chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever 106 F; Sweating; Vomiting; Chills; Fever; A spontaneous report was received from a consumer concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever of 106 F, sweating, fever, vomiting and chills.  The patient's medical history was not provided. Concomitant medications were not provided by reporter.  On 08 Mar 2021, 2 or 3 hours prior to the onset of the events, the patient received first of the two of his planned doses of mRNA-1273 (Lot number: unknown) in the left arm for prophylaxis of COVID-19 infection.   On 08 Mar 2021, After receiving vaccine,and within 2 or 3 hours patient showed symptoms of vomiting, fever, and chills.   On 09 Mar 2021, patient woke up sweating and fever was 106 F.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events fever of 106 F, sweating, fever, vomiting and chills were unknown.; Reporter'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.
SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned an unspecified age female. The patient's race and ethnicity were unknown. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient was hospitalized for Covid (suspected covid-19 infection) confirms suspected clinical vaccination failure and the patient was in home at the time of reporting, discharge dates were not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210858457.; Sender's Comments: V0 - 20210858737- covid-19 vaccine ad26.cov2.s-Suspected Covid-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210858737- covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Client started developing hives and a scratchy throat. She was given 25 mg of Benadryl PO then began to dry heave with no emesis. Then given 0.3 mg of epinephrine IM in right deltoid. A rapid response was called and she was taken to the ED by the house supervisor and respiratory therapist.
I had the flu shot at noon, we returned home and I ate a snack, then aright around the 2:00pm hour I started to have severe stomach pain, I was very short of breath, I started having chills, then sweats, then my hips hurt so bad I couldn?t get comfortable.  I took 3 advil for the pain, and about 4:00 I became with vomiting.  The chills continued, followed by sweating, then about 7:00pm I started having diarrhea and vomiting.  The pain in  my hips and chest eased about 8:30pm and I showered then went to bed, waking occasionally to drink water.
Severe pain shooting up her neck; Felt hot and cold; Sore throat; Developed a rash on her arm that then spread to the larger area of it; Severe migraine pain; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Severe migraine pain), NECK PAIN (Severe pain shooting up her neck), FEELING OF BODY TEMPERATURE CHANGE (Felt hot and cold), OROPHARYNGEAL PAIN (Sore throat) and RASH (Developed a rash on her arm that then spread to the larger area of it) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (slight headache). On 16-Apr-2021, the patient experienced MIGRAINE (Severe migraine pain). On 17-Apr-2021, the patient experienced RASH (Developed a rash on her arm that then spread to the larger area of it). On an unknown date, the patient experienced NECK PAIN (Severe pain shooting up her neck), FEELING OF BODY TEMPERATURE CHANGE (Felt hot and cold) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, MIGRAINE (Severe migraine pain), NECK PAIN (Severe pain shooting up her neck), FEELING OF BODY TEMPERATURE CHANGE (Felt hot and cold), OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (slight headache) outcome was unknown and RASH (Developed a rash on her arm that then spread to the larger area of it) had not resolved.            No concomitant medication was reported. No treatment medication was reported.  Action taken with the mRNA-1273 vaccine in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-080115 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Initial additional (TCR) received on 16-MAY-2021 contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080115:First Dose
The pharmacist administering the vaccine used an appropriately sized needle but still contacted the patient's bone during the vaccination process. The needle was withdrawn an acceptable distance and the vaccine was administered into the muscle as required. The patient developed cellulitis at the injection site with redness and painful swelling within 24 hours of the vaccine being administered. Patient was prescribed cephalexin 250mg/5ml suspension with 5ml to be taken twice daily and it was picked up on 01/26/2022.  If symptoms are not resolved by 01/27/2022, the patient is planning to have the injection site x-rayed for any additional issues.
