chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discomfort, Injection site pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female who vaccinated the first dose of GARDASIL on an unspecified date and second dose of GARDASIL in July 2008. Concomitant therapy included unspecified birth control. The nurse reported the patient who received GARDASIL developed arm discomfort or pain after each dose. After the first dose of GARDASIL, the patient had discomfort and sensitivity around the injection site. It lasted for a short time. After the second dose of GARDASIL, the patient had pain at the vaccinated arm. The arm was sensitive for 2 months and now resolved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Presyncope
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of GARDASIL and experienced a vasovagal reaction. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a consumer concerning her daughter, a 16 year old female who on unspecified dates was vaccinated with a first and second dose of GARDASIL (lot # not reported), respectively.  It was reported that the patient experienced a "little more pain during her 2nd vaccination than her 1st vaccination".  The pain was during the injection while at the physician's office.  The patient recovered on the "day of vaccination".  Additional information is not expected.
Age: 40.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Musculoskeletal pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 40 year old female who experienced pain on her shoulders, knees and sometime in her hips almost like arthritic pain after receiving the first dose of GARDASIL vaccine (Lot # was not available).  It was reported that the patient already completed the series last week (approximately 16-APR-2009) and after receiving the third dose of vaccine she experienced the same symptoms.  The patient sought medical attention by visiting the physician's office.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Neuropathy peripheral, Winged scapula
Clinical narrative: Information has been received from a physician concerning a 19-20 year old female who was vaccinated with the first 0.5 ml dose of GARDASIL (no lot number was provided) over a year ago (approximately 2008). Subsequently the patient experienced "neuropathy" and "winging of scapula". The patient discontinued after the first dose. She partially recovered and had gone to physical therapy. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pharyngitis, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician's assistant concerning a female patient who on unspecified dates was vaccinated with the first, second and third doses of GARDASIL (dose, route and lot number not reported). The patient developed pharyngitis after she received the first, second and third doses of GARDASIL. The patient was seen by the physician. This is one of two reports from the same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient, who was vaccinated with the third dose of GARDASIL, 0.5ml.  No lot number was provided.  The nurse practitioner reported that the patient experienced a "lump" at the injection site, after receiving her third dose of GARDASIL vaccine.  The patient's outcome was unknown.  The patient sought unspecified medical attention.  Follow-up information was received from a nurse practitioner via telephone call indicating that the patient was 20 year old female patient, who on 09-OCT-2008 was vaccinated with the first dose of GARDASIL (Lot # 661044/0548X) in the right deltoid; on 10-DEC-2008 was vaccinated with the second dose of GARDASIL (Lot # 661764-0650X) in the left deltoid and on 18-MAR-2009, was vaccinated with the third dose of GARDASIL Lot # 661952/1129X) in the right deltoid.  The patient did not receive concomitant vaccines Concomitant included YAZ.  It was also reported that 1 week after receiving the third dose of GARDASIL vaccine, the patient experienced a marble sized knot or lump at the injection site.  The patient did not have a fever or pain.  The patient was not hospitalized.  Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Incorrect route of drug administration, Injection site mass, Pain in extremity, Underdose
Clinical narrative: Information has been received from a consumer a 28 year old nurse with latex allergy and a history of paroxysmal supraventricular Tachycardia (PSVT) who on 23-FEB-2009 was vaccinated with a first dose of GARDASIL (IM, dose and lot number not reported) and her second dose on 23-APR-2009 (0.5ml IM/SQ, lot number not reported).  Concomitant therapy included CYMBALTA (manufacture unknown).  No other vaccines was administered at the time of GARDASIL vaccinations.  The patient mentioned, that she received a portion of her second dose of the vaccine subcutaneous instead of intramuscularly.  The patient stated that when the nurse administered the vaccine there was a "giant lump on her arm and some of the vaccine leaked out" and the administering nurse pressed her arm so that the vaccine would be absorbed (on 23-APR-2009).  She also mentioned that after of the first dose of the vaccine, she developed soreness to the muscle of the arm later that the evening lasted for 3 days (on 23-FEB-2009).  She also mentioned that she began her GARDASIL series at the age of 28 years old.  No treatment was sought or required.  The patient indicated that she fully recovered.  No additional information was available.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Fatigue, Neurological examination normal
