chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1-2 weeks prior to event noted lightheadedness, palpitations. Had cardiology evaluation with normal chest x-ray, ECG, Echocardiogram with bubble study. On morning of event, awoke and felt off with noted right arm/leg weakness. Taken to ER where stroke protocol activated. CT, CT angiogram, IR arteriogram and MRI obtained. CT angiogram initially concerning for sigmoid sinus thrombosis. IR arteriogram by interventional neurologist noted sluggish flow in portions of middle cerebral artery and TPA administered. MRI ultimately noted ischemia in areas supplied by posterior cerebral artery.  Prolonged weakness and dyskinesia as sequelae of event. Follow-up MRI by neurology noted: At the site of previously seen acute (diffusion-restricting) infarction of LEFT PCA territory including LEFT thalamus, posterior hippocampus, and calcarine cortex, there is now a small (9 mm) cavity of the dorsal lateral LEFT thalamus, with adjacent mild gliosis extending into the PLIC and centrum semiovale, and sclerosis/encephalomalacia (severe volume loss) of the posteriormost LEFT hippocampus.
This case was reported by a consumer via call center representative and described the occurrence of epistaxis in a 28-year-old male patient who received Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. On 16th November 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On 16th November 2018, 6 hrs after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced epistaxis. On an unknown date, the outcome of the epistaxis was unknown. It was unknown if the reporter considered the epistaxis to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: The patient got flu vaccine and 6 hrs after the injection got a nosebleed and had 26 major nose bleeds since then. The patient never had issues with nosebleeds until after receiving the flu vaccine. No further details were reported regarding the event. The reporter did not consent to follow up.
90 y.o. Caucasian male who presents with aggressive behavior toward family today where police were called to intervene. History is significant for chronic afib not on anticoagulation due to patient/family decision, left basal ganglia cardioembolic stroke in Oct. 2021, seizure disorder on keppra, brain compression from SDH requiring Burr holes (2020), HTN, BPH, femur fracture (2017), TAVR (2020), diverticulosis with hemorrhage and duodenal ulcer, tx lyme disease.
This spontaneous report was received from a pharmacist via a company employee, referring to a non-pregnant female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 PFU, subcutaneous (dose, anatomical location and lot number were not reported). Concomitant medications were not reported. The patient came into the pharmacy on 20-JUN-2016, reporting that she had 'red welts' on or near the injection site of ZOSTAVAX vaccination. The pharmacist advised the patient to use BENADRYL and to consult with her prescribing physician, however the patient did not seek medical attention and no treatment was given. At the time of reporting, the outcome of the event and its causal relationship with the vaccine were unknown. Additional information has been requested.
Possible vaccine failure. Varicella lesions erupted 1/22/05. Exposed to sister with varicella eruption 1/3/05. 50 plus lesions.
3/21/2023 I had a tingly sensation in my nose. That night, I got an alert on my phone saying I had been exposed to COVID. I tested negative until 3/23/23 and I tested positive. I had a headache and a little bit of fatigue. I had a telehealth already scheduled and was prescribed PAXLOVID. 3/24/23 I began taking the PAXLOVID. I took the medication for the full five days.
2/17/2023 I woke up feeling out of sorts. I had cold symptoms. I was achy, congested and a cough. On 2/19/23 I did an at home COVID test which was positive. I had an urgent care visit on 2/20/23. I had another positive COVID test. The doctor prescribed PAXLOVID which I began taking that day. Within 24 hours, my cold like symptoms began to dissipate. I felt like I was returning to normal. I took the full dosage and carried on.
pt recvd vax 5AUG92 & the evening of 5AUG92 mom reports pt had severe hives over body; pt taken to hosp ER; no treatment given & mom told to put a topical lotion on skin (calacort & a corn starch paste); hives lasted for 3 days;
slight swelling on the first dose; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of unspecified age received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had taken both doses of the Pfizer covid vaccine and did not experience any side effects like everybody else. She stated that she is concerned since everyone she had talked to who received the vaccine experienced some kind of side effects (fever, chills, body ache) and was wondering if the vaccine might not be working. She only experienced slight swelling on the first dose. Outcome of the event was unknown.  Information about lot/batch number has been requested.
PATIENT PASSED OUT AND INJURIED HIMSELF DUE TO FALL DURING MANDATORY WAITING PERIOD. HE REGAINED CONSCIOUSNESS RIGHT AWAY. PARAMEDICS CAME AND CHECKED HIS VITAL. HE DID NOT GO TO HOSPITAL AND LEFT THE PHARMACY.
