chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Malnutrition, Mental status changes, Parkinson's disease, SARS-CoV-2 test positive, Sepsis
Clinical narrative: Patient is a 82 y.o. female with a history of parkinsons disease, orthostatic hypotension, and NIDDM who presented to Hospital 9/17/2023 with AMS. She was found to be COVID positive. ID econsulted, after discussion with patient/ family elected to pursue remdesivir, 9/18- 9/20. She has symptomatically improved, worked with therapy and is medically stable for discharge to a SNF.    1. COVID 19 infection, Improving: No hypoxia. Complicated by encephalopathy, and appears to be fatigued and hypotensive. ID followed- Paxlovid would interact with patient's quietapine, this was not given. Discussed with family who favored remdesivir, 9/18- 9/20. Follow up outpatient for monitoring of symptom resolution. Tessalon pearls PRN at disscharge.  2. Sepsis, Resolved: Likely 2/2 above with hypotension exacerbated by history of autonomic dysfunction. However, Vanc & Zosyn started on admission given significant hypotension, sepsis fluids, lactate. Blood cultures 9/18 no growth. Urine cultures with coagulase negative staph likely contaminant. She was deescalated to doxy/ rocephin for CAP coverage 9/18. These were discontinued 9/19 due to low concern for bacterial infection. Follow up outpatient for monitoring of resolution of COVID symptoms as above.  3. Hypokalemia: K 3.0 on admit, repleted as needed. Recommend repeat BMP in one week. Encourage good PO intake.  4. Parkinsons disease with dementia: Patient able to ambulate and talk at baseline. Home medications continued.  5. Autonomic dysfunction: Previous hospital admissions for syncope within the past year. Home midodrine provided with hold parameters for SBP >140, continue on discharge. 6. Bacteriuria: With >100k colonies coagulase negative staph on urine culture. With possible symptoms including dysuria/ increased frequency. Repeat UA without evidence of infection. Continue to monitor for s/s dysuria in the outpatient and repeat UA if needed.  7. NIDDM: on metformin, continue to address outpatient.  8. HTN: held amlodipine, ok to continue on discharge with hold parameters. 9. Constipation: Significant hx of constipation, continue home meds on discharge.  10. Moderate/non-severe, protein calorie malnutrition: related to chronic illness, per RD assessment. BMI 17.45, daughter reports loss of 5lbs over the past week PTA, poor appetite. Recommend Boost glucose control with breakfast and dinner. Encourage good PO intake.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Type 2 diabetes mellitus, Weight decreased
Clinical narrative: Patient is a 82 y.o. female with a history of parkinsons disease, orthostatic hypotension, and NIDDM who presented to Hospital 9/17/2023 with AMS. She was found to be COVID positive. ID econsulted, after discussion with patient/ family elected to pursue remdesivir, 9/18- 9/20. She has symptomatically improved, worked with therapy and is medically stable for discharge to a SNF.    1. COVID 19 infection, Improving: No hypoxia. Complicated by encephalopathy, and appears to be fatigued and hypotensive. ID followed- Paxlovid would interact with patient's quietapine, this was not given. Discussed with family who favored remdesivir, 9/18- 9/20. Follow up outpatient for monitoring of symptom resolution. Tessalon pearls PRN at disscharge.  2. Sepsis, Resolved: Likely 2/2 above with hypotension exacerbated by history of autonomic dysfunction. However, Vanc & Zosyn started on admission given significant hypotension, sepsis fluids, lactate. Blood cultures 9/18 no growth. Urine cultures with coagulase negative staph likely contaminant. She was deescalated to doxy/ rocephin for CAP coverage 9/18. These were discontinued 9/19 due to low concern for bacterial infection. Follow up outpatient for monitoring of resolution of COVID symptoms as above.  3. Hypokalemia: K 3.0 on admit, repleted as needed. Recommend repeat BMP in one week. Encourage good PO intake.  4. Parkinsons disease with dementia: Patient able to ambulate and talk at baseline. Home medications continued.  5. Autonomic dysfunction: Previous hospital admissions for syncope within the past year. Home midodrine provided with hold parameters for SBP >140, continue on discharge. 6. Bacteriuria: With >100k colonies coagulase negative staph on urine culture. With possible symptoms including dysuria/ increased frequency. Repeat UA without evidence of infection. Continue to monitor for s/s dysuria in the outpatient and repeat UA if needed.  7. NIDDM: on metformin, continue to address outpatient.  8. HTN: held amlodipine, ok to continue on discharge with hold parameters. 9. Constipation: Significant hx of constipation, continue home meds on discharge.  10. Moderate/non-severe, protein calorie malnutrition: related to chronic illness, per RD assessment. BMI 17.45, daughter reports loss of 5lbs over the past week PTA, poor appetite. Recommend Boost glucose control with breakfast and dinner. Encourage good PO intake.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: rash at injection site, soreness, redness at injection site
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product packaging quantity issue
Clinical narrative: More than 0.25ml administered as single dose vials were overfilled.
