chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Pt became dizzy as he was leaving, sat in waiting room for 15 minutes, drank water, and ate a lollipop and left feeling "normal". We found that patient had not eaten breakfast which may have contributed to him feeling dizzy.
Age: 1.83
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, PNC13
Symptoms: Dermatitis exfoliative generalised, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Local erythroderma, warmth and painful touch, but no evidence of infection (right and left mid thigh, anterior aspect). Tender x 24h.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Red and swollen injection site (baseball size). No fever but pain.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient received the PNEUMOVAX 23 around 12:30pm. She went home and took a nap. After the nap, her arm was sore and she could hardly move the arm. Her bicep was swollen and swelling is down to her elbow. Patient called next day and swelling was still present. I called PCP and reported the reaction. Pt will also call the Dr. per staff at Dr's office, Dr will call patient. 9/12/18 swelling went down. Pt feeling much better. Redness from bicep to elbow.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema
Clinical narrative: Large, red area to (R) deltoid - (6" x 8" in diameter).
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: Pt reported on 9/5/18 extreme pain in arm ever since inj given, as well as large bump under skin where inj was given. No rash or redness/discoloration in area. Pt informed to treat for now w/heat compressors per provider.
Age: 72.0
Sex: U
Vaccine: FLUA3, PPV
Symptoms: Administration site rash, Administration site swelling
Clinical narrative: Big rash and swelling at site of administration.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Acute disseminated encephalomyelitis, Death, Headache
Clinical narrative: Patient complained of a headache as early as July 20th. Then the next complaint wasnt until the 30th of July. He said he had a headache and sore throat. Then on August 1st again a headache. So i took him to the express. They said it was viral and to treat symptoms. On Monday the 6th he had football and was complaining of a headache and that he was going to pass out. He came home that night and went to bed at 630pm and slept until 230 the next day August 7th. He had practice that day from 3 to 530 them came home and slept from 630 thay night until 730 Wednesday August 8th when i woke him up to go to ER. He was very confused. Didn't know what was going on. They tested him at the er and all test were normal. We then were sent to hospital. Where we were for 8 days before patient suffered an unexplainable ammount of brain swelling and died because of a brain herniation. We were spacifically told by his neurogolist it was indeed his HPV vaccination.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Altered state of consciousness, Blood test, Brain herniation, Brain oedema, Computerised tomogram
Clinical narrative: Patient complained of a headache as early as July 20th. Then the next complaint wasnt until the 30th of July. He said he had a headache and sore throat. Then on August 1st again a headache. So i took him to the express. They said it was viral and to treat symptoms. On Monday the 6th he had football and was complaining of a headache and that he was going to pass out. He came home that night and went to bed at 630pm and slept until 230 the next day August 7th. He had practice that day from 3 to 530 them came home and slept from 630 thay night until 730 Wednesday August 8th when i woke him up to go to ER. He was very confused. Didn't know what was going on. They tested him at the er and all test were normal. We then were sent to hospital. Where we were for 8 days before patient suffered an unexplainable ammount of brain swelling and died because of a brain herniation. We were spacifically told by his neurogolist it was indeed his HPV vaccination.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Confusional state, Death, Headache, Laboratory test normal, Lumbar puncture
Clinical narrative: Patient complained of a headache as early as July 20th. Then the next complaint wasnt until the 30th of July. He said he had a headache and sore throat. Then on August 1st again a headache. So i took him to the express. They said it was viral and to treat symptoms. On Monday the 6th he had football and was complaining of a headache and that he was going to pass out. He came home that night and went to bed at 630pm and slept until 230 the next day August 7th. He had practice that day from 3 to 530 them came home and slept from 630 thay night until 730 Wednesday August 8th when i woke him up to go to ER. He was very confused. Didn't know what was going on. They tested him at the er and all test were normal. We then were sent to hospital. Where we were for 8 days before patient suffered an unexplainable ammount of brain swelling and died because of a brain herniation. We were spacifically told by his neurogolist it was indeed his HPV vaccination.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Nuclear magnetic resonance imaging, Oropharyngeal pain, Viral infection
