chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Substantial pain and swelling of lymph nodes underneath both arms. Pain and swelling began within 24 hours of receiving vaccine and subsided after 5 days. Took ibuprofen (1200 mg/day) to manage symptoms.
Chills within 8 hours. 18 hrs later on Wednesday the 30th muscle aches, extreme fatigue, slept all day Wednesday the 30th.  Left arm developed large red swollen area that as of today, April 2 at 11 pm is still getting  a little worse. 2 ulcers have formed in my mouth. Still tired and achy.
PROBLEMS WITH BREATHING; FOETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a male neonate of unspecified race and ethnicity.  The patient was enrolled in a non-company sponsored study. The patient's weight was 11 pounds, and height was 19 inches (At the time of birth). The neonate's birth weight was 8 pounds and 3 ounces. No birth defects, genetic or inherited disorders have been diagnosed since birth. The male neonate's mother received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total (first dose),administered on 10-MAR-2021 for COVID-19 immunisation and neonate was exposed via transplacental route. Gestational age was seven weeks and three days at the time of vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Concomitant medications included prenatal vitamins (minerals nos; vitamins nos).  On 10-MAR-2021, the patient experienced foetal exposure during pregnancy. Event duration was 229 days. Reaction first and last time was 1 day. At gestational age 40 weeks, the mother delivered a live, full-term, male neonate via caesarean method of delivery (C-section). Primary reason for C-section was reported to be a previous C-section. On an unspecified date, the neonate had problems and he was admitted in the neonatal intensive care unit (NICU) and hospitalized. The number of days of hospitalization was not provided.  In OCT-2021, Laboratory data included: Cardiac function test and Hearing test was performed, results not reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foetal exposure during pregnancy on 24-OCT-2021, and the outcome of problems with breathing was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and problems with breathing, and foetal exposure during pregnancy as not related. The company causality between covid-19 vaccine ad26.cov2.s, and problems with breathing, and foetal exposure during pregnancy was not related.  This report was serious (Hospitalization Caused / Prolonged). This parent/child case is linked to 20211139855.; Sender's Comments: V0: 20220606249 - covid-19 vaccine ad26.cov2.s Neonatal Dyspnoea. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related. (Considering latency more than 7 months) 20220606249 - covid-19 vaccine ad26.cov2.s Fetal exposure during pregnancy. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with RECOMBIVAX HB (route, lot # and expiration date were not provided). On an unknown date, the patients were administered RECOMBIVAX HB that had been improperly stored in the same temperature excursion as the M-M-R II previously reported. No adverse effects were reported. It was unknown if the patient's sought medical attention. At the time of the report, the patients status was unknown. This is one of several reports received from the same source. Additional information has been requested.
9/6 given HIB, PCV, MMR and varicella vaccines. 9/17  eight case of varicella noted. <10 lesions counted.  Treatment: Benadryl.
Swollen, hard spot at injection site; it's sore; Swollen, hard spot at injection site; it's sore; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Lot number: EL3247) at the age of 78 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (There would be Pfizer BioNtech EL3302 that the first one), for Covid-19 immunization. The following information was reported: PAIN (non-serious), INJECTION SITE SWELLING (non-serious), outcome "unknown" and all described as "Swollen, hard spot at injection site; it's sore". Therapeutic measures were not taken as a result of pain, injection site swelling.  Additional information: Patient sated, she got her second vaccine on 17th which was on Wednesday and she woke up yesterday morning injection was given. She was just wondering this was one of the side effects like swollen, hard spot at injection site. When paraphrased the above concern, patient stated, "Yesterday after the vaccine when she woke yesterday morning took the bandage off where she given her vaccine, this was a hard spot, swollen and it's sore." Patient was informed about the role of Pfizer drug safety. Patient was provided with the number of Pfizer Medical Information as # and requested to dial the option 3 and informed about timings as 8 AM to 8 PM from Monday to Sunday. Email Address: Patient stated, No. Patient stated, "she can ask them question. Does a side effects from the injection?" patient stated, "It might be on little card they gave me. There would be Pfizer BioNtech EL3302 that the first one. You want second one. In first she had not any problem. Second one EL3247." Dose: patient stated, "I don't know. I don't see." Treatment: patient stated, "No."  No follow-up attempts are possible. No further information is expected.
arm started itching at vaccination site; became red at the vaccination site; swollen at the vaccination site; A spontaneous report  was received from a consumer (patient) concerning an 65-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm started itching at vaccination site, became red at the vaccination site and swollen at the vaccination site.  No medical history was provided. No relevant concomitant medications were reported.  On 11-Jan-2021, 8 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 19-Jan-2021, the patient experienced arm started itching at vaccination site, became red at the vaccination site and swollen at the vaccination site.   Treatment information included patient took Hydrocortisone, Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, arm started itching at vaccination site, became red at the vaccination site and swollen at the vaccination site were unknown.
