chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, Anticoagulant therapy, Asthma, Blood gases abnormal
Clinical narrative: Discharge Provider: MD Primary Care Provider: NP Admission Date: 7/22/2022 Discharge Date: Jul 26, 2022  PRESENTING PROBLEM: Hyperkalemia [E87.5] AKI (acute kidney injury) (HCC) [N17.9] Urinary tract infection due to Proteus [N39.0, B96.4] Urinary tract infection with hematuria, site unspecified [N39.0, R31.9] UTI due to Klebsiella species [N39.0, B96.89] COVID-19 virus infection [U07.1]   HOSPITAL COURSE: Patient is a  50 year-old female with PMHx for restrictive lung disease secondary to obesity, CKD stage 3, diabetes type 2, CHF, bipolar disorder, depression, neuropathy, morbid obesity presenting with shortness of breath.  The patient was found to have COVID-19 and a severe persistent asthma exacerbation with acute on chronic hypoxic respiratory failure.  She uses 2 L by nasal cannula at baseline at home.  The patient was treated with IV Solu-Medrol with improvement.  She was switched back to Decadron to finish a 10-day course for COVID 19.  She was also treated supportively with nebulizer treatment, Mucinex and subcutaneous heparin.  Of note she had acute kidney injury on admission in the setting of acute urinary tract infection and hypoxia.  This resolved.  She does have chronic kidney disease stage 3. Her diuretics were resumed.  She was treated with IV ertapenem due to multi-drug resistant urinary tract infection.  Infectious Disease evaluated the patient with recommendations for 7 days of therapy.  The patient received a midline to complete IV antibiotic therapy at home.  Pulmonary rehab ordered a home BIPAP device as she qualified due to her CO2 levels on ABG. They also provided the patient with a nebulizer machine.  Ultimately the patient was discharged home with home health care in improved and stable condition.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Carbon dioxide abnormal, Condition aggravated, Diuretic therapy, Dyspnoea
Clinical narrative: Discharge Provider: MD Primary Care Provider: NP Admission Date: 7/22/2022 Discharge Date: Jul 26, 2022  PRESENTING PROBLEM: Hyperkalemia [E87.5] AKI (acute kidney injury) (HCC) [N17.9] Urinary tract infection due to Proteus [N39.0, B96.4] Urinary tract infection with hematuria, site unspecified [N39.0, R31.9] UTI due to Klebsiella species [N39.0, B96.89] COVID-19 virus infection [U07.1]   HOSPITAL COURSE: Patient is a  50 year-old female with PMHx for restrictive lung disease secondary to obesity, CKD stage 3, diabetes type 2, CHF, bipolar disorder, depression, neuropathy, morbid obesity presenting with shortness of breath.  The patient was found to have COVID-19 and a severe persistent asthma exacerbation with acute on chronic hypoxic respiratory failure.  She uses 2 L by nasal cannula at baseline at home.  The patient was treated with IV Solu-Medrol with improvement.  She was switched back to Decadron to finish a 10-day course for COVID 19.  She was also treated supportively with nebulizer treatment, Mucinex and subcutaneous heparin.  Of note she had acute kidney injury on admission in the setting of acute urinary tract infection and hypoxia.  This resolved.  She does have chronic kidney disease stage 3. Her diuretics were resumed.  She was treated with IV ertapenem due to multi-drug resistant urinary tract infection.  Infectious Disease evaluated the patient with recommendations for 7 days of therapy.  The patient received a midline to complete IV antibiotic therapy at home.  Pulmonary rehab ordered a home BIPAP device as she qualified due to her CO2 levels on ABG. They also provided the patient with a nebulizer machine.  Ultimately the patient was discharged home with home health care in improved and stable condition.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Haematuria, Hyperkalaemia, Hypoxia, Klebsiella infection, Multiple-drug resistance
Clinical narrative: Discharge Provider: MD Primary Care Provider: NP Admission Date: 7/22/2022 Discharge Date: Jul 26, 2022  PRESENTING PROBLEM: Hyperkalemia [E87.5] AKI (acute kidney injury) (HCC) [N17.9] Urinary tract infection due to Proteus [N39.0, B96.4] Urinary tract infection with hematuria, site unspecified [N39.0, R31.9] UTI due to Klebsiella species [N39.0, B96.89] COVID-19 virus infection [U07.1]   HOSPITAL COURSE: Patient is a  50 year-old female with PMHx for restrictive lung disease secondary to obesity, CKD stage 3, diabetes type 2, CHF, bipolar disorder, depression, neuropathy, morbid obesity presenting with shortness of breath.  The patient was found to have COVID-19 and a severe persistent asthma exacerbation with acute on chronic hypoxic respiratory failure.  She uses 2 L by nasal cannula at baseline at home.  The patient was treated with IV Solu-Medrol with improvement.  She was switched back to Decadron to finish a 10-day course for COVID 19.  She was also treated supportively with nebulizer treatment, Mucinex and subcutaneous heparin.  Of note she had acute kidney injury on admission in the setting of acute urinary tract infection and hypoxia.  This resolved.  She does have chronic kidney disease stage 3. Her diuretics were resumed.  She was treated with IV ertapenem due to multi-drug resistant urinary tract infection.  Infectious Disease evaluated the patient with recommendations for 7 days of therapy.  The patient received a midline to complete IV antibiotic therapy at home.  Pulmonary rehab ordered a home BIPAP device as she qualified due to her CO2 levels on ABG. They also provided the patient with a nebulizer machine.  Ultimately the patient was discharged home with home health care in improved and stable condition.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Positive airway pressure therapy, Proteus infection, Respiratory failure, Urinary tract infection
