chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Ear discomfort, Fatigue, Feeling abnormal, Headache
Clinical narrative: This spontaneous report as received from a physician refers to a 19 year old female patient with allergy to sulfa. The patient's medical history included intermittent abdominal and back pain. On 12-JUL-2014 the patient was vaccinated with a dose of GARDASIL lot # J010395, expiration date: 29-Apr-2016, 0.5 ml, intramuscular. There was no concomitant medication. On 12-JUL-2014, after receiving a dose of GARDASIL the patient immediately felt kind of weird. The physician stated the patient was monitored in her office, for an unspecified amount of time, and "eventually" felt better and left the office. The physician stated the patient called in to the office on the reporting date, 17-JUL-2014, stating she had developed a "lima bean size" induration at the injection site and was experiencing fatigue, nausea, light headedness that was "on and off" and pressure on her ears and forehead "that was similar to when she was in a car accident 3 years ago". No lab tests were performed. No treatment was received. The outcome of pressure on her ears and forehead "that was similar to when she was in a car accident 3 years ago", light headedness that was "on and off", nausea, fatigue and a "lima bean size" induration at the injection site was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Immediate post-injection reaction, Injection site induration, Nausea
Clinical narrative: This spontaneous report as received from a physician refers to a 19 year old female patient with allergy to sulfa. The patient's medical history included intermittent abdominal and back pain. On 12-JUL-2014 the patient was vaccinated with a dose of GARDASIL lot # J010395, expiration date: 29-Apr-2016, 0.5 ml, intramuscular. There was no concomitant medication. On 12-JUL-2014, after receiving a dose of GARDASIL the patient immediately felt kind of weird. The physician stated the patient was monitored in her office, for an unspecified amount of time, and "eventually" felt better and left the office. The physician stated the patient called in to the office on the reporting date, 17-JUL-2014, stating she had developed a "lima bean size" induration at the injection site and was experiencing fatigue, nausea, light headedness that was "on and off" and pressure on her ears and forehead "that was similar to when she was in a car accident 3 years ago". No lab tests were performed. No treatment was received. The outcome of pressure on her ears and forehead "that was similar to when she was in a car accident 3 years ago", light headedness that was "on and off", nausea, fatigue and a "lima bean size" induration at the injection site was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anion gap normal, Asthenia, Basophil percentage, Dizziness, Dyspnoea
Clinical narrative: This spontaneous report as received from a physician refers to a 19 year old female patient with allergy to sulfa. The patient's medical history included intermittent abdominal and back pain. On 12-JUL-2014 the patient was vaccinated with a dose of GARDASIL lot # J010395, expiration date: 29-Apr-2016, 0.5 ml, intramuscular. There was no concomitant medication. On 12-JUL-2014, after receiving a dose of GARDASIL the patient immediately felt kind of weird. The physician stated the patient was monitored in her office, for an unspecified amount of time, and "eventually" felt better and left the office. The physician stated the patient called in to the office on the reporting date, 17-JUL-2014, stating she had developed a "lima bean size" induration at the injection site and was experiencing fatigue, nausea, light headedness that was "on and off" and pressure on her ears and forehead "that was similar to when she was in a car accident 3 years ago". No lab tests were performed. No treatment was received. The outcome of pressure on her ears and forehead "that was similar to when she was in a car accident 3 years ago", light headedness that was "on and off", nausea, fatigue and a "lima bean size" induration at the injection site was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Ear discomfort, Eosinophil percentage, Fatigue, Feeling abnormal, Headache
Clinical narrative: This spontaneous report as received from a physician refers to a 19 year old female patient with allergy to sulfa. The patient's medical history included intermittent abdominal and back pain. On 12-JUL-2014 the patient was vaccinated with a dose of GARDASIL lot # J010395, expiration date: 29-Apr-2016, 0.5 ml, intramuscular. There was no concomitant medication. On 12-JUL-2014, after receiving a dose of GARDASIL the patient immediately felt kind of weird. The physician stated the patient was monitored in her office, for an unspecified amount of time, and "eventually" felt better and left the office. The physician stated the patient called in to the office on the reporting date, 17-JUL-2014, stating she had developed a "lima bean size" induration at the injection site and was experiencing fatigue, nausea, light headedness that was "on and off" and pressure on her ears and forehead "that was similar to when she was in a car accident 3 years ago". No lab tests were performed. No treatment was received. The outcome of pressure on her ears and forehead "that was similar to when she was in a car accident 3 years ago", light headedness that was "on and off", nausea, fatigue and a "lima bean size" induration at the injection site was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site induration, Low density lipoprotein increased, Lymphocyte percentage
