chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash, starting on lower back and stomach, along with some swelling throughout the body, starting at approximately 8 pm on 4/16. Benedryl (25 mg) was taken at approximately 9 pm. Redness and swelling continued on 4/17, with the redness, swelling, and itching spreading throughout the body. More Benedryl (25 mg) was taken at approximately 6 pm. Symptoms continued, though to a lesser degree on 4/18. Redness and itchiness had disappeared by 4/19, with swelling going away by 4/21.
Little bit of fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Little bit of fever) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A, 007B21A and 060H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Little bit of fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. In May 2021, PYREXIA (Little bit of fever) had resolved.            It was reported that the patient experienced a little bit of fever the next day after the second shot. Reporter stated that it was around 17 to 18 hours later and it lasted for 24 hours.  No concomitant medications were reported.
The patient received two doses of GARDASIL but did not complete the series.; no adverse event; This spontaneous report was received from a nurse concerning a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On an unspecified date in 2005, also reported as about 14 years ago, when the patient was 15 years old she received two doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (dose, route of administration, lot number and expiration date were not reported) but did not complete the series (inappropriate schedule of product administration). No adverse effects reported.  The outcome of inappropriate schedule of product administration was not reported.
Patient experienced just lightheadedness after receiving the vaccine within 15 minutes after receiving the vaccine. No swelling; no rash; no bronchospasms; no trouble breathing. Patient laid down  and drank some water. Patient felt better and left after  15 minutes of resting and gathering herself. When checking up on the patient, she stated that she generally gets lightheaded after any vaccination. Patient was offered water on site, monitored, and felt fine afterwards.
Feb. 4 rash appeared on right shoulder, it seemed very sensitive to the touch as he would shy away from me if I tried to touch that shoulder (looked like chicken pox, I have a photo from Feb. 6) rash became more concentrated and scabby but no longer sensitive to touch(I have a photo from Feb. 21, Feb. 27, and today Mar. 10), the rash seems less thick now and possibly fading but still present. Feb. 4 to Feb. 7 fever ranging from 102 -103 able to be brought down with tylenol and ibuprofen, fever worse at night. Lethargy, decreased appetite, very clingy and fussy Feb. 7 to about Feb.11 severe nasal congestion, unable to nurse. He's never had such severe nasal congestion to the point he couldn't nurse, sleep unless sitting up, etc. Feb. 11 until present has been acting as if right ear is hurting him. Puts his finger in his ear, pulls his hair, hits himself in the head, cries, fussy and clingy. Mar 6 to present severe nasal congestion again. Not as bad as in February but having trouble nursing, sleeping, etc. Sleeping more during the day than normal, appetite decreased, rash still present on right shoulder.
One day after receiving Pfizer COVID-19 vaccine dose #1 at vaccine clinic patient seend by PCP reoprting fever, fatigue, chills, cough, urinary incontinence, and worsening back pain. Lab results consistent with AKI: patient admitted to HRH, urinary catheter placed, received IV fluids and antimicrobials, and discharged to home three days later medically stable.
2 days(2/18/2021) Leg pain in both  from top of foot to below knee with movement or still . Minor pain along back of legs . (2/20/2021) Pain with step to walk. Only can do 3 or 4 steps. ,(2)21/2021) Get up/Walk with help.
Patient is 13 years of age and inadvertently received a Pfizer Booster Dose thinking they were eligible for a booster dose even though booster doses are not authorized in this age group.
CHILD WAS GIVEN MCV4 WITH LATEX AND TDAP WITH LATEX. PT CAME HOME FROM SCHOOL C/O ITCHING AND SL RASH MOM GAVE HER BENADRYL SENT TO BED. NEXT AM RASH WORSE. WENT TO SCHOOL. AFTER SCHOOL TOOK TO ER. WITH C/O RED SWOLLEN ARMS, "BASEBALL BUMPS" ON EA ARM, RASH EVERYWHERE AND ITCHING.
