chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per mom patient had  large knot on left leg, red, hot to touch, size of baseball.
Pt immediately developed redness and swelling at the injection site with local welts, 30 seconds later. No other symptoms. Treated with ice X 30 minutes and redness and swelling subsided.
This spontaneous report as received from a nurse refers to a 12 month old patient of unknown age. On 27-AUG-2014 the patient was  vaccinated with (Oka/Merck) VARIVAX (dose, route and lot number were not reported) and (Oka/Merck) PROQUAD (dose, route and lot number were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Cough Fatigue Muscle or body aches Headaches Congestion or runny nose
Cervical lymphadenopathy and macular rash on trunk.  Present on 5/2 initially and advancing through end of May. Has follow up scheduled in June.
2 year old child inadvertently was given a quadracel injection with no reported adverse event; Initial information received on 06-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old female patient who was inadvertently given a quadracel injection with no reported adverse event ,while receiving vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Prophylactic vaccination.  On 21-Jun-2022, the patient received a  dose number 3 of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE ( lot C5970AA and expiration date:02-Feb-2024)  at a dose of 1 ml via intramuscular route in the thigh nos(vastus lateralis) for immunization.  On 21-Jun-2022, it was reported that the 2 year old child inadvertently was given a quadracel injection with no reported adverse event (accidental exposure to product) (latency: same day)following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event   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.
HEART FAILURE; This spontaneous report received from a patient concerned an 81-year-old elderly female of unspecified race and ethnicity. The patient's weight, height was not reported. The patient's concurrent conditions included heart conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown and expiry: unknown) dose was not reported, 1 total administered on 04-MAR-2021 for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The reporter mentioned that he and his wife had the vaccine administered at their home by vaccine provider. On 25-NOV-2021, his wife died of heart failure and also stated it was not from the vaccine. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211238044-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).; Reported Cause(s) of Death: HEART FAILURE
About 45 minutes after the shot, my eyes started to swell. Then my knees got red, hot and slightly swollen. I took Benadryl and my knees were better within an hour and the swelling slowly decreased in my eyes. It is now the next day and my eyes are just slightly puffy.
One week after patient noticed swelling, redness, soreness, and itchiness at injection site. Redness 5 inch diameter at injection site. Redness is still present at site of injections but soreness and itchiness as subsided. Patient took Claritin and Advil and applied ice
Red warm spot on left arm, approximately size of 4 1/2 inches, no other symptoms.
Left armpit and middle of the back of my arm is completely numb, the area surrounding the numbness burns. Started day after the vaccine and has been 14 days, still numb and burning
Patient woke up on 10/20/2020 and her arm where she received the shot was swollen, red, and hot. She had a regular doctor visit scheduled that day so she mentioned it to her doctor. He said it looked like infection but no medication needed. Patient reported in took around 6 days to clear up.
Approximately 34.5 hours after receiving vaccination, she experienced muscle cramps in her leg, runny nose, sneezing and sensation that her throat was closing. She said she may have been having a panic attack. She used her nebulizer, took benadryl and a steroid. She had her epi pen by side in case she needed it. The episode lasted 5 minutes.
The day after vaccination, redness, swelling and pain onset for 4 days.  By the 5th day it had subsided and my arm looked completely normal.  On the 6th day I developed a patchy redness at the injection site.   (today is the 6th day)
Eight days after vaccine went to emergency room with vertigo. Referred to ENT doctor - who referred me for balance testing. Diagnosis: Vestibular Neuronitis which is caused by a virus in body such as cold sores, shingles or chickenpox. Today is October 16 and I am still suffering from dizzy spells. I start balance therapy this week at a physical therapist office.
This spontaneous report was received from a registered nurse and refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated intramuscularly rather than subcutaneously with M-M-R II albumin status: recombinant human albumin (rHA), lot # N024698, expiration date: 08-SEP-2019 (exact dose was not reported) for prophylaxis. No adverse effects were reported.
