chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose 1 was received 02/07/2020 (15 mts ago) never got the 2nd shot; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 7th February 2020, 15 months ago from the reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows:  The age at vaccination was not applicable for this report. The pharmacist reported that the patient was late for 2nd dose and till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter would like to confirm if it was ok to move forward. The VAERS details was reported for the 1st dose. The reporter consented to follow-up. No other details of the vaccine was available.
Patient came to college on 4/24/21 after she received her Pfizer COVID vaccine from hospital.  She reported chest tightness and itchy throat.  Her pulse ox was 98.  Her lungs were clear.  She accompanied her mother who was coming to college for her COVID vaccine.  EMS spoke with patient as did Dr. Pt refused to go with EMS to the ED.  She claimed if she had any problems she would go back to hospital.
By night-time Wednesday (after the shot Wednesday morning), I had a low-grade fever; it got as high as 101 and was up and down between mid 99 and mid-100 for about 24 hours (my norm is approximately 97.7) - Also had low energy, muscle aches and gastric distress (as well as the tenderness around the shot area). Symptoms had mostly subsided by Friday morning, but I stayed home from work Thursday and Friday to make sure there wasn't something else going on. 5 days later tired and some sinus drainage.
shoulder discomfort and swelling for approximately 4 weeks; mild improvement with Tylenol;
Two days post-vax the patient developed many red, itchy papules on the left upper arm.
Difficulty swallowing; Difficulty breathing ¨she is breathing very strong, hard to talk ¨; Felt bad; Body pain; Muscle pain; Fatigue; Had headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing ¨she is breathing very strong, hard to talk ¨) in a 52-year-old female patient 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 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced MALAISE (Felt bad), PAIN (Body pain), MYALGIA (Muscle pain), FATIGUE (Fatigue) and HEADACHE (Had headache). On 17-May-2021, the patient experienced DYSPNOEA (Difficulty breathing ¨she is breathing very strong, hard to talk ¨) (seriousness criterion life threatening) and DYSPHAGIA (Difficulty swallowing). At the time of the report, DYSPNOEA (Difficulty breathing ¨she is breathing very strong, hard to talk ¨), MALAISE (Felt bad), DYSPHAGIA (Difficulty swallowing), PAIN (Body pain), MYALGIA (Muscle pain), FATIGUE (Fatigue) and HEADACHE (Had headache) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company Comment: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Myalgia, fatigue and headache are consistent with the product known safety profile.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Myalgia, fatigue and headache are consistent with the product known safety profile
Sudden total hearing loss in left ear, treated by daily transtympanic steroid injections over a period of 3 weeks. Regained much of my hearing.
Immediate vasovagal reaction. Recovered with  supine positiion. Vital signs were monitored. Was able to sit after 15 minutes, then stand and walk after 15 more minutes of observation
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022; The administered booster dose was 0.5 ml; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022), PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) and ACCIDENTAL OVERDOSE (The administered booster dose was 0.5 ml) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Acute illnesses at the time of vaccination and up to one month and chronic and long standing health conditions were unknown.     On 11-Mar-2022 at 12:44 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Mar-2022, the patient experienced ACCIDENTAL OVERDOSE (The administered booster dose was 0.5 ml). On 11-Mar-2022 at 12:44 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022), PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) and ACCIDENTAL OVERDOSE (The administered booster dose was 0.5 ml) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  This vaccine was administered up until its Mfg Exp date of 04-Apr-2022. The patient received the booster dose.  No treatment medications were provided.   This case was linked to MOD-2022-542869 (Patient Link).
After receiving the vaccine I startedfeelng naseated, running fever, body started aching really bad. I had chills and a very bad headache for days. The fever and chills lasted 3 days. My temps was 102.4.Also, I couldn't write, it seems like i couldn't remember how.
Itchiness started about 5 minutes after receiving the vaccine, patient was anxious. Diphenhydramine Hcl 25mg tablet given to patient, monitored for an additional 15 mins after medication was taken. Patient felt better, itchiness resolved, no other symptoms reported. Patient left the clinic at 4:23pm.
Initial onset of paralysis evening of 05/19/2013; within eight hours was paralyzed from waist down, including bowels and bladder. Put in ICU at hospital at midnight. Two MRIs, lumbar puncture, etc early morning 05/20/2013.  Received five doses of IVIG beginning AM on 05/20/2013.  Hospitalized for 16 days, with final diagnosis as Transverse Myelitis (initially thought to be Guillain Barre Syndrome).
Patient presented with feeling of "headrush" dizziness, tachycardia to 130's, itching  to neck,  visible hives to face and neck.
