chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Pyrexia, Respiratory tract congestion, Rhonchi
Clinical narrative: Patient developed fever, myalgias and weakness for two days after the event, following this he felt mildly better but continued to have severe fatigue nasal congestion coughing and shortness of breath. I evaluated the patient on January 12 - 6 days after the vaccination, at which time he was still having cough, difficulty breathing, upper respiratory congestion.  He was afebrile but on exam had rhonchi in the lungs.  Ordered chest x-ray was stable.  COVID testing by PCR was negative.  Patient continued to improve with symptomatic therapy for the cough and congestion.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Patient developed fever, myalgias and weakness for two days after the event, following this he felt mildly better but continued to have severe fatigue nasal congestion coughing and shortness of breath. I evaluated the patient on January 12 - 6 days after the vaccination, at which time he was still having cough, difficulty breathing, upper respiratory congestion.  He was afebrile but on exam had rhonchi in the lungs.  Ordered chest x-ray was stable.  COVID testing by PCR was negative.  Patient continued to improve with symptomatic therapy for the cough and congestion.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anger, Feeling abnormal, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Irregularities in my menstrual cycle: I missed my period that comes exactly on time EVERY month like clockwork. I have never had a late or missed period so it was alarming. My period resumed the following month; however, it is now irregular and comes at varying days each month. It now comes during the first or second week of the month instead of at the last week of the month. Furthermore, my cycle no longer lasts 3 days, which was fantastic. Now, my period will start for a day or two, who knows?! And then it stops! For maybe a day or two or three, it?s a guessing game. But, it starts again, infuriatingly so and lasts a week! It?s heavy and long and so miserable. I?m absolutely irate and if I knew that this was a possibility, I would never have gotten the shots. No one mentioned this as a possible side effect and this was not informed consent. I?m angry that this has happened to me and I?m so grateful that I will not be having any more children, because family planning and tracking your cycle would be a nightmare in this situation.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dizziness, Nausea, Pain
Clinical narrative: Severe chills, dizziness, chest pain, palpitations, nausea, severe body aches
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Severe chills, dizziness, chest pain, palpitations, nausea, severe body aches
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing/static sound in ears, noticeable when things are fairly quiet. Always present for the last 3 months.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dyspnoea, Electrocardiogram, Exercise tolerance decreased
Clinical narrative: Extreme fatigue followed by shortness of breath, heart palpitations and elevated heart rate while moving. I can no longer exercise because of my heart.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased, Palpitations
Clinical narrative: Extreme fatigue followed by shortness of breath, heart palpitations and elevated heart rate while moving. I can no longer exercise because of my heart.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Urticaria
Clinical narrative: Urticaria, dermatographia
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Dermatitis contact, Erythema, Erythema multiforme, Mechanical urticaria
Clinical narrative: The morning of 1/8 I noticed my scalp was quite itchy, which continued throughout the day and got worse at night. I woke up at about 2am 1/9, itching like crazy. I had a rash around my torso and on my legs. I took Benadryl and went back to bed but woke up a few hours later and the rash had spread further. I went to urgent care and they diagnosed Contact Dermatitis and prescribed Prednisone and Hydrocortisone. Over the next couple days, my hands and feet began to swell badly and I developed a fever of 102 degrees F. on the morning of 1/11. At that point, I went to the ER and they did bloodwork (which came back normal) and diagnosed Erythema Multiforme. The swelling subsided after a couple of days and the itching has decreased but is still present. When I scratch my skin or apply sharp pressure, a red raised mark develops. I now recognize this as being dermatographia and it has been present from the first rash. I honestly didn't think this had anything to do with the vaccine until I was searching reddit for information about dermatographia and found that there were tons of people all talking about how they had just developed it 10 days after their Moderna booster with all the same symptoms that I had.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Pyrexia, Rash
