chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Dyspnoea, Influenza like illness, Neutrophil count increased, Wheezing
Clinical narrative: Case number PHHY2014US046120, is an initial spontaneous report received from the consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 522196) website on 14 Apr 2014 with a follow up report received from the Quality Assurance department on 24 Apr 2014. This report refers to a 64-year-old female patient. Her medical history included atelectasis, diabetes, asthma, hypoparathyroidism, GERD (gastrooesophageal reflux disease) and small airways disease. Concomitant drugs included metformin, losartan, prednisone, glyburide and hydrochlorothiazide. She was vaccinated with AGRIFLU (batch number: unknown) along with PNEUMOVAX (batch number: H020684) intramuscularly in the left arm on 07 Mar 2013. On 08 Mar 2013, within 12 hours after vaccinations she had flu like symptoms and wheezing with breathing difficulties. She returned to the doctor on 11 Mar 2013, 14 Mar 2013, 03 Apr 2013 and was finally hospitalized on 07 Apr 2013. The lab data showed atelectasis, complement total 193, neutrophil 8.85, chromogranin 900 and ANA (anti-nuclear antibody pattern) positive. The patient was hospitalized for 4 days (reported as prolonged hospitalization). The final outcome of the events reported as not recovered. The causality of the events was not reported. Upon follow up the quality assurance department confirmed that the reported batch number of AGRIFLU (1206401) was a valid batch number for AGRIFLU. Follow up report received from the quality assurance department on 24 Apr 2014: The reported batch number of AGRIFLU (1206401) was confirmed not to be a valid batch number for AGRIFLU by the quality assurance department.
Age: 71.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Fine motor delay, Mobility decreased, Pain in extremity
Clinical narrative: Case number PHHY2014US047188 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 522402) web site on 14 Apr 2014 and a follow-up information was received from Quality Assurance Department (reference number: 295370) on 22 Apr 2014. This report refers to a 71 year old female patient. Her medical history included Paget's disease and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 010021A) in the right arm on 15 Jan 2014. On 16 Jan 2014, she experienced symptoms of pain down arm, problem in lifting the arm and decreased fine motor skill in hand. She first reported symptoms on 19 Jan 2014. she showed slow improvement in between 19 Jan 2014 and 31 Jan 2014 time frame, but reported the symptoms again on 31 Jan 2014. She tried icing and over the counter (OTC) pain medications. She did not see physician yet. The event outcome was unknown at the time of reporting. The events were reported non serious, but was internally upgraded as medically significant by the agency. The causality was not reported. Follow-up received from Quality Assurance Department (reference number: 295370) on 22 Apr 2014: Updated QA reference number and batch number was changed to "010021A", as the already reported one was not correct.
Age: 71.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Mobility decreased, Motor dysfunction, Pain in extremity
Clinical narrative: Case number PHHY2014US047188 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 522402) web site on 14 Apr 2014 and a follow-up information was received from Quality Assurance Department (reference number: 295370) on 22 Apr 2014. This report refers to a 71 year old female patient. Her medical history included Paget's disease and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 010021A) in the right arm on 15 Jan 2014. On 16 Jan 2014, she experienced symptoms of pain down arm, problem in lifting the arm and decreased fine motor skill in hand. She first reported symptoms on 19 Jan 2014. she showed slow improvement in between 19 Jan 2014 and 31 Jan 2014 time frame, but reported the symptoms again on 31 Jan 2014. She tried icing and over the counter (OTC) pain medications. She did not see physician yet. The event outcome was unknown at the time of reporting. The events were reported non serious, but was internally upgraded as medically significant by the agency. The causality was not reported. Follow-up received from Quality Assurance Department (reference number: 295370) on 22 Apr 2014: Updated QA reference number and batch number was changed to "010021A", as the already reported one was not correct.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Abasia, Aphasia, Blood pressure fluctuation, Blood test, Computerised tomogram
Clinical narrative: Case number PHHY2014US045913 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 522606) website on 14 Apr 2014, with a follow up report received from the Quality Assurance department on 23 Apr 2014. This report refers to a 60-year-old male patient. His concurrent condition included high cholesterol. Concomitant medications included LEXAPRO and atorvastatin. He was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into left arm on 24 Sep 2013. On the same day, he was also vaccinated with PNEUMOVAX (other manufacturer, batch number: H014561) intramuscularly into right arm. On 03 Oct 2013, 10 days after vaccinations, he experienced Guillain-Barre syndrome (GBS) with numbness, unable to swallow, unable to walk or speak, move, paralysis, pain, unstable blood pressure. On an unknown date, he was hospitalized for 27 days due to these events. He was on ventilator two times