The patient stated that the morning after the vaccine, she fell and felt weak. She said she could not open her eyes or talk but was concious. She said she had a bad headache and felt tired that day, and her arm was in extreme pain, and had bodyaches. She stated "I felt like I was going to die". She said she started to feel better on Sunday and on Monday she said she felt back to normal.
Severe body aches, bad headache, bad chills, lack of energy. I woke up at 4:30am the morning after receiving the vaccine needing to use the restroom, but I could barely get out of bed because of my severe body aches and lack of energy. When I did manage to get out of bed, I struggled to even stand up. I took 800mg of ibuprofen at that time (around 4:30am) for the pain, which helped. I spent more than the first half of my day in bed under layers of blankets until about 3:00pm, where I finally felt good enough to get out of bed. I didn?t feel the body aches completely go away until the morning of the 8th, 3 days after receiving the vaccine.
On the first 3 days had swelling and pain in right deltoid (no erythema or fluctuance) making it very difficult to sleep. Things calmed down but starting 1/5/22 developed paresthesias in my right arm and hand. On 2/15/22 I had an episode of new-onset AFib which prompted an ED visit and which resolved with metoprolol.  The question of vaccine-induced myocarditis was raised; on a Zio and will have an echo soon
Imovax that expired 17June2022 was given to a patient with no reported adverse event; Initial information was received on 24-Jul-2022 regarding an unsolicited valid non-serious case received from other health professional via call center.   This case involves a 21 years old female patient who experienced imovax that expired 17june2022 was given to a patient with no reported adverse event while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 23-Jul-2022, the patient received 0.25 ml of suspect RABIES (HDC) VACCINE (lot T1C663M, expiry 17-jun-22) (strength: unknown) via intramuscular route in unknown administration site for Immunization.    On 23-JUL-2022 the patient developed a non-serious imovax that expired 17june2022 was given to a patient with no reported adverse event (expired product administered) (latency same day) following the administration of RABIES (HDC) VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event imovax that expired 17june2022 was given to a patient with no reported adverse 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Soon after IM vaccine c/o sore & swollen arm for 2 days. Also felt weak, shaky and tired for those 2 days
Rash at injection site at 48 hrs, gone within a day. Rash across cheeks/nose on day 5/6, gone by day 7. Called clinic and was told to use hydrocortisone cream. Used cream on rash on face. No fever with rash, not itchy or painful.
Is it normal to have fatigue after getting your Shingrix?; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a adult patient 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 fatigue. On an unknown date, the outcome of the fatigue was unknown.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had fatigue. The reporter asked was it normal to have fatigue after getting your Shingrix.
After approximately the next day after injection I noticed congestion but not bad. It progressed to needing medical attention. I was concerned if it was the injection or if I had upper respiratory infection or bronchitis. Caregiver said she was certain it was a reaction to the vaccine shot. Symptoms included congestion, coughing phlegm, nasal congestion, chest soreness due to cough. Prescribed Prednisone. My symptoms lasted 2-3 weeks. After my booster shot in December of 2021, I had a breakthrough infection of COVID in January of 2022. My symptoms included fever, body and very intense joint aches that were debilitating. Nausea and cough. A lot of phlegm. Fatigue. Unable to work because I was a caregiver. It took about 6 weeks before I was well enough to work. I continue to have moderate fatigue. Able to work now, but still fatigued.
Five minutes after the vaccine was administered, my throat tightened and I was having difficulty swallowing. I took Benadryl and the symptoms minimized.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In approximately September 2017 (reported as "fall of 2017"), the pt was vaccinated with ZOSTAVAX for routine adult health maintenance and for its intended purpose: for the prevention of shingles (herpes zoster) (strength, dose, route, lot number and expiration date were not provided). In May of 2018, the pt developed shingles and she was subsequently hospitalized in June of 2018 for 4 days. The shingles had affected her neurologically by causing numbness in her feet and legs causing her to trip often. She was also having pain in her midriff area down her back to the point where she cannot sit, stand, walk, drive or work. The patient, a self-professed workaholic, has been unable to work. On an unknown date, the pt became clinically depressed and had to have eye movement desensitization and reprocessing (EMDR) treatments for the depression. As a direct and proximate result of ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using The Company's product. The patient also experienced mental and emotional distress due to the resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, 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 also suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles, numbness in her feet and legs causing her to trip often, and depression was not recovered. The reporter considered the events to be related to ZOSTAVAX. Shingles, numbness in feet and legs causing her to trip often, and depression were considered disabling due to permanent personal injuries and because the patient was unable to work. Additional information has been requested.
