chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19-2
Symptoms: Anaemia of chronic disease, Auscultation, COVID-19, Computerised tomogram abdomen normal, Cortisol normal
Clinical narrative: Admit date: 7/11/2024  Discharge date:  07/15/2024  Admitting Physician: DO  Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD   Reason for Admission:  Hypoglycemia, myalgias, COVID-19 infection  Brief Summary of Hospital Stay: 51-year-old male with end-stage renal disease on dialysis, type 2 diabetes, multiple finger amputations and bilateral BKA, presents with malaise, nausea, vomiting and severe myalgias.  COVID-19 infection, supportive care, remdesivir for 3 days since patient is at risk for progression to severe disease due to his diabetes and end-stage renal disease.  He also has quite elevated inflammatory markers.  Incentive spirometer.  Cough medications provided as well.  On the day of discharge patient is not requiring any oxygen, denies cough or shortness of breath.  Severe myalgias, were treated with Tylenol, oxycodone, and fentanyl if needed Hypoglycemia, patient had several episodes , in the beginning of the hospital stay needed D10 infusion, later a few ampules of D50 injection.  It seems that S patient is eating 3 times a day, he does not have a problem with hypoglycemia.  Patient was also checked for adrenal insufficiency, random cortisol was normal.  Patient also had CT scan of the abdomen and pelvis and no issues with pancreas or liver were found.  Hypertension, hydralazine Anemia of chronic disease PVD, aspirin, Plavix, Right hand wounds, recent cultures with MRSA and Proteus, patient received several days of doxycycline and Keflex, that later were stopped due to nausea and vomiting.  Patient's wounds look clean and overall healing End-stage renal disease, post dialysis on Saturday  BP 171/88  | Pulse 93  | Temp 36.7 °C (Oral)  | Resp 18  | Ht 1.778 m Comment: "prior to amputation" | Wt 88.1 kg  | SpO2 94%  | BMI 27.87 kg/m²  No acute distress, no pallor, no icterus, no thrush.  Heart S1-S2, regular rate and rhythm, lungs are clear to auscultation bilaterally.  Abdomen with bowel sounds present, soft, nontender, nondistended.  Lower extremities without inflammatory changes, bilateral BKA.  Right hand has a few scabs and a small wound that overall looks clean without cellulitis or drainage.  Issues Requiring Follow Up: (Who, what, when, and how communicated?)  Follow-up with primary care physician, follow-up with dialysis 3 times a week.  Use simple mask for 5 more days if going to the community for COVID Discharged to Home
Age: 49.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cough, Culture positive, Dialysis, Hypertension, Hypoglycaemia
Clinical narrative: Admit date: 7/11/2024  Discharge date:  07/15/2024  Admitting Physician: DO  Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD   Reason for Admission:  Hypoglycemia, myalgias, COVID-19 infection  Brief Summary of Hospital Stay: 51-year-old male with end-stage renal disease on dialysis, type 2 diabetes, multiple finger amputations and bilateral BKA, presents with malaise, nausea, vomiting and severe myalgias.  COVID-19 infection, supportive care, remdesivir for 3 days since patient is at risk for progression to severe disease due to his diabetes and end-stage renal disease.  He also has quite elevated inflammatory markers.  Incentive spirometer.  Cough medications provided as well.  On the day of discharge patient is not requiring any oxygen, denies cough or shortness of breath.  Severe myalgias, were treated with Tylenol, oxycodone, and fentanyl if needed Hypoglycemia, patient had several episodes , in the beginning of the hospital stay needed D10 infusion, later a few ampules of D50 injection.  It seems that S patient is eating 3 times a day, he does not have a problem with hypoglycemia.  Patient was also checked for adrenal insufficiency, random cortisol was normal.  Patient also had CT scan of the abdomen and pelvis and no issues with pancreas or liver were found.  Hypertension, hydralazine Anemia of chronic disease PVD, aspirin, Plavix, Right hand wounds, recent cultures with MRSA and Proteus, patient received several days of doxycycline and Keflex, that later were stopped due to nausea and vomiting.  Patient's wounds look clean and overall healing End-stage renal disease, post dialysis on Saturday  BP 171/88  | Pulse 93  | Temp 36.7 °C (Oral)  | Resp 18  | Ht 1.778 m Comment: "prior to amputation" | Wt 88.1 kg  | SpO2 94%  | BMI 27.87 kg/m²  No acute distress, no pallor, no icterus, no thrush.  Heart S1-S2, regular rate and rhythm, lungs are clear to auscultation bilaterally.  Abdomen with bowel sounds present, soft, nontender, nondistended.  Lower extremities without inflammatory changes, bilateral BKA.  Right hand has a few scabs and a small wound that overall looks clean without cellulitis or drainage.  Issues Requiring Follow Up: (Who, what, when, and how communicated?)  Follow-up with primary care physician, follow-up with dialysis 3 times a week.  Use simple mask for 5 more days if going to the community for COVID Discharged to Home