Clinical narrative: Patient complained of a headache as early as July 20th. Then the next complaint wasnt until the 30th of July. He said he had a headache and sore throat. Then on August 1st again a headache. So i took him to the express. They said it was viral and to treat symptoms. On Monday the 6th he had football and was complaining of a headache and that he was going to pass out. He came home that night and went to bed at 630pm and slept until 230 the next day August 7th. He had practice that day from 3 to 530 them came home and slept from 630 thay night until 730 Wednesday August 8th when i woke him up to go to ER. He was very confused. Didn't know what was going on. They tested him at the er and all test were normal. We then were sent to hospital. Where we were for 8 days before patient suffered an unexplainable ammount of brain swelling and died because of a brain herniation. We were spacifically told by his neurogolist it was indeed his HPV vaccination.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Abnormal behaviour, Acute disseminated encephalomyelitis, Acute haemorrhagic leukoencephalitis, Agitation, Ammonia normal
Clinical narrative: Patient complained of a headache as early as July 20th. Then the next complaint wasnt until the 30th of July. He said he had a headache and sore throat. Then on August 1st again a headache. So i took him to the express. They said it was viral and to treat symptoms. On Monday the 6th he had football and was complaining of a headache and that he was going to pass out. He came home that night and went to bed at 630pm and slept until 230 the next day August 7th. He had practice that day from 3 to 530 them came home and slept from 630 thay night until 730 Wednesday August 8th when i woke him up to go to ER. He was very confused. Didn't know what was going on. They tested him at the er and all test were normal. We then were sent to hospital. Where we were for 8 days before patient suffered an unexplainable ammount of brain swelling and died because of a brain herniation. We were spacifically told by his neurogolist it was indeed his HPV vaccination.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Autopsy, Bacterial test negative, Blood lactic acid normal, Borrelia test negative, Brain herniation
Clinical narrative: Patient complained of a headache as early as July 20th. Then the next complaint wasnt until the 30th of July. He said he had a headache and sore throat. Then on August 1st again a headache. So i took him to the express. They said it was viral and to treat symptoms. On Monday the 6th he had football and was complaining of a headache and that he was going to pass out. He came home that night and went to bed at 630pm and slept until 230 the next day August 7th. He had practice that day from 3 to 530 them came home and slept from 630 thay night until 730 Wednesday August 8th when i woke him up to go to ER. He was very confused. Didn't know what was going on. They tested him at the er and all test were normal. We then were sent to hospital. Where we were for 8 days before patient suffered an unexplainable ammount of brain swelling and died because of a brain herniation. We were spacifically told by his neurogolist it was indeed his HPV vaccination.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Brain oedema, Bronchoscopy, CSF culture negative, CSF glucose normal, CSF lymphocyte count increased
Clinical narrative: Patient complained of a headache as early as July 20th. Then the next complaint wasnt until the 30th of July. He said he had a headache and sore throat. Then on August 1st again a headache. So i took him to the express. They said it was viral and to treat symptoms. On Monday the 6th he had football and was complaining of a headache and that he was going to pass out. He came home that night and went to bed at 630pm and slept until 230 the next day August 7th. He had practice that day from 3 to 530 them came home and slept from 630 thay night until 730 Wednesday August 8th when i woke him up to go to ER. He was very confused. Didn't know what was going on. They tested him at the er and all test were normal. We then were sent to hospital. Where we were for 8 days before patient suffered an unexplainable ammount of brain swelling and died because of a brain herniation. We were spacifically told by his neurogolist it was indeed his HPV vaccination.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: CSF protein normal, CSF red blood cell count positive, CSF virus no organisms observed, Computerised tomogram head abnormal, Confusional state
