chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Fall, Head injury, Laceration, Loss of consciousness
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 17 year old female patient. There was no pertinent medical history, concomitant medications, drug reactions or allergies known by the reporting physician. On unknown date in July 2016 (reported as "during the week of 18-JUL-2016 to 22-JUL-2016"), the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly (dose, lot # and expiration date were not reported). Immediately after the patient received her injection of GARDASIL 9, she fainted and fell off the table to the floor. The patient hit her head on the floor and received a cut on her forehead above her right eyebrow. Then, the patient was taken by an ambulance to a local hospital, where she received stitches to close the wound. Physician later spoke with father of patient who stated that patient was feeling well and had no other ill effects from incident. The outcomes of the events were reported as recovering. The relatedness between the events and GARDASIL 9 was not provided. The reporting physician considered the events to be medically significant as they required intervention to prevent serious criteria (hospital visit). Additional information is not expected as the reporter refused further contact.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Fall, Head injury, Immediate post-injection reaction, Laceration, Suture insertion
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 17 year old female patient. There was no pertinent medical history, concomitant medications, drug reactions or allergies known by the reporting physician. On unknown date in July 2016 (reported as "during the week of 18-JUL-2016 to 22-JUL-2016"), the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly (dose, lot # and expiration date were not reported). Immediately after the patient received her injection of GARDASIL 9, she fainted and fell off the table to the floor. The patient hit her head on the floor and received a cut on her forehead above her right eyebrow. Then, the patient was taken by an ambulance to a local hospital, where she received stitches to close the wound. Physician later spoke with father of patient who stated that patient was feeling well and had no other ill effects from incident. The outcomes of the events were reported as recovering. The relatedness between the events and GARDASIL 9 was not provided. The reporting physician considered the events to be medically significant as they required intervention to prevent serious criteria (hospital visit). Additional information is not expected as the reporter refused further contact.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 17 year old female patient. There was no pertinent medical history, concomitant medications, drug reactions or allergies known by the reporting physician. On unknown date in July 2016 (reported as "during the week of 18-JUL-2016 to 22-JUL-2016"), the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly (dose, lot # and expiration date were not reported). Immediately after the patient received her injection of GARDASIL 9, she fainted and fell off the table to the floor. The patient hit her head on the floor and received a cut on her forehead above her right eyebrow. Then, the patient was taken by an ambulance to a local hospital, where she received stitches to close the wound. Physician later spoke with father of patient who stated that patient was feeling well and had no other ill effects from incident. The outcomes of the events were reported as recovering. The relatedness between the events and GARDASIL 9 was not provided. The reporting physician considered the events to be medically significant as they required intervention to prevent serious criteria (hospital visit). Additional information is not expected as the reporter refused further contact.
Sex: U
Vaccine: HIBV, PNC13, RV5, HIBV, PNC13, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored ROTATEQ orally, lot number was L035510 and expiration date of 13-MAY-2017(strength and dose were not reported), which was stored at 49 Fahrenheit Degree for 8 hours and 9 Fahrenheit Degree for 39 hours and 20 minutes. Then, the vaccines were back in range. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. This is one of several cases from the same reporter. Additional information has been requested.
Age: 0.39
Sex: F
Vaccine: DPP, PPV, RVX
Symptoms: Crying, Diarrhoea, Irritability, Pyrexia
Clinical narrative: Fever, diarrhea, fussy, excessive crying. Given TYLENOL, like warm baths, and ice packs to neck and under arms.
