chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He had not been feeling well after his second Covid vaccination (on 01/23/2021) and was found unresponsive in his room at the nursing home (late evening on 02/02/2021). He was taken to a hospital where they did tests and he had pneumonia and kidney failure, but he was being transferred to a larger hospital when he arrested and died (02/03/2021)
Uncontrollable , convulsive type entire body shaking.   It came on  rather  suddenly .  The shaking was SO violent  and encompassed my entire body- my boyfriend tried to hold me to stop me from shaking so violently.    I have never experienced  anything like that and it was very scarey.  Hadn't not stopped 2.5 hours later - we were going to go to the ER.
PATIENT FAINTED SOME MINUTES AFTER GETTING THE IMMUNIZATIONS (SYNCOPE). WE CALLED EMERGENCY SERVIES AND THE PARAMEDICS CAME AND CHECKED ON HIM. HE WAS GIVING THE CLEAR AND DIDNT NEED TO GO TO THE HOSPITAL
Cold symptoms including rhinorrhea, sore throat, fatigue and diarrhea. Covid testing by bilateral nares swab with a PCR test was positive on January 5, 2021
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with dose 1 of ROTATEQ (Lot # not reported) orally on 21-SEP-2011, dose 2 of ROTATEQ (Lot # not reported) orally on 23-JAN-2012 and dose 3 ROTATEQ (Lot # not reported) orally on 03-AUG-2012 when the child was greater than 32 weeks of age. No adverse effect was reported. Additional information has been requested.
The patient called me today and told me that he had a golf ball sized welt where he was vaccinated.  He also described that he had severe pain on the right deltoid where he recieved the vaccination.  I told him to place an ice pack on it throughout the day and take Tylenol for the pain.  If the pain progressed and the welt did not subside in the next day or two, that he should seek medical attention.
EMS called over to vaccination cubicle for a 29 y/o female AOx3 stating she feels like she's she's going to pass out. Past medical history of anxiety with prescribed Xanax which she did not take today. Allergic to Bactrim She was assisted to stretcher and taken to the hallway for further evaluation. Pt is hyperventilating stating "what did I just take, I feel like I'm going to have a seizure, my hands are contorted, I cant move my hands, why is my stomach twitching like that" Per vaccine administrators pt appeared to be anxious prior to actual administration of vaccine. Vitals obtained BP 138/87 SPO2 99% HR 130 PT was placed on Oxygen 2lpm via nasal cannula for comfort, she was coached and encouraged to take deep breaths. 4-lead ECG- sinus tachycardia Vitals reassessed BP 132/82 SPO2 99%  HR 120 PT called her sister who is a nurse and that seemed to help her calm down. PT requested 911 transport to hospital. 911 notified  Pt care was transferred over to hospital
1/7/21-1/9/21:  fevers consistent >39.5 x 36hrs 1/7/21- 1/8/21  extreme nausea and vomiting--nausea has continued daily, vomiting is decreased to 2-3 days/week.  Zofran 8mg has been used as needed 2/8/21 ALT164, AST 156 (increased from post vaccine January '21) Aldolase 10.2, CK 199, Alk Phos and Bilirubin normal, WBC and neutrophil sudden decrease.  UA 4+ bacteria epith cells and protein... worsening but negative culture  1/2021palpitations and chest pain  intermittent but no  respiratory distress  Other Items: petechial rash to lower flank and extremities, facial rash, peripepheral edema, rash, and pain consistent with vascular inflammation.  Right temporal lobe painful to touch.  Neck pain.   Throat pain and difficulty swallowing
Heart and chest pain that persisted for 2 months. I didn?t seek medical treatment. It eventually went away.
Right deltoid, raised, erythematus, tender lesions 4.5x5cm in diameter. Urticarial wheals all over. Treatment with Cetorax.
Seen in office 9/28/05 for bruising, CBC done, platelets 5000, Dx ITP. Pt hospitalized for Tx 10/3/05 platelets 138,000; 10/6/05 platelets 160,000. Information from 60 day follow-up last CBC 11/9/05 platelets 246 normal labs at this time.