Clinical narrative: Patient complained of a headache as early as July 20th. Then the next complaint wasnt until the 30th of July. He said he had a headache and sore throat. Then on August 1st again a headache. So i took him to the express. They said it was viral and to treat symptoms. On Monday the 6th he had football and was complaining of a headache and that he was going to pass out. He came home that night and went to bed at 630pm and slept until 230 the next day August 7th. He had practice that day from 3 to 530 them came home and slept from 630 thay night until 730 Wednesday August 8th when i woke him up to go to ER. He was very confused. Didn't know what was going on. They tested him at the er and all test were normal. We then were sent to hospital. Where we were for 8 days before patient suffered an unexplainable ammount of brain swelling and died because of a brain herniation. We were spacifically told by his neurogolist it was indeed his HPV vaccination.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Craniectomy, Cryptococcus test, Cytomegalovirus test negative, Death, Depressed level of consciousness
Clinical narrative: Patient complained of a headache as early as July 20th. Then the next complaint wasnt until the 30th of July. He said he had a headache and sore throat. Then on August 1st again a headache. So i took him to the express. They said it was viral and to treat symptoms. On Monday the 6th he had football and was complaining of a headache and that he was going to pass out. He came home that night and went to bed at 630pm and slept until 230 the next day August 7th. He had practice that day from 3 to 530 them came home and slept from 630 thay night until 730 Wednesday August 8th when i woke him up to go to ER. He was very confused. Didn't know what was going on. They tested him at the er and all test were normal. We then were sent to hospital. Where we were for 8 days before patient suffered an unexplainable ammount of brain swelling and died because of a brain herniation. We were spacifically told by his neurogolist it was indeed his HPV vaccination.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Disorientation, Drug screen negative, Dyskinesia, Dyspnoea, Electrocardiogram normal
Clinical narrative: Patient complained of a headache as early as July 20th. Then the next complaint wasnt until the 30th of July. He said he had a headache and sore throat. Then on August 1st again a headache. So i took him to the express. They said it was viral and to treat symptoms. On Monday the 6th he had football and was complaining of a headache and that he was going to pass out. He came home that night and went to bed at 630pm and slept until 230 the next day August 7th. He had practice that day from 3 to 530 them came home and slept from 630 thay night until 730 Wednesday August 8th when i woke him up to go to ER. He was very confused. Didn't know what was going on. They tested him at the er and all test were normal. We then were sent to hospital. Where we were for 8 days before patient suffered an unexplainable ammount of brain swelling and died because of a brain herniation. We were spacifically told by his neurogolist it was indeed his HPV vaccination.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Electroencephalogram abnormal, Endotracheal intubation, Enterovirus test negative, Epstein-Barr virus test negative, Escherichia test negative
Clinical narrative: Patient complained of a headache as early as July 20th. Then the next complaint wasnt until the 30th of July. He said he had a headache and sore throat. Then on August 1st again a headache. So i took him to the express. They said it was viral and to treat symptoms. On Monday the 6th he had football and was complaining of a headache and that he was going to pass out. He came home that night and went to bed at 630pm and slept until 230 the next day August 7th. He had practice that day from 3 to 530 them came home and slept from 630 thay night until 730 Wednesday August 8th when i woke him up to go to ER. He was very confused. Didn't know what was going on. They tested him at the er and all test were normal. We then were sent to hospital. Where we were for 8 days before patient suffered an unexplainable ammount of brain swelling and died because of a brain herniation. We were spacifically told by his neurogolist it was indeed his HPV vaccination.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Fatigue, Full blood count normal, General physical health deterioration, Grip strength decreased, Headache
Clinical narrative: Patient complained of a headache as early as July 20th. Then the next complaint wasnt until the 30th of July. He said he had a headache and sore throat. Then on August 1st again a headache. So i took him to the express. They said it was viral and to treat symptoms. On Monday the 6th he had football and was complaining of a headache and that he was going to pass out. He came home that night and went to bed at 630pm and slept until 230 the next day August 7th. He had practice that day from 3 to 530 them came home and slept from 630 thay night until 730 Wednesday August 8th when i woke him up to go to ER. He was very confused. Didn't know what was going on. They tested him at the er and all test were normal. We then were sent to hospital. Where we were for 8 days before patient suffered an unexplainable ammount of brain swelling and died because of a brain herniation. We were spacifically told by his neurogolist it was indeed his HPV vaccination.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Hemiparesis, Herpes simplex test negative, Hypoxic-ischaemic encephalopathy, Immunoglobulin therapy, Influenza virus test negative
