chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unexpected, spontaneous cardiac arrest 16 days following Moderna COVID shot 1. Witnessed by myself (spouse), called 911, performed CPR until police and EMS arrived. Shocked 3 times, intubated, placed on maximum pressors with BP no higher than 50/30 for nearly a day. Resulted in subsequent multi-organ anoxic injury - many GI issues, 3 brain bleeds, multiple mini-strokes, acidosis, acute kidney failure, among the many issues. Cardiac arrest cause never determined. Prognosis for survival initially poor. One month in ICU followed by 2 weeks in specialty care hospital, then 2 weeks in inpatient rehab hospital. Slowly continues to recover. Still treated for low iron, extreme fatigue, two frozen shoulders and anoxic neurologic issues in right arm/hand and right lower leg and both feet.  Has a large, scarred over injury on scalp that was a "bed sore" injury that will never heal as the hair follicles are now scarred over. On multiple medications including carvedilol, Entresto, spironolactone, iron, multivitamins, B12, calcium/vit D, metformin, sitagliptan, empagliflozin, glimiperimide, rosuvastatin, probiotics, fexofenadine, mometasone, folic acid, gabapentin. DVT of right thigh occurred while in the hospital requiring an ICT filter (subsequently removed).  Pt now has an implantable defibrillator.  After much consultation, she received a second COVID vaccine shot - this time Pfizer lot 320308D - on November 11, 2021.  Pt experienced racing and thudding heart on November 12 for about "5 seconds", then pulse when back to normal feeling.  Cardiologist later revealed her defibrillator registered a 10 second ventricular tachycardia on that day that resolved on it's own without any pacing intervention of the defibrillator device.  On April 10 and 11, 2021, Pt had three shockable ventricular fibrillation episodes.
Initial information received on 17-Aug-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 4 months old female patient who was vaccinated with Dtap-IPV portion (0.5 ml second dose) of PENTACEL (lot C5455AA and expiry date: 18-Dec-2018) in the right thigh (route of administration were not reported) on 24-Jul-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal 13 Valent Vaccine for Immunisation; and Rubella Vaccine  for Immunisation on an unknown date. It was a case of actual medication error due to inappropriate reconstitution technique because child received Dtap-IPV but not the HIB of vaccine. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: None.
Close to 12 hours after receiving both vaccines, I experienced a need to void several times within an hour which was UNUSUAL for me, then experienced SEVERE chills another UNUSUAL occurrence for me, was able to warm up with extra clothing & sleep, (tho up once or twice more during the night to void & drink water feeling pretty unsteady while walking to the bathroom ~ another UNUSUAL for me), then when leaving the bathroom the following AM (about 19 hours after receiving the vaccinations) I fainted (& whacked my head on the wood frame of my bed which I could hear).  My husband waited about 10 sec before finding me prone on the floor ~ I could answer him & he helped me up to sitting on edge of bed.  He then took my b/p which was 81/53 on an automated arm cuff, pulse was 99.  I was pretty sure I had gotten dehydrated by voiding so much.
Sore arm; Fatigue; Headache; Back ache; This is a spontaneous report from a non-contactable consumer, the patient. A 29-years-old non-pregnant female patient received unspecified dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP-6955) via an unspecified route of administration in the arm right on 31Mar2021 at 12:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The relevant medical history was not reported. The concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 10:00 the patient experienced sore arm, fatigue, headache and back ache. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event sore arm, fatigue, headache and back ache was recovered on unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Influenza B-strain/influenza A-strain; This is a spontaneous case reported by physician to agency (reference number: SEQ20-00662) and initially received on 18-Feb-2020, concerning a 18-year-old, male patient.  The patient's relevant medical history and concomitant medications were not reported.   On 08-Oct-2019, the patient was administered Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, batch number: 261207, expiration date: Jun-2020 and anatomical location: not reported,) for prevention of seasonal influenza.  On 10-Jan-2020, 3 months and 2 days after the vaccination, the patient was diagnosed with influenza, B-strain.  On an unspecified date, after the first time the patient was diagnosed with influenza Tamiflu (oseltamivir) was prescribed.  On 12-Feb-2020, 4 months and 4 days after the vaccination, the patient was admitted to accidents and emergency (A&E) two times in that day, with abdominal pains, severe throat pain, difficulty swallowing, fever and chills. The patient was diagnosed with influenza A-strain.  At the time of this report, the patient had not recovered from the event of 'flu', it was reported that the patient was still sick with influenza.  The events of 'flu' was considered as serious due to criterion of medical significance.  The reporter did not provide causality assessment to Flucelvax Quadrivalent.  Company comment: The patient experienced influenza 3 months and 2 days after vaccination with the suspect product, Flucelvax Quadrivalent. Chronology is plausible. No medical history, concomitant medications and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the event is assessed as related.; Sender's Comments: The patient experienced influenza 3 months and 2 days after vaccination with the suspect product, Flucelvax Quadrivalent. Chronology is plausible. No medical history, concomitant medications and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the event is assessed as related.
