chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: COVID19-2, FLU4, MENB
Symptoms: Rash erythematous, Swelling face, Swelling of eyelid
Clinical narrative: Right arm swelling (present but improved at time of presentation), right arm itching (no longer present at time of presentation), right arm erythematous rash (no longer present at time of presentation), face & eyelid swelling (present but improved at time of presentation), fever for 2 days (had resolved as of presentation), ear pain (bilateral, present at time of presentation), itchy eyes (resolved at time of presentation)
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: Started getting a sore throat and felt fatigued. Took a home COVID-19 test and it was positive. Was prescribed PAXLOVID. Took another COVID-19 test 10 days later and it was negative. Started coughing a lot again, took another COVID-19 test and it was positive. Started feeling better a few days later and tested negative for COVID-19.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Cough, Fatigue, Headache
Clinical narrative: I had a runny nose, stuffy headache, fatigue, chills and cough. I tested with a at home test and at the doctor. I was prescribed PAXLOVID. I have seen improvement 48 hours after starting the medication.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I had a runny nose, stuffy headache, fatigue, chills and cough. I tested with a at home test and at the doctor. I was prescribed PAXLOVID. I have seen improvement 48 hours after starting the medication.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: Developed a rash on the side, legs and back
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Throat irritation
Clinical narrative: tickle in throat, coughing, hoarsness
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site urticaria, Injection site warmth, Pruritus
Clinical narrative: Mom called today (01/25/23) to report patient having a large circular red spot on her right thigh at the site of injection. No obvious pain, no fever, she is just a little more irritable than normal. We asked she comes in today to be checked by her PCP, doctor to make sure this is a reaction vs an infection. She had a similar but smaller reaction to MMR/V in 2019 as well, for which she went to the ER for at that time. Doctor concluded it was likely a reaction.  Lateral right thigh with erythema in circle measuring 5cm surrounding injection site with erythematous wheal without fluctuance nor induration. Site is firm, not hot, and itchy.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Pt came in for primary covid shot # 1 but instead received a bivalent booster.  We are in communication with the health department and the Agency to figure out what her next shot should be.  This is complicated by the fact that she was getting vaccinated in order to progress with her immigration status, so time is of the essence.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion.
Age: 38.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was administered the above vaccine after the "Use By" date assigned when removed from the freezer.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood pressure increased, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal
Clinical narrative: Presented to ED with recent episodes of epistaxis, vomiting dark blood, worsening dyspnea. A. fib with rapid ventricular rates in 150s, hypoxic, placed on 6 L NC. BP elevated 200/91. Labs significant for leukocytosis, hemoglobin 8.3.  Treated with 1 unit PRBC, Eliquis was held and Kcentra was used for reversing bleeding, diltiazem drip for A. fib RVR, continued to have worsening hypoxia and alternated between needing BiPAP and Vapotherm, treated with IV antibiotics, steroids for COVID-pneumonia and superimposed bacterial pneumonia.   Patient reported that she did not want to continue with further aggressive cares and was transitioned to inpatient hospice care. Patient expired 11/27/2022 at 1400  Submitter does not have access to patient's full medical record. If further information is needed, please contact Hospital
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Dyspnoea, Epistaxis, Haematemesis, Haemoglobin decreased
Clinical narrative: Presented to ED with recent episodes of epistaxis, vomiting dark blood, worsening dyspnea. A. fib with rapid ventricular rates in 150s, hypoxic, placed on 6 L NC. BP elevated 200/91. Labs significant for leukocytosis, hemoglobin 8.3.  Treated with 1 unit PRBC, Eliquis was held and Kcentra was used for reversing bleeding, diltiazem drip for A. fib RVR, continued to have worsening hypoxia and alternated between needing BiPAP and Vapotherm, treated with IV antibiotics, steroids for COVID-pneumonia and superimposed bacterial pneumonia.   Patient reported that she did not want to continue with further aggressive cares and was transitioned to inpatient hospice care. Patient expired 11/27/2022 at 1400  Submitter does not have access to patient's full medical record. If further information is needed, please contact Hospital
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Hypoxia, Leukocytosis, Lung disorder, Lung infiltration
