chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He got his vaccine, at approximately 4 or 5 in the afternoon he noticed that his right ear was stopping up like a ball of wax obstructing it.  He is totally deaf in his left ear and has been so since the age of 4, so he thought it was wax.  He tried to use peroxide and mineral oil to get the wax out and didn't notice any bubbling from that and knew it wasn't wax.  On the 18th he saw an ENT who diagnosed him as sudden frequency loss in his ear and put him on steroids.  In the process of doing that he also went and did hyperbaric oxygen therapy treatment to save his hearing, the first was on 5/24/22 and had 10 of those every day for the 10 days.  He has gotten back a lot of his hearing, but does not know if it was from the Prednisone or from the oxygen.  He also saw an ENT at the Hospital and then went to another one who put him on Prednisone.    When this started he could hear some things and the frequency of some of them sounded like the "comic background talking".  Also could hear the music of some of his favorite type of music, but not the lyrics of what was being said.  He is scheduled to have an MRI this evening to see if he has a tumor.
Dizziness, fatigue, nausea, body aches, chills, sweating,  sore arm
Tendonitis affecting multiple limbs and joints.  Tendonitis developed less than 2 months after the vaccine, in joints previously unaffected by psoriatic arthritis.  It began in my left elbow, and spread bilaterally to both ankles, both knees, and my left arm and left ring finger.  It has also resulted in increased inflammation in toes on both feet.  Pain and inflammation did not respond to traditional treatments and only responded to steroid medications, including cortisone injections.  The condition has reduced the usefulness of my left arm, has created mobility challenges, and I have had several significant foot surgeries to address the symptoms surgically.
Received DT injection in Rt arm 6/11/07. That night at 6:30 IM injection site became sore and as the night went on noticed swelling. Pt called office 06/12/07. Pt was instructed to apply cool compresses and take Tylenol for pain. Pt called 06/13/07 and stated swelling increasing. Recom. Pt come in. Arm was checked 6/14/07
When I arrived home from work I started running a low-grade fever and had diarrhea, nausea, shakes and vomiting. It continued until late into the night.
Patient received Moderna vaccine on 03/11/2021. Patient was in the emergency department on 07/31/2021 for O2 saturations in the 70's and low blood pressures and tested positive for Covid-19.
Information has been received from a nurse concerning a 28 month old patient who on 20-JAN-2011 was vaccinated with a dose of VARIVAX (Merck) (lot# 667920/0860Z). The nurse mentioned that on 18-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. A lot check has been initiated. Follow-up information has been received from a registered nurse refers to 24 months old (currently 30 months old) female patient with expressive language disorder and no illness at the time of vaccination. On 20-JAN-2012 at 17:00 PM, the patient was vaccinated with the second dose of VARIVAX (Merck) intramuscularly (IM) in right leg (dose not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on 11-MAY-2012, the patient came to clinic with rash described as "generalized maculae, paulae, vesicles, pustules, rash more apparent on legs". Then on 18-MAY-2012, on follow-up visit the patient was diagnosed with varicella healing. No testing was done. No treatment information reported. The patient's outcome was recovered on 18-MAY-2012. The relatedness for the patient's events was not reported for VARIVAX. This was one of the several reports from the same source. Additional information is not expected.
This spontaneous report has been received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # N009964, expiration date 22-NOV-2018 (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47.5 degrees Fahrenheit for 1 hour 30 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint has been filled. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007677: US-009507513-1709USA007678: US-009507513-1709USA004665.
July 6th, patient started to experience itchiness and swelling on her right eye.  Continued to develop upper body rash/hives that spread to her legs.  Patient complained of no relief with over the counter treatments and missed 2 days of work.  Patient came into Urgent care for treatment - prescribed steroids
Severe histamine reaction locally, with angioedema entire (R) arm. Urticaria lasting 48 hours.
had given an expired Tdap to a patient, with no ae; Initial information received on 28-Dec-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves unknown age male patient who had given an expired tdap to a patient (expired product administered), while he received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patients medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Dec-2020, the patient was vaccinated with 0.5 ml  DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6141AB and expiration date: 15-Dec-2020) via unknown route in the right deltoid for prophylactic vaccination.  On an unknown date December-2020, (unknown latency) after initiation suspect medication, patient had given an expired tdap to a patient (expired product administered).  No adverse event reported at the time of reporting.  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 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.