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Asthenia, Ataxia, Blood sodium decreased, COVID-19
Clinical narrative: Patient is a 85 y.o. male with a history of CLL, DM2, CAD, recent ED visit 9/14/23 s/p fall, found to be COVID-19 positive who presented to Hospital 9/17/2023 with worsening cough, fatigue, weakness, and intermittent confusion. He was treated with decadron for covid.      1. COVID-19: Presented as above. Symptom onset 9/14/23, positive test 9/14/23. Vaccinated. CXR with unchanged left basilar opacity (compared to 9/14/23). Initially not needing supplemental oxygen, now on NC. Stopped decadron 9/20 as patient weaned off O2.  2. Acute Hypoxic Respiratory Failure: secondary to Covid, mild and only requiring 2L NC, treatment of Covid as above. Patient weaned off O2 9/20 as above. Resolved.  3. Generalized weakness: Patient with generalized weakness/fatigue. Likely related to viral illness. Supportive measures, PT/OT/CM following. Plan for SNF at discharge.  4. Acute Metabolic Encephalopathy: presented as above, suspect combination of viral illness and hypoxia. Afebrile, no leukocytosis. Supportive care, delirium prevention measures. Decadron as noted but will monitor for side effects. Stopped decadron. Melatonin ordered. Hospital delirium likely contributing. Will trial trazodone 9/21 due to continued delirium and sleep deprivation. Encourage sleep hygiene. Delirium precautions.  Improved with trazodone. DC on trazodone prn.  5. CAD: Per history with prior MI, s/p LHC in 2001, 2007, last LHC 05/2018 with DES to prox circumflex and mid/proximal LAD. Continued home ASA/statin. 6. NIDDM2: HgbA1c 7.5 6/7/23. Held home Metformin on admit, initiated SSI while inpatient. Monitor and titrate as needed.  Improving off of decadron. Adjusted prandial insulin with continued hyperglycemia. Resolved.  7. Gait ataxia: Per history, follows with Dr. (neurology), thought to be sensory ataxia due to DM, CLL, and chemotherapy. Reports multiple recent falls. Supportive care with PT/OT.  8. Mild cognitive impairment: Per history, follows with Dr. (neurology), with short term memory loss. Delirium precautions. 9. CLL, thrombocytopenia: Per history, follows with Dr. (oncology). Completed 6 cycles Obinutuzumab 10/19/21. Admit Platelets 132, Hgb 13. Recommended continued outpatient follow-up with oncology. 10. Mild Hyponatremia: Admit Na 129. Suspect due to dehydration on presentation. Improved w/ IVF in ED. Daily BMP.  11. Code status: Full
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest X-ray abnormal, Confusional state, Cough, Dehydration, Delirium
Clinical narrative: Patient is a 85 y.o. male with a history of CLL, DM2, CAD, recent ED visit 9/14/23 s/p fall, found to be COVID-19 positive who presented to Hospital 9/17/2023 with worsening cough, fatigue, weakness, and intermittent confusion. He was treated with decadron for covid.      1. COVID-19: Presented as above. Symptom onset 9/14/23, positive test 9/14/23. Vaccinated. CXR with unchanged left basilar opacity (compared to 9/14/23). Initially not needing supplemental oxygen, now on NC. Stopped decadron 9/20 as patient weaned off O2.  2. Acute Hypoxic Respiratory Failure: secondary to Covid, mild and only requiring 2L NC, treatment of Covid as above. Patient weaned off O2 9/20 as above. Resolved.  3. Generalized weakness: Patient with generalized weakness/fatigue. Likely related to viral illness. Supportive measures, PT/OT/CM following. Plan for SNF at discharge.  4. Acute Metabolic Encephalopathy: presented as above, suspect combination of viral illness and hypoxia. Afebrile, no leukocytosis. Supportive care, delirium prevention measures. Decadron as noted but will monitor for side effects. Stopped decadron. Melatonin ordered. Hospital delirium likely contributing. Will trial trazodone 9/21 due to continued delirium and sleep deprivation. Encourage sleep hygiene. Delirium precautions.  Improved with trazodone. DC on trazodone prn.  5. CAD: Per history with prior MI, s/p LHC in 2001, 2007, last LHC 05/2018 with DES to prox circumflex and mid/proximal LAD. Continued home ASA/statin. 6. NIDDM2: HgbA1c 7.5 6/7/23. Held home Metformin on admit, initiated SSI while inpatient. Monitor and titrate as needed.  