chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 01-APR-2016, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L031603 with expiration date 18-FEB-2017, therapy type rHA; lot # M007965 with expiration date 15-AUG-2017, therapy type rHA; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion. Data logger was involved. No adverse effect was reported. Follow up information has been received from the physician on 24-OCT-2016. On 24-OCT-2016, a call was placed to the physician. The call was received by another physician. The physician reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow-up information was received on 09-NOV-2016 from an unspecified reporter, who provided the patient's demographics, and stated that the patient was vaccinated with an improperly stored dose of PROQUAD 0.5ml (unspecified dose) number K011188 (unspecified expiration date). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: The spontaneous report was received from a licensed practical nurse referring to a multiple unspecified patients of unknown age and genders. The patients' pertinent medical history or concurrent conditions were not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored M-M-R II Subcutaneous injection (lot # L012480, expiration date 10-MAY-2017) (route, dose and anatomical location were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse reactions were reported. It was reported that the therapy was not discontinued. There was no product quality complaint (PQC) involved. This was one of several reports received from the same reporter. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: Skin assessment was done observed area w erythema, warm to the touch, but no symptoms of infection. Case was consult with the primary case physician who recommended to document the reaction on medical record. And Erythema.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an Office manager refers to a patient of unknown age. On an unknown date, multiple unspecified patients were vaccinated with GARDASIL 9 (lot number M026306, expiration 30-APR-2018) that was improperly stored. No adverse effects reported. No further information was provided. Lot number M026306, expiration 30-APR-2018 is an invalid lot number for GARDASIL 9, Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Rash erythematous
Clinical narrative: This spontaneous report as received from a office manager refers to a 68 year old female patient. The patient's medical history was not reported. She was allergic to lidocaine. On 14-NOV-2016 the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot number were not reported). Concomitant therapies included SYMBICORT and other unspecified blood pressure medications. On 15-NOV-2016, the patient developed a red rash at the injection site that spread from the armpit to the elbow. There were no lab tests performed and no treatment was given for the event. She sought medical attention. The outcome of the event was reported as not recovered/not resolved. The causal relationship between PNEUMOVAX 23 and the event was not reported. There was no product quality complaint involved. Additional information is not expected as there is no consent to contact the physician.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site lymphadenopathy, Lymphadenopathy
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site lymphadenopathy in a 18-year-old male patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, 5 days after receiving BEXSERO, the patient experienced injection site lymphadenopathy. On an unknown date, the outcome of the injection site lymphadenopathy was unchanged. It was unknown if the reporter considered the injection site lymphadenopathy to be related to BEXSERO. Additional details were provided as follows: The exact age at vaccination was not reported. The patient experienced 3 much enlarged lymph nodes at site of injection of BEXSERO vaccine. It was reported that the administration was concluded by a different pediatrician. The date of birth of the patient was wrongly reported. However, no clarification could be obtained. The batch number of BEXSERO was wrongly reported as 0000 with expiry date (same as that of the date of birth of the patient). However, no clarification could be obtained. Follow up information was received from physician on 21st October 2016: The reporter was the patient's aunt. The reporter type was wrongly captured in previous report, the reporter was physician and not consumer. This was also reported by the Medical Science Liaison (MSL).
