chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.83
Sex: M
Vaccine: UNK, UNK
Symptoms: Head banging, Lethargy, Sleep disorder, Tonsillar hypertrophy, Tonsillectomy
Clinical narrative: I was called to pick him up at daycare. He had diarrhea and was repeating everything I said in a pitiful voice. I kept asking him what was wrong and how he felt, but he could only repeat what I was saying. I cared for him that day. He was very lethargic, and would not even look at me when I spoke to him. Drs. later told his parents that he was deaf, and that he needed tubes and adenoids out. They never caught his symptoms, which were very obvious. Just a few months ago, doctors took out his tonsils, saying they were too big. They have been bullied by doctors who want to treat without looking into his obvious reactions and symptoms of encephalitis and encephalopathy. My son reported to me he'd beat his head on the crib and the floor. Doctors are ignorant and our kids feel like they have to follow doctors orders. When they first refused vaccinations, under a year old, the Dr. made them sign a refusal form, then apparently they sent letters stating they'd better get the shots, I don't know when all he might have gotten them, but the 2 year ones (I assume that included the MMR,) were incredibly devastating. Prior, he'd take his baba, lay down for a nap, no problem. He developed sleep disorders that his tonsils were blamed for. They never looked into patient's health history, even though I had myself and my son tested for MTHFR, both homozygous, resulting in about 70% mitochondrial dysfunction.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Diarrhoea, Pyrexia, Tremor, Vomiting
Clinical narrative: About 24 hours after vaccination, patient experienced diarrhea, vomiting and severe chills (hands were shaking uncontrollably) with about 103 fever. Pt took 3 tablets of ADVIL 200 mg and went to bed. All the symptoms were resolved by morning.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Diarrhoea, Nausea, Pyrexia, Tremor
Clinical narrative: About 24 hours after vaccination, patient experienced diarrhea, vomiting and severe chills (hands were shaking uncontrollably) with about 103 fever. Pt took 3 tablets of ADVIL 200 mg and went to bed. All the symptoms were resolved by morning.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: About 24 hours after vaccination, patient experienced diarrhea, vomiting and severe chills (hands were shaking uncontrollably) with about 103 fever. Pt took 3 tablets of ADVIL 200 mg and went to bed. All the symptoms were resolved by morning.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Dizzy - Nausea - Chills - Fever - Headache - Fatigue.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Dizzy - Nausea - Chills - Fever - Headache - Fatigue.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site bruising, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh persistently swollen, bruised and warm to touch 2 months later.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 3 DAYS POST-VACCINATION, PRESENTS TO PHARMACY COUNTER COMPLAINING OF REDNESS, SWELLING, ITCHING, PAIN AT INJECTION SITE. DR. VISIT THAT MORNING, DIAGNOSIS CELLULITIS. ANTIBIOTIC PRESCRIBED AND PICKED UP. RPH COUNSELED TO APPLY ICE PACK AND TAKE BENADRYL TO MINIMIZE REACTION.
Sex: M
Vaccine: VARZOS
Symptoms: Angiogram, Atrial fibrillation, Blood blister, Blood creatine phosphokinase increased, Cerebrovascular accident
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 10-APR-2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On approximately 12-APR-2017 [reported as two days after receiving the ZOSTAVAX vaccine], the patient developed an intermittent, sharp, throbbing pain from the center of top portion of the chest around the back of his ear, progressing up to the back of his head. He was later diagnosed with peripheral neuropathy. Furthermore, on an unknown date in 2017 [reported as less than two months after receiving ZOSTAVAX], the patient suffered a cerebrovascular accident causing left-sided hemiparesis, including a facial droop, abnormal muscle tone, and a cranial nerve deficit. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, 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. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Upon internal review, peripheral neuropathy and cerebrovascular accident were determined to be medically significant. Peripheral neuropathy and cerebrovascular accident were considered to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Chest X-ray, Chest pain, Chronic sinusitis, Computerised tomogram head abnormal, Contusion
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 10-APR-2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On approximately 12-APR-2017 [reported as two days after receiving the ZOSTAVAX vaccine], the patient developed an intermittent, sharp, throbbing pain from the center of top portion of the chest around the back of his ear, progressing up to the back of his head. He was later diagnosed with peripheral neuropathy. Furthermore, on an unknown date in 2017 [reported as less than two months after receiving ZOSTAVAX], the patient suffered a cerebrovascular accident causing left-sided hemiparesis, including a facial droop, abnormal muscle tone, and a cranial nerve deficit. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, 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. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Upon internal review, peripheral neuropathy and cerebrovascular accident were determined to be medically significant. Peripheral neuropathy and cerebrovascular accident were considered to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Cranial nerve disorder, Dizziness, Ear pain, Echocardiogram normal, Ejection fraction normal