and had a complication from ventilation tube. During hospitalization, he underwent multiple tests, rehabilitation, physical therapy, lumbar puncture, computed tomography (CAT) scan, magnetic resonance imaging (MRI), electromyography (EMG) and unspecified laboratory blood work (results not reported). The events were reported as serious (life-threatening, disability and hospitalization). Outcome of the events was reported as condition unchanged as of 13 Feb 2014. Causality of the events was not reported. Upon follow up from the quality assurance department confirmed that, the reported batch number of FLUVIRIN (1358601) was not a valid batch number for FLUVIRIN. Follow up report received from the Quality Assurance Department on 23 Apr 2014: The reported batch number of FLUVIRIN (1358601) was confirmed not to be a valid batch number for FLUVIRIN by the quality assurance department. Hence no batch review will be performed.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Dysphagia, Electromyogram, Guillain-Barre syndrome, Hypoaesthesia, Laboratory test
Clinical narrative: Case number PHHY2014US045913 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 522606) website on 14 Apr 2014, with a follow up report received from the Quality Assurance department on 23 Apr 2014. This report refers to a 60-year-old male patient. His concurrent condition included high cholesterol. Concomitant medications included LEXAPRO and atorvastatin. He was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into left arm on 24 Sep 2013. On the same day, he was also vaccinated with PNEUMOVAX (other manufacturer, batch number: H014561) intramuscularly into right arm. On 03 Oct 2013, 10 days after vaccinations, he experienced Guillain-Barre syndrome (GBS) with numbness, unable to swallow, unable to walk or speak, move, paralysis, pain, unstable blood pressure. On an unknown date, he was hospitalized for 27 days due to these events. He was on ventilator two times and had a complication from ventilation tube. During hospitalization, he underwent multiple tests, rehabilitation, physical therapy, lumbar puncture, computed tomography (CAT) scan, magnetic resonance imaging (MRI), electromyography (EMG) and unspecified laboratory blood work (results not reported). The events were reported as serious (life-threatening, disability and hospitalization). Outcome of the events was reported as condition unchanged as of 13 Feb 2014. Causality of the events was not reported. Upon follow up from the quality assurance department confirmed that, the reported batch number of FLUVIRIN (1358601) was not a valid batch number for FLUVIRIN. Follow up report received from the Quality Assurance Department on 23 Apr 2014: The reported batch number of FLUVIRIN (1358601) was confirmed not to be a valid batch number for FLUVIRIN by the quality assurance department. Hence no batch review will be performed.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Lumbar puncture, Mechanical ventilation complication, Mobility decreased, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Case number PHHY2014US045913 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 522606) website on 14 Apr 2014, with a follow up report received from the Quality Assurance department on 23 Apr 2014. This report refers to a 60-year-old male patient. His concurrent condition included high cholesterol. Concomitant medications included LEXAPRO and atorvastatin. He was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into left arm on 24 Sep 2013. On the same day, he was also vaccinated with PNEUMOVAX (other manufacturer, batch number: H014561) intramuscularly into right arm. On 03 Oct 2013, 10 days after vaccinations, he experienced Guillain-Barre syndrome (GBS) with numbness, unable to swallow, unable to walk or speak, move, paralysis, pain, unstable blood pressure. On an unknown date, he was hospitalized for 27 days due to these events. He was on ventilator two times and had a complication from ventilation tube. During hospitalization, he underwent multiple tests, rehabilitation, physical therapy, lumbar puncture, computed tomography (CAT) scan, magnetic resonance imaging (MRI), electromyography (EMG) and unspecified laboratory blood work (results not reported). The events were reported as serious (life-threatening, disability and hospitalization). Outcome of the events was reported as condition unchanged as of 13 Feb 2014. Causality of the events was not reported. Upon follow up from the quality assurance department confirmed that, the reported batch number of FLUVIRIN (1358601) was not a valid batch number for FLUVIRIN. Follow up report received from the Quality Assurance Department on 23 Apr 2014: The reported batch number of FLUVIRIN (1358601) was confirmed not to be a valid batch number for FLUVIRIN by the quality assurance department. Hence no batch review will be performed.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Paralysis