Clinical narrative: Presented to ED with recent episodes of epistaxis, vomiting dark blood, worsening dyspnea. A. fib with rapid ventricular rates in 150s, hypoxic, placed on 6 L NC. BP elevated 200/91. Labs significant for leukocytosis, hemoglobin 8.3.  Treated with 1 unit PRBC, Eliquis was held and Kcentra was used for reversing bleeding, diltiazem drip for A. fib RVR, continued to have worsening hypoxia and alternated between needing BiPAP and Vapotherm, treated with IV antibiotics, steroids for COVID-pneumonia and superimposed bacterial pneumonia.   Patient reported that she did not want to continue with further aggressive cares and was transitioned to inpatient hospice care. Patient expired 11/27/2022 at 1400  Submitter does not have access to patient's full medical record. If further information is needed, please contact Hospital
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pleural effusion, Pneumonia bacterial, Positive airway pressure therapy, Red blood cell transfusion, SARS-CoV-2 test positive
Clinical narrative: Presented to ED with recent episodes of epistaxis, vomiting dark blood, worsening dyspnea. A. fib with rapid ventricular rates in 150s, hypoxic, placed on 6 L NC. BP elevated 200/91. Labs significant for leukocytosis, hemoglobin 8.3.  Treated with 1 unit PRBC, Eliquis was held and Kcentra was used for reversing bleeding, diltiazem drip for A. fib RVR, continued to have worsening hypoxia and alternated between needing BiPAP and Vapotherm, treated with IV antibiotics, steroids for COVID-pneumonia and superimposed bacterial pneumonia.   Patient reported that she did not want to continue with further aggressive cares and was transitioned to inpatient hospice care. Patient expired 11/27/2022 at 1400  Submitter does not have access to patient's full medical record. If further information is needed, please contact Hospital
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Superinfection
Clinical narrative: Presented to ED with recent episodes of epistaxis, vomiting dark blood, worsening dyspnea. A. fib with rapid ventricular rates in 150s, hypoxic, placed on 6 L NC. BP elevated 200/91. Labs significant for leukocytosis, hemoglobin 8.3.  Treated with 1 unit PRBC, Eliquis was held and Kcentra was used for reversing bleeding, diltiazem drip for A. fib RVR, continued to have worsening hypoxia and alternated between needing BiPAP and Vapotherm, treated with IV antibiotics, steroids for COVID-pneumonia and superimposed bacterial pneumonia.   Patient reported that she did not want to continue with further aggressive cares and was transitioned to inpatient hospice care. Patient expired 11/27/2022 at 1400  Submitter does not have access to patient's full medical record. If further information is needed, please contact Hospital
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The above vaccine was administered after the "Use By" date as assigned after it was removed from the freezer.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Dysphonia, Fatigue, Malaise, SARS-CoV-2 test positive
Clinical narrative: On 12/29/2022 I was not feeling well and contacted my Physician because I had a post nasal drip and assumed it was a Sinus infection. But I was positive for COVID-19 over the next few days I was very tired and hoarse I still have lingering fatigue to date. I was prescribed and completed a course of PAXLOVID.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Upper-airway cough syndrome
Clinical narrative: On 12/29/2022 I was not feeling well and contacted my Physician because I had a post nasal drip and assumed it was a Sinus infection. But I was positive for COVID-19 over the next few days I was very tired and hoarse I still have lingering fatigue to date. I was prescribed and completed a course of PAXLOVID.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Incorrect vaccine administered.  Patient had never received any COVID-19 vaccinations, but was given the Bivalent COVID-19 booster vaccine. No treatment needed.  CDC recommendations for COVID-19 administration errors were followed.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: LPN, administered Proquad that was stored in the refrigerator instead of the freezer.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: PATIENT RECEIVED THE MODERNA BIVALENT VACCINE AS HIS FIRST VACCINE IN ERROR - NO 2 MONOVALENT VACCINES GIVEN PREVIOUSLY --- NO ADVERSE REACTION AT ALL!!!
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Local swelling right deltoid
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Patient had a breakthrough infection and passed away.
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was administered the above vaccine after the "Use By" date as assigned after removed from freeze.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine was given after expiration date
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cerebrovascular accident, Computerised tomogram, Hypoaesthesia, Laboratory test, Limb discomfort
Clinical narrative: ON 12-31-22 CLIENT WOKE AT 5:15 AM, PLANNING TO TRAVEL.  HE HAD GOTTEN DRESSED AND MADE BREAKFAST AND TOOK AM MEDS.  STATED" ALL AT ONCE RIGHT ARM WENT NUMB, THEN RIGHT LEG FELT LIKE IT HAD A 10 POUND WEIGHT ON IT AND IT WENT NUMB.  TOLD HIS WIFE, SHE THEN DROVE HIM TO HOSPITAL.  WHEN ARRIVED AT ER, BLOOD PRESSURE WAS 200+/100+ (DID NOT KNOW VALUES) A CT-SCAN WAS COMPLETED AND LAB WORK. THEN WAS TRANSFERRED TO ALTERNATE HOSPITAL ER VIA GROUND AMBULANCE. HAD ANOTHER CT-SCAN WITH LABS.  WAS ADMITTED AND RELEASED ON JANUARY 2, 2023.  HE WAS TOLD THAT SOME PLAQUE HAD BROKEN LOOSE AND CAUSED A STROKE.  STATED HAD A COUSIN THAT ALSO HAD A STROKE AFTER RECEIVING HER BIVALENT BOOSTER.
