chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Encephalopathy, End stage renal disease, Endotracheal intubation, Fatigue, Feeling abnormal
Clinical narrative: Pt presented to the hospital 3/7/22, reports having 5-7 day history of feeling poorly, coughing, malaise, fatigue and diarrhea.  He denies SOA, edema and fever.  End stage renal disease due to focal glomerulosclerosis with renal transplant in 2006, last creatinine was 3.3. He was found to have acute delirium and unable to complete his hemodialysis session.  He was transferred to the ICU on 3/15/22 where he was found to be hypoxic with a pulse ox in the 70s, he was encephalopathic, extremely agitated and unable to protect his airway - resulting in intubation.  CT of the Head and MRI of the brain done and were both negative. Underwent hemodialysis and uremia improved, he was getting more responsive however he sustained a pulseless electrical activity cardiac arrest.  Time of death 3/18/22 12:26pm. Previously vaccinated Moderna 2/13/21, 3/13/21, 9/4/21
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Focal segmental glomerulosclerosis, Haemodialysis, Hypoxia, Intensive care, Magnetic resonance imaging head normal
Clinical narrative: Pt presented to the hospital 3/7/22, reports having 5-7 day history of feeling poorly, coughing, malaise, fatigue and diarrhea.  He denies SOA, edema and fever.  End stage renal disease due to focal glomerulosclerosis with renal transplant in 2006, last creatinine was 3.3. He was found to have acute delirium and unable to complete his hemodialysis session.  He was transferred to the ICU on 3/15/22 where he was found to be hypoxic with a pulse ox in the 70s, he was encephalopathic, extremely agitated and unable to protect his airway - resulting in intubation.  CT of the Head and MRI of the brain done and were both negative. Underwent hemodialysis and uremia improved, he was getting more responsive however he sustained a pulseless electrical activity cardiac arrest.  Time of death 3/18/22 12:26pm. Previously vaccinated Moderna 2/13/21, 3/13/21, 9/4/21
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pulseless electrical activity, SARS-CoV-2 test positive
Clinical narrative: Pt presented to the hospital 3/7/22, reports having 5-7 day history of feeling poorly, coughing, malaise, fatigue and diarrhea.  He denies SOA, edema and fever.  End stage renal disease due to focal glomerulosclerosis with renal transplant in 2006, last creatinine was 3.3. He was found to have acute delirium and unable to complete his hemodialysis session.  He was transferred to the ICU on 3/15/22 where he was found to be hypoxic with a pulse ox in the 70s, he was encephalopathic, extremely agitated and unable to protect his airway - resulting in intubation.  CT of the Head and MRI of the brain done and were both negative. Underwent hemodialysis and uremia improved, he was getting more responsive however he sustained a pulseless electrical activity cardiac arrest.  Time of death 3/18/22 12:26pm. Previously vaccinated Moderna 2/13/21, 3/13/21, 9/4/21
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Renal colic, Stent placement
Clinical narrative: Patient presented to the ED and was subsequently hospitalized for renal colic on right side, stent placement within 6 weeks of receiving covid vaccination.
Age: 93.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, COVID-19, Condition aggravated, Death, Dementia Alzheimer's type
Clinical narrative: This is an instance of breakthrough COVID-19 disease after which death occurred. I also discovered a possible administration error related to timing of vaccine doses.   According to the information in the state immunization system, the individual was vaccinated with the Moderna product on 09/10/2021, 09/13/2021, and 10/08/2021. Lot number nor clinic administering the dose, nor provider name, nor injection site were available for dose 1 (the one administered on 09/10/2021).   The individual was a resident of a long term care facility and tested positive via antigen test on 01/24/2022. It was not noted that the individual was experiencing any respiratory symptoms but was having a low-grade fever. The individual was overall weak and stopped eating/drinking; this was thought to be a progression of the Alzheimer's Dementia the individual had. The individual was placed on comfort care and died on 02/01/2022.
Age: 93.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fluid intake reduced, Hypophagia, Inappropriate schedule of product administration, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: This is an instance of breakthrough COVID-19 disease after which death occurred. I also discovered a possible administration error related to timing of vaccine doses.   According to the information in the state immunization system, the individual was vaccinated with the Moderna product on 09/10/2021, 09/13/2021, and 10/08/2021. Lot number nor clinic administering the dose, nor provider name, nor injection site were available for dose 1 (the one administered on 09/10/2021).   The individual was a resident of a long term care facility and tested positive via antigen test on 01/24/2022. It was not noted that the individual was experiencing any respiratory symptoms but was having a low-grade fever. The individual was overall weak and stopped eating/drinking; this was thought to be a progression of the Alzheimer's Dementia the individual had. The individual was placed on comfort care and died on 02/01/2022.