Clinical narrative: This spontaneous report as received from a physician refers to a 19 year old female patient with allergy to sulfa. The patient's medical history included intermittent abdominal and back pain. On 12-JUL-2014 the patient was vaccinated with a dose of GARDASIL lot # J010395, expiration date: 29-Apr-2016, 0.5 ml, intramuscular. There was no concomitant medication. On 12-JUL-2014, after receiving a dose of GARDASIL the patient immediately felt kind of weird. The physician stated the patient was monitored in her office, for an unspecified amount of time, and "eventually" felt better and left the office. The physician stated the patient called in to the office on the reporting date, 17-JUL-2014, stating she had developed a "lima bean size" induration at the injection site and was experiencing fatigue, nausea, light headedness that was "on and off" and pressure on her ears and forehead "that was similar to when she was in a car accident 3 years ago". No lab tests were performed. No treatment was received. The outcome of pressure on her ears and forehead "that was similar to when she was in a car accident 3 years ago", light headedness that was "on and off", nausea, fatigue and a "lima bean size" induration at the injection site was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Monocyte percentage increased, Mononucleosis heterophile test negative, Nausea, Neutrophil percentage, Paraesthesia
Clinical narrative: This spontaneous report as received from a physician refers to a 19 year old female patient with allergy to sulfa. The patient's medical history included intermittent abdominal and back pain. On 12-JUL-2014 the patient was vaccinated with a dose of GARDASIL lot # J010395, expiration date: 29-Apr-2016, 0.5 ml, intramuscular. There was no concomitant medication. On 12-JUL-2014, after receiving a dose of GARDASIL the patient immediately felt kind of weird. The physician stated the patient was monitored in her office, for an unspecified amount of time, and "eventually" felt better and left the office. The physician stated the patient called in to the office on the reporting date, 17-JUL-2014, stating she had developed a "lima bean size" induration at the injection site and was experiencing fatigue, nausea, light headedness that was "on and off" and pressure on her ears and forehead "that was similar to when she was in a car accident 3 years ago". No lab tests were performed. No treatment was received. The outcome of pressure on her ears and forehead "that was similar to when she was in a car accident 3 years ago", light headedness that was "on and off", nausea, fatigue and a "lima bean size" induration at the injection site was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: White blood cell count normal
Clinical narrative: This spontaneous report as received from a physician refers to a 19 year old female patient with allergy to sulfa. The patient's medical history included intermittent abdominal and back pain. On 12-JUL-2014 the patient was vaccinated with a dose of GARDASIL lot # J010395, expiration date: 29-Apr-2016, 0.5 ml, intramuscular. There was no concomitant medication. On 12-JUL-2014, after receiving a dose of GARDASIL the patient immediately felt kind of weird. The physician stated the patient was monitored in her office, for an unspecified amount of time, and "eventually" felt better and left the office. The physician stated the patient called in to the office on the reporting date, 17-JUL-2014, stating she had developed a "lima bean size" induration at the injection site and was experiencing fatigue, nausea, light headedness that was "on and off" and pressure on her ears and forehead "that was similar to when she was in a car accident 3 years ago". No lab tests were performed. No treatment was received. The outcome of pressure on her ears and forehead "that was similar to when she was in a car accident 3 years ago", light headedness that was "on and off", nausea, fatigue and a "lima bean size" induration at the injection site was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients. On unknown date the patient was vaccinated with ZOSTAVAX (strength, dosage and route unknown). On unknown date the patients experienced injection site reactions involving redness. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Disorientation, Retinal detachment, Vision blurred
Clinical narrative: This spontaneous report as received from a physician refers to a 20 year old female patient. The patient did not have pertinent medical history and no drug reactions/allergies. In October 2013 (date unspecified) the patient was vaccinated with first dose of GARDASIL (dose, route, lot # not reported). On 07-JUN-2014 or 08-JUN-2014 the patient was vaccinated with second dose of GARDASIL (dose, route, lot # not reported). There was no concomitant medication. On the morning of 05-JUL-2014 the patient woke up with blurred vision in both eyes. She ignored it for the day because she assumed it was her contacts that were causing the issue. On 06-JUL-2014 she awoke with worsening vision and went to unspecified hospital for Emergency Room visit, but they were not helpful. She saw a doctor on 08-JUL-2014 and was diagnosed with Exuda Retinal Detachment in both right and left eyes. The patient was treated with prednisone (manufacturer unknown) 60mg daily. The patient stated she had some improvement but is not fully recovered and the condition is disorienting. No lab diagnostic studies were performed. The relatedness between Exuda Retinal Detachment and GARDASIL was not specified. Follow-up information has been received from the physician on 15-JUL-2014. The physician stated that the patient was seen on 06-JUL-2014 at an unspecified outpatient urgent care center and was not admitted to hospital. He stated that patient was diagnosed with Vogt-Koyanagi-Harada syndrome which was a "panuvitis" and that it came on very suddenly. The treatment for the event was a high dose of prednisone (manufacturer unknown) but that no life saving measures were administered. At the time of call, the patient was unable to read or drive, and therefore was causing disability related to blurred vision and inability to see clearly. No lab diagnostics studies were performed. No concomitant medications, no medical history and no drug reactions/allergies were reported. The outcome of the event was recovering/resolving (also reported as "patient (..) has made significant improvement in the last week") The relationship between the GARDASIL and the event was not specified. Vogt-Koyanagi-Syndrome was considered as disability. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Disorientation, Impaired driving ability, Retinal detachment, Vision blurred
