chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: BCG, DTP
Symptoms: Jaundice, Leukopenia, Myalgia, Nausea, Nephritis
Clinical narrative: Agitation, Blurred Vision, Confusion, Depression, Dizziness, Hallucinations, Headache, Intracranial Bleed, Sedation, Seizures, Parkinsonism, Tardive Dyskinesia, TIA Stroke, Bleeding, Thrombocytopenia, Leukopenia, Anemia, Myalgia, Arthralgia, Phlebitis, Anaphylaxis, Fever, Angioedema, Skin Rash, Tachypnea, Resp Depression, Cough Wheeze, Rash, Erythema Multiforme, Urticaria Pruritus, Purpura, Sloughing, Constipation, Diarrhea, Nausea Vomiting, Gastric Bleeding, Palpitations, Hypertension, Hypotension, Syncope, Angina, Bradycardia, Tachycardia, Abnormal INR, Elevated Liver Enzymes, Jaundice, Elevated BUN SCr, Nephritis, Acute Tubular Necrosis, Acute Renal Failure, Hyperglycemia, Hypoglycemia and turned purple. Bupropion 300 mg BID, Aspirin 4 mg BID, Lisinopril 20 mg BID, Hydrochlorothiazide/propranolol 20 mg every day.
Age: 40.0
Sex: F
Vaccine: BCG, DTP
Symptoms: Palpitations, Parkinsonism, Phlebitis, Pruritus, Purpura
Clinical narrative: Agitation, Blurred Vision, Confusion, Depression, Dizziness, Hallucinations, Headache, Intracranial Bleed, Sedation, Seizures, Parkinsonism, Tardive Dyskinesia, TIA Stroke, Bleeding, Thrombocytopenia, Leukopenia, Anemia, Myalgia, Arthralgia, Phlebitis, Anaphylaxis, Fever, Angioedema, Skin Rash, Tachypnea, Resp Depression, Cough Wheeze, Rash, Erythema Multiforme, Urticaria Pruritus, Purpura, Sloughing, Constipation, Diarrhea, Nausea Vomiting, Gastric Bleeding, Palpitations, Hypertension, Hypotension, Syncope, Angina, Bradycardia, Tachycardia, Abnormal INR, Elevated Liver Enzymes, Jaundice, Elevated BUN SCr, Nephritis, Acute Tubular Necrosis, Acute Renal Failure, Hyperglycemia, Hypoglycemia and turned purple. Bupropion 300 mg BID, Aspirin 4 mg BID, Lisinopril 20 mg BID, Hydrochlorothiazide/propranolol 20 mg every day.
Age: 40.0
Sex: F
Vaccine: BCG, DTP
Symptoms: Pyrexia, Rash, Renal failure acute, Renal tubular necrosis, Respiratory depression
Clinical narrative: Agitation, Blurred Vision, Confusion, Depression, Dizziness, Hallucinations, Headache, Intracranial Bleed, Sedation, Seizures, Parkinsonism, Tardive Dyskinesia, TIA Stroke, Bleeding, Thrombocytopenia, Leukopenia, Anemia, Myalgia, Arthralgia, Phlebitis, Anaphylaxis, Fever, Angioedema, Skin Rash, Tachypnea, Resp Depression, Cough Wheeze, Rash, Erythema Multiforme, Urticaria Pruritus, Purpura, Sloughing, Constipation, Diarrhea, Nausea Vomiting, Gastric Bleeding, Palpitations, Hypertension, Hypotension, Syncope, Angina, Bradycardia, Tachycardia, Abnormal INR, Elevated Liver Enzymes, Jaundice, Elevated BUN SCr, Nephritis, Acute Tubular Necrosis, Acute Renal Failure, Hyperglycemia, Hypoglycemia and turned purple. Bupropion 300 mg BID, Aspirin 4 mg BID, Lisinopril 20 mg BID, Hydrochlorothiazide/propranolol 20 mg every day.
Age: 40.0
Sex: F
Vaccine: BCG, DTP
Symptoms: Sedation, Skin discolouration, Skin exfoliation, Syncope, Tachycardia
Clinical narrative: Agitation, Blurred Vision, Confusion, Depression, Dizziness, Hallucinations, Headache, Intracranial Bleed, Sedation, Seizures, Parkinsonism, Tardive Dyskinesia, TIA Stroke, Bleeding, Thrombocytopenia, Leukopenia, Anemia, Myalgia, Arthralgia, Phlebitis, Anaphylaxis, Fever, Angioedema, Skin Rash, Tachypnea, Resp Depression, Cough Wheeze, Rash, Erythema Multiforme, Urticaria Pruritus, Purpura, Sloughing, Constipation, Diarrhea, Nausea Vomiting, Gastric Bleeding, Palpitations, Hypertension, Hypotension, Syncope, Angina, Bradycardia, Tachycardia, Abnormal INR, Elevated Liver Enzymes, Jaundice, Elevated BUN SCr, Nephritis, Acute Tubular Necrosis, Acute Renal Failure, Hyperglycemia, Hypoglycemia and turned purple. Bupropion 300 mg BID, Aspirin 4 mg BID, Lisinopril 20 mg BID, Hydrochlorothiazide/propranolol 20 mg every day.