Clinical narrative: Patient complained of a headache as early as July 20th. Then the next complaint wasnt until the 30th of July. He said he had a headache and sore throat. Then on August 1st again a headache. So i took him to the express. They said it was viral and to treat symptoms. On Monday the 6th he had football and was complaining of a headache and that he was going to pass out. He came home that night and went to bed at 630pm and slept until 230 the next day August 7th. He had practice that day from 3 to 530 them came home and slept from 630 thay night until 730 Wednesday August 8th when i woke him up to go to ER. He was very confused. Didn't know what was going on. They tested him at the er and all test were normal. We then were sent to hospital. Where we were for 8 days before patient suffered an unexplainable ammount of brain swelling and died because of a brain herniation. We were spacifically told by his neurogolist it was indeed his HPV vaccination.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Intensive care, Liver function test normal, Loss of personal independence in daily activities, Mental status changes, Metabolic function test normal
Clinical narrative: Patient complained of a headache as early as July 20th. Then the next complaint wasnt until the 30th of July. He said he had a headache and sore throat. Then on August 1st again a headache. So i took him to the express. They said it was viral and to treat symptoms. On Monday the 6th he had football and was complaining of a headache and that he was going to pass out. He came home that night and went to bed at 630pm and slept until 230 the next day August 7th. He had practice that day from 3 to 530 them came home and slept from 630 thay night until 730 Wednesday August 8th when i woke him up to go to ER. He was very confused. Didn't know what was going on. They tested him at the er and all test were normal. We then were sent to hospital. Where we were for 8 days before patient suffered an unexplainable ammount of brain swelling and died because of a brain herniation. We were spacifically told by his neurogolist it was indeed his HPV vaccination.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Moaning, Monocytosis, Muscular weakness, Nervous system disorder, Neurological examination abnormal
Clinical narrative: Patient complained of a headache as early as July 20th. Then the next complaint wasnt until the 30th of July. He said he had a headache and sore throat. Then on August 1st again a headache. So i took him to the express. They said it was viral and to treat symptoms. On Monday the 6th he had football and was complaining of a headache and that he was going to pass out. He came home that night and went to bed at 630pm and slept until 230 the next day August 7th. He had practice that day from 3 to 530 them came home and slept from 630 thay night until 730 Wednesday August 8th when i woke him up to go to ER. He was very confused. Didn't know what was going on. They tested him at the er and all test were normal. We then were sent to hospital. Where we were for 8 days before patient suffered an unexplainable ammount of brain swelling and died because of a brain herniation. We were spacifically told by his neurogolist it was indeed his HPV vaccination.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Oedema, Oxygen saturation decreased, Pharyngitis, Pleocytosis
Clinical narrative: Patient complained of a headache as early as July 20th. Then the next complaint wasnt until the 30th of July. He said he had a headache and sore throat. Then on August 1st again a headache. So i took him to the express. They said it was viral and to treat symptoms. On Monday the 6th he had football and was complaining of a headache and that he was going to pass out. He came home that night and went to bed at 630pm and slept until 230 the next day August 7th. He had practice that day from 3 to 530 them came home and slept from 630 thay night until 730 Wednesday August 8th when i woke him up to go to ER. He was very confused. Didn't know what was going on. They tested him at the er and all test were normal. We then were sent to hospital. Where we were for 8 days before patient suffered an unexplainable ammount of brain swelling and died because of a brain herniation. We were spacifically told by his neurogolist it was indeed his HPV vaccination.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Pupil fixed, Scan with contrast abnormal, Specific gravity urine normal, Streptococcus test negative, Tachycardia