Clinical narrative: Discharge Provider: MD Primary Care Provider: NP Admission Date: 7/22/2022 Discharge Date: Jul 26, 2022  PRESENTING PROBLEM: Hyperkalemia [E87.5] AKI (acute kidney injury) (HCC) [N17.9] Urinary tract infection due to Proteus [N39.0, B96.4] Urinary tract infection with hematuria, site unspecified [N39.0, R31.9] UTI due to Klebsiella species [N39.0, B96.89] COVID-19 virus infection [U07.1]   HOSPITAL COURSE: Patient is a  50 year-old female with PMHx for restrictive lung disease secondary to obesity, CKD stage 3, diabetes type 2, CHF, bipolar disorder, depression, neuropathy, morbid obesity presenting with shortness of breath.  The patient was found to have COVID-19 and a severe persistent asthma exacerbation with acute on chronic hypoxic respiratory failure.  She uses 2 L by nasal cannula at baseline at home.  The patient was treated with IV Solu-Medrol with improvement.  She was switched back to Decadron to finish a 10-day course for COVID 19.  She was also treated supportively with nebulizer treatment, Mucinex and subcutaneous heparin.  Of note she had acute kidney injury on admission in the setting of acute urinary tract infection and hypoxia.  This resolved.  She does have chronic kidney disease stage 3. Her diuretics were resumed.  She was treated with IV ertapenem due to multi-drug resistant urinary tract infection.  Infectious Disease evaluated the patient with recommendations for 7 days of therapy.  The patient received a midline to complete IV antibiotic therapy at home.  Pulmonary rehab ordered a home BIPAP device as she qualified due to her CO2 levels on ABG. They also provided the patient with a nebulizer machine.  Ultimately the patient was discharged home with home health care in improved and stable condition.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: COVID Breakthrough case . Tested positive on 07/22/2022 Symptoms -nasal congestion, headache, cough  Still positive  Prescribed Molnupiravir 200mg last dose was on  7/25/2022. Tested positive for COVID again on 8/1/2022. As of this report I am COVID positive
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: COVID Breakthrough case . Tested positive on 07/22/2022 Symptoms -nasal congestion, headache, cough  Still positive  Prescribed Molnupiravir 200mg last dose was on  7/25/2022. Tested positive for COVID again on 8/1/2022. As of this report I am COVID positive
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chills, Cough, Decreased appetite
Clinical narrative: I started taking Vicam and Vitamin C and Zinc lozenge.  My symptoms were  fatigue and scratchy throat.  It felt like my ears itched.  The sore throat progressively got worse.  I opted not to go on anti-viral because it had been so long since blood tests.  Tuesday I developed a dry cough.  I was beginning to feel better.  But Thursday I was wiped out.  I had run fever, low grade, on Monday but it only lasted about a day.  At night I could not sleep because I felt wired.  I was coughing a lot.  I tested positive again Saturday.  Sunday, 7/31, I felt like myself.  I didn't have any symptoms.  Today I still tested positive.  I wasn't very hungry.  And then I felt nauseated.  And then I felt like I may have diarrhea.  I am only taking ibuprofen.  I began having chills and I was shaking so badly and nauseous again.  I did have diarrhea.  I was able to rest.  I got up later and was still very cold.  I took some ibuprofen and feel better now.  I do not have energy.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling abnormal, Feeling cold, Insomnia
Clinical narrative: I started taking Vicam and Vitamin C and Zinc lozenge.  My symptoms were  fatigue and scratchy throat.  It felt like my ears itched.  The sore throat progressively got worse.  I opted not to go on anti-viral because it had been so long since blood tests.  Tuesday I developed a dry cough.  I was beginning to feel better.  But Thursday I was wiped out.  I had run fever, low grade, on Monday but it only lasted about a day.  At night I could not sleep because I felt wired.  I was coughing a lot.  I tested positive again Saturday.  Sunday, 7/31, I felt like myself.  I didn't have any symptoms.  Today I still tested positive.  I wasn't very hungry.  And then I felt nauseated.  And then I felt like I may have diarrhea.  I am only taking ibuprofen.  I began having chills and I was shaking so badly and nauseous again.  I did have diarrhea.  I was able to rest.  I got up later and was still very cold.  I took some ibuprofen and feel better now.  I do not have energy.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pruritus, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I started taking Vicam and Vitamin C and Zinc lozenge.  My symptoms were  fatigue and scratchy throat.  It felt like my ears itched.  The sore throat progressively got worse.  I opted not to go on anti-viral because it had been so long since blood tests.  Tuesday I developed a dry cough.  I was beginning to feel better.  But Thursday I was wiped out.  I had run fever, low grade, on Monday but it only lasted about a day.  At night I could not sleep because I felt wired.  I was coughing a lot.  I tested positive again Saturday.  Sunday, 7/31, I felt like myself.  I didn't have any symptoms.  Today I still tested positive.  I wasn't very hungry.  And then I felt nauseated.  And then I felt like I may have diarrhea.  I am only taking ibuprofen.  I began having chills and I was shaking so badly and nauseous again.  I did have diarrhea.  I was able to rest.  I got up later and was still very cold.  I took some ibuprofen and feel better now.  I do not have energy.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Tremor