1 hour past vaccine, onset of symptoms are as followed and continue to now day 4: generalized fatigue, nausea, sever headache, flu-like symptoms decrease appetite, continuous headache that wakes me up at night. Notified facility that administered vaccine.
Narrative:  Pt is 75 y/o male with a PMH of initial diagnosis of small cell lung cancer and most likely metastatic colorectal adenocarcinoma had received the first dose of Pfizer COVID-19 vaccination on 2/11/2021. Pt was then admitted at a local hospital since 3/1 for surgery to remove tumor. Pt was then seen by non-facility ER on 4/14 and 5/14 for SOB and AMS. On the admission for 5/14, patient was found to be uroseptic. Pt never received 2nd dose of COVID-19 vaccination. Pt passed away 5/23/2021.
This spontaneous report received from a patient concerned an 84 year old female. The patient's height, and weight were not reported. The patient's past medical history included: blood clot in right leg (approximately 8 months, on blood thinners, but now stopped), and concurrent conditions included: type 2 diabetes, non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient did not had any drug abuse or illicit drug usage. The patient did not had any known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 28-FEB-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid.  On 01-APR-2021, the patient experienced lethargic, general feeling of unwell, and numbness in both legs/feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lethargic, numbness in both legs/feet, and general feeling of unwell. This report was non-serious.
Patient described unusual irritation at the site of injection. Both immunizations were given in the same arm and there was slight swelling and irritation after 1 month of administration
Case reported that in the night she would have periods of chills, H/A, and joint pain. Woke up a couple of times but it did not prevent her from getting rest.
expired PENTACEL was administered to a patient with no reported adverse event; Initial information received on 17-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient to whom experienced expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5 ml dose once (1X) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection, (lot UJ640AAA; Expiry Date: 28-JAN-2023)  via unknown route in unknown administration site for Immunization.  On an unknown date the it was reported that an expired pentacel was administered to a patient with no reported adverse event (expired product administered) (latency: on same day).  Action taken : not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
headache, body aches, red spots on arm, sore arm for over 2 days, chills, back aches
Registration #11997006. Patient is a 90 year old elderly female. She came to the vaccination site for her Pfizer COVID-19 booster vaccine. Prior to having her vaccine she was in waiting area near the quiet room. When she went to sit down she felt dizzy and sat at the edge of the chair causing her to lose her balance and fall on the floor on her buttocks. No head trauma and no other body areas were hurt during the fall. Personnel was nearby which assisted in helping her get up and proceeded to sit her in a wheelchair. When MD arrived with supervisor patient was alert and oriented. No loss of consciousness.  EMT arrived at the scene shortly thereafter. Patient was warm and well perfused, equal pulses. She informed us she has type 2 diabetes and is hypertensive. She is treated with Metformin and Losartan. Patient was complaining of a headache scale 3-4. She denied nausea, no abdominal pain and no weakness. Her initial BP was 152/60 and improved to 134/68 ten minutes later. Fingerstick glucose was abnormal, above standard limits read as 234 mg/dL. She had eaten an hour before. The patient was offered water which she took only a few sips and did not want more. Throughout the observation period, Patient was alert and oriented at all times. No worsening of the headache. She later received her Pfizer booster vaccine and was observed for an additional 15 minutes. She tolerated the vaccine well and there were no adverse events from the vaccine. She was taken in the wheelchair to her car. She was able to walk a few steps to the passenger side of the car assisted by Aqueduct vaccination site personnel and her daughter who proceeded to place her seat belt on and later drove away. Patient was offered a ride to the hospital via ambulance for further evaluation but she refused. Patient and her daughter were advised by the EMT and doctor to go to the nearest ER if she had worsening headache or any new symptoms such as vomiting, change in behavior, change in speech or became disoriented. Recommended to give acetaminophen for pain at home if needed. Was also advised to recheck glucose at home and if above 200 mg/dL to check for urine ketones. If ketones present was asked to go to nearest ER for further evaluation and treatment. If glucose still elevated and no urine ketones to contact her primary care provider or go to the ER for further assistance.
Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated by a physician at a medical center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
after about 5 minutes patient started to feel hot, ringing in ears, sweaty, pale and nauseous. lasted about 10 minutes. blood pressure was normal at 113 over 81 but that was toward end when patient was already feeling better
Site was swollen and  very warm - celulitis - antibiotics for a week and getting better
Vaccination was given high in the deltoid resulting in left shoulder and arm pain x 14 days.
When I stand up I feel like I am going to pass out; My arm is so painful I cannot raise it up; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (When I stand up I feel like I am going to pass out) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (When I stand up I feel like I am going to pass out) (seriousness criterion medically significant), VACCINATION SITE PAIN (My arm is so painful I cannot raise it up), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, LOSS OF CONSCIOUSNESS (When I stand up I feel like I am going to pass out), VACCINATION SITE PAIN (My arm is so painful I cannot raise it up), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.5 (High) 100.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter. No treatment information was provided.  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.