Clinical narrative: The morning of 1/8 I noticed my scalp was quite itchy, which continued throughout the day and got worse at night. I woke up at about 2am 1/9, itching like crazy. I had a rash around my torso and on my legs. I took Benadryl and went back to bed but woke up a few hours later and the rash had spread further. I went to urgent care and they diagnosed Contact Dermatitis and prescribed Prednisone and Hydrocortisone. Over the next couple days, my hands and feet began to swell badly and I developed a fever of 102 degrees F. on the morning of 1/11. At that point, I went to the ER and they did bloodwork (which came back normal) and diagnosed Erythema Multiforme. The swelling subsided after a couple of days and the itching has decreased but is still present. When I scratch my skin or apply sharp pressure, a red raised mark develops. I now recognize this as being dermatographia and it has been present from the first rash. I honestly didn't think this had anything to do with the vaccine until I was searching reddit for information about dermatographia and found that there were tons of people all talking about how they had just developed it 10 days after their Moderna booster with all the same symptoms that I had.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: 1St Dose COVID 19 Vaccine Patient Fainted in chair 5 minutes after vaccine administered
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Condition aggravated, Death, Drug screen negative, Seizure
Clinical narrative: Death due to seizure
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Palpitations, Pyrexia
Clinical narrative: Headache, Fever & Palpitations Narrative:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Rash, Swelling face, Vomiting
Clinical narrative: SkinRash, NauseaVomiting, facial swelling Narrative:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Chronic obstructive pulmonary disease, Claustrophobia
Clinical narrative: she states that she had been having worsening cough and felt like she could not breathe at the time of presentation to triage.  She has been having fevers up to 102.  She is also having some nausea and vomiting though may be some soft stools but no frank diarrhea.  At the time of presentation in triage she was at 78% on 3 L and therefore was moved to the stable room.  BiPAP was attempted but the patient was able to tolerate it due to claustrophobia and therefore she was placed on nonrebreather.  Eventually this was able to be weaned to high flow nasal cannula, and as I see her now she is on 8 L per nasal cannula.  At the time of admission, the patient was expected to have an inpatient stay of equal to or greater than 2 midnights in the hospital.  Discharge occurred earlier than expected as the patient showed clinical improvement to treatment more quickly than anticipated. Acute on chronic hypoxic respiratory failure due to COPD and now Covid 19.  Patient insistent on discharge to home with home hospice.  She will be discharged to her home on hospice. 1/6 PROGRESS NOTE  Reiterated to them that patient is welcome to stay in the hospital and we will do everything we can to help her with medical treatments. The benefit of staying in the hospital is that she would get 24/7 care from Drs, nurses, respiratory therapists. If she still chooses to go home on Hospice that is her right but she would not get the best care at home if her goal is to recover from her illness. If her goal is to just be as comfortable as possible then going home may be best but by no means is this a choice we are forcing on her.   DISCHARGE DIAGNOSES: 1. Acute on chronic hypoxic respiratory failure 2. COVID-19 pneumonia 3. Acute exacerbation of COPD 4. T2DM 5. Transaminitis 6. HTN 7. Chronic LE edema 8. Depression, anxiety, schizoaffective 9. Chronic pain 10. Class III obesity
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Cough, Device intolerance, Dyspnoea, Faeces soft