Clinical narrative: Information has been received from a licensed practical nurse concerning a 22 year old female with a medical history of knee operation in 2004 who on 09-OCT-2008 and 26-MAR-2009 were vaccinated with the first dose and second doses of GARDASIL (LOT# 659435/1265U and 661846/1312X respectively). Concomitant therapy included hormonal contraceptives (unspecified birth control pill). After the patient received the second dose, on approximately 08-APR-2009 the patient experienced dizziness, fatigue and general weakness. On an unspecified date the patient had workups done by her general practitioner and a neurologist, results were reported as negative. The patient was not hospitalized and was not recovered. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Influenza like illness, Malaise, Pain
Clinical narrative: Information has been received from a the doctor's nurse concerning a 25 year old female who on 21-APR-2009, was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL. The patient called the office on the night of 23-APR-2009 saying she "felt terrible and had flu like symptoms. She was achy all over and had malaise." The patient sought medical attention and the outcome of the patient was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Muscle twitching, Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning that her son's several female friends developed muscle twitches and tingling sensations after receiving GARDASIL.  All drop down fields refer to all patients.  No further information is available at the time of reporting.  It's unspecified that the patients sought any medical attention.  No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Anorexia, Malaise, Nausea
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter who was vaccinated with the first dose of GARDASIL (lot#, route and site of administration not reported), 0.5ml. The patient experienced malaise, nausea and lack of appetite after vaccination with GARDASIL. She has experienced the symptoms of malaise and nausea for 5 days after receiving her first dose of GARDASIL. Her outcome was not reported. This is one of several reports from the same source. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia
Clinical narrative: Information has been received from Licensed Practical Nurse (LPN) concerning a 19 year old sexually active female who in April 2008, an unspecified date in November 2008 was vaccinated intramuscularly with the first, second and third 0.5 mL dose of GARDASIL respectively (Lot# were not reported). Concomitant therapy included (ORTHO TRI-CYCLEN). On 09-APR-2009 the patient underwent pap smear showed mid dysplasia. At the time of report, the patient was not recovered. Additional information hs been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Skin disorder
Clinical narrative: Information has been received from a medical assistant concerning a 17 year old female who on 26-FEB-2009 was vaccinated with the first dose of GARDASIL. One week after GARDASIL was given, on approximately 05-MAR-2009 the patient experienced bumps on arm, back and face. No other doses of GARDASIL have been given and no further information was reported. The patient had not recovered at the time of reporting. Unspecified medical attention has been sought. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from an office manager concerning a female who was vaccinated with the first, the second and the third dose of GARDASIL on 11-MAY-2007, 19-JUL-2007 and 18-JAN-2008 respectively. The patient was requesting records due to GARDASIL and there was a lawyer involved. The patient did not mention any problems or why the medical records were needed for the lawyer. The office manager thought that this may be due to the patient not wanting to pay her bill. The office manager was also not positive if this was about GARDASIL or the patient was mixed up with another shot such as Depo-provera. It was unknown if the patient sought medical attention. At the time of the report the outcome of the patient was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Fall, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a licensed practical nurse concerning a 16 year old female who in September 2008, was vaccinated with GARDASIL. After receiving the dose of GARDASIL the patient had fainted. The patient was fine to leave the office. The patient sought unspecified medical attention. Follow up information has been received from the licensed practical nurse concerning a 19 year old female (previously reported as "16 year old") who on 27-FEB-2008 (previously reported as September 2008) was vaccinated with a first dose of GARDASIL (lot # 659657/1487U). Concomitant therapy included MENACTRA and ADACEL. The patient fainted and fell on the floor and regained consciousness. The patient recovered. The patient decided not to continue with GARDASIL. No further information was available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning an 18 year old female who was vaccinated with the first dose of GARDASIL on 12-JAN-2007. The patient had normal pap smear test on 12-JAN-2007 and negative HPV test. She then received the first dose of GARDASIL. On 15-MAR-2007, she received the second dose of GARDASIL. On 19-JUL-2007 the patient had the third dose of GARDASIL. Patient had a negative HPV test and normal pap smear on 07-MAR-2008. On 13-MAR-2009, she had a typical pap smear and then she had a high risk HPV. The patient sought medical attention to physician. At the time of the report the AE did not improve. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning an 18 year old female who was vaccinated with GARDASIL. The patient had a negative pap smear test on 22-JUN-2007 and  negative HPV test. Patient then received the first dose of GARDASIL vaccine on 18-DEC-2006 and second dose on 28-FEB-2007 and the third dose on 19-JUN-2007. Patient had a negative pap smear and positive high risk HPV on 19-SEP-2008. On 10-FEB-2009 the patient had a low grade squamous cell HPV high risk positive. Lot #'s were not available. The patient sought medical attention by physician. At the time of the report the patient's status was unknown. Follow-up information has been received from a pediatrician concerning the patient she reported as having negative pap smears/negative HPV tests until after receiving the third dose of GARDASIL. Subsequent to the third dose, the patient had positive results. The pediatrician did not know which HPV strain was detected. The patient received her doses on 18-DEC-2006 (lot # 653938/0954U), 28-FEB-2007 (lot # 654702/0011U) and 19-JUN-2007 (lot # 657868/0523U). No other vaccines were given at the time of the GARDASIL vaccine. The outcome of the patient was unknown. The patient was referred to gynecology. No further information is available. This is one of several reports received from the same source.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 21 year old female who had a negative pap smear test on 09-JAN-2006. Patient then received the first dose of GARDASIL on 02-MAR-2007 and second dose on 21-AUG-2007. Patient had a negative pap smear and negative HPV test on 21-AUG-2007. Patient received the third dose of GARDASIL on 15-JAN-2008 and she had a negative pap smear and negative HPV test on 22-APR-2008. Physician reported that on 09-APR-2009, patient had a positive HPV test for high risk, low grade squamous cell. Lot #'s were not available. The patient sought medical attention by physician. At the time of the report the patient's status was unknown. Follow-up information has been received from a pediatrician concerning the patient, she reported as having negative pap smears / negative HPV tests until after receiving the third dose of HPV. Subsequently to the third dose, the patient had positive results. The pediatrician did not know which HPV strain was detected. The patient received her doses on 02-MAR-2007 (lot # 654702/0011U), 21-AUG-2007 (lot # 656372/0243U) and 15-JAN-2008 (lot # 659653/1448U). No other vaccines were given at the time of the HPV. The outcome of the patient was unknown. The patient was referred to gynecology. No further information is available. This is one of several reports received from the same source.
Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: HIV test positive, Inappropriate schedule of drug administration, Smear cervix normal
Clinical narrative: Information has been received from a registered nurse concerning a 33 year old female with on pertinent medical history and no allergies who in approximately 2008 "over 1 year ago" was vaccinated with the first dose of GARDASIL 0.5ml IM. There was no concomitant medication. In March 2009, "last month" the patient had tested positive for HIV. The patient also had a PAP smear at the same time and that was negative. The patient has not received any additional dose of GARDASIL. The patient sought medical attention by phone call. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a consumer concerning her 21 year old daughter who was vaccinated with the first dose of GARDASIL (lot #, route and site of administration not reported). The patient experienced 36 hours of diarrhea after vaccination with GARDASIL. This is one of several reports from the same source. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site discolouration, Musculoskeletal pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse and a patient care coordinator concerning a 19 year old female who in June 2007, was vaccinated intramuscularly with 0.5 ml of the first GARDASIL vaccine (Lot not reported), in 08-JUL-2008 received intramuscularly 0.5 ml of the second dose of GARDASIL vaccine (lot: 660555/0279X) in the right arm, and on 04-NOV-2008, 0.5 ml of the third dose intramuscularly (Lot: 659184/0843X) in the left arm. Concomitant therapy included CLARITIN and hormonal contraceptives (unspecified). In approximately July 2008, the patient developed white pale patches around injection site after the second dose. In approximately November 2008, the patient developed white pale patches around injection site on the left arm. The skin discoloration on the arm faded quite a bit but it is still there, while the patch on the left arm from November has not changed much. The patient also complained that the last dose has made her whole shoulder sore. At the time of reporting on 29-APR-2009, the patient's discoloration and shoulder sore were recovering. This is one of tow reports from the same source. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy, Human papilloma virus test positive, Smear cervix abnormal, Uterine dilation and curettage
Clinical narrative: Information has been received from a certified medical assistant concerning a 21 year old female with amoxicillin allergy and no pertinent medical history, who in the years 2004 and 2005 was vaccinated with 3 doses of the GARDASIL series. There was no concomitant medication. The medical assistant reported that the patient did not receive the vaccine at her office. In February 2009, the patient had positive atypical cells of undetermined significance PAP smear and was diagnosed positive for HPV. The patient was seen at the physician's office. On 28-APR-2009, the patient had a colposcopy with endocervical curettage. At the time of reporting the patient had not recovered from the event. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Fatigue, Pain
Clinical narrative: Information has been received from certified medical assistant concerning a 3 year old female patient with no drug reaction or allergies and no pertinent medical history who on 06-AUG-2007, was vaccinated with the first dose of GARDASIL (Lot # not provided) 0.5ml IM. On 16-OCT-2007, was vaccinated with the second dose of GARDASIL (Lot # not provided) 0.5ml IM. On 07-JAN-2008, was vaccinated with the third
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain
Clinical narrative: Information has been received from a nurse concerning an "about 20 year old" female who on an unspecified date was vaccinated with third 0.5mL dose of GARDASIL (route and lot number not reported). The nurse reported that "about two months ago", in approximately February 2009, after receiving the third dose of GARDASIL the patient experienced really bad abdominal pain. The patient was taken to the emergency room, however it was unknown if the patient was admitted into hospital. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Therapeutic response unexpected
Clinical narrative: Information has been received from a physician concerning his daughter who on an unknown date was vaccinated with a dose of GARDASIL and the warts in her feet went away. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter with no pertinent medical history or no known drug/allergy reactions who on an unspecified date, was vaccinated with a dose of GARDASIL (lot #659182/1757U).  The mother stated that in February 2009, after receiving GARDASIL vaccine, her daughter started having "flu like 6/5/09-records received for DOS 2/10/09-C/O left sided headache.  6/10/09-records received for ED visit 3/14/09-presented with multiple C/O headache, chest pain for 4 weeks, gradual onset with sharp headache on left side, numbness in fingers/hands, heels, pain in back, hips and knees bilaterally. UTI 3 weeks prior with antibiotics, developed worsening of prior symptoms. At time of ED visit headache getting better, chest pain remains. Assessment: migraine headaches. Anxiety. 4/3/09-neurology visit for evaluation of headaches with photophobia and nausea and generalized weakness. PE unremarkable. Anxiety may be a primary cause of headaches. Referral to psychiatry for anxiety issues. 4/27/09-chronic fatigue syndrome, remains anxious, hyperventilating could be cause of chest pain. 5/7/09 refused exam, screaming. 5/5/09 ED visit for C/O back pain.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter with no pertinent medical history and no known drug allergies/drug reactions who on an unspecified date was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # not reported). There was no concomitant medication reported. It was reported that the patient experienced alopecia after getting first dose of GARDASIL. It was reported that the patient's hair was thinning after getting the second dose of GARDASIL (Lot # was not reported). The patient did not seek medical attention. There were no laboratory diagnostic tests performed. It was reported that the patient had not recovered at the time of the report. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Injection site erythema, Injection site irritation, Pruritus
Clinical narrative: Information has been received from a physician concerning a 21 year old female with sulfonamide allergy who on 18-JAN-2008 was vaccinated intramuscularly, 0.5 ml, a first dose of GARDASIL (Lot # 655327/1287U).  Concomitant therapy included APRI.  On 19-JAN-2008 the patient experienced shortness of breath and pruritus.  She also experienced redness and irritation at the site of injection.  The patient was examined at Emergency Room but was not admitted.  The patient recovered and all symptoms had resolved.  It was reported on 06-APR-2009 that the patient was seen by the physician and the patient reported the event to the physician.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning an 18 year old female who was vaccinated with GARDASIL.  The physician reported that the patient had a "positive pap smear after completing her GARDASIL series" (date not reported).  At the time of reporting, the patient had not received any treatment or additional testing in regards to this incident.  It was unknown if the patient sought medical attention.  Outcome was not reported.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Immunisation reaction, Skin papilloma
Clinical narrative: Initial information was received from a physician and follow up from a licensed practical nurse concerning a 20 year old female who was vaccinated with the first (lot # 657621/0387U), the second (lot # 657736/0389U) and the third (lot # 658563/1063U, 0.5ml) dose of GARDASIL on 21-MAY-2007, 20-JUL-2007 and 23-NOV-2007 respectively. No other vaccinations were given at the time of the GARDASIL doses. Concomitant therapy included ORTHO TRI-CYCLEN for birth control and GEL DIFFERIN and minocycline for acne. When the patient came into the office on 22-APR-2009 for a "wellness exam", she told the physician that in November 2008 she saw the dermatologist for warts on her face. According to the patient, the dermatologist said the warts were caused by the GARDASIL and prescribed ALDARA. At the 22-APR-2009 visit, the physician saw no sign of facial warts, so told the patient to discontinue the ALDARA and follow-up with the dermatologist. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nodule
Clinical narrative: Information has been received from a certified nurse practitioner concerning a female who on an unspecified date was vaccinated with first dose of GARDASIL (dose, route and lot number not reported). The certified nurse practitioner reported that the patient developed a nodule on her neck after receiving vaccination with GARDASIL. The reporter verified that the patient did not receive the vaccine at her office and for this reason she cannot provide any patient details concerning this event. The patient sought medical attention by contacting the nurse practitioner. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Death
Clinical narrative: Information has been received from the office receptionist concerning her friend's girlfriend, an around 20 or 21 years old female, who was vaccinated via injection route with a dose of GARDASIL. Subsequently, the patient had a seizure and died. The patient sought unspecified medical attention. Seizure was considered to be immediately life-threatening. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Abdominal pain upper, Autopsy, Death, Migraine
