chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A very large blister that formed over the injection site, was painful, lasted for several days, she was unable to put clothing over the affected area, resolved without intervention.
Localized erythema extending to elbow with localized pain and muscle edema/induration. Has improved daily and now just slightly tender at injection site. Some backache and joint pain 24 hours after injection.
pt states sudden onset of multiple bruises 5 days p/recv 1st vax; bruises identified as 1'' diam @inject site; 3 each 1'' diam on waistline; 2 each 11/2''x1'' rt leg; 3'' diam rt popliteal area; 1 on lt arm, lt forearm, lt thigh, lt knee
covid vaccine breakthrough case  dose 1 Moderna 4/13/21  025B21A dose 2 Moderna  5/10/21 048B21A
rt upper arm area of redness, hardness, heat, 4"x4" painful;
dizziness; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and VOMITING (vomiting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced DIZZINESS (dizziness) and VOMITING (vomiting). At the time of the report, DIZZINESS (dizziness) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment information were reported by the reporter.
on the morning on 2/6/2021 at 6am, swollen lymph nodes under left arm, migraine, vomiting and diarrhea, fever 99.8. Did not feel well through 2/8/2021.
Developed chills/fever, nausea, headache and stammering/stuttering speech 10 days after vaccination. All symptoms resolved spontaneously with in 24 hours.
itchiness started Monday 1/18/2021 follow by rash three days later on 1/21/2021.  Currently taking Zyrtec, itchiness had gone away, rash has subside but still presented.
Had negative pregnancy test on 7APR06 and had subsequent vaccinations on that day. Subsequently had a ligh period on 27APR06 and missed period May/June. Pregnancy test was found to be positive on 15June06. Last sexual activity noted to be 22Mar06 to 6APR06. Estimated due date 1FEB07.
pt recv vax 8JUN95 & 10JUN95 pt exp a fever of 103-104 that persisted for 5 days; No further details were provided;
PATIENT  CALLED THE PHARMACY, PAIN IN HER LEFT ARM, BRUISING, AND DIFFICULTY LIFTING ARM. THIS IS THE SAME DAY THE PATIENT RECEIVED HER SHOT. PT TOOK TYLENOL SINCE THEN AND THE PAIN IS SUBSIDING SINCE THE SHOT. WILL FOLLOW UP  PT AND MD IF PAIN STILL CONTINUES.
Got FLUZONE-HD 10/12/16; few days later pt and spouse experienced: Nausea, Vomiting , Diarrhea and Weakness. Symptoms lasted 3-4 days.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 23Nov2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 58 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Oct2022) Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient had no other medication in 2 weeks, and he had no known allergies.
Felt light headed right after injection. Hive started on my legs within 15 minutes. My skin was so sensitive that it bled when I scratched it. I felt like I had the flu within an hour of injection. Sunday morning I woke up with severe stomach cramps and diarrhea that lasted until mid afternoon. Nausea and headache began mid morning. Nausea didn't end until Thursday, July 29,2021. By Sunday morning, I had hives all over my body - extreme itching and dryness - still dealing with as of today.  Monday morning, I woke up with phlegm in my throat, when I cleared it from my throat, there was blood in it. Wednesday, I developed a stuffy nose and cough. I started out with Benadryl on Sunday morning , recommended by pharmacy who gave shot.
130/82; 18. Felt light headed, nauseated; lay her on her back with legs up. Sat up at 640; cool cloths to head and base of neck. Crackers/juice stood at 640-ok to go.
