chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Hepatitis viral test, Immunoelectrophoresis, Juvenile idiopathic arthritis, Laboratory test, Metabolic function test
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 24 year old female patient. The patient had no pertinent medical history. Drug reactions/allergies were none. Approximately on an unknown date in July 2012 (reported as shortly before 11-JUL-2012), the patient was vaccinated with a second dose of GARDASIL (dose, route of administration, lot# not reported). Concomitant therapies included vitamins (unspecified). On 11-JUL-2012, the patient was admitted to the hospital due to anemia, ESR (Erythrocyte sedimentation rate), a salmon-colored rash and a fever of 103 Fahrenheit (F). Physician stated that while in the hospital the patient was seen by infectious disease, internal medicine and rheumatology and had multiple lab and diagnostic studies. The patient had a mono screen, a complete metabolic panel, ferritin, CMV, EBV, parvovirus, enterovirus, SSA/SSB, CRP, IFE serum package, LDH, creatine kinase, torch titers, a hepatitis panel, J0-1 antibody, Smith antibody and ANA tests, where results and units not provided. It was reported that the patient was diagnosed with Still's disease by an unspecified physician at the hospital, on an unspecified date in July 2012. The patient sought medical attention (hospitalized). On 19-JUL-2012, the patient was discharged from the hospital. An unspecified physician in the hospital prescribed Prednisone to the patient. On an unknown date in July 2012 to January 2013, the patient took the prednisone (manufacturer unknown) as a treatment. The patient was currently pregnant but gestation and LMP were unspecified by reporter. At the time of the report the physician also stated the patient was no longer taking Prednisone and was only taking prenatal vitamins. The physician stated that the events anemia, ESR (Erythrocyte sedimentation rate), a salmon-colored rash, fever of 103 Fahrenheit and Still's disease had caused significant disability and was potentially life threatening at the time. However the patient was doing very well now, she has only had a few minor flares of her knee and joint pain but nothing severe like her initial presentation. The outcome of the events anemia, ESR (Erythrocyte sedimentation rate), a salmon-colored rash, fever of 103 Fahrenheit and Still's disease were recovered/resolved on an unknown date. The outcome of the event few minor flares of her knee and joint pain was unknown. The pregnancy outcome was pending. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Mononucleosis heterophile test, Parvovirus B19 test, Pyrexia, Rash erythematous, Red blood cell sedimentation rate
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 24 year old female patient. The patient had no pertinent medical history. Drug reactions/allergies were none. Approximately on an unknown date in July 2012 (reported as shortly before 11-JUL-2012), the patient was vaccinated with a second dose of GARDASIL (dose, route of administration, lot# not reported). Concomitant therapies included vitamins (unspecified). On 11-JUL-2012, the patient was admitted to the hospital due to anemia, ESR (Erythrocyte sedimentation rate), a salmon-colored rash and a fever of 103 Fahrenheit (F). Physician stated that while in the hospital the patient was seen by infectious disease, internal medicine and rheumatology and had multiple lab and diagnostic studies. The patient had a mono screen, a complete metabolic panel, ferritin, CMV, EBV, parvovirus, enterovirus, SSA/SSB, CRP, IFE serum package, LDH, creatine kinase, torch titers, a hepatitis panel, J0-1 antibody, Smith antibody and ANA tests, where results and units not provided. It was reported that the patient was diagnosed with Still's disease by an unspecified physician at the hospital, on an unspecified date in July 2012. The patient sought medical attention (hospitalized). On 19-JUL-2012, the patient was discharged from the hospital. An unspecified physician in the hospital prescribed Prednisone to the patient. On an unknown date in July 2012 to January 2013, the patient took the prednisone (manufacturer unknown) as a treatment. The patient was currently pregnant but gestation and LMP were unspecified by reporter. At the time of the report the physician also stated the patient was no longer taking Prednisone and was only taking prenatal vitamins. The physician stated that the events anemia, ESR (Erythrocyte sedimentation rate), a salmon-colored rash, fever of 103 Fahrenheit and Still's disease had caused significant disability and was potentially life threatening at the time. However the patient was doing very well now, she has only had a few minor flares of her knee and joint pain but nothing severe like her initial presentation. The outcome of the events anemia, ESR (Erythrocyte sedimentation rate), a salmon-colored rash, fever of 103 Fahrenheit and Still's disease were recovered/resolved on an unknown date. The outcome of the event few minor flares of her knee and joint pain was unknown. The pregnancy outcome was pending. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Serum ferritin
