chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEART FAILURE; This spontaneous report received from a consumer via a company representative through social media concerned a male of an unspecified age. 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 (series 1) (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered and start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced heart failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211209612-covid-19 vaccine ad26.cov2.s- Heart failure. 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).
The day immediately following administration of my first dose, my arm was tender at the injection site and my body was fatigued. This went away the second day after administration.  There were no other symptoms or side effects after the second day post administration until the following event on March 14th. On March 11th, I flew out of state, direct flight. On March 13th, I flew from that state, to another, direct flight. On the morning of March 14th, I woke up with an approximately 5" diameter, raised red circle around the injection site and the lymph nodes on the left side of my body  were extremely large and swollen. The lymph nodes under my left arm pit were specifically extremely swollen. Anytime my left arm brushed against my lymphnodes in my armpit, it was extremely painful. This lasted until March 18th. My lymphnodes are still slightly swollen, but not as noticeable as before. The rash on my arm went away around the same time, forming a ring like appearance temporarily.
I experienced extremely mild soreness at site of injection; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 46-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot Number: EL3247) via an unspecified route of administration, administered in right arm on 24Feb2021 10:30 AM (at the age of 46 years) as DOSE 1, SINGLE for covid-19 immunization. The patient was non pregnant at the time of vaccination. Prior to vaccination patient was not diagnosed with covid 19. The patient's medical history included known allergies to medications, food, or other products: sulfa from an unknown date and unknown if ongoing. The patient's concomitant medications within 2 weeks of vaccination included oxycodone hydrochloride, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE; PARACETAMOL]) taken for an unspecified indication, start and stop date were not reported. On 24Feb2021 18:30, the patient experienced felt extremely mild soreness at site of injection approximately 8 hours following vaccination. Soreness was gone by the time she woke up the next morning. Patient not been tested for covid 19 since vaccination. Reporter assessed case as non-serious. No treatment received for the events. The outcome of the events was recovered on 25Feb2021.    No follow-up attempts are needed. No further information is expected.
1120 S/p almost immediately following vaccination reports  "feels really dizzy", witnessed loses balance and assisted to floor (left side) by vaccinator; coherent at this time, oriented x 3 at this time, informs "ate a full breakfast" and continues to answer questions on prompt; Vitals assessed:  BP 115/65 P 84 RR16  O2 sat 98% RA; 1125 verbalizes increased dizziness  "be still room is spinning", client attempts to lift head and sit up w/ immediate episode of syncope, soon recovering and responds to verbal stimuli and questions "I'm ok"; sits up with assistance, offered and consumes sips of H2O.  1130  BP 119/ 89  P 84 RR 16 O2 Sat 99%; EMS dispatched for transport to hospital for further evaluation / treatment
Rash/raised bumps at injection site. Looks like a huge bee sting. Very painful, hard and itchy. Did cold compression and took an antihistamine (Zyrtec). Also had a slight nagging headache for the past two day.
It's difficult to say when I first started with this adverse reaction but it was at least 3 months ago.  I have experienced uncontrollable itching since then.  I have also lost my taste/smell for many foods such as coffee, hamburgers, hot dogs, snacking chips/dip, and normal smell of meat cooking.  I experienced a low grade fever (100.6) and chills on the night of March 19 (date I received the vaccine shot) and March 20, 2021.  I don't like to go to the Doctors' but I see that I have been seeing the doctors over 11 times since I received the J&J vaccine shot. I am miserable with the itching and it seems that I am very anxious now.  The itching occurs mainly at night all over my body--and lately, it has begun to itch on my forehead and face.  It is all over my body.  I thought I should get this information to you in case someone else is experiencing it.     I began my quest to stop this itchy feeling with my primary doctor.  She prescribed hydroxyzine 50 mg.  I take 1 pill every 6 hours as needed for anxiety.  She also ordered buspirone 10 mg 1 pill 2xday but it makes no difference so I will not refill it.  I told my doctor that I would go to a dermatologist next for relief.  That's how I began going dermatologist.  So it has been since around March 30, 2021 that I have been trying to stop the uncontrollable itch.  Just not sure if the vaccine caused this problem but I highly suspect that it did.
