chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.18
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot number of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. The report refers to a 9 weeks old infant patient of unknown gender. On 11-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J015437, expiration date: 09-OCT-2016) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
Age: 0.19
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reproter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow up information has been received from the registered nurse who provided patients' details. This report refers to a 9 weeks old infant patient of unknown gender. On 18-JUN-2014, the patient was vaccinated with a dose of PEDVAXHIB lot number J016188, expiration date: 02-OCT-2016, (dose and route were not reported) that was improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Age: 0.61
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot number of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. The report refers to a 7 month old infant patient of unknown gender. On 11-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date: 02-OCT-2014) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
Age: 0.56
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow up information has been received from the registered nurse who provided patients' details. This report refers to a 6 months old infant patient of unknown gender. On 21-JUN-2014, the patient was vaccinated with a dose of PEDVAXHIB lot number J016188, expiration date: 02-OCT-2016, (dose and route were not reported) that was improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Age: 0.18
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unkonwn age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot number of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow up information has been received from the registered nurse who provided patients' details. This report refers to a 9 weeks old infant patient of unknown gender. On 23-JUN-2014, the patient was vaccinated with a dose of PEDVAXHIB  lot number J015437, expiration date: 09-OCT-2016, (dose and route were not reported) that was improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Age: 0.59
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot number of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow up information has been received from the registered nurse who provided patients' details. The report refers to a 7 month old infant patient of unknown gender. On 19-JUN-2014, the patient was vaccinated with a dose of LIQUID PEDVAXHIB lot number J016188, expiration date: 02-OCT-2016, (dose and route were not reported) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Age: 0.18
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot number of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow-up information has been received from the registered nurse who provided patients' details. The report refers to a 9 weeks old infant patient of unknown gender. On 20-JUN-2014, the patient was vaccinated with a dose of LIQUID PEDVAXHIB lot number J016188, expiration date: 02-OCT-2016, (dose and route were not reported) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Age: 0.52
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow up information has been received from the registered nurse who provided patient's details. This report refers to a 6 months old infant patient of unknown gender. On 20-JUN-2014, the patient was vaccinated with a dose of LIQUID PEDVAXHIB lot number J016188, expiration date: 02-OCT-2016, (dose and route were not reported) that was improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Age: 0.36
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow up information has been received from the registered nurse who provided patients' details. This report refers to a 4 months old infant patient of unknown gender. On 20-JUN-2014, the patient was vaccinated with a dose of PEDVAXHIB lot number J016188, expiration date: 02-OCT-2016, (dose and route were not reported) that was improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Age: 0.12
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow up information has been received from the registered nurse who provided patients' details. This report refers to a 6 weeks old infant patient of unknown gender. On 19-JUN-2014, the patient was vaccinated with a dose of PEDVAXHIB lot number J016188, expiration date: 02-OCT-2016, (dose and route were not reported) that was improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a consumer's mother refers to her son, between 14-17 years of age: male patient of unknown age with sulfa drug and penicillin allergy. No pertinent medical history reported. On an unknown date, between 1995-1999, the patient was vaccinated with a dose of RECOMBIVAX HB (dose, route and lot # were not provided). There was no concomitant medication. There was no concomitant medication. On an unknown date, the patient developed severe systemic hives (when he was between the ages 14-17 years of age). Reporter stated that the reaction started right away either on the day of vaccination or the day following vaccination (between 1995-1999). Patient sought medical attention (office visit at the time of the event). Unspecified treatment was given for adverse event. No laboratory tests were performed. Therapy with RECOMBIVAX HB was discontinued (series was not completed). The outcome of severe systemic hives was reported as recovered/resolved on unknown date (at least 1 week after onset date). Causality was not reported. The relationship between severe systemic hives and RECOMBIVAX HB was not reported. Additional information has been requested.
Age: 0.16
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow up information has been received from the registered nurse who provided patients' details. This report refers to a 8 weeks old infant patient of unknown gender. On 17-JUN-2014, the patient was vaccinated with a dose of PEDVAXHIB lot number J016188, expiration date: 02-OCT-2016, (dose and route were not reported) that was improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age. The health professional reported that on an unknown date about 10 patients was vaccinated with PEDVAXHIB, intramuscular that was improperly exposed to 60F for 14 hours. No known adverse effects. All of the data listed here was reconfirmed with the reporter. Additional information has been requested.
Age: 0.19
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot number of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. The report refers to a 10 weeks old infant patient of unknown gender. On 11-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J015437, expiration date: 09-OCT-2016) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: MMRV, 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 gender. The reporter stated that the patient received a dose of (Oka/Merck) PROQUAD (dose and route of administration unknown) and a dose of (Oka/Merck) VARIVAX (0.5 ml, subcutaneous) during the same visit on 30-JUL-2014. Pertinent medical history and concomitant medications were unspecified. No symptoms reported. The outcome of event was unknown. No further details was provided. 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 licensed practical nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date (dates) those patients were vaccinated with RECOMBIVAX HB (dose, units, route of administration, anatomical location, lot number were not reported) that may had been stored improperly. No adverse effects reported. This is one of several reports from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates those patients were vaccinated with PNEUMOVAX 23 (dose, units, route of administration, anatomical location, lot number were not reported) that may had been stored improperly. No adverse effects reported. This is one of several reports from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date (dates) those patients were vaccinated with ROTATEQ (dose, units, route of administration, lot number were not reported) that may had been stored improperly. No adverse effects reported. This is one of several reports from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date (dates) those patients were vaccinated with GARDASIL (dose, units, route of administration, anatomical location, lot number were not reported) that may had been stored improperly. No adverse effects reported. This is one of several reports from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The nurse reported that on an unknown date in 2014 an unspecified number of patients were vaccinated with PNEUMOVAX 23 (dose, route, lot number and expiration date were not provided) which was exposed to 34F for 30 minutes. No adverse event was observed or reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The nurse reported that on an unknown date in 2014 an unspecified number of patients were vaccinated with GARDASIL (dose, route, lot number and expiration date were not provided) which was exposed to 34F for 30 minutes. No adverse event was observed or reported. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous report was received from a consumer regarding his 32 year old wife. Medical history and concurrent conditions were not reported. On 30-JUN-2014 the patient was vaccinated with VARIVAX (Merck) dose 1, subcutaneous (lot number and expiration date unspecified). Concomitant medications were not reported. On an unknown date the patient has taken a home pregnancy test that is showing "positive" for pregnancy. Patient sought no medical attention. There was no Product quality complaint involved. The outcome of event was unknown. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 29 year old (reported as "Age: 29") female patient. No information on her medical history, concurrent conditions or concomitant drugs was reported. On 31-JUL-2014 the patient was vaccinated with a dose of expired MMR II lot # H011907, expiration date 03-JUL-2014, 0.5 ml, subcutaneously in the right arm. No adverse effects were noted by patient. The patient did not seek medical attention. 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/medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date an unspecified number of patients were vaccinated with PNEUMOVA23 (dose, frequency, lot#, expiry date and indication were not reported), which was stored improperly for a period of 25 days. No adverse effect was reported. This is one of three linked 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/medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date an unspecified number of patients were vaccinated with GARDASIL (dose, frequency, lot#, expiry date and indication were not reported), which was stored improperly for a period of 25 days. No adverse effect was reported. This is one of three linked reports from the same reporter. Additional information has been reported.
Age: 16.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 16 year old female patient. On 22-JUL-2014 the patient was supposed to vaccinate with the second dose of M-M-R II (lot #, expiration date, route, frequency and dose were unknown) and (Oka/Merck) VARIVAX (lot #, expiration date, route, frequency and dose were unknown). But the patient was vaccinated with a dose of (Oka/Merck) PROQUAD (lot #, expiration date, route, frequency and dose were unknown) in error. No adverse effect was reported. The (Oka/Merck) PROQUAD was not administered to the patient as a result of medication confusion.  Additional information has been requested.
Age: 0.18
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow up information has been received from the registered nurse who provided patients' details. This report refers to a 9-weeks old infant of unknown gender. On 19-JUN-2014, the patient was vaccinated with a dose of PEDVAXHIB lot number J016188, expiration date: 02-OCT-2016, (dose and route were not reported) that was improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected because follow up had been obtained.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 year old female patient. On 02-NOV-2011 the patient was vaccinated with her first dose of MMR II, and her second dose on 09-AUG-2012 (strength, route, lot# not reported). No adverse effects reported. The outcome of event was unknown. Additional information is not expected as we could not contact physician.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date, when the patient was 1 month of age received RECOMBIVAX HB (lot#, expiration date, dose unknown). The patient received second dose of RECOMBIVAX HB (lot#, expiration date, dose unknown) when was three months of age and third dose of RECOMBIVAX HB (lot#, expiration date, dose unknown) when was four months of age (on unspecified dates). No adverse effect was reported. 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 pharmacist refers to 7 patients of unknown age. On an unknown date in July 2014 the patients were vaccinated with ZOSTAVAX (dose, route and frequency not reported). The reporter reported that 7 patients were administered ZOSTAVAX that had been improperly stored. No adverse effected reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with (Oka/Merck) PROQUAD which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot # and expiration date unknown). No adverse effect had been reported. This is one of several reports received 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 nurse practitioner refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The nurse practitioner reported that, on unspecified dates, 25 patients were inadvertently administered ROTATEQ, orally (lot numbers and doses not provided), and another two vaccines, that had been improperly stored. No adverse effects were reported. This case is linked to cases MARRS # 1408USA001066 and MARRS # 1408USA001207 (same reporter link). Additional information is not expected because there was no consent to follow-up.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report as received from a care coordinator refers to a 74 year old female patient without pertinent medical history, drug reactions or allergies. On an unknown date, the patient was vaccinated with pneumococcal vaccine, (manufacturer unknown) (dose, strength, route and lot number were not reported). Other suspect therapies included influenza virus vaccine (unspecified). Concomitant therapies were not reported. Care coordinator stated that she spoke with the patient on 31-JUL-2014, who stated she had an "allergic reaction" to an unspecified pneumococcal vaccine, (manufacturer unknown) and an unspecified influenza virus vaccine (unspecified). When asking the patient's present status the care coordinator stated the patient was fine. No lab diagnostics studies were performed. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from certified medical assistant refers to 2 unspecified patients of unknown age and gender. On an unknown date the patients were administered doses of GARDASIL (lot #, dose and route not reported) that were improperly stored. Concomitant therapies were not reported. NO adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site reaction, Skin lesion
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with no drug reaction/allergies. On 21-JUL-2014 the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot #, expiration date unspecified), subcutaneous. No concomitant medication included. The patient stated that she was not supported to receive injections in her left arm, because she had her lymph nodes removed as a treatment for breast cancer. The pharmacist stated that the patient returned to the pharmacy on 25-JUL-2014 because she had a small "line" of lesions about an inch below the injection site which "look like they have a head of them". He also reported that the patient had redness at the injection site. He stated that the patient was scheduled to see her physician concerning these side effects. The events outcome was reported as not recovered/not resolved. The patient had sought medical attention. No treatment was given. No lab diagnostics studies performed. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a male patient of unknown age. On an unknown date the patient was vaccinated with Oka/Merck VARIVAX, (0.5 ml; route, dose number and lot number unknown). It was reported that the patient passed out after receiving Oka/Merck VARIVAX. The outcome of the patient passed out was considered to be medically significant. Additional information is not expected because there is no permission to contact physician.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The nurse practitioner reported that, on unspecified dates, 25 patients were inadvertently administered GARDASIL INJ (lot numbers, doses, and routes not provided), and another two vaccines, that had been improperly stored. No adverse effects were reported. This case is linked to cases MARRS# 1408USA001206 and MARRS# 1408USA001207 (same reporter link). Additional information is not expected because there was no consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown age and gender. It was reported that doses of ZOSTAVAX (lot #, dose and route not reported) that were improperly stored since an unspecified date in July 2014, had been administered to patients. No adverse events were reported. This is one of several reports from the same source. Additional information is not expected (reporter refused additional contact).
Age: 0.19
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 10 weeks old infant patient of unknown gender. On 11-JUN-2014 the patient was vaccinated with a dose of PEDVAXHIB (dose and route were not reported, lot# J015437, expiration date: 09-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 1.0
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 a 1 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 02-JUL-2014 the patient was vaccinated with first dose of VAQTA (dose, frequency and route of information were not reported) (lot # J005010 and expiry date: 23-OCT-2015) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA.  This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration, Local swelling, Skin warm, Tenderness
Clinical narrative: Swelling and redness to left arm induration, warm and tender to touch.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL, DTAP, IPV, MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown demography. On 14-APR-2014, the patient was vaccinated with M-M-R II Lot # J003787 (Expiry: 28-MAR-2015) which was exposed to 13C for 68 hours. The patient was also vaccinated with a dose of VARIVAX (merck) Lot # J009729 (Expiry: 29-OCT-2014) (dose, route and frequency were not reported) which was exposed to 13C for 68 hours (MARRS # 1404USA008994). No adverse effects were reported. No further information was provided. Follow up information has been received from the reporting physician who reported that on 14-APR-2014 at 09:00am, a 4 year old female patient was vaccinated with the second dose of M-M-R II Lot # J003787 (Expiry: 28-MAR-2015) subcutaneous in the left arm (dose not reported). Other suspect therapies included DTAP (manufactured in GlaxoSmithKline) (lot # MZ977, exp. date not reported) dose 5, intramuscular in the right arm on 14-APR-2014 at 09:00am and IPV (manufactured in Aventis-Sanofi) (lot # J1406-1, exp. date not reported) (dose not reported) dose 4, intramuscular in the right arm on 14-APR-2014 at 09:00 am. There was no other concomitant therapies. There was no illness at the time of vaccination. The patient had on sibling. Additional information is not expected as the correspondence was received.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL, DTAP, IPV, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown demography. On 14-APR-2014, the patient was vaccinated with (Oka/Merck) VARIVAX lot# J009729 (Expiry: 07-AUG-2015) (dose, route and frequency were not reported) which was exposed to 13C for 68 hours. The patient was also vaccinated with a dose of M-M-R II incorrectly stored (MARRS#140USA010753). No adverse effects were reported. No further information was provided. This is one of several reports from the same source.  Follow up information has been received from the reporting physician who reported that on 14-APR-2014 at 10:30 AM, a 4 year old female patient was vaccinated with (Oka/Merck) VARIVAX lot#J009729 , Exp date 07-AUG-2015, dose 2, subcutaneous in the right arm. Other suspect therapies included DTap (GlaxoSmith) lot#AC14B1698A, dose 5, intramuscular in the right arm and IPV DTAP (Aventis) lot#J14068, dose 6, intramuscular in the right arm. There ws no adverse event and any illness at the time of vaccination. Additional information is not expected.
Age: 1.01
Sex: F
Vaccine: PNC13, VARCEL, PNC13, VARCEL
Symptoms: Adverse reaction, Blood test, Cyanosis, Dyspnoea, Pallor
Clinical narrative: 15 minutes post received VARIVAX vaccine- pt presneted with flushing; GI upset; Hives; Itching; Stridor.
Age: 1.01
Sex: F
Vaccine: PNC13, VARCEL, PNC13, VARCEL
Symptoms: Thyroid function test, Wheezing
Clinical narrative: 15 minutes post received VARIVAX vaccine- pt presneted with flushing; GI upset; Hives; Itching; Stridor.
Age: 1.01
Sex: F
Vaccine: PNC13, VARCEL, PNC13, VARCEL
Symptoms: Abdominal discomfort, Flushing, Pruritus, Stridor, Urticaria
Clinical narrative: 15 minutes post received VARIVAX vaccine- pt presneted with flushing; GI upset; Hives; Itching; Stridor.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site dryness, Injection site erythema, Injection site pain, Injection site reaction, Muscle rigidity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 year old female patient. On 17-JUL-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J013137, expiration date: 17-JUL-2014, 0.65ml) subcutaneous. On 17-JUL-2014 (reported as right after the vaccination, the patient developed irritability and redness at the injection site). The patient came to the pharmacy on 21-JUL-2014 to report this. No treatment was given for the events. No diagnostics studies were performed. The outcome of irritability and redness at the injection site was reported as not recovered. This is one of the several reports from the same reporter. The pharmacist is requesting a lot check. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Irritability
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 year old female patient. On 17-JUL-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J013137, expiration date: 17-JUL-2014, 0.65ml) subcutaneous. On 17-JUL-2014 (reported as right after the vaccination, the patient developed irritability and redness at the injection site). The patient came to the pharmacy on 21-JUL-2014 to report this. No treatment was given for the events. No diagnostics studies were performed. The outcome of irritability and redness at the injection site was reported as not recovered. This is one of the several reports from the same reporter. The pharmacist is requesting a lot check. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: MMR, TDAP, MMR, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: SORE, SWOLLEN ARM, NOT ABLE TO LIFT UP THE ARM, REDNESS AROUND THE VACCINE AREA, SKIN FELT WARM TO THE TOUCH AROUND THE VACCINE AREA. DIZZINESS.
Age: 29.0
Sex: F
Vaccine: MMR, TDAP, MMR, TDAP
Symptoms: Dizziness, Injection site erythema, Injection site oedema, Local swelling, Mobility decreased
Clinical narrative: SORE, SWOLLEN ARM, NOT ABLE TO LIFT UP THE ARM, REDNESS AROUND THE VACCINE AREA, SKIN FELT WARM TO THE TOUCH AROUND THE VACCINE AREA. DIZZINESS.
Age: 29.0
Sex: F
Vaccine: MMR, TDAP, MMR, TDAP
Symptoms: Pain in extremity, Vaccination site warmth
Clinical narrative: SORE, SWOLLEN ARM, NOT ABLE TO LIFT UP THE ARM, REDNESS AROUND THE VACCINE AREA, SKIN FELT WARM TO THE TOUCH AROUND THE VACCINE AREA. DIZZINESS.
Age: 27.0
Sex: M
Vaccine: TDAP, TTOX
Symptoms: Nausea, Vomiting
Clinical narrative: DONOR C/O NAUSEA AND VOMITING 20-30 MINUTES AFTER TETANUS INJECTION. THIS LASTED ALL NIGHT AND THE NEXT DAY.
Age: 1.03
Sex: M
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site mass, Irritability, Pyrexia
Clinical narrative: Child was immediately upset after shot and remained upset the rest of the day. He was fussy and irritable. He ran a low grade fever for 3 full days afterwards. A small lump was under the skin at the site of the injection in his Left Thigh. It became a hard little bump that stayed put for 3 months and was present at his 15 month check up. Child regressed in speech from 10 crystal clear words down to only 5 in 3 months time. Further regression down to only 3 words by 18 months time.
Age: 1.03
Sex: M
Vaccine: PNC13
Symptoms: Speech disorder developmental
Clinical narrative: Child was immediately upset after shot and remained upset the rest of the day. He was fussy and irritable. He ran a low grade fever for 3 full days afterwards. A small lump was under the skin at the site of the injection in his Left Thigh. It became a hard little bump that stayed put for 3 months and was present at his 15 month check up. Child regressed in speech from 10 crystal clear words down to only 5 in 3 months time. Further regression down to only 3 words by 18 months time.
Age: 11.0
Sex: M
Vaccine: HPV4, MEN, TDAP
Symptoms: Convulsion, Loss of consciousness, Vaccine positive rechallenge
Clinical narrative: This spontaneous report as received from a nurse via the field representative refers to a 11 year old male patient. On 31-JUL-2014 the patient was vaccinated with the first dose of GARDASIL, lot# not reported, 1 single shot, intramuscular. Concomitant therapies included Tdap and meningococcal vaccine (unspecified). After receiving GARDASIL, the patient passed out and had a brief seizure. The field representative also reported "the patient had this reaction every time he received a vaccination (specific dates and products unknown). No medical attention was sought and no treatment was received. The outcome of the events was reported as recovered on 31-JUL-2014. Upon internal review, the events of "pass out" and "seizure" were considered to be medically significant. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Malaise, Nausea, Vomiting
Clinical narrative: Reports nausesa and vomiting that lasted the morning and not feeling well the rest of the day.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site bruising, Local swelling, Malaise, Pain
Clinical narrative: Pt states drove to parents home-town (90min) and went to fair, started feeling feverish et malaise, went home.  Fri morning fever et malaise continued with arm becoming puffy with hot, itchy rash et painful to touch. Sat rash continues with pain et malaise increasing.  Ibuprofen et Benadryl taken Sat, pt states slept afterwards, unknown if ibuprofen helped fever. Sun pt starts to feel "a little" better, swelling from rash starts to decrease, no longer red in color, now pink. Monday pt continues to recover. Tuesday pt states site looks bruised, half-dollar size, no longer red, itchy, or raised.  Pt feels a small lump under skin and is tender to the touch. Highest recorded temperature was 102.4.  (Pt agrees to summary)
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash pruritic, Skin warm, Tenderness
Clinical narrative: Pt states drove to parents home-town (90min) and went to fair, started feeling feverish et malaise, went home.  Fri morning fever et malaise continued with arm becoming puffy with hot, itchy rash et painful to touch. Sat rash continues with pain et malaise increasing.  Ibuprofen et Benadryl taken Sat, pt states slept afterwards, unknown if ibuprofen helped fever. Sun pt starts to feel "a little" better, swelling from rash starts to decrease, no longer red in color, now pink. Monday pt continues to recover. Tuesday pt states site looks bruised, half-dollar size, no longer red, itchy, or raised.  Pt feels a small lump under skin and is tender to the touch. Highest recorded temperature was 102.4.  (Pt agrees to summary)