chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5 days after the first shot, she has experienced itchiness at the site, which developed into redness, which has become a red splot about silver dollar sized "kind of like tatooed on arm." Currently treating with ice and peppermint oil; counseled her to use an antihistamine orally like benadryl but patient stated, it "makes her hyper." Advised to use topical steroid then. Read to her CDC statement on "COVID arm".
PULMONARY EMBOLISM; SEVERAL BLOOD CLOTS IN LUNGS; SEVERELY ILL; PAIN IN SIDES; This spontaneous report received from a consumer concerned a 52 year old male. The patient's weight was 180 pounds, and height was 69 inches. The patient's concurrent conditions included: non smoker, and non alcohol user. The patient had no known allergies. The patient did not have any history of drug abuse or illicit drug use. The patient had health with no prior medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: 19-SEP-2021) dose was not reported, 1 total, administered on 10-APR-2021 on left arm for prophylactic vaccination. Concomitant medications included Multivitamins, ergocalciferol, and fish oil.  On 10-OCT-2021, the patient experienced pain in side and was severely ill. On 11-OCT-2O21, the patient was transported by ambulance to emergency room and admitted to hospital. The patient was initially diagnosed incorrectly with pneumonia, but was later found to have pulmonary embolism and several blood clots in lungs after further tests were performed. On 11-OCT-2021, Laboratory data included: CAT scan twice (NR: not provided) Blood clots and pulmonary embolism, Fibrin D dimer (NR: not provided) Positive for blood clots and pulmonary embolism, and X-ray (NR: not provided) Blood clots and pulmonary embolism. On 12-OCT-2021, Laboratory data included: Ultrasound Doppler (NR: not provided) Negative. The patient was discharged on 12-OCT-2021. The patient was hospitalized for 2 days. The patient was treated with heparin, an antibiotic and pain medication in hospital and was sent home on Eliquis (apixaban) 10 mg oral twice daily (dose was being titrated). The patient would be required to take Eliquis for at least 3 months and possibly for the rest of life. The patient was being followed by a pulmonologist and would be seen for follow up in the next 2 weeks on 28-OCT-2021.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pulmonary embolism, several blood clots in lungs, severely ill and pain in sides was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20211025566.; Sender's Comments: V0: 20211025143- covid-19 vaccine ad26.cov2.s-pulmonary embolism, several blood clots in lungs. 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).
1st attempt by Jynneous 0.1ml ID made by RN, there was no wheal seen or felt.  2nd attempt patient was told that we will attempt to vaccinate with wheal being present. 2nd attempt by RN was successful
Fever 101.8, chills, body aches. Swelling, redness, pain, and itching spread throughout entire upper arm. PA diagnosed condition as cellulitis and prescribed antibiotics.
Chills,, hands very cold extreme tired Friday (about 5 hours after shot) and arm ached from fingers to should blade... shot area red.  Saturday,  Swollen Red Spot on Right Arm at shot site that grew to about three inches  in length and width by Sunday morning, hard lump under red area and hot to touch.  Arm sore, shoulder ache to should blade, major pain from finger to shoulder.  Took Amoxicillin and Claratin, and Tylenol was better by Monday evening.  Chilled Sat and Sun evening around 6pm-10pm...had to cover up and slept....Shot site/arm still three inch red/hard  area but has not gotten any larger is a lighter red and hurts a lot less.
I woke up at 5am the day after getting the shot and it felt like I had the flu. I had body aches all over and a bad headache. The injection site was painful and swollen to about 3" long, 2" wide and 1/4" high. I checked my temperature twice and it was 96.4F. The symptoms lasted for roughly 48 hours. I took two Extra Strength Tylenol every 6 hours and that did help alleviate the symptoms.
Severe hives located behind the left ear down to the neck down to the shoulder blade, several hives located on the right shoulder blade and one found of right breast area. Neck stiffness noticed on the day of the vaccine.
This spontaneous case, initially received on 21-Sep-2016, was reported by health professional and concerns a 3-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA from 21-SEP-2016 to 21-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: reported as 12649221A. Site: Left leg. No additional suspect drugs. Adverse reactions/events and outcomes: On 21-Sep-2016, AFLURIA was inadvertently given to a 3 year old (special circumstances: drug administration error). The doctor is aware. Currently the child is not showing any adverse reaction. Outcome for all events: unknown. Reporter comments: The reporter considers the event non-serious (medication error).
