chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lethargy,extreme stomach cramps/pain,extreme sleepiness and vomiting. Came in cycle of 30-40 minutes. In awake state was happy and smiling. When cycle began he would begin with sleepiness and lethargy, then stomach pain then vomit then would fall immediatly to sleep. My son was diagnosed with  intussusception on 11-23-07. Unknow if directly related to any vaccines, however, without sufficient research to rule out reaction for new Rototeq in particular I felt the need to report 12/26/2007-records received for DOS 11/23-11/24/07-DC DX: Intussusception. Air contras enema failed to reduce. Successful laproscopic surgery with incidental appendectomy.One day history of colicky abdominal pain and poor feeding. Three episodes of nausea and vomiting. Temperatue 38.2.
Case number PHEH2014US012577 is an initial spontaneous report received from a nurse on 11 Jun 2014. This report refers to an 18 years old female patient. She was given only Men A component of MENVEO (batch number: M13013 and expiry date: Sep 2014) reconstituted with sterile water instead of MenCYW-135 on 10 Jun 2014. No adverse event was reported following this administration error.
1ST PFIZER COVID VACCINE 19JUL21, 2ND PFIZER COVID VACCINE 09AUG21. PATIENT RECEIVED 3RD VACCINE ON 21DEC21. NO ADVERSE EVENTS NOTED DURING OBSERVATION TIME. SPOKE WITH IMMUNIZATION BRANCH, THEIR MEDICAL DIRECTOR AND NURSE STATED - PATIENT DOES NOT HAVE TO REPEAT DOSE AND THEIR WAS NO INCREASED SIDE EFFECTS FOR RECEIVING DOSE EARLY.
AFTER 3RD VACCINATION PATIENT STATES BOTH KNEE JOINTS STARED TO HURT. ACCOMPANIED WITH TINGLING SENSATION. AFTER 1/2 HOUR OF WALKING PATIENT GOT TIRED OF WALKING.
Vasovagal Syncope. Approximately 3 minutes after vaccine administration pt became pale and lost consciousness for aprox 10 seconds. Eyes were open and pupils were equal and reactive to light. Pt was sitting beside mother so injuries occurred. Upon regaining consciousness pt vomited small amount. Auscultation of lungs were clear in all fiends. pulse strong and regular at 75. Pt stated that she felt ok, that she had just gotten dizzy. She was observed for another 20 minutes before leaving clinic with her Mother at which point she stated that she felt good. Spoke with MD regarding the incident and she recommended having the family follow up with PCP to rule out any underlying illness. Call made to Mother's Cell phone, VM full. Will continue to try to reach her.
Bell's Palsy with facial drooping; This spontaneous case was reported by a health care professional and describes the occurrence of BELL'S PALSY (Bell's Palsy with facial drooping) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced BELL'S PALSY (Bell's Palsy with facial drooping) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's Palsy with facial drooping) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The patient was treated in the Emergency Department with antiviral therapy.  Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.
Initial unsolicited report received from a pharmacist via other company (Merck) (Manufacturer Report Number: 00624653) on 30 October 2017. This case was linked with 2017SA212777 (same patient). This case involves a female patient of unknown age, who was vaccinated with a dose of DIPHTHERIA AND TETANUS TOXOIDS (TD) (dose, dose in series, batch number, expiry date, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications was not reported. On an unspecified date, following the vaccination, the patient developed hives. Lab data and corrective treatment was not reported. The outcome was recovered on an unspecified day. List of documents held by sender: none.
2 days after received vaccine had localized rash at injection site, which progressivley spread to most of her entire body, had itching.
