chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Activated partial thromboplastin time normal, Asthenia, Blood creatine phosphokinase normal, Blood magnesium normal, Cardiac pharmacologic stress test
Clinical narrative: Immediately upon completion of injection, experienced vasovagal response. Unable to leave pharmacy's for about 30 minutes and was unable to drive. Intermittent light-headedness, racing pulse, sense of almost passing out persisted throughout the day. The following week, I had intense headaches for four days, achy body for three days along with being light-headed, no appetite, and general fatigue. One Monday 10/23/23, around 9pm, I experience such light-headedness I couldn't stand up, I began having chills (no fever), rapid pulse, difficulty breathing and chest pain. Despite these symptoms I did not seek medical attention and sometime around 3am the symptoms were lessened somewhat. Tuesday I feel light-headed, no appetite, and achy. Wednesday around noon, I had severe chest pain, rapid pulse, felt weak, light-headed and about to faint. I went to the Emergency Department and was examined for possible cardiac event. All tests came back negative and I was given the choice to discharge to home or stay for overnight observation. I opted to go home. Thursday I visited my PCP and discussed this episode with her and I told her I was going to a cardiologist for follow up the following day. The cardiologist looked at my test results from the ED and saw they were all normal. My labs were all normal and no sign of heart attack. I was still experiencing constant rapid heart rate that would elevate from 80 to 110 (my normal resting heart rate is around 62).  On Saturday, October 28, around 11am, I began having escalating symptoms again - elevated heart rate, feeling faint, light-headed, difficult breathing and walking (due to light-headedness). I returned to the ED where they ran the same tests and kept me overnight for observation. On Sunday, October 29, 2023, they ran a stress test. Through the 24 hour period, I was constantly monitored, they took regular EKGs, they performed extensive lab tests and then the stress test on Sunday. All tests returned normal.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Cardiac stress test normal, Chest X-ray normal, Chest pain, Chills, Decreased appetite
Clinical narrative: Immediately upon completion of injection, experienced vasovagal response. Unable to leave pharmacy's for about 30 minutes and was unable to drive. Intermittent light-headedness, racing pulse, sense of almost passing out persisted throughout the day. The following week, I had intense headaches for four days, achy body for three days along with being light-headed, no appetite, and general fatigue. One Monday 10/23/23, around 9pm, I experience such light-headedness I couldn't stand up, I began having chills (no fever), rapid pulse, difficulty breathing and chest pain. Despite these symptoms I did not seek medical attention and sometime around 3am the symptoms were lessened somewhat. Tuesday I feel light-headed, no appetite, and achy. Wednesday around noon, I had severe chest pain, rapid pulse, felt weak, light-headed and about to faint. I went to the Emergency Department and was examined for possible cardiac event. All tests came back negative and I was given the choice to discharge to home or stay for overnight observation. I opted to go home. Thursday I visited my PCP and discussed this episode with her and I told her I was going to a cardiologist for follow up the following day. The cardiologist looked at my test results from the ED and saw they were all normal. My labs were all normal and no sign of heart attack. I was still experiencing constant rapid heart rate that would elevate from 80 to 110 (my normal resting heart rate is around 62).  On Saturday, October 28, around 11am, I began having escalating symptoms again - elevated heart rate, feeling faint, light-headed, difficult breathing and walking (due to light-headedness). I returned to the ED where they ran the same tests and kept me overnight for observation. On Sunday, October 29, 2023, they ran a stress test. Through the 24 hour period, I was constantly monitored, they took regular EKGs, they performed extensive lab tests and then the stress test on Sunday. All tests returned normal.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Differential white blood cell count normal, Dizziness, Dyspnoea, Dysstasia, Electrocardiogram normal
Clinical narrative: Immediately upon completion of injection, experienced vasovagal response. Unable to leave pharmacy's for about 30 minutes and was unable to drive. Intermittent light-headedness, racing pulse, sense of almost passing out persisted throughout the day. The following week, I had intense headaches for four days, achy body for three days along with being light-headed, no appetite, and general fatigue. One Monday 10/23/23, around 9pm, I experience such light-headedness I couldn't stand up, I began having chills (no fever), rapid pulse, difficulty breathing and chest pain. Despite these symptoms I did not seek medical attention and sometime around 3am the symptoms were lessened somewhat. Tuesday I feel light-headed, no appetite, and achy. Wednesday around noon, I had severe chest pain, rapid pulse, felt weak, light-headed and about to faint. I went to the Emergency Department and was examined for possible cardiac event. All tests came back negative and I was given the choice to discharge to home or stay for overnight observation. I opted to go home. Thursday I visited my PCP and discussed this episode with her and I told her I was going to a cardiologist for follow up the following day. The cardiologist looked at my test results from the ED and saw they were all normal. My labs were all normal and no sign of heart attack. I was still experiencing constant rapid heart rate that would elevate from 80 to 110 (my normal resting heart rate is around 62).  