Age: 49.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incentive spirometry, Inflammatory marker increased, Infusion, Malaise, Myalgia
Clinical narrative: Admit date: 7/11/2024  Discharge date:  07/15/2024  Admitting Physician: DO  Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD   Reason for Admission:  Hypoglycemia, myalgias, COVID-19 infection  Brief Summary of Hospital Stay: 51-year-old male with end-stage renal disease on dialysis, type 2 diabetes, multiple finger amputations and bilateral BKA, presents with malaise, nausea, vomiting and severe myalgias.  COVID-19 infection, supportive care, remdesivir for 3 days since patient is at risk for progression to severe disease due to his diabetes and end-stage renal disease.  He also has quite elevated inflammatory markers.  Incentive spirometer.  Cough medications provided as well.  On the day of discharge patient is not requiring any oxygen, denies cough or shortness of breath.  Severe myalgias, were treated with Tylenol, oxycodone, and fentanyl if needed Hypoglycemia, patient had several episodes , in the beginning of the hospital stay needed D10 infusion, later a few ampules of D50 injection.  It seems that S patient is eating 3 times a day, he does not have a problem with hypoglycemia.  Patient was also checked for adrenal insufficiency, random cortisol was normal.  Patient also had CT scan of the abdomen and pelvis and no issues with pancreas or liver were found.  Hypertension, hydralazine Anemia of chronic disease PVD, aspirin, Plavix, Right hand wounds, recent cultures with MRSA and Proteus, patient received several days of doxycycline and Keflex, that later were stopped due to nausea and vomiting.  Patient's wounds look clean and overall healing End-stage renal disease, post dialysis on Saturday  BP 171/88  | Pulse 93  | Temp 36.7 °C (Oral)  | Resp 18  | Ht 1.778 m Comment: "prior to amputation" | Wt 88.1 kg  | SpO2 94%  | BMI 27.87 kg/m²  No acute distress, no pallor, no icterus, no thrush.  Heart S1-S2, regular rate and rhythm, lungs are clear to auscultation bilaterally.  Abdomen with bowel sounds present, soft, nontender, nondistended.  Lower extremities without inflammatory changes, bilateral BKA.  Right hand has a few scabs and a small wound that overall looks clean without cellulitis or drainage.  Issues Requiring Follow Up: (Who, what, when, and how communicated?)  Follow-up with primary care physician, follow-up with dialysis 3 times a week.  Use simple mask for 5 more days if going to the community for COVID Discharged to Home
Age: 49.0
Sex: M
Vaccine: COVID19-2
Symptoms: Nausea, Peripheral vascular disorder, Proteus test positive, Scab, Staphylococcus test positive
Clinical narrative: Admit date: 7/11/2024  Discharge date:  07/15/2024  Admitting Physician: DO  Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD   Reason for Admission:  Hypoglycemia, myalgias, COVID-19 infection  Brief Summary of Hospital Stay: 51-year-old male with end-stage renal disease on dialysis, type 2 diabetes, multiple finger amputations and bilateral BKA, presents with malaise, nausea, vomiting and severe myalgias.  COVID-19 infection, supportive care, remdesivir for 3 days since patient is at risk for progression to severe disease due to his diabetes and end-stage renal disease.  He also has quite elevated inflammatory markers.  Incentive spirometer.  Cough medications provided as well.  On the day of discharge patient is not requiring any oxygen, denies cough or shortness of breath.  Severe myalgias, were treated with Tylenol, oxycodone, and fentanyl if needed Hypoglycemia, patient had several episodes , in the beginning of the hospital stay needed D10 infusion, later a few ampules of D50 injection.  It seems that S patient is eating 3 times a day, he does not have a problem with hypoglycemia.  Patient was also checked for adrenal insufficiency, random cortisol was normal.  Patient also had CT scan of the abdomen and pelvis and no issues with pancreas or liver were found.  Hypertension, hydralazine Anemia of chronic disease PVD, aspirin, Plavix, Right hand wounds, recent cultures with MRSA and Proteus, patient received several days of doxycycline and Keflex, that later were stopped due to nausea and vomiting.  Patient's wounds look clean and overall healing End-stage renal disease, post dialysis on Saturday  BP 171/88  | Pulse 93  | Temp 36.7 °C (Oral)  | Resp 18  | Ht 1.778 m Comment: "prior to amputation" | Wt 88.1 kg  | SpO2 94%  | BMI 27.87 kg/m²  No acute distress, no pallor, no icterus, no thrush.  Heart S1-S2, regular rate and rhythm, lungs are clear to auscultation bilaterally.  Abdomen with bowel sounds present, soft, nontender, nondistended.  Lower extremities without inflammatory changes, bilateral BKA.  Right hand has a few scabs and a small wound that overall looks clean without cellulitis or drainage.  Issues Requiring Follow Up: (Who, what, when, and how communicated?)  Follow-up with primary care physician, follow-up with dialysis 3 times a week.  Use simple mask for 5 more days if going to the community for COVID Discharged to Home
Age: 49.0
Sex: M
Vaccine: COVID19-2
Symptoms: Vomiting, Wound
Clinical narrative: Admit date: 7/11/2024  Discharge date:  07/15/2024  Admitting Physician: DO  Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD   Reason for Admission:  Hypoglycemia, myalgias, COVID-19 infection  Brief Summary of Hospital Stay: 51-year-old male with end-stage renal disease on dialysis, type 2 diabetes, multiple finger amputations and bilateral BKA, presents with malaise, nausea, vomiting and severe myalgias.  COVID-19 infection, supportive care, remdesivir for 3 days since patient is at risk for progression to severe disease due to his diabetes and end-stage renal disease.  He also has quite elevated inflammatory markers.  Incentive spirometer.  Cough medications provided as well.  On the day of discharge patient is not requiring any oxygen, denies cough or shortness of breath.  Severe myalgias, were treated with Tylenol, oxycodone, and fentanyl if needed Hypoglycemia, patient had several episodes , in the beginning of the hospital stay needed D10 infusion, later a few ampules of D50 injection.  It seems that S patient is eating 3 times a day, he does not have a problem with hypoglycemia.  Patient was also checked for adrenal insufficiency, random cortisol was normal.  Patient also had CT scan of the abdomen and pelvis and no issues with pancreas or liver were found.  Hypertension, hydralazine Anemia of chronic disease PVD, aspirin, Plavix, Right hand wounds, recent cultures with MRSA and Proteus, patient received several days of doxycycline and Keflex, that later were stopped due to nausea and vomiting.  Patient's wounds look clean and overall healing End-stage renal disease, post dialysis on Saturday  BP 171/88  | Pulse 93  | Temp 36.7 °C (Oral)  | Resp 18  | Ht 1.778 m Comment: "prior to amputation" | Wt 88.1 kg  | SpO2 94%  | BMI 27.87 kg/m²  No acute distress, no pallor, no icterus, no thrush.  Heart S1-S2, regular rate and rhythm, lungs are clear to auscultation bilaterally.  Abdomen with bowel sounds present, soft, nontender, nondistended.  Lower extremities without inflammatory changes, bilateral BKA.  Right hand has a few scabs and a small wound that overall looks clean without cellulitis or drainage.  Issues Requiring Follow Up: (Who, what, when, and how communicated?)  Follow-up with primary care physician, follow-up with dialysis 3 times a week.  Use simple mask for 5 more days if going to the community for COVID Discharged to Home
Age: 13.0
Sex: M
Vaccine: HEP, HEPA, HPV9, MMRV, MNQ, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: MMRV  was given to patient at the age of 13, on 6/24/2024 at 3:00pm, patient did not have ant symptoms at time of injection or there after. No treatment was needed.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Affective disorder, Death, Dementia
Clinical narrative: Death
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Eye swelling, Hypersensitivity, Rash, Rash erythematous, Rash vesicular
Clinical narrative: Patient received vaccine on Wed, 7/17/24. No concerns noted or reported during vaccine or while patient was in clinic. Patient stayed and visited with staff for approximately 10 mins after receiving vaccine. Client called Wed, 7/24/24, to report that on Monday, 7/22/24, morning she woke up to swollen eyes and nose. At first she didn't think anything of it. The next morning, Tuesday, 7/23/24, she woke up to her face being so swollen that she was unable to open her eyes. She also had a blistery, red, hot rash that started to form on her face and neck. Patient went to an urgent care and was told that it was an allergic reaction. She can not think of anything different from the last few days except the vaccine.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Skin warm, Swelling face, Swelling of eyelid
Clinical narrative: Patient received vaccine on Wed, 7/17/24. No concerns noted or reported during vaccine or while patient was in clinic. Patient stayed and visited with staff for approximately 10 mins after receiving vaccine. Client called Wed, 7/24/24, to report that on Monday, 7/22/24, morning she woke up to swollen eyes and nose. At first she didn't think anything of it. The next morning, Tuesday, 7/23/24, she woke up to her face being so swollen that she was unable to open her eyes. She also had a blistery, red, hot rash that started to form on her face and neck. Patient went to an urgent care and was told that it was an allergic reaction. She can not think of anything different from the last few days except the vaccine.
Age: 72.0
Sex: F
Vaccine: PNC20
Symptoms: Injected limb mobility decreased, Injection site hypoaesthesia, Syncope
Clinical narrative: Patient called pharmacy on 7/23/24. She said she received vaccine on 7/19/24 and 5 hours after her arm be came numb from shoulder to elbow and couldn't lift her arm- no mobility (frozen shoulder). The next morning the same and she ended up fainting. Her husband called EMS. They took her to ER. They told her it was the vaccine but were unsure if it was vaccine or injection site. She was advised to follow up with her primary. Her primary told her to come in on 7/24/24 and told her to call the pharmacy. She called us on 7/23/24. She went to her primary on 7/24/24 and was given a medrol dose pack.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Joint swelling, Joint warmth, Pain
Clinical narrative: Within 15 hours woke up with R lateral epicondyle pain. Has been worsening, pain with ROM, swelling and warm
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Blood sodium decreased, Blood test, Cardiac monitoring, Contusion, Deep vein thrombosis
Clinical narrative: She got her vaccine, that night she woke up to use the bathroom and felt like she was going to pass out.  She then continued to have episodes and on 6/16/2024 she passed out again, did not remember falling.  She went to the ER at Hospital ER.  She had a lot of things wrong with her and did have DVT.  She had bruises and she also had a multitude in the ER and since then to rule out why she had been dizzy.  She was sent on Lovenox for the blood clot, she was a little low on sodium and had an IV for that.  She had her heart checked and it was ok. She also had an MRI which was negative.  She had a 24-hour heart monitor which was dizzy.  She did nto have any fast heart beat.  She would get up each night to use the bathroom, and would have to take it easy.  By noon she did have the dizziness anymore on 6/19/24.   She saw her PCP last week for her regular  yearly visit and was told that they may not find out what the dizziness was caused from, but they are checking on everything.  She did not have any problems with her heart prior to the vaccine.  She does have a history of blood clots, 2 previously in her legs and is on Warfarin blood thinner for that condition as she has vitamin Deficiencies.   Scheduled for an echocardiogram on 8/20/24.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Electrocardiogram, Fall, Feeling abnormal, Loss of consciousness
Clinical narrative: She got her vaccine, that night she woke up to use the bathroom and felt like she was going to pass out.  She then continued to have episodes and on 6/16/2024 she passed out again, did not remember falling.  She went to the ER at Hospital ER.  She had a lot of things wrong with her and did have DVT.  She had bruises and she also had a multitude in the ER and since then to rule out why she had been dizzy.  She was sent on Lovenox for the blood clot, she was a little low on sodium and had an IV for that.  She had her heart checked and it was ok. She also had an MRI which was negative.  She had a 24-hour heart monitor which was dizzy.  She did nto have any fast heart beat.  She would get up each night to use the bathroom, and would have to take it easy.  By noon she did have the dizziness anymore on 6/19/24.   She saw her PCP last week for her regular  yearly visit and was told that they may not find out what the dizziness was caused from, but they are checking on everything.  She did not have any problems with her heart prior to the vaccine.  She does have a history of blood clots, 2 previously in her legs and is on Warfarin blood thinner for that condition as she has vitamin Deficiencies.   Scheduled for an echocardiogram on 8/20/24.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Magnetic resonance imaging normal, Memory impairment, Middle insomnia, Thrombosis
Clinical narrative: She got her vaccine, that night she woke up to use the bathroom and felt like she was going to pass out.  She then continued to have episodes and on 6/16/2024 she passed out again, did not remember falling.  She went to the ER at Hospital ER.  She had a lot of things wrong with her and did have DVT.  She had bruises and she also had a multitude in the ER and since then to rule out why she had been dizzy.  She was sent on Lovenox for the blood clot, she was a little low on sodium and had an IV for that.  She had her heart checked and it was ok. She also had an MRI which was negative.  She had a 24-hour heart monitor which was dizzy.  She did nto have any fast heart beat.  She would get up each night to use the bathroom, and would have to take it easy.  By noon she did have the dizziness anymore on 6/19/24.   She saw her PCP last week for her regular  yearly visit and was told that they may not find out what the dizziness was caused from, but they are checking on everything.  She did not have any problems with her heart prior to the vaccine.  She does have a history of blood clots, 2 previously in her legs and is on Warfarin blood thinner for that condition as she has vitamin Deficiencies.   Scheduled for an echocardiogram on 8/20/24.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Rash
Clinical narrative: Grandmother returned to pediatrics and showed Dr. patient rash appearing on patient's whole body. Provider order Benadryl to be given and observed. Patient to be referred to Allergist Specialist.  Provider observed and discharged patient.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: After administering vaccine, patient mentioned they would need another dose due to problem with previous vaccination.  Upon further investigation, patient had received full series but office did not see the documentation.   Pharmacist called office to make aware of extra dose and documentation of previous doses.  Further refills discontinued.
Age: 31.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient complained of arm pain for a few days following vaccine.  This pain went away completely after a few days, however today 7/24/24 he called pharmacy and said he has a dull ache in left arm were vaccine was given.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Patient started with rash, raised bumps on her chest 7/22/24 that then spread to he abdomen on 7/23/24
Age: 57.0
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Chills, Heart rate increased, Pain, Urticaria
Clinical narrative: I had chills around 7pm on 6/24/24. The next morning I had a rapid heart beat (97-107 pulse rate). Normally it's at 67. Then on the next day or so I started to have intermittent, generalized itching proceeded by hives. The hives would go away after about 30 minutes or so. This has continued until this day 7/24/2024.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: 30 MINUTES AFTER INJECTION, PT REPORTED SWELLING AND ITCHING AT THE INJECTION SITE. SYMPTOMS RESOLVED AFTER 7 DAYS.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Malaise
Clinical narrative: Pharmacy checked state immunization registry and found patient was due for Shingrix series. Immunization was administered 7/20/24 and patient reported not feeling well later that day. She followed up with her physician the next day. The physician office checked her office records and discovered she had already received two doses of Shingrix (10/8/2020 and 4/19/2021) but had not reported to state registry. Since these doses were not entered into the state registry, the pharmacy had no way of knowing patient had already received the recommended doses.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: INJECTION SITE SWOLLEN, HOT TO TOUCH, REDNESS
Age: 65.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Injected limb mobility decreased, Myalgia, Pain
Clinical narrative: Patient reported typical adverse events listed on VIS for both vaccines. Myalgia resolved in 48 hours, but after he started experiencing extreme soreness and is now unable to move his arm. compares feeling and pain to when he tore his rotator cuff. I asked him questions about how the pharmacist gave the immunizations (ie: too high, etc) and he did not recall. He is still experiencing severe pain and is going to his prescribers office today for a visit regarding the side effects.
Age: 13.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: I was assisting the apprentice and verifying vaccine. I read chart wrong and thought patient was due for MMRV and really was only due for MMR. Pt was given MMRV. it was discovered during documenting that MMRV was incorrect
Age: 1.58
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This 18-month-old male inadvertently received the Gardasil 9 vaccine.
Age: 1.58
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Medication error, No adverse event, Product storage error, Wrong product administered
Clinical narrative: This 18-month-old male inadvertently received the Gardasil 9 vaccine.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Hyperhidrosis, Loss of consciousness, Skin warm, Vision blurred
Clinical narrative: Patient received both vaccines and was walking around. He stated he experienced blurry vision then passed out. He was hot to the touch and sweating. BP was checked several times, a cold compress placed behind his neck, feet elevated above heart. He was given water and observed for 15 to 20 minutes.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine, no patient reaction
Age: 6.0
Sex: M
Vaccine: HEP, IPV
Symptoms: Periorbital swelling, Petechiae
Clinical narrative: swelling around eyes.Petechae around eyes on chest and the back of neck.Benedryl was administered and pt was observed in clinic for 30 minutes.After 30 minutes swelling had significantly decreased petechae on chest and back had cleared.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Diarrhoea, Dizziness, Nausea, Rash pruritic, Vomiting
Clinical narrative: PER PATIENT VISIT NOTES, PATIENT REPORTED NAUSEA, VOMITING, DIARRHEA, AND DIZZINESS ON 7/20 POST VACCINATION AND WENT TO ER ON 7/22.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Cough, Lip swelling, Paraesthesia, Pruritus, Urticaria
Clinical narrative: Patient had reaction 24 hours after receiving Men B vaccine. Patient began having itchy feet, hives all over body, swollen lips, tingling in the body, and a cough. Mom called EMT services and was transferred to ER.
Age: 1.08
Sex: M
Vaccine: HEPA
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: per Mom patient started a hives reaction/rash all over his body - rash was also on his face Patient was itching at the rash No breathing changes or shortness of breath or increased work of breathing at the time No swelling of the face/lips/eyes at the time; no vomiting at the time Gave at Zyrtec at home 2.5ml - one dose only: rash started to improve right away with Zyrtec but did not completely resolve
Age: 1.5
Sex: F
Vaccine: HEPA, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was given a Tdap (Boostrix) instead of a Dtap as indicated for the patient's age. Patient did not have any adverse reactions to this medication error.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Rash, Rash maculo-papular, Rash pustular
Clinical narrative: Rash 8 days after vaccination - maculopapular and pustular lesions to trunk, groin and extremities, non pruritic, non painful.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Feeling abnormal, Nausea
Clinical narrative: Patient states she is feeling nauseous and needed to sit down and stabilize. Patient sat on floor and was given water and a snack to help stabilize her blood sugar and nausea and being monitored.
Age: 5.0
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Induration, Peripheral swelling, Skin warm
Clinical narrative: Left thigh is swollen, hot to touch, and hard.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hyperhidrosis, Pallor, Vomiting
Clinical narrative: SEE ADDITIONAL NOTES BELOW 11 YR OLD PATIENT NOTED TO BE DIAPHORETIC, PALLOR AND VOMMITED IN LOBBY OF HEALTH CENTER WITHIN 10 MINUTES OF RECEIVING FIRST DOSE OF MCV4 VACCINE, FIRST DOSE OF HPV9 VACCINE, AND FIRST DOSE OF TDAP VACCINE. VITAL SIGNS COLLECTED AND RECORDED AS FOLLOWS T98.3, HR 91, BP 104/78, SPO2 INITIALLY 92% ON RA AND INCREASED TO 97% ON RA. LUNGS REPORTEDLY CLEAR. UPON REVIEW OF POLICY AND PROCEDURE FOR THE REACTIONS AND FOLLOWING DIRECTIVE LISTED NEXT TO GASTROINTESTINAL SYMPTOMS TO  REFER TO THE "POLICY AND PROCEDURE",  VERBAL CONSENT FROM MOTHER TO ADMINISTER DIPHENHYDRAMINE 25 MG LIQUID PO X 1 DOSE AND ACTIVATE EMS. DIPHENHYDRAMIME 25 MG LIQUID PO  ADMINISTERED PR PATIENTS WEIGHT. ems CONTACTED. PATIENT NOTED TO RECOVER QUICKLY, EMS ARRIVED WITHIN 5 MINUTES AND RE-ASSESSED PATIENT. EMS AND GUARDIAN WERE OBSERVED DISCUSSING AND VERBALLY AGREEING THAT NO FURTHER ACTION WAS INDICATED AT THAT TIME. GUARDIAN PROVIDED WITH DOCUMENTATION OF VACCINES ADMINISTERED, APPROPRIATE VIS AND WERE VERBALLY EDUCATED ON S/S OF ADVERSE REACTIONS TO REPORT AND WHEN TO SEEK MEDICAL ATTENTION . GUARDIAN VERBALIZED UNDERSTANDING OF ALL INSTRUCTIONS. PATIENT DENIED DIZZINESS, SHORTNESS OF BREATH, NAUSEA OR ANY OTHER SYMPTOM AND AMBULATED OUT OF CLINIC WITH GUARDIAN AT APPROXIMATELY 1220PM
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient was inadvertently given an HPV vaccine after declining it.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anovulatory cycle, Arthritis, COVID-19, Detoxification, Echocardiogram
Clinical narrative: PFIZER #1 5/4/2021 PFIZER #2 5/25/2021 PFIZER #3 12/5/2021   PATIENT DEVELOPED COVID-19 VACCINE INDUCED ECZEMA, ARTHRITIS, AND ANOVULATION.   PATIENT HAS BECOME INFERTILE AND NOW UNDERGOING IVF AND WITH EACH CYCLE ONLY ONE EGG HAS BEEN RETRIEVED.  DIAGNOSED WITH COVID-19 VACCINE INDUCED INFERTILITY.  TREATED WITH PROTOCOL BASE SPIKE DETOXIFICATION AND OTC IRON.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eczema, Electrocardiogram, Immunisation reaction, Infertility female, Laboratory test
Clinical narrative: PFIZER #1 5/4/2021 PFIZER #2 5/25/2021 PFIZER #3 12/5/2021   PATIENT DEVELOPED COVID-19 VACCINE INDUCED ECZEMA, ARTHRITIS, AND ANOVULATION.   PATIENT HAS BECOME INFERTILE AND NOW UNDERGOING IVF AND WITH EACH CYCLE ONLY ONE EGG HAS BEEN RETRIEVED.  DIAGNOSED WITH COVID-19 VACCINE INDUCED INFERTILITY.  TREATED WITH PROTOCOL BASE SPIKE DETOXIFICATION AND OTC IRON.
Sex: U
Vaccine: COVID19-2
Symptoms: Mobility decreased
Clinical narrative: Post injection pain and reduced range of motion for 4 months. Resolved through chiropractic treatment. Pain and reduced range of motion returned less than 1.5 years later.
