chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Back pain, Chills
Clinical narrative: arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experinced arm soreness. Consented to follow up. This case has been linked with case US2020044414 and US2020046854, reported by same reporter.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Diarrhoea, Erythema, Fatigue, Gait disturbance, Musculoskeletal chest pain
Clinical narrative: arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experinced arm soreness. Consented to follow up. This case has been linked with case US2020044414 and US2020046854, reported by same reporter.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, Pyrexia, Rash, Rash macular, Vomiting
Clinical narrative: arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experinced arm soreness. Consented to follow up. This case has been linked with case US2020044414 and US2020046854, reported by same reporter.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Weight decreased
Clinical narrative: arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experinced arm soreness. Consented to follow up. This case has been linked with case US2020044414 and US2020046854, reported by same reporter.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experinced arm soreness. Consented to follow up. This case has been linked with case US2020044414 and US2020046854, reported by same reporter.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Cough, Dysphonia, Dyspnoea, Hyperhidrosis
Clinical narrative: Wheezing, difficulty breathing, extreme nonstop coughing, swelling of mouth and face, hoarseness, weakness, sweating, phlegm
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Mouth swelling, Productive cough, Swelling face, Wheezing
Clinical narrative: Wheezing, difficulty breathing, extreme nonstop coughing, swelling of mouth and face, hoarseness, weakness, sweating, phlegm
Age: 2.5
Sex: F
Vaccine: DTAP
Symptoms: Condition aggravated, Crying, Dysstasia, Eczema, Gene mutation identification test positive
Clinical narrative: The moment the vaccine was injected, patient went into a tight muscle cry. Patient cried on and off for 24 hours. She was not able to stand on her right leg. She just held it up out of natural reflexes. The next morning patient had a rash on her body from head to toe. I bought her back and she was diagnosed with eczema.  When patient would eat eggs, dairy, or oranges the eczema would flair. The treatment is oatmeal baths, cocoa butter, Shea butter,and avoid anything that is processed. This lasted for 18 months and slowly could reintroduce foods. I know when she is going to be sick, because her skin will flair because her immune system is warning me.  The most that came from this, is for parents to research Vaccines. After going to specialist about her condition, she was diagnosed with MTHFR. Her liver cannot detox well. Which makes since why she had such a reaction. There is always a silver lining.
Age: 2.5
Sex: F
Vaccine: DTAP
Symptoms: Methylenetetrahydrofolate reductase gene mutation, Rash
Clinical narrative: The moment the vaccine was injected, patient went into a tight muscle cry. Patient cried on and off for 24 hours. She was not able to stand on her right leg. She just held it up out of natural reflexes. The next morning patient had a rash on her body from head to toe. I bought her back and she was diagnosed with eczema.  When patient would eat eggs, dairy, or oranges the eczema would flair. The treatment is oatmeal baths, cocoa butter, Shea butter,and avoid anything that is processed. This lasted for 18 months and slowly could reintroduce foods. I know when she is going to be sick, because her skin will flair because her immune system is warning me.  The most that came from this, is for parents to research Vaccines. After going to specialist about her condition, she was diagnosed with MTHFR. Her liver cannot detox well. Which makes since why she had such a reaction. There is always a silver lining.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient was administered Improperly stored rotateq; This spontaneous report was received from a physician, referring to an approximately 4-month old male patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.    The vaccine underwent a previous temperature excursion on 25-FEB-2020 (at temperature above of 9°C) 9.3°C for 3 hours 33 minutes; and on 03-MAR-2020 (below 2°C) at 0.8°C for 11 hours 39 minutes, and on the same date, at 0.8°C for 5 hours and 9 minutes; on 04-MAR-2020 at 0.9°C for 11 hours. On 05-MAR-2020 at -1.3°C for 9 hours and 29 minutes.   On 05-MAR-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (dose, frequency and route were not provided; Lot number reported as 1658255 has been verified to be valid; expiration date reported and validated as 07-FEB-2021) for prophylaxis. The excursion was called by a digital data logger. The physician reported that the patient did not experience any adverse event.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; one patient was administered improperly stored VARIVAX.; This spontaneous report was received from a medical assistant and refers to a 13 month old patient. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 13-FEB-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S019581 with expiration date of 25-JUN-2021, for prophylaxis (strength and route of administration were not reported).  The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (STERILE DILUENT MRK) with lo# S021105 with expiration date of 14-MAY-2022.     No adverse effects were reported.  It was stated that the vaccine underwent a temperature excursion of 6 °F (degrees Fahrenheit) to 14°F for 3 hours and 59 minutes; previous temperature excursion was done: 6°F to 14°F for 8 hours and 51 minutes.  The call was because of a "data logger".
