chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red hard lump at the injection site which itches Narrative:  1/23 onset of rash - just at the injection site. It itches and is hard and red. Injected in left arm. 1/25 it looks about the same. It's not spreading but it's not going down yet. 1/27 - rash is much better - decreased redness and hardness. There's still a small amount there. It still itches off and on.
Pt reports unable to move arm for 2 days since immunization. There was tingling in the arm at time of vaccine admin.  Pt reports thumb is still tingling. Her husband is a doctor and information given was through him.
Localized erythema 7.5 cm x 18 cm-warm to touch-no resp involvement-no fever. Rx: antihistamines.
Information has been received from a certified medical assistant concerning a 15 year old female patient with no pertinent medical history and no drug reactions or allergies who on 26-MAY-2011 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL in her right arm (lot # 667878/0180AA, expiration: 08-MAR-2013). There was no concomitant medication or vaccines administered on 26-May-2011. The certified medical assistant reported that on 26-MAY-2011 ("the same day") the patient began to experience shortness of breath, which the patient described as "she walked a few steps and she could not catch her breath". The patient was a dancer who normally danced 4 times per week, she had been unable to dance or perform daily activities due to the shortness of breath. The dyspnea was not improving and shortness of breath was reported as "severe". The certified medical assistant also reported a constant headache, and just an overall feeling of being "off". No treatment was given for the adverse events and no lab diagnostics studies were performed. At the time of reporting, the patient had not recovered. The patient was referred to her primary physician for follow-up. The reporter considered the events to be disabling as the patient was having difficulties with her activities and routines. Additional information has been requested.
patient complained of swelling of throat, shakings, flushing, secretions from mouth and nose. O2 sat-99-100% HR 130 face and upper chest flushing on exam Sent to higher level of care
Got flu shot on 10-11-11 on duty at the Police Department went to Dr on 10-26-11 with flu like symptom and slight shoulder pain. Turned into deep pain in shoulder and upper pectoral with radiating pain down my arm. Pain became terrible in right shoulder front and back and my 3rd and 4th finger started losing mobility and strength. Cortisone, pain meds.
syncope; This spontaneous report was received from an office manager via company representative referring to an 11-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis by a health prefessional (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced syncope after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The event happened at primary care office. The patient had sought medical attention. There were no injuries, and the patient did not need any follow up care. It was unknown if any treatment was given. At the time of reporting, the outcome of the event syncope was unknown.  The causal relationship between syncope and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Upon internal review, the event syncope was determined to be medically significant.
Morning following vaccination redness and swelling at injection site, nausea, stomach ache, headache, low grade fever. Tenderness at injection site still the same 3 days after vaccination, other symptoms still present but lessened.
Narrative:  Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient presented to MC on 3/8/21 with chest pain and suffered cardiac arrest. Patient had history of homelessness and substance abuse along with COPD.
Fever, chills, sever headaches, dizzy, sweats. Started the evening of my shot, It has been 48 hours, still having symptoms, just not as sever now. Did not go to hospital or seek medical attention. Just waiting it out.
Same day, extreme soreness at injection site, numb fingers, light headed, dizzy, nauseous, vomitting, fatigue, metallic taste in mouth. Now twice per week, still experience metallic taste and dizzy spells. Developed vertigo.
