chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vasovagal syncope; I suffered incontinence; Blood pressure dropped; A spontaneous report was received from a 29-year-old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vasovagal syncope, blood pressure dropped, and incontinence.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included multivitamin and fish oil.  On 27 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Approximately five minutes after receiving the vaccine, the patient experienced vasovagal syncope. The patient reported his blood pressure dropped too much and he passed out for about ten seconds. He also suffered incontinence. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On 27 Jan 2021, the outcome of the events, experienced vasovagal syncope, blood pressure dropped, and incontinence, were considered resolved.; Reporter's Comments: This case concerns 29-year-old male patient, who experienced non serious unexpected events of blood pressure decreased with vasovagal syncope and incontinence. The events occurred 5 minutes after the first dose of mRNA-1273 vaccine.  No treatment was reported, and outcome of reported events was reported as resolved.  All events were assessed as related to mRNA-1273 vaccine due to temporal association.
pediatric dose of Engerix-B was given to an adult patient; Adult use of child product; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 25-year-old female patient who received HBV (Engerix B pediatric) (batch number 92DJ3, expiry date 03-MAY-2025) for prophylaxis.   On 21-SEP-2023, the patient received Engerix B pediatric. On 21-SEP-2013, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Adult use of child product). On 21-SEP-2023, the patient experienced underdose (Verbatim: pediatric dose of Engerix-B was given to an adult patient).  The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 21-SEP-2023 The Nurse called to report a pediatric dose of Engerix-B was given to an adult patient, which led to underdose and adult use of a child product The reporter did not consent to follow-up.
temperature excursion for products including opened IPOL with no adverse event; administering a vaccine to a patient after excursion with no reported adverse event; Initial information received on 29-Sep-2022 regarding an unsolicited valid non-serious case via other health professional.  This case is linked to case 2021SA154177.  This case involves a 14 years old male patient who was administered a vaccine IPV (VERO) [IPOL] after excursion with no reported adverse event and temperature excursion for products including opened ipol with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) both for Immunisation.  On 22-Sep-2022, the patient received suspect IPV (VERO) at a dose of 0.5 ml (lot T1E872M, expiry date: 10-Oct-2022) via subcutaneous route in the left arm for immunisation.  On 22-Sep-2022 the patient was administered vaccine after excursion with no reported adverse event (poor quality product administered) same day latency. On an unknown date there was temperature excursion for products including opened ipol with no adverse event (product storage error).  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 guidelines. 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.
Fatigue evening of dose, chills. Morning after dose - dizziness, nausea, chills, fatigue, body aches
"Janssen Covid-19 Vaccine EUA"  flu like symptoms, body aches, running fever, makes you feel like you been hit by a big truck.
None - administration error - diluted vaccine had been left out for 8 hours (6-hour expiration)
Headache, Myalgia, Arthralgia, Fever, injection site pain, fatigue Narrative:
facial drooped right side of face; headache; dry eye, right side; cannot taste anything; tired; This is a spontaneous report from a contactable consumer reported for self. This 73-year-old male received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el9269), via an unspecified route of administration, left arm on 10Feb2021 12:45 at single dose for COVID-19 immunisation. Medical history was none. No covid prior vaccination. No known allergies. Concomitant medications included Pantoprazole and Lisinopril. No other vaccine in four weeks. He experienced facial drooped right side of face; dry eye, right side; cannot taste anything; tired; headache on 13Feb2021 10:00 AM. Ae resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No covid tested post vaccination. No treatments were received. Outcome of the events were not recovered.
teeth-chattering chills, excruciating headache, 101 fever, muscle aches, vertigo, diarrhea, fatigue, achy chest with tingly cough, brain fog
Became white, profuse sweating, felt pressure in head like a tight band around head, ringing in ears, hot at first then cold, lost consciousness for about 30 seconds, body jerked twice.
Patient was given flu shot in left upper arm. Returned on 10-7-16 with 4x4 swollen, tender area.