Sex: U
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: Initial solicited report received from a consumer (online market research respondent) in the below mentioned study on 09 September 2015. The subject (gender and age were not reported) experienced bad reaction on an unspecified date, after receiving a dose of Influenza vaccine (manufacturere was unknown also date of vaccination, site and route of administration and batch number were not reported). Medical history and concomitant therapies details were not reported. The subject experienced last year for the first time in 30 years, a bad reaction to the flu shot. The patient found out that there were 3 levels. He was given the medium shot which made the patient sick therefore the patient decided to not get the flu shot that year. The patient rather had a chance on getting the flu. The lab data and corrective treatment details were not reported. The outcome of the event was not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Initial unsolicited report received from a physician on 28 September 2015. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (batch number, dose, route and site of administration was not reported) in the morning of 28 September 2015. Patient's medical history and concomitant medications were not reported. On 28 September 2015, same day following the vaccination, the patient's whole arm was tingling and numb to fingers. Lab data and corrective treatments were not reported. The patient was not recovered from the events. List of documents held by sender: none. Follow up information received from a physician on 02 November 2015. Illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as no. Patient had no other vaccine within four weeks of vaccination. It was reported that FLUZONE QIV was administered (lot number UI445AA, expiry date 30 June 2016) intramuscularly in right arm. Patient had no Lab test.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2016336904) on 18-Jul-2016. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (Tetanus Vaccine) (batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, patient developed allergy to "tetanus" vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Pain, Pyrexia
Clinical narrative: Fever, chills, achy feeling, feeling weak.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Swelling, discomfort, mild redness at inj site. Afebrile.
Age: 74.0
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Local reaction-redness, swelling.
Age: 18.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Pallor
Clinical narrative: After immunizations, patient sat approx 10 minutes. Then c/o lightheaded, weakness, diaphoretic and was pale. Patient laid down with cold compress water given. Mother called to room. Mother reports patient has low sodium levels. Patient remains alert. After approx 20mins, pt left with no issues/complaints.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Feeling hot, Flushing, Headache
Clinical narrative: After immunizations given, patient sat for approx 15 minutes with no issues. Stood up and became flushed, hot and c/o headache. Cool compress applied, water given and laid down for approx 15 min with no further issues. Food given. States she has not ate in awhile. Left facility with no further issues and no complaints. Mother in room.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site reaction - Swelling , erythema.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: Pt claims she had a bad reaction to a flu vaccine received 12/18/2014. Pt received flu shot on left arm but pt is complaining she is having issue with her right arm. Pt complained on 7/22/2016 to pharmacy staff.
Age: 41.0
Sex: M
Vaccine: IPV, JEV1, MNQ, YF
Symptoms: Facial paralysis, Headache, Pain
Clinical narrative: Received 4 vaccines on July 12th, then 3 days later started having pain, headache on (R) side of head progressed to Bells Palsy (diagnosed by MD) 3 days after symptom onset.
Sex: U
Vaccine: PPV
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: This spontaneous report concerning a patient of unknown gender and age was received from physician via company representative. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, lot and expiration date were not provided) one dose, by intramuscular route. There were no concomitant medications reported. On an unknown date, the patient experienced swollen arms and shoulders. The reporter stated that the patient sought medical attention on an unknown date. No product quality complain was involved. At the time of reporting, the outcome of the events of joint swelling and peripheral swelling was unknown. The causality between PNEUMOVAX 23 and the events joint swelling and peripheral swelling was not assessed. The reporter considered that the events of joint swelling and peripheral swelling were not life threatening. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal X-ray, Abdominal mass, Blood gases, Culture urine, Decreased appetite
Clinical narrative: Decreased appetite; lethargy; decreased responsiveness; decreased urine output; LUQ mass. Abdominal US done showing abnormal gas pattern concerning for intussusception.  Pt transferred for further evaluation and treatment.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Differential white blood cell count, Full blood count, Hyporesponsive to stimuli, Laboratory test, Lethargy