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, White blood cell count increased
Clinical narrative: 11-14-2016: Patient presented with redness, swollen, and warmth on upper right arm where injection had been given. Pharmacist insisted that she be seen at ER. Patient went to ER to be seen. 11-14-16 Antibiotic and Steroids prescriptions filled.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse and refers to multiple unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M002252 with expiration date 28-FEB-2017 (dosage and route of administration were not reported), which were exposed to temperature excursion (temperature was 51.6 degrees F, time frame: 1 hour and 45 minutes) because of data logger. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse and refers to multiple unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L004754 with expiration date 10-NOV-2016 and lot #M010212 with expiration date 21-JAN-2019 (dosage and route of administration were not reported), which were exposed to temperature excursion (temperature was 51.6 degrees F, time frame:1 hour and 45 minutes) because of data logger. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one the several reports from the same reporter.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient who is currently 4 years old. Information regarding his pertinent medical history, concurrent conditions, drug reactions/allergies, and concomitant medications was unknown. On an unknown date, the patient was vaccinated with GARDASIL 9 (which had a lot # of L043214 with and expiration date of 30-AUG-2017; the dose, dosage number, and anatomical location were unknown), intramuscularly. This was an error and it occurred because two of his siblings were also receiving vaccinations during the same sessions and GARDASIL 9 was intended for the older sibling. However, the patient, at the time reporting, had not exhibited or reported any adverse effects. Notably, no product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse and refers to multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions or concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L036301 with expiration date 20-DEC-2017 and lot #M018810 with expiration date 28-MAY-2018 (dosage and route of administration were not reported), which were exposed to temperature excursion (temperature was 51.6 degree F, time frame: 1 hour and 45 minutes) because of a data logger. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 01-APR-2016, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L031603 with expiration date 18-FEB-2017, therapy type rHA; lot # M007965 with expiration date 15-AUG-2017, therapy type rHA; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion. Data logger was involved. No adverse effect was reported. Follow up information has been received from the physician on 24-OCT-2016. On 24-OCT-2016, a call was placed to the physician. The call was received by another physician. The physician reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow-up information was received on 09-NOV-2016 from an unspecified reporter, who provided the patient's demographics, and stated that the patient was vaccinated with an improperly stored dose of PROQUAD 0.5 ml (unspecified dose) with lot number reported as K011188 (unspecified expiration date). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with improperly stored doses of M-M-R II lot # L037356, expiration date 28-AUG-2017 and VARIVAX lot # M024683, expiration date 18-MAY-2018 (strength and dose for both products were not provided) subcutaneously, which had a temperature excursion of 24 Celsius Degrees for 72 hours. There were no concomitant medications and adverse effects reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner regarding multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medication were not reported. On unknown dates the patients were vaccinated with improperly stored GARDASIL lot # L033347 and expiry date: 23-JUL-2017 (dose and route were not reported). The vaccine was exposed to a temperature of 34 Fahrenheit for a time frame of 50 hours. There was no data logger and no previous excursions. No adverse events were reported. There was no product quality complaint involved. This is one of the several cases reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 01-APR-2016, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L031603 with expiration date 18-FEB-2017, therapy type rHA; lot # M007965 with expiration date 15-AUG-2017, therapy type rHA; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion. Data logger was involved. No adverse effect was reported. Follow up information has been received from the physician on 24-OCT-2016. On 24-OCT-2016, a call was placed to the physician. The call was received by another physician. The physician reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow-up information was received on 09-NOV-2016 from an unspecified reporter, who provided the patient's demographics, and stated that the patient was vaccinated with an improperly stored dose of PROQUAD 0.5ml (unspecified dose) with lot number reported as K011188 (unspecified expiration date). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner regarding multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medication were not reported. On unknown dates the patients were vaccinated with improperly stored VAQTA (dose, route, lot number and expiry date were not reported). The vaccine was exposed to a temperature of 34 Fahrenheit for a time frame of 50 hours. There was no data logger and no previous excursions. No adverse events were reported. There was no product quality complaint involved. This is one of the several cases reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to the unknown number of patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 03-NOV-2016 and on 04-NOV-2016, the patients were orally administered improperly stored doses of ROTATEQ oral liquid (lot # M019690 with expiry date on 02-NOV-2017; lot # M014318 with expiry date on 30-SEP-2017; lot # M031802 with expiry date on 09-NOV-2017; dose was not reported). Administered doses of vaccine experienced the temperature excursion of 35 degrees Fahrenheit for 6 hours. Data logger was involved. There were no previous excursions reported. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to the unknown number of patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 03-NOV-2016 and on 04-NOV-2016, the unspecified patients were vaccinated with improperly stored doses of GARDASIL 9 injection (lot # M009378 with expiry date on 23-APR-2018; lot # reported as M011840 with expiry date on 01-FEB-2018; lot # L036301 with expiry date on 20-DEC-2017; lot # M018810 with expiry date on 28-MAY-2018; dose, route of administration and anatomical location were not reported). Administered doses of vaccine experienced the temperature excursion of 35 degrees Fahrenheit for 6 hours. Data logger was involved. There were no previous excursions reported. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 01-APR-2016, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L031603 with expiration date 18-FEB-2017, therapy type rHA; lot # M007965 with expiration date 15-AUG-2017, therapy type rHA; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion. Data logger was involved. No adverse effect was reported. Follow up information has been received from the physician on 24-OCT-2016. On 24-OCT-2016, a call was placed to the physician. The call was received by another physician. The physician reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow-up information was received on 09-NOV-2016 from an unspecified reporter, who provided the patient's demographics, and stated that the patient was vaccinated with an improperly stored dose of PROQUAD 0.5ml (unspecified dose), with lot number L031603 (expiration date 18-FEB-2017). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed nurse practitioner regarding multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medication were not reported. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (dose, route, lot number and expiry date were not reported). The vaccine was exposed to a temperature of 34 Fahrenheit for a time frame of 50 hours. There was no data logger and no previous excursions. No adverse events were reported. There was no product quality complaint involved. This is one of the several cases reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse regarding a patient of unknown demographics. There was no information about concurrent condition, historical medication and concomitant medication. On 11-NOV-2016 the patient was vaccinated with expired dose of ZOSTAVAX lot # L029483, expiration date-06-NOV-2016, subcutaneous. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse regarding a patient of unknown demographics. There was no information about concurrent condition, historical medication and concomitant medication. On 27-OCT-2016 the patient was vaccinated with expired dose of ZOSTAVAX 19400 PFU lot number was unknown, expiration date - 06-OCT-2016. No adverse was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. The ZOSTAVAX did not had any temperature excursions prior to administration. Additional information is not expected as reporter did not wants to get contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 01-APR-2016, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L031603 with expiration date 18-FEB-2017, therapy type rHA; lot # M007965 with expiration date 15-AUG-2017, therapy type rHA; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion. Data logger was involved. No adverse effect was reported. Follow up information has been received from the physician on 24-OCT-2016. On 24-OCT-2016, a call was placed to the physician. The call was received by another physician. The physician reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow-up information was received on 09-NOV-2016 from an unspecified reporter, who provided the patient's demographics, and stated that the patient was vaccinated with an improperly stored dose of PROQUAD 0.5 ml (unspecified dose) with lot number L031603 (expiration date 18-FEB-2017). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Hypersomnia, Influenza like illness, Local swelling
Clinical narrative: Started feeling ill the following day. She felt like she had the flu aching and sleeping all day. Area is swollen and red and in the middle a white area the size of a fist. It has now blistered and arm hurts.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: Started feeling ill the following day. She felt like she had the flu aching and sleeping all day. Area is swollen and red and in the middle a white area the size of a fist. It has now blistered and arm hurts.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Syncope
Clinical narrative: Patient fainted shortly after receiving vaccines.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Dizziness, Haemoglobin normal, Headache, Pyrexia
Clinical narrative: Patient felt dizzy after vaccine - that evening developed headache and fever, problems actualizing sentences - patient felt she was unable to walk well/having problems ambulating.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: (L) deltoid with 7.5 cm x 6 cm area redness and warmth. (L) deltoid sore, unable to fully raise arm.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Feeling cold, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Swelling, warm sensation, red mark around injection site, headache, joint pain, muscle pain, congestion, itching of ears/neck, night sweats, severe headache, shaking and freezing/feeling cold.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia, Nasal congestion, Night sweats, Pruritus
Clinical narrative: Swelling, warm sensation, red mark around injection site, headache, joint pain, muscle pain, congestion, itching of ears/neck, night sweats, severe headache, shaking and freezing/feeling cold.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Swelling, warm sensation, red mark around injection site, headache, joint pain, muscle pain, congestion, itching of ears/neck, night sweats, severe headache, shaking and freezing/feeling cold.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Pruritus
Clinical narrative: Headache, chills, redness, itching, 2 inches.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Cellulitis, Erythema, Myalgia, Swelling
Clinical narrative: Swelling, redness of upper arm, fever approximately 101 degrees F, debilitating muscle and joint pain 24 hrs after vaccine. Cellulitis on exam 4 day after injection. Prescribe clindamycin 300mg tid x 5d.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain, Crying, Dizziness, Nausea, Nervousness
Clinical narrative: Administered vaccine patient then c/o dizziness, ABD pain, nausea and broke out in hives trunk area. Gave Diphenhydramine 25mg IM RA. Pt shaky, nervous, crying, after 1 hr of observation. Rash decreased by 80%. Patient felt better went home with father.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Tremor, Urticaria
Clinical narrative: Administered vaccine patient then c/o dizziness, ABD pain, nausea and broke out in hives trunk area. Gave Diphenhydramine 25mg IM RA. Pt shaky, nervous, crying, after 1 hr of observation. Rash decreased by 80%. Patient felt better went home with father.
