chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10/10 redness/warm around injection ~ 10 x 7 cm. Afebrile.
Really sick; COVID arm; chills; Tired; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Really sick), VACCINATION SITE REACTION (COVID arm), CHILLS (chills), FATIGUE (Tired) and PYREXIA (Fever) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 039K20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced ILLNESS (Really sick), VACCINATION SITE REACTION (COVID arm), CHILLS (chills), FATIGUE (Tired) and PYREXIA (Fever). In September 2021, ILLNESS (Really sick), VACCINATION SITE REACTION (COVID arm), CHILLS (chills), FATIGUE (Tired) and PYREXIA (Fever) had resolved.            No treatment medication was provided. No concomitant medication was provided.  The adverse events lasted a little over a day.   This case was linked to MOD-2021-373350 (Patient Link).
uvula swelled up; This spontaneous case was reported by a consumer and describes the occurrence of ENLARGED UVULA (uvula swelled up) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and PREDNISONE for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced ENLARGED UVULA (uvula swelled up). At the time of the report, ENLARGED UVULA (uvula swelled up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-114280 (Patient Link).
nausea; dragginess; tired; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date and experienced no side effects).   On 26th September 2019, the patient received the 2nd dose of Shingrix. On 27th September 2019, 1 days after receiving Shingrix, the patient experienced nausea, sluggishness and tiredness. On an unknown date, the outcome of the nausea, sluggishness and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the nausea, sluggishness and tiredness to be related to Shingrix.  Additional information received were as follows: The day before the reporting date, the patient received Shingrix. On the reporting date, the patient experienced nausea, dragginess or feeling tired. The reporter did not consent to follow-up. The outcome of events in source document does not match with the reported outcome of events.
blood clotting; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of THROMBOSIS (blood clotting) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clotting) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (blood clotting) 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.   No Treatment informations were reported.  Company comment: This case concerns an uknown age and gender patient with no medical history provided, who experienced the unexpected event of Thrombosis(seriousness criterion medically significant). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine).On an unknown date, the patient experienced THROMBOSIS (blood clotting).The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns an uknown age and gender patient with no medical history provided, who experienced the unexpected event of Thrombosis(seriousness criterion medically significant). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine).On an unknown date, the patient experienced THROMBOSIS (blood clotting).The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Second day after shot symptoms included: fever, severe headache, body aches, dizziness and nausea. I am still having headaches and it now 4 days after I have received the shot.
Case previously recorded as MA2009-3778. Initial case report received from a physician via Novartis Pharma on 04 NOV 2009. A 3-year-old patient was vaccinated with 0.5 mL of S-OIV FLUVIRIN (batch no. 1008136P) i.m., on 04 NOV 2009. MedCom reference no.: NA09-007589.
The patient has a history of COPD. She was seen in the ED and brought in by EMS on 6/27/23 with confusion and "talking nonsense", as reported by her family. Her family notes this has happened in the past when the patient gets sick. A COVID PCR test done in the ED resulted positive. Ultimately, she was admitted 6/27/23 - 6/29/23, with discharge diagnoses including acute metabolic encephalopathy due to COVID pneumonia, generalized weakness due to previously listed, and COPD exacerbation, among other diagnoses. Of note, she was received the primary COVID vaccine series and three boosters.
See attached document - "Patient" had reaction that occurred about five days after receiving Zostavax. She noticed some discomfort over her right eye and when she looked in the mirror she had swelling of the eyelid and above the brow. She denied any redness or rash in this area. The swelling, she reports was fairly significant but the eyelid was not completely shut. She placed ice and took Benadryl for this that evening and the following day and saw that is was improving. A couple days later she did break out with one papular lesion that has since crusted over located just adjacent to the nares on the right side. This is presumed to be reaction to the Zostavax vaccine and will be reported.
Less than 5 minutes after vaccine given - rash to bilateral thighs, within 10 min. swelling of hands and feet with mottling of hands, arms. No swelling of lips, no respiratory difficulty given BENADRYL, TYLENOL and dexamethasone.
Uncontrolable  itch and elephant type skin in mid section.  Trouble breathing..
