chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an unspecified number of unspecified patients of unknown age and gender. On 22-AUG-2015 the patients received improperly stored doses of PNEUMOVAX 23 (lot #: L003188 and expiration date: 06-JUL-2016; dose, route, frequency unspecified). No adverse effect reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site inflammation, Nausea, Vomiting
Clinical narrative: After receiving vaccine, pt experienced nausea, vomiting, chills and has a 7 cm diameter inflamed area at injection site.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, 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 patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-AUG-2015, the patient was vaccinated with the first dose of an improperly stored PROQUAD (Merck) (lot # L010143, expiry date on 24-SEP-2016) subcutaneously. This was the only dose of PROQUAD (Merck), that the patient had ever been administered. No known adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. Some doses of PROQUAD (Merck) lot# reported as L006389, exp. 25-AUG-2016 and lot# K023365, exp. 20-MAY-2016 (dose was not reported), which were exposed to temperatures outside of the recommended range, have been administered to unspecified patients on unspecified dates since 14-AUG-2015. No adverse experience has been reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. Some doses of ZOSTAVAX lot# L006392, exp. 25-MAY-2016 and lot# L003215 exp. 30-APR-2016 (doses were not reported), which were exposed to temperatures outside of the recommended range, have been adminsitered to unspecified patients on unspecified dates since 14-AUG-2015. No adverse experience has been reported. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medicines were not reported. The patient was vaccinated with the second dose of GARDASIL (dose, route, lot # not provided) approximately in August 2014 (reported as "a year before"). On 12-AUG-2015, the patient was in the reporter's office to receive the third dose of GARDASIL injection (lot #, expiry date, dose and route of administration were not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 26-AUG-2015, the patient was inadvertently vaccinated with a dose of GARDASIL which was expired on 06-AUG-2015. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding unspecified patients of unknown age and gender. The patients pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of GARDASIL (dose and route were not reported, lot # K008931 with expiration date 04-MAR-2017 or lot #K004205 with expiration date 12-FEB-2017 or lot #K006960 with expiration date 19-FEB-2017). There was no adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medications, pertinent medical histories, drug reactions and allergies provided. On an unknown dates, the patients were vaccinated with improperly stored VAQTA 50/1.0 U/ml (lot# J003719, expiration date 27-SEP-2015, doses, frequency, site and route of administration were not reported). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patient called complaining of warmth, redness, swelling occurring 1 day after vaccination. Has been swollen and red for several days seeking treatment at urgent care.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, 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 medical history, concurrent conditions and concomitant therapies were not reported. On 11-AUG-2015, the patient was vaccinated with a dose of an improperly stored MMR II (albumin status: rHA; dose and route of administration were not reported; lot #L002873 and expiry date on 27-JAN-2017). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse (also reported as certified medical assistant) refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 18-AUG-2015, the patients were vaccinated with the improperly stored doses of GARDASIL (lot # K010215 with expiration date 05-MAY-2017 and lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported). No adverse experiences were reported. Additional information has been requested.