01/21/2007 pm patient became irritable and began to manifest lesions in the mouth, lips and tongue.  No treatment was administered
Systemic: Tingling sensation in injection arm, went away then noticed on other side of body in leg, then spread to right arm. Described sensation as 'what it feels like when you sleep on your arm funny'.-Mild
pt recv vax 7FEB97 & @ 11AM temp 104R;p/APAP temp dec 102 & stayed there for 24hr (despite dosing w/APAP & Ibuprofen);periods of crying, dazed & gen fussiness, did not eat, but took juice;
Irritability, loss of appetite, crying episodes on day 2. Intractable vomiting (yellow to clear, no green vomitus) on day 3 that lead to ER visit, no IV fluids administered, passed oral challenge with clear liquids. Diarrhea with loose stools 3-4 times a day on days 4 through 6, no mucus or blood. Loss of appetite continued through day 8.
States pain in arm vaccination given in.  Two areas of redness measuring 10x4 and 2x1 on same arm above axillary area.  Fever of 102 at onset time and 101 at 5:45 this am.  Took Ibuprofen.  Reported as recieved Pneumovax in Employee Health.  Reported to physician and seen in ER.  Augmentin 500mg/125mg 30 tablets to be taken twice a day for cellulitis RUE (at injection site) was prescribed in ER.
This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Mild headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination. No medical history reported. Concomitant products included HYDROCHLOROTHIAZIDE and IRBESARTAN for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 20-Jan-2021, the patient experienced HEADACHE (Mild headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (Mild headache) outcome was unknown. Action taken with mRNA-1273 in response to the event  was  not applicable. This case was linked to MOD-2021-020629 (E2B Linked Report).; Sender's Comments:  MOD-2021-020629:Same patient, 2nd dose
Initial solicited report received from an investigator (Defense Health Agency/Immunization Healthcare Branch) in the trial on 08 March 2017 and follow-up information received on 13 March 2017. A 24 year-old male subject with no significant medical history. The subject received concomitant medication with HPV, Quadravalent on 05 April 2016, Anthrax on 05 April 2016. The subject received a dose of ACAM2000  (lot number and route, site of administration not reported) on 28 April 2016. On 13 May 2016, 15 days after vaccination the subject was diagnosed with I40.8 other acute myocarditis. The lab data included 13 May 2016, Troponin I was 0.04 (abnormal), ECG done on 13 May 2016 was normal Echocardiogram done on 18 May 2016 was normal, MRI (heart, brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none.; Sender's Comments: This case involves a healthy 24-year-old male who developed acute myocarditis with favorable temporal association post vaccination with ACAM2000. Subject had confounding factors as concomitant administrations of HPV and Anthrax vaccine. Acute Myocarditis is a listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccines. Alternative etiologies could be myocardial infarction, pulmonary edema and coronary artery vasospasm. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, myocardial biopsy, role of study vaccine can not be ruled out.
Initial report received from a consumer on 29 March 2009 via the ACAM2000 Hotline. A male military service member who received smallpox vaccine (ACAM2000, lot number not reported) and anthrax vaccine (manufacturer and lot number not reported) experienced a reaction around the smallpox vaccination site. He reported a "dark line" around the vaccination site and redness surrounding the area. He also reported shoulder pain. He had not been seen by a health care provider but reported that he may visit the local Emergency Room for evaluation. List of documents held by sender: None. Followup report received from a consumer on 03 April 2009 via telephone contact. The patient reported that he went to an Ambulatory Care Center for evaluation. He could not recall the date he went. He was told that his smallpox vaccination site was healing normally. He reported that his symptoms of a "dark circle" around the vaccination site, redness and shoulder pain had resolved as of 28 March 2009. List of documents held by sender: None.
