chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CHILLS; HEADACHES; EXTREME EXHAUSTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. 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 experienced chills, headaches, and extreme exhaustion. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills, headaches, and extreme exhaustion. This report was non-serious.
CHILLS; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. The company was unable to follow-up request for batch number. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headache. This report was non-serious.
body shaking; Diarrhea; high blood pressure; pain; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (body shaking), DIARRHOEA (Diarrhea), BLOOD PRESSURE INCREASED (high blood pressure) and PAIN (pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced TREMOR (body shaking), DIARRHOEA (Diarrhea), BLOOD PRESSURE INCREASED (high blood pressure) and PAIN (pain). At the time of the report, TREMOR (body shaking), DIARRHOEA (Diarrhea), BLOOD PRESSURE INCREASED (high blood pressure) and PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 30-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.
Given these two vaccines. Five days later noticed our son forgot colors, body parts and stopped dancing. Relearned body parts and colors in 3 months. Now has ASD.
I began having hives on my chest late Thursday night on the 18th, I took Benadryl to try and ease the hives. I continued to have hives spread across my chest, both arms, stomach, and the back of my knees from the 18-22, I suddenly lost my voice on the 21st when I woke up in the morning. I went to a park view clinic in my town on the 22nd and received treatment for my hives. As of the 24th I am taking medications prescribed to me and my hives are slowly going away and my voice is coming back. I have also experienced nasal drainage and a cough from the 19 and onward.
Received the following vaccineson 9/18/15 to prepare for a trip: YF, typhoid, hepatitis A, Td, Menactra. On 9/19 and 20 had myalgias, shoulder pain and headaches. Ibuprofen provided relief. On 9/20 had vaginal irritation and on 9/21 developed 5 small vaginal ulcerations scattered bilaterally. By 9/22 the lesions expanded rapidly with ulcerations as large as 1.5 cm. Lesions were painful with deep ulcerations in the center. Saw ob/gyn on 9/22. She was treated with valacyclovir. Cultures were done to test for herpes. Patient reports tests were negative. She does not have a history of genital herpes. In July she had some subtle changes in her hearing on the left side. It had remained stable until 9/21 when she had significant changes in hearing with constant static noise, occasional high pitched noises and muffled quality. She was started on high doses of prednisone and this helped. Hearing started to improve on 9/27. She also experienced periorbital edema. She never had fevers. She developed 3 urticaria on her chest and forearm but no other rashes. No joint pain or swelling.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: pt stated she was fine for her 1st and 2nd pfizer shots. after her booster, she had a rash that extended her arm and a raised area that was red and tender
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In 2014, a healthcare provider at an internal medicine office administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 20-JAN-2017, the patient was treated by a physician at the same internal medicine office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages.  The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Patient received vaccine on 5/27/21 @ 4:15pm. Patient states that she noticed her arm was swollen, red, and hot to the touch starting in the evening on 5/28/21 and she also stated that it was hard to take a full deep breath due to pain in the left side of her chest. She reported side effects on 5/29/21 in the morning and they told her to seek care from doctors office or urgent care due to difficulty breathing.
Weakness; Feeling sickness; Sore injection arm; Swollen injection arm; Hardness of the arm; Nauseated stomach; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), ILLNESS (Feeling sickness), PAIN IN EXTREMITY (Sore injection arm), PERIPHERAL SWELLING (Swollen injection arm) and INDURATION (Hardness of the arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 018A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included GERD. Concomitant products included ATENOLOL and INSULIN DETEMIR (LEVEMIR) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 03-Mar-2021, the patient experienced ASTHENIA (Weakness), ILLNESS (Feeling sickness), PAIN IN EXTREMITY (Sore injection arm), PERIPHERAL SWELLING (Swollen injection arm), INDURATION (Hardness of the arm) and NAUSEA (Nauseated stomach). On 06-Mar-2021, INDURATION (Hardness of the arm) had resolved. On 08-Mar-2021, ASTHENIA (Weakness), ILLNESS (Feeling sickness), PAIN IN EXTREMITY (Sore injection arm), PERIPHERAL SWELLING (Swollen injection arm) and NAUSEA (Nauseated stomach) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Products known to have been used by the patient, within two weeks prior to the event, included medication for GERD (Gastroesophageal reflux disease). Treatment for the event included naproxen  and acetaminophen.   This case was linked to MOD-2021-071057 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow-up included medical history of the patient, current condition of the patient, concomitant medication and new event information.
