chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: Adacel was given in the gluteal area / no adverse event; Initial information received on 06-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.   This case involves unknown demographic patient who received a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and Expiry date unknown) via unknown route in gluteal area on an unknown date.  The patient past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.   It was an actual medication error due to Vaccine administered at inappropriate site   it was reported that Adacel was given in the gluteal area.   At a time of reporting no AE symptoms reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: facility administered an expired Menactra vaccine; Initial information received on 06-Aug-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves unknown demographic  patient who received an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5916AA (Expiry date 27-Jun-2019) via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At a time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: Expired dose was given; Initial information received on 06-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves male patient of unknown age who received an expired dose of vaccine IPV (VERO) [IPOL] (Lot number: N1G11M, No dosing details reported) on an unknown date.  The patient's past medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  It was of actual medication error case due to expired vaccine used.  It was not reported whether adverse event was experienced.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain, Vomiting, White blood cell count increased
Clinical narrative: Within 4 days of the third HPV shot (he had the original shot and the first booster without issue), my son started having severe abdominal pain at 3am.  Took Pepto-Bismol and Tylenol to try to reduce pain.  Neither worked and he then threw up 6 times.  We took him to an Urgent Care facility because it was not getting better and because he kept throwing up.  He had to have anti-nausea medicine and pain medication administered through an IV because he threw up trying to receive the medications orally.  After the IV administered medications took effect, he started to feel better and was able to leave the Urgent Care facility.  He has stopped throwing up, but 2 days later still has a smaller amount of pain in his stomach.   I am hoping that will continue to subside.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash pruritic, Scab
Clinical narrative: Moderate pain for 1 day,  Itchy rash, about 4 - 6 bumps, crusted over after about 4 days.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Abnormal faeces, Diarrhoea, Pyrexia
Clinical narrative: Mother reports 1 to 2 hours after vaccination child started running a temp or 101.5-101.9 with temporal thermometer with loose, stinky stools. Mother reports alternated giving Tylenol and Motrin for fever. Child would not eat solid food but nursed okay. Mother reported above symptoms to the child's physician and he visited with her over the phone but did not see the child. Mother reports no fever since Tuesday, August 6 and the loose stools were lessening.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia, Rash
Clinical narrative: Fever started 8/6 after vaccines for 36hrs, rash started 8/7/2019.  8/8/2019 seen here in our office and also sent to dermatology for eval, concerns for allergic reaction. Admitted to Hospital for observation 8/8/2019. Given steroid course and monitored.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Feeling abnormal, Nausea, Syncope, Vomiting
Clinical narrative: Client stated he felt "weird" after HPV vaccine and proceeded to faint while sitting on exam table. Client recovered within a few seconds and stated he felt nausea and vomited a scant amount. Provided client with cool rag, water to drink as well as a snack. After a few minutes he stated that he no longer felt weird and was feeling back to normal.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Blood culture, Full blood count, Pyrexia, Rash
Clinical narrative: Fever and Rash from MMR
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Headache, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: Pt reviewed VIS form and said she was ok to have MMR vaccine. Patient on Humera (a biological immunosuppressant), last dose 7/31/2019. Patient provided MMR immunization through Employee Health on 8/1/2019. The patient had a reaction to the vaccine with rash, fever, sore throat, headache and shortness of breath. Patient was seen at Urgent Care later on 8/1/2019 as well as the ED on 8/2/2019 and 8/5/2019. Twice she was diagnosed with potential vaccine mediated measles.
