chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional Adverse event; ROTATEQ was administered after a temperature excursion.; This spontaneous report was received from a Licensed Practical Nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 06-JUL-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) by oral route, lot #1837116, expiration date: 24-MAR-2023, administered for prophylaxis (formulation, and strength were not provided), after the vaccine was exposed to a temperature excursion of 4 hours, 12 minutes and at a temperature of 10.8°C (product storage error). No additional adverse event was reported (no adverse event)
Fever, vomited 15 minutes, shaking vs seizure 10 minutes. Check papules bilaterally. Better 1 hour on Tylenol - Also very lethargic. Occasional fever for days. Check papules 1 week.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Pfizer / BioNTech (Dose Number: 3 Batch/Lot No: Unknown.) in November 2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech. Concurrent medical conditions included Sulfonamide allergy (Sulfa allergy).   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 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 COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 15-May-2022 to 20-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.            Concomitant products were not provided.  It was reported that patient previously received COVID-19 vaccine and it was unknown whether patient took any medications/products within 2 weeks of starting COVID-19 treatment.  Company comment: This spontaneous case concerns a patient (age and gender unspecified) with history of interchange of vaccine products, who experienced the unexpected non-serious AESI of Covid-19, approximately 13 months after receiving the second dose of mRNA-1273 vaccine and 6 months after a dose of Pfizer / BioNTech Covid-19 vaccine. Additionally, interchange of vaccine products was also reported. The outcome of Covid-19 was reported as not resolved. Details of symptoms, clinical course, investigation reports and further treatment details were not provided. Pfizer / BioNTech Covid-19 vaccine could be a confounder. The current pandemic situation of Covid-19 could be a confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient (age and gender unspecified) with history of interchange of vaccine products, who experienced the unexpected non-serious AESI of Covid-19, approximately 13 months after receiving the second dose of mRNA-1273 vaccine and 6 months after a dose of Pfizer / BioNTech Covid-19 vaccine. Additionally, interchange of vaccine products was also reported. The outcome of Covid-19 was reported as not resolved. Details of symptoms, clinical course, investigation reports and further treatment details were not provided. Pfizer / BioNTech Covid-19 vaccine could be a confounder. The current pandemic situation of Covid-19 could be a confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
IMMEDIATELY DEVELOPED PURPLE/BLUE BUMP AT INJECTION SITE. BUMP EVENTUALLY SUBSIDED BUT PATIENT THEN HAD SEVERAL RED BUMPS THE DAY AFTER VACCINATION WITH LARGE BRUISE AT INJECTION SITE. PATIENT ALSO STATED THAT SHE EXPERINCED HEADACHES THAT CAME AND WENT. ALSO SHE HAD SEVERE MALAISE THE DAY AFTER VACCINATION.
Ears hurt-going to ear Dr. Eyes blurry-saw eye Dr- more floaters. Nervous extremely-called psychiatrist told therapist. Weak areas intensified-went to family doctor weak, dizzy. Legs hurt-seeing vein Dr. Teeth hurt-need crowns.
dose was diluted incorrectly with 2.0 mL of diluent instead of 1.8mL
6 days after vaccination on 6-19-22, mother observed infant to have 2 back to back episodes of shaking, 2 minutes apart, lasting 3 seconds each ('like a seizure').  On 6-21-22, infant had 2 more episodes of shaking, the first 3-4 sec long and 2 minutes later the second episode lasting 7-10 minutes, with obvious head and arm shaking. She videoed this episode and showed to her Pediatrician.  Mother reported that after the 7-10 second episode, she held baby to comfort him, he was staring and not responsive to her voice like he typically is. No reported fever after vaccination or other illness symptoms. No medications given during that time. Infant was a little more fussy during that 6 days after vaccination than usual. Pediatrician Dr. referred infant to Pediatric Neurologist for evaluation. Mother waiting on appointment.
pt recv vax 5JAN99 & pt presented w/body rash & itch 13JAN99 papular red, sl raised lesions;
Vaccination failure; Shingles; This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number C523T, expiry date 4th July 2020) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 7X3EJ, expiry date 3rd October 2020) for prophylaxis.   Previously administered products included Zostavax with an associated reaction of herpes zoster.   On 25th April 2018, the patient received the 1st dose of Shingrix (intramuscular). On 31st July 2018, the patient received the 2nd dose of Shingrix (intramuscular). On 10th April 2019, 350 days after receiving Shingrix and 253 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional information was provided as follows: The patient received 1st dose of Shingrix in left deltoid and 2nd dose in right deltoid intramuscularly. The reporter gave consent to follow up. This case has been linked with US2019131757, reported by same reporter.