Clinical narrative: This spontaneous report as received from a physician refers to a 20 year old female patient. The patient did not have pertinent medical history and no drug reactions/allergies. In October 2013 (date unspecified) the patient was vaccinated with first dose of GARDASIL (dose, route, lot # not reported). On 07-JUN-2014 or 08-JUN-2014 the patient was vaccinated with second dose of GARDASIL (dose, route, lot # not reported). There was no concomitant medication. On the morning of 05-JUL-2014 the patient woke up with blurred vision in both eyes. She ignored it for the day because she assumed it was her contacts that were causing the issue. On 06-JUL-2014 she awoke with worsening vision and went to unspecified hospital for Emergency Room visit, but they were not helpful. She saw a doctor on 08-JUL-2014 and was diagnosed with Exuda Retinal Detachment in both right and left eyes. The patient was treated with prednisone (manufacturer unknown) 60mg daily. The patient stated she had some improvement but is not fully recovered and the condition is disorienting. No lab diagnostic studies were performed. The relatedness between Exuda Retinal Detachment and GARDASIL was not specified. Follow-up information has been received from the physician on 15-JUL-2014. The physician stated that the patient was seen on 06-JUL-2014 at an unspecified outpatient urgent care center and was not admitted to hospital. He stated that patient was diagnosed with Vogt-Koyanagi-Harada syndrome which was a "panuvitis" and that it came on very suddenly. The treatment for the event was a high dose of prednisone (manufacturer unknown) but that no life saving measures were administered. At the time of call, the patient was unable to read or drive, and therefore was causing disability related to blurred vision and inability to see clearly. No lab diagnostics studies were performed. No concomitant medications, no medical history and no drug reactions/allergies were reported. The outcome of the event was recovering/resolving (also reported as "patient (..) has made significant improvement in the last week") The relationship between the GARDASIL and the event was not specified. Vogt-Koyanagi-Syndrome was considered as disability. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vogt-Koyanagi-Harada syndrome
Clinical narrative: This spontaneous report as received from a physician refers to a 20 year old female patient. The patient did not have pertinent medical history and no drug reactions/allergies. In October 2013 (date unspecified) the patient was vaccinated with first dose of GARDASIL (dose, route, lot # not reported). On 07-JUN-2014 or 08-JUN-2014 the patient was vaccinated with second dose of GARDASIL (dose, route, lot # not reported). There was no concomitant medication. On the morning of 05-JUL-2014 the patient woke up with blurred vision in both eyes. She ignored it for the day because she assumed it was her contacts that were causing the issue. On 06-JUL-2014 she awoke with worsening vision and went to unspecified hospital for Emergency Room visit, but they were not helpful. She saw a doctor on 08-JUL-2014 and was diagnosed with Exuda Retinal Detachment in both right and left eyes. The patient was treated with prednisone (manufacturer unknown) 60mg daily. The patient stated she had some improvement but is not fully recovered and the condition is disorienting. No lab diagnostic studies were performed. The relatedness between Exuda Retinal Detachment and GARDASIL was not specified. Follow-up information has been received from the physician on 15-JUL-2014. The physician stated that the patient was seen on 06-JUL-2014 at an unspecified outpatient urgent care center and was not admitted to hospital. He stated that patient was diagnosed with Vogt-Koyanagi-Harada syndrome which was a "panuvitis" and that it came on very suddenly. The treatment for the event was a high dose of prednisone (manufacturer unknown) but that no life saving measures were administered. At the time of call, the patient was unable to read or drive, and therefore was causing disability related to blurred vision and inability to see clearly. No lab diagnostics studies were performed. No concomitant medications, no medical history and no drug reactions/allergies were reported. The outcome of the event was recovering/resolving (also reported as "patient (..) has made significant improvement in the last week") The relationship between the GARDASIL and the event was not specified. Vogt-Koyanagi-Syndrome was considered as disability. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Abdominal discomfort, Diarrhoea, Dry mouth
Clinical narrative: Dry mouth, upset stomach and several bouts of diarrhea. Visit with Doctor on 7/25/14. Monitor diet and adequate fluids. Return to clinic if symptoms worsen.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Abasia, Dysstasia, Injection site reaction, Weight bearing difficulty
Clinical narrative: Child could not stand up or walk. We are on day 5 and she still cannot bear any weight or walk on right leg, the leg the vaccine was administered in!!!