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Vaccine error: Patient received 2nd dose  Bivalent instead of Monovalent. No adverse reaction noted.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: patient state she developed 1 blister rash a few days after injection .
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion.
Age: 77.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Anticoagulant therapy, Cardiac disorder, Coronary arterial stent insertion, Dizziness, Fear
Clinical narrative: Since starting the COVID-19 vaccine in January 2021, I started having heart issues. I have a heart attack in May of 2022.It was mild, but I wasn't thinking much. I got a stint in place and been under cardiac care and they changed my blood pressure. I have been taking medicines for 6 or 7 months. Lately I have been declining in my health. I recently checked my blood pressure, and it was high, but I felt fine. This morning it was extremely high 189/185. I was scared and went on about my morning. I took my meds blood pressure and blood thinner. I have had another change in my health, a constant state of dizziness and this erratic blood pressure. This all very strange.
Age: 77.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: General physical health deterioration, Hypertension, Myocardial infarction
Clinical narrative: Since starting the COVID-19 vaccine in January 2021, I started having heart issues. I have a heart attack in May of 2022.It was mild, but I wasn't thinking much. I got a stint in place and been under cardiac care and they changed my blood pressure. I have been taking medicines for 6 or 7 months. Lately I have been declining in my health. I recently checked my blood pressure, and it was high, but I felt fine. This morning it was extremely high 189/185. I was scared and went on about my morning. I took my meds blood pressure and blood thinner. I have had another change in my health, a constant state of dizziness and this erratic blood pressure. This all very strange.
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Atelectasis, COVID-19, Chest X-ray abnormal, Confusional state
Clinical narrative: 11/23/2022 Presented to the ED with high fever and evidence of severe sepsis, COVID-positive which was presumed as the main source of infection. c/o weakness and confusion, cough. erythema and warmth to the right lower leg potentially consistent with cellulitis,  given IV Rocephin Admitted with Principal Problem: COVID-19 virus infection Active Problems: Physical deconditioning not requiring oxygen at this time, will not start dexamethasone Submitter does not have access to full medical record. If additional information is needed, please contact Hospital
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cough, Erythema, Physical deconditioning, Pleural effusion, Pyrexia
Clinical narrative: 11/23/2022 Presented to the ED with high fever and evidence of severe sepsis, COVID-positive which was presumed as the main source of infection. c/o weakness and confusion, cough. erythema and warmth to the right lower leg potentially consistent with cellulitis,  given IV Rocephin Admitted with Principal Problem: COVID-19 virus infection Active Problems: Physical deconditioning not requiring oxygen at this time, will not start dexamethasone Submitter does not have access to full medical record. If additional information is needed, please contact Hospital
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Sepsis, Skin warm
Clinical narrative: 11/23/2022 Presented to the ED with high fever and evidence of severe sepsis, COVID-positive which was presumed as the main source of infection. c/o weakness and confusion, cough. erythema and warmth to the right lower leg potentially consistent with cellulitis,  given IV Rocephin Admitted with Principal Problem: COVID-19 virus infection Active Problems: Physical deconditioning not requiring oxygen at this time, will not start dexamethasone Submitter does not have access to full medical record. If additional information is needed, please contact Hospital
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy skin, Enanthema, Genital rash, Laboratory test, Malaise
Clinical narrative: Generalized itching, arms, legs, face, chest, back. Started April/May 2021. Continued and got progressively worse. Had been using antihistamines, lotions, and creams which I use for eczema. No relief.  Jan. 28, 2022;  Itching getting progressively worse. Saw dermatologist. Stronger topical steroid. May 25, 2022; Itching has been all consuming. Scratching until there were sores. Generally not feeling well. Given Clonazepam and Hydroxyzine. Discussed oral steroids. Oct. 23, 2022; Red raised rash also involving oral and genital mucosa. Given Prednisone x 3 weeks.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oral mucosal eruption, Pruritus, Rash erythematous, Rash papular, Skin lesion
Clinical narrative: Generalized itching, arms, legs, face, chest, back. Started April/May 2021. Continued and got progressively worse. Had been using antihistamines, lotions, and creams which I use for eczema. No relief.  Jan. 28, 2022;  Itching getting progressively worse. Saw dermatologist. Stronger topical steroid. May 25, 2022; Itching has been all consuming. Scratching until there were sores. Generally not feeling well. Given Clonazepam and Hydroxyzine. Discussed oral steroids. Oct. 23, 2022; Red raised rash also involving oral and genital mucosa. Given Prednisone x 3 weeks.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Blepharospasm, Blood test, Muscle spasms, Pain
Clinical narrative: A couple of months after receiving the vaccine, I've been experiencing cramps in my skull area. I've been trying to reduce the pain by taking ADVIL or letting the pain subside on its own. I've also developed an eye twitch since then as well. The twitch developed in September while the skull pain developed over the recent weeks. I saw a specialist, but they stated these symptoms could be fixed through exercise. They didn't really do a thorough examination to diagnosis my symptoms and case.
