chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pallor, Vomiting, Weight decreased
Clinical narrative: Weeklong series of issues starting with chills, weakness, body and joint aches. Progressing to a night of severe abdominal pains followed by strong non stop vomiting over one entire night. Had to lie on floor near toilet. Could barely sit up to vomit, dizzy.  Crying because no relief after vomiting. The abdominal pain would start up right away until the violent vomiting would begin again. Then the watery diarrhea started later near morning. Lost  4 lbs over 2 days.  The following days I was weak, slept a lot. Ocassional cramps. Thankful no vomiting. It was over a week before I was much back to normal. Thank goodness my husband was with me. He also had a similar reaction. Not as prolonged or violent.  I was dizzy and pale post incident.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Back pain, Chills
Clinical narrative: Weeklong series of issues starting with chills, weakness, body and joint aches. Progressing to a night of severe abdominal pains followed by strong non stop vomiting over one entire night. Had to lie on floor near toilet. Could barely sit up to vomit, dizzy.  Crying because no relief after vomiting. The abdominal pain would start up right away until the violent vomiting would begin again. Then the watery diarrhea started later near morning. Lost  4 lbs over 2 days.  The following days I was weak, slept a lot. Ocassional cramps. Thankful no vomiting. It was over a week before I was much back to normal. Thank goodness my husband was with me. He also had a similar reaction. Not as prolonged or violent.  I was dizzy and pale post incident.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Diarrhoea, Erythema, Fatigue, Gait disturbance, Musculoskeletal chest pain
Clinical narrative: Weeklong series of issues starting with chills, weakness, body and joint aches. Progressing to a night of severe abdominal pains followed by strong non stop vomiting over one entire night. Had to lie on floor near toilet. Could barely sit up to vomit, dizzy.  Crying because no relief after vomiting. The abdominal pain would start up right away until the violent vomiting would begin again. Then the watery diarrhea started later near morning. Lost  4 lbs over 2 days.  The following days I was weak, slept a lot. Ocassional cramps. Thankful no vomiting. It was over a week before I was much back to normal. Thank goodness my husband was with me. He also had a similar reaction. Not as prolonged or violent.  I was dizzy and pale post incident.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, Pyrexia, Rash, Rash macular, Vomiting
Clinical narrative: Weeklong series of issues starting with chills, weakness, body and joint aches. Progressing to a night of severe abdominal pains followed by strong non stop vomiting over one entire night. Had to lie on floor near toilet. Could barely sit up to vomit, dizzy.  Crying because no relief after vomiting. The abdominal pain would start up right away until the violent vomiting would begin again. Then the watery diarrhea started later near morning. Lost  4 lbs over 2 days.  The following days I was weak, slept a lot. Ocassional cramps. Thankful no vomiting. It was over a week before I was much back to normal. Thank goodness my husband was with me. He also had a similar reaction. Not as prolonged or violent.  I was dizzy and pale post incident.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Weight decreased
Clinical narrative: Weeklong series of issues starting with chills, weakness, body and joint aches. Progressing to a night of severe abdominal pains followed by strong non stop vomiting over one entire night. Had to lie on floor near toilet. Could barely sit up to vomit, dizzy.  Crying because no relief after vomiting. The abdominal pain would start up right away until the violent vomiting would begin again. Then the watery diarrhea started later near morning. Lost  4 lbs over 2 days.  The following days I was weak, slept a lot. Ocassional cramps. Thankful no vomiting. It was over a week before I was much back to normal. Thank goodness my husband was with me. He also had a similar reaction. Not as prolonged or violent.  I was dizzy and pale post incident.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Weeklong series of issues starting with chills, weakness, body and joint aches. Progressing to a night of severe abdominal pains followed by strong non stop vomiting over one entire night. Had to lie on floor near toilet. Could barely sit up to vomit, dizzy.  Crying because no relief after vomiting. The abdominal pain would start up right away until the violent vomiting would begin again. Then the watery diarrhea started later near morning. Lost  4 lbs over 2 days.  The following days I was weak, slept a lot. Ocassional cramps. Thankful no vomiting. It was over a week before I was much back to normal. Thank goodness my husband was with me. He also had a similar reaction. Not as prolonged or violent.  I was dizzy and pale post incident.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, HEPA, MMR, PNC13
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given vaccines that wasn't needed.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: & Rash
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product distribution issue
Clinical narrative: no symptoms; a shipment of PNEUMOVAX 23 was due to be delivered on 2/26/2020 but was not delivered until 2/27/2020; This spontaneous initial report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided. This report concerned 1 patient and 1 combination product.      On 26-FEB-2020, the shipment of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot # S029542, expiration date 10-JUN-2021) was due to be delivered, but was not delivered until 27-FEB-2020. Consequently, the patient was vaccinated with a dose from a late shipment of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot # S029542, expiration date 10-JUN-2021 (dose, route of administration were not reported) for prophylaxis, on 04-MAR-2020. The patient experienced no symptoms.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2003USA005134: US-009507513-2003USA004890:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: The vaccine did not prevent shingles as intended; herpes zoster or shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Information about concurrent condition, medical history and concomitant therapy was not reported. In 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) by a physician, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2015, the patient was treated at a clinic, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, 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, and pain and suffering, and other damages. The outcome of the events herpes zoster and vaccination failure was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: The vaccine did not prevent shingles as intended; herpes zoster or shingles; Information has been received from a lawyer regarding a case in litigation referring to a male patient of unknown age. Information about concurrent condition, medical history and concomitant therapy was not reported. In 2010, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported), as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2015, the patient was treated by a physician, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, 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, and pain and suffering, and other damages. The outcome of the events herpes zoster and vaccination failure was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: The vaccine did not prevent shingles as intended; herpes zoster or shingles; Information has been received from a lawyer regarding a case in litigation referring to a male patient of unknown age. Information about concurrent condition, medical history and concomitant therapy was not reported. On or about 31-DEC-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2015, the patient was treated by a physician, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, 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, and pain and suffering, and other damages. The outcome of the events herpes zoster and vaccination failure was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2015, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The events were considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles/ severe vesicular rash, which was diagnosed as herpes zoster or shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 28-JAN-2011, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) at the public health department, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 20-OCT-2012, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2016, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The events were considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 02-JUN-2009, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2014, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The events were considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; Information has been received from a lawyer concerning a case in litigation and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On or about 17-MAY-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) by a physician as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 25-JUL-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The causality was related.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: she experienced soreness at injection site; This is a spontaneous report from a contactable consumer.   A female patient of unknown age received Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) at single dose for immunization on unknown date. Relevant medical history and concomitant medications were not reported. After her injection, she experienced soreness at injection site. The outcome of the event was unknown.   Information on the lot/batch number has been requested.  Pfizer is a marketing authorization holder of [Pneumococcal 13- Val Conj Vac (Dipht CRM197 Protein] in the country of incidence. This may be a duplicate report if another marketing authorization holder of [Pneumococcal 13- Val Conj Vac (Dipht CRM197 Protein] has submitted the same report to the regulatory authorities.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Pain
Clinical narrative: Headache, body aches, tired/weak
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: CSF glucose normal, CSF lymphocyte count normal, CSF monocyte count decreased, CSF neutrophil count increased, CSF protein increased
Clinical narrative: Patient developed muscle weakness- initially lower extremity, then upper extremity. MRI cervical spine suggestive of Acute inflammatory demyelinating polyneuropathy. Patient admitted to Neuro ICU  Hospital on 3/7/2020. Received 5 days of IVIG with improvement in muscle weakness
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: CSF red blood cell count positive, CSF white blood cell count increased, Demyelinating polyneuropathy, Immunoglobulin therapy, Intensive care
Clinical narrative: Patient developed muscle weakness- initially lower extremity, then upper extremity. MRI cervical spine suggestive of Acute inflammatory demyelinating polyneuropathy. Patient admitted to Neuro ICU  Hospital on 3/7/2020. Received 5 days of IVIG with improvement in muscle weakness
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Magnetic resonance imaging spinal abnormal, Muscular weakness, Spinal osteoarthritis
Clinical narrative: Patient developed muscle weakness- initially lower extremity, then upper extremity. MRI cervical spine suggestive of Acute inflammatory demyelinating polyneuropathy. Patient admitted to Neuro ICU  Hospital on 3/7/2020. Received 5 days of IVIG with improvement in muscle weakness
Age: 31.0
Sex: F
Vaccine: FLUX, TTOX
Symptoms: Allergy to metals, Asthma, Bronchitis, Condition aggravated, Dairy intolerance
Clinical narrative: In October 1991 & 1992 I had the flu shot. I got very sick within a week, developing bronchitis and asthma. In 1993, I was ill & had to take a medical leave of absence from Chronic Fatigue & Epstein Barr virus. My immune system was compromised. I later learned I have a dairy allergy including allergy to eggs. In 2003, I was at ER for cut to my finger. After receiving a tetanus shot, I had limited mobility in the arm vaccinated & pain for about a month. Soon after I had numbing in my feet & hands.
Age: 31.0
Sex: F
Vaccine: FLUX, TTOX
Symptoms: Epstein-Barr virus infection, Fatigue, Hypoaesthesia, Immunodeficiency, Impaired work ability
Clinical narrative: In October 1991 & 1992 I had the flu shot. I got very sick within a week, developing bronchitis and asthma. In 1993, I was ill & had to take a medical leave of absence from Chronic Fatigue & Epstein Barr virus. My immune system was compromised. I later learned I have a dairy allergy including allergy to eggs. In 2003, I was at ER for cut to my finger. After receiving a tetanus shot, I had limited mobility in the arm vaccinated & pain for about a month. Soon after I had numbing in my feet & hands.
Age: 31.0
Sex: F
Vaccine: FLUX, TTOX
Symptoms: Injected limb mobility decreased, Malaise, Pain, Skin laceration
Clinical narrative: In October 1991 & 1992 I had the flu shot. I got very sick within a week, developing bronchitis and asthma. In 1993, I was ill & had to take a medical leave of absence from Chronic Fatigue & Epstein Barr virus. My immune system was compromised. I later learned I have a dairy allergy including allergy to eggs. In 2003, I was at ER for cut to my finger. After receiving a tetanus shot, I had limited mobility in the arm vaccinated & pain for about a month. Soon after I had numbing in my feet & hands.
Age: 0.08
Sex: M
Vaccine: HPV9, HPV9, UNK, HPV9
Symptoms: Crying, Immediate post-injection reaction, Musculoskeletal stiffness
Clinical narrative: stiffening with crying immediately after injection (per Mom)
Age: 0.08
Sex: M
Vaccine: HPV9, HPV9, UNK, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: stiffening with crying immediately after injection (per Mom)
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; on 24-FEB-2020, patient received a dose of improperly stored ROTATEQ; Information has been received from a registered nurse referring to a patient of unknown age, gender, race or ethnicity. The patient's medical history, concurrent conditions and concomitant medications were not provided.       On 23-DEC-2019, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, lot #, expiration date were unknown) orally for prophylaxis. On 24-FEB-2020, the patient received a second dose of an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose were unknown; lot # 1660112 and expiration date 18-OCT-2020) orally for prophylaxis. The vaccine was exposed to temperature excursion at 1.28 degrees Celsius for 2 hours and 30 minutes (incorrect product storage). There was no previous temperature excursion. The call was due to digital data logger. No additional adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis, Hypoaesthesia
Clinical narrative: Bell's palsy; This initial spontaneous report was received from a lawyer on 13-MAR-2020, regarding a case in litigation and refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 18-JUL-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles. Shortly (on an unspecified date) after receiving the vaccine, the patient suffered sudden onset of facial numbness and was diagnosed with Bell's palsy. As a direct and proximate result of patient's vaccination, his symptoms resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. The patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  Upon internal review, Bell's palsy was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Painful shingles after administered shingles vaccine; This spontaneous report was received from a female patient of unknown age via other pharmaceutical company, referring to herself. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.      On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number, and expiration date were not reported). After vaccinated, she developed painful shingles (herpes zoster).  