chrisvoncsefalvay/vaers-outcomes huggingface dataset:
just before I was due to get the 1st booster, I tested positive for Covid-19.; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (just before I was due to get the 1st booster, I tested positive for Covid-19.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (just before I was due to get the 1st booster, I tested positive for Covid-19.). At the time of the report, COVID-19 (just before I was due to get the 1st booster, I tested positive for Covid-19.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: (Positive) Positive.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Did AE cause patient to seek medical care (office visit, Urgent care, ER, hospitalized): Yes. No concomitant medications was reported. No treatment medications was reported.  Patient had medical history related to mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination.  Company comment: This spontaneous case concerns a patient of unknown age and gender, with underlying medical history of COVID-19, who experienced the unexpected, non-serious adverse event of special interest COVID-19, which occurred at an unknown interval after receiving the second dose of mRNA1273. Patient tested positive for COVID-19 on an unspecified date. Further details regarding the clinical course and treatment were not provided. The patient's underlying medical history of COVID-19 remain as a confounder in this case.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender, with underlying medical history of COVID-19, who experienced the unexpected, non-serious adverse event of special interest COVID-19, which occurred at an unknown interval after receiving the second dose of mRNA1273. Patient tested positive for COVID-19 on an unspecified date. Further details regarding the clinical course and treatment were not provided. The patient's underlying medical history of COVID-19 remain as a confounder in this case.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Starting 11/23/2021, I ended up getting an allergic reaction all over my body. I had hives and was extremely itchy from head to toe. I was away at the time. So, I saw my PCP a week after, and had bloodwork done and was prescribed Prednisone. My bloodwork came back with high levels of something, but unsure what it was. So, I was sent to see a rheumatologist on 12/23/2021, and he indicated I had no signs of an autoimmune disease. Then, referred me to a dermatologist, and when I saw him, they diagnosed me with hives and referred me to an allergist. I saw the allergist and he felt likely it was the booster vaccine, but not 100% sure. I am currently taking a high level of antihistamines, and am still having intermittent bouts of hives.
Pt began to have neck pain about ten days after her second covid shot.  This pain has continued despite PT, Naprosyn, pain consultant for now over 6 months.
Breakthrough case admission after 4 vaccines pfizer 5/2/21 lot# EW0168;  Pfizer 6/2/21 lot# Ew0183;  Pfizer 6/3/21 no lot#;  fizer 1/7/22 lot# 330368D
May 3rd, 2017 patient displayed a great deal of discomfort. He constantly cried and I was not able to calm him like I normally can by holding him or nursing him. I gave him TYLENOL and he went to sleep. May 5th, 2017 patient had a low fever off and on. He still had discomfort but was comforted by being held more. May 6th, 2017 patient continued to show discomfort and just wanted to be held, he was not interested in nursing. I noticed a pattern of movements. Small twitching from his legs to his arms, the rhythm caught my attention and I looked down at him and found a blank look on his face and his lips were blue. His eyes remained open staring as I tried to pat his back for him to breathe. My estimated time of the seizure is maybe a minute. Then his entire body went limp. While this was occurring I called 911 and took him to a neighbor who is a nurse. She was ready to begin CPR when she checked his vitals, then he started breathing on his own and color was returning to normal. He continued to be ?not all there?. The fire department and ambulance arrived, checked him and discovered he had a fever and his blood pressure was elevated. When we arrived to hospital, about 30-45 min later, he had a 103 fever and he cried for the first time after his seizure. They gave him TYLENOL and he slept. After getting discharged patient continued to sleep the rest of the day. I continued TYLENOL until 11 AM on May 7th. May 9th, 2017 patient had a follow-up Dr. appointment. He was doing much better at that time. Later in the day he started a rash all over his body. May 12th, 2017 patient started a fever again after not having one since May 7th. I gave him TYLENOL and took him to the ER, as directed.
client with mitral valve prolapse dx in "20's" has been asymptomatic X 2years. 6 mos ago dx with left ventricular hypertrophy ("mild") with echocardiogram.  Reports experiencing palpitations for approximately the past two weeks (vaccination date 2/25/03). Reports some SOB with the palpitations. Significant family hx: father died at age 45yo from MI. 48yo brother has had "triple bypass with 6 subsequent stent placements."
w/in 48hrs of vax in lt thigh pt devel an approx 7cm rxn @ the site of inj;site had induration & was warm to touch;pt shows no s/s of discomfort;tx w/amoxicillin, warm tub soaks, et APAP
Mild fever (+ 2 degrees over normal); Chills, Fatigue, Muscle aches - All lasted approximately 36 hours
Distinct redness at site of injection. Hives on face. Dad stated child had been breaking out in hives randomly for last few weeks and physician at last visit told parents to use Benadryl if needed. Dad stated they were waiting to hear back on recent allergy testing.
Faint, vaers reaction. BP: 118/72   PR: 68             SPO2:98% Room air Recorded by RN & Medic.