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 24 year old female patient. The patient had no pertinent medical history. Drug reactions/allergies were none. Approximately on an unknown date in July 2012 (reported as shortly before 11-JUL-2012), the patient was vaccinated with a second dose of GARDASIL (dose, route of administration, lot# not reported). Concomitant therapies included vitamins (unspecified). On 11-JUL-2012, the patient was admitted to the hospital due to anemia, ESR (Erythrocyte sedimentation rate), a salmon-colored rash and a fever of 103 Fahrenheit (F). Physician stated that while in the hospital the patient was seen by infectious disease, internal medicine and rheumatology and had multiple lab and diagnostic studies. The patient had a mono screen, a complete metabolic panel, ferritin, CMV, EBV, parvovirus, enterovirus, SSA/SSB, CRP, IFE serum package, LDH, creatine kinase, torch titers, a hepatitis panel, J0-1 antibody, Smith antibody and ANA tests, where results and units not provided. It was reported that the patient was diagnosed with Still's disease by an unspecified physician at the hospital, on an unspecified date in July 2012. The patient sought medical attention (hospitalized). On 19-JUL-2012, the patient was discharged from the hospital. An unspecified physician in the hospital prescribed Prednisone to the patient. On an unknown date in July 2012 to January 2013, the patient took the prednisone (manufacturer unknown) as a treatment. The patient was currently pregnant but gestation and LMP were unspecified by reporter. At the time of the report the physician also stated the patient was no longer taking Prednisone and was only taking prenatal vitamins. The physician stated that the events anemia, ESR (Erythrocyte sedimentation rate), a salmon-colored rash, fever of 103 Fahrenheit and Still's disease had caused significant disability and was potentially life threatening at the time. However the patient was doing very well now, she has only had a few minor flares of her knee and joint pain but nothing severe like her initial presentation. The outcome of the events anemia, ESR (Erythrocyte sedimentation rate), a salmon-colored rash, fever of 103 Fahrenheit and Still's disease were recovered/resolved on an unknown date. The outcome of the event few minor flares of her knee and joint pain was unknown. The pregnancy outcome was pending. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: SEVERE PAIN IN R SHOULDER AND DELTOID INJECTION SITE. I FELT THAT THE PHARMACIST ADMINISTERED THE INJECTION TOO HIGH ON MY ARM.  VISITED ORTHOPEDIC SURGEON ON 12/06/13, AND WAS DIAGNOSED WITH A CASE OF BURSITIS.  ORTHOPOD STATE I WAS INJECTED INTO THE BURSA INSTEAD OF THE MUSCLE.  CURRENTLY ON ANTI INFLAMMATORIES, REST, AND HEAT TREATMENTS.  INSTRUCTED TO RETURN TO SEE HIM IN 4-6 WEEKS IF SYMPTOMS TO NOT RESOLVE.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bursitis, Drug administered at inappropriate site, Injection site pain
Clinical narrative: SEVERE PAIN IN R SHOULDER AND DELTOID INJECTION SITE. I FELT THAT THE PHARMACIST ADMINISTERED THE INJECTION TOO HIGH ON MY ARM.  VISITED ORTHOPEDIC SURGEON ON 12/06/13, AND WAS DIAGNOSED WITH A CASE OF BURSITIS.  ORTHOPOD STATE I WAS INJECTED INTO THE BURSA INSTEAD OF THE MUSCLE.  CURRENTLY ON ANTI INFLAMMATORIES, REST, AND HEAT TREATMENTS.  INSTRUCTED TO RETURN TO SEE HIM IN 4-6 WEEKS IF SYMPTOMS TO NOT RESOLVE.
Age: 29.0
Sex: M
Vaccine: FLUX
Symptoms: Hyperhidrosis, Pain, Productive cough, Vomiting projectile
Clinical narrative: Projectile vomiting and sweating (both better). Productive coughing and full body aches (still current).
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Dizziness
Clinical narrative: Pt was given vaccine, walked to the front of the store and got lightheaded. Took BP which had dropped to 80/36. Pt layed down and sipped on soda waited 5 minutes. BP increased to 100/70 pt felt better and left to go to work f/u later that day and felt ok.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Blood pressure increased, Feeling hot, Pruritus, Tachycardia
Clinical narrative: Feeling hot, itchy face, chest, increased BP 130/80's - tachycardia.  Symptoms started one hour after being vaccinated.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Chest pain, Respiratory tract congestion, Wheezing
Clinical narrative: Chest congestion, wheezing, lasted one week, (chest pain).
