chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse affects reported.; Medical assistant called reporting an improperly stored dose of PROQUAD was administered to a patient.; This spontaneous report was received from medical assistant referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 17-JUN-2020, the patient was administered an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (lot # S031705, expiration date 06-APR-2021, strength, dose and route were not reported) for prophylaxis.    Administered dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) was stored at -11.5 degree Celsius for 37 minutes. There was no previous temperature excursion reported. The digital data logger was involved. No adverse effects reported.
Approximately 2 weeks after my 2nd booster shot (Dose 4), I experienced the following symptoms: Sore throat, runny nose, diarrhea, vomiting. I did a telemedicine and was prescribed with Paxlovid and it did help me with my symptoms and I felt so much better after.
Swollen arm, red and hot to the touch, Hot flashes, fever of 102 °F ( for 4 days), Severe pain throughout my entire arm, couldn't move my arm for 4 days (my arm was practically dead) with only being able to feel constant severe pain in my arm. 3 weeks after the vaccination on 09/05/2022 I was diagnosed with COVID-19, I had COVID-19 from 09/05/2022-09/22/2022.
Received flu shot 10/24/08 in R arm. No discomfort until soreness began on the underside of upper and lower R arm 10/27/08. "Soreness" has been intermittent but still persists.
Patient developed a severe anaphylactic allergic reaction following the 2nd dose of SHINGRIX. The patient reported it started as a moderate tongue swelling that she didn't think too much of. She initially started to ice the tongue, but in time it only got worse and she needed to call for the paramedics to take her to the hospital as it swelled excessively and started to affect her breathing. The hospital course is unknown as this was relayed to us by the coordinator at her place of residence. The patient has since been discharged is said to be doing fine. It was also noted that the patient experienced a mild tongue swelling following her first SHINGRIX dose and didn't think much of it, and as a result was not reported to us prior to administering the 2nd dose. We only learned about this following her severe reaction.
Swelling and dark red feet; swollen pads on bottom of feet, sore throat, pain in ears  Swollen right arm and hand, soreness at injection site, fatigue, headache, dizziness
Experiencing hives on upper R arm after vaccine. Also had headache and felt hot. BP 174/90, HR 94, Respirations 20 SaO2 99%. Pt sat in  ambulance with AC to cool off then left.
Warm, red, pruritic area 2x3" on Right deltoid. Tender to touch. Gave ice/melt on 20 minutes off 20 minutes.
rash; itching allover the body; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient experienced rash and itching all over the body. The patient was fine after the first dose but after second dose she was having itching and rash, no breathing problems. Patient is taking loratadine (CLARITIN) for it. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 04-Oct-2020 and the estimated date of delivery was 11-Jul-2021. On 09-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-sixth week of the pregnancy.  On 09-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medications were not reported.
This case was reported by a other health professional via call center representative and described the occurrence of generalized rash in a 76-year-old male patient who received ENGERIX B adult (batch number 92M2J, expiry date 3rd November 2017. Concomitant products included CIPRO, Hep A vaccine and radioembolization. On 30th November 2015, the patient received ENGERIX B adult, .5 ml. In December 2015, 12 days after receiving ENGERIX B adult, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was recovering/resolving. It was unknown if the reporter considered the generalized rash to be related to ENGERIX B adult. Additional details provided were as follows: The patient received CIPRO and Radio-emobilization two days prior experiencing rash. The patient experienced generalized rash 12 days after receiving ENGERIX B vaccine. The reporter was unsure if the rash was actually related to the vaccination with ENGERIX B, The patient required an emergency room visit. No further information was reported regarding the event.
Swollen arm at location site,  aches, fever, chills and swollen bottom lip
16 year old patient received a second dose Moderna Covid vaccination off-label at patient/parents request. Moderna were consulted and advised. Patient and mother gave consent after receiving informed consent from the pediatrician.
This spontaneous report as received from a consumer refers to a patient of an unknown gender and age. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, route, lot and expiration date were not provided), one dose, then, On 19-JUL-2016, the patient went to her physician and forgot she had already been vaccinated and received another dose of ZOSTAVAX (strength, route, lot and expiration date were not provided). There were no concomitant medications and adverse events reported. No product quality complaint was involved. Additional information is not expected as the reporter did not consent for follow-up attempts.