Improving off of decadron. Adjusted prandial insulin with continued hyperglycemia. Resolved.  7. Gait ataxia: Per history, follows with Dr. (neurology), thought to be sensory ataxia due to DM, CLL, and chemotherapy. Reports multiple recent falls. Supportive care with PT/OT.  8. Mild cognitive impairment: Per history, follows with Dr. (neurology), with short term memory loss. Delirium precautions. 9. CLL, thrombocytopenia: Per history, follows with Dr. (oncology). Completed 6 cycles Obinutuzumab 10/19/21. Admit Platelets 132, Hgb 13. Recommended continued outpatient follow-up with oncology. 10. Mild Hyponatremia: Admit Na 129. Suspect due to dehydration on presentation. Improved w/ IVF in ED. Daily BMP.  11. Code status: Full
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fall, Fatigue, Glycosylated haemoglobin increased, Haemoglobin, Hyperglycaemia
Clinical narrative: Patient is a 85 y.o. male with a history of CLL, DM2, CAD, recent ED visit 9/14/23 s/p fall, found to be COVID-19 positive who presented to Hospital 9/17/2023 with worsening cough, fatigue, weakness, and intermittent confusion. He was treated with decadron for covid.      1. COVID-19: Presented as above. Symptom onset 9/14/23, positive test 9/14/23. Vaccinated. CXR with unchanged left basilar opacity (compared to 9/14/23). Initially not needing supplemental oxygen, now on NC. Stopped decadron 9/20 as patient weaned off O2.  2. Acute Hypoxic Respiratory Failure: secondary to Covid, mild and only requiring 2L NC, treatment of Covid as above. Patient weaned off O2 9/20 as above. Resolved.  3. Generalized weakness: Patient with generalized weakness/fatigue. Likely related to viral illness. Supportive measures, PT/OT/CM following. Plan for SNF at discharge.  4. Acute Metabolic Encephalopathy: presented as above, suspect combination of viral illness and hypoxia. Afebrile, no leukocytosis. Supportive care, delirium prevention measures. Decadron as noted but will monitor for side effects. Stopped decadron. Melatonin ordered. Hospital delirium likely contributing. Will trial trazodone 9/21 due to continued delirium and sleep deprivation. Encourage sleep hygiene. Delirium precautions.  Improved with trazodone. DC on trazodone prn.  5. CAD: Per history with prior MI, s/p LHC in 2001, 2007, last LHC 05/2018 with DES to prox circumflex and mid/proximal LAD. Continued home ASA/statin. 6. NIDDM2: HgbA1c 7.5 6/7/23. Held home Metformin on admit, initiated SSI while inpatient. Monitor and titrate as needed.  Improving off of decadron. Adjusted prandial insulin with continued hyperglycemia. Resolved.  7. Gait ataxia: Per history, follows with Dr. (neurology), thought to be sensory ataxia due to DM, CLL, and chemotherapy. Reports multiple recent falls. Supportive care with PT/OT.  8. Mild cognitive impairment: Per history, follows with Dr. (neurology), with short term memory loss. Delirium precautions. 9. CLL, thrombocytopenia: Per history, follows with Dr. (oncology). Completed 6 cycles Obinutuzumab 10/19/21. Admit Platelets 132, Hgb 13. Recommended continued outpatient follow-up with oncology. 10. Mild Hyponatremia: Admit Na 129. Suspect due to dehydration on presentation. Improved w/ IVF in ED. Daily BMP.  11. Code status: Full
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hyponatraemia, Hypoxia, Lung opacity, Metabolic encephalopathy, Platelet count decreased
Clinical narrative: Patient is a 85 y.o. male with a history of CLL, DM2, CAD, recent ED visit 9/14/23 s/p fall, found to be COVID-19 positive who presented to Hospital 9/17/2023 with worsening cough, fatigue, weakness, and intermittent confusion. He was treated with decadron for covid.      1. COVID-19: Presented as above. Symptom onset 9/14/23, positive test 9/14/23. Vaccinated. CXR with unchanged left basilar opacity (compared to 9/14/23). Initially not needing supplemental oxygen, now on NC. Stopped decadron 9/20 as patient weaned off O2.  2. Acute Hypoxic Respiratory Failure: secondary to Covid, mild and only requiring 2L NC, treatment of Covid as above. Patient weaned off O2 9/20 as above. Resolved.  3. Generalized weakness: Patient with generalized weakness/fatigue. Likely related to viral illness. Supportive measures, PT/OT/CM following. Plan for SNF at discharge.  