chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Eczema, Fibromyalgia, Hypersensitivity, Pain
Clinical narrative: Had a fibro flare from head to toe.  I have never had this before.  My skin/body was in hyper sensitivity and pain from my head to the bottoms of my feet.  I then developed ezcema on my neck, which I have never had before and just went to a doctor for that.  I did not go for the fibro flair as I know there is nothing that can be done for that.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Sensitive skin
Clinical narrative: Had a fibro flare from head to toe.  I have never had this before.  My skin/body was in hyper sensitivity and pain from my head to the bottoms of my feet.  I then developed ezcema on my neck, which I have never had before and just went to a doctor for that.  I did not go for the fibro flair as I know there is nothing that can be done for that.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash macular
Clinical narrative: Areas on the left side of my body look like birthmarks. There are no bumps or actual bruises. They occurred after my vaccinations
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bronchitis bacterial, COVID-19, Cough, Hypoxia, Respiratory symptom
Clinical narrative: Patient up to date on COVID vaccinations who admitted for COVID complications.  Provider discharge note below:  "dx with covid 19 he is ""fully vaccinated and boosted"" and he has had mild URI symptoms with hypoxia on admission. He was placed on decadron and has improved and would like to go home. At rest and ambulatory ox saturation checks day of discharge were 92% or greater. He is discharged on azithromycin Z-pack for a slight increased cough with greenish phlegm production likely bct bronchitis. On the day of discharge he is AO, vss, baseline physical exam ""jumping to get out of here."" He does have a home oximeter and will follow his oxygen saturations to call his physician if <90% and/or increasing SOB"
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Sputum discoloured
Clinical narrative: Patient up to date on COVID vaccinations who admitted for COVID complications.  Provider discharge note below:  "dx with covid 19 he is ""fully vaccinated and boosted"" and he has had mild URI symptoms with hypoxia on admission. He was placed on decadron and has improved and would like to go home. At rest and ambulatory ox saturation checks day of discharge were 92% or greater. He is discharged on azithromycin Z-pack for a slight increased cough with greenish phlegm production likely bct bronchitis. On the day of discharge he is AO, vss, baseline physical exam ""jumping to get out of here."" He does have a home oximeter and will follow his oxygen saturations to call his physician if <90% and/or increasing SOB"
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pediatric Pfizer vaccine batch/lot# FK5127, improperly stored in an immunizations freezer, which maintained a temperature between -15ºC and -24ºC. Per manufacturer's guidelines, the vaccine must be stored in a refrigerator maintaining temperature of 2-8ºC or an ultra-low cold freezer maintaining temperature of -90ºC or lower. The patient received an improperly stored vaccine. Treatment: Not required, patient did not report any adverse reactions to the vaccine. Outcome: Patient's guardian notified and offered to restart the Pediatric Pfizer COVID-19 vaccine series again stored at the proper temperature. Signs, symptoms course, etc. None reported by the patient's guardian.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Dandruff, Eczema, Eosinophil count increased, Interchange of vaccine products
Clinical narrative: Moderna booster after 2-dose Pfizer series, completed 05/13/2021. Eczema rash originally presenting in left elbow crease on 12/20/2021. Intense itching and weeping in the groin area, particularly on the scrotum. Also starts appearing in right elbow crease. No treatment so far. Vacation taken from 01/19/2022 to 01/29/2022 - during this time, elbow crease rashes worsen and groin itching worsens. (2) 10 mg cetirizine tablets taken at once periodically to control itching. Within one week of returning from vacation, rash appears around eyes; on ears - weeping here; around neck; left and right forearms; on backs of hands; webbing of fingers and along fingers; excessive dandruff and itching of the scalp; cont. Rash on cheeks along nose. Rash spots along upper thighs; where thigh folds meet buttocks; inner thighs; lower back; knee creases (behind the knee). OTC hydrocortisone applied on all rashes, but no change in condition. Lamisil is also tried with no results. For itching at night, as many as (4) diphenhydramine 25 mg tablets taken at once. Frequent lukewarm showers with Cetaphil soap. Gradual worsening of all rashes until 02/23/2022 after visit to dermatologist, who prescribes triamcinolone. Applied twice daily on all rash areas except the eyes for one and a half weeks (02/23 to 03/05) until acne spots start appearing where not previously seen. Rashes subside during this time, but not fully on the forearms and lower back. No application of triamcinolone from 03/05 to 03/18, but rashes reappear in all areas. Forearms are worse than before the triamcinolone treatment - larger area and rash is thicker. Around the eyes is particularly bad. Cedar allergies may exacerbate rashes - common  from December to March. Also have sensitivity to oak pollen. No prior history of eczema on self. Older sister had eczema as a child but not as an adult.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test normal, Pruritus, Pruritus genital, Rash, Skin weeping