Age: 0.83
Sex: M
Vaccine: MMR, PNC13
Symptoms: Blood albumin decreased, Blood immunoglobulin A decreased, Blood immunoglobulin E normal, Blood immunoglobulin G increased, Blood immunoglobulin M normal
Clinical narrative: The child received the MMR vaccine which was given early due to an ongoing local measles outbreak. 7 days after receipt of the vaccine the child developed fever to 102F. He developed a rash on his forehead which then spread to his chest and back about 20 minutes later. Later that day he started getting fussy and was noted to have fever to 104F. Mom called a his local doctor who directed him to the local ED for evaluation. He received no treatment at initial ED evaluation but diagnosed with a viral exanthem he was noted to be thrombocytopenic at that time.   He saw his regular pediatrician the following day (Day #2) and they were concerned it looked like measles but thought it was unlikely since he had just been vaccinated and had not been exposed. They recommended supportive care.   He then went back to ED on day #3 of illness due to persistent fever and at this point was not able to take anything by mouth rash was over his whole body. He was admitted and went to two different hospitals by transport. Conjunctivitis noted this date by mom which was transient (only lasted a half a day or so). Mom had also noted cervical lymphadenopathy bilaterally around the same time.   He arrived at hospital on Day 4 of illness and was then transported to the local peds hospital (Medical Center). On this date he was noted to have a strawberry tongue which was also a short lived finding. Mom noted marked swelling and purple hands and feet. She says throughout infancy his feet and hands often turned purple but that this time they were much darker in color and so swollen that the hospital ankle band became tight.   On day 5 he was transferred overnight in PICU. Mom describes him as being lethargic, almost non-responsive during this time (in hindsight I believe he may have had encephalopathy which prompted this report). On day 6 he was treated with IVIG (the local physicians believed he had Kawasaki's disease). Subsequently he had prompt resolution of fever, lethargy, and other symptoms. His swelling took the longest to resolve but also resolved by day 7 of illness (Day 14 post-vaccination).   He was discharged home about 36 hours after completing IVIG and he finished 4 weeks of aspirin without issue.  In hindsight, I believe his symptoms may have been more consistent with measles than with Kawasaki's disease. Notably the onset of symptoms 7 days post vaccination, the thrombocytopenia (unusual with KD but described with measles vaccine), the coryza and conjunctivitis. The dogma in the literature is that measles virus is not shed following MMR vaccine so I'm not sure how to interpret the results of his CDC testing. Based on mom's description of his symptoms in the PICU, he may have been encephalopathic. Finally, coronary artery disease is a common complication of Kawasaki's disease in children < 12 months but all his echocardiograms were negative (though admittedly he was treated early in the course of his fever with IVIG).
Age: 0.83
Sex: M
Vaccine: MMR, PNC13
Symptoms: Blood potassium increased, Blood sodium increased, Complement factor normal, Conjunctivitis, Differential white blood cell count normal
Clinical narrative: The child received the MMR vaccine which was given early due to an ongoing local measles outbreak. 7 days after receipt of the vaccine the child developed fever to 102F. He developed a rash on his forehead which then spread to his chest and back about 20 minutes later. Later that day he started getting fussy and was noted to have fever to 104F. Mom called a his local doctor who directed him to the local ED for evaluation. He received no treatment at initial ED evaluation but diagnosed with a viral exanthem he was noted to be thrombocytopenic at that time.   He saw his regular pediatrician the following day (Day #2) and they were concerned it looked like measles but thought it was unlikely since he had just been vaccinated and had not been exposed. They recommended supportive care.   He then went back to ED on day #3 of illness due to persistent fever and at this point was not able to take anything by mouth rash was over his whole body. He was admitted and went to two different hospitals by transport. Conjunctivitis noted this date by mom which was transient (only lasted a half a day or so). Mom had also noted cervical lymphadenopathy bilaterally around the same time.   He arrived at hospital on Day 4 of illness and was then transported to the local peds hospital (Medical Center). On this date he was noted to have a strawberry tongue which was also a short lived finding. Mom noted marked swelling and purple hands and feet. She says throughout infancy his feet and hands often turned purple but that this time they were much darker in color and so swollen that the hospital ankle band became tight.   On day 5 he was transferred overnight in PICU. Mom describes him as being lethargic, almost non-responsive during this time (in hindsight I believe he may have had encephalopathy which prompted this report). On day 6 he was treated with IVIG (the local physicians believed he had Kawasaki's disease). Subsequently he had prompt resolution of fever, lethargy, and other symptoms. His swelling took the longest to resolve but also resolved by day 7 of illness (Day 14 post-vaccination).   He was discharged home about 36 hours after completing IVIG and he finished 4 weeks of aspirin without issue.  In hindsight, I believe his symptoms may have been more consistent with measles than with Kawasaki's disease. Notably the onset of symptoms 7 days post vaccination, the thrombocytopenia (unusual with KD but described with measles vaccine), the coryza and conjunctivitis. The dogma in the literature is that measles virus is not shed following MMR vaccine so I'm not sure how to interpret the results of his CDC testing. Based on mom's description of his symptoms in the PICU, he may have been encephalopathic. Finally, coronary artery disease is a common complication of Kawasaki's disease in children < 12 months but all his echocardiograms were negative (though admittedly he was treated early in the course of his fever with IVIG).
