chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: TTOX
Symptoms: Headache, Nausea
Clinical narrative: DONOR REPORTS HA AND NAUSEA APPROX 1 HR FOLLOWING IMMUNIZATION. NO OTHER C/O.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Discomfort, Irritability, Malaise, Pain
Clinical narrative: Sore joints, malaise, uncomfortable, irritability, body aches, mild fever.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Sore joints, malaise, uncomfortable, irritability, body aches, mild fever.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mother and patient came by office to show his left deltoid that had a redness and swelling.
Age: 40.0
Sex: F
Vaccine: TYP
Symptoms: Syringe issue
Clinical narrative: The syringe given for typhoid has a luer lock attached that pulls off easily.  When attaching a needle, the luer lock can become displaced.  When removing the needle cap to administer the vaccine, the luer lock can become displaced.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid.  Left lateral deltod. 2in by 2 in area of swelling, erythema, painful to mild deep touch. Area is warm to the touch. No exudate, swelling is not hard, no steaking. Pt feels that the site is improving.  Pt advise to take OTC pain meds prn, warm compresses.
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Convulsion, Decreased appetite, Dizziness, Headache, Lethargy
Clinical narrative: As the nurse gave the HPV vaccine, my daughter fainted and had brief muscle convulsions. She continued to have nausea, lethargy and lightheadedness for the next several hours. She continues to complain of a headache this evening (same day as event).
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea, Somnolence, Syncope
Clinical narrative: As the nurse gave the HPV vaccine, my daughter fainted and had brief muscle convulsions. She continued to have nausea, lethargy and lightheadedness for the next several hours. She continues to complain of a headache this evening (same day as event).
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Immune system disorder
Clinical narrative: Patient claims that flu shot caused his immune system to attack his own body.
Sex: U
Vaccine: MMR
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patient of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, the patient was vaccinated with a dose of MMR II (dose, route, lot number and expiration date not provided). On an unknown date, the patient had "severe reaction". The reporter stated that she did not had any details for the patient or the reaction except for "the patient was hospitalized for a week" at an unspecified hospital. At the time of the report, outcome of "severe reaction" was Recovered/Resolved (on an unknown date). Additional information is not expected.
Age: 2.0
Sex: U
Vaccine: DTAP
Symptoms: Autopsy, Bordetella test positive, Chemotherapy, Death, Lymphocyte percentage decreased
Clinical narrative: This case was reported in a literature article and described the occurrence of pertussis in a 2-year-old subject of unspecified gender who was vaccinated with DTaP (manufacturer unspecified). Concurrent medical conditions included rhabdomyosarcoma for which chemotherapy had been started after he had completed the course of vaccinations. The authors report that no coughing contact was identified for the subject. No further information regarding the subject's medical, family history or concurrent medication has been provided. On unspecified dates, the subject received 4 doses of DTaP vaccine (unknown route, injection site and batch number). In 2012, at an unspecified time after vaccination with DTaP vaccine, the subject experienced pertussis. No information has been provided regarding any symptoms displayed by the subject or any clinical examinations performed on him; but the authors report that the pertussis cases described in the article had to have at least one of the following symptoms along with a nasopharyngeal polymerase chain reaction positive test for Bordetella pertussis to be considered as confirmed pertussis cases: paroxysmal cough, whoop or post-tussive emesis. Therefore, this was considered as a vaccination failure. In 2012, the subject also experienced RSV infection (rhinitis). His level of white blood cells at presentation was 200/ mm3 (83% lymphocytes) and it rose to a maximum of 31000/mm3 (3% lymphocytes) during the course of the illness. The subject was treated with a prolonged extracorporeal membrane oxygenation course including necrotizing pneumonia and tumour progression. Neither leukophoresis nor exchange transfusion was performed. The subject died from death unspecified 78 days after the onset of pertussis. An autopsy was performed and showed evidence of pulmonary fibrosis and pulmonary hypertension. Lung metastasis and metastases to pericardium were noted. There was no evidence of ongoing infection.