Clinical narrative: Case number PHHY2014US045913 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 522606) website on 14 Apr 2014, with a follow up report received from the Quality Assurance department on 23 Apr 2014. This report refers to a 60-year-old male patient. His concurrent condition included high cholesterol. Concomitant medications included LEXAPRO and atorvastatin. He was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into left arm on 24 Sep 2013. On the same day, he was also vaccinated with PNEUMOVAX (other manufacturer, batch number: H014561) intramuscularly into right arm. On 03 Oct 2013, 10 days after vaccinations, he experienced Guillain-Barre syndrome (GBS) with numbness, unable to swallow, unable to walk or speak, move, paralysis, pain, unstable blood pressure. On an unknown date, he was hospitalized for 27 days due to these events. He was on ventilator two times and had a complication from ventilation tube. During hospitalization, he underwent multiple tests, rehabilitation, physical therapy, lumbar puncture, computed tomography (CAT) scan, magnetic resonance imaging (MRI), electromyography (EMG) and unspecified laboratory blood work (results not reported). The events were reported as serious (life-threatening, disability and hospitalization). Outcome of the events was reported as condition unchanged as of 13 Feb 2014. Causality of the events was not reported. Upon follow up from the quality assurance department confirmed that, the reported batch number of FLUVIRIN (1358601) was not a valid batch number for FLUVIRIN. Follow up report received from the Quality Assurance Department on 23 Apr 2014: The reported batch number of FLUVIRIN (1358601) was confirmed not to be a valid batch number for FLUVIRIN by the quality assurance department. Hence no batch review will be performed.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Abasia, Aphasia, Blood pressure abnormal, Blood test, Computerised tomogram
Clinical narrative: Case number PHHY2014US045913 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 522606) website on 14 Apr 2014, with a follow up report received from the Quality Assurance department on 23 Apr 2014. This report refers to a 60-year-old male patient. His concurrent condition included high cholesterol. Concomitant medications included LEXAPRO and atorvastatin. He was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into left arm on 24 Sep 2013. On the same day, he was also vaccinated with PNEUMOVAX (other manufacturer, batch number: H014561) intramuscularly into right arm. On 03 Oct 2013, 10 days after vaccinations, he experienced Guillain-Barre syndrome (GBS) with numbness, unable to swallow, unable to walk or speak, move, paralysis, pain, unstable blood pressure. On an unknown date, he was hospitalized for 27 days due to these events. He was on ventilator two times and had a complication from ventilation tube. During hospitalization, he underwent multiple tests, rehabilitation, physical therapy, lumbar puncture, computed tomography (CAT) scan, magnetic resonance imaging (MRI), electromyography (EMG) and unspecified laboratory blood work (results not reported). The events were reported as serious (life-threatening, disability and hospitalization). Outcome of the events was reported as condition unchanged as of 13 Feb 2014. Causality of the events was not reported. Upon follow up from the quality assurance department confirmed that, the reported batch number of FLUVIRIN (1358601) was not a valid batch number for FLUVIRIN. Follow up report received from the Quality Assurance Department on 23 Apr 2014: The reported batch number of FLUVIRIN (1358601) was confirmed not to be a valid batch number for FLUVIRIN by the quality assurance department. Hence no batch review will be performed.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Lumbar puncture, Mechanical ventilation, Mechanical ventilation complication, Mobility decreased, Nuclear magnetic resonance imaging
Clinical narrative: Case number PHHY2014US045913 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 522606) website on 14 Apr 2014, with a follow up report received from the Quality Assurance department on 23 Apr 2014. This report refers to a 60-year-old male patient. His concurrent condition included high cholesterol. Concomitant medications included LEXAPRO and atorvastatin. He was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into left arm on 24 Sep 2013. On the same day, he was also vaccinated with PNEUMOVAX (other manufacturer, batch number: H014561) intramuscularly into right arm. On 03 Oct 2013, 10 days after vaccinations, he experienced Guillain-Barre syndrome (GBS) with numbness, unable to swallow, unable to walk or speak, move, paralysis, pain, unstable blood pressure. On an unknown date, he was hospitalized for 27 days due to these events. He was on ventilator two times and had a complication from ventilation tube. During hospitalization, he underwent multiple tests, rehabilitation, physical therapy, lumbar puncture, computed tomography (CAT) scan, magnetic resonance imaging (MRI), electromyography (EMG) and unspecified laboratory blood work (results not reported). The events were reported as serious (life-threatening, disability and hospitalization). Outcome of the events was reported as condition unchanged as of 13 Feb 2014. Causality of the events was not reported. Upon follow up from the quality assurance department confirmed that, the reported batch number of FLUVIRIN (1358601) was not a valid batch number for FLUVIRIN. Follow up report received from the Quality Assurance Department on 23 Apr 2014: The reported batch number of FLUVIRIN (1358601) was confirmed not to be a valid batch number for FLUVIRIN by the quality assurance department. Hence no batch review will be performed.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pain, Paralysis
