chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Sepsis, Septic shock, Splenomegaly, Ultrasound abdomen abnormal
Clinical narrative: Patient is a 56 y.o. male patient of DO with history of alcoholic liver cirrhosis, alcohol withdrawal, gastric varices status post banding, iron deficiency anemia, presented on 1/15/2023 with weakness, lightheadedness, fever/chills was admitted to the ICU for septic shock on 1/16/2023 initially requiring pressors. HMS consulted by MD  for transfer of care from ICU to intermediate unit. IR re-consulted for paracentesis today; had 8750 cc of fluid drained. 75g of albumin infusion given   Discharge Diagnoses: Sepsis due to R LE cellulitis Unclear etiology, likely septic shock from RLE cellulitis Or suspected hepatorenal syndrome/COVID infection VSS, BP improved, AF, on 2L NC. AAOX3 Required levophed on adm 1/16, quickly taken off On Midodrine 15 mg TID and octreotide 100 mcg TID VIR c/s for paracentesis 1/17 and removal of 9 liters, no SBP. 100g of albumin given Had repeat paracentesis today with removal of 8750L; 75g of albumin infusion given ID on board; received IV Ancef and completed 7 days of therapy  AKI-improved Adm Cr: 1.4>1.2.GFR:58>70.(Baseline Cr: 0.7-0.9, GFR: >90) Probable cause(s): suspected hepatorenal syndrome/sepsis Avoid nephrotoxic agents including NSAIDs Lasix and aldactone restarted 01/20 Nephrology on board; recommendation appreciated   Covid-19 Virus Infection Date of onset of symptoms: on adm (1/16) Symptoms present on admission:  cough and generalized fatigue on adm (1/16) Date of covid positive test: 1/15/23 Vaccination status: vaccinated Imaging: CXR (1/15/23) Moderate-sized right-sided pleural effusion appears increased.  Oxygen requirements on admission: RA Current oxygen requirements: RA Medical therapy: Dexamethasone and remdesivir started due to hypoxia, which has resolved Consultants following: N/A Anticipated special isolation end date: 1/25/23 ID on board, complete 10 days of Dexa. Remdesivir completed   Alcoholic Liver cirrhosis w/ ascites  Alcohol abuse MELD NA 21 on 1/17/23 Seen by Hepatology 10/14/22 --rec torsemide 20 mg TID.  Noncompliant, patient continues to use alcohol on a weekly basis Overdue for Surveillance EGD (last EGD: 5/2021 S/P banding) Diagnostic paracentesis 1/15/23 (-) SBP or culture growth Therapeutic paracentesis 1/17/23 S/P 9L and 1/23/23 8750L removed.  Albumin given after each session as described above Counseled to quit ETOH use; Lim it acetaminophen < 2 g daily F/u RUQ US w/ dopplers-Cirrhotic liver morphology no masses, Splenomegaly. AFP at 1.3 GI consulted, cont midodrine, 2gm diet Follow up GI as OP
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Decreased appetite, Diarrhoea, Dizziness, Feeling abnormal
Clinical narrative: Patient states, 'So I started feeling sick last Wednesday evening with just a little bit of a headache; which it is very unusual for me to get a headache.' 'Typically, I think my temp runs around 97.' 'Typically if I am feeling feverish it is 99 or 100 and typically the headache will get bad enough. However, 'this time the headache wasn't too bad.' 'However, the fever got pretty high last Thursday and has been 'pretty high since then.' 'It has been regularly going up to 102 or 103. 'I don't know if it would go higher if I hadn't taken Tylenol. Usually 1-2 hours later temp will be down to 99 or 100. She has been resting quite a bit. The fever, headache and just not feeling good when she would stand up and walk was feeling floaty or dizzy. Yesterday and today the fever hasn't been going up quite as fast and staying down a little longer.            Then, she broke out in a rash that was noticed when she came home from lunch today. It has progressively been getting worse.            She has had a little bit of a cough which has been slightly congested as well as slightly congested nose. She has also had a little bit of diarrhea. Appetite has been decreased, as well. She has been drinking a little bit of water and quite a bit of sports drink.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Malaise, Nasal congestion, Pyrexia, Rash
Clinical narrative: Patient states, 'So I started feeling sick last Wednesday evening with just a little bit of a headache; which it is very unusual for me to get a headache.' 'Typically, I think my temp runs around 97.' 'Typically if I am feeling feverish it is 99 or 100 and typically the headache will get bad enough. However, 'this time the headache wasn't too bad.' 'However, the fever got pretty high last Thursday and has been 'pretty high since then.' 'It has been regularly going up to 102 or 103. 'I don't know if it would go higher if I hadn't taken Tylenol. Usually 1-2 hours later temp will be down to 99 or 100. She has been resting quite a bit. The fever, headache and just not feeling good when she would stand up and walk was feeling floaty or dizzy. Yesterday and today the fever hasn't been going up quite as fast and staying down a little longer.            Then, she broke out in a rash that was noticed when she came home from lunch today. It has progressively been getting worse.            She has had a little bit of a cough which has been slightly congested as well as slightly congested nose. She has also had a little bit of diarrhea. Appetite has been decreased, as well. She has been drinking a little bit of water and quite a bit of sports drink.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Respiratory tract congestion