PATIENT REPORTED SHORTNESS OF BREATH, COUGHING AND FLUSHNESS APPROXIMATLEY 30 MINUTES AFTER RECEIVING VACCINE
pain in the eye on the side of the injection site; Overall feeling of sickness; Diarrhea; Weakness; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (pain in the eye on the side of the injection site), MALAISE (Overall feeling of sickness), DIARRHOEA (Diarrhea), ASTHENIA (Weakness) and FATIGUE (Fatigue) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced EYE PAIN (pain in the eye on the side of the injection site), MALAISE (Overall feeling of sickness), DIARRHOEA (Diarrhea), ASTHENIA (Weakness), FATIGUE (Fatigue) and HEADACHE (Headache). On 07-Feb-2021, EYE PAIN (pain in the eye on the side of the injection site), MALAISE (Overall feeling of sickness), DIARRHOEA (Diarrhea), ASTHENIA (Weakness) and HEADACHE (Headache) had resolved. At the time of the report, FATIGUE (Fatigue) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.    Reporter did not allow further contact
This spontaneous report was received from a Certified Medical Assistant (C.M.A) concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. It was reported that on 23-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L003188, expiration date 06-JUL-2016), (dose and route were not provided). Concomitant therapies were not provided. No adverse effects were reported. This is one of two reports from the same source (MARRS # 1512USA012013). Additional information has been requested.
Patient stopped by the pharmacy on 06/11/21 showing injection site reaction with redness and pain, which spread about 3-4 inches. Patient was concerned with pain that radiated under the armpit/breast area (lymph node area). Also, a lump had formed in-between the base of the neck and the shoulder area, near the clavicle. Skin was intact with no redness. Lump was noticeable about a nickel-size in diameter. She complained of stiffness and muscle pulling from the left of the neck when she turned her head to the right.
Vaccine may not have been stored at right temperature and was asked to repeat 2nd dose.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine may not have been stored at right temperature and was asked to repeat 2nd dose.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine may not have been stored at right temperature and was asked to repeat 2nd dose.). On 12-Apr-2021, PRODUCT STORAGE ERROR (Vaccine may not have been stored at right temperature and was asked to repeat 2nd dose.) had resolved. Not Provided          Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Left ear had mild tinnitus and now started experiencing very loud tinnitus on left ear; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en9581) via an unspecified route of administration in the left arm on 24Apr2021 at 15:30 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history included tinnitus; left ear had mild tinnitus. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included prednisone (MANUFACTURER UNKNOWN) from an unknown date for unspecified indication. On 25Apr2021 at 06:00, the patient experienced left ear had mild tinnitus and now started experiencing very loud tinnitus on left ear after day 1 of vaccine. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left ear had mild tinnitus and now started experiencing very loud tinnitus on left ear was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of mobility decreased in a 68-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX (1st dose received in July 2018, no adverse event). On 11th September 2018, the patient received the 2nd dose of SHINGRIX. On 11th September 2018, less than a day after receiving SHINGRIX, the patient experienced mobility decreased, general body pain, headache, shivering, fever, cold sweat and dizziness. In September 2018, the patient experienced stomach pain, tiredness and appetite lost. On an unknown date, the outcome of the mobility decreased, general body pain, headache, shivering, fever, cold sweat, dizziness, stomach pain, tiredness and appetite lost were recovering/resolving. It was unknown if the reporter considered the mobility decreased, general body pain, headache, shivering, fever, cold sweat, dizziness, stomach pain, tiredness and appetite lost to be related to SHINGRIX. Additional information received as follows: The patient reported that she experienced, not being able to move arm and less than a week, after receiving SHINGRIX, the patient experienced shivering, fever, tiredness and loss of appetite. At the time of reporting, the symptoms were resolving slowly. The contact details of the physician were provided.
face was red, scaly, and itchy; face was red, scaly, and itchy; face was red, scaly, and itchy; terrible rash with an allergy in his face it was dry, it was itchy, red; his face was swollen too; rash/it started on his face, it goes to his nose/below his belly button, like 4 inches to the right; terrible rash with an allergy in his face it was dry, it was itchy, red; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).   A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8732) via an unspecified route of administration, administered in right arm on 02Apr2021 at 15:00 (at the age of 79-year-old) as DOSE 1, SINGLE, for COVID-19 immunization. Medical history included throat cancer from 2000 to an unknown date. Patient's concomitant medications were not reported. On 06Apr2021 after vaccination, the patient's face was red, scaly, and itchy. The patient also experienced terrible rash with an allergy in his face it was dry, it was itchy, red; face was swollen, and rash/it started on his face, it goes to his nose/below his belly button, like 4 inches to the right on 06Apr2021. It was reported that the patient's face was red, scaly, and itchy. He had a terrible rash with an allergy in his face. His face was swollen too. Rash/it started on his face, it goes to his nose/it started getting red and dry and then when he got up in the morning it was full blast completely/below his belly button, like 4 inches to the right/like a rash of the same type/rash on the face. He called his primary doctor and his doctor told him to rush to the emergency room; so he did not have any problem with his throat. He had throat cancer in 2000 and so now he had problems swallowing because of the radiation and so his doctor told him to rush to the emergency room before he has any more problems with his throat or with swallowing, so that's what he did. He went to the emergency room on 07Apr2021 because he had a terrible allergy. He did not go to the physician office. At the emergency room, they took his vitals and asked him questions and they gave him medicine and in one hour, he was out. They gave him 2 different medicines that he took for 14 days. The medicine they gave him worked and then 14 days later he was okay, he was back in good shape and the medicine worked. No investigation assessment was performed. His face was back to its normal. He has recovered completely from the rash.  He would like to know if he should get the second dose due to the first reaction. The outcome of the events was resolved on an unspecified date in Apr2021.  No follow-up attempts were needed. No further information was expected.
