chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site became red, hot and swollen the next day. On physical exam, area of redness was about 6 x 6cm with a darker area of redness towards the elbow about 3 x 5cm and warm to touch. There was no rash on any other part of the body and no fever. Pt was diagnosed with localized reaction to the immunization DTP and skin infection. She was treated with Augmentin for 10 days and was told to apply ice to the area.
This spontaneous report as received from a nurse refers to a male patient of an unknown age. The patient's concurrent conditions and medical history were not reported. On 02-NOV-2015, the patient was vaccinated with ZOSTAVAX (unknown route and strength) was reconstituted with a dose of FLUZONE quadrivalent (manufactured by Sanofi Pasteur) rather than sterile diluent. No adverse effect was reported. There was no product quality complaint involved. Aditional information has been requested.
2" diameter erythema @ the site of RA inj;sl swelling & warmth & tender;rx APAP & DPH, cold compresses;
11started with intense itching in scalp and neck54:received COVID vaccine,  within 3 min she felt flushed, dizzy and heart rate increased.  1205:she felt less lightheaded and heart rate was slowing 1208: she felt intense itching in scalp and neck 1215:itiching increasing, given Benadryl 50 mg IM 1245: itching not as intense, but itching had moved to arms, trunk and legs
I received my first dose of covid vaccine on 02/26/21 at Hospital. I felt completely fine the following day just minor soreness which I expected. On 03/07/21, exactly 10 days post my vaccine I developed hives/welts on both hands, both elbows , both knees, and toes  that were elevated. I also developed some minor swelling but no fever, no pain just los of itchiness. I was given a vaccine of Medrol to calm down the sxs and seem to be doing okay.
BODY RASH; 101F FEVER; CONTSTIPATION; ABDOMINAL PAIN (RIGHT SIDE)
4 days after vaccine I have begun experiencing vertigo when I lay down. This has never happened to me before and it feels as if the room is spinning, but goes away very quickly.
Pt given MMR 9-28-15. States LMP 9-21-15. Signed consent form and live vaccine consent. Called 10-17-15 stating home preg. test (+). Did not see Dr. Was advised to contact someone else for options counseling.
Patients right arm became very sore, red, swollen several hours after getting injections(9-5-19).  Pt began vomiting and ran fever.  Went to see physician the following day(9-6-19).  According to patient's family member the physician said pt developed cellulitis from vaccines the previous day.  Patient received rxs for levofloxacin 500mg for 7 days, prednisone 20mg taper, Ventolin inhaler, and sumatriptan 50mg
The evening of the vaccine maybe 2 hours later, I was sitting down eating. My heart rate increased from 70 to 90 on my Fitbit. Then it went up to 100. I could feel it pounding. I was just sitting. All of a sudden it just stopped. Then I also had a pacemaker put in and did a VAERS report after the 3rd dose.
Patient woke up the next day and had a sore arm; by noon had chills, fever and shakes; she felt very sick and even her bones hurt. Patient went to bed and woke up the next day feeling fine.  Patient was thankful she was warned about the side effects again for the second dose.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 10:05 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 10:05 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of patient was reported as 48.47. No concomitant medications were reported. Batch number 031A21A administered on 20-Mar-2021 underwent temperature excursion with temperature range of 34-37 degrees Fahrenheit from 09:00 AM to 10:00 AM. This vial was moved to fridge on 09-Mar-2021 and beyond use date for the vial was reported as 08-Apr-2021. Product moved to clinic on 20-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
Headache, Myalgia, Fever, Diarrhea &  NauseaVomiting Narrative:
This spontaneous report as received from a licensed practical nurse refers to an unspecified number patients of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On unspecified dates, an unspecified amount of patients received improperly stored doses of RECOMBIVAX HB, (lot# M036156, exp. 23-FEB-2019) (dose, frequency, route unknown) for prophylaxis. No adverse effects reported. No further information provided. Vaccines RECOMBIVAX HB. Temperature: 47 degrees Fahrenheit (F) to 77 degrees F. Time frame: 1 Hour 35 Minutes. No previous temperature excursion. Digital Data logger report was involved. As of 30-AUG-2017, a request was made for patient identifiers and dates of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. This is one of several reports from the same reporter (1707USA004913, 1709USA004724 and 1709USA004725). Narrative updated. Sender's Comments: US-009507513-1707USA004913: US-009507513-1709USA004724: US-009507513-1709USA004725.
