chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
A non-serious spontaneous report of itchy rash has been received from a certified medical assistant concerning an eight-year old male patient subsequent to FLUMIST. No relevant medical and medication history were reported for this patient. The patient received FLUMIST via nasal route at a private doctor's office during a Flu Clinic on 05-Nov-2008. Two hours after FLUMIST administration, the patient developed a rash which was described as extremely itchy. The patient recovered on the same day.
myalgias, no fever, no rash; other sx of serum sickness; 8SEP92 f/u subsequent dose day 7 followed by worse reaction (not stated); last 2 doses used w/no adverse effects;
sore arm; This is a spontaneous report from a contactable nurse (patient's parent). A 46-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left on 21Sep2021 at 46 years (Batch/Lot number FFEE39 or FFEE79) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included ongoing overweight. The patient's concomitant medications were not reported. The patient experienced sore arm (non-serious) in 2021 with outcome of unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101384449 Same patient/drug, different dose/events
Whole body erythematous maculopapular rash appeared <12 hours after administration. Treated with benadryl q6h and observation. Rash improved with treatment, still present at time of form submission.
Shingles rash two months later accompanied by outbreak of mouth blisters which may or may not have also been shingles
Patient states when he awoke he had dark brown sores on the inside of his mouth and on his lips. Patient stated they did not hurt or itch. Patient did not call physician and did not report adverse effects until January 9, 2010 at 11:00AM. Some sores still remain as of January 9, 2010 on lips.
Within 24 hours of vaccination developed 14x14 cm diameter area of redness, warmth, tenderness, Administered BENADRYL by mouth every 6 hours and TYLENOL for discomfort.
Pt received 2 immunizations (Spikevax & Fluzone Quad) in left arm.  Immediately after the second was administered pt mentioned shortness of breath, nausea, dizziness, turned very pale, and started sweating. He also had mild vomiting for a few minutes. He said he does get very anxious when receiving vaccines and reported no itching, extreme trouble breathing, swelling of lips/tongue/throat.  Pt appeared to lose consciousness for a very brief time (no more than a few seconds). I had pt remain sitting and placed ice packs on his back/neck.  Offered to call 911 (ambulance services), family/friend, but pt declined. After an extended period of time with ice packs and after pt had some water he felt he was ready to go.  Advised pt if he still had any symptoms to avoid driving and contact someone for a ride, if he had any other symptoms (signs of allergic reaction) call 911 or go to the ER immediately.  Pt again declined for us to call ambulance assistance or driver assistance before he left.  I contacted the pt around an hour after he left and verified pt made it home safely & had experienced no further adverse symptoms.
Adacel was administered to a patient who was 8 years and 2 months old/ No AE; Initial information received on 07-Dec-2021 regarding an unsolicited valid non-serious case received from a other health care professional via Medical Information (MI) number: 00888557.  This case involves an eight years two months old male patient who was administered a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (product administered to patient of inappropriate age).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE, VARICELLA ZOSTER VACCINE and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for prophylactic vaccinations.  On 07-Dec-2021, the patient received a 0.5 ml fifth (total) dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Oral solution lot number: C5863AA, expiry date: 13-Apr-2023, frequency: once, strength: standard via intramuscular route in the left arm for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).  It was reported "Caller stated that they had a dose of ADACEL was administered to a patient who was 8 years and 2 months old. Caller stated that ADACEL is advised for 10 years of age and older. Caller asking if this is okay or what should be done. Caller mentions they use Pediarix in there office for DTaP (diphtheria, tetanus, and acellular pertussis) which is not supposed to be administered past 6 years of age and this child is 8 years and 2 months but does not know why the Medical Assistant gave him Adacel today."  Product used: Used, First time product used: Yes and Still using product: No.  At the time of reporting no adverse event 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.
