chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: JEV1, MMR, RAB, VARCEL, JEV1, MMR, RAB, VARCEL
Symptoms: Depressed mood, Dyspnoea, Fatigue, Haemoglobin decreased, Hypersomnia
Clinical narrative: Beginning in October 2012, I began to feel lethargic.  I was sleeping more than normal and had less energy.  I felt like I had a sinus cold.  As this was the beginning of cold and flu season, I decided to wait it out and not seek medical assistance at that time.  On November 2nd, 2012, I began my work trip.  I met up with a work colleague in the airport.  Upon seeing me, he immediately asked about my health.  We had just concluded a business trip in the previous months and he was surprised that I was not looking very well.  I said that I had been feeling more tired than normal, but hoped it was just the cold season.  I arrived on the third, and returned on the 9th.  I did not seek medical attention while traveling. Upon returning home, my wife noticed that my behavior had changed.  I was less energetic, less enthusiastic, weak, acting depressed, keeping quiet, and keeping to myself.  I decided it was the jet lag, but I did not get better.  In fact, I was getting worse. On December 1st, 2012, my family went out to dinner.  The meal was good, but I did not interact with them very much.  I was quiet and tired.  Upon leaving the restaurant, I had to stop three times to catch my breath while walking to the car.  I was breathing very heavily, I was very weak, my chest hurt, and I was unable to catch my breath.  I went to the emergency room. Upon arriving at the emergency room, they immediately started to pre-treat me for a heart attack.  All of the symptoms matched, and it was standard protocol.  When the cell blood count (CBC) results returned and the heart tests showed negative, they stopped the heart attack treatment and began blood transfusions.  My hemoglobin count was 5.1, normal is above 12.  My white blood cell count was 0.8 (above 5 is normal) and my platelet count was 6 (above 140 is normal).  After transfusing several units of packed red blood cells, a subsequent CBC test reported a hemoglobin level of 4.1.   The doctors reported to me that they had administered upwards of 100 tests to determine what was wrong and what had caused the symptoms.  Based on the results, I was diagnosed with severe Aplastic Anemia.
Age: 43.0
Sex: M
Vaccine: JEV1, MMR, RAB, VARCEL, JEV1, MMR, RAB, VARCEL
Symptoms: Hyperventilation, Lethargy, Myocardial infarction, Nasopharyngitis, Packed red blood cell transfusion
Clinical narrative: Beginning in October 2012, I began to feel lethargic.  I was sleeping more than normal and had less energy.  I felt like I had a sinus cold.  As this was the beginning of cold and flu season, I decided to wait it out and not seek medical assistance at that time.  On November 2nd, 2012, I began my work trip.  I met up with a work colleague in the airport.  Upon seeing me, he immediately asked about my health.  We had just concluded a business trip in the previous months and he was surprised that I was not looking very well.  I said that I had been feeling more tired than normal, but hoped it was just the cold season.  I arrived on the third, and returned on the 9th.  I did not seek medical attention while traveling. Upon returning home, my wife noticed that my behavior had changed.  I was less energetic, less enthusiastic, weak, acting depressed, keeping quiet, and keeping to myself.  I decided it was the jet lag, but I did not get better.  In fact, I was getting worse. On December 1st, 2012, my family went out to dinner.  The meal was good, but I did not interact with them very much.  I was quiet and tired.  Upon leaving the restaurant, I had to stop three times to catch my breath while walking to the car.  I was breathing very heavily, I was very weak, my chest hurt, and I was unable to catch my breath.  I went to the emergency room. Upon arriving at the emergency room, they immediately started to pre-treat me for a heart attack.  All of the symptoms matched, and it was standard protocol.  When the cell blood count (CBC) results returned and the heart tests showed negative, they stopped the heart attack treatment and began blood transfusions.  My hemoglobin count was 5.1, normal is above 12.  My white blood cell count was 0.8 (above 5 is normal) and my platelet count was 6 (above 140 is normal).  After transfusing several units of packed red blood cells, a subsequent CBC test reported a hemoglobin level of 4.1.   The doctors reported to me that they had administered upwards of 100 tests to determine what was wrong and what had caused the symptoms.  Based on the results, I was diagnosed with severe Aplastic Anemia.
