chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M019691, expiration date 02-NOV-2017; lot # M031802, expiration date 09-NOV-2017, dose not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact the physician.
This initial spontaneous report was received from a physician referring to a 6 month old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 16-SEP-2015 at 14:47 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Inconsolable crying began 7/10/16 at 6:30am upon wake up. Was extremely fussy all day 7/10 and 7/11, going in and out of inconsolable crying sometimes crying for 1-2 hours at a time. Not able to be soothed by anything. Beyond fussiness, extreme discomfort was perceived. Refusal to eat, drink, or breastfeed for the majority of 7/10 and morning of 7/11. Visited doctor on 7/11/16 who diagnosed "fussiness due to shots". Began taking more fluids afternoon of 7/11. On 7/12 began running low grade fever and refusal to eat returned. This has continued through 7/13.
Infant dose given instead of 5-11year old. Parent notified of need to receive another vaccine as the dose was too low.
Patient had dose 1 in primary series monovalent. Patient presented wanting the second dose, but MA accidently administered bivalent booster as second dose. There is currently no direction on how to proceed in our organization, she should have waited for instruction.
Pt devel fever 5 days p/which reached 104; devel sz & limpness; went to ER; tx given to reduce fever then released;
Mom said the area where the vaccine was administered with a little red this morning 2/6/2018. Around 11 AM she noticed that it was much bigger redness and felt warm. She also found a picture of his previous reaction to DTaP and displays this on her phone to me which shows macular erythema. Mom did take a picture of the current reaction. He denies any pain. Mom says he still using the arm without hesitancy. Mom says he was so excited and he was "skipping in here" to clinic happy to come. No fever. He slept fine last night without fussiness or any other problems. No wheezing, cough, swelling of the lips or tongue, shortness of breath, vomiting or diarrhea.
Severe headache, nausea, fever, sore arm.  This lasted for 24 hrs.  I took tylenol & ginger ale.  Had to stay in bed all day & night.  Then on Sunday headache was gone and felt more back to normal.
High fever 105. on and off. fever being treated with Tylenol and Motrin rotation. Fever does respond to the tylenol for 3 hours. Patient does have a history of high fevers when sick and has experienced a febrile seizure in the past.  Patient is experiencing fatigue. body aches (Soreness in both arms as expected).  Since the fever has been under control there has been no need for a ER visit at this time. However if her fevers continue over the next 24 hours I will follow-up.
Patient vomited within 3 minutes of receiving vaccine while watching his younger sister get vaccinated.  He had not felt ill prior to vaccination.
Information has been received from a licensed vocational nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unspecified date between 01-SEP-2016 and 09-OCT-2016, the patient received improperly stored VARIVAX injection (lot #L037560, expiration date 29-SEP-2017; dose and route were unknown). No adverse effects were reported. The vaccine was stored under temperature 18.03 Fahrenheit degree for 16 hours. There was no prior temperature excursion. Digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
A 44 year old female presenting for management of pulmonary emboli with significant clot burden and resultant right-sided heart strain in the setting of metastatic adenocarcinoma of gynecologic origin. She previously presented to ED on 4/15 with SOB, and was subsequently admitted to the gyn oncology service for further management after imaging revealed presence of saddle embolism, ascites, and omental caking. She underwent paracentesis and omental biopsy during admission and was started on Eliquis therapy for her PE. Biopsy results were consistent with metastatic adenocarcinoma of gynecologic origin, with plan per Dr. to start neoadjuvant chemotherapy with carboplatin/paclitaxel.