Chills, headache, nausea, fatigue, sore muscles and joints. Lasted 2-3 days
ARTHRALGIA, LOCALIZED EDEMA AND ERYTHEMA AT INJECTION SITE, SITE OF PNEUMOVAX/ LT ARM, LESS THAN 24 HOURS FOLLOWING VACCINATION WITH PNEUMOVAX AND INFLUENZA. PT WAS SEEN IN CLINIC ABOUT 24 HOURS FOLLOWING THE VACCINES AND IS BEING TREATED WITH ANTIBIOTICS AND ANTI-IMFLAMITORIES.
syncope episode occurred about one minute after shot was administered. Patient was slumped in her chair and eyes were rolling to the back of her head, and had sporadic arm/leg movement. Episode lasted approximately 1 minute. Patient was intermittently responsive during episode, opening her eyes and acknowledging questions. face looked very pale. Her significant other or partner who was with her mentioned she hadn't eaten anything all day (it was 4:00 pm). 911 was called, and ems arrived shortly. She was taken by ambulance. We followed up with the patient the next day and she said her arm was numb from the wrist to the shoulder with diminished sensation in the arm she received the vaccine. Otherwise she was feeling ok.
Pt given 1st dose of vax approx 4 days later pt exp urticaria around the site of inject; No further details were provided;
Fever, rash, joint swelling, pedal edema. Tx in hospital  50 gm prednisone with full recovery.
SkinRash, Rash, UrticariaPruritus, Swelling at site of injection Narrative:
CELLULITIS Patient came to pharmacy stating site of injection was red, swollen, and very painful, RPh on duty advised patient to call MD, due to possible cellulitis, patient returned to pharmacy later in the day to state it was in fact cellulitis and MD sent an RX antibiotic to treat
pt recv vax 5MAR97 & approx 3AM awoke w/sweats/chills/nausea;returned to bed & awoke @ 5AM w/severe h/a;pressure all across front;began vomiting 8AM1-2xhr;took APAP & compazine suppository & felt better by afternoon;
Patient received the covid19 vaccine at about 940am on 06/01/21 - dose 1 by Pfizer.  Less than 5 minutes later, patient came to me saying she wasn't feeling good.  I was still sitting at the immunization table.  She sat down and said she was feeling very tired.  I asked if she wanted me to call 911 and she said said no.  She just wanted to rest.  She then slumped over and fainted.  I was able to hold her in the seat while carefully supporting her head.  I loosened her mask and she was breathing normally, but just fainted.  About 2 minutes she woke up and then proceeded to vomit.  I sat with the patient about 15 minutes or so.  The color returned back to her lips and we called her roommate.  When he arrived, the patient got up and started walking and began to feel better.  Patient went home.
Erythematous Rash developed on 8/19/16 on upper arm. Covered proximal body parts and spread to bilateral extremities.
Rash developed approx 24 hours after vaccine - started on both upper arms and flanks, by next day spread to forearms, chest, stomach and thighs. Today is 9 days post vaccine and the rash is still lightly present on arms chest and thighs... small scabs and slightly itchy.
Patient was a little scared about getting the flu shot. He appeared nervous about it. A patient prior to his turn was getting a flu shot in my immunization room and jokingly yelled that it hurt a lot with intent to scare the young child. When it was the time for the patient and his mother to get their flu shot, I brought them into the immunization room and the patient appeared a little nervous. He was laughing out of nervousness. When I administered the vaccine, the patient appeared okay and oriented. After about 30 seconds to a minute he clumped up  (head down to his chest and arms wrapped in a 'X' across his body while he was sitting in the chair. He leaned against his mother. His eyes were closed, wasn't responding, and tongue was out of his mouth. I called 911 and had the paramedics come. They checked his blood pressure and glucose levels and everything was okay. They asked if he wanted to go to the hospital and the mother refused. Paramedics said he was fine to continue his day.
After 2nd dose patient reported fever, sweats chills. Lymphadenopathy of (L) armpit. Low energy.
11/2/21 presents "with bright red bleeding per rectum that he noticed after he started to have diarrhea about one week ago" and "some subjective fever and chills".   ESRD on MWF HD, HTN"
Received flu & pneumonia vaccine 10-13-11. Pt reports ED visit 2 hours following vaccines due to fever of 105 degrees F & chills. Was told by ER she was experiencing an allergic reaction. Seen again in ER on 10-14-11 with sx of redness, vomiting, HA & fever. Again told it was an allergic reaction to vaccine.
