chrisvoncsefalvay/vaers-outcomes huggingface dataset:
burning sensation throughout entire body; This spontaneous case was reported by a pharmacist and describes the occurrence of BURNING SENSATION (burning sensation throughout entire body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced BURNING SENSATION (burning sensation throughout entire body). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (burning sensation throughout entire body) 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 included unspecified high blood pressure medicines.
This spontaneous report was received from a physician, and refers to a 4 month old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-JAN-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # M043836, expiration date 17-JUN-2018 (dose and anatomical location of administration were not reported). On 22-JAN-2018, the patient received other dose. Subsequently, the patient experienced runny nose and fever and went to the emergency room but he was not admitted to hospital; the physician believed that these events were not related to ROTATEQ. The administered dose of vaccine experienced the temperature excursion of below 32 F for 9 hours 6 minutes, 32 degrees Fahrenheit up to 35 degrees Fahrenheit in 19 hours 11 minutes. The outcome of the events and the relatedness between the events and ROTATEQ were not reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1802USA004843.
Pain in joints, abdominal cramps, abdominal pain, acid reflux, high cholesterol, bronchitis, anxiety, arthralgia, loss of concentration, arthritis, conjunctivitis, constipation, cough, dizzy spells, leg cramps, high blood pressure
ROBUST TAKE.  Fevers, (temp 103.1) chills, headache, malaise, myalgia, nausea, local stiffness, induration, tenderness, 10 x 28 cm erythema at vaccine site c 1 cm Jennerian pustule.  Lost a day of work.
Fever up to 103F developed approx 5 days after vaccine administered. Myalgias and arthralgias started 2-3 days after injection.
Woozy; Upset stomach; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Woozy), ABDOMINAL DISCOMFORT (Upset stomach) and VACCINATION SITE PAIN (Arm pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced DIZZINESS (Woozy), ABDOMINAL DISCOMFORT (Upset stomach) and VACCINATION SITE PAIN (Arm pain). On 29-Jan-2021, VACCINATION SITE PAIN (Arm pain) had resolved. At the time of the report, DIZZINESS (Woozy) and ABDOMINAL DISCOMFORT (Upset stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Developed pernio, digital ischemia, ulceration & tissue sloughing 2- 4 weeks after receiving vaccine.
Face swelling; whole bodyTrembling / Legs shaking; Teeth hurting; Achy / So achy even his hair aches; Itching at injection site; Constant headache; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face swelling), TREMOR (whole bodyTrembling / Legs shaking), TOOTHACHE (Teeth hurting), PAIN (Achy / So achy even his hair aches) and VACCINATION SITE PRURITUS (Itching at injection site) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Face swelling), TREMOR (whole bodyTrembling / Legs shaking), TOOTHACHE (Teeth hurting), PAIN (Achy / So achy even his hair aches), VACCINATION SITE PRURITUS (Itching at injection site), HEADACHE (Constant headache), NAUSEA (Nausea) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, SWELLING FACE (Face swelling), TREMOR (whole bodyTrembling / Legs shaking), TOOTHACHE (Teeth hurting), PAIN (Achy / So achy even his hair aches), VACCINATION SITE PRURITUS (Itching at injection site), HEADACHE (Constant headache), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
When I got the shot I immediately got extremely tired witch us normal I belive but a few hours later at 4:30 ish I was swimming bc I felt okay and my heart started pounding more then normal when I'm swimming so we leave and go home my heart was still pounding 2 hours later and now my chest is tight and I'll randomly gasp for air its been I belive 2 days after the vaccine and my heart is still pounding and the gasping for air has not stopped the gasping is a random thing so uts not a continuous cooking feeling just every now and then the heart pounding though has been continuous qnd the night after the shot I had gotten worked up on top of the heart pounding qnd thought I was about to have a heart attack I calmed down and have yet to go to a hospital bc its only really bad when I'm walking or getting worked up if it does not pass by Thursday I will be seeing a doctor
this is 1 of 2 pt @ this site to devel a rash on the dorsal surface of both hands 1.5 wk p/vax;the rash consists blisters & pustules & the area bruised p/scratching;
pt started to exp difficulty breathing, labored breathing, became still, pale, wouldn't respond, eyes stared, around lids under eyes became purple;breathing according to nurse was retracted;taken to ER;MD states nasal passages swollen;
Chills 7:45pm to 10:00pm, fever started at 99.1 8:00 pm peaked at 102 by midnight. nausea, joint aches, tachycardia 135b/min.  Took advil and fever came down sometime during night to 100. Injection site warm to touch and lump present.  Fever, malaise, joint aches (particularly lower back and hands), nausea all next day until about 5pm, when fever finally broke.  Woke with headache the next morning 2/12/21. stabbing headache above right eye.  Lasted all day, did not medicate until evening and responded to excedrin migraine med.  Back and hand aches continued for remainder of day.  Headache returned 2/13/21 evening and took excedrin migraine again and headache responded and did not return.   Injection site had red wheel with indurated center, soreness and itchy beginning on 2/11/21. Soreness and red wheel resolved by 2/13/21 but itchiness lasted until 2/15/21.
