant medications included: potassium, "ZANEX", BUMEX, PROZAC, VERAPAMIL SR, HYDROCODONE APAP. The patient was vaccinated previously with doses of PNEUMOVAX 23 in 2006 (no record of 2006 vaccination found) and July 2007, the patient did not remember any reaction to these vaccinations. On 06-AUG-2008 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # 659150/1384u), 0.5 milliliter (ml), intramuscularly. On 06-AUG-2008, the patient experienced an injection site reaction, severe pain in her arm and neck with generalized aching. It was reported that there was no redness or warmth at the injection site, but there was minor swelling. The patient reported that the pain was severe causing moaning and groaning. The patient also experienced fever, nausea, dizziness, and loss of appetite. On 07-AUG-2008, the patient called the office. The pain was reported to still be present on 08-AUG-2008 but not as severe. At the time of this report, the patient was reported to be recovered, she stated it took about 1 week to return to normal. The events were reported as disabling because the patient could not perform her daily functions due to the level of pain. A lot check was requested. No product quality complaint was involved. This is a consolidation of 2 reports concerning the same patient. Additional information has been requested. It has been determined that WAES#0808USA03710 is a duplicate of WAES#0808USA03652. Therefore, WAES#0808USA03710 will be deleted from our files and consolidated into WAES#0808USA03652.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Moaning, Nausea, Neck pain, Pain, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning an 86 year old female with "no important medical history to report beside normal health problems associated with age" and allergies to penicillin, sulfonamide, indomethacine sodium (MSD), (WAES# 0808USA04821), CELEBREX, rofecoxib (MSD) (WAES# 0808USA04820), and BEXTRA. Concomitant medications included: potassium, "ZANEX", BUMEX, PROZAC, VERAPAMIL SR, HYDROCODONE APAP. The patient was vaccinated previously with doses of PNEUMOVAX 23 in 2006 (no record of 2006 vaccination found) and July 2007, the patient did not remember any reaction to these vaccinations. On 06-AUG-2008 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # 659150/1384u), 0.5 milliliter (ml), intramuscularly. On 06-AUG-2008, the patient experienced an injection site reaction, severe pain in her arm and neck with generalized aching. It was reported that there was no redness or warmth at the injection site, but there was minor swelling. The patient reported that the pain was severe causing moaning and groaning. The patient also experienced fever, nausea, dizziness, and loss of appetite. On 07-AUG-2008, the patient called the office. The pain was reported to still be present on 08-AUG-2008 but not as severe. At the time of this report, the patient was reported to be recovered, she stated it took about 1 week to return to normal. The events were reported as disabling because the patient could not perform her daily functions due to the level of pain. A lot check was requested. No product quality complaint was involved. This is a consolidation of 2 reports concerning the same patient. Additional information has been requested. It has been determined that WAES#0808USA03710 is a duplicate of WAES#0808USA03652. Therefore, WAES#0808USA03710 will be deleted from our files and consolidated into WAES#0808USA03652.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning an 86 year old female with "no important medical history to report beside normal health problems associated with age" and allergies to penicillin, sulfonamide, indomethacine sodium (MSD), (WAES# 0808USA04821), CELEBREX, rofecoxib (MSD) (WAES# 0808USA04820), and BEXTRA. Concomitant medications included: potassium, "ZANEX", BUMEX, PROZAC, VERAPAMIL SR, HYDROCODONE APAP. The patient was vaccinated previously with doses of PNEUMOVAX 23 in 2006 (no record of 2006 vaccination found) and July 2007, the patient did not remember any reaction to these vaccinations. On 06-AUG-2008 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # 659150/1384u), 0.5 milliliter (ml), intramuscularly. On 06-AUG-2008, the patient experienced an injection site reaction, severe pain in her arm and neck with generalized aching. It was reported that there was no redness or warmth at the injection site, but there was minor swelling. The patient reported that the pain was severe causing moaning and groaning. The patient also experienced fever, nausea, dizziness, and loss of appetite. On 07-AUG-2008, the patient called the office. The pain was reported to still be present on 08-AUG-2008 but not as severe. At the time of this report, the patient was reported to be recovered, she stated it took about 1 week to return to normal. The events were reported as disabling because the patient could not perform her daily functions due to the level of pain. A lot check was requested. No product quality complaint was involved. This is a consolidation of 2 reports concerning the same patient. Additional information has been requested. It has been determined that WAES#0808USA03710 is a duplicate of WAES#0808USA03652. Therefore, WAES#0808USA03710 will be deleted from our files and consolidated into WAES#0808USA03652.