chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a registered nurse referring to an unspecified number of patients of unknown ages and genders. Medical history, concurrent condition, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck), (lot # L031600 expiration date: 18-FEB-2017 and lot # L019998 therapy type rHA, expiration date: 02-DEC-2016) (dose, indication, route of administration were unspecified). Concomitant therapies were not provided. No adverse symptoms were reported. No product quality complaint was involved. This is one of several reports from the same source (MARRS: 1511USA014672; 1511USA014713; 1511USA014714; 1511USA014715). Additional information has been requested.
Approximately 24 hrs after shots given, Mom was feeding baby and he turned very pale. Looked blue around eyes and felt ver lethargic. On apnea monitor, resp. rate decreased to 10/min. No fever, no redness at injection site. Mother tried to stimulate baby, but no improvement. Taken to ER for evaluation.
Several minutes after receiving the vaccination, while waiting in the post vaccine area, patient had either a seizure or fainted. I did not witness the occurrence. 911 was called and patient was transported to the hospital.
patient had COVID-19 positive test 8/23/21, acute respiratory failure with hypoxia, COVID 19 infection, encephalopathy, bradycardia, shock. anion gap metabolic acidosis with poor respiratory compensation, COPD, AKI on probable CKD, transaminitis, and decompensated right heart failure with cor pulmonale and volume overload.  Pt intubated on arrival for marked worsening of his encephalopathy. Likely etiology d/f decompensated right heart failure with pulmonary edema and possible Covid pneumonitis.  Shock now resolved. Respiratory status and AKI now improved with diuresis, and extubated 9/7.
shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  Concurrent medical conditions included epstein-barr virus infection and immune disorder (nos).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient for himself/herself. The age at vaccination was not reported. The patient received shingles vaccine and 3 days later had a huge outbreak going down the left side of his/her back, then it crossed the midline and covered his/her entire back and butt. The patient stated its been 4 years now and the shingles had never gone completely away. The patient stated if you had an Epstein Barr, you are at risk with this vaccine and other immune issues could cause it to had harsh reactions also. The patient stated good luck in vaccine injury court getting any help either. The follow up could not be possible as no contact details were available.
PT REPORTS OF MILD COUGH BEFORE THE IMMUNIZATION. PT REPORTS OF VERY SERIOUS COUGH THAT STARTED ABOUT 3 HOURS AFTER THE VACCINE WAS ADMINISTERED AND LASTED THOROUGHOUT EVENING. PT REPORTS COUGH SUBSIDED AFTER 3 TO 4 DAYS.
Injection site pain still persists 3.5 weeks after injection.  Pain in the shoulder and muscle below injection site.
Moderna information says that if we give a shot outside the 42 day window we need to report it.    I tried repeatedly to follow up with patient, no response.
Patient called 7/11/16 and stated her arm was painful with radiation to her shoulder, felt like a bruise however no visible bruising, no nodule, no fever.
Chills; Body aches/ Pain; pain; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (Body aches/ Pain) and PAIN (pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced CHILLS (Chills), MYALGIA (Body aches/ Pain) and PAIN (pain). At the time of the report, CHILLS (Chills), MYALGIA (Body aches/ Pain) and PAIN (pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Patient asked whether she can take ibuprofen to alleviate the pain.
This spontaneous report as received from a physician regarding a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 22-JUN-2015, the patient received improperly stored VARIVAX (lot#J012151, expiry date: 28-SEP-2015, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was not concomitant medication reported. No adverse effects was reported and no product quality complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt got infusion and the next day started to feel itchy, 48 hours after the infusion pt broke out in a shingles-like rash from neck to groin.