Product temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion). On 19-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications are provided. No treatment medications are provided. 6 patients were administered a dose of the Moderna COVID-19 vaccine after a temperature excursion at the frozen range reaching a temperature less than minus 50 degree Celcius. This vaccine was then placed in a different freezer which experienced a temperature excursion on 19NOV2021, reaching a maximum of  10.8°F for 5 hours and 31 minutes.
Vax given 12noon 16SEP92; mom called @ 430PM to say pt had been crying unconsolably since 1230PM; t101 w/vomiting due to crying mom giving APAP as directed by pt unable to keep down;
Fever (101), body aches, joint pain, headaches, cough, nasal congestion, fatigue, short of breath started day after by 11. All persisted through Friday except for fever (2 days). Still had slight congestion and headaches through Saturday (4 days). On Thursday (two days post) injection site red and painful about 2.5-3 inches around it which is still president today (Saturday). Started itching some today. Still get ?winded? when I go up steps or with exertion. Also still coughing some and some nasal congestion.
Patient came into our clinic on 09/09/19 with significant swelling at sight of injection, site was hot to the touch, and felt knotted at the site. According to patient this was the 3rd day she said that the 24 hours after the injection she felt fine but that she started to  notice that the sight was swelling hot to the touch and felt a bump, she also explained that due to pain she was unable to rest on her right side and that she felt fatigued the past 2 days.
she did not disclose any allergies prior to injection. about 10 minutes after the injection, patient c/o dizziness lightheaded feeling flush, she stood up, fanned herself with paperwork, then layed down flat on strecther, noted red blotches on her upper chest, and diaphoretic, removed her facemask. RNs decided to take her into the ER. wheeled her there in wheelchair.  on the way, patient states she may have had a reaction to penicillin in the past. ER  nurses and doctor assessed pt,  according to chart she had several episodes of lightheaded/flushed feelings. given crackers and juice because she had not eaten breakfast. Benadryl po 50mg given. d/c back to work as occupational therapist at hospital outpatient clinic.
Vaccine was adminstered post expiration. A letter was sent to the patient's address on 2/17/2023 stating manufacturer's vaccine activity at the time of administration.   Manufacturer Statement: Moderna reviewed the stability of the vaccine you received and determined that it likely did not maintain the activity necessary to protect against COVID-19 at time of administration. Moderna cannot guarantee the protection you may have received is equivalent to what was seen in studies and data is not available to support administering an additional dose of vaccine to you. However, if you wish to undergo revaccination, we will provide you access as outlined below.
Mild soreness and fever two days . followed by persistent extremr fatigue nausea headache itching, easy bruiising and bleedind Sick  for 6 weeks. No improvement
Fever, nausea--patient was nausea morning after shot, then developed a low grade fever about 24 hours after shot-- patient stated that she might go to an urgent care.
she knows of a young gentleman who took the shot of the vaccine and developed carditis; This is a spontaneous report from a contactable consumer.  A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter state that" she knows of a young gentleman who took the shot of the vaccine and developed carditis" on an unspecified date with outcome of unknown.   No follow-up attempts are needed. No further information is expected.
Taken out of freezer on 20-Apr-2022/Vaccine administered on 24-May-2022; patient was given expired (4 days expired) Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was given expired (4 days expired) Moderna vaccine) and PRODUCT STORAGE ERROR (Taken out of freezer on 20-Apr-2022/Vaccine administered on 24-May-2022) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K2-2A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1, Batch no. EL3302, dose: 0.3 ml  Route: Intramuscular Body site: Left deltoid) on 25-Jan-2021, Pfizer (Dose 2, Batch no. EL9264, dose: 0.3 ml  Route: Intramuscular Body site: Left deltoid) on 22-Feb-2021, Pfizer (Dose 3, Batch no. FF8841 and dose: 0.3 ml  Route: Intramuscular Body site: Left deltoid) on 26-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 24-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 24-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was given expired (4 days expired) Moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Taken out of freezer on 20-Apr-2022/Vaccine administered on 24-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was given expired (4 days expired) Moderna vaccine) and PRODUCT STORAGE ERROR (Taken out of freezer on 20-Apr-2022/Vaccine administered on 24-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was taken out of freezer on 20-Apr-2022 and out of freezer expiration date was 20-May-2022.  The vial did not undergo any temperature excursion.  No treatment medications were reported.
