chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 days post vaccination - developed redness, mild induration @ site of injection and redness. Spread down from injection site, 4 cm wide- on lateral surface of left arm down to mid-forearm. Treated with BENADRL (oral).
As soon as getting the vaccine the Patient Fainted for a few seconds , a few minutes after regaining consciousness few was doing better but a little weak. The ambulance was called and she walked to the ambulance outside the pharmacy and the EMS professionals  checked her vitals and they said they are normal. She was in pharmacy waiting area for another  30 minutes for observation and went home. In the evening we called and talked to her father and we were informed that she is doing good.
After my second dose of the Moderna vaccine, I had an elevated HR that started at 5:00PM the following night. My resting HR was in the 110s and would be 130s with activity. It came back down in about 12-24 hours to "normal", but I am still having episodes of an elevated heart rate at times weeks after the second vaccine.
Recurring episodes of dizziness, passed out 3 times. Seen neurologist, pulmonologist, allergist, cardiologist.
Information has been received from a licensed practical nurse concerning an 8 year old male, with no medical history or allergies, was vaccinated with a first and second (0.5 milliliter, subcutaneous in left arm) dose of Varivax on 05-APR-1999 (lot number 627876/1241H) and 28-APR-2007 (lot number 654527/1043F), respectively. There was no concomitant medication. On 29-APR-2007 the patient experienced significant local reaction. The symptoms were described as hot, red, swollen left arm. The patient could not raise his arm. The patient missed school. Ibuprofen and warm soaks were ordered. Adverse event symptoms were reported to be recovered. Unspecified medical attention was sought. No laboratory tests were performed. No product quality complaint was involved. The nurse requested a lot check from the vaccine with lot number 654527/1043F. The reported felt the event was disabling. It was reported that the patient had no reaction after the first vaccination. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a healthcare worker referring to a 76 year old male patient without any drug reactions/allergies. Information about pertinent medical history was not reported. On 16-JUN-2015 the patient was vaccinated with PNEUMOVAX23 lot # K007826 with expiration date of 03-FEB-2016, 0.5 ml, intramuscularly. Concomitant therapy included unspecified albuterol inhaler. Later, on the same day the patient developed cellulitis just below the injection site. The patient was seen in the physician's office on 17-JUN-2015, and prescribed an unspecified antibiotic to treat the cellulitis. No lab diagnostic studies were performed. The outcome of the event was reported as not recovered. This is one of several reports received from the same reporter. Additional information has been requested.
have used a vial ( Lot # 004F21A ) that was first punctured yesterday ( 26Aug2021 ) at 8:28 am; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (have used a vial ( Lot # 004F21A ) that was first punctured yesterday ( 26Aug2021 ) at 8:28 am) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 27-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (have used a vial ( Lot # 004F21A ) that was first punctured yesterday ( 26Aug2021 ) at 8:28 am). At the time of the report, EXPIRED PRODUCT ADMINISTERED (have used a vial ( Lot # 004F21A ) that was first punctured yesterday ( 26Aug2021 ) at 8:28 am) outcome was unknown.        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.   No concomitant product was provided by the reporter. No treatment medication was provided.
had an colon operation; did not get second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of COLON OPERATION (had an colon operation) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COLON OPERATION (had an colon operation) (seriousness criteria hospitalization and medically significant) and INTENTIONAL PRODUCT USE ISSUE (did not get second dose yet). The patient was treated with Surgery for Colon operation. At the time of the report, COLON OPERATION (had an colon operation) and INTENTIONAL PRODUCT USE ISSUE (did not get second dose yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment medications were reported.  Based on current available information and the temporal association between product use and the start date of the event the Company believes a causal relationship is unlikely.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event the Company believes a causal relationship is unlikely.
Covid19 breakthrough.  Vaccinated on 04/04/2021.  96y/o presents to ED with c/o abdominal pain, vomiting, fevers and cough that started a few days ago when pt tested + for Covid, she was being treated for PNA with doxycycline.  Pt is now requiring oxygen at 2LNC.  Started on IV ABX/ Steroids and Remdesivir.
