chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills @ T+12 to 13 hrs. (from time of injection).  Severe nausea and resultant dehydration/dizziness/Low BP @ T+20 hrs. (lasted about 5 hrs.)   Fever and body ache in the 102-103*F range throughout March 1.  Overall lethargy throughout March 1.  Night sweats night of 3/1 into 3/2.  Laryngeal tissue damage from stomach fluids due to extremity of nausea/vomiting.
This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 23-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot# L016427; expiration date: 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time frame were: 1.4C for 22 hours 52 minutes and 8.6C for 112 hours and 5 minutes. This is one of several reports received from the same source (original report 1602USA004808). Additional information has been requested.
Per the member:  I received shot number 1 Moderna COIVD-19 vaccine on 27FEB21 at approximately 09:47 that morning. Had minor soreness on the injection site on my left arm. Rest of the day did not observe any adverse action. On 28FEB21 at around 12:15, I felt warm and flush. I assessed that my body was reacting to the the vaccine and that afternoon went to the unit aid station at the military compound I was located at and had a slight fever with a temperature of 99.1. I continued to hydrate, eat regular meals, work, and noticed now irregularities in body functions. Continued on page 2...
pt recv vax 28FEB97 rt leg rxn p/vax; 1cm cult area-6cm cellulitis area redness, swelling-lump, fever 102;yellow purulent drainage from inj site;ordered warm compresses;pt screaming & not walking well until Saturday AM;
This spontaneous report as received from a Licensed Practical Nurse. On 30-APR-2013, multiple unspecified patients were vaccinated with VAQTA (lot # 0273AE exp. 06-DEC-2014 and lot # H012669, exp. 17-APR-2015). The nurse reported the dose of VAQTA were exposed to 30.1 degrees Fahrenheit for three hours, which was unsupported by stability data. No adverse effects reported. This is one of several cases received from same source. Additional information has been requested.
pt had a positive COVID test on 9/21/22; on O2 supplementation; no sx until 9/27/22 when he had sudden SOB; O2 saturations in upper 80s on 4L/NC with increase of AMS; on steroids and ABX; brought to ED and admitted; placed on NRB; cellulitis of leg, pneumonia, respiratory failure; comfort measures; pt passed away shortly after admission
Urticaria with large local urticaria around injection site and several other scattered urticaria. Occurred day after vaccine.
Received COVID-19 vaccine while hospitalized for Cellulitis of right foot - on day 2 of a 3 day admission.
Bad acid reflux, abdominal pain, nausea, dizziness, weak, fatigued, vomiting, diarrhea, lost 40 lbs within a month, depression. This went on from July of 2014 to May of 2015. Was prescribed Zofran, and Cymbalta.
Patient called at 6pm stating her flu shot given earlier today is giving her extreme muscle pain and radiating towards her neck, limiting her range of motion. We talked about how VIS -> rare but a serious reaction. I will call her PCP and she will as well and monitor. She thinks it may be b/c her shot was given higher on her arm (near shoulder) than she's used to.
Friday the 18th of June, I started having gas pains and they got worse through the weekend and Monday. I was in in extreme abdominal and lower intestinal pain with chills and fever. I went to ER. Blood cultures and CT scan. Gas had escaped my bowels and noted diverticulitis. I was admitted to the hospital on 21st and released on 24th of June.
developed hypertension; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "developed hypertension".  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This case was reported by a nurse via sales rep and described the occurrence of fever in a 11-year-old female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, 1 day after receiving BEXSERO, the patient experienced fever, wrong vaccine administered and product label confusion. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the wrong vaccine administered and product label confusion were unknown. It was unknown if the reporter considered the fever to be related to BEXSERO. Additional details were provided as follows: The patient was to receive MCV4. The vaccine was drawn up by one person, she left the room. Another person came in and administered vaccine (did not confirm which vaccine). BEXSERO was given instead of MCV4 (apparently labeling was unclear), which led to the wrong vaccine administered and product label confusion. Mother was informed and she reported that her daughter experienced one day of low grade fever one day after administration of vaccine. The reporter gave consent to follow up. Lab Comments: The patient experienced one day of low grade fever measured on an unknown date.
