chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blood clots; This spontaneous case was reported by a patient family member or friend and describes the occurrence of THROMBOSIS (blood clots) in a 37-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clots) (seriousness criteria death and medically significant). The reported cause of death was blood clots. It is unknown if an autopsy was performed.            Concomitant medications details were not reported by the reporter.  It was reported that patient had recently received the booster dose. The patient had dropped dead at the age of 37.   Treatment details was not reported by the reporter. Company comment: This fatal spontaneous case concerns a 37-year-old female patient, with no medical history reported, who received the booster dose of mRNA-1273.222 vaccine and experienced the unexpected and fatal event of thrombosis. Vaccination, event´s onset and death dates were not reported; hence, latency could not be properly assessed. No details of previous doses were provided. The reported cause of death was blood clots (thrombosis). It is unknown if an autopsy was performed. No other clinically relevant information was disclosed. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This fatal spontaneous case concerns a 37-year-old female patient, with no medical history reported, who received the booster dose of mRNA-1273.222 vaccine and experienced the unexpected and fatal event of thrombosis. Vaccination, event´s onset and death dates were not reported; hence, latency could not be properly assessed. No details of previous doses were provided. The reported cause of death was blood clots (thrombosis). It is unknown if an autopsy was performed. No other clinically relevant information was disclosed. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.; Reported Cause(s) of Death: Blood clots
Face and neck covered in swelling/hives at midnight. Not sure if allergic reaction to vaccine or something else but occurred a few hours following receiving shot . Took a Benadryl and adverse event of hives and swelling immediately went away within 20-30 min
Patient fainted and experienced a hard time breathing for 10  mins. Vital signs: BP: uncooperative HR: 110 RR: 24 O2: 90% and Temp: 97.5. He received 3 Ls of oxygen and 911 was called. He was sent to the ER.
Immediate headache, nausea, anaphylaxis, shaking. Patient could not move for a few minutes after vaccine. She did not lose consciousness but felt like she was going to pass out.
Shingles; Burning sensation; Itching; Rash; Irritation; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included chickenpox.   On 28th March 2020, the patient received the 1st dose of Shingrix. On 19th June 2020, 83 days after receiving Shingrix, the patient experienced shingles, burning sensation, pruritus, rash and skin irritation. On an unknown date, the outcome of the shingles, burning sensation, pruritus, rash and skin irritation were not recovered/not resolved.   It was unknown if the reporter considered the shingles, burning sensation, pruritus, rash and skin irritation to be related to Shingrix.  Additional details were reported as follows: The patient got shingles after receiving the 1st dose of Shingrix. He experienced a burning sensation, itching, irritation, and a rash about 3 weeks ago. Adverse events have not resolved. The reporter stated that his healthcare prefessionla was aware of events and still recommended to receive 2nd dose. The outcomes for events were reported as recovering in source document however it was captured as not recovered as per description. The reporter did not consent to follow up.
There was a sore throat, headache, body chills and fatigue, fever, cough, and nasal congestion. They each gradually developed within a couple of days. I took an at-home COVID-19 on 11/26/2022 which came back positive; so to confirm, I went to take a rapid antigen test at my pharmacy on the same day which came back positive as well. I contacted my physician who told me to take MUCINEX and OTC pain reliever like naproxen or acetaminophen. As of now, I'm doing much better and have recovered from my COVID-19 infection.
difficulty breathing, vomited when he coughed, had a mild seizure on 1/24/02
Neck rash; Lethargy; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 02Apr2021(at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021 the patient experienced lethargy. On 04Apr2021(morning), the patient experienced neck rash. It was unknown whether the patient received any treatment for the reported adverse events. The clinical outcome of the event lethargy and neck rash was unknown.   No follow-up attempts are possible. No further information is expected.
