chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On day 7 post-vaccination, I woke up with an itchy right upper arm.  Later in the day, (after being alerted by 2 other members of my office of their reaction), I looked at my arm and noted a 4 x 4 cm area of erythema - warm, indurated, itchy.  The next day, the itch was gone, but the erythema remained throughout that day, but was gone by the following day (about 48 hours after the itching and rash first appeared).  On day 12 post-vaccination, there was a small rim of erythema inferiorly around the area of vaccination measuring 1/2 cm x 6 cm.  This continued to extend throughout the day and by that night was a full ring measuring 6.5 x 8 cm in diameter with a central duskiness.  This was still there the next morning, but resolved by the day after that (post vaccination day 14).
Monovalent mRNA vaccine administered for a bivalent mRNA dose.  I hadn't been made aware that the monovalent vaccine had had it's EUA revoked by the FDA at the time of this vaccines administration..  My supervisor received e-mail notification from our health department on 05/02/2023 with a Department of Health and Human Services update for immediate release to Covid-19 vaccines. This update simply stated that individuals that were previously vaccinated with monovalent Covid-19 vaccines and who had not received a dose of Bivalent vaccine could receive a single dose of bivalent vaccine.   The press release/ immediate release (dated 05/01/2023) did NOT state that the EUA had been revoked  on 04/18/2023.  I received the e-mail forwarded to me  on 05/03/2023 which I then destroyed the remaining MDV of Pfizer monovalent Lot FP7136 vaccine.   This patient did NOT suffer any type of adverse reaction or event.    This patient was notified of this occurrence .  On 05/17/2023 this patient WAS given Pfizer Bivalent vaccine Lot GJ3270 with exp 01/31/24 in right deltoid. Tolerated well! This patent was released from our custody on 05/18/2023.
Information has been received from a registered nurse concerning a 10 year old male with cold symptoms at the time of vaccination who on 15-MAY-2000 was vaccinated with a subcutaneous dose of varicella virus vaccine live (Oka/Merck) (Lot # 631467/1682J) in the left arm. On 30-MAY-2007, the patient developed 20 lesions in various stages after exposure 1-2 weeks prior. The patient did not have any adverse events following prior vaccinations. The patient went to the doctor's office. The patient was treated with Benadryl and calamine. Subsequently, the patient recovered. Additional information is not expected.
No adverse events, reactions, signs Bivalent dose not giving for 3rd dose in series.
The patient received vaccines on 9/8/05 w/ no complications. Two days later the patient had blood streaked stools.  On 9/11/05 the patient had diffuse petechiae and platelet count of 5,000.  Pt. was transfused with platelets and follow up count was 40,000.  The following day 9/13/05 the platelet count was 9,000.  IVIG was given 9/13/05 and platelet count prior to discharge was 24,000.  The remaining CBC was WBC 5.2, H/H 9.1/25.5 with absolute neutrophil count of 0.4 so patient was also neutropenic upon discharge.  The patient had no other symptoms. Per 60 day follow up report: I was a medical student on team. I would suggest contacting this patient's PMD whose info was provided.
Fatigue Nausea Headache Fever- approximately 9pm start, continued for 20 hours Body/Join Aches- caused difficulty sleeping Lasted approximately 24 hours- unable to work during this time
**Administration Error** Patient was given the MMR  vaccine when she was suppose to receive the chicken pox booster.  Patient Complained of extreme pain when the pharmacist was inserting the injection. Patient said that she had numbness in her hand. Patient said that pain lasted about 30min. Patients arm was red.
This spontaneous report as received from the company representative who was reported by the physician and refers to a male patient of unknown age. No demographics were provided for the patient. No medical history and concurrent conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX vial (lot number, dose, frequency, route and site of administration not reported). No concomitant medications were reported. On an unknown date, the patient experienced shingles after receiving ZOSTAVAX which was treated with VALTREX (unspecified dose, frequency and manufacturer). The patient sought for the medical attention and visited the office on an unspecified date. The outcome of shingles was unknown. The reported events were not considered as hospitalisation, cancer, life-threatening, disability or overdose. No product quality complaint (PQC) was filed. Additional information has been requested.