Age: 43.0
Sex: M
Vaccine: JEV1, MMR, RAB, VARCEL, JEV1, MMR, RAB, VARCEL
Symptoms: Platelet count decreased, Transfusion, White blood cell count decreased
Clinical narrative: Beginning in October 2012, I began to feel lethargic.  I was sleeping more than normal and had less energy.  I felt like I had a sinus cold.  As this was the beginning of cold and flu season, I decided to wait it out and not seek medical assistance at that time.  On November 2nd, 2012, I began my work trip.  I met up with a work colleague in the airport.  Upon seeing me, he immediately asked about my health.  We had just concluded a business trip in the previous months and he was surprised that I was not looking very well.  I said that I had been feeling more tired than normal, but hoped it was just the cold season.  I arrived on the third, and returned on the 9th.  I did not seek medical attention while traveling. Upon returning home, my wife noticed that my behavior had changed.  I was less energetic, less enthusiastic, weak, acting depressed, keeping quiet, and keeping to myself.  I decided it was the jet lag, but I did not get better.  In fact, I was getting worse. On December 1st, 2012, my family went out to dinner.  The meal was good, but I did not interact with them very much.  I was quiet and tired.  Upon leaving the restaurant, I had to stop three times to catch my breath while walking to the car.  I was breathing very heavily, I was very weak, my chest hurt, and I was unable to catch my breath.  I went to the emergency room. Upon arriving at the emergency room, they immediately started to pre-treat me for a heart attack.  All of the symptoms matched, and it was standard protocol.  When the cell blood count (CBC) results returned and the heart tests showed negative, they stopped the heart attack treatment and began blood transfusions.  My hemoglobin count was 5.1, normal is above 12.  My white blood cell count was 0.8 (above 5 is normal) and my platelet count was 6 (above 140 is normal).  After transfusing several units of packed red blood cells, a subsequent CBC test reported a hemoglobin level of 4.1.   The doctors reported to me that they had administered upwards of 100 tests to determine what was wrong and what had caused the symptoms.  Based on the results, I was diagnosed with severe Aplastic Anemia.
Age: 43.0
Sex: M
Vaccine: JEV1, MMR, RAB, VARCEL, JEV1, MMR, RAB, VARCEL
Symptoms: Depressed mood, Dyspnoea, Fatigue, Haemoglobin decreased, Hyperventilation
Clinical narrative: Beginning in October 2012, I began to feel lethargic.  I was sleeping more than normal and had less energy.  I felt like I had a sinus cold.  As this was the beginning of cold and flu season, I decided to wait it out and not seek medical assistance at that time.  On November 2nd, 2012, I began my work trip.  I met up with a work colleague in the airport.  Upon seeing me, he immediately asked about my health.  We had just concluded a business trip in the previous months and he was surprised that I was not looking very well.  I said that I had been feeling more tired than normal, but hoped it was just the cold season.  I arrived on the third, and returned on the 9th.  I did not seek medical attention while traveling. Upon returning home, my wife noticed that my behavior had changed.  I was less energetic, less enthusiastic, weak, acting depressed, keeping quiet, and keeping to myself.  I decided it was the jet lag, but I did not get better.  In fact, I was getting worse. On December 1st, 2012, my family went out to dinner.  The meal was good, but I did not interact with them very much.  I was quiet and tired.  Upon leaving the restaurant, I had to stop three times to catch my breath while walking to the car.  I was breathing very heavily, I was very weak, my chest hurt, and I was unable to catch my breath.  I went to the emergency room. Upon arriving at the emergency room, they immediately started to pre-treat me for a heart attack.  All of the symptoms matched, and it was standard protocol.  When the cell blood count (CBC) results returned and the heart tests showed negative, they stopped the heart attack treatment and began blood transfusions.  My hemoglobin count was 5.1, normal is above 12.  My white blood cell count was 0.8 (above 5 is normal) and my platelet count was 6 (above 140 is normal).  After transfusing several units of packed red blood cells, a subsequent CBC test reported a hemoglobin level of 4.1.   The doctors reported to me that they had administered upwards of 100 tests to determine what was wrong and what had caused the symptoms.  Based on the results, I was diagnosed with severe Aplastic Anemia.
Age: 43.0
Sex: M
Vaccine: JEV1, MMR, RAB, VARCEL, JEV1, MMR, RAB, VARCEL
Symptoms: Lethargy, Nasopharyngitis, Platelet count decreased, Somnolence, Transfusion
Clinical narrative: Beginning in October 2012, I began to feel lethargic.  I was sleeping more than normal and had less energy.  I felt like I had a sinus cold.  As this was the beginning of cold and flu season, I decided to wait it out and not seek medical assistance at that time.  On November 2nd, 2012, I began my work trip.  I met up with a work colleague in the airport.  Upon seeing me, he immediately asked about my health.  We had just concluded a business trip in the previous months and he was surprised that I was not looking very well.  I said that I had been feeling more tired than normal, but hoped it was just the cold season.  I arrived on the third, and returned on the 9th.  I did not seek medical attention while traveling. Upon returning home, my wife noticed that my behavior had changed.  I was less energetic, less enthusiastic, weak, acting depressed, keeping quiet, and keeping to myself.  I decided it was the jet lag, but I did not get better.  In fact, I was getting worse. On December 1st, 2012, my family went out to dinner.  The meal was good, but I did not interact with them very much.  I was quiet and tired.  Upon leaving the restaurant, I had to stop three times to catch my breath while walking to the car.  I was breathing very heavily, I was very weak, my chest hurt, and I was unable to catch my breath.  I went to the emergency room. Upon arriving at the emergency room, they immediately started to pre-treat me for a heart attack.  All of the symptoms matched, and it was standard protocol.  When the cell blood count (CBC) results returned and the heart tests showed negative, they stopped the heart attack treatment and began blood transfusions.  My hemoglobin count was 5.1, normal is above 12.  My white blood cell count was 0.8 (above 5 is normal) and my platelet count was 6 (above 140 is normal).  After transfusing several units of packed red blood cells, a subsequent CBC test reported a hemoglobin level of 4.1.   The doctors reported to me that they had administered upwards of 100 tests to determine what was wrong and what had caused the symptoms.  Based on the results, I was diagnosed with severe Aplastic Anemia.