On Saturday, October 28, around 11am, I began having escalating symptoms again - elevated heart rate, feeling faint, light-headed, difficult breathing and walking (due to light-headedness). I returned to the ED where they ran the same tests and kept me overnight for observation. On Sunday, October 29, 2023, they ran a stress test. Through the 24 hour period, I was constantly monitored, they took regular EKGs, they performed extensive lab tests and then the stress test on Sunday. All tests returned normal.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Fibrin D dimer normal, Full blood count normal, Gait disturbance, Headache
Clinical narrative: Immediately upon completion of injection, experienced vasovagal response. Unable to leave pharmacy's for about 30 minutes and was unable to drive. Intermittent light-headedness, racing pulse, sense of almost passing out persisted throughout the day. The following week, I had intense headaches for four days, achy body for three days along with being light-headed, no appetite, and general fatigue. One Monday 10/23/23, around 9pm, I experience such light-headedness I couldn't stand up, I began having chills (no fever), rapid pulse, difficulty breathing and chest pain. Despite these symptoms I did not seek medical attention and sometime around 3am the symptoms were lessened somewhat. Tuesday I feel light-headed, no appetite, and achy. Wednesday around noon, I had severe chest pain, rapid pulse, felt weak, light-headed and about to faint. I went to the Emergency Department and was examined for possible cardiac event. All tests came back negative and I was given the choice to discharge to home or stay for overnight observation. I opted to go home. Thursday I visited my PCP and discussed this episode with her and I told her I was going to a cardiologist for follow up the following day. The cardiologist looked at my test results from the ED and saw they were all normal. My labs were all normal and no sign of heart attack. I was still experiencing constant rapid heart rate that would elevate from 80 to 110 (my normal resting heart rate is around 62).  On Saturday, October 28, around 11am, I began having escalating symptoms again - elevated heart rate, feeling faint, light-headed, difficult breathing and walking (due to light-headedness). I returned to the ED where they ran the same tests and kept me overnight for observation. On Sunday, October 29, 2023, they ran a stress test. Through the 24 hour period, I was constantly monitored, they took regular EKGs, they performed extensive lab tests and then the stress test on Sunday. All tests returned normal.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Heart rate increased, Immediate post-injection reaction, Impaired driving ability, International normalised ratio normal, Laboratory test normal
Clinical narrative: Immediately upon completion of injection, experienced vasovagal response. Unable to leave pharmacy's for about 30 minutes and was unable to drive. Intermittent light-headedness, racing pulse, sense of almost passing out persisted throughout the day. The following week, I had intense headaches for four days, achy body for three days along with being light-headed, no appetite, and general fatigue. One Monday 10/23/23, around 9pm, I experience such light-headedness I couldn't stand up, I began having chills (no fever), rapid pulse, difficulty breathing and chest pain. Despite these symptoms I did not seek medical attention and sometime around 3am the symptoms were lessened somewhat. Tuesday I feel light-headed, no appetite, and achy. Wednesday around noon, I had severe chest pain, rapid pulse, felt weak, light-headed and about to faint. I went to the Emergency Department and was examined for possible cardiac event. All tests came back negative and I was given the choice to discharge to home or stay for overnight observation. I opted to go home. Thursday I visited my PCP and discussed this episode with her and I told her I was going to a cardiologist for follow up the following day. The cardiologist looked at my test results from the ED and saw they were all normal. My labs were all normal and no sign of heart attack. I was still experiencing constant rapid heart rate that would elevate from 80 to 110 (my normal resting heart rate is around 62).  On Saturday, October 28, around 11am, I began having escalating symptoms again - elevated heart rate, feeling faint, light-headed, difficult breathing and walking (due to light-headedness). I returned to the ED where they ran the same tests and kept me overnight for observation. On Sunday, October 29, 2023, they ran a stress test. Through the 24 hour period, I was constantly monitored, they took regular EKGs, they performed extensive lab tests and then the stress test on Sunday. All tests returned normal.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Lipids normal, Metabolic function test normal, Pain, Presyncope, Prothrombin time normal
Clinical narrative: Immediately upon completion of injection, experienced vasovagal response. Unable to leave pharmacy's for about 30 minutes and was unable to drive. Intermittent light-headedness, racing pulse, sense of almost passing out persisted throughout the day. The following week, I had intense headaches for four days, achy body for three days along with being light-headed, no appetite, and general fatigue. One Monday 10/23/23, around 9pm, I experience such light-headedness I couldn't stand up, I began having chills (no fever), rapid pulse, difficulty breathing and chest pain. Despite these symptoms I did not seek medical attention and sometime around 3am the symptoms were lessened somewhat. Tuesday I feel light-headed, no appetite, and achy. Wednesday around noon, I had severe chest pain, rapid pulse, felt weak, light-headed and about to faint. I went to the Emergency Department and was examined for possible cardiac event. All tests came back negative and I was given the choice to discharge to home or stay for overnight observation. I opted to go home. Thursday I visited my PCP and discussed this episode with her and I told her I was going to a cardiologist for follow up the following day. The cardiologist looked at my test results from the ED and saw they were all normal. My labs were all normal and no sign of heart attack. I was still experiencing constant rapid heart rate that would elevate from 80 to 110 (my normal resting heart rate is around 62).  On Saturday, October 28, around 11am, I began having escalating symptoms again - elevated heart rate, feeling faint, light-headed, difficult breathing and walking (due to light-headedness). I returned to the ED where they ran the same tests and kept me overnight for observation. On Sunday, October 29, 2023, they ran a stress test. Through the 24 hour period, I was constantly monitored, they took regular EKGs, they performed extensive lab tests and then the stress test on Sunday. All tests returned normal.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Troponin T normal, Troponin normal
Clinical narrative: Immediately upon completion of injection, experienced vasovagal response. Unable to leave pharmacy's for about 30 minutes and was unable to drive. Intermittent light-headedness, racing pulse, sense of almost passing out persisted throughout the day. The following week, I had intense headaches for four days, achy body for three days along with being light-headed, no appetite, and general fatigue. One Monday 10/23/23, around 9pm, I experience such light-headedness I couldn't stand up, I began having chills (no fever), rapid pulse, difficulty breathing and chest pain. Despite these symptoms I did not seek medical attention and sometime around 3am the symptoms were lessened somewhat. Tuesday I feel light-headed, no appetite, and achy. Wednesday around noon, I had severe chest pain, rapid pulse, felt weak, light-headed and about to faint. I went to the Emergency Department and was examined for possible cardiac event. All tests came back negative and I was given the choice to discharge to home or stay for overnight observation. I opted to go home. Thursday I visited my PCP and discussed this episode with her and I told her I was going to a cardiologist for follow up the following day. The cardiologist looked at my test results from the ED and saw they were all normal. My labs were all normal and no sign of heart attack. I was still experiencing constant rapid heart rate that would elevate from 80 to 110 (my normal resting heart rate is around 62).  On Saturday, October 28, around 11am, I began having escalating symptoms again - elevated heart rate, feeling faint, light-headed, difficult breathing and walking (due to light-headedness). I returned to the ED where they ran the same tests and kept me overnight for observation. On Sunday, October 29, 2023, they ran a stress test. Through the 24 hour period, I was constantly monitored, they took regular EKGs, they performed extensive lab tests and then the stress test on Sunday. All tests returned normal.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Mental impairment, Mental status changes, Somnolence
Clinical narrative: Altered Mental Status. Patient felt physically fine but mentally didn?t feel like himself.  He called it a ?psychedelic effect? He stated that his mind didn?t operate normally. He was more sleepy during this time as well.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Itchy, hot and red arm spreading on arms and face
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Patient's father came into pharmacy to get his annual vaccine. He told our staff patient experienced some issues the day after getting her Pfizer Monovalent Covid Vaccine. She was taken to the hospital and diagnosed with Guillain-Barre Syndrome. She has been treat in is recovering per her father.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Memory impairment, Transient ischaemic attack, Urticaria
Clinical narrative: The day after receiving the vaccine I was at work and I could not remember the names of my coworkers and my boss. They noticed I was acting a little weird. I felt off. I was in a work meeting with 1-0-12 people. I said good morning to one lady but couldn't remember her name. I worked a half day (I work at a school and they had early release) I couldn't remember any kid's names. I went home. My wife went to her brother's birthday party but I did not go because I did not feel good. She went overnight. I stayed home. When I woke up the next morning, I got a call 1-2 hours after I got up and it was my brother. He asked "Mark, is that you?" all I could do was hum/grunt "yes".  He asked if I wanted him to call an ambulance and I grunted "yes". They came and took me to Hospital. I was there about 4-5 days. I was diagnosed with a bunch of mini strokes. I don't remember a lot about the medications I was given. About a week after I got out of the hospital I contracted hives that lasted 2-3 months. I still couldn't talk. I had scabs all over my body.  I started being able to speak 4-5 months after I was out of the hospital and it was still barely understandable with only a few words at a time.  I can't remember things now and I have a hard time talking. I have to slow down and be purposeful with what I need to say. I cannot write good. I have to write slowly, letter by letter, or it is illegible.   I feel like I need to add more to this but my brain doesn't really work well and I get confused easily and I cannot remember things on demand. Mini Strokes did this to me.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Aphasia, Cerebral disorder, Confusional state, Dysgraphia
Clinical narrative: The day after receiving the vaccine I was at work and I could not remember the names of my coworkers and my boss. They noticed I was acting a little weird. I felt off. I was in a work meeting with 1-0-12 people. I said good morning to one lady but couldn't remember her name. I worked a half day (I work at a school and they had early release) I couldn't remember any kid's names. I went home. My wife went to her brother's birthday party but I did not go because I did not feel good. She went overnight. I stayed home. When I woke up the next morning, I got a call 1-2 hours after I got up and it was my brother. He asked "Mark, is that you?" all I could do was hum/grunt "yes".  He asked if I wanted him to call an ambulance and I grunted "yes". They came and took me to Hospital. I was there about 4-5 days. I was diagnosed with a bunch of mini strokes. I don't remember a lot about the medications I was given. About a week after I got out of the hospital I contracted hives that lasted 2-3 months. I still couldn't talk. I had scabs all over my body.  I started being able to speak 4-5 months after I was out of the hospital and it was still barely understandable with only a few words at a time.  I can't remember things now and I have a hard time talking. I have to slow down and be purposeful with what I need to say. I cannot write good. I have to write slowly, letter by letter, or it is illegible.   I feel like I need to add more to this but my brain doesn't really work well and I get confused easily and I cannot remember things on demand. Mini Strokes did this to me.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Grunting, Impaired work ability, Laboratory test, Mental status changes
Clinical narrative: The day after receiving the vaccine I was at work and I could not remember the names of my coworkers and my boss. They noticed I was acting a little weird. I felt off. I was in a work meeting with 1-0-12 people. I said good morning to one lady but couldn't remember her name. I worked a half day (I work at a school and they had early release) I couldn't remember any kid's names. I went home. My wife went to her brother's birthday party but I did not go because I did not feel good. She went overnight. I stayed home. When I woke up the next morning, I got a call 1-2 hours after I got up and it was my brother. He asked "Mark, is that you?" all I could do was hum/grunt "yes".  He asked if I wanted him to call an ambulance and I grunted "yes". They came and took me to Hospital. I was there about 4-5 days. I was diagnosed with a bunch of mini strokes. I don't remember a lot about the medications I was given. About a week after I got out of the hospital I contracted hives that lasted 2-3 months. I still couldn't talk. I had scabs all over my body.  I started being able to speak 4-5 months after I was out of the hospital and it was still barely understandable with only a few words at a time.  I can't remember things now and I have a hard time talking. I have to slow down and be purposeful with what I need to say. I cannot write good. I have to write slowly, letter by letter, or it is illegible.   I feel like I need to add more to this but my brain doesn't really work well and I get confused easily and I cannot remember things on demand. Mini Strokes did this to me.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Scab, Transient ischaemic attack, Urticaria
Clinical narrative: The day after receiving the vaccine I was at work and I could not remember the names of my coworkers and my boss. They noticed I was acting a little weird. I felt off. I was in a work meeting with 1-0-12 people. I said good morning to one lady but couldn't remember her name. I worked a half day (I work at a school and they had early release) I couldn't remember any kid's names. I went home. My wife went to her brother's birthday party but I did not go because I did not feel good. She went overnight. I stayed home. When I woke up the next morning, I got a call 1-2 hours after I got up and it was my brother. He asked "Mark, is that you?" all I could do was hum/grunt "yes".  He asked if I wanted him to call an ambulance and I grunted "yes". They came and took me to Hospital. I was there about 4-5 days. I was diagnosed with a bunch of mini strokes. I don't remember a lot about the medications I was given. About a week after I got out of the hospital I contracted hives that lasted 2-3 months. I still couldn't talk. I had scabs all over my body.  I started being able to speak 4-5 months after I was out of the hospital and it was still barely understandable with only a few words at a time.  I can't remember things now and I have a hard time talking. I have to slow down and be purposeful with what I need to say. I cannot write good. I have to write slowly, letter by letter, or it is illegible.   I feel like I need to add more to this but my brain doesn't really work well and I get confused easily and I cannot remember things on demand. Mini Strokes did this to me.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19
Symptoms: Blood pressure fluctuation, Breast cancer female, Breast operation, Cardiac failure congestive, Cardiac function test normal
Clinical narrative: After day 6 through day 20 of first dose (and for second dose, day 6 though day 16): extreme pulsating pain in heart muscle that lasted 10-15 seconds each episode. Episodes repeated several times an hour; lessening to every few hours.  Extreme weakness developed, close to passing out. Heart rate dropped to 48- 58 beats a minute.  Blood pressure dropped to 50 -60 Systolic/Diastolic.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19
Symptoms: Cardiac perfusion defect, Cardiomyopathy acute, Catheterisation cardiac abnormal, Chest pain, Dizziness
Clinical narrative: After day 6 through day 20 of first dose (and for second dose, day 6 though day 16): extreme pulsating pain in heart muscle that lasted 10-15 seconds each episode. Episodes repeated several times an hour; lessening to every few hours.  Extreme weakness developed, close to passing out. Heart rate dropped to 48- 58 beats a minute.  Blood pressure dropped to 50 -60 Systolic/Diastolic.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19
Symptoms: Ejection fraction decreased, Fatigue, Feeling abnormal, Heart rate decreased, Hypertrophy
Clinical narrative: After day 6 through day 20 of first dose (and for second dose, day 6 though day 16): extreme pulsating pain in heart muscle that lasted 10-15 seconds each episode. Episodes repeated several times an hour; lessening to every few hours.  Extreme weakness developed, close to passing out. Heart rate dropped to 48- 58 beats a minute.  Blood pressure dropped to 50 -60 Systolic/Diastolic.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19
Symptoms: Immunisation reaction, Influenza like illness, Laboratory test normal, Left atrial enlargement, Left ventricular dilatation
Clinical narrative: After day 6 through day 20 of first dose (and for second dose, day 6 though day 16): extreme pulsating pain in heart muscle that lasted 10-15 seconds each episode. Episodes repeated several times an hour; lessening to every few hours.  Extreme weakness developed, close to passing out. Heart rate dropped to 48- 58 beats a minute.  Blood pressure dropped to 50 -60 Systolic/Diastolic.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19
Symptoms: Left ventricular dysfunction, Left ventricular end-diastolic pressure decreased, Left ventricular enlargement, Mitral valve incompetence, Myocardial fibrosis
Clinical narrative: After day 6 through day 20 of first dose (and for second dose, day 6 though day 16): extreme pulsating pain in heart muscle that lasted 10-15 seconds each episode. Episodes repeated several times an hour; lessening to every few hours.  Extreme weakness developed, close to passing out. Heart rate dropped to 48- 58 beats a minute.  Blood pressure dropped to 50 -60 Systolic/Diastolic.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19
Symptoms: Myocardial infarction, Pulmonary arterial pressure increased, Pulmonary arterial pressure normal, Pulmonary hypertension, Right ventricular failure
Clinical narrative: After day 6 through day 20 of first dose (and for second dose, day 6 though day 16): extreme pulsating pain in heart muscle that lasted 10-15 seconds each episode. Episodes repeated several times an hour; lessening to every few hours.  Extreme weakness developed, close to passing out. Heart rate dropped to 48- 58 beats a minute.  Blood pressure dropped to 50 -60 Systolic/Diastolic.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19
Symptoms: Scan myocardial perfusion, Sensory disturbance, Single photon emission computerised tomogram abnormal, Vaccination site pain, Ventricular hypokinesia
Clinical narrative: After day 6 through day 20 of first dose (and for second dose, day 6 though day 16): extreme pulsating pain in heart muscle that lasted 10-15 seconds each episode. Episodes repeated several times an hour; lessening to every few hours.  Extreme weakness developed, close to passing out. Heart rate dropped to 48- 58 beats a minute.  Blood pressure dropped to 50 -60 Systolic/Diastolic.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19
Symptoms: Angina pectoris, Asthenia, Blood pressure decreased, Dizziness, Heart rate decreased
Clinical narrative: After day 6 through day 20 of first dose (and for second dose, day 6 though day 16): extreme pulsating pain in heart muscle that lasted 10-15 seconds each episode. Episodes repeated several times an hour; lessening to every few hours.  Extreme weakness developed, close to passing out. Heart rate dropped to 48- 58 beats a minute.  Blood pressure dropped to 50 -60 Systolic/Diastolic.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19
Symptoms: Left ventricular failure
Clinical narrative: After day 6 through day 20 of first dose (and for second dose, day 6 though day 16): extreme pulsating pain in heart muscle that lasted 10-15 seconds each episode. Episodes repeated several times an hour; lessening to every few hours.  Extreme weakness developed, close to passing out. Heart rate dropped to 48- 58 beats a minute.  Blood pressure dropped to 50 -60 Systolic/Diastolic.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 77.0
Sex: F
Vaccine: RSV, COVID19, UNK
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: developed cellulitis in L arm; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 77-year-old female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 05Sep2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 77 years intramuscular, in left arm for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CELLULITIS (medically significant) with onset 05Sep2023, outcome "recovered" (12Sep2023), described as "developed cellulitis in L arm". Therapeutic measures were taken as a result of cellulitis. Solu-Medrol Injection IM - Cellulitis, Doxycycline 10 mg PO for 15 hours x 10 days and Prednisone 30 mg x 5 days PO from 07Sep2023.  Causality for "developed cellulitis in l arm" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.; Sender's Comments: A possibly contributory role of the administration with RSV VACCINE in triggering the onset of cellulitis cannot be fully excluded, considering the temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 77.0
Sex: F
Vaccine: RSV, COVID19, UNK
Symptoms: Body temperature, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: developed cellulitis in L arm; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 77-year-old female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 05Sep2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 77 years intramuscular, in left arm for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CELLULITIS (medically significant) with onset 05Sep2023, outcome "recovered" (12Sep2023), described as "developed cellulitis in L arm". Therapeutic measures were taken as a result of cellulitis. Solu-Medrol Injection IM - Cellulitis, Doxycycline 10 mg PO for 15 hours x 10 days and Prednisone 30 mg x 5 days PO from 07Sep2023.  Causality for "developed cellulitis in l arm" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.; Sender's Comments: A possibly contributory role of the administration with RSV VACCINE in triggering the onset of cellulitis cannot be fully excluded, considering the temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 77.0
Sex: F
Vaccine: RSV, COVID19, UNK
Symptoms: Cellulitis
Clinical narrative: developed cellulitis in L arm; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 77-year-old female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 05Sep2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 77 years intramuscular, in left arm for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CELLULITIS (medically significant) with onset 05Sep2023, outcome "recovered" (12Sep2023), described as "developed cellulitis in L arm". Therapeutic measures were taken as a result of cellulitis. Solu-Medrol Injection IM - Cellulitis, Doxycycline 10 mg PO for 15 hours x 10 days and Prednisone 30 mg x 5 days PO from 07Sep2023.  Causality for "developed cellulitis in l arm" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.; Sender's Comments: A possibly contributory role of the administration with RSV VACCINE in triggering the onset of cellulitis cannot be fully excluded, considering the temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: U
Vaccine: PPV, PPV
Symptoms: Expired product administered, Product administration error
Clinical narrative: the patient involved has not reported any medical concerns or symptoms related to the administration of the expired dose of PNEUMOVAX 23; HCP calling to report adverse event regarding administration of an expired dose of PNEUMOVAX 23; This spontaneous report has been received from a physician assistant and refers to a 57-year-old patient of unknown gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 17-OCT-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milliliter (ml) (lot number W021636 has been determined to be valid for  pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), expiration date established as 01-OCT-2023) (expire product administered), administered for prophylaxis (strength, and anatomical site of administration were not provided). It was confirmed by the reporter that the patient involved had not reported any medical concerns or symptoms related to the administration of the expired dose.
Sex: U
Vaccine: PPV, PPV
Symptoms: Expired product administered
Clinical narrative: the patient involved has not reported any medical concerns or symptoms related to the administration of the expired dose of PNEUMOVAX 23; HCP calling to report adverse event regarding administration of an expired dose of PNEUMOVAX 23; This spontaneous report has been received from a physician assistant and refers to a 57-year-old patient of unknown gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 17-OCT-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milliliter (ml) (lot number W021636 has been determined to be valid for  pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), expiration date established as 01-OCT-2023) (expire product administered), administered for prophylaxis (strength, and anatomical site of administration were not provided). It was confirmed by the reporter that the patient involved had not reported any medical concerns or symptoms related to the administration of the expired dose.