4. Acute Metabolic Encephalopathy: presented as above, suspect combination of viral illness and hypoxia. Afebrile, no leukocytosis. Supportive care, delirium prevention measures. Decadron as noted but will monitor for side effects. Stopped decadron. Melatonin ordered. Hospital delirium likely contributing. Will trial trazodone 9/21 due to continued delirium and sleep deprivation. Encourage sleep hygiene. Delirium precautions.  Improved with trazodone. DC on trazodone prn.  5. CAD: Per history with prior MI, s/p LHC in 2001, 2007, last LHC 05/2018 with DES to prox circumflex and mid/proximal LAD. Continued home ASA/statin. 6. NIDDM2: HgbA1c 7.5 6/7/23. Held home Metformin on admit, initiated SSI while inpatient. Monitor and titrate as needed.  Improving off of decadron. Adjusted prandial insulin with continued hyperglycemia. Resolved.  7. Gait ataxia: Per history, follows with Dr. (neurology), thought to be sensory ataxia due to DM, CLL, and chemotherapy. Reports multiple recent falls. Supportive care with PT/OT.  8. Mild cognitive impairment: Per history, follows with Dr. (neurology), with short term memory loss. Delirium precautions. 9. CLL, thrombocytopenia: Per history, follows with Dr. (oncology). Completed 6 cycles Obinutuzumab 10/19/21. Admit Platelets 132, Hgb 13. Recommended continued outpatient follow-up with oncology. 10. Mild Hyponatremia: Admit Na 129. Suspect due to dehydration on presentation. Improved w/ IVF in ED. Daily BMP.  11. Code status: Full
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Sleep deficit
Clinical narrative: Patient is a 85 y.o. male with a history of CLL, DM2, CAD, recent ED visit 9/14/23 s/p fall, found to be COVID-19 positive who presented to Hospital 9/17/2023 with worsening cough, fatigue, weakness, and intermittent confusion. He was treated with decadron for covid.      1. COVID-19: Presented as above. Symptom onset 9/14/23, positive test 9/14/23. Vaccinated. CXR with unchanged left basilar opacity (compared to 9/14/23). Initially not needing supplemental oxygen, now on NC. Stopped decadron 9/20 as patient weaned off O2.  2. Acute Hypoxic Respiratory Failure: secondary to Covid, mild and only requiring 2L NC, treatment of Covid as above. Patient weaned off O2 9/20 as above. Resolved.  3. Generalized weakness: Patient with generalized weakness/fatigue. Likely related to viral illness. Supportive measures, PT/OT/CM following. Plan for SNF at discharge.  4. Acute Metabolic Encephalopathy: presented as above, suspect combination of viral illness and hypoxia. Afebrile, no leukocytosis. Supportive care, delirium prevention measures. Decadron as noted but will monitor for side effects. Stopped decadron. Melatonin ordered. Hospital delirium likely contributing. Will trial trazodone 9/21 due to continued delirium and sleep deprivation. Encourage sleep hygiene. Delirium precautions.  Improved with trazodone. DC on trazodone prn.  5. CAD: Per history with prior MI, s/p LHC in 2001, 2007, last LHC 05/2018 with DES to prox circumflex and mid/proximal LAD. Continued home ASA/statin. 6. NIDDM2: HgbA1c 7.5 6/7/23. Held home Metformin on admit, initiated SSI while inpatient. Monitor and titrate as needed.  Improving off of decadron. Adjusted prandial insulin with continued hyperglycemia. Resolved.  7. Gait ataxia: Per history, follows with Dr. (neurology), thought to be sensory ataxia due to DM, CLL, and chemotherapy. Reports multiple recent falls. Supportive care with PT/OT.  8. Mild cognitive impairment: Per history, follows with Dr. (neurology), with short term memory loss. Delirium precautions. 9. CLL, thrombocytopenia: Per history, follows with Dr. (oncology). Completed 6 cycles Obinutuzumab 10/19/21. Admit Platelets 132, Hgb 13. Recommended continued outpatient follow-up with oncology. 10. Mild Hyponatremia: Admit Na 129. Suspect due to dehydration on presentation. Improved w/ IVF in ED. Daily BMP.  11. Code status: Full
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORD IN AN UNAPPROVED STORAGE UNIT
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORD IN AN UNAPPROVED STORAGE UNIT
Age: 76.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Headache, Myalgia
Clinical narrative: muscle aches, heacache 5 hr after shot. lasted 36 hours.  legs felt paralyzed.
