chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 2 minutes after the shot was administered I felt as if I was going to lose consciousness and my airways and tongue began to swell. I immediately took Prednisone and benadryl. I had premedicated before getting the shot due to an increased risk of allergic reaction given my history of anaphylactic responses to other allergens. I have never reacted to a vaccine before. The pre-medications allowed me to treat the reaction with benadryl, prednisone, and albuterol without the need for an Epi pen. I started with 10mg of prednisone and 12.5mg of benadryl (chewable). I took additional doses every 15 min as the reactions continued. I had another wave of reaction where I felt like I would lose conciseness 15 minutes after the shot was administered. I went home after 30 minutes and continued to monitor the reactions and take additional interventions including: benadryl, prednisone, nasal cromolyn sodium, albuterol, Pepcid AC, & oral cromolyn sodium. At 4:45pm I developed hives and treated with cromolyn sodium applied directly to the hives. Digestive upset started around 8pm.
a drop of vaccine came out of the skin; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 52-year-old male patient who received Herpes zoster (Shingrix) (batch number 7Y359, expiry date 15th November 2022) for prophylaxis.   On 24th March 2021, the patient received the 1st dose of Shingrix. On 24th March 2021, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were provided as follows: The pharmacist reported that, the patient received Shingrix vaccine at their pharmacy and a drop of vaccine came out of the skin after administration, which led to accidental underdose. The pharmacist asked does the patient need to be revaccinated. No further information reported. The reporter consented to follow up.
Site of injection was sore the next morning and has progressively gotten. Patient has pain when he touches the area or sleeps on his left side.
headache; tenderness (sore) in the arm that received the injection; feeling achy in my back; feeling achy in my back and large joints (knees and elbows); This is a spontaneous report from a contactable consumer. A male patient (Age: 46; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 23Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient experienced headache, tenderness (sore) in the arm that received the injection and feeling achy in my back and large joints (knees and elbows). Patient took an ibuprofen and the headache and soreness started to go away after a couple of hours. Event took place after use of product. The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt stated with in 6 hours had fever, chills, muscle aches, cough, headache, runny nose, diarrhea, blood pressure increase, hard to breath, weakness and dizziness.  she did start to feel  better and when she took her blood pressure medication her blood pressure did come back down before she thought about going to hospital -- she did go to md office to have md document her reaction in her chart.  We called office also to determine if they gave her high dose last year to make sure if it was a specific reaction to high dose. As of right now , the office had not called to verify
Shortly after the vaccine, she lost color in her face, she said her vision went blurry, then she vomited.  Just a few minutes after vomiting, she said she felt fine.  She waited around with her grandmother for another 20 minutes, then left, feeling well.
Arm was red from shoulder to elbow; Weakness; Lost her appetite; Pajamas were wet like she had a fever; Wart in between shoulder and arm; Dizziness; Arm was itching underneath; Joint pain; Little drowsy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Little drowsy), ERYTHEMA (Arm was red from shoulder to elbow), ASTHENIA (Weakness), DECREASED APPETITE (Lost her appetite) and HYPERHIDROSIS (Pajamas were wet like she had a fever) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced SOMNOLENCE (Little drowsy), PRURITUS (Arm was itching underneath) and ARTHRALGIA (Joint pain). On 20-Feb-2021, the patient experienced ERYTHEMA (Arm was red from shoulder to elbow), ASTHENIA (Weakness), DECREASED APPETITE (Lost her appetite), HYPERHIDROSIS (Pajamas were wet like she had a fever), SKIN PAPILLOMA (Wart in between shoulder and arm) and DIZZINESS (Dizziness). On 19-Feb-2021, SOMNOLENCE (Little drowsy) had resolved. On 20-Feb-2021, HYPERHIDROSIS (Pajamas were wet like she had a fever) had resolved. On 21-Feb-2021, DECREASED APPETITE (Lost her appetite) had resolved. At the time of the report, ERYTHEMA (Arm was red from shoulder to elbow), ASTHENIA (Weakness), SKIN PAPILLOMA (Wart in between shoulder and arm), DIZZINESS (Dizziness), PRURITUS (Arm was itching underneath) and ARTHRALGIA (Joint pain) outcome was unknown.            Treatment and concomitant medications were not provided by reporter.