Clinical narrative: Moderna booster after 2-dose Pfizer series, completed 05/13/2021. Eczema rash originally presenting in left elbow crease on 12/20/2021. Intense itching and weeping in the groin area, particularly on the scrotum. Also starts appearing in right elbow crease. No treatment so far. Vacation taken from 01/19/2022 to 01/29/2022 - during this time, elbow crease rashes worsen and groin itching worsens. (2) 10 mg cetirizine tablets taken at once periodically to control itching. Within one week of returning from vacation, rash appears around eyes; on ears - weeping here; around neck; left and right forearms; on backs of hands; webbing of fingers and along fingers; excessive dandruff and itching of the scalp; cont. Rash on cheeks along nose. Rash spots along upper thighs; where thigh folds meet buttocks; inner thighs; lower back; knee creases (behind the knee). OTC hydrocortisone applied on all rashes, but no change in condition. Lamisil is also tried with no results. For itching at night, as many as (4) diphenhydramine 25 mg tablets taken at once. Frequent lukewarm showers with Cetaphil soap. Gradual worsening of all rashes until 02/23/2022 after visit to dermatologist, who prescribes triamcinolone. Applied twice daily on all rash areas except the eyes for one and a half weeks (02/23 to 03/05) until acne spots start appearing where not previously seen. Rashes subside during this time, but not fully on the forearms and lower back. No application of triamcinolone from 03/05 to 03/18, but rashes reappear in all areas. Forearms are worse than before the triamcinolone treatment - larger area and rash is thicker. Around the eyes is particularly bad. Cedar allergies may exacerbate rashes - common  from December to March. Also have sensitivity to oak pollen. No prior history of eczema on self. Older sister had eczema as a child but not as an adult.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, Dyspnoea, Oxygen saturation decreased, Pulmonary embolism
Clinical narrative: MY MOTHER GOT COVID ON FEB 18TH WITH VERY MILD SYMPTOMS.  ON JAN 31ST, 2022 SHE WAS RUSHED TO THE HOSPITAL WITH LABORED BREATHING.  THE PARAMEDICS SAID ALL HER VITALS WERE OK, EXCEPT HER OXYGEN SATURATION WAS A LITTLE LOW AT 89.  THEY ASKED IF WE STILL WANTED THEM TO TAKE HER.    SHE DIED ON FEB 1, 2022 AT 11:40AM  FROM COVID 19 AND BILATERAL PULMONARY EMBOLISM.  NEITHER OF WHICH WERE PRE-EXISTING CONDITIONS.  MY MOTHER SHOULD NOT HAVE DIED.  THE PFIZER VACCINATION CAUSED THE PULMONARY EMBOLISM.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pediatric Pfizer Vaccine Lot Number FK5127, was improperly stored in an Immunizations Freezer that maintained a temperature between -15 Celsius and -24 Celsius. Per the Manufacture?s guidelines the vaccine must be stored in a Refrigerator maintaining temperature of 2-8 Degrees Celsius or an Ultra-Low Cold Freezer maintaining temperature of -90C or lower. The patient received the vaccine that was improperly stored.  Treatment: Not required, patient did not report any adverse reactions to the Vaccine.  Outcome: Patient?s guardian notified and offered to restart the Pediatric Pfizer Covid Vaccine series again stored at the proper temperature.  Signs, Symptoms course, etc.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pediatric Pfizer Vaccine Lot Number FK5127, was improperly stored in an Immunizations Freezer that maintained a temperature between -15 Celsius and -24 Celsius. Per the Manufacture?s guidelines the vaccine must be stored in a Refrigerator maintaining temperature of 2-8 Degrees Celsius or an Ultra-Low Cold Freezer maintaining temperature of -90C or lower. The patient received the vaccine that was improperly stored.  Treatment: Not required, patient did not report any adverse reactions to the Vaccine.  Outcome: Patient?s guardian notified and offered to restart the Pediatric Pfizer Covid Vaccine series again stored at the proper temperature.  Signs, Symptoms course, etc. None reported by the patient?s guardian
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient received adult dose, she was supposed to get pediatric dose
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Severe case of Shingles approximately 2 weeks after receiving Johnson and Johnson Covid vaccine
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Decreased appetite, Depression, Fatigue
Clinical narrative: After the booster the next day. He sleep a till the evening the next day. He was completely fatigued and was not talking well. He had a difficult time and his depression was very bad. It was 3 months he could not do anything to help his depression. His PCP upped his dosage on his medication for his depression. He made him terrible tired and frustrating. He was having mind problems, like he was out of life. It was difficult for him to sleep at night. He was having extreme sweats when he sleep, day or not. He lost his appetite. In January he started to ease away back to be being better on his supplement medication. But even now he is very weak and tired. Now his memory is not a great as it was before. He has kind of recovered but he is not the same.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hyperhidrosis, Hypersomnia, Insomnia, Mental impairment
