chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: FLUN4, HEPA, MNQ, TD, VARCEL
Symptoms: Migraine, Nausea, Vision blurred
Clinical narrative: Case number PHHY2014US014516 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 515015) on 03 FEB 2014. This report refers to 17-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO and tetanus diphtheria vaccine (other manufacturer, batch number: U4165BA); both vaccines administered intramuscularly in the right arm on 26 NOV 2013. On the same day, she also received FLUMIST (other manufacturer, batch number: BK2062) via intranasal route, HAVRIX (other manufacturer, batch number YG4XA) intramuscularly and VARIVAX (other manufacturer, batch number J003705) subcutaneously, both vaccines administered in the left arm. It was reported that next morning on 27 NOV 2013, when she woke up, she complained of migraine. As per her mother, migraines led to blurry vision and nausea. The outcome of the events was reported as complete recovery. The seriousness and causality of the events were not reported.   Following an internal review of the data received on 03 FEB 2014, a significant case correction was done. Nausea and blurred vision were kept as symptoms of migraine.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Epistaxis, Immunoglobulin therapy, Platelet count decreased, Thrombocytopenia
Clinical narrative: Information has been received from a 76 year old male patient with cholesterol and blood pressure abnormal concerning himself. The patient had no drug reactions/allergies. On 25-NOV-2014 the patient was vaccinated with one injection of ZOSTAVAX (dose, lot# and route were not reported) (recommended by his primary care physician) at the pharmacy. Concomitant therapies included an unspecified cholesterol medication, an unspecified blood pressure medication, one baby aspirin/day, and one multivitamin/day. The patient had a blood test performed "three days prior" to receiving the ZOSTAVAX on 22-NOV-2014. At that time his blood platelet count was at 222 (unit unspecified). On 28-NOV-2014 the patient woke up with a bloody nose "that would not stop bleeding". He visited an unspecified emergency room on the same day. The emergency room treated "it as a regular bloody nose" (the type of treatment unspecified) and sent the patient home. On 30-NOV-2014, he was still experiencing the bloody nose and went to another Hospital Emergency Room. In the emergency room blood test was performed which determined his blood count was at "1". The patient was then admitted into hospital on 30-NOV-2014 where he was diagnosed with thrombocytopenia. The patient was treated with an unspecified "immune-globulin" for two days and was also receiving prednisone (manufacturer unknown) (unspecified dose and frequency) intravenously while in the hospital. He was released from the hospital on 03-DEC-2014 and was prescribed prednisone (manufacturer unknown) 20mg tablets that he took once daily for an unspecified amount of time. The patient reported he was continuing to see an unspecified hematologist (demographics unknown) and he reported his blood platelet count was "back up", however it was unspecified if the blood platelet count had fully recovered. It was also unspecified if the patient was still experiencing a bloody nose. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Activated partial thromboplastin time shortened, Aphthous stomatitis, Back pain, Blood cholesterol increased, Contusion
Clinical narrative: Information has been received from a 76 year old male patient with cholesterol and blood pressure abnormal concerning himself. The patient had no drug reactions/allergies. On 25-NOV-2014 the patient was vaccinated with one injection of ZOSTAVAX (dose, lot# and route were not reported) (recommended by his primary care physician) at the pharmacy. Concomitant therapies included an unspecified cholesterol medication, an unspecified blood pressure medication, one baby aspirin/day, and one multivitamin/day. The patient had a blood test performed "three days prior" to receiving the ZOSTAVAX on 22-NOV-2014. At that time his blood platelet count was at 222 (unit unspecified). On 28-NOV-2014 the patient woke up with a bloody nose "that would not stop bleeding". He visited an unspecified emergency room on the same day. The emergency room treated "it as a regular bloody nose" (the type of treatment unspecified) and sent the patient home. On 30-NOV-2014, he was still experiencing the bloody nose and went to another Hospital Emergency Room. In the emergency room blood test was performed which determined his blood count was at "1". The patient was then admitted into hospital on 30-NOV-2014 where he was diagnosed with thrombocytopenia. The patient was treated with an unspecified "immune-globulin" for two days and was also receiving prednisone (manufacturer unknown) (unspecified dose and frequency) intravenously while in the hospital. He was released from the hospital on 03-DEC-2014 and was prescribed prednisone (manufacturer unknown) 20mg tablets that he took once daily for an unspecified amount of time. The patient reported he was continuing to see an unspecified hematologist (demographics unknown) and he reported his blood platelet count was "back up", however it was unspecified if the blood platelet count had fully recovered. It was also unspecified if the patient was still experiencing a bloody nose. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Electrocauterisation, Epistaxis, Faeces discoloured, Haematocrit normal