Clinical narrative: Case number PHHY2014US045913 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 522606) website on 14 Apr 2014, with a follow up report received from the Quality Assurance department on 23 Apr 2014. This report refers to a 60-year-old male patient. His concurrent condition included high cholesterol. Concomitant medications included LEXAPRO and atorvastatin. He was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into left arm on 24 Sep 2013. On the same day, he was also vaccinated with PNEUMOVAX (other manufacturer, batch number: H014561) intramuscularly into right arm. On 03 Oct 2013, 10 days after vaccinations, he experienced Guillain-Barre syndrome (GBS) with numbness, unable to swallow, unable to walk or speak, move, paralysis, pain, unstable blood pressure. On an unknown date, he was hospitalized for 27 days due to these events. He was on ventilator two times and had a complication from ventilation tube. During hospitalization, he underwent multiple tests, rehabilitation, physical therapy, lumbar puncture, computed tomography (CAT) scan, magnetic resonance imaging (MRI), electromyography (EMG) and unspecified laboratory blood work (results not reported). The events were reported as serious (life-threatening, disability and hospitalization). Outcome of the events was reported as condition unchanged as of 13 Feb 2014. Causality of the events was not reported. Upon follow up from the quality assurance department confirmed that, the reported batch number of FLUVIRIN (1358601) was not a valid batch number for FLUVIRIN. Follow up report received from the Quality Assurance Department on 23 Apr 2014: The reported batch number of FLUVIRIN (1358601) was confirmed not to be a valid batch number for FLUVIRIN by the quality assurance department. Hence no batch review will be performed.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Decreased activity, Decreased appetite, Dizziness, Dyskinesia, Fatigue
Clinical narrative: Fever 102.9 vomiting, somnolence, decreased appetite, difficulty walking, Went to hospital saw Dr. Patient had elevated WBC 18,000.  Has been to ER twice and physician's office twice.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Immediate post-injection reaction, Irritability, Lip discolouration, Pharyngeal erythema, Poor quality sleep
Clinical narrative: Fever 102.9 vomiting, somnolence, decreased appetite, difficulty walking, Went to hospital saw Dr. Patient had elevated WBC 18,000.  Has been to ER twice and physician's office twice.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Tremor, Vomiting, White blood cell count increased
Clinical narrative: Fever 102.9 vomiting, somnolence, decreased appetite, difficulty walking, Went to hospital saw Dr. Patient had elevated WBC 18,000.  Has been to ER twice and physician's office twice.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Gait disturbance, Pyrexia, Somnolence, Vomiting
Clinical narrative: Fever 102.9 vomiting, somnolence, decreased appetite, difficulty walking, Went to hospital saw Dr. Patient had elevated WBC 18,000.  Has been to ER twice and physician's office twice.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: White blood cell count increased
Clinical narrative: Fever 102.9 vomiting, somnolence, decreased appetite, difficulty walking, Went to hospital saw Dr. Patient had elevated WBC 18,000.  Has been to ER twice and physician's office twice.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Asthenia, Cyanosis, Hyperhidrosis, Impaired driving ability, Pallor
Clinical narrative: Administered HPV, MCV vaccine to patient at approx 0920.  While patient was in waiting area, she requested Hep A vaccine.  After administering Hep A vaccine, while patient was again in waiting area, within 5 min. Supervisor and I were called to assist patient to supine position as patient presented with cyanosis of lips, pallor and diaphoresis.  Pt also complained of weakness and vision being diminished.  Assisted patient to supine position with feet elevated.  Pt noted with weakness, cyanosis of the lips, pallor and diaphoresis.  Pt remianed in supine position for approx 15 min.  Pt then slowly raised herself to a sitting position for approx 5 min and was given a lollypop, some ice chips and cold water.  Upon drinking water, pt then proceeded to waiting area.  After in waiting area for approx 7 min, pt became diaphoretic again and stated "can I lay down again?"  Pt assisted to supine position on table in exam rm with feet elevated.  Pt remained in supine position for approx 10 min., then assisted to sitting position.  Pt again, drank another cup of cold water and proceeded to waiting area.  After remaining in waiting area for approx 30 min, pt again complained of feeling shaky.  Pt's nailbeds were cyanotic and pt upper and lower extremities were noted to be shaky.  Pt was also still presenting with diaphoresis.  B/P noted as 92/70.  Notifed ER and assisted pt to ER via wheelchair.  Pt's mother at side.  Also, advised pt and mother that patient should not drive her vehicle but should have mother drive her to destination.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Tremor, Visual acuity reduced