Received the 2nd Moderna vaccine on 27Feb2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd Moderna vaccine on 27Feb2021) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd Moderna vaccine on 27Feb2021). On 27-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd Moderna vaccine on 27Feb2021) had resolved. Not Related          No concomitant or treatment medications were reported.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration, for mRNA-1273, lot # Unkonwn,  with no associated AEs.
pt recvd vax 1030AM nauseated @ 8PM went to bed 29MAR woke up 8AM 30MAR w/severe back 7 joint pain like someone hit w/a bat; also had inc nausea; took APAP;
Pt recvd Engerix-B on 15JUL91, 19AUG91 & 25JAN92 & 31MAR92 titer levels revealed pt had not seroconverted;
pt had an acute myocardial infarction on 25OCT92; pt did not recover; long hx of cornary artery disease & chronic debilitation;
Approximately 12 hours after injection, I began to experience heart palpitations, heart racing and shortness of breath. This went on for several hours before finally falling asleep. The day following the injection, more and more symptoms began to arise such as muscle soreness, cold/hot sweats, low-grade fever (99.5%), chest pain/pressure, sweating, dizziness/disorientation and a headache. Monday night I experienced the low-grade fever however after going to bed, woke up around 5AM barely unable to stand, very disoriented and upon taking my temperature, I took note that I had a fever of 100.9%. Today, Tuesday May 11th, I am experiencing chest pain/pressure, low-grade fever, headache and am lethargic.
pt woke up @ 8PM 15JUN94 & was burning up according to mom, tried to take temp t104 pt taken to hosp 9PM t105.8; stayed @ peds care till 1130 when temp started coming down dx ear infect & react to immun;
pt recv vax on 23JUN93 & 5 days later devel a fever; the following day devel a macular rash w/blanching on the thighs, calf, one arm, & cheek; No further info was provided;
Fever to 102, shaking chills, fatigue lasted three days then red hot patch on arm six by eight inches. Then petechial rash and palpable purpura started on legs and progressed up to arms then truck and breasts started on 02/10/2013 and is still going on although starting to improve on March 4th. Biopsy done IGA found in vasculitis.
This case was reported by a consumer and described the occurrence of vaccination failure in a female patient who received Flu Seasonal TIV Dresden. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. In December 2014, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Seasonal Influenza vaccine. Additional details were reported as follows: the patient received the vaccination every year. the vaccine received by the patient was a quadrivalent (QIV) vaccine. the age at vaccination was not reported. the patient had a severe bout in late December 2014 or in January 2015. In August 2016, the patient again had a flu. The patient was concerned about compensation for the 4 strain vaccine. This case was considered as suspected vaccination failure since the time to onset of the event and confirmatory laboratory data was not reported.
PRESENTED WITH RASH AT ANTERIOR TRUNK AND BILATERAL ARMS TO THE CLINIC ON 3/4/2017. NO BROKEN SKIN, NO DRAINAGE. NO PAIN. C/O ITCH AT RASH SITE. STATE RASH HAS IMPROVED SINCE 2/10/2017.
Arm stiffening, cold on left arm only.  very warm during night,  light headed, body aches to where she could barely get out of bed.  Coughing this morning.
CHEST PRESSURE; CHEST PAIN; This spontaneous report received from a health care professional concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and  expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced chest pressure. On 10-APR-2021, the subject experienced chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pressure and chest pain was not reported. This report was non-serious.