Clinical narrative: I started taking Vicam and Vitamin C and Zinc lozenge.  My symptoms were  fatigue and scratchy throat.  It felt like my ears itched.  The sore throat progressively got worse.  I opted not to go on anti-viral because it had been so long since blood tests.  Tuesday I developed a dry cough.  I was beginning to feel better.  But Thursday I was wiped out.  I had run fever, low grade, on Monday but it only lasted about a day.  At night I could not sleep because I felt wired.  I was coughing a lot.  I tested positive again Saturday.  Sunday, 7/31, I felt like myself.  I didn't have any symptoms.  Today I still tested positive.  I wasn't very hungry.  And then I felt nauseated.  And then I felt like I may have diarrhea.  I am only taking ibuprofen.  I began having chills and I was shaking so badly and nauseous again.  I did have diarrhea.  I was able to rest.  I got up later and was still very cold.  I took some ibuprofen and feel better now.  I do not have energy.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Nasal congestion, Oropharyngeal pain, Productive cough
Clinical narrative: On 7/3/22, woke up with symptoms including productive cough, nasal congestion, fever, sore throat, fatigue. Went to an Urgent Care and received a script for Paxlovid. Took the med for the 5 days and symptoms decreased notably. Productive cough continued. Added Flonase and loratadine. Tested negative on 7/28/22. As of 8/1 feeling back to normal.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: On 7/3/22, woke up with symptoms including productive cough, nasal congestion, fever, sore throat, fatigue. Went to an Urgent Care and received a script for Paxlovid. Took the med for the 5 days and symptoms decreased notably. Productive cough continued. Added Flonase and loratadine. Tested negative on 7/28/22. As of 8/1 feeling back to normal.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: RN made vaccine error on 6/29/22 when patient received first boost dose of COVID-19 vaccine Pfizer pediatric vaccine (orange cap, age 5-11 yrs). RN inadvertently diluted vaccine w/ 1.6 mL 0.9% normal saline instead of recommended 1.3 mL on 6/29/22. Error due to misreading gradations on 5 mL syringe which was used for drawing up diluent. On Fri 7/1/22, RN realized vaccine error made, so contacted area point-of-contact Private. By Tues 7/5/22 morning, still no response received, so RN contacted Pfizer customer service / nurse / pharmacist which referred RN to CDC guidelines (repeat dose immediately w/ no minimum interval between error dose and following dose).  Pfizer internal reference # INT-702042. From Pfizer, RN spoke to (Pfizer Customer Service); RN (Drug & Safety Unit); and (Pharmacist) who provided direct line for medical unit / information: Private. Vaccine error report filed with Pfizer via phone call. Pfizer stated they cannot provide guidelines for specific patients, can only provide information based on Pfizer data only, leaves decision-making up to clinical judgment of clinic provider. RN proceeded to attempt patient contact starting 7/6/22. Private contacted RN via phone & email on 7/7/22 with similar guidance (as Pfizer/CDC) to repeat COVID vaccine dose given circulating variants.  RN successfully made contact with patient's mother via phone call on 7/7/22. Patient arrived to clinic on 7/13/22 for repeat dose COVID vaccine. RN attempted to re-explain situation to patient's mother who later expressed request for different nurse to vaccinate patient, stated "I feel traumatized by you" and "I cannot look at you." RN re-explained situation regarding vaccine error, provided opportunity for questions, successfully re-vaccinated patient. Patient and patient's mother were provided with plan for further COVID vaccines: none recommended at this time.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Body temperature increased, COVID-19, Chest discomfort, Dysphagia
Clinical narrative: On 07/04/2022 someone who I had recently traveled with informed me that they were positive for COVID-19. I then tested for COVID-19 with an at home test and was positive. I had difficulty swallowing, a sore throat, and a strange feeling in my chest but was not coughing much but a few days later I began to develop a cough that was producing phlegm. After testing positive I called my doctor who prescribed PAXLOVID. My symptoms were progressively worse each day. I was very fatigued and had to nap a lot and my voice was extremely horse to the point that I would lose my voice after speaking for as little as 20 minutes. I had to order food in for at least a week because I could not cook. I had a temperature of 103. My doctor advised that I use TYLENOL to treat my fever, but I couldn't swallow the pills. I couldn't sleep through the night due to the inability to swallow. After taking the PAXLOVID I began to feel better but it took at least 2 weeks before I was able to cook again.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Exposure to SARS-CoV-2, Fatigue, Loss of personal independence in daily activities, Oropharyngeal pain
Clinical narrative: On 07/04/2022 someone who I had recently traveled with informed me that they were positive for COVID-19. I then tested for COVID-19 with an at home test and was positive. I had difficulty swallowing, a sore throat, and a strange feeling in my chest but was not coughing much but a few days later I began to develop a cough that was producing phlegm. After testing positive I called my doctor who prescribed PAXLOVID. My symptoms were progressively worse each day. I was very fatigued and had to nap a lot and my voice was extremely horse to the point that I would lose my voice after speaking for as little as 20 minutes. I had to order food in for at least a week because I could not cook. I had a temperature of 103. My doctor advised that I use TYLENOL to treat my fever, but I couldn't swallow the pills. I couldn't sleep through the night due to the inability to swallow. After taking the PAXLOVID I began to feel better but it took at least 2 weeks before I was able to cook again.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Productive cough, Pyrexia, SARS-CoV-2 test positive, Sleep disorder, Somnolence