Patient states forehead and eyes got splotches and some swelling. Patient went to physician who could not determine if from vacccine or not. Resolved a few hours later.
pt recv vax; mild sore throat, malaise,low grade fever; papular petechial erythema;joint stiffness, possible mild swelling in hands & feet; resolved x/ petechial;
blurry vision, kaleidoscope vision accompanied by a headache - entire body soreness, soreness at injection site
head congestion, sore throat, severe cough, chills,low grade fever, lower back pain and fatigue.  I had been having these symptoms that started with the sore throat on 6/24 and by 6/30 it was getting worse so I went to Urgent care and received a negative covid and strep test.  Diagnosed with sinus infection and double ear infection.  Antibiotic and cough syrup given.  Felt better by 7/6 or 7/7 and cough nearly gone by 7/12 and returned to office.  By 7/6 husband had same symptoms with same start with sore throat and congestion/cough that got worse.  Family member visited with inside his home for 2-3 hours reported he became sick around 7/5 or 7/6 and was beginning to feel better by 7/10 when I checked on him.  He also had the J&J vaccine he mentioned during that visit.
Fever immediately. Rash 6 days later. Speech delay, head banging, mobility clumsyness, stomach problems, loose stool, butt rash, vomiting, chronic colds, ear aches. All, but the head banging which is in the past 6 months have taken place after the shot. Follow up: selective hearing, phonating, walking okay.
This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and expiration date were not reported) via an unspecified route of administration on an unspecified date (reported as eight days ago) as first dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced shingles on her right arm on an unspecified date (reported as five days after vaccination). The outcome of the event was unknown. The patient was scheduled for second dose of the vaccine on 19 March 2021. The patient was querying if there was a contraindication if ever she will be using an anti-viral medication prior to her second dose of the vaccine. The patient was also querying if there was an information available on specific populations whether the patient should keep her scheduled second dose of vaccine or should wait for a few days as she had shingles on her right arm after getting the first dose of the vaccine. It was also reported that the patient was already in Pfizer's study and being monitored. Information on the lot/batch number has been requested.
Light headedness, body aches, fever, nausea, rash on arm from 10/20/2020 until afternoon of 10/22/2020.  Rash persists.
The patient was expecting to receive Pfizer Bivalent and instead received Pfizer monovalent. There are no reported ADRs as a result. The patient has been consulted on the regulatory authority recommendation for this error (still covered, able to get Bivalent after 2 months).
Immediate Headache that has now lasted over a week - LARGE lump under the skin after icing and heat that keeps draining, sore arm, Slight flu like symptoms, Red blotches on right arm at injection site
pt presents to ED via EMS from a local urgent care with dyspnea, fever, N/D, body aches x 1 wk; O2 sats in mid 50s on RA; O2 supplementation; treated with remdesivir, dexamethasone, baricitinib, ABX; O2 requirements increased requiring ventilator; on CRRT; pt's condition worsened; family decided on comfort care for the pt; he was removed from ventilator  and passed away
Information has been received from a physician and a consumer concerning a 9 year old female with very mild CP and a former premie who on 09/12/1995 was vaccinated in the right arm with the first dose of varicella vaccine. There were no illnesses at the time of vaccination. On 10/19/2001, the pt developed chicken pox. Subsequently, the pt recovered on 10/29/2001. The physician also reported that the pt's siblings, 2 females and 2 males, developed chicken pox after vaccination with varicella vaccine (WAES0112USA01252,011USA0125, 0112USA01254, and 01100739). The consumer reported that 14 patients at her children's school developed chicken pox after vaccination with varicella vaccine (WAES01110652). No further info is available.
p/vax pt rt thigh red; inflamed; warm to touch; spread from mid thigh to knee; applied cold packs & given tylenol/advil
3/31/21 significant loss of hearing in left ear 4/7/21 Dr.  prescribed prednisone and ciprofloxacin 4/9/21 slight improvement in hearing 4/11/21 Total loss of hearing in right ear 4/12/21 To ER 4/14/21 Back to Dr. Prescribed second round of prednisone No improvement 5/5/21 Began dexamethasone perfusion?alternate shots bilaterally over 6 weeks
Rash developed about 6 inches below the injection site with in hours of injection.  Over course of week it continued to worsen. Day 8 from injection it had reached 4 inches in diameter, was hot to the touch and itched.  Other symptoms included extreme fatigue for 78 hours past initial injection and inability to lift arm for two days.  Arm remained sore for a week.
Rash on my arms, back and front. I have a fever of 103. Rash is slightly raised, started today. Red spots. Not really pimple like. No itching, not painful. No lesions in mouth, or hands or feet. Never had anything like this before. Denies chest pain or sob. Arm around vaccination site is red, swollen and hot. Lymph nodes in armpit tender. Feeling tired and worn out. Little achy. Symptoms: RASH&OTH NONSPEC SKIN ERUPTION(R21).
Started with just what looked to be a normal zoster reaction, but the redness and swelling continued throughout the day into the night, and increased even with Benadryl. A 4in circ reaction emerged by noon 7/31/2013 when patient went in.
