chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by State for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Age: 1.08
Sex: M
Vaccine: HEPA
Symptoms: Crying, Febrile convulsion, Irritability, Pain, Posture abnormal
Clinical narrative: broke out in bright  red confluent rash that started on the face and spread to rest of the body within 1hr- and then high fever - tmax 104.4 occurred about 1 hour after rash started-and holding head like pain - very irritable and hard to console - also had febrile seizure
Age: 1.08
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: broke out in bright  red confluent rash that started on the face and spread to rest of the body within 1hr- and then high fever - tmax 104.4 occurred about 1 hour after rash started-and holding head like pain - very irritable and hard to console - also had febrile seizure
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Diarrhoea, Fatigue
Clinical narrative: It started with a very bad sore throat, fatigue and nasal congestion. Chills, body aches, diarrhea, loss of taste and smell. I still don't have my taste or smell. My fever got up to 102.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Nasal congestion, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: It started with a very bad sore throat, fatigue and nasal congestion. Chills, body aches, diarrhea, loss of taste and smell. I still don't have my taste or smell. My fever got up to 102.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Viral test
Clinical narrative: It started with a very bad sore throat, fatigue and nasal congestion. Chills, body aches, diarrhea, loss of taste and smell. I still don't have my taste or smell. My fever got up to 102.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Oropharyngeal pain, SARS-CoV-2 test positive, Sneezing
Clinical narrative: 05/11/2022 - I had a sore throat and I was tired. I did an at home test COVID-19 test on 5/11 and it was positive. And I went to the urgent care on 5/12 to confirm and it was positive. I was prescribed methyl prednisone. I had sneezing the 2nd day. No other symptoms. No fever. No cough. Note: I got the flu shot in October or November 2021, but I don't remember the exact date.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Palpitations
Clinical narrative: Rapid heart rate/palpitations, shortness of breath, lightheaded lasting approximately 15 minutes at least once every day since 2 days after the Pfizer booster.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, SARS-CoV-2 test negative, Tongue discolouration
Clinical narrative: It felt like I drank something to hot. My mouth was very tingly. I stuck my tongue out and looked at it in the mirror and it was very white. It was very white on Saturday, and continued to be white on Sunday, then, on Monday, the white cleared up, but it was still a little bit tingly.  I'm trying to make an appointment with my doctor, but they haven't called me back yet.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccines where not stored at correct temperature they had been stored in freezer instead of refrigerator.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: I had a sore throat for 2 days. Followed by not a particularly bad cough for 2 days. No fever, no shortness of breath as measured by a pulse oximeter. I took night-time cold medication and it helped me sleep. I used throat lozenges and some chicken soup.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was a refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by State for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was a refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by State for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO ADVERSE REACTYION..., JUST REPORTING THAT ;PATIENT GOT A BIT EXPOIRED VACCINE
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Influenza, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Sought treatment on 5/16/22 after experiencing 2 nights of severe sore throat w/ coughing and cold/respiratory flu symptoms.  Tested positive for COVID in clinic. Not necessarily an adverse reaction to the vaccine, but a failure of the vaccine to protect against infection.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory symptom, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: Sought treatment on 5/16/22 after experiencing 2 nights of severe sore throat w/ coughing and cold/respiratory flu symptoms.  Tested positive for COVID in clinic. Not necessarily an adverse reaction to the vaccine, but a failure of the vaccine to protect against infection.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Blood test normal, Chest pain, Discomfort, Electrocardiogram normal
Clinical narrative: Heart/chest pain and discomfort. Treated with 800mg Advil, then high dose Tylenol, no significant improvement to the pain or discomfort.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin I normal
