chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 03-AUG-2016, the patient was vaccinated with a dose of improperly stored VARIVAX (lot # M006156 with expiration date 15-FEB-2018, dose unknown, subcutaneous). The vaccine was improperly stored at 6 degree Fahrenheit for 11 minutes. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to an adult patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 08-AUG-2016, the patient was vaccinated with M-M-R II (Lot number, expiration date and dose were not provided) intramuscular instead of subcutaneously. There was no concomitant medication reported. No untoward effects were noted. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a health professional refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were inadvertently vaccinated with improperly stored GARDASIL 9 (unspecified lots/expirations) (incorrect product storage). This is one of the four reports received from the same reporter. 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. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 03-AUG-2016, the patient was vaccinated with a dose of improperly stored VARIVAX (lot # L038132 with expiration date 01-OCT-2017, dose unknown, subcutaneous). The vaccine was improperly stored at 6 degree Fahrenheit for 11 minutes. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-JUL-2016, the patient was inadvertently vaccinated with an expired dose of M-M-R II, lot # K010318 with an expiry date of 22-JUL-2016 (dose and route of administration not reported). No adverse effects were reported. The outcome of the events were unknown. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 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 patients were vaccinated with improperly stored doses of GARDASIL 9 (dosing details were not reported) (incorrect product storage). There were several previous temperature excursions. Time frame and temperature excursion were not reported, but the reporter stated that the temperatures the vaccine were exposed were above the range and the range was back. There were prior excursions reported. It was unknown if the call was due to data logger. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received form the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse 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 patients were vaccinated with improperly stored M-M-R II (dosing details were not reported (incorrect product storage). There were several previous temperature excursions. Time frame and temperature excursion were not reported, but reporter stated that the temperatures the vaccine were exposed were above the range and the range was back. There were prior excursions reported. It was unknown if the call was due to data logger. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: 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 age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored doses of ROTATEQ (dosing details were not reported) orally. There were several previous temperature excursions. Time frame and temperature excursion were not reported, but the reporter stated that the temperatures the vaccine were exposed were above the range and the range was back. There were prior excursion reported. It was unknown if the call was due to data logger. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A.) regarding a 4 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-JUL-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the 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: Information has been received from a medical assistant referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 28-JUL-2016, the patient was vaccinated with improperly stored GARDASIL 9 (0.5 ml, lot # L045700, expiration date 22-FEB-2018) intramuscularly. The vaccine had been stored under temperature of 47 Fahrenheit degree for 10 hours. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Head injury, Loss of consciousness
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative refers to a 18 or 19 years old male patient. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with the third dose of GARDASIL 9 injection (dose, route of administration, anatomical location, lot # and expiry date were not specified). On an unknown date, an unspecified time after receiving the third dose of GARDASIL 9, the patient passed out and hit the back of his head. The outcome of the events and the causality assessment were not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Orchitis
Clinical narrative: This spontaneous report as received from a physician to 2 patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (strength, dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date, the patients experienced orchitis. The outcome of orchitis was unknown. The relatedness between vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and the event was not reported. This is one of several reports received from the same reporter. Additional information is not expected because there was not contact details to the physician.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old male patient. The patient did not have any pertinent medical history and drug reactions or allergies. On 18-JUL-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot # reported as M001746, expiration date 17-APR-2017, dose and units were not reported) subcutaneously. Concomitant therapy included FLONASE. The patient experienced an unspecified adverse event approximately in July 2016. The pharmacist stated that she received an electronic prescription for the patient for prednisone (manufacturer unknown) (from an unknown provider) on the day of this report. The pharmacist stated she did not know why the patient was prescribed with prednisone (manufacturer unknown). It was reported that treatment (unspecified) was given for the event and there were no lab diagnostic studies performed. The outcome of the adverse event was unknown. The relatedness between the adverse event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
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. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, the patients received improperly stored ROTATEQ (lot # M019706, expiration date 24-OCT-2017, oral: dose was unknown). No adverse effects reported. This is one of two reports received from the same reported. Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Abnormal dreams, Asthenia, Headache, Nausea, Pain
Clinical narrative: Severe Headaches, body Aches, weird dreams, fever and zero-energy.
Age: 36.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Pyrexia
Clinical narrative: Severe Headaches, body Aches, weird dreams, fever and zero-energy.