The outcome of herpes zoster was not provided.  The causality assessment between zoster vaccine live (ZOSTAVAX) and the aforementioned event was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles/ blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In 2015, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 28-MAY-2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, 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, and pain and suffering, and other damages. The outcome of the events was not provided. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. In 2010, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, patient was treated by a healthcare provider for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered herpes zoster and vaccination failure to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; Information has been received from a lawyer concerning a case in litigation and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. In 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) at the pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2015, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The causality was related.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; Information has been received from a lawyer concerning a case in litigation and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. In 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 18-AUG-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The causality was related.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Body aches, fatigue, headache, sore arm
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Chills, Dizziness, Erythema
Clinical narrative: Woke up the next morning with dizziness, chills, upset stomach, headache, achy muscles and joints.  Left arm sore, red and inflamed.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Inflammation, Myalgia, Pain in extremity
Clinical narrative: Woke up the next morning with dizziness, chills, upset stomach, headache, achy muscles and joints.  Left arm sore, red and inflamed.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Dysphagia, Muscular weakness, Paraesthesia, Paraesthesia oral
Clinical narrative: 1/ Patient presented to health unit with complaint of throat tightness, dysphagia, dizziness and tingling of mouth, lips, and neck. Received rabies vaccine 2 hours prior. States felt a little dizzy during training but only got worried when had difficulty swallowing with lunch. 2/ At presentation received: Epipen IM R thigh           Benadryl 50mg PO 3/ Five minutes after Epipen: Symptoms improved breathing and lips less tingling. Prepared for admission for 24 hour monitoring. 4/ One hour after Epi pen, symptoms resolved except mildly dizzy. Resting in sick bay and PCMOs preparing transport and starting IV line. Given Solumedrol 120mg IV . Patient was able to ambulate steadily to car. Feeling well reports legs feel weak but no other complaints-driven to hospital for admission.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Throat tightness
Clinical narrative: 1/ Patient presented to health unit with complaint of throat tightness, dysphagia, dizziness and tingling of mouth, lips, and neck. Received rabies vaccine 2 hours prior. States felt a little dizzy during training but only got worried when had difficulty swallowing with lunch. 2/ At presentation received: Epipen IM R thigh           Benadryl 50mg PO 3/ Five minutes after Epipen: Symptoms improved breathing and lips less tingling. Prepared for admission for 24 hour monitoring. 4/ One hour after Epi pen, symptoms resolved except mildly dizzy. Resting in sick bay and PCMOs preparing transport and starting IV line. Given Solumedrol 120mg IV . Patient was able to ambulate steadily to car. Feeling well reports legs feel weak but no other complaints-driven to hospital for admission.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Discomfort, Dizziness, Headache, Lymphadenopathy
Clinical narrative: First was dull headache at back of my head, 5 hours after vaccination. 15 hours, heaviness in body, slight body aches, dizziness, extremely sore arm (the LEFT one I had the vaccination in), Lymph nodes in RIGHT armpit were swollen.Temperature up to 100 for a couple of hours. It all subsided after 24 hours post vaccination.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: First was dull headache at back of my head, 5 hours after vaccination. 15 hours, heaviness in body, slight body aches, dizziness, extremely sore arm (the LEFT one I had the vaccination in), Lymph nodes in RIGHT armpit were swollen.Temperature up to 100 for a couple of hours. It all subsided after 24 hours post vaccination.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Blister, Erythema, Pain, Tenderness
Clinical narrative: Patient reports that first few days area was mildly red and sore. Then starting 2-3 days post vaccination noted increasing erythema, widening of reaction area. Also has developed blisters in the area. No fever or chills. No systemic symptoms. No non local skin reactions. On exam, has a 3-4 cm area of erythema, with 2-3 cm in the central portion more erythematous and with presence of multiple blisters. Mildy tender to palpation.   Mentioned reaction incidentally during a routine visit. Did not notify office/hospital of reaction when it started.