Case number PHEH2014US024349, is an initial spontaneous report received from a nurse on 02 Dec 2014. This report refers to a 77 year old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly at a dose of 0.5 ml on 12 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration. No further information was provided.
Vaccine 11 am 12/08/05. Ill around 5 pm. Cold back, face warm, hot itchy eyes and head, headache, puffy eyes. All symptoms x 2 days, weakness and swollen throat. Did not go to ER/doctor. All resolving except still feeling weak.
Information has been received from a physician via a field representative referring to a patient of unknown age. On an unknown date the patient was vaccinated with ROTATEQ (strength, dosage and lot# not reported) orally. On an unknown date the patient was diagnosed with rotavirus after receiving ROTATEQ. The patient was hospitalized on an unspecified date. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Within 48 hours of receiving booster dose patient had confusion and falls. Admitted to hospital with thrombocytopenia, AKI, hepatic encephalopathy
Reported a stomach ache that got better then went away.  nurse aware and checked on pt.   Uncertain of the exact time.
Itching in right arm, 101.6 degree fever, muscle aches, join paint, large red lump on right arm
8PM: Extremely nauseous 4AM: 101.5 fever 11AM: 100.3 fever 11AM: extreme body pain
8 patients had orders for the Moderna Bivalent vaccination and 1 patient had an order for the Moderna Monovalent vaccination.  Treatment nurse was issued 2 vials of 5-dose Moderna bivalent vaccination, and one vial of 10-dose Moderna monovalent vaccination.  The patient who was scheduled to receive the monovalent vaccination refused, so all doses to be administered were Moderna bivalent.  The nurse documented that all 8 patients who were to receive the bivalent vaccine did receive the bivalent vaccine as ordered, HOWEVER, when the vials were returned for account purposes, there was one empty 5-dose vial of bivalent, one full and still-sealed bivalent, and one monovalent vial with 3 doses missing. This indicates that an accounting discrepancy and possible medication administration error.  The patients were all monitored for any adverse outcomes and none were noted.  Hospital administration is aware of the variance.
Given shot 8:30 9/26/2009 4:00 that day I had severe asthma attack. I was taken to South Narsaw Community Hospital by ambulance. I was in the emergency for 4 hours.
erythematous rash on torso and upper extremities, shortness of breath, skin blisters around mouth, on forehead and in right ear - resolved after one week, took diphenhydramine
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 66-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.
Pt received shot on Wednesday 1/16/18, that night got diarrhea, not feeling good. Thursday, pt said her throat started swelling, taking by ambulance from work, left side/arm swollen, numb. Hospital overnight, discharged Friday am 1/18/19. Claims the vaccine was expired, because doctor said it was expired. Claims injected incorrectly. Confirmed with patient that it was injected below the shoulder. Claims injected into the nerve.
Two to three mm pustalr lesions, slight erythema, on both thighs appearing one day after shots. No hard nodules present. No swelling. Lesions appeared clustered at injection site and then progressively worsened.
Infant on 11/27/07 began having small amount of diarrhea (non bloody)and vomiting.  Later that evening there were no stools passed and worsening colicy abdominal pain and bilious vomiting.  Discovered to have an intussuseption unreducible via air contrast barium enema. Infant taken to OR immediately and intussuseption reduced surgically. 02/05/08-records received for DOS 11/27-11/28/07-DC DX: Intussusception, status post appendectomy and laparotomy with reduction of intussusception. Presented to ED with C/O abdominal pain and vomiting. PE: bloody mucous stool.
Severe arm and shoulder pain. Throbbing continuous pain in my shoulder and upper right shoulder blade. Mobility restricted. 17 days later my shoulder is still hurting. I've treated with heat, ice, Aleve, Arincare gel, massage and rest.
Unknown onset of symptom. Symptom was a small bump (smaller than a pencil eraser) under skin layer located on the administration site of the 2013-2014 FLUZONE intradermal vaccine given on the left deltoid.
After receiving vaccines, both legs became itchy, red and swollen. Feet turned purple color. Physician was immediately called to the exam room for assessment and treatment.
Itchy round spot on the skin of my left arm (where I received the injection), about the size of a quarter and near the site of the injection. The spot  came and went for about a week and a half. If I didn't scratch it, it didn't flare very much. It eventually faded away.