12/16/21 -- booster shot of Moderna mRNA covid-19 vaccine.    1/3/22-- > 1/6 --mild URI symptoms "a head cold"    --1/11/22 starts to experience bilateral LW weakness-- very dramatic onset of weakness.  -- worsened over the course of 1 week to result in unsteady gait -- eventually percieving SOME weakness in the arms.  -- > at his nadir, did not feel that he could stand on the legs at all  -- 1/19/22 imaging demonstrates thin mostly central T2 process-- clear in the C spine but present through thte T spine.  -- 1/18/22 CSF with only mild elevation of protein
Mother reports vomiting starting ~ 6 hrs after injection. Was taken to medical center x 2 in the evening and early am of 10/4/02 because of continued vomiting. Recovered completely after ~ 24 hours. No fever or diarrhea. Given injections to stop vomiting.
This spontaneous report received from a parent concerned a 12-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, and other pre-existing medical conditions included: The patient had no known allergies. The patient was not on any medications. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 29-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-DEC-2021, the patient experienced 12-year-old female got the vaccine, vision disturbances, felt whole body was heavy, severe headaches, muscle aches, and injection site pain. Treatment medications included: sulfamethoxazole/trimethoprim. The action taken with covid-19 vaccine was not applicable. The patient recovered from vision disturbances, felt whole body was heavy, severe headaches, muscle aches, and injection site pain on 30-DEC-2021, and the outcome of 12-year-old female got the vaccine was not reported. This report was non-serious.
Patient received Monovalent for booster when according to guidelines changed on 09/01/2022 patient should have received Bivalent. Patient called and informed she can receive Bivalent after 11/01/2022, appointment scheduled on 11/03/2022 for Bivalent.
Patient's wife reported fever, chills, body aches, seizure and states he quit breathing for a short period of time.
Sort at the location of the injection and hot to the touch. I have a red welt that is about 3 inches round.  I have not had a reaction to flu shots in the past.
Painful to lift left arm. Painful to drive car. Painful to push down on an object MD visit on 09/16/2001 indicated 1. No loss of function in left arm. 2. No neurologic deficit.
Developed a rash and redness in face.  Pharmacy and clinic recommended taking Benadryl.  I applied Benadryl cream to effected areas and it burned.  Had an allergic reaction to something and thought for a couple of days and on Saturday 9/28/2013 realized the only thing I was exposed to different was the flu shot.  Improved progressivly and cleared up by Tuesday 10/1/2013.  Have shot annually and have never had a reaction.
PAIN, SWELLING, AND KNOT ON LEFT ARM WHERE SHOT WAS GIVEN
SITE OF VACCINE SWOLLEN, PINK, WARM, PAINFUL-ABOUT 1CM DIAMETER.
Patient was given vaccine. Within 5 minutes patient fainted and revived with smelling salts. Patient sat in pharmacy under care for 30 minutes. Patient was ok to leave pharmacy walking by themselves. Patient was checked on 2 hours later and still doing fine.
Mother presented back at clinic 03/09/2005. She reported that within 24 hours of previous shots (MMR and Varivax) on 02/23/2005, red, rash with raised bumps and itching began. She reported itching continued about 72 hours then red bumps extended down to ankles. Bumps are currently dry. Child afebrile alert and active. Parents did not use any treatment. About to go visit PMD with Nursing Assessmnet summary. Child still has red raised bumps on both legs as of 03/09/2005.
Information has been received from a the doctor's nurse concerning a 25 year old female who on 21-APR-2009, was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL. The patient called the office on the night of 23-APR-2009 saying she "felt terrible and had flu like symptoms. She was achy all over and had malaise." The patient sought medical attention and the outcome of the patient was unknown. Additional information has been requested.