Clinical narrative: Patient states, 'So I started feeling sick last Wednesday evening with just a little bit of a headache; which it is very unusual for me to get a headache.' 'Typically, I think my temp runs around 97.' 'Typically if I am feeling feverish it is 99 or 100 and typically the headache will get bad enough. However, 'this time the headache wasn't too bad.' 'However, the fever got pretty high last Thursday and has been 'pretty high since then.' 'It has been regularly going up to 102 or 103. 'I don't know if it would go higher if I hadn't taken Tylenol. Usually 1-2 hours later temp will be down to 99 or 100. She has been resting quite a bit. The fever, headache and just not feeling good when she would stand up and walk was feeling floaty or dizzy. Yesterday and today the fever hasn't been going up quite as fast and staying down a little longer.            Then, she broke out in a rash that was noticed when she came home from lunch today. It has progressively been getting worse.            She has had a little bit of a cough which has been slightly congested as well as slightly congested nose. She has also had a little bit of diarrhea. Appetite has been decreased, as well. She has been drinking a little bit of water and quite a bit of sports drink.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, Anticoagulant therapy, Asthenia, Blood culture positive
Clinical narrative: The patient is a 83 y.o. male who presented from home on 1/15/2023 with weakness and fall and was found to have COVID-19 and hypoxia.          Assessment and Plan   Acute hypoxemic respiratory failure COVID-19 - Presented with: weakness - Symptom onset: 1/12/23 - Positive COVID-19: 1/15/23 at hospital - Vaccination status: Vaccinated with 2 boosters. - CXR on admission showed no acute findings - Oxygen status: RA - Decadron: Yes. Expected end date 1/25/23 - Remdesivir: Yes. Expected end date 1/20/23 - DVT prophylaxis:Subcutaneous heparin - Serial COVID labs ordered: Yes - Case Management/Social Services consulted: No    Acute UTI with bacteremia  History of left kidney stone s/p ureteral stent and lithotripsy -Recent diagnosis of left sided kidney stone (1.4 cm) s/p left ureteral stent placement and lithotripsy (1/4/23) per Dr., follow up scheduled 1/18/23.  -Frequency and abnormal UA noted on admission.  CT shows stent in position, possible posterior subcapsular hematoma.  Patient without left flank pain. -Urine and blood cultures growing pan-sensitive klebsiella -cont rocephin, will transition to keflex or omnicef at discharge for total of 14 wks   -discussed with Dr.(urology), plan OP follow up with Dr. once UTI resolved.    Acute kidney injury -Likely prerenal in setting of illness above.   -resolved with IVF's. Encouraged po fluids   Weakness Fall -Without significant injury -PT/OT rec HHC    Type 2 diabetes with neuropathy -No marked hyperglycemia on admission, but now on steroids.  On metformin and glipizide at home. -Hold oral agents.  Lantus 10 units nightly with sliding scale coverage ordered.   -cont gabapentin    Essential hypertension -cont home meds   Elevated troponin -Without delta in setting of AKI.  EKG unremarkable. -No further work-up indicated.   OSA -By history, does not use CPAP.   BPH -Continue Flomax and finasteride.   Hyperlipidemia -Continue statin.   History of lung cancer -Stage I adenocarcinoma of RUL. -Completed course of radiation treatment without evidence of recurrence
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram kidney abnormal, Condition aggravated, Culture urine positive, Electrocardiogram normal
