chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This study case was received from the investigator in a trial on 27 November 2013. A male subject (date of birth not reported) with no reported past medical history had received the following vaccines on 06 November 2013: ACAM2000 (lot number, route and site of administration not reported) and Anthrax (lot number, route, site and not reported) and Typhoid vaccine (lot number, route, site and not reported). On 09 November 2013 he experienced a one-time episode of chest pain, chest pressure, shortness of breath, dizziness and palpitations. No treatments were received. On 19 November 2013, a Troponin I level was within normal limits (<0.10) and ECG was normal. The subject did not recall activity prior to the chest pressure. The patient was seen by a physician on 19 November 2013. Smallpox injection site looked scabbed over. The medical history was reviewed and the subject reported that chest pain, chest pressure, shortness of breath, dizziness and palpitations all began while subject was running on 09 November 2013, 3 days post vaccination. The subject went to the ER upon onset of the symptoms. The ER performed an EKG and labs and referred him to the (PCM). On 12 November the subject was seen and referred to a cardiologist. On 13 November 2013, an Echo, EKG and lab tests were performed with all tests normal with the exception of one cardiac enzyme that the subject does not know. The patient was to have a cardiac stress test on 20 November and a Holter monitor. The subject stated that the Holter monitor was faulty and will be repeated at a later time. The subject stated that he was told by the cardiologist that the big symptoms were related to smallpox vaccine. Symptoms had a sudden onset and lasted about 4 hours. No medication use or other adverse events. Subject was not experiencing chest pain at the moment and marked "no hurt" on Baker Wong Scale. An EKG was performed without incident. Blood test for rapid and central lab test were negative. On 22 November 2013, central lab tests and EKG were normal. The patient will be seen by a cardiologist on 03 December 2013 as per the subject, he feels the symptoms are related to the ACAM vaccine. No further information was available at the time of the report. The subject's outcome was recovered on 09 November 2013. According to the investigator, the event of possible myopericarditis was considered another important event and probably related to vaccination. Documents held by sender: none.
Information has been received from an office nurse concerning a patient who on an unspecified date was vaccinated with varicella virus vaccine live (Oka/Merck) (lot# 658586/1272U). In January 2008, the patient experienced cellulitis at the injection site on the thigh. The patient was treated with an antibiotic (therapy unspecified). On an unspecified date the patient recovered. A product quality complaint was not reported. This is of three reports from the same source. Additional information has been requested.
About 12 hours after receiving the vaccine, I developed chills and had a near vasovagal syncope event. I also developed cervical lymphadenopathy, nausea, and felt lightheaded. Because I felt so lightheaded I needed to leave work. The chills, nausea, and lightheadedness lasted for at least 10 hours.
Headache, Diarrhea & NauseaVomiting Narrative:   Other Relevant History:
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. On 17-NOV-2008, the patient was vaccinated with the first dose of GARDASIL (route of administration, dose, lot number and expiry date were not reported), on 19-JUN-2013, with the second dose of GARDASIL (route of administration, dose, lot number and expiry date were not reported) and on 29-SEP-2014, with the third dose of GARDASIL (route of administration, dose, lot number and expiry date were not reported). On 06-JUL-2015, today, the patient received a dose of GARDASIL 9 (route of administration, dose, lot number and expiry date were not reported). No adverse effect was reported for GARDASIL or GARDASIL 9. Additional information has been requested.
My right arm has been numb; My right arm has been causing pain and discomfort; My right arm has been causing pain and discomfort; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (My right arm has been numb), PAIN IN EXTREMITY (My right arm has been causing pain and discomfort) and LIMB DISCOMFORT (My right arm has been causing pain and discomfort) 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 13-Sep-2021, the patient experienced HYPOAESTHESIA (My right arm has been numb), PAIN IN EXTREMITY (My right arm has been causing pain and discomfort) and LIMB DISCOMFORT (My right arm has been causing pain and discomfort). At the time of the report, HYPOAESTHESIA (My right arm has been numb), PAIN IN EXTREMITY (My right arm has been causing pain and discomfort) and LIMB DISCOMFORT (My right arm has been causing pain and discomfort) outcome was unknown.            No concomitant medication details was provided. No treatment medication details was provided.   Reporter did not allow further contact
Missed 2nd dose within 6 month window; This non-serious case was reported by a nurse 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 on an unknown date).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Missed 2nd dose within 6 month window). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-JUN-2023 The reporter reported that the patient missed to receive her second dose of Shingrix vaccine. The reporter did not had expiration date and lot number. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
On June 15, 2018, I received my second Shingrix shot in the arm. (I had received the first shot on February 22, 2018.) Six days later, on June 21, I noticed a weeping, small sore on the bottom of my right front leg. The next day it had developed into an itching, large nichol-sized single blister, oozing and refilling. On June 25 the big leg blister was open and red with mild oozing. On June 26 I saw dermatologist Dr. She was unsure what it was, but prescribed fluocinonide skin cream twice daily for three weeks. It then began getting better. My primary care doctor, said it was a fixed drug eruption on 7/10/2018.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE ST ELEVATION MI, UNSPECIFIED
48 hrs p/vax-sore across back of neck-24 hrs later couldn't use rt arm; seen by MD said nerve damage due to Td-stated may take 12-15 months to go away
For one, I have developed a severe allergy to eggs. This means I can no longer have a flu shot. I've not. I've also had extreme fatigue, swollen joints, edema and rapid weight gain, Difficulty concentrating
Patient was given 0.2 ml of moderna biv "booster doses only" (pink cap). Patient only had 1 previous dose of moderna monovalent and should have received .25ml of moderna blue cap.