Clinical narrative: Heart/chest pain and discomfort. Treated with 800mg Advil, then high dose Tylenol, no significant improvement to the pain or discomfort.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I had been traveling with friends and while we were, one of our friends indicated that they did not feel well and then tested positive on a home test. By Wednesday after returning home all of the people on my trip had tested positive. So I did a home test but was negative but with all of my friends being positive my doctor wanted to test me and it was positive. I have really only had a runny nose. I am drinking lots of fluids and doing really well.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was a refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by State for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: I had a stroke two days later.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Electrolyte imbalance, Hypoxia, Nausea, Pain
Clinical narrative: Patient received moderna vaccine on 5/16/21, 6/13/21 and 1/24/22. Presented to ER on 5/17/22 and found to be COVID 19 positive. presented to the emergency department secondary to refractory vomiting.    Was also positive for COVID-19.  Electrolytes and kidney injury corrected over the course of his 1st 24 hours of admission with IV fluids and p.o. was advanced as nausea and vomiting had resolved. Pain issues were addressed with Tylenol and lidocaine patch.  Was monitored for hypoxia and was oxygenating normally throughout his hospital stay.  Daily alcohol drinker and he was monitored closely for signs of withdrawal but did not show any.  Cessation of alcohol and also nicotine encouraged sun his hospital stay. By 05/18/2022 was tolerating p.o. without difficulty and as there was an absence of COVID-19 symptoms was discharged home with advisement to quarantine for 5 more days and also with discussion as to signs and symptoms that would be of more urgent concern. Discharged on 5/18/22
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Renal injury, SARS-CoV-2 test positive, Vomiting
Clinical narrative: Patient received moderna vaccine on 5/16/21, 6/13/21 and 1/24/22. Presented to ER on 5/17/22 and found to be COVID 19 positive. presented to the emergency department secondary to refractory vomiting.    Was also positive for COVID-19.  Electrolytes and kidney injury corrected over the course of his 1st 24 hours of admission with IV fluids and p.o. was advanced as nausea and vomiting had resolved. Pain issues were addressed with Tylenol and lidocaine patch.  Was monitored for hypoxia and was oxygenating normally throughout his hospital stay.  Daily alcohol drinker and he was monitored closely for signs of withdrawal but did not show any.  Cessation of alcohol and also nicotine encouraged sun his hospital stay. By 05/18/2022 was tolerating p.o. without difficulty and as there was an absence of COVID-19 symptoms was discharged home with advisement to quarantine for 5 more days and also with discussion as to signs and symptoms that would be of more urgent concern. Discharged on 5/18/22
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccines where not stored at correct temperature they had been stored in freezer instead of refrigerator
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was a refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by State for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue
Clinical narrative: Administered pfizer covid vaccine gray cap for patient on 5/20/2022 with the beyond use date of 5/19/2022. Called pfizer and confirmed the total time pfizer covid vaccine gray cap can be stored in the fridge is 72 days which is good until 5/21/2022. patient does not have to revaccinate. Called patient and explained about the incident.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was a refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by State for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Atypical pneumonia, COVID-19, Computerised tomogram thorax abnormal, Cough, Dyspnoea
Clinical narrative: Patient received moderna vaccine on 3/17/21, 4/14/21 and 11/16/21. COVID positive on 5/6/22. Presented to ER on 5/12/22. admitted on 5/12/2022 with shortness of breath, worsening cough             Diagnosis with COVID-19 on 05/06/2022.  Received prednisone at home. SpO2 84% on arrival.  Requiring NC oxygen             CT chest-Hypersensitivity pneumonitis vs NSIP vs atypical pneumonia.  Vaccinated against COVID-19, immunocompromised.              Started on dexamethasone, antibiotic, remdesivir.  Clinically improving.  Short of breath resolved.  Cough significantly improved.  6 minute walk test done.  No recommendation for home oxygen.             No new voiced concerns. Patient is medically stable to be discharge Home with incentive spirometer, pulse oximeter.  Follow-up with PCP and oncologist. Discharged on 5/15/22
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity pneumonitis, Immunodeficiency, Interstitial lung disease, SARS-CoV-2 test positive, Walking distance test