12/29/2020-around 5:00 pm-sore throat and headache for couple of hours; minor blurry vision.  Pain at injection site-hurt to raise arm to head 12/30/2020-little bit of nausea throughout day off and on-around 5:00 pm-fever (99.5), chills, headache, body aches, increased constant nausea.   Moderate pain at injection site, redness 12/31/2020-fever (99.5-100.4), chills, nausea, headache, body aches until about 4:00 pm.  Redness, swelling, moderate pain at injection site-(pain improved-able to move arm more than before), some minor itching off and on at injection site.   1/1/2021-Nausea, headache.    Redness, swelling, pain at injection site-(Pain improved), injection site hard and hot to touch.   Some minor itching off and on.   Receive steroid shot from urgent care and took Benadryl 1/2/2021-Redness, swelling improved.   Minor itching off and on.   Took Benadryl.  Had touch diarrhea. 1/3/2021-Swelling almost gone, redness almost gone.  Minor itching off and on.   Little nausea.  Took Benadryl 1/4/2021-Swelling and redness gone.   Minor itching once or twice-nausea briefly once.   Took Benadryl 1/5/2021-Itching off and on-minor
Initial report received from a health care professional on 08 December 2010. A 49-year-old male patient received on 08 December 2010 a right deltoid intramuscular injection of FLUZONE, lot number U3823AA. The patient had a history of gastroesophageal reflux disease (GERD) and an allergy to penicillin. The patient had no illness at the time of vaccination, had no prior adverse events following vaccination and received no other vaccination within 4 weeks of the FLUZONE. The patient's concomitant medications included PROTONIX, VOLTAREN, and PRAVACHOL. On 08 December 2010, within 4 hours of the vaccine, the patient returned to the physician's office with conjunctivitis in both eyes. The patient had redness, drainage and swelling noted in both eyes. The patient was given KENALOG. The patient was monitored in the office and then sent home when stable. The outcome was reported as recovered. Follow-up information was received on 24 January 2011 from a health care professional. The patient had also received a left deltoid intramuscular injection of ADACEL, lot number C3539AA on 08 December 2010. The patient received the vaccinations at 9:31 AM and the adverse event onset time was 2:54 PM (previously reported as within four hours). No further information was available at the time of the report. The patient's outcome remained recovered. Documents held by sender: None.
Day 1: Left arm hurt like it was punched.   Then stomach muscles hurt, followed by rib cage muscles. Day 2: All my muscles were in pain from head to toes.  Joint muscles in pain.   Headaches, stick neck.  102 Fever for the next 3 days Throughout the 2 weeks: Stomach pain, Rib cage pain, skin pain (burning like on fire), hives on chest, headaches, sleep issues, zero sex drive  Most of the symptoms cleared by the end of the 2 weeks. Stomach muscles and rib cage muscles for the next 6 weeks were tender.  Sex drive was also zero.  I had no interest in partaking in physical activities such as playing VR games for exercise as my torso was sore.  Finally now, it seems all my symptoms are better.  My sex drive is pretty low, but no longer zero.  I hope that improves.
Very dizzy, felt like I was falling over for years. Could not concentrate. Autism qualities. Quiet. Could not articulate or communicate for years
Initial information received on 05-Jul-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 7 years old patient who missed DAPTACEL vaccination, while he/she received vaccine DAPTACEL. The patients past medical history, medical treatment, vaccination and family history were not provided. On an unknown date, the patient missed a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported and he wanted to know if he should just give him the PENTACEL instead. It was a case of actual medication error due to drug dose missed. It was unknown if patient experienced any adverse event post vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
3/23- nothing 3/23- slight leg ache for 20 minutes, fever at 100.8 with 1K MG Tylenol, sore throat, hot and cold but no chills (called doctor for Zithromax) 3/24- fever lessened, arm began hurting (not at deltoid muscle where shot was administered), arm lost mobility in the afternoon (could not lift above my shoulder), sneezing, coughing, runny nose 3/25- could not type in the morning, able to type later in day, 3/28- Covid tested negative 3/29- Advised doctor's Clinical Assistant I didn't remember 3/24-3/25 too well and my arm pain was still present Month of April:  Resolved: Covid type symptoms  loss of arm mobility Armpit pain Shoulder blade pain Present: Breast implant pain on left side (occasional) Left hand and finger numbness All symptoms on left side of body except new back pain
Myalgia, Fever, NauseaVomiting, fatigue Narrative:  Other Relevant History:
No additional AE; Improperly stored PROQUAD had been administered to a patient; This spontaneous report was received from an administrator referring to a 4-year-old patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 30-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number T034826, expiration date 11-APR-2022 (dose, route of administration not provided) for prophylaxis. No adverse event was reported.  The temperature excursion was between -14 degrees Celsius (°C) and -10°C with an average of -14°C for 30 minutes. There was no previous temperature excursion.
