chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Acute saddle pulmonary embolism without acute for pulmonary (Hcc), & 7 blood clots in right leg. Symptoms- acute shortness of breath, pain down both arms at the same time, dizziness, feeling faint
Transverse myelitis/idiopathic; This is a literature report for the following literature source(s):   A 39-year-old female patient received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYELITIS TRANSVERSE (medically significant) with onset 06Jan2021, outcome "unknown", described as "Transverse myelitis/idiopathic".; Sender's Comments: Based on available information and temporal relationship, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the event Myelitis transverse. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
One day post vax, the pt experienced soreness of muscles and bones. Later that evening skin became sensitive to touch. All these symptoms seemed flu like. The pt also had a slight fever on that same evening. The following day, the pt still had soreness of muscle and back along with swelling of lymph nodes under my right arm.
10-11-04: Pt self report 120mm circular reaction with redness, pain, tenderness 10-12-04:Reports that redness disappeared but a lump remained 30mm circular with tenderness and pain 10-14-04:Pt went to PCM for pain with arm movement and lump remains. Prescribed Tequin for possible infection.
COVID vaccine breakthrough case. Pfizer 2/28/21 EN6202, 3/21/21 EN6207, 11/3/21 FE3590, 5/27/22 FM0173, and bivalent 11/2/23 GJ3275.
On May 29, 1999 the patient developed breakthrough varicella with two pink macules on her left arm near the injection site and fever of 104F. In addition the pt experienced febrile seizure and was taken to the ER. Treatment with acetaminophen, ibuprofen, and fluids was initiated and followed by resolution of symptoms. Upon medical review, the pt febrile seizure was considered an important medical event. On May 14, 1999 the pt developed a fever of 102F lasting one day and had a possible rash at site. On May 29, 1999 the pt did experience febrile seizures and was hospitalized overnight and treated with lorazepam.
their nurses used a multi-dose diluent vial witto reconstitute h the Comirnaty vaccine; their nurses used a multi-dose diluent vial witto reconstitute h the Comirnaty vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), PRODUCT PREPARATION ISSUE (non-serious), outcome "unknown" and all described as "their nurses used a multi-dose diluent vial witto reconstitute h the Comirnaty vaccine".  Additional information: Question: E-transmitting AE information to DSU. Was not able to obtain patient age and gender. AE recognized after the call. Caller stated they are informed that the diluent should be disregarded after a single use but their clinic did not receive the single doses of diluent with every order they got so their nurses used a multi-dose diluent vial to reconstitute with the Comirnaty vaccine. Caller wanted to know if there are any ill effects from what they're doing or does that make the vaccine have less strength. Response: Spoke from attached FAQ  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Day following: severe body aches, chills and fever and slight nausea.  The second day following injection felt a bit better but that evening night sweats and third day following quite nauseated.
First, extreme upper arm discomfort after nursing student had difficulty stopping the bleeding.  Then, within 5 minutes, felt somewhat dizzy as pain radiated across shoulder, up spine and neck, into jaw and right ear.  Then, horrible jabbing pain under shoulder blade, followed by a feeling of extreme compression from site of injection to wrist.  Checked every 10 minutes or so by nurses for 50 minutes.  They said that redness first was up arm then down arm.  Once light headedness improved, I left for work (remote teaching from home).  By 3:20, I found it hard to focus, the throbbing under my shoulder and compression feeling of my arm increased with diminished feeling in right hand.  Usually 97.2 temperature but ran low-grade temp of about 99 degrees for 3 to 4 days.  Sleepless night first night with increased pain and discomfort, i.e., no new symptoms but all symptoms increase with difficulty turning neck and head.  Area around injection warm for several days, with swelling first 24 hours, resolving over a few days; still dark black and blue today, 8 days later.
pt had swelling, reddness, itchy, feverish site, around lt deltoid inject site; covering softball size area;
This spontaneous report was received from an office manager and refers to a 12 months old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 16-NOV-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
rash, swelling of face given diphenhydramine by MD transported to hosp vial 911 amb 525PM;given pred;d/c home w/DPH;
Information has been received from a registered nurse referring to 2 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 05-NOV-2015, the patients were vaccinated with ZOSTAVAX (0.65 ml, Lot # L024997, expiration date: 06-OCT-2016), which were improperly stored for 43 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
While baby was sleeping, his body became extremely hot. I woke him up to give him some Tylenol and he began to start convulsing and sweating profusely. I took all of his clothes off and wiped him down with a cool paper towel while he was still convulsing and then he had a bowel movement and stopped convulsing. Then, he became very week, faint, and pale. He also was not alert for about 5 minutes. I then called 911.
