chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARCEL
Symptoms: Apheresis, CSF white blood cell count increased, Condition aggravated, Depressed level of consciousness, Gait disturbance
Clinical narrative: Information has been received from the authors of the published literature article. To describe the case of a devastating multiple sclerosis (MS) relapse that occurred after fingolimod cessation and worsened dramatically after administration of the live varicella virus vaccine (VAR) (manufacturer unknown). A 39-year-old woman with longstanding MS presented for initial evaluation in October 2015, with gait disturbance. Her prior neurologist stopped fingolimod 4 months prior and started glatiramer acetate. She had been on fingolimod for 3 years before it was discontinued and had been clinically, but not radiographically stable. She was admitted to hospital for rescue apheresis. Magnetic resonance imaging (MRI) brain showed diffuse gadolinium enhancement. Her gait improved after apheresis, and the plan was to change MS therapy to alemtuzumab. She had no titer to varicella virus, and so was vaccinated with VAR (manufacturer unknown) at discharge with plan to start alemtuzumab 8 weeks later. She was readmitted two weeks later with clinical worsening. Examination revealed quadraparesis and decreased level of consciousness. MRIs of brain and spine revealed multiple new lesions with diffuse gadolinium enhancement. Cerebrospinal fluid (CSF) had 20 white blood cell (WBC) (86% lymphocytes) and a negative varicella zoster virus (VZV) polymerase chain reaction (PCR). A full infectious work-up was negative. She worsened clinically over the next 6 weeks with repeat MRIs showing multiple new enhancing lesions typical of MS. Rescue therapy included repeat courses of IV solumedrol, apheresis, and IV cyclophosphamide, none of which stabilized her. By 11-DEC-2015 she was quadriplegic. She was then treated with high dose IV methotrexate with leukovorin rescue. On 29-DEC-2015, MRI of the brain finally showed resolution of enhancement, and she stabilized clinically. Rituximab was administered as new long-term immunotherapy. She was transferred to long-term acute care hospital with a feeding tube and tracheostomy. The patient had significant reactivation of MS after cessation of fingolimod, a phenomenon well-described in the literature, and she responded at first in a typical fashion to rescue apheresis. We believe that this garden-variety relapse was transformed into a devastating exacerbation by the VAR (manufacturer unknown). Varicella is a neurotropic virus that has been associated with MS exacerbations. The severity of this exacerbation worsened dramatically after vaccination and resulted in significant permanent disability. Upon internal review Multiple Sclerosis was considered to be a serious event due to medically significant.A copy of the published literature article is attached as further documentation of the patient's experience. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Gastrointestinal tube insertion, Lymphocyte percentage increased, Multiple sclerosis relapse, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Information has been received from the authors of the published literature article. To describe the case of a devastating multiple sclerosis (MS) relapse that occurred after fingolimod cessation and worsened dramatically after administration of the live varicella virus vaccine (VAR) (manufacturer unknown). A 39-year-old woman with longstanding MS presented for initial evaluation in October 2015, with gait disturbance. Her prior neurologist stopped fingolimod 4 months prior and started glatiramer acetate. She had been on fingolimod for 3 years before it was discontinued and had been clinically, but not radiographically stable. She was admitted to hospital for rescue apheresis. Magnetic resonance imaging (MRI) brain showed diffuse gadolinium enhancement. Her gait improved after apheresis, and the plan was to change MS therapy to alemtuzumab. She had no titer to varicella virus, and so was vaccinated with VAR (manufacturer unknown) at discharge with plan to start alemtuzumab 8 weeks later. She was readmitted two weeks later with clinical worsening. Examination revealed quadraparesis and decreased level of consciousness. MRIs of brain and spine revealed multiple new lesions with diffuse gadolinium enhancement. Cerebrospinal fluid (CSF) had 20 white blood cell (WBC) (86% lymphocytes) and a negative varicella zoster virus (VZV) polymerase chain reaction (PCR). A full infectious work-up was negative. She worsened clinically over the next 6 weeks with repeat MRIs showing multiple new enhancing lesions typical of MS. Rescue therapy included repeat courses of IV solumedrol, apheresis, and IV cyclophosphamide, none of which stabilized her. By 11-DEC-2015 she was quadriplegic. She was then treated with high dose IV methotrexate with leukovorin rescue. On 29-DEC-2015, MRI of the brain finally showed resolution of enhancement, and she stabilized clinically. Rituximab was administered as new long-term immunotherapy. She was transferred to long-term acute care hospital with a feeding tube and tracheostomy. The patient had significant reactivation of MS after cessation of fingolimod, a phenomenon well-described in the literature, and she responded at first in a typical fashion to rescue apheresis. We believe that this garden-variety relapse was transformed into a devastating exacerbation by the VAR (manufacturer unknown). Varicella is a neurotropic virus that has been associated with MS exacerbations. The severity of this exacerbation worsened dramatically after vaccination and resulted in significant permanent disability. Upon internal review Multiple Sclerosis was considered to be a serious event due to medically significant.A copy of the published literature article is attached as further documentation of the patient's experience. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Nuclear magnetic resonance imaging spinal abnormal, Polymerase chain reaction, Quadriparesis, Quadriplegia, Tracheostomy
Clinical narrative: Information has been received from the authors of the published literature article. To describe the case of a devastating multiple sclerosis (MS) relapse that occurred after fingolimod cessation and worsened dramatically after administration of the live varicella virus vaccine (VAR) (manufacturer unknown). A 39-year-old woman with longstanding MS presented for initial evaluation in October 2015, with gait disturbance. Her prior neurologist stopped fingolimod 4 months prior and started glatiramer acetate. She had been on fingolimod for 3 years before it was discontinued and had been clinically, but not radiographically stable. She was admitted to hospital for rescue apheresis. Magnetic resonance imaging (MRI) brain showed diffuse gadolinium enhancement. Her gait improved after apheresis, and the plan was to change MS therapy to alemtuzumab. She had no titer to varicella virus, and so was vaccinated with VAR (manufacturer unknown) at discharge with plan to start alemtuzumab 8 weeks later. She was readmitted two weeks later with clinical worsening. Examination revealed quadraparesis and decreased level of consciousness. MRIs of brain and spine revealed multiple new lesions with diffuse gadolinium enhancement. Cerebrospinal fluid (CSF) had 20 white blood cell (WBC) (86% lymphocytes) and a negative varicella zoster virus (VZV) polymerase chain reaction (PCR). A full infectious work-up was negative. She worsened clinically over the next 6 weeks with repeat MRIs showing multiple new enhancing lesions typical of MS. Rescue therapy included repeat courses of IV solumedrol, apheresis, and IV cyclophosphamide, none of which stabilized her. By 11-DEC-2015 she was quadriplegic. She was then treated with high dose IV methotrexate with leukovorin rescue. On 29-DEC-2015, MRI of the brain finally showed resolution of enhancement, and she stabilized clinically. Rituximab was administered as new long-term immunotherapy. She was transferred to long-term acute care hospital with a feeding tube and tracheostomy. The patient had significant reactivation of MS after cessation of fingolimod, a phenomenon well-described in the literature, and she responded at first in a typical fashion to rescue apheresis. We believe that this garden-variety relapse was transformed into a devastating exacerbation by the VAR (manufacturer unknown). Varicella is a neurotropic virus that has been associated with MS exacerbations. The severity of this exacerbation worsened dramatically after vaccination and resulted in significant permanent disability. Upon internal review Multiple Sclerosis was considered to be a serious event due to medically significant.A copy of the published literature article is attached as further documentation of the patient's experience. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test negative
Clinical narrative: Information has been received from the authors of the published literature article. To describe the case of a devastating multiple sclerosis (MS) relapse that occurred after fingolimod cessation and worsened dramatically after administration of the live varicella virus vaccine (VAR) (manufacturer unknown). A 39-year-old woman with longstanding MS presented for initial evaluation in October 2015, with gait disturbance. Her prior neurologist stopped fingolimod 4 months prior and started glatiramer acetate. She had been on fingolimod for 3 years before it was discontinued and had been clinically, but not radiographically stable. She was admitted to hospital for rescue apheresis. Magnetic resonance imaging (MRI) brain showed diffuse gadolinium enhancement. Her gait improved after apheresis, and the plan was to change MS therapy to alemtuzumab. She had no titer to varicella virus, and so was vaccinated with VAR (manufacturer unknown) at discharge with plan to start alemtuzumab 8 weeks later. She was readmitted two weeks later with clinical worsening. Examination revealed quadraparesis and decreased level of consciousness. MRIs of brain and spine revealed multiple new lesions with diffuse gadolinium enhancement. Cerebrospinal fluid (CSF) had 20 white blood cell (WBC) (86% lymphocytes) and a negative varicella zoster virus (VZV) polymerase