Beginning at 2:30am, approximately 14 hours after receiving the 2nd dose, began having chills, fever, and body aches. This lasted for approximately 12 hours.
Sore arm 4 hours after shot.  100 degree temp that night . Woke up next morning with bad headache and 101 degree temp. Tylenol helped with both. Rash on arm at injection site same day as with the first dose the rash did not appear until a week later.  Also developed rash on my stomach. Both rashes were gone in about a day or two. By Feb. 26, two days after shot felt better and by Feb. 27 back to normal.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 28-SEP-2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown). The vaccine did not prevent shingles but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX the patient developed burning and itching in the mid-section of her body. This was followed by an outbreak of a zoster rash around her left eye, jaw, and along her forehead. Thereafter, the patient suffered from loss of hearing in one ear, and palsy. As a direct and proximate result the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using ZOSTAVAX. As a result of the use of ZOSTAVAX the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient had incurred and will continue to incur medical and other economic harm as a direct result of use of ZOSTAVAX. Upon internal review loss of hearing in one ear, zoster rash around her left eye and palsy were considered medically significant events. Hearing loss in one ear, persistent strain of herpes zoster, the vaccine did not prevent shingles, zoster rash around her left eye, jaw, and along her forehead, and palsy were reported as disabling by the lawyer. Additional information has been requested.
Redness, hard induration/swelling, pain, itching. Did not require treatment.
I had a large, raised, itchy rash on my left upper arm. I noticed it about a day or so after my vaccination. The rash lasted about 5 days and then just went away. I spoke to the nurse at my doctors office and was informed that this was just a reaction to the vaccine and not to worry. I did not take any medications to treat the rash.
Information was received on 14-JUL-2017 from a registered nurse regarding a 31 year old female patient. Medical history, concurrent conditions and concomitant medications were not reported. On 13-JUL-2017, the patient was administered an expired dose of VARIVAX (lot # L025206, exp 07-JUL-2017) (dose, route, and site of administration not reported). No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1707USA002872: US-009507513-1707USA009935.
Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. Initial solicited report received on 21 September 2017 from an investigator (Health Agency) in a trial. A 34 year-old male subject with medical history of High Blood Pressure, Elevated Cholesterol. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 01 March 2017. On 12 March 2017, 11 days after vaccination the subject was diagnosed with I51.4 myocarditis, unspecified. The lab data of ECG- Normal, done on 12 March 2017, and Echocardiogram - Normal done on 13 March 2017, Troponin I result abnormal 00.62 done on 14 March 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the event, I51.4 myocarditis, unspecified was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a 34-year-old male subject with significant medical history of high blood pressure and elevated cholesterol who developed acute myocarditis and myocarditis unspecified with favorable temporal association post vaccination with ACAM200. Myocarditis is a listed event for ACAM2000 vaccine. Alternative etiologies could be myocardial infarction, pulmonary edema and coronary artery vasospasm. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, myocardial biopsy, role of study vaccine cannot be ruled out.
Body ache, headache, fever, nausea  Body ache started first in the morning, followed by headache and fever in early evening, then nausea in the evening.  Took two acetaminophen after start of fever. All resolved by the following day.