Age: 0.1
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 10 months old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8  Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAy-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 11 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 01-APR-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot # K004204, exp. date: 12-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medications, pertinent medical histories, drug reactions or allergies provided. On an unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # K001716, 24-NOV-2015, doses, frequency, site of administration were not reported) oral route of administration. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist student refers to a patient of unknown age and gender. No concurrent conditions and medical history were reported. The pharmacist reported that on 27-AUG-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K004542, expiration date 19-AUG-2015) (Route and dose were not provided). No concomitant medication was reported. No adverse effects reported. 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 licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medications, pertinent medical histories, drug reactions or allergies reported. On unspecified dates, since 14-AUG-2015, the patients were vaccinated with doses of ROTATEQ (lot #K023537, expiration date 22-JUN-2016; doses, frequency were not reported; oral route of administration), which were exposed to temperatures outside of the recommended range. No adverse experiences had been reported. This is one of 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 licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medications, pertinent medical histories, drug reactions or allergies reported. On unspecified dates, since 14-AUG-2015, the patients were vaccinated with doses of RECOMBIVAX HB (lot# J000722, expiration date 17-SEP-2015; lot# K024036, expiration date 26-NOV-2016, doses, frequency, site and route of administration were not reported), which were exposed to temperatures outside of the recommended range. No adverse experiences had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 4 year old patient of unknown gender. On 25-AUG-2015, the patient was inadvertently vaccinated with ZOSTAVAX, subcutaneously, lot # reported as L017139 with expiration date: 30-APR-2015 instead of (Oka/Merck) VARIVAX. No adverse effect was reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician assistant referring to a female patient of unknown age. Patient's relevant medical history, concurrent conditions and drug reactions/allergies were unspecified. She was not pregnant. On 12-OCT-2009 the patient was vaccinated with second dose of (Oka/Merck) VARIVAX subcutaneous (strength, dose, frequency, lot # , expiry date not reported) (inappropriate schedule of drug administration). Patient received her first dose of (Oka/Merck) VARIVAX on 17-MAR-1998. No concomitant medications were reported. Reporting physician assistant stated that patient had low titers for (Oka/Merck) VARIVAX (antibody test negative). Patient did not required medical attention. No treatment was provided for the adverse event). Outcome                                                 of the event, antibody test negative was unknown. Reporting physician assistant did not assessed the causality  of the event with respect to vaccination with (Oka/Merck) VARIVAX. Additional information has been requested.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old patient of unknown gender. The patient's concomitant therapy, pertinent medical history and drug allergies were reported as none. On 24-MAY-2015 the patient was vaccinated with ZOSTAVAX, lot # reported as L006357, expiry date 11-JUN-2016, 0.65 ml once subcutaneously. Lot number L006357 is an invalid lot number for ZOSTAVAX. On 25-MAY-2015, reported as 2 days post vaccination the patient experienced redness and itchiness at injection site. ON 25-AUG-2015 the patient was in the pharmacy where sought medical attention and reported the events to the pharmacist. The pharmacist stated that the patient doing fine except itchiness which continued, most notably when coming out of the shower. No treatment was given for redness and itchiness at injection site and no laboratory t4ests were performed. The relatedness between the events and suspect therapy was not reported. 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 and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, pertinent medical history, drug reactions and allergies provided. On 29-JUL-2015, the patient was vaccinated with an improperly stored GARDASIL 9 (lot# K026246, expiration date 28-JAN-2017, dose, route and site of administration were not reported). The vaccine was exposed to temperatures outside of the recommended range. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patients medical history, concurrent conditions and concomitant therapies were not reported. Approximately in August 2015 (reported as from 04-AUG-2015 to 17-AUG-2015) improperly stored GARDASIL (dose and route of administration were not reported; either with lot #K023432 and expiry date on 18-JUN-2016 and/or lot #K006960 and expiry date on 19-FEB-2017) was administered to multiple unspecified patients. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, pertinent medical history, drug reactions and allergies provided. On 28-JUL-2015, the patient was vaccinated with an improperly stored GARDASIL 9 (lot# K026246, expiration date 28-JAN-2017, dose, route and site of administration were not reported). The vaccine was exposed to temperatures outside of the recommended range. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 13 years old non-pregnant female patient. The patient's concurrent conditions included asthma and allergy to amoxicillin and cefdinir. Concomitant therapies included albuterol, ADVAIR, FLOVENT and ZYRTEC. On 18-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 (intramuscularly, lot # reported as L004014 (verified to be non-valid lot # for GARDASIL 9), expiration date 04-MAR-2017; dose was not reported). In August 2015, the patient experienced injection site reaction. The patient visited an unspecified physician and reported that the injection site on her upper arm was red and warm to touch. The physician did not prescribe a treatment, however he told the patient to keep an eye on the injection site to make sure that the redness did not get worse. The outcome of the adverse events was reported as not recovered. The relatedness between the adverse events and the vaccination with GARDASIL 9 was not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, Skin papilloma
Clinical narrative: Started with a few warts on leg, spread to hands and now her entire forehead covered in warts- she is under a dermatologists care- considered a severe outbreak of warts- because of our concerns of this vaccine we only had one dose.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Mobility decreased
Clinical narrative: Pain at injection site and shoulder/arm, limited range of motion.