Age: 62.0
Sex: M
Vaccine: FLUC4
Symptoms: Arthralgia, Decreased appetite, Fatigue, Feeling abnormal, Headache
Clinical narrative: States on morning of 10/14/2023 he didn't feel well. Left Upper arm tender, pain, mild redness and firm. 10/15/23 - 10/16/23 He felt horrible like he had the flu with sleepiness/fatigue as he slept for two days, headache, irritable, loss of appetite, fever/chills, joint pain, muscle pain. States today (5 days after vaccination) he still feels off, but functioning enough to work.   States he didn't receive any other injections that day.
Age: 62.0
Sex: M
Vaccine: FLUC4
Symptoms: Hypersomnia, Influenza like illness, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: States on morning of 10/14/2023 he didn't feel well. Left Upper arm tender, pain, mild redness and firm. 10/15/23 - 10/16/23 He felt horrible like he had the flu with sleepiness/fatigue as he slept for two days, headache, irritable, loss of appetite, fever/chills, joint pain, muscle pain. States today (5 days after vaccination) he still feels off, but functioning enough to work.   States he didn't receive any other injections that day.
Age: 62.0
Sex: M
Vaccine: FLUC4
Symptoms: Irritability, Malaise, Myalgia, Pyrexia, Somnolence
Clinical narrative: States on morning of 10/14/2023 he didn't feel well. Left Upper arm tender, pain, mild redness and firm. 10/15/23 - 10/16/23 He felt horrible like he had the flu with sleepiness/fatigue as he slept for two days, headache, irritable, loss of appetite, fever/chills, joint pain, muscle pain. States today (5 days after vaccination) he still feels off, but functioning enough to work.   States he didn't receive any other injections that day.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORD IN AN UNAPPROVED STORAGE UNIT
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Device connection issue
Clinical narrative: As nurse was giving immunization, needle immediately detached from syringe and pt did not receive any of the immunization. Another dose was given since patient did not receive any from the first vial.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Fatigue, Oropharyngeal pain, Pain
Clinical narrative: Patient had sore throat, fatigue, aches, chills and dizziness.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORD IN AN UNAPPROVED STORAGE UNIT
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects reported; HCP calling to report AE for ROTATEQ. Vaccine administered experienced a temperature excursion. No side effects reported. No other medical information known. See additional AE cases 02475713, 02475789, 02475811, 02475849, 02475861, 02475818, 02475985; This spontaneous report was received from an other health professional (HCP) and referred to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions/allergies were not reported.  On unknown dates, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (manufacture unknown) oral liquid, lot #W026137, expiration date: 05-FEB-2024 (dose, frequency, strength, route of administration were unknown) for prophylaxis.   It was reported that rotavirus vaccine, live, oral, pentavalent (manufacture unknown) experienced a temperature excursion, the temperature was 8.74 C, and time frame was 35 Minutes (Product storage error). No side effects reported (No adverse event). No other medical information known. See additional adverse event (AE) cases 02475713, 02475789, 02475811, 02475849, 02475861, 02475818, 02475985.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No symptoms reported. No additional AE; Staff calling on behalf of a medical assistant.  Per employee, medical assistant had an 18 month old female patient come in to the HCP's office today and the provider wanted to administer the second dose of VAQTA, 2 days prior to being the full; This spontaneous report was received from a medical assistant, referring to a 18-month-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 11-OCT-2023, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) (strength, vaccination scheme, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis, 2 days prior to being the full 6 months from the first dose (inappropriate schedule of product administration). The reporter consulted with the provider and the provider stated that there was a 4-day cushion window between the doses and that it was still a valid dose. Medical assistant was uncomfortable to administer it, but administered the vaccine and the immunization registry accepted it as a valid dose. No symptoms reported. No additional adverse event (AE).