Clinical narrative: she states that she had been having worsening cough and felt like she could not breathe at the time of presentation to triage.  She has been having fevers up to 102.  She is also having some nausea and vomiting though may be some soft stools but no frank diarrhea.  At the time of presentation in triage she was at 78% on 3 L and therefore was moved to the stable room.  BiPAP was attempted but the patient was able to tolerate it due to claustrophobia and therefore she was placed on nonrebreather.  Eventually this was able to be weaned to high flow nasal cannula, and as I see her now she is on 8 L per nasal cannula.  At the time of admission, the patient was expected to have an inpatient stay of equal to or greater than 2 midnights in the hospital.  Discharge occurred earlier than expected as the patient showed clinical improvement to treatment more quickly than anticipated. Acute on chronic hypoxic respiratory failure due to COPD and now Covid 19.  Patient insistent on discharge to home with home hospice.  She will be discharged to her home on hospice. 1/6 PROGRESS NOTE  Reiterated to them that patient is welcome to stay in the hospital and we will do everything we can to help her with medical treatments. The benefit of staying in the hospital is that she would get 24/7 care from Drs, nurses, respiratory therapists. If she still chooses to go home on Hospice that is her right but she would not get the best care at home if her goal is to recover from her illness. If her goal is to just be as comfortable as possible then going home may be best but by no means is this a choice we are forcing on her.   DISCHARGE DIAGNOSES: 1. Acute on chronic hypoxic respiratory failure 2. COVID-19 pneumonia 3. Acute exacerbation of COPD 4. T2DM 5. Transaminitis 6. HTN 7. Chronic LE edema 8. Depression, anxiety, schizoaffective 9. Chronic pain 10. Class III obesity
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Nausea, Oedema peripheral, Positive airway pressure therapy, Pyrexia
Clinical narrative: she states that she had been having worsening cough and felt like she could not breathe at the time of presentation to triage.  She has been having fevers up to 102.  She is also having some nausea and vomiting though may be some soft stools but no frank diarrhea.  At the time of presentation in triage she was at 78% on 3 L and therefore was moved to the stable room.  BiPAP was attempted but the patient was able to tolerate it due to claustrophobia and therefore she was placed on nonrebreather.  Eventually this was able to be weaned to high flow nasal cannula, and as I see her now she is on 8 L per nasal cannula.  At the time of admission, the patient was expected to have an inpatient stay of equal to or greater than 2 midnights in the hospital.  Discharge occurred earlier than expected as the patient showed clinical improvement to treatment more quickly than anticipated. Acute on chronic hypoxic respiratory failure due to COPD and now Covid 19.  Patient insistent on discharge to home with home hospice.  She will be discharged to her home on hospice. 1/6 PROGRESS NOTE  Reiterated to them that patient is welcome to stay in the hospital and we will do everything we can to help her with medical treatments. The benefit of staying in the hospital is that she would get 24/7 care from Drs, nurses, respiratory therapists. If she still chooses to go home on Hospice that is her right but she would not get the best care at home if her goal is to recover from her illness. If her goal is to just be as comfortable as possible then going home may be best but by no means is this a choice we are forcing on her.   DISCHARGE DIAGNOSES: 1. Acute on chronic hypoxic respiratory failure 2. COVID-19 pneumonia 3. Acute exacerbation of COPD 4. T2DM 5. Transaminitis 6. HTN 7. Chronic LE edema 8. Depression, anxiety, schizoaffective 9. Chronic pain 10. Class III obesity
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory failure, SARS-CoV-2 test positive, Transaminases increased, Vomiting
Clinical narrative: she states that she had been having worsening cough and felt like she could not breathe at the time of presentation to triage.  She has been having fevers up to 102.  She is also having some nausea and vomiting though may be some soft stools but no frank diarrhea.  At the time of presentation in triage she was at 78% on 3 L and therefore was moved to the stable room.  BiPAP was attempted but the patient was able to tolerate it due to claustrophobia and therefore she was placed on nonrebreather.  Eventually this was able to be weaned to high flow nasal cannula, and as I see her now she is on 8 L per nasal cannula.  At the time of admission, the patient was expected to have an inpatient stay of equal to or greater than 2 midnights in the hospital.  Discharge occurred earlier than expected as the patient showed clinical improvement to treatment more quickly than anticipated. Acute on chronic hypoxic respiratory failure due to COPD and now Covid 19.  Patient insistent on discharge to home with home hospice.  She will be discharged to her home on hospice. 1/6 PROGRESS NOTE  Reiterated to them that patient is welcome to stay in the hospital and we will do everything we can to help her with medical treatments. The benefit of staying in the hospital is that she would get 24/7 care from Drs, nurses, respiratory therapists. If she still chooses to go home on Hospice that is her right but she would not get the best care at home if her goal is to recover from her illness. If her goal is to just be as comfortable as possible then going home may be best but by no means is this a choice we are forcing on her.   DISCHARGE DIAGNOSES: 1. Acute on chronic hypoxic respiratory failure 2. COVID-19 pneumonia 3. Acute exacerbation of COPD 4. T2DM 5. Transaminitis 6. HTN 7. Chronic LE edema 8. Depression, anxiety, schizoaffective 9. Chronic pain 10. Class III obesity
