chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Myositis, Parvovirus B19 test positive, Parvovirus infection
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 15 year old female patient with no known allergies. No pertinent medical history was provided. On 10-JUL-2013, the patient was vaccinated with the first dose of GARDASIL inj (dose, route and lot number not provided). On 14-SEP-2013, the patient received the second dose of GARDASIL, and on 30-JAN-2014 the patient received the third dose of GARDASIL (doses, routes and lot numbers not provided). No co-suspect or concomitant therapies were provided. The physician reported that the patient was admitted to a hospital on 06-JUL-2014 for unspecified symptoms. The patient tested positive for parvovirus (date not provided, approximately in 2014). The patient was also diagnosed with mild myositis (date not provided, approximately in 2014). The physician stated that the patient was unable to walk at some point during her hospitalization as a result of the myositis which was a significant disability (date not provided, approximately in 2014). The patient was discharged from the hospital on an unspecified date (approximately in 2014). The patient also saw an unspecified Neurologist and Rheumatologist on unspecified dates. On an unspecified date, approximately in 2014, the patient was in recovery according to information received by the primary care physician from the neurologist. The reporting physician considered the events "The patient was also diagnosed with mild myositis" and "The patient was unable to walk at some point during her hospitalization" as disability events. Additional information is not expected because there was no consent to follow-up with the reporting physician.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient reecived Zoster Vaccine on 6-11-14. Returned to clinic on 6-13-14 complaining of a rash, swelling, and warmth at the injection site. Was told to take ADVIL around the clock until symptoms resolve.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 21-AUG-2014 the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, lot# and route administration were not reported). No adverse effects were reported. Additional information is not expected due to the reporter did not want to be contacted again.
Sex: F
Vaccine: MMR
Symptoms: Hypersensitivity, Pharyngeal oedema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's concurrent conditions included allergy to penicillin, codeine, tetracycline, ciprofloxacin, PROVENTIL and erythromycin. The patient's historical drug included penicillin (manufacturer unknown), codeine, tetracycline, ciprofloxacin, PROVENTIL and erythromycin. On an unknown date the patient was vaccinated with MMR II (therapy type HSA) (dose and frequency unknown) (patient was vaccinated when she was a kid). Concomitant therapies included metoprolol, mirtazapine (manufacturer unknown), duloxetine hydrochloride, benzonatate and prednisone (manufacturer unknown). On an unknown date the patient experienced an allergic reaction in which her throat swelled up. Patient sought medical attention. The outcome of events was unknown. Reporter's causality assessment was not provided. No product quality complaint was filed. This case is linked to case # 1408USA015099 (same patient link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On-19-AUG-2014 the patient was vaccinated with expired dose of (Oka/Merck) VARIVAX (dose/frequency not reported) (lot # H015133, expiry date: 09-AUG-2014). No adverse effects reported. No product quality complaint was reported for (Oka/Merck) VARIVAX. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On an unknown date "over a year ago", the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number not reported). On 20-AUG-2014, the patient was in the office to receive the second dose of GARDASIL (dose, route and lot number not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On 21-AUG-2014 the patient was vaccinated with extra dose of (Oka/Merck) VARIVAX (dose/frequency: 0.5 ml, Therapy route: subcutaneous) after receiving a dose of PROQUAD. No adverse effects were reported. No product quality complaint (PQC) was reported for (Oka/Merck) VARIVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. The patient's relevant medical history or drug allergies were not reported. On 25-AUG-2014 the patient was vaccinated with one dose of ZOSTAVAX (strength, dose, route of administration, lot number and expiry date were not reported). No concomitant medications were reported. On 25-AUG-2014, the patient received one dose of ZOSTAVAX which was not stored properly. There were no adverse effects noted. There was no product quality complaint reported. The outcome was unknown. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received on 19-AUG-2014 from Registered Nurse refers to a numerous children (unspecified), exact age and gender not reported. On an unknown date, the patients were vaccinated with GARDASIL (dose, route, lot number reported). Secondary suspect therapy included other unspecified vaccines (dose, route, date of administration, lot number not reported). Registered nurse stated that recently (in an approximately 2014), they have numerous children (unspecified) who have had fainting episodes after receiving GARDASIL and other unspecified vaccines. The outcome of fainting episodes was not reported. The relatedness between GARDASIL, other unspecified vaccines and fainting episodes was unknown. This is one of several reports received from the same reporter. Additional information is not expected, questionnaires previously sent to reporter were returned.