chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MENB, MENB
Symptoms: CSF glucose normal, CSF protein normal, CSF red blood cell count positive, CSF white blood cell count negative, Computerised tomogram head normal
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her daughter. A 16-year-old female patient received the 1st dose of TRUMENBA, via an unspecified route of administration in left arm, on 09Aug2016 at 09:00 AM, at 0.5 ml single. The patient's medical history was not reported. Concomitant medications were none. The patient previously took MMR, at 1 DF, and experienced rash like measles all over her body when she was 2 or 3 years old. The patient experienced headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of recovered on 20Aug2016, weight loss on 09Aug2016 with outcome of recovered on 29Aug2016, nausea on 09Aug2016 between 16:00 and 16:30 with outcome of recovering, not able to eat on 09Aug2016 at 19:00 with outcome of recovering, migraine headache pain that caused the nausea on 09Aug2016 at 16:00 with outcome of recovering; pain, tingling and weakness on the left side of her body on 09Aug2016 at 16:00 with outcome of not recovered; weakness moved into both of her feet and hands in Aug2016 with outcome of not recovered, headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of not recovered, severe fatigue on 09Aug2016 at 22:00 with outcome of not recovered, fever on 09Aug2016 with outcome of recovered on 10Aug2016, intermittent blurred vision where she saw spots on 09Aug2016 with outcome of unknown, sent home with Doxycycline for a possible tick borne illness on 12Aug2016 with outcome of unknown, felt sick on an unspecified date with outcome of unknown. The patient went to the emergency room on 11Aug2016, she stayed overnight and was not admitted. She was released on 12Aug2016. The patient went to the emergency room again on 14Aug2016. During her emergency room visit on 11Aug2016 the patient underwent lab tests and procedures which included: blood panel (performed to look for infection), negative for any condition. The patient underwent lab tests and procedures on 12Aug2016 which included spinal tap which checked for bacterial and viral meningitis (checked for proteins and white blood cells), negative. She was sent home with Doxycycline (unspecified trade name) for a possible tick borne illness on 12Aug2016. Within 48 hours her doctor permanently discontinued the product because symptoms did not improve. During her emergency room visit on 14Aug2016 the patient underwent lab tests and procedures which included: CT scan, negative for any condition; MRI, negative for multiple sclerosis and there was no demyelination for Guillain-Barre; general tests for mononucleosis, negative. The patient went to physician's office and was diagnosed with possible Guillain-Barre syndrome on 30Aug2016 at 10:30 with outcome of not recovered. It was not a certain diagnosis. As treatment she was sent to physical therapy.
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MENB, MENB
Symptoms: Eye pain, Gram stain negative, Haematocrit normal, Haemoglobin normal, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her daughter. A 16-year-old female patient received the 1st dose of TRUMENBA, via an unspecified route of administration in left arm, on 09Aug2016 at 09:00 AM, at 0.5 ml single. The patient's medical history was not reported. Concomitant medications were none. The patient previously took MMR, at 1 DF, and experienced rash like measles all over her body when she was 2 or 3 years old. The patient experienced headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of recovered on 20Aug2016, weight loss on 09Aug2016 with outcome of recovered on 29Aug2016, nausea on 09Aug2016 between 16:00 and 16:30 with outcome of recovering, not able to eat on 09Aug2016 at 19:00 with outcome of recovering, migraine headache pain that caused the nausea on 09Aug2016 at 16:00 with outcome of recovering; pain, tingling and weakness on the left side of her body on 09Aug2016 at 16:00 with outcome of not recovered; weakness moved into both of her feet and hands in Aug2016 with outcome of not recovered, headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of not recovered, severe fatigue on 09Aug2016 at 22:00 with outcome of not recovered, fever on 09Aug2016 with outcome of recovered on 10Aug2016, intermittent blurred vision where she saw spots on 09Aug2016 with outcome of unknown, sent home with Doxycycline for a possible tick borne illness on 12Aug2016 with outcome of unknown, felt sick on an unspecified date with outcome of unknown. The patient went to the emergency room on 11Aug2016, she stayed overnight and was not admitted. She was released on 12Aug2016. The patient went to the emergency room again on 14Aug2016. During her emergency room visit on 11Aug2016 the patient underwent lab tests and procedures which included: blood panel (performed to look for infection), negative for any condition. The patient underwent lab tests and procedures on 12Aug2016 which included spinal tap which checked for bacterial and viral meningitis (checked for proteins and white blood cells), negative. She was sent home with Doxycycline (unspecified trade name) for a possible tick borne illness on 12Aug2016. Within 48 hours her doctor permanently discontinued the product because symptoms did not improve. During her emergency room visit on 14Aug2016 the patient underwent lab tests and procedures which included: CT scan, negative for any condition; MRI, negative for multiple sclerosis and there was no demyelination for Guillain-Barre; general tests for mononucleosis, negative. The patient went to physician's office and was diagnosed with possible Guillain-Barre syndrome on 30Aug2016 at 10:30 with outcome of not recovered. It was not a certain diagnosis. As treatment she was sent to physical therapy.