Severe, head splitting type headache after I initially fell asleep. Worst headache in over 30 years. Motrin, ice packs, cold wash clothes. Changed pain med at 5:30 a.m. to Advil gel capsule. (It worked).
Suspected Vaccination failure; rash / ater diagnosed as herpes zoster; rash / ater diagnosed as herpes zoster; This case was reported by a pharmacist and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th December 2019, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster and rash. On an unknown date, the outcome of the vaccination failure, herpes zoster and rash were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster and rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per the vaccine indication. The patient received dose of Shingrix vaccine and suffered from rash on the side which was later diagnosed as herpes zoster. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease were unknown at the time of reporting.      Lab Comments: On an unknown date Lab test was performed.
Drenching sweat at 3AM day after vaccine, tested positive 1/8/2021 on Binax now POC test 1/8/2021, employer encouraged me to report , thinking it might be a false positive and might be related to vaccine. Have cold like symptoms  and headache.  Had a negative POC on 1/6/2021
Jynneos was administered intramuscularly in error; Case reference number US-BN-2022-001534 is a spontaneous case report initially received on 12-Jul-2022 from other health professional via Communications (reference number: USBAV22-0535) and concerns *a 37-year-old male patient*.  *The patient had no relevant medical history.*  *The patient's concomitant medications included Truvada (emtricitabine, tenofovir disoproxil fumarate).*  On an unspecified date, the patient was vaccinated with a dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: not provided, expiration date: 31-Aug-2023) at *a dose of 0.5 ml, administered intramuscularly in the left deltoid, for monkeypox vaccination* (explicitly coded as 'inappropriate route of vaccination').  *It was confirmed that the patient didn't experience any adverse event due to Jynneos vaccination.*   Additional information received on 12-Jul-2022 from Bavarian Nordic included local BN case ID.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow up information was received from other health professional on 01-Aug-2022: New information included patient's details (initials, age, date of birth and gender), concomitant medication information and details for Jynneos vaccine.  Non-significant case correction received on 17-Aug-2022 due to internal review included recoding of the suspect product due to listedness updated.; Reporter's Comments: On an unspecified date, a 37-year-old male patient was vaccinated with Jynneos vaccine, at a dose 0.5 ml was administered intramuscularly (instead of subcutaneously) at an unknown dose or site of administration, for monkeypox vaccination, which is considered as inappropriate route of vaccination. No associated adverse events were reported as it was confirmed that the patient didn't experience any adverse event due to Jynneos vaccination. The patient had no relevant medical history and concomitant medications included Truvada (emtricitabine, tenofovir disoproxil fumarate). Incorrect  route of product administration is considered listed per company convention. Inappropriate route of administration is not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: On an unspecified date, a 37-year-old male patient was vaccinated with Jynneos vaccine, at a dose 0.5 ml was administered intramuscularly (instead of subcutaneously) at an unknown dose or site of administration, for monkeypox vaccination, which is considered as inappropriate route of vaccination. No associated adverse events were reported as it was confirmed that the patient didn't experience any adverse event due to Jynneos vaccination. The patient had no relevant medical history and concomitant medications included Truvada (emtricitabine, tenofovir disoproxil fumarate). Incorrect  route of product administration is considered listed per company convention. Inappropriate route of administration is not related to Jynneos, but to a human factor. The case is non-serious.
pt recv 2 doses of vax & lab eval on 13MAR97 revealed a lack of seroconversion;pt reported a prev drawn titer was positive;
This spontaneous report as received from a nurse refers to a 2 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 11-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N017094, expiry date: 31-AUG-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
No adverse event-- Patient was given the adult dose of COVID vaccine.  Patient was given adult dose of 0.3 mL instead of the age recommended 0.2 mL dose.  This administration was done in error.
