chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am an RN and therefore am knowledgable in respect of proper/safe IM injection technique. I could tell that the vaccinator was nervous & can remember the feeling so I looked away in hopes of taking some pressure off of him. After the initial stick, I could tell something was wrong and turned to look at what was happening. This is when I noticed the worried look on the administrator's face before he proceeded to withdraw the needle a little bit and then inject the vaccine. I myself was very worried once I realized how very high up on my arm the injection was placed. It felt as if he had administered the shot directly into my joint & completely missed any sliver of muscle tissue altogether. After receiving the vaccine, I instantly/constantly experienced extreme pain in shoulder w/ any movement, range of motion, stretching, weight bearing, etc. The pain has since caused me to wake up in the middle of the night and is only somewhat relieved with high doses of NSAIDS.
nodules on her neck and clavicle; temperature of 102; woke up with golf ball size glands under arm; couldn't wear her bra bc it was so tender; sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Apr-2021 and was forwarded to Moderna on 16-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), BREAST TENDERNESS (couldn't wear her bra bc it was so tender), PARATRACHEAL LYMPHADENOPATHY (nodules on her neck and clavicle), LYMPHADENOPATHY (woke up with golf ball size glands under arm) and PYREXIA (temperature of 102) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2019.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 13-Apr-2021, the patient experienced BREAST TENDERNESS (couldn't wear her bra bc it was so tender) and LYMPHADENOPATHY (woke up with golf ball size glands under arm). On 15-Apr-2021, the patient experienced PARATRACHEAL LYMPHADENOPATHY (nodules on her neck and clavicle) and PYREXIA (temperature of 102). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site pain, Breast tenderness, Paratracheal lymphadenopathy, Lymphadenopathy and Pyrexia, at a dose of 1 dosage form and IBUPROFEN for Paratracheal lymphadenopathy, Lymphadenopathy, Pyrexia, Vaccination site pain and Breast tenderness, at a dose of 1 dosage form. On 15-Apr-2021, BREAST TENDERNESS (couldn't wear her bra bc it was so tender), LYMPHADENOPATHY (woke up with golf ball size glands under arm) and PYREXIA (temperature of 102) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm) and PARATRACHEAL LYMPHADENOPATHY (nodules on her neck and clavicle) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Body temperature: 102 (High) Temperature of 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up received contained: Updated outcome of the events reported: Recovered from all the events; Follow up declined;
DIZZINESS AND HEAD WAS SPINNING; SLEEPY AND DROWSINESS; BODY ACHE; FLU; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced dizziness and head was spinning. On 07-APR-2021, the subject experienced sleepy and drowsiness. On 07-APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced flu. On 07-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness and head was spinning, body ache, and chills on 08-APR-2021, and had not recovered from sleepy and drowsiness, and flu. This report was non-serious.
fatigue low grade fever 100.9 chills nausea lasted for 24 hours
Discharge Provider: MD Primary Care Physician at Discharge: DO  Admission Date: 12/15/2022 COVID positive date: 12/14/2022 PRESENTING PROBLEM: COVID-19 [U07.1]   HOSPITAL COURSE: HOSPITAL COURSE: Patient is a 74 y.o. male with complicated hx of AML s/p allogenic BMT w/ complication of GVHD, hx of EBV, lymphocytic ILD, NIDDM2, chronic diastolic heart failure, HTN, CKD stage 3a who is presenting with COVID-19.    Pt has had multiple recent admissions. He was admitted to Hospital from 10/24-11/03 with acute severe diarrhea. He had been off immunospuression since 7/2022. His infectious w/o was negative. He had EGD and colonoscopy which did confirm Grade II Acute GVHD of gut. He was started back on budesonide and prednisone and started on taper. He was discharged to acute rehab. He was then again admitted to hospital for AKI and weakness. It was felt pt had steroid myopathy. It was felt his GVHD of GI tract had resolved, his prednisone was weaned to 5 mg daily and maintained on tacro and budesonide 3 mg BID with plans to start weaning on12/2. He was noted to have persistent pancytopenia which BMT was following for. PT was then transferred to inpt rehab on 11/29.    On 12/10 pt wife tested positive for COVID, pt was tested on 12/11 but found to be negative. Pt had been stable however then on 12/14 pt started complaining of congestion, sore throat and rhinorrhea. His COVID was repeated and he was found to be positive. CXR was obtained and showed no infiltrate. However then in AM of 12/15 pt was found to be hypoxic in 80s requiring up to 4 L NC. With this ultimately it was decided to admit pt for further treatment. ID was consulted and pt was started on remdesivir. He was able to be weaned to 1-2 L NC. BMT and ID followed throughout the admission.  Despite resolution of his hypoxemia he was exceedingly weak malnourished and lethargic.  He was seen by palliative care/bone marrow transplant and unfortunately had exhausted all therapeutic options.  Multiple goals of care discussions were held and was ultimately decided that the patient would benefit from hospice evaluation. He was transitioned to comfort care on 12/29 and hospice team worked to arrange discharge home. Patient passed away in the hospital on 1/1/23 at 6:35 AM. His wife was notified via phone shortly after his passing and condolences offered.