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site rash, Injection site vesicles
Clinical narrative: Next day had rash at injection site, 3 - 4 inches in length. Filled with blisters. Called pharmacist who gave no recommendations. Still has headache.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Infection, Urine analysis
Clinical narrative: This spontaneous prospective pregnancy report as received from a pregnancy nurse refers to a 23 year old female patient with no pertinent medical history and no drug reactions/allergies. On 05-DEC-2013 the patient was vaccinated with dose one of GARDASIL (lot # H021608, expiration date 13-AUG-2015), intramuscular and was found out a few hours later to be pregnant. No concomitant medication was reported. The patient became pregnant with last menstrual period (LMP) of 08-NOV-2013 and Estimated Date of Delivery (EDD) of 15-AUG-2014. The pregnancy outcome was outcome pending. No treatment was given. The patient underwent urine test. Nurse also reported that patient currently had an unspecified infection as well, and would be treated with an unspecified antibiotic. The events outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with M-M-R II (dose, route, lot number and expiration date not provided). The nurse reported that an unspecified number of patients may had received M-M-R II that went through an unsupported temperature excursion. No adverse effects was reported. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Blindness transient
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female teenage patient of unknown age. In approximately 2013 reported as few months ago, the patient was vaccinated with the first dose of GARDASIL injection (strength, dose, route, lot number and expiration date not provided). Concomitant therapy included hepatitis A vaccine (manufacturer unknown) (dose and route not specified). In 2013, after receiving her 1st dose of GARDASIL the patient experienced a temporary blindness for a few minutes. She sought medical attention. The physician had the patient lay down quietly for a few minutes and the patient fully recovered (date unspecified in 2013). The physician did not continue with GARDASIL series. The relatedness between vaccination with GARDASIL and temporary blindness was not reported. Upon internal review, temporary blindness was considered to be a medically significant event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Immediate post-injection reaction, Panic attack
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. No medical history provided. On an unknown date the patient was vaccinated with ZOSTAVAX. No concomitant medications were provided. Immediately afterwards the patient experienced a panic attack and elevated heart rate. The pharmacist had the patient sit still for a while (time unspecified) and the patient fully recovered. The outcome of panic attack and elevated heart rate was reported as recovered. The patient did not seek medical attention. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Erythremia and swelling localized to L thigh area around 5 cm around vaccination site.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood calcium abnormal, Blood parathyroid hormone abnormal, Blood phosphorus, Blood phosphorus abnormal
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age with drug reactions/allergies to latex. Pertinent medical history was unknown. On 06-NOV-2013 the patient was vaccinated with GARDASIL lot # J009788 and expiry date 17-MAR-2016, dose 1, 0.5 ml, intramuscular. On an unknown date in November 2013, within approximately one week and progressing over time, patient was complained of fatigue, lack of energy, puffy eyes, cough, feeling hot and cold intermittently, and a low grade fever. As of 09-DEC-2013 (reported as yesterday), patient was not as fatigued but other symptoms remained. Patient's mother began giving her multi-vitamins because she thought her daughter was anemic. Anemia was ruled out with testing. Lab tests performed were CBC (Complete Blood Count), CMP (comprehensive metabolic panel). TSH (thyroid stimulating hormone), Mononucleosis ; PTH (parathyroid hormone level), Phosphorus Calcium and Parathyroid Hormone. All lab work completed was negative with exception of Phosphorus Calcium and Parathyroid Hormone, which results are not back yet. The outcome of fatigue was reported as recovering/resolving. The outcome of lack of energy, low grade fever, feeling hot and cold intermittently, cough and puffy eyes was reported as not recovered/not resolved. The patient had sought medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Blood thyroid stimulating hormone normal, Cough, Eyelid oedema, Fatigue
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age with drug reactions/allergies to latex. Pertinent medical history was unknown. On 06-NOV-2013 the patient was vaccinated with GARDASIL lot # J009788 and expiry date 17-MAR-2016, dose 1, 0.5 ml, intramuscular. On an unknown date in November 2013, within approximately one week and progressing over time, patient was complained of fatigue, lack of energy, puffy eyes, cough, feeling hot and cold intermittently, and a low grade fever. As of 09-DEC-2013 (reported as yesterday), patient was not as fatigued but other symptoms remained. Patient's mother began giving her multi-vitamins because she thought her daughter was anemic. Anemia was ruled out with testing. Lab tests performed were CBC (Complete Blood Count), CMP (comprehensive metabolic panel). TSH (thyroid stimulating hormone), Mononucleosis ; PTH (parathyroid hormone level), Phosphorus Calcium and Parathyroid Hormone. All lab work completed was negative with exception of Phosphorus Calcium and Parathyroid Hormone, which results are not back yet. The outcome of fatigue was reported as recovering/resolving. The outcome of lack of energy, low grade fever, feeling hot and cold intermittently, cough and puffy eyes was reported as not recovered/not resolved. The patient had sought medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling of body temperature change, Full blood count, Full blood count normal, Metabolic function test normal, Mononucleosis heterophile test negative