Patient received vaccine outside of the window making it invalid (vaccine had been removed from ultra-freeze for longer than 10 weeks).
herpes zoster; Information has been received regarding a case in litigation from a lawyer, and a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 02-OCT-2012, at age 65, the patient was administered the zoster vaccine live (ZOSTAVAX) by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from his zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
12/11/22    I had a sore throat, runny nose, around 100 degree fever that was gone by nighttime.  I tested with a home COVID test and tested positive. 12/12/22, I called my doctor?s office and spoke with his APN. She prescribed Lagevrio. I did not have many more symptoms for two or three days. I had a lot of postnasal drip and runny nose, very minor symptoms. I continued to test positive for ten days. I have recovered.
Pt in our office on 1/23/17 inadvertently given MMRV instead of MMR. Also given dose of VARIVAX.
After giving the patient a Shingrix shot that he asked about getting, I saw that the patient, had already gotten 2 shingrix. I called him a few days later and he said he had no problems. Some got 3 shingrix doses
Putting on jacket, noticed a painful lymph node in axilla of arm where vaccinated.  Later the same evening the lymph node was larger and there was numbness and pain in arm.
Caller states in early Feb2021 or late Jan2021, she had the pneumonia shot. She had some swelling and itchiness; Caller states in early Feb2021 or late Jan2021, she had the pneumonia shot. She had some swelling and itchiness; This is a spontaneous report from a contactable consumer (patient).  An 83-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot unknown), via an unspecified route of administration on an unspecified date in 2021 (early Feb2021 or late Jan2021) at unknown dose, single for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced some swelling and itchiness on unknown date in 2021. She took Benadryl and it went away. The patient underwent laboratory test on unspecified date which included blood test: good, everything was fine. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
SHARP HEADACHE; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced fatigue. On 22-APR-2021, the subject experienced sharp headache. On 22-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 27-MAR-2021, and had not recovered from sharp headache, and nausea. This report was non-serious.
Experienced side effects; Diarrhea; Dizziness; Headache; Chills; Nausea; I thought my right arm was going to fall off; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Experienced side effects), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), HEADACHE (Headache) and CHILLS (Chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Accident, Squamous cell carcinoma of skin (Stage 1 skin cancer in Sep-2021), Clinical trial participant in 1997, TIA (4 TIAs), MERS and Amputation (On right hand removed) in July 2021. Concurrent medical conditions included Asthma, Cardiac arrhythmia, Seizures (due to car accident) and Allergy (Severe Allergies-with a prescribed epi pen). Concomitant products included EPINEPHRINE (EPIPEN) for Allergy, LEVETIRACETAM (KEPRA), FLECAINIDE, MONTELUKAST SODIUM (SINGULAIR), PANTOPRAZOLE, FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]), ALBUTEROL [SALBUTAMOL], HCTZ and MUPIROCIN for an unknown indication.    On 23-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced DIARRHOEA (Diarrhea). 23-Dec-2021, the patient experienced DIZZINESS (Dizziness), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea). 23-Dec-2021, the patient experienced VACCINATION SITE PAIN (I thought my right arm was going to fall off). On an unknown date, the patient experienced VACCINATION COMPLICATION (Experienced side effects). At the time of the report, VACCINATION COMPLICATION (Experienced side effects), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VACCINATION SITE PAIN (I thought my right arm was going to fall off) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2003, MERS-CoV test: positive (Positive) Positive, in 2003 was out for 3 weeks with MERS.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was stated that patient had no COVID diagnosis and had received a Tetanus shot 08-Jan-2022 because they cut their finger on a garbage can. Concomitant medication include Ellipta 200 m. No treatment information was reported.   This case was linked to MOD-2022-492034 (Patient Link).
On approx. 12/19/00, the pt received his 1st IM-deltoid dose of Engerix-B. "Hours later" he developed a red area with itching at the injection site. His pediatrician dx'd the area as a "spider bite". The pt's allergist indicated that the pt should not receive his 2nd dose at this time. As of 1/9/01, the outcome of the adverse event is ongoing.