Woke with extreme headache that Excedrin migraine didn?t touch. Then started to feel achy with fever, adding nausea and exhaustion.  Slept about 12 hours on Friday taking Tylenol to help with fever and pain.
24 hour after vaccine given - patient with swelling / redness to whole left thigh. Advised ice/observe.
On June 12, 1999 the pt experienced breakthrough varicella with ten lesions. Subsequently, the pt recovered. Another pt was reported with symptoms following vax.
Rt arm axillary swelling and pain. Pain is radiating down rt arm to hand. Red rash itchy rash around torso. And achy joints.
75 mins p/inject pt appeared different-color changed noted, blue cheeks, & generalized mottling w/definite blue cast; pt began shivering & crying; pt seen by MD & given inject depomedral;
Itches; Left arm swelling; Redness; Injection site is hurting; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Apr-2021 and was forwarded to Moderna on 14-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itches), INJECTION SITE SWELLING (Left arm swelling), INJECTION SITE ERYTHEMA (Redness) and INJECTION SITE PAIN (Injection site is hurting) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced INJECTION SITE PRURITUS (Itches), INJECTION SITE SWELLING (Left arm swelling), INJECTION SITE ERYTHEMA (Redness) and INJECTION SITE PAIN (Injection site is hurting). At the time of the report, INJECTION SITE PRURITUS (Itches), INJECTION SITE SWELLING (Left arm swelling), INJECTION SITE ERYTHEMA (Redness) and INJECTION SITE PAIN (Injection site is hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not Applicable
Initially, just pain at the injection site but it was followed by a very large bruise which has lasted over a week.  Yesterday, I noticed that the injection site area has a red rash all around it.
Patient fainted after vaccination and was carefully brought to yoga mat and legs were elevated. Patient felt better after a few minutes. Last set of vitals taken were normal, was given water and snack. Patient left with family members after feeling recovered.
Lymphadenopathy, thrombocytopenia, splenomegaly, acute serum sickness syndrome.
Breaking out in hives everyday, dx with urticaria, no other known cause. Welts and rash all over body.
Sharp, excruciating pain radiating from shoulder down through arm to end of fingers. Pain began the night of the injection, when I could not sleep, and continues even now both night and day, but intermittently during the day, regularly at night. I cannot sleep on the left side because of the extensive pain of doing so.
MMRV was reconstituted with Pedvax HIB instead of sterile dilute
4 x 4 cm indurated, erythematous eruption present on posterior side of (R) arm. Pain at site of vaccination and in axilla area. Minimal itching. No edema in axilla. Normal range of motion. Little bit of neck pain on 9/10/17 but none today. VS signs-afebrile. Used ice and Ibuprofen to treat pain axilla area started 9/10/17. Pt denies chest pain, breathing problems, swelling in tongue or throat, seizures and rash in other areas if body. Conservative treatment continued with ice and Ibuprofen 400 mg every 6 hours for pain. Can take a histamine to help with itching. 9/12/2017 Induration still present erythema, per mother, about the same maybe slightly improved used ice x 1 last night with Ibuprofen. Will continue with conservative treatment. Child in school this am. Will call with update PRN.
A lot of body aches.; had to be in bed for 2 days; digestive system pain; couldn't eat much; This is a spontaneous report from a contactable consumer. A contactable 66-year-old female patient (consumer) reported for herself, that she received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EN6205), dose 2 via an unspecified route of administration, administered in Arm Left on 17Mar2021 (Age 66-Year-old at the time of vaccination) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history was not reported. Historical Vaccine included BNT162B2 taken as first dose on 19Feb2021 (Age 66-Year-old at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. The concomitant medications included denosumab (PROLIA) taken for osteoporosis from Jan2021 and ongoing and sumatriptan succinate (IMITREX) taken for an unspecified indication from an unspecified start date and ongoing at unknown dose, monthly (once every two months). After the second shot, the patient experienced a lot of body aches and had to be in bed for 2 days in 2021. Also, the patient had digestive system pain and could not eat much in 2021. It all lasted for 2 days and on third day felt on. The patient did not receive any treatment for any events. The outcome of the events was reported as not recovered.  No follow-up attempts are needed.