Age: 0.83
Sex: M
Vaccine: MMR, PNC13
Symptoms: Echocardiogram normal, Full blood count normal, Hyperkalaemia, Hypernatraemia, Hypoalbuminaemia
Clinical narrative: The child received the MMR vaccine which was given early due to an ongoing local measles outbreak. 7 days after receipt of the vaccine the child developed fever to 102F. He developed a rash on his forehead which then spread to his chest and back about 20 minutes later. Later that day he started getting fussy and was noted to have fever to 104F. Mom called a his local doctor who directed him to the local ED for evaluation. He received no treatment at initial ED evaluation but diagnosed with a viral exanthem he was noted to be thrombocytopenic at that time.   He saw his regular pediatrician the following day (Day #2) and they were concerned it looked like measles but thought it was unlikely since he had just been vaccinated and had not been exposed. They recommended supportive care.   He then went back to ED on day #3 of illness due to persistent fever and at this point was not able to take anything by mouth rash was over his whole body. He was admitted and went to two different hospitals by transport. Conjunctivitis noted this date by mom which was transient (only lasted a half a day or so). Mom had also noted cervical lymphadenopathy bilaterally around the same time.   He arrived at hospital on Day 4 of illness and was then transported to the local peds hospital (Medical Center). On this date he was noted to have a strawberry tongue which was also a short lived finding. Mom noted marked swelling and purple hands and feet. She says throughout infancy his feet and hands often turned purple but that this time they were much darker in color and so swollen that the hospital ankle band became tight.   On day 5 he was transferred overnight in PICU. Mom describes him as being lethargic, almost non-responsive during this time (in hindsight I believe he may have had encephalopathy which prompted this report). On day 6 he was treated with IVIG (the local physicians believed he had Kawasaki's disease). Subsequently he had prompt resolution of fever, lethargy, and other symptoms. His swelling took the longest to resolve but also resolved by day 7 of illness (Day 14 post-vaccination).   He was discharged home about 36 hours after completing IVIG and he finished 4 weeks of aspirin without issue.  In hindsight, I believe his symptoms may have been more consistent with measles than with Kawasaki's disease. Notably the onset of symptoms 7 days post vaccination, the thrombocytopenia (unusual with KD but described with measles vaccine), the coryza and conjunctivitis. The dogma in the literature is that measles virus is not shed following MMR vaccine so I'm not sure how to interpret the results of his CDC testing. Based on mom's description of his symptoms in the PICU, he may have been encephalopathic. Finally, coronary artery disease is a common complication of Kawasaki's disease in children < 12 months but all his echocardiograms were negative (though admittedly he was treated early in the course of his fever with IVIG).
