chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse, referring to multiple unspecified patients. Ages, genders, medical history or concurrent conditions were not reported. On 18-JAN-2016, 20-JAN-2016, 21-JAN-2016, 22-JAN-2016, 26-JAN-2016, 27-JAN-2016 and on 28-JAN-2016, improperly stored doses of ROTATEQ (lot # L013204, expiration date 28-JAN-2017) 2 ml, oral, were administered to unspecified number of patients. No adverse effects have been reported. It was also reported that temperature ranging was from 31 F to 35 F, the time frame was cumulative for 56 hours, it was not previous temperature excursion, and it was not product quality complaints involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified number of unspecified patients. Patients' medical history and concurrent conditions were not reported. On an unknown date, multiple unspecified patients were vaccinated with improperly stored VARIVAX (Merck), (lot # L031065 and expiry date on 18-AUG-2017) and (lot # L035128 and expiry date on 14-SEP-2017), (strength, route, dose and frequency were not reported). Concomitant mediations were not reported. No adverse effect was reported and no product quality complaint was involved. The stored temperature reported as 7 F degrees for 10 minutes and temperature excursion was reported as 18.2 F degrees for 5 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.2
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to a currently 14 months old, female patient. The patient's medical history and concurrent conditions were not reported. On 26-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 19-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot# L016427; expiration date: 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time frame were: 1.4C for 22 hours 52 minutes and 8.6C for 112 hours 5 minutes. This is one of several reports from the same source (original report 1602USA004808). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse referring to unspecified patients of unknown age or gender. Information about medical history, concurrent condition and concomitant medications were not reported. On an unknown date, the patients were vaccinated with 5 doses of VARIVAX (dose, route and anatomical location were not informed) (Lot No. reported as L019454, exp date: 29-MAY-2017), which were exposed to temperature conditions below since 16-OCT-2015 until 17-FEB-2016. The storage temperature was between 2 degrees C and 8 degrees C. No previous temperature excursion was reported. Reporter was not aware of any adverse effect. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Pyrexia, Rash maculo-papular, Rash pustular
Clinical narrative: Developed fever, weakness, then a maculopapular rash with small pustules first on chest, then extremities.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified number of unspecified patients. Patients' medical history and concurrent conditions were not reported. On an unknown date, multiple unspecified were vaccinated with improperly stored PROQUAD (Merck) lot # L044056 and expiry date 02-MAY-2017, (strength, route, dose and frequency were not reported). Concomitant medications were not reported. No adverse effect was reported and no product quality complaint was involved. The stored temperature was 7 F degrees for 10 minutes and temperature excursion was reported as 18.2 F degrees for 5 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 17-FEB-2016, also reported as today, an expired dose of VARIVAX (lot # K001364, exp date: 17-FEB-2016), subcutaneously (dose or anatomical location were not provided) was administered. No concomitant mediation was informed. No adverse effect was reported. No product quality issue occurred. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Blood test, Herpes zoster, Urine analysis
Clinical narrative: This spontaneous report as received from a 65 year old male consumer reporting on himself. Approximately in February 2014 (reported as 2 years ago), the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiration date were not reported). Concomitant therapies included amlodipine strength: 10mg, omeprazole (manufacturer unknown) strength 40 mg and oxycodone. Approximately on 03-FEB-2016 (reported as approximately 7 days ago), the patient experienced "shingle like symptoms but no rash" and pain "2 inches into to the left of his belly button" (also reported as adverse event experienced while using ZOSTAVAX). The patient sought medical attention. On an unknown date, unspecified blood work and urinalysis was performed (results not provided). At the time of the report, the outcome of herpes zoster and abdominal pain was unknown. Relatedness between the therapy with ZOSTAVAX and the events was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified  number of patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored ZOSTAVAX, lot # L032399, expiry date 26-NOV-2016 and L037791, expiry date 30-DEC-2016. Temperature 0.2 degree centigrade for 5.5 hours and there was no previous temperature excursion and it was administered. This is one of the 4 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age,. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (Merck), lot # L005299, expiry date 17-FEB-2016. Temperature 0.2 degree centigrade for 5.5 hours and there was no previous excursion and it was administered. This is one of the 4 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