Diarrhea (March 23rd-present, treated with pepto-bismol and imodium)  Nausea (March 23rd-present, treated with zofran and phenergan)  Vomiting (March 23rd-March 31st, treated with zofran and phenergan)  Kidney Infection (March 24th, treated with 7 days of Ciprofloxacin)  Blood in stool (March 24th-April 9th)  Body aches (March 23rd-26th, treated with acetaminophen)
Relapse of her rheumatoid arthritis; A spontaneous report was received from a consumer who was also a 65-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced relapse of her rheumatoid arthritis.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unspecified date, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route for prophylaxis of COVID-19 infection. On 02 Mar 2021, the patient received the second of two planned doses of mRNA-1273 (lot#062I70A).  On an unknown date patient had relapse of patient's rheumatoid arthritis. Treatment for the event included Tylenol every 4 hours.  The patient received both scheduled doses of mRNA-1273 prior to the report; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
administration of Arexvy to patient that was stored at 30.308 Fahrenheit by 20 hours; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3AK2K, expiry date 09-DEC-2024) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incorrect storage of drug (Verbatim: administration of Arexvy to patient that was stored at 30.308 Fahrenheit by 20 hours).  The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 06-SEP-2023  The pharmacist reported administration of Arexvy vaccine to patient that was stored at 30.308 Fahrenheit by 20 hours which led to incorrect storage of drug. The date of administration was unknown.
Injection site soreness/pain Fever and Chills Headache  Bitter taste change
Pt given COVID bivalent booster as first dose in series. No adverse reaction, RN confirmed CDC recommendations and spoke with pts father regarding event. Father has no further questions.
ITCHY FACE; RED FACE; WARM FACE; SWOLLEN FACE; DRY FACE; NAUSEA; HEADACHE; THROAT FELT SWOLLEN; This spontaneous report received from a patient concerned a 41 year old of unspecified sex. 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 not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced throat felt swollen. On 20-MAR-2021, the subject experienced nausea. On 20-MAR-2021, the subject experienced headache. Treatment medications included: paracetamol. On 21-MAR-2021, the subject experienced itchy face. On 21-MAR-2021, the subject experienced red face. On 21-MAR-2021, the subject experienced warm face. On 21-MAR-2021, the subject experienced swollen face. On 21-MAR-2021, the subject experienced dry face. Treatment medications included: diphenhydramine hydrochloride. On 12-APR-2021, treatment medications included: loratadine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throat felt swollen, nausea, and headache on 21-MAR-2021, had not recovered from itchy face, red face, warm face, and swollen face, and the outcome of dry face was not reported. This report was non-serious.
This spontaneous report has been received from a pharmacist referring to unspecified number of patients. On unknown dates the patients were vaccinated with GARDASIL (first dose, dose, frequency, route and lot# not reported). It was reported that the patients received either their second or third dose of GARDASIL late on unspecified dates. This is one of two reports from the same reporter. Additional information has been requested.
Case was hospitalized for Covid after completing the primary Covid vaccine series .  * Pneumonia due to COVID-19 virus Assessment & Plan Patient with history of vaccination.  Tested positive for COVID-19 in the evening of 9/26.  Patient with mild cough and had received monoclonal antibody 9/28/2021.  Presented back to emergency room in the evening same day 9/28 with worsening symptoms and noted to have mild hypoxia on evaluation emergency room.   Chest x-ray is consistent with " mild perihilar pulmonary opacities with clear lung peripheries."    Initiated on remdesivir and dexamethasone.  Oxygen for support and wean as tolerated to maintain oxygen saturation above 90%.  Ongoing supportive management encourage nonpharmaceutical interventions such as self proning in side-lying when able, incentive spirometer, ambulation as able.  PT cleared for discharge home.   Off supplemental oxygen 9/29 afternoon.  Remained off oxygen for 24 hours prior to discharge.
Chills, shakes, dizziness, headache, body pain, soreness at site of injection, fatigue
Heated, fevered, red and hard at the injection site. Patient's own words. also swollen.