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Suicidal ideation
Clinical narrative: INCREASED SUICIDAL THOUGHTS; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: congestive heart disease, penicillin allergy, sulfa allergy, and oxycontin allergy. The patient previously received mrna 1273 (Moderna first dose, Dose number in series was 1) (form of admin, route of admin were not reported and batch number: 045A21A, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. Patient did not get a second dose of Moderna. No adverse events reported after taking MRNA 1273 (Moderna First dose) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series was 2) (suspension for injection, route of admin not reported, batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, 1 total, administered on 20-MAR-2021 on left deltoid for prophylactic vaccination which was an off label use and inappropriate schedule of vaccine administered. Patient had chest pain following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series was 3) (suspension for injection, intramuscular, batch number: 211A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 01-NOV-2021 on right deltoid for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in DEC-2021, the patient had increased suicidal thoughts after receiving the booster, started in December and a little bit this month (January). The patient added that she had no plans of acting out these thoughts, did not own a gun, would not cut herself or was not planning to drive her car to hurt herself. It was confirmed with the patient that she had the ability to call emergency services if needed. The consumer stated that she has stopped having suicidal thoughts a couple of days ago (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from increased suicidal thoughts on JAN-2022. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20210426651.; Sender's Comments: V0: 20220110268-covid-19 vaccine ad26.cov2.s- increased suicidal thoughts. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, COVID-19, Heart rate, Heart rate abnormal
Clinical narrative: gave me a very bad heart inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient received BNT162B2 (BNT162B2) as dose 2, single and as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "gave me a very bad heart inflammation".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: gave me a very bad heart inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient received BNT162B2 (BNT162B2) as dose 2, single and as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "gave me a very bad heart inflammation".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: gave me a very bad heart inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient received BNT162B2 (BNT162B2) as dose 2, single and as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "gave me a very bad heart inflammation".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Chills, Cough
Clinical narrative: pt with DM; tested positive for COVID a few days before a hospital admission; pt c/o loss of appetite, cough, headache, dizziness, dyspnea, chills; hyperglycemic; started on insulin drip; chest x ray shows COVID pneumonia; treated with O2 supplementation, Vitamins C and D, zinc, steroids, remdesivir, n-acetylcysteine; currently DKA; pt's condition continued to deteriorate and he died in the hospital
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Decreased appetite, Diabetic ketoacidosis, Dizziness, Dyspnoea
Clinical narrative: pt with DM; tested positive for COVID a few days before a hospital admission; pt c/o loss of appetite, cough, headache, dizziness, dyspnea, chills; hyperglycemic; started on insulin drip; chest x ray shows COVID pneumonia; treated with O2 supplementation, Vitamins C and D, zinc, steroids, remdesivir, n-acetylcysteine; currently DKA; pt's condition continued to deteriorate and he died in the hospital
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: General physical health deterioration, Headache, Hyperglycaemia, SARS-CoV-2 test positive
