chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to five patients of unknown demographics. Pertinent medical history and concomitant therapies were not reported. The nurse reported that patients received improperly stored (Merck) PROQUAD (lot number L008353, expiry date 11-SEP-2016, 0.5 ml, subcutaneously). Four doses were administered on 17-AUG-2015 and one dose was administered on 20-AUG-2015. No adverse effects were reported. Follow up information has been received on 02-OCT-2015 that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received from the nurse on 08-OCT-2015. The nurse reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow up information has been received from the reporting nurse on 08-OCT-2015 and refers to a 4 year old patient of unknown gender. On 17-AUG-2015, the patient was vaccinated with the dose of improperly stored (Merck) PROQUAD. Temperature excursion had place on 09-AUG-2015. This is one of several reports received from the same reporter. Additional information has been requested. The patient details and narrative was updated.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via field representative refers to a male patient of an unknown age. Information regarding medical history and current conditions was not reported. Approximately in 2013 (reported as two years ago) the patient was vaccinated with ZOSTAVAX 19400 PFU, 0.65 ml, one time vaccination. Other co-suspects and concomitant medications were not reported. Approximately in 2014 (about a year ago), the patient developed shingles. The patient sought medical attention and visited doctor. No product quality complaint was reported. The outcome of the event was unknown. The reported did not provide the relatedness of the event with ZOSTAVAX. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding four unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of VARIVAX (Merck) (dose and route were not reported, lot # L006385, expiry date 25-FEB-2017). There were no adverse effects reported. Follow up information was received on 02-OCT-2015. On 02-OCT-2015, a call was placed to the registered nurse and went directly to voice mail. A voice mail message was left requesting the nurse to return the phone call and requesting also for patients identifiers, lot number and expiration date and date of vaccination. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from the reporting nurse on 08-OCT-2015 and refers to an 18 year old patient of unknown gender. On 17-AUG-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck). The temperature excursion had place on 09-AUG-2015. This is one of several reports received from the same source. Additional information has been requested. Patient details and narrative were updated.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to five patients of unknown demographics. Pertinent medical history and concomitant therapies were not reported. The nurse reported that patients received improperly stored (Merck) PROQUAD (lot number L008353, expiry date 11-SEP-2016, 0.5 ml, subcutaneously). Four doses were administered on 17-AUG-2015 and one dose was administered on 20-AUG-2015. No adverse effects were reported. Follow up information has been received on 02-OCT-2015 that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received from the nurse on 08-OCT-2015. The nurse reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow up information has been received from the reporting nurse on 08-OCT-2015 and refers to a 4 year old patient of unknown gender. On 20-AUG-2015, the patient was vaccinated with the dose of improperly stored (Merck) PROQUAD. Temperature excursion had place on 09-AUG-2015. This is one of several reports received from the same reporter. Additional information has been requested. The patient details and narrative was updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to 8 patients of unknown age and gender. On 07-OCT-2015 the patients were vaccinated with improperly stored VARIVAX (Merck) injection (lot # L021216, expiration date 10-JUN-2017; lot # L023592, expiration date 26-JUN-2017) (dose and route were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Menstrual disorder
Clinical narrative: This spontaneous report as received from a consumer refers to his/her 12 year old granddaughter. The patient's pertinent medical history and drug allergies were unspecified. On an unknown date, the patient was vaccinated with first dose of GARDASIL (dose, frequency, route and lot# were not reported) and on the same day, the patient received a booster shot, unknown vaccine name. Concomitant medications were none. From 15-AUG-2015, the patient experienced back to back menstrual cycles (polymenorrhoea). The outcome of the event was unknown. The relatedness of the event with GARDASIL was not reported. Additional information is not expected as the reporter did not wish to contact.
