chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FBE calling to report an AE on behalf of a HCP, who is also a relative of the patient. Per FBE, HCP's granddaughter received Hepatitis A (the clinic that she goes to only has VAQTA), MMR-II and VAXNEUVANCE and experienced febrile seizure an; Information has been received via Company Representative from a Nurse who is also the patient's grandmother referred to her granddaughter, a 14-months-old female patient. No patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitant therapies were reported.     On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA), (strength, dose, dose number, route, anatomical location, lot number, and expiration date were not reported), for prophylaxis. On an unknown date, the patient was also vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), (strength, dose, dose number, route, anatomical location, lot number, and expiration date were not reported), for prophylaxis. On an unknown date, the patient was also vaccinated with pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE), (strength, dose, dose number, route, anatomical location, lot number, and expiration date were not reported), for prophylaxis.  On 29-AUG-2023, the patient experienced febrile seizure (febrile convulsion), and the patient look for medical attention and was observed in the hospital for one day (hospitalization). On an unknown date in August 2023, the patient recovered from the febrile convulsion.  The reporter did not assess the causal relationship between the suspect vaccines and febrile convulsion.
Information has been received from an office manager concerning a 29 year old female with a drug allergy to acetaminophen (+) oxycodone hydrochloride (TYLOX) and asthma who on 19-Dec-2005 was vaccinated intramuscularly in the left arm with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot #650329/0747P). Concomitant therapy included fluticasone propionate (FLOVENT). On 21-Dec-2005 the patient presented to the office with left arm swelling from the shoulder to the bend of her elbow, hive type bumps around the injection site, pain, nausea, vomiting and diarrhea. She was treated with prednisone 5 mg for 6 days with decreasing doses, and cetirizine hydrochloride (ZYRTEC) 10 mg for 3 days. Subsequently, the patient fully recovered. The patient's physician expressed a concern about the lot number. The office manager reported that the patient's physician felt that the hive type bumps around the injection site, pain, nausea, vomiting and diarrhea were considered to be other important medical events because if the patient had not been treated when she came into the office, these adverse events could have led to much more serious problems or an emergency. Additional information has been requested. OMIC
Patient reports arm burning with a rash around injection site 2 days after injection. Patient reports passing out 2 and 3 days after injection.
CLIENT COMPLAINED OF SORENESS AT SITE AND LOW GRADE FEVER FOR TWO HOURS WHICH WAS TREATED WITH TYLENOL.  CLIENT REPORTS SORENESS IN RIGHT BICEP OF ARM WHICH RADIATES TO ELBOW.
90 minutes post injection outside of both eyes felt scratchy.  3 hours after injection intense nausea, salivation, headache, intense grainy eye feeling, dry stuck throat on the right side.  5 hours post injection conjunctivitis in both eyes, heavy sleep in lashes, blurred vision, sensitivity to light, intense thirst, achy eyes, gritty feeling around eyes from discharge, metallic taste and tingling tongue.  Following morning I noticed  swollen eyes and face.  I had continued headache, light sensitivity, brain fog, metallic taste, better but continued blurred vision, occasional eye pain, head pain if bent over, fatigue.
Discharge Provider: MD Primary Care Provider at Discharge: MD Admission Date: 5/20/2023 Discharge Date: 5/23/2023  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute hypoxemic respiratory failure due to COVID-19 (HCC) [U07.1, J96.01] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 84 y.o. male with a history of DM2, HTN, HLD, polymyalgia rheumatica, CKD stage 3a,  who presented to hospital with cough and congestion that started 24 hours prior to presentation. His wife tested positive for COVID 19.  His family member realized that his coughing got worse and tried to swab his nose which started to bleed. The main reason he came to the hospital was to get tested for COVID 19. He has been having generalized weakness, chest congestion but no vomiting or diarrhea. No chronic lung disease and does not use any oxygen at home. No body or muscle aches. On presentation he was febrile, tachycardic, and hypoxic 87% on room air. He was stabilized with 2 liters of supplemental oxygen per NC. Lab work showed leukocytosis, mild worsening of CKD, and Covid positivity. CXR was without acute findings. He was admitted with sepsis due to Covid-19 and acute hypoxic respiratory failure for further supportive treatment and monitoring.   He was started on Remdesivir and prednisone 40 mg daily. He was weaned from oxygen on Day 1 and remained on room air for the duration of his stay. Tachycardia resolved. His cough reduced, appetite and strength remained near baseline. He received 2 doses of Remdesivir. He was discharged home in stable condition on all prior medications, nothing new prescribed. He is recommended to follow up with his PCP as needed. He was given quarantine information before leaving.
Myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). The patient was treated with Surgery (Heart surgery) for Myocarditis. At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.            Concomitant Medication use information was not provided by reporter. 7 months ago patient received the 2 doses of Moderna vaccine at proper timing. It was reported that three days after the second dose he was hospitalized and diagnosed with myocarditis. He had heart surgery for this. Treatment  Medication use information was not provided by reporter.  This Spontaneous case concerns a male patient of an unknown age with no medical history provided, who experienced the expected serious event Myocarditis. The event of Myocarditis occurred three days after the second dose of the mRNA-1273 vaccine and he was hospitalized and diagnosed with myocarditis with heart surgery. Reportedly, the patient had received two doses of properly scheduled vaccine administration mRNA-1273 of which dates are unknown. At the time of the report Myocarditis outcome was unknown. No further information was provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This Spontaneous case concerns a male patient of an unknown age with no medical history provided, who experienced the expected serious event Myocarditis. The event of Myocarditis occurred three days after the second dose of the mRNA-1273 vaccine and he was hospitalized and diagnosed with myocarditis with heart surgery. Reportedly, the patient had received two doses of properly scheduled vaccine administration mRNA-1273 of which dates are unknown. At the time of the report Myocarditis outcome was unknown. No further information was provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
DTP, HIB, IPV, Prevnar given 12/7/2005.  A fibril seizure 12/8/2005, then fever developed 8 hours later to 101.
erythematous vesicular rash started thighs on 30SEP spread trunk 1OCT neck & face; 2OCT pt exposed to chicken pox & suspect pt has varicella; tx Zovirax;
My arm has been red at the injection site for two weeks.   There is no pain, minimal swelling, no hardness at site.   I was concerned because the site has remained red for two weeks.   The redness is approximately 3 inches in diameter with a jagged edge.  I called my physicians resource nurse today to ask if this was common.  The main reason for calling today was the fact that I reread the side effect section of the fact sheet.  It was recommended ot call the vaccination provider or healthcare provider if you had side effects that did not go away.   The resource nurse told me that this was a common side effect and that I should come in to see them if the redness spread or got hard or if I had a fever.   None of these symptoms currently apply to me.   I was advised to have the second vaccination in my left arm.
On 1/12/21 I went to the health department for my first round of COVID 19 vaccine series.  They gave me the vaccination record card with Moderna COVID 19 LOT 026L20A. On 2/9/21 I went to a vaccine clinic put on by the same health department with my vaccination record card, gave them all my information, they placed the sticker with the moderna and lot number on my card and ushered me to a bay with 2 student nurses and what appeared to be a nursing instructor.  one student nurse injects me and then makes a statement that I should keep my card for when I come back for my second vaccine.  I questioned her why she would say that and she stated that she just gave me first wround Pfizer vaccine.
Right leg weakness, pain, tingling in right foot. Physical therapy started and continues to present time. Symptoms continue.
oct.28.2007 treated for upper respritory viral infected.sept.10 2007recieved influensa vaccine.sept.17 2007treated for viral infection complecated by influensa vaccine.oct.27 2007died heart failer complecated by virial infection  11/16/07 Reviewed vaccine record from pcp & VAERS database updated w/same.   11/27/07 ER Final dx: cardiac arrest, expired. Reviewed hospital medical records which reveal patient experienced chest & left arm pain, cold & clammy, skin mottled, nauseated, felt faint & passed out when EMS arrived.  EMS rhythm strip revealed BBB w/ST segment depression.  In ER, vomited & had diarrhea.  EKG revealed atrial fib w/rapid ventricular response.  DX w/acute bronchitis & atrial fib w/RVR.  Became unresponsive & developed cardiac arrest.  Resuscitated & intubated.  While being tansferred to higher level of care via helicopter, coded again.  Returned to ER & unable to resuscitate.  3/7/2008 Judge states he signed death certificate as directed by state law when patient is not in hospital & only seen in ER but paper copy no longer available. States COD as undetermined & manner of death natural.  3/11 Death certificate reviewed & states COD as undetermined & manner of death as natural.