Clinical narrative: After the booster the next day. He sleep a till the evening the next day. He was completely fatigued and was not talking well. He had a difficult time and his depression was very bad. It was 3 months he could not do anything to help his depression. His PCP upped his dosage on his medication for his depression. He made him terrible tired and frustrating. He was having mind problems, like he was out of life. It was difficult for him to sleep at night. He was having extreme sweats when he sleep, day or not. He lost his appetite. In January he started to ease away back to be being better on his supplement medication. But even now he is very weak and tired. Now his memory is not a great as it was before. He has kind of recovered but he is not the same.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: After the booster the next day. He sleep a till the evening the next day. He was completely fatigued and was not talking well. He had a difficult time and his depression was very bad. It was 3 months he could not do anything to help his depression. His PCP upped his dosage on his medication for his depression. He made him terrible tired and frustrating. He was having mind problems, like he was out of life. It was difficult for him to sleep at night. He was having extreme sweats when he sleep, day or not. He lost his appetite. In January he started to ease away back to be being better on his supplement medication. But even now he is very weak and tired. Now his memory is not a great as it was before. He has kind of recovered but he is not the same.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Aphonia, COVID-19, Cough, Feeling abnormal, Impaired work ability
Clinical narrative: I had a severe sore throat, and I had a severe achy body with coughs and various fevers for 2 weeks. I missed 2 weeks of work for that. I lost my voice for a week after that. I still have an achy body just not as severe, and I have brain fog. I had a telehealth visit with a doctor. I was prescribed steroids, antibiotics, and an inhaler.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I had a severe sore throat, and I had a severe achy body with coughs and various fevers for 2 weeks. I missed 2 weeks of work for that. I lost my voice for a week after that. I still have an achy body just not as severe, and I have brain fog. I had a telehealth visit with a doctor. I was prescribed steroids, antibiotics, and an inhaler.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pediatric Pfizer Vaccine Lot Number FK5127, was improperly stored in an Immunizations Freezer that maintained a temperature between -15 Celsius and -24 Celsius. Per the Manufacture?s guidelines the vaccine must be stored in a Refrigerator maintaining temperature of 2-8 Degrees Celsius or an Ultra-Low Cold Freezer maintaining temperature of -90C or lower. The patient received the vaccine that was improperly stored.  Treatment: Not required, patient did not report any adverse reactions to the Vaccine.  Outcome: Patient?s guardian notified and offered to restart the Pediatric Pfizer Covid Vaccine series again stored at the proper temperature.  Signs, Symptoms course, etc. None reported by the patient?s guardian
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Patient called pharmacy and reported itching on face and neck, around 1 hours and 45 minutes after vaccination. Patient stated she would seek medical attention at place of employment ( Hospital/ Clinic)
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pediatric Pfizer Vaccine Lot Number FK5127, was improperly stored in an Immunizations Freezer that maintained a temperature between -15 Celsius and -24 Celsius. Per the Manufacture?s guidelines the vaccine must be stored in a Refrigerator maintaining temperature of 2-8 Degrees Celsius or an Ultra-Low Cold Freezer maintaining temperature of -90C or lower. The patient received the vaccine that was improperly stored.  Treatment: Not required, patient did not report any adverse reactions to the Vaccine.  Outcome: Patient?s guardian notified and offered to restart the Pediatric Pfizer Covid Vaccine series again stored at the proper temperature.  Signs, Symptoms course, etc. None reported by the patient?s guardian
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Cough, Dyspnoea, Fatigue
Clinical narrative: I woke up in the morning extremely tired and weak with difficulty getting out of bed, shortness of breath (went down to 89%). Coughing a lot continuously with no temp. I did not loose my sense of test and did an at home COVID test that came back positive. I continued with the symptoms for almost 2 weeks. I spent a couple of days in bed only getting up to get something drink.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, SARS-CoV-2 test positive
Clinical narrative: I woke up in the morning extremely tired and weak with difficulty getting out of bed, shortness of breath (went down to 89%). Coughing a lot continuously with no temp. I did not loose my sense of test and did an at home COVID test that came back positive. I continued with the symptoms for almost 2 weeks. I spent a couple of days in bed only getting up to get something drink.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Tremor
Clinical narrative: patient experienced sever muscle spasms and shaking that lasted about 1.5 hours
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient hasn't reported any adverse effects. We mistakenly gave a gray cap Pfizer vaccine at 29 hours after draw up time. We called Pfizer and they told us there was a 24 hour excursion period. We were past that at 29 hours. We called the CDC and they recommended we give another vaccine immediately. We called the patient and he is coming back tonight for another vaccine.  How this happened is that the vaccine only had the time on the vial not the date. It said 9:28 AM and we thought that was today but later determined it was from yesterday.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Decreased appetite, Headache, Impaired work ability, Lethargy
Clinical narrative: Diarrhea x 2, low-grade fever and arm soreness. 2nd shot: Patient with severe headache, low-grade fever, lethargy and unable to go to work for 1 day. Nausea and vomiting. Afterwards, she has had a daily headache to this date, poor appetite and weight loss of 40 lbs.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oesophagogastroduodenoscopy, Pyrexia, Vomiting, Weight decreased