Age: 17.0
Sex: U
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 17-year-old patient of unknown gender with no pertinent medical history. On an unknown date, the patient was inadvertently administered PEDVAXHIB, intramuscular (dose, lot number and expiration date were not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored GARDASIL 9 injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No symptoms were reported. The outcome of the event was unknown. There were no product quality complaint (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 77 year old female patient with diabetes and hypertension. The patient had no drug reactions or allergies. The patient had a breast cancer operation on 07-OCT-2013 (reported as 2 years ago). On an unknown date, a long time ago, the patient completed the series of RECOMBIVAX HB (dose, route of administration, lot number and expiration date were not reported). Concomitant therapies included metformin, glipizide and losartan potassium (manufacturer unknown). On 25-SEP-2015, the doctor completed the Hepatitis B surface AB immunity Quantity Test and the patient's levels were less than 5 (units not provided) and should be above 10 (units not provided). There was no treatment given to the patient for that event. The outcome of the event was not reported. The relatedness between the event and the RECOMBIVAX HB was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent conditions and medical history were reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date the patient experienced Bell's Palsy (VIIth nerve paralysis). The action taken with the therapy with ZOSTAVAX was unknown. The outcome of the VIIth nerve paralysis was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 4 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 21-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to two unspecified patients of unknown age and unknown gender. No medical history and concurrent conditions were reported. On 25-SEP-2015, the patients were vaccinated with properly stored MMR II (lot number and expiry date were not reported0 which was reconstituted with improperly stored sterile diluent (lot# K026419 and expiry date: 19-OCT-2017, lot# L012345 and expiry date: 23-JAN-2018), each receiving one dose each on 25-SEP-2015. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 4 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 23-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.24
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding four unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of VARIVAX (Merck) (dose and route were not reported, lot # L006385, expiry date 25-FEB-2017). There were no adverse effects reported. Follow up information was received on 02-OCT-2015. On 02-OCT-2015, a call was placed to the registered nurse and went directly to voice mail. A voice mail message was left requesting the nurse to return the phone call and requesting also for patients identifiers, lot number and expiration date and date of vaccination. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from the reporting nurse on 08-OCT-2015 and refers to a 14 month old patient of unknown gender. On 15-AUG-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck). The temperature excursion had place on 09-AUG-2015. This is one of several reports received from the same source. Additional information has been requested. Patient details and narrative were updated.
Age: 10.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to five patients of unknown demographics. Pertinent medical history and concomitant therapies were not reported. The nurse reported that patients received improperly stored (Merck) PROQUAD (lot number L008353, expiry date 11-SEP-2016, 0.5 ml, subcutaneously). Four doses were administered on 17-AUG-2015 and one dose was administered on 20-AUG-2015. No adverse effects were reported. Follow up information has been received on 02-OCT-2015 that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received from the nurse on 08-OCT-2015. The nurse reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow up information has been received from the reporting nurse on 08-OCT-2015 and refers to a 10 year old patient of unknown gender. On 17-AUG-2015, the patient was vaccinated with the dose of improperly stored (Merck) PROQUAD. The temperature excursion had place on 09-AUG-2015. This is one of several reports received from the same reporter. Additional information has been requested. The patient details and narrative was updated.
Age: 1.03
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding four unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of VARIVAX (dose and route were not reported, lot # L006385, expiry date: 25-FEB-2017). There were no adverse effects reported. Follow up information was received on 02-OCT-2015. On 02-OCT-2015, a call was placed to the registered nurse and went directly to voice mail. A voice mail message was left requesting the nurse to return the phone call and requesting also for patients identifiers, lot number and expiration date and date of vaccination. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from the reporting nurse on 08-OCT-2015 and refers to a 12 month old patient of unknown gender. On 17-AUG-2015, the patient was vaccinated with a dose of improperly stored VARIVAX. The temperature excursion had place on 09-AUG-2015. This is one of several reports received from the same source. Additional information has been requested. Patient details and narrative were updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to ten patients of an unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date, ten patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L001327, expiration date 13-JAN-2017). No adverse events were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to unspecified number of patients of an unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored VARIVAX (Merck) (lot # L015045, expiration date 29-APR-2017). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to three patients of an unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date, three patients were vaccinated with improperly stored VARIVAX (Merck) (lot # L005300, expiration date 17-FEB-2017). No adverse events were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (lot# L013429, expiry date 21-JUL-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effect was reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (lot# reported as L013428, expiry date 03-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effect was reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of an unknown age and gender. The patients concurrent conditions and medical history were not reported. Nurse reported that four doses of GARDASIL which were exposed to temperatures outside of the recommended range, were administered to unspecified patients on unspecified dates since 31-JUL-2015. No adverse experience has been reported. Additional information has been requested.