Age: 0.25
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient had redness and swelling around the site as well as itching. Patient stated that she had no reaction to the first dose only the second
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: states woke up 3/18/20 with right arm burning and in pain and red swollen area extending from injection site down to elbow. states ran 101 fever and up to 102 today.
Age: 1.08
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Cough, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Nasal congestion
Clinical narrative: 3 days after rash,nasal congestion,runny nose and cough. 6 days after rash,cough,fever
Age: 1.08
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Rhinorrhoea, Streptococcus test negative
Clinical narrative: 3 days after rash,nasal congestion,runny nose and cough. 6 days after rash,cough,fever
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Influenza virus test negative, Pain in extremity
Clinical narrative: Patient complained that she had pain in her arm  started to move to her legs and all other joints. she went to the urgent care on 02/28/2020 with negative test for flu.  Her symptoms did not get better and she went to ER on 03/02/2020 and was discharged 03/07/2020.  she  said she had to be hospitalized for 6 days after.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Vaccine was diluted with incorrect diluent solution. Patient did not experienced any symptoms or side effects. Patient was called to advised of need to repeat dose. Has appointment scheduled to repeat dose on 04/16/2020.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Asthma, Dyspnoea, Erythema, Peripheral swelling
Clinical narrative: She had swelling and redness on the arm; asthamtic shortness of breath Nurse came after incidence, examined her and no treatment was given. Pt has a f/u appointment the next week.  Currently  using albterol inhaler, some sort of steroid diskus.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed the worst case of shingles  1 1/2 day later
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Lip swelling, Rash, Throat tightness
Clinical narrative: 3-12-20 - 1600 - pt reported rash to grandmother. rash continued over weekend  3-16-20 - am - woke up with lips swollen & throat tight. Grandmother took pt to PCP - she rcv cortisone shot. 3-17-20 - woke up worse - went back to PCP rcv Singulair & prednisone Rx.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4, TDAP
Symptoms: Influenza virus test, Pain, Peripheral swelling, Streptococcus test, Urine analysis
Clinical narrative: Started body aches + sl swelling on Rt arm NO SOB, with wheezing, without swelling of upper face.