breakthrough case of Covid-19; breakthrough case of Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 56-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "GERD" (unspecified if ongoing); "Limitedscleroderma" (unspecified if ongoing); "Adult asthma" (unspecified if ongoing); "reynaud's phenomenon" (unspecified if ongoing), notes: Echolacea, and Reynaud's phenomenon. All of which were prior to vaccination. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "breakthrough case of Covid-19".  Clinical Course: Underlying health conditions: GERD, Limited Scleroderma, Adult Asthma, Echolacea, and Reynaud's phenomenon. All of which were prior to vaccination. Issue: She has a mild case of Covid 19, and is currently quarantining and has not needed hospitalization at this time   The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received from a pharmacist concerning unspecified patients of unknown age. Concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with 4 additional doses of improperly stored dose of ZOSTAVAX lot # L033311 (expiration date 01-DEC-2016) (dose and route not reported). Concomitant therapies were not provided. No adverse effects were reported. There was no product quality complaint (PQC) involved. Names of vaccines: ZOSTAVAX (L033311, exp 12/01/2016); Temperature: 39F; Time frame: 18 hours 19 minutes; Was it administered (AE)? Yes; Was previous temperature excursion? Yes, 22F for 5 hours and 23F for 35 hours; Was call because of a "data logger"? (Y/N): No. This is one of several reports received from the same source. Additional information has been requested. Event and narrative were updated.
achey all over; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achey all over) and HEADACHE (headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ENALAPRIL and TOLTERODINE L-TARTRATE (DETROL) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced PAIN (achey all over) and HEADACHE (headache). On 22-Mar-2021, PAIN (achey all over) and HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
congestion, cough, chest tightness, SOB, diarrhea, nausea, vomiting
rash; painful ankle; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) and ARTHRALGIA (painful ankle) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash) and ARTHRALGIA (painful ankle). At the time of the report, RASH (rash) and ARTHRALGIA (painful ankle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  The treatment information was  not provided.
Influenza vaccine administered (L) electrical and pneumococcal vaccine administered (R) deltoid on 9/25/14. Approx 3 1/2 hours after administration, patient reported clammy skin, nausea light-headedness, and excruciating (L) arm pain, especially with movement. Patient saw physician on 9/29/14 and "was told to apply heat to (R) arm and take TYLENOL." Patient also saw chiropractor a couple of times. Symptoms continue to exist and patient follow-up with primary care physician on 10/28/14.
had a general itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (had a general itchy rash) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced RASH (had a general itchy rash). At the time of the report, RASH (had a general itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Information has been received from a medical assistant referring to a 26 year old female patient. No relevant medical history or concurrent conditions were reported. On 07-AUG-2015 the patient was vaccinated with VARIVAX (Merck) (lot # L001330, expiration date 13-JAN-2017; dose and route not reported) which had been exposed to temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
10:19.  Sudden onset of dizziness, weakness and feeling spacey.  VS 10:20 145/86; P 90; R 17.  Immediate evaluation by onsite EMS and NP. 10:50 - VS 130/80; p 80; R 14.  Feeling better. Resolution of s/s.  Discharged home at 11:00 pm
Patient presented to the ED on 3/4/2021 with left facial droop, left-sided weakness, and dysarthria that started upon awakening that morning.  Patient found to have an ischemic stroke and ultimately admitted to hospice.  Patient expired on 3/10/2021.
This spontaneous case reported by a consumer, describes the occurrence of discomfort (felt uncomfortable), somnolence (slept a lot) and vaccination complication (mild symptoms only) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included gastrointestinal disorder (intestinal problems), bladder disorder and peripheral neuropathy. On Feb 3, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, the patient experienced discomfort (felt uncomfortable), somnolence (slept a lot) and vaccination complication (mild symptoms only). At the time of the report, discomfort (felt uncomfortable), somnolence (slept a lot) and vaccination complication (mild symptoms only) outcome: unknown. mRNA-1273 (Moderna COVID-19 vaccine), intramuscular dosing remained unchanged. No concomitant medications or treatment information reported. This case linked to MOD-2021-048182 (patient link).
post herpetic neuralgia; herpes zoster outbreaks; Information has been received regarding a case in litigation from a lawyer and refers to a patient of unknown age and gender.  No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 11-JAN-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, lot # and expiration date was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX) vaccine (date not reported), the patient suffered multiple outbreaks of herpes zoster and postherpetic neuralgia. As a result of these symptoms, the patient was seen and treated by medical providers and still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), 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. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered not recovered. Multiple outbreaks of herpes zoster and postherpetic neuralgia were considered to be related to zoster vaccine live (ZOSTAVAX) and disability events.