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age with drug reactions/allergies to latex. Pertinent medical history was unknown. On 06-NOV-2013 the patient was vaccinated with GARDASIL lot # J009788 and expiry date 17-MAR-2016, dose 1, 0.5 ml, intramuscular. On an unknown date in November 2013, within approximately one week and progressing over time, patient was complained of fatigue, lack of energy, puffy eyes, cough, feeling hot and cold intermittently, and a low grade fever. As of 09-DEC-2013 (reported as yesterday), patient was not as fatigued but other symptoms remained. Patient's mother began giving her multi-vitamins because she thought her daughter was anemic. Anemia was ruled out with testing. Lab tests performed were CBC (Complete Blood Count), CMP (comprehensive metabolic panel). TSH (thyroid stimulating hormone), Mononucleosis ; PTH (parathyroid hormone level), Phosphorus Calcium and Parathyroid Hormone. All lab work completed was negative with exception of Phosphorus Calcium and Parathyroid Hormone, which results are not back yet. The outcome of fatigue was reported as recovering/resolving. The outcome of lack of energy, low grade fever, feeling hot and cold intermittently, cough and puffy eyes was reported as not recovered/not resolved. The patient had sought medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age with drug reactions/allergies to latex. Pertinent medical history was unknown. On 06-NOV-2013 the patient was vaccinated with GARDASIL lot # J009788 and expiry date 17-MAR-2016, dose 1, 0.5 ml, intramuscular. On an unknown date in November 2013, within approximately one week and progressing over time, patient was complained of fatigue, lack of energy, puffy eyes, cough, feeling hot and cold intermittently, and a low grade fever. As of 09-DEC-2013 (reported as yesterday), patient was not as fatigued but other symptoms remained. Patient's mother began giving her multi-vitamins because she thought her daughter was anemic. Anemia was ruled out with testing. Lab tests performed were CBC (Complete Blood Count), CMP (comprehensive metabolic panel). TSH (thyroid stimulating hormone), Mononucleosis ; PTH (parathyroid hormone level), Phosphorus Calcium and Parathyroid Hormone. All lab work completed was negative with exception of Phosphorus Calcium and Parathyroid Hormone, which results are not back yet. The outcome of fatigue was reported as recovering/resolving. The outcome of lack of energy, low grade fever, feeling hot and cold intermittently, cough and puffy eyes was reported as not recovered/not resolved. The patient had sought medical attention. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 56 year old female patient with shingles. On 09-DEC-2013 the patient was vaccinated with ZOSTAVAX vial 19400 PFU, with valid lot # J011212 (expiry date 29-AUG-2014). No concomitant medication was reported. On 10-DEC-2013 the patient called the pharmacy to reported she had a large, 2 inch in diameter, "reddened area" around the injection site. The injection site was a little itchy as well. No rash was presented. The outcome was reported as not recovered/not resolved. No causality assessment was provided. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a immunocompromised patient of unknown age (gender not reported). The nurse reported that the patient was administered a first dose of PNEUMOVAX23 (lot#, route and dose not reported) on an unspecified date in August 2006 and was revaccinated with PREVNAR 13 (manufacturer unknown) (lot#, route and dose not reported) on an unspecified date in August 2013. The patient's unspecified physician requested that the patient be vaccinated again with PNEUMOVAX23. A second dose of PNEUMOVAX23 has not been administered at this time. No adverse effects reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral discomfort, Oral mucosal blistering
Clinical narrative: This spontaneous report as received from a 71 year old female patient with sulfa allergy (unspecified) and no pertinent medical history refers to herself. In approximately 2005, reported as 8 years ago, the patient was vaccinated with ZOSTAVAX left arm injection (strength, dose, route, lot number and expiration date not provided). The patient wanted to know if she could get shingles in her mouth. She stated that before the Thanksgiving holiday she visited her mother in the nursing home were her mother did have shingles and days later on 24-NOV-2013 caller felt a burning sensation on the left side of the roof of her mouth which then proceeded to break out in blisters. She sought unspecified medical attention. For a treatment AUGMENTIN was given. NO lab diagnostics studies was performed. The outcome of to break out in blisters and burning sensation on the left side of the roof of her mouth was not reported. The relatedness between vaccination with ZOSTAVAX and burning sensation on the left side of the roof of her mouth which then proceeded to break out in blisters was not reported. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Information has been received from a nurse concerning a 15 year old female with no drug reactions/allergies who was vaccinated with the first dose of 0.5 ml GARDASIL (lot # 670049/1261AA) on 20-AUG-2007 and he second dose of 0.5 ml GARDASIL on 24-JAN-2012 intramuscularly. There was no concomitant medication. Later on 24-JAN-2012 the patient had a urine test which showed she was pregnant. Her last menstrual period was in November 2011 and the estimated delivery date is in August 2012. No treatment was given to the patient Therapy continued. Follow up information was received. The office was called for pregnancy outcome information. The nurse was no longer there and they had no additional information to provide. All telephone attempts to obtain follow up information have been unsuccessful. This case is lost to follow up. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: Information has been received from a physician for VARIVAX (Merck), a Pregnancy Registry product, concerning a 17 year old female patient, who on 13-APR-2012 was vaccinated with a "booster" dose of VARIVAX (Merck) (dose route and lot number not reported). Other suspect therapy included third dose of GARDASIL, administered on the same day. It was reported that the patient was due to begin her menstrual cycle on approximately 16-APR-2012. The patient notified the physician on 23-APR-2012 that she took a home pregnancy test which was positive. No adverse effect was reported. The date of the patient's last menstrual period was approximately 16-MAR-2012 and estimated delivery date is due on 21-DEC-2012. Follow up stated no additional information could be provided since the reporting physician retired the previous year. The pregnancy outcome has been updated to lost to follow up. Additional information is not expected.