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 unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored PROQUAD (Merck), lot# L040415, expiry date 13-APR-2017. Temperature 0.2 degree Centigrade for 5.5 hours and there was no previous excursion and it was administered. This is one of the 4 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored PNEUMOVAX 23, lot # K008410, expiry date 26-FEB-2016. Temperature 12 degree centigrade for 4 hours and there was no previous excursion. This is one of the 4 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 was received from a pharmacist, referring to patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 19-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot # L016427; expiration date: 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects effect reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time frame were: 1.4C for 22 hours 52 minutes and 8.6C for 112 hours 5 minutes. This is one of several reports from the same source (original report 1602USA004808). 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 an unspecified number of patients of unknown age and gender. The patients' concurrent and historical conditions were not reported. The nurse reported that on or after 14-OCT-2015 the patients were vaccinated with improperly stored (at 34 Fahrenheit for 8 hours and 47 Fahrenheit for 14 hours, 45 minutes) doses of ROTATEQ (lot # L010844, expiration date 16-NOV-2016, dose unknown) orally. There were no temperature excursion issues previously. Concomitant therapies were not reported. No adverse effect was reported. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site hypoaesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 year old female patient of unknown age with drug allergies to codeine and penicillin. On 04-FEB-2016 the patient was vaccinated with a 0.65 mo dose of ZOSTAVAX (lot # L035283, expiration date 15-DEC-201) by subcutaneous. Concomitant therapies included morphine, acetaminophen, NORCO, lidocaine, EMLA cream, meloxicam, gabapentin, levetiracetam and amlodipine. In February 2016 the patient developed numbness starting at the injection site (unspecified arm) down to her elbow, and continuing to spread, which started an unspecified amount of time after administration of ZOSTAVAX. The patient sought medical attention by calling pharmacist. No treatment was given for the event. The outcome of the event was reported as not recovered/not resolved. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional referring to a 13 months old female patient. Information about the patient's medical history and concurrent conditions was not reported. On 11-DEC-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional referring to a 12 months old female patient. Information about the patient's medical history and concurrent conditions was not reported. On 23-SEP-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Age: 1.05
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional referring to a 12 months old female patient. Information about the patient's medical history and concurrent conditions was not reported. On 14-DEC-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional referring to a 12 months old male patient. Information about the patient's medical history and concurrent conditions was not reported. On 11-DEC-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Raised red spot at injection site.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional referring to a 12 months old male patient. Information about the patient's medical history and concurrent conditions was not reported. On 06-JAN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Vocational Nurse, referring to an unspecified number of patients older than age 26 years old. Genders, medical history or concurrent conditions were not reported. Concomitant medication was not reported. On unknown dates, the patients were administered doses of GARDASIL (lot number, dose, route and strength were not provided). The reporter also stated that her clinic routinely vaccinated patients older than age 26 years with GARDASIL. No adverse effect was reported and there was not product quality complaint involved. Additional information has been requested.
Age: 1.04
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional referring to a 12 months old female patient. Information about the patient's medical history and concurrent conditions was not reported. On 23-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Age: 1.09
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional referring to a 13 months old male patient. Information about the patient's medical history and concurrent conditions was not reported. On 23-DEC-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to a currently 12 months old, female patient. The patient's medical history and concurrent conditions were not reported. On 05-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Age: 1.56
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to a currently 18 months old, female patient. The patient's medical history and concurrent conditions were not reported. On 18-SEP-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2015US031936, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 556805) website on 16 Mar 2015. This report refers to a 66 years old female patient. Historical condition included unspecified upper respiratory issues and dermatologic condition. Current condition included codeine allergy. Concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 141201) into the left arm and PREVNAR 13 (other manufacturer, batch number: J90092) into the right arm; both vaccines administered intramuscularly on 14 Nov 2014. Patient was vaccinated with on 14 Nov 2014. On 14 Nov 2014, the patient experienced prolonged and more severe injection site pain. The outcome of the event was reported as condition unchanged. The event was reported as non serious. Causality of the event was not reported.