Age: 93.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: This is an instance of breakthrough COVID-19 disease after which death occurred. I also discovered a possible administration error related to timing of vaccine doses.   According to the information in the state immunization system, the individual was vaccinated with the Moderna product on 09/10/2021, 09/13/2021, and 10/08/2021. Lot number nor clinic administering the dose, nor provider name, nor injection site were available for dose 1 (the one administered on 09/10/2021).   The individual was a resident of a long term care facility and tested positive via antigen test on 01/24/2022. It was not noted that the individual was experiencing any respiratory symptoms but was having a low-grade fever. The individual was overall weak and stopped eating/drinking; this was thought to be a progression of the Alzheimer's Dementia the individual had. The individual was placed on comfort care and died on 02/01/2022.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Aortic stenosis, Aortic valve replacement, Transcatheter aortic valve implantation
Clinical narrative: Severe, Symptomatic Aortic Stenosis -S/p Successful Transcatheter Aortic Valve Replacement. Hospital stay after procedure and discharged. Hospital admission within 6 weeks of receiving the COVID vaccine.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Foot operation, SARS-CoV-2 test
Clinical narrative: case was tested prior to having surgery for broken foot. asymptomatic
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Streptococcal infection, Streptococcus test positive
Clinical narrative: Strep throat infection
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Electric shock sensation, Hypoaesthesia, Neurological symptom, Pain
Clinical narrative: Patient stated she she experienced post-vaccination symptoms after receiving the 2nd dose of Pfizer vaccination in her left arm on Wednesday 3/16/22. She stated that she started to have the typical symptoms including the sore arm, fever, body aches, chills at night, and numbness in the left arm. She stated that started to feel better on Friday 3/18/22. However, on Saturday 3/19/22, she began to experience a "stroke-like" symptom which she described as "numbness in her left arm" and "currents from her left shoulder up to the left side of her face."  She called the pharmacy to ask for a referral to a Prescriber that can "bill the agency." She initially stated that she does not have insurance, however her 2nd dose of Pfizer was billed to her Medical. We informed her that she can call the clinic of her choice and ask if they accept her insurance,  and to be seen for a thorough assessment/evaluation of the symptoms she described to endure her safety and peace of mind.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient stated she she experienced post-vaccination symptoms after receiving the 2nd dose of Pfizer vaccination in her left arm on Wednesday 3/16/22. She stated that she started to have the typical symptoms including the sore arm, fever, body aches, chills at night, and numbness in the left arm. She stated that started to feel better on Friday 3/18/22. However, on Saturday 3/19/22, she began to experience a "stroke-like" symptom which she described as "numbness in her left arm" and "currents from her left shoulder up to the left side of her face."  She called the pharmacy to ask for a referral to a Prescriber that can "bill the agency." She initially stated that she does not have insurance, however her 2nd dose of Pfizer was billed to her Medical. We informed her that she can call the clinic of her choice and ask if they accept her insurance,  and to be seen for a thorough assessment/evaluation of the symptoms she described to endure her safety and peace of mind.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A Moderna Covid-19 vaccine was administered beyond the use date.  Moving forward we have clearly labeled all vaccine boxes to represent expiration date.  Also, have spoke with staff to pay closer attention to these details so this incident do not occur in the future.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Patient presented to the ED and was subsequently hospitalized for CVA within 6 weeks of receiving covid vaccination booster.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abscess jaw, C-reactive protein abnormal, Pain, Swelling face
Clinical narrative: Patient presented to the Emergency Room with progressive left facial swelling over 1 week - was found to have a mandibular abscess. He was admitted for intravenous antibiotic treatment.  Patient did improve symptomatically with respect to swelling and pain.  His CRP improved slightly.  He was treated with intravenous Clindamycin throughout hospitalization and did discuss with oral surgeon on-call.  Per oral surgery, the patient will be able to be discharged today and will have an appointment tomorrow in the oral surgery clinic for definitive treatment debridement of abscess and he will continue on his oral Clindamycin on discharge. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, COVID-19, Cough, SARS-CoV-2 test positive