Severe migraine significantly increased over severity of migraines over the last year, combined with axillary pain located in an area consistent with axillary lymphnode in vaccinated arm. The migraine resolved with aggressive treatment (subdermal injection of sumatriptan) but the axillary pain continues 36 hrs later.
is expose to covid-19 positive student; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (is expose to covid-19 positive student) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-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 EXPOSURE TO SARS-COV-2 (is expose to covid-19 positive student). At the time of the report, EXPOSURE TO SARS-COV-2 (is expose to covid-19 positive student) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient wanted to confirm if her exposure to covid-19 student would affect her getting her second dose or not that was scheduled on 14-Feb-2021 or not.   Reporter did not allow further contact
She stated she experienced itching which worsened later in the day after the vaccine. The itching spread all over the following day and her face was swollen. She reported there was some tongue swelling and she decided to go to the ER 4/16. She was given a steroid injection which she reported feeling immediate relief. She was also discharged from the ER with scripts for Medrol dose pack, azithromycin, and was instructed to take benadryl.
The day of the vaccine, started have headache and "everything the [VIS] has about side effects." And continues to have symptoms that are becoming worse. States shingles infection to back started two weeks after injections.
sleeping all day; sweating; redness; Vomiting; Nausea; her arm started getting sore / body aches.; swelling of lymph node; extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleeping all day), HYPERHIDROSIS (sweating), ERYTHEMA (redness), VOMITING (Vomiting) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (sleeping all day), HYPERHIDROSIS (sweating), ERYTHEMA (redness), VOMITING (Vomiting), NAUSEA (Nausea), MYALGIA (her arm started getting sore / body aches.), LYMPHADENOPATHY (swelling of lymph node) and FATIGUE (extremely tired). At the time of the report, SOMNOLENCE (sleeping all day), HYPERHIDROSIS (sweating), ERYTHEMA (redness), VOMITING (Vomiting), NAUSEA (Nausea), MYALGIA (her arm started getting sore / body aches.), LYMPHADENOPATHY (swelling of lymph node) and FATIGUE (extremely tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. Patient states that 6 hours later, arm started getting sore, redness, extremely tired, and the next day she slept all day. Patient also experienced body aches, swelling of the lymph node underneath the same arm of the injection, some nausea and vomiting and sweating. HCP told her should have received something like Tylenol or Ibuprofen for the pain, aches, soreness, and nausea and vomiting. No treatment information was provided.
Began spitting up the day vaccine was administered and feeding patterns changed and stools became loose and has persisted 7 days.
34 Y/O MALE C/O HAVING MODERATED ANTHRAX SENSITIVITY TO RIGHT UPPER DELTOID MUSCLE, PATIENT EXPERIENCED THE FOLLOWING SYMPTOMS: PRURITIS, REDNESS, SORENESS, NUMBNESS, INITIAL ONSET WAS 03/29/08 ONE DAY POST IMMUNIZATION UNCHANGED UNTIL PRESENTATION IN CLINIC FOR EVALUATION TODAY. PT SEEN BY RN, NP. PRESCRIBED A TOPICAL ANTIPRURITIC, HEALTH TAUGHT CONTINUED SX/SX'S OF MEDICATION SENSITIVITY. PATIENT TO FOLLOW UP WITH PCM OR EMERGENCY ROOM IF SX'S PERSIST OR WORSEN.
This spontaneous report as received from a pharmacist refers to a 64 year old female patient. On 01-MAY-2017 the patient was vaccinated with ZOSTAVAX dose 1 for prophylaxis. In approximately May 2017 the patient experienced bruising. In 2017 the patient experienced pain. The outcome of bruising and pain is unknown.
5 1/2 x 7cm raised area (hematoma vs cellulitis) treatments Keflex 500mg and Tylenol #3 prescribed by treating physician.
Pfizer vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED -----------------------------------------------------------------------------------------------------------------------  ACUTE STROKE DUE TO OCCLUSION OF LEFT POSTERIOR CEREBRAL ARTERY 7/2/2021 ACUTE STROKE DUE TO OCCLUSION OF LEFT POSTERIOR CEREBRAL ARTERY  ACUTE STROKE DUE TO OCCLUSION OF LEFT POSTERIOR CEREBRAL ARTERY 7/2/2021 ATRIAL FIBRILLATION, UNSPECIFIED
Flu vaccine left arm 11/9/10. Experienced lightheadedness, weakness & severe nausea 5 hours after shot. Chills and body aches, blood shot eyes, heavy eyelids & feeling like she needed to vomit. Fine by 9pm.
Incident began 9:22am. Patient reports he was anxious. RN  observed patient was diaphoretic and directed to treatment area. VS: BP 118/86, HR 62 O2 98 on room air, and RR 20. Patient alert and verbal. Lungs sounds clear, Heart sounds within normal limits. Patient reports no past medical history, no known allergies, and states he has not eaten breakfast. Patient reports feeling better. Vital signs rechecked 9:32am BP 112/82, HR 70, RR 20, O2 sat 97% on room air. Patient observed for additional 15 minutes. Patient verbalized feeling better and feels ok. Education on adverse effects and signs and symptoms  provided by RN. Patient states understanding. Patient escorted to car at 9:45am with RN.