Clinical narrative: pt with DM; tested positive for COVID a few days before a hospital admission; pt c/o loss of appetite, cough, headache, dizziness, dyspnea, chills; hyperglycemic; started on insulin drip; chest x ray shows COVID pneumonia; treated with O2 supplementation, Vitamins C and D, zinc, steroids, remdesivir, n-acetylcysteine; currently DKA; pt's condition continued to deteriorate and he died in the hospital
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Condition aggravated, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: 12/15/21 presents to ED for "fever". PMHx of "seizures on Keppra, Covid positive, CAD, and CVAs with aphasia"
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea, SARS-CoV-2 test negative, Urticaria, Vomiting
Clinical narrative: Patient has complained of headaches and hives  intermittently since 1/1/2022
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Urticaria
Clinical narrative: Patient has complained of headaches and hives  intermittently since 1/1/2022
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Cough, Decreased appetite, Dizziness, Dyspnoea
Clinical narrative: fever, fatigue, dizzy, nausea, sleepy, achy all over, abd pain, short of breath and weakness with cough.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Sinus disorder
Clinical narrative: fever, fatigue, dizzy, nausea, sleepy, achy all over, abd pain, short of breath and weakness with cough.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: fever, fatigue, dizzy, nausea, sleepy, achy all over, abd pain, short of breath and weakness with cough.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Asthenia, Cough, Dizziness, Dyspnoea
Clinical narrative: fever, fatigue, dizzy, nausea, sleepy, achy all over, abd pain, short of breath and weakness with cough.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Nausea, Pain, Pyrexia, Somnolence
Clinical narrative: fever, fatigue, dizzy, nausea, sleepy, achy all over, abd pain, short of breath and weakness with cough.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Hospitalized, COVID-19 positive.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Dehydration, Dizziness, Electrocardiogram normal, Headache
Clinical narrative: First adverse event - Syncope the day following the vaccination, ie Jan 9, 2021.  Seen in ER, EKG and labs normal, dx was syncope and dehydration.  FU at my office ( Family Medicine) and normal exam. No additional workup. More important adverse event - Chest pain on Sunday Jan 16, 2022 eight days after vaccination.  Seen at my office with left upper chest pain reproducible to palpation but slightly abnormal EKG (T waves 1-2mm elevation in V2 and V3) and abnormal troponin (0.17 with normal <0.03).
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Syncope
Clinical narrative: First adverse event - Syncope the day following the vaccination, ie Jan 9, 2021.  Seen in ER, EKG and labs normal, dx was syncope and dehydration.  FU at my office ( Family Medicine) and normal exam. No additional workup. More important adverse event - Chest pain on Sunday Jan 16, 2022 eight days after vaccination.  Seen at my office with left upper chest pain reproducible to palpation but slightly abnormal EKG (T waves 1-2mm elevation in V2 and V3) and abnormal troponin (0.17 with normal <0.03).
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dehydration, Electrocardiogram, Laboratory test, Palpitations
Clinical narrative: First adverse event - Syncope the day following the vaccination, ie Jan 9, 2021.  Seen in ER, EKG and labs normal, dx was syncope and dehydration.  FU at my office ( Family Medicine) and normal exam. No additional workup. More important adverse event - Chest pain on Sunday Jan 16, 2022 eight days after vaccination.  Seen at my office with left upper chest pain reproducible to palpation but slightly abnormal EKG (T waves 1-2mm elevation in V2 and V3) and abnormal troponin (0.17 with normal <0.03).
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Syncope, Troponin increased
Clinical narrative: First adverse event - Syncope the day following the vaccination, ie Jan 9, 2021.  Seen in ER, EKG and labs normal, dx was syncope and dehydration.  FU at my office ( Family Medicine) and normal exam. No additional workup. More important adverse event - Chest pain on Sunday Jan 16, 2022 eight days after vaccination.  Seen at my office with left upper chest pain reproducible to palpation but slightly abnormal EKG (T waves 1-2mm elevation in V2 and V3) and abnormal troponin (0.17 with normal <0.03).
Age: 10.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received an adult Pfizer Covid 19 vaccine, despite being 10 years old. After realizing the incorrect dose was given, the pediatrician was contacted. Upon follow up with the patient's mother she noted the patient was having a fever and very lethargic.
