chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm is painful; red itchy Rash on injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm is painful) and VACCINATION SITE RASH (red itchy Rash on injection site arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Arm is painful) and VACCINATION SITE RASH (red itchy Rash on injection site arm). At the time of the report, MYALGIA (Arm is painful) and VACCINATION SITE RASH (red itchy Rash on injection site arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medicine include Eczema cream  Concomitant medicines were not provided  Action taken with mRNA-1273 in response to the event was unknown
Death Abdominal pain  Abnormal CT scan Partial gastric outlet obstruction Disorder of common bile duct Hyperbilirubinemia Colon cancer (CMS/HCC) Obstructive jaundice
Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a 22 year old male pt who experienced nausea, vomiting, dizziness, near syncope, generalized weakness, headache, and tiredness.  At 22 years of age, the pt received a dose on 12/11/03.  The pt has a past history of syncope vasovagal.  The pt had no history of egg allergy.  He had passed out previously when having blood drawn.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/11/03.  Dose regimen was 1 dose (IN).  Concomitant therapy included Zirtec (cetirizine hydrochloride).  The pt experienced nausea, vomiting, dizziness, near syncope, generalized weakness, headache, and tiredness on 12/11/03.  No additional information was available at the date of this report.
Felt achy, tense, stiff in neck, tender itchy skin, on - off fever, pink hive like rash all over 3 days after visit. Took Benadryl on 4th day. Rash went away. HA and pressure behind eyes persisted for 3-4 day
patient has had no known side effects; a patient was administered an expired vaccine; This spontaneous report was received from the patient's husband who was also a physician referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions or concomitant medications was not provided.  On 21-DEC-2021, the patient was vaccinated with an expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 milliliters orally (vaccination scheme frequency were not reported; valid lot number 1694410 with expiration date 19-DEC-2021) for prophylaxis (expired product administered).  No adverse event was reported.
Information has been received from a medical assistant referring to multiple patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # I010145, expiration date 24-MAR-2017 or lot # I028277, expiration date 28-JUL-2017, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2022 at 12:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Erythromycin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: The patient received anti-viral treatment for Covid 19 started on 15Jun2022 for one day (Lot number: 6A7394). The patient had rampant diarrhea. Only second dose of paxlovid. No other medication in 2 weeks. If Vaccine received: Yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Oct-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No temperature excursion happened after vial was placed in refrigerator on 18-Oct-2021. No concomitant medication was reported by reporter. No treatment medication was reported by reporter. No adverse event was reported.
Post vax, pt slept mostly the whole day, then woke up complaining of some swelling and tenderness on the injection site. He was asymptomatic after 48 hours.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 21-APR-2015, the patient was vaccinated with one dose of improperly stored ZOSTAVAX vial (19400 PFU) (plague forming unit(s), dose, route of administration, lot # and expiration date were not reported). The patient's concomitant therapy was not reported. No adverse effects were reported. Product Quality Complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Did not get the second dose before 36 days after the first dose; got pregnant after getting the Moderna vaccine; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE and MATERNAL EXPOSURE BEFORE PREGNANCY in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In January 2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE. In January 2021, MATERNAL EXPOSURE BEFORE PREGNANCY had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.  Patient received her first Moderna COVID-19 vaccine a year ago in January 2021, before being pregnant. For whatever reason she did not catch her second dose. A few months later she was pregnant, and her doctor advised her not to get the 2nd dose. Now she was afraid of covid and her doctor told her to get the 2nd dose. She was due her pregnancy in 6 months.