I'm not sure if the Janssen is the same as Johnson and Johnson? But I'm type 1 diabetic and my blood sugars have been at dangerously high levels for 3-4 days now. They still haven't gone down. I've been taking two times as much long acting insulin as I usually take, tripling the amount of fast acting insulin I usually take, and am only eating protein and vegetables (no carbs) to try to keep my sugars in normal range, and even then they are stubbornly sticking around 250  to 400. I want doctors and patients to be aware of this side effect because it was really scary for me and it still hasn't resolved itself.
Worker experienced nausea and vomiting. General feeling of unwellness. Onset of sx; 30 minutes post vaccination. Duration of sx: 24 hours.
Pt reported  chest pain as well as headache, blurry vision and dizziness. BP was found to be 208/110. EMS was called and pt was transported to ED via private car due to pt not wanting to go by ambulance. Per chart notes, pt presented to ED and also reported hives however she left the ED without being seen.
Patient noted small of bruising 1/20/11; 1/21/11 - bruising increased with firm hard nodule noted beneath skin - tender to touch; 1/22/11 area increased in size with erythema noted with tenderness - ROM normal.
The ActHIB (component from a Pentacel) was accidentally mixed with Quadracel (instead of the Pentacel DTaP-IPV component), no AE; Quadracel used as a diluent in 2 months old patient, no AE; Initial information received on 31-Mar-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a two months old male patient who received a 0.5 ml dose of the ACT-HIB component from a PENTACEL was accidentally mixed with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot: C5656AA, expiry date: 13-Aug-2021) instead of the DTaP-IPV component of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (first dose, lot: UJ197AAA, expiry date: 02-Mar-2021) on 26-Mar-2020, via an intramuscular route in the left thigh.   The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was an actual medication error due to wrong solution used in drug reconstitution and inappropriate age at vaccine administration.  It was reported that the Pentacel comes with a diluent. The nurse did not use that diluent. They used the Quadracel, which is the DTaP and polio, but they put it in with the HIB powder. That might happened because they were both blue and they were the same size. They were right down below (in the refrigerator). The ActHIB (component from a Pentacel) was accidentally mixed with Quadracel (instead of the Pentacel DTaP-IPV component). So, the Quadracel DTaP-IPV was put in the ActHIB powder.   At the time of reporting, the patient did not experienced any adverse event.  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 and Module VI of the 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.
Clinic nurse was giving routine vaccines. She gave HPV and flu in the right arm and was going to give Menactra in the left arm, when she gave it the patient passed out. She states that she missed lunch and hasnt ate anything since breakfast. The patient was given some cracker and a drink and regained full response back.
generalized maculopapular (mildly itchy) rash starting on right foot, now on trunk and all extremities, sparing face and oral mucosa. No localized reaction on deltoid.
Chills, shaking, body aches, fever up to 101.4, vomiting Began about 12 hours after administration of shot. Lasted approximately 10 hours; Chills, shaking, body aches, fever up to 101.4, vomiting Began about 12 hours after administration of shot. Lasted approximately 10 hours; Chills, shaking, body aches, fever up to 101.4, vomiting Began about 12 hours after administration of shot. Lasted approximately 10 hours; Chills, shaking, body aches, fever up to 101.4, vomiting Began about 12 hours after administration of shot. Lasted approximately 10 hours; Chills, shaking, body aches, fever up to 101.4, vomiting Began about 12 hours after administration of shot. Lasted approximately 10 hours; This is a spontaneous report from a contactable other health care professional (patient).  A 31-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration (left arm) second dose on 07Jan2021 09:30 at single dose for covid-19 immunisation. The patient's medical history included known allergies: Sulfa drugs and known allergies: latex sensitivity. The patient's concomitant medication included spironolactone, bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]), and multi vitamin. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), for covid-19 immunisation first dose on 17Dec2020, Vaccine location Left arm, lot number EH9899. On 07Jan2021 10:00 PM, the patient experienced Chills, shaking, body aches, fever up to 101.4, vomiting Began about 12 hours after administration of shot. Lasted approximately 10 hours. The patient did not received treatment for the events. The outcome of the events was recovered in Jan2021. Facility where the most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not tested positive for covid post vaccination.
Arm is sore, swollen about 1/2 dollar size, lymph node in armpit sore,  arm puffy and itchy around swollen area as well. Pt instructed to take ibuprofen (swelling) and BENADRYL (all. rxn).