chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12Apr90 pt vax;  26apr90 devel fever, focal rt sided seizures for 25-30 minutes. Tx w/ Valium and admitted to ER.  MD felt that seizures due to viral infection or vax. Tx w/ Ferusal for iron deficiency anemia.   See worm...
Information has been received from a consumer concerning her 35 year old son who received MMR II when he was a young child. It was reported that he developed measles several days after vaccination. No product quality complaint involved. This is one of several reports from the same source. Additional information has been requested.
Breakthrough case admission after three vaccines  Moderna 4/22/21 Lot# 030A21A;  Moderna 05/20/21 Lot# 005C21A; Moderna 3/8/22 Lot# 033K21-2A
Chronic fatigue, dizziness, headaches, brain fog, blurred vision, eye pain and pressure, anxiety, digestive issues, chest pain/palpitations
pt stated day after injection she had some tenderness at injection site day but today has a 6" red swollen area from the top of the arm to almost her elbow  that is hot to the touch.
Tremor in legs, dizziness, unable to perform daily activities as he was able to prior to the second dose of the vaccine. He is now dependent on others to do things for him and has an extreme Tremor in his leg when he walks
102 Fever, chills, nausea, muscle pain, headache from 8pm day of shot, to 5am next day.   Fever broke 5am and April 15.   Muscle aches for one more day to 4/16 but feel much better.   Soreness at the injection site.
Vaccine given 6-6-2012 - 1st sign came suddenly like breaking a stick with weakness and pain in back 10-16-2012. Within 24 hrs. paralyzed on right side with left side extremely hot. Stayed 9 days in hospital - MRIs, spinal fluid tested, blood work - both legs affected - after months of steroids and phy therapy still in bad condition.
This spontaneous report was received from a 82 year old female patient with no pertinent medical history and no drug allergy. On 09-OCT-2012, the patient was vaccinated with ZOSTAVAX (one injection, lot # H012521) for shingles vaccination. Therapy route was unspecified. Concomitant therapies included loratadine (manufacturer unknown) and SYNTHROID. On 13-OCT-2012, the patient had an outbreak of shingles on her face that she described as red and hot, and felt like her face was being cut by glass. Patient was recovered from the event approximately on 10-NOV-2012, "after 4 weeks". No treatment was given. No lab was done. The patient spoke to pharmacist to seek medical significant. Additional information has been requested.
right leg numb in the following areas, right buttocks, right calf, and right side of foot.  After several days is was just the foot.  After second shot numbness  continues..   It felt like something had fallen asleep, like when you set on your leg wrong.
Transverse myelitis; being paralyzed; not receiving 2nd dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (being paralyzed) and MYELITIS TRANSVERSE (Transverse myelitis) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included ANTIDEPRESSANTS for an unknown indication.    On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced PARALYSIS (being paralyzed) (seriousness criteria hospitalization, disability and medically significant). On an unknown date, the patient experienced MYELITIS TRANSVERSE (Transverse myelitis) (seriousness criteria hospitalization, disability and medically significant) and PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose of the Moderna COVID19 vaccine). At the time of the report, PARALYSIS (being paralyzed) had not resolved, MYELITIS TRANSVERSE (Transverse myelitis) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose of the Moderna COVID19 vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       It was reported patient had multiple tests in the hospital.  No concomitant medications were reported. No treatment information was provided by the reporter. Company Comment : Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
On the day after the injection, I experienced a sore arm, a headache, and overall tiredness. Sleep was generally able to resolve the headache and overall tiredness/fatigue by the second day after the injection. On the second day after the injection, the sore arm was a little less sore, however, there was a rash/reddened skin that suddenly appeared at the site of injection. Currently unsure how long this rash will affect me.  Note: the above was regarding the second dose... Following the first dose, the adverse symptoms were a sore arm and overall tiredness for about 2-3 days. It was possible the first dose also led to menstrual cramps in the beginning of the next menstruation after the first dose.
arm got a big bump; This spontaneous case was reported by a consumer and describes the occurrence of MASS (arm got a big bump) 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 MASS (arm got a big bump). At the time of the report, MASS (arm got a big bump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Left arm shoulder and upper left torso swelling done to wrist.  Child brought to hospital seen by doctor will also follow up with medical doctor as needed.