Age: 0.83
Sex: M
Vaccine: MMR, PNC13
Symptoms: Hypophagia, Hyporesponsive to stimuli, Immunoglobulin therapy, Intensive care, Irritability
Clinical narrative: The child received the MMR vaccine which was given early due to an ongoing local measles outbreak. 7 days after receipt of the vaccine the child developed fever to 102F. He developed a rash on his forehead which then spread to his chest and back about 20 minutes later. Later that day he started getting fussy and was noted to have fever to 104F. Mom called a his local doctor who directed him to the local ED for evaluation. He received no treatment at initial ED evaluation but diagnosed with a viral exanthem he was noted to be thrombocytopenic at that time.   He saw his regular pediatrician the following day (Day #2) and they were concerned it looked like measles but thought it was unlikely since he had just been vaccinated and had not been exposed. They recommended supportive care.   He then went back to ED on day #3 of illness due to persistent fever and at this point was not able to take anything by mouth rash was over his whole body. He was admitted and went to two different hospitals by transport. Conjunctivitis noted this date by mom which was transient (only lasted a half a day or so). Mom had also noted cervical lymphadenopathy bilaterally around the same time.   He arrived at hospital on Day 4 of illness and was then transported to the local peds hospital (Medical Center). On this date he was noted to have a strawberry tongue which was also a short lived finding. Mom noted marked swelling and purple hands and feet. She says throughout infancy his feet and hands often turned purple but that this time they were much darker in color and so swollen that the hospital ankle band became tight.   On day 5 he was transferred overnight in PICU. Mom describes him as being lethargic, almost non-responsive during this time (in hindsight I believe he may have had encephalopathy which prompted this report). On day 6 he was treated with IVIG (the local physicians believed he had Kawasaki's disease). Subsequently he had prompt resolution of fever, lethargy, and other symptoms. His swelling took the longest to resolve but also resolved by day 7 of illness (Day 14 post-vaccination).   He was discharged home about 36 hours after completing IVIG and he finished 4 weeks of aspirin without issue.  In hindsight, I believe his symptoms may have been more consistent with measles than with Kawasaki's disease. Notably the onset of symptoms 7 days post vaccination, the thrombocytopenia (unusual with KD but described with measles vaccine), the coryza and conjunctivitis. The dogma in the literature is that measles virus is not shed following MMR vaccine so I'm not sure how to interpret the results of his CDC testing. Based on mom's description of his symptoms in the PICU, he may have been encephalopathic. Finally, coronary artery disease is a common complication of Kawasaki's disease in children < 12 months but all his echocardiograms were negative (though admittedly he was treated early in the course of his fever with IVIG).
Age: 0.83
Sex: M
Vaccine: MMR, PNC13
Symptoms: Lethargy, Lymphadenopathy, Morbillivirus test positive, Peripheral swelling, Platelet count decreased
Clinical narrative: The child received the MMR vaccine which was given early due to an ongoing local measles outbreak. 7 days after receipt of the vaccine the child developed fever to 102F. He developed a rash on his forehead which then spread to his chest and back about 20 minutes later. Later that day he started getting fussy and was noted to have fever to 104F. Mom called a his local doctor who directed him to the local ED for evaluation. He received no treatment at initial ED evaluation but diagnosed with a viral exanthem he was noted to be thrombocytopenic at that time.   He saw his regular pediatrician the following day (Day #2) and they were concerned it looked like measles but thought it was unlikely since he had just been vaccinated and had not been exposed. They recommended supportive care.   He then went back to ED on day #3 of illness due to persistent fever and at this point was not able to take anything by mouth rash was over his whole body. He was admitted and went to two different hospitals by transport. Conjunctivitis noted this date by mom which was transient (only lasted a half a day or so). Mom had also noted cervical lymphadenopathy bilaterally around the same time.   He arrived at hospital on Day 4 of illness and was then transported to the local peds hospital (Medical Center). On this date he was noted to have a strawberry tongue which was also a short lived finding. Mom noted marked swelling and purple hands and feet. She says throughout infancy his feet and hands often turned purple but that this time they were much darker in color and so swollen that the hospital ankle band became tight.   On day 5 he was transferred overnight in PICU. Mom describes him as being lethargic, almost non-responsive during this time (in hindsight I believe he may have had encephalopathy which prompted this report). On day 6 he was treated with IVIG (the local physicians believed he had Kawasaki's disease). Subsequently he had prompt resolution of fever, lethargy, and other symptoms. His swelling took the longest to resolve but also resolved by day 7 of illness (Day 14 post-vaccination).   He was discharged home about 36 hours after completing IVIG and he finished 4 weeks of aspirin without issue.  In hindsight, I believe his symptoms may have been more consistent with measles than with Kawasaki's disease. Notably the onset of symptoms 7 days post vaccination, the thrombocytopenia (unusual with KD but described with measles vaccine), the coryza and conjunctivitis. The dogma in the literature is that measles virus is not shed following MMR vaccine so I'm not sure how to interpret the results of his CDC testing. Based on mom's description of his symptoms in the PICU, he may have been encephalopathic. Finally, coronary artery disease is a common complication of Kawasaki's disease in children < 12 months but all his echocardiograms were negative (though admittedly he was treated early in the course of his fever with IVIG).