not able to move her head; achiness throughout her body; headache; myalgia; Initial information received on 12-Dec-2019 regarding an unsolicited valid serious case received from a physician.  This case involves a 77 years old female patient who experienced serious headache (headache), achiness throughout her body (pain), myalgia (myalgia ) and not able to move her head (musculoskeletal stiffness), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination(s) included FLUZONE HIGH DOSE and was tested positive for A influenza one month after the vaccine. Family history were not provided. At the time of the event, the patient had ongoing Hypothyroidism and Type IIa hyperlipidaemia.  On an unknown date (about 2 weeks ago), the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient developed a serious headache, achiness throughout her body (pain), same day post vaccination. On an unspecified date, patient developed a serious myalgia and not able to move her head (musculoskeletal stiffness) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized for this event.  The headache continued to progress in severity, rating it an 11 on a 0-10 scale.  Relevant laboratory test results included: Computerised tomogram - On an unknown date:  [negative for aneurysm or stroke]  Final diagnosis was not able to move her head, myalgia, achiness throughout her body and headache.  It was not reported if the patient received a corrective treatment.  On an unknown date, the event outcome is reported as Recovered for headache and General body pain,  Patient was not yet recovered from myalgia and outcome was not reported for Stiff neck.; Sender's Comments: This case involves a 77 years old female patient who experienced serious headache, General body pain, myalgia and stiff neck ,while she received vaccine FLUZONE HIGH DOSE. Time to onset is unknown. Moreover, further information including concomitant medications and lab tests excluding other etiology would be needed to fully assess this case. Based on available information, the role of the vaccine cannot be assessed.
Started with extreme fatigue on April 6, 2021 at 2 pm. On April 6, 2021 at 8 pm my stomach and right side started to feel horrible. I felt and continue to feel right side stomach ache and nausea. Started a full headache on April 7, 2021 at 430 pm.
Vision loss, hearing loss, muscle control loss and fell over. Thought I was dying. Feel better now after breathing and trying to call myself down as it panicked me. Cuts and scrapes on hand and knee and elbow from falling. Scary as luckily I made it home driving ok.
Immediate blanching and erythema at injection site. Lasted several days, residual nodule.
This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a unk patient who received BOOSTRIX (batch number AC52B099AA, expiry date 19th January 2015). On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information: the reporter did not know the patient's DOB, sex or initials.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021 at 11:44 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Jan-2021 at 11:44 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 83.30. No concomitant medications were reported. On 12-Jan-2021, excursion time was 08:00 AM temperature was 34 and at 09:00 PM, condition of vaccine prior to administration was not frozen. The vial was initially moved to the fridge on 08-Jan-2021 and beyond use date was 07-Feb-2021. The vials were only punctured right before administration. Temperature recordings were taken using a  temperature monitor at every hour. The patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
body ache; felt tired/body ache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache) and FATIGUE (felt tired/body ache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F3H1) for COVID-19 vaccination.     Concurrent medical conditions included Diuretic effect and Blood pressure high. Concomitant products included LISINOPRIL for Blood pressure high, HYDROCHLOROTHIAZIDE for Diuretic effect.   On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced MYALGIA (body ache) and FATIGUE (felt tired/body ache). At the time of the report, MYALGIA (body ache) and FATIGUE (felt tired/body ache) had resolved.      No treatment medications were provided. Patient stated that symptoms have resolved since I called.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Follow up received contains events Outcome updated and email address of reporter.
Fever.  Sick for 5 days.  Sore arm for a week.
Information has been received from a physician concerning a 12 month old male with no pre-existing allergies, or medical conditions who on 29-AUG-2007 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). Within four weeks of vaccination with varicella virus vaccine live (Oka/Merck, the patient also received the following vaccinations, on unspecified dates: Hib conj vaccine (unspecified carrier) and measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/30 (manufacturer unknown). On 07-SEP-2007, the patient developed a fever and a varicella rash. The reporter noted that the patient's mother was 12-16 weeks pregnant at the time. Mother has received Varicella Zoster Immune Globulin (VZIG). The patient was recovered at the time of reporting. Additional information is not expected.
Injection site is very sore; arm swelling; fatigue; This is a spontaneous report from a contactable Physician (patient). A 34-year-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9321), via an unspecified route of administration on 06Jan2021 at 08:00 at single dose in left arm for covid-19 immunization. There were no medical history or concomitant medications. The patient experienced injection site was very sore, arm swelling, and fatigue on 06Jan2021 at 08:00. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient had not been tested for COVID-19 since vaccination. The outcome of the events was resolving.
ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY 5/3/2023 GERD (GASTROESOPHAGEAL REFLUX DISEASE) ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 4/18/2023 GERD (GASTROESOPHAGEAL REFLUX DISEASE)
I got a full body rash that lasted for 30 days. I also had SOB. My doctor gave me steroid, cream and itchy medicine. Then Jan 5th, I tested positive for COVID-19. I had running nose, weakness, chills, chest pressure and difficult breathing. I went to the doctor about it. They did a chest x-ray and blood work, showed that my WBC was severely low. I also had diarrhea for about 10 days. Then I got rash again that lasted for about 10 to 15 days.
At midnight following vaccination developed severe chills, body aches, headache, and cough that lasted until 9:00 AM.  General aches and headache continued the next several hours.