Intense stomach pain around 12:30am on 2/20/21. Diarrhea and vomiting at the same time. Nausea and dizziness. Vomiting until 2am.  Morning of 2/21/21: diarrhea and stomach ache. Nausea and dizziness.
48 hours after the vacination of Gardasil, I has a reaction. My legs swelled and I had small red bumps all over my legs. I couldn't walk because of the pain and large amout of swelling in my knees and ankles. About 8 days after I had severe abdominal pain with vomiting and fever. I went to the doctor about a week after the shot because my legs were swelling all over and so were my elbows. The dots were spreading and they stung. She looked and examined me and we concluded I had HSP. It's an autoimmune desease that causes the blood veins to pop and leak. It is supposed to go away after 4-8 weeks. I have had it since Sep. 11th of 2008. We went to a skin doctor to make sure and he took a biopsy of my leg in 2 places and it was in fact HSP. About a month or 2 after we found out what I had, we started noticing I got sick very easily. I had my blood and urine tested and the doctors saw that I had an extremely high level of protein and blood in my urine. In the blood they took they saw that my iron was low and I had a low white blood cell count. We kept testing one or twice every 2 or 3 weeks. The protien and blood went up and down but was never at a normal or healthy amount. We then went to a doctor. He looked at my urine and blood and decided to preform a kidney biopsy. He saw that I had scarring on my kidneys and found that I have an IgA protien that causes my kidneys to overwork. I was put on blood pressure medicine and bottomed out so we stopped that. We are still to this day trying to find out what to do about the situation. We've also been to an allergist. She saw that the ingredients in Gardasil along with the protien in my body are reacting. I can't take any medication because I might have a reaction. Plus it goes to my kidneys which could cause damage. I might be put on steroids but we aren't sure. I just hope more people know about Gardasil before someone else gets what I have or worse.  8/17/09 PCP medical records received DOS 8/12/08 to 7/13/09. Assessment: Henoch-Schoenlein Purpura. Patient presents with palpable purple bruises around ankles and lower legs. Mild respiratory virus. Injury to right Achilles tendon. Sudden onset abdominal pain. Constipation. Significant flare of HSP with multiple purpura on buttock, lower legs, ankles, and feet. HSP continues to persist with lesions on forearms. Swelling of legs. Cough and congestion. Orthostatic proteinuria. Chest pain. Inflamed pustular lesions on face. Pneumonia, wheezing. dysmenorrhea and premenstrual syndrome, acne. UTI. ADHD. Herpetic infection. Insomnia. Blood in stool. Anal fissure. Placed on oral contraceptives. HSP Nephritis with IgA nephropathy. Cold intolerance, hands and feet cold. Sunburn.  8/17/09 Consultant records and labs received DOS 11/18/08 to 8/10/09. Assessment: Henoch-Schoenlein Purpura. Patient presents for evaluation of purpuric leasions consistant with Henoch-Schoenlein pupura. Also had pain in both ankles which were swollen. Skin with purpuric lesions distributed over both buttocks and lower and upper extremities.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
Chills and headache, I have taken ibuprofen and it has been a better bet still hurts.
Injection given on 12-17-14. On 12-19-14 patient noticed 4-5 cm red raised area around injection site. Area sore, slept on that arm. No itching. Area also looked a little lumpy.
Patient came into pharmacy 3 days after receiving vaccine, was complaining of bruise at injection site. Looked like it had formed a scab/blister and the patient scratched it open at some point, skin looked raw in a spot. She doesn't know if it was itchy and also it was not warm to the touch. Patient states did not have fever.