Age: 10.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Lethargy, Pyrexia
Clinical narrative: Patient received an adult Pfizer Covid 19 vaccine, despite being 10 years old. After realizing the incorrect dose was given, the pediatrician was contacted. Upon follow up with the patient's mother she noted the patient was having a fever and very lethargic.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Chest pain, Echocardiogram normal, Tachycardia, Troponin increased
Clinical narrative: 10 mins after receiving son stated he started feeling funny. He became tired and achy all over. The next day his body was hurting and he was complaining of chest pains and headaches. A couple days later he was still having chest pains. Was taken to the ER.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest pain, Computerised tomogram, Echocardiogram, Electrocardiogram
Clinical narrative: 10 mins after receiving son stated he started feeling funny. He became tired and achy all over. The next day his body was hurting and he was complaining of chest pains and headaches. A couple days later he was still having chest pains. Was taken to the ER.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Pain
Clinical narrative: 10 mins after receiving son stated he started feeling funny. He became tired and achy all over. The next day his body was hurting and he was complaining of chest pains and headaches. A couple days later he was still having chest pains. Was taken to the ER.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product prescribing issue
Clinical narrative: No other AE; his doctor prescribed him GARDASIL 9; Information was received from a 56 year old male patient referring to himself. Information regarding concomitant medication, medical history and current condition was not provided.  On 01-JUN-2021, his doctor prescribed him hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dosage, frequency, lot # and expiration date were not reported) for prophylaxis (product prescribing issue). The patient had been unable to locate a pharmacy or healthcare provider that would administer the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). He had not had any doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No adverse event.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 19 years old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported. On 21-APR-2021 the patient was vaccinated with first dose of hepatitis A vaccine, inactivated (VAQTA) (once, lot # T023913, expiration date 31-MAR-2022; route was not reported) for prophylaxis. The patient was now back to receive his second dose of hepatitis A vaccine, inactivated (VAQTA), but the patient was now 19. The HCP was asking if a 19 years old patient can receive two pediatric doses of hepatitis a vaccine, inactivated (VAQTA) 0.5mL today (11-NOV-2022) and it counted as a valid adult dose. AE filed due to possibility that 19 years old patient may receive two hepatitis A vaccine, inactivated (VAQTA) 0.5mL pediatric doses on the same day to count as an adult second dose (circumstance or information capable of leading to medication error, product administered to patient of inappropriate age). Second dose/doses of hepatitis A vaccine, inactivated (VAQTA) had not been administered to patient. No additional AE reported.
Age: 36.0
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No other adverse event; Received the first dose on 09-SEP-2021 and second dose on 05-OCT-2021; Patient received first dose of M-M-R II vaccine at 36 years of age; This spontaneous report was received from a registered nurse, and refers to a 36 year old patient. The patient's pertinent medical history, drug reactions, allergies, and concomitant medications were not provided.  On 09-SEP-2021, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and dose 2 was administered on 05-OCT-2021 (Inappropriate schedule of product administration) as prophylaxis (lot#, expiration date, dose, anatomical location and route of administration were not provided).  On 09-SEP-2021, the patient received the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) at 36 years of age (Product administered to patient of inappropriate age). No other adverse event occurred and no further information provided.