Clinical narrative: On 07/04/2022 someone who I had recently traveled with informed me that they were positive for COVID-19. I then tested for COVID-19 with an at home test and was positive. I had difficulty swallowing, a sore throat, and a strange feeling in my chest but was not coughing much but a few days later I began to develop a cough that was producing phlegm. After testing positive I called my doctor who prescribed PAXLOVID. My symptoms were progressively worse each day. I was very fatigued and had to nap a lot and my voice was extremely horse to the point that I would lose my voice after speaking for as little as 20 minutes. I had to order food in for at least a week because I could not cook. I had a temperature of 103. My doctor advised that I use TYLENOL to treat my fever, but I couldn't swallow the pills. I couldn't sleep through the night due to the inability to swallow. After taking the PAXLOVID I began to feel better but it took at least 2 weeks before I was able to cook again.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was vaccinated on 6/23/22.  On the afternoon of Friday, June  24th, expired Moderna Covid-19 Vaccine was discovered in the refrigerator.  Lot 54A22A was placed into the refrigerator on 5/19/22 and expired 30 days after on 6/18/22.  The expired vaccine was immediately removed from inventory.  A clinic pharmacist then called the manufacturer, Moderna, to report the incident and inquire about the stability of the expired product.  The pharmacist from Moderna submitted a ?lot analysis? request to evaluate the effectiveness of the affected lot against Covid-19 past the 30 day expiration date.  On Tuesday, June 28th, Moderna responded and stated that: ?The vaccine administered on June 22 and June 23, 2022 from lot number 054A22A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.?  No patient harm resulted.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Magnetic resonance imaging, Motor dysfunction, X-ray, X-ray of pelvis and hip
Clinical narrative: Rapid progression of ambulatory dysfunction, increase in inflammation of all joints
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Oedema peripheral
Clinical narrative: Sore and Swollen armpit
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with booster
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: Patient inadvertently received undiluted vaccine at roughly 20mcg (double the intended dose). Parents contacted on 7/21/22 and reported 'no side effects'.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pharmacist thought was first dose was informed later was to be a booster dose
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Hyperhidrosis, Loss of consciousness, Pain, Pallor, Visual impairment
Clinical narrative: Pt was given HPV vaccine around 1317. At 1322 I was notified that the patient had "passed out." When I got to the patient he was very pale and diaphoretic. Pt was responding.  Mom states, "He passed out twice. When he woke up the second time he said he was hurting all over." Pt also complained of vison problems. Vitals at 1322 blood pressure 95/59, pulse 46 and o2 sat 95% on room air.  Oxygen applied at 2L/min by nasal cannula at 1323. Vital signs at 1324 blood pressure 104/58, pulse 55, o2 sat 97% on 2L/min.  Pt denies hurting all over at this time. 1325 o2 sat 99% on 2 L/min and pulse 60. 1326 blood pressure 100/65, pulse 58, o2 sat 99% on 2L/min. 1329 blood pressure 130/83, pulse 66, and o2 sat 99% on 2L/min. Pt states he feels much better at this time.
Age: 11.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received Meningococcal B (Bexsero) instead of Meningococcal (Menactra). Patient had no reaction to vaccination while in clinic.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was vaccinated on 6/22/22.  On the afternoon of Friday, June  24th, expired Moderna Covid-19 Vaccine was discovered in the refrigerator.  Lot 54A22A was placed into the refrigerator on 5/19/22 and expired 30 days after on 6/18/22.  The expired vaccine was immediately removed from inventory.  A clinic pharmacist then called the manufacturer, Moderna, to report the incident and inquire about the stability of the expired product.  The pharmacist from Moderna submitted a ?lot analysis? request to evaluate the effectiveness of the affected lot against Covid-19 past the 30 day expiration date.  On Tuesday, June 28th, Moderna responded and stated that: ?The vaccine administered on June 22 and June 23, 2022 from lot number 054A22A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.?  No patient harm resulted.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cyanosis, Opisthotonus, Unresponsive to stimuli
Clinical narrative: 0940 7/30/22  Patient was unresponsive, blue across bilateral upper eyes with back slightly arched. A cool compression was applied across the patient's forehead and chest. After applying cool compression  patient became responsive to name and touch stimuli.  administrated EpiPen 0.3mg in upper right thigh at 0942. Vital signs obtained patient legs elevated and more cool compression was applied as transport arrived.  Report was given to ER Provider . Patient was taken to the ER via wheelchair with his mother holding him in her lap patient was alert and orited x3.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient was given 12yrs> grey top instead of orange top 5yrs -11yrs. Patient did wait 15 min in office after vaccine and no reactions while in office. It is currently 3:42pm and parent has not called back to office reporting any adverse events.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Lethargy, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I had started coughing and that lasted for about two days and the second day I had low grade fever with lethargy. That all got worse and I ended up going into the Doctor and had COVID-19 PCR test which came back as positive. I was given Paxlovid which I started taking on the 28th in the afternoon and by the time I went to bed the symptoms had improved. I did the isolation period of the ten days and I tested negative on the 6th of July. On the 9th I tested positive again and the symptoms had started again which was coughing and a fever. This time my symptoms were more mild than the first time around. I did another ten days of isolating and then tested negative again.