Age: 40.0
Sex: F
Vaccine: BCG, DTP
Symptoms: Tachypnoea, Tardive dyskinesia, Thrombocytopenia, Transient ischaemic attack, Urticaria
Clinical narrative: Agitation, Blurred Vision, Confusion, Depression, Dizziness, Hallucinations, Headache, Intracranial Bleed, Sedation, Seizures, Parkinsonism, Tardive Dyskinesia, TIA Stroke, Bleeding, Thrombocytopenia, Leukopenia, Anemia, Myalgia, Arthralgia, Phlebitis, Anaphylaxis, Fever, Angioedema, Skin Rash, Tachypnea, Resp Depression, Cough Wheeze, Rash, Erythema Multiforme, Urticaria Pruritus, Purpura, Sloughing, Constipation, Diarrhea, Nausea Vomiting, Gastric Bleeding, Palpitations, Hypertension, Hypotension, Syncope, Angina, Bradycardia, Tachycardia, Abnormal INR, Elevated Liver Enzymes, Jaundice, Elevated BUN SCr, Nephritis, Acute Tubular Necrosis, Acute Renal Failure, Hyperglycemia, Hypoglycemia and turned purple. Bupropion 300 mg BID, Aspirin 4 mg BID, Lisinopril 20 mg BID, Hydrochlorothiazide/propranolol 20 mg every day.
Age: 40.0
Sex: F
Vaccine: BCG, DTP
Symptoms: Vision blurred, Vomiting, Wheezing
Clinical narrative: Agitation, Blurred Vision, Confusion, Depression, Dizziness, Hallucinations, Headache, Intracranial Bleed, Sedation, Seizures, Parkinsonism, Tardive Dyskinesia, TIA Stroke, Bleeding, Thrombocytopenia, Leukopenia, Anemia, Myalgia, Arthralgia, Phlebitis, Anaphylaxis, Fever, Angioedema, Skin Rash, Tachypnea, Resp Depression, Cough Wheeze, Rash, Erythema Multiforme, Urticaria Pruritus, Purpura, Sloughing, Constipation, Diarrhea, Nausea Vomiting, Gastric Bleeding, Palpitations, Hypertension, Hypotension, Syncope, Angina, Bradycardia, Tachycardia, Abnormal INR, Elevated Liver Enzymes, Jaundice, Elevated BUN SCr, Nephritis, Acute Tubular Necrosis, Acute Renal Failure, Hyperglycemia, Hypoglycemia and turned purple. Bupropion 300 mg BID, Aspirin 4 mg BID, Lisinopril 20 mg BID, Hydrochlorothiazide/propranolol 20 mg every day.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Presented to clinic 2 days after vaccines with redness and tenderness at injection site. Area of redness is 6 x 6.5 cm increased warmth and tenderness. No swelling. Treated with AUGMENTIN 800mg BID x10 days.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unspecified demographics. Approximately on an unknown date in 2013 (reported as between 18-FEB-2013 and 11-JUN-2013), an unknown number of patients might have received RECOMBIVAX HB injection (dose, lot number and expiry date was unspecified) that had been improperly stored. Concomitant therapy was unspecified. No adverse effects reported. No product quality complaint was involved. The outcome of patients might received improperly stored RECOMBIVAX HB was unknown. No further information was provided. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unspecified demographics. Approximately on an unknown date in 2013 (reported as between 18-FEB-2013 and 11 -JUN-2013), an unknown number of patients might have received dose of PNEUMOVAX 23 (dose, lot number and expiry date was unspecified) that had been improperly stored. Concomitant therapy was unspecified. No adverse effects reported. No product quality complaint was involved. The outcome of patients might have received improperly stored PNEUMOVAX 23 was unknown. No further information was provided. This is one of the several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PPV, VARCEL
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site rash, Pyrexia
Clinical narrative: Received vaccines (listed below) 2/10/14. 2/11/14 - 103 fever, c/o pain, soreness bilateral thighs. Seen in office 2/11/14. No erythema, bruising or rash on exam. Uncooperative with movement of legs due to pain - (L) leg discomfort at SLR and hip flexion. 2/13/14 seen in office with very faint, erythematous rash to (L) thigh, no fever.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unspecified demographics. Approximately on an unknown date in 2013 (reported as between 18-FEB-2013 and 11-JUN-2013), an unknown number of patients might have received dose of GARDASIL (dose, lot number and expiry date was unspecified) that had been improperly stored. Concomitant therapy was unspecified. No adverse effects reported. No product quality complaint was involved. The outcome of patients might have received improperly stored GARDASIL was unknown. No further information was provided. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unspecified demographics. Approximately on an unknown date in 2013 (reported as between 18-FEB-2013 and 11-JUN-2013), an unknown number of patients might have received dose of ROTATEQ (dose, lot number and expiry date was unspecified) that had been improperly stored. Concomitant therapy was unspecified. No adverse effects reported. No product quality complaint was involved. The outcome of patients might have received improperly stored ROTATEQ was unknown. No further information was provided. This is one of the several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Alopecia, Eye swelling