Clinical narrative: Information has been received from a 76 year old male patient with cholesterol and blood pressure abnormal concerning himself. The patient had no drug reactions/allergies. On 25-NOV-2014 the patient was vaccinated with one injection of ZOSTAVAX (dose, lot# and route were not reported) (recommended by his primary care physician) at the pharmacy. Concomitant therapies included an unspecified cholesterol medication, an unspecified blood pressure medication, one baby aspirin/day, and one multivitamin/day. The patient had a blood test performed "three days prior" to receiving the ZOSTAVAX on 22-NOV-2014. At that time his blood platelet count was at 222 (unit unspecified). On 28-NOV-2014 the patient woke up with a bloody nose "that would not stop bleeding". He visited an unspecified emergency room on the same day. The emergency room treated "it as a regular bloody nose" (the type of treatment unspecified) and sent the patient home. On 30-NOV-2014, he was still experiencing the bloody nose and went to another Hospital Emergency Room. In the emergency room blood test was performed which determined his blood count was at "1". The patient was then admitted into hospital on 30-NOV-2014 where he was diagnosed with thrombocytopenia. The patient was treated with an unspecified "immune-globulin" for two days and was also receiving prednisone (manufacturer unknown) (unspecified dose and frequency) intravenously while in the hospital. He was released from the hospital on 03-DEC-2014 and was prescribed prednisone (manufacturer unknown) 20mg tablets that he took once daily for an unspecified amount of time. The patient reported he was continuing to see an unspecified hematologist (demographics unknown) and he reported his blood platelet count was "back up", however it was unspecified if the blood platelet count had fully recovered. It was also unspecified if the patient was still experiencing a bloody nose. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Haemoglobin normal, Immune thrombocytopenic purpura, Immunoglobulin therapy, International normalised ratio normal, Low density lipoprotein increased
Clinical narrative: Information has been received from a 76 year old male patient with cholesterol and blood pressure abnormal concerning himself. The patient had no drug reactions/allergies. On 25-NOV-2014 the patient was vaccinated with one injection of ZOSTAVAX (dose, lot# and route were not reported) (recommended by his primary care physician) at the pharmacy. Concomitant therapies included an unspecified cholesterol medication, an unspecified blood pressure medication, one baby aspirin/day, and one multivitamin/day. The patient had a blood test performed "three days prior" to receiving the ZOSTAVAX on 22-NOV-2014. At that time his blood platelet count was at 222 (unit unspecified). On 28-NOV-2014 the patient woke up with a bloody nose "that would not stop bleeding". He visited an unspecified emergency room on the same day. The emergency room treated "it as a regular bloody nose" (the type of treatment unspecified) and sent the patient home. On 30-NOV-2014, he was still experiencing the bloody nose and went to another Hospital Emergency Room. In the emergency room blood test was performed which determined his blood count was at "1". The patient was then admitted into hospital on 30-NOV-2014 where he was diagnosed with thrombocytopenia. The patient was treated with an unspecified "immune-globulin" for two days and was also receiving prednisone (manufacturer unknown) (unspecified dose and frequency) intravenously while in the hospital. He was released from the hospital on 03-DEC-2014 and was prescribed prednisone (manufacturer unknown) 20mg tablets that he took once daily for an unspecified amount of time. The patient reported he was continuing to see an unspecified hematologist (demographics unknown) and he reported his blood platelet count was "back up", however it was unspecified if the blood platelet count had fully recovered. It was also unspecified if the patient was still experiencing a bloody nose. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Nasal cavity packing, Oral mucosal blistering, Petechiae, Platelet count decreased, Platelet count increased
Clinical narrative: Information has been received from a 76 year old male patient with cholesterol and blood pressure abnormal concerning himself. The patient had no drug reactions/allergies. On 25-NOV-2014 the patient was vaccinated with one injection of ZOSTAVAX (dose, lot# and route were not reported) (recommended by his primary care physician) at the pharmacy. Concomitant therapies included an unspecified cholesterol medication, an unspecified blood pressure medication, one baby aspirin/day, and one multivitamin/day. The patient had a blood test performed "three days prior" to receiving the ZOSTAVAX on 22-NOV-2014. At that time his blood platelet count was at 222 (unit unspecified). On 28-NOV-2014 the patient woke up with a bloody nose "that would not stop bleeding". He visited an unspecified emergency room on the same day. The emergency room treated "it as a regular bloody nose" (the type of treatment unspecified) and sent the patient home. On 30-NOV-2014, he was still experiencing the bloody nose and went to another Hospital Emergency Room. In the emergency room blood test was performed which determined his blood count was at "1". The patient was then admitted into hospital on 30-NOV-2014 where he was diagnosed with thrombocytopenia. The patient was treated with an unspecified "immune-globulin" for two days and was also receiving prednisone (manufacturer unknown) (unspecified dose and frequency) intravenously while in the hospital. He was released from the hospital on 03-DEC-2014 and was prescribed prednisone (manufacturer unknown) 20mg tablets that he took once daily for an unspecified amount of time. The patient reported he was continuing to see an unspecified hematologist (demographics unknown) and he reported his blood platelet count was "back up", however it was unspecified if the blood platelet count had fully recovered. It was also unspecified if the patient was still experiencing a bloody nose. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Prothrombin time normal, Rash, Rash erythematous, Sciatica, Thrombocytopenia