This spontaneous report as received from a consumer refers to her daughter. The patient was vaccinated IM with the first and second dose of 0.5 ml GARDASIL in June 2011 and on 08-AUG-2012 separately. Now, she did not known if she would get the third dose or if she must start the series of shots all over again. It was unknown if the patient sought medical attention or not. No adverse reactions reported. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hoshimotos thyroid disease (hypothyroidism)" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder, start date: 01Sep2010; ZOLOFT taken for depression, start date: 01Nov2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid from 2023 to 2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300320619 same patient, different drug and event;
Patient administered with vaccines that have undergone temperature excursion; Patient administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient administered with vaccines that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered with vaccines that have undergone temperature excursion) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered with vaccines that have undergone temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient administered with vaccines that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered with vaccines that have undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Storage condition at the time of the excursion was reported as refrigerator. Maximum or minimum temperatures reached on 28-Jan-2022 temperature range positive 34.7 degree Fahrenheit to positive 41.2 degree Fahrenheit, on 30-Jan-2022 temperature range was positive 34.7 degree Fahrenheit to positive 41.2 degree Fahrenheit which occurred approximately for 48 hours, on 31-Jan-2022 temperature range was positive 34.7 degree Fahrenheit to positive 41.2 degree Fahrenheit for 12 hours and on 04-Feb-2022 temperature range was positive 35.2 degree Fahrenheit to positive 41.7 degree Fahrenheit for 12 hours.   It was patient's booster dose. Reporter stated that the vial was stored in refrigerator at the time of excursion. Vial was thawed on 28-Jan-2022.  The patient did not experienced any adverse event.  No treatment information was reported.
At 0843, RRT was called at the post-vaccination area for an 82 y/o female C/O chest tightness after administration of the Pfizer vaccine at 0836. RRT RNs responded to scene with E-Kit, stethoscope, and pulse ox at hand. Initial vitals ? BP: 190/94, HR: 86, O2: 96% on RA. Client reports that chest tightness does not radiate anywhere else. Client denies N/V, vision changes, or difficulty breathing. Client appears in no acute distress, no sweats seen. Head-to-toe assessment done, all WNL. Client reports she took Metoprolol, Prilosec, a vitamin supplement, and Synthroid this AM. Has a history of macular degermation, thyroid dx, arthritis, and HTN. Throughout RRT, chest tightness improved. At 0855, BP was 182/92. At 0900, client?s head-to-toe assessment remained in WNL. She remained in no acute distress and was not SOB or had difficulty breathing. 911 assistance not needed at this time. Recommendation to client was to be monitored for an additional 15 minutes and that if symptoms worsen, she should contact her PCP and go to the nearest hospital/ER and/or call 911. Client verbalized understanding. At the end of additional 15-minute waiting period, client felt so much better. Symptoms improved. Client left AMA and left premises at 0915 via car.
patient was given accidently 3 doses of moderna vaccine, first dose from walgreens, 2nd dose was given, if resident missed the 28 day window, she would have to restart series. DON counted 2nd dose by us as 1st dose and subsequently reordered 2nd dose, which would be her third dose..doses were confirmed by LINKS system. Vaccine consent form filled out by DON reveals that "no" was answered for question #2. DON went by information given to her by walgreens pharmacist.
This student accidently received this vaccine at school  without parental consent. After the vaccine, his father reported that the student (and the student's sibling)received the vaccine in the past and became sick. He reported that the student's physician indicated that the student and his siblings shouldn't receive the flu vaccine in the future. The night of the vaccine, his father reported that patient felt ill, but was feeling better the next day.
PT WAS GIVEN VACCINEE. WITHIN 3 TO 5 MINUTES, SHE APPEARED TO BE HAVING A SEIZURE. AID WAS ADMINISTERED.  RPH HELD HER UPRIGHT (PT WAS FALLING OUT OF HER SCOOTER). 911 WAS CALLED AND ICE PACK APPLIED TO CHEST TO HELP WITH FIGHT OR FLIGHT FEELING. SHE WAS NAUSEOUS, LIGHT-HEADED, AND FAINTED. PT WAS HELD UNTIL EMT'S ARRIVE, AT WHICH POITN SHE WAS COHERENT. STAFF AT FACILITY BROUGHT THE PATIENT ORANGE JUICE. SHE WAS OK WITH SITTING AND STANDING BP O F96/62. SHE FELT BETTER AND REFUSED TO GO TO THE HOSPITAL.