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Diarrhoea, Fatigue, Pyrexia, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician via company representative refers to 7 year old female patient. No relevant medical history was reported. Drug reactions or allergies were reported as none. On an unknown date when the patient was one year old, the patient was vaccinated with first dose of (Oka/Merck) VARIVAX (dose, frequency and anatomical location: not reported, (lot #, exp date: unknown). The patient also received second dose of (Oka/Merck) VARIVAX (lot number not reported) on an unknown date for prevention of chicken pox. Concomitant medications were reported as none. It was reported that the patient woke on 08-JUL-2014 with chicken pox, diarrhea, fatigue and low grade fever after receiving (Oka/Merck) VARIVAX vaccine. No laboratory diagnostic studies were performed. The patients sought medical attention (office visit on unspecified dates). The outcome of fatigue, low grade fever, chicken pox and diarrhea was unknown. Causality of the events fatigue, low grade fever, chicken pox and diarrhea and (Oka/Merck) VARIVAX was not reported. Follow up information was received from medical assistant. The medical assistant had no information on recovery of the patient. The patient never called to office with any health difficulties following office visit on 08-JUL-2014. The treatment was just palliative, no prescription was given. The medical assistant had no information on severity or duration of breakouts. Additional information has been requested.
Age: 1.8
Sex: U
Vaccine: VARCEL
Symptoms: Diarrhoea, Fatigue, Pyrexia, Varicella
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 22 month old patient, of unknown gender. (Patient attended daycare at the time of the report). Patient had no medical history and no allergies or reactions to the drugs. On 10-SEP-2013, the patient was vaccinated with VARIVAX (Merck) (dose, frequency and anatomical location: not reported, subcutaneous) (lot # J003222, exp date: 15-MAR-2015). There were no concomitant medications. On 08-JUL-2014, the patient experienced chicken pox, diarrhea, fatigue and low grade fever. No laboratory diagnostic studies were performed. The patients sought medical attention (office visit on unspecified dates). The outcome of fatigue, low grade fever, chicken pox and diarrhea was unknown. The medical assistant had no information on recovery of the patient. The reporter stated that the parents never called the office with any health difficulties following office visit on 08-JUL-2014. Treatment provided was palliative-no prescriptions were written. There was no information on the severity or duration of breakouts. Relatedness between fatigue, low grade fever, chicken pox and diarrhea and VARIVAX (Merck) was not reported. This is one of the several reports, received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unkonwn dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of VAQTA (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. On 23-JUL-2014 the 2 years old patient was vaccinated with a dose of VAQTA lot # K007791 and expiry date 22-AUG-2016 (dose, route not reported) that on 10-JUN-2014 had been exposed to 51 degrees Fahrenheit for 51 minutes and on 18-JUL-2014 to 48 degrees Fahrenheit for 24 minutes. This is one of several reports received from the same reporter. Additional information is not expected as no follow up was obtained.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reports as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of VAQTA (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. Follow up was received from a medical assistant and refers to a 2 years old patient of unknown gender. On 09-JUL-2014 the patient was vaccinated with a dose of VAQTA LOT # J005010 and expiry date 23-OCT-2015 (dose, route not reported) that on 10-JUN-2014 had been exposed to 51 degrees Fahrenheit for 51 minutes. This is one of several reports received from the same reporter. Additional information is not expected as no follow up was obtained.
Age: 8.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of VAQTA (dose number, dose, route and lot number was not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. Follow up was received from a medical assistant and refers to a 6 years old patient of unknown gender. On 09-JUL-2014 the patient was vaccinated with a dose of VAQTA lot # J005010 and expiry date 23-OCT-2014 the patient was vaccinated with a dose of VAQTA lot # J005010 and expiry date 23-OCT-2015 (dose, route not reported) that on 10-JUL-2014 had been exposed to 51 degrees Fahrenheit for 51 minutes. This is one of several reports received from the same reporter. Additional information is not expected as no follow up was obtained.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with VAQTA (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. Follow up was received from a medical assistant and refers to a 17 years old patient of unknown gender. On 10-JUN-2014 the patient was vaccinated with a dose of VAQTA lot # K000943 and expiry date 24-SEP-2016 (dose, route not reported) that on 10-JUN-2014 had been exposed to 51 degrees Fahrenheit for 51 minutes. This is one of several reports received from the same reporter. Additional information is not expected as no follow up was obtained.