Age: 18.0
Sex: F
Vaccine: ANTH, DPP, FLUX, HEPAB, SMALL, TTOX, UNK, VARCEL, YF
Symptoms: Blood test, Burning sensation, Constipation, Depression, Diarrhoea
Clinical narrative: This unsolicited case was received on 10-Feb-2016 via a third party query tool search on the VAERS database, under reference number 606315. This case involves a 18-years old female patient who received the following vaccinations on 01-Jun-2000: A dose of INFLUENZA VACCINE, a dose of TETANUS TOXOID (unknown site), a dose of Diphtheria Toxoid, Pertussis, IPV, a dose of VARICELLA VACCINE (LIVE), and a dose of YELLOW FEVER VACCINE  (manufacturer: unknown, dose and route of administration were not reported for all vaccines) in arm. Patient also received a dose of HEP A and HEP B, a dose of SMALLPOX VACCINE, and first dose of ANTHRAX VACCINE (Anthrax) (manufacturer: other and route of administration was not reported) in arm. "Although the smallpox vaccine manufacturer was reported as unknown in this case, ACAM2000 was not available for use at the time of the patient's vaccination."Patient had history of latex, ginger, and pollen allergies and exercise induced bronchospasm. It was reported that patient did not receive any concomitant medications but was given 16 vaccinations total in under 10 minutes. Patient had no current illness and prior vaccinations were not reported. On 01-Jun-2000, same day post vaccination, patient experienced an initial reaction of swelling, lightheaded and pain at injection site. Within 48 hours patient had felt burning throughout body and lost consciousness and had to be taken by ambulance. Within the next week she began to experience abdominal pain and swelling, fatigue and memory problems. Within the year began to experience tremors that come and go, short term memory, crippling fatigue, severe gastrointestinal problems such as nausea, bloating, alternating constipation and diarrhea, intestinal cramps and spasms, balance problems, increase in allergic reactions and items allergic to, depressed immune system, depression, joint pain, rashes, malabsorption, migraines and nerve pain. Exact date and time of vaccination cannot be recalled and service records with vaccination report cannot be located. But vaccination was given June of 2000. It was reported that patient experienced abdominal pain and swelling, condition aggravation and muscle spasms. Patient required an emergency visit. Laboratory investigations included GI scopes, x-rays, MRIs, allergy testing, autoimmune testing and blood work. All began in July 2000 and still testing. Corrective treatments were not reported. The outcome of the events was reported as not recovered. Case was considered as serious due to disability. List of documents held by sender: none. Sender's Comments: Multiple events have been reported in this case. However, this case is very poorly documented. Further information on the vaccination details, time to onset, patient's medical history, concomitant medications, lab data confirming the final diagnosis, etc. will be needed for complete assessment. However, as multiple vaccines were administered concomitantly, a role of each vaccine cannot be evaluated in particular.