Age: 20.0
Sex: F
Vaccine: HPV9, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Pain
Clinical narrative: After receiving injection patient had local pain and later noticed some redness and a lump at the site of injection.  She presented to the health center 3 weeks later complaining that the site was still tender, there was still a lump and occasional redness overlying the site.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Tremor, Vomiting
Clinical narrative: Shaking, vomiting, pain in arms and legs.
Age: 1.34
Sex: M
Vaccine: HEPA, MMRV, VARCEL, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: The adverse event is the administration of 2 doses of varicella.  One dose as varicella and the second dose as an MMRV vaccine.
Age: 1.34
Sex: M
Vaccine: HEPA, MMRV, VARCEL, MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event
Clinical narrative: The adverse event is the administration of 2 doses of varicella.  One dose as varicella and the second dose as an MMRV vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician and refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 23-JUL-2016, the unspecified patient was vaccinated intramuscularly with 0.5 ml dose of improperly stored ZOSTAVAX (lot# and expiration date were not reported). No adverse effect was reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
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. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, the patients received improperly stored PEDVAXHIB (lot # M001811, expiration date 04-NOV-2018; route and dose were unknown). No adverse effects was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse 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 patients were vaccinated with improperly stored doses of PEDVAXHIB (dosing details were not reported) (incorrect product storage). There were several previous temperature excursions. Time frame and temperature excursion were not reported, but the reporter stated that the temperature the vaccine were exposed were above the range and the range was back. There were prior excursions reported. It was unknown if the call was due to data logger. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reported. 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 nurse 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 patients were vaccinated with improperly stored doses of GARDASIL (dosing details were not reported (incorrect product storage). There were several previous temperature excursions. Time frame and temperature excursion were not reported, but the reporter stated that the temperatures the vaccine were exposed were above the rand and the range was back. There were prior excursions reported. It was unknown if the call was due to data logger. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information had been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a health professional refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were inadvertently vaccinated with improperly stored ROTATEQ (unspecified lots/expirations). This is one of the four reports 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 (also reported as other, details unspecified) referring to multiple unspecified patients. No information about patients' medical history, concurrent condition and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 which had lot # M006922, expiry date: 21-JUN-207 (dose and route not provided). The vaccines were exposed to a minimum f 27 degree Fahrenheit and a maximum of 57 degree Fahrenheit. The temperature excursions were detected by a data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions and concomitant therapies were reported. On 05-AUG-2016, the patient was inadvertently vaccinated with an expired dose of M-M-R II (lot # K007106, expiration date: 16-MAY-2016). Dose, dose number, route and anatomical location were not reported. A product quality complaint was not involved. No adverse events were reported. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A.) regarding a 12 month old patient of unspecified 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 PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 70 patients of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies of medical history provided. On an unknown date, the patients were vaccinated with doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (strength, dose, frequency, route of administration, lot # and expiration date. On an unknown date, the patients experienced not specified adverse events. The outcome of adverse events was unknown. The relatedness between vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and the event was not reported. This is one of several reports received from the same reporter. Additional information is not expected because there was not contact details to the physician.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A.) regarding a 4 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-JUN-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursions. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and unknown gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with improperly stored PNEUMOVAX 23 (0.5 ml, lot # M005286, expiration date 08-OCT-2017) intramuscularly. The vaccine had been stored under the temperature of 47 Fahrenheit degree for 10 hours. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with the improperly stored doses of PROQUAD (strength, dose number, route, anatomical location, lot number and expiration date were not provided.) This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A) regarding a 4 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-JUN-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.84
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A) regarding a 22 month old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-JUL-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Mumps, Polymerase chain reaction positive, Rubulavirus test positive
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (strength, dose frequency, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced mumps which was confirmed by a positive result on a real-time reverse transcription polymerase chain reaction (rRT-PCR) buccal swab test on 01-MAY-2016. The outcome of mumps was unknown. The relatedness between vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and the event was not reported. This is one of several reports received from the same reporter. Additional information is not expected because there was no contact details to the physician.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age. On an unknown date, the patient was vaccinated with PROQUAD and VARIVAX during the same office visit. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: This spontaneous report as received from a physician refers to 5 patients of unknown age and gender. There was not information about the patients concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (strength, dose frequency, route of administration, lot # and expiration date were not reported). On an unknown date, the patients experienced mumps. The outcome of mumps was unknown. The relatedness between vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and the mumps was not reported. This is one of several reports received from the same reporter. Additional information is not expected because there was no contact details to the physician.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Cold sweat, Dizziness, Gait disturbance, Nasopharyngitis, Nausea
Clinical narrative: Dizzy, cold and clammy, nausea, difficulty walking (legs where shaky).