Event: 3/10: itching, swelling, soreness, redness on arm ("COVID arm") around injection site. Treatment: Begin taking Zyrtec. 3/12: Itching, scratchy feeling spread to upper back. 3/12-3/15: Itching on back accompanied by tenderness, burning sensation like sunburn that spread to entire back, neck , head, and upper arms. Itching spread to legs, arms, groin, around eyes. Scratching raised occasional welts on legs and arms but didn't on back, just created more intense pruritus. Saw dermatologist 3/19 who recommended upping dose of antihistamine. Saw allergist 3/23 who gave similar direction. Treated with 1 Zyrtec twice a day until 4/12, then ceased because of excessive fatigue, and started treated with hydrocortisone OTC 3x/day. Outcome: Itching, burning, stinging sensation remains, especially on back, but also on neck and arms and legs.
Around 7 o?clock my throat started itching and around 8 o?clock it started swelling by 9 o?clock I was wheezing so I told my albuterol inhaler, I took Benadryl and ibuprofen. Based on advice online. I had my old expired Epi pen ready. I?m trying to get a new one for the second shot I have scheduled 2/26.
ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 52 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious.
myoclonic seizure lasted approximately 15 minutes; This spontaneous case was reported by a consumer and describes the occurrence of MYOCLONIC EPILEPSY (myoclonic seizure lasted approximately 15 minutes) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced MYOCLONIC EPILEPSY (myoclonic seizure lasted approximately 15 minutes) (seriousness criterion medically significant). At the time of the report, MYOCLONIC EPILEPSY (myoclonic seizure lasted approximately 15 minutes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided by the reporter.  No treatment medication were provided by the reporter.  company's comment: This is a spontaneous case concerning a patient of unknown age and gender with no relevant medical history, who experienced the unexpected serious event of myoclonic seizure. The event myoclonic seizure exact occurrence unknown but stated that the event occurred after the unknown dose number of mRNA-1273 vaccine administration. The rechallenge was not applicable since the only information disclosed was with this unknown dose number. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no relevant medical history, who experienced the unexpected serious event of myoclonic seizure. The event myoclonic seizure exact occurrence unknown but stated that the event occurred after the unknown dose number of mRNA-1273 vaccine administration. The rechallenge was not applicable since the only information disclosed was with this unknown dose number. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Redness & swelling @ inject site, low grade fever until 12JAN91 temp inc to 103 & 105; ER did CXR to r/o pneumonia 12JAN91; APAP enema done in ER; 14JAN91 or 15JAN91 seen by MD;
15 minutes after patient received her Covid Booster she complained of chest pain, She described it as a sharp pain substernal. Pt was not in distress. She denied diaphoresis and SOB. Vitals were taken; BP 120/70, P 83, O2 99%, EKG was done, Normal Sinus Rhythm noted. NP advised pt to follow-up in the ER. Pt declined calling an ambulance, her mother transported her. ER visit was normal per pt report just gave her IV fluids and discharged.
A report has been received from a Health Professional concerning a 3 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 29-Oct-2012. The patient experienced fever for 3 days after receiving FLUMIST which started on 30-Oct-2012. The outcome of the event of fever for 3 days after receiving FLUMIST is unknown. The report was considered to be non-serious by the reporting health professional.
July - started having stomach pain and nausea; had blood labs August 5; diagnosed with Pancreatitis - enzymes were very high; CT scan - August 8; Mid August - haven't been able to keep food down; eating produces pain and nausea;  tested negative for celiac, Chrohn's and autoimmune Pancreatitis.  No treatment yet - still testing.
Some upper arm swelling yesterday 8/7/06 increased swelling, erythema almost completely around humerus today pain 8/8/06.
pt recv vax 1DEC95 & 15DEC95 pt exp a full blown case of rubella which included pain emanating from the spinal column, swelling of the rt shoulder & back muscles, fever, tingling & numbness of hands;facial rash;
No adverse effects; Temperature excursion- vaccine not viable according to manufacturer; This spontaneous report has been received from a physician, regarding a 9-weeks-old female patient. The patient's pertinent medical history included hepatitis B vaccine as historical drug, previous drug reactions or allergies were not reported. Concomitant medications included diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13v (PREVENAR 13).  On 26-JUN-2023, the patient was vaccinated with an improperly storage dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, orally as prophylaxis (lot number: 1968386, which was determined to be valid, with an expiration date on 23-MAY-2024) (strength, dose and scheme were not reported) (Product storage error). The vaccine was bought with public funds and was administered at a private doctor's office.  The administered dose underwent a temperature excursion during unreported amount of time on unreported temperature. It was reported the alarm was believed to be due to sensory issues and the temperatures were monitored with back up logger, which was by the time of the report was replaced with a new one and temperature was then in range. There was a previous temperature excursion reported during unreported amount of time on unreported temperature as well. No adverse effect was reported.  No additional information was reported.
Developed fever, headache around 8:30 pm.   Headache worsened and woke up in night with loss of vision and high fever.  Also, incontinence and sweating, thirsty.