Rash on both legs and hands.  Diagnosed as Granuloma Annulare.  Prescribed topical steroid.  Did not clear rash.....
Employee was administered Fluzone "high dose" Quadrivalent  Flu vaccine by 11-7 Supervisor on 10/5/21. Employee under 65 years of age. Currently, employee has not reported any adverse reactions.
Pain in abdomen and lung pressure when taking a deep breath. Symptoms started at about 4:00pm on Sunday 5/23/2021
Information has been received from a physician concerning a female consumer who on an unspecified date was to be vaccinated with varicella virus vaccine live (Oka/Merck) (MSD), but inadvertently received zoster vaccine live (Oka/Merck). Unspecified medical attention was sought in the office. The physician reported this was a medication error only. There was no product quality complaint involved. No further information is available.
Pt reported fatigue & rash to back,groin, & both wrists. Seen by military dr on 1/5/00 and the dr recommended no futher anthrax vaxs due to risk of anaphylactic reaction.
Seven days after immunization onset of edema and erythema of hands and feet that also turned into some ecchymosis, accompanied by fever, anorexia, decreased fluid intake, malaise, slight dehydration, mild skin rash.  02/11/2010 Follow-up information from the reporting physician indicated that the 20 week old female who on 12-DEC-2007 was vaccinated PO with her second dose of GARDASIL (lot# 657663/1461U). There was no illness at the time of vaccination. Concomitant drug therapy included ZANTAC 2.0 ml PO BID. On 13-DEC-2007 the patient experienced irritability, increased flarulence and colicky symptoms characterized by stomach pain and cramping and was taking less formula. No medical attention was sought. No labs of x-rays were performed. On approximately 20-DEC-2007 within 1 week., the patietn recovered.  Additional information has been requested.
could not sleep; legs ache pretty hard; hips ache pretty hard; soreness on the arm; fatigue; pretty hard headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (could not sleep), PAIN IN EXTREMITY (legs ache pretty hard), MYALGIA (hips ache pretty hard), MYALGIA (soreness on the arm) and FATIGUE (fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included high blood pressure medication and Lipitor and cancer pills and depression medication and matafor medication for an unknown indication.    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced INSOMNIA (could not sleep), PAIN IN EXTREMITY (legs ache pretty hard), MYALGIA (hips ache pretty hard), MYALGIA (soreness on the arm), FATIGUE (fatigue) and HEADACHE (pretty hard headache). At the time of the report, INSOMNIA (could not sleep), PAIN IN EXTREMITY (legs ache pretty hard), MYALGIA (hips ache pretty hard), MYALGIA (soreness on the arm), FATIGUE (fatigue) and HEADACHE (pretty hard headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product also included high blood pressure ,depression medication and cancer pills. Medical history is unknown.
Patient was given the second dose on day 14 after she received the first does.  No adverse events reported by the patient.
Generalized mild urticaria, beginning 24 hours after administration, still present 5 days later.
I had standard aches and a headache for a day. On 12/08/2022 I started feeling unwell with cold like systems. I tested positive on 12/09/2022 with a home test for COVID-19. I lost my sense of taste and smell, and I had the cold like symptoms. I did not go for medical attention. I took over-the-counter medication to help with my symptoms.
Temp 99.1, BP 136/81, HR 93, SPO2 93%, Resp rate 24. Patient was given Yellow Fever and Typhoid vaccines. Developed wheezing, shortness of breath, moderate throat erythema and swelling, diffuse hives on skin and itching. BENADRYL 25mg IM, SOLUMEDROL 125mg IM, and ALBUTEROL 2.5mg/3ml Nebulizer treatment. Breathing better, wheezing reduced, ongoing hives and itchiness, 25 mg of BENADRYL PO given, to ER for monitoring.
Rash began 3/2/07 evaluated in office by doctor. Erythema multiform rash-arms/legs extensor surfaces and face-mild trunk involvement, no palms or soles, no oral lesions.