Clinical narrative: Patient received moderna vaccine on 3/17/21, 4/14/21 and 11/16/21. COVID positive on 5/6/22. Presented to ER on 5/12/22. admitted on 5/12/2022 with shortness of breath, worsening cough             Diagnosis with COVID-19 on 05/06/2022.  Received prednisone at home. SpO2 84% on arrival.  Requiring NC oxygen             CT chest-Hypersensitivity pneumonitis vs NSIP vs atypical pneumonia.  Vaccinated against COVID-19, immunocompromised.              Started on dexamethasone, antibiotic, remdesivir.  Clinically improving.  Short of breath resolved.  Cough significantly improved.  6 minute walk test done.  No recommendation for home oxygen.             No new voiced concerns. Patient is medically stable to be discharge Home with incentive spirometer, pulse oximeter.  Follow-up with PCP and oncologist. Discharged on 5/15/22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient's date of birth was entered incorrected upon being registered in the computer.  Patient was brought in for newborn check and was administered vaccines appropriate for a 2 month old child due to the date of birth being incorrect.  At this time, patient has no side effects reported.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO ADVERSE REACTKION OCCURED!!!!  JUT FREPORTING THAT PATIENT GOT , A BIT, EXPIRED LOT
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was a refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by State for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Malaise, Photophobia
Clinical narrative: I just didn't feel well. I had a massive headache and was kind of tired. I had been traveling a lot and I had gone to another area where the cases were high.  My colleague was ill as well. As soon as I flew back home I took a test which was positive. I became more congested, had sensitivity to light and a fever. I treated the symptoms with Tylenol, DayQuil and NyQuil along with a ton of water. I began to feel better by the 18th. I still feel congestion but the headache went away along with the fever.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I just didn't feel well. I had a massive headache and was kind of tired. I had been traveling a lot and I had gone to another area where the cases were high.  My colleague was ill as well. As soon as I flew back home I took a test which was positive. I became more congested, had sensitivity to light and a fever. I treated the symptoms with Tylenol, DayQuil and NyQuil along with a ton of water. I began to feel better by the 18th. I still feel congestion but the headache went away along with the fever.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccines where not stored in correct temperature they had been stored in freezer instead of refrigerator
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Cardiomegaly, Chest X-ray abnormal, Chills
Clinical narrative: Patient received J&J vaccine on 8/18/21. COVID positive on 5/10/22. PResented to ER on 5/11/22. Patient started to get sick last Wednesday with cough,  cold, and some chills and on Monday which is 2 days ago he was diagnosed with  COVID-19.  He comes to the emergency room because of worsening shortness of  breath and cough without any chest pain.  Mild nausea.  No vomiting.  No  diarrhea.  Denies any bleeds or melenic stools.  He was found to be quite  hypoxemic with a PO2 of only 61 on room air.  Chest x-ray did not reveal  anything acute except for some mild increased size in the cardiac silhouette.   The patient was given Lasix in the ER and then the hospitalist service called  for admission.  When I saw the patient, I discussed with him that he has  acute hypoxemic respiratory failure secondary to COVID-19 and that he would  benefit from Decadron, but the patient says he is "allergic to  corticosteroids" and he is vehemently denying receiving any Solu-Medrol or any  other oral or IV corticosteroids.  The patient will be admitted as an  inpatient to IMC unit with acute hypoxemic respiratory failure secondary to  COVID-19. REceived remdesivir 200 mg x 1 and doxycycline. Discharged on 5/12/22.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Malaise, Nasopharyngitis, Nausea
Clinical narrative: Patient received J&J vaccine on 8/18/21. COVID positive on 5/10/22. PResented to ER on 5/11/22. Patient started to get sick last Wednesday with cough,  cold, and some chills and on Monday which is 2 days ago he was diagnosed with  COVID-19.  He comes to the emergency room because of worsening shortness of  breath and cough without any chest pain.  Mild nausea.  No vomiting.  No  diarrhea.  Denies any bleeds or melenic stools.  He was found to be quite  hypoxemic with a PO2 of only 61 on room air.  Chest x-ray did not reveal  anything acute except for some mild increased size in the cardiac silhouette.   The patient was given Lasix in the ER and then the hospitalist service called  for admission.  When I saw the patient, I discussed with him that he has  acute hypoxemic respiratory failure secondary to COVID-19 and that he would  benefit from Decadron, but the patient says he is "allergic to  corticosteroids" and he is vehemently denying receiving any Solu-Medrol or any  other oral or IV corticosteroids.  The patient will be admitted as an  inpatient to IMC unit with acute hypoxemic respiratory failure secondary to  COVID-19. REceived remdesivir 200 mg x 1 and doxycycline. Discharged on 5/12/22.