Shortly after receiving immunization, patient experienced a "shingle-like" rash up and down the arm. Treatment given not known. Doctor can provide.
ENDED UP PASSING AWAY; GOT WORSE AND WORSE; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient got worse and worse and on an unspecified date patient ended up passing away. It was reported that  "My husband got thanks j j shot too years ago and then he got worse and worse and ended up passing away". On an unspecified date, the patient died from unknown cause of death. It was unknown whether an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got worse and worse was not reported and on an unspecified date the patient ended up passing away. This report was serious (Death).; Sender's Comments: V0: 20221243958-Ended up passing away. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Very sick to my stomach vomiting some  started  @6:30pm. My right arm is very sore.  Headache started @ 10am today
6-21 Inflamation in Right finger joint moved to right elbow tendon inflamation which moved to left elbow inflamation. ongoing issue 1-15-22  Swollen salivary glands. Both left and right. ongoing issue
This spontaneous report as received from medical assistant (patient's mother) refers to a 4 year old female patient. There was no pertinent medical history. The patient had an unknown reaction to Amoxicillin (manufacturer unknown). On 04-MAR-2014 the patient was vaccinated with a dose of PROQUAD (Merck) (lot # H015629, exp date 24-FEB-2014) (0.5 ml, subcutaneous). There was no concomitant therapy. On 04-MAR-2014, the patient experienced diarrhea since administration of expired PROQUAD (Merck). The patient vomited once the night of 04-MAR-2014. The medical assistant stated her daughter had increased her fluid intake as treatment for adverse events and had not required medical attention at the time of the report. Laboratory diagnostic studies were not performed. At the time of the report the patient's outcome was not recovered. Additional information has been requested.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 10-MAR-2015, the patient received improperly stored VARIVAX dose 2, from lot # K007982 (dose, vaccination site, route, expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd vax 30SEP93 & pt's LMP 2AUG93 & was determined to be pregnant on 8OCT93; 20OCT93 pt seen by MD w/vaginal bleeding dx w/threatened abortion;
In Monitoring area, patient stated, I feel heaviness I'm my chest and I feel a little lightheaded. ". Patient assessed by RN and OCFD. Patient refused further care but stated, " I will wait for 30 minutes and I will drink the Gatorade you gave me.". After 30 minutes of monitoring, Patient stated," I am good. I don't feel lightheaded or the heaviness on my chest and my O2 SATs is ninety eight percent. I am ready to go.".
On Friday I woke up with swelling around both eyes and in my forehead. Swelling increased progressively so that by Sunday my left eye was nearly swollen shut. I saw a nurse practitioner on Monday and she gave me some steroid eye drops. This helped reduce inflammation a little bit but the swelling and redness continues. The skin was stretched, red, thin, itchy, and crusty. It has now been 15 days since my vaccine. The worst of the swelling has subsided but my eyelid and the area under my eye are still puffy, itchy, and red.  I am concerned based on the area of the reaction that this was related to an adverse interaction between the vaccine and dermal fillers I had Injected in February of 2020.   In addition to this reaction I had extreme fever, shakes, lethargy, and random superficial bruising. The bruising appeared in places where I had had no injuries 6-9 days after the vaccine and looked similar to those you see on people who do cupping - not round but like tiny red dots with pooled blood à stippled bruise with no pain.
fast heartbeat; Dizziness; Weakness; heart started palpitating; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER2613, Expiration date: Unknown) via an unspecified route of administration, administered in left arm on 16Mar2021 13:30 (at the age of 63-years-old) as dose 1, single for COVID-19 immunization. History of all previous immunization with the Pfizer vaccine considered as suspect was none. No prior vaccinations were given within 4 weeks. Medical history included schizophrenia, blood cholesterol increased, gastrooesophageal reflux disease, calcium deficiency, breast cancer, bone loss, osteopenia, mastectomy. Family medical history was none. Concomitant medications included paliperidone (INVEGA [PALIPERIDONE]) taken for schizophrenia, from unknown start date to 05Mar201; atorvastatin taken for blood cholesterol increased from an unspecified start date and ongoing; famotidine taken for an unspecified indication from 05Mar2021 and ongoing; calcium taken for calcium deficiency from an unspecified start date and ongoing; anastrozole (ARIMIDEX) taken for bone loss, osteopenia, calcium deficiency, start and stop date were not reported. On 16Mar2021 at 15:30, the patient experienced fast heartbeat, dizziness, weakness and heart started palpitating. Patient stated right after the shot her heart started palpitating, fast heartbeat, happened all 16Mar2021 at 15:30 lasted till 5 am of 17Mar2021. Patient stated the fast heartbeat started the same time as heart palpitation, dizziness, and weakness and lasted all the way until about 5 am of 17Mar2021. The events did not result in emergency room or physician office. The patient stated the side effects are almost all gone. The patient underwent lab tests and procedures which included heart rate: fast on 16Mar2021. No treatment was given for the events. The outcome of the events was recovered on 17Mar2021.  No follow-up attempts are possible. No further information is expected.
Employee reported new onset headache, sweats, dizziness, difficulty concentrating approximately two and a half hours after injection
I got my period 2 days after getting my first vaccine, two weeks before it was due. Then I got my period again on the day it was due two weeks later.
Itchy started within 3-5 minutes after injection. Started in scalp this time and then moved throughout body down to feet. After 45 minutes of it not going away, received a shot of Benadryl in left hip. Itching started to subside within 30 minutes of getting the Benadryl shot. Nauseous feelings and joint pain started about 3.5 hours after vaccine was administered.
Itchy red flat dots all over my body. Approximately one to two cm in diameter. Most concentrated in the middle of my back. Stopped itching after 5 or 6 days and have faded noticibly now after 10 days or so. I felt strange at the beginning.  I was experiencing extreme work related stress at the time.  Things have calmed down since then.
Migraine , sore throat , body aches , chills , fever , diarrhea, nausea, loss of appetite, fatigue
Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Nausea-Severe, Systemic: Tachycardia-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Patient had severe case of COVID infection approximately 1/2021 leading to a lengthy hospital stay and has several long term side effects from having had COVID such as respiratory disease and diabetes. He informed pharmacy he was measured to have high levels of antibodies still 1 year after having been infected.
Swelling  in right axilla, pain in right axilla, swelling in right side of neck under mandible., fatigue, headache
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Chills-Medium, Systemic: Fever-Medium, Systemic: Nausea-Mild, Additional Details: SHE CALLED ON 11/02/2021 TO REPORT THE ADVERSE EFFECTS THAT SHE IS HAVING, i ASKED WHETHER YOU CALLED DOCTOR, SHE SAID NO, SHE SAID HAS BURNING, SWELLING, GIANT RED, BLACK INSIDE, FEVER, CHILLS,NAUSEA,ARM AREA(OVAL SHAPED 5 INCH LONG & 4.5 INCH WIDE, TRIPLE INSIDE),
I had a low grade fever; a little bit sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (I had a low grade fever) and VACCINATION SITE PAIN (a little bit sore at injection site) in a 55-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 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. In May 2021, the patient experienced PYREXIA (I had a low grade fever) and VACCINATION SITE PAIN (a little bit sore at injection site). At the time of the report, PYREXIA (I had a low grade fever) and VACCINATION SITE PAIN (a little bit sore at injection site) outcome was unknown.            No concomitant and treatment drug information was provided.   This case was linked to MOD-2021-406713, MOD-2021-406735 (Patient Link).
Diffuse, erythematous rash starting on arm near injection site and spreading toward digits. Progessed/worsened between 10/22 and 10/23. Pt began to experience pruritis on 10/23.
Throat scratchy, generalized severe pruritis, arm swelling, redness nd severe itching at site. Left arm over 2 inches bigger than right.  Required benadryl and epinephrine
Patient received janssen and with in 5 mins got light headed and passed out for a second. We immediately called 911.  Patient was checked out and 911 took him to the hospital .
Seen for PE and vaccines on 01/19/06.  Phone call 01/20/06 25 cent size lump L thigh, painful, afebrile.  Seen by MD 01/21/06, 8 cm X 11 cm raised warm rough fine rash L midthigh, afebrile.  Line drawn around area, advised OTC Benedryl.  Phone call 01/22/06 area now extends 1" beyond line drawn around area, tender, pruritic, afebrile.  Advised to W&W.
pt recv vax 28OCT96 & 9 or 10 days post vax pt devel fever up to 103, chills & body aches;went to see MD & was dx w/flu;pt sx persisted & on a return visit to MD sx were attributed to the flu;
Information has been received from a registered nurse concerning a 29 year old white male patient with no illness at the time of vaccination and no past medical history who on 03FEB2004 had measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live sprayed into his eye. It was reported that a child, accompanied by his dad was being vaccinated and then the nurse inserted the needle into the child's arm the hub separated (also reported as syringe separated from needle) and vaccine sprayed out into the dad's eye. The nurse reported this was not a quality complaint as she had not secured the needle. Unspecified medical attention was sought. Follow up information indicated that the eye was irrigated several times that day with water. A slight burning sensation was reported, but no loss of vision, no blurred vision and no pain. It was recommended that the patient visit a primary care physician or ophthalmologist, but the patient did not feel that was necessary. There were no diagnostic or laboratory tests done. It was noted that the patient was recovered on 03FEB2004. No further information is available.
During the early morning hours within 12 hours of the vaccine I woke up to extreme pain in my right shoulder joint.  Any movement hurt intensely.  As the day went on I took acetaminophen which substantially decreased the pain of movement.  I did that twice during the waking hours the first day after the vaccine.  Within 2 days the pain was gone.
Arm pain. Initially it was swollen and hurt. The arm pain has continued (without swelling); discomfort is daily and is temporarily relieved by rubbing my arm.
Urticaria at injection site spreading to whole extremity. Occurred 2/8/18 and 4/25/18 1-2d after MCV B injection. Patient give BENADRYL with relief.
Aches joints, acid reflux, high colesterol, vertigo, dizziness, bumps on hand, depresions, headaches, ringing in ears, numbness & tingling arms, pain legs, pain groins, pain lower back, pain kness, insomnio, blister in mouth, amblyopia, digestive problems, hemorrhoids, reflux, etc.
Red swollen arm at the site of the injection. Hot to the touch.  Started about 36 hours after injection.
Presents a 0,5cm area of edema located 1cm distance of site of vaccine administration immediately after vaccine administration.  Applied local ice in office. Adviced to follow up if any additional symptoms.
Rash; Swelling on injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and VACCINATION SITE SWELLING (Swelling on injection site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Rash) and VACCINATION SITE SWELLING (Swelling on injection site). At the time of the report, RASH (Rash) and VACCINATION SITE SWELLING (Swelling on injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.   This case was linked to MOD-2022-437596 (Patient Link).
Child began having reddened sclera, red, puffy eyelids and hives on her face.  No respiratory distress. She came back to our office and was given Orapred and Benadryl.
This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect from a contactable consumer. A male 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 a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient woke up this morning (unspecified date) with body aches and chills after receiving COVID-19 vaccine wanted to know if these are normal side effects. The outcome of the events was unknown. No follow-up attempts are completed. No further information is expected. Information on the lot/batch number has been requested.
about 15 hours after shot developed fever (99.5) and chills and headache. This laster about a day.  Then I felt like I had a cold and had ntermittent slight sore throat. On the third day after shot experienced mild nausea.  Headache disappeared as did sore throat.  At no time was there soreness at injection site, and I had no arm pain at all. So in toto, I was out of commission for 3 days.
The first day I had headache, sore throat, fatigue, and mental fogginess.  Tested 2/17 with At Home COVID-19 test positive.  Televisit with doctor, recommended treating symptomatically.    Symptoms were mild in the mornings but as the day progressed, the symptoms got progressively worse.  Developed a burning sensation in upper respiratory system later in the day.  Symptoms lasted about 10 days, and then got gradually better over days 11 and 12 with fatigue that lingers.  During time of fatigue, headache, burning in upper respiratory and mental fogginess reappear.  Participant states they did field research and got upper respiratory illnesses every time.