chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 13 hours of the shot, I ran a fever of 100.6 which lasted 12 hours. I had a severe headache that night, and my joints (knuckles, elbows) were swollen and inflamed, very achy for 36 hours. My arm was swollen at the injection site and was VERY sore, but I expected that.
Patient was administered her 2nd dose of Gardasil on 5/21/07. After 10 minutes the patient was exiting the office and experienced syncope.
Child was in to get vaccines, waited approx 10 minutes after receiving the vaccines and was walking out when he became light headed and lowered to the floor, did not lose consciousness, when asked if he had anything to eat or drink today he replied "No" Patient was given a juice box, dad kept saying, " he will be ok" Patient set with back up against a wall while drinking juice box, regained color and feeling better within five minutes.  After watching for approx 5 more minutes, he walked to his car, where father was driving.
Gland swelling; Headache; body ache; fatigue; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 29Jan2021 (Lot number: EL8982) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma", start date: 1985 (ongoing). Concomitant medication(s) included: PROZAC, start date: 2017 (ongoing); ALBUTEROL [SALBUTAMOL], start date: 1985 (ongoing); WIXELA INHUB, start date: 1990 (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Lot Number: EL1284, Intramuscular, Deltoid, left arm, Time: 20:15), administration date: 11Jan2021, when the patient was 38 years old, for COVID-19 immunisation, reaction(s): "Gland Swelling in neck and clavicle". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 29Jan2021, outcome "recovered", described as "Gland swelling"; HEADACHE (non-serious) with onset 29Jan2021, outcome "recovered", described as "Headache"; PAIN (non-serious) with onset 29Jan2021, outcome "recovered", described as "body ache"; FATIGUE (non-serious) with onset 29Jan2021, outcome "recovered", described as "fatigue"; NAUSEA (non-serious) with onset 29Jan2021, outcome "recovered", described as "nausea". Therapeutic measures were not taken as a result of lymphadenopathy, headache, pain, fatigue, nausea.  Additional information: However, it was also reported that onset of events was 28Jan2021 (Pending clarification). Events did not result to hospital admission, physician office visit and emergency room visit.  No follow-up attempts are possible. No further information is expected.
TRANSIENT ISCHAEMIC ATTACK; CONFIRMED CLINICAL VACCINATION FAILURE; COVID-19; SARS-COV-2 TEST POSITIVE; MALAISE; This spontaneous report received from a health care professional by a Regulatory Authority (VAERS FDA, US-VAERS-1944320-OGNM-20211224160546) on 24-DEC-2021 and concerned a 58 year old male of unknown race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 2 diabetes, obesity, and nephrolithiasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025 expiry: UNKNOWN) dose was not reported, 1 total administered on 18-MAR-2021 for an unspecified indication (Dose number in series 1). Drug start period was 265 days. No concomitant medications were reported.  On 08-DEC-2021, the patient experienced symptoms of transient ischaemic attack, confirmed clinical vaccination failure, covid-19 , sars-cov-2 (Severe acute respiratory syndrome coronavirus 2)test positive, malaise, and was hospitalized (date unspecified). Laboratory data included: SARS-CoV-2 test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the malaise, sars-cov-2 test positive, transient ischaemic attack, covid-19 and confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000208902. The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related based on the PQC evaluation/investigation performed.  Additional information was received from Central Complaint Vigilance on 22-FEB-2022. The following information was updated and incorporated into the case narrative: product quality complaint investigation result was added.; Sender's Comments: V1:This version is created to update the information regarding Product quality complaint investigation result  was added, This updated information does not change the causality of the previously reported events. 20211255599-covid-19 vaccine ad26.cov2.s- transient ischaemic attack, covid-19, sars-cov-2 test positive, malaise. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211255599-covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination failure . This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
fatigue, headache, fever, chills Narrative:  Took OTC Tylenol/Motrin  Other Relevant History:
Left upper arm became swollen, red, warm, and hard to touch from the shoulder to 1 inch above the elbow approx. 30 hours after receiving vaccination at the site.
rash on legs; welts on legs; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on legs) and URTICARIA (welts on legs) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced RASH (rash on legs) and URTICARIA (welts on legs). The patient was treated with PREDNISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (rash on legs) and URTICARIA (welts on legs) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Received Boostrix in the left deltoid 530 pm on 12/27/06, other twenty minutes later she started shaking. She was unconscious for a couple of minutes while jerking. Immediately prior to this she noticed pain in her right arm.