Clinical narrative: This spontaneous report was received from a consumer referring on her son, a male patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with GARDASIL dose 1, 1 single shot, for HPV vaccine. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The reporter stated that after her son had had many of the same symptoms that her daughter (case # 1405USA002064) that also began after his first GARDASIL dose. He additionally had "swelling of the eyes" and loss of hair (on an unknown date). The reporter did not indicate that he had developed any heart condition. Reporter's son received his second dose of GARDASIL. At the time of the report the outcome of the events was unknown. This is one of two reports from the same source. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Fatigue, Headache, Injection site pain, Malaise
Clinical narrative: Arm soreness at injection site. Fatigue, malaise, generalized body aches, generalized weakness, headache, mild fever of 99.6.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Arm soreness at injection site. Fatigue, malaise, generalized body aches, generalized weakness, headache, mild fever of 99.6.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Pruritus, Pyrexia, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 month old male patient. On 31-MAR-2014 the patient was vaccinated with PROQUAD, 0.5 ml, subcutaneous. On 08-APR-2014 (reported as 8 days after vaccination) the patient experienced chickenpox, which was diagnosed on 11-APR-2014 when the patient sought medical attention and was seen by a physician. The patient was treated for the event, he was advised to take ZYRTEC for itching and ibuprofen (manufacturer unknown) for fevers. Lab diagnostics were not performed. The outcome of chickenpox is unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Dizziness, Feeling cold, Pallor
Clinical narrative: After receiving HAVRIX, patient was dizzy and slumped over. Patient felt cold and turned pale. Patient was caught by clinician. Patient regained consciousness after a minutes. Patient remained in the pharmacy for 30 minutes for observation.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Agitation, Anxiety, Arthralgia, Cardiac disorder, Cough
Clinical narrative: This spontaneous report was received from a consumer referring on her daughter, a 16 year old female patient. Medical history and concurrent conditions were not reported. In 2013 the patient was vaccinated with GARDASIL dose 1, 1 single shot. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The reporter stated that after her daughter received her first and only dosage of GARDASIL dose 1 in 2013, she had an immediate and extreme personality change. The daughter also began to have fatigue and joint/muscle pain. She has constant "sinus colds and coughing. The developed "depression, anxiety, agitation and mood swings." In addition, her menstrual cycle was also affected. She had an electrocardiogram (EKG) that indicate that her heart is "acting up" (on an unknown date). Therapy with GARDASIL was discontinued. The outcome of depression, fatigue, muscle pain, joint pain, coughing, menstrual cycle affected, mood swings, agitation, anxiety, heart acting up, sinus colds and extreme personality change was reported as not recovered/not resolved. The patient sought medical attention, she was seen by many unspecified HCPs. This is one of two reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Depression, Electrocardiogram abnormal, Fatigue, Immediate post-injection reaction, Menstrual disorder
Clinical narrative: This spontaneous report was received from a consumer referring on her daughter, a 16 year old female patient. Medical history and concurrent conditions were not reported. In 2013 the patient was vaccinated with GARDASIL dose 1, 1 single shot. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The reporter stated that after her daughter received her first and only dosage of GARDASIL dose 1 in 2013, she had an immediate and extreme personality change. The daughter also began to have fatigue and joint/muscle pain. She has constant "sinus colds and coughing. The developed "depression, anxiety, agitation and mood swings." In addition, her menstrual cycle was also affected. She had an electrocardiogram (EKG) that indicate that her heart is "acting up" (on an unknown date). Therapy with GARDASIL was discontinued. The outcome of depression, fatigue, muscle pain, joint pain, coughing, menstrual cycle affected, mood swings, agitation, anxiety, heart acting up, sinus colds and extreme personality change was reported as not recovered/not resolved. The patient sought medical attention, she was seen by many unspecified HCPs. This is one of two reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Mood swings, Myalgia, Nasopharyngitis, Personality change