Clinical narrative: The patient is a 83 y.o. male who presented from home on 1/15/2023 with weakness and fall and was found to have COVID-19 and hypoxia.          Assessment and Plan   Acute hypoxemic respiratory failure COVID-19 - Presented with: weakness - Symptom onset: 1/12/23 - Positive COVID-19: 1/15/23 at hospital - Vaccination status: Vaccinated with 2 boosters. - CXR on admission showed no acute findings - Oxygen status: RA - Decadron: Yes. Expected end date 1/25/23 - Remdesivir: Yes. Expected end date 1/20/23 - DVT prophylaxis:Subcutaneous heparin - Serial COVID labs ordered: Yes - Case Management/Social Services consulted: No    Acute UTI with bacteremia  History of left kidney stone s/p ureteral stent and lithotripsy -Recent diagnosis of left sided kidney stone (1.4 cm) s/p left ureteral stent placement and lithotripsy (1/4/23) per Dr., follow up scheduled 1/18/23.  -Frequency and abnormal UA noted on admission.  CT shows stent in position, possible posterior subcapsular hematoma.  Patient without left flank pain. -Urine and blood cultures growing pan-sensitive klebsiella -cont rocephin, will transition to keflex or omnicef at discharge for total of 14 wks   -discussed with Dr.(urology), plan OP follow up with Dr. once UTI resolved.    Acute kidney injury -Likely prerenal in setting of illness above.   -resolved with IVF's. Encouraged po fluids   Weakness Fall -Without significant injury -PT/OT rec HHC    Type 2 diabetes with neuropathy -No marked hyperglycemia on admission, but now on steroids.  On metformin and glipizide at home. -Hold oral agents.  Lantus 10 units nightly with sliding scale coverage ordered.   -cont gabapentin    Essential hypertension -cont home meds   Elevated troponin -Without delta in setting of AKI.  EKG unremarkable. -No further work-up indicated.   OSA -By history, does not use CPAP.   BPH -Continue Flomax and finasteride.   Hyperlipidemia -Continue statin.   History of lung cancer -Stage I adenocarcinoma of RUL. -Completed course of radiation treatment without evidence of recurrence
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Essential hypertension, Fall, Hypoxia, Illness, Klebsiella infection
Clinical narrative: The patient is a 83 y.o. male who presented from home on 1/15/2023 with weakness and fall and was found to have COVID-19 and hypoxia.          Assessment and Plan   Acute hypoxemic respiratory failure COVID-19 - Presented with: weakness - Symptom onset: 1/12/23 - Positive COVID-19: 1/15/23 at hospital - Vaccination status: Vaccinated with 2 boosters. - CXR on admission showed no acute findings - Oxygen status: RA - Decadron: Yes. Expected end date 1/25/23 - Remdesivir: Yes. Expected end date 1/20/23 - DVT prophylaxis:Subcutaneous heparin - Serial COVID labs ordered: Yes - Case Management/Social Services consulted: No    Acute UTI with bacteremia  History of left kidney stone s/p ureteral stent and lithotripsy -Recent diagnosis of left sided kidney stone (1.4 cm) s/p left ureteral stent placement and lithotripsy (1/4/23) per Dr., follow up scheduled 1/18/23.  -Frequency and abnormal UA noted on admission.  CT shows stent in position, possible posterior subcapsular hematoma.  Patient without left flank pain. -Urine and blood cultures growing pan-sensitive klebsiella -cont rocephin, will transition to keflex or omnicef at discharge for total of 14 wks   -discussed with Dr.(urology), plan OP follow up with Dr. once UTI resolved.    Acute kidney injury -Likely prerenal in setting of illness above.   -resolved with IVF's. Encouraged po fluids   Weakness Fall -Without significant injury -PT/OT rec HHC    Type 2 diabetes with neuropathy -No marked hyperglycemia on admission, but now on steroids.  On metformin and glipizide at home. -Hold oral agents.  Lantus 10 units nightly with sliding scale coverage ordered.   -cont gabapentin    Essential hypertension -cont home meds   Elevated troponin -Without delta in setting of AKI.  EKG unremarkable. -No further work-up indicated.   OSA -By history, does not use CPAP.   BPH -Continue Flomax and finasteride.   Hyperlipidemia -Continue statin.   History of lung cancer -Stage I adenocarcinoma of RUL. -Completed course of radiation treatment without evidence of recurrence
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Lithotripsy, Nephrolithiasis, Neuropathy peripheral, SARS-CoV-2 test positive, Thrombosis prophylaxis
Clinical narrative: The patient is a 83 y.o. male who presented from home on 1/15/2023 with weakness and fall and was found to have COVID-19 and hypoxia.          Assessment and Plan   Acute hypoxemic respiratory failure COVID-19 - Presented with: weakness - Symptom onset: 1/12/23 - Positive COVID-19: 1/15/23 at hospital - Vaccination status: Vaccinated with 2 boosters. - CXR on admission showed no acute findings - Oxygen status: RA - Decadron: Yes. Expected end date 1/25/23 - Remdesivir: Yes. Expected end date 1/20/23 - DVT prophylaxis:Subcutaneous heparin - Serial COVID labs ordered: Yes - Case Management/Social Services consulted: No    Acute UTI with bacteremia  History of left kidney stone s/p ureteral stent and lithotripsy -Recent diagnosis of left sided kidney stone (1.4 cm) s/p left ureteral stent placement and lithotripsy (1/4/23) per Dr., follow up scheduled 1/18/23.  -Frequency and abnormal UA noted on admission.  