chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Constipation, Diarrhoea, Dry eye, Dyspepsia
Clinical narrative: This spontaneous report as received from a 26 year old female consumer reporting on herself with no pertinent medical history and no drug reactions or allergies who on 09-MAY-2013, was vaccinated intramuscularly with the first and last dose of GARDASIL (dose and lot number not reported). No concomitant therapies were reported. The consumer reported that on 29-MAY-2013, she developed chronic fatigue, vertigo, inability to sleep, migraines, dry eyes, nausea, weakness in her legs, anxiety and tingling in her hands. Detoxifying program including supplements to remove heavy metal, dietary changes, removal of caffeine, vitamins, homeopathic medications and prescription medication for pain management were given as a treatment for the experience. Various unspecified tests including stool sample, endoscopy and magnetic resonance imaging (MRI) were performed on an unspecified dates (results not provided). At the time of the report, the patient was recovering. The patient had been to 10 different office visits with various doctors concerning her post GARDASIL traumas. The relatedness for vertigo, anxiety, inability to sleep, migraines, dry eyes, nausea, weakness in her legs, tingling in her hands and chronic fatigue and GARDASIL was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Endoscopy, Fatigue, Gastrooesophageal reflux disease, Headache, Migraine
Clinical narrative: This spontaneous report as received from a 26 year old female consumer reporting on herself with no pertinent medical history and no drug reactions or allergies who on 09-MAY-2013, was vaccinated intramuscularly with the first and last dose of GARDASIL (dose and lot number not reported). No concomitant therapies were reported. The consumer reported that on 29-MAY-2013, she developed chronic fatigue, vertigo, inability to sleep, migraines, dry eyes, nausea, weakness in her legs, anxiety and tingling in her hands. Detoxifying program including supplements to remove heavy metal, dietary changes, removal of caffeine, vitamins, homeopathic medications and prescription medication for pain management were given as a treatment for the experience. Various unspecified tests including stool sample, endoscopy and magnetic resonance imaging (MRI) were performed on an unspecified dates (results not provided). At the time of the report, the patient was recovering. The patient had been to 10 different office visits with various doctors concerning her post GARDASIL traumas. The relatedness for vertigo, anxiety, inability to sleep, migraines, dry eyes, nausea, weakness in her legs, tingling in her hands and chronic fatigue and GARDASIL was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscular weakness, Nausea, Nuclear magnetic resonance imaging, Paraesthesia, Stool analysis
Clinical narrative: This spontaneous report as received from a 26 year old female consumer reporting on herself with no pertinent medical history and no drug reactions or allergies who on 09-MAY-2013, was vaccinated intramuscularly with the first and last dose of GARDASIL (dose and lot number not reported). No concomitant therapies were reported. The consumer reported that on 29-MAY-2013, she developed chronic fatigue, vertigo, inability to sleep, migraines, dry eyes, nausea, weakness in her legs, anxiety and tingling in her hands. Detoxifying program including supplements to remove heavy metal, dietary changes, removal of caffeine, vitamins, homeopathic medications and prescription medication for pain management were given as a treatment for the experience. Various unspecified tests including stool sample, endoscopy and magnetic resonance imaging (MRI) were performed on an unspecified dates (results not provided). At the time of the report, the patient was recovering. The patient had been to 10 different office visits with various doctors concerning her post GARDASIL traumas. The relatedness for vertigo, anxiety, inability to sleep, migraines, dry eyes, nausea, weakness in her legs, tingling in her hands and chronic fatigue and GARDASIL was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anxiety, Dry eye, Endoscopy, Fatigue, Insomnia
Clinical narrative: This spontaneous report as received from a 26 year old female consumer reporting on herself with no pertinent medical history and no drug reactions or allergies who on 09-MAY-2013, was vaccinated intramuscularly with the first and last dose of GARDASIL (dose and lot number not reported). No concomitant therapies were reported. The consumer reported that on 29-MAY-2013, she developed chronic fatigue, vertigo, inability to sleep, migraines, dry eyes, nausea, weakness in her legs, anxiety and tingling in her hands. Detoxifying program including supplements to remove heavy metal, dietary changes, removal of caffeine, vitamins, homeopathic medications and prescription medication for pain management were given as a treatment for the experience. Various unspecified tests including stool sample, endoscopy and magnetic resonance imaging (MRI) were performed on an unspecified dates (results not provided). At the time of the report, the patient was recovering. The patient had been to 10 different office visits with various doctors concerning her post GARDASIL traumas. The relatedness for vertigo, anxiety, inability to sleep, migraines, dry eyes, nausea, weakness in her legs, tingling in her hands and chronic fatigue and GARDASIL was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Migraine, Muscular weakness, Nausea, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: This spontaneous report as received from a 26 year old female consumer reporting on herself with no pertinent medical history and no drug reactions or allergies who on 09-MAY-2013, was vaccinated intramuscularly with the first and last dose of GARDASIL (dose and lot number not reported). No concomitant therapies were reported. The consumer reported that on 29-MAY-2013, she developed chronic fatigue, vertigo, inability to sleep, migraines, dry eyes, nausea, weakness in her legs, anxiety and tingling in her hands. Detoxifying program including supplements to remove heavy metal, dietary changes, removal of caffeine, vitamins, homeopathic medications and prescription medication for pain management were given as a treatment for the experience. Various unspecified tests including stool sample, endoscopy and magnetic resonance imaging (MRI) were performed on an unspecified dates (results not provided). At the time of the report, the patient was recovering. The patient had been to 10 different office visits with various doctors concerning her post GARDASIL traumas. The relatedness for vertigo, anxiety, inability to sleep, migraines, dry eyes, nausea, weakness in her legs, tingling in her hands and chronic fatigue and GARDASIL was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Stool analysis, Vertigo
Clinical narrative: This spontaneous report as received from a 26 year old female consumer reporting on herself with no pertinent medical history and no drug reactions or allergies who on 09-MAY-2013, was vaccinated intramuscularly with the first and last dose of GARDASIL (dose and lot number not reported). No concomitant therapies were reported. The consumer reported that on 29-MAY-2013, she developed chronic fatigue, vertigo, inability to sleep, migraines, dry eyes, nausea, weakness in her legs, anxiety and tingling in her hands. Detoxifying program including supplements to remove heavy metal, dietary changes, removal of caffeine, vitamins, homeopathic medications and prescription medication for pain management were given as a treatment for the experience. Various unspecified tests including stool sample, endoscopy and magnetic resonance imaging (MRI) were performed on an unspecified dates (results not provided). At the time of the report, the patient was recovering. The patient had been to 10 different office visits with various doctors concerning her post GARDASIL traumas. The relatedness for vertigo, anxiety, inability to sleep, migraines, dry eyes, nausea, weakness in her legs, tingling in her hands and chronic fatigue and GARDASIL was unknown. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HEPA, HPVX, MEN, HEPA, HPV4, MNQ
Symptoms: Dizziness, Pallor, Seizure like phenomena, Syncope
Clinical narrative: Pt walked out to check out area of the office and had syncopal episode.  Was lowered to the floor by his mother.  No injury.  Rested in the office afterwards till feeling better.
Age: 19.0
Sex: M
Vaccine: HEPA, HPVX, MEN, HEPA, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Pt walked out to check out area of the office and had syncopal episode.  Was lowered to the floor by his mother.  No injury.  Rested in the office afterwards till feeling better.
Age: 49.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Dizziness, Dysphagia, Dyspnoea, Ear discomfort, Injection site erythema
Clinical narrative: Cellulitis went to infection. Cephalexin 500 mg 1 QID x 10 days. Vancomycin mometasone crm 0.1% apply 4-6 x D.
Age: 49.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site oedema, Injection site pain, Lip swelling, Oral discomfort, Pain
Clinical narrative: Cellulitis went to infection. Cephalexin 500 mg 1 QID x 10 days. Vancomycin mometasone crm 0.1% apply 4-6 x D.
Age: 49.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pharyngeal oedema, Vision blurred
Clinical narrative: Cellulitis went to infection. Cephalexin 500 mg 1 QID x 10 days. Vancomycin mometasone crm 0.1% apply 4-6 x D.
Age: 49.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Infection
Clinical narrative: Cellulitis went to infection. Cephalexin 500 mg 1 QID x 10 days. Vancomycin mometasone crm 0.1% apply 4-6 x D.
Age: 14.0
Sex: M
Vaccine: MEN
Symptoms: Abdominal pain upper, Dizziness, Presyncope, Tunnel vision
Clinical narrative: As stated before. Treated by taking a seat an given some water.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site nodule, Injection site pruritus, Injection site swelling
Clinical narrative: Red, swollen, itchy knot under skin near site of injection approximately two inches in diameter. Lump continued to grow to more than one swollen subcutaneous, hot-to-the-touch knot throughout the next 29 hours. Once reaction grew to affect entire upper arm, medical attention was sought out. A shot of Benadryl and a shot of Rocephin were administered at approximately 1:30 PM by medical team.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth
Clinical narrative: Red, swollen, itchy knot under skin near site of injection approximately two inches in diameter. Lump continued to grow to more than one swollen subcutaneous, hot-to-the-touch knot throughout the next 29 hours. Once reaction grew to affect entire upper arm, medical attention was sought out. A shot of Benadryl and a shot of Rocephin were administered at approximately 1:30 PM by medical team.
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Condition aggravated, Human papilloma virus test positive, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Patient woke up with whole left arm swollen and tiny raised bumps around injection site. Swelling subsided to just around bicep around by end of day. Sunday morning patient woke with large blisters in a circle around injection site and upper arm still swollen and red.
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site vesicles, Oedema peripheral, Papilloma viral infection
Clinical narrative: Patient woke up with whole left arm swollen and tiny raised bumps around injection site. Swelling subsided to just around bicep around by end of day. Sunday morning patient woke with large blisters in a circle around injection site and upper arm still swollen and red.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 77 year old male patient. On 11-MAY-2012 the patient was vaccinated with ZOSTAVAX (lot number was reported as 0241AC; expired date 26-APR-2013) (dose, route and indication were not reported). On 27-JUN-2013 the patient experienced shingles after vaccination with ZOSTAVAX. The patient was hospitalized at an unknown hospital. The patient was given valacyclovir hydrochloride after discharged from hospital on an unknown date. The outcome of shingles was reported as recovering/resolving. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac disorder, Condition aggravated, Coronary artery disease, Diabetes mellitus, Hypertensive heart disease
Clinical narrative: This spontaneous report was received from a registered nurse and a healthcare worker concerning an approximately 65 year old female patient with asthma, hypertensive cardiac disease, coronary artery disease, diabetes, Penicillin allergy, Sulfa allergy and ZESTRIL allergy. On 18-DEC-2012, the patient first received JANUVIA. On an unknown date in January 2013, the patient started therapy with JANUVIA, 100 milligrams (1 tablet, orally, once daily). Other suspect therapy included 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date unspecified) administered subcutaneously on 29-MAY-2013. Concomitant therapies included COREG, naproxen (reported as NAPROXYN), aspirin, clonidine, famotidine, amlodipine besylate, EXFORGE, BYSTOLIC, NOVOLOG, LIPITOR and nasal aerosol (unspecified). On 12-JUL-2013, the patient was discovered to be deceased. The cause of death was determined to be sudden death related to diabetes, coronary artery disease, and hypertensive cardiovascular disease. It was unknown if autopsy was performed. The patient was hospitalized on 04-JUL-2013 due to symptoms of her heart disease. Her discharge date from the hospital was unable to be determined. The relatedness for the event was unknown for JANUVIA and ZOSTAVAX. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Sudden death
Clinical narrative: This spontaneous report was received from a registered nurse and a healthcare worker concerning an approximately 65 year old female patient with asthma, hypertensive cardiac disease, coronary artery disease, diabetes, Penicillin allergy, Sulfa allergy and ZESTRIL allergy. On 18-DEC-2012, the patient first received JANUVIA. On an unknown date in January 2013, the patient started therapy with JANUVIA, 100 milligrams (1 tablet, orally, once daily). Other suspect therapy included 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date unspecified) administered subcutaneously on 29-MAY-2013. Concomitant therapies included COREG, naproxen (reported as NAPROXYN), aspirin, clonidine, famotidine, amlodipine besylate, EXFORGE, BYSTOLIC, NOVOLOG, LIPITOR and nasal aerosol (unspecified). On 12-JUL-2013, the patient was discovered to be deceased. The cause of death was determined to be sudden death related to diabetes, coronary artery disease, and hypertensive cardiovascular disease. It was unknown if autopsy was performed. The patient was hospitalized on 04-JUL-2013 due to symptoms of her heart disease. Her discharge date from the hospital was unable to be determined. The relatedness for the event was unknown for JANUVIA and ZOSTAVAX. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Abdominal discomfort
Clinical narrative: Abdominal distress x 5d Re: Rotateq dose # 1, Lot J003951. Do not administer additional doses of Rotavirus vaccine per Dr.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Chest X-ray, Chest pain, Electrocardiogram
Clinical narrative: Initial report was received from a consumer on 29 July 2013, who is also the patient. A 58-year-old female patient, with a history of Diabetes Mellitus and hypothyroidism, received a first dose injection of ADACEL vaccine on 19 June 2013 (lot number, route, site and side of administration not reported). On the night of the same day, the patient experienced chest pains, 9 -10 on the pain scale of 10 being the worst pain. The patient went to the emergency room (ER) and was given morphine and nitro tablets. Electrocardiograms, blood tests, and a chest x-ray were performed. The patient was not told she had a heart issue by the ER MD. The issue was resolved with no residual issue. Patient had no illness at the time of vaccination. The patient's outcome was reported as recovered. Documents held by sender: None.
