chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: M
Vaccine: MMR, RAB, SMALL
Symptoms: Sinus arrhythmia, Sinus bradycardia
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This solicited case was received from the investigator in a trial on 17 April 2015. A 30 year-old male subject whose past medical history included high blood pressure and cardiomyopathy was found to have hypertrophic obstructive cardiomyopathy on 13 March 2015, 23 days after the subject had received the following vaccines on 18 February 2015: an injection of Smallpox (Vaccinia) Live Vaccine, (number, route and site of administration not reported), Rabies Vaccine (reported as Rabbies - IM (4)), (manufacturer, lot number, route and site of administration not reported), and MMR (2) (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal ECG (electrocardiogram) on an unreported date. Troponin I, lumbar puncture and MRI of the brain, spinal cord and heart were not performed. An ECG on 27 February 2015 was abnormal. Treatments were not reported. Adjudication Follow-up Report. 9 Days Post Vaccination. Outpatient Visit Patient with history of murmurs presented for a cardiac examination. Labs and CXR were normal but abnormal EKGs showed inverted T-wave activity. Recommend cardiac evaluation. CXR - (Normal) PA/LAT shows satisfactory inspiration with no evidence of active pulmonary disease. The cardiac silhouette is normal with no evidence of enlargement and mediastinum, great vessels, pleura, diaphragm, and bony thorax are unremarkable. EEG1 - (14:20) Sinus bradycardia with sinus arrhythmia, rightward axis, and T wave abnormality with QT-QTc = 432/427ms EEG2 - (14:22) NSR, sinus arrhythmia, rightward axis, and T-wave abnormality with QT/QTc = 420/446ms EEG3 - (14:24) NSR with left posterior fascicular block, T-wave abnormality, and QT/QTc = 422/471ms. 23 Days Post Vaccination Cardiology Visit Patient has history of LVH without evidence of HOCM on stress ECHO done on April, 2014. A/P - Cardiomyopathy hypertrophic with an IVSD = 1.6 and mild SAM without outflow tract obstruction (mean gradient = 4 mmHg). 30 Days Post Vaccination. Cardiology Visit Chief compliant is evaluation of hypertrophic cardiomyopathy. ECHO demonstrated hypertrophic cardiomyopathy with LVEF = 55% and septal wall = 1.8 cm. Left atrium was mildly enlarged at 4.3 cm, myocardial perfusion study with an anteroseptal fixed detect and an LVEF = 53%. No hypotension and/or drop in BP noted on the treadmill test. Patient remains asymptomatic with no SOB, chest pain, or syncope. 33 Days Post Vaccination. Outpatient Visit Patient was screened for cardiovascular disorders. Holter monitor was unremarkable with no episodes of non-sustained ventricular tachycardia. The subject's outcome was not reported. Additional information  will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Condition aggravated, Dizziness, Erythema, Fatigue
Clinical narrative: This is a spontaneous report from a nurse. A 71-year-old female patient received PREVNAR 13 (lot# J20343, Exp. date: 11Mar2016, NDC # unknown) intramuscular on left deltoid at 0.5 ml, single on 11Mar2015 at 9:49 am. Medical history included ongoing hypertension, migraine and depression all from 05Oct2012, shoulder pain, cholesterol problem, sleep disorder. She was not sure whether she had Osteoporosis/Osteopenia. Concomitant medication included trazodone from 2014 at 50mg one at bedtime (as needed) for sleep, paroxetine from 05Oct2012 at 20mg daily for anxiety and depression, NEURONTIN tablet from 05Oct2012 at 300 mg, 3 times a day for neuropathy, MOBIC 7.5 mg daily, as needed for anti inflammatory pain for shoulder, losartan/HCTZ tablet from 28Mar2013 at 50mg/12.5mg one a day for blood pressure, fish oil 2000 mg, 1x/day for cholesterol, EPIPEN as needed for allergy to shellfish, Multivitamins, CENTRUM vitamin once a day supplement for wellness, calcium once a day supplement for wellness, Vitamin D daily, ACTONEL tablet from 10Jan2015 at 35mg daily for osteoporosis/osteopenia. On 11Mar2015 at 10:00am patient started to have severe nausea, dizziness and arm pain at site of injection which intensified to the point that she could barely move her arm. Arm became very swollen and red: she had swelling and redness of deltoid muscle and it was bright red. Patient felt fatigued and got migraine. She also reported fever to office. Patient's temperature at doctor's office was 99. On 16Mar2015 patient visited the doctor's office and antibiotics for cellulitis were given. Arm appeared less red than when it first started. Nausea was better. The patient recovered from all the events on unknown date. Follow-up (21Apr2015): New information received from a contactable nurse includes: vaccination and event details, events updated, concomitants.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Migraine
Clinical narrative: This is a spontaneous report from a nurse. A 71-year-old female patient received PREVNAR 13 (lot# J20343, Exp. date: 11Mar2016, NDC # unknown) intramuscular on left deltoid at 0.5 ml, single on 11Mar2015 at 9:49 am. Medical history included ongoing hypertension, migraine and depression all from 05Oct2012, shoulder pain, cholesterol problem, sleep disorder. She was not sure whether she had Osteoporosis/Osteopenia. Concomitant medication included trazodone from 2014 at 50mg one at bedtime (as needed) for sleep, paroxetine from 05Oct2012 at 20mg daily for anxiety and depression, NEURONTIN tablet from 05Oct2012 at 300 mg, 3 times a day for neuropathy, MOBIC 7.5 mg daily, as needed for anti inflammatory pain for shoulder, losartan/HCTZ tablet from 28Mar2013 at 50mg/12.5mg one a day for blood pressure, fish oil 2000 mg, 1x/day for cholesterol, EPIPEN as needed