CT shows stent in position, possible posterior subcapsular hematoma.  Patient without left flank pain. -Urine and blood cultures growing pan-sensitive klebsiella -cont rocephin, will transition to keflex or omnicef at discharge for total of 14 wks   -discussed with Dr.(urology), plan OP follow up with Dr. once UTI resolved.    Acute kidney injury -Likely prerenal in setting of illness above.   -resolved with IVF's. Encouraged po fluids   Weakness Fall -Without significant injury -PT/OT rec HHC    Type 2 diabetes with neuropathy -No marked hyperglycemia on admission, but now on steroids.  On metformin and glipizide at home. -Hold oral agents.  Lantus 10 units nightly with sliding scale coverage ordered.   -cont gabapentin    Essential hypertension -cont home meds   Elevated troponin -Without delta in setting of AKI.  EKG unremarkable. -No further work-up indicated.   OSA -By history, does not use CPAP.   BPH -Continue Flomax and finasteride.   Hyperlipidemia -Continue statin.   History of lung cancer -Stage I adenocarcinoma of RUL. -Completed course of radiation treatment without evidence of recurrence
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin increased, Type 2 diabetes mellitus, Ureteral stent insertion, Urine analysis abnormal
Clinical narrative: The patient is a 83 y.o. male who presented from home on 1/15/2023 with weakness and fall and was found to have COVID-19 and hypoxia.          Assessment and Plan   Acute hypoxemic respiratory failure COVID-19 - Presented with: weakness - Symptom onset: 1/12/23 - Positive COVID-19: 1/15/23 at hospital - Vaccination status: Vaccinated with 2 boosters. - CXR on admission showed no acute findings - Oxygen status: RA - Decadron: Yes. Expected end date 1/25/23 - Remdesivir: Yes. Expected end date 1/20/23 - DVT prophylaxis:Subcutaneous heparin - Serial COVID labs ordered: Yes - Case Management/Social Services consulted: No    Acute UTI with bacteremia  History of left kidney stone s/p ureteral stent and lithotripsy -Recent diagnosis of left sided kidney stone (1.4 cm) s/p left ureteral stent placement and lithotripsy (1/4/23) per Dr., follow up scheduled 1/18/23.  -Frequency and abnormal UA noted on admission.  CT shows stent in position, possible posterior subcapsular hematoma.  Patient without left flank pain. -Urine and blood cultures growing pan-sensitive klebsiella -cont rocephin, will transition to keflex or omnicef at discharge for total of 14 wks   -discussed with Dr.(urology), plan OP follow up with Dr. once UTI resolved.    Acute kidney injury -Likely prerenal in setting of illness above.   -resolved with IVF's. Encouraged po fluids   Weakness Fall -Without significant injury -PT/OT rec HHC    Type 2 diabetes with neuropathy -No marked hyperglycemia on admission, but now on steroids.  On metformin and glipizide at home. -Hold oral agents.  Lantus 10 units nightly with sliding scale coverage ordered.   -cont gabapentin    Essential hypertension -cont home meds   Elevated troponin -Without delta in setting of AKI.  EKG unremarkable. -No further work-up indicated.   OSA -By history, does not use CPAP.   BPH -Continue Flomax and finasteride.   Hyperlipidemia -Continue statin.   History of lung cancer -Stage I adenocarcinoma of RUL. -Completed course of radiation treatment without evidence of recurrence
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: Both arms became numb and heavy.  It was difficult to use them.  I felt a deep pain in both arms.  This resolved after about 30 minutes but has recently started again to a lesser degree but the arms feel weak.  I am unsure as to whether I have recovered from the adverse event, because it seems to be happening again which is why I decided to report the event.  So I would describe it as a sudden numbing pain and weakness in both arms making it difficult to use the arms.
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Dyspnoea, Electrocardiogram abnormal, Feeling abnormal, Hyperhidrosis
Clinical narrative: Persistent tachycardia, heart racing, pounding heartbeat and palpitations Brain fog Memory issues Lightheadedness Shortness of breath Sweating
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Memory impairment, Palpitations, Tachycardia
Clinical narrative: Persistent tachycardia, heart racing, pounding heartbeat and palpitations Brain fog Memory issues Lightheadedness Shortness of breath Sweating
Age: 74.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reports chills and severe right arm pain started around 5 pm the day she received vaccine (Friday).  On Saturday, her hands swelled up and she couldn't turn her head right or cross her right shoulder.   By Sunday, the only remaining symptom was the swollen hands.  On Monday, (the day of this report ) she said her hands were 50% better and she had no further concerns.