Age: 33.0
Sex: M
Vaccine: RAB
Symptoms: Rash generalised, Swelling
Clinical narrative: Initial report was received on 31 July 2013 from a health care professional. A 33-year-old male patient with a history of allergy to penicillin had received for post exposure series on 25 July 2013 an intramuscular injection of IMOVAX, lot number J1358 (site of administration not reported) and an intramuscular injection of IMOGAM (lot number and site of administration not reported) and "later that day" developed a rash and swelling over much of his body. According to the reporter, the patient had not informed the physician and received the second dose of IMOVAX and again had the same reaction. The patient was hospitalized. Outcome was not recovered. Documents held by sender: none.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 05 August 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 23-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received the following 4 doses of PENTACEL vaccinations: lot C3663AA received on 19 September 2011, lot C3663AA received on 23 November 2011, lot C3747AB received on 18 January 2012, and lot C4131AA received on 18 July 2012. The subject developed a cough on 10 July 2013, approximately 1 year after the last dose, and a paroxysmal cough without a whoop on 15 July 2013. The subject also developed cold like symptoms on 15 July 2013, and posttusive vomiting and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 19 July 2013. Chest x-ray findings were negative. Corrective treatments consisted of azithromycin starting on 19 July 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 01 August 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 22 days. Investigator causality assessment is not required as per protocol. This is one case out of a cumulative total of 205 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 05 August 2013. These 205 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not captured as per study protocol. Documents held by sender: None.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 05 August 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 23-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received the following 4 doses of PENTACEL vaccinations: lot C3663AA received on 19 September 2011, lot C3663AA received on 23 November 2011, lot C3747AB received on 18 January 2012, and lot C4131AA received on 18 July 2012. The subject developed a cough on 10 July 2013, approximately 1 year after the last dose, and a paroxysmal cough without a whoop on 15 July 2013. The subject also developed cold like symptoms on 15 July 2013, and posttusive vomiting and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 19 July 2013. Chest x-ray findings were negative. Corrective treatments consisted of azithromycin starting on 19 July 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 01 August 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 22 days. Investigator causality assessment is not required as per protocol. This is one case out of a cumulative total of 205 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 05 August 2013. These 205 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not captured as per study protocol. Documents held by sender: None.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Back pain, Chills, Deafness, Facial pain
Clinical narrative: This spontaneous report as received from a 20 year old female patient with seasonal allergy refers to herself. On an unknown date the patient was vaccinated with a dose of GARDASIL dose 2, intramuscular (dose, site and lot number not provided). Concomitant therapies included SINGULAIR. On 09-JUL-2013 the patient experienced loss of hearing, back pain, chills, nausea, sore face, abdominal pain and migraine. The patient saw the doctor for medical attention. No treatment was given for the adverse events. The outcome of loss of the events was reported as not recovered. The causal relationship was not reported. Upon internal review loss of hearing was considered medically significant. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine, Nausea
Clinical narrative: This spontaneous report as received from a 20 year old female patient with seasonal allergy refers to herself. On an unknown date the patient was vaccinated with a dose of GARDASIL dose 2, intramuscular (dose, site and lot number not provided). Concomitant therapies included SINGULAIR. On 09-JUL-2013 the patient experienced loss of hearing, back pain, chills, nausea, sore face, abdominal pain and migraine. The patient saw the doctor for medical attention. No treatment was given for the adverse events. The outcome of loss of the events was reported as not recovered. The causal relationship was not reported. Upon internal review loss of hearing was considered medically significant. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: DTAP, HPV4, MNQ, VARCEL
Symptoms: Defaecation urgency, Loss of consciousness, Nausea
Clinical narrative: While pt was being given Gardasil she passed out. Laid her down and elevated her feet--Upon arousing was nauseated and felt the need to have a BM.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Asthenia, Lethargy, Unresponsive to stimuli
Clinical narrative: Pt lethargic not verbally responsive upon first attempt of questioning. Pt responded to second question that he "felt weak" BP: 120/80 P.64
Age: 12.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Abasia, Anaemia, Arthralgia, Bacterial test negative, Blood culture
Clinical narrative: Severe headaches, joint pain in knees, strawberry tongue, nausea and vomiting, severe diarrhea, neck pain, blisters in mouth, irritability, light and sound sensitivity, swelling in palms and ankles/feet, peeling of hands and feet, elevated liver enzymes, anemia. She was taken to ER x 2 for treatment of 103 fever and headache. Was given morphine, IVF and Zofran in ER. Spent approx 5 hours in ER.  2nd trip to ER within 12 hours for fever 103, headache, nausea and vomiting, diarrhea (severe, nearly uncontrolled bowel movements), given Tylenol, IVF, morphine, Zofran, Tylenol. CT of head was negative. Urine culture with some blood and WBC (was not a clean catch sample, and pt started menstral cycle). Was treated with IV Rocephin, IVF. Lumbar puncture offered but waited to see if antibiotics would help first. 3rd day of illness (Monday) she was unable to walk or bear weight on feet, severe pain in knees. Was taken to pediatrician and LP was attempted unsuccessfully. Was admitted to ER for worsening of symptoms, continued fever above 102. HA, nausea and vomiting, sore throat. Strep cultures negative. Swelling in lower extremities and hands. Weight gain of 13 pounds within 3 days. No appetite and did not take anything by mouth for 3 days. Extremely irritable. Was monitored 4 days in hospital, several test ran, all negative results. She was discharged from hospital 8-8-13. Follow up with pediatrician 8-12-13.
Age: 12.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Blood urine present, Computerised tomogram, Computerised tomogram head normal, Culture urine, Decreased appetite
Clinical narrative: Severe headaches, joint pain in knees, strawberry tongue, nausea and vomiting, severe diarrhea, neck pain, blisters in mouth, irritability, light and sound sensitivity, swelling in palms and ankles/feet, peeling of hands and feet, elevated liver enzymes, anemia. She was taken to ER x 2 for treatment of 103 fever and headache. Was given morphine, IVF and Zofran in ER. Spent approx 5 hours in ER.  2nd trip to ER within 12 hours for fever 103, headache, nausea and vomiting, diarrhea (severe, nearly uncontrolled bowel movements), given Tylenol, IVF, morphine, Zofran, Tylenol. CT of head was negative. Urine culture with some blood and WBC (was not a clean catch sample, and pt started menstral cycle). Was treated with IV Rocephin, IVF. Lumbar puncture offered but waited to see if antibiotics would help first. 3rd day of illness (Monday) she was unable to walk or bear weight on feet, severe pain in knees. Was taken to pediatrician and LP was attempted unsuccessfully. Was admitted to ER for worsening of symptoms, continued fever above 102. HA, nausea and vomiting, sore throat. Strep cultures negative. Swelling in lower extremities and hands. Weight gain of 13 pounds within 3 days. No appetite and did not take anything by mouth for 3 days. Extremely irritable. Was monitored 4 days in hospital, several test ran, all negative results. She was discharged from hospital 8-8-13. Follow up with pediatrician 8-12-13.