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse ffect reported; The patient received one improperly stored dose of VARIVAX; This spontaneous report was received from a nurse prescriber concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions and drug reactions or allergies.     On 06-MAR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), lot # S028920, expiration date 16-SEP-2021 for prophylaxis (dosage schedule, anatomical location and route of administration, were not reported) (product storage error). The sterile diluent was stored properly.   The administered dose of the vaccine experienced a temperature excursion 6 degrees Fahrenheit to 14 degrees Fahrenheit (5.69 degrees Fahrenheit) for 1 second and 6 degrees Fahrenheit to 14 degrees Fahrenheit (5.81 degrees Fahrenheit) for 28 minutes, as recorded by a data logger. There was no adverse effect reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received unspecified dose of either VARIVAX or a PROQUAD dose that was improperly stored; No adverse event; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender.      The patient's concurrent conditions, medical history, drug/allergy reactions, were not reported. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).   It was reported by the medical assistant that on 04-FEB-2020, the patient was vaccinated with unspecified doses of improperly stored vaccines: either varicella virus vaccine live (Oka/Merck)(VARIVAX) (strength, vaccination scheme, route of administration, and anatomical location, were not reported) (lot # S025610 (verified to be a valid lot number) expiration date reported and established as 18-AUG-2021 for prophylaxis or measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (strength, vaccination scheme, route of administration, and anatomical location, were not reported) (lot # S017250 (verified to be a valid lot number) expiration date reported and established as 01-DEC-2020 for prophylaxis. The therapy type of the lot number S017250 was rHA. The sterile diluent (MERCK STERILE DILUENT) was properly stored. The temperature excursion occurred at 7.5 Fahrenheit (F) with a time frame of 15 minutes.  There were no previous temperature excursions. The call was given because of a data logger. No symptoms were reported.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 67 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date in 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for prophylaxis. As a result of zoster vaccine live (ZOSTAVAX), in 2014, the patient was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the patient had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Corneal oedema, Eye pain, Herpes zoster, Ocular hyperaemia, Punctate keratitis
Clinical narrative: punctate keratitis in her right eye; Pain soreness and redness in her left eye diagnosed with corneal edema; herpes zoster on her lower back; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 30-JAN-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered pain, soreness and redness in her left eye and was diagnosed with cornel edema. Pt also suffered punctate keratitis in her right eye and herpes zoster on her lower back. It was also specified that the pt 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. The events were considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.  Upon internal review, punctate keratitis was considered medically significant. The events were considered to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Joint stiffness, Pain
Clinical narrative: Pain throughout her entire body, headaches, fatigue, stiff and painful joints, hips and legs. Pt was diagnosed with inflammatory polyarthritis and polymyalgia rheumatica; ain throughout her entire body, headaches, fatigue, stiff and painful joints, hips and legs. Pt was diagnosed with inflammatory polyarthritis and polymyalgia rheumatica; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 26-JUL-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered pain throughout her entire body, headaches, fatigue, stiff and painful joints, hips and legs. Pt was diagnosed with inflammatory polyarthritis and polymyalgia rheumatica. It was also specified that 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. The outcome of the events was not provided. The events were considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.  Upon internal review, polyarthritis and polymyalgia rheumatica were considered medically significant. Additionally, the events were considered to be disabling due to serious, permanent and incurable injuries.