Red hot right ear, red rash right cheek, right nostril side completed blocked, severe vertigo , disequilibrium, wavy imbalance feeling
I95.9 HYPOTENSION 4/24/2023 CARDIOGENIC SHOCK R57.0 CARDIOGENIC SHOCK 4/24/2023 CARDIOGENIC SHOCK
PATIENT BECAME UNREPONSIVE IN SITTING POSITION FOR ABOUT 2 MINUTES. STILL BEATHING BUT NO RESPONSE TO CALLING HIS NAME. AFTER 2 MINUTES PATIENT SLOWLY BECAME RESPONSIVE. HE SAID COULD FEEL VACCINE  GO TATG AND FELT PRESSURE GOING FROM ARM TO CHEST AFTER ABOUT 15 MINUTES PATIENT WAS FEELING FINE
This case was reported in a literature article and described the occurrence of anaphylaxis in a subject of unspecified age and gender who was vaccinated with INFLUENZA (unspecified), manufacturer unspecified. Concurrent medical conditions included allergy (this was discovered after the occurrence of the anaphylactic reaction). No egg allergy was reported in this patient. Previous and/or concurrent vaccination included MMR; manufacturer unspecified. On an unspecified date the subject received unspecified dose of INFLUENZA. At an unspecified time after vaccination with INFLUENZA (either on the day after vaccination or on the day after the administration of multiple vaccines), the subject experienced anaphylaxis. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. Influenza virus infection causes substantial morbidity in children with an attendant need for healthcare utilization, school absenteeism, and secondary illness in families. Also, influenza virus can rarely lead to death in children with underlying medical conditions and in children who are otherwise healthy. Vaccination against influenza virus is the primary method for preventing influenza and its complications. The committee recommendations for influenza vaccination of children have expanded from the long-standing recommendation to vaccinate high-risk children aged 6 months, to vaccinating all 6- to 23-month-olds (2004), 2- to 4-year-olds (2006), and 5- to 18-year-olds (2008). The objective of the authors was to identify new or unexpected adverse events (AEs) after trivalent inactivated vaccine (TIV) in children. Methods: analysis of reports after TIV to the Vaccine Adverse Event Reporting System from 1990-2006 in children aged 2 to 17 years, and from the 2008-2009 influenza season in children ages 5 to 17 years. The techniques were used to identify new or unexpected AEs during 1990-2006. Results: During 1990-2006, the Vaccine Adverse Event Reporting System received 2054 reports of children aged 2 to 17 years with a peak in the 2003-2004 influenza season, In 2006-2009, 506 reports describing 5 to 17 year olds were received. The serious reports of tests performed after TIV were approximately 10% of all reports from 2001-2006, and 6% of the reports in the 2008-2009 season. The data showed an increased proportion of medication errors and Guillain Barre Syndrome (GBS). The findings of GBS could not be interpreted as causally related to vaccination. Among 201 reports of medication error, 94% had no AE reported other than the medication error itself. Conclusion: In this analysis, we found no unexpected AEs. Our review of medication error and GBS reports suggests that ongoing monitoring in these areas is appropriate.
Mom said that pt became lethargic, 1 hour, post vax. Then she developed nausea, vomiting and a bad headache. There is no fever on 9/7/01. Follow-up call to mother. She stated that the pt was back in school today but still has a headache. No nausea and vomiting. No doctor follow-up was done.
Whole body rash, primarily on torso, thighs, upper arms, and face (with swelling and very red cheeks) with a bit on hands and feet. Diagnosed as Hand Foot and Mouth disease.