Clinical narrative: This spontaneous report was received from a consumer referring on her daughter, a 16 year old female patient. Medical history and concurrent conditions were not reported. In 2013 the patient was vaccinated with GARDASIL dose 1, 1 single shot. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The reporter stated that after her daughter received her first and only dosage of GARDASIL dose 1 in 2013, she had an immediate and extreme personality change. The daughter also began to have fatigue and joint/muscle pain. She has constant "sinus colds and coughing. The developed "depression, anxiety, agitation and mood swings." In addition, her menstrual cycle was also affected. She had an electrocardiogram (EKG) that indicate that her heart is "acting up" (on an unknown date). Therapy with GARDASIL was discontinued. The outcome of depression, fatigue, muscle pain, joint pain, coughing, menstrual cycle affected, mood swings, agitation, anxiety, heart acting up, sinus colds and extreme personality change was reported as not recovered/not resolved. The patient sought medical attention, she was seen by many unspecified HCPs. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unspecified demographics. Approximately on an unknown date in 2013 (reported as between 18-FEB-2013 and 11-JUN-2013), an unknown number of patients might have received dose of PEDVAXHIB (dose, lot number and expiry date was unspecified) that had been improperly stored. Concomitant therapy was unspecified. No adverse effects reported. No product quality complaint was involved. The outcome of patients might have received improperly stored PEDVAXHIB was unknown. No further information was provided. This is one of the several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: HEPA, TYP
Symptoms: Fatigue, Sluggishness
Clinical narrative: Patient received Hep A #1 4-25-14. Well appearing. T.C. from patient 4 days later 4-29-14 reporting he felt sluggish/fatigued. Said he did not think he should have received vaccine due to adverse response to topical NEOSPORIN age 5 (inflammation at site) denies severe allergic rxn then or now. Appointment offered - he declined. Called pt next day - feels little more rested - offered allergy appoint - let him know GlaxoSmithKline pharmacist consulted.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect dose administered
Clinical narrative: Pt was given 2 doses of Tdap vaccine (BOOSTRIX). Admin error.
Age: 0.2
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to 8 week old infant patient. On 30-APR-2014, the patient was vaccinated with first dose of GARDASIL (dose, route and frequency were not reported). No adverse symptoms reported. No further information provided. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea
Clinical narrative: Weakness, shortness of breath.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Seizures (onset for first time) within several months of vaccination (3).
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Patient received 4 vaccines in same arm (right).  Mother complained of bruising, swelling and redness to right upper arm.  Parent took child to MD's office, but spoke to nurse only (she did not make a visit note).  Nurse applied cortisone cream and guaze to right upper arm and advised mom to apply ice as necessary for swelling.  Area of redness and swelling was measured at 60mm x 55mm.  Patient had full ROM and no limitations.  Spoke to mother on 4/21/14 and she states he is better and only slight redness remains.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Pt. had redness and enduration to Left arm at varicella injection site measuring 5 X 4.5 inches.  Recommended Benadryl for symptoms, or if worsens to see MD.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram, Laboratory test, Muscular weakness, Nuclear magnetic resonance imaging, Tinnitus
Clinical narrative: Left leg weakness, left ear buzzing, left arm mild weakness.
Age: 1.32
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: Hives to abdomen.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Rash generalised
Clinical narrative: Exanthem over face, arms, chest, thighs, minimally on back and abdomen.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Pt reported to us on 05/06/14 that she developed rash under her arm and on her neck. She said it is very itchy.
Age: 0.44
Sex: M
Vaccine: DTAP, PNC
Symptoms: Emotional distress, Screaming, Somnolence
Clinical narrative: Heavy sleeping period followed by high pitched screaming that lasted 2+ hours. Inconsolable.
Age: 36.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Urticaria
Clinical narrative: Welt 6 inches by 2 inches raised 1/4 inch. This lasted for 48 hours. It has decreased in size. 5 days after shot minimal reaction remains.
Age: 26.0
Sex: M
Vaccine: HPV4
Symptoms: Disturbance in attention, Dysphagia, Headache, Hyperacusis, Loss of consciousness
Clinical narrative: Patient reports having experienced issues with talking, concentrating, swallowing, severe headaches, fever, sensitivity to light and loud noises,and states that he passed out in chair sitting up.  Patient shared that he believes the symptoms are related to aluminum in the vaccine, and that he is currently completing detox process for aluminum poisoning.
Age: 26.0
Sex: M
Vaccine: HPV4
Symptoms: Metal poisoning, Photophobia, Pyrexia, Speech disorder
Clinical narrative: Patient reports having experienced issues with talking, concentrating, swallowing, severe headaches, fever, sensitivity to light and loud noises,and states that he passed out in chair sitting up.  Patient shared that he believes the symptoms are related to aluminum in the vaccine, and that he is currently completing detox process for aluminum poisoning.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local swelling
Clinical narrative: Swelling and redness of upper arm.