Called to evaluate patient in COVID-19 vaccination clinic area after witnessed "fainting" at ~12:30 PM.  Briefly this is a 23 yo female with unremarkable PMHx; Meds- OCPs; Allergies- PCN and Gluten. Pt received the first dose of Moderna COVID-19 vaccine at 12:25 PM with RN. Per RN report the patient informed her that she had a remote history of "passing out" after a vaccine as a child, but it had not happened recently.  The RN observed the patient at her vaccine station for 3 min then accompanied her to the observation area.  Per report of COVID-19 Patient Observer, pt was seen falling out of her chair in a seated position and it was unclear if she hit her head.  Per a witness, pt hit her head on the computer cart that was nearby.  The COVID-19 Patient Observer called for assistance and 911 was called.  She was immediately evaluated by COVID-19 Patient observer and RN and noted to be unresponsive initially.  The RN reported that she opened her eyes and became verbally responsive to verbal stimuli and touch.  Upon my arrival, pt was noted to be responsive and lying on floor on her abdomen.  She initially denied pain, but later complained of pain at crown of her head to touch.  Pt denied CP, HA, SOB, difficulty breathing, pruritis, rash, nausea, or visual disturbances.  Orthostatics were obtained (lying- 124/90-102; sitting- 137/81-115; Standing 123/87 - 96).  Patient maintained her O2 sat at 98% throughout the evaluation.  She was assisted to wheelchair and reported feeling better.   PE: A&O x 3 HEENT: Normocephalic, tenderness to palpation at crown of head, no lacerations or bruising noted, pupils equal CV: Tachycardic, regular rhythm, no M/R/G Resp: CTA B no W/R Ext: No UE or LE pain to palpation or edema noted  A/P: 23 yo s/p COVID-19 vaccine with likely vasovagal reaction and head trauma.    1. Vasovagal Reaction/Head Trauma - Pt transported by EMS to local hospital for evaluation  - Telemedicine visit with COVID-19 vaccine clinic on Monday 4/26/2021  2. COVID-19 Vaccine - VAERS report to be filled by Dr.  - FU for COVID-19 vaccine in 4 weeks  - Pt to receive vaccine in supine position and be observed for min 30 min - Recommend pt to be accompanied by friend/family member at next visit
Information has been received from an office receptionist concerning a 20 year old female patient with family history of heart disease, allergic reaction to antibiotics, who on 02-FEB-2007 was vaccinated IM with a first dose of Gardasil lot #654741/0013U. Concomitant therapy included Ortho Tri-Cyclean Lo. On 02-FEB-2007 the patient developed arm soreness but otherwise felt fine. On 16-APR-2007, the patient was vaccinated IM with the second dose of Gardasil lot #657621/0387U. Within one to one and half hours after the second injection patient developed muscle spasm in chest area which radiated from left chest to center. She described pain as sharp intermittent and took her breath away. On 18-APR-2007 she took Advil for something else (not specified) and it helped pain a little but was not relieved. The physician instructed patient to go the emergency room (ER). Patient was planning to go to the ER on 19-APR-2007. At the time of this report the patient had not recovered. Additional information has been requested.