A rash on my right arm  (got the vaccine in my left arm) from my wrist to elbow.  The rash had 3 raised bumps and was swollen.  It was not painful but was itchy.  It went away in a couple of days.  I did not take anything for it but did put Cletrimazole and Betamethasone Dipropionaate cream on it.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 05-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (VIs 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 40 and 72 hours, the lowest recorded temperature was 28F (-2.222Celsius) and the highest was 47F (8.333 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse refers to a male patient of unknown age. On 23-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 injection, dose 2 (dose and route unspecified). No concomitant medications were reported. The nurse reports that the patient, who received his 1st dose of PNEUMOVAX 23 on an unspecified date "last year", was inadvertently administered a 2nd dose of PNEUMOVAX 23 on 23-OCT-2014. No adverse effect reported. The outcome of the medication error inadvertently administered a second dose of PNEUMOVAX 23 on 23-OCT-2014 is unknown. There was no product quality complaint involved. Additional information has been requested.
can still have shingle ,even after the shot. I did/ suspected vaccination failure; can still have shingle. I did; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she even after the Shingles shot still had shingle. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
1 of 2 children who recvd vax & exp a localized raised rash (eczema-like but not scaly or itchy) which occurred w/in 24 hrs p/vax & lasted 7-10 days;no fever or pain;pt was seen by MD; pt recovered;
The side that I got my shot on, my left side lymph node there is swollen roughly the size of a baseball; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 39-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6200), via an unspecified route of administration (at the age of 39-years), on 06Mar2021 as dose 2, single for COVID-19 immunization. Medical history included ankylosing spondylitis, psoriatic arthritis, fibromyalgia from an unknown date and unknown if ongoing. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization. Concomitant medications included pregabalin (LYRICA) taken as 50 mg three times a day , duloxetine hydrochloride (CYMBALTA) taken as 60mg once a day and adalimumab (HUMIRA) taken as 40 mg once every two weeks for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced the side that i got my shot on, my left side lymph node there is swollen roughly the size of a baseball. It was further reported that he stated, that I had my Covid, my second Covid shot on Saturday (06Mar2021) and when I woke up this morning. The side that I got my shot on, my left side the lymph node there is swollen roughly the size of a baseball. He stated that no, I am a therapist. He stated that I am not sure if it was 1 or I but it was E19262 (further not clarified). So when she put that on LOT for my first visit, underneath for my second visit they on this bottom I don't know if it's important they put EN6200 (second LOT, captured in the tab). The vaccination facility name, stated by the patient was they did it at stadium. For the expiration date, he stated that I do not have, they do not have that, it was not written on the card. He asked that should I got to the Hospital? Is there anything you guys are recommended what I should do. The clinical outcome of the event was reported as unknown.  No follow up attempts are possible. No further information is expected.
20 minutes after receiving DTaP, MMR and Polio Vaccine, child developed generalized hives, flushing, lip swelling, and difficulty breathing.
On 10/4/22 this nurse was charting vaccinations on this patient and realized they were accidentally given the bivalent Pfizer instead of the monovalent Pfizer vaccine as their primary dose. This nurse then notified her supervisor. The vaccines were charted the way they were given. on 10/5/22 this nurse spoke with the vaccine coordinator and the CDC vaccine hotline. The vaccine hotline said to not repeat the dose. On 10/6/22 this nurse contacted Pfizer. No additional side effects outside from the normal side effects were listed on their automated system. On 10/7/22 this nurse contacted the patient's guardian and provided her with the information that was received from Pfizer. If additional information comes out, I will update the guardian. The guardian did not have any questions at this time. The patient tolerated all of her vaccinations well that she received at her appointment and did not have a reaction. An incident report was filled out and given to this nurse's supervisor.
Narrative: pt. receivd wrong vaccine for iniail covid series, did have arm reaction that required treatment by ER.
Moderna 4/2/21, 4/29/21, 12/29,21. Positive on 8/15/22
This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 75-year-old male patient who received BOOSTRIX (batch number unknown, expiry date 16th April 2014) and (batch number unknown, expiry date 16th April 2014). On 14th May 2014, the patient received BOOSTRIX. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information received: On 5/14/2014 administered an injection of BOOSTRIX that, according to this ED record, had an expiration date of 4/16/2014. Now recognizing that the BOOSTRIX was 28 days past expiration date.