Age: 50.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Head injury, Syncope
Clinical narrative: patient upon awakening the next day fainted and hit his head
Age: 50.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Body height, Loss of consciousness, Syncope, Weight
Clinical narrative: patient upon awakening the next day fainted and hit his head
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus- high pitched frequency that is getting worse all the time. Constant sound
Age: 4.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Received unauthorized high dose Moderna bivalent booster vaccine on 01/25/2023.  Had completed primary series with Pfizer vaccines dates 07/06/2022 and 08/01/2022
Age: 4.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received unauthorized high dose Moderna bivalent booster vaccine on 01/25/2023.  Had completed primary series with Pfizer vaccines dates 07/06/2022 and 08/01/2022
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Abdominal X-ray, Enema administration, Intussusception, Laboratory test, Ultrasound scan
Clinical narrative: Pt developed vomitting 7 days after the rotarix vaccine and was sebsequenty diagnosed at Medical Center with Intussusception.  Pt had multiple episodes during that hospital stay requiring reduction air enema.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Vomiting, X-ray gastrointestinal tract
Clinical narrative: Pt developed vomitting 7 days after the rotarix vaccine and was sebsequenty diagnosed at Medical Center with Intussusception.  Pt had multiple episodes during that hospital stay requiring reduction air enema.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Extreme fatigue, headache, fatigue, stomach upset, fever/chills lasting 24 hours.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event, but vaccine administration error. Patient had already received Menveo at 11yo.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bell's palsy, Computerised tomogram normal, Condition aggravated, Ear pain, Eyelid disorder
Clinical narrative: Monday I had pain on my right ear. My salivary gland I have issues with and they thought I had cancer but I had an infection and was taking clindamycin. I started my medication as prescribed but this time the pain was different. I had a sharp pain. Normally once I take my antibiotics I start to feel better but this time I didn't feel better. I had like numbness to right side of my face and tongue. I decided to go to the emergency room on December 24th, 2022. I noticed when I brushed my teeth in the morning when I put water in my mouth, my mouth would not close on the right side. They did tests in the emergency room and was seen by a neurologist. She ordered me an antiviral BACTRIM. I was negative for stroke. The ultimate diagnosis was Bell's Palsy. The following Tuesday I started having trouble with my eye, it was slowly closing. I had had Bell's Palsy previously in 2018 but this was completely a different feeling. I had trouble with speech too because I couldn't close my lips. I was not able to pronounce properly because I couldn't close my lips. On about Thursday December 22nd, 2022 when I stood up from my desk, my right side labia was completely numb.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Full blood count normal, Hypoaesthesia, Hypoaesthesia oral, Lip disorder, Magnetic resonance imaging normal
Clinical narrative: Monday I had pain on my right ear. My salivary gland I have issues with and they thought I had cancer but I had an infection and was taking clindamycin. I started my medication as prescribed but this time the pain was different. I had a sharp pain. Normally once I take my antibiotics I start to feel better but this time I didn't feel better. I had like numbness to right side of my face and tongue. I decided to go to the emergency room on December 24th, 2022. I noticed when I brushed my teeth in the morning when I put water in my mouth, my mouth would not close on the right side. They did tests in the emergency room and was seen by a neurologist. She ordered me an antiviral BACTRIM. I was negative for stroke. The ultimate diagnosis was Bell's Palsy. The following Tuesday I started having trouble with my eye, it was slowly closing. I had had Bell's Palsy previously in 2018 but this was completely a different feeling. I had trouble with speech too because I couldn't close my lips. I was not able to pronounce properly because I couldn't close my lips. On about Thursday December 22nd, 2022 when I stood up from my desk, my right side labia was completely numb.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sialoadenitis, Speech disorder
Clinical narrative: Monday I had pain on my right ear. My salivary gland I have issues with and they thought I had cancer but I had an infection and was taking clindamycin. I started my medication as prescribed but this time the pain was different. I had a sharp pain. Normally once I take my antibiotics I start to feel better but this time I didn't feel better. I had like numbness to right side of my face and tongue. I decided to go to the emergency room on December 24th, 2022. I noticed when I brushed my teeth in the morning when I put water in my mouth, my mouth would not close on the right side. They did tests in the emergency room and was seen by a neurologist. She ordered me an antiviral BACTRIM. I was negative for stroke. The ultimate diagnosis was Bell's Palsy. The following Tuesday I started having trouble with my eye, it was slowly closing. I had had Bell's Palsy previously in 2018 but this was completely a different feeling. I had trouble with speech too because I couldn't close my lips. I was not able to pronounce properly because I couldn't close my lips. On about Thursday December 22nd, 2022 when I stood up from my desk, my right side labia was completely numb.
