chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Subsequent to receiving third dose of rubella virus vaccine live (second generation), the pts laboratory evaluation revealed a lack of response. No further information is available.
Reported nausea, but it went away.  Feels tired.  After conversation, possibly just anxiety.  COVID call center advised return to work.
Soreness at injection site, fatigue, chills, body aches. Symptoms relieved by 4:30pm on 3-12-12.
On day 7 of amoxicillin for a presumed strep infection. Many in daycare positive for it. Rash on buttocks only symptom. Received a PREVNAR and woke up with a whole body rash next day.
Patient received Moderna at approx 12:50 PM 3/16/21. at 1:00PM began experiencing numbness of tongue, tingly rt side of face and throat felt like it might be closing.  No GI, Chest, or skin symptoms or signs. She had a normal pulse rate and exhibited no rash, hives or throat swelling on exam. She received 50mg of diphenhydramine and was closely monitored. Her tingling subside over the next 45 minutes , gradually, and she had no further complaints re: throat or mouth issues. She denied any itchiness. By 1:45, her symptoms had completely resolved.  She was offered ambulance, hospital follow up, and continued monitoring. She declined and chose to go  home with instructions to call 911 if any recurrent symptoms. cont.
Headache,  stomach ache dizzy  nausea pain in shoulder very sore , blood sugar dropped to 60,  blood pressure 185 systolic; has not been to doctor yet
Patient described feeling tingling in the ears and nose. After 15-20 minutes the feeling subsided. Blood pressure was check and was normal
heavy blood in stool and small blood clot passed with stool. blood with stool lasted for approximately one week.
Physician reported that patient developed screaming and irritability which persisted for approximately 24 hours. One day post immunization, the patient was seen by a physician and diagnosed with acute left otitis media. The patient was treated with antibiotics and the screaming and irritability resolved the next day. The patient recovered. A copy of this report has been forwarded to Aventis Pasteur, manufacturer of IPV.
received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA81EZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd February 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: A nurse reported that a patient received a dose of Bexsero which was already expired on 31st January 2022.  No other symptoms were reported. The reporter consented to follow up.
2 min after shot became dizzy, flushed, sweaty. Lasted 6-7 min. Arm soreness and extreme tiredness both for two days. Next day developed itching that progressed over several days. Rash/hives to upper chest, arms, and back started on day 3 after injection. Had to take Benadryl and vistaril initially then Doctor prescribed Prednisone on day six.
Narrative:  COVID infections following completion of COVID vaccine series 12/01/20 COVID POSITIVE 12/31/21 COVID vaccine dose #1 01/21/21 COVID vaccine dose #2 07/25/21 Pt denies any symptoms; preop COVID test - COVID POSITIVE 07/26/21 Pt remains asymptomatic; ID recommends to reschedule procedure after quarantining for 10 days
Within 15 minutes of receiving vaccine, patient began experiencing itching all over. Scalp was reported to be the worst. RN monitor in the observation area also observed urticaric rash over left shoulder/upper body. Patient refused further treatment at the time.
headache; fever of 99.9; itching from belly to knees with hives the size of quarters; itching from belly to knees with hives the size of quarters; This is a spontaneous report received from a contactable consumer reported for himself. A 77-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6201, Expiry date: unknown), via intramuscularly, on 30Mar2021 (at 10:40) single dose on left arm for COVID-19 immunization. Historical vaccination included the patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, on 09Mar2021 (10:10). The patient medical history and concomitant medications were not reported. The patient had COVID in October 2020 and was hospitalized for 17 days. No vaccines were taken prior 4 weeks. On 30Mar2021, by evening (at 17:00), the patient experienced a fever of 99.9, headache that was the worst, itching from belly to knees with hives the size of quarters. All the events lasted for one day. Allegra tablet was taken as a therapeutic measure fore itching from belly to knees with hives the size of quarters. The reporter assessed all events as non-serious. The outcome of the events was resolved on 31Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
body aches, no temp  pt was also concerned about "bumps" on posterior neck. pt had haircut approx 4 days ago and appear to be a folliculitis. treated for follicultis with heat and abx
14 x 14 cm red, tender, warm area around vaccine site. Determined to be larger than normal local reaction. No treatment other than ibuprofen and BENADRYL recommended.