Clinical narrative: Chief Complaint: COVID-19 DIAGNOSIS CONFIRMED (+ COVID x4 days ago, c/o left sided abd pain started 1200. ) and ABDOMINAL PAIN Tested positive for COVID 4 days ago. Has scant cough. No SOB The patient has been screened for common infectious diseases and offered vaccinations as appropriate for the presenting medical condition. Follow-up for medical care and/or behavioral issues has been arranged as clinically appropriate
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test negative, Chronic spontaneous urticaria
Clinical narrative: chronic spontaneous hives all over body, including face. No allergies found in skin test. Been taking antihistamines everyday but body does not respond. Steroids were given in emergency room, body did not respond.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: A Moderna Covid-19 vaccine was administered beyond the use date.  Moving forward we have clearly labeled all vaccine boxes to represent expiration date.  Also, have spoke with staff to pay closer attention to these details so this incident do not occur in the future.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Computerised tomogram thorax normal, Dizziness, Echocardiogram normal, Fatigue
Clinical narrative: When they administered the booster, they gave me a full dose not the half dose required for booster vaccine. At about 06:00PM I started not feeling well. I felt woozy, tired and was not able to think clearly. When I woke up in the morning I passed out. I was taken to the hospital in an ambulance. At the hospital they did a CT Scan of my lungs, CBC, Echocardiogram, Chest CT and they did not find anything wrong. They weren't sure if it was because I was dehydrated when I was vaccinated. I was diagnosed with Syncope and possible dehydration. I was discharged the next day.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count normal, Incorrect dose administered, Loss of consciousness, Malaise, Mental impairment
Clinical narrative: When they administered the booster, they gave me a full dose not the half dose required for booster vaccine. At about 06:00PM I started not feeling well. I felt woozy, tired and was not able to think clearly. When I woke up in the morning I passed out. I was taken to the hospital in an ambulance. At the hospital they did a CT Scan of my lungs, CBC, Echocardiogram, Chest CT and they did not find anything wrong. They weren't sure if it was because I was dehydrated when I was vaccinated. I was diagnosed with Syncope and possible dehydration. I was discharged the next day.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: When they administered the booster, they gave me a full dose not the half dose required for booster vaccine. At about 06:00PM I started not feeling well. I felt woozy, tired and was not able to think clearly. When I woke up in the morning I passed out. I was taken to the hospital in an ambulance. At the hospital they did a CT Scan of my lungs, CBC, Echocardiogram, Chest CT and they did not find anything wrong. They weren't sure if it was because I was dehydrated when I was vaccinated. I was diagnosed with Syncope and possible dehydration. I was discharged the next day.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product preparation issue
Clinical narrative: Patient received adult dose (0.3mls) of undiluted covid19 (pfizer age 5-11) pediatric vaccine on 3/18/22 and as of 3/21/22 states her only symptoms have been a sore arm
Age: 11.0
Sex: F
Vaccine: COVID19, HPV9, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Pediatric Pfizer Vaccine Lot Number FK5127, was improperly stored in an Immunizations Freezer that maintained a temperature between -15 Celsius and -24 Celsius. Per the Manufacture?s guidelines the vaccine must be stored in a Refrigerator maintaining temperature of 2-8 Degrees Celsius or an Ultra-Low Cold Freezer maintaining temperature of -90C or lower. The patient received the vaccine that was improperly stored.  Treatment: Not required, patient did not report any adverse reactions to the Vaccine.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhagic ovarian cyst, Hysterectomy, Pelvic pain, Salpingo-oophorectomy bilateral
Clinical narrative: Patient was admitted on the date of 9/13/21 and underwent a TAH with BSO for severe pelvic pain not relieved with conservative management, a large hemorrhagic ovarian cyst and h/o recurrent ovarian cysts, and large fibroid uterus. Hospital stay for 2 days then discharged. Hospital admission within 6 weeks of receiving the COVID vaccine.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, Malaise, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Pfizer product on 02/17/2021 and 03/10/2021. They became symptomatic for COVID-19 disease approx 12/27/2021 and tested positive via PCR test on 12/29/2021. They were hospitalized 12/29/2021-01/06/2022. They died at home on 01/12/2022. The individual had numerous underlying medical conditions.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Fatigue, Oropharyngeal pain
Clinical narrative: I experienced shortness of breath, tiredness, sore throat and a cough.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I experienced shortness of breath, tiredness, sore throat and a cough.