VERY SICK; VACCINE IS NOT EFFECTIVE AGAINST THE VARIANT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced very sick, and vaccine is not effective against the variant. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the very sick and vaccine is not effective against the variant was not reported. This report was non-serious.
I have been experiencing chills right after my second shot on March 17th at 8:20 am.  Fifteen days so far,  Today is April 1st.
Mother of child called stated child was running a fever of 101.4, 102F in the afternoon of shot day. Child was crying all night and had swollen thighs. Advised mother to give Tylenol and bathe the baby and bring to the Dr if get worse. Advised mother to observe the childs temp and recheck.
CHRONIC DIFFUSE PAIN OF ENTIRE LEFT DELTOID WITH RADIATING QUALITIES. PAIN IS DAILY AND HAS NOT IMPROVED SINCE INJECTION DATE. PAIN IS WORSE WITH ACTIVITIES THAT CONTRACT THE DELTOID MUSCLE.
Full body dermatitis (rash and itching) (5day). Pt prescribed prednisone oral and topical CETAPHIL. ATARAX for itching.
w/in 10min of vax pt started w/cough & diff breathing;pt given DPh;pt then had sore throat & laryngitis lasting approx 4hr;pt described burning pain down arm;
This case meets criteria for vaccine breakthrough review - had booster 11/15/2021.  Sx include 1 week of increasing SOB, cough, subjective fever.
Employee received 1 ml of Hepatitis B vaccine with a 1 1/2 inch syringe/needle. She reported that 1 day post vaccination she experienced some swelling at the same site. It came to a head in the center and reportedly drained a clear opaque "whitish" liquid x 2 days. The area was non tender, non erythematous but area around injection was slightly hardened. No temp was taken - Also reports area around injection was darkened no sign of infection noted.
She fainted twice (back-to-back) while dressing for school in the morning- less than 3 days after  receiving the vaccines.   She also received the dtap vaccine at the same time, but I am not sure who the manufacturer was.  There were no explainable obvious reasons for her fainting.   She had never experienced syncope before.   She lost consciousness and fell, hitting her face resulting in bruises.   She was taken to the emergency room.
This is an instance of breakthorugh COVID-19 disease after which death occurred.   The individual (who was a resident of an assisted living facility) was vaccinated with the Moderna product on 01/13/2021, 02/10/2021, and 11/08/2021. It is not specifically known if they experienced any symptoms, but tested positive for COVID-19 via antigen test on 01/19/2022. They died on 01/26/2022. Complications of COVID-19 are listed in Part I of the Death Certificate.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Apr2023 as dose 3 (booster), single (Lot number: GL2042) at the age of 76 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: Other medical history: No. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Negative, notes: Days 10 & 11 post treatment tested negative; (Sep2023) Positive, notes: Day 7 post treatment tested positive; (21Sep2023) Negative, notes: Covid 19 tested negative two days after completing Paxlovid/Day 12 symptoms gone. Therapeutic measures were taken as a result of drug ineffective, covid-19: treatment with Paxlovid from 14Sep2023 to 19Sep2023.