SHORTNESS OF BREATH; BODY ACHES; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced body aches. On 17-MAY-2021, the subject experienced shortness of breath. Laboratory data (dates unspecified) included: COVID-19 rapid POC test (NR: not provided) Negative. The action taken with covid-19 vaccine was not applicable. The patient recovered from body aches on 16-MAY-2021, and had not recovered from shortness of breath. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Vestibular migraine with unspecified vertigo; severe; ongoing. Caused missed quality of life.
patient received Pentacel instead of Tdap; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case received by physician via consumer. This case involves a 34 years old and unknown gender patient who received pentacel instead of tdap (wrong product administered) while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]. The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE.  On 11-Oct-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE Suspension for injection (lot UJ414AA, expiry-12-Mar-2022) via intramuscular route in unknown administration site.  On an unknown date the patient developed a patient received pentacel instead of tdap (wrong product administered) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  It was reported "The site manager states that she is calling about a 32 year old and a 34 year old that received Pentacel instead of Tdap. She is requesting information on how to proceed with the patient via her e-mail address."  Relevant lab data was not reported.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  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.
We first noticed her eyes moving outward, one or the other, never both at same time, and thought we should take her to an Ophthalmologist. Dr. suggested patching. That didn't work. Then we noticed she would become non-responsive for about 1-11 seconds at a time. This happens multiple times a day. Me and her dad took her back to pediatrician who referred us to ophthalmologist when we though it was just an eye issue. He referred us to another Dr. when he thought she was having Absence Seizures slightly complex. All MRIs and EEGs came back normal, but still no answers.
He first felt nauseated for three days after his first dose of the Pfizer vaccine for COVID-19 six weeks prior. As his symptoms resolved soon after the first dose of the vaccine, he received the second dose as recommended two weeks later. Approximately 5 days later, he began experiencing fevers and chills. This later progressed to cough and shortness of breath. He denied any sick contacts during that time period. Due to the severity of symptoms, he went to urgent care. In spite of a negative work-up, his symptoms persisted. This prompted four additional visits to urgent care. Negative studies included stool studies, influenza viral PCR, COVID-19 PCR, upper respiratory viral panel PCR, and blood cultures. His last visit to urgent care prompted a referral to his local emergency department after an electrocardiogram was performed.    On that day, he was found to have an electrocardiogram concerning for a STEMI in the setting of signs and symptoms of heart failure. Fifth generation troponin was 5,816 ng/L and N-terminal pro B type natriuretic peptide was 15,646 pg/mL. Echo revealed an ejection fraction of 35%, biventricular hypertrophy, and apical hypokinesis. Right and left heart catheterization revealed elevated filling pressures, a cardiac index of 1.8 L/min/M^2, and no obstructive coronary artery disease. An intra-aortic balloon pump was placed. Dopamine and dobutamine were initiated. Endomyocardial biopsy was performed revealing lymphocytes, eosinophils, and giant cells confirming the diagnosis of giant cell myocarditis. Treatment ensued soon after consisting of high dose steroids followed by a long steroid taper, tacrolimus, and mycophenolate mofetil. Soon after these interventions were initiated, his condition improved and both the intra-aortic balloon pump and vasoactive agents were successfully withdrawn. Prior to discharge, cardiac magnetic resonance imaging was performed revealing mildly depressed right and left ventricular systolic function and areas of linear and transmural subepicardial delayed enhancement involving the inferior and septal apical walls compatible with myocarditis. Extensive work-up for the etiology of myocarditis was negative.
Patient started seeing stars, fell up against silver anti-theft gates by front doors, then passed out. Did not hit head, and was awake and alert by the time I reached her.
105.8 temp, hallucinations, chills, body aches, diarrhea, sore throat, 88 % oxygen, hr 150s, tightness in chest, difficulty breathing, extreme fatigue , cold sweats, no appetite.
Kinrix vaccine was administered in the R thigh on 8/16 in the morning. She did fine that day. The next morning (8/17) parents noticed some swelling and redness at the injection site which got progressively worse over the next day. Afebrile. Just started complaining of pain ("burning") the morning of 8/18. Had a slight limp upon waking the morning of 8/18 which resolved. She was seen in the office on 8/18 ~1:10 PM. On exam she appeared well, running and jumping. She had a 16x16cm area that was firm, erythematous and warm, minimally tender. Treatment consistent of ibuprofen.