Age: 24.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Burning sensation, Immediate post-injection reaction, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pt experienced a burning sensation when vaccines were administered and has since experienced worsening pain in her arm and shoulder and is unable to lift her arm more than 45 degrees.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 3 inch red circle around injection site with a sore/tender 1 inch round bump in the center.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt states that she had minor redness at the site of injection on the day of the vaccination.  Over the next day she describes itching and an increase in redness and warmth greater than the size of a quarter at the injection site.  Today, 08/30/2015, pt still has redness and warmth at the site.  She states that the itching is decreasing, and that she thinks the redness is not getting worse.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Dizziness, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Fever, chills, severe inflammation below injection site, tender to touch,  severely swollen arm muscle, fever in muscle below injection site, and dizziness.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Fever, chills, severe inflammation below injection site, tender to touch,  severely swollen arm muscle, fever in muscle below injection site, and dizziness.
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: Acoustic stimulation tests, Alcohol intolerance, Amnesia, Aphasia, Asthenia
Clinical narrative: Dizziness upon standing, loss of balance, near fainting episodes, shooting pains in head and face, constant ache and pressure in head and back of skull/neck area, extreme fatigue and exhaustion causing inability to work, brain fog, cognitive difficulty, forgetting words, difficulty telling time, difficulty focusing, difficulty spelling, easily overwhelmed with stimuli, muscle pain and weakness, mood swings, memory loss, low body temperature, low blood pressure, cold hands and feet, irritability, lack of patience, tingling in body, spots in vision, lack of appetite, nausea, constipation, Bell's Palsy, occular migraines, sensitivity to light and sound, chemical sensitivity, irregular periods, increased urination, night sweats, stiff joints, swollen eyes and lips, rib soreness, occasional facial numbness, lack of energy, heart palpitations, ringing in ears, increased affect from alcohol.
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: Balance disorder, Blood corticotrophin, Blood cortisol, Blood test, Body temperature decreased
Clinical narrative: Dizziness upon standing, loss of balance, near fainting episodes, shooting pains in head and face, constant ache and pressure in head and back of skull/neck area, extreme fatigue and exhaustion causing inability to work, brain fog, cognitive difficulty, forgetting words, difficulty telling time, difficulty focusing, difficulty spelling, easily overwhelmed with stimuli, muscle pain and weakness, mood swings, memory loss, low body temperature, low blood pressure, cold hands and feet, irritability, lack of patience, tingling in body, spots in vision, lack of appetite, nausea, constipation, Bell's Palsy, occular migraines, sensitivity to light and sound, chemical sensitivity, irregular periods, increased urination, night sweats, stiff joints, swollen eyes and lips, rib soreness, occasional facial numbness, lack of energy, heart palpitations, ringing in ears, increased affect from alcohol.
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: Cognitive disorder, Constipation, Decreased appetite, Disturbance in attention, Dizziness postural
Clinical narrative: Dizziness upon standing, loss of balance, near fainting episodes, shooting pains in head and face, constant ache and pressure in head and back of skull/neck area, extreme fatigue and exhaustion causing inability to work, brain fog, cognitive difficulty, forgetting words, difficulty telling time, difficulty focusing, difficulty spelling, easily overwhelmed with stimuli, muscle pain and weakness, mood swings, memory loss, low body temperature, low blood pressure, cold hands and feet, irritability, lack of patience, tingling in body, spots in vision, lack of appetite, nausea, constipation, Bell's Palsy, occular migraines, sensitivity to light and sound, chemical sensitivity, irregular periods, increased urination, night sweats, stiff joints, swollen eyes and lips, rib soreness, occasional facial numbness, lack of energy, heart palpitations, ringing in ears, increased affect from alcohol.