Atrial fibrillation; A spontaneous report was received from a consumer, concerning herself, a 74-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced medically important event of atrial fibrillation.  The patient's medical history included heart surgery on an unspecified date in 2017. No concomitant medications were reported.  On 05 FEB 2021, prior to the onset of event, the patient received their second of two planned doses of mRNA-1273 (batch number: 015L20A) for the prophylaxis of COVID-19 infection.  On an unspecified date in FEB 2021, the patient experienced fast heart rate, felt weakness, dizziness, and had atrial fibrillation. No treatment medication information was provided.  Action taken with second dose of mRNA-1273 in response to the event was not applicable.   The outcome of the event, atrial fibrillation was not reported.; Reporter's Comments: Based on current information the event was assessed as unlikely related to mRNA-1273 vaccine, because of biological implausibility, no clear temporal association, and the patient's history of heart surgery which may promote atrial fibrillation episodes.
Patient was fully vaccinated for COVID with Pfizer vaccine, Dose 1:  2/18/21, dose 2:  3/11/21.  Patient hospitalized for respiratory failure on 10/31/21, and remains hospitalized today, day 4.
shortness of breath; I felt like a elephant is sitting on my chest; tiredness; feeling unwell; diarrhea; runny nose; a little arm pain where the injection went in; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 21Sep2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose number unknown (booster), 15 ug single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization.  The following information was reported: CHEST DISCOMFORT (non-serious) with onset Sep2022, outcome "unknown", described as "I felt like a elephant is sitting on my chest"; VACCINATION SITE PAIN (non-serious) with onset Sep2022, outcome "unknown", described as "a little arm pain where the injection went in"; DIARRHOEA (non-serious) with onset Sep2022, outcome "unknown", described as "diarrhea"; MALAISE (non-serious) with onset Sep2022, outcome "unknown", described as "feeling unwell"; RHINORRHOEA (non-serious) with onset Sep2022, outcome "unknown", described as "runny nose"; DYSPNOEA (non-serious) with onset Sep2022, outcome "unknown", described as "shortness of breath"; FATIGUE (non-serious) with onset Sep2022, outcome "unknown", described as "tiredness".  Additional information: 16Sep2022, the booster and had the, some of symptoms had was shortness of breath and felt like a elephant is sitting on his chest. Started having symptoms on Saturday, the 17th and 18th, on the 19th was fine, no problems on 19th. But the patient had shortness of breath, tiredness, feeling unwell, diarrhea, runny nose and a little arm pain where the injection went in.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unspecified date in 2014, the patient was inoculated with ZOSTAVAX by a pharmacist as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient developed shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about 30-NOV-2016, the patient was treated by a physician for shingles. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include 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; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. The reporter considered events to be related to ZOSTAVAX.
significant rash at injection site; muscle ache; fever; no sleep; sore arm; joint ache; chills; Tiredness; This spontaneous case was reported by a pharmacist and describes the occurrence of INSOMNIA (no sleep), PAIN IN EXTREMITY (sore arm), ARTHRALGIA (joint ache), CHILLS (chills) and FATIGUE (Tiredness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included VERAPAMIL, AMLODIPINE, HYDROCHLOROTHIAZIDE and PANTOPRAZOLE for an unknown indication.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced INSOMNIA (no sleep), PAIN IN EXTREMITY (sore arm), ARTHRALGIA (joint ache), CHILLS (chills), FATIGUE (Tiredness), MYALGIA (muscle ache) and PYREXIA (fever). On 14-May-2021, the patient experienced VACCINATION SITE RASH (significant rash at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) for Rash, at an unspecified dose and frequency. On 13-May-2021, INSOMNIA (no sleep), ARTHRALGIA (joint ache), CHILLS (chills), FATIGUE (Tiredness), MYALGIA (muscle ache) and PYREXIA (fever) had resolved, PAIN IN EXTREMITY (sore arm) outcome was unknown. At the time of the report, VACCINATION SITE RASH (significant rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Received MMR vaccine 3/9/07, came into health department 3/14/07. Positive red rash on upper arm, warm to touch, no induration reports no fever.
Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 42 years old female patient who was vaccinated with a dose of FLUZONE HIGH DOSE (lot number: UI9758AC and expiry date: 30-Jun-2019) (dose, dose in series, route and site of administration were not reported) on 04Sep2018 instead of a dose of Shingles vaccine. Patent was already vaccinated with FLUZONE HIGH DOSE in August. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to Wrong vaccine administered. It was unknown if any adverse event was occurred or not following the vaccination. 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. List of documents held by the sender: None.
7 AM 3/25/2021 - Patient called out to husband from the bathroom where she experienced a syncopal event, then passed out.  An ambulance was called and she was revived for a short period of time.  She was taken to Hospital where she coded 3 times.  She was then life-flighted to second Hospital.  According to the hospital records, tests conducted over the course of several days determined that she had no neurological activity.  Initial reports in the records indicate pulmonary embolism, cardiac and respiratory arrest.  She was on life support for the remainder of her time.  Organ donation is being pursued at present and results of this are pending at time of this report submission.  Date of death is unknown until organ retrieval is accomplished.  Family will be contacted in the next few days to ask further questions about any other kinds of vaccine-related reactions that may have happened more immediately to days after the vaccination on 3/17/2021.  A co-worker thought that she had shortness of breath for 3-4 days before this critical event occurred on 3/25/2021.
Chills, allodynia, nausea, body aches, headache, fatigue, joint pain, rash, swelling at injection site, fever, sleepiness, diarrhea
Moderna COVID-19 Vaccine EUA                              On 03/11/21 I discovered red splotches with swelling underneath, warm to the touch.  They do not hurt or itch, so could have been there longer (just happened to see them this morning).  They are below, and slightly forward of the injection site.
At the beginning of February I noticed I had a small bump on my right breast. I didn't think much of it because I thought it may be an insect bite. I then noticed it was deeper into the breast. About a week later there was puss that came out. One of my children ran into me as they were playing and I felt this huge crunch in my breast. I got nauseous and didn't feel well at all. The area started spreading and the skin looks like it's been burned. Extremely tender. When I was finally able to get a doctor to see me, they tried to look at it and it was a hard mass with no fluid -so lancing was not an option because nothing there to lance. Prescribed - Sulfate Zolon - (Bactrim). Doctor is hopeful that will clear it up. I am wearing bandages over it. Skin is beginning to peel away. Still silver dollar size - has not grown more. Waiting the next 7 days and will try to get into another healthcare provider. Unable to get mammogram because of insurance issues.
Pt had temperature of 99.0F at 8:00pm, gave Tylenol at 8:20pm.  At 8:30pm, mom reports pt became completely limp, turned white, with bluish change to lips.  Patient's eyes were closes, he was breathing, and still arousable, but limp.  Mom called 911, episode lasted about 5-6 minutes, then resolved completely.  Following, patient's vitals were stable, he was awake and fed well.  No convulsions or postictal state.