Age: 0.83
Sex: M
Vaccine: MMR, PNC13
Symptoms: Product administered to patient of inappropriate age, Pyrexia, Rash, Rash generalised, Rash morbilliform
Clinical narrative: The child received the MMR vaccine which was given early due to an ongoing local measles outbreak. 7 days after receipt of the vaccine the child developed fever to 102F. He developed a rash on his forehead which then spread to his chest and back about 20 minutes later. Later that day he started getting fussy and was noted to have fever to 104F. Mom called a his local doctor who directed him to the local ED for evaluation. He received no treatment at initial ED evaluation but diagnosed with a viral exanthem he was noted to be thrombocytopenic at that time.   He saw his regular pediatrician the following day (Day #2) and they were concerned it looked like measles but thought it was unlikely since he had just been vaccinated and had not been exposed. They recommended supportive care.   He then went back to ED on day #3 of illness due to persistent fever and at this point was not able to take anything by mouth rash was over his whole body. He was admitted and went to two different hospitals by transport. Conjunctivitis noted this date by mom which was transient (only lasted a half a day or so). Mom had also noted cervical lymphadenopathy bilaterally around the same time.   He arrived at hospital on Day 4 of illness and was then transported to the local peds hospital (Medical Center). On this date he was noted to have a strawberry tongue which was also a short lived finding. Mom noted marked swelling and purple hands and feet. She says throughout infancy his feet and hands often turned purple but that this time they were much darker in color and so swollen that the hospital ankle band became tight.   On day 5 he was transferred overnight in PICU. Mom describes him as being lethargic, almost non-responsive during this time (in hindsight I believe he may have had encephalopathy which prompted this report). On day 6 he was treated with IVIG (the local physicians believed he had Kawasaki's disease). Subsequently he had prompt resolution of fever, lethargy, and other symptoms. His swelling took the longest to resolve but also resolved by day 7 of illness (Day 14 post-vaccination).   He was discharged home about 36 hours after completing IVIG and he finished 4 weeks of aspirin without issue.  In hindsight, I believe his symptoms may have been more consistent with measles than with Kawasaki's disease. Notably the onset of symptoms 7 days post vaccination, the thrombocytopenia (unusual with KD but described with measles vaccine), the coryza and conjunctivitis. The dogma in the literature is that measles virus is not shed following MMR vaccine so I'm not sure how to interpret the results of his CDC testing. Based on mom's description of his symptoms in the PICU, he may have been encephalopathic. Finally, coronary artery disease is a common complication of Kawasaki's disease in children < 12 months but all his echocardiograms were negative (though admittedly he was treated early in the course of his fever with IVIG).