Patient received  monovalent Pfizer Dose 2 vaccine which is no longer authoriozed.
well check-up 11 hr post vax woke w/body in clammy sweat, vomiting, delirious, distressed, entire body in shock, no urine, tremors, semi-convulsive, dizzy-cant not site;can only lay in bed;
A report was received from a health care professional on 12/19/03 concerning a 3 year old vaccinee of unknown gender who inadvertently received Fluvirin vaccine on an unspecified day in December 2003. On an unspecified day in December 2003, the vaccinee received Fluvirin. No adverse event was observed. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
BAD ACHES; SORE ARM STILL FROM NEEDLE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced bad aches. On 09-APR-2021, the subject experienced sore arm still from needle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad aches on 09-APR-2021, and had not recovered from sore arm still from needle. This report was non-serious.
Had apparent seizure a few hours after immunizations. T=100.8. There is a fit of seizures.
minor swelling and soreness in his arm; minor swelling and soreness in his arm; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Dec2020 (Lot number: EH9899) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "perforated ulcer" (unspecified if ongoing); "Arthritis" (unspecified if ongoing), notes: which he takes Celebrex as needed; "Influenza A", start date: Mar2020 (unspecified if ongoing), notes: suffered for 2 months on and off; "short term disability nd not working" (unspecified if ongoing), notes: when he was diagnosed with influenza A. The patient's concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "minor swelling and soreness in his arm".  Additional Information: As part of the patient's medical history, the patient reported that in Mar2020, he got severely sick while working in the ICU so he went to the Emergency Room and requested a Covid test, but they did not have them. He was then treated with oseltamivir phosphate (TAMIFLU), high dose prednisone, and was tested for Influenza which resulted with a positive Influenza A. He went a couple times more to the Emergency Department for the Influenza A and he reported that he was wheezing and received azithromycin, tami-flu, prednisone, Levaquin or something. They thought it was pneumonia but did not know that, so was being over cautious. That was in Mar2020 and Apr2020. In May2020 he had a Covid negative test. He had an antibody test in Aug2020 negative result. In Sep2020 his blood work was negative.   No follow-up attempts are possible. No further information is expected.
Information has been received from a health professional concerning a 2 month old patient who was vaccinated with a first dose of rotavirus vaccine. No product quality complaint was involved. No other information was provided.  Additional information has been requested.
Case number PHEH2012US010928, is an initial spontaneous report received from a nurse on 25 May 2012 with a follow up information received on 06 Jun 2012. This report refers to 20-year-old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M11071) intramuscularly, without reconstituting with MenA component on 25 May 2012. No adverse event was reported following this administration error. The patient did not wish to receive Men A portion of the vaccine. No other details were provided. Follow up received on 06 Jun 2012: Age of the patient updated.
pt recv vax 12NOV98 2PM & 8PM had onset of sore lt arm, felt like had a fever, generalized myalgia;fever lasted through 15NOV98 afternoon as well as myalgia;sore swollen arm a little better 16NOV98;
No adverse reaction. Patient received monovalent vaccine instead of bivalent booster.  Mislabeled by the person who opened the vial for the day.
Patient was fully vaccinated with Moderna on 1/28/21 and 2/25/21. Patient had increased SOB over past few days and was admitted with COVID since 12/27/21
Bruise; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruise) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Prinzmetal angina since 2004. Concomitant products included EZETIMIBE (ZETIA), PRAVASTATIN, ACETYLSALICYLIC ACID (ASPIRINE), METOPROLOL, OMEPRAZOLE, LOSARTAN and TRAZODONE for an unknown indication.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced CONTUSION (Bruise). At the time of the report, CONTUSION (Bruise) had resolved.            No treatment medications were provided.  The patient felt a knot which was like a pencil eraser under her skin. It was obviously a knot in a vein. A bruise began to spread.  A month later patient got second vaccine, but didn't go to the doctor for that one.   This case was linked to MOD-2021-021685 (Patient Link).