Clinical narrative: Information has been received from the office receptionist concerning her friend's girlfriend, an around 20 or 21 years old female, who was vaccinated via injection route with a dose of GARDASIL. Subsequently, the patient had a seizure and died. The patient sought unspecified medical attention. Seizure was considered to be immediately life-threatening. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Convulsion, Death
Clinical narrative: Information has been received from the office receptionist concerning her friend's girlfriend, an around 20 or 21 years old female, who was vaccinated via injection route with a dose of GARDASIL. Subsequently, the patient had a seizure and died. The patient sought unspecified medical attention. Seizure was considered to be immediately life-threatening. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Chest X-ray normal, Chest pain, Dyspnoea
Clinical narrative: Abnormal ECG  Unspecified disease of pericardium(423.9)  5000011
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Myopericarditis, Tachycardia, Troponin increased
Clinical narrative: Abnormal ECG  Unspecified disease of pericardium(423.9)  5000011
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Pericardial disease, Troponin I
Clinical narrative: Abnormal ECG  Unspecified disease of pericardium(423.9)  5000011
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Blood creatine phosphokinase MB, Blood creatine phosphokinase increased, Blood glucose increased, Blood sodium increased, C-reactive protein increased
Clinical narrative: Abnormal ECG  Unspecified disease of pericardium(423.9)  5000011
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Chest pain, Dyspnoea, Echocardiogram abnormal, Electrocardiogram abnormal, Hyperventilation
Clinical narrative: Abnormal ECG  Unspecified disease of pericardium(423.9)  5000011
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Lymphocyte percentage decreased, Monocyte count normal, Myopericarditis, Neutrophil count increased, Neutrophil percentage increased
Clinical narrative: Abnormal ECG  Unspecified disease of pericardium(423.9)  5000011
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Red blood cell sedimentation rate increased, Tachycardia, Troponin increased, White blood cell count increased, X-ray normal
Clinical narrative: Abnormal ECG  Unspecified disease of pericardium(423.9)  5000011
Age: 11.0
Sex: M
Vaccine: DTAP, MEN, MNQ, TDAP
Symptoms: Dry skin, Rash erythematous, Rash generalised
Clinical narrative: About 15 minutes after getting vaccines, he c/o itchy eyes + throat, face got red + he developed hives on his chest. Mom gave Benadryl + took to ER where he was started on steroids + improved.
Age: 11.0
Sex: M
Vaccine: DTAP, MEN, MNQ, TDAP
Symptoms: Erythema, Eye pruritus, Throat irritation, Urticaria
Clinical narrative: About 15 minutes after getting vaccines, he c/o itchy eyes + throat, face got red + he developed hives on his chest. Mom gave Benadryl + took to ER where he was started on steroids + improved.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a nurse practitioner (N.P.), for the Pregnancy Registry for GARDASIL, concerning a 23 year old female with no pertinent medical history, drug reactions or allergies who on 30-APR-2008 was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (Lot #656372/0243U).  There was no concomitant medication.  Subsequently the patient was discovered that she was pregnant.  On 05-AUG-2008 a urine pregnancy test was performed at the office and result was positive.  Her LMP was 19-JUN-2008.  Expected date of delivery was 26-MAR-2009.  No adverse effects were reported.  The patient had office visit.  Follow-up information was received from the N.P. indicating that the patient terminated her pregnancy.  The date of the termination was not available.  No further information was provided.  Upon internal review, pregnancy termination was determined to be an other important medical event.  Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Accidental exposure, Bronchitis, Chest X-ray normal, Condition aggravated, Cough
Clinical narrative: Information has been received from a 52 year old licensed visiting nurse who was splashed while she was withdrawing a dose of PNEUMOVAX 23 in approximately September 2008 (fall of 2008). Concomitant therapy included hydrochlorothiazide and WELLBUTRIN. In November 2008, the patient experienced bronchitis, shortness of breath and sinus infections. The patient was tested for Valley fever and had a chest x-ray performed (results not reported). The patient was seen by her physician. The outcome was not recovered. Follow-up information has been received from a licensed visiting nurse with a history of sinusitis concerning her experienced while giving residents immunizations at a skilled nursing facility. On approximately 01-NOV-2008 the nurse was drawing up either the PNEUMOVAX 23 or influenza vaccine (NOVARTIS) and small amount of vaccine escaped from the needle/vial as she withdrew the needle. This surprised her and she gasped at the same moment and inhaled either flu vaccine (NOVARTIS) or PNEUMOVAX 23. The nurse stated she only remembered this a week or so after the fact, when on 02-NOV-2008 she ended up in the ER with shortness of breath, unable to catch her breath shorting after the incident. On an unknown date a chest X ray was done and was clear. Ever since the patient has been wheezing, coughing and with shortness of breath and have not recovered. The nurse considered that the events resulted in persistent or significant disability. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Laboratory test, Sinusitis, Wheezing