Age: 74.0
Sex: U
Vaccine: RSV, RSV
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: hearing buzzing/ringing in my both ears; Affecting sleep; Affecting routine work; This non-serious case was reported by a consumer and described the occurrence of ringing in ears in a 74-year-old patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 06-OCT-2023, the patient received Arexvy. In OCT-2023, 3 days after receiving Arexvy, the patient experienced ringing in ears (Verbatim: hearing buzzing/ringing in my both ears), sleep disturbance (Verbatim: Affecting sleep) and activities of daily living impaired (Verbatim: Affecting routine work). The outcome of the ringing in ears was not resolved and the outcome of the sleep disturbance and activities of daily living impaired were not reported.   It was unknown if the reporter considered the ringing in ears, sleep disturbance and activities of daily living impaired to be related to Arexvy.   It was unknown if the company considered the ringing in ears, sleep disturbance and activities of daily living impaired to be related to Arexvy.   Additional Information: GSK Receipt Date: 20-OCT-2023 The case was reported by the patient. Three days later all of a sudden, the patient started hearing buzzing/ringing in his/her both ears. It was all the time.  After almost two weeks, it was still going on.  It was affecting sleep and his/her routine work. The reporter wanted to report this to add in possible side effect of this vaccine made by you. The reporter also asked were there any recommendations from you what to do.
Age: 74.0
Sex: U
Vaccine: RSV, RSV
Symptoms: Impaired work ability, Sleep disorder, Tinnitus
Clinical narrative: hearing buzzing/ringing in my both ears; Affecting sleep; Affecting routine work; This non-serious case was reported by a consumer and described the occurrence of ringing in ears in a 74-year-old patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 06-OCT-2023, the patient received Arexvy. In OCT-2023, 3 days after receiving Arexvy, the patient experienced ringing in ears (Verbatim: hearing buzzing/ringing in my both ears), sleep disturbance (Verbatim: Affecting sleep) and activities of daily living impaired (Verbatim: Affecting routine work). The outcome of the ringing in ears was not resolved and the outcome of the sleep disturbance and activities of daily living impaired were not reported.   It was unknown if the reporter considered the ringing in ears, sleep disturbance and activities of daily living impaired to be related to Arexvy.   It was unknown if the company considered the ringing in ears, sleep disturbance and activities of daily living impaired to be related to Arexvy.   Additional Information: GSK Receipt Date: 20-OCT-2023 The case was reported by the patient. Three days later all of a sudden, the patient started hearing buzzing/ringing in his/her both ears. It was all the time.  After almost two weeks, it was still going on.  It was affecting sleep and his/her routine work. The reporter wanted to report this to add in possible side effect of this vaccine made by you. The reporter also asked were there any recommendations from you what to do.
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Arexvy administered during pregnancy.; 39-year-old patient received a dose of Arexvy; This non-serious prospective pregnancy case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 39-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 20-OCT-2023, the patient received Arexvy. On 20-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim:  39-year-old patient received a dose of Arexvy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy administered during pregnancy.). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date 20 Oct 2023: The physician called to inform that a 39-year-old patient received a dose of Arexvy. Also, that patient was pregnant, which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up.
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age
Clinical narrative: Arexvy administered during pregnancy.; 39-year-old patient received a dose of Arexvy; This non-serious prospective pregnancy case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 39-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 20-OCT-2023, the patient received Arexvy. On 20-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim:  39-year-old patient received a dose of Arexvy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy administered during pregnancy.). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date 20 Oct 2023: The physician called to inform that a 39-year-old patient received a dose of Arexvy. Also, that patient was pregnant, which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up.
Age: 39.0
Sex: F
Vaccine: COVID19-2, COVID19, FLU4
Symptoms: Aphasia, Dysarthria, Full blood count, Impaired work ability, Magnetic resonance imaging head
Clinical narrative: Vaccine received on 10/19/23 on 10/24 patient presented to Er with stroke like symptoms-unable to get her words out, altered speech
Age: 39.0
Sex: F
Vaccine: COVID19-2, COVID19, FLU4
Symptoms: Metabolic function test
Clinical narrative: Vaccine received on 10/19/23 on 10/24 patient presented to Er with stroke like symptoms-unable to get her words out, altered speech
Age: 39.0
Sex: F
Vaccine: COVID19-2, COVID19, FLU4
Symptoms: Aphasia
Clinical narrative: Vaccine received on 10/19/23 on 10/24 patient presented to Er with stroke like symptoms-unable to get her words out, altered speech
Age: 31.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received an expired Influenza Vaccine from the previous influenza season meant for last year's influenza season.
