chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Biopsy, Diarrhoea, Erythema, Hair disorder
Clinical narrative: I had like a little infected hair on my leg, next to my chin below my knee. It was a little bump. The next day it had gotten bigger. The day after thanksgiving I had the ER doctor take a look at it. By Sunday night it was so huge and deep and it looked like it was dying. It had puss. I went to see the surgeon. They did a biopsy and it came back as possible vasculitis. I was supposed to have another biopsy today but I have been throwing up since 2 am, I also have diarrhea, and my body hurts. I do have a history of IGA deficiency, so my immune system is compromised. So they need to do another biopsy and send it to pathology. They might do that tomorrow if I am feeling better. All of those diagnosis that they list when I did the research on it actually says they present after having a new drug or medication in your system when you have a weaken immune system. I have been taking Keflex since it started getting really red and spreading and puss was coming out of it. Since I had the booster I have been having like palpitations and increased anxiety. On 10/25/2021 I tested positive for RSV. I also received the flu vaccine on the early part of October but I cannot remember the exact date.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations, Pustule, Swelling, Vomiting
Clinical narrative: I had like a little infected hair on my leg, next to my chin below my knee. It was a little bump. The next day it had gotten bigger. The day after thanksgiving I had the ER doctor take a look at it. By Sunday night it was so huge and deep and it looked like it was dying. It had puss. I went to see the surgeon. They did a biopsy and it came back as possible vasculitis. I was supposed to have another biopsy today but I have been throwing up since 2 am, I also have diarrhea, and my body hurts. I do have a history of IGA deficiency, so my immune system is compromised. So they need to do another biopsy and send it to pathology. They might do that tomorrow if I am feeling better. All of those diagnosis that they list when I did the research on it actually says they present after having a new drug or medication in your system when you have a weaken immune system. I have been taking Keflex since it started getting really red and spreading and puss was coming out of it. Since I had the booster I have been having like palpitations and increased anxiety. On 10/25/2021 I tested positive for RSV. I also received the flu vaccine on the early part of October but I cannot remember the exact date.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Bursitis
Clinical narrative: Left Shoulder Bursitis. Started PO steroids.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: vaccine vial was diluted with 1.6 ml instead of 1.8 ml so patient received larger dose than expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Person was given 0.3cc dose of Janssen Booster dose instead of standard 0.5 cc. NYSDOH notified and Manufacturer (Janssen) notified and all persons reported to Janssen Manufacturer for their Pharmacy department, recommendations from the Manufacturer and with agreement from NYSDOH are to notify all of the recipients that received an incorrect dose and submit a VAERS report for each.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration error
Clinical narrative: During a routine count of vaccine amounts administered, it was noted that a vial of Moderna had been punctured over the recommended 20 times, and all 8 "over-puncture" doses had been administered. No health concerns noted from any clients during the clinic day related to this med error. We are uncertain of which 8 people on our vaccinated list would have received those 8 doses, so the birthdate given is a best guess of one of those 8 people. Moderna has been notified.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Presents 12/6/2021 with right arm redness, swelling, itching from right deltoid down to elbow.  Denies SOB, wheezing, throat or facial swelling.  Vitals WNL.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Adult PFIZER vaccine formulation given to 11 year old patient in error.  Patient's mother listed patient age as 12yo on registration form.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: patient received 0.3 ml instead of 0.5 ml
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: Patient came to our mobile vaccine clinic for her booster shot of the Covid-19 vaccine. She had received Moderna for her first two doses, but according to current CDC recommendations we offered her the pfizer vaccine for her booster. After administering her vaccine, we found that we had miscalculated how long ago she received her second dose. It had not yet been a full 6 months. Her second dose was on 6/18/21 and her booster was given 12/5/21. The patient was called today 12/6/21 and notified about the mistake. Current CDC recommendations do not require an additional booster to be given when the first booster is given before the recommended time.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect dose administered, Syringe issue
Clinical narrative: Vaccine leaked out of syringe while needle was in arm, luer lock connection was loose. Pt did not receive any vaccine, another dose given.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Exercise tolerance decreased, Headache
Clinical narrative: I am in excellent health, take no prescription drugs, am not overweight, but have many allergies to pollen, molds, dust, cat and dog.  I became very sick the day after injection with flu symptoms.  I had fever and chills, headache, nausea, vomiting and diarrhea.  I was extremely weak having to stay in bed for 1 full day and half of another.  Fever and headache went away on second day, but nausea, diarrhea, and weakness lasted 4 days.   Today is the 5th day and all has gone away except I have little energy and cannot fully resume my normal activities, such as regular exercise.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Nausea, Pyrexia, Vomiting