Age: 0.29
Sex: F
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 week old female baby. On 10-DEC-2013 the patient was vaccinated with oral ROTATEQ dose 1, 2 ml. The baby was inadvertently administered her first dose of with oral ROTATEQ at 15 weeks of age. No adverse effect was reported. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Musculoskeletal pain, Neck pain, Neuralgic amyotrophy, Neurological examination abnormal
Clinical narrative: Developed acute onset neck and shoulder pain on 4/10/13. 4/13/13-treated in ER for robust take of SPV site. 5/13/13 - saw a neurologist, dx'd as neuralgic amyotrophy.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a Registered Nurse and a 21 year old female consumer, as part of a pregnancy registry for GARDASIL, reporting on herself with no pertinent medical history, drug reactions or allergies who on 24-FEB-2012, was vaccinated with the first dose of GARDASIL (lot number 667878/0180AA; dose and route not reported). Concomitant therapy included hormonal contraceptives (unspecified). The registered nurse reported that the patient went in February 2010 for her annual exam; at the tie she was on the pill and had not missed a period so she received GARDASIL. The consumer reported that on 28-FEB-2011 she found out she was pregnant. The consumer estimated that her last menstrual period was in the first week of February (on approximately 01-FEB-2012). The estimated delivery date was on 07-NOV-2012. No lab diagnostic tests were performed. The registered nurse reported that she did not have any information about an OBGYN for the patient. Follow up information received. Case was lost to follow up. Pregnancy outcome was not known. Additional information is not expected.
Age: 1.2
Sex: U
Vaccine: FLUN4
Symptoms: Diarrhoea, Drug administered to patient of inappropriate age, Muscular weakness, Pyrexia, Wheezing
Clinical narrative: A report from a Health Professional concerns a 14 month old patient of unknown gender. Concomitant medications included cetirizine. On 07-Oct-2013 nasal FLUMIST Quadrivalent (intranasal) was administered to a child under two years old. On the same day the patient experienced wheezing, diarrhea, fever, and leg weakness on one side. The patient recovered from the wheezing, diarrhea, fever, and leg weakness on one side on an unspecified date, and the outcome of the administered FLUMIST quadrivalent to a child under two year old was unknown. The reporter assessed the leg weakness on one side and administered FLUMIST quadrivalent to a child under two years old to be serious as important medical events. The company physician assessed the wheezing, diarrhea, and fever to be serious as important medical events that required emergency room/doctor visit. Follow-up information received by AstraZeneca/MedImmune 26-Nov-2013 from Health Professional upgraded this case to expeditable: administered FLUMIST quadrivalent to a child under two year old patient was upgraded to serious, serious events of wheezing, diarrhea, fever, and leg weakness on one side were newly added. Patient details, FLUMIST Quadrivalent start date, and concomitant medication also added.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Cellulitis, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Patient started with pain, redness and swelling below injection site of R upper arm at 1500 yesterday (day after vaccines) the redness had spread and was started to become indurated and warm. She has some tenderness to palpation. She is also experiencing some headache and nausea. No fevers are noted. She was diagnosed with cellulitis and placed on one antibiotic Duricef.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Patient started with pain, redness and swelling below injection site of R upper arm at 1500 yesterday (day after vaccines) the redness had spread and was started to become indurated and warm. She has some tenderness to palpation. She is also experiencing some headache and nausea. No fevers are noted. She was diagnosed with cellulitis and placed on one antibiotic Duricef.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: Information has been received from a medical assistant for HPV vaccine, a Pregnancy Registry product, concerning a 15 year old female patient with no drug reactions/allergies and a history of miscarriage on unspecified date (in February), who on 04-JUN-2012 was vaccinated with the first HPV (dose and route not reported) (lot number 672233/1561AA, Exp: 26-AUG-2014). There was no concomitant medication involved. The reporter stated the patient came in for physical and then received the HPV vaccine. Later in the physical, she was given a pregnancy test and learned she was pregnant. The reporter stated she did not plan to receive the rest of the HPV vaccine. There was no treatment given for an AE. Laboratory diagnostic studies were performed: urine pregnancy test. The patient sought unspecified medical attention. Follow-up information has been received from licensed practical nurse via Pregnancy Questionnaire. The nurse provided following information about the patient, date of last menstrual period: 20-APR-2012 (EDD would be on 25-Jan-2013), no birth defects occurred in previous pregnancy and laboratory diagnostic HCG test was performed to confirm pregnancy 9reason for test  sexually active). Follow-up information has been received from a nurse stating that on an unknown date the patient delivered a full term normal and healthy baby. There were no problems and everything was fine. No further information is available.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Guillain Barre - muscle weakness starting lower extremities - diagnosed by PCP.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unspecified date in July 2010, the patient was vaccinated with the first dose of RECOMBIVAX HB and on 16-OCT-2013 was vaccinated with the second dose of RECOMBIVAX HB (doses, route, lot # were not reported). The patient was in the office to receive the third dose of RECOMBIVAX HB on 11-DEC-2013. No adverse event reported. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pain in extremity, Rash macular
Clinical narrative: Local pain, near deltoid initially. Pain and blotchy redness moved down to biceps area and lateral arm after 2 days.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Blood alcohol, Blood magnesium, Computerised tomogram head, Drug screen, Full blood count
Clinical narrative: Working a gas station at  register became unresponsive collapsed into cigarette rack, seen in ER. Tonic clonic motor activity as per witnesses.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope, Tonic clonic movements, Unresponsive to stimuli, Urine analysis
Clinical narrative: Working a gas station at  register became unresponsive collapsed into cigarette rack, seen in ER. Tonic clonic motor activity as per witnesses.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Developed local reaction - redness at injection site after vaccine 1st 24 hr then had increased redness and swelling rt leg at injection site next day. Seen at office and treatment with antibiotic given. 12-5-13.