Age: 2.0
Sex: U
Vaccine: DTAP
Symptoms: Lymphocyte percentage increased, Metastases to heart, Metastases to lung, Neoplasm progression, Pertussis
Clinical narrative: This case was reported in a literature article and described the occurrence of pertussis in a 2-year-old subject of unspecified gender who was vaccinated with DTaP (manufacturer unspecified). Concurrent medical conditions included rhabdomyosarcoma for which chemotherapy had been started after he had completed the course of vaccinations. The authors report that no coughing contact was identified for the subject. No further information regarding the subject's medical, family history or concurrent medication has been provided. On unspecified dates, the subject received 4 doses of DTaP vaccine (unknown route, injection site and batch number). In 2012, at an unspecified time after vaccination with DTaP vaccine, the subject experienced pertussis. No information has been provided regarding any symptoms displayed by the subject or any clinical examinations performed on him; but the authors report that the pertussis cases described in the article had to have at least one of the following symptoms along with a nasopharyngeal polymerase chain reaction positive test for Bordetella pertussis to be considered as confirmed pertussis cases: paroxysmal cough, whoop or post-tussive emesis. Therefore, this was considered as a vaccination failure. In 2012, the subject also experienced RSV infection (rhinitis). His level of white blood cells at presentation was 200/ mm3 (83% lymphocytes) and it rose to a maximum of 31000/mm3 (3% lymphocytes) during the course of the illness. The subject was treated with a prolonged extracorporeal membrane oxygenation course including necrotizing pneumonia and tumour progression. Neither leukophoresis nor exchange transfusion was performed. The subject died from death unspecified 78 days after the onset of pertussis. An autopsy was performed and showed evidence of pulmonary fibrosis and pulmonary hypertension. Lung metastasis and metastases to pericardium were noted. There was no evidence of ongoing infection.
Age: 2.0
Sex: U
Vaccine: DTAP
Symptoms: Pneumonia necrotising, Polymerase chain reaction, Pulmonary fibrosis, Pulmonary hypertension, Respiratory syncytial virus infection
Clinical narrative: This case was reported in a literature article and described the occurrence of pertussis in a 2-year-old subject of unspecified gender who was vaccinated with DTaP (manufacturer unspecified). Concurrent medical conditions included rhabdomyosarcoma for which chemotherapy had been started after he had completed the course of vaccinations. The authors report that no coughing contact was identified for the subject. No further information regarding the subject's medical, family history or concurrent medication has been provided. On unspecified dates, the subject received 4 doses of DTaP vaccine (unknown route, injection site and batch number). In 2012, at an unspecified time after vaccination with DTaP vaccine, the subject experienced pertussis. No information has been provided regarding any symptoms displayed by the subject or any clinical examinations performed on him; but the authors report that the pertussis cases described in the article had to have at least one of the following symptoms along with a nasopharyngeal polymerase chain reaction positive test for Bordetella pertussis to be considered as confirmed pertussis cases: paroxysmal cough, whoop or post-tussive emesis. Therefore, this was considered as a vaccination failure. In 2012, the subject also experienced RSV infection (rhinitis). His level of white blood cells at presentation was 200/ mm3 (83% lymphocytes) and it rose to a maximum of 31000/mm3 (3% lymphocytes) during the course of the illness. The subject was treated with a prolonged extracorporeal membrane oxygenation course including necrotizing pneumonia and tumour progression. Neither leukophoresis nor exchange transfusion was performed. The subject died from death unspecified 78 days after the onset of pertussis. An autopsy was performed and showed evidence of pulmonary fibrosis and pulmonary hypertension. Lung metastasis and metastases to pericardium were noted. There was no evidence of ongoing infection.