Clinical narrative: Diarrhea x 2, low-grade fever and arm soreness. 2nd shot: Patient with severe headache, low-grade fever, lethargy and unable to go to work for 1 day. Nausea and vomiting. Afterwards, she has had a daily headache to this date, poor appetite and weight loss of 40 lbs.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.) Event: Pediatric Pfizer Vaccine Lot Number FK5127, was improperly stored in an Immunizations Freezer that maintained a temperature between -15 Celsius and -24 Celsius. Per the Manufacture?s guidelines the vaccine must be stored in a Refrigerator maintaining temperature of 2-8 Degrees Celsius or an Ultra-Low Cold Freezer maintaining temperature of -90C or lower. The patient received the vaccine that was improperly stored.  Treatment: Not required, patient did not report any adverse reactions to the Vaccine.  Outcome: Patient?s guardian notified and offered to restart the Pediatric Pfizer Covid Vaccine series again stored at the proper temperature.  Signs, Symptoms course, etc. None reported by the patient?s guardian
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Diarrhoea, Erythema, Pruritus, Rash
Clinical narrative: Patient received first dose of pfizer vaccine on 3/19/22. She had diarrhea first day which still persist. Starting last night she started getting rash on her face starting from her chin, her face, and around her eyes. She also had redness and burning and itching. She took benedryl 25 mg last night but it did not resolve. Patient also added that she had crawfish on 3/19/22 which is the same day she got her covid shot. It is unsure if this reaction was caused by pfizer vaccine or the craw fish. She had covid in September 2021 and was hospitalized for 3 months per patient
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Impaired work ability, Influenza virus test negative, Nasal congestion
Clinical narrative: On 03/27/2022 a few hours after the vaccine, I felt chills, nights sweats, I felt tired, I started feeling head congestion, body aches. The next day I felt more congested. I felt feverish. I was really congested. I tried working the next day, and that was an epic fail. That Tuesday evening I went to the doctor. I was tested for COVID-19-negative. They gave me a breathing treatment. They gave me an oral steroid. They also prescribed a generic for Mucinex. They had me stay home for several days and I went back to work on that Friday. I was still recovering. It took me like a week to recover.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pain, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: On 03/27/2022 a few hours after the vaccine, I felt chills, nights sweats, I felt tired, I started feeling head congestion, body aches. The next day I felt more congested. I felt feverish. I was really congested. I tried working the next day, and that was an epic fail. That Tuesday evening I went to the doctor. I was tested for COVID-19-negative. They gave me a breathing treatment. They gave me an oral steroid. They also prescribed a generic for Mucinex. They had me stay home for several days and I went back to work on that Friday. I was still recovering. It took me like a week to recover.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Streptococcus test negative
Clinical narrative: On 03/27/2022 a few hours after the vaccine, I felt chills, nights sweats, I felt tired, I started feeling head congestion, body aches. The next day I felt more congested. I felt feverish. I was really congested. I tried working the next day, and that was an epic fail. That Tuesday evening I went to the doctor. I was tested for COVID-19-negative. They gave me a breathing treatment. They gave me an oral steroid. They also prescribed a generic for Mucinex. They had me stay home for several days and I went back to work on that Friday. I was still recovering. It took me like a week to recover.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pediatric Pfizer Vaccine Lot Number FK5127, was improperly stored in an Immunizations Freezer that maintained a temperature between -15 Celsius and -24 Celsius. Per the Manufacture?s guidelines the vaccine must be stored in a Refrigerator maintaining temperature of 2-8 Degrees Celsius or an Ultra-Low Cold Freezer maintaining temperature of -90C or lower. The patient received the vaccine that was improperly stored.  Treatment: Not required, patient did not report any adverse reactions to the Vaccine.  Outcome: Patient?s guardian notified and offered to restart the Pediatric Pfizer Covid Vaccine series again stored at the proper temperature.  Signs, Symptoms course, etc. None reported by the patient?s guardian
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Come home after vaccine and had ringing in my ears and it has been present ever since.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bursitis, Cholecystitis, Dyspnoea, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: gall bladder inflamation and shortness of breath days after 2nd injection. iburophen for 3 days to get rid of gall bladder. Shortness of breath lasted 6 months. oct 2021 burcitis in left arm injection site started. do not play sports or any reason for it.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer normal, Injection site reaction, Troponin normal
Clinical narrative: gall bladder inflamation and shortness of breath days after 2nd injection. iburophen for 3 days to get rid of gall bladder. Shortness of breath lasted 6 months. oct 2021 burcitis in left arm injection site started. do not play sports or any reason for it.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pediatric Pfizer Vaccine Lot Number FK5127, was improperly stored in an Immunizations Freezer that maintained a temperature between -15 Celsius and -24 Celsius. Per the Manufacture?s guidelines the vaccine must be stored in a Refrigerator maintaining temperature of 2-8 Degrees Celsius or an Ultra-Low Cold Freezer maintaining temperature of -90C or lower. The patient received the vaccine that was improperly stored.  Treatment: Not required, patient did not report any adverse reactions to the Vaccine.  Outcome: Patient?s guardian notified and offered to restart the Pediatric Pfizer Covid Vaccine series again stored at the proper temperature.  Signs, Symptoms course, etc. None reported by the patient?s guardian