stroke like symptoms; seizures; the wellbutrin most likely interacted with the mRNA vaccine; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (Age: 38, Unit: Unknown) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization and bupropion hydrochloride (WELLBUTRIN), via an unspecified route of administration from an unspecified date to an unspecified date (reported as to approximately being taken for a year), at 150 mg for an unspecified indication. The patient's medical history and concomitant medications were not reported.  On an unspecified date, about 10 days after the vaccine the patient presented to the ER with stroke like symptoms and developed seizures.  The patient had to be put into a medically induced coma and intubated.  The patient had no previous history of seizures. His doctor told him that the wellbutrin most likely interacted with the mRNA vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Cold, cough, next day had a fever of 102, runny nose, coughing, cold.  A week later still had chronic cough, low grade fever, throat starting feeling sore, sweats, lost my voice. Received an antobotic on 12/22/2009 from doctor along with cough syrup. 12/24/2009 still having sweats, lost voice, and still coughing, blowing my nose.  Whatever this is is not letting go. Missing out on all holiday celebration, as people don't want to be around sick people.
On are about 10FEB2023 or a day or two before I noticed out of the blue something strange on my neck quite a large lump and I visited my doctor who saw it himself we understood it to be on my thyroid and a thyroid ultrasound was ordered for 22FEB2023. The imaging showed a very large nodule on my thyroid as well as three smaller ones on the other side not noticed or seen before, the radiology report looked very benign but why they appeared is unknown.
Inadvertently gave MMRV which is not for the age group of 17 and older, also in giving the MMRV, this nurse also gave a dose of Varicella to the client.   After giving the doses Supervisor notified, as well as Dr. notified.  Contact made to current residence of patient.
About 10 hours after the injection, I got slammed with the following: fever, chills, headache, upset stomach, malaise, sore injection site, no appetite, uncontrollable shivering and body aches.  I slept as much as I was able to.  These lasted over 24 hours.  Then it was reduced to sore injection site, malaise, no appetite and very tender entire abdomen area; sternum to pubic bone, pelvis to pelvis.  That was another 24 hours.  By Saturday I was feeling better.  Still needed a nap in the afternoon to recover from very little activity.  All is good now.  With my first injection, in December, I just had a sore injection site that was very red and hot to the touch, body aches and malaise that lasted about 48 hours.
Information has been received from a office manager concerning a 23 year old female who on 19-DEC-2007 was vaccinated (route and site not reported) with the 1st dose of GARDASIL (lot# not reported). The patient was not on any concomitant medications. On 19-DEC-2007, a couple of hours post vaccination, the patient developed pain in injection site arm, the pain went all the way up to her neck. The patient was given ibuprofen (manufacturer not specified) but it did not work. The patient contacted her family practitioner and was given VICODIN (manufacturer not specified) and that worked for the pain. No lab diagnostic test were performed. The patient received medical attention via a call to the clinic. The patient recovered on unknown date. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2008.  Information has been received from an office manager concerning a 23 year old female who on 19-DEC-2007 was vaccinated (IM in deltoid) with the 1st dose of GARDASIL (lot# 558563/1063U).  The patient was not on any concomitant medications.  On 19-DEC-2007, a couple of hours post vaccination, the patient developed pain in injection site arm, the pain went all the wasy up to her neck.  The patient was given IBUPROFEN (manufacturer not specified) but it did not work.  The patient contacted her family practitioner and was given VICODIN (manufacturer not specified) and that worked for the pain.  No lab diagnostic test were performed.  The patient received medical attention via a call to the clinic.  The patient recovered on 21-DEC-2007.  Additional information has been requested.
Rash starting on neck and face and spreading to rest of body. No urticaria. Seen by dermatologist and given hydrocortisone cream.
Patient stated that her feet swelled up on the night after receiving the vaccine. She stated that the swelling subsided by the next day.
This spontaneous report as received from a other health professional refers to 12 patients of unknown age. On an unknown date the patient were vaccinated with improperly stored VARIVAX lot # N002203, expiration date 19-JAN-2019 and lot # N007930, expiration date 18-MAR-2019 for prophylaxis. Concomitant therapies included properly stored sterile diluent (MERCK). Administered doses of vaccines experienced the temperature excursion of 32.5 degrees Fahrenheit for 4 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA000281.