Fever; Chills; Arm was sore at site of the shot; Joint pain/joint aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-PFIZER INC-202200112656 (Pfizer).  A 53 year-old male patient received bnt162b2 (COMIRNATY), administered in deltoid right, administration date 18Jan2022 (Lot number: FJ6369) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, Lot number: EP6955, Expiry date: 30Jun2021, Anatomical location: right deltoid), administration date: 19Mar2021, when the patient was 52 years old, for COVID-19 immunization; Bnt162b2 (Dose 2, single, Lot number: EP6955, Expiry date 30Jun2021, Anatomical location: right deltoid), administration date: 07Apr2021, when the patient was 52 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 19Jan2022, outcome "recovered" (Jan2022), described as "Fever"; CHILLS (non-serious) with onset 19Jan2022, outcome "recovered" (Jan2022), described as "Chills"; VACCINATION SITE PAIN (non-serious) with onset 19Jan2022, outcome "recovered" (Jan2022), described as "Arm was sore at site of the shot"; ARTHRALGIA (non-serious) with onset 19Jan2022, outcome "not recovered", described as "Joint pain/joint aches". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The concomitant medication included unspecified hypertension medication. Caller clarified the typical reaction to be last evening her husband started to have a fever, the highest was 102.3, chills, joint aches, arm was sore at site of the shot. Caller confirmed all these events have resolved, but he still had joint pain; no additional details provided.  No follow-up attempts are possible. No further information is expected.
Patient received vaccines on 12/5/06 in preparation for travel. The next evening she felt a swollen node, approx pea sized, just above her collarbone on the left. Denies fever or any other symptoms.
Within two days of my vaccine I noticed my breathing sounded like a whistle when I breathe normally. It increases when I lay down flat - on my side or my back  It is noticeable when I stand, even when I do not over-exert myself.  I am a runner and the sound is apparent to others nearby. This condition has gotten worse in the last 12 months. I have not visited a doctor for this yet but my doctor has referred me to a cardiologist.
Drug ineffective; Suspected 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 male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, 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: DRUG INEFFECTIVE (medically significant), outcome "unknown"; SUSPECTED COVID-19 (medically significant), outcome "unknown". Clinical Course: It was reported that the patient was fully vaccinated. Patient got COVID, everybody at their house had COVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1. Increase in severity and duration of vestibular migraines. I've always had migraines, but they increased from perhaps one per week to several per week, lasting days. No pain reliever works. Sometimes I am up the entire night with severe pain. I don't take an of the standard migraine meds because I don't want to have them in my body. I take Ibuprofen and Tylenol and even decongestants offer some relief. I continue to suffer these episodes. My doctor's suggestion was migraine meds...PT told me vestibular and while her manual PT did work, I cannot afford to go 2x per week, which was the only way I had some relief. 2. Heart palpitations - I have an underlying heart condition (Mitral valve disease) and was told by my cardiologist that it was fine to take the vaccine. I was concerned reading about possible vaccine issues affecting the heart, but I was so fearful at that time, and wanted to protect my mother, I still took the vaccine. I saw a cardiologist in 2021, but there was nothing conclusive and he didn't see anything too serious. He denied that the vaccine could have harmed my heart further. I currently have palpitations, which happen a lot of the time when I get my migraines. I have an appointment with a new cardiologist in December, once I move. 3. Insomnia - I suffer from severe insomnia, some of it related to migraines. I cannot sleep.  I have been and still am extremely healthy. Despite the migraines and heart issues, I work out 5 days a week, travel extensively, and live an active life. Never did I imagine I would suffer a debilitating issue like this.