Side effects: Elevated  blood pressure 208/96 & 204/94.  Dizziness. Headache/heaviness in the head.  Treatment: Went to emergency room on 1/3/2021. Increased blood pressure medication (DILTIAZEM) to 300mg  and added another one (HYDRALAZINE) 25mg 3 times a day. Which my primary physician increased to 4 times a day,.   Outcome: Lower blood pressure with occasional spikes to the borderline.
Full body ache, headache, swolen glands. Took ibouprofen and it took some of the edge off. Starting to feel better after 24 hours from the vaccine
After receiving the 2nd dose of COVID vaccine become very tired, exhausted, low energy and soreness in the left arm, even a month later.
Information has been received from a physician concerning a male patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # 657526/0555U). Subsequently, the patient experienced "huge induration on his deltoid and also erythema". The patient sought unspecified medical attention. On an unspecified date, the patient recovered. Follow up information has been received from a physician on 07-APR-2009. It was reported that the 26 year old male patient with pneumonia at the time of vaccination, who on 15-DEC-2008 was vaccinated in the right deltoid with one dose of PNEUMOVAX 23 (Lot # 657526/0555U) at 4:00 p.m. On 16-DEC-2008, in the afternoon, the patient experienced significant deltoid swelling, pain, redness and induration. Local reaction at site of injection was more than normally seen with immunization. There was no other rash, no airway obstruction. Subsequently, the patient recovered. This is one of two cases from the same source. Additional information is not expected.
Hives across hands, arms and stomach for two weeks.  Day of vaccine, increased heart rate and temporary difficulty breathing. 24 hours later, flushed face, difficult breathing. Two weeks of sever muscle spasms and muscle twitching through legs, arms and back
The patient did not have a reaction to the Pfizer vaccine, the patient received a third dose(booster) of Pfizer. The patient should not have receive a third dose of the vaccine because she is not 16+ years.
3JUN91 mom phoned stated child inc temp (not taken); child vomiting; Given APAP; Referral to ER
Initially I had arm pain, as expected later in the evening on day of shot.  I iced and took Tylenol as advised by staff at health department.  Saturday morning I woke to nausea, lightheadedness and increased arm pain.  I pushed fluid intake, rested off and on all day, took Tylenol as needed.  Sunday morning felt tired, but other symptoms were better so went about the day.  Sunday afternoon I noticed my joints started hurting, and chills set in.  By Monday morning every joint in my body hurt, and not just an ache - because all of my muscles were aching as well - but my toes, ankles, knees, elbows, hips felt like they had been hammered and were throbbing.  I've been taking Tylenol, resting, fluids as tolerated and three days from onset it's still hanging on.  I've never experienced joint pain like this in my life ...
Vaccinator did not successfully make a weal. Vaccine given on other arm. Weal successful.
I ended up feeling slightly sick with sore arm about 30ish hours after and I thought that was it. .  About 3 days later I ended up having very severe symptoms that landed me in the E.R. 3 times in one week and stayed in the hospital for a few nights.   I truly did not know if I would be making it home.  I did have a sinus infection prior to this but was cleared to get the vaccine from my DR.  I had all the side effects  I couldn't walk very dizzy ringing in ears, (heightened my VM symptoms) fevers as high as 104.7 So lethargic and confused I didn't know my address.. on the top of all the worse symptoms you can possible think of DRS had to run lots of  test, blood work, cat scans , x-rays, and spinal tap because one Dr said my body was in over drive had too many antibodies and kept fighting infections and one lead to viral meningitis . I am so THANKSFUL  and so happy my body was able to fight it,  I will NOT be getting the second one.