Tdap administered approx 9:30AM. Went home, ate complained of slight headache. Dad gave Tylenol and took to school. At approx 1:50pm after gym class became dizzy, passed out, fell to ground. Alert in seconds with laceration to lip. Patient reported to school nurse feeling a headache/pain just prior to blacking out. Child was taken to ER via ambulance where he was examined. Cat scan was done. Negative per father. 3 stitches to lip were done. Patient was discharged to home. Had low grade fever with myalgia and dizziness 2 hours to immunization in AM per ER report.
Just moped around the house for the day; Woke up tired; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (Just moped around the house for the day), FATIGUE (Woke up tired) and HEADACHE (Slight headache) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced DEPRESSED MOOD (Just moped around the house for the day), FATIGUE (Woke up tired) and HEADACHE (Slight headache). On 24-Jan-2021, DEPRESSED MOOD (Just moped around the house for the day), FATIGUE (Woke up tired) and HEADACHE (Slight headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The patient did not receive any treatment.  The patient received the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) on 17-Feb-2021.
Approximately 2 weeks after receiving the meningococcal vaccination and tetanus vaccinations, patient developed optic neuritis.4/15/09-records received for DOS 1/9-1/14/09-DC DX:Bilateral optic neuritis. Presented with 1 week history of headache and 4 day history of increasing blurred vision. Began with right-sided frontal headaches. Mild right facial swelling. Initially diagnosed with sinusitis. Noted to have papilledema with normal pressures.
I have sores on my lip that appear to be a herpes (HSV-1) response to my body being stressed from the vaccine. They are irritating, liquid filled sores on the right side of my mouth where my upper and lower lips merge. I am  currently treating with medicated lip balm.  I also had common, mild symptoms including fever, sweats/chills, exhaustion and pain at injection site. Those side effects have gone away.
pt recv 3rd dose of vax & exp whole arm ache (localized reaction) & exertional dyspnea;
Shingles in right V2 distribution with onset 36 hours after second Moderna vaccine shot. Required immediate treatment with Acyclovir with full recovery within 7 days
a mild full body rash/rash on body; received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a mild full body rash/rash on body on 20Dec2020 and took diphenhydramine hydrochloride (BENADRYL) and rash went away, seemed to be a mild reaction and came to work and had nothing to do with work environment. The outcome of event was recovering.   Information on the Lot/Batch number has been requested.
No adverse effects were reported in the patient.; a patient received one dose each of PROQUAD and VARIVAX on 23-APR-2019.; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's historical conditions, previous drug reactions, allergies, concurrent condition and concomitant medications were not provided.  On 23-APR-2019, the patient was vaccinated one dose each of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneously (strength and dose were not reported; lot # S000622 and expiration date 06-JUL-2020) and varicella virus vaccine live (oka/merck) (VARIVAX) (strength, doses, route of administration were not reported; lot number R030610 and expiration date 23-OCT-2020) (overdose); both as prophylaxis. No adverse effects were reported in the patient.
acute onset of hives on arms only on 7/6/22; gradual daily worsening leading to widespread hives that did not respond to oral antihistamines throughout July & August 2022; worsened to include orbital edema and angioedema of lips and face in September 2022; continued widespread, unresponsive hives through the fall months; December 2022, legs nearly entirely covered with hives, swollen, and very painful. The only times hives were alleviated were when I was on prescribed oral steroid therapy. I recieved Solu-Medrol and oral prednisone monthly from July 2022 through January 2023. I was seen by an allergist who tried a myriad of medications, none of which worked to eliminate the hives. Diagnosed with chronic dermatographic urticaria by the allergist & was told I could not receive any further steroids. This allergist suspected the hives were the result of the Covid booster I received in March 2022. Trial of Xolair in January and March 2023 without success, however, it can take months to be effective. No further doses of Xolair until 7/31/2023. Seen by a 2nd allergist June 2023 for 2nd opinion. Diagnosed with chronic spontaneous urticaria & 2nd allergist agreed likely due to reaction from Covid booster. I am at max dose of Zyrtec (4 tablets daily) & famotidine (2 tablets daily), as well as hydroxyzine at bed time, diphenhydramine as needed, all just to control the hives. I continue to have hives daily & I am waiting for my insurance to approve monthly Xolair. If, after a 6 month trial of Xolair, I fail to improve then I will begin cyclosporine which has a much higher side effect profile and requires routine lab monitoring.