Clinical narrative: Administered HPV, MCV vaccine to patient at approx 0920.  While patient was in waiting area, she requested Hep A vaccine.  After administering Hep A vaccine, while patient was again in waiting area, within 5 min. Supervisor and I were called to assist patient to supine position as patient presented with cyanosis of lips, pallor and diaphoresis.  Pt also complained of weakness and vision being diminished.  Assisted patient to supine position with feet elevated.  Pt noted with weakness, cyanosis of the lips, pallor and diaphoresis.  Pt remianed in supine position for approx 15 min.  Pt then slowly raised herself to a sitting position for approx 5 min and was given a lollypop, some ice chips and cold water.  Upon drinking water, pt then proceeded to waiting area.  After in waiting area for approx 7 min, pt became diaphoretic again and stated "can I lay down again?"  Pt assisted to supine position on table in exam rm with feet elevated.  Pt remained in supine position for approx 10 min., then assisted to sitting position.  Pt again, drank another cup of cold water and proceeded to waiting area.  After remaining in waiting area for approx 30 min, pt again complained of feeling shaky.  Pt's nailbeds were cyanotic and pt upper and lower extremities were noted to be shaky.  Pt was also still presenting with diaphoresis.  B/P noted as 92/70.  Notifed ER and assisted pt to ER via wheelchair.  Pt's mother at side.  Also, advised pt and mother that patient should not drive her vehicle but should have mother drive her to destination.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist via field representative refers to a male patient of unknown age with no documented chicken pox or vaccination history. On an unknown date the patient was vaccinated with ZOSTAVAX (route of administration, anatomical location, lot number and expiration date and dose not reported). No concomitant medications were reported. On an unknown date, the patient experienced varicella like rash. The reporter stated that the patient went on vacation, and when he came back he had rash. Lab diagnostic studies were not reported. The reporter was unsure if treatment for varicella like rash had begun. It was reported that the patient did not recover. The reporter stated that the patient was seen in an unspecified emergency department. It was unclear whether or not the patient was admitted to the hospital. The relatedness between varicella like rash and ZOSTAVAX was not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient with chronic leukemia, rheumatoid arthritis, depression, thyroid disorder, allergy to sulfa and codeine. The patient's medical history included herpes. On 18-APR-2014, the patient was vaccinated with ZOSTAVAX (lot # reported as J012661, Exp date: 10-JAN-2015), 0.65 ml, subcutaneous. Concomitant therapies included piroxicam. On 18-APR-2014, "within a day", the patient developed an unspecified blister at the injection site after receiving ZOSTAVAX. No treatment was given for the events. No lab diagnostic studies performed. The patient called the pharmacist on 21-APR-2014 for medical attention. The events outcome was reported as not recovered/not resolved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: This spontaneous report as received from a nurse via field representative refers to a 25 years old female patient. Patient was not pregnant. No demographic information provided for patient. Pertinent medical history was reported as none. On 26-MAR-2014, the patient was vaccinated with GARDASIL injection, Lot # 5009243, expiry date 23-APR-2016, dose 3, dose (unknown), route of administration (unknown), for human papillomavirus. Concomitant therapies included NUVARING and ACYCLOVIR. On 26-MAR-2014, the patient developed pain at the injection site, lump at the injection site and redness at injection site. On 20-APR-2014, the patient called the doctor's office to report the lump at the injection site had gotten bigger, and changed appearance. The nurse described the lump as the size of a penny. Patient sought medical attention due to office visit. No lab diagnostics studies were performed. No treatment was given for adverse events. Action taken with respect GARDASIL was not applicable. No Product quality complaint was involved. The outcome of events was not resolved. Causality was not provided. No further adverse event information provided. Additional information has been requested.
Age: 0.54
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 month old patient of unknown gender. On 14-APR-2014 the patient was inadvertently administered ROTATEQ (Oral liquid, lot # H015682, dose: 2 ml, orally) that had expired on 18-MAR-2014. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 28-DEC-2012 the patient was vaccinated with a first dose of GARDASIL (intramuscularly, dose, lot#, expiration date not reported). On 07-MAR-2013 the patient was vaccinated with a second dose of GARDASIL and will receive the third dose on 17-APR-2014. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 10-APR-2014, the patient was vaccinated with an expired dose of VARIVAX (Merck) injection (lot # H006952, expiration date 16-MAR-2014, route not reported). No adverse effects was reported. Additional information has been requested.
Sex: U
Vaccine: FLUX
Symptoms: Influenza A virus test positive
Clinical narrative: Initial case received from a literature article on 11 April 2014. This case is linked to the case nos. 2014SA052439, 2014SA052441, 2014SA050453 (same reporter). Out of the 207 patients who received Influenza virus vaccine on an unspecified date, 207 patients were tested influenza A (H1N1) pdm09. And the test of influenza A virus was positive. The patient's demographic details, medical history and concomitant medication were not reported. The batch number, route and site of administration of Influenza vaccine were not reported. Laboratory data and corrective treatment details were not reported. At the time of this report, the outcome was unknown. List of documents held by sender were none.