Red raise area around vaccine administration site.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2022 at 12:00 as dose 4 (booster), single (Lot number: unknown) at the age of 85 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (First booster, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 27Apr2022 at 22:30, outcome "recovering", described as "Red raise area around vaccine administration site.". Therapeutic measures were not taken as a result of vaccination site erythema.  Additional information: Patient did not received any other vaccine in four weeks. Patient did not tested COVID post vaccination. Patient did not had known allergies. Patient did not had any other medical history. Seriousness was reported as no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Low-grade fever of a 100 F; Headache; The right arm is hurting at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low-grade fever of a 100 F), HEADACHE (Headache) and VACCINATION SITE PAIN (The right arm is hurting at the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A, 013M20A and 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN and AMLODIPINE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Low-grade fever of a 100 F), HEADACHE (Headache) and VACCINATION SITE PAIN (The right arm is hurting at the injection site). At the time of the report, PYREXIA (Low-grade fever of a 100 F), HEADACHE (Headache) and VACCINATION SITE PAIN (The right arm is hurting at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) Body temperature 100F.         Treatment details was not reported by the reporter.
8cm x 4cm erythematous, warm, tender, swelling. Ice. Pt can't tolerate NSAIDs. KEFLEX ordered.
Patient received shot, had no problems. Came in with his wife a week later - experienced a rash around injection site & also an elevated pulsating raise a few inches away from injection site. Made appt with MD for x-ray on 6-30- awaiting results.
Vaccine made me very tired soon after receiving, so I went to bed within 2 hours of receiving. I woke up to numbness in my face with muscle spasms in my face. This lasted for 4-6 hours. I also had numbness in both arms and arms felt like lead. This lasted for about 12 hours.
Dizziness (h/o dizziness), lack of sleep before vaccine dose. Monitored for 30 minutes, given water and juice. Cleared by NP for discharge.
RED RAISED RASH TO CHEEKS AND TORSO, FRONT AND BACK.
redness leading to cellulitis & abscess of upper arm & forearm;also lymphangitis;pt went to Er 32hr p/shot;tx claforan;recovered well;
Narrative:  Per LPN, HAD 1ST DOSE 1/16/21 AT LOCAL PHARMACY CARDIOLOGIST ROCOMMENDED THAT PT NOT HAVE 2ND  DOSE DUE TO SEVERE SIDE EFFECTS The patient was instructed to bring a copy of their COVID-19 vaccine information to their next appointment so that this can be accurately recorded in the medical record.
Clipped toenails. Didn't have a reaction. Noticed sensitivity; Slight infection; Touch sensitivity; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced clipped toenails. Didn't have a reaction. Noticed sensitivity, slight infection, touch sensitivity on an unspecified date. Patient stated three or four days ago clipped toenails. Didn't had a reaction. Noticed sensitivity. No bleeding and he didn't had any touch sensitivity. Slight infection two days. Putting on Neosporin. Touch sensitivity was there. Would you indicate that I keep the appointment? No pre existing conditions. Potential AE. The outcome of the events was unknown.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
Pfizer monovalent given as booster AFTER FDA/CDC removal of EUA for monovalent boosters. Bivalent booster was unavailable at time of administration.
Headache flu-like symptoms Narrative:  Per supervisor report: "received vaccine 4/6/21 c/o headache, flu-like symptoms."  Other Relevant History:
This spontaneous report has been received from a pharmacist and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. It was reported by the pharmacist that on 10-MAR-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, route of administration, and frequency were not reported), for prophylaxis. A digital data logger was used. No adverse effects were reported. This is one of multiple reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA014153: US-009507513-1706USA001720: Original Case: 1706USA001714: US-009507513-1706USA001721: Original Case: 1706USA001714: US-009507513-1706USA001722: Original Case: 1706USA001714: US-009507513-1706USA001723: Original Case: 1706USA001714: US-009507513-1706USA001719: Original Case: 1706USA001714: US-009507513-1706USA001724: Original Case: 1706USA001714: US-009507513-1706USA001714: Original Case: 1706USA001714: US-009507513-1706USA001726: Original Case: 1706USA001714: US-009507513-1706USA001727: Original Case: 1706USA001714: US-009507513-1706USA001728: Original Case: 1706USA001714: US-009507513-1706USA001729: Original Case: 1706USA001714.
