chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Eczema vaccination; numerous scattered 2-4 mm vesicles/papules (approx 20) located on deltoid area/axilla/arm, spreading rash without pain/itching. Patient treated with Motrin 400 mg PRN and given Light Duty x5 days.
No adverse event actually happened, 12+ Pfizer Bivalent was given as primary dose.   Patient did stay for 15 minutes in clinic to watch for reactions, none presented .
Information has been received from a doctor of pharmacy concerning a 30 month old female who was vaccinated with varicella virus vaccine live (Oka/Merck). On 02-OCT-2007 the patient experienced chicken pox. The chicken pox was described as mild, only 20 lesions. It was unknown if medical attention was sought. Additional information has been requested.
Altered mental status - Patient was admitted to the medical floor for further medical management on the medical floor the patient was found to have low magnesium this was appropriately replenished with he will she was given IV magnesium and supplemented with oral magnesium 400 mg p.o. twice daily.  Her mental status was found to be within normal limits there was minimal weakness that she required assistance on ambulation.  ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
got my first dose at 12:45 pm on Friday the 12 th of March. At  12:30 am  Saturday morning i started throwing up. I threw up every hour for a total of 3 times. last time was 2:30 am. My stomach was gurgling and it hurt to press on it. and i kept belching. Had no energy. On  Saturday was able to sleep 3 hours in my rocker until 2:15pm when i threw up again. Had no energy. Had chills the first day starting about 4 pm Friday after my shot. Called the emergency room to see if I could take antinausea pills I had . Talked to my doctor and he said I was allowed. It was ondansetron 4 mg. I took one at 3 pm and started feeling less weak.
Itching and rash started two days after injection.  Developed blister at site of Varivax on day three.
Pt experienced sudden severe nausea about approximately 2 hrs after receiving vaccine. Pt. is still experiencing it, but not as severe.
Information has been received from a nurse concerning a 21 month old male who on 20-SEP-2011 was vaccinated with a dose of VARIVAX (Merck) (Lot# 670102/0605AA), (0.5mL, Subcutaneously). In around June 2012, the patient experienced chicken-pox and the physician believes the child got chicken-pox from his grandmother, who received ZOSTAVAX (Merck) (Lot#, dose and route not reported). The patient sought medical attention by an unspecified way. The adverse event was improving. At the time of reporting, the patient was recovering. Follow up information has been received from the physician concerning the 22 month (previous reported as 21 month) old male patient with no pre-existing allergies, birth defects, medical conditions and no illness at time of vaccination who on 20-SEP-2011 at 11:12 was vaccinated with the first dose of VARIVAX (Merck) (Lot# 670102/0605AA), IM (previously reported as subcutaneously) into the right thigh. The physician stated that patient experienced rash for 15 days and itchy started on shoulder and spread scabbed over. No relevant diagnostic tests were performed. At the time of the report, the patient had recovered from rash and itchy. Outcome of chicken pox was unknown. The physician also stated that the patient's grandmother had shingles (MARRS case #1207USA005119). Additional information has been requested.
Patient had vaccine administered by PA and was walking to do his observation period and stopped to get water from a fountain and leaned forward then fell to the floor was unresponsive and had an approximate 20 sec GTC seizure when the seizure was over he came to and was very confused and diaphoretic for approximately 15 minutes after the seizure. 911 was called by RN, and EMS came to assess the patient while waiting  patient was placed into a wheelchair by multiple staff and taken to a cot where oxygen was applied. Vitals were taken and vitals were stable. EMS took blood sugar upon arrival that was stable. Patients sister has significant history of seizures but patient has never had a seizure before. Once patient was no longer sweating, pale and confused he was observed for half and hour. His parents came to get him and drove him home from the event. Patient was stable talking and no confusion or SOB or other symptoms after the half hour and patient was released to his father to drive him home and to monitor him for other symptoms.