Pt. received 2 intramuscular vaccines on 12/06/16. 24 hours later mom noticed rash forming on the leg. Mom reports initial rash was about 3 bumps. Rash then began to spread on legs with induration at injection site. The provided ordered BENADRYL to patient's pharmacy.
more confused this times and confusion at times; forgets more and stops in the middle of her sentence when she is saying something; soreness in right arm; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (more confused this times and confusion at times), MEMORY IMPAIRMENT (forgets more and stops in the middle of her sentence when she is saying something) and PAIN IN EXTREMITY (soreness in right arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced CONFUSIONAL STATE (more confused this times and confusion at times), MEMORY IMPAIRMENT (forgets more and stops in the middle of her sentence when she is saying something) and PAIN IN EXTREMITY (soreness in right arm). On 13-Apr-2021, CONFUSIONAL STATE (more confused this times and confusion at times), MEMORY IMPAIRMENT (forgets more and stops in the middle of her sentence when she is saying something) and PAIN IN EXTREMITY (soreness in right arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant and treatment medications were reported.   This case was linked to MOD-2021-123226 (Patient Link).
An 80 year old female received RSV vaccine or Placebo and Influenza vaccine on 10/22/02 and 174 days later experienced Congestive Heart Failure, shortness of breath, chest discomfort, and was admitted to hospital on 4/14/03. Patient was discharged on 4/18/03. Outcome: Recovered. Follow up information received 4/28/03. The investigator assessed the event as possibly related to the study product. Follow up information received 5/6/03. Cross reference with manufacturer report 200300607. See relevant history. Follow up information received on 5/19/03. HISTORY AND PHYSICAL EXAMINATION 4/15/03. ADMISSION DATE: 4/15/03. INDICATION FOR ADMISSION: Severe weakness, shortness of breath. HISTORY OF PRESENT ILLNESS: An 80 year old white female admitted primarily because of swelling in the lower extremity, flu-like symptoms and generalized weakness Patient is extremely short of breath in the office. Chest x-ray showed questionable early congestive heart failure symptoms. Clinically the patient just feels poorly and it was felt that the patient should be admitted for further evaluation. PAST MEDICAL HISTORY: Significant for coronary artery disease, chronic obstructive pulmonary disease, asthma, and history of diverticular disease as well as stroke. Unblinding information received on 5/16/05. The subject received Non-Adjuvanted RSV vaccine.
moderate pain on the injection site; feverish; feeling unwell; tiredness; This is a spontaneous report received from a contactable other healthcare professional (patient). A 55-years-old male patient received BNT162B2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EL3247 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 15Mar2021 at 13:45 hours as dose number unknown, single (at the age of 55-years-old) for COVID-19 immunisation. Medical history included hypertension and hyperlipidaemia (both from an unknown date and unknown if ongoing). Concomitant medication(s) within 2 weeks of vaccination included nebivolol hydrochloride (Bystolic) and atorvastatin (both taken for an unspecified indication, start and stop date were not reported). Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. Patient had no known allergies to medications, food, or other products. On 16Mar2021, patient experienced moderate pain on the injection site; feverish, feeling unwell and tiredness. Patient received no treatment received for all the events. The outcome of all the events was recovering.  No follow-up attempts are needed. No further information is expected.
Developed hives that come and go, on my head neck, back, chest, torso. Entire body can be itchy, depending on where they flare up. Hands will feel inflamed/burning sensation. I have not found a resolution. I have tried dandruff shampoo and eczema cream to help relieve symptoms, but it is only temporary. The re-occur multiple times a day.
2 days after administration of vaccines, patient began to feel numbness and tingling in lower extremities. Progressively worsened. Then developed headache and jaw pain. Started on amoxicillin for possible sinus infection with no improvement. Then developed gait instability about 2 weeks post-vaccine. Throughout this course, multiple ED visits. On admission to MC, started on IVIG with improvement.
Pt recvd series of 3 hep B vax from spring 1990 thru AUG90.Titer revealed pt was a non-responder.
Patient's arm was magnetic for 24 hour following the vaccination. Patient showed me a video of the arm that she was vaccinated in and she held a magnetic pocket knife up to her arm and it stuck to her arm.
Rash on back, chest & neck, macular papular, pruritic and faint in nature. No swelling of lips or eyes. No shortness of breath. Rash developed 2 days after injection of MENACTRA. Given prescription of methylprednisolone med pack.
Pt stated had flu vaccine on 10/18/23 at 0500 to right arm. Pt stated site was ok on 10/18/23. Pt stated when woke up on 10/19/23 at 0630 she noticed a little redness and bruising at injection site. On 10/20/23 she noticed increase in redness at injection site and site was itchy. Pt concerned and will go to Occ. Health to be seen.
Red itchy/painful rash developed on left upper thigh and butt area a week after Pfizer 1st dose. Likely Shingles (had childhood case of chickenpox). Still present/ongoing. Also "covid arm"  developed a day after Pfizer 1st dose. went away within 6 days.
Majority of vaccine contents leaked out of the syringe as it was being administered. Patient had no complications after vaccine was given.
Patient received second SHINGRIX immunization, called back the next day complaining of red, warm area at vaccination site, myalgia, and a "cold clamy" feeling. Patient is self monitoring and taking ibuprofen.