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Head discomfort, Headache
Clinical narrative: 15 minutes after the injection, I had lightheadedness, and felt like a mild pressure headache was starting.  This is not change or worsen over the next 24 hours.  5 hours after the injection, I had chills without fever for about 2-3 hours. I also began to feel tired, and overall malaise, which continued through the initial 36 hour period.  Moderate headache developed close to the 24 hour mark, and was relieved with Tylenol. Intermittent, mild headaches continued through the second day.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: 15 minutes after the injection, I had lightheadedness, and felt like a mild pressure headache was starting.  This is not change or worsen over the next 24 hours.  5 hours after the injection, I had chills without fever for about 2-3 hours. I also began to feel tired, and overall malaise, which continued through the initial 36 hour period.  Moderate headache developed close to the 24 hour mark, and was relieved with Tylenol. Intermittent, mild headaches continued through the second day.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Event: Pediatric Pfizer Vaccine Lot Number FK5127, was improperly stored in an Immunizations Freezer that maintained a temperature between -15 Celsius and -24 Celsius. Per the Manufacture?s guidelines the vaccine must be stored in a Refrigerator maintaining temperature of 2-8 Degrees Celsius or an Ultra-Low Cold Freezer maintaining temperature of -90C or lower. The patient received the vaccine that was improperly stored.  Treatment: Not required, patient did not report any adverse reactions to the Vaccine.  Outcome: Patient?s guardian notified and offered to restart the Pediatric Pfizer Covid Vaccine series again stored at the proper temperature.  Signs, Symptoms course, etc. None reported by the patient?s guardian
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Pain, Parotitis, Swelling face, Swollen tongue
Clinical narrative: 3/18/2022 oxygen saturation dropped and supplement oxygen needed. 3/19/2022 patient c/o pain with swollen left side of face and tongue. Transferred to hospital. Hospital gave diagnosis of parotitis. Patient still in hospital at this time.
Age: 30.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Abdominal pain, Blood iron decreased, Decreased appetite, Epistaxis, Gastrointestinal disorder
Clinical narrative: I also took the flu shot at the same time of taking the booster. A couple of months after taking the 3rd dose, I get nosebleeds now that I did not have before and my sinuses are off. I am also having abdominal problems, short stabbing pain, and I am losing my appetite. I am very low on vitamins like iron and B12.
Age: 30.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Sinus disorder, Vitamin B12 decreased
Clinical narrative: I also took the flu shot at the same time of taking the booster. A couple of months after taking the 3rd dose, I get nosebleeds now that I did not have before and my sinuses are off. I am also having abdominal problems, short stabbing pain, and I am losing my appetite. I am very low on vitamins like iron and B12.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Covid-19 positive on 09-17-2021. Hospitalized 09-17-2021 Flown to another state 09-22-2021 Died of Covid-19 10-02-2021
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pruritus, Rash
Clinical narrative: Severe rash and itching and tired that are ongoing for 10 months since the injection was given. Have seen dermatology specialist and gone to urgent care. Prescribed Prednisolone Ointment, Prednisone Tablets (several courses over last 10 months, as well as hydroxyzine
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pediatric Pfizer Vaccine Lot Number FK5127, was improperly stored in an Immunizations Freezer that maintained a temperature between -15 Celsius and -24 Celsius. Per the Manufacture?s guidelines the vaccine must be stored in a Refrigerator maintaining temperature of 2-8 Degrees Celsius or an Ultra-Low Cold Freezer maintaining temperature of -90C or lower. The patient received the vaccine that was improperly stored.  Treatment: Not required, patient did not report any adverse reactions to the Vaccine.  Outcome: Patient?s guardian notified and offered to restart the Pediatric Pfizer Covid Vaccine series again stored at the proper temperature.  Signs, Symptoms course, etc. None reported by the patient?s guardian
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Youth patient received a full adult dose of 30 mcg/0.3ml.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Impaired work ability, Oropharyngeal pain, Pyrexia
Clinical narrative: On 02/18/2022 I left work early because I had a sore throat. I was running a fever of 101. I did a rapid test in the same day and it came back positive. I started to feel better after about 3 days. I contact my primary care physician and he prescribed a stronger version of Mucinex. I felt at least 95% better after a week. I still suffer from a cough every now and then.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: On 02/18/2022 I left work early because I had a sore throat. I was running a fever of 101. I did a rapid test in the same day and it came back positive. I started to feel better after about 3 days. I contact my primary care physician and he prescribed a stronger version of Mucinex. I felt at least 95% better after a week. I still suffer from a cough every now and then.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Individual received moderna 3rd dose and under age of 18. No adverse response