Clinical narrative: Information has been received from a 76 year old male patient with cholesterol and blood pressure abnormal concerning himself. The patient had no drug reactions/allergies. On 25-NOV-2014 the patient was vaccinated with one injection of ZOSTAVAX (dose, lot# and route were not reported) (recommended by his primary care physician) at the pharmacy. Concomitant therapies included an unspecified cholesterol medication, an unspecified blood pressure medication, one baby aspirin/day, and one multivitamin/day. The patient had a blood test performed "three days prior" to receiving the ZOSTAVAX on 22-NOV-2014. At that time his blood platelet count was at 222 (unit unspecified). On 28-NOV-2014 the patient woke up with a bloody nose "that would not stop bleeding". He visited an unspecified emergency room on the same day. The emergency room treated "it as a regular bloody nose" (the type of treatment unspecified) and sent the patient home. On 30-NOV-2014, he was still experiencing the bloody nose and went to another Hospital Emergency Room. In the emergency room blood test was performed which determined his blood count was at "1". The patient was then admitted into hospital on 30-NOV-2014 where he was diagnosed with thrombocytopenia. The patient was treated with an unspecified "immune-globulin" for two days and was also receiving prednisone (manufacturer unknown) (unspecified dose and frequency) intravenously while in the hospital. He was released from the hospital on 03-DEC-2014 and was prescribed prednisone (manufacturer unknown) 20mg tablets that he took once daily for an unspecified amount of time. The patient reported he was continuing to see an unspecified hematologist (demographics unknown) and he reported his blood platelet count was "back up", however it was unspecified if the blood platelet count had fully recovered. It was also unspecified if the patient was still experiencing a bloody nose. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Vitamin D, White blood cell count normal
Clinical narrative: Information has been received from a 76 year old male patient with cholesterol and blood pressure abnormal concerning himself. The patient had no drug reactions/allergies. On 25-NOV-2014 the patient was vaccinated with one injection of ZOSTAVAX (dose, lot# and route were not reported) (recommended by his primary care physician) at the pharmacy. Concomitant therapies included an unspecified cholesterol medication, an unspecified blood pressure medication, one baby aspirin/day, and one multivitamin/day. The patient had a blood test performed "three days prior" to receiving the ZOSTAVAX on 22-NOV-2014. At that time his blood platelet count was at 222 (unit unspecified). On 28-NOV-2014 the patient woke up with a bloody nose "that would not stop bleeding". He visited an unspecified emergency room on the same day. The emergency room treated "it as a regular bloody nose" (the type of treatment unspecified) and sent the patient home. On 30-NOV-2014, he was still experiencing the bloody nose and went to another Hospital Emergency Room. In the emergency room blood test was performed which determined his blood count was at "1". The patient was then admitted into hospital on 30-NOV-2014 where he was diagnosed with thrombocytopenia. The patient was treated with an unspecified "immune-globulin" for two days and was also receiving prednisone (manufacturer unknown) (unspecified dose and frequency) intravenously while in the hospital. He was released from the hospital on 03-DEC-2014 and was prescribed prednisone (manufacturer unknown) 20mg tablets that he took once daily for an unspecified amount of time. The patient reported he was continuing to see an unspecified hematologist (demographics unknown) and he reported his blood platelet count was "back up", however it was unspecified if the blood platelet count had fully recovered. It was also unspecified if the patient was still experiencing a bloody nose. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Feeling abnormal, Tremor, Vomiting
Clinical narrative: This case was reported by a consumer and described the occurrence of difficulty breathing in a 22-year-old female patient who received ENGERIX B adult (batch number F2LR7, expiry date unknown). On 3rd December 2014, the patient received ENGERIX B adult 20 mg. On 3rd December 2014, 10 min after received ENGERIX B adult, the patient experienced difficulty breathing, weird feeling, tremor and vomiting. On 3rd December 2014, the outcome of the difficulty breathing, weird feeling, tremor and vomiting were recovered/resolved. It was unknown if the reporter considered the difficulty breathing, weird feeling, tremor and vomiting to be related to ENGERIX B adult. Additional information received: Reporter read that EMS was called to the facility however the patient refused transport to the hospital. Reporter was not aware of the patient being hospitalized and reports the outcome as resolved. They further reported that this was the 2nd event that occurred with this lot number and expiration date. In addition they mentioned using from first box and three vials from the 2nd box of the lot number and to their knowledge no other reports have been made with the lot number other than the two administered from the 2nd box. No egg allergy and patient was healthy.
Age: 0.51
Sex: M
Vaccine: DTAP
Symptoms: Body temperature decreased, Dyspnoea, Peripheral coldness, Skin discolouration, Vomiting
Clinical narrative: He started throwing up again same as at 4 months.  His skin was very cold and when we took his temp it was 94 degrees.  His skin was ash gray and he was gasping for air.  In between episodes he had projectile vomiting.
Age: 0.51
Sex: M
Vaccine: DTAP
Symptoms: Vomiting projectile
Clinical narrative: He started throwing up again same as at 4 months.  His skin was very cold and when we took his temp it was 94 degrees.  His skin was ash gray and he was gasping for air.  In between episodes he had projectile vomiting.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Fatigue, Somnolence
Clinical narrative: Extreme fatigue unable to stay awake showing 14 to 16 hours a day when prior only slept 6 to 8 making it very hard to take care of 2 young children.