Age: 18.0
Sex: F
Vaccine: ANTH, DPP, FLUX, HEPAB, SMALL, TTOX, UNK, VARCEL, YF
Symptoms: Malabsorption, Memory impairment, Migraine, Muscle spasms, Nausea
Clinical narrative: This unsolicited case was received on 10-Feb-2016 via a third party query tool search on the VAERS database, under reference number 606315. This case involves a 18-years old female patient who received the following vaccinations on 01-Jun-2000: A dose of INFLUENZA VACCINE, a dose of TETANUS TOXOID (unknown site), a dose of Diphtheria Toxoid, Pertussis, IPV, a dose of VARICELLA VACCINE (LIVE), and a dose of YELLOW FEVER VACCINE  (manufacturer: unknown, dose and route of administration were not reported for all vaccines) in arm. Patient also received a dose of HEP A and HEP B, a dose of SMALLPOX VACCINE, and first dose of ANTHRAX VACCINE (Anthrax) (manufacturer: other and route of administration was not reported) in arm. "Although the smallpox vaccine manufacturer was reported as unknown in this case, ACAM2000 was not available for use at the time of the patient's vaccination."Patient had history of latex, ginger, and pollen allergies and exercise induced bronchospasm. It was reported that patient did not receive any concomitant medications but was given 16 vaccinations total in under 10 minutes. Patient had no current illness and prior vaccinations were not reported. On 01-Jun-2000, same day post vaccination, patient experienced an initial reaction of swelling, lightheaded and pain at injection site. Within 48 hours patient had felt burning throughout body and lost consciousness and had to be taken by ambulance. Within the next week she began to experience abdominal pain and swelling, fatigue and memory problems. Within the year began to experience tremors that come and go, short term memory, crippling fatigue, severe gastrointestinal problems such as nausea, bloating, alternating constipation and diarrhea, intestinal cramps and spasms, balance problems, increase in allergic reactions and items allergic to, depressed immune system, depression, joint pain, rashes, malabsorption, migraines and nerve pain. Exact date and time of vaccination cannot be recalled and service records with vaccination report cannot be located. But vaccination was given June of 2000. It was reported that patient experienced abdominal pain and swelling, condition aggravation and muscle spasms. Patient required an emergency visit. Laboratory investigations included GI scopes, x-rays, MRIs, allergy testing, autoimmune testing and blood work. All began in July 2000 and still testing. Corrective treatments were not reported. The outcome of the events was reported as not recovered. Case was considered as serious due to disability. List of documents held by sender: none. Sender's Comments: Multiple events have been reported in this case. However, this case is very poorly documented. Further information on the vaccination details, time to onset, patient's medical history, concomitant medications, lab data confirming the final diagnosis, etc. will be needed for complete assessment. However, as multiple vaccines were administered concomitantly, a role of each vaccine cannot be evaluated in particular.
Age: 18.0
Sex: F
Vaccine: ANTH, DPP, FLUX, HEPAB, SMALL, TTOX, UNK, VARCEL, YF
Symptoms: Neuralgia, Nuclear magnetic resonance imaging, Rash, Swelling, Tremor
Clinical narrative: This unsolicited case was received on 10-Feb-2016 via a third party query tool search on the VAERS database, under reference number 606315. This case involves a 18-years old female patient who received the following vaccinations on 01-Jun-2000: A dose of INFLUENZA VACCINE, a dose of TETANUS TOXOID (unknown site), a dose of Diphtheria Toxoid, Pertussis, IPV, a dose of VARICELLA VACCINE (LIVE), and a dose of YELLOW FEVER VACCINE  (manufacturer: unknown, dose and route of administration were not reported for all vaccines) in arm. Patient also received a dose of HEP A and HEP B, a dose of SMALLPOX VACCINE, and first dose of ANTHRAX VACCINE (Anthrax) (manufacturer: other and route of administration was not reported) in arm. "Although the smallpox vaccine manufacturer was reported as unknown in this case, ACAM2000 was not available for use at the time of the patient's vaccination."Patient had history of latex, ginger, and pollen allergies and exercise induced bronchospasm. It was reported that patient did not receive any concomitant medications but was given 16 vaccinations total in under 10 minutes. Patient had no current illness and prior vaccinations were not reported. On 01-Jun-2000, same day post vaccination, patient experienced an initial reaction of swelling, lightheaded and pain at injection site. Within 48 hours patient had felt burning throughout body and lost consciousness and had to be taken by ambulance. Within the next week she began to experience abdominal pain and swelling, fatigue and memory problems. Within the year began to experience tremors that come and go, short term memory, crippling fatigue, severe gastrointestinal problems such as nausea, bloating, alternating constipation and diarrhea, intestinal cramps and spasms, balance problems, increase in allergic reactions and items allergic to, depressed immune system, depression, joint pain, rashes, malabsorption, migraines and nerve pain. Exact date and time of vaccination cannot be recalled and service records with vaccination report cannot be located. But vaccination was given June of 2000. It was reported that patient experienced abdominal pain and swelling, condition aggravation and muscle spasms. Patient required an emergency visit. Laboratory investigations included GI scopes, x-rays, MRIs, allergy testing, autoimmune testing and blood work. All began in July 2000 and still testing. Corrective treatments were not reported. The outcome of the events was reported as not recovered. Case was considered as serious due to disability. List of documents held by sender: none. Sender's Comments: Multiple events have been reported in this case. However, this case is very poorly documented. Further information on the vaccination details, time to onset, patient's medical history, concomitant medications, lab data confirming the final diagnosis, etc. will be needed for complete assessment. However, as multiple vaccines were administered concomitantly, a role of each vaccine cannot be evaluated in particular.