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: PATIENT STATED THEY EXPERIENCED SWELLING AT INJECTION SITE THE SIZE OF GRAPEFRUIT AND HAD FEVER AROUND INJECTION SITE LASTING 2 TO 3 DAYS. PATIENT ALSO DEVELOPED BLISTERS AROUND INJECTION SITE.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Youth patient received a full adult dose of 30 mcg/0.3ml.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Youth patient received a full adult dose of 30 mcg/0.3ml.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Event: Pediatric Pfizer Vaccine Lot Number FK5127, was improperly stored in an Immunizations Freezer that maintained a temperature between -15 Celsius and -24 Celsius. Per the Manufacture?s guidelines the vaccine must be stored in a Refrigerator maintaining temperature of 2-8 Degrees Celsius or an Ultra-Low Cold Freezer maintaining temperature of -90C or lower. The patient received the vaccine that was improperly stored.  Treatment: Not required, patient did not report any adverse reactions to the Vaccine.  Outcome: Patient?s guardian notified and offered to restart the Pediatric Pfizer Covid Vaccine series again stored at the proper temperature.  Signs, Symptoms course, etc. None reported by the patient's guardian
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pediatric Pfizer vaccine batch/lot# FK5127, improperly stored in an immunizations freezer, which maintained a temperature between -15ºC and -24ºC. Per manufacturer's guidelines, the vaccine must be stored in a refrigerator maintaining temperature of 2-8ºC or an ultra-low cold freezer maintaining temperature of -90ºC or lower. The patient received an improperly stored vaccine. Treatment: Not required, patient did not report any adverse reactions to the vaccine. Outcome: Patient's guardian notified and offered to restart the Pediatric Pfizer COVID-19 vaccine series again stored at the proper temperature. Signs, symptoms course, etc. None reported by the patient's guardian.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Apallic syndrome, Brain oedema, Cardiac telemetry normal, Cerebral artery occlusion
Clinical narrative: Presented to the hospital with right sided weakness and small L MCA stroke 3/3/22, which evolved to a large hemispheric left MCA stroke 3/8/22 with malignant cerebral edema requiring decompressive hemicraniectomy 3/9/22. Examination remained poor with essentially vegetative state. She underwent tracheostomy and PEG tube placement.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebral infarction, Cerebral ischaemia, Cerebrovascular accident, Computerised tomogram abdomen normal, Computerised tomogram head abnormal
Clinical narrative: Presented to the hospital with right sided weakness and small L MCA stroke 3/3/22, which evolved to a large hemispheric left MCA stroke 3/8/22 with malignant cerebral edema requiring decompressive hemicraniectomy 3/9/22. Examination remained poor with essentially vegetative state. She underwent tracheostomy and PEG tube placement.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram thorax normal, Decompressive craniectomy, Echocardiogram, Ejection fraction, Gastrostomy
Clinical narrative: Presented to the hospital with right sided weakness and small L MCA stroke 3/3/22, which evolved to a large hemispheric left MCA stroke 3/8/22 with malignant cerebral edema requiring decompressive hemicraniectomy 3/9/22. Examination remained poor with essentially vegetative state. She underwent tracheostomy and PEG tube placement.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Glycosylated haemoglobin increased, Hemiparesis, Low density lipoprotein normal, Magnetic resonance imaging head abnormal, Perfusion brain scan abnormal
Clinical narrative: Presented to the hospital with right sided weakness and small L MCA stroke 3/3/22, which evolved to a large hemispheric left MCA stroke 3/8/22 with malignant cerebral edema requiring decompressive hemicraniectomy 3/9/22. Examination remained poor with essentially vegetative state. She underwent tracheostomy and PEG tube placement.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tracheostomy, Ultrasound Doppler normal, Venogram normal
Clinical narrative: Presented to the hospital with right sided weakness and small L MCA stroke 3/3/22, which evolved to a large hemispheric left MCA stroke 3/8/22 with malignant cerebral edema requiring decompressive hemicraniectomy 3/9/22. Examination remained poor with essentially vegetative state. She underwent tracheostomy and PEG tube placement.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pediatric Pfizer Vaccine Lot Number FK5127, was improperly stored in an Immunizations Freezer that maintained a temperature between -15 Celsius and -24 Celsius. Per the Manufacture?s guidelines the vaccine must be stored in a Refrigerator maintaining temperature of 2-8 Degrees Celsius or an Ultra-Low Cold Freezer maintaining temperature of -90C or lower. The patient received the vaccine that was improperly stored.  Treatment: Not required, patient did not report any adverse reactions to the Vaccine.  Outcome: Patient?s guardian notified and offered to restart the Pediatric Pfizer Covid Vaccine series again stored at the proper temperature.  Signs, Symptoms course, etc. None reported by the patient's guardian