Clinical narrative: Information has been received from a 52 year old licensed visiting nurse who was splashed while she was withdrawing a dose of PNEUMOVAX 23 in approximately September 2008 (fall of 2008). Concomitant therapy included hydrochlorothiazide and WELLBUTRIN. In November 2008, the patient experienced bronchitis, shortness of breath and sinus infections. The patient was tested for Valley fever and had a chest x-ray performed (results not reported). The patient was seen by her physician. The outcome was not recovered. Follow-up information has been received from a licensed visiting nurse with a history of sinusitis concerning her experienced while giving residents immunizations at a skilled nursing facility. On approximately 01-NOV-2008 the nurse was drawing up either the PNEUMOVAX 23 or influenza vaccine (NOVARTIS) and small amount of vaccine escaped from the needle/vial as she withdrew the needle. This surprised her and she gasped at the same moment and inhaled either flu vaccine (NOVARTIS) or PNEUMOVAX 23. The nurse stated she only remembered this a week or so after the fact, when on 02-NOV-2008 she ended up in the ER with shortness of breath, unable to catch her breath shorting after the incident. On an unknown date a chest X ray was done and was clear. Ever since the patient has been wheezing, coughing and with shortness of breath and have not recovered. The nurse considered that the events resulted in persistent or significant disability. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Hypersensitivity, Swelling
Clinical narrative: Information has been received from a 69 year old female patient who "2 or 3 years ago" was vaccinated with a dose of PNEUMOVAX (manufacturer unknown). Secondary suspect vaccine given on the same day included influenza virus vaccine (unspecified). It was reported that "2 or 3 years ago" the patient experienced an allergic reaction like swelling after receiving PNEUMOVAX and influenza virus vaccine together and was hospitalized for couple days. It was reported that the patient had recovered on an unspecified date. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Chest discomfort, Dysphagia, Erythema, Flushing
Clinical narrative: Information has been received from a physician concerning his 54 year old wife with allergy to sulfa drugs like Bactrim and no pertinent medical history who on 20-AUG-1998 was vaccinated with the first dose of PNEUMOVAX. Concomitant therapy included Premarin and Zyrtec. On 20-AUG-1998, after receiving the vaccine, the patient developed neck and shoulder pain, she found it was difficult to swallow and had chest tightness. Her lower back had pressure pain/discomfort when she attempted to lie down at the office. When she sat up, she had flushing and her face and chest was red. She was given a Solumedrol injection. It took about 30 minutes until the symptoms resolved. No lab tests were done. The reporting physician considered the events to be other important medical events. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: Information has been received from a physician concerning his 54 year old wife with allergy to sulfa drugs like Bactrim and no pertinent medical history who on 20-AUG-1998 was vaccinated with the first dose of PNEUMOVAX. Concomitant therapy included Premarin and Zyrtec. On 20-AUG-1998, after receiving the vaccine, the patient developed neck and shoulder pain, she found it was difficult to swallow and had chest tightness. Her lower back had pressure pain/discomfort when she attempted to lie down at the office. When she sat up, she had flushing and her face and chest was red. She was given a Solumedrol injection. It took about 30 minutes until the symptoms resolved. No lab tests were done. The reporting physician considered the events to be other important medical events. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning an approximately 17 week old male who was vaccinated orally with a 2 ml second dose of ROTATEQ. Subsequently the patient experienced intussusception. Unspecified medical attention was sought. On 11-MAY-2009 the patient was admitted into the hospital. At the time of reporting, the outcome was unknown. Additional information has been requested.  6/12/09 Hospital records and DC summary received DOS 5/11/09 t0 5/12/09. FINAL DIAGNOSIS: Intussusception. Post vaccination abdominal pain, emesis, decreased oral intake. No BM for 2 days. Crying, fussy. Successful reduction with barium air contrast enema. ICD-9 Codes: 5600, 53081
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Vaccines given on 5-7-09. Pt admitted to hospital on 5-11-09. Dx with Intussusception.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified dates was vaccinated orally with three doses of ROTATEQ. Subsequently the patient was diagnosed with intussusception. The patient visited the physician's office for medical attention. At the time of reporting, the outcome was unknown. Upon internal review intussusception was considered to be an other important medical events. Additional information has been requested.  5/21/09 Received vaccine & PCP medical records which included hospital H&P. FINAL DX: Intussusception, enema reduced Records reveal patient experienced abdominal pain & decreased energy x 1 day.  Had URI & loose stools x 1 wk.  Saw PCP on 5/11 & sent to ER.  Observed overnight s/p enema reduction.  Improved & d/c to home.  6/4/09 Hospital records received DOS 5/11-12/09. FINAL DX: Intussusception, enema reduced. Post vaccination acute onset of abdominal pain. Loose stools. Decreased energy. Rhinorrhea and cough.   8/27/09 Received ICD9 codes for 5/11-5/12 admit: 560.0, intussusception; 465.9 acute URI NOS; 789.00 abdominal pain, unspecified site.
