chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Facial pain, Feeling abnormal, Hypoaesthesia, Mobility decreased
Clinical narrative: Patient first came back to pharmacy counter and said he didn't feel good, looked like he lost color in his face so had him sit down immediately. Then said he had a ringing in his right ear. Then said he couldn't move his fingers, looked stiff, then said the ringing is going away, but his feet are going numb. Can't move his feet, then said his face hurt, but feet were getting better. Then started to breathe heavier, which is when EMT arrived.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pallor, Tinnitus
Clinical narrative: Patient first came back to pharmacy counter and said he didn't feel good, looked like he lost color in his face so had him sit down immediately. Then said he had a ringing in his right ear. Then said he couldn't move his fingers, looked stiff, then said the ringing is going away, but his feet are going numb. Can't move his feet, then said his face hurt, but feet were getting better. Then started to breathe heavier, which is when EMT arrived.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Computerised tomogram normal, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Two to 3 days (12/20-12/21) after her immunization, she started experiencing an achy pain in her arm. It spread from her upper arm to elbow to wrist. There was redness and some warmth in the arm, but no hardness. On 12/26, her arm got worse and she went to see her PCP. He denied infection and suspected a blood clot. She had a CT scan done which concluded it was not a blood clot. No other workup was done regarding the issue. Her symptoms later improved even though her hand was still swollen.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Abdominal pain upper, Chest X-ray normal, Cough, Decreased interest
Clinical narrative: 1 month after my daughter 2nd HPV vaccine she began having symptoms she has never had before. Symptoms are sore throat, nose hurting, headache, extreme fatigue, then body aches, eyes hurting, dizziness, coughing, hot and cold, nausea, stomach pain, abdominal cramps, bad dreams, hurts to close her eyes, body shakes, fever, spinning, blurry vision, visual disturbances, insomnia, depression, loss of interest.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Depression, Dizziness, Eye pain, Fatigue, Feeling of body temperature change
Clinical narrative: 1 month after my daughter 2nd HPV vaccine she began having symptoms she has never had before. Symptoms are sore throat, nose hurting, headache, extreme fatigue, then body aches, eyes hurting, dizziness, coughing, hot and cold, nausea, stomach pain, abdominal cramps, bad dreams, hurts to close her eyes, body shakes, fever, spinning, blurry vision, visual disturbances, insomnia, depression, loss of interest.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Influenza virus test negative, Insomnia, Laboratory test normal, Nausea
Clinical narrative: 1 month after my daughter 2nd HPV vaccine she began having symptoms she has never had before. Symptoms are sore throat, nose hurting, headache, extreme fatigue, then body aches, eyes hurting, dizziness, coughing, hot and cold, nausea, stomach pain, abdominal cramps, bad dreams, hurts to close her eyes, body shakes, fever, spinning, blurry vision, visual disturbances, insomnia, depression, loss of interest.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Nightmare, Oropharyngeal pain, Pain, Pyrexia, Rhinalgia
Clinical narrative: 1 month after my daughter 2nd HPV vaccine she began having symptoms she has never had before. Symptoms are sore throat, nose hurting, headache, extreme fatigue, then body aches, eyes hurting, dizziness, coughing, hot and cold, nausea, stomach pain, abdominal cramps, bad dreams, hurts to close her eyes, body shakes, fever, spinning, blurry vision, visual disturbances, insomnia, depression, loss of interest.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Streptococcus test negative, Tremor, Vertigo, Vision blurred, Visual impairment
Clinical narrative: 1 month after my daughter 2nd HPV vaccine she began having symptoms she has never had before. Symptoms are sore throat, nose hurting, headache, extreme fatigue, then body aches, eyes hurting, dizziness, coughing, hot and cold, nausea, stomach pain, abdominal cramps, bad dreams, hurts to close her eyes, body shakes, fever, spinning, blurry vision, visual disturbances, insomnia, depression, loss of interest.
Age: 0.17
Sex: F
Vaccine: DTAP, RV1
Symptoms: Blood thyroid stimulating hormone normal, Full blood count normal, Hepatic enzyme increased, Karyotype analysis normal, Prealbumin
Clinical narrative: Very slow weight gain in infant over the next 5 months. Infant gained 2 lbs 5 oz over the course of 5 months after vaccination: +1 mo: +13 oz, +2 mo: +2 oz, +3 mo: +3 oz, +4 mo: +8 oz, +5 mo: +11 oz.