Age: 57.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Induration, Oedema, Swelling
Clinical narrative: Reaction was mild erythema with swelling stated as a +1-2 with firm edema. Reaction occurred 10-15 min after administration. No fever, loss of consciousness, or sudden light headedness. All S/S were gone and recovered in 24 hrs.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Fatigue, Headache, Pharyngeal oedema
Clinical narrative: Client stated she developed throat swelling and difficulties swallowing, headache, exhaustion. Client went to the ER for evaluation, was given BENADRYL and Prednisone for five days.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blindness, Electroencephalogram normal, Eye movement disorder, Gaze palsy
Clinical narrative: 11-17-13: Seizure like activity. Jerky side to side eye movements, followed by eyes rolling to the back of her head. Increased muscle tone throughout her body; then generalized weakness. Lasted 30 min's. Pt was aware of what was going on/followed direction but was unable to see during these events.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Hypertonia, Seizure like phenomena
Clinical narrative: 11-17-13: Seizure like activity. Jerky side to side eye movements, followed by eyes rolling to the back of her head. Increased muscle tone throughout her body; then generalized weakness. Lasted 30 min's. Pt was aware of what was going on/followed direction but was unable to see during these events.
Age: 1.37
Sex: M
Vaccine: PPV
Symptoms: Injection site urticaria
Clinical narrative: Hives on leg ear injection site.
Age: 1.66
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site rash, Rash, Urticaria
Clinical narrative: Rash from hip to ankle on injection leg.  Then spread to arms and torso ending with welts on the face.  Benadryl and Motrin administered.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure to product, Eye pain, Foreign body in eye, Ocular hyperaemia
Clinical narrative: Patient was giving injection of Varicella to patient and the vaccine squirted in her face and eye. This caused pain and redness in eye, diagnosed with corneal foreign body and given Gentamicin ophthalmic eye drops.
Age: 68.0
Sex: M
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Pain, Pruritus, Urticaria
Clinical narrative: Repeated intermittent outbreak of large welts or hives for 60 days occurring on various sites on the body (fingers, arms, neck, chest, legs, e.g.) Become sores and itch severely.  Will recede for 24 to 72 hours and then break out again.  Some outbreaks worse than others.  Treatment with over-the-counter antihistamines and hydrocortisone cream.
Age: 68.0
Sex: M
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Laboratory test, Pruritus, Urticaria
Clinical narrative: Repeated intermittent outbreak of large welts or hives for 60 days occurring on various sites on the body (fingers, arms, neck, chest, legs, e.g.) Become sores and itch severely.  Will recede for 24 to 72 hours and then break out again.  Some outbreaks worse than others.  Treatment with over-the-counter antihistamines and hydrocortisone cream.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy test negative, Discomfort, Joint swelling, Local swelling, Paraesthesia
Clinical narrative: After the initial vaccination I began to randomly experience hives and swelling in my hands, fingers, elbows, and knees. The event was cleared up with allergy medicine but lasted the entire day. The itching of the hives and swelling of my joints were uncomfortable and my fingers tingled from the event. For 2 1/2 years after the initial shot and the 2nd round of the HPV vaccination I experienced these events. They would be random and always around the same body parts from my fingers, hands, elbows, knees, and face. They would only subside with an antihistamine.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: After the initial vaccination I began to randomly experience hives and swelling in my hands, fingers, elbows, and knees. The event was cleared up with allergy medicine but lasted the entire day. The itching of the hives and swelling of my joints were uncomfortable and my fingers tingled from the event. For 2 1/2 years after the initial shot and the 2nd round of the HPV vaccination I experienced these events. They would be random and always around the same body parts from my fingers, hands, elbows, knees, and face. They would only subside with an antihistamine.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature increased, Decreased appetite, Irritability
Clinical narrative: VERY FUSSY, NOT EATING WELL, TEMP 101.5.