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: Electrocardiogram, Emotional distress, Eye swelling, Facial pain, Fatigue
Clinical narrative: Dizziness upon standing, loss of balance, near fainting episodes, shooting pains in head and face, constant ache and pressure in head and back of skull/neck area, extreme fatigue and exhaustion causing inability to work, brain fog, cognitive difficulty, forgetting words, difficulty telling time, difficulty focusing, difficulty spelling, easily overwhelmed with stimuli, muscle pain and weakness, mood swings, memory loss, low body temperature, low blood pressure, cold hands and feet, irritability, lack of patience, tingling in body, spots in vision, lack of appetite, nausea, constipation, Bell's Palsy, occular migraines, sensitivity to light and sound, chemical sensitivity, irregular periods, increased urination, night sweats, stiff joints, swollen eyes and lips, rib soreness, occasional facial numbness, lack of energy, heart palpitations, ringing in ears, increased affect from alcohol.
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: Feeling abnormal, Head discomfort, Headache, Hyperacusis, Hypoaesthesia
Clinical narrative: Dizziness upon standing, loss of balance, near fainting episodes, shooting pains in head and face, constant ache and pressure in head and back of skull/neck area, extreme fatigue and exhaustion causing inability to work, brain fog, cognitive difficulty, forgetting words, difficulty telling time, difficulty focusing, difficulty spelling, easily overwhelmed with stimuli, muscle pain and weakness, mood swings, memory loss, low body temperature, low blood pressure, cold hands and feet, irritability, lack of patience, tingling in body, spots in vision, lack of appetite, nausea, constipation, Bell's Palsy, occular migraines, sensitivity to light and sound, chemical sensitivity, irregular periods, increased urination, night sweats, stiff joints, swollen eyes and lips, rib soreness, occasional facial numbness, lack of energy, heart palpitations, ringing in ears, increased affect from alcohol.
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: Hypotension, Impaired work ability, Impatience, Irritability, Joint stiffness
Clinical narrative: Dizziness upon standing, loss of balance, near fainting episodes, shooting pains in head and face, constant ache and pressure in head and back of skull/neck area, extreme fatigue and exhaustion causing inability to work, brain fog, cognitive difficulty, forgetting words, difficulty telling time, difficulty focusing, difficulty spelling, easily overwhelmed with stimuli, muscle pain and weakness, mood swings, memory loss, low body temperature, low blood pressure, cold hands and feet, irritability, lack of patience, tingling in body, spots in vision, lack of appetite, nausea, constipation, Bell's Palsy, occular migraines, sensitivity to light and sound, chemical sensitivity, irregular periods, increased urination, night sweats, stiff joints, swollen eyes and lips, rib soreness, occasional facial numbness, lack of energy, heart palpitations, ringing in ears, increased affect from alcohol.
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: Lip swelling, Menstruation irregular, Migraine, Mood swings, Multiple chemical sensitivity
Clinical narrative: Dizziness upon standing, loss of balance, near fainting episodes, shooting pains in head and face, constant ache and pressure in head and back of skull/neck area, extreme fatigue and exhaustion causing inability to work, brain fog, cognitive difficulty, forgetting words, difficulty telling time, difficulty focusing, difficulty spelling, easily overwhelmed with stimuli, muscle pain and weakness, mood swings, memory loss, low body temperature, low blood pressure, cold hands and feet, irritability, lack of patience, tingling in body, spots in vision, lack of appetite, nausea, constipation, Bell's Palsy, occular migraines, sensitivity to light and sound, chemical sensitivity, irregular periods, increased urination, night sweats, stiff joints, swollen eyes and lips, rib soreness, occasional facial numbness, lack of energy, heart palpitations, ringing in ears, increased affect from alcohol.