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "Patient is a 57-year-old male with no personal history of coronary artery disease who presented with sudden onset of chest pain.  He developed pressure in his chest which will come from napping in the afternoon.  He did experience some paresthesias in his shoulders, and presented to the emergency department for evaluation.  Administration of aspirin provided some relief, patient had troponins drawn which were elevated to 22 with a 2 hour were repeat showing 35, positive delta.  EKG showed normal sinus rhythm without ischemic changes.  Hospitalist Service asked to admit, Cardiology consulted for further workup.   Patient underwent left heart catheterization, which showed 95 percent occlusion of LAD, drug-eluting stent was placed.  Patient was started on aspirin and Brilinta, plan to continue for 1 year followed by aspirin monotherapy afterwards.  Recommend continuing high-intensity statin, beta-blocker.  Goal-directed medical therapy would also include ACE/ARB, patient did not have hypertension and was started on low-dose lisinopril.  Prior to discharge she received 30 day supply of aspirin and Brilinta the hospital pharmacy.  Set up with a cardiology follow-up for post PCI care   On day of discharge patient denied any chest pain or discomfort.  He was noted to have COVID-19 positive test, but he denied having any respiratory symptoms at time discharge.  He was in isolation during the hospital stay, was recommended to self quarantine for 5 days from onset of symptoms which was 12/31 - hospital discharge was day 5"
Symptoms began on or about Halloween.  Diarrhea and fever, saw MD 2nd week of November.  Started antibiotics for bladder infection; pain in bladder.  Cipro finished-2 weeks.  Due to the circumstances of vaccination that generated this VAERS report, the vaccine manufacturer, the lot number, the injection site and the providers name and phone number were not available to us.
mom called to report pt had left arm stiff x2 days, body aches, bed all day the next day , temp 99.8F
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jun2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZOLOFT. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive; Negative. Therapeutic measures were taken as a result of covid-19.  Additional information: Report about covid treatment was Yes. If vaccine received reported as Yes. Other medication in 2weeks reported as Yes. Anti viral details: Product: COVID 19 Treatment, Brand: pfizer paxlovid, Treatment start date: 05May2022, Treatment stop date: 09May2022. Other medication details: Other medication in 2weeks product: Station, other medication in 2weeks product: Zoloft. Rebound of symptoms at day 12. Rapid antigen test, positive again after being negative a week ago. Known allergies reported as No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This is a spontaneous report from contactable consumer (patient) by a Pfizer sponsored program Pfizer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The patient was about to take the second dose on 11 Feb; however, she needs to take PRP as well (To fertilize stem cells); she was asking if she needs to reschedule her PRP; the reporter considered the events as non-serious. As of 26Feb2021, patient reported that both shots of Pfizer vaccine were taken on an unspecified date and she had a sore arm for a few days on an unspecified date (no further information provided.) Outcome of the events was unknown. Information on Lot/Batch number has been requested. Follow-up (26Feb2021): New information reported from the same contactable consumer (patient) includes clinical course with new event (sore arm). This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Patient experienced soreness the evening she received the pneumovax shot and awoke the next morning with severe swelling in the arm, pain, and warmth to the touch.
Pain; Swelling; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 5MG5E, expiry date 5th May 2021) for prophylaxis.   On 10th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The pharmacy intern stated that the night after getting Shingrix the patient experienced pain and swelling on the right upper arm and the site of injection.  The patient at the time of reporting had recovered. No further details were provided.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN8955), in right arm, on 14Apr2021 as dose 2, single (Lot number: EW0162), in right leg, on 13Sep2021 as dose 3 (booster), single (Lot number: FC3184), in right arm and on 18Feb2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's Disease" (unspecified if ongoing); "Enthethitis" (unspecified if ongoing). Concomitant medication(s) included: STELARA, start date: 15Dec2020; RABEPRAZOLE, start date: 01Feb2021; FAMOTIDINE, start date: 01Feb2021. Past drug history included: Known allergies: uncooked honey, reaction(s): "local dysphasia", notes: Known allergies: Uncooked honey- local dysphasia; Known allergies: trental, reaction(s): "pruritus", notes: Known allergies: trental- Pruritis. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported event Covid-19, Vaccination failure and the administration of the vaccine cannot be excluded.