2 year old male patient was given the quadracel in error with no reported AE; Initial information received on 06-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old male patient who was given the quadracel (DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE) in error with no reported ae( adverse event)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Jun-2022, the patient received a  dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (formulation, strength: unknown) lot 65772AA, expiration date: 17-Sep-2022 via intramuscular route in the left thigh as Immunisation.  On 29-JUN-2022 the 2 year old male patient was given the quadracel in error with no reported ae (product administered to patient of inappropriate age) same day following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (2 year old male patient was given the quadracel in error with no reported AE).  At time of reporting, the outcome was Unknown for the event.    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 the guidelines. 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.
Nausea, short of breath, lost consciousness at a restaurant.  911 called    Fire trucks  & 3 paramedics responded.   3 MD?s in restaurant:  neurologist (patient?s husband), ER doc &  an ntensivist.   Ambulance & 2 paramedics followed.   Severe pain in right shoulder - now on day 3 - no swelling or redness. Continues to have severe weakness, pain & limited use of arm.
CHIEF COMPLAINT Generalized malaise    HISTORY OF PRESENT ILLNESS Patient is a 78 y.o. male with DM 2, CKD 4, atrial fibrillation, heart failure, ANCA vasculitis, DLD who presents with generalized malaise, decreased urinary frequency and acute on chronic AKI.    He states that he was in his usual state of health until the past week or so.  He hasn't had an appetite for the past 4-5 days. No nausea or vomiting. Did have some diarrhea 5 days ago but then took some Imodium and improved a little bit but he still had multiple episodes of watery diarrhea. This corresponded to when he didn't have an appetite. His wife also wasn't feeling well and had diarrhea.  He hasn't been producing as much urine since de CHIEF COMPLAINT Generalized malaise    HISTORY OF PRESENT ILLNESS Patient is a 78 y.o. male with DM 2, CKD 4, atrial fibrillation, heart failure, ANCA vasculitis, DLD who presents with generalized malaise, decreased urinary frequency and acute on chronic AKI.    He states that he was in his usual state of health until the past week or so.  He hasn't had an appetite for the past 4-5 days. No nausea or vomiting. Did have some diarrhea 5 days ago but then took some Imodium and improved a little bit but he still had multiple episodes of watery diarrhea. This corresponded to when he didn't have an appetite. His wife also wasn't feeling well and had diarrhea.  He hasn't been producing as much urine since decreased oral intake. Doesn't have difficulty urinating but doesn't have as good of control as used to.    He was recently being treated for osteomyelitis and underwent partial right great toe amputation on 09/17.  He was started on cephalexin that does correlate with his increasing creatinine.  He states that after the surgery he was not taking any further antibiotics but it appears that he was prescribed Keflex to go home with..  Able to get around the house ok without difficulty but still unable to drive.
?Moderna COVID-19 Vaccine EUA? Difficulty breathing, fever, rapid heartbeat, dizziness and mild uterine cramping. Was driving to work but able to take an Allegra, dizziness was worse while trying to walk. Symptoms subsided 40 minutes after allergy pill, but then returned again around 1pm. Took 20mg of Clairton, again symptoms subsided, but returned again around 5:15pm with fever reaching 100.2 degrees. Took 2 Tylenol Extra Strength Rapid Release for fever and 10mg of Clairton at 7pm. Symptoms subsided, but at this point I had just continued with 4 hour dosing. Today (following day) fever is gone, 24 hour Allegra has one hour left before next dose.
This patient had a high fever of 102, flu like symptoms which began the day following the shot. It lasted 3 days. His arm was sore for 6 weeks after the shot.
On April 17, 2021 I woke up with unexplained inflammation and pain in shoulders and hips/groin/ thighs. I thought possibly it was from swimming the day before but swimming was very minimal. I was on vacation. I came back home and went to my PCP. He ran blood tests and c-reactive protein seemed to be the only test elevated. I was referred to rheumatologist. Unable to get in for months. I visited ER because of persistent pain and inflammation. They ran blood tests and covid test. Negative covid and again high levels on c reactive protein. Finally able to get into rheumatologist.