chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # N009775 and N010115 for prophylaxis with sterile diluent (STERILE DILUENT). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.; Sender's Comments: US-009507513-1708USA002826:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On an unknown date, the patient was vaccinated with improperly stored PROQUAD (lot # M022402, expiration date 01-NOV-2017, dose and route were not reported) for prophylaxis, which was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were unknown). The vaccine was exposed to temperature excursion between -14 degrees Celsius to -10 degrees Celsius (-14 degrees Celsius) for 1 hour and the data logger was not involved. Previous temperature excursion was exposed between -14 degrees Celsius to -10 degrees Celsius (-14 degrees Celsius) for 1 hour. Sterile diluent (MERCK STERILE DILUENT) was not part of the temperature excursion. No adverse effects were reported.
Sex: U
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 03-AUG-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # N000336, expiration date 03-JUL-2018, dose and route not reported) for prophylaxis. The vaccine was improperly stored at 6F to 14 F for 30 minutes. There was no previous temperature excursion. Data logger was involved. The sterile diluent(STERILE DILUENT) used to reconstitute the PROQUAD did not undergo a temperature excursion. No adverse effect was reported.
Age: 11.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 11-year-old patient of unknown gender. No information regarding the patient's medical history, concomitant medications and concurrent conditions was provided. On 04-AUG-2017, the patient was vaccinated with LIQUID PEDVAXHIB lot # N000237, expiration date 25-OCT-2019 (strength, dose and route of administration were not provided). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 2 month old patient. The medical history, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with one dose of improperly stored VARIVAX (N009768, 24-MAR-2019) was administered. Temperature 9 to 8 degree centigrade(-7.3c) for 112 hours. There was no previous temperature excursion. There was data logger. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from an administrator referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with an improperly stored VARIVAX (strength, dosage, frequency and route unspecified) for prophylaxis (incorrect product storage). Temperature was -0.8 C with time frame of 4 hours. No previous temperature excursion was reported. No adverse symptom was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an multiple unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with an unknown amount of improperly stored doses of PROQUAD lot numbers: M048201, M044575, M042500 and N010247, reconstituted with properly stored diluent. No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1707USA012945:
Age: 63.0
Sex: M
Vaccine: 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. On 10-AUG-2017, the patient was vaccinated with an expired dose of ZOSTAVAX lot number M035146, expiration date 10-AUG-2017, for prophylaxis. Concomitant therapies included an sterile diluent lot number M044950, expiration date 30-MAY-2019. No symptoms were reported.
Age: 28.0
Sex: F
Vaccine: HPVX
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a medical assistant refers to a 28 year old female patient. In July 2017 the patient was vaccinated with GARDASIL 9 for prophylaxis.  Other suspect therapies included GARDASIL. Concomitant therapies included pre-natal vitamins and  iron pills. The patient became pregnant with last menstrual period (LMP) of 04-JUN-2017 and estimated date of delivery (EDD) of 11-MAR-2018. Initial exposure to GARDASIL 9 or GARDASIL was at 7 weeks. The pregnancy outcome was outcome pending. In July 2017 the patient experienced exposure during pregnancy. The outcome of exposure during pregnancy was unknown. The reporter considered exposure during pregnancy to be not related to GARDASIL 9 and GARDASIL.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M044399, as prophylaxis. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA006953.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with improperly stored ROTATEQ lot # M035385 and expiration date on 08-APR-2018, oral for prophylaxis. No adverse effects reported.