RED SWELLING LARGER THAN THE SIZE OF A BASE BALL ON UPPER ARM WHERE THE INJECTION WAS GIVEN.  STINGS & HURTS.
Patient returned to clinic diaphoretic, nausea and vomiting per ED co-worker.
Temperature of 104 deg F, Body Aches, Sweats and Chills and mild cough. Symptoms lasted 3 days. Recipient did not seek medical treatment.
Myasthenia Gravis. Shortness of breath, neck and arm function, lack of ability to swallow
I experienced pain in my right arm, I have two big knots on my knee and one on my wrist, I can't use my right shoulder anymore.
Pt recvd series of 3 Engerix-B vax on 20AUG90, 21SEP90, & 21FEB91 & was a non-responder;
pt recv vax 24AUG95 & 11NOV96 pt devel a gen rash (less than 20);
Nurse calling to report VARIVAX was administered to patient while it had a temperature excursion. Exact date of administration not provided. Patient is asymptomatic. No additional AE. No PQC.  Names of vaccines involved (including lot/exp) VARIVAX W0; No additional AE; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The concomitant therapy, concurrent condition, drug reactions/allergies, and medical history were not provided.  On an unknown date, the patient received vaccine with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose (valid lot #W032370 with expiration date: 10-OCT-2024), administered for prophylaxis (strength, and route of administration were not provided), while this vaccine had a temperature excursion with temperature 24.4 Fahrenheit and time frame 5 hours 51 minutes 0 seconds (Product storage error). There was no previous temperature excursion. The patient was asymptomatic and no additional adverse event (No adverse event).
started her period, it was lite; started to ovulate; breasts were sore and tender; breasts were sore and tender; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 12Feb2021 (Batch/Lot Number: EL9261) as 2nd dose, single for Covid-19 immunization. The patient received the first dose of BNT162B2 on 21Jan2021 (at the age of 55years) for Covid-19 immunization. Medical history included menopause from Jul2019, and fibromyalgia from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included duloxetine (DULOXETINE); cyanocobalamin (B12); ergocalciferol (VIT D); sambucus nigra (ELDERBERRY); zinc (ZINC), and Vitamins (unspecified); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she has not had a period since Jul2019. She received her second Pfizer Covid shot on 12Feb2021. Then 7 weeks later, she started to ovulate, 1 week later her breasts were sore and tender, and then a week later she started her period, it was lite. It was just like her normal cycle used to be. The patient asked, "Are the vaccines causing menopausal women to start their cycle again after receiving their Covid vaccines?" There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovered on an unspecified date.
Palindromic Rheumatism; Developed joint pain that would travel around the body; Developed joint pain that would travel around the body; Pain was absolutely debilitating; This is a spontaneous report received from contactable reporter(s) (Consumer). The reporter is the patient. A 29-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 23Aug2021 18:00 (Lot number: FC3181) at the age of 29 years as dose 1, single for COVID-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; PRENATAL DHA; VITAMIN D [VITAMIN D NOS]. The following information was reported: PALINDROMIC RHEUMATISM (disability) with onset 29Aug2021, outcome "not recovered", described as "Palindromic Rheumatism"; ARTHRALGIA (disability), PAIN (disability) all with onset 29Aug2021, outcome "not recovered" and all described as "Developed joint pain that would travel around the body"; ASTHENIA (disability) with onset 29Aug2021, outcome "not recovered", described as "Pain was absolutely debilitating". The events "palindromic rheumatism", "developed joint pain that would travel around the body", "developed joint pain that would travel around the body" and "pain was absolutely debilitating" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (08Dec2021) negative. Therapeutic measures were taken as a result of palindromic rheumatism, arthralgia, pain, asthenia.  Additional information: The patient was reported to have developed joint pain that would travel around the body. Each joint lasting around 24-48 hours. The pain was absolutely debilitating. After seeing two rheumatologists, it was determined that the patient ended up developing Palindromic Rheumatism - subset of RA following the vaccine and have been advised to not get any more doses.
Patient was lethargic, had increased blood pressure and was in and out of consciousness. Patient was taken to hospital at 3 pm and admitted.