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Gave vaccine that had been out of the refrigerator and diluted for a total of 30 hours. Contacted Pfizer and they were unable to "support stability" of vaccine. Notified mother that per CDC dose given is invalid and needs repeated immediately. No symptoms or adverse effects at this time.
Age: 69.0
Sex: F
Vaccine: COVID19-2, PPV
Symptoms: Body temperature increased, COVID-19, Cough, Fatigue, Nasopharyngitis
Clinical narrative: It started on Tuesday 12/27/2022. In the morning, my temperature was 99.9. In the afternoon I was 100.5, then in the evening 100.8. The highest it ever got was 101.3. After that, my temperature  stayed up for a bit, but by 12/30/2022 I was back to normal. During that time, I had cold symptoms, a sore throat, a dry cough, and I felt tired. I felt a little achy and felt like I had a cold. Most of the symptoms lasted those 3 days between 12/27 through 12/29th. I didn't go anywhere and the last couple of days I stayed in my robe all day. Then I started to feel better. I was still positive on 12/31/2022. I went and had a PCR done with my eldest on 01/07/2023. On my day 15, I was still testing positive, then on my day 18 I was testing negative. I felt fine and I was a little bit more tired. I felt like I was resting more during this period, but I felt fine. I continued to wear a mask after 10 days just to be careful. I did not take Paxlovid for this infection, but I did take Tylenol and Mucinex during this infection once for each medication.
Age: 69.0
Sex: F
Vaccine: COVID19-2, PPV
Symptoms: Oropharyngeal pain, Pain, SARS-CoV-2 test positive
Clinical narrative: It started on Tuesday 12/27/2022. In the morning, my temperature was 99.9. In the afternoon I was 100.5, then in the evening 100.8. The highest it ever got was 101.3. After that, my temperature  stayed up for a bit, but by 12/30/2022 I was back to normal. During that time, I had cold symptoms, a sore throat, a dry cough, and I felt tired. I felt a little achy and felt like I had a cold. Most of the symptoms lasted those 3 days between 12/27 through 12/29th. I didn't go anywhere and the last couple of days I stayed in my robe all day. Then I started to feel better. I was still positive on 12/31/2022. I went and had a PCR done with my eldest on 01/07/2023. On my day 15, I was still testing positive, then on my day 18 I was testing negative. I felt fine and I was a little bit more tired. I felt like I was resting more during this period, but I felt fine. I continued to wear a mask after 10 days just to be careful. I did not take Paxlovid for this infection, but I did take Tylenol and Mucinex during this infection once for each medication.
Age: 1.25
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event, but second dose given 3 months early.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: vaccination failure; Herpes zoster; Information has been received from the RA (agency#AU-TGA-0000731022) on 19-JAN-2023.  This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine (conflicting information, also reported as varicella virus vaccine live [manufacturer unknown]). On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 16-APR-2022 Reporter's Comment: This case was reported by a patient via interactive digital media The patient had the shingles vaccine and still got shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Age: 52.0
Sex: U
Vaccine: UNK
Symptoms: Headache
Clinical narrative: headache
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion.
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion.  No adverse event experienced by patient.
Age: 70.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Dizziness, Throat irritation
Clinical narrative: At approximately 9:20 am the patient received her COVID 19 Pfizer Bivalent booster vaccine and Influenza vaccine in opposite arms.  She was asked to wait in observation for 30 minutes due to her history of severe allergic reaction to sulfa, She agreed.  At approximately 9:40 am, the patient reported to staff that her throat was feeling scratchy.  He had her sit in observation and alerted the nurses.  A nurse assessed her while checking her pulse and as she did so the patient then complained of feeling lightheaded.  She was given a bottle of water and encouraged to put her head down between her legs.  As staff assessed patient through conversation, she drank her water without difficulty and was able to talk clearly and easily without difficulty.  She talked about her allergic reactions and said this reaction felt like other allergic reactions she has experienced and stated she normally would take a 25mg tablet of Benadryl and would improve.  She had it in the car but not with her.   Generic Benadryl (diphenhydramine) in liquid form was available in the emergency bag.  When offered, She immediately said yes and took 10ml (equivalent to 25mg tablet).   We continued to talk with her and she said her head was starting to feel more normal and by 10:10am she felt her throat felt normal again.   patient was educated to call emergency assistance number if symptoms return or get worse.  She was asked if she wanted assistance to get home, she reported living fairly close.  She declined assistance.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Dizziness, Dyskinesia, Fall, Immediate post-injection reaction
Clinical narrative: Patient sat on the examination table, and received 3 vaccinations -2 on left arrm, and the last one on right arm. Immediately after the 3rd injection, patient said that she felt dizzy, and slouched forwards. She was placed flat on the examination table immediately. Dr. was summoned from the next examination room, and attended to the patient immediately. The patient was then noticed to have jerking movements of both upper extremities, lasting 15 to 20 seconds. No color changes, no bradycardia, no tachycardia. Soon after the jerking movements stopped, the patient opened her eyes. Dr. asked the patient --- > "Who am I ? ". The patient responded --- > "Dr.". Patient was observed for 45 minutes, then sent home
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion.  No adverse events experienced by patient.