Age: 16.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of VAQTA (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. Follow up was received from a medical assistant and refers to a 16 years old patient of unknown gender. On 23-JUL-2014 the patient was vaccinated with a dose of VAQTA lot # K007791 and expiry date 22-AUG-2016 (dose, route not reported) that on 10-JUN-2014 had been exposed to 51 degrees Fahrenheit for 51 minutes and on 18-JUL-2014 to 48 degrees Fahrenheit for 24 minutes. This is one of several reports received from the same reporter. Additional information is not expected as no follow up was obtained.
Age: 5.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of  unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of VAQTA (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. Follow up was received from a medical assistant and refers to a 5 years old patient of unknown gender. On 23-JUL-2014 the patient was vaccinated with a dose of VAQTA lot # K007791 and expiry date 22-AUG-2016 (dose, route not reported) that on 10-JUN-2014 had been exposed to 51 degrees Fahrenheit for 51 minutes and on 18-JUL-2014 to 48 degrees Fahrenheit for 24 minutes. This is one of several reports received from the same reporter. Additional information is not expected as no follow up was obtained.
Age: 7.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of VAQTA (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. Follow up was received from a medical assistant and refers to a 7 years old patient of unknown gender. On 23-JUL-2014 the patient was vaccinated with a dose of VAQTA lot # K007791 and expiry date 22-AUG-2016 (dose, route not reported) that on 10-JUN-2014 had been exposed to 51 degrees Fahrenheit for 51 minutes and on 18-JUN-2014 to 48 degrees Fahrenheit for 24 minutes. This is one of several reports received from the same reporter. Additional information is not expected as no follow up was obtained.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On an unknown date, unspecified patients were vaccination with doses of VARIVAX (Merck) (dose, dose number, route and lot number were not reported) that were stored improperly. No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information is not expected because there is no permission to contact.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Diarrhoea, Rash generalised, Rash papular
Clinical narrative: Patient developed scattered papular lesions over body and extremities on 7/25/14 - along with diarrhea - parents concerned may have been immunization reaction.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On an unknown date, unspecified patients were vaccinated with doses of PROQUAD (Merck) (dose, dose number, route and lot number were not reported) that were stored improperly. No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information is not expected because there is no permission to contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with PROQUAD (Merck) (lot# and expiration date, route and dose were unknown) which were exposed to unspecified temperatures above 5F on unspecified dates. The nurse practitioner explained that the Department of Health informs facilities to call the manufacturer of vaccines when there had been 4 consecutive temperature readings above the recommended range; these temperature readings were recorded every 15 minutes. The specific temperatures and dates of the excursions were not specified, and it was not known whether or not the temperature excursions would be supported, since the nurse practitioner had not called the MNSC for stability when the freezer was recorded above 5F for fewer than 4 consecutive readings. She stated that she believes the non-reported temperature variances are defrost cycles. No adverse effects has been observed or reported. This is one of two reports from the same reporter (total patients number approximately 50). Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of VAQTA (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. Follow up was received from a medical assistant and refers to a 3 years old patient of unknown gender. On 23-JUL-2014 the patient was vaccinated with a dose of VAQTA lot # K007791 and expiry date 22-AUG-2016 (dose, route not reported) that on 10-JUN-2014 had been exposed to 51 degrees. Fahrenheit for 51 minutes and on 18-JUL-2014 to 48 degrees Fahrenheit for 24 minutes.  This is one of several reports received from the same reproter. Additional information is not expected as no follow up was obtained.
Age: 4.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JU-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of VAQTA (dose number, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. Follow up was received from a medical assistant and refers to a 4 years old patient of unknown gender. On 10-JUN-2014 the patient was vaccinated with a dose of VAQTA lot # J005010 and expiry date 23-OCT-2015 (also reported as 06-NOV-2016) (dose, route not reported) that on 10-JUN-2014 had been exposed to 51 degrees Fahrenheit for 51 minutes. This is one of several reports received from the same reporter. Additional information is not expected as no follow up was obtained.