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MENB, MENB
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Injection site swelling, Metabolic function test, Mononucleosis heterophile test negative
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her daughter. A 16-year-old female patient received the 1st dose of TRUMENBA, via an unspecified route of administration in left arm, on 09Aug2016 at 09:00 AM, at 0.5 ml single. The patient's medical history was not reported. Concomitant medications were none. The patient previously took MMR, at 1 DF, and experienced rash like measles all over her body when she was 2 or 3 years old. The patient experienced headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of recovered on 20Aug2016, weight loss on 09Aug2016 with outcome of recovered on 29Aug2016, nausea on 09Aug2016 between 16:00 and 16:30 with outcome of recovering, not able to eat on 09Aug2016 at 19:00 with outcome of recovering, migraine headache pain that caused the nausea on 09Aug2016 at 16:00 with outcome of recovering; pain, tingling and weakness on the left side of her body on 09Aug2016 at 16:00 with outcome of not recovered; weakness moved into both of her feet and hands in Aug2016 with outcome of not recovered, headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of not recovered, severe fatigue on 09Aug2016 at 22:00 with outcome of not recovered, fever on 09Aug2016 with outcome of recovered on 10Aug2016, intermittent blurred vision where she saw spots on 09Aug2016 with outcome of unknown, sent home with Doxycycline for a possible tick borne illness on 12Aug2016 with outcome of unknown, felt sick on an unspecified date with outcome of unknown. The patient went to the emergency room on 11Aug2016, she stayed overnight and was not admitted. She was released on 12Aug2016. The patient went to the emergency room again on 14Aug2016. During her emergency room visit on 11Aug2016 the patient underwent lab tests and procedures which included: blood panel (performed to look for infection), negative for any condition. The patient underwent lab tests and procedures on 12Aug2016 which included spinal tap which checked for bacterial and viral meningitis (checked for proteins and white blood cells), negative. She was sent home with Doxycycline (unspecified trade name) for a possible tick borne illness on 12Aug2016. Within 48 hours her doctor permanently discontinued the product because symptoms did not improve. During her emergency room visit on 14Aug2016 the patient underwent lab tests and procedures which included: CT scan, negative for any condition; MRI, negative for multiple sclerosis and there was no demyelination for Guillain-Barre; general tests for mononucleosis, negative. The patient went to physician's office and was diagnosed with possible Guillain-Barre syndrome on 30Aug2016 at 10:30 with outcome of not recovered. It was not a certain diagnosis. As treatment she was sent to physical therapy.
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MENB, MENB
Symptoms: Muscular weakness, Nausea, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her daughter. A 16-year-old female patient received the 1st dose of TRUMENBA, via an unspecified route of administration in left arm, on 09Aug2016 at 09:00 AM, at 0.5 ml single. The patient's medical history was not reported. Concomitant medications were none. The patient previously took MMR, at 1 DF, and experienced rash like measles all over her body when she was 2 or 3 years old. The patient experienced headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of recovered on 20Aug2016, weight loss on 09Aug2016 with outcome of recovered on 29Aug2016, nausea on 09Aug2016 between 16:00 and 16:30 with outcome of recovering, not able to eat on 09Aug2016 at 19:00 with outcome of recovering, migraine headache pain that caused the nausea on 09Aug2016 at 16:00 with outcome of recovering; pain, tingling and weakness on the left side of her body on 09Aug2016 at 16:00 with outcome of not recovered; weakness moved into both of her feet and hands in Aug2016 with outcome of not recovered, headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of not recovered, severe fatigue on 09Aug2016 at 22:00 with outcome of not recovered, fever on 09Aug2016 with outcome of recovered on 10Aug2016, intermittent blurred vision where she saw spots on 09Aug2016 with outcome of unknown, sent home with Doxycycline for a possible tick borne illness on 12Aug2016 with outcome of unknown, felt sick on an unspecified date with outcome of unknown. The patient went to the emergency room on 11Aug2016, she stayed overnight and was not admitted. She was released on 12Aug2016. The patient went to the emergency room again on 14Aug2016. During her emergency room visit on 11Aug2016 the patient underwent lab tests and procedures which included: blood panel (performed to look for infection), negative for any condition. The patient underwent lab tests and procedures on 12Aug2016 which included spinal tap which checked for bacterial and viral meningitis (checked for proteins and white blood cells), negative. She was sent home with Doxycycline (unspecified trade name) for a possible tick borne illness on 12Aug2016. Within 48 hours her doctor permanently discontinued the product because symptoms did not improve. During her emergency room visit on 14Aug2016 the patient underwent lab tests and procedures which included: CT scan, negative for any condition; MRI, negative for multiple sclerosis and there was no demyelination for Guillain-Barre; general tests for mononucleosis, negative. The patient went to physician's office and was diagnosed with possible Guillain-Barre syndrome on 30Aug2016 at 10:30 with outcome of not recovered. It was not a certain diagnosis. As treatment she was sent to physical therapy.