Age: 89.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute kidney injury, Agitation, Anticoagulation drug level above therapeutic, Bradycardia, Death
Clinical narrative: 89-year-old male who was previously living in an independent facility presents to the hospital on 1//23 (vaccinated on 12/28/2022) with a chief complaint of bradycardia, rates in the 30s, AKI, supratherapeutic INR, right lower lobe infiltrate.  He did require dopamine and Lasix in the ICU.  Ultimately, he was discharged on 1/10/2023 to skilled nursing facility (previously independent).  On 1/24 patient was readmitted to this hospital with a chief complaint of altered mental status with agitation requiring Haldol.  At this time the patient's POA elected to pursue comfort care for this patient.  On 1/25/2023 patient died.  To reiterate patient did have a seemingly rapid decline in overall health status during the short timeframe status post COVID-19 vaccination.
Age: 89.0
Sex: M
Vaccine: COVID19-2
Symptoms: General physical health deterioration, Intensive care, Lung infiltration, Mental status changes
Clinical narrative: 89-year-old male who was previously living in an independent facility presents to the hospital on 1//23 (vaccinated on 12/28/2022) with a chief complaint of bradycardia, rates in the 30s, AKI, supratherapeutic INR, right lower lobe infiltrate.  He did require dopamine and Lasix in the ICU.  Ultimately, he was discharged on 1/10/2023 to skilled nursing facility (previously independent).  On 1/24 patient was readmitted to this hospital with a chief complaint of altered mental status with agitation requiring Haldol.  At this time the patient's POA elected to pursue comfort care for this patient.  On 1/25/2023 patient died.  To reiterate patient did have a seemingly rapid decline in overall health status during the short timeframe status post COVID-19 vaccination.
Age: 1.0
Sex: F
Vaccine: COVID19-2, HEPA, PNC20
Symptoms: Unevaluable event
Clinical narrative: There is a possibility patient may have received 0.25 ml of vaccine rather than the recommended 0.2 ml. of the Moderna Bivalent presentation for 6 months to 5 years.  A staff member was not aware of the correct dosing of the bivalent vaccine. The system in place for drawing up vaccine and administering vaccine may have allowed for staff member to have drawn up 0.25 ml and another staff member to give the vaccine. It cannot be determined if the correct or incorrect amount was drawn up or given. There has been no reported adverse reaction from the parents to date.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: Severe pain left leg upper region
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given Engerix B 0-19 years of age instead of adult dosing. Patient did not have an adverse reaction.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion. No adverse effects experienced by patient.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Patient's mother says that her daughter used to have regular periods. After getting her vaccination she did not have a period for at least 3 months. She then had a couple of periods. Now she goes many months without a period.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion.  No adverse events experienced by patient.