flu like symptoms; extremally dizzy; shaky; chills; body ache; nausea; fatigue; diminished smell; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), DIZZINESS (extremally dizzy), NERVOUSNESS (shaky), CHILLS (chills) and PAIN (body ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), DIZZINESS (extremally dizzy), NERVOUSNESS (shaky), CHILLS (chills), PAIN (body ache), NAUSEA (nausea), FATIGUE (fatigue) and ANOSMIA (diminished smell). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), DIZZINESS (extremally dizzy), NERVOUSNESS (shaky), CHILLS (chills), PAIN (body ache), NAUSEA (nausea), FATIGUE (fatigue) and ANOSMIA (diminished smell) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    No relevant concomitant medications were reported.  Treatment details included Advil and Tylenol..   Reporter did not allow further contact
pain, redness, swelling at injection site within hours of shot (this was the booster, I had no symptoms from the first shot) and later fever (101.1), fatigue, dizziness on standing too long
MEDICATION ADMINISTRATION ERROR PFIZER DOSE 2 VACCINE GIVEN EARLY, PER PATIENT'S MOTHER, PATIENT RECEIVED DOSE 1 PFIZER ON JULY 10TH 2021. NO RECORD OF FIRST DOSE AVAILABLE IN REGISTRY OR PROVIDED BY THE PARENT.
pt recv vax & devel red rash over entire body 1-2hr p/vax;ER MD exam revealed face trunk extremities covered w/urticaria;ears red & swollen, t97.3 ax;pulse 110, R36, 02 90-95% RA; inc rhonchi;heart reveal tachycardia;
This spontaneous report as received from a Licensed Vocational Nurse regarding an unspecified patients of unknown demographics. There was no information about pertinent medical history, drug reactions or drug allergies. On 27-JUL-2015, the patient was vaccinated with 7 doses of improperly stored PROQUAD (Merck) lot# L003221 and expiry date: 30-JUL-2016. No adverse effect was reported. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Received a dose of HPV9 that had expired on 12/1/2021.  No adverse event noted/ treatment given.
Delayed reaction, 8 days later.   Large red erythema, 3.5 inches X 1.5 inches in size on upper arm near the injection sight.  Lasted 7 days.  Slight soreness and itchy.
Pain; Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) and INFLUENZA LIKE ILLNESS (Flu-like symptoms) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain) and INFLUENZA LIKE ILLNESS (Flu-like symptoms). At the time of the report, PAIN (Pain) and INFLUENZA LIKE ILLNESS (Flu-like symptoms) outcome was unknown.            Concomitant medications were not mentioned.
Swelling of right side of face, two inch wide from ear to neck.  Swelling started 2 hours after shot. Called doctor about 3-4 hours after injection.  Bought Benydrl but never took it because the swelling did not progress further.   Next day, swelling went down (about 80-90%) but not fully gone.  Also had acute diarrhea the day of vaccine.   Had not eaten anything that day because was fasting for a blood test.  Nothing eaten prior to 10pm the night before.
Patient states that they have had no side effects or adverse events.  Vaccine was given from vial that had been in refrigerator longer than 30 days.
Patient was hospitalized with hypoxia, chest pain 3 weeks after 1st shot of COVID19 Pfizer.  Found with bilateral segmental pulmonary emboli and small infiltrates bilateral, also had +PCR for rhinovirus. Being treated for pulmonary emboli and pneumonia with anticoagulation and antibiotics Improved since anticoagulation started, unclear if this is a side effect from COVID19 vaccine, patient will be getting 2nd shot while on anticoagulation.
1st dose rec'd 1/4/21. Mild soreness at injection site.  Slight headache.   A week later, increased soreness at injection site, entire upper third portion of my  arm was red, warm to the touch, sometimes itchy.  Arm felt tight and firm.  Slight headache which advil seemed to manage throughout the day.   1/12/21 woke with jaw pain, neck pain in back of neck on both sides, headache, temp of 99.2.  Took advil.  Two hours later all those symptoms were gone and did not return.  I have felt fine ever since. Arm is no longer sore, but redness still present, though seems to be lessening.