Clinical narrative: Patient complained of a headache as early as July 20th. Then the next complaint wasnt until the 30th of July. He said he had a headache and sore throat. Then on August 1st again a headache. So i took him to the express. They said it was viral and to treat symptoms. On Monday the 6th he had football and was complaining of a headache and that he was going to pass out. He came home that night and went to bed at 630pm and slept until 230 the next day August 7th. He had practice that day from 3 to 530 them came home and slept from 630 thay night until 730 Wednesday August 8th when i woke him up to go to ER. He was very confused. Didn't know what was going on. They tested him at the er and all test were normal. We then were sent to hospital. Where we were for 8 days before patient suffered an unexplainable ammount of brain swelling and died because of a brain herniation. We were spacifically told by his neurogolist it was indeed his HPV vaccination.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Tremor, Unresponsive to stimuli, Urine ketone body present, Varicella virus test negative, Viral infection
Clinical narrative: Patient complained of a headache as early as July 20th. Then the next complaint wasnt until the 30th of July. He said he had a headache and sore throat. Then on August 1st again a headache. So i took him to the express. They said it was viral and to treat symptoms. On Monday the 6th he had football and was complaining of a headache and that he was going to pass out. He came home that night and went to bed at 630pm and slept until 230 the next day August 7th. He had practice that day from 3 to 530 them came home and slept from 630 thay night until 730 Wednesday August 8th when i woke him up to go to ER. He was very confused. Didn't know what was going on. They tested him at the er and all test were normal. We then were sent to hospital. Where we were for 8 days before patient suffered an unexplainable ammount of brain swelling and died because of a brain herniation. We were spacifically told by his neurogolist it was indeed his HPV vaccination.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Vomiting
Clinical narrative: Patient complained of a headache as early as July 20th. Then the next complaint wasnt until the 30th of July. He said he had a headache and sore throat. Then on August 1st again a headache. So i took him to the express. They said it was viral and to treat symptoms. On Monday the 6th he had football and was complaining of a headache and that he was going to pass out. He came home that night and went to bed at 630pm and slept until 230 the next day August 7th. He had practice that day from 3 to 530 them came home and slept from 630 thay night until 730 Wednesday August 8th when i woke him up to go to ER. He was very confused. Didn't know what was going on. They tested him at the er and all test were normal. We then were sent to hospital. Where we were for 8 days before patient suffered an unexplainable ammount of brain swelling and died because of a brain herniation. We were spacifically told by his neurogolist it was indeed his HPV vaccination.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash, Joint stiffness, Paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 63-year-old male patient who received SHINGRIX (batch number 32PE4, expiry date 23rd January 2021) for prophylaxis. On 11th June 2018, the patient received SHINGRIX. On 11th June 2018, unknown after receiving SHINGRIX, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the patient experienced injection site rash, tingling of extremity, shoulder pain and stiff knees. On an unknown date, the outcome of the injection site rash, tingling of extremity, shoulder pain and stiff knees were recovering/resolving and the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the injection site rash, tingling of extremity, shoulder pain and stiff knees to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The healthcare professional reported that the patient inadvertently received a dose of SHINGRIX reconstituted with sterile water diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. After this the patient developed tingling up and down arm, rash at the injection site, left shoulder pain and right knee stiffening up. It was reported that at the time of reporting the patient's symptoms had mostly resolved however the patient did seek medical attention for the reported symptoms. No further information reported at time of reporting. The healthcare professional reported that she was unsure if the incident had been reported already, however she did not have documentation that it had been.