Age: 43.0
Sex: M
Vaccine: JEV1, MMR, RAB, VARCEL, JEV1, MMR, RAB, VARCEL
Symptoms: Tuberculin test, White blood cell count decreased
Clinical narrative: Beginning in October 2012, I began to feel lethargic.  I was sleeping more than normal and had less energy.  I felt like I had a sinus cold.  As this was the beginning of cold and flu season, I decided to wait it out and not seek medical assistance at that time.  On November 2nd, 2012, I began my work trip.  I met up with a work colleague in the airport.  Upon seeing me, he immediately asked about my health.  We had just concluded a business trip in the previous months and he was surprised that I was not looking very well.  I said that I had been feeling more tired than normal, but hoped it was just the cold season.  I arrived on the third, and returned on the 9th.  I did not seek medical attention while traveling. Upon returning home, my wife noticed that my behavior had changed.  I was less energetic, less enthusiastic, weak, acting depressed, keeping quiet, and keeping to myself.  I decided it was the jet lag, but I did not get better.  In fact, I was getting worse. On December 1st, 2012, my family went out to dinner.  The meal was good, but I did not interact with them very much.  I was quiet and tired.  Upon leaving the restaurant, I had to stop three times to catch my breath while walking to the car.  I was breathing very heavily, I was very weak, my chest hurt, and I was unable to catch my breath.  I went to the emergency room. Upon arriving at the emergency room, they immediately started to pre-treat me for a heart attack.  All of the symptoms matched, and it was standard protocol.  When the cell blood count (CBC) results returned and the heart tests showed negative, they stopped the heart attack treatment and began blood transfusions.  My hemoglobin count was 5.1, normal is above 12.  My white blood cell count was 0.8 (above 5 is normal) and my platelet count was 6 (above 140 is normal).  After transfusing several units of packed red blood cells, a subsequent CBC test reported a hemoglobin level of 4.1.   The doctors reported to me that they had administered upwards of 100 tests to determine what was wrong and what had caused the symptoms.  Based on the results, I was diagnosed with severe Aplastic Anemia.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles Virus rash on right side below belt loop/ waistline, Also, rash on right leg below calf muscle area. Treatment: began 05/30/2015 evening by taking anti-viral Valacyclovir medication prescribed for three times daily for one week.
Age: 20.0
Sex: M
Vaccine: HPVX, PPV
Symptoms: Chest X-ray normal, Chills, Computerised tomogram normal, Confusional state, Discomfort
Clinical narrative: Started feeling a little discomfort the day before. Serious effects started at the time given above. These include fever, throwing up, chills, severe cramps throughout body, sweating, difficulty breathing, confusion/dizziness, spreading infection and swelling at site of injection.
Age: 20.0
Sex: M
Vaccine: HPVX, PPV
Symptoms: Dizziness, Dyspnoea, Hyperhidrosis, Infection, Injection site swelling
Clinical narrative: Started feeling a little discomfort the day before. Serious effects started at the time given above. These include fever, throwing up, chills, severe cramps throughout body, sweating, difficulty breathing, confusion/dizziness, spreading infection and swelling at site of injection.
Age: 20.0
Sex: M
Vaccine: HPVX, PPV
Symptoms: Muscle spasms, Pyrexia, Urine analysis normal, Vomiting, White blood cell count increased
Clinical narrative: Started feeling a little discomfort the day before. Serious effects started at the time given above. These include fever, throwing up, chills, severe cramps throughout body, sweating, difficulty breathing, confusion/dizziness, spreading infection and swelling at site of injection.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Tenderness
Clinical narrative: Pt began getting a rash on left side of body that was extremely sensitive to touch. Visit was made to MD office, and pt was diagnosed with Shingles.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR
Symptoms: Headache, Injection site pain, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: Both legs were very sore and would not support his weight.  His fever rose to 102 and remained there for 36 hours.  He had a head ache and said he couldnt see.  He followed me when I talked so I think it was a migraine and not actual lack of vision.  He had unquenchable thirst.  The symptoms lasted for 36-48 hours except for the legs swolleness and inability to hold him.  That lasted 3 days.  After 36 hours his fever bounced between 100 and 102 for another 36 then broke.  He also got a rash on the leg that had 2 vaccines and a large welt where the DTaP was given.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR
Symptoms: Migraine, Pyrexia, Thirst, Urticaria, Visual impairment
Clinical narrative: Both legs were very sore and would not support his weight.  His fever rose to 102 and remained there for 36 hours.  He had a head ache and said he couldnt see.  He followed me when I talked so I think it was a migraine and not actual lack of vision.  He had unquenchable thirst.  The symptoms lasted for 36-48 hours except for the legs swolleness and inability to hold him.  That lasted 3 days.  After 36 hours his fever bounced between 100 and 102 for another 36 then broke.  He also got a rash on the leg that had 2 vaccines and a large welt where the DTaP was given.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR
Symptoms: Weight bearing difficulty
Clinical narrative: Both legs were very sore and would not support his weight.  His fever rose to 102 and remained there for 36 hours.  He had a head ache and said he couldnt see.  He followed me when I talked so I think it was a migraine and not actual lack of vision.  He had unquenchable thirst.  The symptoms lasted for 36-48 hours except for the legs swolleness and inability to hold him.  That lasted 3 days.  After 36 hours his fever bounced between 100 and 102 for another 36 then broke.  He also got a rash on the leg that had 2 vaccines and a large welt where the DTaP was given.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13
Symptoms: Rash generalised, Rash maculo-papular
Clinical narrative: Generalized macule/papule rash.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Caesarean section, Exposure during pregnancy, Gestational diabetes, Laboratory test normal, Pain in extremity
Clinical narrative: Based on additional information received on 22 May 2015, this case initially considered as non-serious was upgraded to serious: important medical event as gestational diabetes. Initial unsolicited pregnancy report received from a healthcare professional (Nurse) on 14 Oct 2014. A 36-year-old female patient, who had no current pregnancy history and concomitant medications were not reported, had received intradermal dose of FLUZONE ID (batch number- UT4993BA, expiry date-05 Jun 2015, dose number not reported) in left deltoid on 14 Oct 2014. The last menstrual period was not reported and estimated date of delivery was 30 Jan 2015. At the time of vaccination the patient was pregnant. At the time of this report, the patient had not experienced any adverse events. Documents held by sender: none. Follow up information received from a physician on 14 May 2015. Physician reported that he had not given flu vaccine to the patient and as per his knowledge patient had no problems. No new information reported. Documents held by sender: none. Follow-up information received from nurse on 14 May 2015 and additional information received on 22 May 2015. A 36-year-old female patient relevant ongoing illness status reported as gestational diabetes with pregnancy. The patient had no family history of congenital abnormality. Date of last menstrual periods was reported as mid of April 2014. The estimated date of delivery was reported as 30 January 2015, Caesarean section due to gestational diabetes. Patient had received treatment for infertility with first child, not with this pregnancy. Previously patient was pregnant with outcome as one live birth. The patient had one pre-term birth with 38 plus 6 weeks - gestational diabetes. Patient's did not had elective abortion, spontaneous abortion prior to 20 weeks gestation and fetal death (<20 weeks gestation). Patient had experienced just arm soreness for 2-3 days as a relevant non serious adverse event. During the current pregnancy the patient had experienced gestational diabetes; therefore caesarean section was performed at 38 weeks. The baby was healthy. Laboratory investigation includes, gender screening all result was negative, ultrasound result was negative and no abnormal test. Pregnancy complication was reported as gestational diabetes. Patient's pregnancy outcome date of delivery was reported with single number of children. It was reported that patient gave birth to single male without any complications of labor, having one minute APGAR score was 8 and five minute APGAR score was 9, delivery mode was C-sec, weeks of gestation was 38, birth weight was 3.91 kg (8 lb 10 oz) and no any congenital abnormality. List of documents held by sender: none.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Ultrasound antenatal screen normal
Clinical narrative: Based on additional information received on 22 May 2015, this case initially considered as non-serious was upgraded to serious: important medical event as gestational diabetes. Initial unsolicited pregnancy report received from a healthcare professional (Nurse) on 14 Oct 2014. A 36-year-old female patient, who had no current pregnancy history and concomitant medications were not reported, had received intradermal dose of FLUZONE ID (batch number- UT4993BA, expiry date-05 Jun 2015, dose number not reported) in left deltoid on 14 Oct 2014. The last menstrual period was not reported and estimated date of delivery was 30 Jan 2015. At the time of vaccination the patient was pregnant. At the time of this report, the patient had not experienced any adverse events. Documents held by sender: none. Follow up information received from a physician on 14 May 2015. Physician reported that he had not given flu vaccine to the patient and as per his knowledge patient had no problems. No new information reported. Documents held by sender: none. Follow-up information received from nurse on 14 May 2015 and additional information received on 22 May 2015. A 36-year-old female patient relevant ongoing illness status reported as gestational diabetes with pregnancy. The patient had no family history of congenital abnormality. Date of last menstrual periods was reported as mid of April 2014. The estimated date of delivery was reported as 30 January 2015, Caesarean section due to gestational diabetes. Patient had received treatment for infertility with first child, not with this pregnancy. Previously patient was pregnant with outcome as one live birth. The patient had one pre-term birth with 38 plus 6 weeks - gestational diabetes. Patient's did not had elective abortion, spontaneous abortion prior to 20 weeks gestation and fetal death (<20 weeks gestation). Patient had experienced just arm soreness for 2-3 days as a relevant non serious adverse event. During the current pregnancy the patient had experienced gestational diabetes; therefore caesarean section was performed at 38 weeks. The baby was healthy. Laboratory investigation includes, gender screening all result was negative, ultrasound result was negative and no abnormal test. Pregnancy complication was reported as gestational diabetes. Patient's pregnancy outcome date of delivery was reported with single number of children. It was reported that patient gave birth to single male without any complications of labor, having one minute APGAR score was 8 and five minute APGAR score was 9, delivery mode was C-sec, weeks of gestation was 38, birth weight was 3.91 kg (8 lb 10 oz) and no any congenital abnormality. List of documents held by sender: none.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericardial disease, Pericarditis, Troponin I increased
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This solicited case was received from the investigator in a trial on 22 May 2015. A 20-year-old male subject, with no significant medical history, had received the following vaccines on 15 April 2015: a dose of ACAM2000 (lot number, route and site of administration not reported) and a dose of Anthrax vaccine (manufacturer, lot number, route and site of administration not reported). The subject was diagnosed with acute idiopathic pericarditis on 24 April 2015 and unspecified disease of pericardium on 25 April 2015 i.e. 9 days and 10 days respectively post-vaccination. On 24 April 2015, the subject's Troponin I result was abnormal, the highest value was 00.80 and electrocardiogram (ECG) was abnormal. Echocardiogram performed on 25 April 2015 was normal. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Company causality is associated. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: MMR, VARZOS
Symptoms: No adverse event
Clinical narrative: No adverse event, but will still monitor patient.
Age: 4.0
Sex: M
Vaccine: MMR, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse event, but will still monitor patient.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Aphagia, Asthenia, Ataxia, Balance disorder, Bone scan
Clinical narrative: Severe debilitating muscle pain, muscle atrophy, muscle tears, muscle spasms, painful spasms of mouth, tongue, throat. Unable to swallow. Gait ataxia, loss of balance. Loss of motor function, loss of sensory function, fatigue, chronic cough, nausea, vomiting, weight loss. Eye pain, peripheral neuropathy, severe achilles pain, one minute before onset I was an athlete. Illness continues.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Cast application, Computerised tomogram, Cough, Electromyogram, Eye pain
Clinical narrative: Severe debilitating muscle pain, muscle atrophy, muscle tears, muscle spasms, painful spasms of mouth, tongue, throat. Unable to swallow. Gait ataxia, loss of balance. Loss of motor function, loss of sensory function, fatigue, chronic cough, nausea, vomiting, weight loss. Eye pain, peripheral neuropathy, severe achilles pain, one minute before onset I was an athlete. Illness continues.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Glossodynia, Infusion, Laboratory test, Malaise
Clinical narrative: Severe debilitating muscle pain, muscle atrophy, muscle tears, muscle spasms, painful spasms of mouth, tongue, throat. Unable to swallow. Gait ataxia, loss of balance. Loss of motor function, loss of sensory function, fatigue, chronic cough, nausea, vomiting, weight loss. Eye pain, peripheral neuropathy, severe achilles pain, one minute before onset I was an athlete. Illness continues.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Motor dysfunction, Muscle atrophy, Muscle rupture, Muscle spasms, Myalgia
Clinical narrative: Severe debilitating muscle pain, muscle atrophy, muscle tears, muscle spasms, painful spasms of mouth, tongue, throat. Unable to swallow. Gait ataxia, loss of balance. Loss of motor function, loss of sensory function, fatigue, chronic cough, nausea, vomiting, weight loss. Eye pain, peripheral neuropathy, severe achilles pain, one minute before onset I was an athlete. Illness continues.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Neuropathy peripheral, Nuclear magnetic resonance imaging, Oral pain, Oropharyngeal pain
Clinical narrative: Severe debilitating muscle pain, muscle atrophy, muscle tears, muscle spasms, painful spasms of mouth, tongue, throat. Unable to swallow. Gait ataxia, loss of balance. Loss of motor function, loss of sensory function, fatigue, chronic cough, nausea, vomiting, weight loss. Eye pain, peripheral neuropathy, severe achilles pain, one minute before onset I was an athlete. Illness continues.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Sensory disturbance, Surgery, Tendon pain, Tongue spasm, Vomiting
Clinical narrative: Severe debilitating muscle pain, muscle atrophy, muscle tears, muscle spasms, painful spasms of mouth, tongue, throat. Unable to swallow. Gait ataxia, loss of balance. Loss of motor function, loss of sensory function, fatigue, chronic cough, nausea, vomiting, weight loss. Eye pain, peripheral neuropathy, severe achilles pain, one minute before onset I was an athlete. Illness continues.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Weight decreased, Wheelchair user, X-ray
Clinical narrative: Severe debilitating muscle pain, muscle atrophy, muscle tears, muscle spasms, painful spasms of mouth, tongue, throat. Unable to swallow. Gait ataxia, loss of balance. Loss of motor function, loss of sensory function, fatigue, chronic cough, nausea, vomiting, weight loss. Eye pain, peripheral neuropathy, severe achilles pain, one minute before onset I was an athlete. Illness continues.
Age: 59.0
Sex: F
Vaccine: IPV, RAB, TDAP, TYP
Symptoms: Cellulitis, Dermatitis psoriasiform, Laceration
Clinical narrative: Initial unsolicited report received from a physician on 20 May 2015. A 59-year-old female patient, whose medical history was reported as none and whose concomitant medication were not reported had received an intramuscular first dose of IMOVAX (batch number, expiration date, dose and site of administration were not reported), dose of TYPHIM VI (batch number, expiration date, dose, dose cycle and site of administration were not reported), intramuscular first dose of IPOL (batch number, expiration date, dose and site of administration were not reported) and dose of ADACEL (batch number, expiration date, dose, dose cycle and site of administration were not reported) on an unspecified date. The patient had received first dose of Yellow Fever vaccine (batch number, expiration date, dose and site of administration were not reported) intramuscularly seven to ten days ago on an unspecified date. Patient had also received Hep A (batch number, expiration date, dose, dose cycle, route and site of administration were not reported) within four weeks timeframe, on an unspecified date. Patient's any pre-existing physician diagnosed allergies, birth defects and medical conditions, illness at the time of vaccination were reported as none. Patient had not received any previous dose of Yellow Fever, IMOVAX and IPOL vaccines. Two weeks ago on an unspecified date, patient had a cut to her leg and it became cellulitis. Patient required treatment in the emergency room where she had a shot of Clindamycin and was given 7 days of oral pills. Reporter saw the patient about 4 days ago and noted a rash which he felt might be due to an allergy to clindamycin and not taking the last few pills. After 4 days the rash did not improve and patient was referred to a Dermatologist who diagnosed her with psoriasiform rash and wanted to start her on STELERA and was not sure if it was due to stress but could not rule out all the vaccines. Laboratory investigation was reported as none provided. At the time of this report, outcome of the event was not resolved. Upon medical review, company assessed the event of had a cut to her leg and it became a cellulitis as serious and important medical event. List of the documents held by sender: none.
Age: 58.0
Sex: M
Vaccine: DTP
Symptoms: Condition aggravated, Diagnostic procedure, Laboratory test normal, Multiple sclerosis
Clinical narrative: Patient was taken to local hospital and admitted due to exacerbation of MS. He denies any infection issues and relays that all diagnostic studies have returned negative. He is currently on the Transitional Care Unit and states that the plan is for him to be discharged to home within the next several days.
Age: 82.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Redness and inflammation at site. Itchy, warm and mild burning sensation-pt given 0.1% triamcinolone acetonele ointment.
Age: 82.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Redness and inflammation at site itchy, warm and mild burning sensation. Pt given 0.1% triamcinolone acetonate ointment.
Age: 1.26
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Body temperature increased, Dyskinesia, Measles antibody negative, Pain, Rash generalised
Clinical narrative: (2/8/15)-rectal temp-103 degrees went up to 104.5. Went to urgent care. Threw up 3xs in waiting room. Nurse checked his urine. Found no UTI. Went home. (2/9/15)-Nurse called but ended up going back b/c he was rolling around on the ground like he was in pain. (2/10/15)-Back to emergency room. (2/11/15)-Ultrasound emergency room. Found nothing. Had rash on body and 1 sore in mouth. Gave him a measles test but it came back negative, was told it was roseola.
Age: 1.26
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Roseola, Stomatitis, Ultrasound scan normal, Urine analysis normal, Vomiting
Clinical narrative: (2/8/15)-rectal temp-103 degrees went up to 104.5. Went to urgent care. Threw up 3xs in waiting room. Nurse checked his urine. Found no UTI. Went home. (2/9/15)-Nurse called but ended up going back b/c he was rolling around on the ground like he was in pain. (2/10/15)-Back to emergency room. (2/11/15)-Ultrasound emergency room. Found nothing. Had rash on body and 1 sore in mouth. Gave him a measles test but it came back negative, was told it was roseola.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Reports red, hard swollen, warm to touch (L) upper arm x 1 week after getting vaccine.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Joint range of motion decreased, Skin warm
Clinical narrative: Pt called office at 1:59pm stating injection site was red and swollen. She said she started itching on her way home at injection site. C/O decreased ROM. Nurse advised cool compress, ibuprofen/ADVIL. 5/22/15 pt has redness down right arm, swelling and warmth. Pt states that arm feels better today than yesterday. Dr advised ibuprofen/ADVIL/MOTRIN, BENADRYL and ZYRTEC.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Rash, swelling over left deltoid area and fever of 100 F developed approximately 24 hrs after vaccine administration. No breathing or systemic symptoms. Treated with BENADRYL.
