chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported.; 2 patients were vaccinated with improperly stored VARNAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 07-AUG-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot # S000132, expiry date 02-JAN-2021; exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature from 15 Fahrenheit degrees (F) to 46 F (from -9 degrees Celsius (C) to 8 C) for 3 hours and 52 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA004040:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported.; 2 patients were vaccinated with improperly stored VARNAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 07-AUG-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot # R035221, expiry date 04-DEC-2020; exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature from 15 Fahrenheit degrees (F) to 46 F (from -9 degrees Celsius (C) to 8 C) for 3 hours and 52 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA004035:
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Muscular weakness
Clinical narrative: Severe Headache, leg weakness
Age: 1.08
Sex: F
Vaccine: PNC13
Symptoms: Culture throat negative, Irritability, Nasal congestion, Rash, Streptococcus test negative
Clinical narrative: Approx. 24 hours after receiving PCV-13 vaccine patient broke out in a full body rash, worse on trunk and less severe on limbs/extremities. Grandmother noted patient to be more fussy than usual. Noted nasal congestion, possible low grade fever, and mild decrease in urine output.   Grandmother was advised to encourage plenty of fluids, use nasal saline drops,  and use of Benadryl per bottle instructions PRN Q6H.
Age: 1.08
Sex: F
Vaccine: PNC13
Symptoms: Urine output decreased
Clinical narrative: Approx. 24 hours after receiving PCV-13 vaccine patient broke out in a full body rash, worse on trunk and less severe on limbs/extremities. Grandmother noted patient to be more fussy than usual. Noted nasal congestion, possible low grade fever, and mild decrease in urine output.   Grandmother was advised to encourage plenty of fluids, use nasal saline drops,  and use of Benadryl per bottle instructions PRN Q6H.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Fatigue, Influenza like illness, Lymph node pain, Lymphadenitis
Clinical narrative: Patient experienced normal reactions (flulike symptoms, muscle aches, fatigue).  However, she also presented with an inflamed lymph node under the right arm.  The lymph node is still inflamed today.  It was a golf-ball size yesterday.  It has flattened out a bit.  However, it is still swollen and tender.  Yesterday, she took Tylenol and Naproxen.  She took Tylenol for the discomfort today.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Myalgia
Clinical narrative: Patient experienced normal reactions (flulike symptoms, muscle aches, fatigue).  However, she also presented with an inflamed lymph node under the right arm.  The lymph node is still inflamed today.  It was a golf-ball size yesterday.  It has flattened out a bit.  However, it is still swollen and tender.  Yesterday, she took Tylenol and Naproxen.  She took Tylenol for the discomfort today.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal X-ray, Blood test normal, Decreased appetite, Diarrhoea, Headache
Clinical narrative: symptoms included headache and severe cramping and diarrhea for 18 hours and then lack of appetite for 2 days.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, X-ray normal
Clinical narrative: symptoms included headache and severe cramping and diarrhea for 18 hours and then lack of appetite for 2 days.
Age: 83.0
Sex: M
Vaccine: UNK
Symptoms: Pain, Pyrexia
Clinical narrative: fever, pain
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Alopecia, Anxiety, Erythema, Fatigue, Rash
Clinical narrative: Days after the vaccine my daughter had pink welts all over her face and arms. She then had a skin  rash all over the crown of her hair. It looked like cradle cap that infants babies get. her skin got crusted and scaly. I took her to her pediatrician for an evaluation 7 mentioned to her that my daughter had never had these rashes before 7 asked if the vaccines might have caused it. She looked at me as if I had asked an idiotic question and didn't respond. i never brought the vaccine inquiry with her again & chose not to complete the vaccination cycle. my daughter started complaining of being tired all the time. her extremities would turn a reddish purple color. She started getting anxiety and her hair that was lush & thick started falling. she is now 19 and has not been the same kid since this vaccine was introduced into her body.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Scab, Skin discolouration, Skin exfoliation, Urticaria
Clinical narrative: Days after the vaccine my daughter had pink welts all over her face and arms. She then had a skin  rash all over the crown of her hair. It looked like cradle cap that infants babies get. her skin got crusted and scaly. I took her to her pediatrician for an evaluation 7 mentioned to her that my daughter had never had these rashes before 7 asked if the vaccines might have caused it. She looked at me as if I had asked an idiotic question and didn't respond. i never brought the vaccine inquiry with her again & chose not to complete the vaccination cycle. my daughter started complaining of being tired all the time. her extremities would turn a reddish purple color. She started getting anxiety and her hair that was lush & thick started falling. she is now 19 and has not been the same kid since this vaccine was introduced into her body.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site swelling, Pain in jaw, Pyrexia