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 10-APR-2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On approximately 12-APR-2017 [reported as two days after receiving the ZOSTAVAX vaccine], the patient developed an intermittent, sharp, throbbing pain from the center of top portion of the chest around the back of his ear, progressing up to the back of his head. He was later diagnosed with peripheral neuropathy. Furthermore, on an unknown date in 2017 [reported as less than two months after receiving ZOSTAVAX], the patient suffered a cerebrovascular accident causing left-sided hemiparesis, including a facial droop, abnormal muscle tone, and a cranial nerve deficit. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, 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. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Upon internal review, peripheral neuropathy and cerebrovascular accident were determined to be medically significant. Peripheral neuropathy and cerebrovascular accident were considered to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Electrocardiogram abnormal, Facial paralysis, Fall, Headache, Hemiparesis
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 10-APR-2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On approximately 12-APR-2017 [reported as two days after receiving the ZOSTAVAX vaccine], the patient developed an intermittent, sharp, throbbing pain from the center of top portion of the chest around the back of his ear, progressing up to the back of his head. He was later diagnosed with peripheral neuropathy. Furthermore, on an unknown date in 2017 [reported as less than two months after receiving ZOSTAVAX], the patient suffered a cerebrovascular accident causing left-sided hemiparesis, including a facial droop, abnormal muscle tone, and a cranial nerve deficit. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, 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. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Upon internal review, peripheral neuropathy and cerebrovascular accident were determined to be medically significant. Peripheral neuropathy and cerebrovascular accident were considered to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Laboratory test, Monoplegia, Muscle tone disorder, Muscular weakness, Neuropathy peripheral
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 10-APR-2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On approximately 12-APR-2017 [reported as two days after receiving the ZOSTAVAX vaccine], the patient developed an intermittent, sharp, throbbing pain from the center of top portion of the chest around the back of his ear, progressing up to the back of his head. He was later diagnosed with peripheral neuropathy. Furthermore, on an unknown date in 2017 [reported as less than two months after receiving ZOSTAVAX], the patient suffered a cerebrovascular accident causing left-sided hemiparesis, including a facial droop, abnormal muscle tone, and a cranial nerve deficit. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, 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. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Upon internal review, peripheral neuropathy and cerebrovascular accident were determined to be medically significant. Peripheral neuropathy and cerebrovascular accident were considered to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash, Rhabdomyolysis
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 10-APR-2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On approximately 12-APR-2017 [reported as two days after receiving the ZOSTAVAX vaccine], the patient developed an intermittent, sharp, throbbing pain from the center of top portion of the chest around the back of his ear, progressing up to the back of his head. He was later diagnosed with peripheral neuropathy. Furthermore, on an unknown date in 2017 [reported as less than two months after receiving ZOSTAVAX], the patient suffered a cerebrovascular accident causing left-sided hemiparesis, including a facial droop, abnormal muscle tone, and a cranial nerve deficit. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, 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. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Upon internal review, peripheral neuropathy and cerebrovascular accident were determined to be medically significant. Peripheral neuropathy and cerebrovascular accident were considered to be disabling. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-NOV-2016, the patient was inoculated with ZOSTAVAX by a pharmacist as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about 2017, the patient was treated by a physician for shingles (Herpes zoster). As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. The outcome of the events vaccination failure, emotional distress, Herpes zoster, pain and injury was unknown. Causality assessment was related.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with ZOSTAVAX by a pharmacist as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date patient was diagnosed with shingles and/or other zoster-related injuries (herpes zoster) after and despite being inoculated with the ZOSTAVAX vaccine. In 2016, the patient was treated for shingles (herpes zoster). The lawyer reported that as a direct and proximate result of the ZOSTAVAX vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries, significant medical and related expenses because of these injuries; including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was reported as related for the events.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 03-AUG-2016, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 31-OCT-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 31-JAN-2013, a pharmacist administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 05-MAR-2013, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries.  