VISION PROBLEMS, SWOLLEN OPTIC NERVE, PAPILLEDEMA. WENT TO SPECIALISTS AND STARTED TESTING. HAD EYE EXAMS, ULTRASOUNDS OF EYES, SPINAL TAP, MRI, BLOOD WORK AND VISUAL FIELD. POSSIBLE OTHER TEST 12/04/09 Opthalmology records received for DOS 04/11/08-09/19/08.  Pt.  presents with difficulty with hand work x 1-2 weeks DX: papilledema 12/04/09 Medical records received for DOS 04/11/08, 04/16/08, 04/18/08, 04/29/08 12/04/09 Neuro-opthalmology records received for DOS 06/18/08 DX: visual fields enlarged blind spot, right eye; bilateral optic nerve drusen 12/04/09 PCP records received for DOS 03/09/07-07/10/09.
no adverse events reported; one dose of improperly stored vaccine, Gardasil 9, was administered to one patient; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported.  On 28-AUG-2019, the patient was vaccinated with one dose of an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection 0.5 milliliter, one time for prophylaxis (lot # R017624, expiration date17-MAR-2021; strength, route of administration were not reported).  The dose of varicella hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) experienced a temperature excursion of -5.57 degrees Celsius for 10 hours and 30 minutes. There were no previous temperature excursions. The temperature excursion was detected by a data logger. No adverse effects were reported.
Fatigue, headache, dizzy and heart palpitations. Patient reports "everything feels jittery inside". Referred to urgent care for further evaluation and tests.
Hurt to turn her neck; Laryngitis/ Could not talk; Arm pits lymph nodes are horribly sore/ attacked all her lymph nodes; Ache all over; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. An 88-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, patient have had a terrible reaction to the first shot she was terrified to get the second shot. It attacked her neck (hurt to turn her neck), laryngitis, could not talk, her arm pits lymph nodes are horribly sore, ache all over on an unspecified date. It was attacked all her lymph nodes. Patient was very afraid of the second shot. The outcome of the events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
When i woke up at 6am on Friday May 31 2019, I could hardly move out of bed , musles were very sore, tryed to go back to sleep but couldn't, I had some coffee to get the day going took a hot shower thinking that would help,  when i got to work I had a temp. of 101, and was still achey.  I did take tylenol before i left the house, fever did go down but was still hurting alot, felt just like the flu . slept when I got home from work and right through the night! The next day all my insides still hurt but not my musles as much. NEVER  again
No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 25-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
This spontaneous report was received from a Licensed Practical Nurse, referring to an unspecified number of patients. Ages, genders, medical history or concurrent conditions were not reported. On an unknown date, doses of ROTATEQ by oral route (Lot #: L026740, exp date 16-APR-2017; L022446, exp date: 14-FEB-2017; L010128, exp date: 24-JAN-2017) (dose was not reported) which were exposed to temperatures outside of the recommended range were inadvertently administered to the unspecified number of patients. It was unknown if the patient sought medical attention. No adverse effects have been reported. The reporter refers that there was not product quality complaints involved. This is one of several reports from the same source. Additional information has been requested.
Post first vax no untoward effects. Post second vax early May experienced right knee joint pain. 05/22/2000 he experienced left knee joint pain. No treatment was given.
I woke in the night on Monday, Feb. 1 to use the bathroom and when I stepped out of bed I felt a sharp pain in the outside ball of my right foot. I thought I had stepped on a needle. I could not step on that side of the foot as I walked without sharp pain. I immediately searched for what might be in my foot and found  nothing.  The pain continued through the night and into the morning.  My shot was in the left shoulder. I have concluded this is a neurological reaction (nerve pain) from the vaccine (Moderna). Never had this pain before.
Vomiting starting 15 minutes after shot, continued for 2 days. Diarrhea lasting 4 days. Hives starting 4 days after shot. Hives have lasted 5 days (so far).
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine "did" [considered an error] function as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 21-JUL-2014, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed VALTREX, hydrocodone and NORVASC for management of his painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
not yet received second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received approximately 5 years ago from 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 patient self-reported this case. The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter declined to provide demographics. The reporter did not consent to follow up.
severe ulcerative colitis - bad diarhhea with blood starting early November; went to ER at Hospital on 11/21/21; diagnosed with Catscan; also caused C-Diff; hospitalized for 9 days; C-Diff resolved with antibiotics but ulcerative colitis worsened; administered IV prednisone for several days; still very ill and had bad diarhhea for weeks; no sleep; released still on prednisone 60 mg; got worse after release; had to have IV fluids several times; eventually was given Remicade/Avsola starting 12/16/21 which is helping the symptoms; just received 2nd infusion of Avsola on 12/30/21.