Sex: M
Vaccine: MMR
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID; This spontaneous report was received from a healthcare business professional referring to a male patient of unknown age. Patient's concurrent conditions, medical history and concomitant medications were refused to be provided.  On an unknown date the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (Lot # and expiration date and anatomical location were not provided) for prophylaxis.  Reporter stated the patient was scheduled to get the second shot of vaccine to go to school but on 06-JAN-2022, the patient tested positive for COVID. No additional AE. No PQC.  The outcome and causality were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Angina pectoris, Dizziness, Heart rate, Heart rate increased, Malaise
Clinical narrative: HEART HURTS; FAST HEART BEAT; REALLY DIZZY; REALLY SICK; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported 1 total for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient had fast heart beat and like the patient's heart hurts and stuff. The patient knew should have gone to the doctor but patient did not. Patient was wondering if it would be like safe to get the booster then based on that like patient did not get like any permanent side effects but other than like the heart beat the patient was like really really dizzy and felt like really sick. The patient had a question about getting the booster shot. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) fast.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fast heart beat, heart hurts, really dizzy and really sick was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220123758-COVID-19 VACCINE AD26.COV2.S-heart hurts. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Localised oedema, Memory impairment
Clinical narrative: I got a brain bleed; I did get a bump on the head around that same time; My memory is worse, since the brain bleed; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (I got a brain bleed) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Dementia since an unknown date.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced CEREBRAL HAEMORRHAGE (I got a brain bleed) (seriousness criterion medically significant), LOCALISED OEDEMA (I did get a bump on the head around that same time) and MEMORY IMPAIRMENT (My memory is worse, since the brain bleed). At the time of the report, CEREBRAL HAEMORRHAGE (I got a brain bleed), LOCALISED OEDEMA (I did get a bump on the head around that same time) and MEMORY IMPAIRMENT (My memory is worse, since the brain bleed) outcome was unknown.            No concomitant medication reported. No Treatment Medication reported.  Patient got a brain bleed, about a month after the shots, He also got a bump on his head around that same time. A board dropped on his head around the same time, about a month, or more, before the last shot. His memory was worse, since the brain bleed. he also mentioned a history of dementia in his  family. He thought that the board caused the brain bleed. He received the shots 6-7 months ago.  Company Comment  This case concerns a 79-year-old male patient with a relevant medical history of head injury with a board, who experienced the serious unexpected (AESI) of Cerebral Haemorrhage. The event occurred after an unspecified dose of mRNA-1273 vaccine. (Date of vaccination not provided). The medical history of head injury with a board is a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting as / medically significant and retained for consistency with the RA report.; Sender's Comments: This case concerns a 79-year-old male patient with a relevant medical history of head injury with a board, who experienced the serious unexpected (AESI) of Cerebral Haemorrhage. The event occurred after an unspecified dose of mRNA-1273 vaccine. (Date of vaccination not provided). The medical history of head injury with a board is a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting as / medically significant and retained for consistency with the RA report.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: I lost my sense of smell before the booster; I lost my sense of taste before the booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ANOSMIA (I lost my sense of smell before the booster) and AGEUSIA (I lost my sense of taste before the booster) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANOSMIA (I lost my sense of smell before the booster) and AGEUSIA (I lost my sense of taste before the booster). At the time of the report, ANOSMIA (I lost my sense of smell before the booster) and AGEUSIA (I lost my sense of taste before the booster) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  Company comment : This case concerns a 67-year-old male patient with no medical history, who experienced the unexpected non-serious adverse events of special interest, Anosmia and Ageusia. The events occurred on an unknown interval after receiving the second dose of mRNA-1273. The rechallenge was not applicable since events intervals are unknown. No other clinical or treatment details were given. It was reported that the outcome of the events has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.    This case was linked to MOD-2022-440979 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jan-2022: Follow-up information included no new information.; Sender's Comments: This case concerns a 67-year-old male patient with no medical history, who experienced the unexpected non-serious adverse events of special interest, Anosmia and Ageusia. The events occurred on an unknown interval after receiving the second dose of mRNA-1273. The rechallenge was not applicable since events intervals are unknown. No other clinical or treatment details were given. It was reported that the outcome of the events has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Troponin