Age: 0.3
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered
Clinical narrative: Only the diluent was given with the injection not the actual vaccine. Age of patient at time of event: 4 months.
Age: 0.2
Sex: U
Vaccine: RV1
Symptoms: Incorrect product formulation administered
Clinical narrative: On 9/22/16, it noticed an uneven amount of diluent vs vaccine, when discussed with new injection nurse, it was found that she was not mixing the two. And only giving diluent.
Age: 20.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: My son was supposed to get a chicken pox vaccine and was administered a shingles vaccine.
Age: 15.0
Sex: U
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: MCIR and Parental Consent was marked with MENACTRA and it was due in June 2017. Given early, parent notified and understands he will need another at age 16 years. Age of patient at time of event: 15 years.
Age: 1.0
Sex: U
Vaccine: DTAPIPVHIB, PPV, RV5
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Patient was administered 6 month immunizations (PENTACEL, PCV, and Rota) instead of 12 month (Hep A, MMR, Varicella, and PCV). Age of patient at time of event: 12 months.
Age: 0.3
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received only the liquid portion of the PENTACEL vaccine. The powder portion (Hib) was not given. Age of patient at time of event: 4 months.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Employee accidently gave BOOSTRIX instead of KINRIX.
Age: 65.0
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Pt. received VARIVAX instead of Zoster as order by provider. Age of patient at time of event: 65 years.
Age: 68.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong drug administered
Clinical narrative: Patient is a 68 year old female. She requested an MMR stating her community college requires the vaccine. Patient was inadvertently given an MMRV instead of MMR.
Age: 2.0
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product formulation administered, Product preparation error
Clinical narrative: HIB was give to patient mixed with the sterile water diluent not the diluent provided with the HIB. Age of patient at time of event: 2 years 2 months 15 days.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Contraindication to vaccination
Clinical narrative: Patient was given MMR-V even though they were on hydroxyurea for sickle cell. Hematologist was notified of the potential contraindication. Hydroxyurea was not discontinued and patient's mother was told to inform them if any fever occurred.
Age: 11.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Administered PROQUAD vaccine and VARICELLA vaccines to same individual. Nurse thought she was administering MMR and VARICELLA separately but upon review, it was noted she administered MMRV in one arm and VARICELLA in the other.
Age: 0.4
Sex: U
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered
Clinical narrative: Pt was due for DTaP, Hep B, IPV and HIB. Clinical staff member grabbed the combination vaccine PEDIARIX (DTaP, HepB, IPV). What was supposed to be administered with that was an HIB but staff member grabbed an additional HepB instead. Pt. received two HepB's and no HIB. Age of patient at time of event: 5 months.
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 16 year old patient was given a dose of PROQUAD.
Age: 3.0
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product formulation administered, Product preparation error
Clinical narrative: Pt was given a HIB vaccination with the incorrect diluent. It was given with sterile water instead of the diluent provided with the vaccination. Age of patient at time of event: 3 years 8 months.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Induration, Peripheral swelling
Clinical narrative: Went in for IPV for both of my two girls ages 2 and 3 1/2 years old. MA said that they no longer have the IPV as a vaccine by itself, but have a DTaP-IPV combo (later finding out it was KINRIX). I agreed even though I was opposed as I am giving vaccines on an altered schedule and spacing them out. Neither have had all DTaP or IPV doses needed and I understand this is a booster. Both age and times the vaccines were administered were incorrect. Not sure what recourse I have, but am scared as it isn't recommended for their age group and the 3 1/2 year old, her arm has been swollen, puffy, red and hard for a week. Called the Dr. and he said that sounded like a mild reaction and to give her comfort measures such as Ib or BENADRYL.
Age: 0.3
Sex: U
Vaccine: DTAPIPVHIB, HPV9
Symptoms: Wrong drug administered
Clinical narrative: I thought I had the PENTACEL vaccine for a patient and administered the GARDASIL 9.
Age: 0.3
Sex: U
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: Patient is 4 months old. KINRIX was given in error. Patient should have received PEDIARIX. Age of patient at time of event: 4 months.