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Hives across body and local redness at site of injection.
Age: 1.02
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Fever for 24 hours - up to 101.  Mild rash on neck, back, and stomach started 7/27/14 - lasted for several days.
Age: 69.0
Sex: M
Vaccine: HEPA, YF
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Patient received Hepatitis A (Havrix) vaccine and yellow fever vaccine on 07/16/2014, both in left arm. On 07/17/2014, patient reports that he received a pneumonia vaccine at another clinic (no further information known about this vaccine) in left arm, and after on 07/17/2014, he reports that his left arm "blew up," and he complained of erythema, edema, and itching of the left arm. Patient reports that he saw his doctor for this problem, and no treatment was required at that visit, as he said his symptoms were improving. By 07/29/2014, patient reported recovery.
Age: 27.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 27 year old male patient. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot#, dose, route, indication not reported), which was outside the recommended age range of 9 to 26 years old. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Local swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 64 year old female patient who was allergic to NASONEX (Marrs:1407USA011706, ALEVE, AMBIEN, MACRODANTIN, LEVAQUIN, probiotics, sulfa drugs and fish oil. On 11-DEC-2009 the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous in the right arm, lot number: 665310/1195Y, expiration date 21-FEB-2011. Concomitant therapies included NEXIUM, CLARITIN. The reporter stated that a patient developed swelling of her right arm at the injection site that extended down to her fingers after receiving ZOSTAVAX. The patient sought medical attention via unspecified method. The outcome of the reported adverse events was reported as recovered (date unknown). The relatedness between reported adverse events and ZOSTAVAX was not reported. This report is linked with other report in MARRS:#1407USA011706 (same patient link). Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Rash pustular, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age with no pertinent medical history. On 02-JUL-2014, the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneously, lot# K003595, expiration date: 07-FEB-2015). There was no concomitant therapy. Three days later, on 05-JUL-2014, the patient experienced itching at the injection site. A couple of days after that, on an unknown date in July 2014, the patient developed a rash that looked like a chickenpox and had pustules. No treatment was given for the events. No laboratory diagnostic studies were performed. At the time of the report the patient was still experiencing itching at the injection site and rash was still present. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen negative, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a lead medical assistant refers to a 25 year old female patient. On an unknown date in 1998 the patient was vaccinated with RECOMBIVAX HB (dosing regimen and frequency unknown) (also reported as complete series) (lot number and expiry date unknown) for an unknown indication. On an unknown date in 2012 the patient received another two injections of RECOMBIVAX HB (dosing regiment and frequency unknown) (lot number and expiry date unknown) for an unknown indication. No concomitant medications were reported. On an unknown date patient was tested for surface antibodies and results were negative. The medical assistant clarified the laboratory testing was the hepatitis surface antigen and not the hepatitis surface antibodies. On 14-JUN-2014, patient was given another dose of RECOMBIVAX HB (dosing regimen and frequency unknown) (lot number and expiry date unknown) for an unknown indication. No adverse events were reported. No product quality complaint (PQC) or Insertion and Removal Related Events (IRRE) was reported. The action taken with the therapy with RECOMBIVAX HB was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with RECOMBIVAX HB was unknown. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Loss of consciousness
Clinical narrative: Pt. passed out after receiving imm.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from an approximately 77 year old female patient. The patient's medical history included chickenpox at a later age in her early 30's (dates not specified). The patient stated it was a severe case of chickenpox, not a mild one. Drug reactions or allergies were not specified. In May 2007, exact date not specified, the patient was vaccinated with a dose of ZOSTAVAX (dose number, dose, lot number and route were not reported). Concomitant medications were not specified. In March 2010, exact date not specified, the patient developed an acute case of shingles. The rash started on her right breast and wrapped around to her spine. The outcome of the acute case of shingles was unknown. The relatedness between the acute case of shingles and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date multiple unspecified patients were vaccinated with a dose of GARDASIL (lot#, expiration date, dose not reported) that was not stored properly (date not reported). No concomitant medication were reported. No adverse effects were reported. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: HEPAB
Symptoms: Arthralgia, Discomfort, Gait disturbance, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: After a couple hours start a very painful discomfort in my knee, can no walk well, stiffness in both knee and legs, and general disconfort.