Age: 12.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Diarrhoea, Epstein-Barr virus test, Full blood count abnormal, Headache, Hepatic enzyme increased
Clinical narrative: Severe headaches, joint pain in knees, strawberry tongue, nausea and vomiting, severe diarrhea, neck pain, blisters in mouth, irritability, light and sound sensitivity, swelling in palms and ankles/feet, peeling of hands and feet, elevated liver enzymes, anemia. She was taken to ER x 2 for treatment of 103 fever and headache. Was given morphine, IVF and Zofran in ER. Spent approx 5 hours in ER.  2nd trip to ER within 12 hours for fever 103, headache, nausea and vomiting, diarrhea (severe, nearly uncontrolled bowel movements), given Tylenol, IVF, morphine, Zofran, Tylenol. CT of head was negative. Urine culture with some blood and WBC (was not a clean catch sample, and pt started menstral cycle). Was treated with IV Rocephin, IVF. Lumbar puncture offered but waited to see if antibiotics would help first. 3rd day of illness (Monday) she was unable to walk or bear weight on feet, severe pain in knees. Was taken to pediatrician and LP was attempted unsuccessfully. Was admitted to ER for worsening of symptoms, continued fever above 102. HA, nausea and vomiting, sore throat. Strep cultures negative. Swelling in lower extremities and hands. Weight gain of 13 pounds within 3 days. No appetite and did not take anything by mouth for 3 days. Extremely irritable. Was monitored 4 days in hospital, several test ran, all negative results. She was discharged from hospital 8-8-13. Follow up with pediatrician 8-12-13.
Age: 12.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Hepatitis A virus test, Hyperacusis, Irritability, Joint swelling, Laboratory test normal
Clinical narrative: Severe headaches, joint pain in knees, strawberry tongue, nausea and vomiting, severe diarrhea, neck pain, blisters in mouth, irritability, light and sound sensitivity, swelling in palms and ankles/feet, peeling of hands and feet, elevated liver enzymes, anemia. She was taken to ER x 2 for treatment of 103 fever and headache. Was given morphine, IVF and Zofran in ER. Spent approx 5 hours in ER.  2nd trip to ER within 12 hours for fever 103, headache, nausea and vomiting, diarrhea (severe, nearly uncontrolled bowel movements), given Tylenol, IVF, morphine, Zofran, Tylenol. CT of head was negative. Urine culture with some blood and WBC (was not a clean catch sample, and pt started menstral cycle). Was treated with IV Rocephin, IVF. Lumbar puncture offered but waited to see if antibiotics would help first. 3rd day of illness (Monday) she was unable to walk or bear weight on feet, severe pain in knees. Was taken to pediatrician and LP was attempted unsuccessfully. Was admitted to ER for worsening of symptoms, continued fever above 102. HA, nausea and vomiting, sore throat. Strep cultures negative. Swelling in lower extremities and hands. Weight gain of 13 pounds within 3 days. No appetite and did not take anything by mouth for 3 days. Extremely irritable. Was monitored 4 days in hospital, several test ran, all negative results. She was discharged from hospital 8-8-13. Follow up with pediatrician 8-12-13.
Age: 12.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Lumbar puncture, Metabolic function test, Mononucleosis heterophile test, Nausea, Neck pain
Clinical narrative: Severe headaches, joint pain in knees, strawberry tongue, nausea and vomiting, severe diarrhea, neck pain, blisters in mouth, irritability, light and sound sensitivity, swelling in palms and ankles/feet, peeling of hands and feet, elevated liver enzymes, anemia. She was taken to ER x 2 for treatment of 103 fever and headache. Was given morphine, IVF and Zofran in ER. Spent approx 5 hours in ER.  2nd trip to ER within 12 hours for fever 103, headache, nausea and vomiting, diarrhea (severe, nearly uncontrolled bowel movements), given Tylenol, IVF, morphine, Zofran, Tylenol. CT of head was negative. Urine culture with some blood and WBC (was not a clean catch sample, and pt started menstral cycle). Was treated with IV Rocephin, IVF. Lumbar puncture offered but waited to see if antibiotics would help first. 3rd day of illness (Monday) she was unable to walk or bear weight on feet, severe pain in knees. Was taken to pediatrician and LP was attempted unsuccessfully. Was admitted to ER for worsening of symptoms, continued fever above 102. HA, nausea and vomiting, sore throat. Strep cultures negative. Swelling in lower extremities and hands. Weight gain of 13 pounds within 3 days. No appetite and did not take anything by mouth for 3 days. Extremely irritable. Was monitored 4 days in hospital, several test ran, all negative results. She was discharged from hospital 8-8-13. Follow up with pediatrician 8-12-13.
