chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient was supposed to get a ppd and he was given ipol intradermal/ No AE; Initial information received on 17-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old male patient who was supposed to get a TUBERCULIN TEST [TUBERCULIN PPD] and accidentally was given IPV (VERO) [IPOL] intradermal,  lot P1A24 expiry date 26-Apr-2020, 0.1 ml in the left arm for tuberculin test on 17-Feb-2020. (wrong product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant vaccinations included INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX).  This is a case of actual medication error due to wrong product administered.  At the time of this report, 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.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Daptacel that was expired 07FEB2020 and given 17FEB2020 to an 18 month old/no AE; Initial information received on 18-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 months old male patient who was vaccinated with an 0.5 mL expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number C5366AA and expiry date: 07-Feb-2020, frequency once) via an intramuscular route in the left leg for prophylactic vaccination on 17-Feb-2020.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE for Immunisation.  It is a case of actual medication error due to expired vaccine used. It was reported that patient was given an expired dose of DAPTACEL.  At the 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.
Age: 54.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Dizziness /of passing out that she had to lay down; Fever; After administration of vaccine, a patient experienced injection site Redness, Swelling, Warmth and Pain.; Redness at injection site; Swelling at injection site; Warmth at injection site; Pain at injection site; Initial information received on 18-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 54 years old female patient who experienced injection site redness, swelling, warmth and pain (vaccination site inflammation), redness at injection site (vaccination site erythema), swelling at injection site (vaccination site swelling), warmth at injection site (vaccination site warmth),pain at injection site (vaccination site pain), dizziness /of passing out that she had to lay down (dizziness) and fever (pyrexia), while she received vaccines DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) [MENVEO].  medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Jul-2019, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On 26-Jul-2019, the patient received a 0.5 ml dose of suspect MENVEO (Solution for injection) not produced by Sanofi Pasteur lot AMVAO 54A (Expiry date 30-Nov-2019) via intramuscular route in unknown administration site for Prophylactic vaccination.  In Jul-2019, the patient developed a non-serious injection site redness, swelling, warmth and pain (vaccination site inflammation), redness at injection site (vaccination site erythema), swelling at injection site (vaccination site swelling), warmth at injection site (vaccination site warmth) and pain at injection site (vaccination site pain) (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and MENVEO.  On 26-Jul-2019, the patient developed a non-serious dizziness /of passing out that she had to lay down (dizziness) and fever (pyrexia) same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and MENVEO.  Details of laboratory data were not reported.  Final diagnosis was Vaccination site inflammation, Vaccination site erythema, Vaccination site Swelling, Vaccination site Warmth, Vaccination site Pain, Dizziness and Fever.  It was not reported if the patient received a corrective treatment.  On an unknown date, the event outcome is reported as Recovered from Dizziness and Fever and Not Recovered from Vaccination site inflammation.
Age: 54.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pyrexia, Vaccination site inflammation
Clinical narrative: Dizziness /of passing out that she had to lay down; Fever; After administration of vaccine, a patient experienced injection site Redness, Swelling, Warmth and Pain.; Redness at injection site; Swelling at injection site; Warmth at injection site; Pain at injection site; Initial information received on 18-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 54 years old female patient who experienced injection site redness, swelling, warmth and pain (vaccination site inflammation), redness at injection site (vaccination site erythema), swelling at injection site (vaccination site swelling), warmth at injection site (vaccination site warmth),pain at injection site (vaccination site pain), dizziness /of passing out that she had to lay down (dizziness) and fever (pyrexia), while she received vaccines DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) [MENVEO].  medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Jul-2019, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On 26-Jul-2019, the patient received a 0.5 ml dose of suspect MENVEO (Solution for injection) not produced by Sanofi Pasteur lot AMVAO 54A (Expiry date 30-Nov-2019) via intramuscular route in unknown administration site for Prophylactic vaccination.  In Jul-2019, the patient developed a non-serious injection site redness, swelling, warmth and pain (vaccination site inflammation), redness at injection site (vaccination site erythema), swelling at injection site (vaccination site swelling), warmth at injection site (vaccination site warmth) and pain at injection site (vaccination site pain) (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and MENVEO.  On 26-Jul-2019, the patient developed a non-serious dizziness /of passing out that she had to lay down (dizziness) and fever (pyrexia) same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and MENVEO.  Details of laboratory data were not reported.  Final diagnosis was Vaccination site inflammation, Vaccination site erythema, Vaccination site Swelling, Vaccination site Warmth, Vaccination site Pain, Dizziness and Fever.  It was not reported if the patient received a corrective treatment.  On an unknown date, the event outcome is reported as Recovered from Dizziness and Fever and Not Recovered from Vaccination site inflammation.