Age: 4.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of VAQTA (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. Follow up was received from a medical assistant and refers to a 4 years old patient of unknown gender. On 10-JUN-2014 the patients was vaccinated with a dose of VAQTA lot # K000943 and expiry date 24-SEP-2016 (dose, route not reported) that on 10-JUN-2014 had been exposed to 51 degrees Fahrenheit for 51 minutes. This is one of several reports received from the same reporter. Additional information is not expected as no follow up was obtained.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding an unspecified number of patients. The patients demographics were unknown. There were no pertinent medical history and drug reaction or allergies of the patients reported. The physician reported that on an unknown date, an unspecified number of patients were vaccinated with second dose of GARDASIL (dose, route, product lot and expiry date was not reported). The second dose in the GARDASIL series were administered seven to eight months after the first dose in the series. No adverse effects reported. There was no product quality complaint involved. The outcome of the event was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: YF
Symptoms: Diarrhoea, Injection site mass, Lymphadenopathy, Pyrexia, Upper respiratory tract infection
Clinical narrative: Call received today 8/26. Fever, swollen lymph, mass on site of injection noted 8/23. 8/26 URI symptoms, diarrhea, fever. Taking TYL./MOTRIN. Will week medical tx if continue/worsen.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 53 year old female patient. The patients pertinent medical history and drug reactions or allergies were not reported. On 19-AUG-2014, the patient was vaccinated with ZOSTAVAX (lot # J005849, expiry date: 17-AUG-2014), 0.65 ml, subcutaneously in the right arm. No concomitant medications were reported. It was reported that the patient was vaccinated with expired vaccine on 19-AUG-2014. No adverse effects were reported. There was no product quality complaint (PQC) involved. The outcome was unknown. 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 refers to a unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with VARIVAX (dose, route and lot# not reported) which underwent supported temperature excursions. No adverse experiences were reported. This is one of several reports the same source. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain in extremity, Presyncope
Clinical narrative: Nausea, near syncope and arm soreness approx. 3 hours after receiving injection; 2 days past injection date pt reports not as bad but still very painful.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal pain upper, Chills, Dehydration, Diarrhoea, Headache
Clinical narrative: HPV given 8-8-14 10:00 am. He went to bed at 9:00pm having chills and headache. Up all night with vomiting and stomach pain. 8-9-14 he took MOTRIN at 9:00 am rested all day, drank 7up. By noon he was feeling better. His symptoms of headaches, nausea, vomiting, diarrhea continue to come and go since August 8th. Went to PCP yesterday. Diagnosed with dehydration and sinus infection. IV fluids given at ER. Given zithromycin 3 day treatment.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Nausea, Sinusitis, Vomiting
Clinical narrative: HPV given 8-8-14 10:00 am. He went to bed at 9:00pm having chills and headache. Up all night with vomiting and stomach pain. 8-9-14 he took MOTRIN at 9:00 am rested all day, drank 7up. By noon he was feeling better. His symptoms of headaches, nausea, vomiting, diarrhea continue to come and go since August 8th. Went to PCP yesterday. Diagnosed with dehydration and sinus infection. IV fluids given at ER. Given zithromycin 3 day treatment.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: REDNESS EXTENDING FROM SHOULDER TO ELBOW HOT TO TOUCH, ITCHY.
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Pyrexia, Rash pustular
Clinical narrative: Dad noted a new blister (pustules rash and high fever).