Patient presented to clinic and stated she needed repeat vaccination, as she was in nursing school and had negative hepatitis B titers. The patient received 2 previous heplisav-b vaccinations on 8/25/2023 and 10/6/2023. Patient contacted approximately 1 hour after dose administered, no reported adverse symptoms at that time. Patient was counseled that CDC recommends at least 4 weeks between dose and to report to ER if adverse reaction occurs.
Fever 102 degrees, body aches, blurry vision, headache for 48 hours after injection. Disrupted mentruation cycle both dose 1 and dose 2.
Vaccine Administration Error.  On December 16, 2020 Hospital received 99 vials of BioNTech COVID-19 vaccine with Lot #EK5730. On December 17, 2020 vaccine doses were prepared in the Pharmacy using aseptic technique under the laminar flow hood to provide vaccinations for a  employee clinic. 57 vials of vaccine were used to prepare 384 doses. 5 of the doses were prepared using a pooling technique with vaccine from more than one vial. The syringes with pooled doses were labeled in the same manner as the full doses withdrawn from a single vial and we were unable to identify which employees received pooled doses. The situation and corrective actions were reported to the Health Department.
Visual impairment in both eyes.  Lasted for about 1/2 hour.  Blind spots similar to having looked directly into the sun.  Next day eye soreness and some tearing.  No outside treatment.  Will seek treatment if it reoccurs or does not get completely resolved.
consumer felt the wetness, sprayed some of the injection out upon removing the needle from the consumer arm, no AE; plunger was more difficult than usual, no AE; Initial information received on 10-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 72 years old female patient who was vaccinated with a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (frequency once) lot UJ221AB, expiry date: 01-Apr-2020 via intramuscular route in the left deltoid on 10-Sep-2019.  The patient's past medical history, medical treatment(s), concomitant medications and family history were not provided.  It is an actual medication error case due to vaccine under dose and it is also a case of syringe issue. It was reported that having difficulty while pressing down the plunger, the plunger was more difficult than usual and nurse reported that may have sprayed some of the injection out upon removing the needle from the consumer arm.  At the time of this report, 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 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.  List of documents held by sender: none.
Received two COVID vaccines 1/11 and 2/1. Tested on 2/9 secondary to exposure to + case in household. PCR results were POSITIVE. No symptoms. Subsequent test on 3/2 and 3/8 were negative.
About 18 hours after my second covid vaccination  I became quite ill. I requested from my boss that I be allowed to leave as I was not feeling well. I was ache all over, skin sensitivity, light sensitivity, feeling feverish and suddenly exhausted. Very tired. Just wanted to close my eyes. I went home and went to bed where for the next 5 hours I was in and out of poor dream disturbed sleep. Waking up moaning and very uncomfortable. Constant headache. Mild blurry vision. Very sore arm at injection site.
1229 patient was administered Moderna booster, at 1300 patient stated "I feel my chest really right, and I feel short of breath and a little dizzy" Patient was transferred to gurney to be monitored, juice and vital signs taken. 1314 patient noted worsening chest tightness and difficulty breathing. Patient face and neck became visually more red. At 1314 Epi .30 mg was administered on the L vastus lateralis. 1320 patient was transferred down to ED via gurney. Upon hand off, patient is AxOx4 speaking in full complete sentences.
I have had headaches nausea lightheadedness/dizziness body chills every now and then hot flashes. I have gone to my personal clinic. I went to urgent care there and was seen by the doctor I had a CT bloodwork and urine test I?ll run and everything came back normal. I still get random spurts of headaches nausea they did give me some medications to help treat the symptoms but I still in continue to get the symptoms.
Patient received Zostavax on 9/9/13. Came into pharmacy on 10/5/13 with large red whelp at injection site. MD confirmed an infection.