Felt hot and sweaty; Felt hot and sweaty; Horrible horrible itching; Rash on left arm, injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on left arm, injection site), FEELING HOT (Felt hot and sweaty), HYPERHIDROSIS (Felt hot and sweaty) and VACCINATION SITE PRURITUS (Horrible horrible itching) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and PROBIOTICS NOS for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced VACCINATION SITE RASH (Rash on left arm, injection site) and VACCINATION SITE PRURITUS (Horrible horrible itching). On 22-Apr-2021, the patient experienced FEELING HOT (Felt hot and sweaty) and HYPERHIDROSIS (Felt hot and sweaty). At the time of the report, VACCINATION SITE RASH (Rash on left arm, injection site), FEELING HOT (Felt hot and sweaty), HYPERHIDROSIS (Felt hot and sweaty) and VACCINATION SITE PRURITUS (Horrible horrible itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not reported
Swollen lymph nodes; This is a spontaneous report from a contactable other healthcare professional (HCP, patient herself). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3246, expiration date was unknown), via an unspecified route of administration on the left arm on 13Jan2021 at 10:30 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the hospital. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Jan2021 at 10:00, the patient experienced swollen lymph nodes, which was considered non-serious. The adverse event did result in a doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse event. The patient was not recovered from the event.
Asking to be held she was crying, her behavior, she was angry and mad, she was wheezing, paleness and had small bumpy all over her neck and arms. The bumps went away after 1 week and has a cough still.
I developed a red, itchy, raised and tender welt/rash around my injection site.  "Covid Arm."
Friday night, sore red swollen arm. Lump under injection site.Sat: swollen lymph nodes, fatigue,  fever chills nausea.Sunday: fever fatigue chills vomiting.
The next evening, fever and chills and that was pretty much it on January 10th. On January 22, I developed a persistent cough and I went into the Urgent Care on the 22nd. I was given Tessalon Pearls  for the cough and an inhaler - Flovent. These helped with the the symptoms.  By January 25th, the cough was resolved.
No side effects reported; HBP reporting that VARIVAX was administered after it experienced a supported temperature excursion; Varivax - Lot number W025277 expiration date 28-Sep-2022; This spontaneous report was received from a healthcare professional, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and historical drugs were nor reported. Concomitant medications included sterile diluent (manufacturer unknown).    On 12-JUL-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, 1st dose (lot number W025277 was verified to be valid, expiration date reported as 10-AUG-2024 but upon internal validation established as 28-SEP-2022 [conflicting information]) (Expired product administered), administered as prophylaxis (route of administration and anatomical location were not provided). The vaccine was given after it experienced a supported temperature excursion of -8.6 Celsius (C) degrees, during a time frame of 51 minutes. The vaccine suffered a previous temperature excursion of -11.5 C for 1 hour, 16 minutes, 0 seconds (Product storage error). No side effects were reported.  This is one of several reports received from the same reporter.
Numbness started in feet and fingers. Progressively got worse with numbness moving up arms and legs. Saw doctor on 12/31/2009 and was admitted to hospital. Diagnosis: Guillain Barre Syndrome. Treatment: I.V. immune globulin.
This spontaneous report was received from a female patient of unknown age via a company representative referring to herself. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was unknown. On an unknown date, the patient was vaccinated with GARDASIL 9 (strength, dose, lot # and expiration date were not reported) intramuscularly for prophylaxis. On an unknown date, the patient developed a "swollen right posterial oracle lymph node". The lymph node was "the size of a walnut", and "hard to the touch", but went away after a week "on its own". No treatment was given for the event. It was unknown if the patient sought medical attention and any lab diagnostics/studies was performed. The outcome of the event was reported as recovered. The causality between GARDASIL 9 and the event was not provided.
This spontaneous report as received from a nurse refers to an unspecified number of patients with unspecified demographics. Approximately in 2014 (reported as unspecified dates since 13-FEB-2014 and prior to 14-APR-2014), the patients were administered doses of PNEUMOVAX 23 which were improperly stored. Concomitant therapy was unspecified. No adverse events were reported. No product quality complaint was involved. The outcome of improperly stored PNEUMOVAX 23 vaccine administered was unknown. No further information was provided. This case is linked with MARRS # 1404USA011760 and MARRS # 1404USA008845 as same reporter link. Additional information has been requested.