Patient received FLUZONE High Dose on 11-2-14. When she was in pharamcy today (4-22-15), she said that she still has some pain and numbness in the arm that vaccine was administered that has lingered since vaccination.
Wednesday evening Right arm felt heavy 3 hours after vaccination, right had went numb that night.  Next day on Thursday,  Left hand went numb and had swelling in both hands.  On Friday. Right arm was numb from hand to elbow and left hand continued to be numb.  Went to the emergency room and was given high dose steroids and sent home on  prednisone.
Administred VAQTA, then GARDASIL, immediately after GARDASIL child became unresponsive, stiff, pale about 30 sex. Child lost bladder control, pulse 46-55 after event, child alert and aware after events.  11/27/06 Received medical records from provider/reporter which reveal patient had LOC, tonic/clonic movements & loss of bladder control after received 2nd GARDASIL vax.  HR was 46-55.  This was the 3rd episode of LOC within a year (1st after tetanus shot, 2nd after finding a tick & 3rd after 2nd dose of GARDASIL).  PCP recommended cardiac & neuro w/u.  Received cardiac consultation which revealed final dx: probable fainting.  Holter monitor was WNL.  Awaiting neuro consult.
She developed allergic reactions from taking Butalbital; This is a spontaneous report from a program support. A contactable consumer (patient) reported that a 52-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 18Feb2021 (Batch/Lot Number: EN6201) as dose 1, single, via an unspecified route of administration, administered in Arm Left on 10Mar2021 (Batch/Lot Number: EN6202) as dose 2, single for covid-19 immunisation. BUTALBITAL SODIUM, route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included migraine (has migraine ever since she was a child). On 30Sep2021, she took a dose of Butalbital for the first time since she was administered Pfizer Covid Vaccine and experienced an allergic reaction to the Butalbital because of the Pfizer Covid Vaccine. The patient received Benadryl as treatment. Event was serious, medically significant. The outcome of the events not recovered. The action taken in response to the events for butalbital sodium was unknown.   Follow-up attempts are completed. No further information is expected.
Patient called to report "red blotches" on arm where vaccine was administered, non-pruritic.
Initial report received on 22/Nov/2005 from a health care provider. A 4 year old female patient, with a medical history of allergies to penicillin and sulfa, received an intramuscular, left thigh injection of Fluzone No Preservative 2005-2006, lot number U1802EA, on 05/Nov/2005. On 21/Nov/2005, the patient developed generalized hives and was treated with Benadryl without effect. She was diagnosed by her physician with Erythema Multiforme. Her "strep" test was negative. The patient had no illness at the time of vaccination and denied other medications. At the time of this report, the patient had not recovered. Follow-up information received on 30/Jan/2006 from a health care professional. Per the reporter, the mother called the facility on 23/Nov/2005 and indicated the patient was diagnoses by an allergist with the hives and it was felt that the hives were secondary to a random even and not the Fluzone vaccination. The patient was started on steroids and the rash was much better that day. The patient was seen by her physician on 23/Jan/2006 and she had completely recovered from all the events. No further information is expected.
12 hours after shot awoken to projectile vomiting. 6 times in 3 hours. Followed by 8 hours of bed ridden nausea, body aches, chills. About 24hours of terrible sickness and pain. Side effects lasted over 48 hours
Large red itching whelp at injection site within 24 hrs. Continued to get larger and covered upper arm hot, red, profuse itching. MD visit - order for 7 days BENADRYL 50 mg q 6 hours, ZANTAC 150 Bid x 7, and topical oint.
No additional AE; patient was administered expired ROTATEQ.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not provided.  On 16-MAR-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, lot #1707460, expiration date: 14-MAR-2022, route of administration defaulted to oral, for prophylaxis (expired product administered). The vaccine did not have any prior temperature excursions. No additional adverse event was reported (no adverse event).