Age: 1.5
Sex: F
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Computerised tomogram, Condition aggravated, Febrile convulsion, Laboratory test
Clinical narrative: Patient with prolonged febrile seizure (20 minutes) within 24 hours of vaccine administration
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 6/3/21 Lot# Ew0183;  Pfizer 6/22/21 Lot# EW0186
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after one dose Janssen
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Musculoskeletal stiffness, Pain in extremity, Swelling, Vaccination site pain, Vaccination site swelling
Clinical narrative: PATIENT REPORTED BOTH HANDS TURNING BLUE, TENDONITIS, AND STIFF LEFT ARM WHERE VACCINE WAS GIVEN
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Cyanosis, Injection site reaction, Musculoskeletal stiffness, Tendonitis
Clinical narrative: PATIENT REPORTED BOTH HANDS TURNING BLUE, TENDONITIS, AND STIFF LEFT ARM WHERE VACCINE WAS GIVEN
Age: 1.08
Sex: F
Vaccine: HEPA, FLUX, HEPA, MMR, PNC13, VARCEL
Symptoms: Expired product administered
Clinical narrative: No adverse effect; administered an expired dose of VAQTA; The involved VAQTA had also underwent a temperature excursion.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On 20-JAN-2023, the patient was vaccinated with an improperly stored and expired dose of hepatitis a vaccine, inactivated (VAQTA SYRINGE (DEVICE)) for prophylaxis (lot number W007375 had been verified to be a valid number; expiration date 16-JAN-2023, and upon internal validation established as the same date) (dosage, vaccination scheme, frequency, route of administration, and anatomical site of injection were not reported) (expired product administered and product storage error). The administered dose of the vaccine was stored at a temperature of 11.1 degree Celsius (C), for a time frame of 14 hours, as recorded by a data logger. There was no previous temperature excursion reported. There was no adverse effect reported.  Follow-up information was received from the nurse on 14-FEB-2023.  The report concerns to a 13-month-old female patient, who birth weight was 3.09 kilograms  On 20-JAN-2023, the patient was also vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number U033046 was verified to be a valid number, expiration date 21-OCT-2023, administered subcutaneosly; mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II) subcutaneous injection, lot number U039664 was verified to be a valid number, expiration date 15-DEC-2023, administered subcutaneosly; influenza vaccine lot number 5M2H2, expiration date 30-JUN-2023, administered intramuscularly; and pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) lot number FX0079, expiration date 30-NOV-2024, administered intramuscularly, all administered for prophylaxis (doses, strengths, anatomical injection sites and vaccination schemes were not reported). Hepatitis a vaccine, inactivated (VAQTA) was administered intramuscularly.   It was reported that temperature excursion was on 12-JAN-2023, vaccines were used on 13-JAN-2023 (also reported as 20-JAN-2023, conflicting information).  The vaccines were administered at private doctor's office/hospital with private funds.  The reporter considered expired product administered related to hepatitis a vaccine, inactivated (VAQTA).
Age: 1.08
Sex: F
Vaccine: HEPA, FLUX, HEPA, MMR, PNC13, VARCEL
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No adverse effect; administered an expired dose of VAQTA; The involved VAQTA had also underwent a temperature excursion.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On 20-JAN-2023, the patient was vaccinated with an improperly stored and expired dose of hepatitis a vaccine, inactivated (VAQTA SYRINGE (DEVICE)) for prophylaxis (lot number W007375 had been verified to be a valid number; expiration date 16-JAN-2023, and upon internal validation established as the same date) (dosage, vaccination scheme, frequency, route of administration, and anatomical site of injection were not reported) (expired product administered and product storage error). The administered dose of the vaccine was stored at a temperature of 11.1 degree Celsius (C), for a time frame of 14 hours, as recorded by a data logger. There was no previous temperature excursion reported. There was no adverse effect reported.  Follow-up information was received from the nurse on 14-FEB-2023.  The report concerns to a 13-month-old female patient, who birth weight was 3.09 kilograms  On 20-JAN-2023, the patient was also vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number U033046 was verified to be a valid number, expiration date 21-OCT-2023, administered subcutaneosly; mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II) subcutaneous injection, lot number U039664 was verified to be a valid number, expiration date 15-DEC-2023, administered subcutaneosly; influenza vaccine lot number 5M2H2, expiration date 30-JUN-2023, administered intramuscularly; and pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) lot number FX0079, expiration date 30-NOV-2024, administered intramuscularly, all administered for prophylaxis (doses, strengths, anatomical injection sites and vaccination schemes were not reported). Hepatitis a vaccine, inactivated (VAQTA) was administered intramuscularly.   It was reported that temperature excursion was on 12-JAN-2023, vaccines were used on 13-JAN-2023 (also reported as 20-JAN-2023, conflicting information).  The vaccines were administered at private doctor's office/hospital with private funds.  The reporter considered expired product administered related to hepatitis a vaccine, inactivated (VAQTA).