8AUG97 pt recv vax;20AUG97 knot of lt arm;2SEP97 dx w/abscess of inj site of lt arm;drained cleansed w/betadine,flushed w/h2-2 analgesia 1% lidocaine;4SEP97 abscess redressed & repacked;15SEP97 abscess resolved;
Allergic reaction type redness / swelling / inflammation.  An un-even blotchy red patch about 4 inches across, slightly below injection site. Patient started anti-histamines. No further follow-up at this point.
tested positive   few weeks after  receiving first dose of Moderna Covid-19 Vaccine; second dose on 26th Jan2021 but could not take due to the covid-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive   few weeks after  receiving first dose of Moderna Covid-19 Vaccine) and PRODUCT DOSE OMISSION ISSUE (second dose on 26th Jan2021 but could not take due to the covid-19 infection) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure fluctuation.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive   few weeks after  receiving first dose of Moderna Covid-19 Vaccine) and PRODUCT DOSE OMISSION ISSUE (second dose on 26th Jan2021 but could not take due to the covid-19 infection). At the time of the report, COVID-19 (tested positive   few weeks after  receiving first dose of Moderna Covid-19 Vaccine) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (second dose on 26th Jan2021 but could not take due to the covid-19 infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) tested positive few weeks after receiving first dose of Moderna Covid-19 Vaccine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product include unspecified blood pressure pill.  No treatment medications provided by the reporter.
This case was reported by a consumer via call center representative and described the occurrence of chills in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On 1st April 2019, immediately after receiving SHINGRIX, the patient experienced chills, fever, muscle soreness and headache. On an unknown date, the patient experienced injection site pain and pruritus. On an unknown date, the outcome of the chills, fever and muscle soreness were unknown and the outcome of the headache, injection site pain and pruritus were recovering/resolving. It was unknown if the reporter considered the chills, fever, muscle soreness, headache, injection site pain and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX and day before reporting, the second the patient had chills, fever and body temperature was recorded as 101.6 and headache and sore muscles. The next day patient woke up with headache and soreness at the injection site and kind of itchiness. The patient felt slightly better. The reporter asked were all these normal side effects of SHINGRIX.
Initial report was received from a healthcare professional on 12 August 2013. A female patient (age and date of birth not reported) had received a dose 3 injection of DTaP (Manufacturer Unknown) on 26 April 2002 (lot number, route, site, and side of administration not reported). On the same day, the patient experienced a seizure and had to be taken to the emergency room. The pediatrician who administered the vaccine was deceased. A note in the chart from the current physician stated the patient experienced a "fever reaction" and was not to receive any vaccine containing pertussis. The patient had a history of receiving DTaP, manufacturer unknown, on 18 January 2001 and 16 July 2001 (lot number, route, site and side of administration not reported). The patient's outcome was recovered. Documents held by sender: None.
The patient said that 4 to 5 hours after receiving the vaccine for the first time this year, she felt a burning sensation in her sinuses, a low grade fever of 99.9 degree F and a headache and general malaise. Symptoms lasted for 24 hours.
first episode of shingles (herpes zoster) in L 3 dermatome. (mild)
Patient was initially given varicella vaccine 0.2ml in the left forearm as an intradermal shot.  Patient was later given the remaining 0.3ml SC in the left upper arm.  There was an immediate localized skin erythema and itching at left forearm.
This report is only in response to the request from the Department of Health to submit all patients into VAERS that received the COVID19 vaccine and subsequently tested positive for COVID19.  No other adverse reactions to the vaccine were reported. The patient had a positive COVID19 test on 12/30/20.
POSSIBLE PLANTAR FASCIITIS; SOMETIMES SHARP PAINS ON THE BOTTOM OF THE FEET/FEEL PAIN IN THE RIGHT LEG; LEFT LEG HAD NUMBNESS ON THE BOTTOM OF THE FOOT; TINGLING IN BOTH FEET; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: 23-AUG-2021) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the patient experienced sometimes sharp pains on the bottom of the feet/feel pain in the right leg, left leg had numbness on the bottom of the foot, and tingling in both feet. Laboratory data included: Diagnostic ultrasound (NR: not provided) Normal. On 07-MAY-2021, the patient experienced possible plantar fasciitis. Laboratory data included: Neurological examination (NR: not provided) plantar fasciitis. Treatment medications (dates unspecified) included: cortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left leg had numbness on the bottom of the foot, and sometimes sharp pains on the bottom of the feet/feel pain in the right leg, and the outcome of tingling in both feet and possible plantar fasciitis was not reported. This report was non-serious.