Clinical narrative: I am in excellent health, take no prescription drugs, am not overweight, but have many allergies to pollen, molds, dust, cat and dog.  I became very sick the day after injection with flu symptoms.  I had fever and chills, headache, nausea, vomiting and diarrhea.  I was extremely weak having to stay in bed for 1 full day and half of another.  Fever and headache went away on second day, but nausea, diarrhea, and weakness lasted 4 days.   Today is the 5th day and all has gone away except I have little energy and cannot fully resume my normal activities, such as regular exercise.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Feeling abnormal, Feeling hot
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA I woke up the morning after my innoculation  (about 18 hours from injection) with severe body aches, a low-grade fever, loss of appetite, headache, chills, brain fog, sore injection site, swollen lymph nodes in the arm pit on the side of the injection, and I was extremely tired. I slept most of the day and took acetaminophen and ibuprofen, alternating every two hours or so to remain comfortable and reduce the fever. In the evening I slept but would get very hot at times. The fever,  sleeping, and body aches ended 30 hours after they started.  I remained tired after and the injection site is sore and I have swollen lymph nodes.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA I woke up the morning after my innoculation  (about 18 hours from injection) with severe body aches, a low-grade fever, loss of appetite, headache, chills, brain fog, sore injection site, swollen lymph nodes in the arm pit on the side of the injection, and I was extremely tired. I slept most of the day and took acetaminophen and ibuprofen, alternating every two hours or so to remain comfortable and reduce the fever. In the evening I slept but would get very hot at times. The fever,  sleeping, and body aches ended 30 hours after they started.  I remained tired after and the injection site is sore and I have swollen lymph nodes.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA I woke up the morning after my innoculation  (about 18 hours from injection) with severe body aches, a low-grade fever, loss of appetite, headache, chills, brain fog, sore injection site, swollen lymph nodes in the arm pit on the side of the injection, and I was extremely tired. I slept most of the day and took acetaminophen and ibuprofen, alternating every two hours or so to remain comfortable and reduce the fever. In the evening I slept but would get very hot at times. The fever,  sleeping, and body aches ended 30 hours after they started.  I remained tired after and the injection site is sore and I have swollen lymph nodes.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Person was given 0.3cc dose of Janssen Booster dose instead of standard 0.5 cc. notified and Manufacturer (Janssen) notified and all persons reported to Janssen Manufacturer for their Pharmacy department, recommendations from the Manufacturer and with agreement from are to notify all of the recipients that received an incorrect dose and submit a VAERS report for each.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Eye disorder, Muscular weakness
Clinical narrative: Nausea, vomiting, diarrhea, fever, stomach pain, dizziness, eyes going sideways, weak legs
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea, fever, stomach pain, dizziness, eyes going sideways, weak legs
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Extra dose administered, Herpes zoster, Rash
Clinical narrative: Patient was seen in UC on 11/27/21 for suspected shingles. He received the Covid booster on 11/20 and developed the rash 1-2 days later. No symptoms of respiratory distress or throat closing. He was prescribed Valtrex for suspected shingles but his rash worsened and spread. He was seen again in UC on 11/29/21 and received Solu-Medrol. A course of prednisone was prescribed as well as cephalexin to cover for cellulitis. Uncertain if his rash may be related to the booster or not.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Patient received only the powder vial of this two part vaccine.  It was inadvertently diluted with sterile water diluent instead of the included part two liquid vial.  This dose was deemed invalid and was repeated on 11/29/2021  The root cause of this error is due to the packaging by manufacturer.  Unlike all other vaccines, this two part vaccine must be mixed together in order to be effective.  It is not a sterile water diluent like our other vaccines.   Other vaccines packaged this way come as 10 vials in a box = 10 doses.  Menveo is 5 vials each of the liquid and powder therefore only 5 doses.  The two vials do not come "attached" in any way.  GSK knows this is an issue and therefore has created bands that we can pair the vials to each other after opening.  In a busy clinic, or new staff when the box is opened its easy for staff to pull just one vial - if its the powdered vial - reconstituting with sterile water diluent like other powedered vaccines is a common error.  If the liquid vial is pulled, its easy to administer just this liquid without mixing.    When this happens, its difficult to trace to one patient therefore often the entire 5 doses need to be tracked and revaccinated since its difficult to know who may have received the correct dose vs incorrect.   In this instance an inexperienced MA administered the powder only, diluted with water to a total of 4 patients before the error was discovered.      Recommended packaging change so that it is very clear that its a two part vaccine , perhaps a peel pack with the two vials together or apply the band before packaging instead of having the end user apply the band.  Better yet. similar to solumedrol vials - its one vial with two chambers, that when the lid is pushed down, it pushes the rubber stopper and the two parts mix together.  This would also prevent unnecessary access to the vial with needles to remove and inject into the other.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient given Moderna booster in error, requested PFIZER booster
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Adult dose (0.3 mL) administered in error to child (8 y.o.)..  No adverse events have been reported as of the time this form was completed.  A date/time was required to be entered on page 1 for "Time of adverse event onset."