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a unspecified number of patient of unknown age and gender. On an unknown date, the patients were vaccinated with LIQUID PEDVAXHIB (dose, route and Lot# not reported) which underwent supported temperature excursions. No adverse experiences were reported. This is one of several reports from the same source. 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 healthcare worker refers to a unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with ROTATEQ (dose and Lot# not reported) which underwent supported temperature excursions. No adverse experiences were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to 2 patients of unknown demographics. The current condition included sickle cell disease in both the patients. No medical history and concomitant medications were reported. On an unknown date the patients were vaccinated with 3 doses of RECOMBIVAX HB (strength, route not reported) and have tested seronegative on an unknown date. The outcome of the event reported is unknown. No product quality complaint was involved. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site scab
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old male patient. The patient's pertinent medical history included history of seizure. The patient had no known allergies. On 08-AUG-2014, the patient was vaccinated with ZOSTAVAX 0.65ml (lot # K003597, expiration date: 12-MAR-2015) subcutaneous in the left upper arm rear. Concomitant medications included unspecified seizure medication. On an unspecified date in August 2014, the patient experienced a large scab at the injection site of left arm. The pharmacist stated that the scab was about size of quarter, itchy and painful. The pharmacist stated that there was no rash, no vesicles, no chicken pox, no shingles, just a scab at the injection site of left arm, that was looking like it was already healing. The pharmacist stated that she thought that it might have an infection at the injection site, prior to it crusting over. The pharmacist stated that client was going to follow up with his health care provider. There was no treatment given for adverse event. The outcome of the events was reported as not recovered. The relatedness between the events and the vaccination with ZOSTAVAX was unknown. The patient sought medical attention by coming into pharmacy on 20-AUG-2014. Additional information is not expected because there is no consent to further contact with the pharmacist.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 21-AUG-2014 the patient was vaccinated with M-M-R II (Batch/lot # H014989, expiration date: 10-AUG-2014) 0.5 ml, subcutaneous after the labeled expiration date. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a unspecified number of patient of unknown age and gender. On an unknown date, the patients were vaccinated with VAQTA (dose, route and Lot# not reported) which underwent supported temperature excursions. No adverse experiences were reported. This is one of several reports from the 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 refers to a unspecified number of patient of unknown age and gender. On an unknown date, the patients were vaccinated with M-M-R II (dose, route and Lot# not reported) which underwent supported temperature excursions. No adverse experiences were reported. This is one of several reports from the 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 refers to a unspecified number of patient of unknown age and gender. On an unknown date, the patients were vaccinated with RECOMBIVAX HB (dose, route and Lot# not reported under which supported temperature excursions. No adverse experiences were reported. 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 refers to a unspecified number of patient of unknown age and gender. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 (dose, route, and Lot# not reported) which underwent supported temperature excursions. No adverse experiences were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurser refers to a patient of unknown age and gender. On 26-AUG-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23, 0.5ml, intramuscular (lot number and expiration date not reported). No adverse effects reported. Additional information is not expected because the reporter refused additional contact.
Age: 52.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Immediately site of shingles injection got red, itchy, 2-3 tiny little hives appeared showed nurse/doctor before leaving. They said it was ok to go home and take BENADRYL. Next morning was fine but by night area was itchy, hard, swollen, hot to the touch, area shaped like an oval (2 1/2" by 2"). Called nurse line who advise to take BENADRYL. Continued taking BENADRYL over the weekend. Area got worse over time, got bigger especially at night time. It was better by Monday. Since then, has developed isolated hives in different areas of body at different times. Hive on right breast, right torso above hip area, right forearm. The hive in forearm still is itchy but healing. Still has shadow of redness in injection area. Doctor mentioned that must have reacted to preservative. Area is periodically itchy/sensitive.