Fluvirin Vaccine - administered at 1045am left deltoid. 1230pm S/S left arm weak, nausea, diaphoresis, arm sore, SOB, fine rash at chest and pruritis and on neck. Presented back to clinic at 12:45
with in  20 min. i was feeling almost like i had been drinking, a little sore throat, then the chills started to set in. By the evening i was exhausted and feeling like crap muscle aches set in in the early morning hours and all day the following day between 12-24 hrs i felt horrible arm was swollen and very red and painful and hot at the injection site. Hands and feet started to swell to the point my wedding ring didn't fit, chills and fever started to set in massive excruciating muscle pains in my biceps, and quads.  Fever was 101.2 as the highest, coughing and lethargic, extreme exhaustion. at 48 hrs everything was still the same. and then by wednesday i started to get a strange rash and such bad itching all over the injection site which is still hurting pretty bad and sooo itchy. rash on my back left thigh and  hives on the left arm/ wrist . i was unable to go to work since Monday 12/6/2021 till 12/9/2021 and even then it is very hard to work when my arm is very painful to touch or even the rubbing of my shirt on it. i'm itchy all over my body and I have tried to take Benadryl for the allergic reaction but it only works for  a little while
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Systemic: Chills-Medium, Additional Details: Pt states she has asthma and is experiencing SOB, cough, "can't catch her breath", congestion, hot/chills at the same time, and is constantly clearing her throat. She has a bruise at injectino site about 6"X3".
Around 1 am 10/17/18 (within 12 hours of vaccine) I had fever, violent shivers, sweating. I was unable to verify my temperature due to worry of biting the thermometer. Upon rising in the morning, I was very dizzy. Fever was still present but  shivering had subsided. I was in bed the remainder of day feeling very sore muscles (flu like  symptoms but without vomiting or diarrhea). Thursday, again, very sore muscles, dizzy, sweating, very hard to control my body temperature (no-I am not going thru menopause :)). Friday, soreness is gone, sweating still happening and body temp still hard to manage. Still very dizzy. Getting  lots of rest as standing/walking brings on dizziness. Today, Saturday, feeling almost normal but very dizzy still, like I've place the wrong prescription glasses on.
Ceased having BMs.  Called on Monday and Dr told me to try suppository.  After 8 hrs, patient had BM.  Waited another 4 days and had to use another suppository for BM.  After another 4 days, called and Dr told me to add Karo syrup to bottle on 4 and 5th day after no BM.  Patient had restless sleep/naps, arching of the back and thrashing.  Has since been diagnosed with silent reflux.  Mother tried homeopathic remedy (Nat Phos and arnica) and after 5 days reflux stopped and BMs were 2 times per day.  Stopped Nat Phos and arnica and reflux did not come back and BMs continued.  Had Hib and Prevnar shots and BMs ceased again. Put on Axid and Lactulose by Pedi and GI specialist.  After DTap and Rotovirus vaccines again, BMs ceased again and had to use multiple suppositories and doubled lactulose for patient to have BMs. Pedi recommended no more vaccines until child is older.
COVID-19 Moderna Vaccine Patient received 2nd dose of Moderna COVID-19 vaccine on 2/15/2021 and developed urticaria the next day.  Patient has a history of multiple allergic reactions, came to ED for evaluation of generalized hives after vaccine.  Patient denies angioedema, throat swelling, SOB, voice change, difficulty swallowing, fever, chills, chest pain, chest tightness, nausea or vomiting. Patient given famotidine 20 mg, hydroxyzine 50 mg and then discharged at 3:13 am on 2/16/2021
Became Dizzy and was acessed by Nursing staff.  B/P 180\100  p-59 , O2 sat 98%.  Became diaphoretic.  No difficulty breathing no itching.  A&O.  1:17pm B/p 150/90 p-121 O2 sat 100%.  Continued to remain in clinic.  Released at 1:30pm
I got up in the morning and I felt like was getting a chest cold. I had mucous and coughing. I felt stuffy in my chest but not in my head. I was coughing up mucous. I didn't know if I had COVID-19 yet but my wife was positive prior. I test negative on December 30th, 2022 but then tested positive on December 31st, 2022. I had a headache and a fever so I took some ADVIL. I was given a prescription for PAXLOVID tablets that I filled at a pharmacy.