Age: 44.0
Sex: F
Vaccine: FLUR3
Symptoms: Headache, Malaise, Rash erythematous
Clinical narrative: DIFFUSE RED RASH, MALAISE, HEADACHE.  EVALUATED IN THE ED AND GIVEN IV SOLUMEDROL AND BENADRYL.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC13, RV5
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure within 48 hours of receiving vaccines. No other neurological hx of seizures.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Hives withiin 24 hrs of vaccination. Treated with OTC Benadryl, and resolved within 24 hours.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: Information has been received from a third party administrator on behalf of a pharmacy concerning a female patient, who on 02NOV2013 was vaccinated with PNEUMOVAX vaccine with lot # H021941 and an expiration date of 11JUL2014. It was reported that the patient was diagnosed with pneumonia days after receiving the vaccine. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Since injection on 9-25-2013 patient has experienced left arm pain.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: Itchiness at injection site lasting over 3 months - no redness or rash.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: The patient received the HPV vaccine and felt light-headed and faint. She was given Gatorade and laid down for about twenty minutes until vials were back to baseline. BP 90/50 at time of episode. 100/80 post rest.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Haematoma, Liver function test normal, Nausea, Weight decreased
Clinical narrative: Reported 12/12/13 at 10 AM. Received TC from Dr. office. Dr. reported that this pt developed hematoma 4-5 days after vaccines were given to pt. Pt is on aspirin po QD. Also, Dr. reported that pt developed nausea, anorexia and weight loss 6-7 day after shots. LFTs were done - WNL, as per Dr. Pt. completely recovered.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: Pt started with a sore neck a few hours after getting shot. Progressed to stiff neck and by the next day late morning couldn't move neck without much pain. Pt is going to contact Dr.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: The evening the vaccine was given mom noticed an area of erythema over the site that became more indurated and warm. She complained of pain and itching at the site on her left leg. On exam she had an area of erythema around the injection site of 3.5x2.5 inches with the middle 1.5x2 inches being indurated, darker in the middle lighter red on the borders warm to touch. Right thigh had 2x1 inch area of erythema no induration.
Age: 36.0
Sex: F
Vaccine: FLUR3
Symptoms: Pruritus, Rash macular
Clinical narrative: 1245 pm, vaccine given, 1300 noted red blotches to her neck and she said she felt 'itchy' she denied resp distress or difficulty. EHS ambulated her to the ER triage for eval. Prednisone 60 mg po x 1; BENADRYL 25 mg po x 1.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist via field representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot #, dose and route not provided). Other suspect therapies included on an unknown date, influenza virus vaccine(manufacturer unknown). On an unknown date, after receiving PNEUMOVAX 23 with influenza virus vaccine (manufacturer unknown) the patient developed swelling of the arm. At the time of the report, the swelling of the arm was unknown. This is one of two reports received from the same source. Additional information has been requested.
Age: 1.28
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Body temperature increased, Convulsion, Otitis media
Clinical narrative: Approx 7 hours post vaccine, parent states 104 degree temp, "seizure" to ER. ER reports TX from OM - Rocephin - sent home with Amox RX. Poss febrile seizure.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Lymph node pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Received flu vaccine on 12/9/13 and 12/10/13 started to experience flu-like symptoms - body aches, fever enlarged tender cervical nodes and swollen vagina vulva.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Vulvovaginal swelling
Clinical narrative: Received flu vaccine on 12/9/13 and 12/10/13 started to experience flu-like symptoms - body aches, fever enlarged tender cervical nodes and swollen vagina vulva.
Age: 31.0
Sex: F
Vaccine: TTOX
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: COMPLAINING OF SORENESS LEFT UPPER ARM WITH LIMITED RANGE OF MOTION BECOMING INCREASINGLY MORE PAINFUL OVER THE WEEK BEFORE SHE REPORTED THE REACTION TO FACILITY.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Increased upper airway secretion, Lip swelling, Pyrexia, Vomiting, Wheezing
Clinical narrative: Developed wheezing, throat congestion, vomitings around 1.30 pm, fever around 4.15 pm, swelling of lips around 9.30 pm. Symptoms subsided after taking Benadryl tablet. Symptoms subsided next day.
Age: 20.0
Sex: F
Vaccine: MNQ, YF
Symptoms: Pruritus, Throat tightness, Urticaria
Clinical narrative: Recieved meningococcal and yellow fever vaccines and within an hour recieved call from client at local hospital emergency stating on route home she started itching, hives and throat tightness.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoacusis, Malaise, Tinnitus
Clinical narrative: "I feel like my head is underwater...I'm having difficulty hearing and there's constant ringing in my ears. Some sounds are very muffled and other tones are very intensified.  It's an odd feeling and doesn't make me feel well."