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient received J&J vaccine on 8/18/21. COVID positive on 5/10/22. PResented to ER on 5/11/22. Patient started to get sick last Wednesday with cough,  cold, and some chills and on Monday which is 2 days ago he was diagnosed with  COVID-19.  He comes to the emergency room because of worsening shortness of  breath and cough without any chest pain.  Mild nausea.  No vomiting.  No  diarrhea.  Denies any bleeds or melenic stools.  He was found to be quite  hypoxemic with a PO2 of only 61 on room air.  Chest x-ray did not reveal  anything acute except for some mild increased size in the cardiac silhouette.   The patient was given Lasix in the ER and then the hospitalist service called  for admission.  When I saw the patient, I discussed with him that he has  acute hypoxemic respiratory failure secondary to COVID-19 and that he would  benefit from Decadron, but the patient says he is "allergic to  corticosteroids" and he is vehemently denying receiving any Solu-Medrol or any  other oral or IV corticosteroids.  The patient will be admitted as an  inpatient to IMC unit with acute hypoxemic respiratory failure secondary to  COVID-19. REceived remdesivir 200 mg x 1 and doxycycline. Discharged on 5/12/22.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was a refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by the Regulatory Authority for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was Refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccines where stored at incorrect temperature they had been stored in freezer instead of refrigerator
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by State for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccines where stored at incorrect temperature they had been stored in freezer instead of refrigerator
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac operation, Cardiomegaly, Chest X-ray abnormal, Cough, Dyspnoea
Clinical narrative: The shot itself wasn't abnormal it was sore like normal. A month later I got a cold that lasted for a week then it cleared for two days. Then I started feeling sick cough, headache mainly the cough. Everyday it got worse harder to breath Jan 10 I lost the ability to bear weight. I took a few test they all came back negative. I went to my doctor, and she checked my lungs they were clear, and I went home. Jan 31 my dr. sent me for a chest x-ray and it showed I had a enlarged heart. I then went to a HCF they did a echocardiogram the assist kept making faces and told me I was very symptomatic. They did transfer me to the ER department. They gave me two IV and then send me by ambulance with lights to another facility where they did surgery inserted a needle pulling fluid off the heart. Then I was in cardiac ICU I was there until the 20th which is when I was discharged. Two weeks later I went to see the Cardiologist and he said everything was fine. The medication they put me on for my heart has created even more issues and now I have to see another dr. about that.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram abnormal, Headache, Intensive care, Laboratory test normal, Malaise
Clinical narrative: The shot itself wasn't abnormal it was sore like normal. A month later I got a cold that lasted for a week then it cleared for two days. Then I started feeling sick cough, headache mainly the cough. Everyday it got worse harder to breath Jan 10 I lost the ability to bear weight. I took a few test they all came back negative. I went to my doctor, and she checked my lungs they were clear, and I went home. Jan 31 my dr. sent me for a chest x-ray and it showed I had a enlarged heart. I then went to a HCF they did a echocardiogram the assist kept making faces and told me I was very symptomatic. They did transfer me to the ER department. They gave me two IV and then send me by ambulance with lights to another facility where they did surgery inserted a needle pulling fluid off the heart. Then I was in cardiac ICU I was there until the 20th which is when I was discharged. Two weeks later I went to see the Cardiologist and he said everything was fine. The medication they put me on for my heart has created even more issues and now I have to see another dr. about that.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain, Pericardial drainage, Weight bearing difficulty