Age: 1.77
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Injection site swelling, Rash maculo-papular, Urticaria
Clinical narrative: Localized erythema and swelling to left deltoid, maculopapular rash and hives noted.
Sex: M
Vaccine: HBHEPB
Symptoms: Drug name confusion, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse via field representative refers to an adult male patient of unknown age. On an unknown date the patient was vaccinated with COMVAX (lot #, expiration date, dose, route of administration not provided), which is other-than-indicated int he prescribing information, instead of RECOMBIVAX HB, due to product confusion. No concomitant medications were reported. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Developed chicken pox.  Her brother and mother also developed.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker to a patient of unknown age and gender. On an unknown date in 2013 (reported as approximately one year ago) the patient received first dose of GARDASIL (dose, route not reported). On 22-JUL-2014 the patient was at the office and would like to receive second dose of GARDASIL (dose, route not reported). No adverse symptoms reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Information about concurrent medical conditions and medical history was not reported. In approximately 2004 (reported as "about ten years ago"), the patient was vaccinated with ZOSTAVAX (dose, frequency, route of administration: unknown) (lot #, exp date: not provided). No concomitant medication was reported. In approximately 2011 (reported as "for the last three years"), the patient has had ongoing outbreaks of shingles. The outcome of ongoing outbreaks of shingles was unknown. Relatedness between ongoing outbreaks of shingles and ZOSTAVAX was not provided. Additional information is not expected, as the reporter did not have any patient information available.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a pediatric patient of unknown age and gender. On 27-MAR-2012 the patient was vaccinated too early with third dose of RECOMBIVAX HB 5 MCG/0.5 ML, intramuscular. Other doses of RECOMBIVAX HB were given respectively on 18-NOV-2011 (first dose), 17-JAN-2012 (second dose). No adverse effect reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a pediatric patient of unknown age. On 06-JUL-2011 the patient was vaccinated with first dose of RECOMBIVAX HB 5 MCG/0.5 ML, 0.5 ml, intramuscular. Other doses RECOMBIVAX HB were given respectively on 06-SEP-2011 (second dose), 06-FEB-2012 (third dose), 2013 (4th dose). The patient received 4 doses of RECOMBIVAX HB. No adverse effect reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: MMR
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report as received from registered nurse refers to a 47 year old male patient. Concurrent conditions and relevant medical history was not reported. On 10-JUN-2014 the patient was vaccinated with first dose of M-M-R II, (0.5 ml, subcutaneously) (Lot number: H018950 with expiry date 18-OCt-2014) in the left deltoid. Concomitant medications were not reported. On 17-JUN-2014 (reported as approximately one week after), the patient experienced prolonged injection site pain in his left deltoid. The patient did not specify at what time and on what date he began to have this pain, but he reported that approximately one week after he received the dose of M-M-R II, his left arm was very sore for up to three weeks. The patient rates his pain on a scale of 1-to-10 as a "3 or 4." He stated that the last night his arm hurt, he rates the pain an "8" on a scale of 1-to-10. The following day, the pain completely gone. The patient did not specify the specific dates that he experienced this pain, but he told the nurse that he thought he may have injured his left arm while lifting weights. On 23-JUL-2014, the patient was vaccinated with second dose of M-M-R II,(0.5 ml, subcutaneously)(Lot number: J014876 with expiry date 21-NOV-2015) in the left deltoid. The patient informed the nurse that he experienced pain with this injection, much like he did after he received his first M-M-R II dose. The nurse provided the patient with ibuprofen after he received his second M-M-R II yesterday, 23-JUL-2014. The patient did not sought any medical attention. The outcome of vaccination site pain and pain in left arm experienced on 17-JUN-2014 was reported as recovered/resolved. The outcome of the vaccination site pain experienced on 23-JUL-2014 was not recovered/not resolved. The causality of the events with M-M-R II was not reported. Action taken with suspect therapy was not applicable. Product quality issue was not involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Headache
Clinical narrative: On 7/14/2014 - patient was given an additional dose of Hep A. As of 7/29/14 patient complains of headaches.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. On 25-JUL-2014 the patient was vaccinated with an expired dose of VARIVAX (Merck), subcutaneous, Lot # reported as 0138AE, Expiration Date reported as: 10-JAN-2014, (dose was not reported). No known adverse effects. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Cold sweat, Dizziness, Pallor
Clinical narrative: Received PPD placement, HPV #1, MENACTRA #2. When walking to waiting room to wait 15 min. he became dizzy, skin cool and clammy and pale. No LOC. Sat down, head down, ice applied to back of neck. VS: HR 52 BP 97/54. After 5 min skin W/O, color returned. Drank AJ. Waited in waiting room.