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: received 1 booster of pfizer in october and now the moderna
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Moderna vaccine booster was administered on 11/5/2021 with an expiration date of 10/11/2021. Inquiry has been submitted to Moderna requesting validation of vaccine potency.  A response from Moderna is expected to be received between 8-10 business days.  Expiration date is currently not printed on the vaccine vial or carton and vaccine expiration date listed is 12/31/2069.  To find the expiration date, ?look up expiration date? tool is to be used from Vial Expiration Date Lookup | Moderna COVID-19 Vaccine (EUA) (modernatx.com). Patient contacted on 12/4/2021 and no adverse effects reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Adnexa uteri pain, Back pain, Burning sensation, Contusion, Eye pruritus
Clinical narrative: Deep dark purple bruise on her left inner thigh. Muscle in left leg was swollen and very sore and had a burning feeling. She also had little bumps on her outer thigh. Cramps and pain on her left ovary area and on her lower left back. Pain in her lung area and also her neck broke out in hives which caused her to have itchiness in her eyes and ears.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle swelling, Pain in extremity, Pruritus, Pulmonary pain, Rash
Clinical narrative: Deep dark purple bruise on her left inner thigh. Muscle in left leg was swollen and very sore and had a burning feeling. She also had little bumps on her outer thigh. Cramps and pain on her left ovary area and on her lower left back. Pain in her lung area and also her neck broke out in hives which caused her to have itchiness in her eyes and ears.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Deep dark purple bruise on her left inner thigh. Muscle in left leg was swollen and very sore and had a burning feeling. She also had little bumps on her outer thigh. Cramps and pain on her left ovary area and on her lower left back. Pain in her lung area and also her neck broke out in hives which caused her to have itchiness in her eyes and ears.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, SARS-CoV-2 test, Urine analysis, Vertigo
Clinical narrative: Headache, Vertigo, Fever
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue, Underdose
Clinical narrative: Patient received a Pfizer vaccine dose, where the wrong amount of diluent was used to prepare the dose. Provider and patient were informed.  Provider recommended that patient receive repeat dose.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Mild allergic reaction - facial urticarial rash - no anaphylaxis
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Condition aggravated, Dyspepsia, Dyspnoea
Clinical narrative: STARTED HAVING ACID REFLUX A COUPLE OF NIGHTS AFTER RECEIVING THE INJECTION. WOKE UP A FEW TIMES EACH NIGHT AND TOOK TUMS, WHICH RESOLVED THE INDEGESTION. I HAVE NEVER HAD GERD BEFORE, EXCEPT WITH 20+ WEEKS OF PREGNANCY. THE FOLLOWING MONDAY, I HAD CHEST PAIN,  SHORTNESS OF BREATH THAT WORSENED WITH TIME. THE EMERGENCY DEPARTMENT R/O PULMONARY EMBOLI, OR AN ADVERSE CARDIAC EVENT. THE PHYSICIAN CHALKED IT UP TO ANXIETY, WHICH IT WAS MOST DEFINATELY NOT. RIGHT BEFORE DISCHARGE HOME, I GOT REALLY NAUSEATED AND THREW UP, WHICH COMPLETELY RELIEVED THE CHEST PAIN. THE GERD CONTINUED UNTIL I WAS ABLE TO SEE MY PCP, WHO PLACED ME ON OMEPERZOLE QAM. I HAVE BEEN ON IT SINCE. WHEN I SKIP A DOSE, THE GERD RETURNS.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Nausea, Sleep disorder, Vomiting
Clinical narrative: STARTED HAVING ACID REFLUX A COUPLE OF NIGHTS AFTER RECEIVING THE INJECTION. WOKE UP A FEW TIMES EACH NIGHT AND TOOK TUMS, WHICH RESOLVED THE INDEGESTION. I HAVE NEVER HAD GERD BEFORE, EXCEPT WITH 20+ WEEKS OF PREGNANCY. THE FOLLOWING MONDAY, I HAD CHEST PAIN,  SHORTNESS OF BREATH THAT WORSENED WITH TIME. THE EMERGENCY DEPARTMENT R/O PULMONARY EMBOLI, OR AN ADVERSE CARDIAC EVENT. THE PHYSICIAN CHALKED IT UP TO ANXIETY, WHICH IT WAS MOST DEFINATELY NOT. RIGHT BEFORE DISCHARGE HOME, I GOT REALLY NAUSEATED AND THREW UP, WHICH COMPLETELY RELIEVED THE CHEST PAIN. THE GERD CONTINUED UNTIL I WAS ABLE TO SEE MY PCP, WHO PLACED ME ON OMEPERZOLE QAM. I HAVE BEEN ON IT SINCE. WHEN I SKIP A DOSE, THE GERD RETURNS.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Catheterisation cardiac, Chest pain, Coronary arterial stent insertion, Electrocardiogram abnormal, Impaired work ability
Clinical narrative: I started having chest pains early in the morning. On November 29, 2021 at about 7:30pm  I went to the ER. I had severe chest pains. The doctor said I was having a heart attack. I had stents punt in, and they did a cardio catherization. I was then hospitalized for 2 days. I was prescribed Atorvastatin 40mg 1xday, Aspirin 81mg 1xday, Carvedilol 3.125mg 2xday, and Brilinta 90mg 2xday. I am still out of work and recovering from this.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: I started having chest pains early in the morning. On November 29, 2021 at about 7:30pm  I went to the ER. I had severe chest pains. The doctor said I was having a heart attack. I had stents punt in, and they did a cardio catherization. I was then hospitalized for 2 days. I was prescribed Atorvastatin 40mg 1xday, Aspirin 81mg 1xday, Carvedilol 3.125mg 2xday, and Brilinta 90mg 2xday. I am still out of work and recovering from this.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Irregular Cycles; Started 9/3 lasted for 4 Days, started again 9/15 lasted 2 days, started again 9/28 lasted until end of September 2021.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Person was given 0.3cc dose of Janssen Booster dose instead of standard 0.5 cc. NYSDOH notified and Manufacturer (Janssen) notified and all persons reported to Janssen Manufacturer for their Pharmacy department, recommendations from the Manufacturer and with agreement from NYSDOH are to notify all of the recipients that received an incorrect dose and submit a VAERS report for each.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Anaphylactic reaction, Cough, Pharyngeal swelling, Stridor, Tachycardia