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; ROTATEQ was administered after a temperature excursion; inappropriate age at vaccination ; This spontaneous report has been received from an Other Health Professional, regarding to a 4-years-old patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 16-DEC-2022, when the patient had 4-years-old (Product administered to patient of inappropriate age), was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), oral liquid, orally administered, for prophylaxis (lot number: 1892784, which was determined to be valid, with an expiration date on 03-DEC-2023) (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not reported).   Administered dose was stored at a temperature of 47.9, during a time frame of 47 minutes (product storage error).   No additional adverse events were reported in the patient.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No addtional AE; The office manager is reporting that a patient received improperly stored vaccine.; This spontaneous report has been received from office manager, regarding to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 01-FEB-2023, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), oral liquid, orally administered, for prophylaxis (lot number: 1892788, which was determined to be valid, with an expiration date on 02-DEC-2023) (strength, dose, and vaccination scheme were not reported).   Administered doses were stored at a temperature of 9.5 degrees Celsius (C), during a time frame of 30 minutes and 0. 28 C for 5 hours and 30 minutes (product storage error). There was no previous temperature excursion.   No additional adverse events were reported in the patient.
Age: 5.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event, Wrong product administered
Clinical narrative: No adverse effects were noted; patient received a dose of PROQUAD and VARIVAX, but was scheduled to receive a dose of VARIVAX and MMR II.; patient received a dose of PROQUAD and VARIVAX, but was scheduled to receive a dose of VARIVAX and MMR II.; This spontaneous report was received from a nurse and refers to a 5-year-old female patient. The patient's pertinent medical history, other concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.   On 10-FEB-2023, the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection, 0.5 milliliter (ml) once, lot #W010528, expiration date: 25-SEP-2023, and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml once, lot #W003818, expiration date: 02-FEB-2024; both vaccines administered subcutaneously for prophylaxis (strengths and anatomical sites injection were not provided), but was scheduled to receive a dose of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection. The patient had never received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) in the past. The patient did not receive the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), as the nurse inadvertently administered the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) instead (wrong product administered and accidental overdose). No adverse effects were noted (no adverse events).
Age: 59.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional AE's were reported; an adult patient was administered a dose of PROQUAD; This spontaneous report was received from a medical assistant and refers to a 59-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 21-APR-2022, the adult patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) subcutaneous injection, at dose of 0.5 milliliter, lot number U028183 was verified to be a valid number, expiration date reported and established as 08-MAR-2023, administered subcutaneously for prophylaxis (strength was not provided) (product administered to patient of inappropriate age). No additional adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; Caller reported expired dose of PNEUMOVAX 23 was administered.; This spontaneous report has been received a medical assistant, regarding to patient of unknown age and gender. The patient's pertinent medical history, current conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 16-FEB-2023, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (Expired product administered), injection, intramuscular (IM), at a dose of 0,5 milliliter (ml), administered for prophylaxis (lot number U026796 which was determined to be valid, with an expiration date on 28-JAN-2023) (strength and anatomical sites of injection were not provided).  No adverse event was reported.
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: States that two pediatric patients received the Moderna COVID-19 bivalent vaccine for their 2nd dose instead of the monovalent vaccine dose. No adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of NO ADVERSE EVENT (No adverse reaction) and WRONG PRODUCT ADMINISTERED (States that two pediatric patients received the Moderna COVID-19 bivalent vaccine for their 2nd dose instead of the monovalent vaccine dose.) in a 2-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Feb-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced NO ADVERSE EVENT (No adverse reaction). On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (States that two pediatric patients received the Moderna COVID-19 bivalent vaccine for their 2nd dose instead of the monovalent vaccine dose.). At the time of the report, NO ADVERSE EVENT (No adverse reaction) and WRONG PRODUCT ADMINISTERED (states that two pediatric patients received the Moderna COVID-19 bivalent vaccine for their 2nd dose instead of the monovalent vaccine dose.) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment medications were not provided. States that two pediatric patients received the Moderna COVID-19 bivalent vaccine for their 2nd dose instead of the monovalent vaccine dose. They got the correct dosage of the bivalent vaccine but the incorrect product as their 2nd dose. No adverse reactions have been reported by the patients at this time.
Age: 37.0
Sex: M
Vaccine: COVID19-2
Symptoms: Vision blurred, Visual impairment, Vitreous floaters
Clinical narrative: perception of floaters in the field of view; vison became impaired/had looked at a bright light too long (i.e. colored patch in the central area); slight blurriness; This spontaneous case was reported by a patient and describes the occurrence of VITREOUS FLOATERS (perception of floaters in the field of view), VISUAL IMPAIRMENT (vison became impaired/had looked at a bright light too long (i.e. colored patch in the central area)) and VISION BLURRED (slight blurriness) in a 37-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Feb-2023, 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 16-Feb-2023, the patient experienced VITREOUS FLOATERS (perception of floaters in the field of view), VISUAL IMPAIRMENT (vison became impaired/had looked at a bright light too long (i.e. colored patch in the central area)) and VISION BLURRED (slight blurriness). At the time of the report, VITREOUS FLOATERS (perception of floaters in the field of view) was resolving and VISUAL IMPAIRMENT (vison became impaired/had looked at a bright light too long (i.e. colored patch in the central area)) and VISION BLURRED (slight blurriness) outcome was unknown.        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.   No concomitant medications were provided.  The patient's vision became impaired approximately 60 minutes after receiving the booster. The impairment presented as slight blurriness, and the perception of floaters in the field of view. It was unknown if the patient experienced any additional symptoms/events.   No treatment medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Interchange of vaccine products, Laboratory test, Peripheral coldness, Poor peripheral circulation
Clinical narrative: received the Moderna COVID-19 Vaccine and booster; cold feet 2 or 3 weeks ago which comes and goes; started taking for circulation/also mentioned about a gas leak in his home which may cause issues in circulation according to his research; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID: The reporter is the patient.  A 48-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing), notes: Caller's thyroid also looked good. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine Moderna (Primary Immunization series complete but unknown manufacturer.), for COVID-19 Immunization; Covid-19 vaccine Moderna (Dose number unknown booster), for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "received the Moderna COVID-19 Vaccine and booster"; PERIPHERAL COLDNESS (non-serious), outcome "unknown", described as "cold feet 2 or 3 weeks ago which comes and goes"; POOR PERIPHERAL CIRCULATION (non-serious), outcome "unknown", described as "started taking for circulation/also mentioned about a gas leak in his home which may cause issues in circulation according to his research". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: 48-year-old male patient called stating that he received the Moderna COVID-19 Vaccine and booster 8 and a half months ago. Patient received the Pfizer COVID-19 Vaccine a month and a half ago. Caller started having cold feet 2 or 3 weeks ago which comes and goes. taking for circulation, garlic, and fish oil, had his lab and blood work return as normal, thyroid also looked good and also mentioned about a gas leak in his home which may cause issues in circulation according to his research.  The information on the batch/lot number for (BNT162B2, BNT162B2 OMI BA.4-5), has been requested and will be submitted if and when received.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: patient was inadvertently administered a dose of MenQuadfi that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees F with no reported adverse event; Initial information received on 15-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a meningococcal a-c-y-w135 (t conj) vaccine [menquadfi] where 16 years old female patient  was inadvertently administered a dose of menquadfi that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included influenza vaccine inact split 4v (fluzone quadrivalent) for Immunisation.  On 08-Feb-2023, the patient received a 0.5 ml of suspect meningococcal a-c-y-w135 (t conj) vaccine  Solution for injection lot U7594AC (strength and expiry date not reported)  via intramuscular route in the left deltoid for immunization where patient was inadvertently administered a dose of menquadfi that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f with no reported adverse event (poor quality product administered) (same day: latency). Vaccines that had undergone temperature excursion down to 30 degrees F for 3 hours and 15 minutes, due to a refrigerator malfunction  Action taken: not applicable.  Outcome:  Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA056272:01493882
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: inadvertently administered a dose of Fluzone Quadrivalent prefilled syringe that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees F with no reported adverse event; Initial information received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 13 years old male patient who experienced inadvertently administered a dose of fluzone quadrivalent prefilled syringe that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient received no concomitant vaccines.    On 07-Feb-2023, the patient received a 0.5 ml of suspect influenza quadrival a-b vaccine Suspension for injection, lot UT7752MA (strength and expiry date not reported) via intramuscular route in the left deltoid for Immunization was inadvertently administered, a dose of fluzone quadrivalent prefilled syringe that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f with no reported adverse event (poor quality product administered) (latency: same day). Vaccines that had undergone temperature excursion down to 30 degrees F for 3 hours and 15 minutes, due to a refrigerator malfunction  Action taken: not applicable.  Outcome:  Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA056272:01495050