Age: 1.0
Sex: M
Vaccine: RV5
Symptoms: Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a 12 month old male who on 07-JUL-2008 was vaccinated with the first dose of ROTATEQ and on 10-NOV-2009, was vaccinated orally with the third 2ml dose of ROTATEQ. After receiving all three doses of ROTATEQ, the patient experienced rotavirus. The patient was admitted into the hospital for 3 days. Test for rotavirus were performed. At the time of this report, the patient was recovered (date unspecified). Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: Band neutrophil count increased, Erythema, Lymphocyte percentage decreased, Monocyte count increased, Neutrophil count normal
Clinical narrative: 3yo with isolated IgA deficiency, administered pneumococcal vaccine. 4 days before admit she developed swelling, redness & fever within 24 hrs of injection. Swelling increased, cellulitis. Admitted for IV ABX, prednisone.6/8/09-records received for DOS 4/24-4/26/09 DC DX:Cellulitis of Buttock at site of pneumoccoal immunization. Admitted because of painful red swelling and fever follow vaccine four days ago. Fever within 24 hours of injection with increased swelling.  6/25/09 Hospital records DC summary DOS 4/24/09 to 4/26/09. Includes medical records DOS 4/30/09. Assessment: Cellulitis of buttock at site of pneumococcal immunization. Patient presents with fever, cough, redness of injection site, cries if leg is touched. Violatious/red/purple area sligh above injection site extending onto thigh and posterior to buttock. Prednisone and IV antibiotics administered.
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: Platelet count normal, Pyrexia, Swelling, White blood cell count increased
Clinical narrative: 3yo with isolated IgA deficiency, administered pneumococcal vaccine. 4 days before admit she developed swelling, redness & fever within 24 hrs of injection. Swelling increased, cellulitis. Admitted for IV ABX, prednisone.6/8/09-records received for DOS 4/24-4/26/09 DC DX:Cellulitis of Buttock at site of pneumoccoal immunization. Admitted because of painful red swelling and fever follow vaccine four days ago. Fever within 24 hours of injection with increased swelling.  6/25/09 Hospital records DC summary DOS 4/24/09 to 4/26/09. Includes medical records DOS 4/30/09. Assessment: Cellulitis of buttock at site of pneumococcal immunization. Patient presents with fever, cough, redness of injection site, cries if leg is touched. Violatious/red/purple area sligh above injection site extending onto thigh and posterior to buttock. Prednisone and IV antibiotics administered.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Burning sensation, Convulsion, Hypoaesthesia, Musculoskeletal stiffness, Nuclear magnetic resonance imaging normal
Clinical narrative: Initial report received from a consumer on 08 May 2009, who is also the patient's parent. A 37-year-old female patient with an unknown medical history, had received a booster dose left arm injection of DECAVAC, lot number U2348CA on 21 April 2009 and approximately 20 hours later, she developed stiffness on the left side of her neck with a deep burning sensation with numbness and tingling down the left arm which also extended to the left leg. The event required a doctors visit and the patient was reported to have been hospitalized three times (dates not reported); and she was hospitalized at the time of the report. Per the reporter, the patient had a seizure (date of onset and duration not reported) and tests had been performed to rule out stroke and a brain tumor. According to the reporter, the MRI "doesn't show anything". The patient's recovery status was unknown and the reporter declined to provide any additional information at the time of the report. Documents held by sender: None.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Paraesthesia
Clinical narrative: Initial report received from a consumer on 08 May 2009, who is also the patient's parent. A 37-year-old female patient with an unknown medical history, had received a booster dose left arm injection of DECAVAC, lot number U2348CA on 21 April 2009 and approximately 20 hours later, she developed stiffness on the left side of her neck with a deep burning sensation with numbness and tingling down the left arm which also extended to the left leg. The event required a doctors visit and the patient was reported to have been hospitalized three times (dates not reported); and she was hospitalized at the time of the report. Per the reporter, the patient had a seizure (date of onset and duration not reported) and tests had been performed to rule out stroke and a brain tumor. According to the reporter, the MRI "doesn't show anything". The patient's recovery status was unknown and the reporter declined to provide any additional information at the time of the report. Documents held by sender: None.