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion. No adverse events experienced by patient.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Head injury, Neurological examination normal, Seizure, Syncope
Clinical narrative: Pt fainted and convulsed after HPV and flu vaccine given. Pt hit head against wall, in sitting position, as he was being lowered to lying on the exam table. Vitals taken: 99% O2 sat and HR 68. MD called. MD examined patient. . Pt returned to baseline, neuro exam normal. Provided pt popsicles and apple sauce, which pt tolerated.  Advised to skip hockey practice tonight; OK to go to school tomorrow, per MD.  *Pt should lay down on table for next vaccine/shot. Mom and pt in agreement with plan.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Hyperhidrosis
Clinical narrative: SOB, sweating profusely, needed oxygen mask, dizzy, lightheaded. We had pt lie down due to symptoms, we were going to get an EKG but decided to call 991 was more appropriate. We administered oxygen at 2 liters. Paramedics showed up and gave Epi and check pt vitals again and was taken to hospital.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Arthralgia, Chills, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: 03/11/21 - slight headache rest of Day after shot. OK 04/04/21 - Same as above, OK NEXT DAY after shot. 12/16/21 - Same as above. 06/06/22 - Same as above.  *See Next page for last shot - issues. 01/04/2023 - 3rd Booster shot. After morning shot, headache in afternoon. Gone by evening. Arm sore. 01/06/2023 - Morning wake up with bad nausea. This lasted all day.  Barely ate anything all day, chills. Repeated diarrhea all day, along with severe tiredness. Joint pain. Rested all day. this was all gone by Next day. Arm sore.  01/10/2023 - Woke up with diarrhea and intestonal gas. Gone buy next day. 01/18/2023 - Woke up with left eye blurred vision. This was gone next day. 01/19/2023 - Woke up with nausea and intestonal gas. Texted my Doctor about this repeat issue. Advised virtually that the latest Covid Booster is causing this. Told to treat with over the counter remedies. Symptoms gone next day. 01/20/2023 - Feeling well again.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Flatulence, Nausea, Pain in extremity, Vision blurred
Clinical narrative: 03/11/21 - slight headache rest of Day after shot. OK 04/04/21 - Same as above, OK NEXT DAY after shot. 12/16/21 - Same as above. 06/06/22 - Same as above.  *See Next page for last shot - issues. 01/04/2023 - 3rd Booster shot. After morning shot, headache in afternoon. Gone by evening. Arm sore. 01/06/2023 - Morning wake up with bad nausea. This lasted all day.  Barely ate anything all day, chills. Repeated diarrhea all day, along with severe tiredness. Joint pain. Rested all day. this was all gone by Next day. Arm sore.  01/10/2023 - Woke up with diarrhea and intestonal gas. Gone buy next day. 01/18/2023 - Woke up with left eye blurred vision. This was gone next day. 01/19/2023 - Woke up with nausea and intestonal gas. Texted my Doctor about this repeat issue. Advised virtually that the latest Covid Booster is causing this. Told to treat with over the counter remedies. Symptoms gone next day. 01/20/2023 - Feeling well again.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Cerebral haemorrhage, Cerebrovascular accident
Clinical narrative: APPROXIMATELY 9PM ON 9/22/22 IN THE EVENING AFTER COVID 19 BOOSTER SHOT, PATIENT, SUFFERED A BRAIN BLEED (STROKE). SUBSEQUENT TO HOSPITALIZATION, PATIENT TRANSFERRED TO REHABILITATION FOR 32 DAYS THEN HOME CARE FOR 10 DAYS, NOW IN OUTPATIENT PHYSICAL, SPEECH, AND OCCUPATIONAL THERAPY.
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was injected with an expired vial that had passed the 12 hour mark. No side effects reported as of today.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Haematochezia, Mucous stools, Occult blood positive
Clinical narrative: Blood and mucus in stool after event. I suspect that this is infant protein allergic colitis related to maternal soy ingestion, but given timing of event was within 24 hours of rotavirus vaccine, unable to rule this out as a cause at this time. No evidence of intussusception.
Age: 66.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Adverse event: inadvertently administered expired Hep A vaccine. APRN inadvertently administered an expired vaccine to her patient because she failed to verify the expiration date on the vaccine vial before administration. Patient was monitored for 15 minutes after administration and did not experiences any adverse reactions to vaccine.
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: patient was given moderna bivalent booster that was expired after the 12 hour expiration date. This has been reported to moderna. Case spoke with agent. Per agent states we must wait for moderna to contact us when patient is able to get revaccinated.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Engerix B 10mg birth to 19 years of age dosage form dispensed instead of adult dosing Engerix B 20mg
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administered vaccine that was drawn the day before and thus expired. no adverse effects seen at this time.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Was given 2nd bivalent vaccine, had one on 9/23/2022
Age: 45.0
Sex: M
Vaccine: COVID19-2
Symptoms: Anaemia, Laboratory test, Leukopenia, Pancytopenia, Platelet count decreased
Clinical narrative: Drastic reduction in White Blood cells and platelets. Some time of pancytopenia, leukopenia, or anemia.
Age: 45.0
Sex: M
Vaccine: COVID19-2
Symptoms: White blood cell count decreased
Clinical narrative: Drastic reduction in White Blood cells and platelets. Some time of pancytopenia, leukopenia, or anemia.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered.