The patient arm has a red rash, is hot and swollen feels like a black and blue. Patient whole arm feels like a black and blue. This all started feeling this way within half hour. Patient had flu shots before, and the pneumonia shot last year. She has never had this type of reaction before. It still feels very hot. Patient has put some cortisone, ice on the area, and will take some BENADRYL. She will also mark the area to see in if get bigger or not. Patient is home tomorrow, will see how it is upon awakening. If it gets bigger or smaller she will call us and let us know right away. If the area gets any larger she will go to the center right away.
Immediate reaction burning in wrist, light headedness, feeling of confusion, out of it, strange, tingling of tongue and face, overall tingling starting in feet.  High blood pressure 160/90 usually it's normal. 45 minutes later while driving home - burning in chest, creeping vapor sensation went up to throat, feeling I might pass out.  Tinnitus has worsened it's constant now and much louder.  Nerve issues are worse when blood sugar is low. 12/1/21 symptoms are worsening.
Headache, Myalgia & Fever Narrative: per nursing report: "headaches, chills, bodyaches, low grade fever following 2nd dose of vaccine"
Sudden sensorineural hearing loss, 24 hours after injection, profound hearing loss in left ear
I got a cold sore inside the right nostril of my nose. The same thing happened after the second dose of the Moderna vaccine. Although I get cold sores, they are always on my top lip, never inside my nostril. I noticed it after the Moderna vaccine as well. When it happened again with the Pfizer vaccine, I decided to report it.
I woke up in the middle of the night with fever and profuse sweating. I took ibuprofen to lower the fever symptoms. I was weak for 48 hs after jab.
Swelling; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization, hyaluronic acid (RESTYLANE, Restylane kysse), via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose and frequency for an unspecified indication as fillers. The patient's medical history and concomitant medications were not reported. The reporter became aware of a case in Israel wherein a patient previously treated with Restylane and Teosyal fillers had swelling at the filler placement sites after her first Pfizer vaccine injection. The reporter stated that here's a high-level summary of what the reporter had on the cases to-date that involve the Pfizer vaccine. It included this patient in US. It was reported that Vaccine (Dose#): Pfizer: (2), date: 05Jan2021 The patient experienced swelling at the filler placement sites. The action taken in response to the event for hyaluronic acid was unknown. The outcome of event was recovered on unknown date.  No follow-up attempts are Possible; information about batch/ lot number cannot be obtained. No further information is expected.
Onset of infantile spasms two days after administration.  A 60 day follow up report adds: Pt's EEG has become normal. She responds on ACTH and phenoembiam for seizure. Annual follow up on 04/14/04: "Pt has not recovered from adverse events.  Pt continues on Phinobarbitor for seizure disorder."
COVID Vaccine Breakthrough Case  Moderna Dose 1 3/13/21 (002B21A) Moderna Dose 2 4/10/21 (041B21A) COVID Positive 12/12/21  12/13/21: -Patient is an 88 yo male with medical history of COPD not on home oxygen, DMT2, HLD, Obesity , Prostate and bladder cancer s/p TURP / TURBT  -History obtained from EMR and ER provider as patient is a poor historian and no family at bedside  -Per EMR he presented with SOB and was being managed for COPD exacerbation with improving symptoms after steroids, duoneb treatment and levaquin. He is on supplemental oxygen for comfort.  -CT chest showed small pleural effusions,possible mild interstitial pulmonary edema,indeterminate nodule left upper lung but ruled out pulmonary embolism  -He was also confused and weak on presentation but CT head did not show any acute infarct. Of note he is also being treated at home for UTI  -He was also noted to be in new onset atrial flutter RVR rates in 120s-130s and hypotensive with SBP 80-90s for which cardiology  was consulted by ER provider and recommends  anticoagulation with heparin gtt. Personally discussed with Dr and he also recommended digoxin 0.5 IV x 1 followed by 0.125 digoxin IV daily.  -Patient denies chest pain , SOB , nausea, vomiting , palpitation during my encounter but endorses weakness and lightheaded ness when he gets up from bed.  12/15/21: P.o. vitamin-C and zinc sulfate  Nebulizer treatments  P.o. prednisone course  P.o. theophylline per home dose  Hemodynamically stable for discharge  Will discharge home with heath care services  Follow-up with PCP in 3-5 days  Patient agrees with plan of care