dizzy, nausea w/in 10min of vax;arm swollen, bled into site;BP nl 164/94, pulse 94;9NOV follow/up call still swollen & bruised; has had heat & cold tx;
I woke up in a full sweat and it was cold in the house after waking up had a massive headache with body pain was very hard to wake up to go to work when I did go to work I was in pain and very nauseous was sent home from work and go home lay down and went back to the pain in suffering woke up the next day feeling good
pt recvd vax & had inc t 103 w/ vomiting; chills; screaming; wakefullness all noc; this am quiet & protective of site;
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. On 09SEP2015 the patient was vaccinated with incorrectly stored dose of ROTATEQ (dose and frequency were not reported, lot # K020181 with expiration date: 24JUN2016). No adverse effects reported. This is one of the several reports received form the same reporter. Additional information has been requested.
He had a lot of congestion; Body aches; Cough; This is a spontaneous report from a contactable consumer (patient) via Regulatory Authority.   A 33-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0177, expiry date: unknown), via an unspecified route of administration, administered in arm left on 17May2021 at 15:15 (at the age of 33-years-old) as dose 1, single to COVID-19 immunization at hospital. Patient medical history and family medical history was none. On an unspecified date in May2021, the patient had a lot of congestion, body aches and had cough. Caller stated he had side effects to the Pfizer Covid-19 vaccine and went to emergency room. The patient had a lot of congestion since the first dose and body aches since the first injection and also cough but after the second dose. He was discharged from the emergency room. The emergency room ran some tests and told him to take some Tylenol. He had a Covid-19 test and he was expecting a call with the results and the staff at the hospital took his temperature. He explained to the hospital staff that he was having the symptoms that are on the Covid 19 vaccine paperwork and that was the reason for his visit, since he had the two Covid 19 vaccines. He would like to point out that he asked the nurse when he was going to have the second dose, since the first vaccine he was still having side effects, he asked her if he was in danger to have the second vaccine. The nurse told him he was ok to get the second vaccine. The nurse told him he might have some muscle pain but he should not be worried about it. He provided Pfizer with what happened so far since he had the vaccine. He was not able to stand up with the muscle pain and he could not support his legs any longer. On 16Jun2021, the patient underwent lab tests and procedures which included blood work, temperature and COVID-19 virus test with unknown results. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
The day after the vaccine she started to have a low-grade fever 99.5-101.2, and moderately fatigued. Still continuing, Nov 10th fever went up to 103.3, we contacted her pediatrician and had an appointment the next day. They tested for COVID-19, influenza, UA, strep throat, blood work (mono CBC, CMP, CRP) negative and within parameters. They are not sure what the cause is. Said to make sure she gets plenty of rest and drink fluids. If symptoms worsen to call and come back in.
Chest pain  1 month later , unsure of onset because I was so depressed I was confusing physical symptoms  as being mental
Prickly, tingling sensation in skin, especially in hands & feet. Itching face, lips, forehead & scalp. Small red area on forehead, started with itching & tingling before rash appeared within a week of vaccination. Fatigue & sleepiness. Itching & red oval rash at injection site, persisting over a week.
(L) deltoid red, hot and swollen after PCV13 vaccine. Also c/o body aches.
I have been experiencing periodic dizziness since dose one of the covid-19 vaccine. The first dose I fainted the night of receiving dose one and had an unusual period. Now two months later and my period is super heavy with increased blood and and cramping. I haven?t had a period like this since my early 20s.
Headache, Myalgia, Arthralgia, Fatigue, chills Narrative: Myalgia, headache, chills, arthralgia, fatigue; taking ibuprofen
three test on 5/4  antibodies both negative  then positive for PCR from same day results came Thursday evening 5/6 retested Friday per employee 5/7/2021 on review of activities noted PAPR had turned off 4/21 in COVID + room, believed to be the source of my COVID exposure.  ER Visit 5/7 then again on 5/14 resulting in admit with discharge Sunday, received betamethasone two injections 24 hours apart.  Continue to be sick, cough, headache, severe fatigue-sleeping more than 1/2 the day.