24hr temp to 39.6, lethargy & won't suck x 24hr;
flu like symptoms; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in an unknown number of patients patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter had a few patients that reported a severe reaction following Shingrix, flu like symptoms that lasted several days. The reporter consented to follow up. No additional details available. The case has been linked with the case US2020244472 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020244472:same reporter
On 4/4/21 pt got 101 temp.  Next day her temp was down but she was having problems breathing.  She had to get cans of O2 to help her breathe.  Her O2 was going from the 80's to 60's.  She went to her pulmonologist on 4/22/21 pulmonologist and he sent to Hospital.  She was put on O2 and other medicines.  They did CT, X-rays, and blood work.  They found a blood clot in her lung so was admitted for treatment.  She will be there for a minimal for three more days till they can get her an O2 tank to send her home.
swelling of throat and tightness of airway .  Took 100 mg of benadryl around 4pm swelling of throat improved immediately. Air was tight most of the night the next morning took inhaler and losen up my airway
Approx 3 hrs after 2nd DTP developed limpness, paleness, projectile vomiting, elevated temp of 104 (R) & screeming episode last over 3 hrs. MD consulted & mom was advised by MD that child had a reaction to DTP.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 12-MAR-2015, the patient was vaccinated with the improperly stored dose of PNEUMOVAX 23 "10 PK 0.5 ml SD-PFS LLok wTip" lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration and anatomical location were not provided), which was stored at -2.77 Celsius Degrees for 528 hours. The type of excursion was refrigerator. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Seven days after receiving vaccine developed hives, swelling and pruritus around injection site.  Required cold pack and topical Benadryl
pt recv vax 29OCT93 & 26NOV93 pt exp h/a, blurred vision, gen pain;pt was allegedly dx w/GBS on 29NOV93;it is alleged that pt exp & cont to exp paralysis, loss of mobility, impaired, & periodic loss of equilibrium;
body aches; frequent headache; I felt nauseous; temperature was 99.6; This is a spontaneous report from a contactable consumer (patient) via from Pfizer sponsored. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on 17Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received her second shot on the 17th and had some body aches. The patient underwent lab tests and procedures which included body temperature increased: 99.6 on an unspecified date. The patient had a frequent headache and when the patient went to work today (19Apr2021) and had temperature was 99.6 so the patient could not go and felt nauseous. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
NOTICED GIANT PURPLE BRUISES ON FOREARMS, LEGS COVERED IN SMALL PURPLE SPOTS, GUMS BLEEDING AND BIG BLOOD BLISTERS INSIDE MOUTH UNDER TONGUE.
At COVID-19 Vaccine Public Health event.  Patient received her vaccine at 4:40pm on 2/21/2021.  At 4:50pm, patient reported a believed vaccination reaction.  Reported bilateral hand and forehead erythema and urticaria.  EMS Alerted, Medical Provider on-site notified, both parties attended patient.  Patient given 25mg of Benadryl PO at 4:48pm.  At 5:02, patient reported "sensation in her throat".  Patient given second dose of 25mg of Benadryl PO at 5:04pm.  Visual examination of mouth by HCP showed mild redness.  Vitals taken at 5:05pm: BP 122/82, pulse ox 97%, pulse 90.  At 5:07pm, patient reports feeling "much better", and said she felt that the Benadryl was working.  At 5:09pm, patient joking, laughing, speaking clearly.  At 5:11pm, reported her hands "looked better" and less red.  Denied throat tightness.  Notified to contact Medical Personnel if any exacerbation of symptoms, asthma, chest tightness, itching.  Patient left with her family.
Injection site rxn after a few days - that lasted 3 weeks - large knot and bluish purple color - discoloration still visible. Fine red vesicular rash around neck and on chest - felt chapped with small blisters. No fever, nausea, headache. Resolved with hydrocortisone and BENADRYL - minor discoloration visible at injection site.