feeling extremely tired/extreme fatigue; sleepy; low grade fever, or I was feeling feverish; I could not sleep that night; lack of appetite; chills; cold (it was 75 F that day); head felt heavy; minor headache; On other hand my injection site pain was not as bad as first dose; This is a spontaneous report from a contactable Pharmacist (patient) reporting for herself. A 27-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0183), via an unspecified route of administration, administered in Right arm on 18May2021 17:30 at the age of 27-years-old as dose 2, single for covid-19 immunisation. Medical history included PCOS (polycystic ovarian syndrome) and Kidney stones from an unknown date. The patient had no known allergies. There were no concomitant medications. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0171), via an unspecified route of administration, administered in Right arm on 24Apr2021 17:30 at the age of 27-years-old as single dose for covid-19 immunisation and experienced on other hand my injection site pain was not as bad as first dose. The patient did not receive other vaccine in four weeks of vaccination. The patient did not receive other medications in two weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 18May2021 at 20:30, the patient experienced feeling extremely tired/extreme fatigue, sleepy, low grade fever, or I was feeling feverish, i could not sleep that night, lack of appetite, chills, cold (it was 75 f that day), head felt heavy, minor headache, on other hand my injection site pain was not as bad as first dose. The clinical course was reported as follows: In the Evening of 18May2021, after receiving second dose of Pfize vaccine, the patient started feeling extremely tired and sleepy. After she had her dinner, she had low grade fever, or she was feeling feverish. That night she took Ibuprofen (Mortrin, 400 mg). She could not sleep that night, she was getting her sleep in bits and pieces. Second day morning, she continued to feel feverish and had to take a day off from the work. She noticed lack of appetite, chills and cold (it was 75 F that day), feeling feverish, extreme fatigue. Towards the evening on the same day, she experienced her head felt heavy and there was minor headache. On other hand her injection site pain was not as bad as first dose and on 20May she did not experience injection site pain. And tiredness continued, she resumed her work today. Treatment for adverse events included Ibuprofen (400 mg) doses on 18May and 19May. The patient underwent lab tests and procedures which included body temperature: 75 fahrenheit on 18May2021. Adverse events resulted in none of the above. The outcome of event, injection site pain was recovered on 20May2021 while other events were recovering.  Follow-up attempts are completed. No further information is expected.
Information has been received from a physician concerning a 4-month-old patient who on 07-MAR-2007 was vaccinated PO with the first 2.0 mL dose of Rotateq. It was unknown if medical attention was sought. The patient had not developed an adverse event. Additional information is not expected.
10 minutes after getting her first COVID-19 vaccine, patient experienced L sided numbness and tingling of her face, 5 minutes later this was followed by a globus sensation. Patient had CN 2-12 grossly intact and 5/5 muscle strength of the upper extremity. She had a patent airway without stidor. She was able to swallow liquids. Due to her history of angioedema, she was evaluated by EMS and sent to ED for further evaluation.
The morning after his first COVID19 vaccine, per wife, patient started with confusion, feeling of impeding doom, and disorientation. Wife had left him in the morning to go shopping and when she returned he had urinated on himself and was wandering around. He was taken to the ER that afternoon. Upon arrival to the ER, patient was noted to have mild confusion, tachycardia, and a mild fever of 100.8 F. Symptoms improved with Tylenol and IV fluids. His chest x-ray showed bilateral mid and lower lung interstitial airspace opacities, concerning for interstitial pneumonia and/or edema. However, it should be noted that patient was hospitalized due to pneumonia from COVID in November 2020. The ER doctor felt the chest x-ray findings were likely chronic changes from COVID, however, he was started on treatment for possible pneumonia. Patient was stable in the ER, so we was discharged.
Ankylosing Spondylitis got worse in colder weather; after booster vaccine injection patient got teniduious; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4142709.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 17Apr2021 as dose 1, single (Batch/Lot number: unknown), on 08May2021 as dose 2, single (Batch/Lot number: unknown) and on 09Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for ankylosing spondylitis. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "unknown", described as "Ankylosing Spondylitis got worse in colder weather"; IMMUNISATION REACTION (non-serious), outcome "unknown", described as "after booster vaccine injection patient got teniduious". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "ankylosing spondylitis got worse in colder weather" and "after booster vaccine injection patient got teniduious" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The reporter's causality for the event(s) of after booster vaccine injection patient got teniduious with Adalimumab Solution for Injection was no reasonable possibility. The reporter's causality for the event(s) of after booster vaccine injection patient got teniduious and condition got worse in colder weather with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was not provided.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of  subject product, BNT162B2 vaccine, cannot be excluded for the reported events, based on temporal relationship. However, the reported event of spondylitis ankylosing aggravated  may possibly represent intercurrent medical condition in this patient . There is  limited information provided in this report.  This case will be reassessed upon receipt of follow-up information.