Patient developed rash on abdomen, chest, back and face about 12 days after immunization.  Also had malaise from about two days after immunization.
This spontaneous report was received from an office manager refers to a patient of unknown age and gender. On 25-NOV-2013, the patient was vaccinated with first dose of M-M-R II (therapy type, strength, dose, lot number, expiry date and route unspecified) for prophylaxis. On 08-AUG-2017, the patient was vaccinated with second dose of M-M-R II (therapy type, strength, dose, lot number, expiry date and route unspecified) for prophylaxis. On 06-FEB-2018 the patient was vaccinated with third dose of M-M-R II (strength, dose and therapy type unspecified) lot # M044350 and expiry date: 04-NOV-2018, subcutaneously for prophylaxis. No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided.
Vomiting; Nausea; Diarrhea; Headache; Chills; Fever; This is a spontaneous report from a contactable consumer (patient). A 42 years old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route, administered in Left arm on 04Mar2021 at 13:45 (at an age of 42 years during vaccination) as 1st dose, single dose for covid-19 immunisation. Medical history included known latex allergy. The patient had received other medications in two weeks prior to vaccination. The patient was not tested for covid prior to vaccination. Facility type vaccine was reported as Other. The patient had no other vaccine in four weeks to Covid-19 vaccination. On 04Mar2021 at 14:30, the patient experienced vomiting, nausea, diarrhea, headache, chills, fever. The patient was not tested for covid post to vaccination. The patient had not received any treatment medication for the resulted events. The outcome of the events was recovering.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Patient had CVA in July of 2022. Patient had worked that day but reports he was extra tired that evening so he went to bed early. Family members saw him that evening and determined patient was not exhibiting his normal behavior.  EMT was called and patient life flighted to hospital. Patient had surgery the following day (carotid stenting). Patient sense diagnosed with moderate aphasia. Patient is able to understand verbal language but has difficulty writing and expressing himself verbally. Patient remembers faces but unable to recall names of people he does not see on a daily basis. Patient is no longer able to drive due to a deficit in reading skills. Patient is no longer able to conduct his finances due to deficits in math skills.
neck, ear and facial pressure; neck, ear and facial pressure; neck, ear and facial pressure; Pain on left side; My left arm, shoulder and neck were sore; My left arm, shoulder and neck were sore; My left arm, shoulder and neck were sore; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 25Mar2021 at 09:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux. The patient did not take any concomitant medication. The patient had no allergies to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 06Mar2021 at 11:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021, several hours after getting the vaccine the patient experienced left arm, shoulder and neck were sore. On 28Mar2021, couple of days after the vaccine, the patient neck, ear and facial pressure and pain on my left side, which continued for several days. The patient took painkillers to control it. It was finally calming down two weeks after the vaccine was administered. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events and included treatment himself with pain killers. The clinical outcome of the events left arm, shoulder and neck were sore, neck, ear and facial pressure and pain on my left side was recovering.  No follow-up attempts are needed. No further information is expected.
1 month following a flu vax (mfr unknown), pt inadvertently received inject of Flu Shield, (97-98 formula). Within 2 days, pt devel fever and chills.
Fainted while urinating and started seizure like twitching and convulsing for less than two minutes.  Ambulance was called and EMT's checked vitals.  I declined to go to hospital.
Patient seen at clinic less than 24 hours from vaccination for headache and sleep loss.  Seen at hospital, 22 Feb for altered mental status: delirium, mania and/or psychosis.  Hospitalized 1 night in hospital and chemically restrained, then hospitalized 3 nights at another hospital.  Not believed to not be related to vaccination, but cause for mental status change unknown at date of submission.  Patient not yet returned to baseline functioning. The follow up recieved on 6/2/03 states pt stil has diagnosis and symptoms of bipolar disorder. It is unlikely but not known whether this new diagnosis is related to his smallpox vaccine, but the diagnosis will never go away. Annual follow up on 04/06/04: "Pt has recovered from adverse events.  I believe this pt suffered from post-vaccine encephalitis and not bipolar-disease.  In an year, he has had no other evidence of mood disorder, off all meds-very atypical for Bipolar vaccinia encephalitis is a more likely diagnosis in my opinion. While he has, apparently, recovered, he has lost his career as a military pilot.