Clinical narrative: Decreased appetite; lethargy; decreased responsiveness; decreased urine output; LUQ mass. Abdominal US done showing abnormal gas pattern concerning for intussusception.  Pt transferred for further evaluation and treatment.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Platelet count, Ultrasound abdomen abnormal, Urine analysis, Urine output decreased
Clinical narrative: Decreased appetite; lethargy; decreased responsiveness; decreased urine output; LUQ mass. Abdominal US done showing abnormal gas pattern concerning for intussusception.  Pt transferred for further evaluation and treatment.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal X-ray, Barium enema, Enema administration, Intestinal resection, Intussusception
Clinical narrative: Decreased appetite; lethargy; decreased responsiveness; decreased urine output; LUQ mass. Abdominal US done showing abnormal gas pattern concerning for intussusception.  Pt transferred for further evaluation and treatment.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Laparotomy, Ultrasound abdomen
Clinical narrative: Decreased appetite; lethargy; decreased responsiveness; decreased urine output; LUQ mass. Abdominal US done showing abnormal gas pattern concerning for intussusception.  Pt transferred for further evaluation and treatment.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain
Clinical narrative: Symptoms: Left Shoulder Soreness, pain, weakness, reduced range of motion. Treatment: Tried  unsupervised exercises at home.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Heart rate increased, Hepatic enzyme increased, Hypopnoea, Oxygen saturation decreased, Skin discolouration
Clinical narrative: 5 hours after 2 month vaccinations, patient projectile vomited, turned a grey-blue color, shallow breathing, staring, rapid heart rate, low oxygen level.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Staring, Vomiting projectile
Clinical narrative: 5 hours after 2 month vaccinations, patient projectile vomited, turned a grey-blue color, shallow breathing, staring, rapid heart rate, low oxygen level.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Peripheral swelling
Clinical narrative: Arms swollen.  Patient was advised to take benadryl the night of 7/27/16.  Follow up on 7/28/16 10 Am, the swelling decreased and patient said she is much better now with a little ache.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to an unspecified number of patients of unknown ages and genders. Pertinent medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown dates the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number L051123 expiration date 13-OCT-2018, lot number L03065 expiration date 07-JUN-2018. Dose, the patient's frequency, anatomical location and route of administration were not provided. Temperature: 32.9 Fahrenheit degrees, time: 5 hours. Digital data logger was involved, no previous exposures and no product quality complaint involved. No other suspect medications or concomitant therapies were reported. No adverse effects were reported. This is one of four reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from Registered Nurse regarding to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-JUN-2016, the patient was vaccinated with improperly stored VARIVAX (lot # L004649, expiry date 11-FEB-2017) (therapy type digital data logger) dosage regimen unknown. It was reported that the vaccine was exposed to a temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes and the temperature was back in range. It was reported that the vaccine was not subjected to previous temperature excursion. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from Registered Nurse regarding to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-MAY-2016, the patient was vaccinated with improperly stored VARIVAX (lot # L004649, expiry date 11-FEB-2017) (therapy type digital data logger) dosage regimen unknown. It was reported that the vaccine was exposed to a temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes and the temperature was back in range. It was reported that the vaccine was not subjected to previous temperature excursion. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: DTP
Symptoms: Erythema, Skin warm
Clinical narrative: Patient came to nursing at 12:00 noon. Patient stated that he had a tetanus shot recently 2 or 3 days ago. Patients arm is red and warm to the touch. Vitals were obtained. Temp 98.6, B/P 138/80, pulse 110, Resp 20, PO2 was 98% on room air.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On multiple unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (dose and route of administration were not reported) (Lot # L030867; expiration date 09-MAY-2018. Concomitant medications were not reported. No adverse effects reported. The PEDVAXHIB highest reached temperature was 52.5F for a time frame of 2 Hours and 54 minutes. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of male patients of unknown age. The patients' pertinent medical history and concurrent conditions were not reported. In approximately July 2016 (reported as "after June 2016"), the patients were vaccinated with VARIVAX injection, subcutaneously, lot # L050956, expiration date:17-DEC-2017(strength, dose and anatomical location of administration were not reported), which were improperly stored. It was unknown if a digital data logger was involved. No adverse events were reported and no product quality complaint was involved. This is one of two 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 was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L027719 and expiration date 28-APR-2017, lot # L044476 and expiration date 07-SEP-2017, orally, exact doses were not reported). No adverse effects were reported. This is one of the several reports received from the same source. Additional information is not expected as there was no consent for follow-up.