fever; chills; Vaccination site pain; Difficulty sleeping; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), VACCINATION SITE PAIN (Vaccination site pain) and INSOMNIA (Difficulty sleeping) 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.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-2021, 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 23-Jun-2021, the patient experienced PYREXIA (fever), CHILLS (chills), VACCINATION SITE PAIN (Vaccination site pain) and INSOMNIA (Difficulty sleeping). At the time of the report, PYREXIA (fever), CHILLS (chills), VACCINATION SITE PAIN (Vaccination site pain) and INSOMNIA (Difficulty sleeping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication provided by reporter. No concomitant medication provided by reporter.
Fatigue; brain fog; joint pains; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EN5318) at the age of 73 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: FATIGUE (non-serious) with onset 29Jan2021, outcome "recovered"; FEELING ABNORMAL (non-serious) with onset 29Jan2021, outcome "recovered", described as "brain fog"; ARTHRALGIA (non-serious) with onset 29Jan2021, outcome "recovered", described as "joint pains"; NAUSEA (non-serious) with onset 29Jan2021, outcome "recovered". Therapeutic measures were not taken as a result of fatigue, feeling abnormal, arthralgia, nausea.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201135285 same reporter/patient/product, different dose/AE;
Information has been received from a nurse practitioner concerning a 6 month old whose sibling was vaccinated with a single dose of Proquad. It was reported that the patient broke out with the same type of rash which did not appear to be wild-type chicken pox. The patient's sibling developed a rash following vaccination with Proquad. Additional information has been requested.
Rash and hives-forearms, calves, chest, stomach so far.  Trying to keep on top of it with Benadryl and Fluocinonide cream that I already had on hand.  Clears up in one area, pops up in another.
Client lied and reported being 12 years old. Dose accidentally given to ineligible client.
Difficulty breathing in fully. Progressively got worse. Airway felt constricted. Lasted from 8:30 PM to 1:00 AM. Didn't do anything to treat it.
Tested for Covid which came back positive; Cough; Runny nose; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested for Covid which came back positive), COUGH (Cough), RHINORRHOEA (Runny nose), HEADACHE (Headache) and FATIGUE (Fatigue) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced COUGH (Cough), RHINORRHOEA (Runny nose), HEADACHE (Headache) and FATIGUE (Fatigue). On 22-Feb-2021, the patient experienced COVID-19 (Tested for Covid which came back positive). The patient was treated with PARACETAMOL ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested for Covid which came back positive), COUGH (Cough), RHINORRHOEA (Runny nose), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: significant FU : AE outcome provided
I started to develop symptoms of shingles 7 days after my vaccine (vaccine was 2/16/2021, symptoms started 2/23/2021). It started as slight itchiness and tenderness. On 2/26/2021 I woke up with a pretty swollen eye which alerted me to make a virtual visit with a Nurse Practitioner at my Dr's office. The same day I got a Covid test (both rapid antigen and PCR -- both came back negative) and eventually was seen at an urgent care. The urgent care took a sample of the shingles, based on observation the provider stated they thought it was shingles. I was prescribed valacyclovir. It was later confirmed to be shingles. After about a week the symptoms subsided.  During this time I had a mild/severe headache for about 7-9 days as well. The shingles was only on my left eyelid and left eyebrow. It caused swelling, redness and tenderness. The rash did blister at certain areas. The shingles did not seem to infect my eyeball. I followed up with an Ophthalmologist to confirm that the shingles did not affect my vision.
severe fatigue; chest pressure; shortness of breath/lose my breath; dizziness; They have continued for several weeks making it difficult for me to jog as I usually do. I lose my breath and feel like my heart is struggling.; They have continued for several weeks making it difficult for me to jog as I usually do. I lose my breath and feel like my heart is struggling.; This is a spontaneous report from a contactable other health care professional, the patient. A 42-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on the right arm on 20Mar2021 at 09:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic pain, fibromyalgia and migraines. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medication. The Patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 21Mar2021 at 17:00, approximately 30 hours after the shot, the patient experienced severe fatigue, chest pressure, shortness of breath and dizziness. It was reported that  the patient had severe fatigue, chest pressure, shortness of breath and dizziness occurred. They had continued for several weeks and on unknown date in 2021, making it difficult for the patient to jog as she usually did and she lost her breath and felt like heart was struggling. On 09Apr2021, the patient underwent COVID test (nasal swab) and the result was negative. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events severe fatigue, chest pressure, shortness of breath, dizziness, had continued for several weeks making it difficult for her to jog as she usually did, lost her breath and felt like heart was struggling was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Initially after vaccines were given she had approx 2-3 days of soreness, slight swelling. All symptoms went away within 3 days. 8 days after immunization she woke up with a swollen left deltoid. No pain, redness, numbness, tingling, weakness, SOB, or any other symptoms. Nothing can contribute to the swelling- no recent illness, activity, medications, injury.