Had severe HA and muscle aches,.Patient with mostly resolving side effects from Tdap Vaccination, but new symptoms- vaginal bleeding and report of LOC
This non-valid spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. In approximately 2017 (reported as "an unknown recent date"), the patient was vaccinated with PNEUMOVAX 23 (dose, lot number and expiration date were not provided) via the patient's injection port. No adverse effects were reported. The outcome of the event was unknown.
Immediately after the shot I felt fatigued for weeks and on Friday went into AFib and have been in the hospital since with rapid irregular heart beat, extreme chest pain and fatigue. My heart rate will drop to 88/67 then jump to 157/100 it feels like my heart wanted to come out my chest. I was put on a blood thinner and I?m currently in the hospital being monitored waiting for more testing to be done .
Inappropriate schedule of vaccine administered; Mild headache; Fever; pain at site of injection; Moderna vaccine administered to Unauthorized age group; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine administered to Unauthorized age group), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered), HEADACHE (Mild headache), PYREXIA (Fever) and VACCINATION SITE PAIN (pain at site of injection) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine administered to Unauthorized age group), HEADACHE (Mild headache), PYREXIA (Fever) and VACCINATION SITE PAIN (pain at site of injection). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) on 14-Apr-2021 at a dose of 500 milligram. On 14-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine administered to Unauthorized age group) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved and HEADACHE (Mild headache), PYREXIA (Fever) and VACCINATION SITE PAIN (pain at site of injection) 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.   Concomitant product use was not provided.   This case was linked to MOD-2021-244785 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Significant follow up event details added. cross linking done.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: called 911 and paramedics took him to hospital to further asess his low blood pressure paramedics said most likely not reaction to vaccine
I had a rash on my stomach and my back.  I did not notice it until about 30 hours after the shot.  It may have came earlier, but I didn't notice it.  It was a small patch on my stomach and my entire back (hundreds of dots).  It didn't itch or bother me at all.  The next day it pretty much went away (without taking anything), but my back did itch a little bit the next day.
Low grade temperature  of 100°, diarrhea, slight swelling, redness and sore.  Nothing lasted more than 48 hours.
Information has been received from a consumer concerning his wife who was vaccinated with Hepatitis A virus vaccine inactivated. The reporter stated, "that his wife experienced many adverse reactions similar to those listed in the PI (product Insert)". Additional information has been requested.
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown date, the patients were vaccinated with unspecified number of improperly stored doses of (Oka/Merck) VARIVAX injection, lot # reported as M105731, expiration date 30-MAR-2018 or lot # M009766, expiration date 23-FEB-2018 (dose, route and site of administration were not reported). No adverse effect were reported. Product quality complaint was not involved. The administered doses of (Oka/Merck) VARIVAX were stored in the temperature of 10 degrees Fahrenheit for 3 hours and in the temperature of 14 degrees Fahrenheit for 17 minutes. Data logger was involved. Additional information has been requested.
marked swelling rt ant thigh; fussier; hard crying 2 1/2 hrs; fever 102 6SEP & 7SEP; emesis & diarrhea 8SEP
7 weeks after receiving the vaccine patient complains of pain on the arm that goes all the way down to the arm.  There is stiffness and can feel some muscle knots.
FIVE HRS AFTER 1ST INJECT OF ENGERIX-B, WELTS UNDER ARMS, IN GROIN, AROUND WAIST AND ON VARIOUS PLACES ON TRUNK. WELTS WENT AWAY, RESURFACED, CLEARED WITH NO PROBS. 36 HRS POST INJECT PT EXP WATERY DIARRHEA. TOOK LOMOTIL.EXP NAUSEA & CRAMPS
Systemic: Fainting/Unresponsive-Medium, Additional Details: pt received vaccine and went to waiting area. Pt fell faint and went out of chair to ground and then started to get back up. I went out and helped pt up into chair and when talking to pt his head drooped and stopped talking.  Pt was unresponsive. Vaccination pharmacists came over and I called 911. Pt had undetectable pulse according to (Pharmacist) Epipen administered. Pt stated was fine when came back to and that he fainted often. Ambulance assessed pt and then pt left on his own.
This patient had an injection; the site (left deltoid) became painful the afternoon of the injection with redness 4-5 inches in circumference. Occuring approximately 24 hours after the injection and has not worsened since then. She states it is slightly less red. We saw the patient (11 y/o) came in with her guardian for immunizations 2 days ago and the guardian was unaware of the patient's history of 1-2 years ago when she received TD following a dog bite and injection site became red, swollen, and oozing. The patient referred to private MD for evaluation today.