Patient experienced Large local reaction w/ erythema and significant pain 1 day s/p Biothrax injection IMRD. Local reaction was identified and erythema was noted from upper should area throughout the arm to the lower tricep/near elbow area. Symptoms began resolving with time.
Pt had localized swelling from elbow to shoulder and reported nausea and dizziness.
Monday had Shortness of breath throat tightness about 20min after inj, tongue felt thick and body was itchy. 911 had to be called at pharmacy I was taken by ambulance to ER. I was given 2 Epi, 1 solumedrol, 1 albuterol treatment and 02. Then tuesday around 1300 I started to itch. I was driving to get medrol dose back. My became short of breath throat became tight, tongue numb and tingling. I had to call 911 and was taken by ambulance to ER. I was given 2 EPI, solumedrol, 02, 3 IV Benadryl. Thursday around 11am became itchy throat tight and shortness.of breath was driven to ER. I was given EPI, solumedrol, Benadry, and Pepcid. Labs were drawn, Xray, Ct, and ultrasound. I was admitted over night at a different local hospital and taken by ambulance. Monday still slightly itchy and muscular chest pain
Noticed a change in pigment of right forearm around 8:00 p.m. on the day of the shot. This is the opposite arm from the vaccine site. By the next day there was very noticable bruising between my right thumb and forefinger and a rash of spots that looks like bruising  going up my forearm and midway up my upper arm. Other bruising spots located on left forearm, minor, and left top of foot, minor. I have taken pictures of the bruising / rash.
Temperature 102  days 2 & 3 post-vaccine Intense  constant head pressure and vertigo days 2, 3, & 4 post-vaccine inability to focus joint pain arms, hands, hips, legs days 2, 3 & 4 post-vaccine left arm spasms below injection site day 2 to 4 post-vaccine bilateral jaw pain days 2, 3, & 4 post-vaccine nausea urticaria and welt below injection site onset day 4 - ongoing
3 hours after vaccine given, patient developed right arm pain, warmth, and swelling with fever.
24 hrs after VARIVAX some hives on abdomen and feet hurt. 36 hrs later (R) knee red & swollen & tender. 48 hrs later rash resolved, knee tender but no further swelling or redness. No fever.
slight headache; loose bowels (was in the bathroom 6 times yesterday); slight nausea; general feeling of the flu; weakness; tired/wanted to lay down and sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu shot, for immunization, reaction(s): "weakness", "loose bowels", "wanted to lay down and sleep", "slight headache", "all over general feeling of the flu", "slight nausea". The following information was reported: HEADACHE (non-serious) with onset 23Mar2021, outcome "recovered", described as "slight headache"; DIARRHOEA (non-serious) with onset 23Mar2021, outcome "unknown", described as "loose bowels (was in the bathroom 6 times yesterday)"; NAUSEA (non-serious) with onset 23Mar2021, outcome "not recovered", described as "slight nausea"; INFLUENZA LIKE ILLNESS (non-serious) with onset 23Mar2021, outcome "unknown", described as "general feeling of the flu"; ASTHENIA (non-serious) with onset 23Mar2021, outcome "unknown", described as "weakness"; FATIGUE (non-serious) with onset 23Mar2021, outcome "unknown", described as "tired/wanted to lay down and sleep".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately 10-12 hours after second dose I started to have severe throbbing pain in my lower right extremeity. I continue to have severe throbbing/numbing muscle aches in both lower extremeties, joint pain in my wrist, knees and ankle area with occassional weakness in both lefts. Pain is continous and scheduling MD appointment this week.