Age: 0.75
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Fever, multiple recordings at home over 2 days, to Tmax 103.5F.  Nothing else, no other symptoms.  Resolved within another 1-2 days.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Alcohol withdrawal syndrome, Alcoholism
Clinical narrative: Patient presented to the ED and was subsequently hospitalized for chronic alcoholism/alcohol withdrawal within 6 weeks of receiving covid vaccination.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: A Moderna Covid-19 vaccine was administered beyond the use date.  Moving forward we have clearly labeled all vaccine boxes to represent expiration date.  Also, have spoke with staff to pay closer attention to these details so this incident do not occur in the future.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Bacteraemia, COVID-19, Chills, Cough, Dyspnoea
Clinical narrative: Consolacion Sannicolas is a 61 Y female with DM, HTN, ESRD on dialysis (Tues, Thurs, Sat), CHF, atrial flutter/atrial fibrillation who presents to the emergency department with fevers and shortness of breath. Pt notes a chronic cough as well. She states fevers and chills began last night. + nausea. No vomiting. She notes the shortness of breath began last night as well. Pt is due for dialysis today. No abdominal pain. Pt notes she has a right arm fistula. Differential diagnosis includes COVID-19, pneumonia, bacteremia from other source, viral illness, occult infection  shortness of breath, fevers and chills is due to COVID-19 and not significant volume overload -Covid19 infection: Fully vaccinated/boosted. Suspect moreso cause of her SOB > hypervolemia.  Reviewed excellent HBS note. Symptom onset 3/16. Given this + hospitalization, would be considered contagious for 20 days after symptom onset. She will need to isolate until 4/5 (out of isolation 4/6). Decadron 3/17-3/26. No other meds given.  Once stable for d/c, will need to dialyze at Satellite Covid19
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fistula, Hypervolaemia, Illness, Nausea, Pneumonia
Clinical narrative: Consolacion Sannicolas is a 61 Y female with DM, HTN, ESRD on dialysis (Tues, Thurs, Sat), CHF, atrial flutter/atrial fibrillation who presents to the emergency department with fevers and shortness of breath. Pt notes a chronic cough as well. She states fevers and chills began last night. + nausea. No vomiting. She notes the shortness of breath began last night as well. Pt is due for dialysis today. No abdominal pain. Pt notes she has a right arm fistula. Differential diagnosis includes COVID-19, pneumonia, bacteremia from other source, viral illness, occult infection  shortness of breath, fevers and chills is due to COVID-19 and not significant volume overload -Covid19 infection: Fully vaccinated/boosted. Suspect moreso cause of her SOB > hypervolemia.  Reviewed excellent HBS note. Symptom onset 3/16. Given this + hospitalization, would be considered contagious for 20 days after symptom onset. She will need to isolate until 4/5 (out of isolation 4/6). Decadron 3/17-3/26. No other meds given.  Once stable for d/c, will need to dialyze at Satellite Covid19
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Viral infection
Clinical narrative: Consolacion Sannicolas is a 61 Y female with DM, HTN, ESRD on dialysis (Tues, Thurs, Sat), CHF, atrial flutter/atrial fibrillation who presents to the emergency department with fevers and shortness of breath. Pt notes a chronic cough as well. She states fevers and chills began last night. + nausea. No vomiting. She notes the shortness of breath began last night as well. Pt is due for dialysis today. No abdominal pain. Pt notes she has a right arm fistula. Differential diagnosis includes COVID-19, pneumonia, bacteremia from other source, viral illness, occult infection  shortness of breath, fevers and chills is due to COVID-19 and not significant volume overload -Covid19 infection: Fully vaccinated/boosted. Suspect moreso cause of her SOB > hypervolemia.  Reviewed excellent HBS note. Symptom onset 3/16. Given this + hospitalization, would be considered contagious for 20 days after symptom onset. She will need to isolate until 4/5 (out of isolation 4/6). Decadron 3/17-3/26. No other meds given.  Once stable for d/c, will need to dialyze at Satellite Covid19
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A Moderna Covid-19 vaccine was administered beyond the use date.  Moving forward we have clearly labeled all vaccine boxes to represent expiration date.  Also, have spoke with staff to pay closer attention to these details so this incident do not occur in the future.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Rash, Rash erythematous, Rash pruritic, Skin abrasion
Clinical narrative: Pt states since she got the Covid booster, she began to have a rash that spreads from one area to another. It's so itchy she scratches herself raw. She hasn't changed detergents and even rewashed all clothes. She uses All Sensitive Skin Laundary detergent which she has used since her son was born. No new foods or other products. One day on the back the next on the leg and another on the arm or breast area. On exam she has excoriations on the the breasts. There is an eczematous type reddish rash on both upper breast areas
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hypoxia
Clinical narrative: Acute on chronic respiratory failure with hypoxia. Patient hospitalized for 14 days; received first dose of COVID vaccine in the hospital.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Biopsy lymph gland, Cardiac monitoring abnormal, Dyspnoea, Echocardiogram