Age: 0.36
Sex: M
Vaccine: HBHEPB, PNC13, RV5
Symptoms: Eye swelling, Pyrexia
Clinical narrative: Fever and eye swelling.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Cardiac monitoring, Ear swelling, Generalised erythema, Urticaria
Clinical narrative: 12 PM Pick the patient up from school. Ears tripled in size. Red face neck arms and back. Hives all over her face. Wheezing. Oxygen was 89% and we got to ER. Patient was treated with prednisone, Pepcid, Benadryl and breathing treatment.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Wheezing
Clinical narrative: 12 PM Pick the patient up from school. Ears tripled in size. Red face neck arms and back. Hives all over her face. Wheezing. Oxygen was 89% and we got to ER. Patient was treated with prednisone, Pepcid, Benadryl and breathing treatment.
Age: 1.6
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Abnormal behaviour, Crying, Ear pain, Injection site pain, Irritability
Clinical narrative: Fever. Not herself x 2 days.. increased fussiness. Mother notes usually well mannered, now crying more. Pulling at ears last night, fever spike 101.5, 11:30pm last night. LEG PAIN, TREAT WITH IBUPROFEN. SEIZURES-SENT TO HOSPITAL.
Age: 1.6
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Pyrexia, Seizure
Clinical narrative: Fever. Not herself x 2 days.. increased fussiness. Mother notes usually well mannered, now crying more. Pulling at ears last night, fever spike 101.5, 11:30pm last night. LEG PAIN, TREAT WITH IBUPROFEN. SEIZURES-SENT TO HOSPITAL.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Headache, Injection site swelling, Muscle tightness, Pain in extremity
Clinical narrative: Neck started getting really tight, arm of injection became extremely painful, had diarrhea and headache.  Fever of 102.3.  Arm swelled and hurt from elbow to neck base. Headache has continued from 10PM last night to now.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Neck started getting really tight, arm of injection became extremely painful, had diarrhea and headache.  Fever of 102.3.  Arm swelled and hurt from elbow to neck base. Headache has continued from 10PM last night to now.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Computerised tomogram normal, Dyspnoea, Electromyogram abnormal
Clinical narrative: Pt. woke up with numb and tingling hands and feet. Symptoms grew worse and pt went to ED 10/19/2014. Negative CT scan, sent home to f/u with PCP, who advised f/u with neurologist. On 10/27/14, pt went back to PCP with c/o cont. numbness and tingling and increasing SOB with increasing joint pain and trouble ambulating.  Admitted to local hospital where lumbar puncture and EMG confirmed Guillain-Barre Syndrome. IV IG treatments given, after five days pt dc'd home.  As of the day of this report, pt has still not regained full feeling in hands and feet, still has pain in hands, shoulders, left arm, and lower back, still has occasional difficulty with full movement.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture abnormal
Clinical narrative: Pt. woke up with numb and tingling hands and feet. Symptoms grew worse and pt went to ED 10/19/2014. Negative CT scan, sent home to f/u with PCP, who advised f/u with neurologist. On 10/27/14, pt went back to PCP with c/o cont. numbness and tingling and increasing SOB with increasing joint pain and trouble ambulating.  Admitted to local hospital where lumbar puncture and EMG confirmed Guillain-Barre Syndrome. IV IG treatments given, after five days pt dc'd home.  As of the day of this report, pt has still not regained full feeling in hands and feet, still has pain in hands, shoulders, left arm, and lower back, still has occasional difficulty with full movement.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity, Paraesthesia
Clinical narrative: Pt. woke up with numb and tingling hands and feet. Symptoms grew worse and pt went to ED 10/19/2014. Negative CT scan, sent home to f/u with PCP, who advised f/u with neurologist. On 10/27/14, pt went back to PCP with c/o cont. numbness and tingling and increasing SOB with increasing joint pain and trouble ambulating.  Admitted to local hospital where lumbar puncture and EMG confirmed Guillain-Barre Syndrome. IV IG treatments given, after five days pt dc'd home.  As of the day of this report, pt has still not regained full feeling in hands and feet, still has pain in hands, shoulders, left arm, and lower back, still has occasional difficulty with full movement.