Patient was mistaken for a 12 month old patient with similar name and address, mistakenly given a Influenza and Hep A vaccination. No reaction seen while under observation for 1 hour in public health clinic.
gotten the flu everytime i got the shot; Initial information received on 17-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who gotten the flu everytime i got the shot after receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant disease or risk factor and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine by unknown manufacturer (strength, formulation, dose,  batch number and expiry date: unknown) via subcutaneous route in unknown administration site for prophylactic vaccination.  On an unknown date the patient gotten the flu everytime i got the shot (influenza) (unknown latency). It was reported that patient got the flu everytime  he got the shot... so no thanks. He is not falling for that trick again.   It is unknown if there were lab data/results available.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (gotten the flu everytime i got the shot).  At time of reporting, the outcome was Unknown for the event gotten the flu everytime i got the shot.
BODY ACHE; HEADACHE; FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch no was not reported ,The company is unable to performed follow up to request batch /Lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced body ache, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever and body ache was not reported. This report was non-serious.
Vomited about 10 min. after vaccine and continued to vomit intermittently for 5 hrs. Developed hive-like rash on trunk and extremities within 1 hour of vaccine which persisted about 5 hrs.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 5/7/2023 Discharge Date: May 11, 2023  PRESENTING PROBLEM: Shortness of breath [R06.02] COPD with acute exacerbation [J44.1] COPD exacerbation [J44.1]   HOSPITAL COURSE: Patient is a 76 y.o. female with past medical history significant for COPD, CAD - MI (2012), Afib, HTN, and HLD, who presented with increasing shortness of breath since 5/3 as well as productive cough with yellow sputum. She has noticed some wheezing. Pt Pt is on 3L O2 at baseline.  Pt is tachycardic with afib RVR in ED. Pt ststaes she was feeling her heart race a little earlier in the day but no longer symptomatic. Denies headaches, dizziness,  chest pain, N/V, abdominal pain, diarrhea, constipation and leg swelling.    In ED, CXR without evidence of pneumonia. There is patchy areas of mild interstitial prominence suggestive of inflammation. COVID-PCR is positive. BNP 4400, Troponins unremarkable. No leukocytosis. She was tachycardiac and was found in A-fib with RVR. The patient was given nebulizers as well as solu-medrol 125mg IV. Lopressor 5mg IV push given for rate control.    The patient was initially admitted for chronic obstructive pulmonary disease exacerbation as well as COVID infection.  She was initiated on remdesivir and switched to Decadron.  A 2D echo was obtained and showed normal ejection fraction but elevated RVSP of 53 mmHg.  The patient's shortness of breath did improve after few doses of IV Lasix.  Throughout her stay, the patient maintained oxygenation above 90% on 3 L of nasal cannula which is her baseline.  The patient was eventually discharged home in a stable condition on Decadron as well as Lasix.  She was instructed to follow up with Pulmonary Medicine for further treatment of her pulmonary hypertension.
Hives, clammy, dizziness, tongue/throat swelling, facial swelling, disoriented.
Vaccines given - 1/7/14. ED visit on 1/12/14 - for vomiting and hematochezia. Admitted to hospital for evaluation and possible surgery. Pt presently monitored at hospital.
red raised area, three inches long, two inches wide.    Not painful, itchy, red, raised
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a ten-year-old female. Neither the patient's past medical history nor any concomitant medications were reported. The product expired on 15-Dec-2010. The patient received the expired FLUMIST on 21-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Information has been received from a physician assistant concerning a 24 month old male who on 20-AUG-2010 was vaccinated subcutaneously with a first dose of VARIVAX (Merck) (dose not reported, lot # 665960/1742Y). The patient experienced a "breakout of lesions around injection site several days after administration of VARIVAX (Merck)". At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. This is an amended report. "Vaccinated at: Unknown and vaccine purchased with: Unknown" have been added. Additional information has been requested.
Woke up in morning to get ready for work.  Went into the bathroom to urinate, had crushing chest pain, got back to bed.  Subsided after after a couple minutes.  Very scary, took my breath away.  I cried and called into work to say I wouldn't be in.  Called MD clinic when they opened and got seen.  As an RN, I knew the serious nature of heat pain.