Clinical narrative: swelling at site :fist size " per patient. Jaw pain.  Fever and flu-like SX for 36 hours
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Cervical radiculopathy, Electromyogram, Hypoaesthesia, Muscle spasms, Nerve conduction studies
Clinical narrative: Pain, numbness and muscular spasms in the arm where the vaccine was given  later spreading to the other arm.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Radiculopathy
Clinical narrative: Pain, numbness and muscular spasms in the arm where the vaccine was given  later spreading to the other arm.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Aggression
Clinical narrative: Mother noticed increased tantrums, length of tantrums, and significant increase in their severity a few days after her MMR vaccine
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Nausea, Nonspecific reaction
Clinical narrative: nauseous; flu-like symptoms; few little reactions; This case was reported by a consumer via call center representative and described the occurrence of nausea in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced nausea, influenza-like symptoms and nonspecific reaction. On an unknown date, the outcome of the nausea, influenza-like symptoms and nonspecific reaction were recovered/resolved.   It was unknown if the reporter considered the nausea, influenza-like symptoms and nonspecific reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The caller asked if she could visit a patient in the intensive care unit even though she has completed the Shingrix series. The caller reported that the Shingrix made her nauseous, with flu-like symptoms and few little reactions but she was ok at the time of reporting. No health care professional information was obtained.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: severe arm pain, pain shooting up into shoulder, burning
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Computerised tomogram head, Dizziness, Face oedema, General physical health deterioration, Lip injury
Clinical narrative: Patient had received two immunizations (Bexsero and Menactra) and passed out about 30 seconds after both immunizations were given. Patient fell off the exam table due to passing out and endured a laceration to the right side of his bottom lip due to the impact of the fall and the braces that that patient has. The provider was in the next room down when this occurred and quickly came to assist with the patient. The patient's vitals were taken several times and the provider did neurological checks as well. The patient stated to feel nauseous again and started to get tremors throughout his body. Provide states was neurologically intact,. When patient attempted to sit up became lightheaded and dizzy twice. Due to the patient not bouncing back quickly and declining in his state of health the provider decided to transport to ER.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Loss of consciousness, Nausea, Tremor
Clinical narrative: Patient had received two immunizations (Bexsero and Menactra) and passed out about 30 seconds after both immunizations were given. Patient fell off the exam table due to passing out and endured a laceration to the right side of his bottom lip due to the impact of the fall and the braces that that patient has. The provider was in the next room down when this occurred and quickly came to assist with the patient. The patient's vitals were taken several times and the provider did neurological checks as well. The patient stated to feel nauseous again and started to get tremors throughout his body. Provide states was neurologically intact,. When patient attempted to sit up became lightheaded and dizzy twice. Due to the patient not bouncing back quickly and declining in his state of health the provider decided to transport to ER.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature, Diarrhoea, Injection site rash, Myalgia
Clinical narrative: diarrhea, rash at site, muscle aches, temperature
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood test, Decreased appetite, Dehydration, Electroencephalogram normal, Fatigue
Clinical narrative: Fever, Aches, Irritability, No appetite nor the want to drink ANY fluids. Tonic Clonic (Grand Mal) Seizures with the first event at 4:21AM on Friday, July 26th along with another confirmed Tonic Clonic (Grand Mal) at 10:42 PM on Friday, July 26th  Was then admitted at Hospital.  Patient continued to show extreme signs of sickness.  Dehydration, Fatigue, inability to hold head up, inability to walk, crawl or sit up on own.  Was incapable of keeping eyes focused on anything nor hold them open for any length of time.  As of 8/7/19 now has rash and hives all over her body that is potentially related to Vaccinations.   EEG performed - Inconclusive/Normal MRI performed - Normal
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Gait inability, Generalised tonic-clonic seizure, Inability to crawl, Irritability, Malaise
Clinical narrative: Fever, Aches, Irritability, No appetite nor the want to drink ANY fluids. Tonic Clonic (Grand Mal) Seizures with the first event at 4:21AM on Friday, July 26th along with another confirmed Tonic Clonic (Grand Mal) at 10:42 PM on Friday, July 26th  Was then admitted at Hospital.  Patient continued to show extreme signs of sickness.  Dehydration, Fatigue, inability to hold head up, inability to walk, crawl or sit up on own.  Was incapable of keeping eyes focused on anything nor hold them open for any length of time.  As of 8/7/19 now has rash and hives all over her body that is potentially related to Vaccinations.   EEG performed - Inconclusive/Normal MRI performed - Normal
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Nuclear magnetic resonance imaging normal, Pain, Posture abnormal, Pyrexia, Rash generalised