Age: 12.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Oedema peripheral, Oral mucosal blistering, Oropharyngeal pain, Photophobia, Pyrexia
Clinical narrative: Severe headaches, joint pain in knees, strawberry tongue, nausea and vomiting, severe diarrhea, neck pain, blisters in mouth, irritability, light and sound sensitivity, swelling in palms and ankles/feet, peeling of hands and feet, elevated liver enzymes, anemia. She was taken to ER x 2 for treatment of 103 fever and headache. Was given morphine, IVF and Zofran in ER. Spent approx 5 hours in ER.  2nd trip to ER within 12 hours for fever 103, headache, nausea and vomiting, diarrhea (severe, nearly uncontrolled bowel movements), given Tylenol, IVF, morphine, Zofran, Tylenol. CT of head was negative. Urine culture with some blood and WBC (was not a clean catch sample, and pt started menstral cycle). Was treated with IV Rocephin, IVF. Lumbar puncture offered but waited to see if antibiotics would help first. 3rd day of illness (Monday) she was unable to walk or bear weight on feet, severe pain in knees. Was taken to pediatrician and LP was attempted unsuccessfully. Was admitted to ER for worsening of symptoms, continued fever above 102. HA, nausea and vomiting, sore throat. Strep cultures negative. Swelling in lower extremities and hands. Weight gain of 13 pounds within 3 days. No appetite and did not take anything by mouth for 3 days. Extremely irritable. Was monitored 4 days in hospital, several test ran, all negative results. She was discharged from hospital 8-8-13. Follow up with pediatrician 8-12-13.
Age: 12.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Skin exfoliation, Strawberry tongue, Streptococcus test negative, Vomiting, Weight bearing difficulty
Clinical narrative: Severe headaches, joint pain in knees, strawberry tongue, nausea and vomiting, severe diarrhea, neck pain, blisters in mouth, irritability, light and sound sensitivity, swelling in palms and ankles/feet, peeling of hands and feet, elevated liver enzymes, anemia. She was taken to ER x 2 for treatment of 103 fever and headache. Was given morphine, IVF and Zofran in ER. Spent approx 5 hours in ER.  2nd trip to ER within 12 hours for fever 103, headache, nausea and vomiting, diarrhea (severe, nearly uncontrolled bowel movements), given Tylenol, IVF, morphine, Zofran, Tylenol. CT of head was negative. Urine culture with some blood and WBC (was not a clean catch sample, and pt started menstral cycle). Was treated with IV Rocephin, IVF. Lumbar puncture offered but waited to see if antibiotics would help first. 3rd day of illness (Monday) she was unable to walk or bear weight on feet, severe pain in knees. Was taken to pediatrician and LP was attempted unsuccessfully. Was admitted to ER for worsening of symptoms, continued fever above 102. HA, nausea and vomiting, sore throat. Strep cultures negative. Swelling in lower extremities and hands. Weight gain of 13 pounds within 3 days. No appetite and did not take anything by mouth for 3 days. Extremely irritable. Was monitored 4 days in hospital, several test ran, all negative results. She was discharged from hospital 8-8-13. Follow up with pediatrician 8-12-13.
Age: 12.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Weight increased, White blood cells urine positive
Clinical narrative: Severe headaches, joint pain in knees, strawberry tongue, nausea and vomiting, severe diarrhea, neck pain, blisters in mouth, irritability, light and sound sensitivity, swelling in palms and ankles/feet, peeling of hands and feet, elevated liver enzymes, anemia. She was taken to ER x 2 for treatment of 103 fever and headache. Was given morphine, IVF and Zofran in ER. Spent approx 5 hours in ER.  2nd trip to ER within 12 hours for fever 103, headache, nausea and vomiting, diarrhea (severe, nearly uncontrolled bowel movements), given Tylenol, IVF, morphine, Zofran, Tylenol. CT of head was negative. Urine culture with some blood and WBC (was not a clean catch sample, and pt started menstral cycle). Was treated with IV Rocephin, IVF. Lumbar puncture offered but waited to see if antibiotics would help first. 3rd day of illness (Monday) she was unable to walk or bear weight on feet, severe pain in knees. Was taken to pediatrician and LP was attempted unsuccessfully. Was admitted to ER for worsening of symptoms, continued fever above 102. HA, nausea and vomiting, sore throat. Strep cultures negative. Swelling in lower extremities and hands. Weight gain of 13 pounds within 3 days. No appetite and did not take anything by mouth for 3 days. Extremely irritable. Was monitored 4 days in hospital, several test ran, all negative results. She was discharged from hospital 8-8-13. Follow up with pediatrician 8-12-13.
Age: 55.0
Sex: F
Vaccine: HEPA, MMR, TDAP
Symptoms: Abdominal discomfort, Arthralgia, Chills, Dizziness, Headache
Clinical narrative: Chills and take Tylenol which makes it followed by sweating, headache, achy arm where shots administered, dizziness, upset stomach, achy muscles and joints.
Age: 55.0
Sex: F
Vaccine: HEPA, MMR, TDAP
Symptoms: Hyperhidrosis, Injection site pain, Myalgia
Clinical narrative: Chills and take Tylenol which makes it followed by sweating, headache, achy arm where shots administered, dizziness, upset stomach, achy muscles and joints.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Local reaction
Clinical narrative: Large red local reaction on right arm.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Pyrexia, Rash generalised
Clinical narrative: Fatigue, followed by low grade fever, followed by facial rash that developed into upper body rash.