Patient had injection site reaction on left arm.   She described having significant swelling and redness.  The swelling lasted "almost 2 weeks"  and the redness is still present but improving.
Red blotches - rash arms, legs, stomach, rash on face, itching.  Benadryl for itching and go directly to ER if any respiratory distress is experienced.
21 daysschedule with little sore arm mentioned; This is a spontaneous report from a Pfizer-sponsored program. A contactable female (patient) of an unspecified age received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 17Feb2021 2nd dose, single for covid-19 immunisation. The patients medical history and concomitant medications were not reported. In 2021, patient had both doses of vaccination with little sore arm mentioned. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Swollen injection site, swollen injection site, headache, body aces, fatigue, fever, heart palpitations, Shortness of breath, Chest pain .. none that have gone away.
Diarrhea; A spontaneous report was received from a healthcare professional concerning a 73-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diarrhea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 8 Feb 2021, the patient experienced diarrhea.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event diarrhea was unknown.
Left upper arm area size of 3 1/2 x 4 raised reddened warm area. Dr took pt home. Benadryl 25mg and 1 Tylenol at 11AM. 2pm felt tachycardia 117/71 p87 2:55pm 120/80 p 84.
GARDASIL vaccine was stored at temperature that was stored at temperature that was out of normal range.
This spontaneous report as received from a 40 year old female physician (who is also the patient) refers to herself with rheumatoid arthritis and sulfa reactions/allergies. The patient was vaccinated with her first dose of PNEUMOVAX23 injection, 0.5ml, intramuscular in the left arm (lot# and expiry date not reported) in approximately December 2006 ("7 years ago"). On 04-DEC-2013 the patient was vaccinated with her second dose of PNEUMOVAX23 injection, 0.5ml, intramuscular in the left arm (lot# and expiry date not reported). Concomitant therapies included HUMIRA for rheumatoid arthritis (reported as "I have rheumatoid arthritis and on HUMIRA"), omega-3 marine triglycerides (reported as "fish oil"), vitamin D (unspecified), LEXAPRO and cephalexin. On 04-DEC-2013, 6 hours after vaccination, the patient's left shoulder was uncomfortable and frozen to the point that it could not be moved. The physician mentioned the pain was severe to the point that she could not sleep. The patient used ice pack on the area VICODIN last night (04-DEC-2013 night) to treat the adverse events. No lab diagnostics studies were performed. The patient didn't sought medical attention. At the time of reporting, the outcome of the events getting a little better. The patient considered the events were significant disability or incapacity because she couldn't move the left arm. Additional information has been requested.
Pt administered 2nd dose of ROTATEQ. Rec'd this dose prior to administration of IM vaccines due today. Pt had projectile vomiting immediately after swallowing  Emesis came through nostrils and mouth, struggling + gagging. Airway remained clear. After vomiting no other symptoms presented.
This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 01-SEP-2016, the patient was vaccinated with improperly stored dose of VAQTA lot number reported as: LN749, expiry date: 26-AUG-2018 (strength, dose number, route and anatomical location were not provided). Concomitant therapies were not provided. This is one of the several reports received from the same reporter. Additional information has been requested.
Per mom's report on 10/09/2003, patient had "hives" on left thigh near injection sites.  Red, hot, and swollen thigh.  I saw patient next day 10/10/2003.  No adverse reaction noted at all.
Moderate otalgia post-vaccination day 1 plus some hearing loss. Tried carbamide peroxide once, did not resolve hearing loss nor otalgia. Then took Tylenol 500mg x1. Otalgia improved post-vaccination day 2 but some hearing loss is still noted, and is currently still affecting me (post-vaccination day 5)
The vaccine was mixed incorrectly with 1% lidiocane injection solution  (lot # 6023922 expiration 4/24) instead of 9% sodium chloride. Patient was called and patient did not report any adverse event.