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: liquid Pentacel and Acthib was administered incorrectly/no AE`; Initial information received on 18-Feb-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a patient who was administered liquid DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and HIB (PRP/T) VACCINE [ACT-HIB] incorrectly/no AE(incorrect route of product administration) on an unknown date for prophylactic vaccination [batch number; dosing details; expiry date; route and site of administration not reported].  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate route of vaccination.  At the time of reporting, no adverse event 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.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Ear infection, Pyrexia, Rash
Clinical narrative: the patient was started on amoxicillin for otitis on 2/13. same day was given MMR. Fever 103 on 2/20. Rash began on 2/21/2020. DXerythemamultiforme
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Fever, Severe chills, headache, body aches, nausea, fatigue, beginning approx 11 hours after vaccine administration. Treated with ibuprofen 14 hours after symptom onset. Interferes with normal activities.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, Severe chills, headache, body aches, nausea, fatigue, beginning approx 11 hours after vaccine administration. Treated with ibuprofen 14 hours after symptom onset. Interferes with normal activities.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site mass, Injection site nodule, Injection site pruritus
Clinical narrative: Patient has what feels like a knot or lump under her skin at the injection site on her right leg. She says that it itches.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hypersomnia, Malaise
Clinical narrative: Arm mildly sore few hours post injection (second injection).  Awoke @ 0100: restless, body aches, chills (shivering), fever (questionable?), headache. Felt malaise & existing symptoms all next day (2/18), including very sore left arm. Slept most of day. Relief from Tylenol 1000mg every 5-6 hours.   Next day (/2/19) just minimally tired, but able to resume normal activities.  Arm soreness subsided each day, but lasted about 5 days.      After 1st injection on 11/20/2019, just very sore arm
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia, Restlessness
Clinical narrative: Arm mildly sore few hours post injection (second injection).  Awoke @ 0100: restless, body aches, chills (shivering), fever (questionable?), headache. Felt malaise & existing symptoms all next day (2/18), including very sore left arm. Slept most of day. Relief from Tylenol 1000mg every 5-6 hours.   Next day (/2/19) just minimally tired, but able to resume normal activities.  Arm soreness subsided each day, but lasted about 5 days.      After 1st injection on 11/20/2019, just very sore arm
Age: 30.0
Sex: F
Vaccine: YF
Symptoms: Decreased appetite, Depression, Diarrhoea, Disturbance in attention, Fatigue
Clinical narrative: Aura migraines lasting 3+ days, GI issues including diarrhea and nausea, extreme tiredness, excessive sleeping (12+ hours for 3 days consecutively), loss of appetite, inability to focus, feelings of depression and helplessness
Age: 30.0
Sex: F
Vaccine: YF
Symptoms: Gastrointestinal disorder, Helplessness, Hypersomnia, Migraine with aura, Nausea
Clinical narrative: Aura migraines lasting 3+ days, GI issues including diarrhea and nausea, extreme tiredness, excessive sleeping (12+ hours for 3 days consecutively), loss of appetite, inability to focus, feelings of depression and helplessness
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Hallucination, auditory, Headache, Pain
Clinical narrative: Patient had shooting pain up from her shoulder to her neck, very severe headache and patient experienced auditory musical sound that kept playing over that only patient could hear that others could not hear.
Age: 83.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 7.0
Sex: F
Vaccine: MMRV
Symptoms: Rash vesicular
Clinical narrative: 18 days post reaction patient exhibited a varicella like rash.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site urticaria, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site rash
Clinical narrative: Patient was seen in a walk-in clinic on 2/1/20 Described as rash, erythema and induration in a large wheal greater than 4cm surrounding vaccination site with marked tenderness The walk-in clinic prescribed Atarax 25mg q8 PRN Kenalog ointment 0.1% ointment Keflex 500 mg BID for 7 days
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Nausea
Clinical narrative: Tdap given on 2-9-2020. Patient noted HA & nausea on 2-10-2020 & continous symptoms till today (2-23-2020), no other symptoms.
Age: 65.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Blood test normal, Dizziness, Hypoaesthesia, Myalgia, Neuralgia
Clinical narrative: Initial side effects of muscle aches legs, arms and light headedness after all shots 11/6, 11/9, 11/13 and 11/20. Contacted Health Department 11/30 questioned how long side effects should continue..was told they should have already gone away.  Mine were not resolving and in fact got worse. Within 3-4 wks post last injection have ongoing symptoms:  Muscle pains buttocks,legs, arms;  Intermittent sharp nerve pains anywhere on the body, pins, needles, numbness hands/feet. Intermittent ice pick pains head/scalp.  Saw Neuro Dr. 1/24/20. Possible Small fiber Neuropathy discussed due to adverse reaction to vaccine. Prescribed Gabapentin for nerve pain.
Age: 65.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Paraesthesia, Vitamin D decreased
Clinical narrative: Initial side effects of muscle aches legs, arms and light headedness after all shots 11/6, 11/9, 11/13 and 11/20. Contacted Health Department 11/30 questioned how long side effects should continue..was told they should have already gone away.  Mine were not resolving and in fact got worse. Within 3-4 wks post last injection have ongoing symptoms:  Muscle pains buttocks,legs, arms;  Intermittent sharp nerve pains anywhere on the body, pins, needles, numbness hands/feet. Intermittent ice pick pains head/scalp.  Saw Neuro Dr. 1/24/20. Possible Small fiber Neuropathy discussed due to adverse reaction to vaccine. Prescribed Gabapentin for nerve pain.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Headache, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient developed swelling and pain at the vaccine sites, especially above right arm above meningococcal B was placed. He developed a headache that night with a fever of 102F. His mother was giving him Tylenol for the pain. Next night and again following morning and afternoon 02/18/20. He started talking Motrin on 2/19/20 for the pain as per phone call with his mother. His mother also reported that he started to feel better that day.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Joint swelling, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: Pt reported soreness in right deltoid area going down into right forearm with some tingling in her whole hand. Pt stated swelling around her right wrist which has been present before vaccine, possibly ganglion cyst.
Sex: F
Vaccine: VARZOS
Symptoms: Basal ganglia stroke, Coordination abnormal, Dizziness, Facial paralysis, Gait disturbance
Clinical narrative: acute right periventricular and right basal ganglia ischemic stroke; acute right periventricular and right basal ganglia ischemic stroke; vertigo; dizziness; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient (pt) of unknown age. No information regarding the concurrent conditions, medical history and concomitant medications was provided. On or around 06-OCT-2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose, the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the pt suffered left upper extremity and lower extremity weakness, facial drop, altered speech, altered gait and altered coordination and was diagnosed with acute right periventricular and right basal ganglia ischemic stroke (ischaemic stroke/basal ganglia stroke), vertigo and dizziness. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the pt's symptoms had resulted in physical limitations not present prior to inoculation. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the pt sustained sever and permanent personal injuries. Further, as a tragic consequence the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, she also suffered and incurred damages, including medical expenses; loss of accumulations; and other economic and non-economic damages. At the reporting time, the pt had not recovered from ischaemic stroke, basal ganglia stroke, vertigo and dizziness. The reporter considered all the events to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the ischaemic stroke and basal ganglia stroke were considered to be medically significant events.
Sex: F
Vaccine: VARZOS
Symptoms: Ischaemic stroke, Muscular weakness, Speech disorder, Vertigo
Clinical narrative: acute right periventricular and right basal ganglia ischemic stroke; acute right periventricular and right basal ganglia ischemic stroke; vertigo; dizziness; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient (pt) of unknown age. No information regarding the concurrent conditions, medical history and concomitant medications was provided. On or around 06-OCT-2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose, the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the pt suffered left upper extremity and lower extremity weakness, facial drop, altered speech, altered gait and altered coordination and was diagnosed with acute right periventricular and right basal ganglia ischemic stroke (ischaemic stroke/basal ganglia stroke), vertigo and dizziness. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the pt's symptoms had resulted in physical limitations not present prior to inoculation. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the pt sustained sever and permanent personal injuries. Further, as a tragic consequence the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, she also suffered and incurred damages, including medical expenses; loss of accumulations; and other economic and non-economic damages. At the reporting time, the pt had not recovered from ischaemic stroke, basal ganglia stroke, vertigo and dizziness. The reporter considered all the events to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the ischaemic stroke and basal ganglia stroke were considered to be medically significant events.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness neurosensory
Clinical narrative: sensorineural hearing loss; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient (pt) of unknown age. No information regarding the concurrent conditions, medical history and concomitant medications was provided. On or around 12-AUG-2011, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and route of administration were not provided) for routine health maintenance and for its intended purpose, the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the pt suffered and was diagnosed with sensorineural hearing loss (deafness neurosensory). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the pt's symptoms had resulted in physical limitations not present prior to inoculation. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the pt sustained severe and permanent personal injuries. Further, as a tragic consequence the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, she also suffered and incurred damages, including medical expenses; loss of accumulations; and other economic and non-economic damages. At the reporting time, the pt had not recovered from deafness neurosensory. The reporter considered deafness neurosensory to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the deafness neurosensory was considered a medically significant and disabling event.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abnormal behaviour, Blepharospasm, Body temperature increased, Crying, Decreased appetite
Clinical narrative: After vaccinations I nursed him in the office until he fell asleep. After leaving the appointment he slept as expected. We traveled 3 hours via car to visit family. Upon arrival, I couldn't get him to wake up long enough to nurse. He felt warm. I removed his clothing and allowed him to sleep longer. I tried to wake him up to eat another hour later and he would only wake up for a few minutes, cry, nurse for a few minutes and fall asleep again. He was still warm. I checked his temperature and he was at 102 degrees F temporal. I attempted to keep nursing and keeping him cool. He wouldn't wake up and when he did open his eyes they would twitch. I called the nurse who gave the injections and she told me this was his immune response. I am also a nurse and have never seen this reaction before. I did not notice this reaction in my older child. I used cool packs to keep him cool, his temperature rose to 103, then 104.5. I kept dripping breast milk into his cheek to keep him hydrated and nourished. He continued to be lethargic and a repeat phone call encouraged me that this was normal. I didn't feel that it was and by 11pm that night I placed him back in the car and headed towards home to be close to our providers. The lethargy and eye twitching continued through the night and next day. He did continue to have wet diapers though they were fewer than normal. He was reluctant to nurse for 2 days for his regular amount and time. He appeared "off"-not making his regular eye contact and sounds as he previously did. His next provider recomended we hold off on vaccines. He went on to be delayed in speech and increased illnesses. I came home to be with him becuase daycare could not keep hime well.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Decreased eye contact, Ill-defined disorder, Lethargy, Skin warm, Somnolence
Clinical narrative: After vaccinations I nursed him in the office until he fell asleep. After leaving the appointment he slept as expected. We traveled 3 hours via car to visit family. Upon arrival, I couldn't get him to wake up long enough to nurse. He felt warm. I removed his clothing and allowed him to sleep longer. I tried to wake him up to eat another hour later and he would only wake up for a few minutes, cry, nurse for a few minutes and fall asleep again. He was still warm. I checked his temperature and he was at 102 degrees F temporal. I attempted to keep nursing and keeping him cool. He wouldn't wake up and when he did open his eyes they would twitch. I called the nurse who gave the injections and she told me this was his immune response. I am also a nurse and have never seen this reaction before. I did not notice this reaction in my older child. I used cool packs to keep him cool, his temperature rose to 103, then 104.5. I kept dripping breast milk into his cheek to keep him hydrated and nourished. He continued to be lethargic and a repeat phone call encouraged me that this was normal. I didn't feel that it was and by 11pm that night I placed him back in the car and headed towards home to be close to our providers. The lethargy and eye twitching continued through the night and next day. He did continue to have wet diapers though they were fewer than normal. He was reluctant to nurse for 2 days for his regular amount and time. He appeared "off"-not making his regular eye contact and sounds as he previously did. His next provider recomended we hold off on vaccines. He went on to be delayed in speech and increased illnesses. I came home to be with him becuase daycare could not keep hime well.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Speech disorder developmental, Urine output decreased
Clinical narrative: After vaccinations I nursed him in the office until he fell asleep. After leaving the appointment he slept as expected. We traveled 3 hours via car to visit family. Upon arrival, I couldn't get him to wake up long enough to nurse. He felt warm. I removed his clothing and allowed him to sleep longer. I tried to wake him up to eat another hour later and he would only wake up for a few minutes, cry, nurse for a few minutes and fall asleep again. He was still warm. I checked his temperature and he was at 102 degrees F temporal. I attempted to keep nursing and keeping him cool. He wouldn't wake up and when he did open his eyes they would twitch. I called the nurse who gave the injections and she told me this was his immune response. I am also a nurse and have never seen this reaction before. I did not notice this reaction in my older child. I used cool packs to keep him cool, his temperature rose to 103, then 104.5. I kept dripping breast milk into his cheek to keep him hydrated and nourished. He continued to be lethargic and a repeat phone call encouraged me that this was normal. I didn't feel that it was and by 11pm that night I placed him back in the car and headed towards home to be close to our providers. The lethargy and eye twitching continued through the night and next day. He did continue to have wet diapers though they were fewer than normal. He was reluctant to nurse for 2 days for his regular amount and time. He appeared "off"-not making his regular eye contact and sounds as he previously did. His next provider recomended we hold off on vaccines. He went on to be delayed in speech and increased illnesses. I came home to be with him becuase daycare could not keep hime well.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site bruising, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Redness, swollen lump, pain, bruising at injection site 1 day post injection. Fever of 101-102 degrees F for 4 days, starting 2/15/20 through 2/20/20 post injection. On 2/21/20, approx. 8 small, red pinpoint bumps/rash noted across arms, abdomen, and back. Rash resolved by 2/23/20.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: Redness, swollen lump, pain, bruising at injection site 1 day post injection. Fever of 101-102 degrees F for 4 days, starting 2/15/20 through 2/20/20 post injection. On 2/21/20, approx. 8 small, red pinpoint bumps/rash noted across arms, abdomen, and back. Rash resolved by 2/23/20.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Febrile convulsion
Clinical narrative: Febrile Seizure
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Chills, Decreased appetite, Diarrhoea
Clinical narrative: 2 of 2 shots (1 of 2 shots administered in Oct 2019 with no ill side effects) Symptoms began 12 hours after dosage. Stomach pain with diarrhea/loose stool then nausea, headache, shivering all night with very cold hands/feet but did not feel feverish. Woke up after several hours of sleeping on my left side with left leg pain, feeling of swollen leg (but it was not swollen), sore joints/sore left hip. Slept for another 12 hours.  The next day I felt as though I was "beat up." Little appetite, very achy.  Injection site has been warm and sensitive to touch.    Note:  The pharmacy date of prescription is 2/20/2020 because I called to order the shot on 2/20, but I did not actually get the shot until Saturday, 2/22/2020.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypersomnia, Injection site pain, Injection site warmth, Nausea
Clinical narrative: 2 of 2 shots (1 of 2 shots administered in Oct 2019 with no ill side effects) Symptoms began 12 hours after dosage. Stomach pain with diarrhea/loose stool then nausea, headache, shivering all night with very cold hands/feet but did not feel feverish. Woke up after several hours of sleeping on my left side with left leg pain, feeling of swollen leg (but it was not swollen), sore joints/sore left hip. Slept for another 12 hours.  The next day I felt as though I was "beat up." Little appetite, very achy.  Injection site has been warm and sensitive to touch.    Note:  The pharmacy date of prescription is 2/20/2020 because I called to order the shot on 2/20, but I did not actually get the shot until Saturday, 2/22/2020.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Peripheral coldness, Swelling
Clinical narrative: 2 of 2 shots (1 of 2 shots administered in Oct 2019 with no ill side effects) Symptoms began 12 hours after dosage. Stomach pain with diarrhea/loose stool then nausea, headache, shivering all night with very cold hands/feet but did not feel feverish. Woke up after several hours of sleeping on my left side with left leg pain, feeling of swollen leg (but it was not swollen), sore joints/sore left hip. Slept for another 12 hours.  The next day I felt as though I was "beat up." Little appetite, very achy.  Injection site has been warm and sensitive to touch.    Note:  The pharmacy date of prescription is 2/20/2020 because I called to order the shot on 2/20, but I did not actually get the shot until Saturday, 2/22/2020.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia, Pyrexia
Clinical narrative: Burning Muscle Pain and Fever that was alleviated by Ibuprofen.  It happened the next day after immunization was given.  On 02/21/20, patient stated that pain felt better and no longer needed Ibuprofen
Age: 70.0
Sex: M
Vaccine: FLUA3
Symptoms: CSF test, Myelitis transverse
Clinical narrative: Patient's wife came in to alert us that patient was hospitalized and eventually discharged with transverse myleitis.  After leaving the hospital he followed up with a neurologist and his primary.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Acute respiratory distress syndrome, Adenovirus infection, Adenovirus test positive, Arthropathy, Cellulitis
Clinical narrative: Patient is a previously healthy 13 month old boy who presented with respiratory failure, then developed ARDS and multiorgan dysfunction on VA ECMO, requiring vasoactive support and CRRT. Subsequently found to have multiple disseminated viral infections, including HSV, adenovirus, and low level positive CMV and EBV. Suspected immunodeficiency, workup pending. In setting of recent MMR and varicella vaccinations, critical illness, and suspected immunodeficiency, workup for disseminated vaccine strain measles sent at CDC. Positive for vaccine-strain measles from nasopharynx and urine.  Patient initially presented with an otitis media on 1/30 and then re-presented with stridor and rapid respiratory failure. Evidence of epiglottic inflammation with "white dots" noted during intubation and cervical & retropharyngeal lymphadenitis. He had a respiratory PCR positive for adenovirus and RSV and serum positive for adenovirus, though not remarkably high level. EBV PCR in serum also low-level positive but serology from OSH suggestive of past infection. I&D of L neck lymphadenitis performed; cultures from lymph node I&D are negative. CT with evidence of developing retropharyngeal phlegmon.  Subsequently developed knee lesion which was positive for HSV, HSV PCR from serum shows disseminated HSV at high viral levels. EBV and CMV positive at low levels, also HHV6 positive, likely represent reactivation in setting of severe illness. Based on multiple viral infections, immunology team involved and on DDX are immunodeficiencies such as TLR defects. HLH/MAS was considered and he met some criteria for this; was on anakinra and received intermittent steroid dosing. BAL cytology from 2/14 showed multinucleated giant cells. ETT quantitative RSV level pending. When measles results from NP/urine returned on 2/21, started on oral ribavirin (while pursuing IV ribavirin), high dose vitamin A, and redosed IVIG. HSV level continuing to fall. Unclear of contribution of measles vaccine strain to respiratory presentation; felt to be unclear whether represented prolonged shedding versus true pneumonia/pneumonitis.  Further testing at CDC pending including measles IgM and measles PCR on deep respiratory sample.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Culture negative, Cytomegalovirus infection, Cytomegalovirus test positive, Endotracheal intubation, Epiglottitis
Clinical narrative: Patient is a previously healthy 13 month old boy who presented with respiratory failure, then developed ARDS and multiorgan dysfunction on VA ECMO, requiring vasoactive support and CRRT. Subsequently found to have multiple disseminated viral infections, including HSV, adenovirus, and low level positive CMV and EBV. Suspected immunodeficiency, workup pending. In setting of recent MMR and varicella vaccinations, critical illness, and suspected immunodeficiency, workup for disseminated vaccine strain measles sent at CDC. Positive for vaccine-strain measles from nasopharynx and urine.  Patient initially presented with an otitis media on 1/30 and then re-presented with stridor and rapid respiratory failure. Evidence of epiglottic inflammation with "white dots" noted during intubation and cervical & retropharyngeal lymphadenitis. He had a respiratory PCR positive for adenovirus and RSV and serum positive for adenovirus, though not remarkably high level. EBV PCR in serum also low-level positive but serology from OSH suggestive of past infection. I&D of L neck lymphadenitis performed; cultures from lymph node I&D are negative. CT with evidence of developing retropharyngeal phlegmon.  Subsequently developed knee lesion which was positive for HSV, HSV PCR from serum shows disseminated HSV at high viral levels. EBV and CMV positive at low levels, also HHV6 positive, likely represent reactivation in setting of severe illness. Based on multiple viral infections, immunology team involved and on DDX are immunodeficiencies such as TLR defects. HLH/MAS was considered and he met some criteria for this; was on anakinra and received intermittent steroid dosing. BAL cytology from 2/14 showed multinucleated giant cells. ETT quantitative RSV level pending. When measles results from NP/urine returned on 2/21, started on oral ribavirin (while pursuing IV ribavirin), high dose vitamin A, and redosed IVIG. HSV level continuing to fall. Unclear of contribution of measles vaccine strain to respiratory presentation; felt to be unclear whether represented prolonged shedding versus true pneumonia/pneumonitis.  Further testing at CDC pending including measles IgM and measles PCR on deep respiratory sample.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Epstein-Barr virus infection, Epstein-Barr virus test positive, Herpes simplex, Herpes simplex test positive, Immunodeficiency
