chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Colon ulcer; This spontaneous case was reported by a consumer and describes the occurrence of LARGE INTESTINAL ULCER (Colon ulcer) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced LARGE INTESTINAL ULCER (Colon ulcer) (seriousness criterion medically significant). At the time of the report, LARGE INTESTINAL ULCER (Colon ulcer) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: Ulcers in colon.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID 19 Vaccine Trial. No concomitant medication information was reported. No treatment medication information was reported. The reporter's causality for the event of ULCERS IN COLON with respect to Humira was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a Spontaneous case reported by a consumer, concerning an adult female patient, with relevant medical condition of Crohn´s disease, who experienced the unexpected and serious (due to medically significant) event of Large intestinal ulcer, which occurred related to an unspecified dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. Co-suspect product included non-company product Adalimumab for Crohn´s disease. Colonoscopy was performed and revealed ulcers in colon. No information disclosed about treatments received. At the time of the report, the event had not resolved. Underlying Crohn´s disease could be a confounding factor for Large intestinal ulcer. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning an adult female patient, with relevant medical condition of Crohn´s disease, who experienced the unexpected and serious (due to medically significant) event of Large intestinal ulcer, which occurred related to an unspecified dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. Co-suspect product included non-company product Adalimumab for Crohn´s disease. Colonoscopy was performed and revealed ulcers in colon. No information disclosed about treatments received. At the time of the report, the event had not resolved. Underlying Crohn´s disease could be a confounding factor for Large intestinal ulcer. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Within a minute of receiving IM injection in R deltoid heat and stiffness ran up neck toward head, feeling of nausea and redness observed over neck and face.  Symptoms lasted about 30 minutes.  No treatment administered.
allergies; hard of breathing/lung problems; heart is racing; Pain on arm/arm keeps hurting up to the shoulder/arm keeps hurting down to her hand and fingers; nerve is numb; pains in my lymphnode on my arm; This spontaneous case was reported by a patient and describes the occurrence of ALLERGY TO VACCINE (allergies), DYSPNOEA (hard of breathing/lung problems), PALPITATIONS (heart is racing), PAIN IN EXTREMITY (Pain on arm/arm keeps hurting up to the shoulder/arm keeps hurting down to her hand and fingers) and HYPOAESTHESIA (nerve is numb) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1) in March 2021, JANSSEN COVID-19 VACCINE (1st booster dose) on 15-Dec-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 2 and no record). Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 09-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced ALLERGY TO VACCINE (allergies), DYSPNOEA (hard of breathing/lung problems), PALPITATIONS (heart is racing), PAIN IN EXTREMITY (Pain on arm/arm keeps hurting up to the shoulder/arm keeps hurting down to her hand and fingers), HYPOAESTHESIA (nerve is numb) and LYMPH NODE PAIN (pains in my lymphnode on my arm). At the time of the report, ALLERGY TO VACCINE (allergies), DYSPNOEA (hard of breathing/lung problems), PALPITATIONS (heart is racing), HYPOAESTHESIA (nerve is numb) and LYMPH NODE PAIN (pains in my lymphnode on my arm) had not resolved and PAIN IN EXTREMITY (Pain on arm/arm keeps hurting up to the shoulder/arm keeps hurting down to her hand and fingers) outcome was unknown.            No concomitant medication information provided.  Patient had second booster dose.  It was stated that they did not had problems after getting the Pfizer and J and J and There was something with the Moderna vaccine because 4 out of 5 people are affected when they got it.  It was reported that they thought they were going to get pneumonia and they were given antibiotic for it.  They already consulted with their doctor and the nurse they see had advised putting cold pad but they are putting heat pad on the affected side.  Treatment medications reported was antibiotics and heat pads.   Most recent FOLLOW-UP information incorporated above includes: On 21-Nov-2022: Follow up contains Non-significant information: ID added
Little more tired; Second dose given 23 days too early; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of FATIGUE (Little more tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 23 days too early) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 008B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 23 days too early). On an unknown date, the patient experienced FATIGUE (Little more tired). On 31-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 23 days too early) had resolved. At the time of the report, FATIGUE (Little more tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not provided.  Company comment: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (batch nos. 008B21A and 026B21A) with associated AEs of fatigue reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Follow up Information was received on 09-APR-2021.Contact Number Updated; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (batch nos. 008B21A and 026B21A) with associated AEs of fatigue reported.
severe dizziness - almost syncope but patient did not faint which lasted for 10 minutes - patient was instructed to lie do supine position with feet elevated - applied cold compresses to face, neck and wrist - pt was fasting for religious reasons
pregnant patient receives Flublok with no reported adverse event; Initial information received on 12-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who was exposed to vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] in context of pregnant patient receives flublok with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported pregnant patient receives Flublok with no reported adverse event occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (formulation, strength: unknown) lot number not reported in unknown administration site as Immunization.  On an unknown date the pregnant patient receives flublok with no reported adverse event (exposure during pregnancy) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was asked If a pregnant patient receives Flublok, do they still need to call Sanofi to report the dose given.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (pregnant patient receives Flublok with no reported adverse event).  At time of reporting, the outcome was Unknown for the event pregnant patient receives flublok with no reported adverse event. Additionally, at time of reporting, the outcome of the pregnancy is unknown
Eczema all over his back and butt which has been there since the vaccine and he is almost one now. It is becoming worse and more prominent.