Age: 0.17
Sex: F
Vaccine: DTAP, RV1
Symptoms: Weight gain poor
Clinical narrative: Very slow weight gain in infant over the next 5 months. Infant gained 2 lbs 5 oz over the course of 5 months after vaccination: +1 mo: +13 oz, +2 mo: +2 oz, +3 mo: +3 oz, +4 mo: +8 oz, +5 mo: +11 oz.
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. The reporter considered the vaccination failure and influenza to be unrelated to Influenza vaccine Quadrivalent. Additional details were provided as follows: This case was reported by a receptionist from physician's office. The age at vaccination was not reported. The receptionist advised that, the patient got the flu even though she had received the flu vaccine, inferring the flu vaccine (brand unknown) the patient received was ineffective. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule and lab test confirmation for targeted disease was unknown. No other details were available at the time of call. The sales representative did not know the reporter's contact information. This case is 2 of the 3 cases reported by the same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. The reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: This case was reported by a receptionist from physician's office. The age at vaccination was not reported. The receptionist advised that, her granddaughter also got the flu even though she had received the flu vaccine, inferring the flu vaccine (brand unknown) the patient received was ineffective. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule and lab test confirmation for targeted disease was unknown. No other details were available at the time of call. The sales representative did not know the reporter's contact information. This case is 1 of the 3 cases reported by the same reporter.
Age: 38.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Asthenia, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right upper arm redness, swelling, warmth, pain, Feeling of weakness.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Leg swelled and turned red.
Age: 7.0
Sex: M
Vaccine: FLU4, HEP
Symptoms: Syncope
Clinical narrative: Patient had brief episode of fainting.
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus generalised, Rash macular
Clinical narrative: Itching all over. Red blotches.
Age: 0.5
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Rhinorrhoea
Clinical narrative: Running nose , breathing difficulty, cough.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Chapped lips, Eczema, Fatigue, Injection site pain, Lip erythema
Clinical narrative: Injection site soreness and pain shooting down the injected arm, starting the day of injection and continuing for 3-4 weeks following the injection. The day following the injection I started breaking out with an itchy eczema type rash around my lips that progressed to the point that my lips were red, swollen and cracking at the corners. The rash worsened over the first week after the injection then slowly improved. It was a full 4 weeks before the rash began to heal and stop hurting badly. I also had the usual fatigue and body ache so that come with getting the vaccine but the lasted 2-3 weeks, which is longer than usual for me.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Pain, Pain in extremity, Rash, Rash pruritic
Clinical narrative: Injection site soreness and pain shooting down the injected arm, starting the day of injection and continuing for 3-4 weeks following the injection. The day following the injection I started breaking out with an itchy eczema type rash around my lips that progressed to the point that my lips were red, swollen and cracking at the corners. The rash worsened over the first week after the injection then slowly improved. It was a full 4 weeks before the rash began to heal and stop hurting badly. I also had the usual fatigue and body ache so that come with getting the vaccine but the lasted 2-3 weeks, which is longer than usual for me.
Age: 64.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Cardiac stress test, Chest X-ray, Chest discomfort, Dizziness, Dry mouth
Clinical narrative: Fast heart beat, chest discomfort, dizziness, dry mouth, headache and neck ache and feeling of fainting. I went to the Emergency room on 12/28/17 and was admitted for 3 days.
Age: 64.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Echocardiogram, Electrocardiogram, Headache, Heart rate increased, Laboratory test
Clinical narrative: Fast heart beat, chest discomfort, dizziness, dry mouth, headache and neck ache and feeling of fainting. I went to the Emergency room on 12/28/17 and was admitted for 3 days.
Age: 64.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Neck pain, Ventilation/perfusion scan
Clinical narrative: Fast heart beat, chest discomfort, dizziness, dry mouth, headache and neck ache and feeling of fainting. I went to the Emergency room on 12/28/17 and was admitted for 3 days.
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: Crying, Decreased appetite, Pyrexia
Clinical narrative: Fever 102.5, body temp drop before fever to 97. Excessive crying 2+ hours after vaccines. Fever with acetaminophen 99. Decreased appetite.
Age: 0.58
Sex: M
Vaccine: FLU4
Symptoms: Abnormal behaviour, Blood test, Computerised tomogram, Fear, Muscle spasms
Clinical narrative: Two days after the immunization my son started having episodes where it looked like he was being electrically shocked. He starts to spaz out and stare into his hands making weird face gestures. As well he has become more frantic and afraid of things he used to like.