This case was considered medically important (OMIC). Information regarding Hib titer vaccine Haemophilus B conjugate vaccine diphtheria crm 197 protein conjugate injection was received from a consumer regarding a 3 year old male patient who experienced autism. The patient received the second dose on 5/6/2002, The patient also received the second dose of Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection), the second dose of Ipol (poliovirus vaccine inactivated) and the second dose of Infanrix (diphtheria, tetanus toxoid, acellular pertussis vaccine) on 6/6/02. Relevant medical history was not provided. Indication for Hib titer vaccine was immunisation. Product was administered on 5/6/03. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) Tripedia (diphtheria, tetanus toxoid, acellular pertussis vaccine), Act Hib haemophilus b conjugate vaccine tetanus, MMR measles, mumps and rubella vaccine, Recombivax HB Hepatitis B vaccine, Engerix B hepatitis B vaccine, Infanrix (diphtheria, tetanus toxoid, acellular pertussis vaccine) and Ipol poliovirus vaccine inactivated. Concomitant medications were not reported. A mother reported that her son was diagnosed with autism in 6/2005. The outcome is unknown. No additional information was available at the time of this report.
Developed a rash a day after the injection on top of right hand.As of this morning 04Mar is on top of my left hand.; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 02Mar2021 at 10:45 (at the age of 42-year-old) as dose 1,single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included losartan; colecalciferol (VITAMIN D); ascorbic acid (VITAMIN C). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 03Mar2021, the patient developed a rash a day after the injection on top of right hand and also reported that as of the morning of 04Mar2021, the rash was on top of her left hand. Therapeutic measures were taken as a result of the event. The patient did seek medical treatment and the dermatologist did not believe this was related to the vaccine. The outcome was recovered in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a medical assistant concerning an unknown number of patients of an unknown gender and age. On an unknown date, the patients were vaccinated with dose of RECOMBIVAX HB (dose, dose number, lot number, expiration date and route were reported). Co-suspect and concomitant therapies were not reported. The medical assistant reported doses of RECOMBIVAX HB that were exposed to a supported temperature excursion have been administered to unspecified patients on unspecified dates. No adverse effects have been observed or reported. This is one (1) of five (5) reports from the same source. Additional information has been requested.
vaso vagal syncope approx 2-3 minutes after vaccine administration. patient recovered consciousness in 60-90 seconds. assisted to wheelchair & then moved to stretcher after regaining consciousness. remained in observation for 45 minutes & given juice. recovered & left clinic accompanied by a family member. VS wnl in observation. bp 110/60 HR 85 O2 97% Patient stated he had history of similar issues with other injections and blood draws.
2 days of fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (2 days of fever) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (2 days of fever). At the time of the report, PYREXIA (2 days of fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported  No treatment medication was reported   This case was linked to MOD-2021-218190 (Patient Link).
Patient didn't experience anything abnormal. Common symptoms. However, patient took ill around Oct. 2021 and on 29th, legs were swollen. Went to urgent care several times and went to doctor on the 3rd. Mouth was full of blood on 11/4 and was rushed to ER. Was admitted and test were ran. They told parents to take him home after slight improvement and later that night he coded and died. Hospital thought he would've been fine. Mother claims they were shocked he died.  Urgent care ruled out an enlarged heart with possible pneumonia and pulmonary embolism. Medical examiner's report states dilated cardiomyopathy.
at least half of the volume was administered; Syringe leak; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 3-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 53HA4, expiry date 26th March 2021) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Pediarix. On an unknown date, unknown after receiving Pediarix, the patient experienced accidental underdose and syringe leak. On an unknown date, the outcome of the accidental underdose and syringe leak were unknown.  Additional details were reported as follows: The age at vaccination was not reported. While receiving the Pediarix vaccine the needle came out and only half of the volume was administered which led to accidental under dose and syringe leak.  No further details were provided.
PATIENT STATES THE VACCINE TRIGGERED AN AUTOIMMUNE DISORDER SHE HAS AND THAT SHE HAS BEEN EXPERIENCING EFFECTS FOR 2 WEEKS.
50 mm red, swollen, hard area, very hot to touch on left deltoid, also c/o itching on site.  Recommended cool wash cloth, ibu, Benadryl.
I started feeling pain at the site of the injection on 9/23 shortly thereafter I started getting a headache. I took TYLENOL 500 mg and 1000mg for the pain. However the pain in my left arm did not subside and radiated thru my upper body. My arm started itching and burning and I took BENADRYL. Today I am feeling much better but continue to have red welts at the site of the injection.