for allergy to shellfish, Multivitamins, CENTRUM vitamin once a day supplement for wellness, calcium once a day supplement for wellness, Vitamin D daily, ACTONEL tablet from 10Jan2015 at 35mg daily for osteoporosis/osteopenia. On 11Mar2015 at 10:00am patient started to have severe nausea, dizziness and arm pain at site of injection which intensified to the point that she could barely move her arm. Arm became very swollen and red: she had swelling and redness of deltoid muscle and it was bright red. Patient felt fatigued and got migraine. She also reported fever to office. Patient's temperature at doctor's office was 99. On 16Mar2015 patient visited the doctor's office and antibiotics for cellulitis were given. Arm appeared less red than when it first started. Nausea was better. The patient recovered from all the events on unknown date. Follow-up (21Apr2015): New information received from a contactable nurse includes: vaccination and event details, events updated, concomitants.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Peripheral swelling, Pyrexia
Clinical narrative: This is a spontaneous report from a nurse. A 71-year-old female patient received PREVNAR 13 (lot# J20343, Exp. date: 11Mar2016, NDC # unknown) intramuscular on left deltoid at 0.5 ml, single on 11Mar2015 at 9:49 am. Medical history included ongoing hypertension, migraine and depression all from 05Oct2012, shoulder pain, cholesterol problem, sleep disorder. She was not sure whether she had Osteoporosis/Osteopenia. Concomitant medication included trazodone from 2014 at 50mg one at bedtime (as needed) for sleep, paroxetine from 05Oct2012 at 20mg daily for anxiety and depression, NEURONTIN tablet from 05Oct2012 at 300 mg, 3 times a day for neuropathy, MOBIC 7.5 mg daily, as needed for anti inflammatory pain for shoulder, losartan/HCTZ tablet from 28Mar2013 at 50mg/12.5mg one a day for blood pressure, fish oil 2000 mg, 1x/day for cholesterol, EPIPEN as needed for allergy to shellfish, Multivitamins, CENTRUM vitamin once a day supplement for wellness, calcium once a day supplement for wellness, Vitamin D daily, ACTONEL tablet from 10Jan2015 at 35mg daily for osteoporosis/osteopenia. On 11Mar2015 at 10:00am patient started to have severe nausea, dizziness and arm pain at site of injection which intensified to the point that she could barely move her arm. Arm became very swollen and red: she had swelling and redness of deltoid muscle and it was bright red. Patient felt fatigued and got migraine. She also reported fever to office. Patient's temperature at doctor's office was 99. On 16Mar2015 patient visited the doctor's office and antibiotics for cellulitis were given. Arm appeared less red than when it first started. Nausea was better. The patient recovered from all the events on unknown date. Follow-up (21Apr2015): New information received from a contactable nurse includes: vaccination and event details, events updated, concomitants.
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site reaction, Rash, Rash macular, Urticaria
Clinical narrative: Red blotching at injection site. Whelp on right inner arm. 5 min after varicella injection. Injection given at 1353pm. Rash on face, and left arm. Dr order BENADRYL 5 mL. Pt watched every 5 min until 1 hr. Pt recovered and discharged.
Age: 12.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Haematochezia
Clinical narrative: Patient had bloody stools for one day a few days after having the vaccine.
Age: 12.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Drug administered to patient of inappropriate age, Haematochezia
Clinical narrative: Patient had bloody stools for one day a few days after having the vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEP, HIBV, MMRV
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: Mild swelling at the site occurred about 24 hours after the vaccines. Fever (Tmax 102). Rx-supportive care, TYLENOL PM pain.
Sex: U
Vaccine: RV5
Symptoms: Oral administration complication, Regurgitation, Vomiting
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. No pertinent history was reported. On an unknown date, the patients were vaccinated with ROTATEQ SUSPENSION 2. On an unknown date, patients were either regurgitated or vomited after receiving a dose of ROTAROTATEQ and may not have received full dose. Action taken was not applicable. The outcome of event was unknown. Causality was not assessed by the reporter. This is one of the two reports from the same source. 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 a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that an improperly stored dose of GARDASIL inj was administered to a patient (dose, route and lot number were not provided). No adverse effects were reported. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 4 month old female patient. No pertinent medical history was reported. On 22-APR-2015, the patient was vaccinated with ROTATEQ SUSPENSION 2  (lot# K022990 and expiration date 26-JUN-2016) 2 ml once, oral. On an unknown date, the patient mother reported that the patient vomited during the car ride home after receiving ROTATEQ. The patient mother was enquired whether the patient received a full dose of ROTATEQ and if the vaccine would still be efficacious because the patient vomited shortly after receiving it. Patient sought medical attention, patient mother called to the office. Treatment was not given to the patient. No Product Quality Complaint (PQC) was involved. Action taken was not applicable. On 22-APR-2015, the outcome of event was reported as recovered/resolved. Causality was not assessed by the reporter.  This is one of the two reports from the same source. Additional information has been requested.