Age: 3.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report a TE with PROQUAD.  Improperly stored. TE case reference 02490108.  No adverse effects reported.  Consent to contact is no. No additional AE/No PQC. AE cross reference cases 02490153, 02490133, 02490163, 02490160, 02490148, 02490; This spontaneous report was received from medical assistant and refers to a 3-years-old patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHa) (PROQUAD) injection, 0.5 milliliter, lot #W029555, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration (Product storage error).No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report a TE with PROQUAD.  Improperly stored. TE case reference 02490108.  No adverse effects reported.  Consent to contact is no. No additional AE/No PQC. AE cross reference cases 02490153, 02490133, 02490163, 02490160, 02490148, 02490; This spontaneous report was received from medical assistant and refers to a 12-month-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHa) (PROQUAD) injection, 0.5 milliliter, lot #W029555, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration (Product storage error). No additional adverse event was reported.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No symptoms or side effects reported; HCP called to report that a dose of PROQUAD, Lot: X007358 Expiration: 9/8/2024, was delivered to a 36-year-old female patient on 10/9/2023. No symptoms or side effects reported. HCP gives permission to contact. No further AE information available. No; This spontaneous report was received from a nurse and refers to a 36-year-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 09-OCT-2023 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status: rHA) lot # X007358 and expiration date 08-SEP-2024, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided) (product administered to patient of inappropriate age and no adverse event).
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/No PQC.; HCP called to report a TE with PROQUAD.  Improperly stored. TE case reference 02490108.  No adverse effects reported.  Consent to contact is no. No additional AE/No PQC. AE cross reference cases 02490153, 02490133, 02490163, 02490160, 02490148, 02490; This spontaneous report was received from a medical assistant, referring to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 03-AUG-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 0.5 milliliter (mL) (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number W029555, expiration date reported and validated as 14-MAR-2024) as prophylaxis, that was improperly stored and experienced a temperature excursion (product storage error). No adverse effects reported. No additional adverse event (AE).  This is one of several reports received from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No further AE information available; dose of PNEUMOVAX 23 that expired on 10/1/2023 was given to a patient on 10/10/2023. Lot: W021636 EXP: 10/1/2023; This spontaneous report was received from physician to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 10-OCT-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # W021636 expiration date reported as 01-OCT-2023 (dose and route of administration were not reported) for prophylaxis (expired product administered). No further adverse event (AE) information was available (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP called to report inadvertent administration of expired MMR-II to a patient. MMR-II expired on 10/07/2023 and was given to the patient on 10/13/2023.; This spontaneous report was received from a nurse referring to patient of unknown age and gender. The patient's medical history, concurrent condition, and concomitant medications were not reported.   On 13-OCT-2023, the patient was inadvertently vaccinated with expired measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live recombinant human albumin ([rHA]) (M-M-R II) injection (lot# U031359, expiry date: 07-OCT-2023; dose, route of administration, and anatomical location not reported) as prophylaxis (expired product administered). There was no additional adverse event (AE) (no adverse event).
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event, Wrong product administered
Clinical narrative: The patient was not experiencing any adverse events at the time of the call; an adult patient received ProQuad and Varivax during the same visit; An adult patient was supposed to receive MMR II and Varicella but the patient inadvertently received ProQuad and Varivax; This spontaneous report was received from a nurse concerning an adult patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was supposed to receive Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), however they were inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (wrong product administered), administered for prophylaxis (strength, dose, lot #, expiry date, route of administration, and anatomical location were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, dose, lot #, expiry date, route of administration, and anatomical location were not provided) (accidental overdose). The nurse added that the facility just switched to measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for child vaccines so inadvertently the patient received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and  varicella virus vaccine live (oka/merck) (VARIVAX). The patient was not experiencing any adverse events at the time of the call.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: developed Shingles even though she was fully vaccinated with Shingrix/suspected vaccination failure; shingles; first dose 21Mar2018, second dose 25Apr2019; This serious case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received zostavax on 10th December 2015).   On 21-MAR-2018, the patient received the 1st dose of Shingrix. On 25-APR-2019, the patient received the 2nd dose of Shingrix. On 25-APR-2019, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: first dose 21Mar2018, second dose 25Apr2019). On 27-SEP-2023, the patient experienced vaccination failure (Verbatim: developed Shingles even though she was fully vaccinated with Shingrix/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles).  The outcome of the vaccination failure and drug dose administration interval too long were unknown and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 10-Oct-2023 The patient developed Shingles even though she was fully vaccinated with Shingrix.  Appears to be past the acute phase. The reporter consented to follow-up. The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: M
Vaccine: MENB
Symptoms: Seizure, Syncope