FEVER, CHILLS, SEVERE BODY ACHES, FOGGINESS/ PALMS OF HANDS HURT  AND STILL HURTING
I was in full menopause. After the vaccines I started my period. It was very painful and produced black sludgy clots.  My period lasted about 10 days which is very unusual. My past typical cycle lasted 2 days and very lite. Now I'm having breakthrough bleeding and feel very tired and restless.
THE PATIENT WAS 16 YEARS OLD AT THE TIME OF THE FIRST DOSE VACCINATION. THE MODERNA VACCINE IS ONLY CURRENTLY APPROVED FOR PATIENTS THAT ARE 18 YEARS OF AGE OR OLDER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE REACTIONS. ACCORDING TO CURRENT CDC INTERIM RECOMMENDATION THE PATIENT SHOULD GET THE SECOND DOSE BECAUSE HE IS OVER 16 YEARS OF AGE. I AM REPORTING THIS EVENT ONLY BECAUSE OF THE PATIENT'S AGE.
Shot #1--no after effects Shot #2--temperature and red arm at point of injection for several days
Patient states having pain in arm and shoulder for 6 days.  Thinks may have had a fever the first night.  Taking nonsteriodal anti-inflammatory drugs.
Teenage patient who inadvertently received one dose of Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Teenage patient who inadvertently received one dose of Moderna COVID-19 vaccine) in a 16-year-old patient of an unknown 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Teenage patient who inadvertently received one dose of Moderna COVID-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Teenage patient who inadvertently received one dose of Moderna COVID-19 vaccine) outcome was unknown.        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.   Concomitant medications were not reported.  Treatment was not reported.   Patient received Moderna Vaccine and per source document the patient will meet the age criteria for the Pfizer-BioNTech COVID-19 vaccine and wanted to know how long to wait before receiving the Pfizer Vaccine.
Contracted COVID-19; Contracted COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), as dose number unknown, 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Contracted COVID-19".  Additional information: Patient contracted COVID-19 after initial Comirnaty vaccine series. Patient contracted COVID-19 after receiving the Comirnaty vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
administered with vaccine that experienced more than 1 temperature excursion; administered with vaccine that experienced more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 12:03 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 12:03 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient was reported as 52.63.  Concomitant medication of the patient was not reported.  Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature of 34 degrees Fahrenheit at 09:00 AM and 37 degrees Fahrenheit at 10:00 AM. These vials were moved to fridge on 09-Mar-2021 and beyond use date for the vials was reported as 08-Apr-2021. The vaccines moved to clinic on 20-Mar-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and fisher brand traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
Pt had fever and chills and the injection site became red and inflamed. The redness and inflammation has persisted down her arm from the injection site past her elbow and into her forearm. The site is noticeably inflamed and red. The site also is warm to the touch. The reaction has limited her range of motion as she is unable to fully bend or extend her arm at the elbow.
45 minutes after the shot, I developed bright red hives on left shoulder and neck.  I received the shot on my left arm.  My throat felt tight.  I was shaky for a couple of more hours.  I had an upset stomach. I was very cold, but had waited in a 2 hour line outside in 20 degree weather because they were overwhelmed at the facility. And only had 3 doctors giving the shots.    I was able to swallow the whole time.
MMR given 11/2/04. Approximately 2 weeks later started with flu-like symptoms: fever and chills, headache and fever, then joint pains including low back , fingers, hips and knees. 11/23/04 went to ED for swelling in throat and diagnosed with esophageal spasm. Lyme titer negative. 12/7/04: Still with generalized aches and sensation of swelling in throat . 12/2/4: symptoms are improving slowly.
FEVER... IMMFLAMATION AT SIGHT OF INJECTION...RED BRUSING...SON SAID IT WAS PAINFUL
ERYTHEMA MULTIFORME RASH - GIVEN ORAL STEROIDS AND ZYRTEC.
The same evening of the vaccine I notice a large bump on my right ankle.   And a mass below my knee which is still visible today.  I was on vacation and I notified my cardiologist during a routine check, I discussed with 2 of my primary care Physicians.  The Pain in the ankle started that evening and still ongoing.  Today I am still experiencing pain in both legs, pain in both feet, toes, leg cramps, tingling, cramping and at night while sleeping numbness in both legs.