Pt recv vax on 11/3/97; over last 3 mon pt exp more local pain & tenderness
Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), on 29Jul2022 at 11:30 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: PYREXIA (non-serious) with onset 30Jul2022, outcome "unknown", described as "Fever".  Additional Information: The reporter son was given COVID vaccine on 29Jul2022 morning and did not have any symptoms of fever and cold on that day. On 30Jul2022, in the evening he was having fever. The reporter asked if any medicine needs to be given for reducing temperature or not.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Well and received Menactra 5/3/05 at 16:30PM. Developed malaise 5/4/05 and on 5/5 fever to 103 Ax and nausea, headache and vomited. No loose stools. Achy all over.
Received J&J CoVid vaccine on September 28, 2021. Ended up in hospital after experience of classic symptoms for stroke. Lost mobility and paralyzed on left side. Regained most functions but still have minor disabilities.
Blotchy red spots all over body; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Blotchy red spots all over body) and PAIN IN EXTREMITY (Arm pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced RASH MACULAR (Blotchy red spots all over body) and PAIN IN EXTREMITY (Arm pain). At the time of the report, RASH MACULAR (Blotchy red spots all over body) and PAIN IN EXTREMITY (Arm pain) outcome was unknown. Not Provided          The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: Follow up information included reporter contact information and route of administration for dose one were updated.
This spontaneous report as received from a pharmacist refers to a 60 year old female patient with no drug reactions/allergies. On 08-OCT-2014 the patient was vaccinated with ZOSTAVAX, lot# reported as K008881, expiry date 20-SEP-2015, (dose and route not reported). Pharmacist reported patient received ZOSTAVAX and experienced a red, itchy, sore and raised rash at the injection site. VZV was not offered as pharmacist terminated the call. No treatment was given for the events. None lab diagnostics studies were performed. The outcome of a red, itchy, sore and raised rash at the injection site was reported as not recovered. The patient had seen the pharmacist. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (lot # M036156 with expiration date at 23-FEB-2019 and lot # N002913 with expiration date at 23-FEB-2019; dose, route of administration and anatomical location were not reported), for prophylaxis. The administered doses of vaccine experienced multiple temperature excursions. From16-MAR-2017 to 31-MAR-2017, the doses of RECOMBIVAX HB with lot numbers: M036156 and N002913 were exposed to a temperatures in the range between 47 degrees Fahrenheit (F) to 77 degrees Fahrenheit (F) for 1 hour and 52 minutes in total. On 21-MAR-2017, took place the longest (35 min) excursion with temperature of 49 degrees Fahrenheit (F). Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected since all scheduled correspondence was received.; Sender's Comments: US-009507513-1705USA015599: US-009507513-1705USA015600: US-009507513-1705USA015601: US-009507513-1705USA015602: US-009507513-1705USA015597: US-009507513-1705USA000770:
9/1- Small rash site of injection, fever 1021,chills muscle spasms 9/2- Rash larger, body aches, fever 101.8, chest pain 9/3- Rash larger, headache, chest pain, cough, bodyaches
The pt developed a fever of 103 to 105 the evening after receiving the vaccine. The pt also complained of severe headache. White lesions on inside of mouth. Temp and headache still severe as of 1:00 PM on 3/27/00. Mother reports no relief with Motrin.
I got a rash and afterward it turned into a blister It started to get red two days after shot. Four days after the shot it became itchy. I used ice packs at night to relieve the itch. I went to the doctor and she gave me ointment. The rash was 2-3 inches and was spreading to the elbow. After 10 days I got a blister about the size of a blister at the site of the shot. The blister took  four days to slowly go down. I still have a scar where the blister was. I got the second shot in the other arm and I got a little rash but it did not blister.
This case was reported by a healthcare professional (nurse) and a consumer (mother of another subject at the nurse's office) and described the occurrence of injection site reaction in a child subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of KINRIX (details unknown). At an unspecified time after vaccination with KINRIX, the subject experienced injection site reaction. The mother of another subject at the nurse's office reported that her daughter (see case A0987998A) and other children had the "same reaction". The nurse in the physician's office informed that they have different information from what was provided by the consumer reporter. The nurse stated that she conferred with the physician. According to the nurse, there were a total of 3 children (including the subject whose mother had called) with local reactions, but not confirmed to be systemic and the other two were different lot numbers. The nurse did not have the lot numbers of the two subjects or their information. This is case one of the two subjects. See case A0989133A for the second subject and A0987998A for the daughter of the consumer reporter. At the time of reporting the outcome of the event was unspecified.