Age: 52.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site warmth, Urticaria
Clinical narrative: Immediately site of shingles injection got red, itchy, 2-3 tiny little hives appeared showed nurse/doctor before leaving. They said it was ok to go home and take BENADRYL. Next morning was fine but by night area was itchy, hard, swollen, hot to the touch, area shaped like an oval (2 1/2" by 2"). Called nurse line who advise to take BENADRYL. Continued taking BENADRYL over the weekend. Area got worse over time, got bigger especially at night time. It was better by Monday. Since then, has developed isolated hives in different areas of body at different times. Hive on right breast, right torso above hip area, right forearm. The hive in forearm still is itchy but healing. Still has shadow of redness in injection area. Doctor mentioned that must have reacted to preservative. Area is periodically itchy/sensitive.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Neck pain
Clinical narrative: Approximately starting at 9:00 pm 8/19/14 (day of vaccine), patient reported pain in neck radiating to engulf her head, causing a knife-stabbing like pain. She was taken to emergency room and while there pain subsided. She was not treated at the ER - per mother.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 19-AUG-2014 the patient was vaccinated with a expired dose of PNEUMOVAX 23 lot# J009827, expiration date 10-AUG-2014, intramuscular, Dose not reported. No known adverse effects. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Blister, Erythema, Induration
Clinical narrative: 4 cm area of redness with induration underneath and vesicles overlying skin > 2 weeks duration; treatment given - ibuprofen.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a clinical coordinator (who is also a registered nurse) refers to a patient of unknown age. The patient's medical history and current conditions are not reported. It was reported that the patient received an expired dose of MMR II (lot # H01467 and expiry date 3-AUG-2014) on 11-AUG-2011. Other co-suspects and concomitant medications are not reported. No symptoms reported. Product quality complaint was not reported. The outcome of the event is unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local swelling, Nodule
Clinical narrative: Left arm/red swollen - golf ball sized knot 3 x 3 1/2 inches in diameter.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Incorrect dose administered, Vomiting projectile
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a infant patient of unknown age and gender. The reporter stated that an infant received less than a full first dose of ROTATEQ (oral, dose unknown) when she regurgitated the dose of the vaccine that was administered on 28-JUL-2014. Pertinent medical history and concomitant medications were unspecified. No adverse symptoms reported. The outcome of the event was unknown. Follow up information was received on 12-AUG-2014. Patient was a female of 2 months (8 weeks) old. At the time of the event patient's weight was reported as 10. It was reported patient did not presented preexisting allergies, birth defect, medical conditions, or illness at the time of vaccination and no adverse event following prior vaccination. Patient was vaccinated a private doctor's office, on 28-JUL-2014, at 10:47 am, with the first dose of ROTATEQ, lot number K003524, expiration date 29-JAN-2016. On 28-JUL-2014 at 10:47 am, patient had projectile vomit. On the same date the patient recovered from projectile vomit. No relevant diagnostics test and laboratories were performed. Additional information is not expected because all follow ups requested to complete the case was received.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pyrexia, Urine analysis, Vomiting
Clinical narrative: Headache, 100 degree fever, Puking.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant to a patient of unknown age and gender. On 18-AUG-2014 the patient was vaccinated with ZOSTAVAX lot # J003798, expiration date: 28-JUN-2014 (dose and route not reported) that expired on 28-JUN-2014. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to a patient of unknown age and gender. Patient's medical history and other previous drug allergic reaction were not reported. On 23-MAR-2013, patient was vaccinated with first dose of GARDASIL injection (strength, lot# and expiry date unknown) 0.5 ml, intramuscularly. No concomitant therapies were reported. Patient received second dose on 25-JUN-2014 and third dose on 22-AUG-2014. No adverse effect was reported. The outcome of a patient received the GARDASIL series as followed: first dose on 23-MAR-2013, second dose on 25-JUN-2014, and third dose on 22-AUG-2014 and no adverse effect were unknown. No further information was provided. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report was received from a pharmacy student refers to a male patient of unknown age. No pertinent medical history of the patient was reported. Approximately on an unknown date in 2009 (reported as 5 years ago) the patient was vaccinated with PNEUMOVAX 23 (strength, dose, route of administration, lot number and expiry date were not reported). No concomitant medications were reported. It was reported that the patient was diagnosed with pneumonia twice (unknown dates) since he received PNEUMOVAX 23. It was unspecified if any treatment was given for the event. It was unspecified whether the patient had sought any medical attention. There was no product quality complaint involved. The outcome of pneumonia was unknown. The causality of the event was not provided. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered Nurse concerning a patient of unkonwn age and gender. On 18-AUG-2014 the patient was vaccinated with PROQUAD (Merck), lot number and other details unspecified, 0.5 ml, subcutaneously which underwent a temperature excursion. No concomitant therapy was reported. However, no adverse effect was reported. No product quality complaint was filed. The action taken was assessed as not applicable. The outcome of events was not reported. The causality was assessed as not related to the therapy with PROQUAD (Merck). This is one of several reports received from the same reporter. 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 registered nurse concerning a patient of unknown age and gender. On 01-JUL-2014 the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX (Lot #, dose and route not reported). On 01-JUL-2014 The patient received an improperly stored first dose of (Oka/Merck) VARIVAX. No adverse symptoms reported. This is one of several reports received from the same source. Additional information is not expected due to all follow ups requested to complete the case was received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 18-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX, lot number and other details unspecified, 0.5 ml, subcutaneously. On an unknown date the patient experienced the nurse reports that PROQUAD and VARIVAX that underwent a temperature excursion were administered and no adverse effect. The outcome of the nurse reports that PROQUAD and VARIVAX that underwent a temperature excursion were administered and no adverse effect is unknown. The reporter considered the nurse reports that PROQUAD and VARIVAX that underwent a temperature excursion were administered and no adverse effect to be related to (Oka/Merck) VARIVAX. This is one of several reports received from the same reporter. 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 another healthcare professional refers to a patient of unknown age. On 21-AUG-2014 the patient was vaccinated with VARIVAX, lot number and other details unspecified, 0.5 ml, subcutaneously. On an unknown date the patient experienced the nurse reports that PROQUAD and VARIVAX that underwent a temperature excursion were administered and no adverse effect. The outcome of the nurse reports that PROQUAD and VARIVAX that underwent temperature excursion were administered and no adverse effects to be not related to VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: FLUX
Symptoms: Chest pain, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: This case was reported by a consumer (patient's daughter) via agency and described the occurrence of Guillain Barre syndrome in a 78-year-old female patient who vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Co-suspect medication included ADVAIR multi dose powder inhaler for problem breathing. On 23 July 2013, the patient started ADVAIR (unknown route) 250/50mcg, unknown dosing. On an unspecified date, the subject received unspecified dose of Influenza vaccine (unknown route, injection site and batch number). In February 2014, at an unspecified time after vaccination with Influenza vaccine and after starting ADVAIR, the subject was hospitalized during 2 weeks due to Guillain Barre syndrome. The subject experienced weakness in foot when walking which moved up into subject's hands. The subject had been taking ADVAIR medication and was on oxygen, however when she went by ambulance to hospital and while in the hospital, the doctor interrupted the treatment with ADVAIR and oxygen since her breathing was good. The doctor put the subject back on ADVAIR due to chest pains. At the time of reporting, the outcome of the events was unspecified.
Age: 0.34
Sex: M
Vaccine: RV1
Symptoms: Anuria, Cough, Decreased appetite, Diarrhoea, Erythema
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of anuria in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 20 August 2014, the subject received 2nd dose of ROTARIX. The dose was inadvertently administered intramuscularly, in the right thigh. On 21 August 2014, 1 day after vaccination with ROTARIX, the subject experienced anuria for 5 hours, fever at 102 Deg. F, rash on cheek of face, lethargy, diarrhea (1 episode), runny nose, cough, throat erythema and erythema of ear. The subject was also not eating well. The healthcare professional considered the events were clinically significant (or requiring intervention). On 22 August 2014, the events were resolved.
Age: 0.34
Sex: M
Vaccine: RV1
Symptoms: Incorrect route of drug administration, Lethargy, Pharyngeal erythema, Pyrexia, Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of anuria in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 20 August 2014, the subject received 2nd dose of ROTARIX. The dose was inadvertently administered intramuscularly, in the right thigh. On 21 August 2014, 1 day after vaccination with ROTARIX, the subject experienced anuria for 5 hours, fever at 102 Deg. F, rash on cheek of face, lethargy, diarrhea (1 episode), runny nose, cough, throat erythema and erythema of ear. The subject was also not eating well. The healthcare professional considered the events were clinically significant (or requiring intervention). On 22 August 2014, the events were resolved.
Age: 0.34
Sex: M
Vaccine: RV1
Symptoms: Rhinorrhoea
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of anuria in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 20 August 2014, the subject received 2nd dose of ROTARIX. The dose was inadvertently administered intramuscularly, in the right thigh. On 21 August 2014, 1 day after vaccination with ROTARIX, the subject experienced anuria for 5 hours, fever at 102 Deg. F, rash on cheek of face, lethargy, diarrhea (1 episode), runny nose, cough, throat erythema and erythema of ear. The subject was also not eating well. The healthcare professional considered the events were clinically significant (or requiring intervention). On 22 August 2014, the events were resolved.
Age: 53.0
Sex: M
Vaccine: MMR
Symptoms: Face oedema, Inflammation, Urticaria
Clinical narrative: Generalized hives, facial edema, local inflammation.