Pt DOB was altered @ registration & passed verbal and written verification. Guardian stated the 11-year old was 18 years old.
FELT WEAK; REALLY BAD HEADACHE; CHILLS; FEVER; BODY HURT; BODY ACHES; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included abstains from alcohol, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies. patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 12:00 for prophylactic vaccination. Concomitant medications included for drug used for unknown indication. On 06-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced body hurt. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. On 07-APR-2021 09:00, the subject experienced really bad headache. On 07-APR-2021 21:00, the subject experienced felt weak. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from body hurt, body aches, chills, fever, and really bad headache on 07-APR-2021, and felt weak. This report was non-serious.
Approx. 7 days after the booster my I had dizziness, vertigo, pressure on his ears and muffled hearing.  Three days later, 10 days after our booster shot, my wife lost hearing in her right ear, same pressure  but she appears to have worse hearing loss and I seem to have worse tinnitus.   We both have taken a course of prednisone.   She had an MRI on January 23, 2022 which came back normal.  The ENT can find no reason for the hearing loss, tinnitus.  My family doctor can find mo reason for my hearing loss, tinnitus.  We both got our booster shots the same day and we both had severe unexplainable hearing loss within 7-10 days.
upset stomach; insomnia; chills; headache; mild fever; This is a spontaneous report received from a non-contactable consumer, the patient. A 76-year-old female patient received BNT162B2, (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 26Jan2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Jan2021, the patient experienced upset stomach, insomnia, chills, headache and mild fever. The outcome for events were unknown.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Had immunizations 8-7-07 started to develop a fever went to ER 8-8-07 temp 103, crying. Also mother stated baby was at a restaurant on Tuesday 8-7-07 syrup spills and went in right ear. ER Physician diagnosed patient with otitis media right - Amoxil. RTC 8-9-07 doing better continue Amoxil.
Shingrix in August, but neglected a second dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received in August).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 05-Jun-2022 Reporter's Comments: The reporter reported the case via interactive digital media. The reporter stated that we (unspecified patients) had a Shingrix vaccination in August but neglected a second dose.  At the time of reporting, the reporter asked if it was still beneficial to get a second dose. Additional Supportive Information:  Till the time of reporting, the patients did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available. This case is linked to the case US2022AMR089782, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR089782:same report, other patient
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 which had lot # M003659 with expiry: 20-SEP-2017, (dosing details not reported). No adverse effects reported. The vaccine with above lot number was exposed to a temperature excursion of 72.1 degree Fahrenheit for 1 hour 42 minutes, and it had no previous temperature excursion. It was detected by data logger. No further information provided. This is one of three reports received from the same reporter. Additional information has been requested.
invasive H. influenzae type B disease (meningitis & bacteremia); s/p receipt of age appropriate immun
Within a few hours of receiving the vaccination I started to feel dizzy and light headed, my arms and legs also began to feel weak which was accompanied by a severe headache later that evening. The following day my symptoms seemed to have gotten worst I had a fever along with joint pain and muscle spasms by mid afternoon I started to have chest pains and heart palpitations within next few hours my symptoms continued to get worst they were accompanied with swelling of my lips and an even more rapid heartbeat. I remember going upstairs to sit down and before I made it to the couch I had passed out, I do not recall the length of time but by the time I came to the ambulance was at our home. They completed the regular first responders assessment and advised me that If I continue have cheat pain, to feel light headed or weak that I should go to the hospital. I then made an initial appointment with hospital which at that point I was scheduled for follow up x-rays and examinations. I had never received the flu shot prior, and I had never had any medical issues, on any medication and neither does my family have any history of any medical complications. I exercise 4 to 5 times per week and live and maintain a healthy lifestyle and diet, I do not consume alcohol or smoke. In the months that followed I continue to have unexplained frequently occurring chest pains, shortness of breath and heart palpitations.