Age: 0.58
Sex: M
Vaccine: FLU4
Symptoms: Staring, Tremor
Clinical narrative: Two days after the immunization my son started having episodes where it looked like he was being electrically shocked. He starts to spaz out and stare into his hands making weird face gestures. As well he has become more frantic and afraid of things he used to like.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, TDAP, VARCEL
Symptoms: Immunisation, Wrong drug administered
Clinical narrative: A dose of Tdap was given in error to a 5 year old for his 3rd DTaP dose by mistake. The error was noted while the patient and his mother were still in the clinic. Mother was informed that this dose was given in error and would not count for school shots. She agreed to have him receive his 3rd dose of DTaP immediately in his other thigh and it was explained that this may cause more soreness. Comfort measure were taught and all VIS forms were provided to this parent.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash macular
Clinical narrative: Patient called to describe a red splotchy rash on left arm. She stated it had grown since yesterday but was not sure if it was warm to the touch.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Abdominal pain, Arthralgia, Hypoaesthesia, Joint stiffness, Pain in extremity
Clinical narrative: Mother of pt reports numbness/tingling on both feet, jaw stiffness, left abdominal pain, and knees/legs pain. Symptoms started 1-2 days after receiving the shots. Pt had previously received Meningococcal MCV4 on 25 Jan 2017 at another location.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Paraesthesia
Clinical narrative: Mother of pt reports numbness/tingling on both feet, jaw stiffness, left abdominal pain, and knees/legs pain. Symptoms started 1-2 days after receiving the shots. Pt had previously received Meningococcal MCV4 on 25 Jan 2017 at another location.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Discomfort, Erythema, Loss of personal independence in daily activities, Pain, Swelling
Clinical narrative: 2 hours post influenza vaccine, redness and swelling, much discomfort - missing school today d/t the pain.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Encephalopathy
Clinical narrative: Vaccine recipient called stating that she was hospitalized 01/22--01/24/2018, diagnosed with encephalopathy.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: Pain in Left shoulder.
Age: 57.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Hyperaesthesia, Pain, Pain in extremity
Clinical narrative: I had the first of two injections yesterday. Overnight I developed a bad headache and all of my skin is ultra sensitive, and my arm is very sore. (to be expected). I got the injection at pharmacy, not by my physician. I don't know that I need anything addressed medically, but I just ache all over. I had shingles 2 years ago, and I will go thru this again to prevent it. It is a lot better than shingles.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Headache, Injection site swelling, Injection site warmth
Clinical narrative: Large 5in diameter round, raised, hot, swollen area at injection site. Headache and felt dizzy. He was given steroids, BENADRYL and MOTRIN by urgent care clinic around 36 hours after injection given.
Age: 55.0
Sex: M
Vaccine: FLU4, FLU4, UNK
Symptoms: Angiotensin converting enzyme, Antibody test negative, Asthenia, Balance disorder, CSF test normal
Clinical narrative: 12/7/2017 received immunization. 12/10/2017 noted right arm immunization site extremely sore and developed severe headache, nausea, vomiting, stiff neck, pain radiating down into right shoulder and arm especially with head movement. 12/13/2017 developed diplopia with worsening of all symptoms. Around 12/23 experiencing global weakness, mental status changes, confusion, difficulties of concentration, speech and balance. Completely incapacitated by 12/25 when he presented to the emergency department. CT of brain completed with evidence of acute right cortical vein thrombosis. Transferred emergently to another Hospital. He underwent intensive workup confirming right posterior, parietal and frontal cortical vein thrombosis with associated subarachnoid and subdural inflammation with effusions. Left complete sixth cranial nerve palsy. Evidence of right cervical neuralgia. Hospitalized 12/25-12/31/2017. Symptoms slowly improving except for a sixth nerve palsy which is unchanged.
Age: 55.0
Sex: M
Vaccine: FLU4, FLU4, UNK
Symptoms: Cerebral venous thrombosis, Cervical radiculopathy, Coagulation test, Computerised tomogram head abnormal, Confusional state
Clinical narrative: 12/7/2017 received immunization. 12/10/2017 noted right arm immunization site extremely sore and developed severe headache, nausea, vomiting, stiff neck, pain radiating down into right shoulder and arm especially with head movement. 12/13/2017 developed diplopia with worsening of all symptoms. Around 12/23 experiencing global weakness, mental status changes, confusion, difficulties of concentration, speech and balance. Completely incapacitated by 12/25 when he presented to the emergency department. CT of brain completed with evidence of acute right cortical vein thrombosis. Transferred emergently to another Hospital. He underwent intensive workup confirming right posterior, parietal and frontal cortical vein thrombosis with associated subarachnoid and subdural inflammation with effusions. Left complete sixth cranial nerve palsy. Evidence of right cervical neuralgia. Hospitalized 12/25-12/31/2017. Symptoms slowly improving except for a sixth nerve palsy which is unchanged.
Age: 55.0
Sex: M
Vaccine: FLU4, FLU4, UNK
Symptoms: Culture negative, Diplopia, Disturbance in attention, Haematology test normal, Headache
Clinical narrative: 12/7/2017 received immunization. 12/10/2017 noted right arm immunization site extremely sore and developed severe headache, nausea, vomiting, stiff neck, pain radiating down into right shoulder and arm especially with head movement. 12/13/2017 developed diplopia with worsening of all symptoms. Around 12/23 experiencing global weakness, mental status changes, confusion, difficulties of concentration, speech and balance. Completely incapacitated by 12/25 when he presented to the emergency department. CT of brain completed with evidence of acute right cortical vein thrombosis. Transferred emergently to another Hospital. He underwent intensive workup confirming right posterior, parietal and frontal cortical vein thrombosis with associated subarachnoid and subdural inflammation with effusions. Left complete sixth cranial nerve palsy. Evidence of right cervical neuralgia. Hospitalized 12/25-12/31/2017. Symptoms slowly improving except for a sixth nerve palsy which is unchanged.
Age: 55.0
Sex: M
Vaccine: FLU4, FLU4, UNK
Symptoms: Injection site pain, Loss of personal independence in daily activities, Lumbar puncture, Mental status changes, Musculoskeletal stiffness
Clinical narrative: 12/7/2017 received immunization. 12/10/2017 noted right arm immunization site extremely sore and developed severe headache, nausea, vomiting, stiff neck, pain radiating down into right shoulder and arm especially with head movement. 12/13/2017 developed diplopia with worsening of all symptoms. Around 12/23 experiencing global weakness, mental status changes, confusion, difficulties of concentration, speech and balance. Completely incapacitated by 12/25 when he presented to the emergency department. CT of brain completed with evidence of acute right cortical vein thrombosis. Transferred emergently to another Hospital. He underwent intensive workup confirming right posterior, parietal and frontal cortical vein thrombosis with associated subarachnoid and subdural inflammation with effusions. Left complete sixth cranial nerve palsy. Evidence of right cervical neuralgia. Hospitalized 12/25-12/31/2017. Symptoms slowly improving except for a sixth nerve palsy which is unchanged.
Age: 55.0
Sex: M
Vaccine: FLU4, FLU4, UNK
Symptoms: Nausea, Noninfective encephalitis, Nuclear magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: 12/7/2017 received immunization. 12/10/2017 noted right arm immunization site extremely sore and developed severe headache, nausea, vomiting, stiff neck, pain radiating down into right shoulder and arm especially with head movement. 12/13/2017 developed diplopia with worsening of all symptoms. Around 12/23 experiencing global weakness, mental status changes, confusion, difficulties of concentration, speech and balance. Completely incapacitated by 12/25 when he presented to the emergency department. CT of brain completed with evidence of acute right cortical vein thrombosis. Transferred emergently to another Hospital. He underwent intensive workup confirming right posterior, parietal and frontal cortical vein thrombosis with associated subarachnoid and subdural inflammation with effusions. Left complete sixth cranial nerve palsy. Evidence of right cervical neuralgia. Hospitalized 12/25-12/31/2017. Symptoms slowly improving except for a sixth nerve palsy which is unchanged.
Age: 55.0
Sex: M
Vaccine: FLU4, FLU4, UNK
Symptoms: Polymerase chain reaction, Scan with contrast, Serology negative, Speech disorder, Subdural effusion
Clinical narrative: 12/7/2017 received immunization. 12/10/2017 noted right arm immunization site extremely sore and developed severe headache, nausea, vomiting, stiff neck, pain radiating down into right shoulder and arm especially with head movement. 12/13/2017 developed diplopia with worsening of all symptoms. Around 12/23 experiencing global weakness, mental status changes, confusion, difficulties of concentration, speech and balance. Completely incapacitated by 12/25 when he presented to the emergency department. CT of brain completed with evidence of acute right cortical vein thrombosis. Transferred emergently to another Hospital. He underwent intensive workup confirming right posterior, parietal and frontal cortical vein thrombosis with associated subarachnoid and subdural inflammation with effusions. Left complete sixth cranial nerve palsy. Evidence of right cervical neuralgia. Hospitalized 12/25-12/31/2017. Symptoms slowly improving except for a sixth nerve palsy which is unchanged.
Age: 55.0
Sex: M
Vaccine: FLU4, FLU4, UNK
Symptoms: VIth nerve paralysis, Venogram, Vomiting
Clinical narrative: 12/7/2017 received immunization. 12/10/2017 noted right arm immunization site extremely sore and developed severe headache, nausea, vomiting, stiff neck, pain radiating down into right shoulder and arm especially with head movement. 12/13/2017 developed diplopia with worsening of all symptoms. Around 12/23 experiencing global weakness, mental status changes, confusion, difficulties of concentration, speech and balance. Completely incapacitated by 12/25 when he presented to the emergency department. CT of brain completed with evidence of acute right cortical vein thrombosis. Transferred emergently to another Hospital. He underwent intensive workup confirming right posterior, parietal and frontal cortical vein thrombosis with associated subarachnoid and subdural inflammation with effusions. Left complete sixth cranial nerve palsy. Evidence of right cervical neuralgia. Hospitalized 12/25-12/31/2017. Symptoms slowly improving except for a sixth nerve palsy which is unchanged.
Age: 55.0
Sex: M
Vaccine: FLU4, FLU4, UNK
Symptoms: Allergy to vaccine, Asthenia, Cerebral venous thrombosis, Confusional state, Headache
Clinical narrative: 12/7/2017 received immunization. 12/10/2017 noted right arm immunization site extremely sore and developed severe headache, nausea, vomiting, stiff neck, pain radiating down into right shoulder and arm especially with head movement. 12/13/2017 developed diplopia with worsening of all symptoms. Around 12/23 experiencing global weakness, mental status changes, confusion, difficulties of concentration, speech and balance. Completely incapacitated by 12/25 when he presented to the emergency department. CT of brain completed with evidence of acute right cortical vein thrombosis. Transferred emergently to another Hospital. He underwent intensive workup confirming right posterior, parietal and frontal cortical vein thrombosis with associated subarachnoid and subdural inflammation with effusions. Left complete sixth cranial nerve palsy. Evidence of right cervical neuralgia. Hospitalized 12/25-12/31/2017. Symptoms slowly improving except for a sixth nerve palsy which is unchanged.
Age: 55.0
Sex: M
Vaccine: FLU4, FLU4, UNK
Symptoms: Nausea, Paralysis, VIth nerve paralysis, Vomiting
Clinical narrative: 12/7/2017 received immunization. 12/10/2017 noted right arm immunization site extremely sore and developed severe headache, nausea, vomiting, stiff neck, pain radiating down into right shoulder and arm especially with head movement. 12/13/2017 developed diplopia with worsening of all symptoms. Around 12/23 experiencing global weakness, mental status changes, confusion, difficulties of concentration, speech and balance. Completely incapacitated by 12/25 when he presented to the emergency department. CT of brain completed with evidence of acute right cortical vein thrombosis. Transferred emergently to another Hospital. He underwent intensive workup confirming right posterior, parietal and frontal cortical vein thrombosis with associated subarachnoid and subdural inflammation with effusions. Left complete sixth cranial nerve palsy. Evidence of right cervical neuralgia. Hospitalized 12/25-12/31/2017. Symptoms slowly improving except for a sixth nerve palsy which is unchanged.
Age: 55.0
Sex: M
Vaccine: FLU4, FLU4, UNK
Symptoms: Unevaluable event
Clinical narrative: 12/7/2017 received immunization. 12/10/2017 noted right arm immunization site extremely sore and developed severe headache, nausea, vomiting, stiff neck, pain radiating down into right shoulder and arm especially with head movement. 12/13/2017 developed diplopia with worsening of all symptoms. Around 12/23 experiencing global weakness, mental status changes, confusion, difficulties of concentration, speech and balance. Completely incapacitated by 12/25 when he presented to the emergency department. CT of brain completed with evidence of acute right cortical vein thrombosis. Transferred emergently to another Hospital. He underwent intensive workup confirming right posterior, parietal and frontal cortical vein thrombosis with associated subarachnoid and subdural inflammation with effusions. Left complete sixth cranial nerve palsy. Evidence of right cervical neuralgia. Hospitalized 12/25-12/31/2017. Symptoms slowly improving except for a sixth nerve palsy which is unchanged.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Middle insomnia, Pruritus, Pyrexia, Skin warm
Clinical narrative: Mom calls, reports patient have vaccine administered in left arm around 6 pm and at 1 am patient woke her up because the "itching was unbearable" and she had hives all over back / both arms / both shoulders, left arm was warmer than the rest of her body, fever of 100.7, and fatigue. Mom gave 50 mg BENADRYL, a dose of TYLENOL, and a cool cloth to her back - patient then went to sleep. Patient woke up at 8 am and another dose of 25 mg of BENADRYL was given - patient's hives had decreased, no longer had a fever, arm no longer warm, but still had fatigue. At last contact, patient was sleeping. Never had any airway problems or swelling. Mom advised to monitor patient at home and no need to be seen in the clinic.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Mom calls, reports patient have vaccine administered in left arm around 6 pm and at 1 am patient woke her up because the "itching was unbearable" and she had hives all over back / both arms / both shoulders, left arm was warmer than the rest of her body, fever of 100.7, and fatigue. Mom gave 50 mg BENADRYL, a dose of TYLENOL, and a cool cloth to her back - patient then went to sleep. Patient woke up at 8 am and another dose of 25 mg of BENADRYL was given - patient's hives had decreased, no longer had a fever, arm no longer warm, but still had fatigue. At last contact, patient was sleeping. Never had any airway problems or swelling. Mom advised to monitor patient at home and no need to be seen in the clinic.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Nuclear magnetic resonance imaging abnormal, Tendon disorder
Clinical narrative: Severe left shoulder pain after flu shot and it has been lasting for more than two months.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: Patient was given immunization SHINGRIX by SQ instead of IM.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Pt. states that she became significantly dizzy and has remained dizzy since. Pt. states arm also felt "weird".
Age: 9.0
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: Redness and warm to touch about the size of 50 cent piece.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Confusional state, Immediate post-injection reaction, Pyrexia
Clinical narrative: Immediate reaction (a couple hours) of fever, chills, confusion. Pt could not find door knob. Progressed to pt being admitted to ER (1-25-18).
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Painful, itchy rash on right deltoid in region mom reports both vaccines were given. Rash covered entire shoulder and half of upper arm. It was treated in our ED on 1/30 and resolved when I saw her 2/1. Successfully treated with BENADRYL.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Vaccination complication
Clinical narrative: Painful, itchy rash on right deltoid in region mom reports both vaccines were given. Rash covered entire shoulder and half of upper arm. It was treated in our ED on 1/30 and resolved when I saw her 2/1. Successfully treated with BENADRYL.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt called to ask why her arm hurt so badly. She is not able to lift her arm. Advised to continue ALEVE (which she started when it began hurting) if not improved by Monday to visit to PCP f/u 1/22/18. Pt states better but not completely gone.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site papule, Injection site reaction, Rash macular
Clinical narrative: Pt. rec'd 12 mo immunizations 01/22/18 at WCE o.v. mom reported on 01/31/18 that s/s began 01/29/18. Seen for check 02/01/18. S/s= (Rt) arm with positive erythema 3.5 cm x 1.8 cm; splotchy redness with firm 0.4 cm papule; afebrile. Monitor for tiredness fever tenderness = Re-check PRN.
Age: 1.42
Sex: M
Vaccine: PNC13
Symptoms: Decreased appetite, Initial insomnia, Irritability, Screaming
Clinical narrative: Extreme difficulty falling asleep, screaming for hours on end, complete drop in appetite and thirst for a total of 8 days and then fully recovered. Exam on day 7 was normal except irritability.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient states her arm is still sore and she doesn't have full range of motion.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Started running fevers of 101-103 the day after his shots. Enc. fluids and alt. Tyl./MOTRIN. Sunday early AM broke out in rash that spread. Took to Urgent Care. Treated with Prednisolone, Diphenhydramine and Hydrocortisone 1% lotion.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient complaining of severe pain at injection site, complaining that she is unable to move her arm,  no redness, warmth, or swelling at the site, no sign of infection. Patient advised to use hot compresses, take acetaminophen 1000 mg QID, advised to also take take ibuprofen 600 mg QID or 800 mg TID with food. Patient encouraged to follow-up if symptoms persist or worsen.
Age: 61.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Pain, Sleep disorder
Clinical narrative: Throbbing, aching pain in right upper arm. Comes and goes. Wakes me up at night. Pain worsening lately.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Development of vesicular rash 13 days after varicella vaccine.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Pt. was given HPV and MCV injections. Pt. then needed to lay back and when she laid back pt passed out. After a few seconds pt. came back and had water and juice. Pt. observed for 15 min. Pt was rechecked and then pt. was released to go home with parent. Pts mother instructed to with further concerns or questions.
Age: 68.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Patient came into pharmacy to received PPSV23 (PNEUMOVAX 23), but was administered PCV13 (PREVNAR 13) inadvertently. Patient had already received  PCV13 on 7/13/2016.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient Noticed redness, swelling and pain on 1/31/18 at the injection site. She said that all those reactions were worse as of 2/1/18. Patient took a picture of her reaction on Thursday 2/1/18 and said she would watch to see if it went down but if it did not she would see a doctor about it. She was worried about cellulitis.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Dysphemia
Clinical narrative: Stuttering, Childhood onset fluency disorder.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Inflammation, Mobility decreased, Pain in extremity, Swelling
Clinical narrative: Very large red, inflamed bump an inch or two below injection site. Then pain in the arm and less mobility ever since. (per patient)
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Electroencephalogram, Nuclear magnetic resonance imaging, Speech disorder
Clinical narrative: About the middle of November, I noticed patient having problems speaking fluent sentences. I didn't think much of it. By Christmas, he was really struggling with conversation. I would ask specific questions to try to assist him with finding his words. I requested that he make an appointment with our family. When he did not, I did. We saw Dr. He noticed the decline in patient's speech and ordered an MRI. We then received a call to see a neurologist. We met with Dr. We had a lengthy visit. He ordered an EEG and put patient on a week of steroids thinking that if this was a reaction to the flu shot, which never even crossed our minds, the steroids my slow or stop the deterioration of this reaction on his speech. We saw him again yesterday and Dr. was amazed by the improvement to patient's speech. Dr's best hope was for an overall 25% improvement. We are guestimating that this treatment has helped somewhere around 25% - 35%.  He ordered another month's worth of steroids and we will see him again in about 30 days.  The ultimate hopeful outcome is that patient will recover near 80% of the speech ability he demonstrated prior to this event.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Discomfort, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pain in left arm started the night of vaccination. Pain started radiating into the chest. Patient tried icing and used ADVIL but pain still persists. Pain is better than Monday night, but is still uncomfortable sore with limited range of motion. No tingling reported.
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The patient caught the flu after she had an unknown manufacturer's flu shot in 2017-2018 season. The patient had denied permission to contact their physician. This case was considered as suspected vaccination failure as details regarding the lab test confirmation for targeted disease and exact time to onset of event were unknown.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Somnolence
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received SHINGRIX (batch number FJ578 ?, expiry date 30th January 2020). Concomitant products included folic acid, meloxicam and methotrexate. On 16th January 2018, the patient received SHINGRIX. In January 2018, 12 hours after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, injection site warmth, general body pain and sleepiness. In January 2018, the outcome of the injection site erythema, injection site swelling, injection site warmth, general body pain and sleepiness were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, general body pain and sleepiness to be related to SHINGRIX. Additional details were provided as follows: The reporting pharmacist stated there were no concomitant vaccines, and was not aware of any other medical history for the patient. The patient was administered SHINGRIX in the right deltoid and experienced pain head to toe, sleepiness, and injection site redness, swelling, and warmth to touch. The events lasted for 36 hours. The reporting pharmacist stated that she was not aware of the patient seeking medical attention for symptoms. The reported batch number FJ578, was not available in sales data sheet.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a 75-year-old female patient who received SHINGRIX. On 24th January 2018, the patient received SHINGRIX. In January 2018, less than a week after receiving SHINGRIX, the patient experienced heart rate increased and injection site pain. On an unknown date, the outcome of the heart rate increased and injection site pain were unknown. It was unknown if the reporter considered the heart rate increased and injection site pain to be related to SHINGRIX. Additional details were provided as follows: A day after vaccination, the patient had contacted in regards to a slightly elevated heart rate and also mentioned she was a little sore at the injection site. Contact details of the prescribing physician was provided, however unsure if the details corresponded to vaccine administration details.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: The next day my daughter started to get a rash on her arms and legs. It has never receded, she seems to have this bumpy rash permanently.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: The patient presented to the pharmacy with very sore arm and redness and swelling all along the upper inner arm.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood iron, Full blood count, Tinnitus, Vitamin B12
Clinical narrative: Ringing in my ears. A buzzing feeling in my head. Started 48 hours later and i still have it now.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Acoustic stimulation tests normal, Apraxia, Injection site reaction, Speech disorder developmental
Clinical narrative: My daughter had a reaction at each injection site and within 6 months, had lost her intelligibility. She has been diagnosed with a speech delay and apraxia. We are doing speech therapy and trying to get her to 50% intelligibility.