This case was reported by a healthcare professional, via another manufacturer (Merck) and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included 1st dose of ROTARIX ;GlaxoSmithKline;oral given when the subject was 2-months-old. On an unspecified date, at 4-months-old, the subject received 2nd dose of ROTARIX (oral). Approximately one month after vaccination with ROTARIX, the subject experienced intussusception. This case was assessed as medically serious by GSK. The subject was treated with surgery. At the time of reporting the outcome of the event was unspecified. Follow-up information received from healthcare professional on 18 May 2010: Previous and/or concurrent vaccination included DTPA-POLIO-HIB (non-GSK) ;non-GSK manufacturer given on 12 January 2010 and 9 March 2010; either ENGERIX B or RECOMBIVAX ;manufacturer unspecified given on 12 January 2010 and 9 March 2010; ROTARIX ;GlaxoSmithKline;oral given on 12 January 2010; PREVNAR (non-GSK) ;non-GSK manufacturer given on 12 January 2010 and 9 March 2010. On 9 March 2010 the subject received 2nd dose of ROTARIX (oral). On 9 April 2010, 31 days after vaccination with ROTARIX, the subject experienced intussusception, vomiting and abdominal pain. The subject was hospitalised and the healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). Relevant test results included abdominal ultrasound on 09 April 2010 which revealed intussusception. The subject was treated with surgical repair. On 15 April 2010, the events were resolved. Relationship of the events to vaccination with ROTARIX was not specified, but the healthcare professional identified ROTARIX as the suspect product.
Headache, Diarrhea, c/o chills,fatigue,injection site pain. Told to follow up with primary care physician.
Body aches,  chills,  fever up to 103, jaw pain,  migraine,  exhaustion Full body rash/ hives beginning 4 days post injection
Pt presented to ER three days after second COVID vaccination with chest pain. Elevated troponin found. Admitted to PICU overnight with normal hemodynamics and stable troponin.
I have had flu shots for the last 10 years and I have never had one hurt as bad as this one did. The shot was administered higher on my arm than I have ever had. It was very sore to move for the first few days and then it felt better. About a week later, I woke up and could barely move my arm. It was sore where I received the shot and my arm was tingling even down into my fingers. I couldn't undress my self, doing the simplest tasks were made very difficult. My arm felt very heavy and ached. I felt a rushing of coldness in my upper arm. Sleeping is impossible on my right side. I will wake up at least 5 times throughout the night in pain because my arm is in a position that hurts me. This pain did go away for about a week and then I woke up yesterday morning, and the same pain is back.
No additional AE reported; received first dose at another facility when they were 15 years old in September 2018/now 18 years old and did not complete the series; This spontaneous report has been received from a registered nurse referring to a 15 years old male patient and his twin brother. No information was provided regarding the patient's medical history, concurrent conditions, drug and allergy history or concomitant medications.  On an unknown date in September 2018, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, frequency, lot# and expiration date were not provided) for prophylaxis.  The reporter stated that at the reporting time, the boy was 18 years old and had not complete the series and missed the second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(inappropriate schedule of product administration). No additional adverse events were reported.       This is one of two reports from the same reporter (#2103USA000715, twin brother case).; Sender's Comments:  US-009507513-2103USA000715:
I had a fever that ran high for 2-3 days. The highest it got was to 103 degrees. I ended up with bronchitis. I was given amoxicillin and another pill for a cough suppressant. Today I am feeling fine.
Vertigo starting 4/20, day of injection, lasting > 6 hrs, another event started 6am on 4/21 lasting > 6 hrs, third vertigo attack started on 4/22 at about 8 pm lasting > 6 hrs, fourth vertigo attack started on 4 /23 lasting 2 hrs.  During all events I was unable to stand or move from bed.  I took meclazine for the nausea and diazepam to reduce the spinning.  I do have meniere's which can cause vertigo but haven't had an attack prior to the shot for 1 year.
This case was reported by a nurse and described the occurrence of pervasive developmental disorder in a 2 year old male subject who was vaccinated with hepatitis B vaccine recombinant Engerix B for prophylaxis. This report was initially received via manufacturer research. On 3/29/1996, the subject received the first dose of hepatitis B vaccine unknown manufacturer. On 5/10/1996, the subject received the second dose of hepatitis B vaccine recombinant Engerix B (lot ENG2004A2). Approximately nine months after the first dose of hepatitis B vaccine, on 12/9/1996 the subject received the third dose of Engerix B (lot ENG2132A2). The recommended interval between the first and third dose of Engerix B is six months. On 10/9/1998, 22 months after the third dose of Engerix B, the subject was diagnosed with pervasive developmental disorder. The outcome of the event was not reported. The nurse considered the pervasive developmental disorder to not be related to vaccination with Engerix B.