Clinical narrative: The shot itself wasn't abnormal it was sore like normal. A month later I got a cold that lasted for a week then it cleared for two days. Then I started feeling sick cough, headache mainly the cough. Everyday it got worse harder to breath Jan 10 I lost the ability to bear weight. I took a few test they all came back negative. I went to my doctor, and she checked my lungs they were clear, and I went home. Jan 31 my dr. sent me for a chest x-ray and it showed I had a enlarged heart. I then went to a HCF they did a echocardiogram the assist kept making faces and told me I was very symptomatic. They did transfer me to the ER department. They gave me two IV and then send me by ambulance with lights to another facility where they did surgery inserted a needle pulling fluid off the heart. Then I was in cardiac ICU I was there until the 20th which is when I was discharged. Two weeks later I went to see the Cardiologist and he said everything was fine. The medication they put me on for my heart has created even more issues and now I have to see another dr. about that.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by State for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient was 11 years and 6 months old. The NP at the site was given the go ahead to give the vaccine by his Supervisor.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccines where stored at incorrect temperature they had been stored in freezer instead of refrigerator
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: When our facility received the Covid - 19 vaccine, I spoke to the department of health and was told that the exp. date for the vaccine was 9 months from the mfg. date on the box. Which made the exp. date 5/31/22. On 5/20/22 the dept. of health contacted me stating that we have given exp. vaccines to patients and that the exp. date was 10 weeks from the date the vaccine was received which would have been 5/2/22. Thus we unknowingly gave exp vaccine to patient.   Patient tolerated vaccine well, no adverse effects have been reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Pain, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I started having runny nose, fatigue, body aches, post nasal drip with no fever on 4-25-2022. I took a home Covid test on 4-27-2022 and it was positive. I called my PCP on 4-27 and they told me to wait until quarantine is up. I was not prescribed any medications. I went in to the doctors office on approx. 5-2-2022. They still did not order/prescribed anything and just suggested antihistamine but I did not take any. I am feeling better now, symptoms are resolved. I am reporting my breakthrough case of Covid.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Upper-airway cough syndrome, Vaccine breakthrough infection
Clinical narrative: I started having runny nose, fatigue, body aches, post nasal drip with no fever on 4-25-2022. I took a home Covid test on 4-27-2022 and it was positive. I called my PCP on 4-27 and they told me to wait until quarantine is up. I was not prescribed any medications. I went in to the doctors office on approx. 5-2-2022. They still did not order/prescribed anything and just suggested antihistamine but I did not take any. I am feeling better now, symptoms are resolved. I am reporting my breakthrough case of Covid.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: When our facility received the Covid - 19 vaccine, I spoke to and was told that the exp. date for the vaccine was 9 months from the. date on the box. Which made the exp. date 5/31/22. On 5/20/22  Contacted me stating that we have given exp. vaccines to patients and that the exp. date was 10 weeks from the date the vaccine was received which would have been 5/2/22. Thus we unknowingly gave exp vaccine to patient.   Patient tolerated vaccine well, no adverse effects have been reported.
Age: 59.0
Sex: M
Vaccine: PNC20
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PATIENT WAS ADMINISTERED VACCINE OUTSIDE GUIDELINE. HE HAS NO MEDICAL CONDITION AND IS UNDER 65 YEARS OLD
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: When our facility received the Covid - 19 vaccine,  and was told that the exp. date for the vaccine was 9 months from the mfg. date on the box. Which made the exp. date 5/31/22. On 5/20/22 Contacted me stating that we have given exp. vaccines to patients and that the exp. date was 10 weeks from the date the vaccine was received which would have been 5/2/22. Thus we unknowingly gave exp vaccine to patient.   Patient tolerated vaccine well, no adverse effects have been reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vertigo, Vomiting
Clinical narrative: I awoke with vertigo on a Tuesday. On Tuesday and Wednesday I was vomiting.  I took some Bomine 75MG. It slightly improved and returned that evening. On Wednesday I felt better, but it worsened again that evening. It was gone that Thursday, but had lingering fatigue. I have not ever had vertigo.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Dizziness, Feeling abnormal, Malaise
Clinical narrative: On 05/13 I started sneezing and I felt like I was having an Allergic. On 05/14 I took Flonase for allergies in the morning. After which I went outside and started feeling sick. I had severe pain in my back and I started feeling congested, dizzy and "brain fog." Tested positive for COVID on 05/15. Dr. prescribed  Paxlovid for symptoms.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive, Sneezing
Clinical narrative: On 05/13 I started sneezing and I felt like I was having an Allergic. On 05/14 I took Flonase for allergies in the morning. After which I went outside and started feeling sick. I had severe pain in my back and I started feeling congested, dizzy and "brain fog." Tested positive for COVID on 05/15. Dr. prescribed  Paxlovid for symptoms.