Age: 3.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Bacterial infection, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Fever rectal 102.1. Red swollen and hot at injection site. Called ped office and as instructed drew ring around red area. We're told to call back if it grew larger we also gave Tylenol. 8pm spot larger, hot to touch fever returned 102.7 rectal. Gave Benadryl. Next morning (Sunday) still hot, spot larger fever down to 99.9 rectal. Drs office closed called ER for advice they suggested coming in. ER Dr diagnosed bacterial infection. Placed her on antibiotic. As of today her fever is gone still has a spot but not red.  It is now pink and not warm to touch. We will continue with antibiotic for remaining 8 days.
Age: 3.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever rectal 102.1. Red swollen and hot at injection site. Called ped office and as instructed drew ring around red area. We're told to call back if it grew larger we also gave Tylenol. 8pm spot larger, hot to touch fever returned 102.7 rectal. Gave Benadryl. Next morning (Sunday) still hot, spot larger fever down to 99.9 rectal. Drs office closed called ER for advice they suggested coming in. ER Dr diagnosed bacterial infection. Placed her on antibiotic. As of today her fever is gone still has a spot but not red.  It is now pink and not warm to touch. We will continue with antibiotic for remaining 8 days.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Edema, erythema at injection site. Onset several hours after injection. No treatment necessary.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 17 year old male patient. On 06-AUG-2013, the patient was vaccinated with first dose GARDASIL, (lot # H020002, expiry date was 08-AUG-2015, route was not reported). Other suspect therapies which were also administered on 06-AUG-2013, included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (DIPHTHERIA TOXOID (+) PERTUSSIS ACELLULAR VACCINE (UNSPECIFIED) (+) TE), meningococcal conj vaccine (unspecified) (MENINGOCOCCAL CONJ VACCINE (UNSPECIFIED)) and chickenpox vaccine (unspecified) (VARICELLA VIRUS VACCINE LIVE (UNSPECIFIED)). On 06-AUG-2013, the patient fainted. The patient had not eaten all day. The patient was given oxygen as a treatment. There were laboratory diagnostics provided. The outcome of fainted was reported as recovered on the same day. It was stated that the patient planned to continue with the series. The patient sought medical attention. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Antibody test abnormal
Clinical narrative: Case number PHEH2013US016741 is an initial spontaneous report received from nurse on 06 Aug 2013. This is also a quality complaint report (reference number: 238867). This report refers to a 23-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with RABAVERT (batch number: 467011C) at a dose of one ml on 03 Oct 2011 (day 0), 10 Oct 2011 (day 7) and 24 Oct 2011 (day 21). On 14 May 2013, she had equivocal rabies titer, which was an insufficient result. She required a rabies booster. Reporter assessed the case as serious (significant). No other information was provided.
Age: 22.0
Sex: M
Vaccine: RAB
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Case number PHEH2013US017048 is an initial spontaneous report from the physician received on 05 Aug 2013. This report refers to a 22-year-old male patient. He received first dose of RABAVERT on 15 Jul 2013. On 18 Jul 2013, he developed red itchy spots all over his legs and trunk and these events eventually went away (see case: PHEH2013US016817). On 22 Jul 2013, he received his second dose of RABAVERT (batch number: 524011C) via intramuscular route. On an unknown date, three days after second dose of RABAVERT he again developed red itchy spots. The event itching was so severe that he sought medical treatment at an urgent care clinic. It was reported that the spots were more intense after the second dose of RABAVERT. The outcome of the events reported as resolved at the time of reporting. The seriousness and causality of the events were not reported.
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Antibody test abnormal
Clinical narrative: Case number PHEH2013US016744 is an initial spontaneous report received from a nurse on 06 Aug 2013. This is also a quality complaint report (reference number: 245488). This report refers to a 23-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with RABAVERT (batch number: 473011C) at a dose of one ml, intramuscularly, with first dose on 07 Sep 2011 (day 0) in right deltoid, second dose on 14 Sep 2011 (day 7) in left deltoid and third dose on 05 Oct 2011 (day 28) in right deltoid. On 15 May 2013, she had equivocal rabies titer (insufficient result). She required a booster dose of rabies. Reporter assessed the case as serious (medically significant). Outcome of the event was not reported. No other information was provided.