Clinical narrative: symptoms were numbness in his left arm and pain in the chest / Myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (symptoms were numbness in his left arm and pain in the chest / Myocarditis) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050F21A and 045C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, the patient experienced MYOCARDITIS (symptoms were numbness in his left arm and pain in the chest / Myocarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 17-Sep-2021 to 19-Sep-2021 due to MYOCARDITIS. The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 18-Nov-2021, MYOCARDITIS (symptoms were numbness in his left arm and pain in the chest / Myocarditis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Troponin: high (High) Troponin elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Treatment medications included unspecified blood thinner.  The patient called to report that he had myocarditis after getting the second dose of the Moderna Covid-19 vaccine. His symptoms were pain in the chest, numbness in his left arm.. Lab results included, troponin elevated. He was told that he has myocarditis when the lab results came in. Patient was hospitalized from 17-Sep-2021 to 19-Sep-2021.  Company Comment: This case refers to a 29-year-old male patient with no known medical history who experienced the expected event of Myocarditis approximately 4 days after the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case refers to a 29-year-old male patient with no known medical history who experienced the expected event of Myocarditis approximately 4 days after the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. The vials were placed in refrigerator on 6-Dec-2021.  It was reported that patient took booster dose.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain, Pain in extremity, Peripheral swelling, Sciatica
Clinical narrative: Hurt and swollen arm; had some pain with prior doses but nothing compared to this; Injection site is hot at touch; Patient's left arm hurts; scoliosis pain 24x7; sciatic pain; back pain 24/7; This spontaneous case was reported by a non-health professional and describes the occurrence of PERIPHERAL SWELLING (Hurt and swollen arm), PAIN (had some pain with prior doses but nothing compared to this), VACCINATION SITE WARMTH (Injection site is hot at touch), PAIN IN EXTREMITY (Patient's left arm hurts) and SCOLIOSIS (scoliosis pain 24x7) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sciatica (Pain medication is used) and Walking difficulty. Concurrent medical conditions included Scoliosis (Pain medication is used).   On 24-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Hurt and swollen arm), PAIN (had some pain with prior doses but nothing compared to this), VACCINATION SITE WARMTH (Injection site is hot at touch), PAIN IN EXTREMITY (Patient's left arm hurts), SCOLIOSIS (scoliosis pain 24x7), SCIATICA (sciatic pain) and BACK PAIN (back pain 24/7). At the time of the report, PERIPHERAL SWELLING (Hurt and swollen arm), PAIN (had some pain with prior doses but nothing compared to this), VACCINATION SITE WARMTH (Injection site is hot at touch), PAIN IN EXTREMITY (Patient's left arm hurts), SCOLIOSIS (scoliosis pain 24x7), SCIATICA (sciatic pain) and BACK PAIN (back pain 24/7) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   NO concomitant medication reported.  Patient is on Pain medication for scoliosis & sciatic pain.
Sex: F
Vaccine: COVID19
Symptoms: Scoliosis, Vaccination site warmth
Clinical narrative: Hurt and swollen arm; had some pain with prior doses but nothing compared to this; Injection site is hot at touch; Patient's left arm hurts; scoliosis pain 24x7; sciatic pain; back pain 24/7; This spontaneous case was reported by a non-health professional and describes the occurrence of PERIPHERAL SWELLING (Hurt and swollen arm), PAIN (had some pain with prior doses but nothing compared to this), VACCINATION SITE WARMTH (Injection site is hot at touch), PAIN IN EXTREMITY (Patient's left arm hurts) and SCOLIOSIS (scoliosis pain 24x7) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sciatica (Pain medication is used) and Walking difficulty. Concurrent medical conditions included Scoliosis (Pain medication is used).   On 24-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Hurt and swollen arm), PAIN (had some pain with prior doses but nothing compared to this), VACCINATION SITE WARMTH (Injection site is hot at touch), PAIN IN EXTREMITY (Patient's left arm hurts), SCOLIOSIS (scoliosis pain 24x7), SCIATICA (sciatic pain) and BACK PAIN (back pain 24/7). At the time of the report, PERIPHERAL SWELLING (Hurt and swollen arm), PAIN (had some pain with prior doses but nothing compared to this), VACCINATION SITE WARMTH (Injection site is hot at touch), PAIN IN EXTREMITY (Patient's left arm hurts), SCOLIOSIS (scoliosis pain 24x7), SCIATICA (sciatic pain) and BACK PAIN (back pain 24/7) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   NO concomitant medication reported.  Patient is on Pain medication for scoliosis & sciatic pain.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were reported. The vials were placed in the refrigerator on 6 Dec 2021.