Sex: F
Vaccine: VARZOS
Symptoms: Polyarthritis, Polymyalgia rheumatica
Clinical narrative: Pain throughout her entire body, headaches, fatigue, stiff and painful joints, hips and legs. Pt was diagnosed with inflammatory polyarthritis and polymyalgia rheumatica; ain throughout her entire body, headaches, fatigue, stiff and painful joints, hips and legs. Pt was diagnosed with inflammatory polyarthritis and polymyalgia rheumatica; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 26-JUL-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered pain throughout her entire body, headaches, fatigue, stiff and painful joints, hips and legs. Pt was diagnosed with inflammatory polyarthritis and polymyalgia rheumatica. It was also specified that 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. The outcome of the events was not provided. The events were considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.  Upon internal review, polyarthritis and polymyalgia rheumatica were considered medically significant. Additionally, the events were considered to be disabling due to serious, permanent and incurable injuries.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness, Herpes zoster
Clinical narrative: hearing loss; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 64-year-old male patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 29-AUG-2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosaje, route of administration and indication were not provided). On an unspecified date in 2016, the pt suffered shingles and hearing loss, including any and all of its sequelae. It was also specified that the pt suffered severe personal injuries, pain, suffering and emotional distress, as well as incurred in substantial economic damages. The outcome of the events was not provided. The events were considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.  Upon internal review, deafness was considered medically significant. Additionally, the events were considered to be disabling.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an 85 years old (also reported as 86 years old when administered vaccine) female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In January 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for prophylaxis. As a result of her receipt of zoster vaccine live (ZOSTAVAX), in March 2014, the patient suffered shingles, including any and all of its sequelae and had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions the patient requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. The patient is informed and believes and further alleges that patient will in the future be required to obtain further medical and/or hospital care, attention, and services. The outcome of the event was considered not recovered/not resolved. The event was considered related to zoster vaccine live (ZOSTAVAX).   The lawyer considered the event to be medically significant and disability.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 55 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for prophylaxis. As a result of her receipt of zoster vaccine live (ZOSTAVAX), in 2014, the patient was caused to suffer serious and dangerous side effects including shingles, including any and all of its sequelae, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish. The patient was caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a direct consequence of zoster vaccine live (ZOSTAVAX), the patient also suffered other related health complications. In addition, the patient had required healthcare and services. The patient had incurred medical and related expenses. The patient also had suffered diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The outcome of the event was considered not recovered/not resolved. The event was considered related to zoster vaccine live (ZOSTAVAX).  The lawyer considered the event to be medically significant and disability.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 61 years old (also reported as 64 years old when administered vaccine) female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In January 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for prophylaxis. As a result of her receipt of zoster vaccine live (ZOSTAVAX), in May 2014, the patient suffered shingles, including any and all of its sequelae and had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the patient suffered shingles and other related health complications. In addition, the patient requires and will continue to require healthcare and services. The patient has incurred and will continue to incur medical and related expenses. The patient also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient's direct medical losses and costs include physician care, monitoring, and treatment. The patient has incurred and will continue to incur mental and physical pain and suffering. The outcome of the event was considered not recovered/not resolved. The event was considered related to zoster vaccine live (ZOSTAVAX).  The lawyer considered the event to be medically significant and disability.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Cardiac failure congestive, Herpes zoster
Clinical narrative: shingles; vision loss; congestive heart failure; This spontaneous legal report was received from a lawyer referring to a 62 year old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date in May 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (the dosage regimen information was not reported). As a result of vaccination, in August 2015, the patient was caused to suffer vision loss and congestive heart failure, including any and all of its sequalae. As a result of vaccination, she had been caused to suffer personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages, serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. She would require more health care and services and did incur in medical, health, incidental and related expenses.  Upon internal review, vision loss and cardiac failure congestive were considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: post herpetic neuralgia; shingles; This spontaneous legal report was received from a lawyer referring to a 68 year old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 23-OCT-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (the dosage regimen information was not reported). As a result of vaccination, in 2012, the patient was caused to suffer shingles, including any and all of its sequalae. As a result of vaccination, the patient was caused to suffer serious and dangerous side effects including postherpetic neuralgia, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications.  The reporter considered postherpetic neuralgia as serious (medically significant).