Age: 18.0
Sex: F
Vaccine: ANTH, DPP, FLUX, HEPAB, SMALL, TTOX, UNK, VARCEL, YF
Symptoms: X-ray, X-ray gastrointestinal tract
Clinical narrative: This unsolicited case was received on 10-Feb-2016 via a third party query tool search on the VAERS database, under reference number 606315. This case involves a 18-years old female patient who received the following vaccinations on 01-Jun-2000: A dose of INFLUENZA VACCINE, a dose of TETANUS TOXOID (unknown site), a dose of Diphtheria Toxoid, Pertussis, IPV, a dose of VARICELLA VACCINE (LIVE), and a dose of YELLOW FEVER VACCINE  (manufacturer: unknown, dose and route of administration were not reported for all vaccines) in arm. Patient also received a dose of HEP A and HEP B, a dose of SMALLPOX VACCINE, and first dose of ANTHRAX VACCINE (Anthrax) (manufacturer: other and route of administration was not reported) in arm. "Although the smallpox vaccine manufacturer was reported as unknown in this case, ACAM2000 was not available for use at the time of the patient's vaccination."Patient had history of latex, ginger, and pollen allergies and exercise induced bronchospasm. It was reported that patient did not receive any concomitant medications but was given 16 vaccinations total in under 10 minutes. Patient had no current illness and prior vaccinations were not reported. On 01-Jun-2000, same day post vaccination, patient experienced an initial reaction of swelling, lightheaded and pain at injection site. Within 48 hours patient had felt burning throughout body and lost consciousness and had to be taken by ambulance. Within the next week she began to experience abdominal pain and swelling, fatigue and memory problems. Within the year began to experience tremors that come and go, short term memory, crippling fatigue, severe gastrointestinal problems such as nausea, bloating, alternating constipation and diarrhea, intestinal cramps and spasms, balance problems, increase in allergic reactions and items allergic to, depressed immune system, depression, joint pain, rashes, malabsorption, migraines and nerve pain. Exact date and time of vaccination cannot be recalled and service records with vaccination report cannot be located. But vaccination was given June of 2000. It was reported that patient experienced abdominal pain and swelling, condition aggravation and muscle spasms. Patient required an emergency visit. Laboratory investigations included GI scopes, x-rays, MRIs, allergy testing, autoimmune testing and blood work. All began in July 2000 and still testing. Corrective treatments were not reported. The outcome of the events was reported as not recovered. Case was considered as serious due to disability. List of documents held by sender: none. Sender's Comments: Multiple events have been reported in this case. However, this case is very poorly documented. Further information on the vaccination details, time to onset, patient's medical history, concomitant medications, lab data confirming the final diagnosis, etc. will be needed for complete assessment. However, as multiple vaccines were administered concomitantly, a role of each vaccine cannot be evaluated in particular.
Age: 27.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Inappropriate schedule of drug administration, Injection site swelling, Myalgia, Pain
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 27 year old male patient. The patient's pertinent medical history and concurrent conditions were not provided. On 05-NOV-2015, the patient was vaccinated with the first dose of VARIVAX (Merck) (dose, route and lot# not provided). On 17-NOV-2015, the patient was administered dose two of the VARIVAX (Merck) series (in the other arm), only 12 days after the first dose (inappropriate schedule of drug administration). Concomitant medication was not provided. On 17-NOV-2015, the patient experienced swelling at injection site of the second dose, slight muscle pain, aches and a low grade temperature. it was reported that according to the patient these symptoms resolved within 48 hours. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Chest X-ray, Dyspnoea, Electrocardiogram, Pharyngoscopy, Wheezing
Clinical narrative: This spontaneous report was received from the mother regarding a 13 year old female patient. The patient uses a rescue inhaler when she runs. Patient was possibly allergic to GARDASIL. On an unknown date in 2015 (also reported as "near the end of 2015"), the patient was vaccinated with first dose of GARDASIL injection, intramuscularly (strength, frequency, lot# and expiration date was not provided). On 18-JAN-2016, the patient was vaccinated with second dose of GARDASIL injection, intramuscularly (strength, frequency, lot# and expiration date was not provided). On 19-JAN-2016 (also reported as "19-FEB-2016"), almost exactly 24 hours after administration of second dose of vaccination, the patient experienced serious larynx spasm (medically significant) which caused wheezing and difficulty in breathing. It was reported that the patient tried to use her rescue inhaler (an unspecified albuterol product), thinking she was having an asthma attack, however this did not work for her. The patient had sought medical attention for the adverse events and visited the emergency room. While in emergency room the patient was prescribed with epinephrine as treatment for the adverse events. The reporter highlighted the seriousness of the events by explaining that the emergency room discussed the possibility of a tracheostomy to resolve the event. It was reported that fortunately tracheostomy was not necessary. The patient was not admitted to the hospital. Lab data: unspecified chest x-rays; on unknown date: results were not provided. The outcome of the adverse events was reported to recovered on an unspecified date in 2016. There was no PQC involved. Upon internal review the events laryngospasm and possibly allergic to suspect therapy (hypersensitivity treated with epinephrine) was considered to be medically significant. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Chest X-ray, Dyspnoea, Laryngospasm, Wheezing
Clinical narrative: This spontaneous report was received from the mother regarding a 13 year old female patient. The patient uses a rescue inhaler when she runs. Patient was possibly allergic to GARDASIL. On an unknown date in 2015 (also reported as "near the end of 2015"), the patient was vaccinated with first dose of GARDASIL injection, intramuscularly (strength, frequency, lot# and expiration date was not provided). On 18-JAN-2016, the patient was vaccinated with second dose of GARDASIL injection, intramuscularly (strength, frequency, lot# and expiration date was not provided). On 19-JAN-2016 (also reported as "19-FEB-2016"), almost exactly 24 hours after administration of second dose of vaccination, the patient experienced serious larynx spasm (medically significant) which caused wheezing and difficulty in breathing. It was reported that the patient tried to use her rescue inhaler (an unspecified albuterol product), thinking she was having an asthma attack, however this did not work for her. The patient had sought medical attention for the adverse events and visited the emergency room. While in emergency room the patient was prescribed with epinephrine as treatment for the adverse events. The reporter highlighted the seriousness of the events by explaining that the emergency room discussed the possibility of a tracheostomy to resolve the event. It was reported that fortunately tracheostomy was not necessary. The patient was not admitted to the hospital. Lab data: unspecified chest x-rays; on unknown date: results were not provided. The outcome of the adverse events was reported to recovered on an unspecified date in 2016. There was no PQC involved. Upon internal review the events laryngospasm and possibly allergic to suspect therapy (hypersensitivity treated with epinephrine) was considered to be medically significant. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Headache, Injection site pain, Nausea, Pain
Clinical narrative: Severe pain at injection site and all through upper arm, headache, body aches, nausea, exhaustion, and fever.