Patient did not have any symptoms or adverse effects of administration; Caller is a nurse who reports an expired dose of PROQUAD was given to a patient today.; Information has been received from a nurse regarding a 4-years-old female patient (conflicting information, also reported as 5 years old). Patient's concomitant vaccines included diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid(PEDIARIX). The patient's medical history, drug allergies, previously drug reactions and concurrent conditions were not reported.  On 19-APR-2022, the patient was vaccinated with an expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) 0.5 ml once, for prophylaxis, lot number T032144 with expiration date in 20-MAR-2022, administered by route/site reported as "LOT" which was reconstituted with sterile diluent (MERCK STERILE DILUENT) lot number W000452 with expiration date on 23-JUL-2024, with route/site reported as "ROT" (strength, dose, route of administration, strength and anatomical location not reported) (expired vaccine administered).  It was reported that organization workflow policy was not followed and immunization was missed when checking expired terms. Documentation completed at primary care physician (PCP) site and proper workflow trained was completed again.  It was reported that the patient did not have any symptoms or adverse effects of administration.
Pain in left arm down to finger tips, shoulder pain, neck pain.  Severe restriction of range of motion.  Treated with steroids with temporary improvement.  As soon as steroids stopped, symptoms returned.
Headache, NauseaVomiting, CHILLS AND FATIGUE Narrative:
Hives started 11 days after Moderna booster shot. First head and neck and spread to other areas.  Been going on 7 weeks now.
Total body rash, fever 101, nausea, vomiting, lasted 48 hours so far, Dramamine, Phenergan 25mg TID.
urticaria covering body began 4 days p/vax @ inj site; eventual dx of mastocytosis;
5/15/21 - 2nd Moderna shot given to me.    No reaction 1st 15 minutes.    5/15/21 - small fever in the evening    5/16/21  In bed all day with Fever and Fatigue.     5/20/21 Becoming short of breathe going upstairs in my residence.   Complained to my wife after a couple of days saying I was getting winded just climbing the stairs.   I thought maybe it was  common chest cold.   5/29/21 1:00 am - woke up to 102 degree fever.    Fever went down to 99 and up to 100.8 over the next 4 days cycling throughout the day and night.     Shortness of breath was getting a little worse and it would take 10 seconds to recover going up the stairs in my home, after several deep breathes.    June 1st, I went to CVC pharmacy to take a COVID19 test.   The scheduled me for the next morning, June 2, 2021 at 10:00 am.   I completed that test and returned home.  At about 2:00 - 2:30 pm, I stood up from the couch and walked out to my front porch.  I bent over to pick up some light items from the porch so the gardener could trim the bushes near the porch.  As I walked to the garage (main front 2 car entrance), I suddenly became very short of breathe, my heart began racing, and I could not get a full breathe.    I walked slowly inside my house and used my blood pressure cuff and oximeter.  Blood pressure was at 170/121  heart rate 112, and the oximeter showed oxygen level 75  %SPo2 with heart rate 110.    I was taken directly to the Emergency Room where X-ray and CT scans showed I had numerous blood clots throughout my lung arteries.   I am on oxygen and blood thinners for an indefinite amount of time.
cold sensation -- uncontrolled shaking -- projectile vomiting --  temp 101.3 - body aches -- lower extremity mottling -- severe headache
Hospitalized;  COVID-19 positive;  fully vaccinated.  BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider: DO Admission Date: 8/29/2021 Discharge Date: 9/5/2021  1:34 PM DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hyponatremia [E87.1] Non-traumatic rhabdomyolysis [M62.82] Pneumonia of left upper lobe due to infectious organism [J18.9] Acute renal failure superimposed on stage 3b chronic kidney disease, unspecified acute renal failure type [N17.9, N18.32] COVID-19 [U07.1] Acute hypoxemic respiratory failure [J96.01]   HOSPITAL COURSE: Patient is an 82 y.o. male with a past medical history significant for chronic atrial fibrillation refractive to aggressive medical therapy status post AV node ablation and biventricular pacemaker placement, currently undergoing outpatient eval for transcatheter MVR, aortic valve replacement, CABG in March 2011, obstructive sleep apnea (on CPAP), hypertension, transitional cell cancer of the bladder (2000), DM 2, COPD, CKD stage IIIA,  throat cancer status post surgery and chemotherapy (1999) who presented to the emergency department 8/29 due to dyspnea and weakness.   The patient lives at home and is a caretaker for his wife who has dementia.  On Friday evening patient tried to get up to go to the bathroom and felt too weak in his legs and lowered himself to the ground.  He was unable to get up.  The patient slept on the floor overnight.  The next day his wife called their daughter who told them to call EMS.  EMS came and assisted the patient to get up.  