Age: 1.3
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered
Clinical narrative: Vaccine/component omission - Only one component of multi-component vaccine administered.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Pruritus, Rash erythematous, Swelling
Clinical narrative: Upon follow-up courtesy call on 11/16/16 with pharmacist, the patient reported onset of significant swelling, pain/tenderness, itching, and red rash that spread down past deltoid site down upper half of arm and back of arm 3-4 days post vaccination. Pharmacist suggested dose of BENADRYL and follow-up with doctor ASAP with no improvement. On 11/18/16, patient followed up to report swelling much reduced with slight redness that comes and goes. Patient stated she would follow-up with doctor as necessary.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Tenderness
Clinical narrative: Upon follow-up courtesy call on 11/16/16 with pharmacist, the patient reported onset of significant swelling, pain/tenderness, itching, and red rash that spread down past deltoid site down upper half of arm and back of arm 3-4 days post vaccination. Pharmacist suggested dose of BENADRYL and follow-up with doctor ASAP with no improvement. On 11/18/16, patient followed up to report swelling much reduced with slight redness that comes and goes. Patient stated she would follow-up with doctor as necessary.
Age: 11.0
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: Pt was given this vaccine and had already received it.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a office manager refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On 28-OCT-2016, the patient was inadvertently vaccinated with an expired dose of VARIVAX lot # K015968 and expiry date 23-SEP-2016 subcutaneously. No adverse effects were reported. No product quality complaint was filed. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a office manager refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On 28-OCT-2016, the patient was inadvertently vaccinated with an expired dose of VARIVAX lot # K015968 and expiry date 23-SEP-2016 subcutaneously. No adverse effects were reported. No product quality complaint was filed. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Induration, Inflammation, Pruritus
Clinical narrative: Redness, itch, inflamed, hard.
Age: 0.67
Sex: F
Vaccine: PPV
Symptoms: Disorientation, Lethargy, Pallor, Pyrexia
Clinical narrative: High fever: 103. Lethargic, pale, disoriented.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Induration, Injection site pain, Peripheral swelling, Rash erythematous
Clinical narrative: Muscle pain where injection was, chills, red rash, a little swelling and hardness of arm.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Ataxia, Chills, Dyskinesia, Flushing, Full blood count
Clinical narrative: Headache, low grade fever (100.5 F), chills, flushed face, sensitivity to light, muscle aches. Sudden ataxia with involuntary leg muscle movements; when attempted to walk feet lifted by themselves in a prancing or marching step. Legs were giving out and difficulty to walk and weakness in both legs as if unable to support weight. This occurred 3 times between 11:00 AM and 3:00 PM. Lost voluntary motor function in both legs.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Gait disturbance, Headache, Metabolic function test, Motor dysfunction, Muscular weakness
Clinical narrative: Headache, low grade fever (100.5 F), chills, flushed face, sensitivity to light, muscle aches. Sudden ataxia with involuntary leg muscle movements; when attempted to walk feet lifted by themselves in a prancing or marching step. Legs were giving out and difficulty to walk and weakness in both legs as if unable to support weight. This occurred 3 times between 11:00 AM and 3:00 PM. Lost voluntary motor function in both legs.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Myalgia, Photophobia, Pyrexia, Weight bearing difficulty
Clinical narrative: Headache, low grade fever (100.5 F), chills, flushed face, sensitivity to light, muscle aches. Sudden ataxia with involuntary leg muscle movements; when attempted to walk feet lifted by themselves in a prancing or marching step. Legs were giving out and difficulty to walk and weakness in both legs as if unable to support weight. This occurred 3 times between 11:00 AM and 3:00 PM. Lost voluntary motor function in both legs.
Age: 1.58
Sex: M
Vaccine: HIBV, PNC, VARCEL
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous, Rash generalised
Clinical narrative: Child woke up with red rash all over body, but largest spot was where the vaccine was administered in left thigh. Rash felt hot to the touch. Rash lasted a couple days.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling abnormal, Middle insomnia, Musculoskeletal pain, Pain in extremity, Sleep disorder
Clinical narrative: When I was given the shot I felt the shot go down thru my arm. Later that evening I could not lift my arm or lay on it without it hurting so bad. It woke me up at night and I still can not lay on my right arm. I can not raise my arm very high without my shoulder and arm hurting. I feel like I just got the shot. I have tried using ibuprofen and Tylenol with a heating pad. It was working but not anymore.The pain would go away for a couple of hours. There is still pain in my shoulder and arm.