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and an elderly male patient (pt) of unknown age regarding a case in litigation. Information about the pt's concurrent condition, medical history and concomitant medication was not reported.   In 2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for prophylaxis.   On an unknown date, as a result of zoster of his receipt of vaccine live (ZOSTAVAX), the pt was caused to suffer shingles, including any an all of its sequelae. The pt had suffer severe personal injuries, pain, suffering, and emotional distress as well as to incur substantial economic damages. The use of vaccine live (ZOSTAVAX) cussed the pt injuries, harm and economic loss that the pt suffered and would continue to suffer. The pt was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. The pt required and/or would require more health care and services and incurred medical, health, incidental and related expenses. The pt was informed and believed and further alleged that he would in the future be required to obtain further medical and/or hospital care, attention and services
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer on 24-MAR-2020, regarding a case in litigation and refers to a 66-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In June 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (the dosage regimen information was not reported). As a result of vaccination, in September 2014, the patient was caused to suffer serious and dangerous side effects including shingles and any and all of its sequel. She has been caused to suffer severe personal injuries which are permanent and lasting in nature, physical pain, suffering, emotional distress, and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications, as well as to incur substantial economic damages.  The reporter considered that shingles was serious (medically significant).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; a 36 year old patient received ZOSTAVAX; This initial spontaneous report was received from a lawyer on 24-MAR-2020, regarding a case in litigation and refers to a 36-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 01-AUG-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (the dosage regimen information was not reported). As a result of vaccination, on 09-SEP-2017, the patient was caused to suffer serious and dangerous side effects including shingles and any and all of its sequel. She has been caused to suffer severe personal injuries which are permanent and lasting in nature, physical pain, suffering, emotional distress, and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications, as well as to incur substantial economic damages.  The reporter considered that shingles was serious (medically significant).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: post herpetic neuralgia; shingles; This initial spontaneous report was received from a lawyer on 24-MAR-2020, regarding a case in litigation and refers to a 60-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 30-MAY-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (the dosage regimen information was not reported). As a result of vaccination, on an unspecified date in 2014, the patient was caused to suffer serious and dangerous side effects including postherpetic neuralgia and shingles, and any and all of its sequel. She has been caused to suffer severe personal injuries which are permanent and lasting in nature, physical pain, suffering, emotional distress, and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications, as well as to incur substantial economic damages.  The reporter considered that postherpetic neuralgia and shingles were serious (medically significant).
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Other severe and personal injuries which are permanent and lasting in nature; Shingles including any and all of its sequelae; This initial spontaneous report was received from a lawyer and a 76 year old female patient regarding a case in litigation on 24-MAR-2020. Her Medical history, concurrent conditions, concomitant medication, drug reactions or allergies were not provided. On an unspecified date in 2012, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, lot number, expiration date, route of administration, and anatomical location not provided) as prophylaxis. As a result of her receipt of zoster vaccine live (ZOSTAVAX), in 2012, the patient suffered shingles, including any and all of its sequelae. As a result, patient had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. Also, the patient was caused to suffer other severe and personal injuries (unspecified), which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. The patient required and/or would require more health care and services and did incur medical, health, incidental and related expenses. The patient was informed and believed and further alleged that would in the future be required to obtain further medical and/or hospice care, attention, and services. At the reporting time, the outcome of shingles and the other unspecified permanent injuries was considered as not recovered. The reporters considered the events to be related to zoster vaccine live (ZOSTAVAX).   The reporters considered the other severe and permanent injuries (unspecified) event to be disabling.