Age: 0.83
Sex: M
Vaccine: MMR, PNC13
Symptoms: Rhinitis, Skin discolouration, Strawberry tongue, Thrombocytopenia, Urine analysis normal
Clinical narrative: The child received the MMR vaccine which was given early due to an ongoing local measles outbreak. 7 days after receipt of the vaccine the child developed fever to 102F. He developed a rash on his forehead which then spread to his chest and back about 20 minutes later. Later that day he started getting fussy and was noted to have fever to 104F. Mom called a his local doctor who directed him to the local ED for evaluation. He received no treatment at initial ED evaluation but diagnosed with a viral exanthem he was noted to be thrombocytopenic at that time.   He saw his regular pediatrician the following day (Day #2) and they were concerned it looked like measles but thought it was unlikely since he had just been vaccinated and had not been exposed. They recommended supportive care.   He then went back to ED on day #3 of illness due to persistent fever and at this point was not able to take anything by mouth rash was over his whole body. He was admitted and went to two different hospitals by transport. Conjunctivitis noted this date by mom which was transient (only lasted a half a day or so). Mom had also noted cervical lymphadenopathy bilaterally around the same time.   He arrived at hospital on Day 4 of illness and was then transported to the local peds hospital (Medical Center). On this date he was noted to have a strawberry tongue which was also a short lived finding. Mom noted marked swelling and purple hands and feet. She says throughout infancy his feet and hands often turned purple but that this time they were much darker in color and so swollen that the hospital ankle band became tight.   On day 5 he was transferred overnight in PICU. Mom describes him as being lethargic, almost non-responsive during this time (in hindsight I believe he may have had encephalopathy which prompted this report). On day 6 he was treated with IVIG (the local physicians believed he had Kawasaki's disease). Subsequently he had prompt resolution of fever, lethargy, and other symptoms. His swelling took the longest to resolve but also resolved by day 7 of illness (Day 14 post-vaccination).   He was discharged home about 36 hours after completing IVIG and he finished 4 weeks of aspirin without issue.  In hindsight, I believe his symptoms may have been more consistent with measles than with Kawasaki's disease. Notably the onset of symptoms 7 days post vaccination, the thrombocytopenia (unusual with KD but described with measles vaccine), the coryza and conjunctivitis. The dogma in the literature is that measles virus is not shed following MMR vaccine so I'm not sure how to interpret the results of his CDC testing. Based on mom's description of his symptoms in the PICU, he may have been encephalopathic. Finally, coronary artery disease is a common complication of Kawasaki's disease in children < 12 months but all his echocardiograms were negative (though admittedly he was treated early in the course of his fever with IVIG).
Age: 0.83
Sex: M
Vaccine: MMR, PNC13
Symptoms: Viral rash
Clinical narrative: The child received the MMR vaccine which was given early due to an ongoing local measles outbreak. 7 days after receipt of the vaccine the child developed fever to 102F. He developed a rash on his forehead which then spread to his chest and back about 20 minutes later. Later that day he started getting fussy and was noted to have fever to 104F. Mom called a his local doctor who directed him to the local ED for evaluation. He received no treatment at initial ED evaluation but diagnosed with a viral exanthem he was noted to be thrombocytopenic at that time.   He saw his regular pediatrician the following day (Day #2) and they were concerned it looked like measles but thought it was unlikely since he had just been vaccinated and had not been exposed. They recommended supportive care.   He then went back to ED on day #3 of illness due to persistent fever and at this point was not able to take anything by mouth rash was over his whole body. He was admitted and went to two different hospitals by transport. Conjunctivitis noted this date by mom which was transient (only lasted a half a day or so). Mom had also noted cervical lymphadenopathy bilaterally around the same time.   He arrived at hospital on Day 4 of illness and was then transported to the local peds hospital (Medical Center). On this date he was noted to have a strawberry tongue which was also a short lived finding. Mom noted marked swelling and purple hands and feet. She says throughout infancy his feet and hands often turned purple but that this time they were much darker in color and so swollen that the hospital ankle band became tight.   On day 5 he was transferred overnight in PICU. Mom describes him as being lethargic, almost non-responsive during this time (in hindsight I believe he may have had encephalopathy which prompted this report). On day 6 he was treated with IVIG (the local physicians believed he had Kawasaki's disease). Subsequently he had prompt resolution of fever, lethargy, and other symptoms. His swelling took the longest to resolve but also resolved by day 7 of illness (Day 14 post-vaccination).   He was discharged home about 36 hours after completing IVIG and he finished 4 weeks of aspirin without issue.  In hindsight, I believe his symptoms may have been more consistent with measles than with Kawasaki's disease. Notably the onset of symptoms 7 days post vaccination, the thrombocytopenia (unusual with KD but described with measles vaccine), the coryza and conjunctivitis. The dogma in the literature is that measles virus is not shed following MMR vaccine so I'm not sure how to interpret the results of his CDC testing. Based on mom's description of his symptoms in the PICU, he may have been encephalopathic. Finally, coronary artery disease is a common complication of Kawasaki's disease in children < 12 months but all his echocardiograms were negative (though admittedly he was treated early in the course of his fever with IVIG).