Clinical narrative: patient fainted; This serious case was reported by a nurse via sales rep and described the occurrence of faint in a 16-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On 11-OCT-2023, the patient received Bexsero. On 11-OCT-2023, 3 min after receiving Bexsero, the patient experienced faint (Verbatim: patient fainted) (serious criteria GSK medically significant).  The outcome of the faint was not reported.   It was unknown if the reporter considered the faint to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the faint to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 11-OCT-2023 The nurse wanted to know if you knew of a lot of instances of patients fainting after receiving a dose of Bexsero. She had this happen to approximately 5 in the last year.  Bexsero was administered to the patient today, 11 October 2023 and he was standing and talking, while the mother and the nurse were conversing.  After about 3-5 minutes the patient fainted and in the nurse's work appeared to be seizing. An ambulance was called and he was taken to a local hospital. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose did not receive/ do i have to start over, or just get the second one; This non-serious case was reported by a consumer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (patient thought he/she had his/her first shot a long time ago in 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose did not receive/ do i have to start over, or just get the second one). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 12-OCT-2023 The patient self-reported this case. The patient wanted to know do he/she have to start over the Shingles vaccine series, or just get the second dose. The patient further stated that, he/she received different answers from different professionals. Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The consent to follow up requested.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy tongue abnormal, Condition aggravated, Incomplete course of vaccination, Oral lichen planus, Tongue blistering
Clinical narrative: flare-up of Oral Lichen Planus: blisters on her tongue; flare-up of Oral Lichen Planus: blisters on her tongue; flare-up of Oral Lichen Planus: blisters on her tongue; has yet to get the second shingrix shot; This non-serious case was reported by a consumer via call center representative and described the occurrence of oral lichen planus in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included oral lichen planus and tongue blistering.   On 01-MAR-2023, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced oral lichen planus (Verbatim: flare-up of Oral Lichen Planus: blisters on her tongue), tongue blistering (Verbatim: flare-up of Oral Lichen Planus: blisters on her tongue), condition aggravated (Verbatim: flare-up of Oral Lichen Planus: blisters on her tongue) and incomplete course of vaccination (Verbatim: has yet to get the second shingrix shot).  The patient was treated with metronidazole (Flagyl) and fluconazole (Diflucan). The outcome of the oral lichen planus, tongue blistering and condition aggravated were resolved and the outcome of the incomplete course of vaccination was unknown.   The reporter considered the oral lichen planus, tongue blistering and condition aggravated to be related to Shingrix.     The company considered the oral lichen planus, tongue blistering and condition aggravated to be related to Shingrix.   Additional Information: GSK receipt date: 9-Oct-2023 The reporter was the patient.   She had a shot of Shingrix but did not had the lot number available but did provide the contact information for her physician's office where she got the shot. A couple days after Shingrix shot and had a flare-up of oral lichen planus: blisters on her tongue.  She saw a dermatologist for this and a biopsy was taken of her tongue.  She was told that if she was to receive 2nd shot of Shingrix that she should pre-medicate herself for two weeks with Flagyl and Diflucan before the immunization to prevent another oral lichen planus flare.  She did not want to share her email address. The reporter consented to follow-up. Till the time of reporting the patient did not receive the 2nd shot Shingrix, which led to incomplete course of vaccination.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Pain, Paraesthesia
Clinical narrative: tingling not much of the pain; Pain; late 2nd dose; shingles; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number ZS3D7, expiry date 08-OCT-2024) for prophylaxis.   In OCT-2022, the patient received the 1st dose of Shingrix. On 09-OCT-2023, the patient received the 2nd dose of Shingrix. On 15-AUG-2023, between 9 and 11 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: shingles). On 09-OCT-2023, the patient experienced drug dose administration interval too long (Verbatim: late 2nd dose). On an unknown date, the patient experienced tingling (Verbatim: tingling not much of the pain) and pain (Verbatim: Pain).  The outcome of the shingles was not resolved and the outcome of the tingling and pain were not reported and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the shingles, tingling and pain to be related to Shingrix.     It was unknown if the company considered the shingles, tingling and pain to be related to Shingrix.   Additional Information: GSK Receipt date: 09-OCT-2023 A pharmacist reported that a female patient received the 1st dose of Shingrix about a year ago (October 2022), developed shingles about 1.5-2 months ago (Aug 2023), and today (09Oct2023) she received the 2nd dose of Shingrix.  The shingles was mild, tingling not much of the pain, saw doctor and got treatment. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule The reporter consented to follow up by email.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Havrix late booster; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 61-year-old male patient who received HAV (Havrix) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   Previously administered products included Hepatitis A vaccine (1st dose received on 09-FEB-2019, unknown if it was Havrix).   On 15-SEP-2023, the patient received Havrix. On 15-SEP-2023, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too long (Verbatim: Havrix late booster). The outcome of the drug dose administration interval too long was unknown.  Additional Information: GSK Receipt Date: 09-OCT-2023 The pharmacist reported that a patient received a first dose of Hepatitis A vaccine (unknown if it was Havrix) in 2019 and then a second dose (booster dose) of Hepatitis A vaccine (Havrix) in 2023.  The vaccine administration facility was the same as primary reporter. Lot number for first dose of vaccine was not available. The patient received booster dose of Havrix delayed than the recommended time interval, which led to lengthening of the vaccination schedule. Follow up via email agreed.