Age: 2.0
Sex: U
Vaccine: DTAP
Symptoms: Rhinitis, Vaccination failure, White blood cell count decreased, White blood cell count increased
Clinical narrative: This case was reported in a literature article and described the occurrence of pertussis in a 2-year-old subject of unspecified gender who was vaccinated with DTaP (manufacturer unspecified). Concurrent medical conditions included rhabdomyosarcoma for which chemotherapy had been started after he had completed the course of vaccinations. The authors report that no coughing contact was identified for the subject. No further information regarding the subject's medical, family history or concurrent medication has been provided. On unspecified dates, the subject received 4 doses of DTaP vaccine (unknown route, injection site and batch number). In 2012, at an unspecified time after vaccination with DTaP vaccine, the subject experienced pertussis. No information has been provided regarding any symptoms displayed by the subject or any clinical examinations performed on him; but the authors report that the pertussis cases described in the article had to have at least one of the following symptoms along with a nasopharyngeal polymerase chain reaction positive test for Bordetella pertussis to be considered as confirmed pertussis cases: paroxysmal cough, whoop or post-tussive emesis. Therefore, this was considered as a vaccination failure. In 2012, the subject also experienced RSV infection (rhinitis). His level of white blood cells at presentation was 200/ mm3 (83% lymphocytes) and it rose to a maximum of 31000/mm3 (3% lymphocytes) during the course of the illness. The subject was treated with a prolonged extracorporeal membrane oxygenation course including necrotizing pneumonia and tumour progression. Neither leukophoresis nor exchange transfusion was performed. The subject died from death unspecified 78 days after the onset of pertussis. An autopsy was performed and showed evidence of pulmonary fibrosis and pulmonary hypertension. Lung metastasis and metastases to pericardium were noted. There was no evidence of ongoing infection.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 2 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 13-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot # J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.32
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 16 months old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 11-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: TYP
Symptoms: Rash
Clinical narrative: Rash.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Headache, Myalgia, Pyrexia, Rash
Clinical narrative: Headache, Sedation, Myalgia, Fever, Skin Rash and Chills.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Sedation
Clinical narrative: Headache, Sedation, Myalgia, Fever, Skin Rash and Chills.
Age: 1.75
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 21 months old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 13-MAR-2014, the patient was vaccinated with VARIVAX lot #J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 5 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 13-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 4 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 13-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J007955; expiration date 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. 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 healthcare worker, practice manager refers to a unknown patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL (dose and route not provided). The health care worker reported, the storage compartments that contained GARDASIL were not monitored at all from 03-MAY-2014 until the report time. Doses of the vaccines that were exposed to unknown temperatures were administered to unspecified patients. The practice manager will provide the names of the patients who received doses of the unmonitored vaccines in during the period of time from 03-MAY-2014 until the present. The reporter stated that her practice has not been informed of any adverse experiences. No additional information was provided. This is one of several reports from same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, practice manager refers to a unknown patients of unknown age and gender. On an unknown date the patients were vaccinated with RECOMBIVAX HB (dose and route not provided). The health care worker reported, the storage compartments that contained RECOMBIVAX HB were not monitored at all from 03-MAY-2014 until the report time. Doses of the vaccines that were exposed to unknown temperatures were administered to unspecified patients. The practice manager will provide the names of the patients who received doses of the un-monitored vaccines in during the period of time from 03-MAY-2014 until the present. The reporter stated that her practice has not been informed of any adverse experiences. No additional information was provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, practice manager refers to a unknown patients of unknown age and gender. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (dose and route not provided). The health care worker reported, the storage compartments that contained PNEUMOVAX 23 were not monitored at all from 03-MAY-2014 until the report time. Doses of the vaccines that were exposed to unknown temperatures were administered to unspecified patients. The practice manager will provide the names of the patients who received doses of the unmonitored vaccines in during the period of time from 03-MAY-2014 until the present. She states that her practice has not been informed of any adverse experiences. No additional information was provided. This is one of several reports from same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, practice manager refers to an unknown patients of unknown age and gender. On an unknown date the patients were vaccinated with VARIVAX (dose and route not provided). The health care worker reported, the storage compartments that contained VARIVAX were not monitored at all from 03-MAY-2014 until the report time. Doses of the vaccines that were exposed to unknown temperatures were administered to unspecified patients. The practice manager will provide the names of the patients who received doses of the un-monitored vaccines in during the period of time from 03-MAY-2014 until the present. The reporter stated that her practice has not been informed of any adverse experiences. No additional information was provided. This is one of several reports from same source. Additional information has been requested.