I had a fever, chills, serve fatigue, and a dry cough. The fatigue was the worst. I had some discomfort around the injection site for about 12 hours. I went to the doctor about this. They did a complete blood work and a urine sample. Everything came out normal. I also did a Covid-19 test on Sept 13th, which came back negative.
After first injection, developed itchy skin rash inside elbow left arm (near injection site).  This cleared up in about 6 weeks.  After second injection, developed itchy skin rash on upper left chest (near injection site).  Doctor thought it might be a "contact allergy", administered a steroid injection.  Cleared up for two weeks, then returned and continues to this day (now about 10 months).  I have no known allergies, this is not a contact allergy because it is confined to a specific area on my body.
Pt. states that after receiving the 1st dose of Shingrix 11/08/2021, started experiencing symptoms that evening of shivering, stomach pain, soreness, and nausea. Symptoms lasting 12 hours, symptoms have subsided. No noted Primary visit/communications.
7 days after receiving the MMR vaccine, Evan came down with 103 degree fever.  The following day (8 days after vaccine), his fever is 104 degrees.
swelling like a goose egg on arm at injection site; Injection site sore to touch; Bruising at injection site; This is a spontaneous report from a contactable other healthcare professional. A 70-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: er8730), via an unspecified route of administration in the left arm on 26Mar2021 at 17:00 (at the age of 70-years-old), as a single dose for COVID-19 immunisation. Concomitant medications included monascus purpureus (RED YEAST RICE), and valsartan; hydrochlorothiazide (MANUFACTURER UNKNOWN) 160-25 (units unspecified); both for unknown indications, from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced swelling like a goose egg on the arm at injection site also sore to the touch and bruising at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of swelling like a goose on the arm at injection site also sore to the touch and bruising at injection site were recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.
"pain/swelling/burning in arm, chills, shaking, extreme fatigue, temp 101.8 first day second day, today low grade temp, some soreness in arm , slight sore throat" "call sick yesterday and today"
03Mar98 pt recv 1 dose vax. 20 mins. after vax, pt exp h/a, dizziness, nausea, sweats, loss of appetite & confusion. Symptoms varied in intensity. 11Mar98 pt exp arthralgia in hands & feet. Tx w/Motrin & Tigan
FLU SYMPTOMS; SORE ON THE INJECTION SITE; This spontaneous report received from a patient via Facebook account concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced flu symptoms, and sore on the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu symptoms, and sore on the injection site. This report was non-serious.
Both of them then contracted COVID19; Both of them then contracted COVID19; This is a spontaneous report received from a contactable consumer. This consumer reported for a 78-year-old male patient (husband) that:   A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 2 via an unspecified route of administration on 31Jan2021 (Batch/Lot Number: EL9262) (at the age of 78-year-old) and dose 1 via an unspecified route of administration in Arm Right on 10Jan2021 12:50 (Batch/Lot Number: EL3246) (at the age of 78-year-old) as single dose  for COVID-19 immunisation. Patient's medical history (including any illness at time of vaccination) was none. The patient concomitant medications were not reported. Additional vaccines administered on same date of the Pfizer suspect was none. Patient did not received any other vaccine within 4 weeks of COVID vaccine. No adverse event prior to vaccination. The patient experienced as, both of them then contracted COVID-19 on 09Jun2021, and mild cold on an unspecified date. Reported as, they received the COVID-19 Vaccine, both doses, 1st: 10Jan2021 and the 2nd dose: 31Jan2021. Both of them then contracted COVID19 09Jun2021. One question being how could she and or her husband become part of a clinical study or trial that may help with the data for a needed booster dose. Her husband went to (withheld) and on the way back, both tested positive. They were both over the age of 70 and are concerned. The short and long tests were before the trip, on 02Jun2021, and both were negative. On 09Jun2021 they did the nasal swab and had immediate results, this was while in (withheld).  After testing positive, the department of health came and did another test, they did the longer one they had to wait 24 hours for and it was still positive. They then had 14 days of quarantine. No treatments reported. It was explained that all the information is the same for her and her husband, they had the same product details, same positive results, and the same symptoms after testing positive. Once testing positive they had 3 days of a mild cold, it was very mild. They thought it was just a cold, they couldn't believe they had COVID. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Jun2021, sars-cov-2 test: positive on 09Jun2021(nasal swab). Outcome of the event was unknown.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (incorrect product storage) (lot #, expiry date unspecified) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. On an unknown date, the vaccine was exposed to temperature of 6 Fahrenheit (F) for 1 hour. Previous temperature excursion was reported on an unknown date, at a temperature of 22.6 F, for a duration of 13 hours. This case was reported because of a data logger. No product quality complaint (PQC) was reported. This case is linked to case number 1611USA005078 via same reporter link. Additional information has been requested.