chain reaction (PCR). A full infectious work-up was negative. She worsened clinically over the next 6 weeks with repeat MRIs showing multiple new enhancing lesions typical of MS. Rescue therapy included repeat courses of IV solumedrol, apheresis, and IV cyclophosphamide, none of which stabilized her. By 11-DEC-2015 she was quadriplegic. She was then treated with high dose IV methotrexate with leukovorin rescue. On 29-DEC-2015, MRI of the brain finally showed resolution of enhancement, and she stabilized clinically. Rituximab was administered as new long-term immunotherapy. She was transferred to long-term acute care hospital with a feeding tube and tracheostomy. The patient had significant reactivation of MS after cessation of fingolimod, a phenomenon well-described in the literature, and she responded at first in a typical fashion to rescue apheresis. We believe that this garden-variety relapse was transformed into a devastating exacerbation by the VAR (manufacturer unknown). Varicella is a neurotropic virus that has been associated with MS exacerbations. The severity of this exacerbation worsened dramatically after vaccination and resulted in significant permanent disability. Upon internal review Multiple Sclerosis was considered to be a serious event due to medically significant.A copy of the published literature article is attached as further documentation of the patient's experience. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information had been received on 20-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 21-NOV-2013 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused patient to contract a persistent strain of Herpes Zoster. On or about 18-DEC-2013, the patient was treated by a nurse practitioner at a family health center for a painful rash which was diagnosed as shingles. Although shingles is an incurable viral condition, the patient was prescribed acyclovir, gabapentin, and ZORIVAX for management of his symptoms.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Rash
Clinical narrative: Information regarding the patient's past medical history, concurrent conditions, or concomitant medication was not provided. It was alleged in litigation that a male patient of unknown age was vaccinated with ZOSTAVAX vaccine (dose, route, lot # and expiration date were not provided) on or about 04-NOV-2013 at a Healthcare Center as recommended for routine adult health maintenance for the prevention of shingles. It was reported, that the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-JAN-2016, the patient was treated at the Healthcare Center for a painful rash and nerve pain which was then diagnosed as shingles. On or about 01-FEB-2016, the patient was treated at the same facility for ongoing and worsening symptoms of shingles. Although shingles is an incurable viral condition, a physician has prescribed gabapentin for the management of the patient's symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a Medical Assitant referring to a multiple unspecified patients of unknown age and gender. The medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies of the patients were not provided. On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX lot # M043581 and expiration date 28-OCT-2018 for prophylaxis (route of administration, dose and anatomical location were unknown), reconstitued with a properly stored sterile diluent (Lot number and expiration date were unknown). No adverse events were reported. It was reported that on an unspecified date, the vaccine was exposed to a temperature of 34 Fahrenheit for 1 hour and 24 minutes. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. There was not product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse and refers to an unspecified number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL 9, (dose number, frequency, route, anatomical location, lot number and expiration date were not reported), for prophylaxis. On 19-DEC-2016 the vaccines experienced a temperature excursion of 29.8 Fahrenheit Degrees for 30 minutes, and, on 03-APR-2017 experienced a temperature excursion of 49 Fahrenheit Degrees for 15 minutes. The digital data logger was involved. No side effects were reported by the reporter. Concomitant therapies included sterile diluent, however, the registered nurse did not provide any lot number or expiration date for the properly stored sterile diluent. This is one of several reports from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1704USA012147: US-009507513-1704USA012148: US-009507513-1704USA012149:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 20-APR-2017, the patient was administered an expired dose of ZOSTAVAX lot number L046900, expiration date 23-FEB-2017 (dose and route were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of VAQTA (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccine were exposed to temperature of 11 centigrade degrees (°C) (9 °C to 25 °C) for a time frame of 1 hour and 5 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA012144: US-009507513-1704USA012143: US-009507513-1704USA003984: US-009507513-1704USA012142:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of Hepatitis B vaccine (Recombinant) (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccine were exposed to temperature of 11 centigrade degrees (°C) (9 °C to 25 °C) for a time frame of 1 hour and 5 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. ; Sender's Comments: US-009507513-1704USA012144: US-009507513-1704USA012143: US-009507513-1704USA012141: US-009507513-1704USA003984:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of ROTATEQ (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccine were exposed to temperature of 11 Centigrade degrees (°C) (9 °C to 25 °C) for a time frame of 1 hour and 5 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA012144: US-009507513-1704USA003984: US-009507513-1704USA012141: US-009507513-1704USA012142.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of GARDASIL 9 (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccine were exposed to temperature of 4 Centigrade degrees for a time frame of 2 hours and 55 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA003984: US-009507513-1704USA012143: US-009507513-1704USA012141: US-009507513-1704USA012142.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse and refers to an unspecified number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB, (dose number, frequency, route, anatomical location, lot number and expiration date were not reported), for prophylaxis. On 19-DEC-2016 the vaccines experienced a temperature excursion of 29.8 Fahrenheit Degrees for 30 minutes, and, on 03-APR-2017 experienced a temperature excursion of 49 Fahrenheit Degrees for 15 minutes. The digital data logger was involved. No side effects were reported by the reporter. Concomitant therapies included sterile diluent, however, the registered nurse did not provide any lot number or expiration date for the properly stored sterile diluent. This is one of several reports from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1704USA012148: US-009507513-1704USA012149: US-009507513-1704USA011906:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse and refers to an unspecified number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX23, (dose number, frequency, route, anatomical location, lot number and expiration date were not reported), for prophylaxis. On 19-DEC-2016 the vaccines experienced a temperature excursion of 29.8 Fahrenheit Degrees for 30 minutes, and, on 03-APR-2017 experienced a temperature excursion of 49 Fahrenheit Degrees for 15 minutes. The digital data logger was involved. No side effects were reported by the reporter. Concomitant therapies included sterile diluent, however, the registered nurse did not provide any lot number or expiration date for the properly stored sterile diluent. This is one of several reports from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1704USA011906: US-009507513-1704USA012149: US-009507513-1704USA012147:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse and refers to an unspecified number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored M-M-R II, (dose number, frequency, route, anatomical location, lot number and expiration date were not reported), for prophylaxis. On 19-DEC-2016 the vaccines experienced a temperature excursion of 29.8 Fahrenheit Degrees for 30 minutes, and, on 03-APR-2017 experienced a temperature excursion of 49 Fahrenheit Degrees for 15 minutes. The digital data logger was involved. No side effects were reported by the reporter. Concomitant therapies included sterile diluent, however, the registered nurse did not provide any lot number or expiration date for the properly stored sterile diluent.  This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA012148: US-009507513-1704USA011906: US-009507513-1704USA012147:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. From 24-MAR-2017 to 06-APR-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # L046884, expiration date: 23-NOV-2017 for prophylaxis. The patients experienced no adverse effects. Administered doses of vaccines experienced the temperature excursion of -14 to -10 degrees Celsius for 7 hours 30 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA003016:
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates since October 2016, the patients were vaccinated with a dose of PNEUMOVAX23 (dosage, route of administration, lot # and expiry date were not provided) which were improperly-monitored. No adverse experience was reported. The temperatures, when recorded, were always within the recommended storage range. There was a period, when the temperature would not be recorded for 3 or 4 days and there were occasions when the temperature would be recorded only once a day. There was no previous temperature excursion reported. Digital data logger was not involved. No product quality complaint was involved. Follow up information has been received from an unspecified reporter referring to a patient of unknown age and gender on 11-APR-2017. The first dose of PNEUMOVAX23 was vaccinated in October 2016. On 06-FEB-2017, the patient was vaccinated with the second dose of PNEUMOVAX23 (Inappropriate schedule of vaccine administered) (dose and expiration date unknown, lot# reported as M0366728, right deltoid) intramuscularly for prophylaxis. There was potential compromise of PNEUMOVAX23 due to multiple in monitoring refrigerator temperature. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA013522:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates since October 2016, the patients were vaccinated with a dose of PNEUMOVAX 23 (dosage, route of administration, lot # and expiry date were not provided) which were improperly-monitored. No adverse experience was reported. The temperatures, when recorded, were always within the recommended storage range. There was a period, when the temperature would not be recorded for 3 or 4 days and there were occasions when the temperature would be recorded only once a day. There was no previous temperature excursion reported. Digital data logger was not involved. No product quality complaint was involved. Follow up information has been received on 11-APR-2017 referring to a patient of unknown age and gender. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA013522.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates since October 2016, the patients were vaccinated with a dose of PNEUMOVAX23 (dosage, route of administration, lot # and expiry date were not provided) which were improperly-monitored. No adverse experience was reported. The temperatures, when recorded, were always within the recommended storage range. There was a period, when the temperature would not be recorded for 3 or 4 days and there were occasions when the temperature would be recorded only once a day. There was no previous temperature excursion reported. Digital data logger was not involved. No product quality complaint was involved. Follow up information has been received on 11-APR-2017 referring to a patient of unknown age and gender.  Route/ site was reported as 1. The patient declined to be re-vaccinated. There was potential compromise of PNEUMOVAX23 due to multiple in monitoring refrigerator temperature. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA013522:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates since October 2016, the patients were vaccinated with a dose of PNEUMOVAX23 (dosage, route of administration, lot # and expiry date were not provided) which were improperly-monitored. No adverse experience was reported. The temperatures, when recorded, were always within the recommended storage range. There was a period, when the temperature would not be recorded for 3 or 4 days and there were occasions when the temperature would be recorded only once a day. There was no previous temperature excursion reported. Digital data logger was not involved. No product quality complaint was involved. Follow up information has been received from an unspecified reporter referring to a patient of unknown age and gender on 11-APR-2017. The first dose of PNEUMOVAX23 was vaccinated in October 2016. On 04-FEB-2017, the patient was vaccinated with the second dose of PNEUMOVAX23 (Inappropriate schedule of vaccine administered) (dose and expiration date unknown, lot# M036728, right deltoid) intramuscularly for prophylaxis. There was potential compromise of PNEUMOVAX23 due to multiple in monitoring refrigerator temperature. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA013522:
Age: 87.0
Sex: M
Vaccine: PNC13
Symptoms: Abnormal behaviour, Arthralgia, Fatigue, Lethargy, Myalgia
Clinical narrative: This is a spontaneous report from Pfizer sponsored program. A contactable consumer reported for a male patient (father). A 87 year old male patient received, on 29Mar2017, at 15:00, PREVNAR 13 single dose, in the left upper arm, for immunization. Relevant medical history included heart failure (bypass performed in 1990) and fell on 06Feb2017 (resulting in T4 compression fracture). Family medical history was none. Concomitant medications included oral TYLENOL 500 mg or 650 mg one or two as needed for pain (ongoing); ASPIRIN 81 mg once daily, for heart problems (ongoing); oral CENTRUM SILVER 1 tablet daily, as supplementation therapy (ongoing); NEXIUM 40 mg once daily, for gastrooesophageal reflux disease (ongoing); oral finasteride 5 mg once daily, for prostatic disorder (ongoing); oral pravastatin 20 mg once daily, for heart problems (ongoing); oral ropinirole 0.25 mg once daily, for restless legs (ongoing); oral spironolactone 25 mg once daily, as diuretic therapy, from an unspecified date, in Jan2017 (ongoing); oral torsemide 40 mg once daily, as diuretic therapy, from an unspecified date, in Sep2016 (ongoing); oral tamsulosin 0.4 mg once daily, for prostatic disorder from an unspecified date, in Jan2017 (ongoing); ophthalmic latanoprost 0.002 % one drop each eye once daily, (ongoing); and SIMBRINZA 1-0.2% drops; 1 drop each eye twice daily, (ongoing). On 01Apr2017, the patient experienced muscle and joint pain, change in demeanor, pain in front part of upper bilateral legs and fatigue. On an unspecified date, in 2017, he exhibited more than usual lethargy and muscular pain. Relevant tests were none. The patient did not recover from the events at time of this report.