Pt complained of feeling dizzy, pt then complained of feeling her throat was closing. Epi and IM Benadryl were administered to pt
Pt recv vax on 10/16/98; on 10/17/98 pt exp redness/erythema x1 day at vax site
tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positve.         No concomitant medications were reported. Treatment included Regeneron IV monoclonal antibodies  This is a spontaneous case concerning a 61-year-old, male patient with no relevant medical history, who experienced the unexpected, non serious event of SARS-CoV-2 test positive. The patient received 2 doses of mRNA-1273 (dose 1: 2 March 2021, dose 2: 30 March 2021) with appropriate dosage interval of 28 days. The event SARS-CoV-2 test positive exact occurrence unknown but stated that the event occurred after receiving the primary series of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 61-year-old, male patient with no relevant medical history, who experienced the unexpected, non serious event of SARS-CoV-2 test positive. The patient received 2 doses of mRNA-1273 (dose 1: 2 March 2021, dose 2: 30 March 2021) with appropriate dosage interval of 28 days. The event SARS-CoV-2 test positive exact occurrence unknown but stated that the event occurred after receiving the primary series of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
swelling under his underarms, guessing that it was his lymph nodes; swelling under his underarms, He raised both arms to compare and the right arm is much bigger.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Apr2021 13:40 (Lot number: ER8732, Expiration Date: 31Jul2021) at the age of 60 years as dose 2, 0.3 ml, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, Time given: 13:40, Lot Number: EN6208, Expiration date: 30 JUN 2021), administration date: 15Mar2021, when the patient was 60 years old, for Covid-19 Immunisation, reaction(s): "No adverse event". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 06Apr2021, outcome "not recovered", described as "swelling under his underarms, guessing that it was his lymph nodes"; SWELLING (non-serious) with onset 06Apr2021, outcome "not recovered", described as "swelling under his underarms, He raised both arms to compare and the right arm is much bigger.".  Additional information: There were no additional vaccines administered on the same date of Pfizer suspect. It was reported that patient was swelling under his underarms, so reporter was guessing that it was his lymph nodes. It was under the one arm that he got the vaccine. Reporter stated that patient noticed the swelling on 06Apr2021, but on 07Apr2021, the patient called the reporter down to show her the increased swelling. He raised both arms to compare and the right arm was much bigger. Reporter said that it has worsened from 06Apr2021.  No follow-up attempts are possible. No further information is expected.
Child was put to nap after arriving home from clinic. Swelling under left eye and of upper lip described by mother. No other symptoms reported. 1 Dose Benadryl administered by mom and symptoms resolved. No further events noted.
Injection site began to hurt within the 15 minutes of wait time after the injection. Left arm was very painful within 24 hours of injection and physically exhausted   Tinnitus set in approximately two weeks after second injection. Accompanied by pain in both ears, sometimes throbbing. The tinnitus is day and night and sleep is affected. I have contacted my doctor asking for help.
Very high fever ran for four days. Reached 104.1 with Tylenol in system for an hour.
35 mins after shot patient crying and writhing, could not be consoled for approx 20-30 mins. no rash, no tachycardia, no diff breathing, had similar reaction with hive like rash when eggs were ingested so patient pre treated with Benadryl.
Pt was observed post Covid-19 immunization for 30 minutes.  During the observation period, she experienced an adverse reaction with the following symptoms: Chest tightness, SOB, hives to chest, back of neck, behind ears, forehead, cheeks   Assessment : Time of assessment .   Actions taken: EMS onsite and patient walked out to the stretcher and triage area.   0904 BP 153/100; Pulse 83; Oxygen saturation 100% room air   Medications administered: All medications given by EMS Benadryl IM to right deltoid; Solumedrol IV given via saline lock in right A/C.   Disposition: Hospital
Patient presented to hospital on 4/23 after experiencing stroke-like symptoms the evening of 4/22. Symptoms included slurred speech, confusion, and repetitive grasping of his L hand. Patient was diagnosed with DM2 and HTN during his hospital admit, but had not previously received treatment.
Gout developed in middle toe on right foot following 2 days after both Covid Vaccine shots in March. Cholchincine prescribed by doctor relieved pain.   Unsure if related... Osteoid Osteoma found in right arm October 4th 2021 after MRI, CT Scan and Xray on right shoulder after experiencing severe shoulder pain. Osteoid Osteoma is located on humerus right under shot site on right arm
Information has been received from a registered pharmacist concerning her mother's approx. 22 year old female niece who was vaccinated with MMRII "as a child". She could not report any specifics on the date of the vaccination, the lot # or the name of the pediatrician who administered the vaccine. She reported that the pt received the vaccine "when she was still in a walker". The registered pharmacist reported that the pt was a "dry birth" and that the pt was "fine" until she received her MMRII vaccine. The registered pharmacist reported that the pt developed neurological problems. She reported that the pt "has a mind of a 3 year old" and has learning disabilities. She reported that "she attends a special school for the Mentally Handicapped". The pt did not seek medical attention. Upon internal review, neurological problems was determined to be an "Other Important Medical Event". Additional information has been requested.
24 hours after administration patient had a slight bump & redness at the site. 48 hours after administration patient said bump had grown to 3 in x 4 in, was red, hard and itchy.