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Musculoskeletal stiffness
Clinical narrative: The symptoms began on 08/09/2019. The symptoms have improved. The patient presents with chills, fatigue, fever and headache. The illness is associated with neck stiffness and muscle pain. Additional information: pt had a tdap vaccine on friday august 9 2019 and same night started feeling the flu like symptoms pt has had fever at home fro 100-101 f. pt complains of muscle soreness and muscle pain mostly in shoulder and neck.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia, Pyrexia
Clinical narrative: The symptoms began on 08/09/2019. The symptoms have improved. The patient presents with chills, fatigue, fever and headache. The illness is associated with neck stiffness and muscle pain. Additional information: pt had a tdap vaccine on friday august 9 2019 and same night started feeling the flu like symptoms pt has had fever at home fro 100-101 f. pt complains of muscle soreness and muscle pain mostly in shoulder and neck.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Inflammation, Skin warm
Clinical narrative: patient had similar reaction on first dose he states, he has talked to his health care provider and has marked the line of inflammation. it was warm to the touch, he said it has gotten better on some spots and progressed a little in another spot
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, X-ray
Clinical narrative: Patient called pharmacy at 12:32 pm on 8/12/19 to report his injection reaction that he received last month. He said that his arm is still sore. He said at first the soreness lasted about 2-3 days then it stop. However when patient tried moving his arm, he can still feel the pain there. He said with his first dose that he received in April, he also have pain. He complained that it would hurt for over 1 week then it trends down. Patient said he went to see his doctor and they did x-ray to check up. Patient is still pending for his x-ray results w/ his next doctor appointment. I suggested patient to use some ice pack or take some NSAIDs to help with his pain until further follow up with his doctor.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Band sensation, Hypoaesthesia, Multiple sclerosis, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: Girdling and bilateral palmar numbness/paresthesias
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Paraesthesia, Scan with contrast abnormal
Clinical narrative: Girdling and bilateral palmar numbness/paresthesias
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Fatigue, Malaise, Nausea, Pain
Clinical narrative: patient initially complained of nausea &  feeling lightheaded, fatigue & body aches along with swelling in right arm the evening of vaccination.  She still did not feel well on Saturday (day after) Right arm continued swelling down to & including fingers. Sunday (2nd day after) Mom called the pharmacy. She stated that patient had taken ibuprofen, she still did not feel well but swelling in arm had gone down.  I advised her to watch closely for any other signs of allergic reaction (ie trouble breathing) and seek emergency medical attention as needed.  Patient went to ER, and was flown to hospital to seek treatment.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Peripheral swelling
Clinical narrative: patient initially complained of nausea &  feeling lightheaded, fatigue & body aches along with swelling in right arm the evening of vaccination.  She still did not feel well on Saturday (day after) Right arm continued swelling down to & including fingers. Sunday (2nd day after) Mom called the pharmacy. She stated that patient had taken ibuprofen, she still did not feel well but swelling in arm had gone down.  I advised her to watch closely for any other signs of allergic reaction (ie trouble breathing) and seek emergency medical attention as needed.  Patient went to ER, and was flown to hospital to seek treatment.