After the shot, she was shopping. About 10 min. later, she fell down with a case of wine. We call 911. She was bleeding from head. Head is swollen. She had flu shot here before without any problem.
Muscle thing under their arm; 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 LIMB DISCOMFORT (Muscle thing under their arm) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Muscle thing under their arm). At the time of the report, LIMB DISCOMFORT (Muscle thing under their arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Treatment medication was not provided by the reporter.   Reporter did not allow further contact
Report A0376618A describes leg cramping in a 64 year old male who received Lyme disease vaccine recombinant OspA for prophylaxis. This report was received from the subject and has not been verified by a physician or other healthcare professional. There was no reported medical history, concurrent conditions, or concurrent medications. In 2000, the subject reportedly received his first "intravenous" LYMErix injection. He stated that during mid-summer 2000, 12 hours post-immunization, and after flying to his vacation destination, he "was walking down the beach and noticed that his legs were cramping. The subject reported he needed to sit down due to the cramping which was described as "sudden and went away quickly." The subject did not continue the LYMErix immunization series. He indicated that his physician never informed him that the LYMErix immunization series consisted of three injections.
Initial misuse report received from a healthcare professional on 24 September 2013. A 02-year-old patient had received 0.5 ml FLUZONE. It's an over dose. No adverse event was reported. List of documents held by sender. none
Patient received DTAP< IPV and MMRV as part of his 4 year physical exam.  He remainedin the department for 30-45 minutes then left for home.  hortly after leaving he complained of difficulty breathing and Mom noted facial swelling.  he symptoms increased.  She came back to the hospital, to the clinic.  A nurse examined him upon arrival.  He was given Epinephrine and taken immediately to ED.  He was treated in the ED and observed until 9am this morning.  He was free of symptoms upon discharge.  Sent home on rapred, Benadryl and with EPI PEN.
I stayed at the facility for about ten minutes and didn?t have an issue. They wanted me to stay longer but a homeless person was coughing on me maliciously. I had an epipen and a cellphone with me and walked 3 or so blocks home. On the way home, I noticed my forearm was red and felt hot, though not the side that got the shot and I had a single hive. I thought maybe I had scratched myself. I came home, and my face was very flushed and my skin started burning and itching, mostly my scalp and face, but also my body. I had already taken Pepcid and Xyrtec for allergies I had in the early morning. I added Singulair and Benadryl. I would have called 911 if my breathing had been impaired but I was not asthmatic. The symptoms resolved by later that day after a few hours but I do not believe I will be getting another shot as allergies are often worse on second exposure. It was scary though considering I was already in strong allergy meds. I had some asthma later that night and the following day but not bad. Was very fatigued and dizzy all day.
Felt tired, after second vaccine; First and Second vaccines were administered 9 weeks apart.; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported for herself. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization and patient experienced felt sick, vertigo, dizziness. On an unspecified date, the patient felt tired, after second vaccine, first and second vaccines were administered 9 weeks apart. Outcome of the event was unknown. Information on lot/batch number has been requested.
Area raised and reddened and warm to touch 8:30 PM 12/11/03. Grandmother concerned 12/12/03 and called as induration approx 2 1/4" to 2 1/2". On 12/13/03 took child to ER. Seen by MD, CBC done. Stated infection and MD treated with antibiotic. Rocephin IM and Augmentin tsp every 8 hours.
Pt received FLUMIST on 12/2/15 and then on 12/4/15, woke up c//o eye pain (L eye) and was unable to see doctor optho exam WNL; no other s/s besides loss of color vision in L eye. Pt will be seeing opthalmology specialist on 12/14/15.
pain at injection site, fever, chills, anorexia, muscle aches, extreme exhaustion, productive cough
Sore arm, lump at injection site, headache, body ache, and muscle weakness.
Flu like symptoms including bad headache, joint pain, fatigue. Wasn't able to do anything today, and this is the first day. Not much relief after taking MOTRIN.
Went to stand up after 15 mins of observation. Felt flush, hot, dizzy. Heartrate was irregular per observation RN who was checking pulse. Went to ED, EKG and bloodwork normal. Patient released home.
Moderna - Booster; Headache, body ache, core body very cold, dry heaving, temperature went to 100.1 - lasted only about 12 hours; I was fine the next day.
No adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.).    No relevant concomitant medications were reported. Staff gave patients vaccines past the use date of 18 Jun 2023. On 26 Jun 2023, one dose was administered at administration site 1. No treatment medication reported.   This case was for the 2nd patient out of 47 reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Vaccine information reported and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master Case (Patient 1)
This initial spontaneous report was received from a lawyer regarding a case in litigation concerning an adult patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On or about 20-MAR-2015, according to the report, the patient was inoculated, in a store, with a dose of ZOSTAVAX as recommended for routine adult health maintenance and for the long-term prevention of shingles (strength, route, anatomical location, dose number, lot/batch # and expiration date were not reported). Later, in March 2015, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. Later, on or about 06-APR-2015, the patient sought subsequent treatment, by the same physician, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. The vaccine did not prevent shingles as intended, and subsequently contracted a persistent strain of herpes zoster or shingles (vaccination failure).  As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages (injury), and required extensive medical care and treatment. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering (emotional distress), and other damages (injury). At the time of reporting, the outcome of vaccination failure, herpes zoster, emotional distress, injury and pain was unknown. The reporter considered all the events to be related to ZOSTAVAX.