This case was reported by a nurse via interactive digital media and described the occurrence of Guillain Barre syndrome in a male patient who received Flu Seasonal TIV Dresden for prophylaxis. On an unknown date, the patient received Influenza vaccine unspecified 2011-12 season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine unspecified 2011-12 season, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was unknown. It was unknown if the reporter considered the Guillain Barre syndrome to be related to Influenza vaccine unspecified 2011-12 season. Additional details were provided as follows: The age at the vaccination was not reported. The reporter reported high fevers for weeks and intractable coughing and whooping. At the time, the patient did not know what the whoop was and kept going back to the physician and they never told her what was wrong with her, but one physician yelled at her because she had assumed she had pneumonia. The patient reported that do not forget to quarantine yourself for several weeks after you get the vaccine, as you might become an asymptomatic carrier.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2012, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. On or about 2016, the patient was treated by a physician at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Fever, fatigue, body aches starting with fatigue a few hours after the dose, and fever starting 20 hours after vaccination
Developing within 3 hours of booster: Significant soreness in left arm.  Inflammation of left hand. Inflammation and tenderness in left underarm.  Stiffness in left side of neck.  Significant eye sensitivity to light. Black spots in vision.  Increased fatigue.  Inability to focus.  Short term memory retention issues.
Fatigue continuing onto next day 06/02/2012. By 6:00 PM mild headache presented. 7:00 PM fever and aches presented.
Screening questions for patient completed. Administered FluMist to patient 0.1 mL to each nostril. Scanned medication for documentation. This nurse observed medication had expired. Medication documented as given and Immunization Nurse notified. Remainder of expired vaccine removed from fridge and given to pharmacy for disposal. Mother of patient notified.
Swelling in armpit of injection arm, chills, sharp pains, joint aches, foggy head, headache, muscle pain.
No noticeable effects after first dose. Second dose produced extreme sleepiness and body aches which lasted from the afternoon of injection (3/10) until around midnight (3/12).
This case was reported by a physician via sales rep and described the occurrence of intussusception in a infant patient who received ROTARIX for prophylaxis. On an unknown date, the patient received ROTARIX (oral). On an unknown date, less than a year after receiving ROTARIX,  the patient experienced intussusception (serious criteria GSK medically significant). On an unknown date, the outcome of the intussusception was unknown. It was unknown if the reporter considered the intussusception to be related to ROTARIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter had seen patient that developed intesessuption after having received ROTARIX. No specific details were available. The reporter did not agree to follow up from GlaxoSmithKline. This case has been linked to the cases US2019AMR047518 and US2019GSK048421, reported by same reporter.
Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (omprezole). Concomitant products included LEVOTHYROXINE for Hypothyroidism, BUPROPION for Mood disorder NOS, TESTOSTERONE, BECLOMETASONE DIPROPIONATE (QNASL) and FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for an unknown indication.   On 15-Feb-2021 at 4:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) had not resolved.            No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.   Cause of tinnitus provided as minor hearing loss.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up information received on 19-JUL-2021 and contains patient demographics added, relevant history updated, suspect drug details and lot number added, concomitant drugs added, adverse event details updated On 29-Jul-2021: Contained no new information.
T-99.5 to 101.4  Baby with difficulty breathing, 'twitch' all 4 estremeties, head twitching sideways, eyes deviated to (R)--lasted 3-5 minutes, then normal.  Not postictal.Hx GERD with apnea 03/08/07-records from facility received for DOS 07/26-07/27/06. DC DX: fever. Movement disorder. Vaccine reaction. No fevers during hospitalization. No abnormal movemnts noted. Experienced a 3-5 minute episode with no postictal phase no loss of consciousness before or after seizue. The episode that caused her to be admitted may have been reaction to Reglan or a possible vaccine reaction. Mostly likely to Reglan.  FMH:father has had seizure disorder when he was a baby, through childhood.