noticed a nodule right below the left side of the neck below the cheek; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (noticed a nodule right below the left side of the neck below the cheek) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concomitant products included ACEBUTOLOL HYDROCHLORIDE and ENALAPRIL MALEATE for Hypertension, POTASSIUM CHLORIDE for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced NODULE (noticed a nodule right below the left side of the neck below the cheek). At the time of the report, NODULE (noticed a nodule right below the left side of the neck below the cheek) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported include steroid. Treatment for the event included
This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 50-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). Previously administered products included SHINGRIX with an associated reaction of injection site erythema (received 1st dose of SHINGRIX on 6th March 2018, for tolerance see case US2018087770). Concomitant products included ASACOL, EFFEXOR SR, PORTIA 28 and SYNTHROID. On 15th May 2018 09:00, the patient received the 2nd dose of SHINGRIX. On 15th May 2018 16:00, 7 hrs after receiving SHINGRIX, the patient experienced injection site itching, lymph node pain, axillary adenitis, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site itching, lymph node pain, axillary adenitis, injection site erythema and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the injection site itching, lymph node pain, axillary adenitis, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the doctor. On 15th May 2018, the patient received SHINGRIX at 9:00. At 16:00 hours, the patient experienced itching near the injection site, which spread to the elbow. The patient also experienced redness, a warm sensation at the injection site, stiffness and soreness on glands of her neck, left side, and under her left arm gland. At time of reporting, the events was not resolved. The patient was vaccinated at her place of work. This case has been linked with case US2018087770, reported by the same reporter for the same patient.
Syncopal episode, lasting 30 seconds, that cause patient to fall off exam table and hit face and mouth on  the floor. Patient was picked up and placed supine.  Ice applied to face and was given ice cream when fully awake.  Patient was later seen in ER for evaluation of amnesia, vomiting and concussion. He was D/Ced home from ER with no imaging done instructed to follow up in the office
Skin on left arm at injection site bruised immediately, next day it formed a 3?x6? red raised rash. 12 hours after injections fever and chills started, along with a headache and lightheadedness, unable to sleep at all.
arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036D21A and 036D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). At the time of the report, PAIN IN EXTREMITY (arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Mediations were provided by the reporter. No Treatment History was provided by the reporter.   This case was linked to MOD-2021-162243 (Patient Link).
2 days later I noticed about 3 small lumps on my left front bone below my neck.
Severe panic attacks, altered perception of reality, fear, suicidal thoughts, odd thoughts, depression, severe anxiety
Pt is 15 years old at time of 1st dose of vaccination. Moderna vaccine to give to those older then 18 years old. Per CDC website okay to proceed with 2nd dose of Moderna, must notify VAERS and PT's parents. Both complete. New methods implented in clinic to insure this does not occur again. MA
Patient was given the booster shot about two weeks too early.  His first dose was 8/18/21 and his second dose was 9/17/21.  His booster should have been given on or after 2/17/22, but was mistakenly given on 2/4/22 after making an appointment for his booster.
Information has been received from a Nurse concerning a 1 year old male who on 27-MAR-2007 was vaccinated with a dose of MMRV. On 29-MAR-2007 the patient was seen in the doctor's office for redness, warmth and pain at the thigh injection site. Warm compress and an unknown cream were recommended as treatment. As of 04-Apr-2007 the patient has been recovering from redness, warmth and pain at the thigh injection site. No product quality complaint was involved. Additional information has been requested.
shaking-chilled 3DEC92 t101 ax, dry cough, runny nose, pulling @ ears for 3 wks;
Information has been received through the Merck pregnancy registry from a physician concerning a 25 year old female with a history of tonsillectomy who on 29-NOV-2007 was vaccinated with the third dose of GARDASIL.  No information was provided concerning the first or second dose of GARDASIL.  On 29-NOV-2007 the patient also had blood work taken "which had showed she was pregnant" (LMP=05-SEP-2007).  The patient sought unspecified medical attention and reported that she was about "three weeks pregnant".  No further information was provided.  Follow-up information has been received from a physician concerning the patient who was induced on 12-AUG-2008 because she was 41 weeks gestation, and had a vaginal delivery of a normal baby with "good Apgars", "everything went well".  The reporter indicated that the patient did well and was discharged home with the baby on the next day  No further information is available.
Fever (? how high) mother had no thermometer. She gave her MOTRIN at 7 AM on 06-25-15. Temperature returned to normal. No medical tx given by MD or ER.
I went hoarse for about a month. I called my PCP and they referred me to an ear, nose, and throat doctor. They found white spots on my vocal chords. I feel like I have to constantly clear my throat. I can't get in to see a throat specialist until September.