Diarrhea for 5-6 days.  No treatment GI distress treated with TUMS.
roughly an hour + after receiving the shot my whole left side became very sore, to the point where I couldn't turn my neck or rotate my back. It was painful to sit or lay. This lasted roughly 48 hours
No adverse event; Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine; doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     Specific product reported? Yes, specific product known from information provided.    On 19-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    Concomitant medications details were not reported by the reporter.  Reportedly, Pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. the excursion was found out in an audit and all the vaccines were viable.  Treatment details were not reported by the reporter.
Nonproductive cough, nasal congestion, ear pain, diarrhea, sore throat, shortness of breath, loss of taste, and loss of smell.  All starting 1/1/2022.
This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of bruise injection site in a 31-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included allergy to amoxicillin and heavy menstruation. Concurrent medications included Birth control pill. On 14 December 2012 at 11:00 the subject received 1st dose of ENGERIX B ("entire dose", unknown route, left arm). On 1 January 2013, 18 days after the vaccination with ENGERIX B, the subject experienced bruise injection site, injection site movement impairment and injection site pain. The nurse practitioner reported that heat applied to the injection site was helpful to the subject. At the time of reporting the events were improved. At the time of reporting, it was unknown if the immunization series was delayed or discontinued.
(L) deltoid - erythema and warmth border drawn with pen to monitor over 24 hrs. ZYRTEC 10 mg daily. BENADRYL nightly.
Information has been received from a physician concerning her 4 year old son, with no medical history and no allergies, who, at one year of age, on 22-AUG-2002, was vaccinated with a first dose in the left arm of Varivax (Lot# 642995/0475M). "Now," on 22-APR-2006, at 8:00 am, the patient experienced mild, breakthrough chickenpox, with 10-30 lesions. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. The patient's sisters experienced varicella following vaccination with Varivax (WAES# 0603USA00757 and 0603USA02407). Additional information has been requested.
Pain in left leg and back; Pain in left leg and back; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 13Apr2021 at 10:00 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vitamins (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. On 20Apr2021 at 13:00, the patient experienced pain in left leg and back. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events and the patient would see a doctor on the day of report. The clinical outcome of the events pain in left leg and back were resolving at the time of the report.  No follow-up attempts are possible. No further information is expected.
Dizziness, vertigo, headaches, fatigue. Seen by primary care physician and a neurologist. Bloodwork: Mono, Lyme testing, CBC, CMV, ESR, Thyroid and urine cultures - normal.
I got extremely light headed and dizzy after my first dose and this lasted for about 15-20 minutes. I was feeling weak from the light headedness for another 15 minutes. Then, I spiked a low grade fever.
Altered mental status, possible seizure activity occurred approximately 24 hours after appt of vaccination. Full evaluation pending. Had variable levels of consciousness x 18-24 hours after first episode. 9/23/08-records received for DOS 8/19-8/21/08-DC DX: Altered mental status, possible new onset seizures. Seizure activity day prior, presented to ED after not returning to baseline. Appeared to be hallucinating and less interactive, followed by throwing back of her head and posturing of left hand. Sleepy after event. Transferred.  -
1st Hep A vaccination 2/20/09 - only 2 mo - Between 1st and 2nd dose -should be 6 mo.
Constant humming in Left ear that has not stopped like tinnitus (MD appointment pending ) , headache - constant, joint stiffness in neck, Left eye twitching several times / day
LEFT ARM WHICH SHE GOT AN INJECTION IN DEVELOPED A RASH APPROXIMATELY ~5 IN FROM BELOW THE INSIDE OF ELBOW TO WRIST. NO TROUBLE BREATHING, NO SWELLING. FLAT RED RASH, NOT HIVES, NOT ITCHY, NOT PAINFUL OR BOTHERSOME.  NO PREVIOUS REACTIONS TO PREVIOUS DOSES OF PFIZER NOTICED IT ABOUT 1 HOUR AND 15 MIN AFTER THE INJECTION.