On 8/18/09 I took my son to his primary care doctor for the following symptoms: fever, headache, weakness, pain in arms and legs, loss of appetite, neck pain, uncoordinated movement (not being able to walk straight without losing balance), being very tired (sleeping a lot). She diagnosed him with a very bad virus and told us he would be better the following day. The following morning when I went to check on him, I found him incontinent, unable to move, and unable to speak clearly. I called 911 and we were taken to the emergency room hospital and spent 7 days in the Intensive Care Unit and the Pediatric floor. He was treated for (IDEM) with high doses of (IV) methylprednisolone and is currently tapering off orally. He is doing better but not 100%. In physical therapy
This spontaneous report as received from a licensed practical nurse refers to a currently 15 year old male patient. Medical history and concurrent conditions were not reported. On 23-JUL-2014, the patient was vaccinated with the first dose of GARDASIL (dose, route, lot number and expiry date were not provided). On 04-OCT-2014, the patient was vaccinated with the second dose of GARDASIL (dose, route, lot number and expiry date were not provided). On 09-DEC-2014, the patient was vaccinated with the third dose of GARDASIL 0.5 ml, intramuscular in the left deltoid. Nurse stated the patient was given his third dose early. No adverse effects reported. There was no concomitant medication. Additional information has been requested.
Fever, chills, body aches, severe headache, vertigo, nausea, vomiting, rash at site and extending down arm
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 03-AUG-2016 the patient was vaccinated with an improperly stored dose of VAQTA 50 U/1ML (lot # L048460, expiration date 14-JAN-2017). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) were 144, 12 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
sore arm, nausea, dizzy, horrible body aches, bones hurt at back and neck, tired, no appetite
Lower extremity joint pain; Nerve pain; Fatigue; This is a spontaneous report from a contactable Pharmacist via a Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced lower extremity joint pain and nerve pain along with fatigue after receiving the Pfizer/BioNTech vaccine. Symptoms started at 3 am, the morning after the vaccine was administered and persisted until 5 pm that day. Outcome of the events was unknown.  No follow-up attempts are possible. Information about batch number cannot be obtained.
some allergic reaction; Difficulty breathing; Fast heart beat; blurry eyes; felt sick/Not feeling well; Sore in left arm; body ache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ALLERGY TO VACCINE (some allergic reaction), DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Fast heart beat), VISION BLURRED (blurry eyes) and VACCINATION COMPLICATION (felt sick/Not feeling well) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced ALLERGY TO VACCINE (some allergic reaction), HEART RATE INCREASED (Fast heart beat) and VISION BLURRED (blurry eyes). 23-Apr-2021, the patient experienced DYSPNOEA (Difficulty breathing), VACCINATION COMPLICATION (felt sick/Not feeling well), PAIN IN EXTREMITY (Sore in left arm) and MYALGIA (body ache). On 23-Apr-2021, ALLERGY TO VACCINE (some allergic reaction), DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Fast heart beat) and VISION BLURRED (blurry eyes) had resolved. On 24-Apr-2021, VACCINATION COMPLICATION (felt sick/Not feeling well), PAIN IN EXTREMITY (Sore in left arm) and MYALGIA (body ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Heart rate: fast (High) Fast.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.  The patient took Tylenol (acetaminophen) as advised by the pharmacy.