Age: 87.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from Pfizer sponsored program. A contactable consumer reported for a male patient (father). A 87 year old male patient received, on 29Mar2017, at 15:00, PREVNAR 13 single dose, in the left upper arm, for immunization. Relevant medical history included heart failure (bypass performed in 1990) and fell on 06Feb2017 (resulting in T4 compression fracture). Family medical history was none. Concomitant medications included oral TYLENOL 500 mg or 650 mg one or two as needed for pain (ongoing); ASPIRIN 81 mg once daily, for heart problems (ongoing); oral CENTRUM SILVER 1 tablet daily, as supplementation therapy (ongoing); NEXIUM 40 mg once daily, for gastrooesophageal reflux disease (ongoing); oral finasteride 5 mg once daily, for prostatic disorder (ongoing); oral pravastatin 20 mg once daily, for heart problems (ongoing); oral ropinirole 0.25 mg once daily, for restless legs (ongoing); oral spironolactone 25 mg once daily, as diuretic therapy, from an unspecified date, in Jan2017 (ongoing); oral torsemide 40 mg once daily, as diuretic therapy, from an unspecified date, in Sep2016 (ongoing); oral tamsulosin 0.4 mg once daily, for prostatic disorder from an unspecified date, in Jan2017 (ongoing); ophthalmic latanoprost 0.002 % one drop each eye once daily, (ongoing); and SIMBRINZA 1-0.2% drops; 1 drop each eye twice daily, (ongoing). On 01Apr2017, the patient experienced muscle and joint pain, change in demeanor, pain in front part of upper bilateral legs and fatigue. On an unspecified date, in 2017, he exhibited more than usual lethargy and muscular pain. Relevant tests were none. The patient did not recover from the events at time of this report.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 11-Apr-2017. This case involves a 30-year-old male patient who was vaccinated with a dose of ADACEL (batch number, expiry date, dose form and frequency not reported) intramuscularly in the left detoid on 06-Apr-2017. The illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. The concomitant medications were not reported. Any other vaccinations within four weeks of vaccination were not reported. On 09-Apr-2017, three days following the vaccination, the patient developed red area at injection site on left arm which was three inches in diameter and hard lump at site. The patient was seen by a pharmacist on 10-Apr-2017. It was reported that, patient Required ER/doctor visit. Relevant laboratory investigations and corrective treatment was not reported. The patient had not recovered from the events. List of documents held by the sender: None
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, FLUX, MEN, TDAP
Symptoms: Brain operation, Electroencephalogram, Seizure
Clinical narrative: Seizures.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Autopsy, Death
Clinical narrative: Layed down to take a nap and never woke up.
Sex: F
Vaccine: MMRV
Symptoms: Accidental exposure to product, Exposure via eye contact, Eye irritation
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age who was a nurse. There was no information about patient's concomitant medications and pertinent medical history reported. On 28-MAR-2017, while nurse was administering a PROQUAD recombinant human albumin (rHA) (lot # M021427; expiry date 29-OCT-2017, dose was not provided) the needle blew off of the syringe and PROQUAD sprayed into the nurse's eye. The vaccinated patient did not receive any of that dose and received another dose of PROQUAD (lot # M021427; expiry date 29-OCT-2017) and did not experience any adverse symptoms. The nurse experienced some burning in her eye but they flushed it with water and saline and the burning resolved on the same day. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of an unknown age. No information regarding patient's concurrent conditions, medical history and concomitant therapies was reported. On 04-APR-2017, the patient inadvertently received an expired dose of ZOSTAVAX (route of administration was not provided) lot # L028279, expiration date: 28-OCT-2016.  The vaccine was reconstituted with sterile diluent (STERILE DILUENT) (lot# and expiration date were not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 11 year old patient of unknown gender.  Information regarding the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On 26-JAN-2007, the 11 year old patient was vaccinated with M-M-R II, (dose, route of administration, lot # and expiration date were not provided) for prophylaxis (considered an inappropriate schedule of drug administration and drug administered to patient of inappropriate age). On 18-JUL-2011 and 04-APR-2017,  the patient was vaccinated with M-M-R II, (dose, route of administration, lot # and expiration date were not provided) for prophylaxis (considered  overdose). No adverse symptoms were reported. Additional information has been requested.