Sudden onset muscle, leg aching (never had before), nausea, fever of 99 degrees, slight headache. Took one Advil and tried to sleep. After about 2 hours symptoms were much better, no aching or nausea. Fever was gone. Strange and fleeting but thought I should report. Was fine that evening and next day with no recurrence. Did not seek medical treatment or care.
No additional adverse effects reported.; One patient received an improperly stored dose of VARIVAX; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug/allergy reactions, and concomitant therapies were not reported.  On 20-APR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route of administration, vaccination scheme and anatomical site of administation were not reported;  lot number S022755, expiration date 22-JUL-21) as prophylaxis. Additionally, the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the vaccine was reported as "properly stored".  The administered dose of the vaccine was stored in a temperature between 6 degrees Fahrenheit (°F) to 14 °F, in a timeframe of 90 minutes, as recorded by a data logger. The previous temperature excursion reported was 15°F to 46 °F  in a timeframe of 36 hours.  No additional adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2004USA007458:
Patient received MMR @0730 on 08/06/2002 at 13:30, patient fainted, fell, and lacerated head and right elbow. Seen in ER, suture of lacerations done. Cardiac work up consisting of treadmill stress test, echocardiogram, serial enzymes, EKG x3, continuous cardiac monitoring done while patient was admitted on cardiac floor overnight for observation. Patient did not have a cardiac event as all testing was WNL. Physicians question of patient had an adverse event from MMR. Reports his daughter had similar episode after receiving MMR vaccine.   Discharge Summary states diagnosis is Syncope.
Chief complaint: Pt received COVID booster (Pfizer) this morning @ about 10:45 am today at unknown location. (Primary was J&J per pt). No s/s noted during observation period, per pt. But once back @ work, began feeling "fuzzy"/dizzy at about 11:30. School nurse checked pt's BP: 100/60, which was about 20 points below pt's normal, per her. No indication of erratic pulse; O2 fine, per pt who said nurse also checked. Pt  point of triage call had some redness on both arms, much like when she'd had previous more severe allergic reaction to milk encounter. Denied fever, difficulty swallowing, swelling of mouth/throat; able to speak but speaking in short words/phrases.. Plan: Given pt describes s/s as progressing/worsening, has hx of severe allergic reaction, it was recommended that pt seek immediate Seek immediate medical attention. Pt gave verbal permission to speak with coworker & phone put on speaker with pt permission to discuss current medical concern. Pt & coworker educated to seek medical attention now, with coworker tasked to get pt to medical care & monitor pt on trip there for s/s of worsening/emergent need, e.g. swelling of face, throat, SOB, chest pain, increased confusion or decrease in mentation, etc. Both pt & coworker affirmed understanding & intent to seek appropriate medical attention now, likely urgent care but possibly ER, depending on where they decide is best to go. Know to call 911 if acute s/s arise en route.
Pt received vaccine approximately 6 PM. She woke up at 3 AM  feeling cold, clammy unable to feel her legs. Crawled to BG monitor-sugar level approximately 159 (normal). Crawled to bed woke up ok.
RabAvert administered in a leg; Case reference number US-BN-2022-001533 is a spontaneous case report initially received on 12-Jul-2022 from a pharmacist (reference number: USBAV22-0533) and concerns a female patient of unknown age.  The patient was immunocompromised.  Concomitant medication details were not reported.  On an unspecified date, the patient received RabAvert (Rabies Virus (Inactivated, Strain Flury LEP), batch number: Unknown), at an unknown dosage, administered in a leg, via unknown route of administration, for post-exposure immunisation against rabies due to a flying bat. As reported, the patient did not have a site for RabAvert vaccination and chose leg for administration (explicitly coded as 'Product administered at inappropriate site')  At the time of this report, it was unknown if the patient experienced any adverse event due to RabAvert vaccination.  Additional information received on 12-Jul-2022 from Bavarian Nordic included local case ID.; Reporter's Comments: On an unspecified date, a female patient of unknown age received RabAvert at an unknown dosage, administered in a leg, via unknown route of administration, for post-exposure immunisation against rabies due to a flying bat, which is considered as product administered at inappropriate site. No associated adverse events were reported. Product administered at inappropriate site is listed per company convention. The patient was immunocompromised and concomitant medication details were not reported. Product administered at inappropriate site is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: On an unspecified date, a female patient of unknown age received RabAvert at an unknown dosage, administered in a leg, via unknown route of administration, for post-exposure immunisation against rabies due to a flying bat, which is considered as product administered at inappropriate site. No associated adverse events were reported. Product administered at inappropriate site is listed per company convention. The patient was immunocompromised and concomitant medication details were not reported. Product administered at inappropriate site is not related to RabAvert, but to a human factor. The case is non-serious.