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dysphonia, Ear pain, Musculoskeletal stiffness, Oropharyngeal pain
Clinical narrative: "Last night I had some chest pain on deep inspiration.  Today I have a sore throat, a raspy voice, neck and shoulder stiffness and jaw pain radiating to my ears."
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in jaw, Painful respiration
Clinical narrative: "Last night I had some chest pain on deep inspiration.  Today I have a sore throat, a raspy voice, neck and shoulder stiffness and jaw pain radiating to my ears."
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Tympanic membrane hyperaemia
Clinical narrative: FEVER UP TO 102 OR ABOVE THROUGH 10/11/13. NO FEVER 10/12 THEN FEVER RETURNED AGAIN 10/13/13.  SEEN IN OFFICE 10/15/12 FOR FEVER WITH MILD REDNESS OF EAR DRUM.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Eyelid oedema
Clinical narrative: Swelling of eyes, slowly progresive, mother gave Benadryl and improved eye lid swelling, having no anaphylactic symptoms.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Body temperature increased, Chills, Frostbite, Tremor
Clinical narrative: Began to get chills and was shaking uncontrollably.  By the time I got home I was shivering and fingers felt like frost bite.  My temp reached 101.7. Fever broke by morning.
Age: 17.0
Sex: F
Vaccine: FLU3, HIBV, PPV
Symptoms: Blood test, Cellulitis, Erythema, Pain in extremity, Swelling
Clinical narrative: Vaccines given 10/23/13. (L) arm pain 10/24/13, redness and swelling 10/25, to ER 10/26, admitted to hospital 10/27/13. Dx: cellulitis to (L) arm. IV clindamycin and Vancomycin in hospital. Discharged 10/30/13, on oral BACTRIM now. See hospital notes.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Eczema, Injection site rash, Injection site urticaria, Rash, Rash pruritic
Clinical narrative: Within 24 hours developed hives at the right deltoid injection site that spread up to the right side of his neck. The rash was itchy. He took Benadryl and the rash was gone in 24 hours. Four days later the rash started again at the injection site and spread up to the right side of neck. It then spread to the back of his neck. All the rash cleared in 24 hours after the use of Benadryl except for the back of neck. Then 4 weeks later he developed a eczema type rash on the sides of his neck, torso and is no spreading down the arms. He was seen by his MD who believes this is related to the vaccine and recommends he not get the flu shot. The associate has gotten flu shots for the past 25 years without a problem. This year he received Fluzone and in previous years he has received Afluria without issue.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Within 24 hours developed hives at the right deltoid injection site that spread up to the right side of his neck. The rash was itchy. He took Benadryl and the rash was gone in 24 hours. Four days later the rash started again at the injection site and spread up to the right side of neck. It then spread to the back of his neck. All the rash cleared in 24 hours after the use of Benadryl except for the back of neck. Then 4 weeks later he developed a eczema type rash on the sides of his neck, torso and is no spreading down the arms. He was seen by his MD who believes this is related to the vaccine and recommends he not get the flu shot. The associate has gotten flu shots for the past 25 years without a problem. This year he received Fluzone and in previous years he has received Afluria without issue.
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Cough, Headache, Pyrexia, Tremor
Clinical narrative: Shaking chills that lasted about 2 1/2 hours, fever of 102 degrees F.  Headache lasting about 8 hours, cough (non-productive). Headache and fever lessened with Tylenol.  By the next afternoon symptoms had resolved.
Age: 4.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Incorrect dose administered
Clinical narrative: Vaccination given in error.  Patient had already received fourth dose of Prevnar on 6/24/2010 at 15 months of age.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Asthenia, Burning sensation, CSF protein increased, Hyporeflexia
Clinical narrative: Pain in ankle starting 12/3/13. The next day she developed tingling, burning in both legs. She developed weakness, decreased reflexes and restless legs and was sent to the ER 12-9-13 spinal fluid showed elevated protein and IVIG treatment given.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immunoglobulin therapy, Lumbar puncture abnormal, Metabolic function test, Nuclear magnetic resonance imaging spinal, Paraesthesia
Clinical narrative: Pain in ankle starting 12/3/13. The next day she developed tingling, burning in both legs. She developed weakness, decreased reflexes and restless legs and was sent to the ER 12-9-13 spinal fluid showed elevated protein and IVIG treatment given.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Restless legs syndrome
Clinical narrative: Pain in ankle starting 12/3/13. The next day she developed tingling, burning in both legs. She developed weakness, decreased reflexes and restless legs and was sent to the ER 12-9-13 spinal fluid showed elevated protein and IVIG treatment given.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Lumbar puncture abnormal, Muscular weakness, Pain in extremity
Clinical narrative: Pain in ankle starting 12/3/13. The next day she developed tingling, burning in both legs. She developed weakness, decreased reflexes and restless legs and was sent to the ER 12-9-13 spinal fluid showed elevated protein and IVIG treatment given.