Fever as high as 101.6, headache, chills, muscle pain, vomiting
Bell's palsy; A spontaneous report was received from a consumer concerning a 58-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy (facial paralysis).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Feb 2021, approximately eight days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 6 Mar 2021, the patient started showing symptoms of numbness in face. She went to emergency response on 08 Mar 2021 and was diagnosed with Bell's palsy. She said she didn't have drooping or paralysis, but still have numbness. She went to other provider for second opinion and was given high dose of Vitamin B-12 and Acyclovir. No additional treatment information was given.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, Bell's palsy was considered not recovered.; Reporter's Comments: Based on the information provided which includes a temporal association between the reported events, administration of mRNA-1273 vaccine and excluded all other etiologies, a causal association cannot be excluded
Injection received around 10:45 AM on 4/12/2021.  By 10:00PM that night I noticed the development of Tinnitus. It has been constant and nonstop sense.
Regurtitate mucus and Blood,White substance in mouth; White foam like substance; Spitting up Mucus; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATEMESIS (Regurtitate mucus and Blood,White substance in mouth) in a patient of an unknown age and gender 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HAEMATEMESIS (Regurtitate mucus and Blood,White substance in mouth) (seriousness criterion medically significant), FOAMING AT MOUTH (White foam like substance) and SECRETION DISCHARGE (Spitting up Mucus). At the time of the report, HAEMATEMESIS (Regurtitate mucus and Blood,White substance in mouth), FOAMING AT MOUTH (White foam like substance) and SECRETION DISCHARGE (Spitting up Mucus) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. Very limited information regarding these events has been provided at this time. Further information has been requested.   This case was linked to MOD-2021-102334 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
5/11/2023-Upper lip swelling, Swollen eyes, Body itching, itching eyes, and extreme fatigue after waking up the day after her vaccine Given Claritin and told to follow up with Health Dept. if symptoms did not improve  05/12/2023- Now has Diarrhea and continued fatigued, though swelling and itching has ceased
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. Developed autoimmune diabetes following anthrax vaccination in addition to severely elevated liver and pancreatic enzymes. (OMIC)
Rash all over. Bumps under injection site, hot to touch, redness and swelling.
Itching on the shot site; Red splotches around the shot site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching on the shot site) and VACCINATION SITE ERYTHEMA (Red splotches around the shot site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching on the shot site) and VACCINATION SITE ERYTHEMA (Red splotches around the shot site). At the time of the report, VACCINATION SITE PRURITUS (Itching on the shot site) and VACCINATION SITE ERYTHEMA (Red splotches around the shot site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Case number PHEH2013US016729 is a spontaneous report received from the nurse on 06 Aug 2013. This report refers to a 23-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with the first dose of RABAVERT (batch number: 473011C) intramuscularly at a dose of 1 ml, in the right deltoid on 07 Sep 2011, second dose of RABAVERT (batch number; 473011C) intramuscularly a dose of 1 ml, in the left deltoid on 14 Sep 2011, third dose of RABAVERT (batch number: 473011C) intramuscularly at a dose of 1 ml, in the right deltoid on 05 Oct 2011. It was reported that he tolerated the vaccine in the past. On 16 MAY 2013, his rabies titer showed equivocal levels (insufficient result) and it was reported that he needed a rabies booster. The event outcome was not reported. The case was assessed as medically significant by the reporter. The causality was not reported. No additional information was available.
Please see attached notes. Copy of PHN notes sent to family medical center. R/T has visit scheduled following day for well child. Suspects probable vasovagal also and may try to vacinate one at a time with next due dose. 1/30/03 father states baby is fine and has had no further episodes. Pt was given immz today. After all four shots given pt's LE's turned purplish/blue, baby was crying hard but still breathing. Torso, face and arms were still pink. Baby was able to move all four ext's, airway was fine and good air mumt auscultated bilat. Cyanosis resolved within 1-2 minutes spontaneously kept baby in office for observation. Baby calmed down nicely and pinked leg well and moved all four ext's equally on D/C. Dismissed s/s to watch for with parents. Baby has apt tomorrow for well child. Suspect probable vasovagal reaction today. The baby has Ho crying after and formula was changed to lacto free. Baby has many dry, rough areas on LE's and face, A and D ointment suggested and see PMD. Lacto free formula seemed to help per parents. Tylenol given with instructions.