Age: 0.52
Sex: M
Vaccine: PNC13, RV5, MER, RV5
Symptoms: Abdominal pain, Diarrhoea, Diet refusal, Enema administration, Faeces discoloured
Clinical narrative: Patient is a 6 M old male who presents with a one day history of illness. He was well up until 1000 this morning, when he started "screaming", per his parents, which was very unusual for him. He had eaten last around 0500, took 6 oz of Gerber Good Start, so thinking that he was hungry, they offered him a bottle, but then he refused to eat. They took him to ER, as this was the closest. There he started vomiting (NB) about 3 times, appeared yellowish in color. There they did an abdominal ultrasound, which was suspicious for intussusception, thus sent him directly here. They also gave him a dose of TYLENOL and a dose of ZOFRAN prior to transfer. In the ER here, he was able have an air enema performed in IR, but with a difficult reduction. Since then, per his parents, he has appeared more like his baseline. He has had no further vomiting. He took 6 oz of Gerber Good Start here without difficulty. In terms of bowel movements, he has had more watery stools over the past 2 days, yesterday two that appeared green, watery, and one today at 0900 which appeared more dark brown, but negative for blood or mucous. He has had no fevers. He has had at least 3-4 wet diapers today. Here in the ER, he had an air enema with successful pneumatic reduction of ileocolic intussusception. He received a NS bolus of 20 mL/kg due to concern for dehydration initially. He is being admitted for observation overnight given the difficult reduction after discussion between surgery, SRED and SRPAC. The patient was admitted to the General Pediatrics service, and was placed on IVF and allowed to eat normally. He did well, with no return of abdominal pain or vomiting, and his mother felt comfortable taking him home late the following morning.
Age: 0.52
Sex: M
Vaccine: PNC13, RV5, MER, RV5
Symptoms: Intussusception, Screaming, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Patient is a 6 M old male who presents with a one day history of illness. He was well up until 1000 this morning, when he started "screaming", per his parents, which was very unusual for him. He had eaten last around 0500, took 6 oz of Gerber Good Start, so thinking that he was hungry, they offered him a bottle, but then he refused to eat. They took him to ER, as this was the closest. There he started vomiting (NB) about 3 times, appeared yellowish in color. There they did an abdominal ultrasound, which was suspicious for intussusception, thus sent him directly here. They also gave him a dose of TYLENOL and a dose of ZOFRAN prior to transfer. In the ER here, he was able have an air enema performed in IR, but with a difficult reduction. Since then, per his parents, he has appeared more like his baseline. He has had no further vomiting. He took 6 oz of Gerber Good Start here without difficulty. In terms of bowel movements, he has had more watery stools over the past 2 days, yesterday two that appeared green, watery, and one today at 0900 which appeared more dark brown, but negative for blood or mucous. He has had no fevers. He has had at least 3-4 wet diapers today. Here in the ER, he had an air enema with successful pneumatic reduction of ileocolic intussusception. He received a NS bolus of 20 mL/kg due to concern for dehydration initially. He is being admitted for observation overnight given the difficult reduction after discussion between surgery, SRED and SRPAC. The patient was admitted to the General Pediatrics service, and was placed on IVF and allowed to eat normally. He did well, with no return of abdominal pain or vomiting, and his mother felt comfortable taking him home late the following morning.
Age: 0.52
Sex: M
Vaccine: PNC13, RV5, MER, RV5
Symptoms: Intussusception
Clinical narrative: Patient is a 6 M old male who presents with a one day history of illness. He was well up until 1000 this morning, when he started "screaming", per his parents, which was very unusual for him. He had eaten last around 0500, took 6 oz of Gerber Good Start, so thinking that he was hungry, they offered him a bottle, but then he refused to eat. They took him to ER, as this was the closest. There he started vomiting (NB) about 3 times, appeared yellowish in color. There they did an abdominal ultrasound, which was suspicious for intussusception, thus sent him directly here. They also gave him a dose of TYLENOL and a dose of ZOFRAN prior to transfer. In the ER here, he was able have an air enema performed in IR, but with a difficult reduction. Since then, per his parents, he has appeared more like his baseline. He has had no further vomiting. He took 6 oz of Gerber Good Start here without difficulty. In terms of bowel movements, he has had more watery stools over the past 2 days, yesterday two that appeared green, watery, and one today at 0900 which appeared more dark brown, but negative for blood or mucous. He has had no fevers. He has had at least 3-4 wet diapers today. Here in the ER, he had an air enema with successful pneumatic reduction of ileocolic intussusception. He received a NS bolus of 20 mL/kg due to concern for dehydration initially. He is being admitted for observation overnight given the difficult reduction after discussion between surgery, SRED and SRPAC. The patient was admitted to the General Pediatrics service, and was placed on IVF and allowed to eat normally. He did well, with no return of abdominal pain or vomiting, and his mother felt comfortable taking him home late the following morning.