March 22, 2021 ? 1st shot of Moderna (was a bit shaky just after and mentioned it to the person but subsided later) March 23 ? heat and pain in upper arm, took Tylenol, better the next day April 1 ? extreme heat and pain in upper and lower left arm, came on suddenly April 2 ? extreme heat and pain in upper and lower left arm, weak in both arms and legs, called my Dr ? went to ER April 2 - Could not stand or hold anything; ER checked for stroke or heart attack first with CT and chest X-ray; then suspected Guillain-Barre Syndrome (GBS); neurologist consulted, ER doctor attempted a lumbar puncture twice that he could not perform. Admitted to hospital.  Next two days, needed assistance walking to restroom, weak;  April 4 ? Physical Therapist evaluated me, said there was a slight delay when I took steps; improving with strength in my arms and legs, just winded April 5 ? MRI, lumbar puncture, blood work, CT ? all tests were clear; did not need the walker to restroom, took little steps April 6 ? discharged with excruciating headache, could not lift head for one week (told it was from lumbar puncture) April 13 ? Head pain finally subsided but still pressure in my head I noticed when I coughed or sneezed. Slowly gained strength. April 15 ? Able to walk and drove car to the store.  Still tired each day but getting much better. Dr. advised: No 2nd Moderna shot.
This spontaneous reprot as received from a registered nurse reders to an unspecified number of patients (demographics unknown). On unknown dates, the patients were vaccianted with (Oka/Merck) VARIVAX vial (1350 U) (dose, route and lot numbers were not repored) that was exposed to a high temperature of 20.3 degrees F for short periods of time during what the nurse believed to be defrost cycles. No adverse effect reported. Additional information has been requested.
Two weeks after getting vaccinated I began to hear loud hissing in my ears.  This noise has gotten worse and now it is loud enough to wake me up from a sound sleep.  I had a very mild form of Tinnitus, from 1 to 10 maybe a 2.  Since getting the vaccine that number is now  a 6 or 7.  I would welcome any help.
Information has been received from a licensed practical nurse (L.P.N.) who was told by a patient's mother that she heard from a school staff member concerning a female child who was vaccinated with doses of GARDASIL on an unspecified date. Subsequently the patient experienced a seizure. At the time of reporting, the outcome was unknown. Upon internal review, seizures was considered to be an other important medical event. Attempts to verify the existence of an identifiable patient have been unsuccessful. This is one of two reports from the same source. Additional information is not expected.
Client complained of feeling lightheaded and dizzy while sitting in the observation unit. RN moved client to lay down on a cot. Client stated had not eaten since noon. Client's skin pale and moist, vitals taken: at 1913: BP 103/70, HR 93 bpm, SpO2 97% RR: 20.  Client stated dizziness gone while lying down, denies itchiness or SOB. At 1917 RN sat client up and he was able to eat food and drink water. Vitals taken: 912/50, HR 111 bpm, SpO2 99%, RR 19. At 1920 client c/o dizziness returned while sitting, still pale and skin moist,  PHN instructed client to lie back down.  Denied nausea. Client AxO x4. At 1923 client stated dizziness is gone.  Vitals taken" BP 98/57, HR 93 bpm, SpO2 100%, RR 21. At 1935 client was sat up, vitals taken: BP 106/72, HR 111, RR 18. Skin dry and appropriate color for Ethnicity. Client stated symptoms resolved, stated "feeling better." RN educated client to f/u with PMD. Client stood up at 1943 and walked off with a steady gait unassisted.
Received initial set of Moderna vaccines on 1/12/21 and 2/09/21 then experienced an episode of headaches, high blood pressure and sudden fluid retention about 3 months later in April 2021.  Blood pressure peaked at 191/97, pulse 53 on 5/29/21 then subsided to 90/58 pulse 66 on 10/14/21 following use of Lisinopril.  Water retention of 16 pounds was eliminated following use of Lasix for two weeks. The second episode also followed 3 months after the Booster vaccine on 11/1/22 and was apparent on 2/8/22 due to reoccurrence of headaches and sudden fluid retention.  Blood pressure peaked at 149/77 pulse 59 so far due to reinitiating of Lisinopril and water retention amounted to 8 pounds at that time.  Lasix was increased also at this time.
a haziness in the eyes, as if the sun is glaring into them; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (a haziness in the eyes, as if the sun is glaring into them) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VISION BLURRED (a haziness in the eyes, as if the sun is glaring into them). At the time of the report, VISION BLURRED (a haziness in the eyes, as if the sun is glaring into them) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter.