chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphocyte count normal, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume increased
Clinical narrative: Narrative:  Pt recently treated for COVID-19 (July 2022). Pt presented to facility 9/6/2022 with productive cough / SOB. Pt did not appear to be in any acute distress. He stated if he talks, he starts coughing and it hurts to breath deep. Patient is a smoker of 30 years. 9/6/2022 Triage Notes: Recently treated for COVID-19 end of July 2022 states he was improving, now having harsh cough with pain to left side of chest with cough - continued mild cough s/p COVID, states over past 4-5 days increased chest congestion, prod. cough with thick yellow sputum production, states soreness in chest due to frequent coughing. **Patient admitted 9/6 - 9/20/22 and treated with remdesivir, dexamethasone, Tessalon Perles, Combivent to name a few**
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Mean platelet volume normal, Metamyelocyte percentage, Monocyte count increased, Monocyte count normal, Monocyte percentage
Clinical narrative: Narrative:  Pt recently treated for COVID-19 (July 2022). Pt presented to facility 9/6/2022 with productive cough / SOB. Pt did not appear to be in any acute distress. He stated if he talks, he starts coughing and it hurts to breath deep. Patient is a smoker of 30 years. 9/6/2022 Triage Notes: Recently treated for COVID-19 end of July 2022 states he was improving, now having harsh cough with pain to left side of chest with cough - continued mild cough s/p COVID, states over past 4-5 days increased chest congestion, prod. cough with thick yellow sputum production, states soreness in chest due to frequent coughing. **Patient admitted 9/6 - 9/20/22 and treated with remdesivir, dexamethasone, Tessalon Perles, Combivent to name a few**
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Neutrophil percentage, Neutrophil toxic granulation present, Painful respiration, Platelet count normal, Platelet function test
Clinical narrative: Narrative:  Pt recently treated for COVID-19 (July 2022). Pt presented to facility 9/6/2022 with productive cough / SOB. Pt did not appear to be in any acute distress. He stated if he talks, he starts coughing and it hurts to breath deep. Patient is a smoker of 30 years. 9/6/2022 Triage Notes: Recently treated for COVID-19 end of July 2022 states he was improving, now having harsh cough with pain to left side of chest with cough - continued mild cough s/p COVID, states over past 4-5 days increased chest congestion, prod. cough with thick yellow sputum production, states soreness in chest due to frequent coughing. **Patient admitted 9/6 - 9/20/22 and treated with remdesivir, dexamethasone, Tessalon Perles, Combivent to name a few**
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Polychromasia, Productive cough, Red blood cell count decreased, Red blood cell elliptocytes present, Red cell distribution width normal
Clinical narrative: Narrative:  Pt recently treated for COVID-19 (July 2022). Pt presented to facility 9/6/2022 with productive cough / SOB. Pt did not appear to be in any acute distress. He stated if he talks, he starts coughing and it hurts to breath deep. Patient is a smoker of 30 years. 9/6/2022 Triage Notes: Recently treated for COVID-19 end of July 2022 states he was improving, now having harsh cough with pain to left side of chest with cough - continued mild cough s/p COVID, states over past 4-5 days increased chest congestion, prod. cough with thick yellow sputum production, states soreness in chest due to frequent coughing. **Patient admitted 9/6 - 9/20/22 and treated with remdesivir, dexamethasone, Tessalon Perles, Combivent to name a few**
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive, Sputum discoloured, Stomatocytes present, White blood cell count increased
Clinical narrative: Narrative:  Pt recently treated for COVID-19 (July 2022). Pt presented to facility 9/6/2022 with productive cough / SOB. Pt did not appear to be in any acute distress. He stated if he talks, he starts coughing and it hurts to breath deep. Patient is a smoker of 30 years. 9/6/2022 Triage Notes: Recently treated for COVID-19 end of July 2022 states he was improving, now having harsh cough with pain to left side of chest with cough - continued mild cough s/p COVID, states over past 4-5 days increased chest congestion, prod. cough with thick yellow sputum production, states soreness in chest due to frequent coughing. **Patient admitted 9/6 - 9/20/22 and treated with remdesivir, dexamethasone, Tessalon Perles, Combivent to name a few**
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Angina unstable, Catheterisation cardiac, Chest pain, Electrocardiogram normal
Clinical narrative: Narrative:  On 01/9/22 Patient presented to ER with chest pain. Pt had received a covid (Moderna) booster vaccine on 1/5/22 (location pt received vaccine is not reported & unknown- not at this facility). This was his #3 covid vaccine after 2 other full doses from unknown location (dated reported were 4/8/21 and 5/6/21. Pt was admitted and had cardiology workup. # NSTEMI/unstable angina, POA - woke up from sleep with chest pain - initial troponin 2.85 then 5.9, 6.0, 5.3, 10.1, 6.6, 3.8 - EKG NSR with no ST changes or T wave abnormalities - patient without risk factors or significant family history - trend trop and EKG q6 - given ASA 325mg in ED; start ACS protocol with heparin drip - atorvastatin 80mg and metoprolol 25mg q6 as BP allows - TIMI score 1 (low risk) Pt got cardiac cath on 1/10/22. Pt discharged home after with no medications. On 3/4/22 Primary Care Md noted possible SE from covid vaccine caused the chest pain and possible myocarditis. Pt's chart was flagged with ADE and reporting to VAERs (& CDC through VAERS).
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Troponin
Clinical narrative: Narrative:  On 01/9/22 Patient presented to ER with chest pain. Pt had received a covid (Moderna) booster vaccine on 1/5/22 (location pt received vaccine is not reported & unknown- not at this facility). This was his #3 covid vaccine after 2 other full doses from unknown location (dated reported were 4/8/21 and 5/6/21. Pt was admitted and had cardiology workup. # NSTEMI/unstable angina, POA - woke up from sleep with chest pain - initial troponin 2.85 then 5.9, 6.0, 5.3, 10.1, 6.6, 3.8 - EKG NSR with no ST changes or T wave abnormalities - patient without risk factors or significant family history - trend trop and EKG q6 - given ASA 325mg in ED; start ACS protocol with heparin drip - atorvastatin 80mg and metoprolol 25mg q6 as BP allows - TIMI score 1 (low risk) Pt got cardiac cath on 1/10/22. Pt discharged home after with no medications. On 3/4/22 Primary Care Md noted possible SE from covid vaccine caused the chest pain and possible myocarditis. Pt's chart was flagged with ADE and reporting to VAERs (& CDC through VAERS).
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Haematochezia
Clinical narrative: Product use in unapproved population; Blood in stools for a week.; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2220967-1. The original narrative from the sender is as below:  Blood in stools for a week.  No further information expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Body temperature increased, Epistaxis
Clinical narrative: brief epistaxis which occured about 6 hours after immunization, epistaxis lasted 5-10 min total.; otherwise had temp up to 101.3; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System(VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2225739-1. The original narrative from the sender is as below:  Brief epitaxis which occured about 6 hours after immunization epistaxis lasted 5-10 min total. Otherwise had temp up to 101.3 but was otherwise well. Had same epistaxis following the 4 months vaccines as well.  Same epitaxis following 4 month vaccines. same vaccinevaxelis,PCV13 and Rotateq
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV1, DTPPVHBHPB, PNC13, RV1
Symptoms: Incorrect route of product administration, No adverse event, Product administration error, Product preparation error
Clinical narrative: 2 month baby received rotarix vaccine by IM instead of orally; 2 month baby received rotarix vaccine by IM instead of orally. Rotarix reconstituted using sterile water and administered IM; 2 month baby received rotarix vaccine by IM instead of orally. Rotarix reconstituted using sterile water and administered IM; No adverse event noted for about 2 hours and the next two days; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System(VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2231142-1. The original narrative from the sender is as below:  Vaccine administartion error** 2 month baby received rotarix vaccine by IM instaed of orally. Rotarix reconstituted using sterile water and administered IM. No any adverse reactions noted for about 2 hrs and the next two days. We haven't heard anything from parent that baby developed any adverse reaction after that up until now as of 4/13/2022.  Parent brought the baby to ED that afternoon not because of adverse reaction but because they wanted to make sure if everything was okay and received counselling regarding vaccine.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV1, DTPPVHBHPB, PNC13, RV1
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: 2 month baby received rotarix vaccine by IM instead of orally; 2 month baby received rotarix vaccine by IM instead of orally. Rotarix reconstituted using sterile water and administered IM; 2 month baby received rotarix vaccine by IM instead of orally. Rotarix reconstituted using sterile water and administered IM; No adverse event noted for about 2 hours and the next two days; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System(VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2231142-1. The original narrative from the sender is as below:  Vaccine administartion error** 2 month baby received rotarix vaccine by IM instaed of orally. Rotarix reconstituted using sterile water and administered IM. No any adverse reactions noted for about 2 hrs and the next two days. We haven't heard anything from parent that baby developed any adverse reaction after that up until now as of 4/13/2022.  Parent brought the baby to ED that afternoon not because of adverse reaction but because they wanted to make sure if everything was okay and received counselling regarding vaccine.
Sex: F
Vaccine: DTPPVHBHPB, FLU4, HEPA, MMRV, DTPPVHBHPB, FLU4, HEPA, MMRV
Symptoms: Incorrect dose administered
Clinical narrative: 1 year old child was given High Dose influenza injection rather than the regular dose; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-Jul-2022 with the following VAERS Primary ID 2231161-1. The original narrative from the sender is the following:  1 year old child was given High Dose influenza injection rather than the regular dose  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported event "1 year old child was given High Dose influenza injection rather than the regular dose".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, FLU4, HEPA, MMRV, DTPPVHBHPB, FLU4, HEPA, MMRV
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 1 year old child was given High Dose influenza injection rather than the regular dose; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-Jul-2022 with the following VAERS Primary ID 2231161-1. The original narrative from the sender is the following:  1 year old child was given High Dose influenza injection rather than the regular dose  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported event "1 year old child was given High Dose influenza injection rather than the regular dose".  No further information is expected.
Age: 0.17
Sex: F
Vaccine: PPV, PPV
Symptoms: Wrong product administered
Clinical narrative: physician ordered Pneumo 23 instead of Prevnar.  This was not caught by the medical assistant at the time.  We received a call 4/19/22 from the Health Department when patient was brought in for her 4 month shots there.  )it was thought that they completed a VAERS at that time)  Received call today that they did not complete one.  Patient's mother was informed of the error.  No reaction or harm to the infant.  Staff re-educated on verifying and having another MA double check all vaccines prior to administration
Age: 0.17
Sex: F
Vaccine: PPV, PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: physician ordered Pneumo 23 instead of Prevnar.  This was not caught by the medical assistant at the time.  We received a call 4/19/22 from the Health Department when patient was brought in for her 4 month shots there.  )it was thought that they completed a VAERS at that time)  Received call today that they did not complete one.  Patient's mother was informed of the error.  No reaction or harm to the infant.  Staff re-educated on verifying and having another MA double check all vaccines prior to administration
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Injection site mass, Soft tissue swelling, Ultrasound scan abnormal
Clinical narrative: Lump at site of injection, size comparable to a dime.; Lump at site of injection, size comparable to a dime.; Left thigh ultrasound revealed soft tissue swelling; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2267700-1. The original narrative from the sender is as below:  Lump at site of injection, size comparable to a dime.
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Injection site mass
Clinical narrative: Lump at site of injection, size comparable to a dime.; Lump at site of injection, size comparable to a dime.; Left thigh ultrasound revealed soft tissue swelling; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2267700-1. The original narrative from the sender is as below:  Lump at site of injection, size comparable to a dime.
Sex: F
Vaccine: DTPPVHBHPB, PPV, RV5, DTPPVHBHPB, PPV, RVX
Symptoms: Wrong product administered
Clinical narrative: 2 month old infant was given Pneumovax  23 instead of the  ordered Prevnar  13; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2290665-01. The original narrative from the sender is as below:  2 month old infant was given Pneumovax 23 instead of the ordered Prevnar 13.  Current illness reported as none.
Sex: F
Vaccine: DTPPVHBHPB, PPV, RV5, DTPPVHBHPB, PPV, RVX
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 2 month old infant was given Pneumovax  23 instead of the  ordered Prevnar  13; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2290665-01. The original narrative from the sender is as below:  2 month old infant was given Pneumovax 23 instead of the ordered Prevnar 13.  Current illness reported as none.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Muscle spasms, Pyrexia
Clinical narrative: Developed fever (101F) and muscle spasms in both legs/thighs one day after receiving vaccines; Developed fever (101F) and muscle spasms in both legs/thighs one day after receiving vaccines; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2298737-1. The original narrative from the sender is as below:  Developed  fever (101F) and muscle spasms in  both legs/thighs one day  after receiving  vaccines.  No current illness was reported.
Sex: F
Vaccine: DTPPVHBHPB, HIBV, PNC13, DTPPVHBHPB, HIBV, PNC13
Symptoms: Wrong product administered
Clinical narrative: Extra dose administered; Wrong product administered; No adverse event; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System(VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2312796-1  . The original narrative from the sender is as below:  No adverse event was reported. It was discovered on 6/1/2022 while checking inventory that pediarix was documented as given but vaxelis was actually administered. Baby received 2 doses of Hib in error. Mother/guardian if child was telephoned on 6/1/2022, at number provided in patients record, but message "not accepting calls" was received. her voice mail box was full, so no message was left.