Clinical narrative: Fever, Aches, Irritability, No appetite nor the want to drink ANY fluids. Tonic Clonic (Grand Mal) Seizures with the first event at 4:21AM on Friday, July 26th along with another confirmed Tonic Clonic (Grand Mal) at 10:42 PM on Friday, July 26th  Was then admitted at Hospital.  Patient continued to show extreme signs of sickness.  Dehydration, Fatigue, inability to hold head up, inability to walk, crawl or sit up on own.  Was incapable of keeping eyes focused on anything nor hold them open for any length of time.  As of 8/7/19 now has rash and hives all over her body that is potentially related to Vaccinations.   EEG performed - Inconclusive/Normal MRI performed - Normal
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urticaria, Vision blurred
Clinical narrative: Fever, Aches, Irritability, No appetite nor the want to drink ANY fluids. Tonic Clonic (Grand Mal) Seizures with the first event at 4:21AM on Friday, July 26th along with another confirmed Tonic Clonic (Grand Mal) at 10:42 PM on Friday, July 26th  Was then admitted at Hospital.  Patient continued to show extreme signs of sickness.  Dehydration, Fatigue, inability to hold head up, inability to walk, crawl or sit up on own.  Was incapable of keeping eyes focused on anything nor hold them open for any length of time.  As of 8/7/19 now has rash and hives all over her body that is potentially related to Vaccinations.   EEG performed - Inconclusive/Normal MRI performed - Normal
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a consumer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unspecified date in 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced herpes zoster. The outcome of shingles was considered as not recovered.  The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
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 female patient of unknown age. No information regarding her medical history, concurrent conditions or concomitant medications was provided.  On or about 23-APR-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the patient inoculation, on an unknown date, the patient experienced shingles, due to which she was hospitalized and treated. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was determined to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
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 male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or around 09-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions by the healthcare provider in a hospital. On an unspecified date, subsequent to patient's inoculation, the patient was treated by healthcare provider for shingles.  As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
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 female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 20-AUG-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose#, lot#, expiration date and route of administration were not provided) for the long-term prevention of shingles and/or zoster-related conditions at the physician's office. Subsequent to patient's inoculation, the patient was treated by a healthcare provide for shingles.  As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
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 patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2008, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions.  Subsequent to patient's inoculation, patient was treated by a healthcare provide for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.   The outcome of shingles was reported as not recovered.   The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 03-JUL-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose#, lot#, expiration date and route of administration were not provided) for the long-term prevention of shingles and/or zoster-related conditions at the pharmacy. Subsequent to patient's inoculation, the patient was treated by a healthcare provide for herpes zoster. As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
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 patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions.  Subsequent to the patient's inoculation, the patient was treated by the physician for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.   At the time of the report, the outcome of shingles was considered as not recovered. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Hypoaesthesia, Mononeuropathy, Muscle atrophy
Clinical narrative: right femoral mononeuropathy; pain in his back; shingles; muscle atrophy; denervation edema along the right femoral nerve and obturator nerve distributions; mental and emotional distress; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt) of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for routine health maintenance and the prevention of shingles (herpes zoster). On an unspecified date, after the injection, pt suffered pain in his back and right leg, accompanied by weakness, numbness and atrophy of the muscles in his right leg. As a result of his symptoms, he presented to a medical provider and was diagnosed with shingles, as well as, right femoral mononeuropathy, muscle atrophy and denervation edema along the right femoral nerve and obturator nerve distributions, greatest along the right femoral nerve. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX).Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. PAs a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), 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. As a direct and proximate result of vaccination, pt 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 not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered all the events to be disabling.