Child was given Hep-B and varicella vaccines on 7/16/02 AM. Generalized fever in the afternoon while at the beach between 10:00 and 13:00. On and off up to 7/18/02.
Information was received on 12-APR-2017 from a medical assistant regarding a 7 month old female patient. Medical history, concurrent conditions and concomitant medications were not reported. On 18-NOV-2016 the patient received her first dose of ROTATEQ (lot # M007125, expiration date 06-OCT-2017) (dose not specified) at the age of 7 months (considered inappropriate age at vaccine administration). No additional doses have been administered (considered missed doses). No adverse effects were reported. The action taken was not applicable and the outcome was not reported. The causal relationship was not reported. Additional information has been requested.
patient became diaphoetic, pale, and reported feeling weak immediately after vaccination. Blood pressure 79/41 mmHg, heart rate 45-50 beats per minute. Patient reports not eating eating anything yet that day. On arrival to emergency department (ED) patient was awake, alert, and oriented. No respiratory, gastrointestinal, or respiratory symptoms noted. Administered diphenhydramine and IV fluids. Patient's symptoms and vital signs improved and discharged to home stable.
Patient received a booster dose outside of the approved age range. Mom reported no adverse effects after he received the dose.
Extensive warmth, erythema, redness at the injection site. ? allergic reaction vs cellulitis. Rx: Ice, DARVOCET for pain, KEFLEX 500 TID.
lightheadedness;nausea, drowsy (initial) w/in 12hrs; fever, congestion, body aches, joint pain 1wk later
Patient insistent that they had Pfizer for first dose and did not have immunization card. It wasn't determined until after Pfizer was given that first dose was Moderna.
sore arm; redness; swelling; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm, erythema and swelling. On an unknown date, the outcome of the pain in arm, erythema and swelling were recovered/resolved.   It was unknown if the reporter considered the pain in arm, erythema and swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: Office manager reported the case for her daughter. The age at vaccination was not reported. The patient had had sore arm, redness, and swelling for approximately one week following a dose of Bexsero. The reporter did not consent to follow up. For tolerance of 2nd dose of Bexsero refer link case US2021AMR073690.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR073690:same patient
Five days after the vaccine, 05/15/2021, the patient began having seizures and was not able to speak. The patient arrived to the emergency department of the hospital at 10:30 PM and was seen by the ED doctor at 2:30 AM. The patient's seizure medications dose was increased and the patient was initiated on hydrochlorothiazide. She was discharged from the hospital on 05/19/2021.
This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 03Jul2022, outcome "unknown" and all described as "contracted COVID-19". Additional information: Patient was a vaccinated and twice boosted mother of 4 children and part time acute care speech language pathologist. Patient's husband and four children (Ages 5,5 (twins), 7, and 9) have each had 3 doses of the vaccine designed to lessen severe illness from a COVID-19 infection. Patient stated they were all vaccinated and boosted with Covid-19 vaccines and have contracted the virus. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : PFIZER INC-202200950512 Same reporter/vaccine/event, different patient. PFIZER INC-202200950513 Same reporter/vaccine/event, different patient. PFIZER INC-202200950514 Same reporter/vaccine/event, different patient. PFIZER INC-202200950515 Same reporter/vaccine/event, different patient. PFIZER INC-202200952811 Same reporter/vaccine/event, different patient;
pt recv vax 17APR96 & 1MAY96 t100, tender, swollen rt axillary lymph node;8MAY96 pt had completely recovered;reporter felt that the swollen auxiliary lymph node was not r/t vax;attributed swollen lymph node to pt smoking;
passed out; psychosis and on 3 different occasions; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (COMIRNATY, Solution for injection) (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome unknown, described as passed out; PSYCHOTIC DISORDER (non-serious), outcome unknown, described as psychosis and on 3 different occasions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.