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Tremor
Clinical narrative: Dizzy, cold and clammy, nausea, difficulty walking (legs where shaky).
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Injection site swelling, Skin warm
Clinical narrative: Moderate swelling and redness to arm that continued to expand.  Hot to touch.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Circular area over L upper arm after Trumenba, redness developed 1 day after shot, then bumps came up 3 days later. As of today 08/12/16 still present.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Rash, Urticaria
Clinical narrative: SKIN RASH, HIVES.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A) regarding a 4 years old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUN-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 24 year old female patient. The patient did not have any known drug reactions or allergies. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-JUL-2016, the patient was vaccinated with doses of VAQTA, RECOMBIVAX HB and diphtheria toxoid, pertussis acellular vaccine (unspecified) (+) tetanus toxoid (lot#, expiration date, strength, dose and frequency were not reported for all this vaccines). Next day, the patient was vaccinated with a dose of M-M-R II (lot # M0012418, expiration date: 12-JAN-2018 subcutaneously. On approximately 26-JUL-2016 (reported as 11 days after the M-M-R II was given), the patient developed a head to toe rash. The patient sought medical attention (unspecified). There was no treatment given for adverse event. The outcome of rash was not reported. The relatedness between vaccination with VAQTA, RECOMBIVAX HB, diphtheria toxoid, pertussis acellular vaccine (unspecified) (+) tetanus toxoid and M-M-R II and the patient event was not reported. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 02-AUG-2016, the patient was vaccinated with their first dose of RECOMBIVAX HB (lot number reported as L032596, expiration date 02-AUG-2017, dose and route of administration were not reported). On 04-AUG-2016, the patient was inadvertently vaccinated with a second dose of RECOMBIVAX HB (lot number reported as M015775, expiration date 16-JUN-2018, dose and route of administration were not reported). No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a health professional refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were inadvertently vaccinated with improperly stored GARDASIL (unspecified lots/expirations) (incorrect product storage). This is one of the four reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Parotitis, Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a 21 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a first dose of M-M-R (manufacturer unknown). Subsequently, on an unknown date, the patient received the second dose of M-M-R (manufacturer unknown) (strength, frequency, route of administration, lot # and expiration date for both regiments were not reported). On 09-APR-2015, the patient experienced pyrexia and parotitis. On 15-APR-2015, the patient was presented to the health center. The outcome of pyrexia and parotitis was unknown. The relatedness between vaccination with M-M-R (manufacturer unknown) and the events was not reported. This is one of several reports received from the same reporter. Additional information is not expected because there was no contact details to the physician.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as other; details unspecified) referring to multiple unspecified patients. No information about patients' medical history, concurrent condition and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 which had lot # M004116, expiry date: 12-OCT-2017 (dose and route not provided). The vaccines were exposed to unspecified multiple previous excursions since March 2016 and a current excursion in July 2016 for 15 days exposed to a minimum of 27 degree Fahrenheit and maximum 57 degree Fahrenheit. The temperature excursions were detected by a data logger. No adverse effects were reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 6cm circular red area with warmth and tenderness to touch to left thigh. Located below injection sites x 2. Started 1 day after injections administered. TX: TYLENOL/MOTRIN for discomfort and cool compresses to site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Blood glucose normal, Breath holding, Dystonia, Pallor, Somnolence
Clinical narrative: At 1610 patient and parent was brought back to the exam room for vaccine administration.  Mom of patient was educated on vaccines that the patient would be receiving (Kinrix, MMR, Varicella) and given Vaccine Information Statements for each.  Allergy information was verified and mom advised that the patient had no known allergies and no previous vaccine reactions.  At 1615 patient was administered vaccines.  Patient began holding his breath and and developed tonic movement of the body.  Patient then urinated on himself.  Patient began to respond to verbal commands.  Patient's physician was contacted, vital signs were taken.  Patient was responsive but pale and sleepy.  SPO2 was 98% on room air and blood sugar was 91 and other vital signs were within normal range. Mom stated afterwards that child has had similar attacks, but it was not mentioned prior.  911 was called and patient was transferred to the hospital for further evaluation.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Urinary incontinence