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: Muscular weakness, Musculoskeletal chest pain, Myalgia, Nausea, Neck pain
Clinical narrative: Dizziness upon standing, loss of balance, near fainting episodes, shooting pains in head and face, constant ache and pressure in head and back of skull/neck area, extreme fatigue and exhaustion causing inability to work, brain fog, cognitive difficulty, forgetting words, difficulty telling time, difficulty focusing, difficulty spelling, easily overwhelmed with stimuli, muscle pain and weakness, mood swings, memory loss, low body temperature, low blood pressure, cold hands and feet, irritability, lack of patience, tingling in body, spots in vision, lack of appetite, nausea, constipation, Bell's Palsy, occular migraines, sensitivity to light and sound, chemical sensitivity, irregular periods, increased urination, night sweats, stiff joints, swollen eyes and lips, rib soreness, occasional facial numbness, lack of energy, heart palpitations, ringing in ears, increased affect from alcohol.
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: Night sweats, Nuclear magnetic resonance imaging, Pain, Palpitations, Paraesthesia
Clinical narrative: Dizziness upon standing, loss of balance, near fainting episodes, shooting pains in head and face, constant ache and pressure in head and back of skull/neck area, extreme fatigue and exhaustion causing inability to work, brain fog, cognitive difficulty, forgetting words, difficulty telling time, difficulty focusing, difficulty spelling, easily overwhelmed with stimuli, muscle pain and weakness, mood swings, memory loss, low body temperature, low blood pressure, cold hands and feet, irritability, lack of patience, tingling in body, spots in vision, lack of appetite, nausea, constipation, Bell's Palsy, occular migraines, sensitivity to light and sound, chemical sensitivity, irregular periods, increased urination, night sweats, stiff joints, swollen eyes and lips, rib soreness, occasional facial numbness, lack of energy, heart palpitations, ringing in ears, increased affect from alcohol.
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: Peripheral coldness, Photophobia, Pollakiuria, Presyncope, Tinnitus
Clinical narrative: Dizziness upon standing, loss of balance, near fainting episodes, shooting pains in head and face, constant ache and pressure in head and back of skull/neck area, extreme fatigue and exhaustion causing inability to work, brain fog, cognitive difficulty, forgetting words, difficulty telling time, difficulty focusing, difficulty spelling, easily overwhelmed with stimuli, muscle pain and weakness, mood swings, memory loss, low body temperature, low blood pressure, cold hands and feet, irritability, lack of patience, tingling in body, spots in vision, lack of appetite, nausea, constipation, Bell's Palsy, occular migraines, sensitivity to light and sound, chemical sensitivity, irregular periods, increased urination, night sweats, stiff joints, swollen eyes and lips, rib soreness, occasional facial numbness, lack of energy, heart palpitations, ringing in ears, increased affect from alcohol.
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: Urine analysis, VIIth nerve paralysis, Visual acuity tests, Visual impairment
Clinical narrative: Dizziness upon standing, loss of balance, near fainting episodes, shooting pains in head and face, constant ache and pressure in head and back of skull/neck area, extreme fatigue and exhaustion causing inability to work, brain fog, cognitive difficulty, forgetting words, difficulty telling time, difficulty focusing, difficulty spelling, easily overwhelmed with stimuli, muscle pain and weakness, mood swings, memory loss, low body temperature, low blood pressure, cold hands and feet, irritability, lack of patience, tingling in body, spots in vision, lack of appetite, nausea, constipation, Bell's Palsy, occular migraines, sensitivity to light and sound, chemical sensitivity, irregular periods, increased urination, night sweats, stiff joints, swollen eyes and lips, rib soreness, occasional facial numbness, lack of energy, heart palpitations, ringing in ears, increased affect from alcohol.
Age: 11.0
Sex: M
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Anti-thyroid antibody, Arthralgia, Autoimmune disorder, Autoimmune thyroiditis, Blood creatine phosphokinase
Clinical narrative: Chronic pain (all muscle and joint pain), chronic and persistent headache, autoimmune disease (Hashimoto's Thyroiditis), ear, nose, and throat issues, Ligamentous Laxity.