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Attendee was inadvertently given the adult dose of the Pfizer vaccine at 10:30 a.m.   The attendee did not have any adverse reaction to the vaccine while at the site and had left the site before the error was discovered. The error was not caught until the end of the day, when the RN reconstituter made mention, that he had not opened a vial of Pediatric Vaccine that day. Investigation of how this error occurred and action steps, to prevent this from happening again are underway.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Dyspnoea, Emphysema, Pulmonary function test abnormal
Clinical narrative: SOB stated about a few weeks after injection, no relief from 12/21/21 Flovent was prescribed and prednisone and f/u on 12/23/21 with a steroid injection. SOB was so bad I could not eat or talk. Chest X-ray, Pulmonary function test, mild emphysema. Medication was changed again to Symbicort. Now being referred to a pulmonologist. All COVID tests have been negative.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.) Event: Pediatric Pfizer Vaccine Lot Number FK5127, was improperly stored in an Immunizations Freezer that maintained a temperature between -15 Celsius and -24 Celsius. Per the Manufacture?s guidelines the vaccine must be stored in a Refrigerator maintaining temperature of 2-8 Degrees Celsius or an Ultra-Low Cold Freezer maintaining temperature of -90C or lower. The patient received the vaccine that was improperly stored.  Treatment: Not required, patient did not report any adverse reactions to the Vaccine.  Outcome: Patient's guardian notified and offered to restart the Pediatric Pfizer Covid Vaccine series again stored at the proper temperature.  Signs, Symptoms course, etc. None reported by the patient's guardian
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Dyspnoea, Hypoxia
Clinical narrative: Case was vaccinated for Covid in March 2021, then was hospitalized for Covid in January 2022. Hospitalized at:  hospital. * Pneumonia due to COVID-19 virus Assessment & Plan Presented with 9 days of respiratory symptoms that progressed to shortness of breath. Covid positive in the ED 1/17 although she reports a negative test at urgent care a few days after symptom onset. CXR on admission with multifocal infiltrates. Has received 1 dose of J&J vaccine, no booster. Mildly hypoxic initially but progressed to needing HFNC on 1/20. Repeat CXR on 1/19 showed slight worsening of infiltrates but no new lobar infiltrate, and WBC's and procalcitonin normal which point against another superimposed infection. PE seems unlikely since her INR has been therapeutic. No improvement with diuresis so discontinued furosemide on 1/21. - Continue dexamethasone x10 days, last day 1/26 - Tocilizumab given on 1/21 - Roxanol PRN air hunger - Remdesivir not started due to duration of symptoms - Encourage IS, ambulation, proning - pt had been on HHFNC for days, finally weaned to 5-6 lpm on 1/25, then down to 2 lpm on 1/27
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: International normalised ratio, Lung infiltration, Polyuria, Procalcitonin normal, Respiratory symptom
Clinical narrative: Case was vaccinated for Covid in March 2021, then was hospitalized for Covid in January 2022. Hospitalized at:  hospital. * Pneumonia due to COVID-19 virus Assessment & Plan Presented with 9 days of respiratory symptoms that progressed to shortness of breath. Covid positive in the ED 1/17 although she reports a negative test at urgent care a few days after symptom onset. CXR on admission with multifocal infiltrates. Has received 1 dose of J&J vaccine, no booster. Mildly hypoxic initially but progressed to needing HFNC on 1/20. Repeat CXR on 1/19 showed slight worsening of infiltrates but no new lobar infiltrate, and WBC's and procalcitonin normal which point against another superimposed infection. PE seems unlikely since her INR has been therapeutic. No improvement with diuresis so discontinued furosemide on 1/21. - Continue dexamethasone x10 days, last day 1/26 - Tocilizumab given on 1/21 - Roxanol PRN air hunger - Remdesivir not started due to duration of symptoms - Encourage IS, ambulation, proning - pt had been on HHFNC for days, finally weaned to 5-6 lpm on 1/25, then down to 2 lpm on 1/27
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 RNA, SARS-CoV-2 test positive, White blood cell count normal
Clinical narrative: Case was vaccinated for Covid in March 2021, then was hospitalized for Covid in January 2022. Hospitalized at:  hospital. * Pneumonia due to COVID-19 virus Assessment & Plan Presented with 9 days of respiratory symptoms that progressed to shortness of breath. Covid positive in the ED 1/17 although she reports a negative test at urgent care a few days after symptom onset. CXR on admission with multifocal infiltrates. Has received 1 dose of J&J vaccine, no booster. Mildly hypoxic initially but progressed to needing HFNC on 1/20. Repeat CXR on 1/19 showed slight worsening of infiltrates but no new lobar infiltrate, and WBC's and procalcitonin normal which point against another superimposed infection. PE seems unlikely since her INR has been therapeutic. No improvement with diuresis so discontinued furosemide on 1/21. - Continue dexamethasone x10 days, last day 1/26 - Tocilizumab given on 1/21 - Roxanol PRN air hunger - Remdesivir not started due to duration of symptoms - Encourage IS, ambulation, proning - pt had been on HHFNC for days, finally weaned to 5-6 lpm on 1/25, then down to 2 lpm on 1/27
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Unresponsive to stimuli, Wheezing