A hospital dialysis unit director reported that hepatitis B surface antigenemia appears to have occurred in 2 or 3 to chronic dialysis pt;
Warm to the touch Injection Site; Red Rash on the Injection Site; swollen injection site; Red Rash on the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm to the touch Injection Site), VACCINATION SITE RASH (Red Rash on the Injection Site), VACCINATION SITE SWELLING (swollen injection site) and VACCINATION SITE ERYTHEMA (Red Rash on the Injection Site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history information was reported.     On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced INJECTION SITE WARMTH (Warm to the touch Injection Site), VACCINATION SITE RASH (Red Rash on the Injection Site), VACCINATION SITE SWELLING (swollen injection site) and VACCINATION SITE ERYTHEMA (Red Rash on the Injection Site). At the time of the report, INJECTION SITE WARMTH (Warm to the touch Injection Site), VACCINATION SITE RASH (Red Rash on the Injection Site), VACCINATION SITE SWELLING (swollen injection site) and VACCINATION SITE ERYTHEMA (Red Rash on the Injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up information was received, events outcome was updated to recovered.
Headache, Myalgia, Arthralgia, CHILLS, SORE SARM Narrative:
febrile sz the day p/vax;pt seen @ ER w/T102, elevated WBC,nl blood culture;dx febrile sz;pt ok 9/13/99;
Fever, full body urticarial rash 24 hours after vaccination last 24 hours.
Information has been received from a medical assistant via a field representative referring to a 15 year old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On an unspecified date when the patient was 11 years old, the patient was vaccinated with first dose of GARDASIL (lot number, expiration date, frequency and route were unknown) in the "HPV vaccination series" for prophylaxis. On an unspecified date in October 2018 when the patient was 15 years old, the patient received second dose GARDASIL 9 (lot number, expiration date, frequency and route were unknown) in the "HPV vaccination series" for prophylaxis (inappropriate schedule of drug administration and interchange of vaccine products). No adverse effects reported. It was not reported if treatment was given or if lab diagnostics or studies were performed for the events. It was not reported if the patient sought medical attention. The outcome of the events was unknown. The causality assessment was not provided by the reporter.
High fever, chills, headache, body ache, inability to perform normal daily tasks for 3 solid days. Burning & itching rad manifested on 3rd day.  This is still continuing on 5th day after vaccination.
75 cm-90 cm swelling - hot to touch and firm. Pt adv to treat with BENADRYL & cold compresses adv to watch for fever, streaking or growing area.
I first started feeling tired, I had no other feeling than that. I took a test that morning, it was negative. I knew my husband was positive, so I knew it was coming, I tested that evening, and it was positive.  I contacted PCP the day before and I wanted to have a plan, because of my current medications and decided that day to go off of my medications and it was called in for Paxlovid. But I waited another 12 hours to start the Paxlovid 36 hours. I stayed on it for 5 days. I had no problems other the taste. With my cardiologist I researched when to start my medication again waiting a additional after 12 days and went back on to my medication with no problem.
?Moderna710 COVID?19 Vaccine EUA? On a typical day, my feet normally swell to twice their size unless I wear compression socks. Since getting my first dose of the vaccine, my feet have NOT swelled-up at all. That is from 12:15 pm on Tuesday, March 2nd until today, Friday, March 5th at 03:30 I count it as a blessing but, I thought it should be reported nonetheless.
seen 18JAN95; doing well until then, nl development; immun given on that day; devel a fever (104) that noc, irritability; adm to hosp 28JAN95 w/the dx of meningismus, roseola, irritability, diarrhea; now has hearing loss & devel delay
On 10/26/99, the pt experienced fever, muscle aches, and soreness at injection site.
Flu like symptoms for 2 days followed by severe headache currently in 2nd day.  Symptoms (pain) only moderately impacted by taking nsaids or Tylenol.  Similar to migraine.
covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Dec2021 as dose 2 (initial pfizer dose), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 11Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "interchange of vaccine administered" (unspecified if ongoing). There were no concomitant medications. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 30Apr2022, outcome "recovered" (04May2022), DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown" and all described as "covid-19". Therapeutic measures were taken as a result of suspected covid-19.  Clinical Course: Treatment include of paxlovid from 20Apr2022 to 27Apr2022. Patient Not taken any other medications/products within 2 weeks of starting COVID-19 treatment and patient previously receive a COVID-19 Vaccine  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
03/24/2021 I was in bed for 11 days not able to eat or drink I had severe nauseousness with dry heaving. I contacted my Physician but there was not any treatment for COVID-19 at that time. Paxlovid was not available yet.  I do not have any long-term effects of COVID-19 other than tiredness whenever I get a vaccine.