EYE PAIN; SEVERE HEADACHE; FEVER; FEELING THIRSTY; FELT MASSIVE PAIN RADIATING IN BODY AND PAIN IN LEGS AND ARMS; BLURRY VISION AND WHITE CLOUD OVER EYES; FELT LIKE LOSING SIGHT; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient did have no known drug allergies and no known health conditions and not on any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced felt like losing sight. On 2021, the subject experienced blurry vision and white cloud over eyes. On 2021, the subject experienced felt massive pain radiating in body and pain in legs and arms. Laboratory data included: CAT scan (NR: not provided) couldn't diagnose, Electrocardiogram (NR: not provided) couldn't diagnose, Eye exam (NR: not provided) couldn't diagnose, Lab test (NR: not provided) didn't see any blockage and couldn't figure out, and MRI (NR: not provided) couldn't diagnose. On 08-MAR-2021, the subject experienced feeling thirsty. On 09-MAR-2021, the subject experienced eye pain. On 09-MAR-2021, the subject experienced severe headache. On 09-MAR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: macrogol 400/propylene glycol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from eye pain, blurry vision and white cloud over eyes, and felt massive pain radiating in body and pain in legs and arms, and the outcome of feeling thirsty, severe headache, fever and felt like losing sight was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment is not needed as per standard procedure since case is assessed as non-serious.
Pt felt SOB, c/o hand/lip numbness   Vitals: 1400, HR 82, BP 198/118, O2 99, @1406 HR 80, BP 174/111, O2 100, @1419 HR 77, BP 166/97, O2 100 Pt discharged to home with others at 1432
Patient had Covid in November 2020, recovered & tested postive for the Antibodies. On the morning/early afternoon of 3/4/2020 her took the 2nd dose of the Pfizer vaccine and became violent ill early that evening. He was throwing up and his entire body was on fire to the touch, but he had no fever. the subsequent 5-7 days he was ill (chills, aches, fatigue), much the same as when he had Covid the prior November. Approximately 2 weeks after these Covid like symptoms subsided (3/27/2021), Patient had felt off later in mid-day but could not pin point the feeling he was experiencing, a few hours later he felt fine, he ate dinner later that evening and went to bed. The next morning (3/28/21) he woke up and commented her didn't have any peripheral vision in his right eye and he had, as he said "massive headache". His wife drove him to Medical Center where he was told he was in "AFib" and after tests it was determined he had suffered a mild stroke, which ultimately took his right eye outer peripheral vison where his left eye inside peripheral vison and also left him short term memory, recall issues. Patient has no family history of "Afib" and he himself has never been diagnosed with "Afib" or an irregular heartbeat. The coincidence of this stroke happening on the heals of a severe iliness reaction to the 2nd Pfizer vaccine is too much to ignore.
Soreness and redness at inj. site. Afebrile. C/O stiff neck.
Two weeks after vaccination still have a rash. The day of the vaccination had chills. Starting to use Hydrocortisone cream today
Pt stated that she has vasovagal syncope when she has needles and stresses.  Pt received vaccine lying down on recovery cot. Friend was at her side providing support. Ice to back of neck, feet elevated. status post receiving vaccine approx 30 sec while talking to pt she had syncope  unable to recover with verbal  nurse provide sternal rub pt came to alert and oriented smiling and laughing. She stated this happens and is normal for her to pass out due to vasovagal syncope condition that it happens all the time. refused to go to hospital. She has had all kinds of tests (cardiac, neurological, ENT per pt it has been dx as vit def, NA def, nutritional def )  While talking to her she had a 2nd syncopal episode used ammonia salts to recover pt awakened immediately.  VS 110/72, HR 84 reg strong, resps 12 reg nonlabored, SpO2 98%. Provided water for hydration.  Friend stayed a side the whole time. after 20 min sat pt up,  no LOC again, no SOB no N/V.  Sat in recovery 30 minutes. Pt stated  I feel fine . OK'd to exit
I felt like I had a fever and I felt achy. The next day I got a sore throat. On the third day I was really congested, and I was coughing. I tried to get tested and when I got an appointment, I tested Positive for COVID-19. I went to the urgent care, and I was not prescribed anything. On the fourth day I lost my sense of taste and smell. Most of the symptoms lasted about ten days. I felt miserable and I had the fever, coughing and congestion and I was fatigued. My sense of taste returned first but not all the way. It took three weeks to feel normal. It has been two months and my sense of smell and taste are still not returned to normal but it is getting better.