Age: 59.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, Vaccination error
Clinical narrative: PATIENT WAS ADMINISTERED VACCINE OUTSIDE GUIDELINE. SHE HAS NO MEDICAL CONDITION AND IS UNDER 65 YEARS OLD
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, COVID-19, Febrile neutropenia, Neutrophil count decreased, Pyrexia
Clinical narrative: Moderna COVID-19 Vaccine EUA: presented to clinic with a new fever of 38.7 and ANC of 0. She was admitted to the hospital for management of neutropenic fever. Found to be COVID positive. Received remdesivir, antimicrobials, and anticoagulation. Discharged to home medically stable.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Moderna COVID-19 Vaccine EUA: presented to clinic with a new fever of 38.7 and ANC of 0. She was admitted to the hospital for management of neutropenic fever. Found to be COVID positive. Received remdesivir, antimicrobials, and anticoagulation. Discharged to home medically stable.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: Breakthrough COVID Case: The case started last Friday, the 13th of May. Symptoms: headache, sore throat, dry cough, general fatigue. That's it for that day. Treatment: Called  my primary doctor. I told her I had a positive test at home. She prescribed Paxlovid, Tessalon for the cough, Doxycycline 100mg 2xday for 10 days, Prednisone 20mg 1 tab per day for 5 days.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID Case: The case started last Friday, the 13th of May. Symptoms: headache, sore throat, dry cough, general fatigue. That's it for that day. Treatment: Called  my primary doctor. I told her I had a positive test at home. She prescribed Paxlovid, Tessalon for the cough, Doxycycline 100mg 2xday for 10 days, Prednisone 20mg 1 tab per day for 5 days.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: When our facility received the Covid - 19 vaccine,  Health was told that the exp. date for the vaccine was 9 months from the mfg. date on the box. Which made the exp. date 5/31/22. On 5/20/22 Contacted me stating that we have given exp. vaccines to patients and that the exp. date was 10 weeks from the date the vaccine was received which would have been 5/2/22. Thus we unknowingly gave exp vaccine to patient.   Patient tolerated vaccine well, no adverse effects have been reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport  refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by State for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: 05/19/2022  (Thursday) approximately 2:00 PM administered Moderna vaccine #1 (0.5cc, Lot# 004M21A) to Right Deltoid of patient.  No adverse effects observed at time of injection or for 15 minutes afterward.  5/20/2022 (Friday) Approximately 2:25 PM I was informed by ID nurse that had experienced multiple grand mal seizures very recently.  I was informed that patient was en route to hospital.     5/20/2022 (Friday) Approximately 3:30 PM Spoke with patient , brother and POA for resident.  Mr. informed me that as acting POA for his brother, he had not given consent for any covid vaccinations.  I informed Mr. that I was instructed to provide Moderna Covid Vaccine injections to both Mr. as well as his roommate in Room 413.   I exchanged contact information for follow up from himself and hospital if needed.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever of 102.5, body aches, fatigue and a sore arm. This lasted about 24 hours.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Ear pain
Clinical narrative: I noticed on 4/13/22 that I was unable to hear out of my left ear and I decided to go to my doctor. I noticed that my ear hurt and was in pain, and it felt like it was full. My doctor sent to a specialist and they determined that I had profound hearing loss in left ear. I am still dealing with this at this time.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was a refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by the Regulatory Authority for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: This spontaneous report received from a healthcare professional concerned a 51-year-old male. No medical history, height, weight, concomitant medications or concurrent conditions reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number not reported), dose not reported, administered Apr 5, 2021, for immunization. The batch number requested. Age at time of vaccination: 51 years old. On Apr 5, 2021, Janssen COVID-19 vaccine refrozen and administered to patient. On an unspecified date, patient experienced product storage error. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of the the Janssen COVID-19 vaccine refrozen and administered to patient and product storage error:  not reported. This case, involving the same patient linked to 20220538347. This case, from the same reporter linked to 20220537683, 2005084289, 20220537356, 20220538238, 20220537444, 20220537507, 20220537532, 20220537688, 20220538146, 20220538210, 20220538292, 20220538297, 20220538379, 20220538316, 20220537341, 20220538573, 20220538437, 20220538428, 20220538425, 20220538411, 20220539045, 20220538480, 20220538149, 20220540435, 20220538666, 20220540611, 20220538693, 20220540524, 20220538758 and 20220538210.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Myelitis, Renal failure