Age: 11.0
Sex: M
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Blood thyroid stimulating hormone, Borrelia test, Ear disorder, Headache, Ligament laxity
Clinical narrative: Chronic pain (all muscle and joint pain), chronic and persistent headache, autoimmune disease (Hashimoto's Thyroiditis), ear, nose, and throat issues, Ligamentous Laxity.
Age: 11.0
Sex: M
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Myalgia, Nasal disorder, Nuclear magnetic resonance imaging, Pain, Pharyngeal disorder
Clinical narrative: Chronic pain (all muscle and joint pain), chronic and persistent headache, autoimmune disease (Hashimoto's Thyroiditis), ear, nose, and throat issues, Ligamentous Laxity.
Age: 11.0
Sex: M
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Red blood cell sedimentation rate, Thyroxine free, Tri-iodothyronine, Ultrasound thyroid, Urine analysis
Clinical narrative: Chronic pain (all muscle and joint pain), chronic and persistent headache, autoimmune disease (Hashimoto's Thyroiditis), ear, nose, and throat issues, Ligamentous Laxity.
Age: 11.0
Sex: M
Vaccine: HPV4, TDAP, VARCEL
Symptoms: X-ray
Clinical narrative: Chronic pain (all muscle and joint pain), chronic and persistent headache, autoimmune disease (Hashimoto's Thyroiditis), ear, nose, and throat issues, Ligamentous Laxity.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: First muscle and joint pain of body and redness at injection site. Next morning, injection site was hard and redness grew to size of quarter, then half dollar. Muscle pain, itching and burning and pain of injection site continued throughout the day. Called doctor around 3pm was told it was my body's immune system reacting how it should. Took 800mg ibuprofen throughout day and night, also 60mg fexofenadine every 12 hours. Also applied ice as directed by doctor. Sunday morning, woke up worse pain and injection site size of a baseball and very painful, less itchy but still hard and hot. Plan on calling doctor Monday morning for further advice.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Injection site warmth, Myalgia
Clinical narrative: First muscle and joint pain of body and redness at injection site. Next morning, injection site was hard and redness grew to size of quarter, then half dollar. Muscle pain, itching and burning and pain of injection site continued throughout the day. Called doctor around 3pm was told it was my body's immune system reacting how it should. Took 800mg ibuprofen throughout day and night, also 60mg fexofenadine every 12 hours. Also applied ice as directed by doctor. Sunday morning, woke up worse pain and injection site size of a baseball and very painful, less itchy but still hard and hot. Plan on calling doctor Monday morning for further advice.
Age: 0.33
Sex: F
Vaccine: DTP, MMR
Symptoms: Crying, Emotional distress, Pyrexia, Restlessness, Screaming
Clinical narrative: I have 2 older daughters so I was not looking for adverse event- I'd read papers given to me by County Health Dept & I'd noticed- watch for a "cat cry" - thought "hmm ?" & we went to bed the PM of the shot- the 4mo old's crib was in my bedroom-I had work the next AM so I was tired- the baby woke up screaming & she could not be comforted - I noticed she had a fever so I took her temperature - it was elevated some- she continued to cry - I noticed a unusual sound to her cry- finally I ran a lukewarm/cool bath & sat in the tub with her- I did not call the emergency room- possibly because the vaccine was not from a clinic- it was close to the time we needed to get up - she was crying less after the bath but continued to be restless- she seemed better in the AM - I went to work and her dad took care of her that day.