Age: 16.0
Sex: F
Vaccine: HPV4, MENB, MNQ
Symptoms: Hypoaesthesia, Laboratory test normal, Urticaria
Clinical narrative: Pt had vaccines on 3/9 approximately 1:30 pm. Approx 5.00 her right arm & right trunk had welts. Gave Benadryl & helped. Next day, welts still on right arm. On 3/12, pt had hives on right elbow & right hand went numb for a little bit. * Pt had dental work on same side on same day*
Age: 46.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age, Wrong patient received product
Clinical narrative: wrong patient received medication; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (745855). This spontaneous report was received from a health professional via Agency and refers to a 46 year old female patient with joint pain/swelling, psychiatric illness and diverticulitis.  On 26-APR-2018, the patient was accidentally vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # N019103, 03-FEB-2020) dose 2, intramuscularly in the right arm for prophylaxis. Medical assistant went into the patient's room and asked whether their name was (correct patient's name). The patient confirmed, so injection was administered. Discovered upon leaving the room that it was administered to wrong patient. Concomitant therapies included amlodipine, atenolol, baclofen, formoterol fumarate, mometasone furoate(DULERA), duloxetine hydrochloride, fluticasone propionate (FLONASE), lurasidone hydrochloride (LATUDA), pregabalin (LYRICA), naproxen (NAPROSYN), pantoprazole, potassium chloride, albuterol sulfate (PROAIR), trazodone hydrochloride, trihexyphenidyl hydrochloride and vitamin D.  Follow-up information has been received from Registered Nurse on 29-OCT-2019 referring to a patient. The patient was not pregnant at the time of vaccination. On 26-APR-2018 09:31, the patient was accidentally vaccinated first dose with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  Follow up information was received from the registered nurse on 27-FEB-2020.  The patient's age was reported as 47 years old. It was reported that the patient's concurrent conditions included fibromyalgia, hypertension (HTN), asthma, chronic obstructive pulmonary disease (COPD), paranoid schizophrenia, depression and anxiety. Additional concomitant therapies were reported clonazepam, loxapine and atenolol, chlorthalidone (TENORETIC).  It was also reported that the patient was vaccinated on the left deltoid. It was confirmed that the vaccine was appropriately prescribed, prepared and that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) had been double checked as the correct vaccine. Immediately after vaccination, the medical assistant realized that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) had been adminestered to the wrong patient. The patient was told to contact the physician in case of any adverse reactions.  All available medical records will be provided upon request.
Age: 14.0
Sex: F
Vaccine: HPV9, UNK, UNK, UNK
Symptoms: Abdominal pain, Asthenia, Drug hypersensitivity, Electromyogram normal, Fatigue
Clinical narrative: leg muscle pain; 4 wisdom tooth removals; drug allergy to tylenol, codeine, hydrocodone (all from tooth extraction); fatigue; tremor (in the right arm, the jaw, right leg) / tremor like lower leg shaking; abdominal pain; decreased grip and decresead overall body strength; general lost of entire body strength / decreased overall body strength; This spontaneous report was received from a physician referring to a 14 year old non-pregnant female patient with unspecified respiratory problems.  There was none concomitant medications.  No information was provided regarding patient's pertinent medical history or concurrent conditions.  On an unspecified day in November 2018, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 1, intramuscular in the left arm, for routine immunisation (dose, lot number and expiration date were not reported).   Two days later in November 2018, the patient began to experience tremors, abdominal pain and fatigue. The tremors started in the right arm then within two to three weeks the patient also experienced tremor in the the jaw and then the right leg as well.   Within that 2 to 3 weeks, on an unspecified date in approximately 2018, the patient also experienced decreased grip (grip strength decreased) and decreased overall body strength (asthenia).   On unspecified dates after initial symptoms began, patient has sought medical attention of one pediatrician and three neurologist.   Between March and July 2019, the patient had transient recovery of tremors.  On an unspecified day in end of June 2019, the patient received acetaminophen (TYLENOL), codeine and hydrocodone due to 4 wisdom tooth removal performed on a single day.  The patient developed drug reaction/allergy to acetaminophen(TYLENOL), codeine and hydrocodone (drug hypersensitivity).  In August  2019 tremors persisted.  On unspecified date in August 2019, jaw tremors resolved.  Abdominal pain and fatigue completely resolved on unspecified date after November 2019.   On an unknown date the patient experienced leg muscle pain (myalgia) that started within seconds of attempted exercise or dance.  It was stated that tremors and muscle pain only occurred with activity and did not present on rest or mild daily routines like walking.  On unspecified date, an electromyography (EMG) was performed and results were normal.  No treatment was given for the events.    At the time of reporting, the patient had not recovered from tremor, asthenia, myalgia and grip strength decreased.  The outcome of wisdom teeth removal and drug hypersensitivity was unknown.   The reporter did not assess the causal relationship between therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the events  Physician stated that patient was a dancer that could no longer perform or exercise. Therefore, the events of tremor, asthenia, myalgia and grip strength decreased were considered serious due to disability.