THE DAY I GOT THE SHOT LATER IN THE AFTERNOON I FELT COLD BUT DIDN'T FEEL BAD. NEXT MORNING I WORK UP FEELING EXTREMLY COLD, BAD HEADACHE, COULD GET WARM, SLEPT ALL DAY. NEXT DAY FELT A LITTLE BETTER AND BY NOON FELT BACK TO MYSELF. I DON'T KNOW WHEN BUT IT WAS MUCH AFTER THE 2ND DOSE VACCINE THAT I WASN'T FEELING WELL, EVERY ONCE IN A WHILE MY ASTHMA KICKS IN AND I HAVE TO GET STEROIDS OR NEBULIZER.  I WENT TO THE ER  BECAUSE I WAS HAVING AN ASTHMA ATTACK AND THEY GAVE ME THE NEUBLIZER. IT SEEMS I HAVE TO HAVE MORE PREDNISONE MORE THAT I USUALLY HAVE TO GET PRIOR TO THE VACCINE BUT I ATTRIBUTED IT TO HAVING TO WEAR A MASK ALL THE TIME BECAUSE I WORK AT A HOSPITAL.
HYPOTENSION 1/5/2022  -- RECURRENCE OF SAME SYMPTOMS
On day 7 after my first dose, I became itchy all over my body and had a full body rash.  It continued to get worse.  Five days after the reaction, I went to my doctor.  She put me on steroids.  It took 6 days of steroids to make the rash subside.
Patient got diagnosed with COVID after first shot; Patient missed the recommended interval between two doses; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Patient got diagnosed with COVID after first shot) and PRODUCT DOSE OMISSION ISSUE (Patient missed the recommended interval between two doses) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Patient got diagnosed with COVID after first shot) and PRODUCT DOSE OMISSION ISSUE (Patient missed the recommended interval between two doses). At the time of the report, SARS-COV-2 TEST POSITIVE (Patient got diagnosed with COVID after first shot) and PRODUCT DOSE OMISSION ISSUE (Patient missed the recommended interval between two doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had received Monoclonal antibodies & had to wait for 90 days for the second shot.  No concomitant medication information was provided.   No treatment information was given.
Pfizer COVID Vaccine EUA: Formulation/Dosage Error. Patient received Pfizer vaccines on 2/12/2022 and 3/5/2022. The product provided on 3/5/2022 was 0.3 ml of the adult formulation.
12APR96 9:45 mom called clinic concerned w/pt lethargy;mom states pt has been very sleepy & diff to arouse since shots yesterday & cannot get pt to wake up enough to breast feed;mom states pt is sl warm, but had been giving pt APAP;
My cycle will not go off. It has been 26 days and it is a continuous flow. I received my first shot May 12, 2021 and that was the same day my cycle started.
Patient called clinic and states that he awoke during the night with a fever of 101 and chills. He took some Motrin and went back to bed. He woke up this morning with a temp of 102.7. He then took some more Motrin and used a cold cloth to lower fever. As of now patient is monitorting temp. at home with last reading (0745a.m. 08/12/2015) being 100.7, blood pressure of 136/68 and pulse of 91. Member further stated that the chills he had have dissipated. This is patient's 7th Anthrax shot and he has no hx of adverse reactions or effects. Patient denies any reaction at the site or hives, shortness of breath, dizziness or tachycardia. I told patient that his symptoms are consider less common with this particular vaccine and that it should resolve in less than a week and if symptoms persist or worsen to seek medical care/treatment.
HISTORY OF PRESENT ILLNESS:  The patient is a 71-year-old male patient with a complex medical history with multiple problems and cancers and debilities.  He received a second dose of COVID vaccine yesterday about midday.  Shortly thereafter, he started having shivers and shakes.  The concern that I had when he called the office was a possible bacteremia.  He was sensitive emergency room for evaluation.  He was noting that he was chilled and was unable to get warm. He said his temperature was up to 100.5.  He had generalized weakness and inability to get up and walk and had malaise.  He has no known exposures to pneumonia or other illnesses.  He has basically been homebound for the past year with the COVID.  He was evaluated in the emergency room and found to have an elevated white blood cell count on the right upper lobe pneumonia on portable chest x-ray.  Blood cultures and urine culture were obtained since he had a urine abnormality as well.  The patient was admitted to observation while we wait on cultures and we treat the pneumonia with antibiotics.