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect dose administered, Injection site rash, Joint stiffness, Musculoskeletal pain, Paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 63-year-old male patient who received SHINGRIX (batch number 32PE4, expiry date 23rd January 2021) for prophylaxis. On 11th June 2018, the patient received SHINGRIX. On 11th June 2018, unknown after receiving SHINGRIX, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the patient experienced injection site rash, tingling of extremity, shoulder pain and stiff knees. On an unknown date, the outcome of the injection site rash, tingling of extremity, shoulder pain and stiff knees were recovering/resolving and the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the injection site rash, tingling of extremity, shoulder pain and stiff knees to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The healthcare professional reported that the patient inadvertently received a dose of SHINGRIX reconstituted with sterile water diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. After this the patient developed tingling up and down arm, rash at the injection site, left shoulder pain and right knee stiffening up. It was reported that at the time of reporting the patient's symptoms had mostly resolved however the patient did seek medical attention for the reported symptoms. No further information reported at time of reporting. The healthcare professional reported that she was unsure if the incident had been reported already, however she did not have documentation that it had been.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Product preparation error
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 63-year-old male patient who received SHINGRIX (batch number 32PE4, expiry date 23rd January 2021) for prophylaxis. On 11th June 2018, the patient received SHINGRIX. On 11th June 2018, unknown after receiving SHINGRIX, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the patient experienced injection site rash, tingling of extremity, shoulder pain and stiff knees. On an unknown date, the outcome of the injection site rash, tingling of extremity, shoulder pain and stiff knees were recovering/resolving and the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the injection site rash, tingling of extremity, shoulder pain and stiff knees to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The healthcare professional reported that the patient inadvertently received a dose of SHINGRIX reconstituted with sterile water diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. After this the patient developed tingling up and down arm, rash at the injection site, left shoulder pain and right knee stiffening up. It was reported that at the time of reporting the patient's symptoms had mostly resolved however the patient did seek medical attention for the reported symptoms. No further information reported at time of reporting. The healthcare professional reported that she was unsure if the incident had been reported already, however she did not have documentation that it had been.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced swelling, redness, and soreness in left deltoid following immunization. Patient stated that she took some NSAIDs and put an ice pack on the area, which did not significantly change outcome. Patient is able to move arm.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: Dizziness, Pallor
Clinical narrative: Pt's face looked pale after the shots. She complained of a little dizziness. No sob, no rash. No difficulty in breathing. Nurse assisted to lie down on the table with legs elevated. HR 53 bpm, BP 110/66, SpO2 94 initially. About 1min later, SpO2 to 98, HR 58. Pt's dizziness went away in about 2-3mins. Recheck HR 5 mins later, HR 70. Pt acted fine and looked fine. No dizziness. Pt went home together with her mom.
Age: 83.0
Sex: M
Vaccine: UNK
Symptoms: Pain, Pollakiuria
Clinical narrative: Aches and pains, urinary frequency.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Decreased appetite, Headache, Influenza like illness
Clinical narrative: This was my second injection in the SHINGRIX series. I had a similar reaction with the first. Pain and stiffness at the site of the injection; flu-like symptoms beginning at night and peaking in the morning: pain in joints and muscles, weakness in muscles, lethargy, chills, mild nausea, headache, redness and swelling at the injection site, no appetite. Most of the flu-like symptoms had resolved by 4pm, 24 hrs from receipt of the vaccination, except for the redness and swelling at the injection site, which is still present at 7:30 am the next day.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Lethargy
Clinical narrative: This was my second injection in the SHINGRIX series. I had a similar reaction with the first. Pain and stiffness at the site of the injection; flu-like symptoms beginning at night and peaking in the morning: pain in joints and muscles, weakness in muscles, lethargy, chills, mild nausea, headache, redness and swelling at the injection site, no appetite. Most of the flu-like symptoms had resolved by 4pm, 24 hrs from receipt of the vaccination, except for the redness and swelling at the injection site, which is still present at 7:30 am the next day.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: This was my second injection in the SHINGRIX series. I had a similar reaction with the first. Pain and stiffness at the site of the injection; flu-like symptoms beginning at night and peaking in the morning: pain in joints and muscles, weakness in muscles, lethargy, chills, mild nausea, headache, redness and swelling at the injection site, no appetite. Most of the flu-like symptoms had resolved by 4pm, 24 hrs from receipt of the vaccination, except for the redness and swelling at the injection site, which is still present at 7:30 am the next day.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Discomfort, Feeling abnormal, Headache, Nausea