Age: 1.0
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant referring to a 1 year old patient. On 10-AUG-2017 the patient was vaccinated with PNEUMOVAX 23 lot # N011491 and expiration date of 04-NOV-2018 for prophylaxis. No adverse effect reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 10-AUG-2017 the patient was vaccinated with a dose of improperly stored VARIVAX (lot # M044347, expiration date: 04-NOV-2018) for prophylaxis. Temperature and time frame: 6 F to 14 F for 1 hour 36 minutes. There was no previous temperature excursion. The sterile diluent vials used for reconstitution did not undergo a temperature excursion. No adverse effects reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA007000.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX injection, lot # L038132 with expiration date of 01-OCT-2017 (dose and route of administration were not reported), reconstituted with properly stored sterile diluent (manufacturer unknown). Administered doses of vaccines experienced the temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 15 hours and 50 minutes. There was a previous temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 10 hours and 45 minutes and 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour. Digital data logger was involved in recording the excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA003977.
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 16 year old patient.    On 12-JUL-2012 the patient was vaccinated with GARDASIL dose 1 for prophylaxis. Other suspect therapies included GARDASIL 9. On 15-AUG-2017, 5 years 1 month 4 days after onset of therapy the patient experienced inappropriate schedule of drug administration and interchange of vaccine products. On an unknown date the patient experienced no adverse event. The outcome of inappropriate schedule of drug administration, no adverse event and interchange of vaccine products is unknown. The reporter considered inappropriate schedule of drug administration, no adverse event and interchange of vaccine products to be not related to GARDASIL 9 and GARDASIL.
Sex: U
Vaccine: MMR
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II, subcutaneous for prophylaxis. On an unknown date the patient experienced underdose, no adverse event and needle issue. The outcome of underdose, no adverse event and needle issue is unknown. The reporter considered underdose, no adverse event and needle issue to be not related to M-M-R II.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a consumer refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with incorrect storage doses of PEDVAXHIB. Temperature excursion: 48.0 degrees Fahrenheit for about 5 and a half hours. This is one of three reports received from the same source. Sender's Comments: US-009507513-1708USA006931: Original Case: 1708USA006823; US-009507513-1708USA006823: Original Case: 1708USA006823.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 lot # N000326 as prophylaxis. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA006315:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a other nurse regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored VARIVAX lot # M036272 and expiry date: 07-AUG-2018 (dose and route were not reported) for prophylaxis. The vaccine was exposed to a temperature range of 6 Fahrenheit to 14 Fahrenheit for 41 minutes. There was a previous excursion of the range 15 Fahrenheit to 46 Fahrenheit for 1 hour and 42 minutes. The call was because of a digital data logger. No adverse effect reported. No additional information was provided. No product quality complaint involved. This is one of the two reports from the same reporter. Sender's Comments: US-009507513-1708USA007128.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via eye contact, Eye pain
Clinical narrative: This spontaneous report was received from a female pharmacist unknown age regarding herself. Her medical history, current conditions and concomitant medications were not reported. On 15-AUG-2017, the pharmacist was she was about to administer a dose of ZOSTAVAX for prophylaxis, lot number and expiration date unknown by the reporter, and the pharmacist accidentally squirted some of the vaccine into her eye. The pharmacist then used an unspecified eye wash containing benzalkonium chloride. She stated that her eye "stings a bit", but noted that "she had sensitive eyes" and that she anticipated that the stinging will resolve soon. Treatment was given for the event and no medical attention was sought. No other information was available. There was no product quality complaint involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 10-AUG-2017 the patient was vaccinated with a dose of improperly stored VARIVAX (lot # M044347, expiration date: 04-NOV-2018) for prophylaxis. Temperature and time frame: 6 F to 14 F for 1 hour 36 minutes. There was no previous temperature excursion. The sterile diluent vials used for reconstitution did not undergo a temperature excursion. No adverse effects reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA006597:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were inadvertently administered with GARDASIL 9 (lot # M044717, expiration date 19-JUL-2019, 0.5 ml, intramuscular) that had been improperly stored (incorrect product storage) for prophylaxis. The temperature was 1 centigrade degree (°C), and the time frame was 2 hours 23 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA007035: US-009507513-1708USA007034:
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding a 14 year old patient of unknown gender. Information on pertinent medical history, concomitant medication and drug reactions/allergies were not reported. On 14-AUG-2017, the patient inadvertently received PROQUAD, lot# M037010 with expiry date of 22-FEB-2018,  0.5 ml, Subcutaneously for prophylaxis (frequency not provided). No adverse effects were reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were inadvertently administered vaccinated with RECOMBIVAX HB (lot # N002202, expiration date 04-NOV-2019, lot# N002914, expiration date 04-NOV-2019) that had been improperly stored for prophylaxis. The temperature was 1 centigrade degree (°C), and the time frame was 2 hours 23 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA007035: US-009507513-1708USA007006.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were inadvertently administered with VAQTA (lot # N008823, expiration date 26-MAY-2018) that had been improperly stored (incorrect product storage) for prophylaxis. The temperature was 1 centigrade degree (°C), and the time frame was 2 hours 23 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA007006: US-009507513-1708USA007034:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant via physician regarding a multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB injection lot # M001813 with expiration date 14-OCT-2018 and lot # M046134 with expiration date 27-SEP-2019 (dose and route were not reported), for prophylaxis. The storage temperature was 32 F to 35 F and time frame was 1 hour (incorrect product storage). The patients has no previous temperature excursion. The patients used data logger. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a other nurse regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored ROTATEQ lot # M043563 and expiry date: 09-JUN-2018 (dose and route were not reported) for prophylaxis. The vaccine was exposed to a temperature range of 6 Fahrenheit to 47 Fahrenheit to 77 Fahrenheit for 41 minutes. There was no previous excursion. The call was because of a digital data logger. No adverse effect reported. No additional information was provided. No product quality complaint involved. This is one of the two reports from the same reporter. Sender's Comments: US-009507513-1708USA006988.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to 15 patients of unknown age. On unknown dates the patients were vaccinated with improperly stored doses of VARIVAX lot # N008829 for prophylaxis. No adverse event was reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to VARIVAX. The reporter considered no adverse event to be not related to VARIVAX. Additional information has been requested.; Sender's Comments: US-009507513-1708USA005788:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to 15 patients of unknown age. On unknown dates the patients were vaccinated with improperly stored doses of ROTATEQ lot # N000172, oral for prophylaxis. No adverse event was reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to ROTATEQ. The reporter considered no adverse event to be not related to ROTATEQ. Additional information has been requested.; Sender's Comments: US-009507513-1708USA005788:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to 15 patients of unknown age. On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M043731 for prophylaxis. No adverse event was reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to GARDASIL 9. The reporter considered no adverse event to be not related to GARDASIL 9. Additional information has been requested.; Sender's Comments: US-009507513-1708USA005788:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a office manager referring to an unspecified number of patients of unspecified gender and age. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On unknown dates, the unspecified number of improperly stored doses of PNEUMOVAX 23 lot# N001007, expiration date 19-SEP-2017 (dose number, route of administration and anatomical location were not reported) were administered to the patients. The doses were stored in temperatures from 47 degrees Fahrenheit to 77 degrees Fahrenheit for 1 hour and 5 minutes. Digital data logger was involved. There was no previous excursion reported. No adverse effects have been reported. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a office manager referring to an unspecified number of patients of unspecified gender and age. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On unknown dates, the unspecified number of improperly stored doses of M-M-R II lot# M049212, expiration date 16-DEC-2018 (dose number, route of administration and anatomical location were not reported) reconstituted with properly stored sterile water diluent (MRK) were administered to the patients. The doses were stored in temperatures from 47 degrees Fahrenheit to 77 degrees Fahrenheit for 1 hour and 5 minutes. Digital data logger was involved. There was no previous temperature excursion reported. No adverse effects have been reported. Product quality complaint was not involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA007201: US-009507513-1708USA005756:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, those patients were administered doses of improperly stored doses of GARDASIL 9 lot # M041990, expiration date: 28-JUN-2019 (dosage and route were not reported). No adverse events were reported. Vaccines were stored in the temperature of 47 to 77 degrees Fahrenheit for 18 hours. On 16-AUG-2017 a call was placed to the reporter. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA005591:Original Case : 1707USA005591
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, those patients were administered doses of improperly stored doses of ROTATEQ lot# M035456, expiration date: 01-MAY-2018 (dosage and route were not reported). No adverse events were reported. Vaccines were stored in the temperature of 47 to 77 degrees Fahrenheit for 18 hours. On 16-AUG-2017 a call was placed to the reporter. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA005591: Original Case: 1707USA005591.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, those patients were administered doses of improperly stored doses of M-M-R II lot# M035388, expiration date: 02-AUG-2018 (dosage and route were not reported). No adverse events were reported. Vaccines were stored in the temperature of 47 to 77 degrees Fahrenheit for 18 hours. On 16-AUG-2017 a call was placed to the reporter. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA005591.