Clinical narrative: pt states she developed covid arm after 1st covid vax and about a week later she developed a hard red raised area the size of a tennis ball around the injection site.  This lasted about a week. After getting the second vaccine she started having heart palpitations about a couple of weeks after getting second covid vaccine.  She would get nauseated and had shortness of breath.  It would come and go.  During the day and at night while she was sleeping.  At least 3 times a week.  She went to her PCP and was referred to a cardiologist.  She was given a heart monitor to wear for 2 weeks.  She was diagnosed w/ AFIB.  She had a heart ultra sound and was told there was no problem with her heart valves.   During this time she  developed a melanoma on her back.  She also developed lesions on her neck and nose.  She had to have surgery quickly and had to get clearance from her cardiologist to have surgery.  She had outpatient surgery.   Over time the palpitations have stopped.  She went to her cardiologist to confirm it was safe to get the covid booster shot.  Her doctor recommends she wears the heart monitor again before getting it.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Laboratory test, Malignant melanoma, Nausea, Palpitations
Clinical narrative: pt states she developed covid arm after 1st covid vax and about a week later she developed a hard red raised area the size of a tennis ball around the injection site.  This lasted about a week. After getting the second vaccine she started having heart palpitations about a couple of weeks after getting second covid vaccine.  She would get nauseated and had shortness of breath.  It would come and go.  During the day and at night while she was sleeping.  At least 3 times a week.  She went to her PCP and was referred to a cardiologist.  She was given a heart monitor to wear for 2 weeks.  She was diagnosed w/ AFIB.  She had a heart ultra sound and was told there was no problem with her heart valves.   During this time she  developed a melanoma on her back.  She also developed lesions on her neck and nose.  She had to have surgery quickly and had to get clearance from her cardiologist to have surgery.  She had outpatient surgery.   Over time the palpitations have stopped.  She went to her cardiologist to confirm it was safe to get the covid booster shot.  Her doctor recommends she wears the heart monitor again before getting it.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Skin lesion, Surgery
Clinical narrative: pt states she developed covid arm after 1st covid vax and about a week later she developed a hard red raised area the size of a tennis ball around the injection site.  This lasted about a week. After getting the second vaccine she started having heart palpitations about a couple of weeks after getting second covid vaccine.  She would get nauseated and had shortness of breath.  It would come and go.  During the day and at night while she was sleeping.  At least 3 times a week.  She went to her PCP and was referred to a cardiologist.  She was given a heart monitor to wear for 2 weeks.  She was diagnosed w/ AFIB.  She had a heart ultra sound and was told there was no problem with her heart valves.   During this time she  developed a melanoma on her back.  She also developed lesions on her neck and nose.  She had to have surgery quickly and had to get clearance from her cardiologist to have surgery.  She had outpatient surgery.   Over time the palpitations have stopped.  She went to her cardiologist to confirm it was safe to get the covid booster shot.  Her doctor recommends she wears the heart monitor again before getting it.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Mitral valve repair, Mitral valve replacement
Clinical narrative: Mitral valve repair with placement of 5 CV GORE-TEX NeoChord loops to the prolapsing segments; recovery hospital stay. Hospital admission within 6 weeks of receiving the COVID vaccine.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Event: Pediatric Pfizer Vaccine Lot Number FK5127, was improperly stored in an Immunizations Freezer that maintained a temperature between -15 Celsius and -24 Celsius. Per the Manufacture?s guidelines the vaccine must be stored in a Refrigerator maintaining temperature of 2-8 Degrees Celsius or an Ultra-Low Cold Freezer maintaining temperature of -90C or lower. The patient received the vaccine that was improperly stored.  Treatment: Not required, patient did not report any adverse reactions to the Vaccine.  Outcome: Patient?s guardian notified and offered to restart the Pediatric Pfizer Covid Vaccine series again stored at the proper temperature.  Signs, Symptoms course, etc. None reported by the patient?s guardian
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Erythema, Nodule, Pain
Clinical narrative: Knot in right arm the size of a pin pong with occasional pain that started 3/19/22. has some redness but not hot to touch
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Patient is experiencing hives on his torso and fine rash on his legs bilaterally.  They tried a topical Benadryl spray but he continues to have itching so they are going to try an oral Benadryl.  The rash and hives appeared approximately one week after the vaccine and the patient denies any other changes with hygiene products or medications.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: A Moderna Covid-19 vaccine was administered beyond the use date.  Moving forward we have clearly labeled all vaccine boxes to represent expiration date.  Also, have spoke with staff to pay closer attention to these details so this incident do not occur in the future.
Age: 35.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: PATIENT REPORTS THAT 3 DAYS AFTER RECEIVING SECOND DOSE OF GARDASIL 9 SHE STARTED HAVING INTERMITTENT HIVES.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: Patient filed complaint with the local authority on March 17, 2022 stating that he experienced arm pain immediately after the injection and has been hurting every day since.