Clinical narrative: Fever of 102, severe headache that wouldn't go away with ADVIL, severe total body aches and pains, weakness, nausea. I couldn't even walk. Stayed in bed, but difficult to get comfortable, body pain. The second day I feel better, but still have the headache, and feel slightly out of it.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia
Clinical narrative: Fever of 102, severe headache that wouldn't go away with ADVIL, severe total body aches and pains, weakness, nausea. I couldn't even walk. Stayed in bed, but difficult to get comfortable, body pain. The second day I feel better, but still have the headache, and feel slightly out of it.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Information has been received from a medical assistant referring to a 34 year old patient of unknown gender. Information about concomitant medication, concurrent condition, and medical history was not reported. On 23-AUG-2018, the patient was inadvertently administered with PROQUAD, lot # R011804 (expiration date 21-OCT-2019), subcutaneously for prophylaxis. No adverse effect reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On 27-AUG-2018, the patient was vaccinated with an improperly stored dose of PROQUAD for prophylaxis, lot # R011215 and expiration date 15-OCT-2019 (reported as 15-MAR-2019) (dose, strength, and route of administration were unknown). No adverse effects were reported. The reporter stated that the vaccine was stored at a temperature of -14°C to -10°C for 30 minutes and -9°C to 8°C for 2 hours. Digital data logger was involved.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions or concomitant medications. On 31-AUG-2018, the patient was inadvertently vaccinated with (rHA) (M-M-R II) lot number M034857 with expiration date on 27-JUL-2018 with sterile diluent (MERCK) lot number M031575 with expiration date on 26-MAR-2019 (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, No adverse event
Clinical narrative: This spontaneous report was received from nurse referring to a 31 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date the patient was vaccinated with VARIVAX (doses, routes of administration, lot numbers and expiration dates were not reported) for chickenpox prophylaxis. On 05-JUN-2018, the patient had a VARIVAX/ZOSTER AG/IGG test performed and the results showed negative titre levels. No adverse effects reported. The outcome of varicella virus test negative was reported as not recovered. The causality between the event and the therapy with VARIVAX was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Varicella zoster pneumonia
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 31-AUG-2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 30-SEP-2016, the patient was treated by a physician at a clinic for the onset of varicella pneumonia which is caused by the varicella zoster virus. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Upon internal review, varicella pneumonia was considered to be a medically significant event. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Pain
Clinical narrative: This spontaneous report was received from a physician, via a company representative, referring to a 14 year old female patient. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 15-AUG-2016, the patient was vaccinated with GARDASIL 9 for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported). On 16-AUG-2016, the patient was sent to an unspecified emergency room for unspecified pain and was released on the same day. On unspecified day after the emergency room visit, the patient was seen by unspecified rheumatologist and was diagnosed with amplified pain syndrome. It was unknown by the reporter whether the patient received treatment or if any laboratory tests were carried out. The outcome of amplified pain syndrome was reported as not recovered. The reporter did not assess the relatedness of amplified pain syndrome with GARDASIL 9; however, in the rheumatologist's opinion the amplified pain syndrome was not from GARDASIL 9 but it was from the patient's physical activity as gymnast.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 14-AUG-2018, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX subcutaneously, lot # R011808 expiration date of 23-APR-2020, for prophylaxis (strength was not reported) that was reconstituted with properly stored MERCK STERILE DILUENT lot # M033585 with expiration date of 21-APR-2019. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion 15°F to 46°F (degrees Fahrenheit) for 5 days. No previous temperature excursion was performed. The call was not because of a "data logger".