Bells palsy; miscarriage; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 08Apr2021 at 17:00 (Lot Number: ER8729) (at the age of 30-year-old) as single dose for COVID-19 immunisation. The patient was pregnant at time of vaccination, last menstrual date was 20Feb2021, due date was 27Nov2021, the patient was 6 weeks pregnant at the onset of the events. The patient did not test positive to COVID-19, pre or post vaccination. Medical history was none. No known allergies. There were no concomitant medications.  On 15Apr2021 at 07:00, the patient experienced Bell's palsy and miscarriage.  the events required emergency room visit and physician office visit, the patient was hospitalized for one day due to the events.  Therapeutic measures were taken as a result of the events and included ultrasound. The patient outcome of the events  not recovered.
Massive headache. Began forgetting things. She was asking the same questions over, and over. She never showed signs of concern over her memory.
Event started with tingling in lower back and by the time I got to the car I had extreme pain in almost my entire body that felt like pins.  It was so extreme that I headed to the ER.  The ER was about 15 minutes away and by the time I got there the pain was subsiding and before I got out of the car the pain was gone so I didn't go in.  It ended almost as quickly as it started.
6 hours after injection I started itching all over, turning red, had a rash, my chest got tight, no difficulty breathing. I went to sleep and woke up very hot, some sweating. Had to get out from under the cover, cooled off in a few minutes. Eyes are burning, some redness, rash like on arms.
felt dizzy-post vax-eyes rolled up in head & fell over sideways-body went limp & then started shaking-then went stiff & blue white around mouth given 02, stiff neck-glazed eyes staring straight ahead lasting over 1hr;h/a, light sensitive, t
10:45a 32yo female complains of lite chest pain ofter receiving 2nd dose of Moderna. Pain level is a 4 out of 10 on a 0-10 pain scale 10 being the worst. Vital signs 118/86, 88, RR16. Patient will stay in observation for 30 minutes breathing is normal and unlabored. 11:20a vital signs were rechecked B/P 100/86, HR 84, RR16 pain level is a 3 out of 10, 10 being the worst. Patient states she felt good, patient was discharged to go home. Patient was educated on the side effect and allergic reaction if symptoms continue to call 911.
This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Since 22-AUG-2016, the patients were vaccinated with the doses of the improperly stored ROTATEQ (orally, lot # reported as M017514, expiration date 07-NOV-2017; dose was not reported). The vaccines were stored in 35.8 F for one hour and 15 minutes. All the vaccines were supported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (side effects) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (side effects). At the time of the report, ADVERSE EVENT (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Discharge Provider: MD Primary Care Provider: PA Admission Date: 2/17/2023 Discharge Date: 2/19/2023   Clinical Narrative: Acute encephalopathy likely metabolic on admission resolved, patient is awake alert oriented x3, able to engage in a conversation and answer questions.  CT scan of the head done on admission was unremarkable She was started on IV ceftriaxone for urinary tract infection, she is afebrile no leukocytosis, blood cultures are negative to date, urine culture also pending to be completed.  Patient is asymptomatic presently in and she has completed 3 days of IV ceftriaxone, will give a dose of fosfomycin and discharged without antibiotics.  Family physician to follow up on finalization of cultures and the need for continued antibiotics COVID-19 positive of which she is asymptomatic no shortness of breath no chest pain no significant cough, she is advised to continue to follow social distancing Constipation as evident on abdominal x-ray patient received MiraLax and later Doculax suppository I was able to have bowel movement.  She can continue with p.r.n. MiraLax at home
Patient received 2nd dose Moderna vaccine early (day 20) following initial dose. Patient has had no evidence of adverse reactions at present. Patient is being monitored by caregivers and daily per agency and has been instructed to notify home health of any adverse reactions noted in the future.
Same day of vaccine, seemed sore around injection site, 6-7 hours later was hit in the arm at work, hurt worse afterwards. The night of 7-14-2023 red area around injection site and felt worse. On 7-17-2023 woke up with a migraine and prism type vision, changes in OD, vomiting.
Diaphoresis and lightheadedness shortly after Tdap administration, resolved after 15 minutes. Fever 103 by history 18 hours after injection, lasted 2 days, also diaphoresis.