Age: 0.42
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient was too young to receive vaccine. Parent doesn't report any adverse reactions.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A Moderna Covid-19 vaccine was administered beyond the use date.  Moving forward we have clearly labeled all vaccine boxes to represent expiration date.  Also, have spoke with staff to pay closer attention to these details so this incident do not occur in the future.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Bradycardia, Death, Haemodynamic instability, Pneumonia, Respiratory distress
Clinical narrative: Pt died in hospital on 3/3/22. He was admitted on high-flow oxygen with high velocity therapy secondary to respiratory failure complicated by pneumonia.  He was slowly making some improvements with nutritional status but his respiratory status remained difficult to improve in terms of ability to wean his oxygen demands.  On March 3rd he developed increased respiratory distress and quickly developed bradycardia with hemodynamic instability.  He was a do not resuscitate.  He received medications for comfort as he was not making any recovery is with conservative interventions.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory failure
Clinical narrative: Pt died in hospital on 3/3/22. He was admitted on high-flow oxygen with high velocity therapy secondary to respiratory failure complicated by pneumonia.  He was slowly making some improvements with nutritional status but his respiratory status remained difficult to improve in terms of ability to wean his oxygen demands.  On March 3rd he developed increased respiratory distress and quickly developed bradycardia with hemodynamic instability.  He was a do not resuscitate.  He received medications for comfort as he was not making any recovery is with conservative interventions.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Ischaemic stroke
Clinical narrative: Acute ischemic stroke - neurologist recommendations was to give TPA.  Post TPA her symptoms significantly improve.  Hospital admission within 6 weeks of receiving the COVID vaccine.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Rash
Clinical narrative: pinprick rash over most of body, general malaise, fatigue
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis to left arm at injection site
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Fatigue, Oropharyngeal pain
Clinical narrative: I had fever, body ache, chills, sore throat, fatigue, and severe cough. These lasted for about 7 days. On Jan 13th, I tested positive for COVID-19.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I had fever, body ache, chills, sore throat, fatigue, and severe cough. These lasted for about 7 days. On Jan 13th, I tested positive for COVID-19.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A Moderna Covid-19 vaccine was administered beyond the use date.  Moving forward we have clearly labeled all vaccine boxes to represent expiration date.  Also, have spoke with staff to pay closer attention to these details so this incident do not occur in the future.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Blood test, Computerised tomogram, Gynaecological examination, Heavy menstrual bleeding
Clinical narrative: With first vaccine, I had post menopausal spotting, which turned into flooding after my booster.  I also had pulmonary emboli after the booster. Had 2 internal exams, 2 D&C's for the post menopausal bleeding. I was in the ER overnight for the pulmonary emboli and was put on Xarelto, blood thinner.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage, Pulmonary embolism, Ultrasound scan, Uterine dilation and curettage
Clinical narrative: With first vaccine, I had post menopausal spotting, which turned into flooding after my booster.  I also had pulmonary emboli after the booster. Had 2 internal exams, 2 D&C's for the post menopausal bleeding. I was in the ER overnight for the pulmonary emboli and was put on Xarelto, blood thinner.
Age: 70.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Acute respiratory failure, Respiratory failure
Clinical narrative: Acute on chronic hypoxic respiratory failure - She was given Solumedrol in ED and then was continued on with oral prednisone on admission. Her Levaquin was also continued to complete therapy recommended by Pulmonology. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Confusional state, Death, Encephalopathy, Endotracheal intubation
Clinical narrative: admitted to hospital with confusion, encephalopathy, respiratory failure; intubated in the ED; positive test for COVID; transferred to ICU; placed on steroids and vasopressors; pt's condition continued to deteriorate and she was placed on DNR; she passed away in the hospital
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: General physical health deterioration, Intensive care, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: admitted to hospital with confusion, encephalopathy, respiratory failure; intubated in the ED; positive test for COVID; transferred to ICU; placed on steroids and vasopressors; pt's condition continued to deteriorate and she was placed on DNR; she passed away in the hospital
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein normal, Eosinophil percentage, Pharyngeal swelling, Rash, Rash pruritic
Clinical narrative: 11 days after booster dose, patient reported to PCP an itchy ash on her face, neck, head, back and axillary. Small red bumps.  No new foods, soaps or bedding.   Provided with hydroxyzine for relief of rash.  Seen in office 3 days later and noted to have had some throat swelling along with the itching.  Received systemic corticosteroids, famotidine and Zyrtec.   referred to allergist.  Rash persisted to dat.   Allergist visit 3/14/22 - idiopathic versus autoimmune uticaria syndrome , possibly related to Moderna booster dose.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue pruritus