Age: 46.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Severe pain at injection site and all through upper arm, headache, body aches, nausea, exhaustion, and fever.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PPV, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: First RotaTeq administered past 15 weeks of age. No side-effect noted.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PPV, RV5
Symptoms: Crying, Haematochezia, Mucous stools, Opisthotonus, Poor feeding infant
Clinical narrative: Near constant screaming, crying, arching of back. Poor feeding, poor sleeping. Excessive mucus in stools; blood in stools. Lasted for ~5 weeks.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PPV, RV5
Symptoms: Poor quality sleep, Screaming
Clinical narrative: Near constant screaming, crying, arching of back. Poor feeding, poor sleeping. Excessive mucus in stools; blood in stools. Lasted for ~5 weeks.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction
Clinical narrative: Upon second medical examination of the case during internal review, a significant correction performed on 3 February 2016 to update product screen, event screen, assessment screen and company narrative. Initial unsolicited report received from a pharmacist via other company (Merck) on 3 December 2015. Manufacturing report number: 1-14146974439. That report is from a Partner and contact information in based upon the location of our trading partner. This case involves a 72-year-old female patient who was vaccinated with a dose of Fluzone high dose (batch number, expiration date, dose, dose number and route of administration were not reported) and a dose of Pneumovax 23 (batch number, expiration date, dose, dose number and route of administration were not reported) both in same arm on 22 September 2015. The patient's medical history and concomitant medication were not reported. On 22 September 2015, same day following the vaccination, the patient develpoed unspecified reaction from shoulder to elbow on the unspecified arm that the patient received the Pneumovax 23 and Fluzone high dose. Laboratory investigation was not reported. The patient was treated with unspecified steroids. The outcome of the event was not reported. List of documents held by sender: none. Addendum 3 February 2016: Upon second medical examination of case at time of internal review, the following has been modified in this case: Administration site updated as arm. Manufacturer updated as Merck for PNEUMOCOCCAL (POLYSACCHARIDE) (23 SEROTYPES) VACCINE. Reaction site updated as shoulder to elbow. Required ER/Doctor Visit marked as "Y". Medically confirmed changed from "C" to blank. Corrective treatment updated in company narrative.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Wrong drug administered
Clinical narrative: Initial unsolicited misuse report received from a nurse (consumer) on 15 December 2015. This case involves a female (age was not reported) patient who was vaccinated with a 0.1 ml intradermal dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (Fluzone QIV) (batch number UI431AC, expiration date, dose in series were not reported) in forearm on 15 December 2015 instead of Tubersol. Reporter denied illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions included Fibromyalgia, HTN (hypertension), elevated cholesterol. Concomitant medication was not reported. On 15 December 2015, same day following the vaccination, the patient experienced a site reaction of redness and a lump at the injection site. It was also a wrong vaccine administered case. Lab data and corrective treatments were not reported. Outcome of events was reported as unknown. Follow-up information received from a physician on 09 February 2016. It was reported that this case involves a 61-Year-old patient who was vaccinated with a first dose of Fluzone QIV. No Lab data was performed. On an unknown date, patient recovered from the events. List of documents held by sender: none.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Diarrhoea, Electrocardiogram change, Gastrointestinal disorder, Heart rate increased, Joint swelling
Clinical narrative: Rapid heart beat vomiting diarrhea chronic throat infection with growth in throat.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Mass, Pericarditis, Pharyngitis, Vomiting
Clinical narrative: Rapid heart beat vomiting diarrhea chronic throat infection with growth in throat.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Joint contracture, Laboratory test normal, Loss of consciousness, Nausea