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Other severe and personal injuries which are permanent and lasting in nature; shingles including any and all of its sequelae; This initial spontaneous report was received from a lawyer and a 61 year old female patient regarding a case in litigation on 24-MAR-2020. Her medical history, concurrent conditions, concomitant medication, drug reactions or allergies were not provided. On 17-MAR-2016, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, lot number, expiration date, route of administration, and anatomical location not provided) as prophylaxis. As a result of her receipt of zoster vaccine live (ZOSTAVAX), in 2016, the patient suffered shingles, including any and all of its sequelae. As a result, patient had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. Also, the patient was caused to suffer other severe and personal injuries (unspecified), which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. The patient required and/or would require more health care and services and did incur medical, health, incidental and related expenses. The patient was informed and believed and further alleged that would in the future be required to obtain further medical and/or hospice care, attention, and services. At the reporting time, the outcome of shingles and the other unspecified permanent injuries was considered as not recovered. The reporters considered the events to be related to zoster vaccine live (ZOSTAVAX).   The reporters considered the other severe and permanent injuries (unspecified) to be a disabling event.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Other severe and personal injuries which are permanent and lasting in nature; shingles including any and all of its sequelae; This initial spontaneous report was received from a lawyer and a 63 year old male patient regarding a case in litigation on 24-MAR-2020. His medical history, concurrent conditions, concomitant medication, drug reactions or allergies were not provided. On an unspecified date in 2014, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, lot number, expiration date, route of administration, and anatomical location not provided) as prophylaxis. As a result of his receipt of zoster vaccine live (ZOSTAVAX), in 2014, the patient suffered shingles, including any and all of its sequelae. As a result, patient had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. Also, the patient was caused to suffer other severe and personal injuries (unspecified), which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. The patient required and/or would require more health care and services and did incur medical, health, incidental and related expenses. The patient was informed and believed and further alleged that would in the future be required to obtain further medical and/or hospice care, attention, and services. At the reporting time, the outcome of shingles and the other unspecified permanent injuries was considered as not recovered. The reporters considered the events to be related to zoster vaccine live (ZOSTAVAX).   The reporters considered the other severe and permanent injuries (unspecified) to be a disabling event.
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: ROTATEQ was administered at 3 weeks of age; This spontaneous report was received from a medical assistant regarding a 3 week old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-FEB-2019, at 3 weeks of age, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, frequency, lot number and expiration date unknown) via route defaulted to oral for prophylaxis (inappropriate schedule of product administration).
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects were reported in the patient; A patient received doses of vaccines following a temperature excursion; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies.     On 25-MAR-2020,  the patient was vaccinated with doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), lot # S036823, expiration date 31-MAR-2022 (dosage schedule, anatomical location and route of administration were not reported) and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) by oral route, lot #S006053, with an expiration date of 07-DEC-2020 (dosage schedule and anatomical location were not reported), both administered as prophylaxis; following a temperature excursion (product storage error).  The vaccines involved were stored in a lowest temperature below 36 degrees Fahrenheit  (°F) / 2 degrees Celsius (°C) (25.2 °F) for 23 hours, as recorded by a data logger for a time frame of 23-hours. There was no previous temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported.  Lot numberS036823 has been verified to be a valid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; The patient received an improperly stored dose of ROTATEQ; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions, concomitant medication, previous drug reactions or allergies were not reported.  On 16-MAR-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (product storage error), one dosage form for prophylaxis (lot number 1660112 has been verified to be a valid number; expiration date reported and validated as 18-OCT-2020) (concentration, route of administration, frequency of vaccination scheme and anatomical location of vaccination were not reported).  The medical assistant reported that the Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) underwent a temperature excursion above 47 degrees Fahrenheit (52.1 degrees Fahrenheit) for a time frame of 15 minutes, as recorded by the data logger. There was a previous temperature excursion above 47 degrees Fahrenheit (52.1 degrees Fahrenheit) for 21 minutes, also recorded by the data logger.   No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: The patient received an improperly stored dose of ROTATEQ; This spontaneous report was received from the medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.   