Clinical narrative: JANSSEN COVID-19 VACCINE   Patient received 0.5 mL Dose of Janssen Covid-19. Within 5 minutes of injection, patient began complaining of "dizziness." Patient sat down with water.  Patient then became unresponsive and was not able be aroused by myself (pharmacist) or wife, who was present. Patient began experiencing obvious Labored breathing (wheezing, gargling) while unresponsive. This prompted the pharmacist (myself) to administer one adult dose of epinephrine (0.3 mg) IM to the left thigh. Within 20 seconds, the patient became responsive and coherent and able to answer questions. However, the patient was unaware of what had happened. Paramedics were called. Patient was transported to (withheld) for evaluation.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Insomnia, Pain, Pollakiuria, Thirst
Clinical narrative: The night of the vaccine (about 8 p.m.) I had chills and could not sleep due to body aches.  I experienced profound thirst and also urination.  I finally fell asleep around 5:00 a.m. on Sunday morning.  When I woke to care for husband (he is a stroke victim), I was feeling some better but now had a crackling sound in my head whenever I moved by body, head, or just eyes.  I notified my physician, but assumed it was from the vaccine since # 2, #3 also gave me weird after-effects.  Cracking is some better today (3/21) but still present.  It sounds like the pilot light trying to ignite a gas stove in my kitchen.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: The night of the vaccine (about 8 p.m.) I had chills and could not sleep due to body aches.  I experienced profound thirst and also urination.  I finally fell asleep around 5:00 a.m. on Sunday morning.  When I woke to care for husband (he is a stroke victim), I was feeling some better but now had a crackling sound in my head whenever I moved by body, head, or just eyes.  I notified my physician, but assumed it was from the vaccine since # 2, #3 also gave me weird after-effects.  Cracking is some better today (3/21) but still present.  It sounds like the pilot light trying to ignite a gas stove in my kitchen.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pediatric Pfizer Vaccine Lot Number FK5127, was improperly stored in an Immunizations Freezer that maintained a temperature between -15 Celsius and -24 Celsius. Per the Manufacture?s guidelines the vaccine must be stored in a Refrigerator maintaining temperature of 2-8 Degrees Celsius or an Ultra-Low Cold Freezer maintaining temperature of -90C or lower. The patient received the vaccine that was improperly stored.  Treatment: Not required, patient did not report any adverse reactions to the Vaccine.  Outcome: Patient?s guardian notified and offered to restart the Pediatric Pfizer Covid Vaccine series again stored at the proper temperature.  Signs, Symptoms course, etc. None reported by the patient?s guardian
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Deafness unilateral, Headache, Myalgia
Clinical narrative: Weakness, muscle pain, severe nausea, shivering, fever, headache, loss of hearing in right ear for several hours. Laid on the bathroom floor and waited it out..... Symptoms subsided about 12:00 a.m. 3/21/22.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Weakness, muscle pain, severe nausea, shivering, fever, headache, loss of hearing in right ear for several hours. Laid on the bathroom floor and waited it out..... Symptoms subsided about 12:00 a.m. 3/21/22.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Diarrhoea, Headache, Injection site pain
Clinical narrative: 104.2 temp, chills, head to toe body ache, headache, sensitivity to light, felt nauseous, excessive arm or injection site pain. A couple of days later cause this lasted for almost a week, I got diarrhea.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Photophobia
Clinical narrative: 104.2 temp, chills, head to toe body ache, headache, sensitivity to light, felt nauseous, excessive arm or injection site pain. A couple of days later cause this lasted for almost a week, I got diarrhea.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pediatric Pfizer Vaccine Lot Number FK5127, was improperly stored in an Immunizations Freezer that maintained a temperature between -15 Celsius and -24 Celsius. Per the Manufacture?s guidelines the vaccine must be stored in a Refrigerator maintaining temperature of 2-8 Degrees Celsius or an Ultra-Low Cold Freezer maintaining temperature of -90C or lower. The patient received the vaccine that was improperly stored.  Treatment: Not required, patient did not report any adverse reactions to the Vaccine.  Outcome: Patient?s guardian notified and offered to restart the Pediatric Pfizer Covid Vaccine series again stored at the proper temperature.  Signs, Symptoms course, etc. None reported by the patient?s guardian
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood thyroid stimulating hormone, Differential white blood cell count, Fatigue, Full blood count
Clinical narrative: The next week my pulse was pounding, I could feel my heart work hard especially at night. i had tenderness in the perineum, achy teeth, overall myalgia and fatigue.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Metabolic function test, Myalgia, Pulse abnormal, Tenderness
Clinical narrative: The next week my pulse was pounding, I could feel my heart work hard especially at night. i had tenderness in the perineum, achy teeth, overall myalgia and fatigue.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Thyroxine free, Toothache
Clinical narrative: The next week my pulse was pounding, I could feel my heart work hard especially at night. i had tenderness in the perineum, achy teeth, overall myalgia and fatigue.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Dyspnoea, Headache
Clinical narrative: I initially experienced numbness in left arm. Hours later I had shortness of breath, dizziness, nausea, body aches, headache on the left side of my head, chills and stiffness on the left side of my body. I also experienced weakness I couldn't even lift a pen. My doctor wanted me to come in but I couldn't drive. He told me to take 2 Aleve. It didn't subside until Sunday 03/20/2022.