5/1/21: Patient woke with chest pain, elevated respiratory rate, nausea, and sweating.  Recognizing symptoms of a heart attack, the patient presented to the emergency room at 5:30am.  ECG normal, Troponin at 2.1 at presentation, continued to increase to 4.6 prior to being taken to Cath Lab.  Coronary angiography showed no occlusion; patient admitted to telemetry unit for continued monitoring; discharged following day with order for cardiac MRI.  Outpatient cardiac MRI conducted 5/5/21 revealed myocarditis.  Treatment with beta blockers (Metopolol Succinate 25MG QID) and anti-inflamatory (indomethacin 25MG TID) with direction to avoid exercise.  Light yardwork on 5/22 resulted in patient feeling "racing heart".
Swelling and blister formation around the site of both Hep A and Influenza injections (R) THIGH.
Patient states that he now has a reduce range of motion and primary care physician is wanting to follow up with patient to review if there are any other reasons for onset of event.  Patient thought that medication was injected into the bone.
Complained of stomach ache in AM went to school came home asked to take a nap woke up 30 minutes later running a 103.9 temp. Given Tylenol every fours hours for fever, complaining of sore throat and body aches not being able to walk legs hurting so bad, fever wouldn't drop past 102 went on that way till Saturday went to urgent care was tested for strep and flu being she was having flu like symptoms, both short tests came back Negative, sent strep out for culture given Amoxicillin in case culture came back positive, sent home, went to doctor on Monday was told it is a virus and had double ear infection, upped the antibiotic and sent home that evening lesions/blisters started forming on the lips and under the lips thought it was fever blisters called doctor back and was told not to give any abreva that it fits with Hand foot and mouth disease, was told this could not be a reaction to vaccine, Tuesday more lesions/blisters formed in the mouth and tongue and inside on cheeks, fever down grading but then spiking again, very little drinking and eating, Wednesday more lesions/blisters can't talk can barely open mouth no solid food very little in take of fluids, Thursday seen in Dr. office Dr. released to go back to school for part day still infested with blisters and lesions and running slight fever 100.4, notified school and no reports of this going around school or in classroom, and no one in the home has gotten Hand foot and mouth and its been over a week since she became ill.
At 26 months the patient's mother called with complaints of chicken pox and would like Benadryl and calamine lotion .
Severe chills, fever(100.9)  severe Headache (lasting 3 days) mild headache still on day 5, severe body aches (3 days), under arm lymph node swelling,  nausea.  Fatigue
I had a welt that was 12? by 9? on my hip. I have been Nassau?s for 2 weeks. My legs are weak.
A physician reported the occurrence of injection site cellulitis in a 4-year-old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The pt's medical history, concurrent conditions and concurrent medications were not reported. The pt was described as a "well child". The pt had no adverse experiences following previous immunizations. On an unspecified date, the pt received an injection of Infanrix (lot DTPA382B2). Subsequently on 02/18/2003 the pt developed a "huge" area of and warmth at the injection site. The pt was seen in the local ER, where the physician made a diagnosis of injection site cellulitis. The injection site cellulitis resolved after an unspecified period of time.
We've administered expired Moderna Covid-19 vaccine to several patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was stored in the refrigerator on approximately 26 Dec 2021 and not undergone temperature excursion. Patient was administered with booster 1/2 dose. No concomitant medication were provided. No treatment information were given.
chest pain occured 4.5 hrs post second dose vaccine. next day, he felt fine, but fatigued. On the second day, chest pain occurs again upon inspiration and expiration, no shortness of breath. Only upon deep breathing, not shallow. On third day, pain is still an issue, he gets taken to urgent care. All test are normal (chest xray, EKG, lab, cbc, chem) lung sounds are normal. Chest pain continues for 3 more days. He rests and takes ibuprofen as directed. Is never is respiratory distress.