Clinical narrative: MYELITIS; KIDNEY FAILURE; This spontaneous report received from a consumer concerned a 52 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: unknown) dose was not reported, 1 total administered at left arm on 01-JUN-2021 for prophylactic vaccination. Age at time of vaccination 52 years old. No concomitant medications were reported. On 08-JUN-2021, a week after vaccination, the patient had been suffering from severe pain and that his muscles were being eaten away that had prompted his hospitalization more than six times with symptoms ranging from pain to collapse. The patient was diagnosed with myelitis. He was hospitalized on an unspecified date and for unspecified days, it was unknown whether the patient was discharged from the hospital or not. On 11-MAY-2022, the patient's kidney function began to deteriorate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from myelitis, and kidney failure. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Disability Or Permanent Damage).; Sender's Comments: V0: 20220537814-covid-19 vaccine ad26.cov2.s -Myelitis, kidney failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS REFROZEN; ADMINISTRATION OF REFROZEN VACCINE; This spontaneous report received from a health care professional concerned a 54 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: 20-MAR-2022) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. Age at time of vaccination 54 years old. No concomitant medications were reported.  On 24-MAY-2021, the patient experienced administration of refrozen vaccine. On an unspecified date, the patient experienced vaccine was refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of refrozen vaccine and vaccine was refrozen was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Electromyogram, Lymphoedema, Magnetic resonance imaging, Ultrasound Doppler
Clinical narrative: This spontaneous report received from a consumer concerning a patient of unspecified age and gender. The patient's height, weight and concomitant medications not reported. Medical conditions included no risk factors for lymphedema. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number not reported), dose, start therapy date not reported, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient experienced lymphedema. Laboratory data (dates unspecified) included: Blood test (NR: not provided) not reported. EMG (NR: not provided) not reported. MRI (NR: not provided) not reported. Vascular ultrasound (NR: not provided) not reported and X-ray (NR: not provided) not reported. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of lymphedema not reported.
Sex: U
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: This spontaneous report received from a consumer concerning a patient of unspecified age and gender. The patient's height, weight and concomitant medications not reported. Medical conditions included no risk factors for lymphedema. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number not reported), dose, start therapy date not reported, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient experienced lymphedema. Laboratory data (dates unspecified) included: Blood test (NR: not provided) not reported. EMG (NR: not provided) not reported. MRI (NR: not provided) not reported. Vascular ultrasound (NR: not provided) not reported and X-ray (NR: not provided) not reported. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of lymphedema not reported.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS REFROZEN; ADMINISTRATION OF REFROZEN VACCINE; This spontaneous report received from a health care professional concerned an 18 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 20-MAY-2022) dose was not reported, administered on 11-MAY-2022 for prophylactic vaccination. Age at time of vaccination 18 years old. No concomitant medications were reported.  On 11-MAY-2022, the patient experienced administration of refrozen vaccine. On an unspecified date, the patient experienced vaccine was refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of refrozen vaccine and vaccine was refrozen was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537683, 20220537548, 20220537341, 20220537356, 20220537444, 20220537507, 20220537532, 20220537548, 20220537683, 20220537688, 20220538146, 20220538210, 20220538238, 20220538292, 20220538316, 20220538428, 20220538297, 20220538573 and 20220538480.