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Chills, Diarrhoea, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 54-year-old female patient. The patient's medical history included influenza B virus the week prior to getting the vaccination. In approximately April 2017, reported as "last week", the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). Other suspect therapies included sterile diluent (manufacturer unknown). Concomitant therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid administered in the separate arm. In approximately April 2017, the patient experienced vomiting, injection site swelling, injection site erythema, body aches, diarrhoea, chills, pyrexia and nauseousness. The patient did not seek medical attention. Unspecified treatment was given for the adverse events. The patient's symptoms lasted for 5 days after she had received the ZOSTAVAX vaccination. The patient recovered from the events in approximately April 2017. Relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 54-year-old female patient. The patient's medical history included influenza B virus the week prior to getting the vaccination. In approximately April 2017, reported as "last week", the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). Other suspect therapies included sterile diluent (manufacturer unknown). Concomitant therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid administered in the separate arm. In approximately April 2017, the patient experienced vomiting, injection site swelling, injection site erythema, body aches, diarrhoea, chills, pyrexia and nauseousness. The patient did not seek medical attention. Unspecified treatment was given for the adverse events. The patient's symptoms lasted for 5 days after she had received the ZOSTAVAX vaccination. The patient recovered from the events in approximately April 2017. Relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a nurse practitioner via company representative and refers to a 11 year old female patient. No information regarding the patient's pertinent medical history and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9, intramuscularly for prophylaxis. Concomitant therapy included unspecified medication for pneumococcal. On an unknown date, the patient fainted after receiving dose of GARDASIL 9. It was not known which dose the patient was receiving. On an unspecified date, the patient recovered from syncope. The relationship between the event and GARDASIL 9 was not reported. Additional information is not expected as there was no consent to contact reporter.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient received the first dose of VAQTA 50/1.0 U/ml (route of administration, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patient received the second dose of VAQTA 50/1.0 U/ml, lot number reported as N005605, expiration date 08-APR-2018; 20 months apart which was outside the prescribing information (inappropriate schedule of drug administration). There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided.  In March 2017 (reported as "from 06-MAR-2017 to 27-MAR-2017"), some patients were vaccinated with VARIVAX (lot #: M040137 with expiration date: 28-SEP-2018) (dosage schedule, route of administration and anatomical location were not reported), for prophylaxis. On 31-MAR-2017, some patients were vaccinated with VARIVAX (lot #: M042858 with expiration date: 21-OCT-2018) (dosage schedule, route of administration and anatomical location were not reported), also for prophylaxis. According to the reporter, VARIVAX doses were exposed to the following temperature excursions: 8 hours between 6 degrees Fahrenheit (F) and 14F (-14 degrees Celsius (C) to -10C), 13.5 hours between 15 F and 46 F (-9C to 8C), and 28.5 hours between 47F and 77F (9C to 25C). A digital data logger was involved. No adverse effects were reported.   This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA001065: US-009507513-1704USA001066: US-009507513-1704USA001068: US-009507513-1704USA001069: US-009507513-1704USA001070: US-009507513-1704USA001064: US-009507513-1704USA001067: US-009507513-1703USA012554:
Age: 1.42
Sex: M
Vaccine: DTAP
Symptoms: Aphasia, Immediate post-injection reaction, Pyrexia
Clinical narrative: Patient had a 104.5 fever for three days that MOTRIN and TYLENOL did not help. He immediately lost all speech until he was just over 3. He could no longer even say Momma or Dada. Before the vaccine he was speaking over 20 words and lost every single one.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Headache, Pain, Peripheral swelling
Clinical narrative: Swelling of arm, arm redness, fever in the arm, body aching, headaches, treatment with aspirin and TYLENOL. I slept for about 3 days on the sofa and bed with an ice pack on my arm and neck. Just woke up to take more TYLENOL. I had chills on the second night. Eventually took temp and it was 100.2 F. Called consulting nurses. Still having headaches off and on.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Swelling of arm, arm redness, fever in the arm, body aching, headaches, treatment with aspirin and TYLENOL. I slept for about 3 days on the sofa and bed with an ice pack on my arm and neck. Just woke up to take more TYLENOL. I had chills on the second night. Eventually took temp and it was 100.2 F. Called consulting nurses. Still having headaches off and on.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Headache, fever, nausea with onset between 12-24 hours after vaccine administration and duration of about 7-8 days.
Age: 88.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Right arm pain at the site of injection and unable to raise arm.
Age: 0.5
Sex: M
Vaccine: PNC13, RV5
Symptoms: Grip strength decreased, Irritability, Pyrexia, Respiratory tract congestion, Secretion discharge
Clinical narrative: Extreme irritability, mucus, congestion, inability to hold bottle as previously able, fever of 100 degrees.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Joint range of motion decreased
Clinical narrative: Redness and pain at injection site, limited range of motion.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Our practice's immunization schedule gives the 2nd Hepatitis A vaccine at the 2 year well check. This patient came for a travel consult before traveling internationally, and was given the 2nd dose. When he came in for his 2 year well check, the nurse was unaware of the vaccine given off-schedule and administered a 3rd dose by error. No adverse reaction occurred. MD followed up with parent 2 days later and child was doing well.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 06-APR-2017, the patient was vaccinated with an expired dose of PROQUAD injection, lot # L039268 with expiration date of 05-APR-2017, for prophylaxis (dose, frequency, route and anatomical location were not reported). It was reported that the PROQUAD did not have any previous temperature excursions. No adverse symptoms were reported and no product quality complaint (PQC) was involved. Additional information has been requested.