Age: 1.47
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Full blood count, Pyrexia, Urine analysis
Clinical narrative: Fever for 8 days.  Fever ranging 100.4 - 104 axillary.
Age: 1.48
Sex: F
Vaccine: MMRV
Symptoms: Full blood count, Pyrexia, Urine analysis
Clinical narrative: Fever for 8 days.  Fever ranging 100.4 -104 axillary.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles Virus Started.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: DONOR STATES FEELING FEVERISH ACCOMPANIED WITH BODYACHES AND HEADACHE WHICH LASTED FOR THE MOST PART OF THE DAY UNTIL 5:00 PM.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Bronchitis, Cough, Dyspnoea, Influenza
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of flu in a 68-year-old male patient who received Flu vaccine. Co-suspect products included ADVAIR Diskus inhalation powder for COPD, emphysema and asthma. Concurrent medical conditions included hypercholesterolemia, chronic obstructive pulmonary disease, emphysema and asthma. Concomitant products included SPIRIVA, Albuterol Inhaler, cortisone cream and simvastatin. On an unknown date, the patient received Flu vaccine (unknown) and ADVAIR Diskus (inhaled) 1 puff(s) twice daily (2 puff(s) daily). In February 2015, an unknown time after receiving Flu vaccine and ADVAIR Diskus, the patient experienced Flu (serious criteria hospitalization), bronchitis (serious criteria hospitalization), coughing and breathing difficult. In February 2015, the outcome of the Flu, bronchitis, coughing and breathing difficult were recovered/resolved. The reporter considered the Flu, bronchitis, coughing and breathing difficult to be unrelated to Flu vaccine and ADVAIR Diskus. Additional details were provided as follows: The patient used ADVAIR for 5-6 years but recently had to switch to SYMBICORT because his insurance will no longer cover ADVAIR. On an unspecified date, the patient had high cholesterol. This patient was hospitalized for 8 days and released on 25 February 2015. During this hospitalization, he was diagnosed with Flu and bronchitis. He said that he was having difficulty breathing and uncontrollable coughing. No information will be available because the patient had denied permission to contact his physician or to provide any contact information. He did not provide the completed details for this report.
Age: 1.79
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient received 2 vaccines containing varicella; PROQUAD and Varicella. Each vaccine gave in opposite legs (right and left).
Age: 1.39
Sex: F
Vaccine: DTAP, DTAPIPVHIB, FLU4, PNC13
Symptoms: Extra dose administered
Clinical narrative: Pt phone number is disconnected, pt has not come back for any reason. Please contact MA, for any questions. Please and thank you.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: On Sunday pt noticed her arm was sore but on Monday it became red, started to swell and was hot to touch/itchy. When reported it was the size of a baseball. Pt already reported to MD. I advised her take BENADRYL.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: 3" L x 1" W red area noted. Pt reports on day before (4/28/15) it was "hot and itchy". Today it is not itching or warm to touch. Pt. denies discomfort and feels site is improving. No treatment was done. Provider updated.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Electromyogram, Injection site pain, Musculoskeletal pain, Neuralgic amyotrophy
Clinical narrative: Pain in right shoulder in October, then pain and progressive weakness in left shoulder in February, diagnosed with Parsons-Turner Syndrome in March.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Pain in right shoulder in October, then pain and progressive weakness in left shoulder in February, diagnosed with Parsons-Turner Syndrome in March.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Ocular hyperaemia, Rash erythematous, Rash generalised, Rash morbilliform, Rhinorrhoea
Clinical narrative: 3-4 days ago started having red eyes and runny nose, then on 4/28/15 (Tuesday in the am) developed red spotted rash on face that spread to body, arms and legs (measles like rash after vaccination).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEP, HEPA, MMRV
Symptoms: Seizure like phenomena, Tremor
Clinical narrative: Mother states seizure like symptoms "shaking with eyes closed". First aid rendered.
Age: 15.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Pain in extremity, Rash
Clinical narrative: Rash and arm soreness.
Age: 15.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Reddened area to right arm, moderate swelling, warmth. Given Benadryl.
Age: 45.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Chills, Dizziness, Headache, Heart rate increased
Clinical narrative: Headache, chills high fever muscles aches, dizziness, weakness, fast heartbeat and numbness and tingling on right side of my face. Treated with Aleve and Ibuprofen.
Age: 45.0
Sex: F
Vaccine: RAB
Symptoms: Hypoaesthesia, Myalgia, Paraesthesia, Pyrexia
Clinical narrative: Headache, chills high fever muscles aches, dizziness, weakness, fast heartbeat and numbness and tingling on right side of my face. Treated with Aleve and Ibuprofen.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Hypersensitivity, Pruritus, Skin warm, Swelling
Clinical narrative: Received MMR-VZV combination vaccine on 4/28/15 to the left deltoid during routine WCC. Developed some itching to the left arm later that night and then developed a localized allergic reaction with swelling, warmth, erythema in a welt that was 2.5cm in radius (clear circle with the puncture of the vaccine in the center). No lip swelling, shortness of breath, wheezing, throat swelling or other signs of anaphylaxis. Had a rash prior from a vaccine, mother not sure of the vaccine type or date.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Received MMR-VZV combination vaccine on 4/28/15 to the left deltoid during routine WCC. Developed some itching to the left arm later that night and then developed a localized allergic reaction with swelling, warmth, erythema in a welt that was 2.5cm in radius (clear circle with the puncture of the vaccine in the center). No lip swelling, shortness of breath, wheezing, throat swelling or other signs of anaphylaxis. Had a rash prior from a vaccine, mother not sure of the vaccine type or date.
Age: 0.16
Sex: M
Vaccine: DTAP, RVX
Symptoms: Eczema, Seborrhoeic dermatitis
Clinical narrative: Severe seborrea dermatitis and eczema reaction to face and body.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Joint range of motion decreased, Oedema peripheral, Pain
Clinical narrative: Patient examined on 4/28/2015. Had significant soft tissue edema of left arm from upper deltoid thru mid forearm, limited flexion at elbow. No bruising, no redness, minimal pain.
Age: 18.0
Sex: M
Vaccine: YF
Symptoms: Erythema, Pruritus, Throat tightness, Urticaria
Clinical narrative: Hives, throat close, head red and itchy. Subsequent reaction 04/26/2016, 2:00 AM.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Back pain, CSF protein normal, Haematology test normal, Muscular weakness, Myelitis transverse
Clinical narrative: Back started hurting on the 6 of March and legs felt weak, Saturday morning woke up paralyzed from the chest down T4 level.  Took to hospital and they started treating for Transverse myelitis but all MRIs and CSF were negative for Transverse Myelitis.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Nuclear magnetic resonance imaging spinal normal, Nuclear magnetic resonance imaging thoracic normal, Paralysis
Clinical narrative: Back started hurting on the 6 of March and legs felt weak, Saturday morning woke up paralyzed from the chest down T4 level.  Took to hospital and they started treating for Transverse myelitis but all MRIs and CSF were negative for Transverse Myelitis.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Contusion, Immune thrombocytopenic purpura, Petechiae, Platelet count decreased
Clinical narrative: Idiopathic Thrombocytopenic Purpura, with platelet count dropping to 5k and pt with extensive bruising/petechiae. Pt currently being monitored at home.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea
Clinical narrative: Diarrhea, watery, x 6. Nonbloody.
Age: 11.0
Sex: M
Vaccine: TD
Symptoms: Eye movement disorder, Mobility decreased
Clinical narrative: Overhead lights flickered and he froze mid-activity and his eyes rolled up for approx. 10-15 sec., now seizure evaluation/testing by neurologist.
Age: 0.5
Sex: M
Vaccine: HIBV, IPV, PNC13, RV5
Symptoms: Lethargy, Pallor, Unresponsive to stimuli, Vomiting
Clinical narrative: Throwing up multiple times-had never done this before. Extremely lethargic, pale and quite unresponsive. Checked out at ER, but was fine.
Age: 69.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: ZOSTAVAX administered at 10 AM on 4/27/15. Arm is all red, swollen, and warm to touch. Reaction in above right elbow, site of injection, and even a little below elbow.
Age: 69.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Skin warm
Clinical narrative: ZOSTAVAX administered at 10 AM on 4/27/15. Arm is all red, swollen, and warm to touch. Reaction in above right elbow, site of injection, and even a little below elbow.
Age: 8.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site.
Age: 1.03
Sex: F
Vaccine: HEP, HIBV, MMRV, PNC13
Symptoms: Wrong drug administered
Clinical narrative: MA found that she had given this patient a Hep B vaccine instead of a Hep A. Before vaccines where administered they were double checked by another M.A. Incident report filed.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site bruising, Peripheral swelling, Pruritus
Clinical narrative: Left arm in which shot administered has redness, swelling, occasional itching, Kw/ grayish bruise at site of injection, pt reported this 6 days after shot, advised to apply ice pack, CLARITIN if needed, call PCP.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Pruritus, Rash, Rash papular
Clinical narrative: Pt. received vaccine 4/24/15. 4/28 was reported to have developed tine papular rash on chin/perioral area. Was prescribed BENADRYL cream 1% for itch.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: By history, received shingles vaccine 2 mos ago. Presented today for eval of rash which on exam appears to be shingles rash (R) posterior thigh.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Patient received MCV 4 and Tdap vaccines in right deltoid on 4-27-15. Mom states increased redness and swelling noted the evening of 4-27-15, and symptoms worsening last evening. Patient seen in office today and redness noted to be 6" by 5" diameter. IM cefazolin given in office and PO clindamycin rx'd for 10 days.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Vaccination site rash
Clinical narrative: Patient indicates that since 3/26/15 she has a rash on the vaccination area.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of injection site erythema in a patient who received DTaP. On an unknown date, the patient received DTaP vaccine at an unknown dose. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to DTaP vaccine. No additional information available at the time of reporting.
Age: 87.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 87 year old patient of unknown gender. On 23-APR-2015 the patient was inadvertently vaccinated with PNEUMOVAX23 (lot # K004281, 0.5 ml, once, intramuscularly) that was expired 22-MAR-2015. No adverse effects reported. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Acute kidney injury, Death, Dehydration, Diarrhoea, Pulmonary embolism
Clinical narrative: This health authority report (initial receipt: 05-Jun-2013) concerns a 79-year-old male patient. The patient had no current illness at time of onset. No pre-existing conditions were noted. It was unknown if he was taking any other medications. On 24-Sep-2012 the patient received AFLURIA (batch number P58406) intramuscularly. On 24-Sep-2012 the patient developed diarrhoea. The patient's daughter reported next day that explosive diarrhoea occurred. Urgent care or ER (emergency room) was recommended. The patient also had dehydration, pulmonary embolism, renal failure acute and urinary tract infection. On 28-Sep-2012, 4 days after vaccination the patient died due to sepsis. Batch record review for Lot P58406 received on 17 June 2013. On completion of this investigation, it has been determined that for manufacturing to bulk stage all deviations related to the bulk manufacture of this lot were assessed as having no impact on product Safety, Quality, Identity, Purity or Potency; all QC testing was satisfactory with no out of specification results reported; there are no outstanding issues related to this lot that would potentially affect product quality. In conclusion, there has been no assignable case drawn from this investigation that would indicate any association with the adverse event reported. Follow-up (17-Jun-2013): batch record review. Follow-up (16-Apr-2015): New AEs #3-6.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Sepsis, Urinary tract infection
Clinical narrative: This health authority report (initial receipt: 05-Jun-2013) concerns a 79-year-old male patient. The patient had no current illness at time of onset. No pre-existing conditions were noted. It was unknown if he was taking any other medications. On 24-Sep-2012 the patient received AFLURIA (batch number P58406) intramuscularly. On 24-Sep-2012 the patient developed diarrhoea. The patient's daughter reported next day that explosive diarrhoea occurred. Urgent care or ER (emergency room) was recommended. The patient also had dehydration, pulmonary embolism, renal failure acute and urinary tract infection. On 28-Sep-2012, 4 days after vaccination the patient died due to sepsis. Batch record review for Lot P58406 received on 17 June 2013. On completion of this investigation, it has been determined that for manufacturing to bulk stage all deviations related to the bulk manufacture of this lot were assessed as having no impact on product Safety, Quality, Identity, Purity or Potency; all QC testing was satisfactory with no out of specification results reported; there are no outstanding issues related to this lot that would potentially affect product quality. In conclusion, there has been no assignable case drawn from this investigation that would indicate any association with the adverse event reported. Follow-up (17-Jun-2013): batch record review. Follow-up (16-Apr-2015): New AEs #3-6.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Acupuncture, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: Painful injection site.  Male who administered shot said he "must have hit a nerve."  I believe he gave the injection too high on my arm.  Currently I have had so much pain, I have had trouble sleeping.  I will start PT and have sought acupuncture to relieve pain and freezing up of my left shoulder where shot was given. It gradually got worse over time.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Haematochezia, Mucous stools
Clinical narrative: After vaccination baby start having blood in the stool same day. Blood was present for almost 3 months, mucus is present at every stool from that time. Still ongoing problem.
Age: 63.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Electromyogram, Gait disturbance, Influenza like illness, Peroneal nerve palsy
Clinical narrative: This medically confirmed spontaneous report (initial receipt 20-Apr-2015) concerns a 63 year-old male patient who was not taking any medications nor had any significant medical history before he had received AFLURIA. He had no current illness. On 11-Dec-2014 or 14-Dec-2014, the patient received intramuscular AFLURIA (batch number T54009) 0.5mL once in the left arm. On the 15-Dec-2014, the patient developed left foot drop and a slapping gait. On the 17-Dec-2014, about 4 or 5 days after the vaccine, the patient experienced flu like symptoms. He had developed left shoulder pain, and pain in his left ankle and foot. He characterised the pain as a burning pain that fluctuated and was accompanied by drop foot and a skipping gait. He was taking acetaminophen or ibuprofen for the pain, and gabapentin. He was also undergoing physical therapy for this condition. The symptoms persisted to date (at the time of reporting). An electromyogram (EMG) was done. Oseltamivir phosphate was administered for the flu-like symptoms that he was experiencing around 18-Dec-2014 and resolved about five days later (around 23-Dec-2014). The outcome was not recovered (but recovered from the flu-like symptoms). Reporter comments: The regulator reported the case as serious (permanent disability) and reported the term 'electromyogram'.
Age: 63.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Burning sensation, Electromyogram, Gait disturbance, Influenza like illness
Clinical narrative: This medically confirmed spontaneous report (initial receipt 20-Apr-2015) concerns a 63 year-old male patient who was not taking any medications nor had any significant medical history before he had received AFLURIA. He had no current illness. On 11-Dec-2014 or 14-Dec-2014, the patient received intramuscular AFLURIA (batch number T54009) 0.5mL once in the left arm. On the 15-Dec-2014, the patient developed left foot drop and a slapping gait. On the 17-Dec-2014, about 4 or 5 days after the vaccine, the patient experienced flu like symptoms. He had developed left shoulder pain, and pain in his left ankle and foot. He characterised the pain as a burning pain that fluctuated and was accompanied by drop foot and a skipping gait. He was taking acetaminophen or ibuprofen for the pain, and gabapentin. He was also undergoing physical therapy for this condition. The symptoms persisted to date (at the time of reporting). An electromyogram (EMG) was done. Oseltamivir phosphate was administered for the flu-like symptoms that he was experiencing around 18-Dec-2014 and resolved about five days later (around 23-Dec-2014). The outcome was not recovered (but recovered from the flu-like symptoms). Reporter comments: The regulator reported the case as serious (permanent disability) and reported the term 'electromyogram'.
Age: 63.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Pain in extremity, Peroneal nerve palsy
Clinical narrative: This medically confirmed spontaneous report (initial receipt 20-Apr-2015) concerns a 63 year-old male patient who was not taking any medications nor had any significant medical history before he had received AFLURIA. He had no current illness. On 11-Dec-2014 or 14-Dec-2014, the patient received intramuscular AFLURIA (batch number T54009) 0.5mL once in the left arm. On the 15-Dec-2014, the patient developed left foot drop and a slapping gait. On the 17-Dec-2014, about 4 or 5 days after the vaccine, the patient experienced flu like symptoms. He had developed left shoulder pain, and pain in his left ankle and foot. He characterised the pain as a burning pain that fluctuated and was accompanied by drop foot and a skipping gait. He was taking acetaminophen or ibuprofen for the pain, and gabapentin. He was also undergoing physical therapy for this condition. The symptoms persisted to date (at the time of reporting). An electromyogram (EMG) was done. Oseltamivir phosphate was administered for the flu-like symptoms that he was experiencing around 18-Dec-2014 and resolved about five days later (around 23-Dec-2014). The outcome was not recovered (but recovered from the flu-like symptoms). Reporter comments: The regulator reported the case as serious (permanent disability) and reported the term 'electromyogram'.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ, HPV4
Symptoms: Arthralgia, Blood test, Fatigue, Headache, Migraine
Clinical narrative: Information has been received from a licensed Practical Nurse via company representative referring to a 18 years old female patient. No concurrent condition or medical history was reported. On 06-FEB-2015 the patient was vaccinated with a dose of GARDASIL (dose and route not reported, lot# U4800AB was not a valid lot#, expiration date October 2015). Concomitant therapy was not reported. On an unspecified date in 2015 the patient experienced joint pain, dizziness and muscular weakness. The patient sought medical attention by visiting emergency department, but was not admitted. The outcome of muscular weakness, dizziness and joint pain was unknown. On an unspecified date, the reporter stated that the vaccine the patient received was "MCV4" (manufacturer unknown). It was unclear if the patient received GARDASIL or another vaccine. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ, HPV4
Symptoms: Muscular weakness, Nausea, Painful respiration, Paraesthesia, Retching
Clinical narrative: Information has been received from a licensed Practical Nurse via company representative referring to a 18 years old female patient. No concurrent condition or medical history was reported. On 06-FEB-2015 the patient was vaccinated with a dose of GARDASIL (dose and route not reported, lot# U4800AB was not a valid lot#, expiration date October 2015). Concomitant therapy was not reported. On an unspecified date in 2015 the patient experienced joint pain, dizziness and muscular weakness. The patient sought medical attention by visiting emergency department, but was not admitted. The outcome of muscular weakness, dizziness and joint pain was unknown. On an unspecified date, the reporter stated that the vaccine the patient received was "MCV4" (manufacturer unknown). It was unclear if the patient received GARDASIL or another vaccine. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ, HPV4
Symptoms: Spinal pain, Urine analysis normal
Clinical narrative: Information has been received from a licensed Practical Nurse via company representative referring to a 18 years old female patient. No concurrent condition or medical history was reported. On 06-FEB-2015 the patient was vaccinated with a dose of GARDASIL (dose and route not reported, lot# U4800AB was not a valid lot#, expiration date October 2015). Concomitant therapy was not reported. On an unspecified date in 2015 the patient experienced joint pain, dizziness and muscular weakness. The patient sought medical attention by visiting emergency department, but was not admitted. The outcome of muscular weakness, dizziness and joint pain was unknown. On an unspecified date, the reporter stated that the vaccine the patient received was "MCV4" (manufacturer unknown). It was unclear if the patient received GARDASIL or another vaccine. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ, HPV4
Symptoms: Arthralgia, Blood creatine phosphokinase normal, Blood folate normal, Borrelia test negative, CSF cell count normal
Clinical narrative: Information has been received from a licensed Practical Nurse via company representative referring to a 18 years old female patient. No concurrent condition or medical history was reported. On 06-FEB-2015 the patient was vaccinated with a dose of GARDASIL (dose and route not reported, lot# U4800AB was not a valid lot#, expiration date October 2015). Concomitant therapy was not reported. On an unspecified date in 2015 the patient experienced joint pain, dizziness and muscular weakness. The patient sought medical attention by visiting emergency department, but was not admitted. The outcome of muscular weakness, dizziness and joint pain was unknown. On an unspecified date, the reporter stated that the vaccine the patient received was "MCV4" (manufacturer unknown). It was unclear if the patient received GARDASIL or another vaccine. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ, HPV4
Symptoms: Computerised tomogram normal, Diplegia, Epstein-Barr virus test negative, Herpes simplex serology negative, Myalgia
Clinical narrative: Information has been received from a licensed Practical Nurse via company representative referring to a 18 years old female patient. No concurrent condition or medical history was reported. On 06-FEB-2015 the patient was vaccinated with a dose of GARDASIL (dose and route not reported, lot# U4800AB was not a valid lot#, expiration date October 2015). Concomitant therapy was not reported. On an unspecified date in 2015 the patient experienced joint pain, dizziness and muscular weakness. The patient sought medical attention by visiting emergency department, but was not admitted. The outcome of muscular weakness, dizziness and joint pain was unknown. On an unspecified date, the reporter stated that the vaccine the patient received was "MCV4" (manufacturer unknown). It was unclear if the patient received GARDASIL or another vaccine. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ, HPV4
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Spinal pain, Vitamin B12 normal
Clinical narrative: Information has been received from a licensed Practical Nurse via company representative referring to a 18 years old female patient. No concurrent condition or medical history was reported. On 06-FEB-2015 the patient was vaccinated with a dose of GARDASIL (dose and route not reported, lot# U4800AB was not a valid lot#, expiration date October 2015). Concomitant therapy was not reported. On an unspecified date in 2015 the patient experienced joint pain, dizziness and muscular weakness. The patient sought medical attention by visiting emergency department, but was not admitted. The outcome of muscular weakness, dizziness and joint pain was unknown. On an unspecified date, the reporter stated that the vaccine the patient received was "MCV4" (manufacturer unknown). It was unclear if the patient received GARDASIL or another vaccine. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ, HPV4
Symptoms: Arthralgia, Dizziness, Muscular weakness
Clinical narrative: Information has been received from a licensed Practical Nurse via company representative referring to a 18 years old female patient. No concurrent condition or medical history was reported. On 06-FEB-2015 the patient was vaccinated with a dose of GARDASIL (dose and route not reported, lot# U4800AB was not a valid lot#, expiration date October 2015). Concomitant therapy was not reported. On an unspecified date in 2015 the patient experienced joint pain, dizziness and muscular weakness. The patient sought medical attention by visiting emergency department, but was not admitted. The outcome of muscular weakness, dizziness and joint pain was unknown. On an unspecified date, the reporter stated that the vaccine the patient received was "MCV4" (manufacturer unknown). It was unclear if the patient received GARDASIL or another vaccine. Additional information has been requested.
Sex: U
Vaccine: DTAP, IPV, MMR, MMR
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 20-APR-2015, the patient was vaccinated with MMR II, subcutaneous, lot number reported as K021952, expiration date 10-NOV-2016 (dose was not reported). No co-suspect and concomitant therapies were reported. The nurse reported that other nurse administered a second dose of MMR II to the patient due to being distracted during the administration of vaccines (coded as accidental overdose). The child was to be administered MMR II and (Merck) VARIVAX. The two doses of MMR II were administered at the same office visit. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTPIPV, HEPA, MMRV
Symptoms: Rash
Clinical narrative: Severe rash.
Age: 1.01
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever, febrile seizure.