Age: 51.0
Sex: F
Vaccine: MEN
Symptoms: Rash, Skin exfoliation, Skin plaque, Urticaria
Clinical narrative: Initial unsolicited report received from pharmacist on 03-Aug-2017. This case involves two-month-old female patient who was vaccinated with a dose of MENOMUNE (Batch number: UI041AA, expiration date, dose, route and site of administration was not reported) via subcutaneous route on 15-Jun-2017. The patient's medical history was reported as none. Illness at time of vaccination was no. pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was none. Patient's concomitant medications was not reported. On 22-Jun-2017, one week following the vaccination, the patient broke out is a rash on her arms and trunk. It was reported that rash appears to look like hives, but larger, and it now looks like a plaque, where the skin is flakey. The patient required ER/ doctor visit. The relevant diagnostic tests or laboratory data was none. The patient's corrective treatment was not reported. The patient had not recovered from the events (reported as symptoms persists). List of documents held by sender: none.
Age: 64.0
Sex: M
Vaccine: MMR
Symptoms: Headache, Pyrexia, Rash
Clinical narrative: Rash bumps low fever headache.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Initial insomnia, Pyrexia
Clinical narrative: Trouble sleeping, fever.
Age: 54.0
Sex: F
Vaccine: YF
Symptoms: Dizziness, Syncope
Clinical narrative: Post vaccination the patient had a dizzy spell within 2-3 minutes of being vaccinated and then fainted while seated in the waiting room. She came too moments later and the pharmacist on duty had the manager on duty call 911. EMS arrived within 5 minutes of the call, monitored the patient's blood pressure/pulse rate and temperature. The patient was monitored for roughly 10 minutes, and then left the pharmacy on her own power. She declined a visit to the hospital, signed a waiver from the EMS.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Differential white blood cell count normal, Erythema, Full blood count normal, Mobility decreased, Neck pain
Clinical narrative: Fever, arm redness, pain and swelling, pain radiating into neck causing loss of movement.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Fever, arm redness, pain and swelling, pain radiating into neck causing loss of movement.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: Immediately follow administration of vaccine patient turned pale and had syncope episode. Patient immediately was responsive. Patient was laid down for 15 minutes, given juice, and a nutra grain bar. After laying for 15 minutes patient was able to get up and get dressed.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Abnormal faeces, Anal fissure, Blood electrolytes normal, Blood glucose normal, Blood magnesium normal
Clinical narrative: Pt was seen for 15 month EPSDT in office on 8/14/17. She was doing well per mom's report but continues to have issues with poor weight gain/underweight. She had no acute symptoms upon presentation to clinic and was doing well, meeting developmental milestones. She was given her 4th DTaP and 4th Hib vaccine. She has tolerated prior vaccines without adverse reactions. She has never had a seizure before. No family h/o seizures. Mom called the office at 12:45pm and spoke with CRNP stating she had 1 large vomitus of Pediasure formula after today's visit but was otherwise well. At 2:30 pt was sleeping and mom noted her to be having a tonic clonic seizure lasting 8 minutes and 45 seconds. 911 was called and she was transported to local ER. CT scan was normal. Electrolytes and chemistry was within normal limits. She was afebrile. She was discharged to home from ER following return to baseline status. She presented to clinic on 8/15/17 for follow-up with PCP. She was doing well at the time, at baseline, with constipation.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Computerised tomogram normal, Electroencephalogram, Faeces hard, Full blood count normal, Generalised tonic-clonic seizure
Clinical narrative: Pt was seen for 15 month EPSDT in office on 8/14/17. She was doing well per mom's report but continues to have issues with poor weight gain/underweight. She had no acute symptoms upon presentation to clinic and was doing well, meeting developmental milestones. She was given her 4th DTaP and 4th Hib vaccine. She has tolerated prior vaccines without adverse reactions. She has never had a seizure before. No family h/o seizures. Mom called the office at 12:45pm and spoke with CRNP stating she had 1 large vomitus of Pediasure formula after today's visit but was otherwise well. At 2:30 pt was sleeping and mom noted her to be having a tonic clonic seizure lasting 8 minutes and 45 seconds. 911 was called and she was transported to local ER. CT scan was normal. Electrolytes and chemistry was within normal limits. She was afebrile. She was discharged to home from ER following return to baseline status. She presented to clinic on 8/15/17 for follow-up with PCP. She was doing well at the time, at baseline, with constipation.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Laboratory test normal, Occult blood positive, Vomiting
Clinical narrative: Pt was seen for 15 month EPSDT in office on 8/14/17. She was doing well per mom's report but continues to have issues with poor weight gain/underweight. She had no acute symptoms upon presentation to clinic and was doing well, meeting developmental milestones. She was given her 4th DTaP and 4th Hib vaccine. She has tolerated prior vaccines without adverse reactions. She has never had a seizure before. No family h/o seizures. Mom called the office at 12:45pm and spoke with CRNP stating she had 1 large vomitus of Pediasure formula after today's visit but was otherwise well. At 2:30 pt was sleeping and mom noted her to be having a tonic clonic seizure lasting 8 minutes and 45 seconds. 911 was called and she was transported to local ER. CT scan was normal. Electrolytes and chemistry was within normal limits. She was afebrile. She was discharged to home from ER following return to baseline status. She presented to clinic on 8/15/17 for follow-up with PCP. She was doing well at the time, at baseline, with constipation.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Chills
Clinical narrative: Chills a few hours after the vaccine.
Age: 12.0
Sex: F
Vaccine: MNQ, TTOX
Symptoms: Abdominal pain upper, Headache, Injection site reaction, Pyrexia
Clinical narrative: Site Reaction. Fever. Headache. Stomach Ache.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Electrocardiogram, Electrocardiogram QT prolonged, Electrocardiogram ST segment abnormal, Electrocardiogram abnormal
Clinical narrative: EKG, Oxygen, albuterol and epi injection administered through the emergency department.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient experienced redness and itching at injection site. Red area was about 4 inches in diameter.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Chills, Diarrhoea, Injection site erythema, Injection site pain
Clinical narrative: Pain at injection site with swelling (large red bump and hot to touch); pain in entire arm that was injected; next day low grade fever with chills and muscle aches; 24 hours from injection diarrhea and vomiting still with low grade fever and lack of energy.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site swelling, Injection site warmth, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Pain at injection site with swelling (large red bump and hot to touch); pain in entire arm that was injected; next day low grade fever with chills and muscle aches; 24 hours from injection diarrhea and vomiting still with low grade fever and lack of energy.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: Pain at injection site with swelling (large red bump and hot to touch); pain in entire arm that was injected; next day low grade fever with chills and muscle aches; 24 hours from injection diarrhea and vomiting still with low grade fever and lack of energy.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash, Rash maculo-papular
Clinical narrative: ER visit on 8/2/2017 for patchy raised macular papular rash to torso, extremities and cheeks. No fever, playful and drinking a bottle at ER visit. Benadryl liquid 12.5 mg PO X1 ordered at 2336- continue to give benadryl as needed every 6 hours.
Age: 1.75
Sex: M
Vaccine: HEPA, HIBV, HEPA, HIBV
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: 08/14/2017 approx 1000. Vaccines were given, client waited recommended 15 minutes post immunization without issue. 08/16/2017 approx 1200. Mom called "just to let us know" that child developed hives around 8PM the day of vaccination and that they remained to date. Nurse advised mom to have physician evaluate child urgently. Mom stated she would take child to private physician day of call. 08/17/2017 approx 0930. Mom called back to clinic stating that child had seen physician. He said it was an allergic reaction probably related to the shots and was given a steroid. 08/17/2017 approx 0945. RN from Health Department phoned Dr.'s office to confirm diagnosis and treatment. Per nurse, actual diagnosis at appointment on 08/17/2017 was delayed allergic reaction probably related to vaccines. ORAPRED taper and over the counter BACTROBAN were prescribed as treatment.
Age: 1.75
Sex: M
Vaccine: HEPA, HIBV, HEPA, HIBV
Symptoms: Urticaria
Clinical narrative: 08/14/2017 approx 1000. Vaccines were given, client waited recommended 15 minutes post immunization without issue. 08/16/2017 approx 1200. Mom called "just to let us know" that child developed hives around 8PM the day of vaccination and that they remained to date. Nurse advised mom to have physician evaluate child urgently. Mom stated she would take child to private physician day of call. 08/17/2017 approx 0930. Mom called back to clinic stating that child had seen physician. He said it was an allergic reaction probably related to the shots and was given a steroid. 08/17/2017 approx 0945. RN from Health Department phoned Dr.'s office to confirm diagnosis and treatment. Per nurse, actual diagnosis at appointment on 08/17/2017 was delayed allergic reaction probably related to vaccines. ORAPRED taper and over the counter BACTROBAN were prescribed as treatment.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Expired product administered
Clinical narrative: Tdap was administered on 8/16/2017 and the expiration date was 8/15/2017. Caregiver was notified of CDC recommendation to repeat the dose.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal discomfort, Urticaria
Clinical narrative: Patient given 11 y.o vaccines at well check. Approx 8-9 min after vaccinations of Tdap, HPV, MCV-pt developed hives on Left cheeks only and complained of abdominal discomfort. NO resp distress or vomiting. nml vital signs. Pt given a cup of water which resolved abd pain. Given 25mg of Benadryl-approx 5 min post benadryl minimal resolving of uritcaria. no new sites of Urticaria. Pt was observed for another 30 min. normal vitals and was able to ambulate normally out of office with no new symptoms nor worsening of urticaria.  Mother reports that on 8/11/17 evening Pt developed hives on left arm which resolved after benadryl. no reports of any other symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 10-AUG-2017 the patient was vaccinated with an expired dose of ZOSTAVAX lot # L029482 for prophylaxis. No adverse event were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Breath holding
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was reported. On an unknown date, the patient was vaccinated with a dose of ROTATEQ (lot # N003392, expiration date: 11-OCT-2018; dose was not reported) orally. On an unknown date, the patient experienced a breath-holding spell for a few seconds. No lab diagnostic studies were performed. The patient quickly recovered from the adverse event on an unknown date and no treatment was necessary. No product quality complaint was involved.  The relatedness between the breath-holding spell and ROTATEQ was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received on 15-AUG-2017 from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 26-OCT-2014 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-OCT-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by a weakened immune system, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot# N002913, expiration Date: 23-FEB-2019; lot# N002914, expiration date: 04-NOV-2019) (route: intramuscular) (incorrect product storage). The vaccine was stored at a temperature of 0 to 1°C (1.2 C) for 34 minutes. There was no previous temperature excursion. The call was because of the data logger. No adverse effects reported. The outcome of the events was unknown.  This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA007198: US-009507513-1708USA007438: US-009507513-1708USA007425: US-009507513-1708USA007441:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9(lot # M043731, expiry date: 26-JUN-2019) (incorrect product storage) reconstituted with sterile water diluent. The vaccine was stored at a temperature of 0 to 1°C (1.2 C) for 34 minutes. There was no previous temperature excursion. The call was because of the data logger. No adverse effects reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA007422: US-009507513-1708USA007425: US-009507513-1708USA007441:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # N000172, expiry date: 10-JUN-2018) (incorrect product storage) reconstituted with sterile water diluent. The vaccine was stored at a temperature of 0 to 1°C (1.2 C) for 34 minutes. There was no previous temperature excursion. The call was because of the data logger. No adverse effects reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA007422: US-009507513-1708USA007425: US-009507513-1708USA007438: US-009507513-1708USA007198:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with RECOMBIVAX HB lot # N002202, N006321, M031574, N009802, M023892 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to RECOMBIVAX HB.     ; Sender's Comments:  US-009507513-1708USA007447: US-009507513-1708USA002081:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VAQTA lot # N008823, M018767, N014945, M033611 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VAQTA.; Sender's Comments: US-009507513-1708USA002081: US-009507513-1708USA007446:
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Somnolence
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient of an unspecified ethnicity started to receive PREVNAR 13 via an unspecified route of administration, from an unspecified date (on Monday), single dose; and PNEUMOVAX 23 via an unspecified route of administration, on "17Jul" at unknown dose and frequency, both given for immunization. Relevant medical history and concomitant medications not reported. It was reported that the patient was in the hospital on "17Jul" and was given pneumococcal vaccine polysacch 23V. On an unknown date, the patient was feeling sleepy. Outcome of the event was unknown.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site abscess
Clinical narrative: This is a spontaneous report from a healthcare professional via a Pfizer sales representative. A 56-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. Medical history included diabetes mellitus and perirectal abscess, both from unknown dates. The patient's concomitant medications were not reported. On an unspecified date, 3 days post immunization, the patient developed 2 cm cavitation in arm around injection site/abscess. Patient was on antibiotic therapy for abscess and treated locally with triple antibiotic ointment. Symptoms resolved 1 week post immunization. No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Asthenia, Chills, Contusion, Fall
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received PREVNAR 13 via an unspecified route of administration in left arm on 31Jul2017 13:00 at 0.5 ml single for dr. recommended. She received the vaccine at Physician Office. No additional vaccine was administered on same date. Medical history included colon cancer from 2009 and got blockages because of the adhesions in her stomach and was in the hospital 3 weeks prior to getting the shot, compromised immune system, urinary tract infection. There was no family medical history relevant to AE. Prior vaccinations (within 4 weeks) was none. The patient's concomitant medications were not reported. The patient experienced very weak, rash all over, hurt from head to toe, joints and muscles, fever and chills on 02Aug2017, fell twice while getting up, scratched her arm when she fell, bruising, didn't remember a lot from the past 2 weeks on an unspecified date. She stated that she had the worst reaction and thought she was dying. She was so sick and couldn't bring herself to go to the hospital. She stated she didn't remember a lot from the past 2 weeks. She said she fell twice. She scratched her arm when she fell. She hit the side of her dresser. She has bruising as well. She had a history of colon cancer and got blockages because of the adhesions in her stomach. She questioned her doctor before she took it the shot. She called him after she got the shot and he told her to take MOTRIN and BENADRYL. She started taking Cephalexin 500mg four times a day for a urinary tract infection on 02Aug2017. She would like to know if this medication and the shot were contraindicated for each other. She didn't take relevant tests. She was too weak to visit Emergency Room. On 14Aug2017 (yesterday) was the first day that she felt like getting up and going to the living room. She had an appointment with Doctor on 15Aug2017. The outcome of events very weak, rash all over, hurt from head to toe, joints and muscles, fever and chills was recovering, outcome of other events was unknown.