Sex: F
Vaccine: DTPPVHBHPB, HIBV, PNC13, DTPPVHBHPB, HIBV, PNC13
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Extra dose administered; Wrong product administered; No adverse event; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System(VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2312796-1  . The original narrative from the sender is as below:  No adverse event was reported. It was discovered on 6/1/2022 while checking inventory that pediarix was documented as given but vaxelis was actually administered. Baby received 2 doses of Hib in error. Mother/guardian if child was telephoned on 6/1/2022, at number provided in patients record, but message "not accepting calls" was received. her voice mail box was full, so no message was left.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Injection site swelling, Ultrasound scan
Clinical narrative: Swelling at injection site; Ultrasound scan; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System(VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2313407-1. The original narrative from the sender is as below:  Swelling at injection site, left thigh. Non-tender. No fluid collection.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Injection site swelling
Clinical narrative: Swelling at injection site; Ultrasound scan; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System(VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2313407-1. The original narrative from the sender is as below:  Swelling at injection site, left thigh. Non-tender. No fluid collection.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Discomfort, Dyskinesia, Lethargy, Mobility decreased, Nystagmus
Clinical narrative: Discomfort; Dyskinesia; Mobility decreased; Nystagmus; Respiratory tract congestion; Rhinorrhea; Vision blurred; Weight decreased; Lethargy; Pyrexia; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System(VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2315452-1. The original narrative from the sender is as below:  "mother states after getting most recent vaccines, patient  developed  fever, congestion,  abnormal movements. He was unable to hold his head up,  was lethargic, '"'whining like a  puppy,"" and eyes were unfocused.  She took him to the ED 6/1/22, but they  were unable to  do anything for the patient. She states he seems to  be feeling better, but  she  would like the reaction documented  and to discuss  with provider the best  way to  proceed  with vaccinations.  PCP office received a call on 6/1/22 from patient's physical therapist reporting patient's eyes were  not  focusing, he had nystagmus, and he had lost weight. PT was concerned  there was a neurological issue. PCP office directed them to ED. ED note from 6/1/22: 9 month old male with hx of neonatal abstinence syndrome, cerebral  palsy, seizure disorder,  was brought to the ED by  his  mother for general  evaluation. She was advised  by PT to  to  come to  the  ED for  evaluation  for  possible seizure. While  patient  was at  physical therapy  today  he seemed  uncomfortable, had some rhythmic movements  with bobbing  his head and arching his back  for  a few seconds. Patient had immunizations  4 days ago and had  a couple fevers after the shots. He also has runny nose and  congestion  for  the  last 5 days."
Sex: M
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Pyrexia, Respiratory tract congestion, Rhinorrhoea, Vision blurred, Weight decreased
Clinical narrative: Discomfort; Dyskinesia; Mobility decreased; Nystagmus; Respiratory tract congestion; Rhinorrhea; Vision blurred; Weight decreased; Lethargy; Pyrexia; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System(VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2315452-1. The original narrative from the sender is as below:  "mother states after getting most recent vaccines, patient  developed  fever, congestion,  abnormal movements. He was unable to hold his head up,  was lethargic, '"'whining like a  puppy,"" and eyes were unfocused.  She took him to the ED 6/1/22, but they  were unable to  do anything for the patient. She states he seems to  be feeling better, but  she  would like the reaction documented  and to discuss  with provider the best  way to  proceed  with vaccinations.  PCP office received a call on 6/1/22 from patient's physical therapist reporting patient's eyes were  not  focusing, he had nystagmus, and he had lost weight. PT was concerned  there was a neurological issue. PCP office directed them to ED. ED note from 6/1/22: 9 month old male with hx of neonatal abstinence syndrome, cerebral  palsy, seizure disorder,  was brought to the ED by  his  mother for general  evaluation. She was advised  by PT to  to  come to  the  ED for  evaluation  for  possible seizure. While  patient  was at  physical therapy  today  he seemed  uncomfortable, had some rhythmic movements  with bobbing  his head and arching his back  for  a few seconds. Patient had immunizations  4 days ago and had  a couple fevers after the shots. He also has runny nose and  congestion  for  the  last 5 days."
Sex: M
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Dyskinesia, Lethargy, Nystagmus, Pyrexia, Respiratory tract congestion
Clinical narrative: Discomfort; Dyskinesia; Mobility decreased; Nystagmus; Respiratory tract congestion; Rhinorrhea; Vision blurred; Weight decreased; Lethargy; Pyrexia; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System(VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2315452-1. The original narrative from the sender is as below:  "mother states after getting most recent vaccines, patient  developed  fever, congestion,  abnormal movements. He was unable to hold his head up,  was lethargic, '"'whining like a  puppy,"" and eyes were unfocused.  She took him to the ED 6/1/22, but they  were unable to  do anything for the patient. She states he seems to  be feeling better, but  she  would like the reaction documented  and to discuss  with provider the best  way to  proceed  with vaccinations.  PCP office received a call on 6/1/22 from patient's physical therapist reporting patient's eyes were  not  focusing, he had nystagmus, and he had lost weight. PT was concerned  there was a neurological issue. PCP office directed them to ED. ED note from 6/1/22: 9 month old male with hx of neonatal abstinence syndrome, cerebral  palsy, seizure disorder,  was brought to the ED by  his  mother for general  evaluation. She was advised  by PT to  to  come to  the  ED for  evaluation  for  possible seizure. While  patient  was at  physical therapy  today  he seemed  uncomfortable, had some rhythmic movements  with bobbing  his head and arching his back  for  a few seconds. Patient had immunizations  4 days ago and had  a couple fevers after the shots. He also has runny nose and  congestion  for  the  last 5 days."