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MENB, MENB
Symptoms: Phonophobia, Photophobia, Platelet count normal, Pyrexia, Reflex test normal
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her daughter. A 16-year-old female patient received the 1st dose of TRUMENBA, via an unspecified route of administration in left arm, on 09Aug2016 at 09:00 AM, at 0.5 ml single. The patient's medical history was not reported. Concomitant medications were none. The patient previously took MMR, at 1 DF, and experienced rash like measles all over her body when she was 2 or 3 years old. The patient experienced headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of recovered on 20Aug2016, weight loss on 09Aug2016 with outcome of recovered on 29Aug2016, nausea on 09Aug2016 between 16:00 and 16:30 with outcome of recovering, not able to eat on 09Aug2016 at 19:00 with outcome of recovering, migraine headache pain that caused the nausea on 09Aug2016 at 16:00 with outcome of recovering; pain, tingling and weakness on the left side of her body on 09Aug2016 at 16:00 with outcome of not recovered; weakness moved into both of her feet and hands in Aug2016 with outcome of not recovered, headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of not recovered, severe fatigue on 09Aug2016 at 22:00 with outcome of not recovered, fever on 09Aug2016 with outcome of recovered on 10Aug2016, intermittent blurred vision where she saw spots on 09Aug2016 with outcome of unknown, sent home with Doxycycline for a possible tick borne illness on 12Aug2016 with outcome of unknown, felt sick on an unspecified date with outcome of unknown. The patient went to the emergency room on 11Aug2016, she stayed overnight and was not admitted. She was released on 12Aug2016. The patient went to the emergency room again on 14Aug2016. During her emergency room visit on 11Aug2016 the patient underwent lab tests and procedures which included: blood panel (performed to look for infection), negative for any condition. The patient underwent lab tests and procedures on 12Aug2016 which included spinal tap which checked for bacterial and viral meningitis (checked for proteins and white blood cells), negative. She was sent home with Doxycycline (unspecified trade name) for a possible tick borne illness on 12Aug2016. Within 48 hours her doctor permanently discontinued the product because symptoms did not improve. During her emergency room visit on 14Aug2016 the patient underwent lab tests and procedures which included: CT scan, negative for any condition; MRI, negative for multiple sclerosis and there was no demyelination for Guillain-Barre; general tests for mononucleosis, negative. The patient went to physician's office and was diagnosed with possible Guillain-Barre syndrome on 30Aug2016 at 10:30 with outcome of not recovered. It was not a certain diagnosis. As treatment she was sent to physical therapy.
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MENB, MENB
Symptoms: Vision blurred, Wheelchair user, White blood cell count normal
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her daughter. A 16-year-old female patient received the 1st dose of TRUMENBA, via an unspecified route of administration in left arm, on 09Aug2016 at 09:00 AM, at 0.5 ml single. The patient's medical history was not reported. Concomitant medications were none. The patient previously took MMR, at 1 DF, and experienced rash like measles all over her body when she was 2 or 3 years old. The patient experienced headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of recovered on 20Aug2016, weight loss on 09Aug2016 with outcome of recovered on 29Aug2016, nausea on 09Aug2016 between 16:00 and 16:30 with outcome of recovering, not able to eat on 09Aug2016 at 19:00 with outcome of recovering, migraine headache pain that caused the nausea on 09Aug2016 at 16:00 with outcome of recovering; pain, tingling and weakness on the left side of her body on 09Aug2016 at 16:00 with outcome of not recovered; weakness moved into both of her feet and hands in Aug2016 with outcome of not recovered, headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of not recovered, severe fatigue on 09Aug2016 at 22:00 with outcome of not recovered, fever on 09Aug2016 with outcome of recovered on 10Aug2016, intermittent blurred vision where she saw spots on 09Aug2016 with outcome of unknown, sent home with Doxycycline for a possible tick borne illness on 12Aug2016 with outcome of unknown, felt sick on an unspecified date with outcome of unknown. The patient went to the emergency room on 11Aug2016, she stayed overnight and was not admitted. She was released on 12Aug2016. The patient went to the emergency room again on 14Aug2016. During her emergency room visit on 11Aug2016 the patient underwent lab tests and procedures which included: blood panel (performed to look for infection), negative for any condition. The patient underwent lab tests and procedures on 12Aug2016 which included spinal tap which checked for bacterial and viral meningitis (checked for proteins and white blood cells), negative. She was sent home with Doxycycline (unspecified trade name) for a possible tick borne illness on 12Aug2016. Within 48 hours her doctor permanently discontinued the product because symptoms did not improve. During her emergency room visit on 14Aug2016 the patient underwent lab tests and procedures which included: CT scan, negative for any condition; MRI, negative for multiple sclerosis and there was no demyelination for Guillain-Barre; general tests for mononucleosis, negative. The patient went to physician's office and was diagnosed with possible Guillain-Barre syndrome on 30Aug2016 at 10:30 with outcome of not recovered. It was not a certain diagnosis. As treatment she was sent to physical therapy.