Age: 68.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: patient had redness and slightly warm to touch  on the left arm that seem to have been spreading.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Irritability, Vomiting
Clinical narrative: 2 days of irritability, vomiting and diarrhea following dose
Age: 69.0
Sex: M
Vaccine: FLUA3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient called pharmacy on Sunday stating his arm hurt a lot.  He stated that he was in extreme pain and could not life his arm above his shoulder.  I advised patient to go to an urgent care provider for further care.   I also followed up with patient on 8/12/19 and his arm still hurt a lot and he made an appointment to see his doctor the next day.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects reported; He inadverntently administered a dose of MMRII intramuscularly rather than subcutaneously; This spontaneous report was received from a pharmacist referring to a patient of unknown gender and age. The patient's concurrent conditions and medical history were not reported. There was no concomitant medication reported.     The pharmacist reported that on 08-AUG-2019, he inadvertently administered a dose o f measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # R031628, expiration date; 01-NOV-2020) intramuscularly rather than subcutaneously for prophylaxis. No adverse effect were reported.
Sex: F
Vaccine: TD
Symptoms: Product administered at inappropriate site
Clinical narrative: a female patient was administered a booster dose of Tenivac vaccine in wrong muscle at supraspinatus part of the rotator cuff or in the joint or in the bursa; Initial information received on 02-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves an unknown age female patient who was administered a booster dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] vaccine in wrong muscle at supraspinatus part of the rotator cuff or in the joint or in the bursa lot number not reported via unknown route on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to vaccine administered at inappropriate site.  Adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: patient recive two dose of Menactra vaccine; Initial information received on 05-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA217984.  This case involves a 13 years old patient who received 0.5 ml second dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number U6204AA and Expiry date 08-May-2020) via unknown route in unknown administration site on an unknown date and first dose receive on Jul-2018.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due extra dose administered.   It was reported that patient came in today and received a Menactra vaccination. Caller says that the patient had previous received the Menactra vaccine from clinic in July of 2018 and they are not told by the family that the patient had received the vaccine.  At a time of vaccination it was unknown if any adverse events were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 1.83
Sex: U
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: use expired Ipol yesterday that was dated for August 2; Initial information received on 06-Aug-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 22 months old patient who was vaccinated with a fourth dose of expired vaccine IPV (VERO) [IPOL] (lot N1G511M and Exp. Date 02-Aug-2019) via intramuscular route in the left deltoid on 05-Aug-2019.  The patient's medical history not reported and concomitant medications included HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA); DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  It was an actual medication error case due to expired vaccine used.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPV, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 11-year-old male patient inadvertently received Quadracel vaccination instead of Adacel; 11-year-old male patient inadvertently received Quadracel vaccination instead of Adacel; Initial information received on 06-Aug-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 11 years old male patient who inadvertently received 0.5 ml dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number: C5325BA and expiry date: 14-Nov-2019) via intramuscular route in left upper arm, for school requirements instead DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE (MENACTRA) for Immunisation in right arm.  It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of document held by sender: none.
Sex: U
Vaccine: DTAP, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 12 years old patient was given a dose of Daptacel and the doctor had ordered Adacel; a 12 years old patient was given a dose of Daptacel and the doctor had ordered Adacel; Initial information received on 05-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA216854 (same reporter).  This case involves a 12 years old patient who was given a 0.5ml dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5523aa, expiry date: 20-Sep-2020 via intramuscular route in the right deltoid on 01-Aug-2019 and the doctor had ordered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) and HPV VACCINE (HPV VACCINE).  It was an actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Extra dose administered
Clinical narrative: fourth dose Ipol administered on 06/05/2019 and Extra dose (5th dose) administered 08/06/2019; Initial information received on 06-Aug-2019 regarding an unsolicited valid non-serious case received from a non-health care professional (office Staff).  This case involves a five years old female patient who was vaccinated with a fourth dose of vaccine IPV (VERO) [IPOL] on 05-Jun-2019 and vaccinated with a 0.5 ml fifth dose of same vaccine on 06-Aug-2019 via intramuscular route in the left deltoid on 06-Aug-2019 (lot P1A371M and Exp. Date 27-Apr-2020).  The patient's medical history not reported and concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It was an actual medication error case due to extra dose administered.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.