Lethargy spell with seizure-like activity with 2-3 weeks of prolonged poor feeding and decreasing LOC.
patient who received the 1st dose of the Moderna vaccine "4 months ago"; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient who received the 1st dose of the Moderna vaccine "4 months ago") in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 PRODUCT DOSE OMISSION ISSUE (patient who received the 1st dose of the Moderna vaccine "4 months ago"). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient who received the 1st dose of the Moderna vaccine "4 months ago") had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. action taken with mRNA-1273 (COVID 19 Vaccine Moderna)(unknown), was unknown
Sore arm; This is a spontaneous report from a contactable patient. A 49-years old no pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), via an unspecified route of administration in left arm on 19Feb2021 at 02:00 PM as a single dose for COVID-19 immunisation. Medical history included Dysfibrinogenemia. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient not received any other medications within 2 weeks of vaccination. The patient experienced sore arm on 19Feb2021 at 09:00 PM. Sore arm got worst on 2nd and 3rd day of vaccination. The patient experienced sore arm for about a week. The patient experienced soreness in arm similar to any other vaccine received as a child. Treatment was not received for event. The clinical outcome of sore arm recovered at time of reporting. No follow-up attempts are needed. No further information is expected.
A week after first shot  the area where injection was started to itch, and turn red. The area became hard and continued to itch.
This medically confirmed spontaneous report (initial receipt 15-Sep-2015) concerns an unknown demographics patient. On an unspecified date "a few years ago", the patient received unspecified H1N1 vaccine (H1N1 Influenza virus vaccine, manufacturer and batch number not provided). On an unspecified date, after receiving the H1N1 vaccine, the patient experienced swelling of the throat and shortness of breath. No further information was provided. The outcome was not provided. Sender's Comments: Seriousness: Serious (Medically significant). Listedness: Unlisted. Assessment according to Assessment according to the CCDS for CSL's H1N1 Influenza vaccine, and the PI for Influenza A (H1N1) 2009 Monovalent Vaccine, swelling of throat and shortness of breath are unlisted. Causality: Unassessable. Insufficient information such as time to onset, event description, investigation, treatment and outcome. Allergic reaction including anaphylaxis is a known adverse event of H1N1 vaccination; however the case did not meet Brighton collaboration case definition for anaphylaxis. Hence causality is unassessable.
he returned to work with the vaccination card he was told You no longer work here; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF EMPLOYMENT (he returned to work with the vaccination card he was told You no longer work here) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 048C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jun-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 LOSS OF EMPLOYMENT (he returned to work with the vaccination card he was told You no longer work here). At the time of the report, LOSS OF EMPLOYMENT (he returned to work with the vaccination card he was told You no longer work here) outcome was unknown.       Concomitant medication was not provided Treatment information was not reported. It was reported that, Consumer had called to find out if there was something wrong with the Moderna vaccine. Patient was fully vaccinated.
8 mins after receiving first dose, I became very dizzy, my heart rate increased and I started sweating.  I never passed out and remained sitting.  The episode lasted 1-2 minutes.  I did not need assistance.    Then 2 -3 hours later I had the exact same episode and reported it to the downtown clinic and they only urged me to self monitor or report to ER if needed.  Those were the only 2 episodes.    My blood pressure was elevated that afternoon but was very low for 3 days and I did not take my atenolol for those days.
Evening of 8/2/16 child had fever 102°F-Mom gave ibuprof. AM of 8/3/16 child had swelling, redness, tenderness and warmth to left distal upper arm - ice applied. 8/4/16 child seen in office 6 cm x 7 cm area lateral lower upper (L) arm with moderate edema and redness - BENADRYL ordered.
Redness started to develop on the third day and the area extended to 3/4 inch by 3 inches. It hurts to touch. No fever or shortness of breath.
pt recv vax & devel redness, soreness & induration @ the inj site which lasted 2 days
vesicular lesions-appearing 1mo p/vax, no fever only 10-15 lesions total, now lesions still present @2.5 mo p/vax on 7OCT96;vax recv 2AUG96;lesions located on arms, trunk, head, these rupture & scales appear;