This spontaneous report as received from a nurse practitioner via company representative refers to a 59 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were unknown. On 11-OCT-2016, the patient was vaccinated with ZOSTAVAX, (dose, lot # and expiry date not reported), parenterally. On 12-OCT-2016 (reported as following day of administration), the patient developed eye irritation for an unspecified reason. The patient sought medical attention from an unspecified urgent care location and he was diagnosed with pink eye which was treated with an unspecified eye drops. On an unknown date in 2016, he was still experiencing discomfort, hence he sought medical attention from a physician and he was diagnosed with shingles. No laboratory tests were performed. At the time of this report, the patient was recovering from the events. Causality was not provided by the reporter. Product quality complaint was not involved. Upon internal review, Herpes zoster ophthalmic was determined to be medically significant. Additional information has been requested.
fluish symptoms; Headache; Sore throat; This is a spontaneous report from a contactable Consumer or Other Non-Healthcare professional, the patient. A 47-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via the right arm on 16Mar2021 16:45 as a single dose for Covid-19 immunisation. The patient medical history includes depression/anxiety. Concomitant medication includes Clonazepam (MANUFACTURER UNKNOWN), Sertraline (MANUFACTURER UNKNOWN), Venlafaxine (MANUFACTURER UNKNOWN), Trazodone (MANUFACTURER UNKNOWN). Allergies to medications include sulfa-meds, Biaxin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. The patient was tested negative for nasal swab COVID-19 virus test in Mar2020, Jun2020, Jul2020, Oct2020. On 16Mar2021 20:00, the patient experienced exhaustion/lethargy, chills, body aches (fluish symptoms), headache, sore throat. The patient did not receive any treatment for the reported events. The patient was not recovered from flu symptoms. No further information is expected.
temperature excursion; No other AE; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On an unknown date, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX) lot # U015845, expiration date 19-MAY-2023, 1 time dose (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported).   The vaccine was stored in a temperature of 17 degree Fahrenheit (°F) for 30 minutes. There was no previous temperature excursion reported.  This is one of several reports received from the same reporter.
Parent stated left thigh was red and swollen. Tx: Benadryl 12.5mg every 8 hours prn instructed to apply warm/ cold compresses.
Covid Vacc - Covid-19 5-11y administered 2nd dose in series with mother holding pt - pt was whimpering  but held still - vaccine administered, patient stated stung a little - band-aid applied - time taken was about 5 minutes as we talked with patient for a white about vaccine series completed - patient and Mother were exiting vaccine booth when pt stopped and said she felt nauseous and couldn't see - Mother immediately sat Pt down and we checked for rash, breathing, clammy skin, temp, etc. - Pt remained lucid and answered all questions- episode lasted about 10 seconds -  the Mother, wanted EMS to come out and double check Pt - EMS called and examined Pt and did not perceive any immediate danger. EMS wanted to take  pt to Hospital --EMS service was denied at this point as Mother wanted to take pt to Hospital herself, EMS, Mother and pt left pharmacy. 45 Minutes later I called the family and spoke to pt's Father and was told that the Mom took pt to her Pediatrician's house as they were personal friends and that pt experienced an anxiety attack not an allergic reaction and pt was outside outside playing with a friend . I made a second call on 12/5/2021 at 11AM  to follow up on pt and again pt was fins sitting with Dad reading
No fever; sudden persistent, uncontrollable cry followed by pallid spell (approx 5 min) cry w/rolling of the eyes; no sz reported;
Severe pain in upper right arm. Unable to lift arm fully starting Tuesday night. Mild fever started Tuesday evening increased to 102 on Wednesday and Thursday. Pain in arm began moving lower in muscle on Thursday including new redness goind down my arm and away from injection site and skin was sore to the touch similar to a sunburn. I went to urgent care and they diagnosed me with an infection. Fever had subsided slightly by then but returned to nearly 102 later that night. Started anti-biotics Thursday evening and by Saturday I finally started getting some relief. No fever after Saturday but arm was very weak. Could not hold my cell phone or do any regular lifting or use of my arm. Had cold feelings in waves inside my arm and down the side of my arm Saturday. On Sunday, strength seemed a little better but I had to keep my arm in a resting position on my leg or by laying down or I would experience sharp pains in my shoulder and back similar to over exertion. Today (Monday) right shoulder is sore, under my arm is sore and still feel some pain in back shoulder blade and some soreness in my right pec. Arm is still weak. No fever since Saturday. Still taking anti-biotics for another 4 days. I contacted pharmacy and they were less than interested in hearing these issues.