Sex: M
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Vision blurred, Weight decreased
Clinical narrative: Discomfort; Dyskinesia; Mobility decreased; Nystagmus; Respiratory tract congestion; Rhinorrhea; Vision blurred; Weight decreased; Lethargy; Pyrexia; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System(VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2315452-1. The original narrative from the sender is as below:  "mother states after getting most recent vaccines, patient  developed  fever, congestion,  abnormal movements. He was unable to hold his head up,  was lethargic, '"'whining like a  puppy,"" and eyes were unfocused.  She took him to the ED 6/1/22, but they  were unable to  do anything for the patient. She states he seems to  be feeling better, but  she  would like the reaction documented  and to discuss  with provider the best  way to  proceed  with vaccinations.  PCP office received a call on 6/1/22 from patient's physical therapist reporting patient's eyes were  not  focusing, he had nystagmus, and he had lost weight. PT was concerned  there was a neurological issue. PCP office directed them to ED. ED note from 6/1/22: 9 month old male with hx of neonatal abstinence syndrome, cerebral  palsy, seizure disorder,  was brought to the ED by  his  mother for general  evaluation. She was advised  by PT to  to  come to  the  ED for  evaluation  for  possible seizure. While  patient  was at  physical therapy  today  he seemed  uncomfortable, had some rhythmic movements  with bobbing  his head and arching his back  for  a few seconds. Patient had immunizations  4 days ago and had  a couple fevers after the shots. He also has runny nose and  congestion  for  the  last 5 days."
Sex: M
Vaccine: DTPPVHBHPB, IPV, RV1, DTPPVHBHPB, IPV, RV1
Symptoms: Extra dose administered
Clinical narrative: Extra dose administered; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System(VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2317328-1. The original narrative from the sender is as below:  Patient was inadvertently given an IPV when IPV is contained in the combination vaccine which resulted in a double dose of IPV being given in the same visit.
Sex: M
Vaccine: DTPPVHBHPB, HEPA, MMRV, DTPPVHBHPB, HEPA, MMRV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient age at vaccination: 5-year-old; Vaxelis was given instead of quadracel. Extra dose of HIB and HEPB given.; Vaxelis was given instead of quadracel. Extra dose of HIB and HEPB given.; Client is okay, no reaction noticed. No symptoms at all after.; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2321950-1. The original narrative from the sender is the following:  Vaxelis was given instead of quadracel. Extra dose of HIB and HEPB given. Client is okay, no reaction noticed. No symptoms at all after. No treatment needed. Will call client later today and check on client again to make sure he is still doing okay.   The assessment of causal relationship between Vaxelis and the reported events was not provided.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HEPA, MMRV, DTPPVHBHPB, HEPA, MMRV
Symptoms: Extra dose administered
Clinical narrative: Patient age at vaccination: 5-year-old; Vaxelis was given instead of quadracel. Extra dose of HIB and HEPB given.; Vaxelis was given instead of quadracel. Extra dose of HIB and HEPB given.; Client is okay, no reaction noticed. No symptoms at all after.; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2321950-1. The original narrative from the sender is the following:  Vaxelis was given instead of quadracel. Extra dose of HIB and HEPB given. Client is okay, no reaction noticed. No symptoms at all after. No treatment needed. Will call client later today and check on client again to make sure he is still doing okay.   The assessment of causal relationship between Vaxelis and the reported events was not provided.  No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Chronic left ventricular failure, Crying, Electrocardiogram
Clinical narrative: Patient who developed myocarditis which resolved. Onset of symptoms 3/4/21 which included low grade fever, chills, N/V, and diarrhea for which patient was seen in ED on 3/9/21. Patient did not have any chronic diseases prior to this. Temporal relationship to the first Moderna COVID-19 vaccine received on 2/6/21 at pharmacy. She had positive troponins and EKG with borderline inferior and possible anterior ST elevations, inferior T wave inversions. She was transferred to a local hospital where she underwent cardiac cath on 3/12/22 and found to have normal coronaries but EF of 35% at time of cath.  She was placed on appropriate meds. She had followed up with Dr. at a HCF and had echo 7/2021 with normal EF and again had echo 5/2022 was described as normal with EF of 55%.  Possible Takotsubo mentioned but usually that is associated with an event that causes increased  catecholamine surge (extreme emotional event usually) which she did not have and is not associated with low grade fever, diarrhea, vomiting.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired driving ability, Pyrexia, Vomiting
Clinical narrative: Patient who developed myocarditis which resolved. Onset of symptoms 3/4/21 which included low grade fever, chills, N/V, and diarrhea for which patient was seen in ED on 3/9/21. Patient did not have any chronic diseases prior to this. Temporal relationship to the first Moderna COVID-19 vaccine received on 2/6/21 at pharmacy. She had positive troponins and EKG with borderline inferior and possible anterior ST elevations, inferior T wave inversions. She was transferred to a local hospital where she underwent cardiac cath on 3/12/22 and found to have normal coronaries but EF of 35% at time of cath.  She was placed on appropriate meds. She had followed up with Dr. at a HCF and had echo 7/2021 with normal EF and again had echo 5/2022 was described as normal with EF of 55%.  Possible Takotsubo mentioned but usually that is associated with an event that causes increased  catecholamine surge (extreme emotional event usually) which she did not have and is not associated with low grade fever, diarrhea, vomiting.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Catheterisation cardiac abnormal, Chills, Diarrhoea, Echocardiogram normal, Ejection fraction decreased
Clinical narrative: Patient who developed myocarditis which resolved. Onset of symptoms 3/4/21 which included low grade fever, chills, N/V, and diarrhea for which patient was seen in ED on 3/9/21. Patient did not have any chronic diseases prior to this. Temporal relationship to the first Moderna COVID-19 vaccine received on 2/6/21 at pharmacy. She had positive troponins and EKG with borderline inferior and possible anterior ST elevations, inferior T wave inversions. She was transferred to a local hospital where she underwent cardiac cath on 3/12/22 and found to have normal coronaries but EF of 35% at time of cath.  She was placed on appropriate meds. She had followed up with Dr. at a HCF and had echo 7/2021 with normal EF and again had echo 5/2022 was described as normal with EF of 55%.  Possible Takotsubo mentioned but usually that is associated with an event that causes increased  catecholamine surge (extreme emotional event usually) which she did not have and is not associated with low grade fever, diarrhea, vomiting.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram ST segment elevation, Electrocardiogram T wave inversion, Myocarditis, Nausea, Pyrexia
Clinical narrative: Patient who developed myocarditis which resolved. Onset of symptoms 3/4/21 which included low grade fever, chills, N/V, and diarrhea for which patient was seen in ED on 3/9/21. Patient did not have any chronic diseases prior to this. Temporal relationship to the first Moderna COVID-19 vaccine received on 2/6/21 at pharmacy. She had positive troponins and EKG with borderline inferior and possible anterior ST elevations, inferior T wave inversions. She was transferred to a local hospital where she underwent cardiac cath on 3/12/22 and found to have normal coronaries but EF of 35% at time of cath.  She was placed on appropriate meds. She had followed up with Dr. at a HCF and had echo 7/2021 with normal EF and again had echo 5/2022 was described as normal with EF of 55%.  Possible Takotsubo mentioned but usually that is associated with an event that causes increased  catecholamine surge (extreme emotional event usually) which she did not have and is not associated with low grade fever, diarrhea, vomiting.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin increased, Vomiting
Clinical narrative: Patient who developed myocarditis which resolved. Onset of symptoms 3/4/21 which included low grade fever, chills, N/V, and diarrhea for which patient was seen in ED on 3/9/21. Patient did not have any chronic diseases prior to this. Temporal relationship to the first Moderna COVID-19 vaccine received on 2/6/21 at pharmacy. She had positive troponins and EKG with borderline inferior and possible anterior ST elevations, inferior T wave inversions. She was transferred to a local hospital where she underwent cardiac cath on 3/12/22 and found to have normal coronaries but EF of 35% at time of cath.  She was placed on appropriate meds. She had followed up with Dr. at a HCF and had echo 7/2021 with normal EF and again had echo 5/2022 was described as normal with EF of 55%.  Possible Takotsubo mentioned but usually that is associated with an event that causes increased  catecholamine surge (extreme emotional event usually) which she did not have and is not associated with low grade fever, diarrhea, vomiting.