Age: 16.0
Sex: F
Vaccine: HPVX
Symptoms: Asthenia, Dizziness, Headache, Muscular weakness, Nausea
Clinical narrative: Patient had a fever of 104, 5 hrs. after vaccine.  Patient had  normal temperature at time of vaccine.  Fever was sudden.  Patient had a headache described at "skull feels too tight, skin on my face feels too tight, eyes are too tight, they just want to pop free because the pressure is too great."  Patient was having seizures when brought into urgent care. Patient was given Ibuprofen by way of IV to drop temperature.  Patient was released 2.5 hours later.  Patient was advised to return to emergency if more symptoms presented, especially dizzy sign and vomiting.  6 hours later patient went to Emergency at Hospital with dizzy spells and nausea.  Patient was released.  On 8/30/15 she was admitted to Urgent Care again with feelings of weakness in her legs, spreading through her upper body.
Age: 16.0
Sex: F
Vaccine: HPVX
Symptoms: Ocular discomfort, Pyrexia, Seizure, Sensory disturbance, Skin tightness
Clinical narrative: Patient had a fever of 104, 5 hrs. after vaccine.  Patient had  normal temperature at time of vaccine.  Fever was sudden.  Patient had a headache described at "skull feels too tight, skin on my face feels too tight, eyes are too tight, they just want to pop free because the pressure is too great."  Patient was having seizures when brought into urgent care. Patient was given Ibuprofen by way of IV to drop temperature.  Patient was released 2.5 hours later.  Patient was advised to return to emergency if more symptoms presented, especially dizzy sign and vomiting.  6 hours later patient went to Emergency at Hospital with dizzy spells and nausea.  Patient was released.  On 8/30/15 she was admitted to Urgent Care again with feelings of weakness in her legs, spreading through her upper body.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: This spontaneous report was received from consumer (patient's daughter) regarding a 89 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. Approximately on 19-AUG-2015 (also reported as one week ago) the patient was vaccinated with booster for the PNEUMOVAX 23 dose, route unknown. Concomitant medications were not reported. On an unspecified date in August 2015, the patient was admitted into the hospital. Reporter reported that the patient was very sick and probably will die. The outcome of was very sick and probably will die was reported as not recovered. Causality assessment was not provided. PQC was not involved. Additional information has been requested.
Age: 0.8
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 9 months 1 day old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.7
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 8 months 30 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.8
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 8 months 30 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) Liquid PEDVAXHIB (injection, lot # K016965, exp. date: 20-JUL-2017)(dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reproted so far. THere were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected. no contact details were provided.
Age: 0.8
Sex: F
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 8 months 21 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) Liquid PEDVAXHIB (injection, lot # K016965, exp. date: 20-JUL-2007) (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. NO additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 1.11
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 23 months 13 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) liquid PEDVAXHIB (injection, lot # K016965, exp date: 20-JUL-201)(dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.9
Sex: F
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 9 months 5 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) liquid PEDVAXHIB (injection, lot # K016965, exp date: 20-JUL-201)(dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 14 year old female patient. There was no information about concurrent condition and historical medication. On an unknown date, the patient was vaccinated with GARDASIL 9 too soon at the age of 14 years (dose strength, route and lot number was unknown). No concomitant medication was reported. No product quality complaint (PQC) was involved. Patient enquired that what should be done now. The outcome of the event was unknown. Additional information has been requested.
Age: 0.1
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 10 months 28 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) liquid PEDVAXHIB (injection, lot # K016965, exp date: 20-JUL-201)(dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date in August 2014, the patient was vaccinated with GARDASIL dose 1 and dose 2 on 25-AUG-2015 (inappropriate schedule of drug administration) (dose, strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. Additional information has been requested.
Age: 0.8
Sex: F
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 8 months 16 days old  female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) liquid PEDVAXHIB (injection, lot # K016965, exp date: 20-JUL-201)(dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.1
Sex: F
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 10 months 28 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) liquid PEDVAXHIB (injection, lot # K016965, exp date: 20-JUL-201)(dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.8
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 8 months 3 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.8
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 8 months 27 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) liquid PEDVAXHIB (injection, lot # K016965, exp date: 20-JUL-201)(dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Injection site bruising
Clinical narrative: Left arm has bruises at injection site. Irregular shape (2 inches length x 1 inch wide). No fever or any s/s complained. The bruise occurred next day after injection.