Contracted COVID after being receiving the vaccine; Contracted COVID after being receiving the vaccine; Sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 40 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Contracted COVID after being receiving the vaccine"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm". Clinical course-Clinical course- Reporters whole family except 12 years has gotten the Pfizer and had no problems just a sore arm."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Feeling unwell; fever; body aches; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell), PYREXIA (fever), MYALGIA (body aches) and ARTHRALGIA (joint pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced MALAISE (Feeling unwell), PYREXIA (fever), MYALGIA (body aches) and ARTHRALGIA (joint pain). On 15-Feb-2021, MALAISE (Feeling unwell), PYREXIA (fever), MYALGIA (body aches) and ARTHRALGIA (joint pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and  treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Non significant follow up: Reporter's information has been updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
cycle lasted for 12 days First 2 days was extremely heavy soreness at injection site and it felt numb headache and cough Unsure if the below information is related:  I though I had Food poisonous  severe cramping sweating
I first noticed that I was shaking inside. I felt hot, sweaty, and then cold, and then hot again. My body hurt like I had been beat up. My back hurts up to my right side. It hurts all the way up into my shoulder and neck. I felt nauseated the next morning. I had no appetite. I would sleep, wake, sleep, wake. I was thirsty and I drank water constantly and Pedialyte. I have a hard time going to sleep if  I wake up. I am very tired.
GAVE PFIZER COVID VACCINE FOR 12 AND UP TO 11 YR OLD
12/02/2021 I had some skipped heart beats, that lasted for couple minutes about 5 times a day. It is still ongoing.
Mother called and stated that her son's arm appeared, 'Red and swollen down almost to the elbow, and it is itchy and warm to the touch, and there are very fine goosebump like areas of rashes'. Mother denies any trouble breathing or fever for patient.
COVID-19 Treatment; COVID-19 Treatment; rebound COVID; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 10Aug2022, outcome "recovered", described as "rebound COVID"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient received paxlovid from 10Aug2022 as COVID 19 treatment, then experienced rebound COVID on 10Aug2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a causal association between the reported events and BNT162b2 cannot be excluded.
Right sided migraine base of head radiate to near forehead hairline started 4 hours after vaccine. Lasted several hours. Felt dizzy and mild nausea. Slept that night for 8 hours, woke up very dizzy difficulty walking to bathroom bc of dizziness, headache, nausea. Went back to bed and slept 4 additional hours. Woke up and the dizziness and headache were gone. Felt tired and run down that day and the following day. Then fine.
Patient complains of itching and minor hives on hands. Self medicated with 10 mg loratadine after leaving observation area. Returned when itching was not better. A nurse administered  Zyrtec and symptoms resolved within 15 minutes.
Extreme fatigue, dizziness, fogginess, slurred speech, headaches, nystagmus. Extreme fatigue started within 2 weeks of injection and remainder of symptoms followed. Daughter would look out window on sunny day and say "it's raining outside". Signs observed by classmates and family members. The second injection in Nov, noted extreme fatigue and fogginess but third (final injection) were followed by the above.
Patient is a 58-year-old male with history of DM2 on insulin, bovine aortic valve replacement, nonischemic cardiomyopathy (unknown EF), hypertension, obesity, presented to Medical Center on 4/26/21 for left leg pain and swelling.   Symptoms began about 2 days ago when he drove to visit some friends and started to " feel under the weather" hence drove back yesterday.  He then had acute onset of left leg swelling and pain which prompted him to present to the ED.  He was reportedly concerned about " having a clot" as he just received the Johnson & Johnson Covid vaccine this past week.
Patient was first presenting chest tightness, chills, cold sweats, and shortness of breath.  This all in a time course of one hour. Patient presented wheezing upon auscultation. Epinephrine dose was administered (0.3mg). Patient was monitored and continued with same symptoms. Wheezing did not improve.  Second dose of epinephrine was administered sixteen to seventeen minutes prior to second dose (0.3mg).
9:00pm injection area sore, woke up at 11:00am to body aches and swelling of face along with rash on left side of the face.