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID case confirmed by PCR. Initial positive antigen test at home on 7/25/22.  Negative test on 7/30/22 after treatment with Paxlovid.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was vaccinated on 6/22/22.  On the afternoon of Friday, June  24th, expired Moderna Covid-19 Vaccine was discovered in the refrigerator.  Lot 54A22A was placed into the refrigerator on 5/19/22 and expired 30 days after on 6/18/22.  The expired vaccine was immediately removed from inventory.  A clinic pharmacist then called the manufacturer, Moderna, to report the incident and inquire about the stability of the expired product.  The pharmacist from Moderna submitted a ?lot analysis? request to evaluate the effectiveness of the affected lot against Covid-19 past the 30 day expiration date.  On Tuesday, June 28th, Moderna responded and stated that: ?The vaccine administered on June 22 and June 23, 2022 from lot number 054A22A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.?  No patient harm resulted.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error, Sluggishness
Clinical narrative: patient inadvertently received undiluted vaccine of roughly 20mcg (twice the intended dose).  Parents contacted and reported that the patient was "okay but a little sluggish".
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Pain, Pain in extremity, Skin swelling
Clinical narrative: Patient is still 1 week later experiencing pain radiating from shot arm (left) over to right arm and puffiness at injection site.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Feeling hot, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: I had a runny nose, sneezing and I could tell I was warm & I had a bad cough. I had 2 nights of a bad cough & 2 mornings of a sore throat. I went to the urgent care and got prescription for Z-PAK and nasal spray. I tested positive for COVID19.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sneezing
Clinical narrative: I had a runny nose, sneezing and I could tell I was warm & I had a bad cough. I had 2 nights of a bad cough & 2 mornings of a sore throat. I went to the urgent care and got prescription for Z-PAK and nasal spray. I tested positive for COVID19.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Pt has complained of dizziness and lightheadedness after vaccinated with the first dose of pediatric Pfizer
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: patient received undiluted vaccine at a dose of approximately 20mcg (double the intended dose).  Patient's mother contacted on 7/21/22 and reported no adverse effects.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, COVID-19, Dry throat, Fatigue
Clinical narrative: I received my second Moderna booster for COVID-19 on 4/28/2022. On the morning of 7/21/2022, I began having sinus trouble. I had a headache. Also, my throat wasn't sore, but it was dry; the dry sensation lasted until 7/23/2022. I also had a minor ache in the upper left region of my abdomen, which lasted until 7/24/2022; during this time, this region also felt bloated. When I went to bed on the night of 7/21/2022, I felt very fatigued and had a fever of 99 degrees. On 7/22/2022, the fever reached 100.5. On 7/22/2022, I took a home COVID-19 test, and I got a positive result. On 7/23/2022, I contacted a doctor through their website, and she explained to me that my abdominal pain was caused by my body's immune response. When I asked her about being prescribed PAXLOVID, the doctor said that as a policy, they do not prescribe PAXLOVID online. The doctor just recommended that I rest and recuperate, and if my symptoms got worse, I was to go to the emergency room. Later in the evening of 7/23/2022, I virtually contacted another doctor, and he prescribed a 5-day course of PAXLOVID. After I started taking PAXLOVID, my fever finally went away on 7/26/2022 and my headache diminished, though it didn't completely go away. Along with the PAXLOVID, I have also been taking ibuprofen, which has helped with the fever and headache. At the time of this writing, I still often feel tired. My headache, sinus issues, and abdominal pain are now gone, though. I also took another home test for COVID-19 on 7/30/2022, and the result was negative.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, SARS-CoV-2 test positive, Sinus disorder
Clinical narrative: I received my second Moderna booster for COVID-19 on 4/28/2022. On the morning of 7/21/2022, I began having sinus trouble. I had a headache. Also, my throat wasn't sore, but it was dry; the dry sensation lasted until 7/23/2022. I also had a minor ache in the upper left region of my abdomen, which lasted until 7/24/2022; during this time, this region also felt bloated. When I went to bed on the night of 7/21/2022, I felt very fatigued and had a fever of 99 degrees. On 7/22/2022, the fever reached 100.5. On 7/22/2022, I took a home COVID-19 test, and I got a positive result. On 7/23/2022, I contacted a doctor through their website, and she explained to me that my abdominal pain was caused by my body's immune response. When I asked her about being prescribed PAXLOVID, the doctor said that as a policy, they do not prescribe PAXLOVID online. The doctor just recommended that I rest and recuperate, and if my symptoms got worse, I was to go to the emergency room. Later in the evening of 7/23/2022, I virtually contacted another doctor, and he prescribed a 5-day course of PAXLOVID. After I started taking PAXLOVID, my fever finally went away on 7/26/2022 and my headache diminished, though it didn't completely go away. Along with the PAXLOVID, I have also been taking ibuprofen, which has helped with the fever and headache. At the time of this writing, I still often feel tired. My headache, sinus issues, and abdominal pain are now gone, though. I also took another home test for COVID-19 on 7/30/2022, and the result was negative.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test negative, Sinus congestion, Sinus operation, Sinusitis