4/10/21: Fatigue, headache, body aches, chills 4/11/21: Fatigue, headache, body aches, chills, fever (101-102) 4/12/21: Fatigue, woozy 4/13/21: No symptoms
Cold sores came on the right side of my mouth with first shot. The second shot resulted with cold sores on both sides of my mouth. Second shot resulted in having fog brain. Noticed second guessing myself when driving,  making decisions and a slight headache.
felt tired a day after receiving the Moderna Covid-19 vaccine.; painful injection site.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired a day after receiving the Moderna Covid-19 vaccine.) and VACCINATION SITE PAIN (painful injection site.) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced FATIGUE (felt tired a day after receiving the Moderna Covid-19 vaccine.) and VACCINATION SITE PAIN (painful injection site.). At the time of the report, FATIGUE (felt tired a day after receiving the Moderna Covid-19 vaccine.) and VACCINATION SITE PAIN (painful injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. The patient received his first vaccine in his left arm shoulder deltoid muscle. No treatment information was provided by the reporter.   This case was linked to MOD-2022-543480, MOD-2022-543477 (Patient Link).
Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster).    No concomitant product reported by reporter.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.  It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  No treatment medication reported by reporter.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Master case
Initial report received from a health care professional on 07 April 2011. A 5-year-old patient received the following vaccinations on 05 April 2011: an intramuscular left thigh injection (dose 5) of DAPTACEL, lot number C3718AA, an intramuscular left thigh injection of IPOL (dose 4), sanofi pasteur SA lot number E0330, an intramuscular right thigh injection (dose 2) of VAQTA, Merck lot number 0039AA, and a subcutaneous thigh injection (dose 2)of PROQUAD, Merck lot number 1440Z. The patient had no medical history, no known allergies and no concomitant medications. The patient had no illness at the time of vaccination and no other vaccinations within 4 weeks of the recent vaccines. The patient had no adverse events following prior vaccination. On 06 April 2011, the patient developed within 24 hours, left thigh swelling twice the normal size. The mother removed the band aid and noticed a blister, the size of a nickel, at the site of immunization on the left thigh with clear white liquid. The patient was seen by a doctor. The outcome was reported as not recovered. Follow-up information was received 22 June 2011 from a health care professional. PROQUAD had been administered subcutaneously in the patient's right thigh. On 07 April 2011, the patient was seen by their physician and was released. It was not reported if the patient had received any corrective treatments. According to the reporter, the blister had been looking better the next few days after vaccination. An updated recovery status was not provided at the time of the report. Documents held by sender: None.
COVID Pneumonia.  HPI  Patient was in  Rehab. Had wheezing and desaturating to 86% Stat CXR reveal b/l infiltrate. Patient noted to be lethargic. Decision made- sent to ER Upon evaluation noted COVID Ag positive.
This case was reported by a physician via call center representative and described the occurrence of itchy rash in a 84-year-old female patient who received SHINGRIX for prophylaxis. On 21st November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced itchy rash and pruritus. On an unknown date, the outcome of the itchy rash and pruritus were recovered/resolved. It was unknown if the reporter considered the itchy rash and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. The patient developed a slightly itchy purpuric rash a few days after receiving SHINGRIX. The patient was seen in the office 8 days after vaccination for another reason and informed the physician about the rash on the vaccinated arm. Nothing was prescribed. This dose of SHINGRIX was not administered at the reporter's office and further details were not available. The reporter gave consent to follow up.
Patient received immunizations. Immediately had a witnessed convulsion and then passed out for approximately 45 minutes (post-ictal state).