Clinical narrative: Patient received a TDaP vaccine and  within 15-30min developed anaphylactic reation involving throat tightness, audible breathing, cough, shortness of breath, swellig of throat and tachycardia.. Patient administered Epi pen and oral benadryl and was transported to ED via EMS/ambulance
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Throat tightness
Clinical narrative: Patient received a TDaP vaccine and  within 15-30min developed anaphylactic reation involving throat tightness, audible breathing, cough, shortness of breath, swellig of throat and tachycardia.. Patient administered Epi pen and oral benadryl and was transported to ED via EMS/ambulance
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: No adverse event noted. The vial that this dose was withdrawn from was diluted with Sodium Chloride 23% instead of 0.9%. Contacted Pfizer and they stated that no info was available regarding this scenario and referred me to recommendation of revaccinating this individual.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Wheezing
Clinical narrative: After receiving the second dose of the vaccine, I began experiencing mild/moderate wheezing. I was seen by my primary care doctor and diagnosed with asthma. I have not had wheezing at any point prior in my life.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Blood test, Computerised tomogram thorax, Deep vein thrombosis, Iron deficiency
Clinical narrative: Nothing happened initially the first couple of weeks, but then I noticed leg pain and swelling. I am a nurse and work 12 hour shifts and I was working 6-7 days a week at that point. I thought that it was fatigue but it got to the point where it was the normal deep vein thrombosis pain in the back of my legs, so I had another nurse check my pulse and the Doctor there sent me for an ultrasound and that's when we discovered it. He sent me to ER to get injection of Enoxaparin and to do a CT of chest to make sure I didn't have a pulmonary embolism and I was sent home on Eliquis for 3 months and then was seen by hematology. Hematologist did the work up with the blood work to determine any other reason for the DVT and there was no reason and only found that I was anemic and iron deficient.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Ultrasound scan
Clinical narrative: Nothing happened initially the first couple of weeks, but then I noticed leg pain and swelling. I am a nurse and work 12 hour shifts and I was working 6-7 days a week at that point. I thought that it was fatigue but it got to the point where it was the normal deep vein thrombosis pain in the back of my legs, so I had another nurse check my pulse and the Doctor there sent me for an ultrasound and that's when we discovered it. He sent me to ER to get injection of Enoxaparin and to do a CT of chest to make sure I didn't have a pulmonary embolism and I was sent home on Eliquis for 3 months and then was seen by hematology. Hematologist did the work up with the blood work to determine any other reason for the DVT and there was no reason and only found that I was anemic and iron deficient.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Immunisation, Product preparation issue
Clinical narrative: Patient received only the powder vial of this two part vaccine.  It was inadvertently diluted with sterile water diluent instead of the included part two liquid vial.  This dose was deemed invalid and was repeated on 11/29/2021  The root cause of this error is due to the packaging by manufacturer.  Unlike all other vaccines, this two part vaccine must be mixed together in order to be effective.  It is not a sterile water diluent like our other vaccines.   Other vaccines packaged this way come as 10 vials in a box = 10 doses.  Menveo is 5 vials each of the liquid and powder therefore only 5 doses.  The two vials do not come "attached" in any way.  GSK knows this is an issue and therefore has created bands that we can pair the vials to each other after opening.  In a busy clinic, or new staff when the box is opened its easy for staff to pull just one vial - if its the powdered vial - reconstituting with sterile water diluent like other powedered vaccines is a common error.  If the liquid vial is pulled, its easy to administer just this liquid without mixing.    When this happens, its difficult to trace to one patient therefore often the entire 5 doses need to be tracked and revaccinated since its difficult to know who may have received the correct dose vs incorrect.   In this instance an inexperienced MA administered the powder only, diluted with water to a total of 4 patients before the error was discovered.      Recommended packaging change so that it is very clear that its a two part vaccine , perhaps a peel pack with the two vials together or apply the band before packaging instead of having the end user apply the band.  Better yet. similar to solumedrol vials - its one vial with two chambers, that when the lid is pushed down, it pushes the rubber stopper and the two parts mix together.  This would also prevent unnecessary access to the vial with needles to remove and inject into the other.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, C-reactive protein increased, Catheterisation cardiac normal, Chest pain