Her stomach is still weirded out/sour stomach; feeling sick; arm pain; She was sick to her stomach; kidneys were hurting; body aches; tested positive; tested positive; The arm wasn't swollen it was just burning.; This is a spontaneous report from a contactable consumer (patient).  A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284) via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization.  Medical history was none.  The patient's concomitant medications were not reported.  At first, she thought she was having a reaction, but then she started feeling sick so she got tested. She was positive so she wasn't having a reaction. She was scared from the pain of COVID. She experienced sickness. Her stomach was still weirded out. She did experience arm pain from the vaccine. Her doctor told her it was fine that it needed to air out. She left the bandage on too long.  She didn't have a prescribing doctor. She received the vaccine on the 29Dec2020. She tested positive 02Jan2020. The arm wasn't swollen it was just burning. She was sick to her stomach when she got the stomach. The sick to the stomach lasted maybe two days, but then she got COVID. The burning was around the arm. It wasn't that bad. It lasted for a day. It started the day she got the shot (on the 29Dec2020). On 07Jan2021, she went to the hospital because her kidneys were hurting. The doctor said her kidneys were good. They did labs which were good. She was still going through body aches. She was told she was currently in the worst part of the virus. She still had a sour stomach going on from the virus as well. The outcome of the body aches and sour stomach was not recovered, for other events was unknown.
pain on my right arm for about 48 hours after the first shot, slighthty pain on my right arm for about 12 hrs after the 2 shot.
A couple days after receiving the Moderna booster I began to experience tachycardia while lying down, sitting, and standing. Symptoms initially included only elevated heart rates (140-180 while standing up to go to the bathroom and 80-120 lying down). Symptoms continued to worsen and by Dec 10, symptoms progressed to include extreme fatigue, loss of appetite, nausea, palpitations, dizziness, difficulty breathing, and inability to perform basic tasks like walking to the kitchen/bathroom, cooking food, or standing for more than a couple seconds. Went to the ER twice and was seen for tachycardia the first time on Dec 13 and second time on Dec 15th. Have been treating with high fluid intake, high salt intake, beta blockers, and bed rest. Symptoms persist and are modestly improved with treatment but still unable to before basic functions and continue to experience extremely elevated heart rates.
Excessive swelling from top of shoulder to right above elbow. Affected shoulder/upper arm area is about twice as big as non-vaccinated arm/shoulder. Affected arm has a large, hard, and hot red mark extending the width of upper arm. The mark extends to downward and stops right above his elbow measuring approximately 6 inches long. Fever began approximately 2:00 on 1/19/2020 of 101.4.
VanishPoint syringe malfunctioned while in patient's arm and vaccine squirted out of syringe and not into patient's arm. RN notified manager who gave guidance to revaccinate based on CDC recommendations.
Patient arrived to clinic today reporting adverse reaction to Moderna COVID vaccine received on 12/30/20.  She states she experienced pain immediately after injection, and small amount of localized redness and swelling.   She reports hx similar reaction to a previous vaccine approximately 5-6 years ago although this is not well documented.   She arrived to clinic today to report this reaction and states she continues to have localized redness and swelling.   Today is Day 8 after vaccine.  Upon inspection, patient has area of redness and edema approximately 3 x 4 inches in size, slightly below right deltoid.  She reports self treating at home with Tylenol and Benedryl topical cream and experienced temporary relief.   Denies SOB, hives, nausea/vomiting, itching, rash, fever, headaches, or any other symptoms.  Advised patient speak with PCP today regarding treatment for localized reaction as well as advice regarding receiving the second dose of vaccine.  Patient agreed with plan and verbalized her understanding.  She will contact her PCP and if not available will utilize virtual urgent care via the app.
passed out without warning  around 10pm. woke up on floor. couldn't move right leg. slept on floor all night.