Sex: M
Vaccine: VARZOS
Symptoms: Muscular weakness, Neuropathic muscular atrophy, Oedema, Pain in extremity
Clinical narrative: right femoral mononeuropathy; pain in his back; shingles; muscle atrophy; denervation edema along the right femoral nerve and obturator nerve distributions; mental and emotional distress; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt) of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for routine health maintenance and the prevention of shingles (herpes zoster). On an unspecified date, after the injection, pt suffered pain in his back and right leg, accompanied by weakness, numbness and atrophy of the muscles in his right leg. As a result of his symptoms, he presented to a medical provider and was diagnosed with shingles, as well as, right femoral mononeuropathy, muscle atrophy and denervation edema along the right femoral nerve and obturator nerve distributions, greatest along the right femoral nerve. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX).Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. PAs a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), 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. As a direct and proximate result of vaccination, pt 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 not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered all the events to be disabling.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Headache, Influenza like illness, Myalgia
Clinical narrative: headache; cold feeling; muscle pain; flu like symptoms; tired; bilateral jaw pain; Cold feet and hands; This case was reported by a consumer via call center representative and described the occurrence of headache in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included paracetamol (Tylenol) for headache.   On 30th July 2019, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, the patient started Tylenol at an unknown dose and frequency. On 31st July 2019, 1 days after receiving Shingrix, the patient experienced headache, feeling cold, muscle pain, influenza-like symptoms, tiredness, jaw pain and cold feet. On an unknown date, the outcome of the headache was recovering/resolving and the outcome of the feeling cold, muscle pain, influenza-like symptoms, tiredness, jaw pain and cold feet were unknown.   It was unknown if the reporter considered the headache, feeling cold, muscle pain, influenza-like symptoms, tiredness, jaw pain and cold feet to be related to Shingrix.  Additional details were provided as follows: The patient received first dose of Shingrix in right arm. The patient experienced headache, cold feeling her hands and feet were cold, she had muscle pain all over like she had the flu. The patient was tired, and bilateral jaw pain.  The patient called her physician who didn't believe she would see these symptoms this quick from the product and she said he told her she might had the flu. She was advised to take Tylenol, which she did, and her headache has gotten better.  She was concerned about getting the 2nd dose since she had these events. So the prescribing information was reviewed and she was encouraged to speak with her physician about the 2nd dose.  The reporter did not consent to follow up. There was discrepancy between the outcome of the event Headache, reported in the structured field (recovering) and the outcome reported in the source document (Fatal).
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in jaw, Peripheral coldness
Clinical narrative: headache; cold feeling; muscle pain; flu like symptoms; tired; bilateral jaw pain; Cold feet and hands; This case was reported by a consumer via call center representative and described the occurrence of headache in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included paracetamol (Tylenol) for headache.   On 30th July 2019, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, the patient started Tylenol at an unknown dose and frequency. On 31st July 2019, 1 days after receiving Shingrix, the patient experienced headache, feeling cold, muscle pain, influenza-like symptoms, tiredness, jaw pain and cold feet. On an unknown date, the outcome of the headache was recovering/resolving and the outcome of the feeling cold, muscle pain, influenza-like symptoms, tiredness, jaw pain and cold feet were unknown.   It was unknown if the reporter considered the headache, feeling cold, muscle pain, influenza-like symptoms, tiredness, jaw pain and cold feet to be related to Shingrix.  Additional details were provided as follows: The patient received first dose of Shingrix in right arm. The patient experienced headache, cold feeling her hands and feet were cold, she had muscle pain all over like she had the flu. The patient was tired, and bilateral jaw pain.  The patient called her physician who didn't believe she would see these symptoms this quick from the product and she said he told her she might had the flu. She was advised to take Tylenol, which she did, and her headache has gotten better.  She was concerned about getting the 2nd dose since she had these events. So the prescribing information was reviewed and she was encouraged to speak with her physician about the 2nd dose.  The reporter did not consent to follow up. There was discrepancy between the outcome of the event Headache, reported in the structured field (recovering) and the outcome reported in the source document (Fatal).
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Pruritus
Clinical narrative: Pruritis; Arthralgia; This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 30 days after receiving Shingrix, the patient experienced pruritus and arthralgia. On an unknown date, the outcome of the pruritus and arthralgia were not recovered/not resolved.   It was unknown if the reporter considered the pruritus and arthralgia to be related to Shingrix.  Additional details were provided as follows: The reporter indicated that a consumer came into his pharmacy on 29th July 2019, and reported that he began to experience pruritus and arthralgia in both hands approximately 1month after receiving the 1st dose of the Shingrix vaccine. The reporter was unable to provide additional information.