Clinical narrative: Myocarditis, chest pain, elevated troponin.  Patient presented to ED on 11/29/2021 with 3 day history of chest pain.  Patient stated he started to feel sick in the evening after he had his COVID-19 booster shot. He reported pain in the middle of the chest, radiating to the left. EKG showed ST elevation  in ant leads, labs showed elevated trops of 234. CPK 427, CPK MB 26, CRP cardiac marker 54. Mild elevated LFTs. Hba1c 5. on admission. patient was taken to cath lab for LHC, which revealed a normal ejection fraction and normal coronaries. Patient was discharged on 11/30/21 but came back on 12/1/21 with complaints of recurrent chest pain. He admits the pain is somewhat worse with deep inspiration but not movement. He describes it as a midsternal pain that can radiate to his left arm, occurs and resolves spontaneously.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ejection fraction normal, Electrocardiogram ST segment elevation, Glycosylated haemoglobin, Liver function test increased, Malaise
Clinical narrative: Myocarditis, chest pain, elevated troponin.  Patient presented to ED on 11/29/2021 with 3 day history of chest pain.  Patient stated he started to feel sick in the evening after he had his COVID-19 booster shot. He reported pain in the middle of the chest, radiating to the left. EKG showed ST elevation  in ant leads, labs showed elevated trops of 234. CPK 427, CPK MB 26, CRP cardiac marker 54. Mild elevated LFTs. Hba1c 5. on admission. patient was taken to cath lab for LHC, which revealed a normal ejection fraction and normal coronaries. Patient was discharged on 11/30/21 but came back on 12/1/21 with complaints of recurrent chest pain. He admits the pain is somewhat worse with deep inspiration but not movement. He describes it as a midsternal pain that can radiate to his left arm, occurs and resolves spontaneously.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Pain, Pain in extremity, Painful respiration, Symptom recurrence
Clinical narrative: Myocarditis, chest pain, elevated troponin.  Patient presented to ED on 11/29/2021 with 3 day history of chest pain.  Patient stated he started to feel sick in the evening after he had his COVID-19 booster shot. He reported pain in the middle of the chest, radiating to the left. EKG showed ST elevation  in ant leads, labs showed elevated trops of 234. CPK 427, CPK MB 26, CRP cardiac marker 54. Mild elevated LFTs. Hba1c 5. on admission. patient was taken to cath lab for LHC, which revealed a normal ejection fraction and normal coronaries. Patient was discharged on 11/30/21 but came back on 12/1/21 with complaints of recurrent chest pain. He admits the pain is somewhat worse with deep inspiration but not movement. He describes it as a midsternal pain that can radiate to his left arm, occurs and resolves spontaneously.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: Myocarditis, chest pain, elevated troponin.  Patient presented to ED on 11/29/2021 with 3 day history of chest pain.  Patient stated he started to feel sick in the evening after he had his COVID-19 booster shot. He reported pain in the middle of the chest, radiating to the left. EKG showed ST elevation  in ant leads, labs showed elevated trops of 234. CPK 427, CPK MB 26, CRP cardiac marker 54. Mild elevated LFTs. Hba1c 5. on admission. patient was taken to cath lab for LHC, which revealed a normal ejection fraction and normal coronaries. Patient was discharged on 11/30/21 but came back on 12/1/21 with complaints of recurrent chest pain. He admits the pain is somewhat worse with deep inspiration but not movement. He describes it as a midsternal pain that can radiate to his left arm, occurs and resolves spontaneously.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No adverse event noted; The vial that this dose was withdrawn from was diluted with Sodium Chloride 23% instead of 0.9%. Contacted Pfizer and they stated that no info was available regarding this scenario and referred me to CDC's recommendation of revaccinating this individual.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Dizziness, Dysgeusia, Nausea, Syncope
Clinical narrative: About 15 minutes after receiving the Pfizer vaccine patient experienced a strange taste in her mouth, dizziness and nausea. Patient is still experiencing episodes of drops in her blood pressure and syncope. Patient advised not to get the second Pfizer vaccine but to get the J&J instead. Pt agreeable to this.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Person was given 0.3cc dose of Janssen Booster dose instead of standard 0.5 cc. notified and Manufacturer (Janssen) notified and all persons reported to Janssen Manufacturer for their Pharmacy department, recommendations from the Manufacturer and with agreement are to notify all of the recipients that received an incorrect dose and submit a VAERS report for each.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: PT states he had Moderna covid booster administered on Friday, 12/3/21 and experienced swelling of lymph nodes, and it has not gone away since then. He says it seems it has gotten a little better as of today, 12/6/21.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Trouble breathing within 30 minutes and everyday since then continuously. I?ve had this feeling before but it went away after several months. I can breath but I feel like I?m struggling in my throat feels closed up.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: patient received 0.3 ml instead of 0.5 ml
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No adverse event noted; The vial that this dose was withdrawn from was diluted with Sodium Chloride 23% instead of 0.9%. Contacted Pfizer and they stated that no info was available regarding this scenario and referred me to CDC's recommendation of revaccinating this individual.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Joint swelling, Pain in extremity
Clinical narrative: High fever (103.5 degrees F) over a 4 day period, severe fatigue, chills, arm pain, swelling of joints (hands, knees and feet), headaches.  All symptoms except for the swelling of hands and knees have been resolved.  Swelling is worst in the early morning but consistent since the 2nd vaccine with no improvement.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: High fever (103.5 degrees F) over a 4 day period, severe fatigue, chills, arm pain, swelling of joints (hands, knees and feet), headaches.  All symptoms except for the swelling of hands and knees have been resolved.  Swelling is worst in the early morning but consistent since the 2nd vaccine with no improvement.
Age: 16.0
Sex: M
Vaccine: FLUN4, HEP, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Feeling hot, Nausea
Clinical narrative: Client became warm, nauseous and light headed about 20+ minutes after receiving vaccine
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Bone pain, Chills, Fatigue, Nausea
Clinical narrative: rigors, t max 103.9, severe bone pain, nausea and vomiting, severe fatigue - symptoms lasted > 72 hours
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: rigors, t max 103.9, severe bone pain, nausea and vomiting, severe fatigue - symptoms lasted > 72 hours
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Idiopathic urticaria, Urticaria
Clinical narrative: I developed hives "idiopathic urticaria" that would come and go all over my body.  They have not stopped since 10 days after the event, including at the time of writing this.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Underdose
Clinical narrative: Patient was given 0.3cc dose of Janssen Booster dose instead of standard 0.5 cc. Manufacturer (Janssen) notified and all persons reported to Janssen Manufacturer for their Pharmacy department, recommendations from the Manufacturer and with agreement they are to notify all of the recipients that received an incorrect dose and submit a VAERS report for each.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough Case    ***Possible duplicate entry
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Product label issue, Product preparation error
Clinical narrative: Patient received only the powder vial of this two part vaccine.  It was inadvertently diluted with sterile water diluent instead of the included part two liquid vial.  This dose was deemed invalid and was repeated on 12/1/21  The root cause of this error is due to the packaging by manufacturer.  Unlike all other vaccines, this two part vaccine must be mixed together in order to be effective.  It is not a sterile water diluent like our other vaccines.   Other vaccines packaged this way come as 10 vials in a box = 10 doses.  Menveo is 5 vials each of the liquid and powder therefore only 5 doses.  The two vials do not come "attached" in any way.  GSK knows this is an issue and therefore has created bands that we can pair the vials to each other after opening.  In a busy clinic, or new staff when the box is opened its easy for staff to pull just one vial - if its the powdered vial - reconstituting with sterile water diluent like other powedered vaccines is a common error.  If the liquid vial is pulled, its easy to administer just this liquid without mixing.    When this happens, its difficult to trace to one patient therefore often the entire 5 doses need to be tracked and revaccinated since its difficult to know who may have received the correct dose vs incorrect.   In this instance an inexperienced MA administered the powder only, diluted with water to a total of 4 patients before the error was discovered.      Recommended packaging change so that it is very clear that its a two part vaccine , perhaps a peel pack with the two vials together or apply the band before packaging instead of having the end user apply the band.  Better yet. similar to solumedrol vials - its one vial with two chambers, that when the lid is pushed down, it pushes the rubber stopper and the two parts mix together.  This would also prevent unnecessary access to the vial with needles to remove and inject into the other.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Person was given 0.3cc dose of Janssen Booster dose instead of standard 0.5 cc. DOH notified and Manufacturer (Janssen) notified and all persons reported to Janssen Manufacturer for their Pharmacy department, recommendations from the Manufacturer and with agreement from DOH are to notify all of the recipients that received an incorrect dose and submit a VAERS report for each.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No adverse event noted; The vial that this dose was withdrawn from was diluted with Sodium Chloride 23% instead of 0.9%. Contacted Pfizer and they stated that no info was available regarding this scenario and referred me to CDC's recommendation of revaccinating this individual.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Aldolase normal, Arthralgia, Asthenia, Blood creatine phosphokinase normal, C-reactive protein normal