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Bronchitis, Chills, Decreased appetite, Disorientation
Clinical narrative: Shivering uncontrollably, high fever above 102F, minor disorientation. Cleared up after 12 hours followed by severe headache. Painful joints /mucsles and loss of appitite along with bronchitis like symptoms. Still no appitite and chest congestion
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Headache, Myalgia, Pyrexia, Respiratory tract congestion
Clinical narrative: Shivering uncontrollably, high fever above 102F, minor disorientation. Cleared up after 12 hours followed by severe headache. Painful joints /mucsles and loss of appitite along with bronchitis like symptoms. Still no appitite and chest congestion
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Body temperature increased, Decreased appetite, Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Per mom - infant had temperature under 100 degrees.  Both legs were red, inflamed, swollen - the left leg more symptomatic (Pentacel) than right (Prevnar).  Infant had decreased appetite and was fussy for two to three days following immunization.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Irritability
Clinical narrative: Per mom - infant had temperature under 100 degrees.  Both legs were red, inflamed, swollen - the left leg more symptomatic (Pentacel) than right (Prevnar).  Infant had decreased appetite and was fussy for two to three days following immunization.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Erythema, Headache, Oedema, Skin discolouration
Clinical narrative: Headache, erythema, edema, black and blue discoloration.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Full blood count, Intussusception, Ultrasound abdomen, Vomiting
Clinical narrative: Persistent vomiting x 3 days. Dx with Intussusception on 3-31-14.
Age: 1.27
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Balance disorder, Hemiparesis, Injection site movement impairment, Musculoskeletal disorder, Nuclear magnetic resonance imaging normal
Clinical narrative: Weakness of right side of the body suddenly and couldn't balance herself and couldn't use her right hand and right leg for few hours.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a 13 year old patient. On 10-APR-2014, the 13 year old patient was vaccinated with PROQUAD 0.5 ml, subcutaneous. No adverse effect reported. No further information was provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Medical history and concurrent conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength, route and lot number were not reported). Secondary and concomitant therapies were not reported. Pharmacist stated that an unspecified patient that received ZOSTAVAX on an unspecified date presented with shingles four days after receiving ZOSTAVAX. Pharmacist was unable to provide any further information as the unspecified patient had returned at a much later unspecified date to provide this information. Outcome of shingles was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to two patients of unknown age and gender. On 01-MAY-2014 the patients received a dose of (Oka/Merck) PROQUAD (Lot #, 0.5ml dose, subcutaneous route) that were improperly stored. Concomitant medications were not reported. All doses were administered according to the prescribing information. No adverse event reported. This case is linked to MARRS 1405USA003236. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Differential white blood cell count normal, Full blood count normal, Injection site cellulitis, Injection site erythema, Petechiae
Clinical narrative: Seen 4/30/14 in pediatrician office for red mark on (L) thigh at immun site and rash on torso. Dx with cellulitis on (L) thigh and petechiae rash. Had rec'd 12 mo immuns Hep A, MMR, VARIVAX on 4/22. CBC wnl.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Seen 4/30/14 in pediatrician office for red mark on (L) thigh at immun site and rash on torso. Dx with cellulitis on (L) thigh and petechiae rash. Had rec'd 12 mo immuns Hep A, MMR, VARIVAX on 4/22. CBC wnl.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Larger erythematous area on (L) thigh, not tender, localized to area around vaccine, no pustules, or vesicles, no other lesions anywhere else, slightly warm.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to two patients of unknown age and gender. On 01-MAY-2014 the patients received a dose of VARIVAX (Merck) (Lot #, 0.5ml dose and subcutaneous route) that were improperly stored. Concomitant medications were not reported. All doses were administered according to the prescribing information. No adverse event reported. This case is linked to MARRS 1405USA002081. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Complicated migraine, Dizziness, Dysarthria, Headache, Hypoaesthesia
Clinical narrative: This spontaneous report as received from registered nurse via company representative refers to a 15 year old female patient. On 01-MAY-2014 the patient was vaccinated with the first dose in regimen of GARDASIL (lot # J013324, exp date 12-FEB-2016). Concomitant therapy was not reported. On 01-MAY-2014, the patient started to experience light headedness. Later that evening she experienced numbness, slurred speech and a headache. She went to the emergency room (location unspecified) and she was diagnosed with a complicated migraine. As a treatment for the adverse events, the patient received ZOFRAN and intravenous fluids. The patient recovered from complicated migraine on 02-MAY-2014. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A., also reported as nurse) refers to a 70 year old male patient. No pertinent medical history or drug reactions/allergies were provided. On 02-MAY-2014, the patient was vaccinated with VARIVAX (Merck) INJ (dose, route and lot number was not provided). Co-suspect therapies included ZOSTAVAX (dose, route and lot number was not provided). No concomitant therapies were reported. The reporter stated that on 02-MAY-2014, the patient received VARIVAX (Merck) in error rather than ZOSTAVAX. No adverse effect was reported. The reporter also stated that no product confusion was discovered, just medication error. It was reported that the patient was in the office at the time of the report and the office was intending to administer a dose of ZOSTAVAX to the patient that just received the VARIVAX (Merck) in error. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site reaction, Skin tightness
Clinical narrative: ZOSTAVAX given subcutaneously in left upper arm - patient immediately complained of tightness at injection site - redness at site 3cm - induration 1cm - progressed to 3cm induration in 15 minutes observed for 45 minutes.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Serum sickness, Urticaria
Clinical narrative: Serum sickness - painful joints and hives progressing 12-24 hours after vaccine.