Sex: U
Vaccine: HPV4, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients medical history and concurrent conditions were not reported. On an unknown dates, the patient were vaccinated with improperly stored dose of GARDASIL (Lot#K011562, expiration date 08-APR-2017; Lot#K016966 and expiration date 10-MAY-2017) (dose and route of administration were not reported) or ROTATEQ (Lot#K007247, expiration date 17-MAR-2016; Lot#K011948 and expiration date 07-JUN-2016) (dose and route of administration were not reported). No adverse effect were reported. Additional information is not expected as there is no consent for follow up.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients were vaccinated with doses of improperly stored ROTATEQ (lot#, dose and frequency were unknown). No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose (incorrect product storage) of GARDASIL (lot # K010215, expiration date 05-MAY-2017) (dose, frequency, route of administration and anatomical location were not reported). There was no concomitant medication reported. No adverse effect or product quality issue 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 an unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients were vaccinated with doses of improperly stored VAQTA (lot#, dose and frequency were unknown). No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot#, dose and frequency were unknown). No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 3 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 25-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient with aspirin and IV iodine allergies. On 09-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX (route, dose lot # and expiration date were not provided). There was no concomitant medication. On 11-OCT-2015, the patient experienced injection site rash and injection site warmth referred to as a warm "rug burn" like rash around the injection site - about 2.5 inches in diameter. The patient sought medical attention by visiting pharmacy and no treatment was given for the events. No lab diagnostics studies were performed. At the time of this report, the outcome of injection site rash and injection site warmth was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 2 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 24-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HPV4, RV1, HPV4
Symptoms: Wrong drug administered
Clinical narrative: I was working on this day. We had an emergency patient come in with a deep laceration that our provider had to stitch, as I assisted her. This was around 12:45 pm. This took around 45 min. Our regular scheduled 1:00 pm was the mother of the 1:15 pm and 1:15 pm patient was the mother of the infant. This is why they were all in one room. Patient was here for a nurse visit for immunizations. I was only available due to lunch. After assisting with the laceration I roomed both the 1:00 pm and 1:15 pm patients in same room along with the pediatric patient which was the 1:15 pm patients son. I had already written down the vaccinations that patient needed by looking in his chart and looking at vaccination chart. I drew up two intramuscular vaccinations, PENTACEL, hib and an oral vaccination which was the rotavirus. Gave patient the shots one in each leg and then the oral dose. I then proceeded to go to my desk to document the immunizations. I read the first vial and I realized that one of the intramuscular shots which was supposed to be the Hib was in fact a HPV. I reported this to provider but had to wait for the next day to report it. Spoke with employer first thing on 10/13/15, she contacted state immunization program and they said the only adverse reaction was swollen leg and redness. I contacted the mother to let her know.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HPV4, RV1, HPV4
Symptoms: Drug administered to patient of inappropriate age, Irritability, Lethargy