Clinical narrative: Patient woke up on Thursday (Dec 2) complaining of widespread muscle/joint pain.  no headache, neck pain only when moving head, walking like 80 yo man. Significant limp was present, and he was almost unable to walk up/down stairs. Right leg is worse, hurts to bend knee. little to no energy and not wanting to move around. Unable to bend to pick things up off the floor.  Drinking significantly less than normal. Took him to urgent care - they tested for covid (negative) and said to follow up with doctor after a few weeks. We talked to the nurse at the pediatricians office that same day - they made an appointment for that afternoon. We saw the doctor he did a number of tests (I'll include those in the next line), did an assessment and said it was likely post-viral myositis. (negative for strep, both flu's, and negative urine sample) Sent us home to push liquids and rest.  Patient slept poorly, waking frequently (which is not normal for him.) When he woke up Friday morning (Dec 3) around 6:30 am he was unable to keep liquids down. He puked 3-4 times over a 2-3 hour period before being able to slowly rehydrate. His energy was really low, and he had a dusty looking rash over/around his left eye (with mild swelling).  Symptoms started diminishing Saturday morning (Dec 4), and had reduced to only mild limping by the time of our follow up that afternoon. Lab results were all normal.  Symptoms almost entirely gone today (Dec 6) at our 2nd follow up.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Eyelid rash, Gait disturbance, Influenza virus test negative, Metabolic function test
Clinical narrative: Patient woke up on Thursday (Dec 2) complaining of widespread muscle/joint pain.  no headache, neck pain only when moving head, walking like 80 yo man. Significant limp was present, and he was almost unable to walk up/down stairs. Right leg is worse, hurts to bend knee. little to no energy and not wanting to move around. Unable to bend to pick things up off the floor.  Drinking significantly less than normal. Took him to urgent care - they tested for covid (negative) and said to follow up with doctor after a few weeks. We talked to the nurse at the pediatricians office that same day - they made an appointment for that afternoon. We saw the doctor he did a number of tests (I'll include those in the next line), did an assessment and said it was likely post-viral myositis. (negative for strep, both flu's, and negative urine sample) Sent us home to push liquids and rest.  Patient slept poorly, waking frequently (which is not normal for him.) When he woke up Friday morning (Dec 3) around 6:30 am he was unable to keep liquids down. He puked 3-4 times over a 2-3 hour period before being able to slowly rehydrate. His energy was really low, and he had a dusty looking rash over/around his left eye (with mild swelling).  Symptoms started diminishing Saturday morning (Dec 4), and had reduced to only mild limping by the time of our follow up that afternoon. Lab results were all normal.  Symptoms almost entirely gone today (Dec 6) at our 2nd follow up.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Myositis, Neck pain, Pain in extremity, Poor quality sleep
Clinical narrative: Patient woke up on Thursday (Dec 2) complaining of widespread muscle/joint pain.  no headache, neck pain only when moving head, walking like 80 yo man. Significant limp was present, and he was almost unable to walk up/down stairs. Right leg is worse, hurts to bend knee. little to no energy and not wanting to move around. Unable to bend to pick things up off the floor.  Drinking significantly less than normal. Took him to urgent care - they tested for covid (negative) and said to follow up with doctor after a few weeks. We talked to the nurse at the pediatricians office that same day - they made an appointment for that afternoon. We saw the doctor he did a number of tests (I'll include those in the next line), did an assessment and said it was likely post-viral myositis. (negative for strep, both flu's, and negative urine sample) Sent us home to push liquids and rest.  Patient slept poorly, waking frequently (which is not normal for him.) When he woke up Friday morning (Dec 3) around 6:30 am he was unable to keep liquids down. He puked 3-4 times over a 2-3 hour period before being able to slowly rehydrate. His energy was really low, and he had a dusty looking rash over/around his left eye (with mild swelling).  Symptoms started diminishing Saturday morning (Dec 4), and had reduced to only mild limping by the time of our follow up that afternoon. Lab results were all normal.  Symptoms almost entirely gone today (Dec 6) at our 2nd follow up.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate normal, SARS-CoV-2 test negative, Streptococcus test negative, Urine analysis normal, Vomiting
Clinical narrative: Patient woke up on Thursday (Dec 2) complaining of widespread muscle/joint pain.  no headache, neck pain only when moving head, walking like 80 yo man. Significant limp was present, and he was almost unable to walk up/down stairs. Right leg is worse, hurts to bend knee. little to no energy and not wanting to move around. Unable to bend to pick things up off the floor.  Drinking significantly less than normal. Took him to urgent care - they tested for covid (negative) and said to follow up with doctor after a few weeks. We talked to the nurse at the pediatricians office that same day - they made an appointment for that afternoon. We saw the doctor he did a number of tests (I'll include those in the next line), did an assessment and said it was likely post-viral myositis. (negative for strep, both flu's, and negative urine sample) Sent us home to push liquids and rest.  