New and different headaches and dizziness; New and different headaches and dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Lot number: FC3181) at the age of 15 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mild asthma" (unspecified if ongoing); "history of migraines" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE; LORATADINE; TERBINAFINE; ACETAMINOPHEN. Vaccination history included: Bnt162b2 (lot number: FA7485, dose 1, single, vaccine location: Left arm), when the patient was 15 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), DIZZINESS (non-serious) all with onset 04Sep2021, outcome "not recovered" and all described as "New and different headaches and dizziness". Therapeutic measures were not taken as a result of headache, dizziness.  Additional information: No other vaccines in four weeks, other medications in two weeks and no COVID prior vaccination: no and If COVID tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: immediately after first dose pt head started to lower, eyes closed, slid down in chair. respiratory rate decreased for several seconds then panic breathing occured thereafter. pt was sweating profusely and skin was cold and clammy. could not verbally respond for 30-45 seconds. after a minute pt could talk and answer question. blood pressure was taken 3 different times 5 minutes apart 75/43, 87/46, 93/52. Pt was feeling fine a half hour later and was called 4 hours later to follow up.
FETAL EXPOSURE DURING PREGNANCY; FETAL ABNORMALITIES; This solicited pregnancy report received from a consumer concerned a fetus of unspecified sex, race and ethnic origin. The patient was enrolled in a non-company sponsored study. The patient's height, and weight were not reported. No concurrent conditions were reported. The patient's parent's medical history: the mother of baby had no medical history, her obstetrical history included two previous pregnancies that resulted in one live newborn (outcome of the second pregnancy was not reported). She did not use drugs for recreational use, tobacco, or alcoholic beverages during pregnancy. Her last menstrual period (LMP) was calculated to be 09-NOV-2020. The estimated delivery date (EDD) was reported unknown and the type of pregnancy was singleton. On 01-Jun-2021, gestational age was 29 weeks and 1 day. The patient initiated treatment with Covid-19 vaccine ad26.cov2.s (suspension for injection, transplacental, and batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 01-JUN-2021 for prevention of covid-19. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included prenatal vitamins (ascorbic acid/biotin/minerals nos/nicotinic acid/retinol/tocopherol/vitamin b nos/vitamin d nos) for unknown indication. On an unspecified date in JUN-2021, the patient experienced fetal abnormalities. Laboratory data included: Ultrasound scan (NR: not provided) Fetal abnormalities were detected. On 01-JUN-2021, the patient had fetal exposure during pregnancy. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fetal abnormalities and fetal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and fetal abnormalities was related, and between covid-19 vaccine ad26.cov2.s, and fetal exposure during pregnancy was not related.  This report was serious (Congenital Anomaly/Birth Defect, and Other Medically Important Condition). This parent/child case is linked to 20210760453.; Sender's Comments: V0-20211106577- covid-19 vaccine ad26.cov2.s- Fetal exposure during pregnancy. 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   20211106577- covid-19 vaccine ad26.cov2.s  Fetal abnormalities. This event(s) is considered related. 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).
Syncope with possible seizure-like activity immediately following vaccine administration. Patient was observed, and transported to the ED by EMS.
Severe full body aches, severe headaches, 103.6 temp for at least 12 hours, severe fatigue. Patient has a better temp after 24 hrs from shot but still has the other symptoms.
This spontaneous report as received from a medical assistant refers to a multiple, unspecified number of patients of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of GARDASIL (lot # K008931, exp. date: 04-MAR-2017) (dose number and route were not reported). The doses of GARDASIL were stored in 11.4 Celsius degree for 1 hour and 14 minutes. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
metallic taste in mouth, lip numbness, injection site pain, tingling in fingers, neck pain or strain Narrative: RN asked to assess patient in post vaccination observation area. Patient c/o metallic taste in mouth, lip numbness, left upper arm pain (injection site), left fingers tingling, neck (trapezius muscle) pain or strain. Denies SOB, chest pain, difficulty breathing or swallowing, drinking fluids without difficulty. Denies air hunger or throat swelling, no rash observed or itching. Alert and oriented. Skin pink warm and dry. Symptoms subsided at 9:20. Attending provider plans to contact patient to discuss second vaccine dose. Patient declined further work up in ER. At 9:45 denies metallic taste or lip numbness. States "maybe I am overthinking this, I am feeling better." No neck or finger issues, slight tenderness at injection site, no rash, SOB, throat swelling or chest pain. Discharged to home at 9:50 in stable condition.