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered, Malaise
Clinical narrative: Not feeling well; Extra dose; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 14-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix at an unknown dose. On an unknown date, unknown after receiving Boostrix, the patient experienced feeling unwell and extra dose administered. On an unknown date, the outcome of the feeling unwell and extra dose administered were unknown.   It was unknown if the reporter considered the feeling unwell to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Injection site erythema; Injection site swelling; Injection site inflammation; Vaccine Administered at Inappropriate Site; This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site inflammation and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site inflammation and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site inflammation to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received the Shingrix vaccination subcutaneously in left arm, which led to intramuscular formulation administered by other route. The patient experienced erythema, swelling, and inflammation at the injection site. The reporter was unable to provide any additional information. The reporter indicated that this case was initially presented by someone during a conference.  The reporter followed up to get the details and obtained the details at the time of reporting.  The adverse event was already reported to VARS (vaccine adverse event reporting system) as described by the reporter.  The reporter provided the patient's email address and was told she gave permission to be contacted. The reporter granted consent to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: may be shingles; Rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 49Y35, expiry date 22nd October 2021) for prophylaxis.   On 30th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on the left arm. The patient experinced a little rash and felt that it might be shingles. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Rash erythematous, Skin lesion, Skin warm
Clinical narrative: may be shingles; Rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 49Y35, expiry date 22nd October 2021) for prophylaxis.   On 30th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on the left arm. The patient experinced a little rash and felt that it might be shingles. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ill-defined disorder, Insomnia, Nausea, Pain, Pyrexia
Clinical narrative: I did BOTH shingrix shots and both times I had 48 hours of illness including aches, pains, sleeplessness, nausea. The first time I had a fever. The second time I had no fever, but I took tylenol every 6 hours.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Chills, Dehydration, Disorientation, Fall
Clinical narrative: Shortly after vaccination administration, patient appeared faint, disoriented. Wife states he appeared the same way recently because of dehydration.  911 called, wife reports paramedics state patient was dehydrated  and given fluids. Followed up with wife next day, patient complained of sore and painful arm, weakness, chills during the night.  Patient fell that morning, 911 called again and patient taken to hospital.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Syncope
Clinical narrative: Shortly after vaccination administration, patient appeared faint, disoriented. Wife states he appeared the same way recently because of dehydration.  911 called, wife reports paramedics state patient was dehydrated  and given fluids. Followed up with wife next day, patient complained of sore and painful arm, weakness, chills during the night.  Patient fell that morning, 911 called again and patient taken to hospital.
Age: 26.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Injection site pain, Mass, Soft tissue necrosis, Ultrasound scan abnormal
Clinical narrative: Patient seen 7/22/2019 c/o tenderness in R deltoid. Mass palpable 3 cm X 2cm.
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 female patient of an unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On or about 08-NOV-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose #, lot #, expiration date and route of administration were not provided) for the long-term prevention of shingles and/or zoster-related conditions by a healthcare provider. Subsequent to the patient's inoculation, the patient was treated by a physician for shingles. As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX) vaccine, patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
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 female patient of an unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On or about 28-MAR-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose #, lot #, expiration date and route of administration were not provided) for the long-term prevention of shingles and/or zoster-related conditions by a pharmacist in a pharmacy. Subsequent to the patient's inoculation, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
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 male patient of an unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unspecified date in 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose #, lot #, expiration date and route of administration were not provided) for the long-term prevention of shingles and/or zoster related conditions by a physician in a physician's office. Subsequent to the patient's  inoculation, the patient was treated by the physician for shingles. As a direct and proximate result of the patient's use of zoster vaccine live (ZOSTAVAX) vaccine, patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash erythematous, Rash vesicular
Clinical narrative: herpes zoster; Information has been received regarding a case in litigation from a lawyer concerning a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not reported.     On 22-AUG-2016, the pt was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) as routine health maintenance and for the prevention of shingles (herpes zoster) (Strength, dose, route of administration, lot # and expiration date were not reported).        Subsequently to Plaintiff's zoster vaccine live(ZOSTAVAX) inoculation, Plaintiff suffered herpes zoster with a red vesicular rash on the left breast and radiating to the dorsal thorax. As a direct and proximate result of defective zoster vaccine live(ZOSTAVAX), Plaintiffs symptoms have resulted in physical limitations not present prior to product. Plaintiff also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition.As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live(ZOSTAVAX), Plaintiff sustained severe and permanent personal injuries. Further, as a tragic consequence of wrongful conduct, Plaintiff 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 of Defendants' conduct, Plaintiff has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster was reported as not recovered.    The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported/ no side effects for the patient; the one dose of MMR II vaccine that was administered to the patient on 7/29/2019 was administered 27 days after the first dose and was one day earlier, than the 28 days that is recommended in the prescribing information; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  The patient received the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) on either 30-JUN-2019 or 01-JUL-2019 (strength, dose, frequency, route of administration, lot #, expiration date and indication were not reported), later on 29-JUL-2019, the patient was vaccinated with a second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), 0.5 milliliter/28 days apart (strength, route of administration, lot #, and expiration date were not reported)  indicated for prophylaxis reconstituted with sterile diluent(MERCK STERILE DILUENT) 0.5 milliliter/28 days apart, this second dose was administered 27 days after the first dose and was one day earlier, than the 28 days that was recommended in the prescribing information.  No adverse effects reported by the pharmacist.