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information was received on 25-JUL-2016 from a lawyer regarding a case in litigation. The patient is a seventeen year old autistic who on an unknown date experienced vaccine-induced autism. On 10-JUL-2000 the patient was vaccinated with M-M-R II. It was reported that medical records on 10-JUL-2000 showed the patient received a series of vaccines and began to regress into autism. Upon internal review, vaccine-induced autism was determined an important medical event. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. Pertinent medical history, drug reaction and concomitant medication were not provided. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL (lot # L035105, expiration date 14-MAY-2017; dose and route were unknown). No adverse effects was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown ages and gender. Information about medical history, concurrent condition and concomitant medication was unspecified. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX lot # L049536 with expiration date of 08-DEC-2017, strength, dosage, frequency and route unspecified). Temperature/ time frame was 10.8 F for 4 hour 48 minutes and previously temperature excursion was 30 F for 10 hours 45 minutes. This is one of two report received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with doses of PNEUMOVAX 23 injection (dose, lot number, expiration date, route and anatomical location of administration were not reported), which were improperly stored. It was unknown if a digital data logger was involved. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received form the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: Information was received from a physician referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 09-JUN-2016 the patient was administered the 1st dose of GARDASIL (dose and route unknown). On 23-JUN-2016 the patient received the 2nd dose of GARDASIL (dose and route unknown) (inappropriate schedule of drug administration). On 20-JUL-2016 the patient was administered dose three of the series with GARDASIL 9 (interchange of vaccine products) (inappropriate schedule of drug administrations). This interval was shorter than recommended. No adverse effect was reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from Registered Nurse regarding 12 month old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-JUN-2016, the patient was vaccinated with improperly stored VARIVAX (lot # L004649, expiry date 11-FEB-2017) (therapy type digital data logger) dosage regimen unknown. It was reported that the vaccine was exposed to a temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes and the temperature was back in range. It was reported that the vaccine was not subjected to previous temperature excursion. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.02
Sex: M
Vaccine: MMR
Symptoms: Hydrocephalus, Opisthotonus, Pain, Screaming, Vomiting
Clinical narrative: Throwing up, could not keep milk down, screaming, arching in pain.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The patients pertinent medical history, drug allergies and concomitant medications were not reported. ON an unspecified date in November of 2015, the patient was vaccinated with ZOSTAVAX, 0.65 ml/once, subcutaneously, (lot # and expiry date unknown). The patient was administered ZOSTAVAX (0.65 ml/ once, subcutaneously, (lot# and expiry date unknown) again on 21-JUL-2016 (product use issue). No adverse effects were reported. It was also reported that therapy was continued. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding an unspecified number patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with doses of ROTATEQ oral liquid, orally (dose, lot number and expiration date were not reported), which were improperly stored. It was unknown if a digital data logger was involved. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 06-JUL-2016 from a Certified Medical Assistant. It was reported that a male patient of unknown age was administered a dose of PROQUAD (lot # M004893, expiration 26-JUL-2017) 0.5 ml on an unknown date (route and injection site not reported), that was improperly stored (details not specified). No adverse effects were reported. No further information was provided. Additional information has been requested.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from Registered Nurse regarding to a 13 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-JUN-2016, the patient was vaccinated with improperly stored VARIVAX (lot # L004649, expiry date 11-FEB-2017) (therapy type digital data logger) dosage regimen unknown. It was reported that the vaccine was exposed to a temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes and the temperature was back in range. It was reported that the vaccine was not subjected to precious temperature excursion. Product quality complaint (PQC) was not filed. This is one of the several reports received form the same reporter. Additional information had been requested.