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MENB, MENB
Symptoms: Blood test normal, Computerised tomogram normal, Fatigue, Feeding disorder, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her daughter. A 16-year-old female patient received the 1st dose of TRUMENBA, via an unspecified route of administration in left arm, on 09Aug2016 at 09:00 AM, at 0.5 ml single. The patient's medical history was not reported. Concomitant medications were none. The patient previously took MMR, at 1 DF, and experienced rash like measles all over her body when she was 2 or 3 years old. The patient experienced headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of recovered on 20Aug2016, weight loss on 09Aug2016 with outcome of recovered on 29Aug2016, nausea on 09Aug2016 between 16:00 and 16:30 with outcome of recovering, not able to eat on 09Aug2016 at 19:00 with outcome of recovering, migraine headache pain that caused the nausea on 09Aug2016 at 16:00 with outcome of recovering; pain, tingling and weakness on the left side of her body on 09Aug2016 at 16:00 with outcome of not recovered; weakness moved into both of her feet and hands in Aug2016 with outcome of not recovered, headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of not recovered, severe fatigue on 09Aug2016 at 22:00 with outcome of not recovered, fever on 09Aug2016 with outcome of recovered on 10Aug2016, intermittent blurred vision where she saw spots on 09Aug2016 with outcome of unknown, sent home with Doxycycline for a possible tick borne illness on 12Aug2016 with outcome of unknown, felt sick on an unspecified date with outcome of unknown. The patient went to the emergency room on 11Aug2016, she stayed overnight and was not admitted. She was released on 12Aug2016. The patient went to the emergency room again on 14Aug2016. During her emergency room visit on 11Aug2016 the patient underwent lab tests and procedures which included: blood panel (performed to look for infection), negative for any condition. The patient underwent lab tests and procedures on 12Aug2016 which included spinal tap which checked for bacterial and viral meningitis (checked for proteins and white blood cells), negative. She was sent home with Doxycycline (unspecified trade name) for a possible tick borne illness on 12Aug2016. Within 48 hours her doctor permanently discontinued the product because symptoms did not improve. During her emergency room visit on 14Aug2016 the patient underwent lab tests and procedures which included: CT scan, negative for any condition; MRI, negative for multiple sclerosis and there was no demyelination for Guillain-Barre; general tests for mononucleosis, negative. The patient went to physician's office and was diagnosed with possible Guillain-Barre syndrome on 30Aug2016 at 10:30 with outcome of not recovered. It was not a certain diagnosis. As treatment she was sent to physical therapy.