Age: 22.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site inflammation, Pyrexia
Clinical narrative: Fever, headache, inflammation under the place of injection (10x3 cm) that is worst with the days.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal discomfort, Nausea, Vomiting
Clinical narrative: Nausea/Vomiting. GI discomfort.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Rash pruritic
Clinical narrative: Reported to ED 6 hours after receiving HPV9, MGC, INfluenza vaccine with midly pruritic but diffusely popular rash. Vital signs WNL Resp 14, Pulse 78, Temp 97.7 orally SPO2 99%. Treated with benedryl 12.5 mg. Sent home with Mother to continue benedryl. Was seen in ED two other time for continued rash. Followed up by Providers x 3 with no improvement of rash. Seen finally by Dr on 9 Nov 2016. Refered to Dermatology.
Age: 50.0
Sex: M
Vaccine: FLUC4
Symptoms: Abdominal discomfort, Asthenia, Diarrhoea, Fatigue
Clinical narrative: Fatigue, weakness, GI discomfort, diarrhea for 24 hours.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Gait disturbance, Malaise, Movement disorder, Muscular weakness
Clinical narrative: PATIENT REPORTS "FEELING FUNNY" ALL OVER. THEN SHE STARTED HAVING MUSCLE WEAKNESS AND INABILITY TO COORDINATE WALKING FROM THE FRONT DOORS OF THE STORE TO HER VEHICLE. ONCE PATIENT ARRIVED HOME, THESE SYMPTOMS WORSENED TO THE POINT OF THE PATIENT NOT BEING ABLE TO MOVE AT ALL. AT HOME, SHE WAS FEELING VERY SICK SO 911 WAS CALLED AND THE PATIENT WAS TAKEN TO THE HOSPITAL BECAUSE SHE COULDN'T MOVE.
Age: 55.0
Sex: M
Vaccine: FLUC4
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: GI discomfort, Diarrhea X 24 hours.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Peripheral swelling
Clinical narrative: Patient explained that his right wrist and also his right elbow were hurting and swollen.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Arm/Shoulder pain since administration.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Pain malaise headache feverish weakness tired lack energy chills.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Pain malaise headache feverish weakness tired lack energy chills.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Limb discomfort, Musculoskeletal pain, Paraesthesia, Vaccination site pain
Clinical narrative: Patient stated she had lots of pain at sight of vaccination the day of administration but it was gone by the next morning. In the afternoon the day after the shot, the patient had tingling and numbness in her fingers and discomfort on the underside of her arm and shoulder blade. She states that the pain decreased when pressure was applied at the base of her armpit or if she held her arm up. On the 18th the patient went to the ER. MD told her that the vaccine affected her muscle and prescribed Percocet, cyclobenzaprine and prednisone. The MD told her that other patients had come in with the same issue.  The medications have decreased her symptoms but have not fully resolved them.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema
Clinical narrative: Left arm had excessive redness that extended down to elbow. It was severe enough to patient that she went to ER to be checked out.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Arthritis, Gastrointestinal disorder, Influenza, Myalgia
Clinical narrative: Muscle aches , joint inflammation, sporadic intestinal tightness, and finally and flu blown case of the flu - this happened up and including the date of report 11/19/2016.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: Patient has soreness at the injection site  of her PNEUMOVAX 23.
Age: 23.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Dizziness, Headache, Injection site erythema, Injection site swelling
Clinical narrative: 102 degree fever that lasted 2-3 days; bright red, swollen left shoulder to half way down arm from site of injection; headache; chills' dizziness; blurry vision.