Sex: F
Vaccine: DTPPVHBHPB, HEP, PNC13, RV5, DTPPVHBHPB, HEP, PNC13, RV5
Symptoms: Extra dose administered
Clinical narrative: Upon charting, RN noticed an extra dose in Hepatitis B present in Vaxelis vaccine; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2325512-1. The original narrative from the sender is the following:  RN administered vaccine. Upon charting, RN noticed an extra dose in Hepatitis B present in Vaxelis vaccine. This was the first time RN had administered Vaxelis vaccine.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Crying, Diarrhoea, Hypersomnia, Infantile spitting up, Injection site swelling
Clinical narrative: Product use in unapproved population; Had a high pitched scream like he was in a lot of pain and was not consolable; Had a high pitched scream like he was in a lot of pain and was not consolable; Had a lot of blowouts and spitting up more than usual; Had a high pitched scream like he was in a lot of pain and was not consolable; Diarrhoea; Slept a lot; Significant right leg swelling after getting vaccine; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2329055-1. The original narrative from the sender is the following:  Significant right leg swelling hours after getting vaccine. 100.2 temp. Had a high pitched scream like he was in a lot of pain and was not consolable. Tylenol and icing the area helped. slept a lot. had a lot of blowouts and spitting up more than usual. was doing a lot better the next day.    The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Pain, Screaming
Clinical narrative: Product use in unapproved population; Had a high pitched scream like he was in a lot of pain and was not consolable; Had a high pitched scream like he was in a lot of pain and was not consolable; Had a lot of blowouts and spitting up more than usual; Had a high pitched scream like he was in a lot of pain and was not consolable; Diarrhoea; Slept a lot; Significant right leg swelling after getting vaccine; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2329055-1. The original narrative from the sender is the following:  Significant right leg swelling hours after getting vaccine. 100.2 temp. Had a high pitched scream like he was in a lot of pain and was not consolable. Tylenol and icing the area helped. slept a lot. had a lot of blowouts and spitting up more than usual. was doing a lot better the next day.    The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Diarrhoea, Hypersomnia, Infantile spitting up, Peripheral swelling, Product use issue
Clinical narrative: Product use in unapproved population; Had a high pitched scream like he was in a lot of pain and was not consolable; Had a high pitched scream like he was in a lot of pain and was not consolable; Had a lot of blowouts and spitting up more than usual; Had a high pitched scream like he was in a lot of pain and was not consolable; Diarrhoea; Slept a lot; Significant right leg swelling after getting vaccine; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2329055-1. The original narrative from the sender is the following:  Significant right leg swelling hours after getting vaccine. 100.2 temp. Had a high pitched scream like he was in a lot of pain and was not consolable. Tylenol and icing the area helped. slept a lot. had a lot of blowouts and spitting up more than usual. was doing a lot better the next day.    The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Screaming
Clinical narrative: Product use in unapproved population; Had a high pitched scream like he was in a lot of pain and was not consolable; Had a high pitched scream like he was in a lot of pain and was not consolable; Had a lot of blowouts and spitting up more than usual; Had a high pitched scream like he was in a lot of pain and was not consolable; Diarrhoea; Slept a lot; Significant right leg swelling after getting vaccine; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2329055-1. The original narrative from the sender is the following:  Significant right leg swelling hours after getting vaccine. 100.2 temp. Had a high pitched scream like he was in a lot of pain and was not consolable. Tylenol and icing the area helped. slept a lot. had a lot of blowouts and spitting up more than usual. was doing a lot better the next day.    The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Irritability postvaccinal, Seizure like phenomena, Staring, Tremor, Unresponsive to stimuli
Clinical narrative: He was staring and not responsive to her voice like he typically is; He was staring and not responsive to her voice like he typically is; 2 back to back episodes of shaking, 2 minutes apart, lasting 3 seconds each ('like a seizure'); Infant had 2 more episodes of shaking, the first 3-4 sec long and 2 minutes later the second episode lasting 7-10 minutes, with obvious head and arm shaking; Infant was a little more fussy during that 6 days after vaccination than usual; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2331704-1. The original narrative from the sender is as below:  6 days after vaccination on 6-19-22, mother observed  infant to have 2 back to  back episodes of shaking, 2 minutes apart, lasting 3 seconds each ('like a  seizure'). On 6-21-22, infant had 2 more episodes of shaking, the first 3-4 sec long and 2 minutes later the second episode lasting 7-10 minutes, with obvious head and arm  shaking. She videoed this episode and  showed to her Pediatrician. Mother reported that after the 7-10 second episode, she held baby to  comfort him, he was staring and not responsive to  her  voice like he typically is. No reported  fever after vaccination or other illness symptoms. No medications  given during that time. Infant  was a little more fussy during that 6 days after vaccination  than usual. Pediatrician  Dr. referred infant to Neurologist  for evaluation. Mother waiting on appointment.  Current illness reported as none.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Irritability, Staring, Tremor, Unresponsive to stimuli
Clinical narrative: He was staring and not responsive to her voice like he typically is; He was staring and not responsive to her voice like he typically is; 2 back to back episodes of shaking, 2 minutes apart, lasting 3 seconds each ('like a seizure'); Infant had 2 more episodes of shaking, the first 3-4 sec long and 2 minutes later the second episode lasting 7-10 minutes, with obvious head and arm shaking; Infant was a little more fussy during that 6 days after vaccination than usual; This non-serious spontaneous case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2331704-1. The original narrative from the sender is as below:  6 days after vaccination on 6-19-22, mother observed  infant to have 2 back to  back episodes of shaking, 2 minutes apart, lasting 3 seconds each ('like a  seizure'). On 6-21-22, infant had 2 more episodes of shaking, the first 3-4 sec long and 2 minutes later the second episode lasting 7-10 minutes, with obvious head and arm  shaking. She videoed this episode and  showed to her Pediatrician. Mother reported that after the 7-10 second episode, she held baby to  comfort him, he was staring and not responsive to  her  voice like he typically is. No reported  fever after vaccination or other illness symptoms. No medications  given during that time. Infant  was a little more fussy during that 6 days after vaccination  than usual. Pediatrician  Dr. referred infant to Neurologist  for evaluation. Mother waiting on appointment.  Current illness reported as none.