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MENB, MENB
Symptoms: Hemiparesis, Lumbar puncture normal, Malaise, Migraine, Mononucleosis heterophile test negative
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her daughter. A 16-year-old female patient received the 1st dose of TRUMENBA, via an unspecified route of administration in left arm, on 09Aug2016 at 09:00 AM, at 0.5 ml single. The patient's medical history was not reported. Concomitant medications were none. The patient previously took MMR, at 1 DF, and experienced rash like measles all over her body when she was 2 or 3 years old. The patient experienced headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of recovered on 20Aug2016, weight loss on 09Aug2016 with outcome of recovered on 29Aug2016, nausea on 09Aug2016 between 16:00 and 16:30 with outcome of recovering, not able to eat on 09Aug2016 at 19:00 with outcome of recovering, migraine headache pain that caused the nausea on 09Aug2016 at 16:00 with outcome of recovering; pain, tingling and weakness on the left side of her body on 09Aug2016 at 16:00 with outcome of not recovered; weakness moved into both of her feet and hands in Aug2016 with outcome of not recovered, headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of not recovered, severe fatigue on 09Aug2016 at 22:00 with outcome of not recovered, fever on 09Aug2016 with outcome of recovered on 10Aug2016, intermittent blurred vision where she saw spots on 09Aug2016 with outcome of unknown, sent home with Doxycycline for a possible tick borne illness on 12Aug2016 with outcome of unknown, felt sick on an unspecified date with outcome of unknown. The patient went to the emergency room on 11Aug2016, she stayed overnight and was not admitted. She was released on 12Aug2016. The patient went to the emergency room again on 14Aug2016. During her emergency room visit on 11Aug2016 the patient underwent lab tests and procedures which included: blood panel (performed to look for infection), negative for any condition. The patient underwent lab tests and procedures on 12Aug2016 which included spinal tap which checked for bacterial and viral meningitis (checked for proteins and white blood cells), negative. She was sent home with Doxycycline (unspecified trade name) for a possible tick borne illness on 12Aug2016. Within 48 hours her doctor permanently discontinued the product because symptoms did not improve. During her emergency room visit on 14Aug2016 the patient underwent lab tests and procedures which included: CT scan, negative for any condition; MRI, negative for multiple sclerosis and there was no demyelination for Guillain-Barre; general tests for mononucleosis, negative. The patient went to physician's office and was diagnosed with possible Guillain-Barre syndrome on 30Aug2016 at 10:30 with outcome of not recovered. It was not a certain diagnosis. As treatment she was sent to physical therapy.
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MENB, MENB
Symptoms: Muscular weakness, Nausea, Nuclear magnetic resonance imaging normal, Pain, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her daughter. A 16-year-old female patient received the 1st dose of TRUMENBA, via an unspecified route of administration in left arm, on 09Aug2016 at 09:00 AM, at 0.5 ml single. The patient's medical history was not reported. Concomitant medications were none. The patient previously took MMR, at 1 DF, and experienced rash like measles all over her body when she was 2 or 3 years old. The patient experienced headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of recovered on 20Aug2016, weight loss on 09Aug2016 with outcome of recovered on 29Aug2016, nausea on 09Aug2016 between 16:00 and 16:30 with outcome of recovering, not able to eat on 09Aug2016 at 19:00 with outcome of recovering, migraine headache pain that caused the nausea on 09Aug2016 at 16:00 with outcome of recovering; pain, tingling and weakness on the left side of her body on 09Aug2016 at 16:00 with outcome of not recovered; weakness moved into both of her feet and hands in Aug2016 with outcome of not recovered, headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of not recovered, severe fatigue on 09Aug2016 at 22:00 with outcome of not recovered, fever on 09Aug2016 with outcome of recovered on 10Aug2016, intermittent blurred vision where she saw spots on 09Aug2016 with outcome of unknown, sent home with Doxycycline for a possible tick borne illness on 12Aug2016 with outcome of unknown, felt sick on an unspecified date with outcome of unknown. The patient went to the emergency room on 11Aug2016, she stayed overnight and was not admitted. She was released on 12Aug2016. The patient went to the emergency room again on 14Aug2016. During her emergency room visit on 11Aug2016 the patient underwent lab tests and procedures which included: blood panel (performed to look for infection), negative for any condition. The patient underwent lab tests and procedures on 12Aug2016 which included spinal tap which checked for bacterial and viral meningitis (checked for proteins and white blood cells), negative. She was sent home with Doxycycline (unspecified trade name) for a possible tick borne illness on 12Aug2016. Within 48 hours her doctor permanently discontinued the product because symptoms did not improve. During her emergency room visit on 14Aug2016 the patient underwent lab tests and procedures which included: CT scan, negative for any condition; MRI, negative for multiple sclerosis and there was no demyelination for Guillain-Barre; general tests for mononucleosis, negative. The patient went to physician's office and was diagnosed with possible Guillain-Barre syndrome on 30Aug2016 at 10:30 with outcome of not recovered. It was not a certain diagnosis. As treatment she was sent to physical therapy.