motion sickness; feeling uncomfortable; persistent nausea, varying degrees severity; 3x vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MOTION SICKNESS (motion sickness), DISCOMFORT (feeling uncomfortable), NAUSEA (persistent nausea, varying degrees severity) and VOMITING (3x vomiting) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 022B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced MOTION SICKNESS (motion sickness), DISCOMFORT (feeling uncomfortable), NAUSEA (persistent nausea, varying degrees severity) and VOMITING (3x vomiting). At the time of the report, MOTION SICKNESS (motion sickness), DISCOMFORT (feeling uncomfortable), NAUSEA (persistent nausea, varying degrees severity) and VOMITING (3x vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable. Treatment medicines includes Imodium (1 tab, twice a day)
This shot was the absolute worst experience I?ve had from all the Covid shots I?ve received. About 12 hours after receiving the shot, I started experiencing joint pain. Then, I got chills so bad I couldn?t stop shaking. I tried piling blankets on top of me but couldn?t get warm. I was sweating profusely but still couldn?t get warm. My body aches hurt so bad, I couldn?t stop moving. I didn?t sleep all night. The next morning, my head was pounding. The next evening, I had ice pick headaches. Two days later, my joints still ache. My headache has gone away as long as I?m eating Tylenol. My kidneys hurt for 2 full days even though all I was drinking was water. This was the absolute worst experience I?ve had from the Covid shots. Based on this experience, I will not do anymore boosters. This was awful.
Dizzy/ off center; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy/ off center) and NAUSEA (Nausea) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 031AZ(or2)1A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced DIZZINESS (Dizzy/ off center) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizzy/ off center) and NAUSEA (Nausea) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-076491 (Patient Link).
73 year old gentleman with obesity, h/o stage III diffuse large B cell lymphoma s/p R-CHOP 4/2021 to 8/2021 (in remission), h/o H.pylori gastritis and BPH/LUTS who presented to ER on 1/10/22 with cough, shortness of breath and weakness of 2-3 days duration. Home COVID test was positive. Family noted desaturations on home pulse ox.   In ED, he was febrile to 103.5F, tachycardic and hypoxic to 80s on RA. COVID-19 swab was positive. Labs significant for LDH 478, ferritin 501, CRP 14, D dimer >4 and WBC 2.8K. CTA chest showed bilateral PE and ground glass consolidations. He was given Decadron, Remdesivir, Lovenox and admitted.    He had worsening hypoxic failure immediately after admission requiring oxymizer from 1/11/22 and then high flow oxygen from 1/14/22. He was given higher dose of Decadron and received Tocilizumab on 1/14 and 1/15/22.    Hospital course was also significant for possible superimposed bacterial PNA (Ceftriaxone 1/11-1/17, Doxycycline 1/11-1/22), S.epidermidis in blood culture 1/10 (Vanco 1/11-1/12, stopped as contaminant bacteria), possible fluid overload (BNP elevated 1/20, Lasix x 1), mild delirium and moderate PCM.    Hospitalization was prolonged due to his high oxygen needs.    o COVID-19 pneumonia, acute hypoxemic respiratory failure: Symptom onset on 1/7/22. COVID positive on 1/10/22. Last fever on 1/10/22. CRP decreased from 14 on 1/10 to 0.9 on 1/17/22.  - Weaned to 3-4 lpm nasal cannula now. Home oxygen arranged; goal SpO2 >92%. - He received Decadron 6mg on admission, 20mg daily from 1/11-1/17 then 10mg daily (1/18-1/22).  - He received Remdesivir course and Tocilizumab on 1/14 and 1/15.  - Continue isolation until 1/27/22 per Regional/Local ID guidance. - Follow up CXR in 4-6 weeks.  o Acute PE: He was on Lovenox 100mg sc bid and then switched to Pradaxa for 3 months duration.  o Moderate PCM: Intake has improved over last few days. Encourage intake. o H/o lymphoma, BPH/LUTS: Out-pt follow up advised. Out-patient CBC has been requested to monitor low WBC and platelets.    Primary Procedures:  CXR    Secondary Procedures: CTA chest
Symptoms were extreme pain in lower legs. I could not stand in one location for more than a minute.  At this point all of the pain was below my waist.  The symptoms began on or around June 15th 2021.  I took Tylenol trying to relieve the pain until my emergency room visit  visit on July 4th, 2021.  On July 6th I was hospitalized for 2 weeks.  After being home after that hospitalization the pain began to spread into my upper extremities. Mostly in my arms.  I was re-admitted to the hospital after another visit to the emergency room.
Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with INFLUENZA (manufacturer unknown, batch number: unknown) during 2007/2008 season. The child presented with influenza which later lead to death on unknown date.  The causality was not reported.  The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition.  Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion.  Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.
Vaccine site on Right upper arm became very hot, red, swollen and itchy.  She did not experience any respiratory difficulty or tongue or lip swelling.
QUADRACEL was administered instead of PENTACEL with no reported adverse event; QUADRACEL was administered to an 18 month old patient with no reported adverse event; Initial information received on 03-Nov-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 17 months old male patient who was administered Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) vaccine [Quadracel] instead of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 03-Nov-2023, the patient received 0.5 ml dose (dose 4) of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) vaccine Suspension for injection of lot U7931AB and expiry: 09-Nov-2025 via intramuscular route in the left deltoid for immunization; instead of Diphtheria/Tetanus/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) vaccine (Pentacel) at an age of 17 months with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency: same day).  No lab data was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Left arm vigorous convulsions, eyes rolled back, loss of consciousness, O2 dropped to 80%
7-14 "heat rash" in crotch, behind knees. Gets worse daily
Girl's mom specifies that child was vaccinated on October 15,2016. KINRIX was administered on the right arm. MMR on the left arm. Varicella on the left arm. Around 3:00pm the right arm was swollen, red and hard. Mother applied ice. It looks swollen and warm to touch.
At work suddenly became dizzy drunk feeling with I went on FLMA. nausea. Unsteady on my feet. felt as if my heart was  vibrating. I am sure later I had a TIA. Was unable to communicate. I knew what I wanted to say but I could not get the words out. March 1/2021   I went on FLMA. It never dawned on me the vaccine could have affected my already stressed heart. I am still experiencing these symptoms. I just thought of this this week. I still have extreme fatigue, increased palpitations,  and increased SOB. I do not feel able to work right now.
Rash at immunization site. Pt advised to speak w/MD and to use BENADRYL and hydrocortisone cream allergies for profile were also updated.
the night of my first dose i had some brief fleeting palpitations lasting only a few moments that came and went quickly.  the days following my first dose i had fevers x 11 days.  i went for subsequent covid testing d/t symptoms which was negative. i also developed blue discoloration in the 3rd toe of my left foot, i sought out treatment from my pcp who put me on procardia thinking it was a raynauds flare which i have never had something like this before, 3 doses in my HR was in the 170's and i went to the ED.  all testing was negative and procardia was d/c'ed.  four days later i had f/u with a cardiologist who sent me back to the ED d/t continued elevated HR's and EKG changes (HR was in the 130's).  i had further testing in the ED and was put on Metoprolol twice daily and released.  cardiology had me do outpt labs for any autoimmune issues which came back with some abnormal results (previous labs from when i was dx'ed with raynauds about 5 years earlier were negative) and they also sent me for an ECHO, holter monitor and stress test .  i also had a PCP follow up and was referred to rheumatology d/t abnormal findings from my labwork panel as well as vascular d/t continued blue toe on my left foot.  i ended up needing f/u stress test d/t abnormalities found on my first one and was send for a stress ECHO which i passed.  i had my second covid shot which i had done in my work place hospital setting d/t cardiac issues and my HR went into the 150's about 30 mins after the shot.  i contacted cardiology who advised to take extra dose of metoprolol (i was given the option to go back to the ED as well by vaccine clinic staff).  i was eventually cleared by rheumatology who felt that perhaps the vaccine kicked something up in my system but that ultimately they cleared me, vascular feels as though my toe may be chalked up to a vasospasm from my 11 days of fevers and that it may not be reversible, cardiology said all tests were negative.  my neurologist that treats my migraines is having me see a electrophysiologist to r/o POTS as my HR still elevating when going outside in the heat and goes up during exercise in the heat.  i am an active person at baseline and still aren't feeling at my baseline.  my fingers in the spring swelled out of no where to the point i had to get my wedding rings resized.  i am seeing that cardiologist in Oct as that is the soonest they could get me in and i see my PCP again in august.
Information has been received from a registered nurse via a field representative concerning a female who on an unknown date was vaccinated with a dose of ZOSTAVAX, subcutaneous injection in her arm (not further specified). Two days after she was vaccinated, the nurse reported that most of the patient's upper arm was red, swollen and itching. The field representative did not have knowledge in which arm the vaccine was administered. The patient self-treated herself with hydrocortisone cream, and was recovering at the time of report. No further information is expected.
child deleloped rash bilaterally over both thighs  According to mom and maternal grand mother the maculopapularv rash started from the the sites =of vaccination on the day he received the shots  The rash then spread upwards towards the groin and down towards knee  the rash is non blanchable  seems to be non pruritic (child does not seemed to be in discomfort no resp distress no other constitutional symptoms rash compared to yesterday is not progressing nor it is regressing