Age: 28.0
Sex: F
Vaccine: HEPAB, TYP, YF
Symptoms: Rash
Clinical narrative: Rash on inner arms where the crease is, lasted the first couple days after the vaccinations and a rash on lower neck towards the chest, lasted almost two weeks. Took BENADRYL and used cortizone cream
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: About an hour after pneumonia 23 Imm. Pt. began having (L) arm pain, redness and swelling that continued to get worse. Went to E.R. 4 1/2 hours after getting immunization. No shortness of breath.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Nerve conduction studies normal
Clinical narrative: Immediate pain upon injection, pain worsened and has not gone away (7 months after the fact); ROM decreased and normal daily activities very painful; now experiencing sleep interruption; physical therapy ordered but not yet completed, Motrin for pain as tolerated, ice/heat not helpful.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Sleep disorder, Tendon rupture, Ultrasound scan abnormal, X-ray limb abnormal
Clinical narrative: Immediate pain upon injection, pain worsened and has not gone away (7 months after the fact); ROM decreased and normal daily activities very painful; now experiencing sleep interruption; physical therapy ordered but not yet completed, Motrin for pain as tolerated, ice/heat not helpful.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pruritus
Clinical narrative: Itching at the injection site.
Age: 1.02
Sex: M
Vaccine: HEP, MMR, PPV, VARCEL
Symptoms: Rash generalised, Rash morbilliform
Clinical narrative: Widespread rash resembling measles.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient received the Zostavax vaccine on 05/28/2015. Patient came by the pharmacy on 06/01/2015 b/c she had experienced an injection site reaction. The area where the vaccine was given was red, patient was told to take some Benadryl, and she said she was putting the spray on and is getting better.
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Fatigue, Influenza like illness, Pain in extremity, Rash, Skin warm
Clinical narrative: Pain in left arm for 4 days; fatigue; flu-like symptoms; rash with warmth in area.
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pain in extremity, Rash, Somnolence
Clinical narrative: Pain in left arm for 4 days; fatigue; flu-like symptoms; rash with warmth in area.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Amnesia, Syncope
Clinical narrative: He came to office for yearly check-up. Gave him GARDASIL and MENACTRA. Like 20 min once he left office mom came running into to office that her son had got in a accident. He went into syncope and collapse because he didn't remember anything that happen. Doctor examine him was ok and able to go home. Lab work was ordered, but has not been done yet.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Headache, Peripheral swelling, Tenderness, Vomiting
Clinical narrative: Vaccine administered Friday 05/29/15 at 4:00 PM. Patient fine until late Saturday (approx 11:00 PM). Experienced 4 hours of vomiting-Sunday morning had headache. Arm remains swollen, red and tender through Tuesday.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Vaccine administered Friday 05/29/15 at 4:00 PM. Patient fine until late Saturday (approx 11:00 PM). Experienced 4 hours of vomiting-Sunday morning had headache. Arm remains swollen, red and tender through Tuesday.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Skin warm, Vomiting
Clinical narrative: Vaccine administered Friday 05/29/15 at 4:00 PM. Patient fine until late Saturday (approx 11:00 PM). Experienced 4 hours of vomiting-Sunday morning had headache. Arm remains swollen, red and tender through Tuesday.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Atrioventricular block second degree, Electrocardiogram abnormal, Feeling hot, Local swelling, Pain
Clinical narrative: Initial local swelling, warmth, pain and itching - resolved over 3 days family believes CLARITIN helped. 4 hours of palpitations with new diagnosis of 2nd degree AV block in ER.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Palpitations, Pruritus
Clinical narrative: Initial local swelling, warmth, pain and itching - resolved over 3 days family believes CLARITIN helped. 4 hours of palpitations with new diagnosis of 2nd degree AV block in ER.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cough, Injection site reaction, Lacrimation increased, Lip pruritus, Ocular hyperaemia
Clinical narrative: He started coughing, complaining of lips and skin itching/tingling. Eyes were red and watching. Also site reaction to Right arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Paraesthesia, Paraesthesia oral, Pruritus
Clinical narrative: He started coughing, complaining of lips and skin itching/tingling. Eyes were red and watching. Also site reaction to Right arm.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting at 1am, 1:15am, 1:46am, 2:10am and 3:02 a.m. No fever (97 degree via ear) on May 29. At 8 am 5/29, fever of 99 degrees via ear.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Measles antibody positive, Pyrexia, Rash, Streptococcus test negative
Clinical narrative: Rash-diffuse. Fever-101 degrees F.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Erythema, Pain, Pruritus, Rash
Clinical narrative: Redness, swelling, rash, chills, pain and itching.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Swelling
Clinical narrative: Redness, swelling, rash, chills, pain and itching.