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MENB, MENB
Symptoms: Pyrexia, Vision blurred, Visual impairment, Weight decreased
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her daughter. A 16-year-old female patient received the 1st dose of TRUMENBA, via an unspecified route of administration in left arm, on 09Aug2016 at 09:00 AM, at 0.5 ml single. The patient's medical history was not reported. Concomitant medications were none. The patient previously took MMR, at 1 DF, and experienced rash like measles all over her body when she was 2 or 3 years old. The patient experienced headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of recovered on 20Aug2016, weight loss on 09Aug2016 with outcome of recovered on 29Aug2016, nausea on 09Aug2016 between 16:00 and 16:30 with outcome of recovering, not able to eat on 09Aug2016 at 19:00 with outcome of recovering, migraine headache pain that caused the nausea on 09Aug2016 at 16:00 with outcome of recovering; pain, tingling and weakness on the left side of her body on 09Aug2016 at 16:00 with outcome of not recovered; weakness moved into both of her feet and hands in Aug2016 with outcome of not recovered, headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of not recovered, severe fatigue on 09Aug2016 at 22:00 with outcome of not recovered, fever on 09Aug2016 with outcome of recovered on 10Aug2016, intermittent blurred vision where she saw spots on 09Aug2016 with outcome of unknown, sent home with Doxycycline for a possible tick borne illness on 12Aug2016 with outcome of unknown, felt sick on an unspecified date with outcome of unknown. The patient went to the emergency room on 11Aug2016, she stayed overnight and was not admitted. She was released on 12Aug2016. The patient went to the emergency room again on 14Aug2016. During her emergency room visit on 11Aug2016 the patient underwent lab tests and procedures which included: blood panel (performed to look for infection), negative for any condition. The patient underwent lab tests and procedures on 12Aug2016 which included spinal tap which checked for bacterial and viral meningitis (checked for proteins and white blood cells), negative. She was sent home with Doxycycline (unspecified trade name) for a possible tick borne illness on 12Aug2016. Within 48 hours her doctor permanently discontinued the product because symptoms did not improve. During her emergency room visit on 14Aug2016 the patient underwent lab tests and procedures which included: CT scan, negative for any condition; MRI, negative for multiple sclerosis and there was no demyelination for Guillain-Barre; general tests for mononucleosis, negative. The patient went to physician's office and was diagnosed with possible Guillain-Barre syndrome on 30Aug2016 at 10:30 with outcome of not recovered. It was not a certain diagnosis. As treatment she was sent to physical therapy.
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MENB, MENB
Symptoms: Blood test, Computerised tomogram, Electroencephalogram, Electromyogram, Lumbar puncture
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her daughter. A 16-year-old female patient received the 1st dose of TRUMENBA, via an unspecified route of administration in left arm, on 09Aug2016 at 09:00 AM, at 0.5 ml single. The patient's medical history was not reported. Concomitant medications were none. The patient previously took MMR, at 1 DF, and experienced rash like measles all over her body when she was 2 or 3 years old. The patient experienced headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of recovered on 20Aug2016, weight loss on 09Aug2016 with outcome of recovered on 29Aug2016, nausea on 09Aug2016 between 16:00 and 16:30 with outcome of recovering, not able to eat on 09Aug2016 at 19:00 with outcome of recovering, migraine headache pain that caused the nausea on 09Aug2016 at 16:00 with outcome of recovering; pain, tingling and weakness on the left side of her body on 09Aug2016 at 16:00 with outcome of not recovered; weakness moved into both of her feet and hands in Aug2016 with outcome of not recovered, headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of not recovered, severe fatigue on 09Aug2016 at 22:00 with outcome of not recovered, fever on 09Aug2016 with outcome of recovered on 10Aug2016, intermittent blurred vision where she saw spots on 09Aug2016 with outcome of unknown, sent home with Doxycycline for a possible tick borne illness on 12Aug2016 with outcome of unknown, felt sick on an unspecified date with outcome of unknown. The patient went to the emergency room on 11Aug2016, she stayed overnight and was not admitted. She was released on 12Aug2016. The patient went to the emergency room again on 14Aug2016. During her emergency room visit on 11Aug2016 the patient underwent lab tests and procedures which included: blood panel (performed to look for infection), negative for any condition. The patient underwent lab tests and procedures on 12Aug2016 which included spinal tap which checked for bacterial and viral meningitis (checked for proteins and white blood cells), negative. She was sent home with Doxycycline (unspecified trade name) for a possible tick borne illness on 12Aug2016. Within 48 hours her doctor permanently discontinued the product because symptoms did not improve. During her emergency room visit on 14Aug2016 the patient underwent lab tests and procedures which included: CT scan, negative for any condition; MRI, negative for multiple sclerosis and there was no demyelination for Guillain-Barre; general tests for mononucleosis, negative. The patient went to physician's office and was diagnosed with possible Guillain-Barre syndrome on 30Aug2016 at 10:30 with outcome of not recovered. It was not a certain diagnosis. As treatment she was sent to physical therapy.