PATIENT RECEIVED 2ND COVID VACCINE AND WAS TOLD TO SIT DOWN FOR 15 MINUTES. SHE WAS WITH 3 OTHER FRIENDS AND SHE DECIDED TO WATCH ONE OF HER FRIENDS RECEIVE HER VACCINE. WHILE STANDING, SHE SUDDENLY FAINTED. SHE WAS OUT FOR A FEW MINUTES AND WAS SURROUNDED BY HER FRIENDS. SHE CAME TO AFTER A COUPLE OF MINUTES AND WAS COHERENT. I ASKED HER A FEW QUESTIONS AND SHE RESPONDED WELL. EMS SHOWED UP AND TOOK VITALS, ALL NORMAL. EMS TOOK HER BY STRETCHER TO THEIR MOBILE UNIT TO MONITOR HER. SHE DID RECEIVE A BUMP ON THE HEAD DUE TO THE FALL. NO BLOOD, NO SWELLING, JUST REDNESS AROUND THE AREA.
Pain at injection site, headache, nausea, dizziness, chills,malaise, weakness, fatigue,  temperature 101
The patient is an employee and received ADACEL on 8-05-2009 from the hospital's employee health office. The patient became seriously ill within 2 days and was initially hospitalized on 8-09-2009. Patient had an adverse reaction to the vaccine and developed severe necrotizing pancreatitis, IDDM, ascites, infected pancreatic pseudocysts.
Immediate global headache followed by left sided ear and dental pain, not alleviated by NSAIDs or APAP.  Symptoms lasting >7 days, gradually resolving.
Since being fully vaccinated in April 2021, I noticed my known condition (Vitiligo) spread a lot quicker within the past 3 months then prior months/years; his is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) (at the age of 36 years old) as dose 2, single for COVID-19 immunisation. Medical history included ongoing vitiligo. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. The patient received the first dose of BNT162B2 in left arm on COVID-19 immunization on 02Apr2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01May2021, since being fully vaccinated in Apr2021 patient noticed known condition vitiligo spread a lot quicker within the past 3 months than prior months/years. No treatment for the events. The outcome of the event was not recovered.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Did not receive second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not receive second dose) 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 04-May-2021, 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 (Did not receive second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not receive second dose) had resolved.            No concomitant medication was reported. No treatment information was provided. Consumer reported no symptoms from the first dose, he mentioned he was lazy and did not want to get second dose.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. About five years ago, in approximately November 2008 the patient was vaccinated with first 0.5 ml dose of PNEUMOVAX23 (route and lot number unspecified). On 28-OCT-2013, the patient was received the second 0.5 ml dose of PNEUMOVAX23 (lot number unspecified) in the deltoid region in the arm. The pharmacist stated that immediately after the dose was administered, on 28-OCT-2013, the patients arm was swollen and immobilized. The patient was seen in an unspecified walk in clinic and was diagnosed with rotator cuff tendonitis. The patient was to follow up with an orthopedist, but it was unknown if she had. The patient's arm was no longer immobilized, but the shoulder was swollen and had decreased function. The patient reported no injury or previous problems with her rotator cuff. No treatment was given for the events. At the time of the report, the patient was recovering from the events. Additional information has been requested.
A cancer patient received 0.25 mL of Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (A cancer patient received 0.25 mL of Moderna) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (A cancer patient received 0.25 mL of Moderna). On 22-Oct-2021, ACCIDENTAL UNDERDOSE (A cancer patient received 0.25 mL of Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The reporter stated that a patient came in requesting a booster dose of the Moderna COVID-19 vaccine and was given 0.25 mL of the same on 22-Oct-2021. The reporter later found out that the patient had a history of cancer and the reporter was unsure whether the patient was receiving active treatment for cancer at this time. The patient had not reported any adverse reactions to the booster dose so far.
Body aches, chest pain/tightness, diffusely throughout chest with palpation, especially around pacemaker site
12 hrs after vaccine developed diffuse joint pain , nausea, malaise, then fever, d 12, dizziness - no IgE mediated 2nd dose of rabies on 8/1/16 yielded similar reaction for 2-3 days. No sequelae. He declined 3rd dose of prophylactive HDCV.
On 2/25/03 had fever 104.5; 2/26/03 No Sx's flu test negative, WBC 10.1. Had febrile seizure 2/26 at office. Blood culture negative Normal head CT.