AFTER 5 MINUTES AFTER RECEIVING THE VACCINE, SHE COMPLAINED OF BEING WEAK. ONSITE EMS RESPONDED. SHE WAS EVALUATED BY EMS AND TRANSPORTED TO A LOCAL HOSPITAL FOR FURTHER EVALUATION. VITALS BELOW
Initial and follow up information has been received from a physician concerning a currently 22 year old male patient, with no allergies and no medical history, who in 1983 and in 1994 was vaccinated with a dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  There were no concomitant medications.  Subsequently the patient had a titer drawn that showed that he was not immune to mumps.  Laboratory evaluation on 05/24/2004 revealed:  IgG 0.91 and IgM 0.3.  The patient was given a prescription for mumps virus vaccine live, which was given at another facility.  Unspecified medical attention was sought.  It was noted that no symptoms manifested.  Additional information was not expected as the reporter had no knowledge of the patient's status since 07/28/2004.
Patient was unable to eat within 2 weeks of the second Covid-19 shot. Her nausea got worse and worse until she went back into the doctor on 12/1 and it was found that she has many large cysts surrounding her pancreas.  Patient made several appointments with some having to schedule months out due to availability.  Died 1/13/22.
second dose is schedule outside of the 21 days; she has been waiting for so long that she is just in a brain fog dead; This is a spontaneous report from a contactable consumer. A 69-Yerars-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an 23Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  On 26Jan2021, the patient received first dose of bnt162b2 (Batch/Lot number: EL9623). She had adverse event, like joint pain and headache with first dose. Her chills have went away, but was still getting a little bit of a headache. She had some pain in her arm, but it was much better now. She had waited for over an hour and a half. She was schedule for the second dose tomorrow. She had been waiting for so long that she was just in a brain fog dead, she at first stating that she was on Valacyclovir 1mg but then corrects herself stating that she was taking Valacyclovir 500mg once in the morning and once in the evening, she asks will that interfere with the covid vaccine. She also states that her second dose was schedule outside of the 21 days. The events assessed as non-serious with outcome of unknown.  Follow up (29Jan2021): This is a follow up spontaneous report from a contactable Consumer. This Consumer reported that: vaccine questions answered received.  Information about lot/batch number has been requested.  Follow-up (21Feb2021): The initial case was missing the following minimum criteria: of a true adverse event, upon receipt of follow-up information on 21Feb2021, this case now contains all required information to be considered valid.  Follow-up (22Feb2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reporter for herself that: Patient details (age), events, clinical information were added.  No follow-up attempts are possible, information about lot/batch number cannot been obtained.
The patient consented to Jansen COVID-19 vaccination. Patient was given Pfizer 1st dose in error by the nurse. Patient did not experience any adverse reactions from the Pfizer vaccine. Patient was informed of the benefits and risks of both the pfizer and Jansen vaccination. Patient was informed of the efficacy of pfizer and Jansen and the warning associated with Jansen from ages 18-49. Patient was informed that a 2nd dose of pfizer is needed to complete the entire vaccination series. Patient agreed with receiving the 2nd dose of the Covid-19 vaccine. Patient was informed that she received the 1st dose of pfizer instead of Jansen.
In January I started feeling sick. I went and got tested on Jan 30. I tested positive. I had flu-like symptoms, severe headache and body aches, fatigue and low-grade fever.
I have been diagnosed with a lifelong autoimmune disease/condition known as dermatographia urticaria which causes painful burning/itching flare ups on different parts of my body.  Also anytime my system ha to work due to a real injury to the body ?a bee sting for example? the symptoms are exaggerated and frightening. The treatment is currently to take antihistamines as needed and as a immune suppression treatment and to always take them in the event I will need additional booster shots. There is apparently no cure and something I have to live with.
Nausea, diarrhea,stomach ache, head ache, lethargic, sore throat, tingling mouth, ear ache, dizzy, trouble focusing,
2 hrs after IZ noted to have tonic clonic seizure.  Negative for fever or rash.
Patient with hx of epilepsy and cognitive delay presenting to ER from home with change of mental status. Evaluation on arrival noting hypotension and fluid boluses initiated. Further work up including negative head CT, venous critical care profile demonstrating a pH of 7.33 with pCO2 of 49 and PO2 of 116. COVID 19 positive with hypoxia. Patient subsequently admitted for further evaluation and management.