Clinical narrative: I was working on this day. We had an emergency patient come in with a deep laceration that our provider had to stitch, as I assisted her. This was around 12:45 pm. This took around 45 min. Our regular scheduled 1:00 pm was the mother of the 1:15 pm and 1:15 pm patient was the mother of the infant. This is why they were all in one room. Patient was here for a nurse visit for immunizations. I was only available due to lunch. After assisting with the laceration I roomed both the 1:00 pm and 1:15 pm patients in same room along with the pediatric patient which was the 1:15 pm patients son. I had already written down the vaccinations that patient needed by looking in his chart and looking at vaccination chart. I drew up two intramuscular vaccinations, PENTACEL, hib and an oral vaccination which was the rotavirus. Gave patient the shots one in each leg and then the oral dose. I then proceeded to go to my desk to document the immunizations. I read the first vial and I realized that one of the intramuscular shots which was supposed to be the Hib was in fact a HPV. I reported this to provider but had to wait for the next day to report it. Spoke with employer first thing on 10/13/15, she contacted state immunization program and they said the only adverse reaction was swollen leg and redness. I contacted the mother to let her know.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 23-JUL-2015 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # K009745, expiry date 17-FEB-2016, dose and dose number were unspecified) orally. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 21-JUL-2015 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # K009745, expiry date 17-FEB-2016, dose and dose number were unspecified) orally. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: TYP
Symptoms: Pharyngeal oedema, Urticaria
Clinical narrative: Took medication Saturday 9/26/15 night. Woke up Sunday morning with severe hives and swollen throat. Went to urgent care received EPIPEN and prednisone therapy and discontinued therapy.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Agitation, Asthenia, Asthma, Conjunctivitis, Cough
Clinical narrative: Having adverse side of Hep B shot, which are swelling of eyes and face, dizziness, flushing, weakness and sleepiness, cough and upper respiratory illness, stiffness in my legs and arm, runny nose, irritable and agitated, asthma like symptoms, conjunctivitis in the eyes.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Eye swelling, Flushing, Irritability, Musculoskeletal stiffness
Clinical narrative: Having adverse side of Hep B shot, which are swelling of eyes and face, dizziness, flushing, weakness and sleepiness, cough and upper respiratory illness, stiffness in my legs and arm, runny nose, irritable and agitated, asthma like symptoms, conjunctivitis in the eyes.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Rhinorrhoea, Somnolence, Swelling face, Upper respiratory tract infection
Clinical narrative: Having adverse side of Hep B shot, which are swelling of eyes and face, dizziness, flushing, weakness and sleepiness, cough and upper respiratory illness, stiffness in my legs and arm, runny nose, irritable and agitated, asthma like symptoms, conjunctivitis in the eyes.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 17-SEP-2015 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # K009745, expiry date 17-FEB-2016, dose and dose number were unspecified) orally. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 01-OCT-2015 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # K009745, expiry date 17-FEB-2016, dose and dose number were unspecified) orally. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 22-JUL-2015 the patient was vaccinated with an improperly stored dose of oral, ROTATEQ (lot # K009745, expiry date 17-FEB-2016, dose and dose number were unspecified) orally. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 08-JUL-2015 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # K009745, expiry date 17-FEB-2016, dose and dose number were unspecified) orally. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 22-SEP-2015 the patient was vaccinated with an imiproperly stored dose of oral, ROTATEQ (lot # K009745, expiry date 17-FEB-2016, dose and dose number were unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot# J003707, exp. 27-MAR-2015) or (lot# K005426, exp. 15-APR-2016) (dose, route and dose number were unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Incorrect route of drug administration
Clinical narrative: Pt inadvertently given ROTARIX via intramuscular (IM). Pt returning to office 10/8/15 to revaccinate ROTARIX PO
Age: 1.19
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness to L thigh not painful except to touch. Measured by parent 3 in x 4.5 in.