Menactra given intradermal in error-student was here to receive a PPD. 24 hours later there was 4.4 x 3 cm erythematous reaction, 48 hrs. 4.5 x 5 cm erythematous reaction-started on Cephalexin 500mg, 72 hours-8x9cm erythematous reaction. Pt will be rechecked again on 9/17/07.
Within 4 hours after shot pt stated he had shortness of breath, tongue swelling and general malaise that he contacted his doctor about.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
81 year old male patient reports injection site pain for three days following his second pfizer COVID-19 vaccine on 02/19/2021. No issues reported following first pfizer vaccine on 01/29/2021
Severe pain in arm where injection was given immediately after; weakness in arm, bump still where injection was given and pain when moving; swollen painful lymph nodes in both left and right under arms; more painful and heavier menstrual cycles (2 now to date); chills; fever; severe body aches and brain fog for days.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB injection (lot# L035878, expiry date 11-AUG-2018, lot# M006710, expiry date 06-DEC-2018 and lot# reported as M025193, expiry date 21-MAR-2019; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Aches Chills Headache Tired Miserable Nauseous Treat with sleep and ibuprofen Still Ill 24+ hours later
vaccine leaked out of site of injection down patient's arm after injection.  Gave pt a replacement dose
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date), PRODUCT STORAGE ERROR (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No Adverse Event) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes.    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 EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date), PRODUCT STORAGE ERROR (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date), PRODUCT STORAGE ERROR (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) and PRODUCT STORAGE ERROR (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date).    Concomitant products were not reported.  Patient identifiers for patient number 5 are documented in this case.  Treatment medications were not reported.
12 year old male patient was given under 12 year old  dose of Pfizer vaccine.   Patient arrived for 2nd dose in series. 1st dose was 12 and up dose given by PCP.   The flow monitor serving as a greeter, did not properly direct the patient to the 12+ Pfizer registration section. Patient was sent to pediatric registrar, with verbal instructions to register the patient for a pediatric dose. Registrar wrote the date of birth and age at the top of the Emergency Use Authorization form, per instructions from site lead.  Registrar sent the patient to the under 12 year old vaccine section.   RN, reports checking age but delivering under 12 year old dose.  When RN checked the lot number, she noticed it did not match the lot number assigned in the chart (which was the lot number for 12 and older Pfizer vaccine).  On site Clinical lead doctor was immediately notified.  The lead doctor notified her supervisor, and informed the patient and parent..
Brain bleed?.Drain tubes placed, blood webbing at sight of bleed, 21 days in ICU and rehabilitation?.Dismissed early March and 6 weeks od outpatient rehab?Now having dizziness?
I usually experience a sore arm for a week or so after a flu or COVID vaccine. With this one (the COVID booster), the soreness in my upper arm did not fade after a week or so but instead got worse and spread across my shoulder and up into my trapezius muscles. .After about a month, I consulted my doctor and started physical therapy. Xrays showed mild early arthritis in my left shoulder, but when I was examined by a physical therapist on December 8, she observed impingement and tendinitis in my left arm and shoulder area, with inflammation particularly acute in the tendons that connect my bicep and supraspinatus muscles to my shoulder. While my range of motion and strength have both improved following a course of physical therapy, I still experience pain multiple times a day during the course of routine activities (washing dishes, getting dressed, getting into the car, any weight bearing exercise, etc.) I think that either the COVID booster injection was administered too high in my arm and triggered SIRVA, or my body had an excessive inflammatory response to the booster that triggered tendinitis and perhaps frozen shoulder that will take more time to resolve. I'm now five months out from my booster shot and want to get a fourth shot given my auto-immune disease profile, but I'm nervous about this happening again. I would welcome advice on this subject.
Patient had first covid vaccine on 2/26/21. On 3/10 patient woke up with swollen nodules on his neck. Suspected lymph node swelling with hives noted.