He thought he was doing better.  Over the last 24 hours patient continued to have weakness with increased dyspnea.  Patient reported increased orthopnea, productive cough with gray phlegm, and shortness of breath.  He reported he has had a chronic cough for the last 2-3 months but it has recently worsened.  However reported that he has been 1-2 lb above his dry weight recently. He was vaccinated with Moderna in March/April.   In the emergency department the patient was febrile and hypoxic. Chest x-ray showed changes consistent with CHF.  Labs otherwise significant for sodium of 129, WBC 7.2, COVID swab obtained was positive.  Patient was given Decadron and 500 mL of IV fluid.   Given worse LUL airspace disease and elevated procalcitonin patient was started on Ceftriaxone and Azithromycin for CAP coverage. He was continued on Dexamethasone for possible COVID pneumonia. He was diuresed with IV Furosemide.  Noted to be hyperglycemic and was on steroids, the diabetes service was consulted. He developed elevation in creatinine. His lasix was help. He was given gentle IV hydration. It improved his AKI. He finished 5 days of antibiotics. His oral lasix was restarted. His kidney function returned to baseline. His oxygen requirement went down to 0.5 liters.  PT evaluated him and recommended discharge to inpatient rehab. PMR consulted. He was discharged to rehab with oral steroids for 2 more days.
An 8 year old was administered 0.25ml of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (An 8 year old was administered 0.25ml of the Moderna COVID-19 vaccine) in an 8-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 10-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (An 8 year old was administered 0.25ml of the Moderna COVID-19 vaccine). On 10-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (An 8 year old was administered 0.25ml of the Moderna COVID-19 vaccine) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.  The patient did not experience any side effects.
pt recvd vax 14AUG90 & on 18SEP90 pregnancy test was pos; during pregnancy devel hypertens; 1JUN91 delivered a full-term 10 pound 2 ounce;
severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diarrhea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     codine shellfish.  Concurrent medical conditions included Drug allergy (codine) and Shellfish allergy.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (severe diarrhea). On 23-May-2021, DIARRHOEA (severe diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information was provided.
This spontaneous report as received from a currently 88 years old female consumer reporting on herself with hypertension and without any pertinent drug reactions or allergies. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength, route, lot number and expiration date were not reported). Secondary therapies were not reported. Concomitant therapies included pravastatin sodium, metoprolol, benazepril hydrochloride and Warfarin. The consumer stated that "a few weeks ago", she developed a rash underneath her breast that was "red blood". The consumer stated that she saw an unspecified pharmacist on an unspecified date, in regards to the reaction and they instructed her to use an antibacterial ointment (manufacturer unknown) on the rash. The consumer stated that the antibacterial ointment "did not do anything". At the time of the report, the rash was still present. No labs diagnostics were performed. Additional information is not expected.
patient felt lighte headed thought he was going to pass out, given amonia sulfate salts did improve given water states" I am stressed and dehydrated. VSS 109/70,60,18 98%, did stay in clinic for 30min  was discharged without any issues.
Area at inj. site sore. Feels warm. No temp taken. C/o slight ha.
This spontaneous report as received from an office administrator refers to an unspecified number of patients of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date starting February 2015, the patients were vaccinated with an unspecified number of doses of oral, ROTATEQ (lot # K001453, exp.date 21-NOV-2015 (dose and dose number were not provided). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of two reports received from the same reporter (MARRS # 1509USA001811). Additional information has been requested.
Severe arm pain at site of injection.  Has become worse over time.  Unable to lift arm above head or raise behind back.
Pain and tingling on top and back of head, pain in lumbar area of back, muscle weakness, nausea, dizziness.
Information has been received from a physician concerning a 5 year old male who on 11/11/99 was vaccinated with a dose of varicella virus vaccine live. The patient presented to the office on 6/2/04 and was diagnosed with varicella breakthrough, described as 75-100 lesions on the child's body. The patient was afebrile. There were no diagnostic laboratory tests performed. It was noted that the physician did not provide any treatment at the time of visit. Unspecified medical attention was sought. The outcome was not recovered. there was no product quality complaint involved. Additional information has been requested.