Sex: U
Vaccine: HEPA, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 07-JUN-2014, the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular. Lot number reported as J014129, expiration date 05-OCT-2015. Other suspect therapies included VAQTA 0.5ml, intramuscular. Lot number J009441, expiration date 29-AUG-2015. On 07-JUN-2014, the patient received improperly stored GARDASIL, and VARIVAX (Merck) exposed to 31F for 86 hours. No adverse event were reported. This is one of several reports from the same source. Lot number J014129 is an invalid lot number for GARDASIL. It is a Lot number valid for VARIVAX (Merck). Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 70 year old male patient. On an unknown date the patient was vaccinated with one single shot of ZOSTAVAX. One day after vaccination with ZOSTAVAX, the patient developed herpes zoster (shingles) in the eye. The patient saw the doctor for medical attention. The physician prescribed ZOVIRAX, NEURONTIN, and Vitamin B12 as treatment for the herpes in the eye. The patient's outcome was unknown. The causal relationship was not reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Approx. 2 days post injection patient had warm, red area about 2 inches diameter at site of injection. Not raised. Checked area and notified PCP. Told patient to come back if worsened or call 911 if trouble breathing.
Age: 47.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Limb discomfort, Pain in extremity, Pyrexia
Clinical narrative: Rt arm -felt heavy and soreness - still feels heavy and sore after 28 days. Had slight fever/aching 2-3 after vaccine administered. Educated pt re: live virus vaccine. Pt advised f/u with PMD for evaluation.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Red, raised lump around injection site, tender to touch.
Age: 60.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site discharge, Injection site rash, Injection site scab
Clinical narrative: Injection given 09-19-2013. Pt noticed a nickel-sized rash to the left of where injection was given, which grew and became weepy. It's now crusting over. This happened approximately 6 months after injection was given. Dr. says it's from ZOSTAVAX inj.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: Injection site reaction 4" x 2" sized red, raised hot injection site. Continued to grow for 2 days.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Pt had vomiting, diarrhea and fever.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Body temperature increased, Pain in extremity, Tenderness
Clinical narrative: Hot tender, really sore. Hands/knees/joints hurt. Took BENADRYL OTC - symptoms resolved.
Age: 4.0
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 3 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 13-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot # J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 4 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 13-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. 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 medical assistant refers to an unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL, oral (Dose and frequency not provided). Medical assistant reported that unknown number of improperly stored. GARDASIL doses were administered to unspecified number of patients. GARDASIL have been exposed to temperatures below 36 F for total of 2 hours and 30 minutes. No adverse effects reported. No additional information provided. This is one on several reports from same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 4 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 17-MAR-2014, the patient was vaccinated with VARIVAX lot #J007955; expiration date: 27-JUN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 4 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 18-MAR-2014, the patient was vaccinated with VARIVAX lot #J007955; expiration date: 27-JUN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 5 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 18-MAR-2014, the patient was vaccinated with VARIVAX lot #J007955; expiration date: 27-JUN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been receive from a pharmacist regarding a 5 year old male patient who on an unknown date the patient was vaccinated with dose 1 of VARIVAX (Merck) (dose not reported). The pharmacist reported that her grandson on an unknown date experienced varicella like rash "afterwards". The reporter stated that she "believe his mom probably took him to the doctor", but she did not have any details, except that the patient got the rash. She also stated that her grandson on an unknown date (reported as "just") received his second dose of VARIVAX (Merck). No adverse event reported with the second dose. On an unknown date the patient recovered from varicella like rash. Relationship between varicella like rash and vaccination with VARIVAX (Merck) was not reported. Additional information is not expected.