Age: 54.0
Sex: M
Vaccine: HEPAB
Symptoms: Chromaturia, Pruritus generalised, Rash
Clinical narrative: Received HAB vaccine on 9/1/2015 - approximately 2 weeks later - urine color changed darker, generalized itching, bumps developed on arms and back, advised to follow-up with PCP and advise as to findings.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Pt inadvertently administrated - ROTARIX via intramuscular (IM) - 10/5/15. Pt returned to office 10/7/15 and given ROTARIX PO. No local RX seen at site from gettnig ROTARIX IM.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: (L) arm deltoid. Pain, itchy, warm to touch. 7cm x 5 1/2 cmw.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Cerebellar ataxia, Fall, Gait disturbance
Clinical narrative: Twelve month old boy, 12 days post vaccination, became unsteady when walking, falling easily. No head trauma, no access to drugs or toxins. Dx: Acute Cerebellar Ataxia.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No adverse event. Patient received third HPV dose on 9/23/15. Dose was not due till after 10/8/15.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Skin lesion, Smallpox
Clinical narrative: 3 years after small pox vaccine developed small pox (severe) pain and lesions.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Blister, Pyrexia, Rash
Clinical narrative: Pt received 4 yo vaccines on Tues 9-23-15. Pt ran low grade temp that p.m. No other issues. Friday when aunt picked him up at pre-K pt had 2 blisters on (L) lower leg. School nurse unsure what the cause. Pt grandparent applied Band-Aid over the blisters that popped Fri PM. Small rash, irritation type, around 2 almost healed blisters on (L) lower leg in shape of Band-Aid. No s/s of infection. Aunt whom has custody states he is fine just don't know what the blisters were from and making sore not from vacc. Nurse adv aunt as lets take to PCP she declined.
Age: 47.0
Sex: U
Vaccine: TDAP
Symptoms: Back pain, Herpes zoster, Musculoskeletal pain, Neck pain, Rash
Clinical narrative: Shoulder, neck and back pain. Rash consistent with shingles 1-3 days following. Currently receiving treatment.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Urticaria
Clinical narrative: Given vaccines 10/7/15. Mom called that night - patient sent to ER - DX urticaria - pt given Prednisone and Benadryl. Follow up visit 10/9/15 - doing well.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Blood culture, C-reactive protein, Full blood count, Injection site erythema, Injection site pain
Clinical narrative: Left thigh large area of redness, swelling extended from front of left thigh, extending to the sides, tender to palpation.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site swelling, Metabolic function test
Clinical narrative: Left thigh large area of redness, swelling extended from front of left thigh, extending to the sides, tender to palpation.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site hypoaesthesia, Injection site pain, Injection site swelling
Clinical narrative: Patient suffered swelling, numbness, and pain in arm where she received vaccination for more than one week.
Age: 0.21
Sex: U
Vaccine: HEP, PPV, RV1
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional referring to an approximately 9 weeks old patient of unknown gender. Information about the patient's medical history or concurrent conditions were not reported. On 04-AUG-2015, the patient was vaccinated with hepatitis b vaccine (manufacturer unknown), (dose, route of administration, lot # and expiration date were not provided). Other suspect therapies included pneumococcal vaccine (manufacturer unknown), (dose, route of administration, lot # and expiration date were not provided) and ROTARIX, (dose, route of administration, lot#, expiration date and indication were not provided, all vaccinations administered on the same date. Concomitant medication was not reported. On an unknown date, in 2015, the patient experienced an adverse event, described as "vaccine adverse experience" At the time of reporting, the outcome of vaccine adverse experience was unknown. The causal relationship between the adverse event and the suspect therapies was not reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody positive, Serology negative
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of hepatitis B antigen positive in a 65-year-old male patient who received ENGERIX B adult (batch number 2FJ73, expiry date 8th July 2017). On 13th June 2015, the patient received the 1st dose of ENGERIX B adult (intramuscular) 40 ug. On 2nd July 2015, 19 days after receiving ENGERIX B adult, the patient experienced hepatitis B antigen positive. On an unknown date, the outcome of the hepatitis B antigen positive was unknown. It was unknown if the reporter considered the hepatitis B antigen positive to be related to ENGERIX B adult. Additional details were provided as follows: The patient was a dialysis patient who received 1st dose of ENGERIX B. The patient experienced prolonged antigenemia of hepatitis B surface antigen. On 2nd July 2015, the patient underwent laboratory test and was found to be positive for HBsAg (Hepatitis B surface antigen) and all other serologic markers were negative. The anti HBsAg was less than 3 mIU/ml, which was the lower limit of the test. On 6th October 2015, at the time of reporting, the patient underwent laboratory test and found to be positive for HBsAg (Hepatitis B surface antigen) and negative with regard to all other serological markers. The reported batch number (2SJ73) of ENGERIX B did not exist and was updated to 2FJ73 as per the sales database.