Age: 19.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema
Clinical narrative: Discovered reddened area (L) upper arm and sent picture to mother via phone who advised a BENADRYL cream. Not used here today with >2x the circumference of the initial reddened area.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Induration, Injection site erythema, Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: Vaccines rec'd 5/1/2014, that evening upper (L) thigh began swelling, red and splotchy. Sat morning, screaming with no leg pain. No fever. In office, 4cm, mild, non-tender induration on 5/5/14.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Screaming
Clinical narrative: Vaccines rec'd 5/1/2014, that evening upper (L) thigh began swelling, red and splotchy. Sat morning, screaming with no leg pain. No fever. In office, 4cm, mild, non-tender induration on 5/5/14.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Axillary pain, Erythema, Injection site erythema, Injection site swelling, Rash
Clinical narrative: Faint redness and rash with pain under axilla x 5 days. Redness and swelling around injection site.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Faint redness and rash with pain under axilla x 5 days. Redness and swelling around injection site.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site rash, Irritability, Pyrexia
Clinical narrative: Rash on both thighs starting 5/3/14, day after vaccine anterior thighs. Rash more raised on (R) thigh than (L). Had similar rash both anterior thighs after 2 mth shots though fewer bump than currently. Had fever 2 days ago (5-3) fussy (5-4) happy today 5-5-14. Not scratching thighs today.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Asthma, Basophil percentage decreased, Basophil percentage increased, Bronchial hyperreactivity, Chest pain
Clinical narrative: Hives: started immediately, continues now. Increased asthma: results in troubled sleeping, coughs, chest pains before flu shot asthma was restricted to spring.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Cough, Dyspnoea exertional, Eosinophil percentage increased, Eosinophilia
Clinical narrative: Hives: started immediately, continues now. Increased asthma: results in troubled sleeping, coughs, chest pains before flu shot asthma was restricted to spring.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Full blood count, Immediate post-injection reaction, Insomnia, Nasal oedema, Ocular hyperaemia
Clinical narrative: Hives: started immediately, continues now. Increased asthma: results in troubled sleeping, coughs, chest pains before flu shot asthma was restricted to spring.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Productive cough, Rhinitis allergic, Skin test positive, Smear test, Spirometry abnormal
Clinical narrative: Hives: started immediately, continues now. Increased asthma: results in troubled sleeping, coughs, chest pains before flu shot asthma was restricted to spring.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria, Wheezing
Clinical narrative: Hives: started immediately, continues now. Increased asthma: results in troubled sleeping, coughs, chest pains before flu shot asthma was restricted to spring.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL, VARCEL
Symptoms: Injection site erythema, Pyrexia, Skin warm, Vaccination complication
Clinical narrative: This spontaneous report was received from a Nurse refers to a 12 year old male patient. On 03-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot # J009165, 0.5 ml one dose, subcutaneous. On 06-MAR-2014, 4 days after onset of therapy the patient experienced redness and swelling at injection site (which measured 5.5 inches by 6 inches) and was also hot to the touch. The patient sought medical attention and contacted the physician. On 11-MAR-2014, the patient recovered from redness and swelling at the injection site and was also hot to the touch. The reporter did not provide the causality between the event and the suspect drug. This case is linked to the SR 1-11326380997 and SR 1-11326381095 (same reporter link). Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a Nurse refers to a 12 year old male patient. On 03-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot # J009165, 0.5 ml one dose, subcutaneous. On 06-MAR-2014, 4 days after onset of therapy the patient experienced redness and swelling at injection site (which measured 5.5 inches by 6 inches) and was also hot to the touch. The patient sought medical attention and contacted the physician. On 11-MAR-2014, the patient recovered from redness and swelling at the injection site and was also hot to the touch. The reporter did not provide the causality between the event and the suspect drug. This case is linked to the SR 1-11326380997 and SR 1-11326381095 (same reporter link). Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Erythema, Induration, Pruritus, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old female patient. The patient had no known drug allergies. On 23-APR-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, strength and route not reported. The pharmacist stated that the evening on the same day that the patient received ZOSTAVAX, the patient reported that she experienced a fever of unspecified elevation. The patient had been developing redness and soreness at the injection site, and the area of redness and soreness was "going around the arm" to her axilla region. The pharmacist reported that yesterday, 24-APR-2014, the area of redness, "hardness" and soreness was 2 inches by 4 inches in size, and today (25-APR-2014), the area was larger. The patient stated that it was difficult for her to apply her deodarant this morning, 25-APR-2014, because of the soreness. The patient informed the pharmacist that she had been treating herself with BENADRYL in the evening, but since she was at work today (25-APR-2014), she was not taking any BENADRYL currently. The physician, in whose office the patient worked, had offered to prescribe prednisone to help with the inflammation. No lab diagnostics studies was perforned. No intervention to prevent serious criteia. At the time of reporting, the patient was still developing redness and soreness and "hardness" at her injection site, the outcome of the events was not recovered. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old female patient. The patient had no known drug allergies. On 23-APR-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, strength and route not reported. The pharmacist stated that the evening on the same day that the patient received ZOSTAVAX, the patient reported that she experienced a fever of unspecified elevation. The patient had been developing redness and soreness at the injection site, and the area of redness and soreness was "going around the arm" to her axilla region. The pharmacist reported that yesterday, 24-APR-2014, the area of redness, "hardness" and soreness was 2 inches by 4 inches in size, and today (25-APR-2014), the area was larger. The patient stated that it was difficult for her to apply her deodarant this morning, 25-APR-2014, because of the soreness. The patient informed the pharmacist that she had been treating herself with BENADRYL in the evening, but since she was at work today (25-APR-2014), she was not taking any BENADRYL currently. The physician, in whose office the patient worked, had offered to prescribe prednisone to help with the inflammation. No lab diagnostics studies was perforned. No intervention to prevent serious criteia. At the time of reporting, the patient was still developing redness and soreness and "hardness" at her injection site, the outcome of the events was not recovered. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Inflammation, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old female patient. The patient had no known drug allergies. On 23-APR-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, strength and route not reported. The pharmacist stated that the evening on the same day that the patient received ZOSTAVAX, the patient reported that she experienced a fever of unspecified elevation. The patient had been developing redness and soreness at the injection site, and the area of redness and soreness was "going around the arm" to her axilla region. The pharmacist reported that yesterday, 24-APR-2014, the area of redness, "hardness" and soreness was 2 inches by 4 inches in size, and today (25-APR-2014), the area was larger. The patient stated that it was difficult for her to apply her deodarant this morning, 25-APR-2014, because of the soreness. The patient informed the pharmacist that she had been treating herself with BENADRYL in the evening, but since she was at work today (25-APR-2014), she was not taking any BENADRYL currently. The physician, in whose office the patient worked, had offered to prescribe prednisone to help with the inflammation. No lab diagnostics studies was perforned. No intervention to prevent serious criteia. At the time of reporting, the patient was still developing redness and soreness and "hardness" at her injection site, the outcome of the events was not recovered. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old female patient. The patient had no known drug allergies. On 23-APR-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, strength and route not reported. The pharmacist stated that the evening on the same day that the patient received ZOSTAVAX, the patient reported that she experienced a fever of unspecified elevation. The patient had been developing redness and soreness at the injection site, and the area of redness and soreness was "going around the arm" to her axilla region. The pharmacist reported that yesterday, 24-APR-2014, the area of redness, "hardness" and soreness was 2 inches by 4 inches in size, and today (25-APR-2014), the area was larger. The patient stated that it was difficult for her to apply her deodarant this morning, 25-APR-2014, because of the soreness. The patient informed the pharmacist that she had been treating herself with BENADRYL in the evening, but since she was at work today (25-APR-2014), she was not taking any BENADRYL currently. The physician, in whose office the patient worked, had offered to prescribe prednisone to help with the inflammation. No lab diagnostics studies was perforned. No intervention to prevent serious criteia. At the time of reporting, the patient was still developing redness and soreness and "hardness" at her injection site, the outcome of the events was not recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4, FLUX, HPV4
Symptoms: Fatigue, Headache, Nausea, Syncope, Vomiting
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 year old (reported as 17 year old, now 17 year old) female patient. The patient received an initial dose of GARDASIL (lot # not reported) in November 2012 concomitantly with a flu vaccine (manufacturer unknown) and she had GI (gastrointestinal) effects such as nausea, vomiting and also syncope. She received her second dose of GARDASIL (lot # not reported) in February of 2013. Nurse was told that the patient had been bedridden since second dose. Patient decided not to receive the third dose. Patient sought unspecified medical attention. The outcome of events was unknown. Upon internal review, bedridden was considered to be disability. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4, FLUX, HPV4