Clinical narrative: Patient is a previously healthy 13 month old boy who presented with respiratory failure, then developed ARDS and multiorgan dysfunction on VA ECMO, requiring vasoactive support and CRRT. Subsequently found to have multiple disseminated viral infections, including HSV, adenovirus, and low level positive CMV and EBV. Suspected immunodeficiency, workup pending. In setting of recent MMR and varicella vaccinations, critical illness, and suspected immunodeficiency, workup for disseminated vaccine strain measles sent at CDC. Positive for vaccine-strain measles from nasopharynx and urine.  Patient initially presented with an otitis media on 1/30 and then re-presented with stridor and rapid respiratory failure. Evidence of epiglottic inflammation with "white dots" noted during intubation and cervical & retropharyngeal lymphadenitis. He had a respiratory PCR positive for adenovirus and RSV and serum positive for adenovirus, though not remarkably high level. EBV PCR in serum also low-level positive but serology from OSH suggestive of past infection. I&D of L neck lymphadenitis performed; cultures from lymph node I&D are negative. CT with evidence of developing retropharyngeal phlegmon.  Subsequently developed knee lesion which was positive for HSV, HSV PCR from serum shows disseminated HSV at high viral levels. EBV and CMV positive at low levels, also HHV6 positive, likely represent reactivation in setting of severe illness. Based on multiple viral infections, immunology team involved and on DDX are immunodeficiencies such as TLR defects. HLH/MAS was considered and he met some criteria for this; was on anakinra and received intermittent steroid dosing. BAL cytology from 2/14 showed multinucleated giant cells. ETT quantitative RSV level pending. When measles results from NP/urine returned on 2/21, started on oral ribavirin (while pursuing IV ribavirin), high dose vitamin A, and redosed IVIG. HSV level continuing to fall. Unclear of contribution of measles vaccine strain to respiratory presentation; felt to be unclear whether represented prolonged shedding versus true pneumonia/pneumonitis.  Further testing at CDC pending including measles IgM and measles PCR on deep respiratory sample.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Immunoglobulin therapy, Immunology test, Incisional drainage, Lung assist device therapy, Lymphadenitis
Clinical narrative: Patient is a previously healthy 13 month old boy who presented with respiratory failure, then developed ARDS and multiorgan dysfunction on VA ECMO, requiring vasoactive support and CRRT. Subsequently found to have multiple disseminated viral infections, including HSV, adenovirus, and low level positive CMV and EBV. Suspected immunodeficiency, workup pending. In setting of recent MMR and varicella vaccinations, critical illness, and suspected immunodeficiency, workup for disseminated vaccine strain measles sent at CDC. Positive for vaccine-strain measles from nasopharynx and urine.  Patient initially presented with an otitis media on 1/30 and then re-presented with stridor and rapid respiratory failure. Evidence of epiglottic inflammation with "white dots" noted during intubation and cervical & retropharyngeal lymphadenitis. He had a respiratory PCR positive for adenovirus and RSV and serum positive for adenovirus, though not remarkably high level. EBV PCR in serum also low-level positive but serology from OSH suggestive of past infection. I&D of L neck lymphadenitis performed; cultures from lymph node I&D are negative. CT with evidence of developing retropharyngeal phlegmon.  Subsequently developed knee lesion which was positive for HSV, HSV PCR from serum shows disseminated HSV at high viral levels. EBV and CMV positive at low levels, also HHV6 positive, likely represent reactivation in setting of severe illness. Based on multiple viral infections, immunology team involved and on DDX are immunodeficiencies such as TLR defects. HLH/MAS was considered and he met some criteria for this; was on anakinra and received intermittent steroid dosing. BAL cytology from 2/14 showed multinucleated giant cells. ETT quantitative RSV level pending. When measles results from NP/urine returned on 2/21, started on oral ribavirin (while pursuing IV ribavirin), high dose vitamin A, and redosed IVIG. HSV level continuing to fall. Unclear of contribution of measles vaccine strain to respiratory presentation; felt to be unclear whether represented prolonged shedding versus true pneumonia/pneumonitis.  Further testing at CDC pending including measles IgM and measles PCR on deep respiratory sample.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Morbillivirus test positive, Multiple organ dysfunction syndrome, Otitis media, Polymerase chain reaction positive, Respiratory failure