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age (herself). Patient's medical history was not provided. In 2005 the patient was vaccinated with PNEUMOVAX 23. Patient's concomitant medications were not reported. The patient reported, "I received the PNEUMOVAX 23 vaccine on an unspecified date sometime in 2005 and I need to get it again." The patient then explained, "I experienced many unspecified adverse reactions when I received the vaccine the first time and I don't want to experience it again." The patient confirmed that she had still not yet received a "second injection of PNEUMOVAX 23". The outcome of many unspecified adverse reactions after patient received the vaccine for the first time was unknown. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. On an unknown date in 2013 (also reported as at least a year ago) the patient was vaccinated with ZOSTAVAX (dose, route and frequency were not reported). On an unknown date in 2013 (also reported as about a month after receiving ZOSTAVAX) the patient experienced shingles. The pharmacist also reported that the dose of ZOSTAVAX that the patient received, may have been exposed to room temperature for 1 to 2 hours prior to administration of the vaccine. It was also reported that the dose of ZOSTAVAX was dispensed or given at the pharmacy, but was administered at an unspecified physician's office. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect drug. It was reported that the pharmacist had conferenced with the generalist and asked whether the patient get chicken pox from ZOSTAVAX and can a patient who has never had chicken pox receive ZOSTAVAX. The pharmacist also asked should a patient be revaccinated if they received a dose of ZOSTAVAX that was exposed to room temperature for 1-2 hours. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Biopsy brain, Blood test, Encephalopathy, Lumbar puncture, Nuclear magnetic resonance imaging brain
Clinical narrative: Suicidal ideation which turned into a two week stay for "psychosis" and then a month-long stay and treatment in the hospital for "Acute Disseminated Encephalomyelopathy.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging spinal, Psychotic disorder, Suicidal ideation, Ultrasound pelvis
Clinical narrative: Suicidal ideation which turned into a two week stay for "psychosis" and then a month-long stay and treatment in the hospital for "Acute Disseminated Encephalomyelopathy.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Dizziness, Mood swings, Muscle fatigue, Muscular weakness
Clinical narrative: Fever, extreme body soreness, sore throat, muscle weakness & fatigue, dizziness, abdominal pain, severe mood swings.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Tonsillitis
Clinical narrative: Fever, extreme body soreness, sore throat, muscle weakness & fatigue, dizziness, abdominal pain, severe mood swings.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Decreased appetite, Dizziness, Lymphadenopathy, Migraine
Clinical narrative: Sore throat, swollen glands, migraine headache, dizziness, body aches & pain, continued weight loss, loss of appetite, abdominal pain.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Oropharyngeal pain, Pain, Weight decreased
Clinical narrative: Sore throat, swollen glands, migraine headache, dizziness, body aches & pain, continued weight loss, loss of appetite, abdominal pain.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to two patients of unknown demographics. The reporting physician stated that "over the course of the last three years, on unspecified date two patients were vaccinated with ZOSTAVAX (lot#, route of administration, expiration date, dose not provided), and later, on unspecified date, developed a mild case of shingles. At the time of vaccination all two patients were 65 years of age or older. The outcome of the event for two patients was reported as recovered from shingles (date of recovery not provided). The relatedness between the event and vaccination with ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 46.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 46 year old male patient with diabetes, depression, high blood pressure and high cholesterol and none drug allergies. On 15-APR-2014 the patient was vaccinated with ZOSTAVAX (subcutaneous, lot#: J011826, expiry date: 26-DEC-2014). Concomitant therapies included simvastatin (manufacturer unknown), lisinopril (manufacturer unknown), metformin, LEXAPRO, glimepiride and JANUVIA. On 16-APR-2014 the patient developed "flu-like syndrome". The patient's wife sought medical attention and called the pharmacist. No lab diagnostic studies were performed, there was no treatment given for the event. The outcome of the patient developed "flu-like syndrome" was reported as not recovered/not resolved. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Reaction at injection site.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Joint range of motion decreased, Muscular weakness, Musculoskeletal pain
Clinical narrative: Shoulder pain, muscle weakness in arm and shoulder, decreased range of motion, decreased strength in Left arm.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Bedridden, Erythema, Injection site erythema, Injection site mass, Pyrexia
Clinical narrative: This spontaneous report was received from approximately 71 year old female consumer. The patient's medical history includes drug reactions/allergies to penicillin (manufacturer unknown) and BIAXIN (manufacturer unkonwn) (dosages and frequencies unkonwn). On 17-APR-2014 the patient was vaccinated with booster shot of PNEUMOVAX23 (lot # J009827), 0.5 ml, subcutaneous. Concomitant therapies included betaxolol hydrochloride (manufacturer unkonwn) (dosage and frequency unknown) and SINGULAIR (dosage and frequency unknown). On 18-APR-2014, the patient developed a fever of 102F which kept her bedridden (disability), and there is redness that spread 5 more inches past the injection site (disability). The patient also reported that she had a lump at the injection site (disability), and her arm is now sensitive to touch (disability). The patient received the treatment with the cold compress. There were no lab diagnostic studies performed. The patient sought medical attention by visiting the physician. There was no hospitalization reported. There was no PQC involved. The outcome of the events, developed a fever of 102F which kept her bedridden, there is redness that spread 5 more inches past the injection site, my arm is now sensitive to touch, and she has a lump at the injection site was reported as not recovered/not resolved. The causality of the events was unspecified. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: This spontaneous report was received from approximately 71 year old female consumer. The patient's medical history includes drug reactions/allergies to penicillin (manufacturer unknown) and BIAXIN (manufacturer unkonwn) (dosages and frequencies unkonwn). On 17-APR-2014 the patient was vaccinated with booster shot of PNEUMOVAX23 (lot # J009827), 0.5 ml, subcutaneous. Concomitant therapies included betaxolol hydrochloride (manufacturer unkonwn) (dosage and frequency unknown) and SINGULAIR (dosage and frequency unknown). On 18-APR-2014, the patient developed a fever of 102F which kept her bedridden (disability), and there is redness that spread 5 more inches past the injection site (disability). The patient also reported that she had a lump at the injection site (disability), and her arm is now sensitive to touch (disability). The patient received the treatment with the cold compress. There were no lab diagnostic studies performed. The patient sought medical attention by visiting the physician. There was no hospitalization reported. There was no PQC involved. The outcome of the events, developed a fever of 102F which kept her bedridden, there is redness that spread 5 more inches past the injection site, my arm is now sensitive to touch, and she has a lump at the injection site was reported as not recovered/not resolved. The causality of the events was unspecified. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Concussion, Convulsion, Fall, Lip injury, Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to approximately 14 year old male patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unspecified. On 28-MAR-2014 the patient was vaccinated with GARDASIL, [lot # not reported], intramuscular (dose and frequency not reported). No other concomitant therapies reported. On 28-MAR-2014, the physician reported that the patient stood up after receiving GARDASIL in an office visit and fainted. On 28-MAR-2014 the patient fell and received concussion, busted lip and had seizure activity. It was reported that the patient was taken to the emergency room but was not admitted. The patient received the treatment (unspecified) for the events. The patient sought medical attention in doctor's office. There was no intervention to prevent the seriousness criteria. The event was not life-threatening. There was no PQC reported. The outcome of the events, had seizure activity, fainted, the patient fell and received concussion and busted his lip was unknown. The causality of the events was unspecified. Additional information has been requested.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Accidental exposure to product, Eye irritation
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a physician who is a male patient of unknown age. On 16-APR-2014 (reported as "today" at the time of report) the patient administered both VARIVAX (Merck) and M-M-R II (lot#, dose, frequency for both vaccines were not reported) to the patient. On 16-APR-2014 the physician experienced burning to his left eye when a small amount of vaccine squirted from the syringe while the needle was "retracting" after the injection was completed. The physician was not sure if the vaccine in question was VARIVAX (Merck) and M-M-R II. The physician flushed out his eye with water for an unspecified time. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information was received from a pharmacist regarding at least one adult patient, age unknown, and possibly up to 3 more adult patients (names and demographics unspecified), who on 18-MAR-2014, may have received PROQUAD (Merck) (SDV, MDV or additive) in error, subcutaneously. No known adverse effects. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Blood glucose increased
Clinical narrative: This spontaneous report as received from a consumer refers to a 70 year old male patient with diabetes. Patient had no drug reactions/allergies. On 07-APR-2014 the patient was vaccinated with PNEUMOVAX 23 (single shot), subcutaneous. No concomitant medication was used. The patient stated that on 08-APR-2014 his blood sugar went up 20 points after receiving the PNEUMOVAX 23. The patient stated that his blood sugar had remained 20 points higher since 08-APR-2014. The patient did not seek medical attention and no lab diagnostics studies were performed. No treatment was given for the adverse event. The outcome of the event was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 69 year old female patient. On 24-APR-2014, the patient was vaccinated with ZOSTAVAX lot # J012660. Concomitant medication included unspecified blood pressure medication. On 24-APR-2014, the patient felt lightheaded and dizzy after receiving ZOSTAVAX. The patient was given water and told to sit down. The patient was then able to walk out of the pharmacy. The pharmacist noted that the patient's blood pressure was high before administration. The outcome of felt lightheaded and dizzy after receiving ZOSTAVAX was reported as recovered/resolved. The reporter did not assess the relationship between the event and ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On an unknown date, the patients were vaccinated with VARIVAX (Merck) improperly stored over the last year (approximately 2013) (dose and lot number not provided). No adverse effects reported. At the time of the report, the outcome of improperly stored VARIVAX (Merck) was unknown. Additional information was received: All telephone attempts to obtain follow up information had been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: This spontaneous report as received from dean of students office refers to 8 patients ranging from 18-21 years of age. On an unknown date the patients were vaccinated with two documented doses of M-M-R II (lot number not reported). No other concomitant medications were reported. It was reported that on an unknown date the mumps identified among students who were fully vaccinated with two doses of M-M-R II. It was reported that patients who may have recently visited its campus or who had close contact with a student or staff member to contact their doctor if they are exhibiting symptoms. The outcome of the event was not reported. The causality of the event was not reported. Additional information has been requested.