The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation, from a lawyer, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-FEB-2012, the patient was vaccinated with ZOSTAVAX, due to health care professional recommendation, for permanent prevention and protection against shingles and zoster-related injuries (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided). On an unknown date, the patient experienced shingles and other zoster-related injuries despite being inoculated with the ZOSTAVAX vaccine. On an unknown date in 2015, the patient was treated by a health care provider for shingles. It was also reported that, on unknown dates, the patient suffered serious physical, emotional and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of pre-existing conditions and activations of latent conditions, lost wages, loss of earning capacity and other losses and damages. At the time of report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased, and the pre-existing unspecified conditions aggravated was unknown. The reporter considered the adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation, from a lawyer, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2016, the patient was vaccinated with ZOSTAVAX, due to health care professional recommendation, for permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided). On an unknown date in 2016, the patient experienced shingles (herpes zoster) and other zoster-related injuries despite being inoculated with the ZOSTAVAX vaccine (vaccination failure). On an unknown date in 2016, the patient was treated by a health care provider for shingles. It was also reported that, on unknown dates, the patient suffered serious physical, emotional and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering (Emotional distress and pain), extensive medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of pre-existing conditions and activations of laten conditions, lost wages, loss of earning capacity and other losses and damages. At the time of report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased, and the pre-existing unspecified conditions aggravated was unknown. The reporter considered the adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-treathening and medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On or about 21-JUL-2013, the patient was vaccinated with ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by a pharmacist. On an unknown date, the patient experienced shingles (herpes zoster) and on an unspecified date in 2016, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (vaccination failure) and suffered serious physical, emotional, and economic damages (emotional distress), as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered (emotional distress, pain); extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (condition aggravated); lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient had not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On or about 14-NOV-2012, the patient was vaccinated with ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries as recommended by the healthcare professional. On an unknown date, the patient experienced shingles and on or about 2015, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages, as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient had not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around January 2016, the patient was inoculated with the ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles. In approximately 2016 [reported as "shortly after" receiving the ZOSTAVAX vaccine], the patient suffered a stroke. The outcome of the stroke is unknown. As a direct and proximate result of the ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX, including but not limited to, pain and suffering for severe and permanent personal injuries sustained by the patient. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of the patient's condition. Upon internal review, stroke was determined to be medically significant. Stroke was considered to be disabling. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Syringe issue
Clinical narrative: This spontaneous report was received from a pharmacy student regarding a unknown age patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions allergies were not provided. On 04-DEC-2018, the patient was vaccinated with one dose of PNEUMOVAX 23 lot# reported as R01250 and 08-JAN-2020 expiration date for prophylaxis (strength, frequency and route of administration were not reported) which leaked during administration. No adverse effect reported. At the reporting time, the outcome of product use issue was not reported. The causal relationship between PNEUMOVAX 23 and the product use issue was not reported.
Sex: F
Vaccine: MMR
Symptoms: Seroconversion test negative
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age (who is now 41 years old). The patient's concurrent conditions, medical history and concomitant medications were not provided. On an unknown date (reported as "many years ago, when the patient was a child"), the patient was vaccinated with M-M-R II (strength, dose, route, frequency, lot# and expiration date were not provided) for prophylaxis; which was reconstituted with the sterile diluent (manufacturer unknown). It was stated that the patient's physician did a titer for measles, mumps and rubella which showed the patient ''failed to seroconvert" (date unspecified). It was unknown why the patient was getting titers done. The pharmacist reported that "the patient was scheduled for revaccination (unspecified what date) with M-M-R II." The outcome of seroconversion test negative was reported as not resolved. No further information provided. The causal relationship between the event and the M-M-R II vaccine was not provided.