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MENB, MENB
Symptoms: Migraine, Nuclear magnetic resonance imaging, Paraesthesia, Scan with contrast, Vision blurred
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her daughter. A 16-year-old female patient received the 1st dose of TRUMENBA, via an unspecified route of administration in left arm, on 09Aug2016 at 09:00 AM, at 0.5 ml single. The patient's medical history was not reported. Concomitant medications were none. The patient previously took MMR, at 1 DF, and experienced rash like measles all over her body when she was 2 or 3 years old. The patient experienced headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of recovered on 20Aug2016, weight loss on 09Aug2016 with outcome of recovered on 29Aug2016, nausea on 09Aug2016 between 16:00 and 16:30 with outcome of recovering, not able to eat on 09Aug2016 at 19:00 with outcome of recovering, migraine headache pain that caused the nausea on 09Aug2016 at 16:00 with outcome of recovering; pain, tingling and weakness on the left side of her body on 09Aug2016 at 16:00 with outcome of not recovered; weakness moved into both of her feet and hands in Aug2016 with outcome of not recovered, headache worsened and experience a possible spinal leak after a spinal tap on 13Aug2016 at 08:00 with outcome of not recovered, severe fatigue on 09Aug2016 at 22:00 with outcome of not recovered, fever on 09Aug2016 with outcome of recovered on 10Aug2016, intermittent blurred vision where she saw spots on 09Aug2016 with outcome of unknown, sent home with Doxycycline for a possible tick borne illness on 12Aug2016 with outcome of unknown, felt sick on an unspecified date with outcome of unknown. The patient went to the emergency room on 11Aug2016, she stayed overnight and was not admitted. She was released on 12Aug2016. The patient went to the emergency room again on 14Aug2016. During her emergency room visit on 11Aug2016 the patient underwent lab tests and procedures which included: blood panel (performed to look for infection), negative for any condition. The patient underwent lab tests and procedures on 12Aug2016 which included spinal tap which checked for bacterial and viral meningitis (checked for proteins and white blood cells), negative. She was sent home with Doxycycline (unspecified trade name) for a possible tick borne illness on 12Aug2016. Within 48 hours her doctor permanently discontinued the product because symptoms did not improve. During her emergency room visit on 14Aug2016 the patient underwent lab tests and procedures which included: CT scan, negative for any condition; MRI, negative for multiple sclerosis and there was no demyelination for Guillain-Barre; general tests for mononucleosis, negative. The patient went to physician's office and was diagnosed with possible Guillain-Barre syndrome on 30Aug2016 at 10:30 with outcome of not recovered. It was not a certain diagnosis. As treatment she was sent to physical therapy.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Injection site swelling, Nausea
Clinical narrative: Initial unsolicited report received from a pharmacist on 02-Sep-2016. This case involves a 66-year-old female patient, who was vaccinated FLUZONE HD via intramuscular route (batch number: UI644AA, expiry date: 17-Mar-2017) (dose and dose in series not reported) in left deltoid on 31-Aug-2016. Patient's illness at time of vaccination was reported as no. It was also reported that pre-existing physician diagnosed allergies, birth defects, medical conditions are not reported. Concomitant medications were not reported. On 31-Aug-2016, on the same day following the vaccination, the patient experienced pain, redness and swelling at injection site. Lab test was reported as none. Patient received cold pack and Tylenol as corrective treatment. On an unknown date patient recovered from all the events. Documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial unsolicited report received from a pharmacist on 02-Sep-2016. This case involves a 66-year-old female patient, who was vaccinated FLUZONE HD via intramuscular route (batch number: UI644AA, expiry date: 17-Mar-2017) (dose and dose in series not reported) in left deltoid on 31-Aug-2016. Patient's illness at time of vaccination was reported as no. It was also reported that pre-existing physician diagnosed allergies, birth defects, medical conditions are not reported. Concomitant medications were not reported. On 31-Aug-2016, on the same day following the vaccination, the patient experienced pain, redness and swelling at injection site. Lab test was reported as none. Patient received cold pack and Tylenol as corrective treatment. On an unknown date patient recovered from all the events. Documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: SWELLING FROM WRIST TO SHOULDER WITH RED "STREAKS".
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: SWELLING FROM WRIST TO SHOULDER WITH RED "STREAKS".
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient received injection at office, left office feeling no adverse effects. Patient reports roughly 1-2 hrs later swelling and red at injection site. Self treated with BENADRYL.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient received injection at office, left office feeling no adverse effects. Patient reports roughly 1-2 hrs later swelling and red at injection site. Self treated with BENADRYL.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Swelling and itching on right upper arm same side as vaccine given.