pt experienced fever, and rash throughout face, neck, armpit, and waistline area. Also complained of sore eyes.
on or around 2/23/2023 while sitting next to a very sick passenger unmasked (both of us) i was exposed to and subsequently contracted Covid-19 confirmed by rapid testing on 2/24/2023
Had cold like symptoms off and on for 3 weeks. Around week 2 I started getting flare ups at the injection site which would turn red, hurt to the touch and eventually look like a hive with swelling. After a flare up, the next day I'd be very weak and tired with worsening cold/flu like symptoms with fever around 100.9-101. 3 weeks later I'm still experiencing flare ups at the injection site.
Swelling and pain in arm for several days.  About 1 week after the vaccination, I developed chills, headache, muscle aches,fatigue, swelling of the knees and difficulty walking.  I began to improve after 2  days, but recovery was slow.
had a horrible like a rectum bleeding; Really bad menstrual period; Nervous; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 14Apr2021 (Lot Number: EW0164) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. On 20Apr2021, approximately six days later, the patient had a horrible like a rectum bleeding and really bad menstrual period that made her nervous. The patient was not aware that it could be a side effect until she talked to her doctor. The patient had a recent lab work (2021) and it was normal. The events resulted to the physician office visit. No treatment was received for the events. Patient was unsure about taking the second vaccine because of what happened. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Patient voiced nausea and dizziness within 2 minutes after vaccines administered. Code blue called at 4:40, patient vomited mild amount of emesis. Remained conscious BP 90/54 at 4:44pm, 100/44 at 4:47 pm. EMS called and responded at 4:48pm. Left health dept. ambulating with steady gait, no acute distress, unlabored breathing with parents.
This spontaneous report was received from a currently 18 year old female patient of unknown age. No pertinent medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with GARDASIL, dose route and frequency unknown. No concomitant medications were reported. On an unknown date, the patient experienced being dizzy and light headed while on GARDASIL. The patient reported that on an unknown date, she received a fifth dose of GARDASIL. The patient sought medical attention with the health professional via. The outcome of being dizzy and light headedness was unknown. The reporter did not assess the causality of the events with GARDASIL. Additional information has been requested.
Had immun on 3/28/06, elevate temp, fever 102 and had febrile seizure on 4/4/06, ER only.
Localized pain and large swelling around injection site. Recommended ALEVE, BENADRYL, and cold compress to be applied to area of swelling. Recommended that patient follow up with us in a few days if the reaction does not dissipate.
Information has been received for the Merck Pregnancy Registry for Gardasil from a licensed practical nurse concerning a 25 year old female with a history of 2 pregnancies and 1 live birth who on 21-AUG-2007 was vaccinated with Gardasil (lot# 655849/0263U).  The patient's date of last menstrual period was 10-OCT-2007.  The patient became pregnant.  The estimated conception date was 24-OCT-2007.  On 29-NOV-2007 the patient experienced vaginal bleeding and insufficient weight gain and was in the emergency room.  On 24-JAN-2008 an ultrasound was performed for the second trimester and the results were IUP.  The estimated date of delivery is 16-JUN-2008.  Additional information has been requested.
Chest was heavy; Making it difficult to breath; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest was heavy) and DYSPNOEA (Making it difficult to breath) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced CHEST DISCOMFORT (Chest was heavy) and DYSPNOEA (Making it difficult to breath). At the time of the report, CHEST DISCOMFORT (Chest was heavy) and DYSPNOEA (Making it difficult to breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
12/21 - Fever (101.5), lethargy, headaches  12/22 - lethargy and headaches 12/23 - lethargy and headaches