On 16-MAR-2020, the patient was vaccinated with a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (strength, dose,  frequency, were not provided) orally for prophylaxis. The valid Lot No. 1660112 had been verified to be a valid lot number for [Rotavirus Vaccine, Live, Oral, Pentavalent], expiration date reported as 18-OCT-2020, and upon internal validation established as the same.   The reporter stated that on this date, the vaccine dose was administered was improperly stored (incorrect product storage). The vaccine presented a temperature excursion with temperature above 47°F and 52.1°F for 15 minutes. Another previous temperature excursion was above 47°F and 55°F for 21 minutes.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; patient was administered an improperly stored dose of ROTATEQ; This spontaneous report was received from a medical assistant referring to a patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 18-MAR-2020, the patient was administered an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, oral for prophylaxis (lot # 1660112, expiration date 18-OCT-2020). The vaccine was incorrectly stored for 15 minutes above 47 Fahrenheit degrees (F)(52.1 F) and had a previous temperature excursion above 47 Fahrenheit degrees (F)(55 F) for 21 minutes. The error was identified due to a data logger. No additional AE information provided (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; The patient was administered an improperly stored dose of VARIVAX; This spontaneous report has been received from a vaccine coordinator concerning a patient of unknown age and gender.      The patient's pertinent concurrent conditions, medical history, drug/allergy reactions, and concomitant therapies were not reported.  On 23-MAR-2020, the patient was administered an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, dose, vaccination scheme, route of administration, and anatomical location, were not reported) with lot number (lot # S020159 (verified to be a valid lot number) expiration date reported and stablished as 30-JUN-2021) for prophylaxis. The vaccine temperature was -13.3 Celsius. The time frame was 5 hours and 5 minutes. The vaccine had a previous temperature excursion with a temperature excursion of -13.6 Celsius for 24 minutes. The call was due to a datalogger.  No additional adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; the patient was administered an improperly stored dose of ROTATEQ; Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 11-MAR-2020, the patient was administered an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660112 with expiration date 18-OCT-2020 orally for prophylaxis (dose number and exact dose were not provided) (product storage error).  The temperature excursion was above 47 degrees Fahrenheit (52.1 Fahrenheit) for a time frame of 15 minutes. There was a previous temperature excursion of above 47 degrees Fahrenheit (55 Fahrenheit) for a time frame of 21 minutes. The digital data logger was involved. No additional adverse event was provided. No PQC was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; on unspecified date on or after 3/23/2020, a patient  received a dose of improperly stored ROTATEQ; Information has been received from a registered nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.      On 23-JAN-2020, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose detail, lot # and expiration date were unknown) orally for prophylaxis.          On approximately 23-MAR-2020 (reported as on or after 23-MAR-2020), the patient received a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose detail were unknown; lot # 1660146 and expiration date 20-OCT-2020) orally for prophylaxis. The vaccine was exposed to temperature excursion at above 47 degrees Fahrenheit (59.7 degrees Fahrenheit) for 6 hours and 1 minute (incorrect product storage). There was multiple previous temperature excursion at above 47 degrees Fahrenheit (53.2 degrees Fahrenheit) for 7 hours and 38 minutes. The call was due to digital data logger. No additional adverse effect was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; lhe patient was administered an improperly stored dose of ROTATEQ on 3/10/2020.; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's historical condition, current condition and concomitant medication were not reported.  On 10-MAR-2020, the patient was administered an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (orally, lot#1660112 with expiration date: 18-OCT-2020; dose, strength and frequency were unknown) for prophylaxis. No additional adverse event (AE) information provided.  The vaccine was stored above 47 Fahrenheit (F) to 52.1F  for 15 minutes. The previous temperature excursion was above 47F to 55F for 21 minutes. The digital data logger was involved.
Sex: M
Vaccine: TYP
Symptoms: Oral administration complication, Vomiting
Clinical narrative: TOOK VIVOTIF AND VOMITED 2 HOURS LATER; This spontaneous case report (PVX2019-1627) was received from a pharmacist on 22-Jun-2019. It describes a 17-year-old male consumer who "took Vivotif and vomited 2 hours later". He was receiving Vivotif for an unknown indication.  Case report: The consumer took a dose of Vivotif on 22-Jun-2019 and vomited 2 hours later.  Action taken with Vivotif was unknown.  The clinical outcome of the event was unknown.  Company's Comment: In this case, it was reported that the consumer "took Vivotif and vomited 2 hours later". There seems to be a temporal association between the intake of the vaccine and the event. Also, vomiting is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer "took Vivotif and vomited 2 hours later". There seems to be a temporal association between the intake of the vaccine and the event. Also, vomiting is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.