Clinical narrative: This spontaneous report was received from a nurse via field representative refers to a 18 year old male patient. The concurrent condition included no allergy. The patient had never passed out during sports. No family history of sudden cardiac death. There was no weight changes and no current vision abnormalities. The patient's medical history included headaches. On 12-FEB-2016, the patient was vaccinated with GARDASIL 9 (lot # L014415, dose 1, intramuscular in the left arm, dose not provided). No concomitant therapy was reported. After dose 1 was administered, the patient was discharged to waiting area. Approximately after 60 seconds in waiting area, patient suffered sudden loss of consciousness. Ammonia salts were applied but the patient remained unresponsive. There was onset of hand clenching and tightening but no clonic movements were noted. Oxygen mask was applied at 2L but the patient remained unresponsive. Oxygen was increased to 3L and the patient became responsive but very sluggish, pale, nauseated, lightheaded. Oxygen saturation was 99-100%, heart rate was 55, blood pressure was 108/62. Later emergency medical service arrived and blood pressure improved to 112/69 and pulse improved to 85. The patient was taken to the emergency department. The patient denied any chest pain or palpitation before losing consciousness. There was no loss of urine or tongue bite. All diagnostic tests for systems were normal. The patient was finally discharged with instructions to come back if he passes again especially if he don't get dizzy beforehand or if he has chest pain or palpitations. The outcome of the event was unknown. The causality assessment was not reported. No product quality issue was involved. The case was considered serious due to life threatening event. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Pallor, Sluggishness, Unresponsive to stimuli
Clinical narrative: This spontaneous report was received from a nurse via field representative refers to a 18 year old male patient. The concurrent condition included no allergy. The patient had never passed out during sports. No family history of sudden cardiac death. There was no weight changes and no current vision abnormalities. The patient's medical history included headaches. On 12-FEB-2016, the patient was vaccinated with GARDASIL 9 (lot # L014415, dose 1, intramuscular in the left arm, dose not provided). No concomitant therapy was reported. After dose 1 was administered, the patient was discharged to waiting area. Approximately after 60 seconds in waiting area, patient suffered sudden loss of consciousness. Ammonia salts were applied but the patient remained unresponsive. There was onset of hand clenching and tightening but no clonic movements were noted. Oxygen mask was applied at 2L but the patient remained unresponsive. Oxygen was increased to 3L and the patient became responsive but very sluggish, pale, nauseated, lightheaded. Oxygen saturation was 99-100%, heart rate was 55, blood pressure was 108/62. Later emergency medical service arrived and blood pressure improved to 112/69 and pulse improved to 85. The patient was taken to the emergency department. The patient denied any chest pain or palpitation before losing consciousness. There was no loss of urine or tongue bite. All diagnostic tests for systems were normal. The patient was finally discharged with instructions to come back if he passes again especially if he don't get dizzy beforehand or if he has chest pain or palpitations. The outcome of the event was unknown. The causality assessment was not reported. No product quality issue was involved. The case was considered serious due to life threatening event. Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: FLU3, HEP, HEPA, IPV, VARCEL
Symptoms: Rash generalised
Clinical narrative: Client reports having rash all over his body that lasted for 3 weeks.
Age: 8.0
Sex: M
Vaccine: DPP
Symptoms: Urticaria
Clinical narrative: Moderate/severe hives starting at limb and spreading to trunk and head.
Age: 0.05
Sex: F
Vaccine: HEP
Symptoms: Rash, Scab, Secretion discharge
Clinical narrative: Client's mother reports that the child had a rash on head, shoulders, torso, arms and legs. Also reports that she got an area on her hear that had yellow drainage and became "crusted". Client's mother reports that the rash lasted for 3 and a half weeks. She reports that she took the child to her doctor and they gave her an antibiotic.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Drug administered at inappropriate site
Clinical narrative: Tdap Vaccine given in the buttock.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse through a Pfizer sales representative who reported similar events for two different patients. This is the 1st of 2 reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13 (lot M35761) at 0.5 ml single, on 11Feb2016 at 12:00. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced a severe reaction with redness, fever and cellulitis, all on an unspecified date in Feb2016, with outcome of unknown. The reporter added that subsequently they just quitted administering any vaccine from that lot.