pt recv vax 11APR96 & concurrent conditions include abd pain which was dx as upper gastrointestinal bezoar;3APR97 pt devel a spreading rash;chickenpox was suspected;tx w/DPH & colloid oatmeal baths;
pt devel chickenpox OCT97 p/having had the varivax on MAY96;
Pt was given Tdap at 11:45AM and at 6:30 PM the same day had nausea, vomiting x 4, hot/cold flashes, fever.  4/21/2011: pt vomited x 1 and still nauseated.  Mother told pt that pt unable to tolerate pertussis as a child and got the vaccine without it.  Pt unaware of information at time of injection.
Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient indicated a rash formed on their arm after receiving both their COVID bivalent booster and flu shot. The rash began to form the day after receiving them. Pharmacist counseled patient to monitor and go to MD if it doesn't get better.
Information had been received on 10-MAY-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 01-SEP-2011 as logged in the vaccine registry, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-AUG-2013, patient was treated at a clinic for a painful rash that was then diagnosed as shingles. On or about 19-SEP-2013, patient was treated at the same facility for worsening symptoms that were diagnosed as severe shingles. On or about 09-OCT-2013, patient was treated again at the clinic for severe shingles which had developed into postherpetic neuralgia. On or about 15-NOV-2013, patient was treated for ongoing postherpetic neuralgia and chronic pain at the clinic. Patient was prescribed valacyclovir, lidocaine and gabapentin for management of these excrutiating symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Less than 24 hours after IM vaccine of 3rd dose of COVID, developed chills, body aches, back pain that started at shoulders extending down back into legs, light headedness, "felt like eyes were on fire."  Very fatigued and diaphoretic for 1 day after vaccine.  Developed pain in axilla of left arm in the injection and left arm soreness.   continues to have episodes of diaphoresis/clammy
On the 17th of December and I woke up with a ton of chest congestion and coughing up mucus.  I had a productive cough.  Originally I did not have any sinus symptoms.  About 7 days I had a bed headache and congestion.  I also had diarrhea.  I have had it over the last 3 weeks.  I still do not feel right.  I was see by the doctor on the 22nd.  I was swabbed on the 23rd for Flu and COVID.  Those both came back negative.  I started a z-pack from the 24th through the 28th.  I started on the 27th to feel a little better, the congestion went away but I still had nausea.  The nausea went away on the 1st of January but now I have a sore throat.
Generalized maculopapular, pruritic rash to  bilateral arms, legs, abdomen.
delayed reaction at injection site - on the 7th day after the injection there was pain, swelling, itching ,redness and it was hot to the touch. The eight day it grew larger, I am reporting on the ninth day and the redness and swelling is covering an even larger area of my upper arm.
JOINTS STARTED SWELLING AND DEVELOPED MULTIPLE RETINAL TEARS DUE TO EYE INFAMATION
Mom called another provider in one of our satellite offices stating arm where the KINRIX was given had areas of pinprick redness. Mom said shoulder is purple and swollen to size of softball. Swelling from shoulder to elbow. The provider mom spoke to advised visit to walk in clinic. Mom said walk in clinic gave BENADRYL swelling went down significantly.
"severe stomach cramping after 1st dose /stomach cramping started on 5/25; ilietis; This is a spontaneous report from a contactable consumer (patient) reported for herself that.  A 50-years-old female patient received BNT162B2 (BioNTech/Pfizer vaccine solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 24May2021 09:15 (Batch/Lot Number: Ew0187.) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on 29Apr2021 (Batch/Lot Number: EW0167) as DOSE 1, SINGLE for covid-19 immunization (Age at vaccination 50 years). Facility where the most recent COVID-19 vaccine was administered: Doctor's office/urgent care. The patient past medical history included High cholesterol from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing and hypothyroidism from an unknown date and unknown if ongoing. The patient has received other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. Since the vaccination, has the patient has not been tested for COVID-19. On 03May2021, 10 days after the administration of vaccine the patient experienced severe stomach cramping after 1st dose /stomach cramping started on 5/25 and ER and a CT scan showed ileitis on unspecified date in May2021. The Ae resulted in - Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included computerized tomogram: CT scan showed ileitis on unspecified date. The patient received a treatment with antibiotics and the pain was gone. The event outcome was not recovered for Stomach cramps and unknown for ileitis.  Device Date: 26May2021  Follow-up attempts are completed. No further information is expected.