Age: 0.5
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13
Symptoms: Wrong drug administered
Clinical narrative: I gave patient KINRIX and they should have received PEDIARIX. They need to come back and get a Hep B dose.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a patient who received SHINGRIX. On 25th January 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 25th January 2018, 2 hrs after receiving SHINGRIX, the patient experienced injection site erythema and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema was recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site erythema and intramuscular formulation administered by other route to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that patient received SHINGRIX subcutaneously instead of intramuscularly, which led to inappropriate route of vaccination. The patient experienced redness of 6-inch diameter after receiving vaccination. The reporter stated that it occurred within hours of the vaccine, but unsure of specifics. No lot number, expiry date and patient details were provided. The reporter was not 100 percent certain about the vaccination date and thought it was last Thursday before the reporting date. The health care professional had limited information about the adverse event. The health care professional was the pharmacist who dispensed the vaccine, but did not administer.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a patient who received SHINGRIX. On 25th January 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 25th January 2018, 2 hrs after receiving SHINGRIX, the patient experienced injection site erythema and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema was recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site erythema and intramuscular formulation administered by other route to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that patient received SHINGRIX subcutaneously instead of intramuscularly, which led to inappropriate route of vaccination. The patient experienced redness of 6-inch diameter after receiving vaccination. The reporter stated that it occurred within hours of the vaccine, but unsure of specifics. No lot number, expiry date and patient details were provided. The reporter was not 100 percent certain about the vaccination date and thought it was last Thursday before the reporting date. The health care professional had limited information about the adverse event. The health care professional was the pharmacist who dispensed the vaccine, but did not administer.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Skin lesion
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of blister in a female patient who received SHINGRIX. On 12th January 2018, the patient received SHINGRIX. In January 2018, 1 days after receiving SHINGRIX, the patient experienced blister and skin lesion. On an unknown date, the outcome of the blister and skin lesion were unknown. It was unknown if the reporter considered the blister and skin lesion to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. One or 2 days after being vaccinated with SHINGRIX, the patient developed lesions or blisters in her nostrils and under her ear. The pharmacist that called in was not the healthcare professional who vaccinated this patient, so he did not have any other details. No further information was provided.
Age: 77.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt complained of redness, pain, and swelling in right upper arm. 01/29/2018 10:10 AM Pt walkin. C/O redness, pain and swelling developed right upper arm where she received vaccination. Sought treatment at clinic but told to F/U PCP because she received the vaccination here. Pt ended up going to urgent care and will placed on cephalexin with some improvement. Pt denies any swelling of mucous membrane, shortness of breath, nausea, vomiting, fever. Associated symptoms itching.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, swelling, redness to left shoulder down arm, tingling down arm, site warm to touch could not lift her arm up without 8/10 pain.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Paraesthesia, Peripheral swelling, Ultrasound scan normal
Clinical narrative: Pain, swelling, redness to left shoulder down arm, tingling down arm, site warm to touch could not lift her arm up without 8/10 pain.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: X-ray limb normal
Clinical narrative: Pain, swelling, redness to left shoulder down arm, tingling down arm, site warm to touch could not lift her arm up without 8/10 pain.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Breast pain, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt had localized redness, warmth, swelling and pain at and around the injection site. Stated that it had gotten worse in the last 2 days since the vaccine and was experiencing some pain in her breast under the arm that was vaccinated. Pt will be seeing the MD on 2/2 and will speak with them about the issue.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest X-ray normal, Chills, Electrocardiogram normal, Headache, Influenza virus test negative
Clinical narrative: Patient woke up the next day with fever, chills, headache, and muscle aches. She went to hospital because she thought she had the flu. She was checked with EKG, flu test, and other exams all negative. She had chest x-ray negative. She got IV fluids and took TYLENOL. She felt better after 6-12 hours on TYLENOL.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Patient woke up the next day with fever, chills, headache, and muscle aches. She went to hospital because she thought she had the flu. She was checked with EKG, flu test, and other exams all negative. She had chest x-ray negative. She got IV fluids and took TYLENOL. She felt better after 6-12 hours on TYLENOL.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Pain in extremity
Clinical narrative: Severe to moderate pain in left arm depending on movement.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Injection site pain, Injection site pruritus, Vision blurred
Clinical narrative: Patient called after receiving flu vaccine and called to say shortly after she started feeling light headed and having blurry vision and itching at site and soreness when raising arm. Advised pt to go to the ER and get evaluated. Pt declined and said she only wanted to lay down. I called pt back about an hour later and she said she had went to lay down and felt better but was still having some light headedness and blurred vision. Pt encouraged again to go to ER or at least follow up with PMD that the symptoms may or may not be related to the flu vaccine.