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a male patient of unknown age with hypertension. The patient's medical history and allergies were not reported. On 16-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX, (lot # L012478 with expiration date 10-JUL-2016), 0.65 ml, subcutaneous in the back of the right arm. Concomitant therapies included unspecified hypertension medication. It was also reported that there was not other vaccines administered on the same day. That same day, after vaccination with ZOSTAVAX, the patient experienced injection site swelling. On 22-OCT-2015, the patient went to the pharmacy and he had an injection site nodule described as he had a know at the injection site, back of the right arm (unknown date in 2015). The pharmacist stated she would have the patient follow up with his primary care provider. Treatment was not given for the adverse events and no laboratory diagnostics studies were performed. The outcome of injection site nodule and injection site swelling was reported as not recovered. The relatedness between injection site nodule and injection site swelling and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: DTAP, HEP, PPV, RV5
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a healthcare professional referring to an approximately 6 months old patient of unknown gender. Information about the patient's medical history or concurrent conditions were not reported. On 04-AUG-2015, the patient was vaccinated with Hepatitis B vaccine (manufacturer unknown) (dose, route of administration, lot # and expiration date were not provided). Other suspect therapies included pneumococcal vaccine (manufacturer unknown), (dose, route of administration, lot # and expiration date were not provided); rotavirus vaccine, oral, (manufacturer unknown), (dose, lot # and expiration date were not provided); and DTaP (manufacturer unknown), (dose, route of administration, lot # and expiration date were not provided), all vaccinations on the same date. Concomitant medication was not reported. On an unknown date, in 2015, the patient experienced an adverse event, described as "vaccine adverse experience". At the time of reporting, the outcome of vaccine adverse experience was unknown. The causal relationship between the adverse event and the suspect therapies was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and allergies were not reported. On an unknown date, the patients were vaccinated with doses of GARDASIL 9 (lot # L013429 with expiration date 21-JUL-2017 and lot # K026246 with expiration date 28-JAN-2017), (strength, dose, frequency, route and anatomical location were not reported), which were improperly stored. No adverse events were reported. Additional information is not expected as the reporter did not consent for further follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no pertinent medical history, concurrent conditions or drug allergies/drug reactions described. On unspecified dates, the patient was inadvertently vaccinated with 4 doses of ZOSTAVAX injection (dose, route, frequency, lot # and dates of vaccination were not provided). It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 12-OCT-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (Lot# K008883; expiration date 20-SEP-2015) subcutaneous (dose was not reported). The registered nurse stated that this was the only dose of ZOSTAVAX that this patient has ever been administered. No adverse effect was reported. There was not a product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 12-OCT-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (Lot# K008883; expiration date 20-SEP-2015) subcutaneous (dose was not reported). The registered nurse stated that this was the only dose of ZOSTAVAX that this patient has ever been administered. No adverse effect was reported. There was not a product quality complaint (PQC) involved. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis contact, Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a male patient of unknown age. No concurrent conditions or medical history were reported. In approximately 2012, reported as "approximately 3 years ago" the patient was vaccinated with a dose of VARIVAX (dose, Lot No., route and anatomical location of administration were not reported). No concomitant therapy was provided. In approximately 2013, reported as "one year after vaccination", the patient developed a rash on one leg. The physician had seen the patient in her office on an unspecified date and diagnosed the patient with contact dermatitis. One month later, the patient also developed ulcers on his tongue and the leg rash was still present. The patient was then seen by an unspecified dermatologist on an unspecified date and diagnosed with shingles. The symptoms lasted for approximately 1 month and had then resolved. No Product Quality Complaint (PQC) was involved. The outcome of dermatitis contact and herpes zoster was reported as recovered on unspecified date. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via company representative referring to a male patient of unknown age. Patient's medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously (lot# and expiry date not reported). Other co-suspect or concomitant medications were not reported. Last week, in October 2015, the patient developed an injection site reaction. Patient's arm was red and it was swelling (arm not specified). The outcome of application site reaction site, injection site swelling and injection site erythema was unknown. Additional information is not expected.