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 15-APR-2019,  the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R024906 with expiration date 30-AUG-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
When I got the shot my lymph nodes in my left arm in my armpit swelled up for about a week. 2 weeks later I woke up with my whole body itching. There was no rash but when I would scratch my skin anywhere on my body my skin would get very red and produce welts. This has lasted about a month. In addition to that my asthma has flared up. My Asthma is normally sports induced meaning I wont feel it unless I run at a significant length. Now it will flare up  just sitting at a desk.
Bell's palsy; Gastric distress; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell's palsy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FACIAL PARALYSIS (Bell's palsy) (seriousness criterion medically significant) and GASTRIC DISORDER (Gastric distress). At the time of the report, FACIAL PARALYSIS (Bell's palsy) and GASTRIC DISORDER (Gastric distress) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On an unspecified date, 4-5 days later, the patient had gastric distress and 8 days later, patient had Bell's palsy (diagnosed by a doctor 10 days post vaccination). He was prescribed with Prednisone for 1 week.  This case concerns a male of unknown age with a serious unexpected event of facial paralysis and a nonserious unexpected event of gastric distress. Event onset 8 days after first dose mRNA-1273. Treated with prednisone. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a male of unknown age with a serious unexpected event of facial paralysis and a nonserious unexpected event of gastric distress. Event onset 8 days after first dose mRNA-1273. Treated with prednisone. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report as received from a certified Medical Assistant refers to a patient of unknown age. On 31-AUG-2102, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number not reported).  On 06-Aug-2013, the patient was vaccinated with the second dose of GARDASIL (dose, route and lot number not reported). On 12-NOV-2013, the patient was vaccinated with the third dose of GARDASIL (dose, route and lot number not reported). No concomitant medications were reported. No adverse symptoms reported. Additional information has been requested.
Had headaches; Had migraines; This case was reported by a consumer via call center representative and described the occurrence of headache in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2022, the patient received the 1st dose of Shingrix. On 3rd February 2022, 2 days after receiving Shingrix, the patient experienced headache and migraine. On an unknown date, the outcome of the headache and migraine were not recovered/not resolved.   It was unknown if the reporter considered the headache and migraine to be related to Shingrix.  Additional details were provided as follows: On 1st February 2022 Tuesday, the patient had first shot of the vaccine. The patient had headaches and migraines since Thursday (3rd February 2022). The patient enquired if it could be a reaction to Shingrix. The reporter consented to follow-up
Rash on the back side of Left arm that started 4 weeks after vaccination; Cluster migraines headaches which effected the left eye; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Cluster migraines headaches which effected the left eye) and RASH (Rash on the back side of Left arm that started 4 weeks after vaccination) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history provided by the reporter.  Concurrent medical conditions included Arthritis. Concomitant products included CODEINE PHOSPHATE, PARACETAMOL (TYLENOL WITH CODEINE NO. 3) for Arthritis, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), CHONDROITIN SULFATE SODIUM, GLUCOSAMINE HYDROCHLORIDE, MANGANESE ASCORBATE (COSAMIN DS [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE HYDROCHLORIDE;MANGANESE ASCORBATE]), VITAMIN D3, SIMETICONE (GAS-X), AZELASTINE HCL, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]), PIMECROLIMUS, HYDROCORTISONE, BETAMETHASONE, LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL), MULTIVITAMIN FOR WOMEN and VITAMIN B12 NOS for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced MIGRAINE (Cluster migraines headaches which effected the left eye). On 11-Mar-2021, the patient experienced RASH (Rash on the back side of Left arm that started 4 weeks after vaccination). At the time of the report, MIGRAINE (Cluster migraines headaches which effected the left eye) outcome was unknown and RASH (Rash on the back side of Left arm that started 4 weeks after vaccination) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up information was received on 4 May 2021 and  included no new information.
MMR given 04/23/2003 on 04/27/2003 child developed fever, vomiting, seen at clinic 04/28/2003.  Symptoms resolved; on 04/29/2003, rash appeared on abdomen and spread to extremities.  Seen in clinic 05/02/2003-rash still there, somewhat itchy.