Patient slept poorly, waking frequently (which is not normal for him.) When he woke up Friday morning (Dec 3) around 6:30 am he was unable to keep liquids down. He puked 3-4 times over a 2-3 hour period before being able to slowly rehydrate. His energy was really low, and he had a dusty looking rash over/around his left eye (with mild swelling).  Symptoms started diminishing Saturday morning (Dec 4), and had reduced to only mild limping by the time of our follow up that afternoon. Lab results were all normal.  Symptoms almost entirely gone today (Dec 6) at our 2nd follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pfizer Pediatric (5-11) dose given to adult aged >18 years in lieu of Moderna Booster intended. No adverse reaction. Client was informed of error and CDC's clinical considerations for COVID Vaccine errors and revaccination was reviewed. Provided second dose of Pfizer Pediatric (5-11) dose per CDC recommendations.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No adverse event noted; The vial that this dose was withdrawn from was diluted with Sodium Chloride 23% instead of 0.9%. Contacted Pfizer and they stated that no info was available regarding this scenario and referred me to recommendation of revaccinating this individual.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough Case
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Booster dose  rigors, diffuse severe bone pain, nausea, headache, itching, severe fatigue, loss of appetite, swollen lymph nodes
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Pruritus
Clinical narrative: Booster dose  rigors, diffuse severe bone pain, nausea, headache, itching, severe fatigue, loss of appetite, swollen lymph nodes
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: Migrane for 3 weeks, 24/7.  Changed to persistent headache, with intermitant migraine.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Administration error - The pharmacist accidentally gave me two booster doses, one in each arm.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Booster dose given 18 days too early.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Ear pain, Facial pain, Headache, Night sweats
Clinical narrative: Starting Oct 18, 2021, headaches daily mostly on the right side, blurred vision lasting weeks , double vision, tenderness below the ear by the jaw bone, light sensitive some days.  pain on my right brow bone lasting 2 weeks, occasion sharp pains in my head or brain,  October 27, and October 28 night sweats, tender under the left arm comes and goes.  November 4, earache,  occasion pain in the ear.  Headaches are still continuing not everyday, but a few times a week lasting half hour to hour plus. November 8, in the morning a spell of vertigo lasting hour and half to 2. December 6,  morning a spell of vertigo lasting hour.  In December blurred vision and double vision improving.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, Tenderness, Vertigo, Vision blurred
Clinical narrative: Starting Oct 18, 2021, headaches daily mostly on the right side, blurred vision lasting weeks , double vision, tenderness below the ear by the jaw bone, light sensitive some days.  pain on my right brow bone lasting 2 weeks, occasion sharp pains in my head or brain,  October 27, and October 28 night sweats, tender under the left arm comes and goes.  November 4, earache,  occasion pain in the ear.  Headaches are still continuing not everyday, but a few times a week lasting half hour to hour plus. November 8, in the morning a spell of vertigo lasting hour and half to 2. December 6,  morning a spell of vertigo lasting hour.  In December blurred vision and double vision improving.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test abnormal, Catheterisation cardiac, Chest pain, Computerised tomogram thorax, Electrocardiogram
Clinical narrative: Chest pains that woke me up on during a weekend night (either Saturday or Sunday). Pain went away about an hour later. Occasional chest pains continued. Went to ER on Tuesday, and was admitted. Primary diagnosis was acute myocarditis. Also had a fever (around 101 degrees, but varied) for 2 days following the vaccine, but no fever after those 2 days. I also had arm soreness for about 2 days following the vaccine.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging heart, Myocarditis, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: Chest pains that woke me up on during a weekend night (either Saturday or Sunday). Pain went away about an hour later. Occasional chest pains continued. Went to ER on Tuesday, and was admitted. Primary diagnosis was acute myocarditis. Also had a fever (around 101 degrees, but varied) for 2 days following the vaccine, but no fever after those 2 days. I also had arm soreness for about 2 days following the vaccine.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin increased
Clinical narrative: Chest pains that woke me up on during a weekend night (either Saturday or Sunday). Pain went away about an hour later. Occasional chest pains continued. Went to ER on Tuesday, and was admitted. Primary diagnosis was acute myocarditis. Also had a fever (around 101 degrees, but varied) for 2 days following the vaccine, but no fever after those 2 days. I also had arm soreness for about 2 days following the vaccine.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough Case
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Chills, Dry mouth, Feeling abnormal, Headache
Clinical narrative: The next day I started having a headache and feeling foggy. I woke up that night with a pounding headache and chills. I have continued to have headaches and dry mouth.  Yesterday I developed canker sores around my mouth