Age: 1.52
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 18 month old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 25-MAR-2014, the patient was vaccinated with VARIVAX lot #J007955; expiration date: 27-JUN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 3 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 27-MAR-2014, the patient was vaccinated with VARIVAX lot #J007955; expiration date: 27-JUN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.06
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 1 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 27-MAR-2014, the patient was vaccinated with VARIVAX lot #J009165; expiration date: 24-JUL-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 4 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 27-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.16
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 14 months old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 28-MAR-2014, the patient was vaccinated with VARIVAX lot #J009165; expiration date: 24-JUL-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 5 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 02-APR-2014, the patient was vaccinated with VARIVAX lot #J009165; expiration date: 24-JUL-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 4 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 03-APR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J009165; expiration date: 24-JUL-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 5 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 17-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with ROTATEQ, oral (dose and frequency not provided). Medical assistant reported that unknown number of improperly stored ROTATEQ doses were administered to unspecified number of patients. ROTATEQ have been exposed to temperature below 36 F for total of 2 hours and 30 minutes. No adverse effects reported. No additional information provided. This is one of several reports from same source. 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 healthcare worker, practice manager refers to a unknown patients of unknown age and gender. On an unknown date the patients were vaccinated with MMR II (dose and route not provided). The health care worker reported, the storage compartments that contained MMR II were not monitored at all from 03-MAY-2014 until the report time. The MMR II was stored in the same compartment as the VARIVAX (MARRS # 1406USA007318) and ZOSTAVAX (MARRS # 1406USA007321). Doses of the vaccines that were exposed to unknown temperatures were administered to unspecified patients. The practice manager will provide the names of the patients who received doses of the un-monitored vaccines in during the period of time from 03-MAY-2014 until the present. She states that her practice has not been informed of any adverse experiences. No additional information was provided. This is one of several reports from same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, practice manager refers to a unknown patients of unknown age and gender. On an unknown date the patients were vaccinated with VAQTA (dose and route not provided). The health care worker reported, the storage compartments that contained VAQTA were not monitored at all from 03-MAY-2014 until the report time. Doses of the vaccine that were exposed to unknown temperatures were administered to unspecified patients. The practice manager will provide the names of the patients who received doses of the un-monitored vaccines in during the period of time from 03-MAY-2014 until the present. The reporter stated that her practice has not been informed of any adverse experiences No additional information was provided. This is one of several reports form the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, practice manager refers to a unknown patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (dose and route not provided). The health care worker reported, the storage compartments that contained ZOSTAVAX were not monitored at all form 03-MAY-2014 until the report time. Doses of the vaccines that were exposed to unknown temperatures were administered to unspecified patients. The practice manager will provide the names of the patients who received doses of the un-monitored vaccines in during the period of time from 03-MAY-2013 until the present. The reporter stated that her practice has not been informed of any adverse experiences. No additional information was provided. This id one of several reports from the same source. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 2 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 27-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J007955; expiration date 27-JUN-2015, (doe, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 4 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 03-APR-2014, the patient was vaccinated with VARIVAX (Merck) lot # J009165; expiration date: 24-JUL-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 4 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 03-APR-2014, the patient was vaccinated with VARIVAX (Merck) lot # J009165; expiration date: 24-JUL-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 3 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 27-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.38
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 16 months old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 26-MA-2014, the patient was vaccinated with VARIVAX (Merck) lot #J007955; expiration date 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 4 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 24-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on one leg, then next day larger, then opposite leg, then up both thighs. No pain, no itching or pustules. did NOT respond to Benadryl or topical treatments for poison ivy/Gold Bond etc.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Local swelling, Pain
Clinical narrative: Patient's arm is red at injection site, and has swollen considerably from immediately around injection site down to just below his elbow. He also complained of a constant headache all day following administration. In addition, arm was warm to the touch, and painful to move.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Patient's arm is red at injection site, and has swollen considerably from immediately around injection site down to just below his elbow. He also complained of a constant headache all day following administration. In addition, arm was warm to the touch, and painful to move.
Age: 1.61
Sex: M
Vaccine: DTAP
Symptoms: Crying, Diarrhoea, Lethargy, Screaming
Clinical narrative: Ongoing crying and screaming, lethargic, diarrhea.
Age: 1.61
Sex: M
Vaccine: DTAP
Symptoms: Crying, Diarrhoea, Lethargy, Screaming
Clinical narrative: Screaming and crying, lethargic and having diarrhea.