Pt brought to ED with SOB and hemoptysis; approximately a month ago, pt dx with PE, on Eliquis; found to be positive for COVID in ED; Dexamethasone, Remdesivir, O2 supplementation; transitioned to DNR, comfort care; passed away in the hospital
Client was noted to have Red spots first on arms, trunk and then legs. Rash lasted 5-6 client was taken to ER with 104. fever, client TX for pneumonia.
Developed pain at injection site, knot in arm, redness going down arm to elbow.  Also headache, nausea, joint aches, 101 fever, stomach cramps.
I contracted COVID-19 on 06/13/2022 with symptoms of chest tightness, sore throat, congestion, headache, body aches, fever of 100.3, loss of taste and loss of smell. I was given monoclonal antibodies on 06/16/2022. I was prescribed cough medicine with codeine. I was ill for 14 days before my symptoms began to resolve. I have fully recovered with no lingering symptoms.
soreness & reported lump in rt deltoid; no sx until 26FEB94; sl thickening in area noted; c/o tenderness to touch;
Swollen, hot and sore at injection site; Terrible muscle and body aches and pain flu-like; fatigue, lethargy and headache; loss of appetite
A serious spontaneous report of important medical event BELL's Palsy with facial symptoms has been received from a physician, concerning a child of unspecified age and gender subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of  2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on an unspecified date. A physician reported a child experienced BELL's Palsy with facial symptoms after FLUMIST. The symptoms resolved on an unspecified date.
severe left injection site pain, severe general muscle aches, left neck pain, severe headache, chills, fever for 24 - 36 hours starting several hours after injection
Rash two days after shot administered on 9/21/15. Rash did not spread and was itchy. Rash only surrounding site of injection. No other symptoms. Treated with ice and antihistamines.
No ADE, but the undiluted pediatric (5-11yo) dose was given instead of the adult dose.
7qk p/vax scattered papules-no vesicles;reporter does not feel r/t vax but mom of child says something happened w/HIB in 1995 7wk p/vax;
RUNNING NOSE, SORETHROAT,SINUS CONGESTION, RECURRENT SNEEZINGHEADACHE, MALAIZE,FATIGUE,
Red, raised rash approx 4 inches in diameter. Very hot to the touch and painful.
Pt recv vax on 10/24/98; on 10/27/98 pt exp itchy rash over body; tx=Benadryl
Pt passed out after 2nd injection. 1st PNEUMOVAX 23 2d was AFLURIA. Pt stated to me after the fact "I sometimes pass out after a injection."
morning after vaccination, patient's left arm (area where the vaccine was given) was red, swollen, sore and warm to touch
Began with aches all over. By 10:00 PM I was hoarse and found myself clearing my throat. I never felt nauseous, but I started coughing and vomited. After that, my head began to hurt badly. By midnight, I had chills. I was very thirsty and felt like I could not get enough to drink to satisfy my thirst. I felt feverish during the night but did not take my temperature. After getting out of bed at 6:30 AM on 09/26/2013, I was very week and achy and my eyes were swollen. At 6:30 PM, I am still week, achy, and hoarse.
I know that sometimes with the booster side effects can be headache and tiredness I did have those. However, my injection site has a welt the size of a half dollar which is unusual for me. Another symptom to report is dry mouth, I was drinking plenty of water but felt my mouth was severally dry.
Patient doing well per mom. Dr. reviewed all information with mother via phone and is schedule to come back for a follow up within the week.
couldn't walk, problems with controlling her bowels, urine was coming out when it shouldn't be, had numbness in lower area
pt recvd vax & had inconsolable crying w/ pallor & cyanotic lips; had fever of 102; similar episode approx 12 after vax;
Tender area surrounding the injection site (approximately 3-4 inch diameter), warm to touch, redness.
This spontaneous report as received from a pharmacist refers to an 9 year old female patient with arthritis. The patient was allergic to iodine, macrolides, SULFA, and organic nitrates. On 24-APR-2013 the patient was vaccinated subcutaneously with ZOSTAVAX (lot # H021711, expiry date 07-MAR-2014) (dose, frequency, site unspecified). The patient developed diarrhea the night she received the vaccine and "a red area about the size of a quarter at the injection site" on 24-APR-2013. The patient had contacted the pharmacist for medical attention. The outcome of the events was reported as recovering/resolving. Additional information has been requested.