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Neck pain, Pain in extremity
Clinical narrative: patient experienced severe pain hours after rsv vaccination, so severe she had to go to er in the middle of the night, The pain was down her arm and up her neck
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Incorrect vaccine given. Prevnar 20 was ordered for patient. Staff drew up HPV Gardasil instead and administered all three vaccines from above. Immediately after admin, staff documented vaccines realizing the vaccine error. Clinical Coordinator was made aware. Staff and Clinical Coordinator notified the ordering MD. No known symptoms or adverse reactions at this point.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema multiforme, Skin warm, Urticaria
Clinical narrative: "12-month-old female presents with an urticarial type rash concern for erythema versus urticarial multiforme but also could be bug bites with local inflammation just does not make as much sense since it showed up acutely after waking up this morning and no obvious exposure was seen.  Low concern for it being cellulitis although one of the lesions is slightly warm to the touch, no fever or other cold type symptoms at this time.  Discussed the possibility of a viral etiology but again no cold type symptoms to prompt testing at this time.  She did receive shots that were new on Monday I do not think it is related but we will still file report given the proximity of the reaction as a possible vaccine side effect and we will need to bear this in mind with vaccines going forward.  I do not think it is related to the whole milk since she has tolerated dairy in the past but I would hold the whole milk for right now until this resolves in case it is something that is triggering it.    Photo was obtained and added to the chart   -Recommend to continue the daily Zyrtec  -Discussed that they could do Benadryl as needed mom is hesitant to use this because she herself is allergic to it so we may try to avoid and trial at some time when she is healthy  -Dose of Orapred was given here in the office, discussed with mom I would like to continue this once to twice daily over the next 3 days if the rash is still present or returns tonight would do another dose tonight but if it is improving by tomorrow I would hold the dose in the morning just to dose in the evening as needed and continue that going forward until this is completely resolved.   If still present by Friday, that I would recommend a follow-up visit going into the weekend.  If this is continuing to spread despite the steroids and Zyrtec, associated with lethargy or irritability, vomiting, wheezing or issues breathing, then she needs to be seen in the ER for assessment."
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Blood glucose, Dizziness
Clinical narrative: Patient reported feeling dizziness and feeling faint.
Age: 22.0
Sex: M
Vaccine: MMR
Symptoms: Lip swelling
Clinical narrative: 22 year old patient came in on 7/23/24 at 1:30 Pm for MMR#1  vaccine. MMR vaccine was administered to upper left arm. Patient contacted clinic that he woke up the next morning on 7/24/24 at 6:30 am with a swollen upper right lip. Patient states that there is no pain, no throat or tongue swelling, no diffculty breathing report. Injection site is not red and swollen. No rash reported by patient on body. Contacted patient to come in for follow on possible allergic reaction. NP evaluated the possible rection. Continue loratadine or zyrtec. Patient was advised if difficulty breathing or your symptoms change  and  feel you are having  a medical emergency,  please call 911 or go the nearest emergency room.
Age: 32.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Erythema, Urticaria
Clinical narrative: Large red welt ( 9 cm x 5 cm), 3 days duration
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Burning sensation, Full blood count, Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: Severe right shoulder and arm pain- burning pain sensation , numbness extending to all right fingers, progressive loss of shoulder and UE ROM since vaccination month prior
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity, Red blood cell sedimentation rate, X-ray limb
Clinical narrative: Severe right shoulder and arm pain- burning pain sensation , numbness extending to all right fingers, progressive loss of shoulder and UE ROM since vaccination month prior
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: REDNESS AROUND INJECTION SITE LEFT ARM, PAIN IN LEFT ARM. MOM NOTICED THIS MORNING 7/24/24.
Age: 90.0
Sex: M
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: Patient deceased on 7/19/2024
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Dyspnoea, Erythema, Headache, Pruritus
Clinical narrative: Patient experienced redness, itching, swelling, shortness of breath, headache, joint pain, This started a few hours after the vaccination
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Swelling
Clinical narrative: Patient experienced redness, itching, swelling, shortness of breath, headache, joint pain, This started a few hours after the vaccination
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; HCP called to report PROQUAD was administered to a patient after experiencing a T/E.  No symptoms reported.  HCP provided consent to contact.  No additional AE/PQC reported.; This spontaneous report was received from nurse and refers to a 4-year-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-MAR-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, lot #X022920, expiration date: 12-MAR-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event reported; HCP called to report that a dose of expired ROTATEQ was inadvertently administered to patient. No symptomatic adverse events were reported. The dose was supported by the post expiry memo. No additional information was provided. No additional AE/ no P; This spontaneous report was received from nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-JUL-2024, the patient was vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #1933912, expiration date: 21-APR-2024, administered orally for prophylaxis (strength was not provided) (Expired product administered). No additional adverse event was reported.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improper storage of product in use; This spontaneous report was received from a medical assistant, referring to a 12-month-old male patient.  The patient's medical history, concurrent conditions, and drug reactions/allergies were not reported. Concomitant therapy included pneumococcal vaccine conj 20v (crm197) (PREVNAR 20). Historical vaccines included pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), and pneumococcal vaccine conj 20v (crm197) (PREVNAR 20). It was reported that there were no vaccines received within 4 weeks prior to the administration.   On 14-MAY-2024, the patient was vaccinated with improperly stored vaccines of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection, lot #W035041, expiration date: 24-MAY-2024, the first dose, administered on the right thigh as prophylaxis (strength, dose, and route of administration were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X010531, expiration date: 11-APR-2025, the first dose, administered on the right thigh as prophylaxis (strength, dose, and route of administration were not provided) (product storage error). The vaccines were exposed to multiple current excursions since 22-APR-2024, There was no previous temperature excursion. It was reported that the temperature excursion occurred as a result of reading from a digital data logger. No adverse event was reported (no adverse event). And on the same date, the patient was vaccinated with the second dose of pneumococcal vaccine conj 20v (crm197) (PREVNAR 20), lot # HA2258, expiration date: 31-JAN-2025, administered on left thigh as prophylaxis (strength, formulation, dose, and route of administration were not provided) (reported as concomitant medication).