Age: 22.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: the administration of Infanrix to a 22 y/o patient instead of Boostrix; the administration of Infanrix to a 22 y/o patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 22-year-old female patient who received DTPa (Infanrix) (batch number 9R2D7, expiry date 23-MAY-2025) for prophylaxis.   On 27-SEP-2023, the patient received Infanrix. On 27-SEP-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: the administration of Infanrix to a 22 y/o patient instead of Boostrix) and inappropriate age at vaccine administration (Verbatim: the administration of Infanrix to a 22 y/o patient).  The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 9-Oct-2023 The case was reported by medical assistant. The reporter did not consent to follow-up. The patient received a dose of Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 37.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: mediation was noted to be expired after administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 37-year-old female patient who received HAB (Twinrix) (batch number 2ke55, expiry date 22-SEP-2023) for prophylaxis.   On 09-OCT-2023, the patient received Twinrix (left deltoid). On 09-OCT-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: mediation was noted to be expired after administration). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 9-OCT-2023 A healthcare professional (HCP) reported that a twinrix injection was administered to a patient and the mediation was noted to be expired after administration, which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Oral pain, Stomatitis
Clinical narrative: Non painful mouth sores; This non-serious case was reported by a consumer via call center representative and described the occurrence of sores mouth in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-SEP-2023, the patient received the 1st dose of Shingrix. In SEP-2023, 1 week after receiving Shingrix, the patient experienced sores mouth (Verbatim: Non painful mouth sores).  The outcome of the sores mouth was unknown.   It was unknown if the reporter considered the sores mouth to be related to Shingrix.     It was unknown if the company considered the sores mouth to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-OCT-2023 The reporter reported that the patient received Shingrix vaccine and 1 week later experienced 2 or 3 mouth ulcers that were painless on the inside of her bottom lip. The reporter asked if this could be a side effect from her Shingrix vaccine.   The patient was referred to her healthcare professional.  The reporter stated that her dentist believed that they are just normal oral mucosa damaged by trauma biting or nicotine tablets. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: patient received a less than recommended vaccine volume dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number 3B2YJ, expiry date 16-AUG-2025) for prophylaxis.   On 11-OCT-2023, the patient received the 1st dose of Shingrix. On 11-OCT-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: patient received a less than recommended vaccine volume dose). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 11-Oct-2023 A pharmacist called in to request information about how to procced after a patient received a less than recommended vaccine volume dose, which led to incomplete dose administered. The provided partial information and consented to receive follow up. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Headache
Clinical narrative: had a headache for 3 weeks on the left side along the occipital bone; had a headache on the left side along the occipital bone; This non-serious case was reported by a nurse via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 08-SEP-2023, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: had a headache for 3 weeks on the left side along the occipital bone) and bone pain (Verbatim: had a headache on the left side along the occipital bone). The outcome of the headache and bone pain were resolved (duration 3 weeks).   It was unknown if the reporter considered the headache and bone pain to be related to Shingrix.     It was unknown if the company considered the headache and bone pain to be related to Shingrix.   Additional Information: GSK receipt date: 11-OCT-2023 The reporter was a GSK representative who was reporting on behalf of an HCP (nurse).  The HCP was the patient, and she received her second dose of Shingrix. In 2023, she had a headache for 3 weeks on the left side along the occipital bone.  Headache had resolved in 2023. The reporter consented to follow up.