Age: 0.18
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Cyanosis, Foaming at mouth, Respiratory arrest
Clinical narrative: Woke up and found him blue, not breathing, and foaming at the mouth.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site discomfort, Injection site mass
Clinical narrative: Softball sized lump at injection site on Right arm. Discomfort at injection sites on both arms. Decreased with ice and ibuprofen temporarily through the evening. States just as bad on morning of 02/11/2015 as it was the day before.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site pain, Pain, Pain in extremity, Skin warm
Clinical narrative: Swollen, redness, pain and hot to touch, pain when lifting arm, swollen/red area is approximately 3 inches in diameter. It started on 2/9/15 at night but the pain and swelling worsened on 2/10/15 and still have not subsided as of today 2/11/15. No fever or pain other than the local injection site.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Swollen, redness, pain and hot to touch, pain when lifting arm, swollen/red area is approximately 3 inches in diameter. It started on 2/9/15 at night but the pain and swelling worsened on 2/10/15 and still have not subsided as of today 2/11/15. No fever or pain other than the local injection site.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Emotional distress, Hypersomnia, Lethargy, Screaming
Clinical narrative: She slept for over 24 hours, completely lethargic when waking for feeds.  Following her waking up, she screamed for about 2 weeks.  Inconsolable screaming.  Today is 2/11/15 and just in the last couple of days has she gone back to her calm self.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Patient's current condition or medical history was not reported. On 09-FEB-2015 the patient was vaccinated with a dose of ROTATEQ (lot#, dose not reported, orally) which underwent a supported temperature excursion. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Since 19-JAN-2015 the patients were vaccinated with ROTATEQ (dose: 2 ml, administered orally) which were improperly stored. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Pain, Pyrexia, Rash generalised
Clinical narrative: Severe full body rash, fever, body aches.
Age: 21.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Dermal cyst, Hidradenitis, Laboratory test abnormal
Clinical narrative: Sebaceous cyst in groin area.
Age: 12.0
Sex: M
Vaccine: FLU4, HEPA, HPV4, MNQ, TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: EXPERIENCED NAUSEA AND VOMITING 5-6 TIMES DURING THE NIGHT; 6 PM, 8PM, 11PM - 3AM 6AM.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Immunisation, Needle issue, Underdose
Clinical narrative: Pharmacist administered less than total dose of vaccine most likely due to needle malfunction. Manufacturer and MD were notified and shot regiven 1 month later.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: PT RECEIVED PEDIARIX, HIB, AND PREVNAR ON 02/06/15. NO ADVERSE EVENT REPORTED DURING THAT DAY. NO SYMPTOMS. PT WAS FOUND UNRESPONSIVE AROUND 8AM ON 02/07/15. CAUSE OF DEATH HAS YET TO BE DETERMINED.
Age: 1.18
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Apnoea, Convulsion, Injection site pain, Rash, Swelling face
Clinical narrative: Seizures, facial swelling, apnea, rash, pain at injection site (Motrin given, unknown if she had fever or not).
Age: 1.18
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Dyskinesia, Erythema of eyelid, Eye swelling, Eyelid oedema, Ocular hyperaemia
Clinical narrative: Seizures, facial swelling, apnea, rash, pain at injection site (Motrin given, unknown if she had fever or not).
Age: 1.18
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Apnoea, Convulsion, Injection site pain, Rash, Swelling face
Clinical narrative: Possible seizure activity - arm jerking. Swollen and red (R) eye and eyelid.
Age: 1.18
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Dyskinesia, Erythema of eyelid, Eye swelling, Eyelid oedema, Ocular hyperaemia
Clinical narrative: Possible seizure activity - arm jerking. Swollen and red (R) eye and eyelid.
Age: 36.0
Sex: F
Vaccine: RAB
Symptoms: Back pain, Diarrhoea, Headache, Nausea
Clinical narrative: Nausea and headache twenty minutes after 1st dose.  Proceeded to get 2nd dose on 1/21/15 without telling nurse about symptoms.  later developed diarrhea and back pain.
Age: 12.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Vaccinated child fainted approximately 3 minutes after his vaccines were administered.  Was vaccinating brother when child saw needle and heard click of retractable needle and fainted. Called mother of child later in afternoon to check on him and she stated he had bump on head from fall related to fainting.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Wrong drug administered
Clinical narrative: Discussed flu and Tdap vaccines. Client decided just Tdap at this visit. I administered flu vaccine instead. Noticed my mistake when client had already left the building. I phoned her and she plans to receive her Tdap when fiance also comes to health dept for Tdap next week.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: About 1.5-2 weeks after receiving the Gardasil vaccine I had a large lymph node at the base of my neck, right behind my ear, swell up. This happened with my 1st and 2nd Gardasil vaccine. I waited past the reccommended time to get the third vaccine because I had had adverse reactions to the first two. The third time I did not have the swelling.
Age: 31.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: Pain at site of injection, fever, flu like symptoms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pallor
Clinical narrative: Child became pale approximately 5 minutes following vaccines. No history of seizures or fainting.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Incorrect route of drug administration, Irritability
Clinical narrative: Rotavirus Monovalent vaccines was adminitered intramuscularly instead of orally. No adverse effects noted in clinic. Mother states child was irritable at home.