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Antibody test, Anxiety, Autonomic nervous system imbalance, Blood cortisol
Clinical narrative: 09/13/2021- Started experiencing tachycardia and lightheadedness.  10/2021- Worsening of symptoms, hospitalized at Local Hospital, evaluated for intermittent headaches, vertigo, and losing consciousness. Normal Brain CT and MRI, placed on meclizine to prevent nausea/vomiting. 11/20210 ECG, echocardiogram, stress test, and lab tests completed by pediatric cardiologist Dr. Determined to not be cardiac related and referred to neurology.  12/2021- Hospital Emergency dept evaluated patient for chest tightness, heart feeling "fuzzy," hyperventilation, dizziness, vomiting, and abdominal pain. Discharged with diagnosis of menstrual syndrome and acid reflux, placed on
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Blood iron decreased, Blood pressure fluctuation, C-reactive protein, COVID-19, Cardiac discomfort
Clinical narrative: 09/13/2021- Started experiencing tachycardia and lightheadedness.  10/2021- Worsening of symptoms, hospitalized at Local Hospital, evaluated for intermittent headaches, vertigo, and losing consciousness. Normal Brain CT and MRI, placed on meclizine to prevent nausea/vomiting. 11/20210 ECG, echocardiogram, stress test, and lab tests completed by pediatric cardiologist Dr. Determined to not be cardiac related and referred to neurology.  12/2021- Hospital Emergency dept evaluated patient for chest tightness, heart feeling "fuzzy," hyperventilation, dizziness, vomiting, and abdominal pain. Discharged with diagnosis of menstrual syndrome and acid reflux, placed on
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test abnormal, Chest discomfort, Computerised tomogram head normal, Crying, Depression
Clinical narrative: 09/13/2021- Started experiencing tachycardia and lightheadedness.  10/2021- Worsening of symptoms, hospitalized at Local Hospital, evaluated for intermittent headaches, vertigo, and losing consciousness. Normal Brain CT and MRI, placed on meclizine to prevent nausea/vomiting. 11/20210 ECG, echocardiogram, stress test, and lab tests completed by pediatric cardiologist Dr. Determined to not be cardiac related and referred to neurology.  12/2021- Hospital Emergency dept evaluated patient for chest tightness, heart feeling "fuzzy," hyperventilation, dizziness, vomiting, and abdominal pain. Discharged with diagnosis of menstrual syndrome and acid reflux, placed on
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Echocardiogram abnormal, Electrocardiogram abnormal, Fall, Full blood count
Clinical narrative: 09/13/2021- Started experiencing tachycardia and lightheadedness.  10/2021- Worsening of symptoms, hospitalized at Local Hospital, evaluated for intermittent headaches, vertigo, and losing consciousness. Normal Brain CT and MRI, placed on meclizine to prevent nausea/vomiting. 11/20210 ECG, echocardiogram, stress test, and lab tests completed by pediatric cardiologist Dr. Determined to not be cardiac related and referred to neurology.  12/2021- Hospital Emergency dept evaluated patient for chest tightness, heart feeling "fuzzy," hyperventilation, dizziness, vomiting, and abdominal pain. Discharged with diagnosis of menstrual syndrome and acid reflux, placed on
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Glycosylated haemoglobin, Head injury, Headache, Heart rate abnormal
Clinical narrative: 09/13/2021- Started experiencing tachycardia and lightheadedness.  10/2021- Worsening of symptoms, hospitalized at Local Hospital, evaluated for intermittent headaches, vertigo, and losing consciousness. Normal Brain CT and MRI, placed on meclizine to prevent nausea/vomiting. 11/20210 ECG, echocardiogram, stress test, and lab tests completed by pediatric cardiologist Dr. Determined to not be cardiac related and referred to neurology.  12/2021- Hospital Emergency dept evaluated patient for chest tightness, heart feeling "fuzzy," hyperventilation, dizziness, vomiting, and abdominal pain. Discharged with diagnosis of menstrual syndrome and acid reflux, placed on
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperventilation, Iron deficiency anaemia, Joint injury, Laboratory test, Loss of consciousness
Clinical narrative: 09/13/2021- Started experiencing tachycardia and lightheadedness.  10/2021- Worsening of symptoms, hospitalized at Local Hospital, evaluated for intermittent headaches, vertigo, and losing consciousness. Normal Brain CT and MRI, placed on meclizine to prevent nausea/vomiting. 11/20210 ECG, echocardiogram, stress test, and lab tests completed by pediatric cardiologist Dr. Determined to not be cardiac related and referred to neurology.  12/2021- Hospital Emergency dept evaluated patient for chest tightness, heart feeling "fuzzy," hyperventilation, dizziness, vomiting, and abdominal pain. Discharged with diagnosis of menstrual syndrome and acid reflux, placed on