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of widespread rash in a 52-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020) for prophylaxis. On 23rd April 2018 10:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced widespread rash. On an unknown date, the outcome of the widespread rash was recovered/resolved. It was unknown if the reporter considered the widespread rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The patient developed a diffuse rash within 24 to 48 hours.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a 71-year-old male patient who received SHINGRIX (batch number M77B4, expiry date 8th February 2021) for prophylaxis. On 1st September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 1st September 2018, less than a day after receiving SHINGRIX, the patient experienced shivering and joint pain. On an unknown date, the outcome of the shivering and joint pain were not recovered/not resolved. It was unknown if the reporter considered the shivering and joint pain to be related to SHINGRIX. Additional information was reported as follows: On 1st September 2018, the same day after vaccination with SHINGRIX, the patient experienced shivering and joint pain from the hip down which occurred more specifically at the left leg. Till the time of reporting the patient was still experiencing the events. The reporter was unable to provide further additional information.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain and product supply issue. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on right arm. The patient reported that she had pain and soreness at the injection site, which had lasted for 3 days. At the time of reporting, it had been 6 months and 2 weeks since the 1st dose, the patient did not receive the 2nd dose of the SHINGRIX vaccine due to shortage. The patient had denied permission to contact their physician. No further details were provided.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Bedridden, Chills, Feeling cold, Headache, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 67-year-old male patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, several hours after receiving SHINGRIX, the patient experienced shivering, coldness, headache, fever, pain in arm and bedridden. On an unknown date, the outcome of the shivering, coldness, headache, fever, pain in arm and bedridden were recovered/resolved. It was unknown if the reporter considered the shivering, coldness, headache, fever, pain in arm and bedridden to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccination in the early afternoon and developed the effects as noted later that evening and into the night. The patient felt better the next day, but had relapsed chills and fever and also developed a headache that lasted a day and a half. The symptoms were lasted about 3 days in all.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 67-year-old male patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, several hours after receiving SHINGRIX, the patient experienced shivering, coldness, headache, fever, pain in arm and bedridden. On an unknown date, the outcome of the shivering, coldness, headache, fever, pain in arm and bedridden were recovered/resolved. It was unknown if the reporter considered the shivering, coldness, headache, fever, pain in arm and bedridden to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccination in the early afternoon and developed the effects as noted later that evening and into the night. The patient felt better the next day, but had relapsed chills and fever and also developed a headache that lasted a day and a half. The symptoms were lasted about 3 days in all.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Breath sounds abnormal, Cough, Influenza, Oxygen consumption decreased, Pneumothorax
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 70-year-old male patient who received Influenza vaccine Quadrivalent for prophylaxis. Co-suspect products included ADVAIR HFA inhaler (batch number 8ZP0313, expiry date 30th September 2019) for chronic obstructive pulmonary disease and TAMIFLU (batch number UNKNOWN, expiry date unknown) for an unknown indication. In October 2017, the patient received Influenza vaccine Quadrivalent 2017-2018 season. On an unknown date, the patient started ADVAIR HFA (inhaled) 1 puff(s) twice daily (2 puff(s) daily). On an unknown date, the dose was changed to an unknown dose and frequency. In March 2018, the patient started TAMIFLU at an unknown dose and frequency. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2017-2018 season and not applicable after starting ADVAIR HFA, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza (serious criteria hospitalization), collapse of lung (serious criteria hospitalization and GSK medically significant), lung injury (serious criteria hospitalization), diminished lung sounds (serious criteria hospitalization), cough (serious criteria hospitalization) and oxygen consumption decreased (serious criteria hospitalization). ADVAIR HFA was continued with no change. On an unknown date, the outcome of the vaccination failure, influenza, collapse of lung, lung injury, diminished lung sounds, cough and oxygen consumption decreased were unknown. It was unknown if the reporter considered the vaccination failure, influenza, collapse of lung, lung injury, diminished lung sounds, cough and oxygen consumption decreased to be related to Influenza vaccine Quadrivalent 2017-2018 season. It was unknown if the reporter considered the influenza, collapse of lung, lung injury, diminished lung sounds, cough and oxygen consumption decreased to be related to ADVAIR HFA. Additional details were provided as follows: This case was reported by the patient's wife. The patient received flu shot in his left arm. In March 2018, the patient was diagnosed with the flu and started on TAMIFLU. Five days after receiving TAMIFLU, he had a coughing spell and he heard his left lung pop. The patient was diagnosed with a collapsed lung. He went to the hospital. In an effort to inflate his lung, a breathing tube was inserted but it blew two small holes in his lung. He was in the hospital for eight weeks. The reporter indicated that the patient had been on 24 hour oxygen since being discharged from the hospital. It was unknown if the reporter considered the collapse of lung, lung injury, diminished lung sounds, cough and oxygen consumption decreased to be related to TAMIFLU as well. The reporter was unable to provide any additional details related to the TAMIFLU because he no longer had the container. The reporter gave permission for his physician to be contacted.