Age: 41.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Abdominal discomfort, Cough, Headache, Injection site erythema, Injection site swelling
Clinical narrative: This case was received on 13 May 2009 from a consumer. A 41 year old female patient received ACAM2000 (lot number unknown) in her left arm and anthrax vaccine (manufacturer and lot number unknown) in her right arm on 02 May 2009. Nine days after vaccination the patient noticed increased redness and swelling around the ACAM2000 vaccination. The patient also experienced fever, an extremely bad headache, abdominal discomfort and mild cough. The redness progressively increased to approximately 3 inches in diameter with a 1 inch wide red streak radiating laterally around arm to under the armpit. The patient also reports mild lymphadenopathy. The patient was advised to see a local healthcare provider for evaluation of possible cellulitis. List of Documents held by Sender: None.  7/7/09 ED  records received DOS 5/2/09. Assessment: Cellulitis, reaction to smallpox vaccination. Patient presented with loss of band-aid covering immunization site. Site demonstrated 'redness and erythema', red streaking, warm and hard, headache.  ICD-9 Codes: V5989, V5889
Age: 41.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: This case was received on 13 May 2009 from a consumer. A 41 year old female patient received ACAM2000 (lot number unknown) in her left arm and anthrax vaccine (manufacturer and lot number unknown) in her right arm on 02 May 2009. Nine days after vaccination the patient noticed increased redness and swelling around the ACAM2000 vaccination. The patient also experienced fever, an extremely bad headache, abdominal discomfort and mild cough. The redness progressively increased to approximately 3 inches in diameter with a 1 inch wide red streak radiating laterally around arm to under the armpit. The patient also reports mild lymphadenopathy. The patient was advised to see a local healthcare provider for evaluation of possible cellulitis. List of Documents held by Sender: None.  7/7/09 ED  records received DOS 5/2/09. Assessment: Cellulitis, reaction to smallpox vaccination. Patient presented with loss of band-aid covering immunization site. Site demonstrated 'redness and erythema', red streaking, warm and hard, headache.  ICD-9 Codes: V5989, V5889
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt developed pain, swelling and redness at site of vaccine LD after receiving it.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Ear discomfort, Electrocardiogram, Electroencephalogram, Hypoaesthesia facial
Clinical narrative: Mother states pt received vaccine then had some blood work in office.  After ten minutes pt complained of dizziness accompanied with numbness in her face also feeling of ears being blocked.  Pt felt faint.  These episodes continue to occur.  Mom states never happened before vaccine.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 6.5 cm long  by 8 cm wide erythema & warmth ant/lad @ thigh.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Full blood count, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Abrupt onset (10-12 hours) post vaccine fever.  104 T max.  Fever lasted 48 hours, then abruptly stopped, and a lacy red rash appeared head to toe.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: Pt was given Adacel, Menactra + PPD. Began feeling light headed, sat in chair and became faint.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: 3 days later, I awoke with a 3 inch red, hot, itchy, swollen circular patch on my upper right arm.  I called pharmacist and saw my doctor.  Benadryl prescribed
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Local reaction, Skin warm
Clinical narrative: Pt was given MENACTRA 0.5 ml @ deltoid on 5/12/09.  On 5/13/09 at approx 7pm pt & parent noted large localized reaction.  Redness & warmth 5x5 inch area L upper arm.
Age: 12.0
Sex: M
Vaccine: MEN, VARCEL
Symptoms: Injection site swelling, Rash erythematous, Urticaria
Clinical narrative: Within 24 hours- Left arm (between elbow and deltoid) became swollen 3x normal size at site of varicella vaccine.  Within 48 hours red welted rash developed on upper arm as well.  Steroids, benedryl and motrin were prescribed.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Approximately 24 post Kinrix vaccination patient had marked non-pitting edema to his right upper leg with redness that extended from his right greater trochanter to his right knee.  Patient complaint of pain rated 2 on a scale of 1-10.  Afebrile.  Patient given prescription for Prednisone and Keflex.  Patient was unable to tolerate Prednisone per telephone follow up, but is taking the Keflex.  After 2 days on Keflex, the edema and redness resolved and patient no longer complaining of pain.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Headache
Clinical narrative: HPV #3 GIVEN 4-14-09 AND PATIENT REPORTS ONSET OF SEVERE HEADACHE ON 4-15-09.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Chills, Erythema, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Temp - 102 degrees  Body aches.chills,fever, red swollen left arm.  Applied ice to left arm, Tylenol