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: NO EVENT
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest discomfort, Fatigue, Flatulence, Irritability, Malaise
Clinical narrative: pt says that after her bivalent moderna vaccine on 1/9/23 she started having post-nasal drip, heaviness in the chest, gas, irritability, exhaustion and  malaise. pt denies fever or chills
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Upper-airway cough syndrome
Clinical narrative: pt says that after her bivalent moderna vaccine on 1/9/23 she started having post-nasal drip, heaviness in the chest, gas, irritability, exhaustion and  malaise. pt denies fever or chills
Age: 28.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: swelling redness and warmth at injection site painful to the touch
Age: 44.0
Sex: M
Vaccine: PNC20
Symptoms: Blood glucose normal, Dizziness, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: Patient presented back to clinic from lab complaining of nausea and sweating following OV today. Patient had received 3 vaccines at end of OV, Prevnar 20, flu shot, and tdap. RN brought patient back to a private clinic room and performed vitals, blood pressure was 156/97, heart rate 86, respirations 20. Patient was visibly diaphoretic. Patient denied shortness of breath, chest pain, throat tightness, itching/rash.  Patient stated he hadn't had anything to eat or drink since dinner yesterday. Apple juice and cookies provided to patient. Patient ate cookies and drank juice, however he complained of feeling very warm, sweaty, and nauseated. Patient was laid down, cold cloth applied to forehead. Writer reviewed with Dr who ordered POC blood glucose and Zofran 8 mg oral disintegrating tablet now. While RN was getting Zofran, patient vomited. Blood glucose was checked, which was 99. Oral Zofran given per orders. After about 15 minutes blood pressure rechecked - 127/85, heart rate 65. Patient stated he was feeling better. Patient stated he no longer felt nauseated and his diaphoresis stopped. Patient was sat up and he walked with a steady gait over to a chair. Patient denied lightheadedness or nausea. Patient stated his only complaint is mild headache which was improving the longer he sat up. Dr assessed patient, noted reaction was likely from Prevnar vaccine. Patient stated he felt fine and that he was okay to drive. Emergency ER plan reviewed. Last blood pressure check 136/85. Patient was released from clinic and advised to call office with any further concerns. Patient agreed with plan. Allergy list updated.
Age: 44.0
Sex: M
Vaccine: PNC20
Symptoms: Laboratory test, Nausea, Vomiting
Clinical narrative: Patient presented back to clinic from lab complaining of nausea and sweating following OV today. Patient had received 3 vaccines at end of OV, Prevnar 20, flu shot, and tdap. RN brought patient back to a private clinic room and performed vitals, blood pressure was 156/97, heart rate 86, respirations 20. Patient was visibly diaphoretic. Patient denied shortness of breath, chest pain, throat tightness, itching/rash.  Patient stated he hadn't had anything to eat or drink since dinner yesterday. Apple juice and cookies provided to patient. Patient ate cookies and drank juice, however he complained of feeling very warm, sweaty, and nauseated. Patient was laid down, cold cloth applied to forehead. Writer reviewed with Dr who ordered POC blood glucose and Zofran 8 mg oral disintegrating tablet now. While RN was getting Zofran, patient vomited. Blood glucose was checked, which was 99. Oral Zofran given per orders. After about 15 minutes blood pressure rechecked - 127/85, heart rate 65. Patient stated he was feeling better. Patient stated he no longer felt nauseated and his diaphoresis stopped. Patient was sat up and he walked with a steady gait over to a chair. Patient denied lightheadedness or nausea. Patient stated his only complaint is mild headache which was improving the longer he sat up. Dr assessed patient, noted reaction was likely from Prevnar vaccine. Patient stated he felt fine and that he was okay to drive. Emergency ER plan reviewed. Last blood pressure check 136/85. Patient was released from clinic and advised to call office with any further concerns. Patient agreed with plan. Allergy list updated.
Age: 63.0
Sex: F
Vaccine: FLUR4
Symptoms: Extra dose administered
Clinical narrative: administered second flu block. Patient, however  received on  12/9/22. Patient was notified of med error as of today 1/25/23 no side effects.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Injection site pain
Clinical narrative: Head ache with sharp pains Neck and shoulder pain Swollen and soreness left underarm Fatigue  Light headed  Nausea
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Nausea, Neck pain
Clinical narrative: Head ache with sharp pains Neck and shoulder pain Swollen and soreness left underarm Fatigue  Light headed  Nausea
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Biopsy, Limb mass, Mantle cell lymphoma
Clinical narrative: About 2 months after the vaccine, patient developed a large lump under his right arm. On 01/24/2023, patient was diagnosed with Mantle Cell Lymphoma.  Pet Scan is scheduled for 01/27/2023. Chemotherapy will begin shortly thereafter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Headache, Magnetic resonance imaging, Migraine
Clinical narrative: Migranes started 8/7/2022 daily headaches continued until January 2023; slowly better January 2023
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head normal, Diplopia, Feeling abnormal, Head discomfort, Somnolence
Clinical narrative: At approximately 3:15 pm on  March 6, 2021  I was sitting on the couch and all of a sudden felt like something happened in my head and I was going cross eyed and double vision/impaired vision and thought I was going to black out, but after a minute started to get better. After which i felt i had to be very careful walking around like something was going to happen again in my head.. and I felt like i was groggy or in the fog for about 3 or 4 hours following the incident.  I was sure I had experienced a TIA because I never had anything like that happen in my life.