It was reported that a female patient (1 of 3) received a Fluzone SV vaccination. Reportedly the patient developed reaction of warmth, erythematous area around the injection site for 24+ hours, measuring more than 5cm and up to 10cm. Further information is requested. From additional correspondence received 03/06/2001, it was reported that the patient recovered from this experience. Additional patient, vaccine, vaccine administrator and responsible physician information were provided.
This spontaneous report as received from a medical assistant refers to a 16 year old of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 18-JUN-2014 the patient was vaccinated with first dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # J009788, expiry date: 17-MAR-2016) and first dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J011385, expiry date: 10-MAR-2016) which were stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL and VAQTA. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927,  1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013, and 1407USA013014 (same reporter link). Additional information has been requested.
Body aches, chills, dizzy, redness, pain, swelling, itching. 1st day & 2nd day redness & headache worse still other symptoms. 3rd day sore throat & stuffy head face puffy redness worse after 24 ice. Recommended go to MD.
1 week after receiving tetanus vaccine, red bump, pruritic, induration 2cm bump erythema. Treated with Atarax 25mg and warm compress.
Patient felt dizziness and giddiness. Onsite EMS was called vitals BP 130/76 BG 103    100% O2 room air HR 76. Patient Refused Evaluation/Care, Left aginst medical advice.
Patient received 2 doses about one hour apart; A spontaneous report was received from  a healthcare professional concerning an unidentified patient (demographics not provided), who received Moderna's COVID-19 vaccine (mRNA-1273) and received two doses of the Moderna COVID 19 vaccine about one hour apart.  The patient's medical history was not reported by the reporter. Concomitant product use was not provided.  On an unknown date, the patient received their first and second of two planned doses of mRNA-1273 (Lot number: unknown) through unknown route at unspecified site for prophylaxis of COVID-19 infection.  On an unknown date, the patient received two doses of the Moderna COVID 19 vaccine about one hour apart.  Treatment for events was not provided.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug is not applicable.   The outcome of event, received 2 doses of the Moderna COVID 19 vaccine about one hour apart was resolved on an unknown date.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # unknown, with no associated AEs.
1602 PT C/O OF FEELING LIGHTHEADED, AAO X3, RESPIRATIONS EVEN AND UNLABORDED, DENIES SOB OR CHEST PAIN. 1603 B/P 110/60, 18, 95, 99% 1610 126/69, 18, 93, 99%, IS AAO X4 SKIN WARM AND DRY, RESP. EVEN AND UNLABORDED. PER PT " I'M FEELING OK NOW". DENIES N/V/D. PT IS IN NO ACUTE DISTRESS AND HAS REFUSED FURTHER EMERGENCY MEDICAL CARE. PT WAS EDUCATED ABOUT COVID PFIZER VACCINE SIDE EFFECTS . 1631 129/81 88 24 98% PT VERBALIZES UNDERSTANDING  1635 PT IS AAO X4 SKIN W/D RESP EVEN AND UNLABORDED, DENIES ANY ACUTE DISTRESS. PT EDUCATED TO SEEK MEDICAL ATTENTION IF CONDITION WORSENS. REPORT SIGNED BY RN.
dizziness, itching/small hives on forearm (not at injection site) , 30 minutes after vaccine given.   Vitals monitored, were normal, sent home and advised to take Benadryl.  More hives on upper lip/chin appeared 36 hours after vaccine given.   Patient was at home, self-treated with benadryl, zyrtec, famotidine and ice pack applied to area.
This spontaneous report was received from an other health professional (healthcare worker) refers to a 5 week old patient of unknown gender. On 28-OCT-2014 the patient was vaccinated with VAQTA, .5 ml, intramuscular. No adverse experience was reported. Outcome of the event is unknown. No product quality complaint (PQC) was reported. Causality assessment was reported as not related to therapy with VAQTA. This case is related to MARRS# 1410USA015847. Additional information has been requested.
Patient experience palpitations at outside vaccination site after first dose of covid vaccine. no further details explained.