Age: 23.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pyrexia, Vision blurred
Clinical narrative: 102 degree fever that lasted 2-3 days; bright red, swollen left shoulder to half way down arm from site of injection; headache; chills' dizziness; blurry vision.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Dizziness, Dyspnoea, Nausea, Throat irritation
Clinical narrative: Cough, shortness of breath, nausea, light headed, itchy throat. I had to see my allergist and was put on steroids and oxygen.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Decreased eye contact, Diarrhoea, Gastric disorder, Generalised tonic-clonic seizure
Clinical narrative: She had high fever before lunch time. She was pale, limp and lethargic before leaving fr office. By the next day fever had spiked very high and remained high for 3 days. Fever came and went for more than a week and her body broke out in a rash all over. Then on 02/13/15 she began having seizures at 10:00 in the evening. We called an ambulance and took her to the hospital. No treatment or tests were done. The following day at 3:30 PM, she had a grand Mal seizure lasting 10 minutes and the post-seizure state lasted all evening. We saw loss of appetite, stomach damage and zero weight gain for 6 months. She was taken to the ER for consistent diarrhea. X-rays and stool samples were done but no treatment was administered. Seizures have continued intermittently but no treatment has been recommended.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Hypotonia, Lethargy, Pallor, Pyrexia, Rash generalised
Clinical narrative: She had high fever before lunch time. She was pale, limp and lethargic before leaving fr office. By the next day fever had spiked very high and remained high for 3 days. Fever came and went for more than a week and her body broke out in a rash all over. Then on 02/13/15 she began having seizures at 10:00 in the evening. We called an ambulance and took her to the hospital. No treatment or tests were done. The following day at 3:30 PM, she had a grand Mal seizure lasting 10 minutes and the post-seizure state lasted all evening. We saw loss of appetite, stomach damage and zero weight gain for 6 months. She was taken to the ER for consistent diarrhea. X-rays and stool samples were done but no treatment was administered. Seizures have continued intermittently but no treatment has been recommended.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Seizure, Stool analysis, Weight gain poor, X-ray
Clinical narrative: She had high fever before lunch time. She was pale, limp and lethargic before leaving fr office. By the next day fever had spiked very high and remained high for 3 days. Fever came and went for more than a week and her body broke out in a rash all over. Then on 02/13/15 she began having seizures at 10:00 in the evening. We called an ambulance and took her to the hospital. No treatment or tests were done. The following day at 3:30 PM, she had a grand Mal seizure lasting 10 minutes and the post-seizure state lasted all evening. We saw loss of appetite, stomach damage and zero weight gain for 6 months. She was taken to the ER for consistent diarrhea. X-rays and stool samples were done but no treatment was administered. Seizures have continued intermittently but no treatment has been recommended.
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Pain in extremity, Pruritus
Clinical narrative: Arm began hurting, itching, burning.  Several days now, tried cortisone, cool rags, Tylenol. Pharmacist that gave shot was excellent, no pain of needle or stinging of vaccine entering arm.  Best shot I've ever had.  And have never had a reaction before!
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, TDAP
Symptoms: Dizziness, Fall, Seizure like phenomena
Clinical narrative: Patient started feeling faint after vaccination while sitting. Patient slowly slid out of seat onto the ground. Parents report child having seizure-like jerking activity.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Significant vomiting and high fever.  Patient treated with hydration, observation, and Ibuprofen 200/5ml (2 ml dose).
Age: 72.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Swelling, redness of right arm, forearm, elbow, down to wrist area. Started on late evening of 11/16/2016, symptoms get worse over 2 days. Patient started antibiotic treatment on morning of 11/19/2016 Cephalexin 1000mg twice daily and doxycycline Hyclate 100mg twice daily. Patient has improved in the afternoon.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Pyrexia, Respiratory tract congestion
Clinical narrative: Fever, cough, chest congestion that lasted for over a week. Treated with doxycycline.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Pain in arm and numbness in fingers. Numbness continues up arm following activity. Pain occurs mostly with activity. Patient received a cortisone shot from office listed above but no relief (11/17/16).
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were administered an unknown number of doses of RECOMBIVAX HB (lot#M033334, expiry date: 11-AUG-2018) (route: intramuscular) that was exposed to 52.2F for 3.5 hours. No adverse effects were 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.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were administered an unknown number of doses of ROTATEQ (lot#M004544, expiry date: 18-NOV-2018, Lot # M005732, expiry date: 19-OCT-2017) that was exposed to 52.2F for 3.5 hours. No adverse effects were 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.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were administered an unknown number of doses of VARIVAX (lot # M025867, expiry date: 24-MAY-2018; lot # M023382, expiry date: 11-MAY-2018) that was exposed to 29.6 F for 7 hours 45 minutes. No adverse effects were 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.