Clinical narrative: Starting in early 07/2022, I developed a very bad head cold. I took a COVID-19 test at home which came back negative. It ended up being a sinus infection with bad sinus drainage. I went to see the Nurse Practitioner at my Drs office on 07/12/2022 and she prescribed me Amoxicillin and Clavulanate Potassium, which made me sick for 4-5 days. I stopped it due to making me sick and I hadn't taken it for 4 days and went to the ER on 07/24/2022. They diagnosed me with a UTI (marginal) and they did a scan to make sure I didn't have kidney stones. They prescribed me cefdinir and my UTI went away in 2 days. My head was still congested at the time I went to the ER but it no longer is now and I still have a few days of the medicine to take. I am feeling better now.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound kidney normal, Urinary tract infection, Urine analysis abnormal
Clinical narrative: Starting in early 07/2022, I developed a very bad head cold. I took a COVID-19 test at home which came back negative. It ended up being a sinus infection with bad sinus drainage. I went to see the Nurse Practitioner at my Drs office on 07/12/2022 and she prescribed me Amoxicillin and Clavulanate Potassium, which made me sick for 4-5 days. I stopped it due to making me sick and I hadn't taken it for 4 days and went to the ER on 07/24/2022. They diagnosed me with a UTI (marginal) and they did a scan to make sure I didn't have kidney stones. They prescribed me cefdinir and my UTI went away in 2 days. My head was still congested at the time I went to the ER but it no longer is now and I still have a few days of the medicine to take. I am feeling better now.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Constipation, Herpes zoster, Neuralgia, Rash erythematous
Clinical narrative: On 06/13/2022 received pain in back; 2 red dots on belly; developed into rash size of hand; nerve pain; constipation; and is still going on.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Urticaria
Clinical narrative: fussy, body aches , hives red rash noted all over body. Doctor treated with benadryl,  oral steroid and steroid cream. Mother unsure for how long  the treatment is for.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: I started feeling icky, fatigued and then chills.  At first I thought I had a sinus infection.  We had returned.  Took the home test and it was positive.  I had a low grade fever on Sunday.  No cough.  No shortness of breath.  I saw the doctor on July 25th and PCR was positive and began Paxlovid.  I got cough medicine and an inhaler as needed.  About Wednesday I began to have diarrhea.  Not sure if it was because of Paxlovid or just COVID symptoms.  I did have a bit of a headache on and off throughout the entire week.  I took Advil.  As of today I am a little tired and my stomach is still not 100%.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Gastric disorder, Headache, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I started feeling icky, fatigued and then chills.  At first I thought I had a sinus infection.  We had returned.  Took the home test and it was positive.  I had a low grade fever on Sunday.  No cough.  No shortness of breath.  I saw the doctor on July 25th and PCR was positive and began Paxlovid.  I got cough medicine and an inhaler as needed.  About Wednesday I began to have diarrhea.  Not sure if it was because of Paxlovid or just COVID symptoms.  I did have a bit of a headache on and off throughout the entire week.  I took Advil.  As of today I am a little tired and my stomach is still not 100%.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Blood test, Electrocardiogram, Epistaxis, Feeling abnormal
Clinical narrative: bloody nose at least a couple times daily for a month, still have a bloody nose infrequently but had not had a history of a bloody nose prior to the vaccination; heart palpitations or heavy pumping of the heart especially when laying down; random sense of anxiety; diagnosed by a cardiologist as picking up an extra heart beat intermittently; sometimes fogginess or forgetfulness.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate irregular, Memory impairment, Palpitations
Clinical narrative: bloody nose at least a couple times daily for a month, still have a bloody nose infrequently but had not had a history of a bloody nose prior to the vaccination; heart palpitations or heavy pumping of the heart especially when laying down; random sense of anxiety; diagnosed by a cardiologist as picking up an extra heart beat intermittently; sometimes fogginess or forgetfulness.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red welt at injection site  about 48 hours after injection. Injection site is warm to the touch.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Joint swelling
Clinical narrative: starting day after vaccine, swelling in one ankle. was painful to touch and made walking difficult. went away after 24-36 hours.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Compression garment application, Hysterectomy, Inflammation, Magnetic resonance imaging abnormal
Clinical narrative: Sometime in May 2021, I started having bilateral lower leg pain. I have often had leg pain and anemia and thought my symptoms were related to it. In July 2021, I had a hysterectomy and the pain got better. In Sept 2021, I started working on my feet all day long and noticed swelling to both of my feet. Sometime in September 2021, I went to a hospital ER and they referred me to podiatry due to my foot swelling. I went to the podiatry clinic in Oct 2021. He had me do an MRI in Oct 2021 and Conduction Nerve Study done in Jan 2022. I went to a vascular doctor for vein studies who asked me to wear compression socks and made an appointment for ultrasound to be done on August 19, 2022.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nerve conduction studies abnormal, Pain in extremity, Peripheral swelling, X-ray limb normal