Presented w/ COVID+ (+ test one day prior at PCP) and SOB, diarrhea X 1. Tx w/ IV steroids, O2, Remdesivir, Vit C, Zinc
Follow-up info received 11/20/02 from investigator. The subject experienced asthma exacerbation on 10/13/02 and was subsequently hospitalized on 10/14/02. He was treated with Ventolin, Atrovent, paracetamol and prednisolone. He recovered and was discharged on 10/16/02 with Flixotide inhalers for preventative therapy. The investigator, who remains blinded, has changed his assessment to "probably not related" to the study vaccine. The original assessments made by the medical monitor remain unchanged. An investigator reported that a 20 month old male received a 2nd dose of influenza virus vaccine on 3/26/02, when he was 14 months old, as part of the study entitled: "A Randomized, Placebo-Controlled, Trial To Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A & B, Live, Cold Adapted (FluMist) and MMR II, and Varivax Vaccines Administered Concurrently To Healthy Children." On 2/4/02, the subject received a 1st dose of FluMist, along with Varivax and MMRII. On 5/9/02, the subject also received Placebo. Medical history includes tow previous hospitalizations on 6/20/02 and 7/1/02, for asthma exacerbation and an emergency department visit on 8/21/02 for asthma. On 10/1/02, the pt was re-admitted for asthma exacerbation. On 10/3/02, he was discharged following a complete recovery. The investigator (who remains blinded) assessed the event as severe and "probably not related" to the study vaccine and definitely "not related" to MMR II and Varivax. The medical monitor considers the event "probably not related" to the study vaccine due to the lack of a temporal relationship between vaccination and event onset.
Sore throat, fever, & fine skin rash, erythematous generalized w/ cervical adenopathy;
vaccinated on May 8 with the first dose , I then left the country and will not be back until July 19th; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccinated on May 8 with the first dose , I then left the country and will not be back until July 19th) 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 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccinated on May 8 with the first dose , I then left the country and will not be back until July 19th). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccinated on May 8 with the first dose , I then left the country and will not be back until July 19th) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Left foot went numb immediately after vaccine. 5 days later i got a headache with throbbing and pressure and tingling that has lasted 3 weeks and 4 days. No medication helps the headache
Acute ischemic stroke; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 04May2021 08:00 (at age 49-years-old) (Batch/Lot Number: ER8735) as 2nd dose, single for covid-19 immunisation. The first dose was received on 13Apr2021 (lot number: ER8735) on the left arm at age 49-years-old. Medical history included high cholesterol and penicillin allergy. Concomitant medication included rosuvastatin. No other vaccine was received within 2 weeks of vaccination. The patient experienced acute ischemic stroke which started afternoon of 05May2021 13:00. Patient visited ER on 06May2021 at 07:00 and was hospitalized for stroke from 06May2021 to 07May2021. He started physical therapy to rebuild strength and coordination in left arm and leg. Treatment atorvastatin 40,aspirin 81,Hydrochlorothiazide 25 was given. Patient was not diagnosed with covid prior to vaccination and has been tested on 06May2021 (nasal swab): negative. Outcome of the event was recovering.
By 3pm vaccine site (left arm) painful and swollen from shoulder to elbow. 9 pm: chills; teeth chattering. 2 am: wake up, go to bathroom, faint on floor.  Unconscious maybe 30 seconds.  Wake up dazed & confused.  After maybe a minute, able to talk and get up and go back to bed. Go back to doctor on 11/22/2013 to report adverse side effects.  They suggest hospital visit for sonogram to insure I do not have blood clot in swollen arm.  I go to hospital; have sonogram.  No blood clot. Today 11/23/2013, arm swelling and pain reduced.  Think I am getting over bad reaction.