Age: 61.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Activities of daily living impaired, Injection site pain, Weight bearing difficulty
Clinical narrative: I received the shot as one requirement of becoming a volunteer with Hospital.  I also received the TDAP shot at the same time, in the same arm (right).  Since that time I have had persistent pain in my right deltoid muscle, during activities that engage that muscle.  I have seen my personal physician who has prescribed physical therapy.  I've had 4 massages which have not helped.  The pain affects daily tasks that require lifting or pushing actions with my right arm. I have fairly good range of motion still in that arm, but when downward weight is applied to my arm the pain is evident.  It's been almost 6 months since the shot, and the muscle pain has not abated.  I would like to know if there is a strategy or treatment that will relieve the pain.  I cannot afford to have an MRI.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Abscess, Bacterial infection, Blood culture positive, Cellulitis, Injection site erythema
Clinical narrative: 2 yr old male with no pmhx presented with increasing LUE+LLE swelling and erythema 5 days following administration of HIB to left arm, PCV right arm; Hep A, MMR and Dtap on LLE. Admitted with diffuse cellulitis.  MRI showed multiloculated abscesses of the humeral shaft, osteomyelitis of the distal humerus and osteomyelitis of proximal radius and ulna. Patient required surgical intervention by orthopedics. There is concern that vaccine lot may be contaminated and patient was seeded with bacteria. Blood culture are growing back gram + cocci in clusters. Please evaluate and take appropriate measures. Would appreciate cultures to be taken from vaccine lot.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Injection site swelling, Nuclear magnetic resonance imaging abnormal, Osteomyelitis, Surgery
Clinical narrative: 2 yr old male with no pmhx presented with increasing LUE+LLE swelling and erythema 5 days following administration of HIB to left arm, PCV right arm; Hep A, MMR and Dtap on LLE. Admitted with diffuse cellulitis.  MRI showed multiloculated abscesses of the humeral shaft, osteomyelitis of the distal humerus and osteomyelitis of proximal radius and ulna. Patient required surgical intervention by orthopedics. There is concern that vaccine lot may be contaminated and patient was seeded with bacteria. Blood culture are growing back gram + cocci in clusters. Please evaluate and take appropriate measures. Would appreciate cultures to be taken from vaccine lot.
Age: 1.26
Sex: F
Vaccine: HIBV, MMR
Symptoms: Chills, Febrile convulsion, Pallor, Pyrexia, White blood cell count increased
Clinical narrative: Fever ranging between 102 and 104 degrees Fahrenheit for several days, febrile seizures, palor, and chills. Went to emergency room at onset and doctor after seizures started. Put on a broad spectrum antibiotic.
Sex: M
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: This spontaneous report was received from social media regarding a male patient of unknown age. No information about medical history, concurrent conditions was reported. On an unknown date the patient was vaccinated with GARDASIL (batch #, lot #, dose, frequency, route, indication not reported). No concomitant medications were reported. On an unknown date the patient experienced seizures (medically significant). The outcome of seizures was unknown. The causality of the event was not specified by the reporter. This is one of the two reports received from the same reporter (sibling case 1406USA005357). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: This spontaneous report was received from a social media regarding a female patient of unknown age. No information about medical history, concurrent conditions was reported. On an unknown date the patient was vaccinated with GARDASIL (batch #, lot #, dose, frequency, route, indication not reported). No concomitant medications were reported. On an unknown date the patient experienced seizures (medically significant). The outcome of seizures was unknown. The causality of the event was not specified by the reporter. This is one of the two reports received from the same reporter (sibling case # 1406USA006887). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to unspecified number of patients of unknown age. On an unknown date unspecified number of the patients were vaccinated with improperly stored (Oka-Merck) PROQUAD, 0.5 ml dose, subcutaneous (Oka/Merck) VARIVAX and (Oka-Merck) PROQUAD, have been exposed to -14 degree centrigrade for 60 hours. No adverse effects reported. The outcome of the event was unknown. The causality of the event was unspecified. There was no PQC reported. The case has been linked with the case 1406USA007434 (same patient link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to unspecified number of patients of unknown age. On an unknown date unspecified number of the patients were vaccinated with improperly stored VARIVAX, subcutaneous (dose not reported). VARIVAX and PROQUAD, have been exposed to -14 degree Centigrade for 60 hours. No adverse effects reported. The outcome of the events was unknown. The causality of the events was unspecified. There was no PQC reported. The case has been linked with the case 1406USA006872 (same patient link). Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Mobility decreased, Myalgia
Clinical narrative: Extreme shoulder joint and muscle pain unable after 12hrs of receiving shot to raise arm waist high continued severe pain and immobility for next 12 hrs after continued use of salonspas getting minor relief.
Age: 1.05
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Cough, Injection site erythema, Injection site swelling, Lethargy, Pyrexia
Clinical narrative: Fever between 100.0 - 102.0 degrees F that lasted until 06/11/2014 AM; redness and severe swelling at injection site, vomited once on 06/10/2014 AM, lethargic on 06/10/2014 - 06/11/2014, became sick with a cough, runny nose, sneezing on 06/13/2014.