I've had a few episodes of dizziness. Since a few days after the vaccine I've a pain in the left side of my neck that radiates to my left eye. It seems that this pain is traveling. I've also had several headaches. I do not get headaches. I have not been treated for these events. Still having soreness/pain in left side of neck and eye to this date. 01/12/2021.
This spontaneous report as received from the patient's mother refers to a 1 year old patient of unknown gender. The patient was vaccinated with VARIVAX (Merck) injection (dose, route, lot # and expiration date unknown) and PROQUAD (Merck) (dose, route, lot # and expiration date unknown) on the same day 05-DEC-2013. No adverse effect was reported. No adverse event (AE) or product quality complaint (PQC) was involved. Additional information is not expected.
Pt was found deceased at approximately 0745 on 12/2/21.  Found in room face down absent of vital signs.  Resident is a full code, CPR was initiated, EMS notified, AED applied and shock not advised.  EMS rhythm strip showed asystole.  Resident was cool to touch.
Patient with multi-vessel coronary artery disease.  On November 17, 2021 the patient was admitted underwent elective CABG x3. REcovered in hospital and discharged. Hospital admission was within 6 weeks of receiving the CVOID vaccine.
Starting on the 16th of Jan I became very sick to my stomach.This lasted the the AM on the 18th no other syptoms present. I left work at 8:00am on the 18th with no fever ( I checked three times during the midnight shift ) I went home to bed and woke up at 6:00pm with 100.8 fever ( I never run a fever ) had fever chills and joint pain in the upper body no respiratory issues .Within 48 hours  the fever was gone as well as the chills but I continued to be sick to my stomach for another two days.I wanted to report this delayed reaction because of my underlying HIV and given the fact no individuals with HIV were included in the initial study. I tested negative with the nasal swab test on the 20th.
Shoulder pain with redness and swelling, fever, chills, and eventually a frozen shoulder.
On October 24th, 2017, at approximately 9:45am, I met with patient, a student, to administer a flu vaccine. The parental consent form was present and verified. Patient states he had received the vaccine in the past and was "nervous" to receive another one. The flu vaccine was administered as ordered in the patient's right deltoid. Immediately following the injection, patient tensed his whole body, lost consciousness, had tremors and was unresponsive. I placed patient on the floor and checked that he was breathing and had a pulse - bother were present. This lasted for approximately 30 seconds and patient opened his eyes, tried to sit up and he lost consciousness again. Employee was present and went to retrieve the school nurse. Vital signs were checked by the school nurse and were stable. EMS was also activated. Police and Fire, along with paramedics responded. Patient's mom was called and present at the school. Patient was alert and oriented and transported via ambulance to emergency room per his mother's request.
Patient reports feeling flushed; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Patient reports feeling flushed) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced FLUSHING (Patient reports feeling flushed). At the time of the report, FLUSHING (Patient reports feeling flushed) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-362026 (Patient Link).
This spontaneous case reported by a consumer, describes the occurrence of sluggishness (dopey), abdominal discomfort (upset stomach), pain in extremity (pain in legs), cough (still have a cough) and inappropriate schedule of vaccine administered in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037C21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Aug 1, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 29, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 29, 2021, patient experienced sluggishness (dopey), abdominal discomfort (upset stomach), pain in extremity (pain in legs), cough (still have a cough), inappropriate schedule of product administration (inappropriate schedule of vaccine administered), chills, fatigue (tired) and pyrexia (on that night had fever). Patient treated with Tylenol (paracetamol) for fever, at an unspecified dose and frequency. On Sep 29, 2021, inappropriate schedule of product administration (inappropriate schedule of vaccine administered): resolved. At the time of the report, sluggishness (dopey), abdominal discomfort (upset stomach), pain in extremity (pain in legs), chills, fatigue (tired) and pyrexia (on that night had fever) outcome: unknown and cough (still have a cough): not resolved. No concomitant medication reported. This case linked to MOD-2021-307264 (patient link).