Information has been received from a pharmacist concerning an approximately 70 year old male (reported as 70+) who was vaccinated with dose of pneumococcal 23v polysaccharide vaccine during a flu vaccination at his pharmacy. "It is thought that this dose was a revaccination". Concomitant therapy that day included as dose of influenza virus vaccine. The reporter indicated that the pt developed severe swelling and tenderness at the injection site. No other information or lot number was available. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Patient had rash on back and thigh with erythematous pinpoint lesions improved with benadryl cream. Doing well after 1 day of cream use.
Mom called next day stating that patient had two seizures and had not had any in a while previously. Mom said she would follow up with Dr.
Patient received the vaccine at pharmacy at 3 pm 7/20/2023.  His arm became sore overnight and he noticed his heart rate was escalated at 7:30 am on 7/21/2023.  Home blood pressure monitor recorded pulse was 165 beats/min, BP was 95/85.  Patient was sweating and complained of some difficulty breathing.
Burning rash on chest, neck and left arm, client reports she went to a walk in clinic and doctor told her that the rash was a reaction from the TDaP vaccine.
Severe left arm pain beginning 6 hours post vaccine. Required loss of work. Prednisone 5 days after administration. Pain reoccured after stopping prednisone. approx 10 occupational therapy appointments and cortisone injection without 100% improvement. Tachycardia, elevated d dimer, elevated WBC count x 3 months.
12 hours (approx.) after INFLUENZA 0.25 was given to patient in left thigh, he presented with a bright red dime sized swelling at the injection site. No other reaction reported.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Patient had brief syncope and fell on table in the waiting room; suffered superficial bruising-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Emergency called for bruising around left neck; EKG and orthostatics WNL. BG WNL and BP normal. PAtient recovered well and was A&O throughout even when found immediately after fall. refused ER evaluation/transport.
The event that happened, I had a sensitivity and a pain that was like shingles. It was all the way around my core, my skin was extremely sensitive to touch and my left arm and wrist broke out in welts that same day. I went to Urgent Care the next day. The nurse at Urgent care gave me prednisone and by 24 hours later it started to improve.
Received DTAP and Vaivax in left thigh and noted with increase redness and swelling at left thigh after ten minutes. Area very warm and painful to touch.Redness area measured three inches on left thigh and nodule measured about two inches. Ice pack applied to area and after ten minutes area decreased to one inch for redness and one inch for nodule. No difficulty breathing noted. Patient was given prescription for Benadryl.
Dizziness, nauseous, allergy symptoms (runny nose, watery eyes, sneezing, weak) Symptoms lasted two full days.
Myalgia, Arthralgia, Fever sneezing  Narrative: missed several days of work following second dose to the above symptoms.
discomfort to the throat area, unable to talk, swallow. No difficulty breathing. observed for 30 minutes and gave epi pen.
Almost immediately following the injection I had vision abnormalities and tingling in the arm, up to my hand, that had received the vaccine. Ten minutes later I had pain and soreness in the same arm. About three hours later I had mild nausea and the next day the pain and soreness in that arm increased at the beginning of the day and began to decrease as the day went on.
pt recv vax 23OCT95 & 27MAY97 pt exp 10 to 15 lesions on face & trunk;
temperature excursion; No adverse event on patient; This spontaneous report was received by customer refers to a 13-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-FEB-2023, the patient was vaccinated with one dose of improper storage hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #1775827, expiration date: 27-JUN-2024, or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #U032681, expiration date: 26-OCT-2023, or or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #1780876, expiration date:09-NOV-2023, or or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #1775811, expiration date: 07-DEC-2023, or or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot# W009829, expiration date: 19-OCT-2024 (exact dose, route of administration and anatomical location were not reported) for prophylaxis.    Administered dose of vaccine was exposed to the temperature excursions. Total time 25 minutes (09-SEP-2022 for 8 minutes, 16-SEP-2022 for 5 minutes and 03-JAN-2023 for 12 minutes (product storage error). No additional adverse event (no adverse event).
After about 5 minutes felt: hot/clammy -nausea -Ringing in Ear, after approximately 10 minutes after EMS arrived symptoms improved and pt and mother refused to go to ER.
Itchy; Rash; Redness spreading down to the elbow; Redness of arm; A spontaneous report was received from a reporter like consumer concerning a 77 yr old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness in her arm, which is itchy and is slowly "going down" to the elbow. The patient was under treatment for immunosuppression. Concomitant medications reported include medication for immunocompromised. On 16th Jan 2021, prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (lot/batch-026L20A) in the anatomical location for prophylaxis of of COVID-19 infection. On 23rd Jan 2021 the patient experienced events like rash and itchy, redness spreading down to the elbow.. Laboratory details were not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events were not reported
More than half of the initial dose leaked down arm. Pt given another dose per CDC error and deviation guidelines.