Age: 13.0
Sex: F
Vaccine: MMRV
Symptoms: Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Information has been received from a medical assistant referring to a 13 years old female patient. The patient had no concomitant medication, pertinent medical history or drug reactions/allergies. On 25-JUL-2016, the patient was vaccinated with a dose of PROQUAD (lot #, expiration date, dose and route were not reported). On an unknown date in July 2016, the patient experienced sore throat and swollen lymph nodes following the administration of PROQUAD. The patient sought medical attention on an unknown date in July 2016. It was reported that treatment was given in the form of an unspecified dose of TYLENOL to treat the patient's symptoms on an unknown date. No lab diagnostics studies were performed. The outcome of the events was unknown. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to one or two unspecified patients of unknown age and gender. Concurrent, historical condition and concomitant therapy were not provided. On unknown dates the patients were vaccinated with improperly stored VARIVAX (lot # L048465, expiration date 02-DEC-2017; dose and route were unknown). No adverse effects was reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from Registered Nurse regarding to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-JUN-2016, the patient was vaccinated with improperly stored VARIVAX (lot # L004649, expiry date 11-FEB-2017) (therapy type digital data logger) dosage regimen unknown. It was reported that the vaccine was exposed to a temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes and the temperature was back in range. It was reported that the vaccine was not subjected to precious temperature excursion. Product quality complaint (PQC) was not filed. This is one of the several reports received form the same reporter. Additional information had been requested.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from Registered Nurse regarding to a 2 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-MAY-2016, the patient was vaccinated with improperly stored VARIVAX (lot # L004649, expiry date 11-FEB-2017) (therapy type digital data logger) dosage regiment unknown. It was reported that the vaccine was exposed to a temperature excursion if 23 degree Celsius for a time frame of 1 hour and 29 minutes and the temperature was back in range. It was reported that the vaccine was not subjected to previous temperature excursion. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from Registered Nurse regarding to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-MAY-2016, the patient was vaccinated with improperly stored VARIVAX (lot # L004649, expiry date 11-FEB-2017) (therapy type digital data logger) dosage regimen unknown. It was reported that the vaccine was exposed to a temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes and the temperature was back in range. It was reported that the vaccine was not subjected to precious temperature excursion. Product quality complaint (PQC) was not filed. This is one of the several reports received form the same reporter. Additional information had been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from Registered Nurse regarding to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUN-2016, the patient was vaccinated with improperly stored VARIVAX (lot # L004649, expiry date 11-FEB-2017) (therapy type digital data logger) dosage regimen unknown. It was reported that the vaccine was exposed to a temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes and the temperature was back in range. It was reported that the vaccine was not subjected to previous temperature excursion. Product quality complaint (PQC) was not filed. This is one of the several reports received form the same reporter. Additional information had been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from Registered Nurse regarding to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-JUN-2016, the patient was vaccinated with improperly stored VARIVAX (lot # L004649, expiry date 11-FEB-2017) (therapy type digital data logger) dosage regimen unknown. It was reported that the vaccine was exposed to a temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes and the temperature was back in range. It was reported that the vaccine was not subjected to previous temperature excursion. Product quality complaint (PQC) was not filed. This is one of the several reports received form the same reporter. Additional information had been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from Registered Nurse regarding to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUN-2016, the patient was vaccinated with improperly stored VARIVAX (lot # L004649, expiry date 11-FEB-2017) (therapy type digital data logger) dosage regimen unknown. It was reported that the vaccine was exposed to a temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes and the temperature was back in range. It was reported that the vaccine was not subjected to previous temperature excursion. Product quality complaint (PQC) was not filed. This is one of the several reported received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: This spontaneous report concerning a patient of an unknown gender and age was received from a nurse. The patient's concurrent conditions and medical history were not provided. On 19-JUL-2016, the patient was inadvertently vaccinated with an expire dose (expired product administered) of PNEUMOVAX 23 lot # L001311, expiration date 06-JUL-2016 (strength, dose, and route were not provided). There were no concomitant medications and adverse events reported. No product quality complain was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M005973; expiration date 02-FEB-2018) 0.5 ml, subcutaneously. There was not product quality involved. Concomitant medication was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to multiple patients of unknown ages and genders. Medical history and current conditions were not reported. On an unknown dates over an unspecified 7 month period, the patients were vaccinated with improperly stored doses of M-M-R II lot number K0111888, expiration date 12-AUG-2016, and lot number L035674, expiration date 17-SEP-2017. Dose and route of administration were not