Age: 17.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Right deltoid pain after flu and Menactra vaccines 2/9/15; red and swollen area 10cm by 6cm developed 2/10/15.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Cognitive disorder, Diplegia, Memory impairment, Migraine, Nausea
Clinical narrative: Date of flu vaccine: September 10th, 2015. Date of obvious symptoms: December 12, 2015. Date of diagnosis: December 18th, 2015. Symptoms: Constant extremely severe migraine, very pronounced vertigo, constant nausea, paralyzation of the right side of the face, partial paralyzation of the legs, significant sudden hearing loss in the right ear, pronounced nystagmus, extreme sensitivity to light, and memory and cognitive blunting.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Nystagmus, Photophobia, Sudden hearing loss, VIIth nerve paralysis, Vertigo
Clinical narrative: Date of flu vaccine: September 10th, 2015. Date of obvious symptoms: December 12, 2015. Date of diagnosis: December 18th, 2015. Symptoms: Constant extremely severe migraine, very pronounced vertigo, constant nausea, paralyzation of the right side of the face, partial paralyzation of the legs, significant sudden hearing loss in the right ear, pronounced nystagmus, extreme sensitivity to light, and memory and cognitive blunting.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain upper, Arthralgia, Chills, Diarrhoea, Faeces discoloured
Clinical narrative: Chills, fever, vomiting, diarrhea, achy joints and muscles, stomach pain, swollen roof of mouth and gums, headache.  02/02/2015. Arm swollen and red at injection site with itchy rash. 02/09/2015 Stools green had not eaten anything green for over week.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Gingival swelling, Headache, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Chills, fever, vomiting, diarrhea, achy joints and muscles, stomach pain, swollen roof of mouth and gums, headache.  02/02/2015. Arm swollen and red at injection site with itchy rash. 02/09/2015 Stools green had not eaten anything green for over week.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Palatal swelling, Pyrexia, Rash pruritic, Vomiting
Clinical narrative: Chills, fever, vomiting, diarrhea, achy joints and muscles, stomach pain, swollen roof of mouth and gums, headache.  02/02/2015. Arm swollen and red at injection site with itchy rash. 02/09/2015 Stools green had not eaten anything green for over week.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Bursitis, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Paraesthesia
Clinical narrative: Lt arm pain and paresthesias.  MRI obtained in Feb 2014 after failing conservative tx, consistent with sybacromial bursitis.
Age: 0.18
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Decreased appetite, Emotional distress, Screaming
Clinical narrative: Newborn was inconsolable, with continuous screaming for two hours. Newborn not interested in breastfeeding, although it had been several hours since last session.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site pain, Injection site warmth, Pain, Pain in extremity
Clinical narrative: Pt was not in office when reaction occurred; was a few hours after administration of vaccine; she reported arm was painful and hot, from fingers to injection site, had to keep arm stiff, she went to the hospital, not treatment was given; reported this to my office on 2/2/2015.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: Pt was not in office when reaction occurred; was a few hours after administration of vaccine; she reported arm was painful and hot, from fingers to injection site, had to keep arm stiff, she went to the hospital, not treatment was given; reported this to my office on 2/2/2015.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Pain in extremity
Clinical narrative: PATIENT SAYS HER ARM HAS BEEN SORE AND BRUISED SINCE RECEIVING THE SHOT ON 11/4/15...SHE CAME TO REPORT IT 2/11/2015.
Age: 10.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Abdominal pain upper, Arthralgia, Headache, Injection site pain, Myalgia
Clinical narrative: Headache (7/10 pain scale), neck pain, fever 101.4, pain at injection site (right leg) (8/10 pain scale) feet tingling, joint tenderness, muscle tenderness, stomach ache.
Age: 10.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Neck pain, Paraesthesia, Pyrexia
Clinical narrative: Headache (7/10 pain scale), neck pain, fever 101.4, pain at injection site (right leg) (8/10 pain scale) feet tingling, joint tenderness, muscle tenderness, stomach ache.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Back pain, Chest pain, Diarrhoea, Dizziness
Clinical narrative: Reported symptoms on 2/3/15: Extremely nauseous, heartburn, neck and back aches, diarrhea, sore chest, headache and fatigue. Reported symptoms on 2/6/15: Dizzy and weak. No treatment.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspepsia, Fatigue, Headache, Nausea, Neck pain
Clinical narrative: Reported symptoms on 2/3/15: Extremely nauseous, heartburn, neck and back aches, diarrhea, sore chest, headache and fatigue. Reported symptoms on 2/6/15: Dizzy and weak. No treatment.
Age: 1.04
Sex: M
Vaccine: HEPA, MMRV, PPV
Symptoms: Abasia, Aphasia, C-reactive protein normal, Crying, Full blood count normal
Clinical narrative: Large red warm welt where Prevnar #4 was given. Within 24 hours he stopped trying to walk, stopped talking and would just sit and scream. Ran a low grade fever for 11 days straight. Blister like rash developed late Jan 2015. Low grade fever every day with the exception of a few day. Still has not gained all of his words back. Still will cry and scream sometimes with no known reason.  Acts like he has a sore throat.
Age: 1.04
Sex: M
Vaccine: HEPA, MMRV, PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Oropharyngeal pain, Pyrexia
Clinical narrative: Large red warm welt where Prevnar #4 was given. Within 24 hours he stopped trying to walk, stopped talking and would just sit and scream. Ran a low grade fever for 11 days straight. Blister like rash developed late Jan 2015. Low grade fever every day with the exception of a few day. Still has not gained all of his words back. Still will cry and scream sometimes with no known reason.  Acts like he has a sore throat.