Clinical narrative: At 1610 patient and parent was brought back to the exam room for vaccine administration.  Mom of patient was educated on vaccines that the patient would be receiving (Kinrix, MMR, Varicella) and given Vaccine Information Statements for each.  Allergy information was verified and mom advised that the patient had no known allergies and no previous vaccine reactions.  At 1615 patient was administered vaccines.  Patient began holding his breath and and developed tonic movement of the body.  Patient then urinated on himself.  Patient began to respond to verbal commands.  Patient's physician was contacted, vital signs were taken.  Patient was responsive but pale and sleepy.  SPO2 was 98% on room air and blood sugar was 91 and other vital signs were within normal range. Mom stated afterwards that child has had similar attacks, but it was not mentioned prior.  911 was called and patient was transferred to the hospital for further evaluation.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Back pain, Fatigue, Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: Immediately after receiving vaccine, patient complained of pain to right deltoid. Continued pain, low grade fever, fatigue, back and body aches.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: Immediately after receiving vaccine, patient complained of pain to right deltoid. Continued pain, low grade fever, fatigue, back and body aches.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: Redness and induration on left deltoid were vaccine was administered. Pt stated she had a slight fever day after receiving vaccine.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse 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 patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (dosing details were not reported). There were several previous temperature excursions. Time frame and temperature excursion were not reported, but the reporter stated that the temperatures the vaccine were exposed were above the range and the range was back. There were prior excursions reported. It was unknown if the call was due to data logger. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as other; details unspecified) referring to multiple unspecified patients. No information about patients' medical history, concurrent condition and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB which had lot # M006708, expiry date: 02-JUN-2018 and lot # M013639, expiry date: 15-SEP-2017 (dose and route not provided). The vaccines were exposed to unspecified multiple previous excursions since March 2016 and a current excursion in July for 15 days exposed to a minimum of 27 degree Fahrenheit and maximum of 57 degree Fahrenheit. The temperature excursions were detected by a data logger. No adverse effects were reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse referring to a 17 years old female patient. The patient was allergic to BACTRIM. The patient had no pertinent medical history or concomitant therapy. On 26-JUL-2016, the patient was vaccined with VARIVAX (lot # M004330, expiration 23-JAN-2018) 0.5 ml/x1, subcutaneously. On an unknown date in July 2016, after receiving VARIVAX, the patient's injection site (11.5 cm by 6.2 cm located on the right upper arm) became raised, warm, itchy and painful to touch. On 28-JUL-2016, the patient went to the office for follow up and was advised to follow up with the clinic again if the side effect worsened. Unspecified treatment was given to the patient. No lab test was done. The outcome of the adverse event was reported as not recovered. The causal relationship between the VARIVAX and the events was not reported. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Burning sensation, Decreased appetite, Fatigue, Feeling cold
Clinical narrative: For one week nausea, chills, no appetite extremely fatigued, weak - no energy, fever (ears, teeth, back, neck spine hurt) (nose-severe pain and burning. Energy level down after 3 weeks. Dose too strong for 130 pound woman?) After 3 weeks plus - still do not feel ok. I would never get this shot again.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Pyrexia, Rhinalgia
Clinical narrative: For one week nausea, chills, no appetite extremely fatigued, weak - no energy, fever (ears, teeth, back, neck spine hurt) (nose-severe pain and burning. Energy level down after 3 weeks. Dose too strong for 130 pound woman?) After 3 weeks plus - still do not feel ok. I would never get this shot again.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Bradycardia, Hyperhidrosis, Pallor
Clinical narrative: A few minutes after blood draw and vaccine admin, pallor, diaphoresis, bradycardia, BP and pulse ox - normal.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with a dose of improperly stored (GARDASIL 9) (lot # L037554, expiration date 25-DEC-2017; route was not reported) (incorrect product storage) (temperature/time frame: 9.3 Celsius degree for 1 hour, 10 minutes; back in range: yes; data logger: unknown). There were no previous excursions. No adverse effects were reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema
Clinical narrative: 8-1-16 got shot that night is started turning red an it kept getting bigger over the next day had no fever.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as other; details unspecified) referring to multiple unspecified patients. No information about patients' medical history, concurrent condition and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA which had lot # M00978, expiry date: 26-MAY-2017 (dose and route not provided). The vaccines were exposed to unspecified multiple previous excursions since March 2016 and a current excursion in July 2016 for 15 days exposed to a minimum of 27 degree Fahrenheit and maximum of 57 degree Fahrenheit. The temperature excursions were detected by a data logger. No adverse effects were reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site rash, Pyrexia, Roseola, Viral titre increased