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: Initial information received on 28-Nov-2018 regarding an unsolicited valid non-serious case received from nurse. This case involves a 3 months old female patient where hub of the needle was cracked and because of this the 0.5 ml dose of PENTACEL (lot C5552AA/C5409AA and Exp. Date 10-OCT-2019 via unknown route in the left thigh) leaked all down the patient's leg, on 28-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTATEQ and PNEUMOCOCCAL 13 VALENT VACCINE for Immunisation. It was as actual medication error case due to vaccine underdose and exposure via skin contact. It was reported that, the hub of the needle there was a crack and because of this the vaccine leaked all down the patient's leg. It wasn't the vial but the hub of the needle that caused the issue. It was a case of needle issue. It was unknown whether the patient had any adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 28-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 30 months old female patient who was vaccinated with a 0.5 ml of  FLUZONE lot UJ005AC expiry date: 20-Jun-2019 (frequency once) via unknown route in the left thigh on 28-NOV-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was as actual medication error case due overdose. It was reported that 2.5 years old received 0.5 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. It was not reported whether the patient had any adverse reaction. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 1.25
Sex: F
Vaccine: DTAP, FLUX, HIBV, PNC13
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial information received on 29-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional (office staff). This case involves a 15 months old female patient who was vaccinated with 0.5 ml second dose of ACT-HIB (Batch number: UI937AAA and expiration date: 05-Nov-2019) in the left thigh (route of administration not reported) on 28-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DTAP for Immunisation; PREVENAR for Immunisation; and INFLUENZA VACCINE for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique because ACTHIB was reconstituted with sterile water instead of the supplied 0.4% NaCl saline solution diluent. No symptoms were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 29-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer (Office Staff) via phone. This case involves 18 months old male patient who was vaccinated with a 0.5 ml dose of ACT-HIB (Expiration date: 19-Nov-2018, lot UI821AAA via intramuscular route in the right thigh) on 26-Nov-2018. The patient's medical history and concomitant medications were not reported. Concomitant medications included DTAP VACCINE for Immunisation; and INFANRIX for Immunisation. It was an actual medication error due to expired vaccine used. Caller reports an expired dose of ACT-HIB was given to a patient. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Additional information was received on 30-Nov-2018 from a consumer (Office Staff) via phone. Patient details, concomitant medication and vaccination details updated. List of documents held by sender: none.
Age: 0.42
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Product storage error
Clinical narrative: Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a five months old female patient who was vaccinated with a 0.5 ml second dose of ACT-HIB lot UI913AA and Exp. Date 22-NOV-2019 via intramuscular route in the left thigh on 29-Nov-2018. The patient's medical history not reported and concomitant medications included PREVNAR for Immunization. It was reported that, reporter received an email from Sanofi stating their shipment of ACT-HIB was delayed in transit and the vaccine should not be used once received at their facility; and shipment arrived on 29 Nov 2018 and it should have been delivered by 28 Nov 2018 to avoid any shipping excursions. It was an actual medication error case due to incorrect product storage. It was unknown whether the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 29-Nov-2018 regarding an unsolicited valid non-serious case received from a non health professional. This case involves an Adult patient of an unknown age and gender who may had received vaccine IPOL (formulation Suspension for injection) (lot number, expiry date, dose, dose in series, route, site of administration were not reported). The vaccine exposed to a temperature excursions above 46 degrees Fahrenheit on 26-Nov-2018 between 4:41 AM to 5:41 AM at 47.3 degree F. On 27-Nov-2018 between 9:11 PM to 9:56 PM at 46.9 degree F and again at 1:26 AM to 2:26 AM at 47.1 degree F. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. It was a case of actual medication error due to incorrect product storage because IPOL was exposed to temperatures greater than 46F for almost 2 hours. It was not reported if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: M
Vaccine: FLUR4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 29-Nov-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 54 years old male patient who received two doses of vaccine FLUBLOK QIV in a year. The patient's past medical history and concomitant medication were not provided. On 26-Oct-2018, patient received a dose of suspect Influenza Quadrivalent Recombinant Vaccine, lot QFAA1821 (expiry date:30-Jun-2019) via unknown route in the left deltoid. On 14-Nov-2018, the patient again received a 0.5 ml dose of suspect Influenza Quadrivalent Recombinant Vaccine, lot QFAA1821 (expiry date:30-Jun-2019) via unknown route in the left deltoid. It was a case of actual medication error due to extra dose administered. As per recommended dosage schedule, FLUBLOK QIV should be given once in a year. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB, MNQ
Symptoms: Product storage error
Clinical narrative: Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves three patients (with unknown demographic) who received a dose of PENTACEL and MENACTRA (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patients' medical history and concomitant medications were not reported. It was an actual medication error case due to incorrect product storage. Three patients received invalid doses of MENACTRA and PENTACEL due to a temperature excursion for 48 hours. It was unknown whether the patients had any adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.