This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 16-JUN-2017, the patient was vaccinated with first dose of ROTATEQ orally, lot # M044396, expiration date 19-MAR-2019, and on 16-JUN-2017 the patient was vaccinated with a second dose of ROTATEQ orally, lot # M044396, expiration date 19-MAR-2018. No adverse effects were reported. Additional information has been requested.
Pt recv vax on 5/3/99; on 5/6/99 pt exp local area of erythema on lt upper arm
Vasovagal event without syncope post vaccine.  Clammy and nauseous with tingling to hands.  EMS and  Dr  on site.  Blood pressure 90/49 at 18.10.  at 18.15 blood pressure was 114/81.  Released home and advised to seek medical attention later if needed, client verbalized understanding.
Severe shoulder pain, unable to lift arm.  Pain and restricted movement persistent for 1 week without improvement in intensity.  Points to injection site
MenA vial was expired.; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA380A, expiry date 31st August 2021) for prophylaxis.   On 22nd October 2021, the patient received Menveo. On 22nd October 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse stated that a patient had administered MENVEO vaccine, in which the MenA vial was expired. However, MenCYW vial was not expired (MenCYW vial Lot: AMXA380A Expiry date July 2022. The reporter gave a consent to follow-up herself. The following information about patient's initials, date of birth, gender, dose, and route of administration was not provided. The reporter consented to follow up.
Received vaccine 11/14/2005. 11/16/2005 in office with 4 inch diameter erythema warm, very painful to touch, slight swelling, no fever. By pm increased pain in arm and increased swelling. Placed on Cephazolin. 11/17/2005 am pt had fever 101 continued pain, erythema more blotchy, swelling same. 11/18/2005 erythema migrated but decreased afebrile, less painful.
Pt became unresponsive approximately 5 minutes after receiving vaccination. Tapped pt shoulder and cheek and got them to wake up and had somewhat irregular breathing (no wheezing or blocked airway), eyes were rolled back. 911 Was called and pt became responsive. Pharmacy staffed cared for pt until ems arrived and pt was taken to emergency room for assessment.
At a medical checkup 2 days following my vaccination, the PA noted that my blood pressure was high.  My arm was extremely painful.  The next day I checked my blood pressure at home at it was lower than normal.  The next day I awoke feeling very bad; I was sweating, which is very abnormal for me.  I took my blood pressure and it was 179/101 mmHg.  This is extremely high for me.  In addition I had an extreme tinnitus, much louder than the tinnitus that resulted from my second injection of the vaccine (previously reported).  I alerted my family of my distress and took a naproxen having read in a medical journal article that it helped relieve symptoms of the viral infection by stopping a "cytokine storm".  I have a Ph.D. in medical virology with published peer-reviewed articles.  Within a short time span, my symptoms subsided, except for the tinnitus) such that I no longer felt at risk for a stroke or other catastrophic event.  The next morning I awoke again with the same signs and symptoms; I repeated the naproxen and again my signs and symptoms subsided except for the tinnitus.  By the next day, I was much better and did not need any further naproxen.  But my tinnitus unfortunately was more profound that it had been.  I had hoped that the tinnitus would subside, but it is persistent and profound.  It causes me much difficulty falling asleep and upon awakening, it is blaring and profound.  It also becomes apparent many times a day.  I did not suffer from tinnitus prior to being vaccinated for COVID as I had reported before.  I made an appointment with an otolaryngologist, but was offered no relief from my condition.  This has affected my daily life.
Patient states the injection was given very close to the shoulder which caused injury possibly to the rotator cuff
I feel like my brain, the nerves I don't you know I don't sleep too well; I am going paranoid; Headache; I feel like my brain, the nerves I don't you know I don't sleep too well; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as Dose 1,Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported I took my vaccine, You know and after two days started seeing some side effect like you know the addict. I felt like a headache you know and I am going to have my 2nd shot in a 90 days. On an unspecified date ,the patient experienced headache, abnormal feeling, lack of sleep and paranoia on an unspecified date with outcome of unknown.  Product details (Expiration date, NDC# UPC# and Treatment) and Pharmacy details could not be probed as consumer was unwilling to share further information. Hence further probing could not be done.  Information about lot/batch number has been requested..
1st shot the next day had fever which lasted 24 to 48 hours. Cold/hot chills/sweats.  Fever was 100 to 101. Treated with Tylenol. Had severe headache the 3rd day after receiving it. Very tired. 2nd shot was given 4/20/21 at 4pm. Woke up next morning with fever of 101. Had severe headache all days and cold/hot chills/sweats. Very tired.