Clinical narrative: Patient is a previously healthy 13 month old boy who presented with respiratory failure, then developed ARDS and multiorgan dysfunction on VA ECMO, requiring vasoactive support and CRRT. Subsequently found to have multiple disseminated viral infections, including HSV, adenovirus, and low level positive CMV and EBV. Suspected immunodeficiency, workup pending. In setting of recent MMR and varicella vaccinations, critical illness, and suspected immunodeficiency, workup for disseminated vaccine strain measles sent at CDC. Positive for vaccine-strain measles from nasopharynx and urine.  Patient initially presented with an otitis media on 1/30 and then re-presented with stridor and rapid respiratory failure. Evidence of epiglottic inflammation with "white dots" noted during intubation and cervical & retropharyngeal lymphadenitis. He had a respiratory PCR positive for adenovirus and RSV and serum positive for adenovirus, though not remarkably high level. EBV PCR in serum also low-level positive but serology from OSH suggestive of past infection. I&D of L neck lymphadenitis performed; cultures from lymph node I&D are negative. CT with evidence of developing retropharyngeal phlegmon.  Subsequently developed knee lesion which was positive for HSV, HSV PCR from serum shows disseminated HSV at high viral levels. EBV and CMV positive at low levels, also HHV6 positive, likely represent reactivation in setting of severe illness. Based on multiple viral infections, immunology team involved and on DDX are immunodeficiencies such as TLR defects. HLH/MAS was considered and he met some criteria for this; was on anakinra and received intermittent steroid dosing. BAL cytology from 2/14 showed multinucleated giant cells. ETT quantitative RSV level pending. When measles results from NP/urine returned on 2/21, started on oral ribavirin (while pursuing IV ribavirin), high dose vitamin A, and redosed IVIG. HSV level continuing to fall. Unclear of contribution of measles vaccine strain to respiratory presentation; felt to be unclear whether represented prolonged shedding versus true pneumonia/pneumonitis.  Further testing at CDC pending including measles IgM and measles PCR on deep respiratory sample.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Respiratory syncytial virus test positive, Roseolovirus test positive, Stridor, Viral infection
Clinical narrative: Patient is a previously healthy 13 month old boy who presented with respiratory failure, then developed ARDS and multiorgan dysfunction on VA ECMO, requiring vasoactive support and CRRT. Subsequently found to have multiple disseminated viral infections, including HSV, adenovirus, and low level positive CMV and EBV. Suspected immunodeficiency, workup pending. In setting of recent MMR and varicella vaccinations, critical illness, and suspected immunodeficiency, workup for disseminated vaccine strain measles sent at CDC. Positive for vaccine-strain measles from nasopharynx and urine.  Patient initially presented with an otitis media on 1/30 and then re-presented with stridor and rapid respiratory failure. Evidence of epiglottic inflammation with "white dots" noted during intubation and cervical & retropharyngeal lymphadenitis. He had a respiratory PCR positive for adenovirus and RSV and serum positive for adenovirus, though not remarkably high level. EBV PCR in serum also low-level positive but serology from OSH suggestive of past infection. I&D of L neck lymphadenitis performed; cultures from lymph node I&D are negative. CT with evidence of developing retropharyngeal phlegmon.  Subsequently developed knee lesion which was positive for HSV, HSV PCR from serum shows disseminated HSV at high viral levels. EBV and CMV positive at low levels, also HHV6 positive, likely represent reactivation in setting of severe illness. Based on multiple viral infections, immunology team involved and on DDX are immunodeficiencies such as TLR defects. HLH/MAS was considered and he met some criteria for this; was on anakinra and received intermittent steroid dosing. BAL cytology from 2/14 showed multinucleated giant cells. ETT quantitative RSV level pending. When measles results from NP/urine returned on 2/21, started on oral ribavirin (while pursuing IV ribavirin), high dose vitamin A, and redosed IVIG. HSV level continuing to fall. Unclear of contribution of measles vaccine strain to respiratory presentation; felt to be unclear whether represented prolonged shedding versus true pneumonia/pneumonitis.  Further testing at CDC pending including measles IgM and measles PCR on deep respiratory sample.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Incorrect route of product administration, Wrong technique in product usage process
Clinical narrative: When drawing up the vaccines, the Rotovirus was drawn up into Pedarix, before it was given to the patient. New vaccines were drawn and given to the patient.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Injection site inflammation, Swelling
Clinical narrative: Looks like a 5 cm area of inflammation to arm at injection site. Mother gave Loratadine antihistamine and cold compress. As of today's date redness and swelling have gone.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, VARCEL
Symptoms: Epistaxis, Head injury, Headache, Lip injury, Loss of consciousness
Clinical narrative: After receiving vaccines client stood up so sister could receive hers. Client was instructed to sit down in the other chair, but before he sat down he fainted and landed on his right side. He regained consciousness right away. Client was place on cot with leg elevated and juice given. Upon examination he had bit his right upper lip, his right side of his head and his nose. Client had slight amount of blood coming from right nare. Ice pack placed behind client's neck and on client's nose. Juice was given. Client stated his nose was hurting and he thought it was broken. After 20 minutes on the client resting in supine position he sat up and stated his head hurt. Client's mother was instructed to bring client to the Urgent Care once they left to be evaluated. At 14:45 client stated he felt ok to leave. He slowly stood up and the nurse and his mother walked him to the car.