Clinical narrative: 104 fever or higher, bump at injection site, Roseola. Elevated titers/off the chart to high for measles, mumps, Rubella immune response.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A) regarding a 4 year old patient of unspecified 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 PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursions. No adverse effect was reported. 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: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Feeling abnormal, Malaise
Clinical narrative: C/O feet feeling funny after injection and dizzy/not feeling well the day after.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age. Their pertinent medical history and concurrent conditions were not provided. On an unknown dates, the multiple unspecified patients were vaccinated with doses of M-M-R II lot # L027591, expiration date:23-JUL-2017 (routes, anatomical location and doses number were not reported) that were improperly stored. No adverse effects were reported. It was reported that the temperature of the refrigerator had reached a -3.7 Celsius and not previously reported 0 Celsius with the time frame of 548 hours and 48 minutes and data logger was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Induration, Pain, Skin warm
Clinical narrative: Mother called 8/5/16 stated patient has a red sore area warm and hard BENADRYL and TYLENOL advised.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Red, swollen and warm to touch. R arm.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as other; details unspecified) referring to multiple unspecified patients. No information about patients' medical history, concurrent condition and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II which had (lot # L012480, expiry date: 10-APR-2017; lot # L043702, expiry date: 03-NOV-2017 and lot # L035674, expiry date: 17-SEP-2017)(dose and route not provided). The vaccines were exposed to a minimum of 27 degree Fahrenheit and maximum of 57 degree Fahrenheit. The temperature excursions were detected by a data logger. No adverse effects were reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Anxiety, Nervousness, Visual acuity reduced
Clinical narrative: Patient felt her vision going black and became very anxious and shaky.
Age: 1.91
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13
Symptoms: Pyrexia
Clinical narrative: The mother informed us today when the child came in for additional vaccines to the public health department, that back in 2012, the child had a fever for 6 days after his set of shots. He had a prior history of febrile seizures, but did not have a febrile seizure during the 6 days of fever post-vaccine. Mom states that she informed the child's primary care provider.
Age: 19.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Back pain, Blood glucose decreased, Dizziness, Feeling hot, Headache
Clinical narrative: Yesterday was seen for PE. Had Trumenba #1 and Flu shot. Hadn't had breakfast before visit, but left and had breakfast and then had a snack and went to the mall. While there, started feeling dizzy, knees were buckling and she sat down and put her head between her knees. The medics came and they checked her blood sugar (60) and then gave her a glucose tablet and it rose to 90. She has also felt hot on and off (no fever). Has had a lot of pain at the injection site (left arm). Has HA, was worse yesterday but has a mild HA today. Felt lower back pain and nausea.
Age: 19.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Injection site pain, Nausea
Clinical narrative: Yesterday was seen for PE. Had Trumenba #1 and Flu shot. Hadn't had breakfast before visit, but left and had breakfast and then had a snack and went to the mall. While there, started feeling dizzy, knees were buckling and she sat down and put her head between her knees. The medics came and they checked her blood sugar (60) and then gave her a glucose tablet and it rose to 90. She has also felt hot on and off (no fever). Has had a lot of pain at the injection site (left arm). Has HA, was worse yesterday but has a mild HA today. Felt lower back pain and nausea.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Dysphagia
Clinical narrative: Her throat started to feel dry and she stated she was having trouble swallowing. She was given 20 mg liquid Benadryl at 2:16 PM and vital signs were stable.  She left the Health Center at 2:30 PM in good condition.  She stated that she had this after her first dose but she didn't report it as it was after she had returned to work and she was at her desk.  At that time she had gotten the first doses of Hep A and B vaccines.
Age: 13.0
Sex: M
Vaccine: HPV9, MEN, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, itching, redness at site of varicella vaccine adminsitration.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.  KINRIX given to a 4 month old.
Age: 12.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Dizziness
Clinical narrative: Dizziness.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Local swelling
Clinical narrative: 14x16 cm area of erythema and swelling in left arm.
Age: 1.92
Sex: F
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Blood culture, Blood test, Culture urine, Febrile convulsion, Generalised tonic-clonic seizure
Clinical narrative: Generalized tonic/clonic seizure and fever (febrile seizure) T102. Seizure while in bed "felt warm" per mom - lasted approximately 2 minutes. 30-60 min post-ictal phase transfer to ER via ambulance, blood work and fld and urine cultures