Had this flu shot was ok.  The next day was ok, the day after that had full blown flu symptoms.  Coughing, aching neck, back, foot, upset stomach, sore throat.  kept on sleeping.  Felt utterly horrible.  Called the doctor, he did not prescribe medicine. He said it just has to run it's course.  He said you probably got ill from the shot.  Still ill at this time.
Fatigue and moderate pain in the left arm later that day and night.  At 10:00 pm (approximately 10 hours after the injection) experienced extreme body heat, but temperature from oral thermometer was normal at 98.6 degrees.  Took 400mg Ibuprofen at bedtime (11:45 pm).  Got up at 1:45 am, could not sleep because of extreme body heat, oral thermometer temperature was 98.8 degrees.  Took 200 mg ibuprofen at 5:30 am and 400 mg at 11:45 am.  Approximately 26 hours after the injection, body heat was no longer a problem and only minor muscle pain in the left arm. Resumed normal activity 32 hours after the injection.  Note: First Shingrix dose was on 11/21/2019 with no side effects.
The patient received one dose of Menveo LOT: AMVA419A EXP: 10/2021 on 11/30/21. The prescriber was notified of the error. The patient's mother was also notified. The  patient's mother stated that no ADRs were experienced by the patient. No other S/S were noted.
Case number PHEH2013US018488 is an initial spontaneous report received from a physician on 28 AUG 2013. This report refers to an 18-years-old male patient. His medical history and concomitant medications were not reported. It was reported that he received two doses of MENVEO (batch number: A12004) intramuscularly on 06 JUN 2013 and on unknown date, within 2-months of each other. No adverse events were reported following the inadvertent administration.
Child received vaccinations on 09/02/04 in AM.  That evening child developed 101 degree temperature and complained of legs hurting. During the weekend of 09/04 & 09/05/04, child with complaints of legs hurting, stiff and sore joints and was unable to walk. Right arm on 09/02/04 evening where shots were given had large raised, red area. Seen LMD on 09/04/04 which he was placed on ATB for red arm.  09/07/04, mom reported child slowly getting better.
pt recv vax 17OCT97 & became feverish @ approx 3:30 100ax-fussy & irritable, inj site was red, swollen inc fifty cent piece;instructed to go ahead & given motrin;530PM fever to100.8;630PM 101.4ax;7PM 102.8ax;diarrhea, gas, rash;
Full body hives from 3 days after the second shot and continuous till now.  Especially bad at night and early mornings.  Received a cortisone injection on Friday 5/14/21 from Dr, and the hives have mostly (90%) cleared up.  There are small patches, but they usually disappear mid-morning.
Pain at the injection site for 3 days; 7 days after vaccination rash, itching and some pain around injection
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. On or about 22-OCT-2009, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 16-NOV-2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
SKIN BREAKDOWN (ON ARMS AND TORSO AREA AND LITTLE BIT REDNESS); LITTLE BIT OF REDNESS; This spontaneous report received from a patient concerned a 56 year old male. The patient's weight was 190 pounds, and height was 180 centimeters. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies, had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced skin breakdown (on arms and torso area and little bit redness). On 13-APR-2021, the subject experienced little bit of redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from skin breakdown (on arms and torso area and little bit redness), and the outcome of little bit of redness was not reported. This report was non-serious.
Patient presented to COVID vaccine clinic. Despite RN Manager writing ADULT PFIZER #1 on patient monitoring slip that was delivered to MA, MA administered COVID vaccine for children (ages 5-11) to patient. Patient should have received the adult dose of the vaccine. Error immediately discovered and mother counselled on error. MA also counselled on her error.
Patient is a 72 y.o. female who received the Janssen Covid vaccine Lot# 1805020 on 3/12/2021. The patient experienced the following reaction(s) during the immediate   of observation: Dizziness  Patient was treated/managed as follows:    Pt given gatorade and VS taken  0948: BP: 106/82 HR 76 O2: 96% 0958: BP: 122/82 HR: 78 O2: 97% Pt reports feeling better  Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted to car by RN.
Left leg venous thrombosis.  Presented as medial left leg pain one day after receiving her booster vaccine.
coughing; vomiting; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 23Mar2021 (lot number was not reported) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on an unspecified date in Mar2021, since she received the second dose of BNT162B2, she had been coughing and vomiting. The patient wanted to know if this reaction is still related to the vaccine. She also wanted to know how long the side effects would last. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
10/7/04: Dizzy getting out of bed. Held onto wall to walk. Could walk very slowly. Less dizzy when eyes closed: 6 A. By 11:30 AM, some improvement : still dizzy. Walking slowly. Resolved in 24 hours.