Age: 1.04
Sex: M
Vaccine: HEPA, MMRV, PPV
Symptoms: Rash vesicular, Screaming, Streptococcus test negative, Urticaria
Clinical narrative: Large red warm welt where Prevnar #4 was given. Within 24 hours he stopped trying to walk, stopped talking and would just sit and scream. Ran a low grade fever for 11 days straight. Blister like rash developed late Jan 2015. Low grade fever every day with the exception of a few day. Still has not gained all of his words back. Still will cry and scream sometimes with no known reason.  Acts like he has a sore throat.
Age: 1.81
Sex: U
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 21-month-old patient who received FLUARIX QUADRIVALENT (batch number 7TU92, expiry date 30th June 2015). On 26th December 2014, the patient received the 1st dose of FLUARIX QUADRIVALENT .5 ml. On 26th December 2014, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.
Age: 0.53
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus test positive
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 8 month old female patient. The patient's pertinent medical history, drug reactions and allergies were not reported. The physician reported that, the patient was vaccinated with ROTATEQ (dose unspecified) oral as follows: 24-JUL-2014, dose 1 (lot # K004620), on 30-SEP-2014, dose 2 (lot # K007444) and on 03-DEC-2014, dose 3 (lot # K010755) (the expiration dates were unknown). Concomitant therapies included PEDVAXHIB, PREVENAR 13 and PEDIARIX. On an unspecified date in approximately February 2015 (reported as "approximately 2 months after completion of the vaccine series"), the patient experienced eight episodes of diarrhea and then, on 04-FEB-2015, the patient went to physician for evaluation. It was reported that during the office visit, on 04-FEB-2015, the physician tested the patient for rotavirus and the results came back as positive on 06-FEB-2015. The outcome of the events was reported as recovered/resolved on an unspecified date in approximately February 2015. The relatedness between the event and the vaccination within oral, ROTATEQ was not provided. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal distension, Asthenia, Eyelid oedema, Nephrotic syndrome, Peripheral swelling
Clinical narrative: Swelling in face, legs, arms, belly, weakness, loss of urine. Symptoms came on slowly, swelling in eyelids week after vaccine. Steroid treatment.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Protein urine present, Swelling face, Urinary incontinence
Clinical narrative: Swelling in face, legs, arms, belly, weakness, loss of urine. Symptoms came on slowly, swelling in eyelids week after vaccine. Steroid treatment.
Age: 1.3
Sex: M
Vaccine: FLU3, HIBV, VARCEL
Symptoms: Croup infectious, Nasal congestion, Pyrexia
Clinical narrative: Patient presented with croup cough, fever, and nasal congestion. Another patient presented with similar symptoms following varicella vaccine.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (via oral route of administration; dose, lot# and exp. date were not reported). No adverse effects were reported. The outcome of the event was unknown. This is one of the two reports received from the same source. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Back pain, Gastrooesophageal reflux disease, Headache, Injection site erythema, Injection site induration
Clinical narrative: Evening of vaccine administration client had swelling at injection site raised approx 1/4" and diameter approx 1". Next day blister size of a half dollar arose at inj. site surrounded by bright red ring/swollen and hot. Client took BENADRYL/and ibuprofen at that point. Client reports swelling reached size of donut and she had a headache, backache and acid reflux for next four days 1/29-1/30-1/31 and 2/4 when sx began to subside. Then on 2/7/2015 injection site became swollen, hard and very painful. Client went to ER that evening where physician dx it as an allergic reaction, no test were done and no medication was given. Client has recuperated completely and had no further reaction.