This spontaneous report was received from a healthcare worker concerning a female patient of unknown age. The healthcare professional reported that the patient's daughter was vaccinated with a dose of VARIVAX (merck) (lot number H007141, expiration date not provided) on 06-OCT-2012 and the patient developed shingles approximately one month later on approximately 06-SEP-2012. At the time of the report, the patient was recovering from the event of shingles. Additional information has been requested.
developed a swollen left Infraclavicular lymph node about the size of a gumball and very painful.; developed a swollen left Infraclavicular lymph node about the size of a gumball and very painful.; This is a spontaneous report from a contactable consumer (patient). This 44 year-old female consumer (Patient) reported for herself.  A 44-year-old non-pregnant female (not-pregnant at the time of vaccination) patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FF2589), via an unspecified route of administration, administered in Left arm on 09Sep2021 11:00 AM (age at vaccination 43-year-old), as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: PF2590), via an unspecified route of administration, administered in Left arm on 11Oct2021 11:30 AM (age at vaccination 44-year-old), as dose 2, single for covid-19 immunisation. The patient's medical history was none. The patient had no known allergies. Concomitant medications included trazodone (TRAZODONE) and escitalopram oxalate (LEXAPRO) taken for an unspecified indication within 2 weeks of vaccination. On 21Sep2021 08:00 AM within 1-2 days after each shot, the patient experienced a swollen left infraclavicular lymph node about the size of a gumball and very painful. The patient did not receive any treatment for the events. The patient had no COVID prior vaccination. The patient did not receive any other vaccine in four weeks. The patient was not tested for COVID post vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 04Apr2021. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
The first reaction I had on 05/19/2021 was body pain from my back to all over my front side which feels like I'm having a heart attack without the shortness of breathe. Whenever I moved my head forward, I experienced a cramping pain and it was the first time for me. I alerted my wife that my back was really hurting and the next day when I woke up, I felt sick with eye pain even though I wear glasses (have never happened to me before). The pain became worst as the day progressed (a pulsating pain at the back of my eyes and whenever I moved, I felt like I was going to faint. I stayed in bed because I could not move (includes light sensitivity...room has to be dim all the time and on May 27, I lost partial hearing in the left ear along with ringing in my ear). I was not sick and wanted to know what was going on (went to the ENT). The lost happened for 4 days and then it moved to the right ear on May 29 and I lost my hearing and it made me afraid that I would lose my hearing (went on and off for several weeks with both ears). I'm a Nurse and I told my wife that it may be an autoimmune reaction but I have never had any illness; therefore, I took  Loratadine. My PCP prescribed me Advil and Tylenol but the pain did not go away in my ears and it didn't work. I also still have eye pain and can drive because now (having been taking Vitamins B-12 and B-6 to help me recover). I also have a change in my taste buds. The ringing in my ears and the hearing lost scared me the most. The headaches will probably be with me a while since the progress is so slow. I also still have pain at the back of my eyes. I also had one episode of vertigo and also a time when I felt that my legs had weakness in them.
pt recvd vax; devel a little red raised knot & a warm area near inject site in the thigh;
About 20 minutes after vaccine pt vomited x2. Started with hives about 10 minutes later. Large urticarial wheal at injection site and diffuse hives. Given Benadryl 25mg orally. Observed for 1/2 hour with further spreading. Pt felt well and sent home. 16 hours later hives regressed.
About 2 weeks after my 2nd shot in the left arm, my arm became extremely achey, weak, hot, red. It has ached (from my shoulder down to my fingers). Mostly achey where both shots were administered in the muscle. It radiates down the arm. Feels weak at times. I either deal with it & I'm miserable or I take tylenol or put CBD balm on the achey areas. It hurts alot at bedtime. I have this everyday now.
Patient developed chest discomfort the day after receiving her COVID booster. She describes it as midsternal, occasionally radiates to the left of the sternum, has been rather constant dull achy pain at baseline, occasionally gets worse but without any trigger with exertion, eating, position, or anything really in general.
Information has been received from a pharmacist concerning a 75-year-old female on 01-NOV-2007 was vaccinated intramuscularly instead of subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot# 658398/1087U).  On 04-NOV-2007 the patient experienced warmth and pain at the injection site.  It was reported that the patient contacted the pharmacist.  At the time of this report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.