Age: 54.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse event; Pharmacist calling regarding a GARDASIL 9 vaccine that was administered to a 54-year-old male patient. Requesting information on potential side effects. See request case #02637500. HCP did not provide patient information, additional details or lot nu; This spontaneous report was received from registered pharmacist and refers to a 54-year-old male.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-JUL-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). Due to leaft the male patient shoud be given this vaccin to 45-years-old (Product administered to patient of inappropriate age ). No additional adverse event was reported.
Age: 9.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Product storage error; This spontaneous report was received from physician and refers to a 9-year-old female.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-JUN-2024, the patient was vaccinated with second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, unk, lot #W028734, expiration date: 08-SEP-2024, administered for prophylaxis (strength, and route of administration were not provided); and second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, unk, lot #X015939, expiration date: 05-DEC-2024 (strength, route of administration, and indication were not provided). Those vaccines underwent temperature excursion (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: RVX
Symptoms: Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Vaccination failure/suspected vaccination failure; Respiratory syncytial virus infection/ got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   In OCT-2023, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Vaccination failure/suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: Respiratory syncytial virus infection/ got it). The outcome of the vaccination failure was unknown and the outcome of the respiratory syncytial virus infection was not resolved.   It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine.     The company considered the vaccination failure to be related to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 15-JUL-2024 The case was received from the patient via interactive digital media. The patient reported that he or she got the RSV vaccine in October of last year and anyway got it (Respiratory syncytial virus infection).  Two weeks long, and better for a week then it came back for over a week.  The patient was still dealing with it (Respiratory syncytial virus infection). This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of Respiratory Syncytial Virus were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine RSV vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In AUG-2023, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   The reporter considered the vaccination failure and shingles to be probably related to Shingrix.     The company considered the vaccination failure to be related to Shingrix. The company considered the shingles to be probably related to Shingrix.   Additional Information: GSK Receipt Date: 17-JUL-2024 This case was received by the patient via interactive digital media. The patient got shingles in last August (from the date of reporting) even though he/she got the Shingrix vaccine.  The patient had a mild case, likely because he/she got the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Wrong dose administered; Wrong dose administered; This non-serious case was reported by a nurse via patient support programs and described the occurrence of underdose in a 41-year-old female patient who received HBV (Engerix B pediatric) (batch number H39Z4, expiry date 04-DEC-2025) for prophylaxis.   The patient's past medical history included methylenetetrahydrofolate reductase gene mutation (MTHFR gene mutation).   On 02-JUL-2024, the patient received Engerix B pediatric .5 ml. On 02-JUL-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Wrong dose administered) and adult use of a child product (Verbatim: Wrong dose administered). The outcome of the underdose and adult use of a child product 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: 02-JUL-2024 This report was submitted via the online direct entry reporting system. On 2nd July 2024, the patient received Ener-B, expiry Date of Ener-B: 25 Dec 2025 and Batch / Lot number of Ener-B:H39Z4 The adult patient received Engerix B pediatric, which led to underdose and adult use of a child product.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue
Clinical narrative: Painful joints; Excess fatigue; This non-serious case was reported by a consumer and described the occurrence of joint pain in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose produced no side effects to be of note other than right at the site injection). Concurrent medical conditions included blood pressure high. Concomitant products included losartan.   In JUL-2024, the patient received the 2nd dose of Shingrix. On 09-JUL-2024, less than a week after receiving Shingrix, the patient experienced joint pain (Verbatim: Painful joints). In JUL-2024, the patient experienced fatigue (Verbatim: Excess fatigue). The patient was treated with ibuprofen sodium (Ibuprofen). The outcome of the joint pain was resolving and the outcome of the fatigue was not reported.   It was unknown if the reporter considered the joint pain and fatigue to be related to Shingrix.     It was unknown if the company considered the joint pain and fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-JUL-2024 The patient self-reported this case. The first shingrix injection produced no side effects to be of note other than right at the site injection.  The second injection took several hours to be noticed that the patient had excess fatigue the following morning, joint pain in shoulders, hips, knees and ribs.  The patient decided on ibuprofin, to bed and slept 10 hours.  This morning (on the reporting day) some residual pain but mostly gone. The patient had Losartan daily and was ongoing. The patient reported the event onset date as 09-JUL-2024 and outcome date as 10-JUL-2024 for painful joints.  The reporter consent to follow-up via email.