Age: 31.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Expired product administered
Clinical narrative: Patient received an expired Influenza Vaccine from the previous influenza season meant for last year's influenza season.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypertension
Clinical narrative: HIGH BLOOD PRESSURE FOR 6 WEEKS. WENT TO HOSPITAL
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram, Hypertension, Laboratory test
Clinical narrative: HIGH BLOOD PRESSURE FOR 6 WEEKS. WENT TO HOSPITAL
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia universalis
Clinical narrative: Rapid, extreme and whole-body alopecia,  Treatment provide was by a dermatologist - treated with oral and injectable steroids
Age: 11.0
Sex: F
Vaccine: HPV9, UNK, UNK, UNK
Symptoms: Dizziness, Lethargy, Nausea, Vomiting
Clinical narrative: Throw up, lethargy, nausea, dizzy
Age: 66.0
Sex: M
Vaccine: FLUA4
Symptoms: Arthralgia, Back pain, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: 65+ Fluad shot on Thursday afternoon 4:35pm.  Also got RSV in left arm at the same time.  On Friday, both shoulders were sore.  Late Friday, started to feel bad.  Came down w/ full blown flu symptoms - freezing and shaking all night, even though wearing a sweatshirt and under multiple blankets.  Dizzy when getting up and going to the bathroom.  Sweating at times.  Finally slept well from 6am to 10am on Saturday.  Felt tired w/ backache and headache all day Saturday.  Had a low fever, likely about 101F.  Went to bed 9pm Saturday and started the whole freezing/ shaking thing all over again.  Slept poorly again.  On sunday, sojewhat better but still tired and headache/ backache, though not as bad as on Saturday.
Age: 66.0
Sex: M
Vaccine: FLUA4
Symptoms: Feeling cold, Headache, Hyperhidrosis, Influenza, Pyrexia
Clinical narrative: 65+ Fluad shot on Thursday afternoon 4:35pm.  Also got RSV in left arm at the same time.  On Friday, both shoulders were sore.  Late Friday, started to feel bad.  Came down w/ full blown flu symptoms - freezing and shaking all night, even though wearing a sweatshirt and under multiple blankets.  Dizzy when getting up and going to the bathroom.  Sweating at times.  Finally slept well from 6am to 10am on Saturday.  Felt tired w/ backache and headache all day Saturday.  Had a low fever, likely about 101F.  Went to bed 9pm Saturday and started the whole freezing/ shaking thing all over again.  Slept poorly again.  On sunday, sojewhat better but still tired and headache/ backache, though not as bad as on Saturday.
Age: 66.0
Sex: M
Vaccine: FLUA4
Symptoms: Sleep disorder, Tremor
Clinical narrative: 65+ Fluad shot on Thursday afternoon 4:35pm.  Also got RSV in left arm at the same time.  On Friday, both shoulders were sore.  Late Friday, started to feel bad.  Came down w/ full blown flu symptoms - freezing and shaking all night, even though wearing a sweatshirt and under multiple blankets.  Dizzy when getting up and going to the bathroom.  Sweating at times.  Finally slept well from 6am to 10am on Saturday.  Felt tired w/ backache and headache all day Saturday.  Had a low fever, likely about 101F.  Went to bed 9pm Saturday and started the whole freezing/ shaking thing all over again.  Slept poorly again.  On sunday, sojewhat better but still tired and headache/ backache, though not as bad as on Saturday.
Age: 51.0
Sex: F
Vaccine: FLUN4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt filled out consent from for Flumist for 2-49 years old patients. Pt was 51. RN did not catch it until entering in computer system on 10/31/2023
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Blood test, Cardiac stress test, Chest pain, Dyspnoea
Clinical narrative: Chest Pain, Shortness of Breathe, Increased Heart Rate, Left Arm numb from shoulder to middle of forearm, Tingling in jaw from ear to ear, Tingling in both right and left hand from wrist down, Tingling in both feet from ankle down. A month later I started to experience nose bleeds. First nose bleed occurred in Oct 2021. Other nose bleeds occurred: Dec 2021, Feb 2022, and Summer of 2022. Patient has encountered some pain around the heart area. At times it is a sharp pain, others are dull and shortness of breath.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Epistaxis, Heart rate increased, Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: Chest Pain, Shortness of Breathe, Increased Heart Rate, Left Arm numb from shoulder to middle of forearm, Tingling in jaw from ear to ear, Tingling in both right and left hand from wrist down, Tingling in both feet from ankle down. A month later I started to experience nose bleeds. First nose bleed occurred in Oct 2021. Other nose bleeds occurred: Dec 2021, Feb 2022, and Summer of 2022. Patient has encountered some pain around the heart area. At times it is a sharp pain, others are dull and shortness of breath.