10:30 pm: fatigue and chills 12:00am (1/15/21):100.5 degree fever, headache, neck pain on both sides, pain in joints of hands, neck, knees, ankles and pelvis, ear ache on the right side, skin hypersensitivity 1:00am (1/15/21): 100.9 degree fever, pain in wrists and  hands with inability to grip pencil, burning pain in abdomen at skin crease, burning pain in left armpit,  pain in joints of hand, wrists, elbow, pelvis, hips, throughout left deltoid near injection site, 2:00am (1/15/21): 99.3 degree fever, profusely sweating, chills
Initial information received on 11-October-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 70 years old female patient foe whom FLUZONE HD was given to a patient that was beyond the expiration date was reported, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 01-Oct-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI840AC via intramuscular route in unknown administration site. The patient developed a non-serious fluzone hd was given to a patient that was beyond the expiration date. (expired product administered) unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was not reported whether patient experienced any adverse event or not. The case is actual medication error due to expired vaccine used. Final diagnosis was fluzone hd was given to a patient that was beyond the expiration date. It was unknown whether patient experienced any adverse reaction after vaccination. Outcome of the event was not applicable. 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 Directive 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. Documents held by sender: none
Rash started at injection site and quickly spread. Parents report patient had a fever along with the ras. Patient was seen in the ER last night(07/10) due to irritanbility, conservative measures prescribed. Father states he is much better today. He is breast feeding well. he continues to have a rash which appears to be chicken pox like. Treated with Tylenol and Mupirocin
Fever of 102, severe chills, head pain. Motrin and Tylenol given alternately every 4 hours.
Patient received 1st dose of Pfizer on 1/22/21 and today received 2nd dose, however, Moderna was given in error.  While in observation, pt experienced dizziness, BP elevated at 242/108. Patient reports not taking BP medications today.
Itching and rash in diferent areas (thats occasionaly), insect bites got infected (that did not happened before the vaccination and still happening.
Patient received Flu vaccine at approx 10:30 AM and at about 7:30 PM she started losing her vision and 10 min later it was completely gone, but within 10 min it started coming back - pupils dilated, memory loss of days events. Physicians checking for seizure or TIA, but now leaning toward migraine caused by flu shot. Appeared to have mild case of Bell's Palsy.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-395985 (Patient Link).
Pt to clinic for immunizations.  Pt received two immunizations to L deltoid. After receiving second immunization pt lost consciousness for approximately 3 to 5 seconds. Pt positioned on exam table in semi sitting position with feet elevated. Pt remained in exam room for approximately 5 minutes and stated she felt light headed and lost consciousness again for 3 to 5 seconds.. Pt drank a box of juice and ate a pack of peanut butter crackers. Pt stated she did not feel dizzy or light headed. Mother and pt advised to see pediatrician today for evaluation. Mother stated she would take child to pediatrician after leaving clinic today.
Vaccine diluted with 0.8ml of diluent rather than 1.8ml
Tinnitus; This is a spontaneous report from a non-contactable consumer (patient). A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number was ER8732), via an unspecified route of administration, in Left Arm on 01Mar2021 (at the age of 52-years-old) at single dose for COVID-19 immunization. The patient's medical history includes penicillin and sulfa allergy. Concomitant medications included thyroid (ARMOUR THYROID) 15mg daily, received within 2 weeks of vaccination. The patient was not pregnant at time of vaccination. No other vaccines have been administered within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient experienced tinnitus on 04Mar2021 after first dose of vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included audiology test with unknown results. The outcome of the event was not recovered. Therapeutic measure has been given in response to the event.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot number: M032141 with an expiration date of 02-OCT-2017; dose regimen details and anatomical location were not provided) reconstituted with sterile water diluent (unknown lot number and expiration date) for prophylaxis. The sterile water diluent did not undergo an excursion. The temperature was 6°F to 14°F for a time frame of  2.5 hours and 15°F to 46°F for 1.5 hours. No previous excursions were reported. The temperature excursions were detected by a data logger. There was no PQC involved. This is one of two cases from the same reporter. Additional information is not expected since consent to contact the patient's physician was not provided. Sender's Comments: US-009507513-1705USA009248.