I started feeling tired at first with shortness of breath. The shortness of breath was my worse symptom. I took a COVID-19 test that was positive. My symptoms progressed to fatigue, pressure on my chest, body aches, and fever. My symptoms lasted for approximately 3 weeks. I went to an emergency room because I was so sick on 6/9/2022 and I was prescribed a cold and flu medication that did not help. I did not work from 6/7/2022 until 6/17/2022. I still have lingering affects of chest heaviness, shortness of breath, and fatigue.
This spontaneous consumer report (initial receipt date 11-JUL-2011) concerns a 64-year old male patient. Concomitant medication included omeprazole, esomeprazole, metoprolol, trazodone, codaine phosphate; paracetamol combination and other unspecified medication. There were no known drug reactions or allergies. On 30-Sep-2009 the patient received a 0.5mL dose of AFLURIA (batch: 075491111A) by intra-muscular injection for influenza prevention. On 30-Sep-2009, since the patient had received the vaccine, he remained sick. He experienced pain throughout his body, mostly in the stomach. He said his physicians believed that the sickness was a coincidence and that the pain was acid reflux. The patient was hospitalised for the event (went to the emergency room for 5 hours after receiving his shot on 30-SEP-2009). Diagnostic tests have included CAT (computerized axial tomography) scans, stool samples taken, MRI's (magnetic resonance imaging), x-rays, EKG's (electrocardiographs) and other unspecified tests. The patient had his gall bladder removed around Jun-2011. The patient outcome is not recovered.
Extreme fatigue, considerable head congestion, sore throat, lots of fever blisters developed on mouth
Fine through the day except sore arm. Less sore this time than first shot. Arm sore at night, slightly restless night, less sore this time and subsided by dawn. Mild flu like symptoms next day, nausea, fever, pain in calf muscles and around hip peaking in afternoon. In bed 2-3 hrs through afternoon; preferred not to move around. 10 hr sleep night of day-02. Body returned to normal when awake.
Following administration of Influenza vax, pt devel pain @ inject site which persisted for one day;
sinus headache; Headache; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a 76-year-old male patient (husband) received BNT162B2 (COVID-19 VACCINE, Batch/lot number: EL1283) on 19Jan2021 at about 10:30 AM on Arm Left for covid-19 immunization. Medical history was ongoing chronic sinusitis. Concomitant drug was warfarin. Reported that both her and her husband had a headache all day long after receiving the COVID-19 Vaccine. She said her husband believes his headache was from the COVID-19 Vaccine. Reported her husband developed a headache during his sleep the night of receiving the COVID-19 Vaccine. She said her husband and her have chronic sinusitis. She said her husband's headache went away after he started moving around. She said because of having other conditions, her husband's headache was worse than with only his sinus issues. She clarified his whole head hurt. She said his headache was not a frontal headache like a person may get from their sinuses. Reported her husband thinks the COVID-19 Vaccine contributed to his headache, because his headache was a little different from what he normally experiences. She said his headache only lasted 1 day. She clarified her husband had a little sinus headache this morning. She said he blows his nose, and the headache goes away. She said his headache was short lived after getting the COVID-19 Vaccine. She said both her husband's and her headaches were mild. Outcome of the event headache was Recovered on 20Jan2021, for sinus headache was unknown. Reporter considered Related causality.  No follow-up attempts possible. No further information expected.
On 4/19/01 had a little cough with a runny nose off and on throughout the day and progressed to a labored breathing with an asthmatic-like cough (deep, barking, croupy cough). On 4/20/01 couldn't catch breath due to coughing forcefully and was given prednisolone at ER. Then complained about right side "cranking my mouth", complained of severe right neck (below ear) pain. No swelling at this time. On 4/23/01 went to NP and had congestion in nose and throat. No swelling noted. On 4/24/01 woke up with right jaw/neck pain with severe swelling.
Sick of the stomach; cold; Headache; Fever from 99 to 101.9 F; Chills, cold; Vomiting incontrollable; can´t keep anything down, muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Sick of the stomach), NASOPHARYNGITIS (cold), HEADACHE (Headache), PYREXIA (Fever from 99 to 101.9 F) and CHILLS (Chills, cold) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthritis rheumatoid and COVID-19 (left her with some lung issues) in April 2020. Concurrent medical conditions included Blood pressure.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (Sick of the stomach), HEADACHE (Headache), PYREXIA (Fever from 99 to 101.9 F), CHILLS (Chills, cold), VOMITING (Vomiting incontrollable) and MYALGIA (can´t keep anything down, muscle aches). On an unknown date, the patient experienced NASOPHARYNGITIS (cold). The patient was treated with PARACETAMOL (TYLENOL) on 19-Jan-2021 at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Sick of the stomach), NASOPHARYNGITIS (cold), HEADACHE (Headache), PYREXIA (Fever from 99 to 101.9 F), CHILLS (Chills, cold), VOMITING (Vomiting incontrollable) and MYALGIA (can´t keep anything down, muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitantly patient was taking blood pressure medication, rheumatic arthritis (that has been stopped for some time this year) , Lung medication (after Covid disease on April2020)