Clinical narrative: Sometime in May 2021, I started having bilateral lower leg pain. I have often had leg pain and anemia and thought my symptoms were related to it. In July 2021, I had a hysterectomy and the pain got better. In Sept 2021, I started working on my feet all day long and noticed swelling to both of my feet. Sometime in September 2021, I went to a hospital ER and they referred me to podiatry due to my foot swelling. I went to the podiatry clinic in Oct 2021. He had me do an MRI in Oct 2021 and Conduction Nerve Study done in Jan 2022. I went to a vascular doctor for vein studies who asked me to wear compression socks and made an appointment for ultrasound to be done on August 19, 2022.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-thyroid antibody increased, Basedow's disease, Blood thyroid stimulating hormone decreased, Chest pain, Dysphonia
Clinical narrative: 2 weeks after the vaccine, she developed a sensation of pain in her thyroid gland, mild hoarseness, and then within a week she was having chest pains, heart palpitations, and hot flashes.    She initially presented to me on 6/15/22 and was reporting  severe fatigue x 2 months, hard to even get up.    Overwhelming sense of exhaustion.    Also she had arm soreness for a couple days at injection site starting the day after the vaccine.    Her baseline fatigue since age 41 after birth of her son is 4-5/10 but after vaccine had increased to 8-9/10.    Never has felt this fatigued in the past.     Labs on 6/15/22 revealed she was hyperthyroid with TSH <0.01 and free T4 1.72 (RR 0.7 to 1.8).   Thyroid stimulating antibodies were elevated.     Baseline TSH August 2021 was 0.65.    Thyroid function studies were also normal in 2017 and 2015.    Methimazole was started for Graves hyperthyroidism and on follow-up 8/1/22 her TSH had improved to 0.02 and her symptoms had largely improved except for ongoing thyroid tenderness.   Endocrinology consultation pending for Graves Disease which I believe onset was most likely triggered by the Pfizer-BioNTech COVID-19 vaccine given temporal onset and also other case reports in the literature of new onset Graves or exacerbations of existing Graves with COVID-19 mRNA vaccines.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hot flush, Hyperthyroidism, Injection site pain, Laboratory test abnormal
Clinical narrative: 2 weeks after the vaccine, she developed a sensation of pain in her thyroid gland, mild hoarseness, and then within a week she was having chest pains, heart palpitations, and hot flashes.    She initially presented to me on 6/15/22 and was reporting  severe fatigue x 2 months, hard to even get up.    Overwhelming sense of exhaustion.    Also she had arm soreness for a couple days at injection site starting the day after the vaccine.    Her baseline fatigue since age 41 after birth of her son is 4-5/10 but after vaccine had increased to 8-9/10.    Never has felt this fatigued in the past.     Labs on 6/15/22 revealed she was hyperthyroid with TSH <0.01 and free T4 1.72 (RR 0.7 to 1.8).   Thyroid stimulating antibodies were elevated.     Baseline TSH August 2021 was 0.65.    Thyroid function studies were also normal in 2017 and 2015.    Methimazole was started for Graves hyperthyroidism and on follow-up 8/1/22 her TSH had improved to 0.02 and her symptoms had largely improved except for ongoing thyroid tenderness.   Endocrinology consultation pending for Graves Disease which I believe onset was most likely triggered by the Pfizer-BioNTech COVID-19 vaccine given temporal onset and also other case reports in the literature of new onset Graves or exacerbations of existing Graves with COVID-19 mRNA vaccines.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Palpitations, Thyroid pain, Thyroxine free normal
Clinical narrative: 2 weeks after the vaccine, she developed a sensation of pain in her thyroid gland, mild hoarseness, and then within a week she was having chest pains, heart palpitations, and hot flashes.    She initially presented to me on 6/15/22 and was reporting  severe fatigue x 2 months, hard to even get up.    Overwhelming sense of exhaustion.    Also she had arm soreness for a couple days at injection site starting the day after the vaccine.    Her baseline fatigue since age 41 after birth of her son is 4-5/10 but after vaccine had increased to 8-9/10.    Never has felt this fatigued in the past.     Labs on 6/15/22 revealed she was hyperthyroid with TSH <0.01 and free T4 1.72 (RR 0.7 to 1.8).   Thyroid stimulating antibodies were elevated.     Baseline TSH August 2021 was 0.65.    Thyroid function studies were also normal in 2017 and 2015.    Methimazole was started for Graves hyperthyroidism and on follow-up 8/1/22 her TSH had improved to 0.02 and her symptoms had largely improved except for ongoing thyroid tenderness.   Endocrinology consultation pending for Graves Disease which I believe onset was most likely triggered by the Pfizer-BioNTech COVID-19 vaccine given temporal onset and also other case reports in the literature of new onset Graves or exacerbations of existing Graves with COVID-19 mRNA vaccines.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalization with covid; fully vaccinated
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: Patient reported pustules or blisters in opposite arm.
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, COVID-19, Cough, Dyspnoea, Dyspnoea at rest
Clinical narrative: 7-31-2022 patient presented to our ER with c/o SOB while resting.  Pt was already aware that he had covid.  Pt also c/o weakness, AMS and coughing.  Pt was admitted for further evaluation and treatment.