Lump on site, itching, redness, sore, & warm to the touch. -cellulitis over entire upper arm
HPV vaccine given, no adverse events but patient returned for 2nd injection & said was pregnant when got 1st dose
SUPER SLEEPY; FATIGUED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced super sleepy, and fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the super sleepy and fatigued was not reported. This report was non-serious.
Varicella - Information has been received from a health care profesional concerning a 6 year old male patient who on 21 Oct 1999 was vaccinated sc with a first dose of varicella virus vaccine live (lot 631479/1007J) There was past medical history of illnesses at the time of vaccination.  On 08 May 2000 the patient developed macular red lesions on his buttock and thigh.  There was positive blanching with no scabs or vesicles noted.  The case was reported as questionable atypical varicella.  Unspecified medial attention was sought.  It was noted that the patient had been exposed to variecella two weeks prior to the rash.  The patient's two borther weas 00051544/0051545 had a similar experienced following exposure to varicella virus vaccine live
Day after first reaction, person has symptoms of fatigue. After second dose (lot # ep6955) on 3-25-21 Started feeling bad right away, but did not tell anyone. Went home arm was very sore, next day pt had trouble breathing. She talked to Doctor a few days later and she has continued to feel bad and continues to feel bad.
pt recvd vax;severe ha, muscle & joint aches as reported by pt;adm to hosp on 8may94;being tx w/ demerol for pain;had local rxn at site immediately p/ dose;
headache; fever; body aches; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  Historical Vaccine BNT162B2 1st dose covid-19 vaccine for Covid-19 immunisation. on an unspecified date the patient experienced headache fever body aches. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Received injection on Tues afternoon.  When woke up on Wed. morning noticed face to have red blotches & was hot to touch.  Some diarrhea & general body aches.  No redness at injection site.  Called MD, but no visit.
Patient received the J&J covid vaccine 5/6/21 and started to feel symptoms of dizziness, weakness, fatigue, and black stools on 5/8/21. She was hospitalized due to symptoms and required a blood transfusion 2 units packed red blood cells due to hemoglobin below 10 and symptoms.
Patient chief complaints were localized swelling at the injection site, redness, pain, and itching.
Four hours after booster, 24/7 migraines started.  Three weeks afterward, I had a tele-health visit and he tried different medications.  I was referred to a neurologists since the medications weren't helping.  I went to the ER on 1/10 because my BP and temp fell.  My bloodwork showed I had an injection.  I have to scans scheduled.
Patient presented to the Emergency room for concern of trouble breathing. Pt was bradycardic with heart rate in 40's. Patient eventually needed to be subcutaneously paced, intubated, and brought to cath lab for temporary pacemaker.
A large patch of redness at the injection site, getting larger, hot painful at times, I put ice on to ease the pain and swelling and redness, today I noticed just this afternoon my LEFT armpit my Lymph node is VERY LARGE and sore if you feel around it, Also last night I noticed my RIGHT lypmh node just under my RIGHT ear has popped out.
Bad headache reported when he woke up that Sunday morning. Gave him 2 200mg ibuprofen tablets. An hour or so later he reported his headache was gone.
within 3 minutes of injection within 3 minutes had a seizure with (per nurses) generalized increased tone, gasping and unresponsive.  Patient with multiple medical problems including sz disorder (off meds past 6 months), copd, anxiety, glaucoma, pacer  When I got there patient breathing well, slumped back in wheelchair, not gasping and not seizing. VSS (110-120/54-68, pulse 70s, RR 18-20, O2 sat initially 95% on room air, put on oxygen while watching her), skin color pink. Initially unresponsive but when I was discussing with husband that we were going to call 911 and have her taken to ER, she opened her eyes and responded. Both patient and husband refused 911/ER saying that patient with sz disorder (also dissociative convulsions) and that she has a seizure at least daily, sometimes due to stressful situations, and that afterwards sometimes awakens quickly and sometimes takes longer. Usually sleeps for a few hours afterwards.  As patient and husband refused transfer and VSS, patient was monitored for about 45 mins and released.