Symptoms: Bedridden, Gastrointestinal disorder, Incomplete course of vaccination, Nausea, Syncope
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 year old (reported as 17 year old, now 17 year old) female patient. The patient received an initial dose of GARDASIL (lot # not reported) in November 2012 concomitantly with a flu vaccine (manufacturer unknown) and she had GI (gastrointestinal) effects such as nausea, vomiting and also syncope. She received her second dose of GARDASIL (lot # not reported) in February of 2013. Nurse was told that the patient had been bedridden since second dose. Patient decided not to receive the third dose. Patient sought unspecified medical attention. The outcome of events was unknown. Upon internal review, bedridden was considered to be disability. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4, FLUX, HPV4
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 year old (reported as 17 year old, now 17 year old) female patient. The patient received an initial dose of GARDASIL (lot # not reported) in November 2012 concomitantly with a flu vaccine (manufacturer unknown) and she had GI (gastrointestinal) effects such as nausea, vomiting and also syncope. She received her second dose of GARDASIL (lot # not reported) in February of 2013. Nurse was told that the patient had been bedridden since second dose. Patient decided not to receive the third dose. Patient sought unspecified medical attention. The outcome of events was unknown. Upon internal review, bedridden was considered to be disability. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Febrile convulsion, Laboratory test, Pneumonia, Pyrexia, Urinary tract infection
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 4 year old male patient. On 23-APR-2014 the patient was vaccinated with PROQUAD (lot number J013857; valid). Other suspect therapies included KINRIX administered at the same time. On 24-APR-2014 the patient was sent to the hospital (ER) with a 102.7 fever and a 10 minute long febrile seizure, but he was not admitted. After (unspecified) tests were run while the patient was at the ER, the physician said that the patient had an urinary tract infection and pneumonia. "The patient also experienced a febrile seizure some time ago when he was sick, this was not the first time". The outcome of the events was reported as recovering/resolving. The relatedness was not provided. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 4 year old male patient. On 23-APR-2014 the patient was vaccinated with PROQUAD (lot number J013857; valid). Other suspect therapies included KINRIX administered at the same time. On 24-APR-2014 the patient was sent to the hospital (ER) with a 102.7 fever and a 10 minute long febrile seizure, but he was not admitted. After (unspecified) tests were run while the patient was at the ER, the physician said that the patient had an urinary tract infection and pneumonia. "The patient also experienced a febrile seizure some time ago when he was sick, this was not the first time". The outcome of the events was reported as recovering/resolving. The relatedness was not provided. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Rash pruritic
Clinical narrative: Itchy rash- responded to Benadryl.
Age: 16.0
Sex: M
Vaccine: HPVX
Symptoms: Skin papilloma
Clinical narrative: Developed warts on hands after HPV vaccine...has been treated in office and now using over the counter remedies.
Age: 65.0
Sex: F
Vaccine: HEP
Symptoms: Angina pectoris, Chest discomfort, Fatigue, Feeling abnormal, Throat tightness
Clinical narrative: Significant pain around heart and in chest cavity and tightness in chest cavity and throat.  This happened about 10 minutes after shot.  Blurry vision for about 1-2 hours and very fatiqued for evening and next day. Very fuzzy headed for a few days.
Age: 65.0
Sex: F
Vaccine: HEP
Symptoms: Vision blurred
Clinical narrative: Significant pain around heart and in chest cavity and tightness in chest cavity and throat.  This happened about 10 minutes after shot.  Blurry vision for about 1-2 hours and very fatiqued for evening and next day. Very fuzzy headed for a few days.
Age: 40.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain upper, Back pain, Pain in extremity, Paraesthesia
Clinical narrative: Left arm pain, stomach pain, back pain, parasthesis.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Swelling
Clinical narrative: Swelling and redness no fever no discharge. Given Cephalexin 500mg capsule 2 times daily x 14 days. Given Keflex 500 BID x 14 days.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist via field employee refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX vial, dose (unknown), route of administration (unknown). Concomitant therapies included many therapy unspecified. On an unknown date, the patient became dizzy and developed redness of her arm at the injection site, shortly after receiving with ZOSTAVAX. Patient sought medical attention because adverse event occurred in pharmacy. BENADRYL was given as treatment for adverse events. Action taken with respect to ZOSTAVAX was not applicable. No product quality complaint was involved. The outcome of events was reported as resolved. Causality was not provided. No other information was available. Additional information has been requested.