Patient experienced mild facial swelling and injection site reaction with redness/warmth. Counseled to place cold compress on arm and take benadryl.
Headache, Myalgia, NauseaVomiting, Throat dryness, fatigue Narrative:
Began experiencing constant ringing in both ears (tinnitus) hours after receiving the second dose of the Pfizer COVID-19 vaccine.
Headache SORE ARM AND HEADACHE DAY AFTER INJECTION Narrative:  Other Relevant History:
Pt devel t105 given APAP @ Hosp, given Advil; Pt to ER 22MAY91
Doctor advised to expect only usual shot soreness. Experienced immediate pain and burning sensation. Increasing soreness treated with TYLENOL and after Dr. returned call evening 3-3-17 began ibuprofen. Patient has been quite sore to the point of having difficulty walking. She has been using a heating pad for sore muscles at night. Has had headaches, nausea and fatigue. General feeling of malaise. Poor athletic performance beginning on Thursday 3-2-17. Patient indicated her leg (right, two shot) felt swollen, but she acknowledged that the pain could have made her feel that way without actual swelling. Injection points looked normal Thursday. Friday in PE (the second day after the injections) patient was expected to do 3 miles using two machines. Walking at 1/2 her usual pace on the treadmill resulted in a pulled/strained muscle. This was nearly 48 hours after the injections. Do keep in mind that this is a young, healthy athlete who swims competitively, runs cross country, and runs track. Tue March 7th, it was a struggle to do yoga in PE, due to lack of energy. Pain in leg gradually improved over the week. By Wed 3-8-17 energy levels were improved and soreness in leg was much improved. Returned to track practice and was able to run albeit with "warnings" from leg muscles not to push the stretching. Patient appears better, but will continue concerned observation.
17MAR93 presented to ER; c/o low grade fever, rash across upper chest, nasal congestion; given Epi & APAP;
Myalgia, Arthralgia,  Injection site pain, Fatigue Narrative: All events lasted 24 hours after vaccination
Patient received Hepatitis A vaccine on 02/21/2005, right deltoid intramuscular.  Patient called to report possible adverse event and was told to come in to health department.  Patient came in on 02/23/2005 and reported experiencing hives on arms and trunk of body.  Patient had taken Benadryl to relieve symptoms.  On examination, few small, pink, circular areas less than 5mm diameter on arms.  Injection site - no redness, no induration, no swelling, no pain.  Patient experienced hives 4 hours after injection.
Pt received the vaccine on 3/9/2021  reports to ED on 3/19/2021   s/p fall while transferring from wheelchair no fractures on x-ray, sent home at 2246.  started to c/o chest pain and shortness of breath.  Went into cardiac arrest at home approximately 4 hours  after leaving ER.   Pt was pronounced DOA 3/20/201 @ 0343
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. In 2015 (reported for all vaccines as since 14-MAY-2015, which was the date the excursion occurred), the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route, lot # were not reported), which underwent supported temperature excursions. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Case previously recorded as MA2009-4539. Case report received from a nurse, on 18 NOV 2009. 19 months-old male patient was accidentally vaccinated with 0.5 mL i.m. S-OIV FLUVIRIN (batch no. 102126P1A) on 17 NOV 2009. It was an out of label use because the patient was younger than 4 years. No adverse events were reported. Reference no.: NA09-008426.
patient received High dose influenza vaccine on 10/13/2022 and on 10/29/2022 she developed bells palsy .
Patient said her arm was fine for the first 2 days after the vaccine was given, then it started to swell a little and get a hard spot when injection was given, then it continued to swell and get red and fevered.  The redness kept spreading so she went to the doctor and he gave her an antibiotic
Pt presents 5/3/18 for Hives that started the day she got her immunizations. Started with a band around her arm the day she got her imms-hives developed that day. Has been giving BENADRYL twice in the past 4 days - hives had been on chest, neck, back, now on face and whole body. Worsened after getting hot (running outside, sleeping wrapped in blankets). Itchy, not painful. No SOB, no runny/stuffy nose, NOS. Eats, milk, eggs, and gelatin products without problems.