Clinical narrative: 11 days after booster dose, patient reported to PCP an itchy ash on her face, neck, head, back and axillary. Small red bumps.  No new foods, soaps or bedding.   Provided with hydroxyzine for relief of rash.  Seen in office 3 days later and noted to have had some throat swelling along with the itching.  Received systemic corticosteroids, famotidine and Zyrtec.   referred to allergist.  Rash persisted to dat.   Allergist visit 3/14/22 - idiopathic versus autoimmune uticaria syndrome , possibly related to Moderna booster dose.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Death, Feeding disorder, General physical health deterioration, SARS-CoV-2 test positive
Clinical narrative: This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Pfizer product on 01/05/2021, 01/26/2021, and 10/06/2021. The individual tested positive for COVID-19 on 02/05/2022 but COVID-19 symptoms were not the primary complaint on admission to hospital. The individual was in overall declining health at this time. It is not known if the individual had a specific symptom onset date as they had been non-verbal for a number of weeks, having suffered a CVA some time previous. The individual had been receiving end-of-life comfort cares at home but was brought to hospital on 02/05/2022 because the family no longer thought they were able to manage their condition and keep the individual comfortable at home. The individuals' end-of-life, comfort cares were continued in the hospital until their death on 02/06/2022.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Speech disorder, Vaccine breakthrough infection
Clinical narrative: This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Pfizer product on 01/05/2021, 01/26/2021, and 10/06/2021. The individual tested positive for COVID-19 on 02/05/2022 but COVID-19 symptoms were not the primary complaint on admission to hospital. The individual was in overall declining health at this time. It is not known if the individual had a specific symptom onset date as they had been non-verbal for a number of weeks, having suffered a CVA some time previous. The individual had been receiving end-of-life comfort cares at home but was brought to hospital on 02/05/2022 because the family no longer thought they were able to manage their condition and keep the individual comfortable at home. The individuals' end-of-life, comfort cares were continued in the hospital until their death on 02/06/2022.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Mechanical urticaria, Pruritus, Skin swelling
Clinical narrative: Began with itchy scalp and progressed to hives / urticaria all over body. Hives move around body - flare up on one body party causing itching/burning sensation then disappear and flare up on other body parts. Hives are accompanied by dermatographia, i.e., ability to write on skin with light pressure resulting in red, raised lines that burn for 15-20 minutes and then disappear. Problem has been ongoing for approximately 11 weeks.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Began with itchy scalp and progressed to hives / urticaria all over body. Hives move around body - flare up on one body party causing itching/burning sensation then disappear and flare up on other body parts. Hives are accompanied by dermatographia, i.e., ability to write on skin with light pressure resulting in red, raised lines that burn for 15-20 minutes and then disappear. Problem has been ongoing for approximately 11 weeks.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood test, Chest X-ray, Fatigue, Magnetic resonance imaging
Clinical narrative: My blood pressure was extremely elevated and I had to go to the ER and they held me for 6 hours. I was also very fatigued for about 3 weeks after the shot.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A Moderna Covid-19 vaccine was administered beyond the use date.  Moving forward we have clearly labeled all vaccine boxes to represent expiration date.  Also, have spoke with staff to pay closer attention to these details so this incident do not occur in the future.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: The staff made appt, received consent from the POA, presented a card with 2 doses, upon entry to IMMPACT a dose has previously been administered on 11/7/2021. This was confirmed had administered but staff at the facility did not record.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Breast pain, Chest discomfort, Electrocardiogram normal, Mobility decreased, Muscular weakness
Clinical narrative: MUSCLE SORENESS THAT IS CONSTANT IN MY UPPER LEFT ARM, THE SORENESS IS SURROUNDING UPPER LEFT CHEST AROUND BREAST UP TO SHOULDERS. LEFT ARM IS GROWING WEAK. DIFFICULT TO LIFT OR RAISE LEFT ARM
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia
Clinical narrative: MUSCLE SORENESS THAT IS CONSTANT IN MY UPPER LEFT ARM, THE SORENESS IS SURROUNDING UPPER LEFT CHEST AROUND BREAST UP TO SHOULDERS. LEFT ARM IS GROWING WEAK. DIFFICULT TO LIFT OR RAISE LEFT ARM
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site muscle weakness, Myalgia, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: MUSCLE SORENESS THAT IS CONSTANT IN MY UPPER LEFT ARM, THE SORENESS IS SURROUNDING UPPER LEFT CHEST AROUND BREAST UP TO SHOULDERS. LEFT ARM IS GROWING WEAK. DIFFICULT TO LIFT OR RAISE LEFT ARM
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hepatic enzyme increased
Clinical narrative: Lab results from April 20211 for liver enzymes were elevated. Discontinued methrotrexate treatment.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: A Moderna Covid-19 vaccine was administered beyond the use date.  Moving forward we have clearly labeled all vaccine boxes to represent expiration date.  Also, have spoke with staff to pay closer attention to these details so this incident do not occur in the future.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Dizziness, Fatigue, Gastrointestinal disorder
Clinical narrative: For 6 weeks I was bed bound and when I initially got sick with a chronic illness 7 years ago I was bed bound due to fatigue and dizziness this felt exactly the same. I also had joint pain. I went to see my pediatrician who I still see and he thought I was having a flare up in my symptoms from my chronic illness. I went to my cardiologist three weeks later, she confirmed that she had seen multiple patients with similar issues and thought it was from the vaccine due to the patients with the same condition responding the same. They both thought it was flare in my symptoms due to the vaccine. I also saw my Endocrinologist in June 2021 and my numbers were the worst they had seen in years. My Thyroid levels and antibodies were stable for 9 months straight but then after the vaccination they were 50-100 times what they should have been. In June they raised my dose of Tirosint in June and then again in October. I haven't seen the Endocrinologist since October and I am still having stomach issues that I do not think that is related to my Vaccine because I have suffered that for years. I have had an increase in joint pain in the last year. Also on or around  April 7th I had a anaphylactic shock from Fish which I have not had in years and I am not sure if that is related to the Vaccine as well. I have mostly recovered but I still have joint pain.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Inflammatory marker increased, Laboratory test, Mobility decreased
Clinical narrative: For 6 weeks I was bed bound and when I initially got sick with a chronic illness 7 years ago I was bed bound due to fatigue and dizziness this felt exactly the same. I also had joint pain. I went to see my pediatrician who I still see and he thought I was having a flare up in my symptoms from my chronic illness. I went to my cardiologist three weeks later, she confirmed that she had seen multiple patients with similar issues and thought it was from the vaccine due to the patients with the same condition responding the same. They both thought it was flare in my symptoms due to the vaccine. I also saw my Endocrinologist in June 2021 and my numbers were the worst they had seen in years. My Thyroid levels and antibodies were stable for 9 months straight but then after the vaccination they were 50-100 times what they should have been. In June they raised my dose of Tirosint in June and then again in October. I haven't seen the Endocrinologist since October and I am still having stomach issues that I do not think that is related to my Vaccine because I have suffered that for years. I have had an increase in joint pain in the last year. Also on or around  April 7th I had a anaphylactic shock from Fish which I have not had in years and I am not sure if that is related to the Vaccine as well. I have mostly recovered but I still have joint pain.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bacterial infection, Chest X-ray abnormal, Death, Endotracheal intubation
Clinical narrative: Pt died on 3/7/22 in hospital.  The patient  developed significant debilitation due to his prolonged illness and severe pneumonia needing prolonged and focused rehabilitation efforts.  He appeared to show some improvement and were able to wean his oxygen to nasal cannula. He subsequently developed melena with no significant drop in hematocrit.  He was started on IV Protonix.  He subsequently developed worsening hypoxia requiring non-rebreather face mask.   Chest x-ray showed findings suggestive of nosocomial pneumonia with secondary bacterial infection. Patient was started on IV cefepime/Vancomycin and IV Solu-Medrol. He continued to deteriorate and was intubated emergently on the 7th March 2022 and was started on mechanical ventilation support.  Patient's brother was contacted and he stated that the patient did not want to continue aggressive care under the circumstances and requested to change his code status to DNR.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: General physical health deterioration, Hypoxia, Mechanical ventilation, Melaena, Pneumonia
Clinical narrative: Pt died on 3/7/22 in hospital.  The patient  developed significant debilitation due to his prolonged illness and severe pneumonia needing prolonged and focused rehabilitation efforts.  He appeared to show some improvement and were able to wean his oxygen to nasal cannula. He subsequently developed melena with no significant drop in hematocrit.  He was started on IV Protonix.  He subsequently developed worsening hypoxia requiring non-rebreather face mask.   Chest x-ray showed findings suggestive of nosocomial pneumonia with secondary bacterial infection. Patient was started on IV cefepime/Vancomycin and IV Solu-Medrol. He continued to deteriorate and was intubated emergently on the 7th March 2022 and was started on mechanical ventilation support.  Patient's brother was contacted and he stated that the patient did not want to continue aggressive care under the circumstances and requested to change his code status to DNR.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Computerised tomogram abnormal, Discomfort, Dyspnoea, Injected limb mobility decreased
Clinical narrative: I was given the 2nd injection, waited the 20 minutes, with no reaction. At that time, I was going to physical therapy because I slipped in mud and hurt my sciatica. When they had me doing stretching, I told the therapist I couldn't stretch out with my left arm and he said that it's because of the injection. 2 weeks passed and it was still hurting to the point it was uncomfortable, and my range of motion was horrible. I had to go back to the doctor for my 6-week check up for my leg, which was okay, but my arm I couldn't move. I went to ortho and they did x-rays and a CT scan or ultrasound and I was diagnosed with deltoid myositis. There was nothing they could do and he told me I could put lidocaine and numb it. I've been doing exercise with it and it feels like there's a lump near injection site between shoulder and elbow. He told me if he gave me steroid shot it would only make it worse. I've also noticed shortness of breath and leg cramps and I've never had that before. Shortness of breath started after the first shot but it went away, and it happened again last night with the leg cramps and feels like a stabbing pain in my leg and lasts for a few seconds and then goes away. I feel like my heart is fluttering a little, but it may be COVID related. It's alleviated, and the only thing that has helped is hemp cream. March 2021 I also seen internist and he told me to get a massage gun and try to use that to see if it breaks it up. Possibly had COVID late 2019.