Age: 24.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Evening of vaccine administration client had swelling at injection site raised approx 1/4" and diameter approx 1". Next day blister size of a half dollar arose at inj. site surrounded by bright red ring/swollen and hot. Client took BENADRYL/and ibuprofen at that point. Client reports swelling reached size of donut and she had a headache, backache and acid reflux for next four days 1/29-1/30-1/31 and 2/4 when sx began to subside. Then on 2/7/2015 injection site became swollen, hard and very painful. Client went to ER that evening where physician dx it as an allergic reaction, no test were done and no medication was given. Client has recuperated completely and had no further reaction.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Haematochezia, Mucous stools
Clinical narrative: Infant received PENTACEL, PREVNAR, and rotavirus vaccine on 11/19/14 and mother noted bright red blood and mucous in stool on 11/20/14. She had been taking rectal temps on infant but this never happened before or since, with temp. taking. Lasted only that day. Resolved simultaneously.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Convulsion, Dyskinesia, Fall, Generalised tonic-clonic seizure
Clinical narrative: Within 3 hours of vaccine - grand mal seizure which resulted in bruised sternum, ribs and forehead. Bit both sides of my tongue and broke out a tooth. Convulsed for over 3 minutes with no memory of event. Husband found me on our kitchen floor. Had to have head MRI and X-rays at medical center. Another episode occurred April 18, 2014 at approx. 6:30 pm. This was not as severe in nature, lasting less than 2 minutes. Loss of consciousness and convulsions. I was in my recliner so therefore I did not hall or suffer injury. Had episode number 3 on 6-19-14 at approx 10:30 am. Was cooking and my husband caught me before I hit the floor. I hit the refrigerator door and cut my lip and chipped a tooth. Lasted approx. 40-45 seconds. July 11th 2014 at 7:45 pm while eating dinner. My husband said he held me in my chair and loss of consciousness for 20-25 seconds and body jerking. I have no memory of the episode. Loss bladder control.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Lip injury, Loss of consciousness, Nuclear magnetic resonance imaging normal, Tongue biting, Tooth fracture
Clinical narrative: Within 3 hours of vaccine - grand mal seizure which resulted in bruised sternum, ribs and forehead. Bit both sides of my tongue and broke out a tooth. Convulsed for over 3 minutes with no memory of event. Husband found me on our kitchen floor. Had to have head MRI and X-rays at medical center. Another episode occurred April 18, 2014 at approx. 6:30 pm. This was not as severe in nature, lasting less than 2 minutes. Loss of consciousness and convulsions. I was in my recliner so therefore I did not hall or suffer injury. Had episode number 3 on 6-19-14 at approx 10:30 am. Was cooking and my husband caught me before I hit the floor. I hit the refrigerator door and cut my lip and chipped a tooth. Lasted approx. 40-45 seconds. July 11th 2014 at 7:45 pm while eating dinner. My husband said he held me in my chair and loss of consciousness for 20-25 seconds and body jerking. I have no memory of the episode. Loss bladder control.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Urinary incontinence
Clinical narrative: Within 3 hours of vaccine - grand mal seizure which resulted in bruised sternum, ribs and forehead. Bit both sides of my tongue and broke out a tooth. Convulsed for over 3 minutes with no memory of event. Husband found me on our kitchen floor. Had to have head MRI and X-rays at medical center. Another episode occurred April 18, 2014 at approx. 6:30 pm. This was not as severe in nature, lasting less than 2 minutes. Loss of consciousness and convulsions. I was in my recliner so therefore I did not hall or suffer injury. Had episode number 3 on 6-19-14 at approx 10:30 am. Was cooking and my husband caught me before I hit the floor. I hit the refrigerator door and cut my lip and chipped a tooth. Lasted approx. 40-45 seconds. July 11th 2014 at 7:45 pm while eating dinner. My husband said he held me in my chair and loss of consciousness for 20-25 seconds and body jerking. I have no memory of the episode. Loss bladder control.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: According to mother, the right forearm has swelling, redness, warm to touch, and pain.  We advised cold compresses.
Age: 16.0
Sex: M
Vaccine: FLUN4, HEPA, MNQ
Symptoms: Burning sensation, Rash erythematous, Rash papular
Clinical narrative: Red, papular eruption locally and down right arm below where HAVRIX was given. Also complained of a "burning sensation" locally for about 20 min 5 hours after vaccine given.
Age: 50.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Gave flu vaccine by mistake came for BOOSTRIX. Completed both.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy skin, Blood test, Hypersensitivity vasculitis, Purpura, Rash erythematous
Clinical narrative: Head to toe purpura raised/unraised, itchy and non itchy reddish-purple scattered spots. Developed one week after receiving flu vaccine. Prednisone, Dapsone. Please excuse patient from getting the flu vaccination from this point forward. She has been diagnosed with leukocytoclastic vasculitis, which was due to the flu vaccine, so we recommend that she not receive it in the future.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: Head to toe purpura raised/unraised, itchy and non itchy reddish-purple scattered spots. Developed one week after receiving flu vaccine. Prednisone, Dapsone. Please excuse patient from getting the flu vaccination from this point forward. She has been diagnosed with leukocytoclastic vasculitis, which was due to the flu vaccine, so we recommend that she not receive it in the future.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Asthma, Bronchospasm, Cough, Dyspnoea, Wheezing
Clinical narrative: Shortness of breath, wheezing, coughing onset of asthma symptoms, bronchial spasms.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site vesicles, Pruritus generalised
Clinical narrative: Patient had a flu shot on 10-29-14 and the next day he noticed a fluid filled blister at the injection site. He states the blister burst the next day causing a small open area at site. He states the area itches and all over his body as well. He states he washed the area with warm soapy water and placed a Band-Aid at the site.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Gait disturbance, Muscular weakness, Pain, Pyrexia
Clinical narrative: High fever to 103F. Muscle weakness and pain (generalized) w/ assoc difficulty walking.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chest discomfort, Dysphonia, Eye pruritus, Eye swelling
Clinical narrative: Client received vaccine just prior to noon on 1/21/15. TC to HD at 1650 with c/o swollen itchy eyes, raspy voice, swelling in throat and chest tightness. Advised to take BENADRYL 50mg and if experiencing prob. breathing to go to ER. 1/22/15 TC to HD at 8:10 AM. States had T-101.5 at 7:30PM. Took ALEVE, went to bed, slept well in NOC. States feels fine this AM and is afebrile.