Age: 0.25
Sex: M
Vaccine: DTPPHIB, PNC13, RV5
Symptoms: Faeces discoloured, Urine output decreased
Clinical narrative: Mother describes 8 to 9 liquid yellow green stringy stools daily starting 2 days after administration of ROTATEQ, PENTACEL, and PREVNAR, afeb, decreased urination, comfort nursing.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itchiness, & painful at injection site.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (Administrator) refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medications were not reported. On 16-AUG-2016 at 04:03 pm, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX injection, Lot#L0435128 (expiry date: 14-SEP-2017) (dosage not reported). The (Oka/Merck) VARIVAX was exposed the current excursion of a maximum of 10.3F for 3 hours and 45 minutes and a minimum of 7.3F for 33 minutes. The (Oka/Merck) VARIVAX was also exposed to three previous excursions described as: "The first excursion was on 22-JUN-2016 for 7 hours exposed to a maximum 26.63F, the second excursion exposed to a maximum of 24F for 64 hours and a third excursion ranging over a 6 day period of temperatures ranging from minimum 7.6F to  maximum 12.4F for a total of 3 hours and 5 minutes." No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 54 year old male patient with no pertinent medical history, drug reactions or allergies. On 05-SEP-2016, the patient was intramuscularly vaccinated with PNEUMOVAX 23 (dose was not reported, lot# M024673, expiry date on 17-NOV-2017). The patient was taking multiple unspecified concomitant medications. On 06-SEP-2016, the patient experienced pain at the injection site and he could not sleep at night. The patient also could not move the arm because of the pain. The patient did not have any laboratory test performed. The patient sought medical attention via calling pharmacy. The outcome of the events was reported as not recovered. Causality assessment was not provided. The reporter considered the events of pain at injection site, could not move the arm and could not sleep at night to be disabling. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: FLU4
Symptoms: Contusion, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Pain in (R) arm. Red; swollen. Arm bruised. Asked patient to visit her MD.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On an unknown date the patient was vaccinated with improperly stored VARIVAX (lot # K021936, expiration date 10-NOV-2016, dose and route unknown). No adverse symptoms were reported. Additional information has been requested.
Age: 1.58
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office worker refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories and concomitant therapies were not reported. On unknown dates, the patients received three doses of improperly stored RECOMBIVAX HB (lot # M010671, expiration date: 02-JUN-2017) (dose and route of administration were not provided). No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates in 2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L016427 and expiration date 13-APR-2017; exact doses and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 34.4 Fahrenheit degrees (F) for 10 minutes on 11-MAR-2016, 35.6 F for 10 minutes on 03-AUG-2016, 35.6 F for 10 minutes on 20-AUG-2016, 35.6 F for 10 minutes on 23-AUG-2016 and 35.6 F for 10 minutes on 26-AUG-2016 before administration to the patients. No previous temperature excursion was reported. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist via a company representative referring got a 55 years old female patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 PFU (dose, lot #, expiration date and route not reported). On an unknown date, the patient experienced tenderness and swelling at the injection site after administration of ZOSTAVAX. The patient sought medical attention. It was unknown if treatment was given for the events. The outcome of the events was unknown. The causality between ZOSTAVAX and the events was not provided. This is one of two reports received from the same reporter. Additional information is not expected as no consent to contact the physician.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist via a company representative referring got a 60 years old female patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 PFU (dose, lot #, expiration date and route not reported). On an unknown date, the patient experienced tenderness and swelling at the injection site after administration of ZOSTAVAX. The patient sought medical attention. It was unknown if treatment was given for the events. The outcome of the events was unknown. The causality between ZOSTAVAX and the events was not provided. This is one of two reports received from the same reporter. Additional information is not expected as no consent to contact the physician.
Age: 0.6
Sex: F
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a consumer referring to her daughter, a 7 month old female patient. The patient was in stage 4 kidney failure. The patient's medical history and concomitant therapy were not reported. On 26-AUG-2016 at about 11 am (reported as "today"), the patient was vaccinated with GARDASIL (dose, lot # and expiration date not reported) intramuscularly instead of RECOMBIVAX HB. The nurse inadvertently administered the wrong vaccine. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates in 2016, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L027076 and expiration date 25-MAY-2017, lot # M019706 and expiration date 24-OCT-2017, orally; exact doses were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 34.4 Fahrenheit degrees (F) for 10 minutes on 11-MAR-2016, 35.6 F for 10 minutes on 03-AUG-2016, 35.6 F for 10 minutes on 20-AUG-2016, 35.6 F for 10 minutes on 23-AUG-2016 and 35.6 F for 10 minutes on 26-AUG-2016 before administration to the patients. No previous temperature excursion was reported. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.