Age: 37.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Fatigue, Hypoaesthesia, Paraesthesia
Clinical narrative: Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: PATINET REPORTED THAT SHE STARTED HAVING TINGLING AFTER 2 DAYS
Age: 37.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Paraesthesia
Clinical narrative: Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: PATINET REPORTED THAT SHE STARTED HAVING TINGLING AFTER 2 DAYS
Age: 68.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Adverse event, Condition aggravated, Flushing, Hypertension, Tachycardia
Clinical narrative: facial flushing; tachycardia; blood pressure went 140 over 85; allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (facial flushing), TACHYCARDIA (tachycardia), BLOOD PRESSURE INCREASED (blood pressure went 140 over 85) and HYPERSENSITIVITY (allergic reaction) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     Concurrent medical conditions included Sulfonamide allergy, Hypertension in 2019 and Depression since 1997. Concomitant products included MODAFINIL and LAMOTRIGINE for Depression, CHLORTALIDONE (CHLORTHALIDONE) for Hypertension.    On 22-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 22-Sep-2022, the patient experienced FLUSHING (facial flushing), TACHYCARDIA (tachycardia), BLOOD PRESSURE INCREASED (blood pressure went 140 over 85) and HYPERSENSITIVITY (allergic reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N) on 22-Sep-2022 at a dose of 50 milligram. On 22-Sep-2022, FLUSHING (facial flushing), TACHYCARDIA (tachycardia), BLOOD PRESSURE INCREASED (blood pressure went 140 over 85) and HYPERSENSITIVITY (allergic reaction) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Sep-2022, Blood pressure measurement: 140/85. On 22-Sep-2022, Heart rate: 94.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient was physician working in pharmacovigilance had several leadership positions in Drug Safety/ PV organizations at multiple companies.   This case was linked to MOD-2022-651090 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2022: Significant follow up was received.
Age: 68.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Flushing, Heart rate, Hypersensitivity
Clinical narrative: facial flushing; tachycardia; blood pressure went 140 over 85; allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (facial flushing), TACHYCARDIA (tachycardia), BLOOD PRESSURE INCREASED (blood pressure went 140 over 85) and HYPERSENSITIVITY (allergic reaction) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     Concurrent medical conditions included Sulfonamide allergy, Hypertension in 2019 and Depression since 1997. Concomitant products included MODAFINIL and LAMOTRIGINE for Depression, CHLORTALIDONE (CHLORTHALIDONE) for Hypertension.    On 22-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 22-Sep-2022, the patient experienced FLUSHING (facial flushing), TACHYCARDIA (tachycardia), BLOOD PRESSURE INCREASED (blood pressure went 140 over 85) and HYPERSENSITIVITY (allergic reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N) on 22-Sep-2022 at a dose of 50 milligram. On 22-Sep-2022, FLUSHING (facial flushing), TACHYCARDIA (tachycardia), BLOOD PRESSURE INCREASED (blood pressure went 140 over 85) and HYPERSENSITIVITY (allergic reaction) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Sep-2022, Blood pressure measurement: 140/85. On 22-Sep-2022, Heart rate: 94.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient was physician working in pharmacovigilance had several leadership positions in Drug Safety/ PV organizations at multiple companies.   This case was linked to MOD-2022-651090 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2022: Significant follow up was received.