Age: 59.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Pain, Vaccination site pain
Clinical narrative: Arm ached at vaccination site for a couple of days.  It is the upper left arm, between elbow and shoulder.  I noticed over the next few months that certain backward motion of the arm caused some discomfort.  I stopped using the arm other than for forward motion.  The upper left arm and shoulder area became painful when use.  After months of discomfort, I went to the doctor who prescribed Naproxen and physical therapy.  The Naproxen upset my stomach, so I am just continuing with physical therapy for now.  The arm and shoulder are still painful and I am working on regaining some mobility in the arm.  It is difficult to get dressed or put on or take off a garment because my left arm will not cooperate in an extended up or backward motion.
Age: 59.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Limb discomfort, Mobility decreased, Vaccination site pain
Clinical narrative: Arm ached at vaccination site for a couple of days.  It is the upper left arm, between elbow and shoulder.  I noticed over the next few months that certain backward motion of the arm caused some discomfort.  I stopped using the arm other than for forward motion.  The upper left arm and shoulder area became painful when use.  After months of discomfort, I went to the doctor who prescribed Naproxen and physical therapy.  The Naproxen upset my stomach, so I am just continuing with physical therapy for now.  The arm and shoulder are still painful and I am working on regaining some mobility in the arm.  It is difficult to get dressed or put on or take off a garment because my left arm will not cooperate in an extended up or backward motion.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: 3hrs post HPV9 pt had sorethroat and headache
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Abscess limb, Bacterial test negative, Purulent discharge
Clinical narrative: Child received PEDIARIX IM to thigh on 3/18/15. Developed abscess to thigh and pus. Lesion cultured->culture negative. Treated cephalexin, warm compresses.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: PCV13 vaccine given to me May 22, 2015 on arm. Swelling disappear after 3 days. The redness is now spreading dowm to elbow. Antibiotics given May 22, 2015 by doctors office.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Patient started with hives aprox 5 mins after receiving vaccines on face and neck symptoms resolved 15 mins after given 12.5 mg BENADRYL. No respiratory symptoms.
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Reported swelling at injection site and entire arm. Within 8-12 hours of injection. She did not report reaction to provider until today 5/28/15. Site still reddened today about the size of a fifty cent piece. No further treatment necessary.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt was having redness, swelling, warm sensation at injection site.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red swollen about 10" long down to elbow pt put ice on it to left arm. Lasted about a week!
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Ecchymosis, Local swelling, Tenderness
Clinical narrative: Local swelling, tenderness, ecchymosis without fevers or vesicles.
Age: 1.06
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 12 month old female patient. Patient's concurrent conditions, concomitant medication and medical history were not provided. On 29-MAY-2015 the patient was inadvertently vaccinated with a dose of PROQUAD (Merck) (lot# was reported as L005295, expiry date 17-AUG-2016) and a dose of VARIVAX (Merck) (lot# was reported as L001327, expiry date 13-JAN-2017) (dose, route and dose number were unspecified). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Mucosal inflammation, Stomatitis
Clinical narrative: Information has been received from a pharmacist via field representative concerning a patient of unknown age and gender. The patient's medical history and concurrent condition were not provided. On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose and route not provided). Co-suspect and concomitant therapy were not provided. On an unknown date, a "couple of days" after administration of ZOSTAVAX, the patient developed mouth sores, mucosal sores. The outcome of the events was unknown. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 23-MAR-2015, the patient was vaccinated with an improperly stored GARDASIL dose 1, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Age: 12.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 23-MAR-2015, the patient was vaccinated with an improperly stored GARDASIL dose 1, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Incorrect route of drug administration
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. Information about patient's concurrent conditions and medical history was not reported. On an unspecified date in January 2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose not reported) intramuscularly instead of subcutaneously. Concomitant medications were not provided. On an unknown date the patient experienced congestive heart failure after receiving ZOSTAVAX> The patient had seek medical attention via an office visit. Beta blocker was given for congestive heart failure. The outcome of the congestive heart failure was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning 2 patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose and route were not reported, lot # was reported as K021881, expiry date: 30-JUL-2016). The temperature excursion for PNEUMOVAX 23 was supported with in-horse stability data. No adverse symptoms were reported. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Scab
Clinical narrative: Made a scab on arm and the scab stayed.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site scab
Clinical narrative: Made a scab on arm and the scab stayed.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chest pain, Electrocardiogram normal, Laboratory test
Clinical narrative: Severe joint pain all over body, chest pain.  Was given Tamiflu.