Age: 22.0
Sex: M
Vaccine: RAB
Symptoms: Antibody test abnormal
Clinical narrative: Case number PHEH2013US016729 is a spontaneous report received from the nurse on 06 Aug 2013. This report refers to a 23-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with the first dose of RABAVERT (batch number: 473011C) intramuscularly at a dose of 1 ml, in the right deltoid on 07 Sep 2011, second dose of RABAVERT (batch number; 473011C) intramuscularly a dose of 1 ml, in the left deltoid on 14 Sep 2011, third dose of RABAVERT (batch number: 473011C) intramuscularly at a dose of 1 ml, in the right deltoid on 05 Oct 2011. It was reported that he tolerated the vaccine in the past. On 16 MAY 2013, his rabies titer showed equivocal levels (insufficient result) and it was reported that he needed a rabies booster. The event outcome was not reported. The case was assessed as medically significant by the reporter. The causality was not reported. No additional information was available.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Antibody test abnormal
Clinical narrative: Case number PHEH2013US016733 is an initial spontaneous report received from a nurse on 06 Aug 2013. This report refers to a 24-years-old female patient. Her medical history included allergy to penicillin, sulfa drugs and cephalosporins. Her concomitant medications were not reported. She was vaccinated with three doses of RABAVERT (batch number: 473011C) at a dose of 1 ml intramuscularly into left deltoid on 07 Sep 2011, 14 Sep 2011 and 05 Oct 2011 respectively. On 15 May 2013, she had equivocal rabies titers and the level was insufficient. It was reported that she required a rabies booster. The reporter assessed the event as medically significant. The outcome of the event was not reported. No further information was provided.
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Antibody test abnormal
Clinical narrative: Case number PHEH2013US016736 is an initial spontaneous report received from a nurse on 06 Aug 2013. This is also a quality complaint report (reference number: 238867). This report refers to a 23-year-old female patient. The patient's history included allergy to Penicillin and CECLOR. Concomitant medication were not reported. She was vaccinated with RABAVERT (batch number: 473011C) at a dose of one ml, intramuscularly, with first dose on 07 Sep 2011 (day 0) at left deltoid, second dose on 14 Sep 2011 (day 7) at left deltoid and third dose on 05 Oct 2011 (day 28) at left deltoid. On 14 May 2013, she had equivocal rabies titer, which was an insufficient result. She required a booster dose of rabies. Reporter assessed the case as serious (significant). Outcome of the event was not reported. No other information was provided.
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Antibody test abnormal
Clinical narrative: Case number PHEH2013US016731 is an initial spontaneous report received from a nurse on 06 Aug 2013. This report refers to a 23-years-old female patient. Her medical history included allergy to penicillin. Her concomitant medications were not reported. She was vaccinated with three doses of RABAVERT (batch number: 473011C) at a dose of 1 ml intramuscularly on 07 Sep 2011, 14 Sep 2011 and 05 Oct 2011 respectively. The first dose was administered on left deltoid and the second and third doses were given on right deltoid. It was reported that on 15 May 2013, she had equivocal rabies titer and that the level was insufficient. She required a rabies booster. The reporter assessed the event as medically significant. The outcome of the event was not reported. No further information was provided.
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Antibody test abnormal
Clinical narrative: Case number PHEH2013US016728 is a spontaneous report received from the nurse on 06 Aug 2013. This report refers to an adult female patient. The patient had a history of allergies to BACTRIM and DURACEF. She was vaccinated with the first dose of RABAVERT (batch number: 473011C) intramuscularly at a dose of 1 ml, in the left deltoid on 07 Sep 2011. The patient received second and third doses of RABAVERT (batch number: 473011C) each 1ml intramuscularly in the right deltoid on 14 Sep 2011 and 05 Oct 2011 respectively. On 11 Jun 2013, her rabies titer equivocal levels were insufficient and it was reported that she needs a rabies booster. The event outcome was not reported. The case was assessed as medically significant by the reporter. The causality was not reported.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Zoster rash in T11 dermatome. I treated the patient for shingles with valcyclovir 1000mg TID for seven days.
Age: 23.0
Sex: M
Vaccine: TYP
Symptoms: Anxiety, Blood culture, Chills, Culture stool, Fatigue
Clinical narrative: Pt in usual state of health reports getting oral typhoid vaccine (Vivotif-Live attenuated vaccine) on 7Aug2013 from his BAS despite his immune-compromised state. Pt has taken 3 of the 4 pills given. Four days ago (8Aug2013), pt noted unusual generalized fatigue, nausea, anxiety, and alternating subjective fever/chills.
Age: 23.0
Sex: M
Vaccine: TYP
Symptoms: Full blood count, Nausea, Pyrexia, Red blood cell sedimentation rate, Sigmoidoscopy
Clinical narrative: Pt in usual state of health reports getting oral typhoid vaccine (Vivotif-Live attenuated vaccine) on 7Aug2013 from his BAS despite his immune-compromised state. Pt has taken 3 of the 4 pills given. Four days ago (8Aug2013), pt noted unusual generalized fatigue, nausea, anxiety, and alternating subjective fever/chills.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever, redness, swelling and pain started at left arm injection site 1 day after vaccine was administered. Treated with 7 days of Augmentin for diagnosis of cellulitis.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hyperaesthesia, Pain, Pruritus, Rash erythematous
Clinical narrative: Raised red painful rash on right buttock and right perineal area. Hypersensitive, itchy skin in described areas & in right hip. Rash, pain, & itching lasted for 2 weeks. Naprosyn and Lidocaine gel topical used as Rx by PCP. PCP reported to me it appeared to be a "shingles" rash.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Chromatopsia, Convulsion, Dizziness, Fall, Head injury
Clinical narrative: Light headed, aurora sensation, nausea immediately.  Then syncope & seizure less than 1 min. Fell from chair when he went unconscious hitting head on floor as per nurse.