provided. No other suspect or concomitant medications were reported. As reported, temperature: uncertain, surmising worst case 51 Fahrenheit degrees for 7 months; digital data logger was involved. Previous: uncertain. No adverse effects were reported. This is one of four reports received from the same source. Additional information had been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding an unspecified number patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with doses of VAQTA injection (dose, lot number, expiration date, route and anatomical location of administration were not reported), which were improperly stored. It was unknown if a digital data logger was involved. No adverse effects were reported and no product quality complaint was involved. This is one of several 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 was received from a healthcare worker regarding an unspecified number patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with doses of GARDASIL 9 (dose, lot number, expiration date, route and anatomical location of administration were not reported), which were improperly stored. It was unknown if a digital data logger was involved. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 15-JUL-2016 the patient was vaccinated with an expired dose of ZOSTAVAX (19400 PFU, lot #K020185, expiry date 27-JAN-2016, dose unknown) subcutaneously. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On 21-JUL-2016 the patient was vaccinated with improperly stored VARIVAX (lot # L042265, expiration date 26-OCT-2017, dose and route were not reported). The vaccine had been stored under temperature of 52.3 degree Fahrenheit for 11 hours. No previous excursions. No adverse effects were reported. This is one of three reports received from 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 Licensed Practical Nurse refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug allergies and concomitant medications were not reported. On 26-JUL-2016, the patient was inadvertently administered an expired dose of ZOSTAVAX (lot # L011534, expiry date 03-JUL-2016), dose and route unknown. No adverse effect was reported. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus
Clinical narrative: Patient said she is having itching at the injection site. I advised patient to notify her Dr. right away and to go to emergency room for evaluation.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Back pain, Swelling
Clinical narrative: Swelling and pain on (L) side of upper back 1 day after vaccine given.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Approx 10 minutes after imm's given patient became very pale, dizzy, diaphoretic and c/o nausea. Patient transferred to bed via w/c and lies down in dark room. Ammonia inhalant used prior to patient being transferred to w/c. Pt requires a very cool compress, applied. H2O, bed monitors X 20 minutes with no further c/o. Left facility with no issues or complaints. Mother present.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Cyanosis, Sick relative, Vomiting
Clinical narrative: About 10 hours after the vaccine administration, pt vomited 3-4 times in span of 1 hour and turned blue. May be due to contact with sick cousin.
Age: 17.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Dizziness, Headache, Nausea, Pallor
Clinical narrative: Pt felt light headed and went pale post Men B vaccine. Pt had to lye down x20min in office with ice packs due to heat. Pt was very nausea and had a mild headache. After about 30-40 min pt was well enough to leave office, but didn't feel better till next am.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Fatigue, Headache, Immediate post-injection reaction, Malaise
Clinical narrative: Patient had a swelling at time of injection that we were told was normal. Patient did not feel well the week following vaccine. Patient continue to feel nausea, dizzy and fatigue headache. These symptoms continue to this day.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Nausea, Swelling
Clinical narrative: Patient had a swelling at time of injection that we were told was normal. Patient did not feel well the week following vaccine. Patient continue to feel nausea, dizzy and fatigue headache. These symptoms continue to this day.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions/allergies and medical history were not reported. In August 2015, the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose and route of administration were unknown) with lot # K026246 and expiration date of 28-JAN-2017. Then in October 2015, the patient received the second dose of GARDASIL 9 with lot # L011846 and expiration date of 16-JUN-2017; in January 2016, the patient received the third dose of GARDASIL 9 with lot # L011846 and expiration date of 16-JUN-2017. Subsequently, on 05-JUL-2016, the patient received a fourth dose of GARDASIL 9 (strength, dose and route of administration were unknown) with lot # L025737 and expiration date of 28-JUL-2017 for the same indication. This last dose was outside the recommendations per the prescribing information of the therapy. There were no concomitant therapies nor adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV9, MENB, MNQ
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with GARDASIL 9 (dosing details were not reported). The reporter stated that multiple patients has issues (unspecified issues) (adverse event) an unspecified time after receiving an unspecified dose of GARDASIL 9 that was concomitantly administered with MENACTRA and TRUMENBA. The outcome of adverse event is unknown. The reporter did not provided the causality assessment between the event and the suspect therapy. There was no product quality complaint involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MENB, MNQ, TDAP, VARCEL
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: Client presented self to clinic 7/27/2016 at 2:30 PM with red rash on left arm at SQ site, 2.5 X 3 inches. Area was hard, warm and painful to touch. Client states it itches also. Client received the following vaccines: HPV, MCV4, Men B, Tdap and Varicella. Rash occurred at the site of the Varicella injection. Temp taken- 98.54 F. Cool compress applied and instructed client to report to emergency room or primary care physician if symptoms worsen.