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Mental status changes
Clinical narrative: 7-31-2022 patient presented to our ER with c/o SOB while resting.  Pt was already aware that he had covid.  Pt also c/o weakness, AMS and coughing.  Pt was admitted for further evaluation and treatment.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy bone marrow normal, Blood test, Dyspnoea, Haemoglobin decreased, Transfusion
Clinical narrative: I was feeling shortness of breath for some time. On May 2, I had my wife drive me to the ER at the hospital because the shortness of breath was acute. On testing, they found that my hemoglobin testing was critically low. My score was at 4. While I was in the hospital, they gave me 3 units of blood and did a bone marrow biopsy. I was discharged after those treatments on May 5. I was put under the care of the hematologist on May 11. Since then, I've had 3 more blood transfusions to raise my hemoglobin level. I also received a new medication that's injected in the arm that's called Retacrit. My hemoglobin went up to 8.6 recently, which is well above 4 and 7. The doctor said that the bone marrow biopsy was inconclusive for anemia and other issues. On July 19, I was sent back to the hospital because at my biweekly scheduled blood draw, they found that my hemoglobin dropped to 5.8. I was sent to the hospital to receive two more pints of blood. This coming Thursday, I will get my second injection of the Retacrit medication.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Brain natriuretic peptide normal, Bronchoscopy normal, Cardiac imaging procedure abnormal, Chest pain, Electrocardiogram normal
Clinical narrative: PATIENT DEVELOPED ATYPICAL CHEST PAIN AND EFFORT INTOLERANCE.   EXTENSIVE PULMONARY EVALUATION INCLUDING BRONCHOSCOPY WAS NOT REVEALING.  CARDIAC MRI 7/27/2022 POSITIVE FOR LGE AND MILD LV AND MODERATE RV DYSFUNCITON. MILD PERICARDIAL EFFUSION.   JUL 2022 CTNI, GAL-2, BNP, ST2, ALL WNL ON 5/22/22.  DIAGNOSIS IS COVID-19  VACCINED-INDUCED MYO-PERICARDITIS.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exercise tolerance decreased, Laboratory test normal, Left ventricular dysfunction, Myopericarditis, Pericardial effusion
Clinical narrative: PATIENT DEVELOPED ATYPICAL CHEST PAIN AND EFFORT INTOLERANCE.   EXTENSIVE PULMONARY EVALUATION INCLUDING BRONCHOSCOPY WAS NOT REVEALING.  CARDIAC MRI 7/27/2022 POSITIVE FOR LGE AND MILD LV AND MODERATE RV DYSFUNCITON. MILD PERICARDIAL EFFUSION.   JUL 2022 CTNI, GAL-2, BNP, ST2, ALL WNL ON 5/22/22.  DIAGNOSIS IS COVID-19  VACCINED-INDUCED MYO-PERICARDITIS.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary function test normal, Right ventricular dysfunction, Troponin I normal
Clinical narrative: PATIENT DEVELOPED ATYPICAL CHEST PAIN AND EFFORT INTOLERANCE.   EXTENSIVE PULMONARY EVALUATION INCLUDING BRONCHOSCOPY WAS NOT REVEALING.  CARDIAC MRI 7/27/2022 POSITIVE FOR LGE AND MILD LV AND MODERATE RV DYSFUNCITON. MILD PERICARDIAL EFFUSION.   JUL 2022 CTNI, GAL-2, BNP, ST2, ALL WNL ON 5/22/22.  DIAGNOSIS IS COVID-19  VACCINED-INDUCED MYO-PERICARDITIS.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pediatric patient given adult dose.   No reaction or negative side effects noted as of time of reporting.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, No adverse event, SARS-CoV-2 test positive
Clinical narrative: No adverse event. Got Covid. Became symptomatic 6/21/22.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, COVID-19, Cough, Fatigue
Clinical narrative: I starting having sore throat and a dry cough on 06/03/2022 .  On 06/05/2022 I tested positive for COVID-19 at my doctors office.  The next day I started feeling tired and weak and that went on around 10 days  and I isolated additional days to make sure.  My doctor gave me Paxlovid at a lower dose because of my current health conditions. I am still having weakness, joint pain and feeling tired.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: I starting having sore throat and a dry cough on 06/03/2022 .  On 06/05/2022 I tested positive for COVID-19 at my doctors office.  The next day I started feeling tired and weak and that went on around 10 days  and I isolated additional days to make sure.  My doctor gave me Paxlovid at a lower dose because of my current health conditions. I am still having weakness, joint pain and feeling tired.
Age: 8.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event
Clinical narrative: No adverse events. Pt had no reaction.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue, Respiratory tract congestion
Clinical narrative: PHARMACIST DID NOT DILUTE WITH THE DILUENT BEFORE WITH DRAWING THE 0.2ML DOSE FOR INJECTION. ON 8/1/22, PATIENT'S AUNT WAS CONTACTED AND PER AUNT, PATIENT HAD CONGESTION ONLY DURING THE NIGHT WHICH WAS CLEARED UP THE NEXT DAY.  AUNT WAS ADVISED TO MONITOR PATIENT AND IF ANY CHANGE TO LET THE PHARMACY KNOW.