Age: 1.63
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Varicella post vaccine
Clinical narrative: Mother of patient states that the childs whole body is covered in chicken pox with only one spot that is blistered.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to his now 81 year old wife with no drug allergies/reactions. The patient's medical history included history of melanoma on back and shingles 3-4 times. 2 years ago, in approximately April 2012 the patient was vaccinated with a single dose of ZOSTAVAX, subcutaneous (dose unknown). Concomitant medications include a lot of medications. The patient experienced several shingles outbreaks on an unspecified date since receiving ZOSTAVAX and was successfully treated with unspecified antiviral medication after each shingles episode. The patient experienced a burning, itchy rash all over her back and breast for the last 3 months, in approximately January 2014. She had been evaluated by an unspecified allergist and an unspecified dermatologist at office. The physicians both stated that the rash "is not shingles" and prescribed skin moisturizer and topical cortisone cream. The outcome of burning, itchy rash all over her back and breast was reported as not recovered/not resolved. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAPH, HEP, PNC13, RV1
Symptoms: Blood test, Crying, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Cried alot with pain then both legs turn red, swollen and hot to touch. Lasts for 25-30 minutes. Cried whole time and became everything normal after 30 minutes.
Age: 0.18
Sex: M
Vaccine: DTAPH, HEP, PNC13, RV1
Symptoms: Pain, Ultrasound scan
Clinical narrative: Cried alot with pain then both legs turn red, swollen and hot to touch. Lasts for 25-30 minutes. Cried whole time and became everything normal after 30 minutes.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Prior to leaving exam room, pt complained of itching on the leg where PROQUAD was administered. Redness extending approx. 3 inches surrounding the injection site and it appeared as though a raised area of approx 1 inch. Cold pack was applied, given BENADRYL.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Large area of erythema at injection site. Ice, MOTRIN.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Fatigue, Feeling hot, Lethargy, Pallor
Clinical narrative: Approx 10 min. after injection, pt became hot, faint feeling and pale. B/P 84/58, P 72, R 20. Laid down on cot with feet elevated, cool cloth to head and fan. After 20 min, color improved BP 80/60, P 64 but still lethargic. At 50 min tired but alert BP 80/60.
Age: 0.52
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Muscle twitching, Staring
Clinical narrative: Per patient's mom 3-5 days after receiving PCV13, DTaP patient would have staring episodes with muscle twitching. This would occur 2x per day for 3 days.
Age: 18.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 4-23-14 school nurse called reporting patient had a red localized swollen area at site of chicken pox vaccine. Advised warm compresses, TYLENOL and offered appt to see MD if warranted. 4-24-14 PC to school nurse about pt's status. Patient fine and area of concern completely resolved.
Age: 0.45
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Crying
Clinical narrative: Patient's mom stated that patient cried for "hours on end" after received Hib and PCV13.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Body temperature increased, Emotional distress, Irritability
Clinical narrative: Pt had 1st set of shots around 1030 on 4-21-14, 1 hr after shots started with 101 and up then became very fussy, could not console her all day. Doing better today, still has sl. temp.
Age: 0.57
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Crying, Irritability, Pyrexia
Clinical narrative: Woke up with fever 10:30AM 4-9-14 100.4. Was irritable 4-9-14. Patient cried for 1 hour non stop.
Age: 11.0
Sex: M
Vaccine: FLUN4
Symptoms: Abdominal pain, Blood test normal, Constipation, Diarrhoea, Nausea
Clinical narrative: Abdominal pain, nausea Nov. 21 2013 - present. Probiotics, diet change. Ondansetron ODT (11/30/13), Loperamide (11/30/13), omeprazole (12/4/13 - present). Constipation, diarrhea Nov. 21, 2013 - early Jan. 2014 now sometimes but less frequent.