Age: 66.0
Sex: M
Vaccine: FLUC3
Symptoms: Blood test, Computerised tomogram, Dizziness, Electrocardiogram, Nausea
Clinical narrative: Awoke from nap very dizzy and feeling nauseated.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Abdominal pain upper, Bowel movement irregularity, Constipation, Crying, Flatulence
Clinical narrative: Child stopped having regular bowel movements and was experiencing severe gas pains, stomach pains, sleeplessness, and prolonged periods of crying.  Child went over 14 days without having bowel movement.  Parent had to administer several interventions to try to prompt bowel movement- anal stimulation, suppositories, and stool softener- all utilized after long periods of being unable to pass a bowel movement on her own.  All interventions done under the guidance and suggestion of pediatrician.  Child did not pass her own stools without assistance until approximately 12 weeks after Rotavirus (Rotateq) was initially administered.  Mother was breastfeeding during this time and began taking high amounts of probiotics to also help with GI health.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Insomnia
Clinical narrative: Child stopped having regular bowel movements and was experiencing severe gas pains, stomach pains, sleeplessness, and prolonged periods of crying.  Child went over 14 days without having bowel movement.  Parent had to administer several interventions to try to prompt bowel movement- anal stimulation, suppositories, and stool softener- all utilized after long periods of being unable to pass a bowel movement on her own.  All interventions done under the guidance and suggestion of pediatrician.  Child did not pass her own stools without assistance until approximately 12 weeks after Rotavirus (Rotateq) was initially administered.  Mother was breastfeeding during this time and began taking high amounts of probiotics to also help with GI health.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Blister, Rash, Rash erythematous, Skin irritation
Clinical narrative: Child woke up with raised, blistery patches/rash on buttocks, knees, and wrists.  Rash was red and irritated with white center.
Age: 0.76
Sex: F
Vaccine: HIBV, HIBV, PNC13
Symptoms: Abnormal behaviour, Fatigue, Pyrexia
Clinical narrative: The baby is mellow, cannot stay up for a long time, looks tired, very quiet which is unusual, runs a fever of 103,9; Tylenol and ibuprofen do not really bring it down.
Age: 0.76
Sex: F
Vaccine: HIBV, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: The baby is mellow, cannot stay up for a long time, looks tired, very quiet which is unusual, runs a fever of 103,9; Tylenol and ibuprofen do not really bring it down.
Age: 0.76
Sex: F
Vaccine: HIBV, HIBV, PNC13
Symptoms: Abnormal behaviour, Fatigue, Pyrexia
Clinical narrative: Pt developed a fever 2 hrs after receiving vaccines up to 103.9.
Age: 0.76
Sex: F
Vaccine: HIBV, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Pt developed a fever 2 hrs after receiving vaccines up to 103.9.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Convulsion, Presyncope
Clinical narrative: Spoke with the parent and she stated the child had a seizure.  She was seen by a physician who indicated to the parent it was a vasovagal reaction.
Age: 45.0
Sex: M
Vaccine: HEP, PPV
Symptoms: Arthralgia, Injection site erythema, Injection site pain
Clinical narrative: Shoulder joint pain in arm that was vaccinated. Large area of pain around the injection site. Reddening of the skin 5-6cms around the injection site. 1st sign persisted for a week and half.  The second two signs persisted for 4 days.
Age: 10.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: REDNESS, SWELLING, HOT, PRURITUS ON THE INJECTION SITE.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site induration, Papule, Skin lesion
Clinical narrative: Fine erythematous to skin colored papules on the trunk as well as localized erythema and induration at the site of the injections in the bilateral thighs.  Right thigh showed this lesion, resolved, then left thigh showed it on about 25 Jul.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: RED ITCHY FULL BODY RASH. ADMINISTERED DIPHENHYDRAMINE. OBSERVED FOR 20 MIN. NO IMPROVEMENT. CALLED 911. PATIENT ALERT, NO DIFFICULTY BREATHING.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Cold sweat, Hyperhidrosis, Pallor
Clinical narrative: Patient got very pale, sweaty, clammy.  Placed cold towels behind the patient's neck and on patient's forehead; ambulance called and patient transported to ER.  B/P 70/40; Pulse 80; Resp 18 during "epoisode".
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Rhinorrhoea, Secretion discharge
Clinical narrative: PATIENT CALLED TODAY AND REPORTED THAT LAST NIGHT HE STARTED GETTING RUNNY NOSE AND SORE THROAT WITH MUCUS.
Age: 29.0
Sex: F
Vaccine: MMR, TDAP, MMR, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT NOTED WITH LARGE REDDENED HARDENED SWELLING TO RIGHT DELTOID/BICEP AREA, WARM TO TOUCH, PAIN TO TOUCH (6/10).