Age: 73.0
Sex: M
Vaccine: FLUX
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Blood test normal, Chest X-ray normal
Clinical narrative: This medically confirmed literature report (initial receipt 28-Apr-2015) concerns a 73 year-old male patient who had a past medical history of lymphoma and prostate cancer. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date, one month after the vaccination, the patient was brought to the Emergency Department, and subsequently hospitalised, with a change in mental status and fall. He reported having a fever, muscle ache, sore throat and fatigue for the 1 day. His temperature was 99.5 F and the rest of the physical examination was unremarkable. The laboratory data demonstrated normal BMP (basic metabolic panel), mild elevation in WBC (white blood count), elevation of liver enzymes (AST 300, ALT 100). Creatinine kinase was 3000 and continued to rise to as high as 12000 which was thought to be out of proportion to the duration of fall (30 minutes), Influenza A subtype H3 was positive, Mycoplasma IgM antibody was positive, and PCR (Polymerase Chain Reaction) was negative. His EEG (electroechocardiogram), chest radiograph were unremarkable. He had aggressive intravenous fluids and was treated with azithromycin and oseltamivir. His renal function remained stable and patient improved remarkably within 3 days. His creatinine kinase did trend down. The outcome was not reported (recovered for fever, muscle aches, sore throat and fatigue). Reporter comments: 48% of the influenza A (H3N2) viruses collected and analyzed from October 1 through November 22, 2014 were antigenically 'like' the 2014-2015 influenza A (H3N2) vaccine component, but that 52% were antigenically different (drifted) from the H3N2 vaccine virus. Decreased vaccine effectiveness has been observed with antigenic drift in past seasons. Vaccine effectiveness in patients over 65 years of age is with time, in preventing laboratory-confirmed influenza infection was 61 percent (95% CI 5 to 84 percent) during the first 100 days after vaccination. Influenza vaccine prevents the severity of illness in patients over 65 years of age.
Age: 73.0
Sex: M
Vaccine: FLUX
Symptoms: Electroencephalogram normal, Fall, Fatigue, Influenza A virus test positive, Mental status changes
Clinical narrative: This medically confirmed literature report (initial receipt 28-Apr-2015) concerns a 73 year-old male patient who had a past medical history of lymphoma and prostate cancer. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date, one month after the vaccination, the patient was brought to the Emergency Department, and subsequently hospitalised, with a change in mental status and fall. He reported having a fever, muscle ache, sore throat and fatigue for the 1 day. His temperature was 99.5 F and the rest of the physical examination was unremarkable. The laboratory data demonstrated normal BMP (basic metabolic panel), mild elevation in WBC (white blood count), elevation of liver enzymes (AST 300, ALT 100). Creatinine kinase was 3000 and continued to rise to as high as 12000 which was thought to be out of proportion to the duration of fall (30 minutes), Influenza A subtype H3 was positive, Mycoplasma IgM antibody was positive, and PCR (Polymerase Chain Reaction) was negative. His EEG (electroechocardiogram), chest radiograph were unremarkable. He had aggressive intravenous fluids and was treated with azithromycin and oseltamivir. His renal function remained stable and patient improved remarkably within 3 days. His creatinine kinase did trend down. The outcome was not reported (recovered for fever, muscle aches, sore throat and fatigue). Reporter comments: 48% of the influenza A (H3N2) viruses collected and analyzed from October 1 through November 22, 2014 were antigenically 'like' the 2014-2015 influenza A (H3N2) vaccine component, but that 52% were antigenically different (drifted) from the H3N2 vaccine virus. Decreased vaccine effectiveness has been observed with antigenic drift in past seasons. Vaccine effectiveness in patients over 65 years of age is with time, in preventing laboratory-confirmed influenza infection was 61 percent (95% CI 5 to 84 percent) during the first 100 days after vaccination. Influenza vaccine prevents the severity of illness in patients over 65 years of age.
Age: 73.0
Sex: M
Vaccine: FLUX
Symptoms: Metabolic function test normal, Myalgia, Mycoplasma test positive, Oropharyngeal pain, Polymerase chain reaction
Clinical narrative: This medically confirmed literature report (initial receipt 28-Apr-2015) concerns a 73 year-old male patient who had a past medical history of lymphoma and prostate cancer. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date, one month after the vaccination, the patient was brought to the Emergency Department, and subsequently hospitalised, with a change in mental status and fall. He reported having a fever, muscle ache, sore throat and fatigue for the 1 day. His temperature was 99.5 F and the rest of the physical examination was unremarkable. The laboratory data demonstrated normal BMP (basic metabolic panel), mild elevation in WBC (white blood count), elevation of liver enzymes (AST 300, ALT 100). Creatinine kinase was 3000 and continued to rise to as high as 12000 which was thought to be out of proportion to the duration of fall (30 minutes), Influenza A subtype H3 was positive, Mycoplasma IgM antibody was positive, and PCR (Polymerase Chain Reaction) was negative. His EEG (electroechocardiogram), chest radiograph were unremarkable. He had aggressive intravenous fluids and was treated with azithromycin and oseltamivir. His renal function remained stable and patient improved remarkably within 3 days. His creatinine kinase did trend down. The outcome was not reported (recovered for fever, muscle aches, sore throat and fatigue). Reporter comments: 48% of the influenza A (H3N2) viruses collected and analyzed from October 1 through November 22, 2014 were antigenically 'like' the 2014-2015 influenza A (H3N2) vaccine component, but that 52% were antigenically different (drifted) from the H3N2 vaccine virus. Decreased vaccine effectiveness has been observed with antigenic drift in past seasons. Vaccine effectiveness in patients over 65 years of age is with time, in preventing laboratory-confirmed influenza infection was 61 percent (95% CI 5 to 84 percent) during the first 100 days after vaccination. Influenza vaccine prevents the severity of illness in patients over 65 years of age.