Age: 17.0
Sex: F
Vaccine: HPV4, MENB, MNQ, TDAP, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Client presented self to clinic 7/27/2016 at 2:30 PM with red rash on left arm at SQ site, 2.5 X 3 inches. Area was hard, warm and painful to touch. Client states it itches also. Client received the following vaccines: HPV, MCV4, Men B, Tdap and Varicella. Rash occurred at the site of the Varicella injection. Temp taken- 98.54 F. Cool compress applied and instructed client to report to emergency room or primary care physician if symptoms worsen.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, VARCEL
Symptoms: Angioedema, Cough
Clinical narrative: Angioedema Cough.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, HEPA, HPV9
Symptoms: Altered state of consciousness, Eye movement disorder, Muscle contractions involuntary, Seizure
Clinical narrative: About five to ten minutes after injection of HPV vaccine, my daughter said she felt like she was passing out. Her eyes rolled up into her head and her hands curled inward. She had a seizure and I helped her lay back on the table and on her side, as informed by nurse as she was present. Nurse put and cooling pack on patient's forehead. Nurse said it was a seizure and lasted less than 30 seconds.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, HEPA, HPV9
Symptoms: Seizure, Syncope
Clinical narrative: About five to ten minutes after injection of HPV vaccine, my daughter said she felt like she was passing out. Her eyes rolled up into her head and her hands curled inward. She had a seizure and I helped her lay back on the table and on her side, as informed by nurse as she was present. Nurse put and cooling pack on patient's forehead. Nurse said it was a seizure and lasted less than 30 seconds.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an immunization official, refers to an unspecified number of patient of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not mentioned. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # L047307, expiry date: 23-MAY-2017, (dose#, site of administration and route not provided). No adverse effects were reported. No additional information was provided. Product quality complaint was not filed. Additional information is not expected as the reporter did not wish further contact. This is one of the two reports from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning an unknown number of patients of unknown age and gender. On unknown dates, incorrectly stored vaccines could have been administered to an unknown number of patients. The vaccine incorrectly stored was GARDASIL 9 (lot # M005714, Exp date: 03-OCT-2017 and lot # reported as M003655, Exp date: 20-SEP-2017). It was reported that, on an unknown date, the refrigerator was out of range for 22 hours, with the highest temperature 48.6 degrees F and temperature was back in range at the time of call. The Registered Nurse reported that vaccines could have been administered before the excursion was identified. Lot number M003655 is an invalid lot number for GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning an unknown number of patients of unknown age and gender. On unknown dates incorrectly stored doses of inactivated PNEUMOVAX 23 ( lot # M006139; exp date: 13-MAY-2017) could have been administered. It was reported that, on an unknown date, the refrigerator was out of range for 22 hours, with a highest temperature of 48.6 degree F. Temperature was back in range at the time of call. The Registered Nurse reported that vaccines could have been administered before the excursion was identified. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.