Age: 29.0
Sex: F
Vaccine: MMR, TDAP, MMR, TDAP
Symptoms: Dizziness, Injection site erythema, Injection site oedema, Local swelling, Mobility decreased
Clinical narrative: PATIENT NOTED WITH LARGE REDDENED HARDENED SWELLING TO RIGHT DELTOID/BICEP AREA, WARM TO TOUCH, PAIN TO TOUCH (6/10).
Age: 29.0
Sex: F
Vaccine: MMR, TDAP, MMR, TDAP
Symptoms: Pain in extremity, Vaccination site warmth
Clinical narrative: PATIENT NOTED WITH LARGE REDDENED HARDENED SWELLING TO RIGHT DELTOID/BICEP AREA, WARM TO TOUCH, PAIN TO TOUCH (6/10).
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Flushing, Oropharyngeal pain
Clinical narrative: Sore throat, flushing, shortness of breath.
Age: 45.0
Sex: F
Vaccine: PER, TTOX
Symptoms: Acupuncture, Muscle tightness, Musculoskeletal stiffness, Nuclear magnetic resonance imaging normal, X-ray normal
Clinical narrative: I had stiff neck muscles for about 3 months that started approx a week after tetanus shot. I had physical therapy, massage therapy, acupuncture followed by muscle relaxant and pain reliever (ibuprofen 800mg and acetaminophen+hydrocodone) prescribed. All the tests done including x-ray and MRI did not indicate any underlying illness. The symptoms (tight muscles in the neck region) were finally resolved after 3-4 months of the above treatments. I have been without symptoms since.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza like illness, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain and swelling at injection sight within 1 hour, the area grew to two inches in diameter. The area was hot to the touch and had a knot approximately the size of a fingernail. The entire area hurt constantly and is just beginning to fade today 07/29/2014. I received the injection at the start of the appointment and before I was finished I felt fluish and malaise. These symptoms lasted seven full days. I took Ibuprofen several times during this reaction. No other treatment.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Laboratory test, Malaise
Clinical narrative: Pain and swelling at injection sight within 1 hour, the area grew to two inches in diameter. The area was hot to the touch and had a knot approximately the size of a fingernail. The entire area hurt constantly and is just beginning to fade today 07/29/2014. I received the injection at the start of the appointment and before I was finished I felt fluish and malaise. These symptoms lasted seven full days. I took Ibuprofen several times during this reaction. No other treatment.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: Whole top of arm red, very hot, itching, lump at injection site; these symptoms lasted about 1 week then resolved.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Computerised tomogram head abnormal, Convulsion, Electroencephalogram normal, Full blood count, Intensive care
Clinical narrative: Had a fever with seizure, >10 minutes. Brought to ER by EMS. Had CT and MRI of head showing cerebellar ectopia, 3 day stay in PICU, EEG unremarkable, followed by neurosurgery and neurology and infectious disease. Had CBC, CMP, stool for enteric pathogens.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Metabolic function test, Nervous system disorder, Nuclear magnetic resonance imaging brain abnormal, Pyrexia, Stool analysis
Clinical narrative: Had a fever with seizure, >10 minutes. Brought to ER by EMS. Had CT and MRI of head showing cerebellar ectopia, 3 day stay in PICU, EEG unremarkable, followed by neurosurgery and neurology and infectious disease. Had CBC, CMP, stool for enteric pathogens.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Myectomy, Subclavian vein thrombosis, Surgery
Clinical narrative: This spontaneous report as received from a physician via field representative (learning of the AE within 24 hours) refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL (strength, dosage and route unknown) in the left arm. Concomitant therapies included oral typhus vaccine given at the same time with GARDASIL. The patient was diagnosed with subclavian deep vein thrombosis, approximately 2-3 weeks after receiving GARDASIL. The patient was treated with Tissue plasminogen activator (t-PA) and had surgery involving the removal of her first rib and 2 unspecified muscles. The patient was in hospital on the reporting time. The outcome of the event was not reported. Upon internal review, subclavian deep vein thrombosis which needs surgery, removal of first rib and 2 unspecified muscles was determined to be medically significant. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Soreness (R) arm began day after vaccination. Erythema 4 x 7 cm around injection site. Cool compresses / KEFLEX 500 Q 6 hours x 7 days.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash, Skin warm
Clinical narrative: Localized rash warm and itchy on (R) arm began 2 days after Tdap injection.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on 21-JUL-2014 the patient was vaccinated with an expired dose of ROTATEQ (dose strength not reported) lot J002355, expiration date 10-JUL-2014, route oral. No adverse effect reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.