chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The lymph node in my right arm pit has become very swollen and is tender.  It became noticeable a few hours after my injection and remain swollen and sore now (48 hours post-injection).
COVID-19 positive after full immunization. Symptomatic with headache, fever, malaise.
Pt. received ZOSTAVAX on 5/20/17. On 5/27/17 pt noticed itchy rash on abdomen, backs of arms and legs - painful rash.
I'm on my first trimester of pregnancy; sore in arm for a couple of days; This spontaneous prospective pregnancy case was reported by a dietician and describes the occurrence of   in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 25-Aug-2021. Not Provided      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.   Concomitant medication information was not provided.  Treatment information was not provided.   Company Comment   This is a case of product exposure during pregnancy with associated event of pain in extremity for this 32-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. The event of exposure during pregnancy is assessed as not applicable. The event of pain in extremity is assessed to be possibly related to mRNA-1273.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow up received as no new information.; Sender's Comments: This is a case of product exposure during pregnancy with associated event of pain in extremity for this 32-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. The event of exposure during pregnancy is assessed as not applicable. The event of pain in extremity is assessed to be possibly related to mRNA-1273.
After leaving Pharmacy she came to my house stated she felt nauseated, within a few minutes she vomited. She complained that her lips and tongue felt funny.  I immediately gave her 75mg of Benadryl and Tylenol 500mg.  She proceeded to have severe itching all over  and still complained of severe nausea.  She was also given vistaril 50mg.  She was able to sleep within an hour or so but later woke up and vomited again. She was given a zofran 4mg.  I alternated Tylenol and ibuprofen throughout the evening and did another dose of Benadryl 50mg around 11pm.  The itching was still present along with nausea and a rash had started to be present on her trunk.  She stayed with me that night and the following morning the itching and nausea were better however still present. I continued medicating her Saturday and Sunday.  She did not starting feeling better and more like herself until Tuesday.
Scratchy, itchy throat as well as feeling of throat  swelling.  Patient denied any chest pain, SOB, lip or tongue swelling.  Airway clear, no notable obstruction. Patient was transferred to UC, clinician ordered:  Benadryl 50mg IM, Solumetrol 125mg IM, and Epinephrine 0.3mg IM. Patient was transferred to ED where he recovered and was released.
ED visit for COVID symptoms, given Regeneron antibodies. Fully vaccinated April 2021.
Vaccine was administered to patient after the beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient after the beyond use date) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 02-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient after the beyond use date). On 02-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient after the beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided Moderna COVID-19 Vaccine was administered to THREE Patients on 2Jun2021 after the beyond use date of the vial. the vial was received on 23Apr2021 and stored in the fridge and the vaccine was administered after 30 days.
Horrible pain swelling of lymph nodes on left armpit not alleviated by tylenol moritrin,  itchy left arm, fever over 101 for 48 hrs, armpit pain still continuing.
bleeding in her mouth/bleeding from her mouth and nose; nasal bleeding/bleeding from her mouth and nose; when she spit blood come out; bruise; This is a spontaneous report from a contactable nurse. This Nurse reported for an 83-year-old female patient (mother). An 83-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation and warfarin (COUMADIN) via an unspecified route of administration from an unspecified date to an unspecified date at an unspecified dose as  blood thinner. Patient's medical history and concomitant medications were not reported. On an unknown date, caller asked if the patient (mother) should receive the second dose of the vaccine if she has bleeding in her mouth at night and nasal bleeding. Reporter mentioned that the patient takes Coumadin but has never had bleeding until now. It was reported that the patient had a normal INR prior to getting the vaccine but started having bleeding from her mouth and nose after she received the first vaccine dose. Patient's after having the vaccine was 3.1 The reporter asked for more information about patient's on blood thinner. Reporter also asked for information about if the second vaccine dose is given more than 21 days apart. It was then clarified that patient got the Covid vaccine on Saturday (unspecified date) at 1:00. Reporter stated that the patient had bleeding in her mouth that night. Stated that on Monday (unspecified date) patient had another bleeding during the night and when she spit blood come out. Reporter called just now and mentioned that patient had nasal bleeding. Stated that the patient never had bleeding before and that patient had been on blood thinners for years. Stated that sometimes, the patient had bruise. It was also reported that patient's INR was 3.1 before the Covid vaccine which is in acceptable range. Reporter mentioned that she is not sure if patient should have the second dose. Stated that she is on a low dose of warfarin. Outcome of the events was unknown.  Information on Lot/Batch has been requested.
Tingling in L arm & HA immediately after the injection.  The next day 5/13 still had severe HA, dizziness, fatigue, numbness in L arm & R wrist.  Also c/o pain & soreness in hips.
p/vax devel severe flu-like symptoms;diarrhea;cough;fever;body achiness; & local inj site soreness; lasted approx 2wk;site soreness lasted 4day, however redness & swelling for 2 1/2 wk; treating MD felt probably had combo flu & react to vax
pt recvd vax & noticed rash around inject site; on observation, rash broke out on chest & both cheeks of face; pt was in no resp distress;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 28-OCT-2014, the patient was inoculated with ZOSTAVAX at a medical office for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-MAR-2016, the patient was treated at a family practice for persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related.  Additional information has been requested.
Arm sore in injection site, slight fever, slight headache, full body ache that still is occurring
Pt devel rxn of redness,swelling at inj site following receipt of vax. Tx w/Tylenol. Med Affairs note: Reporter indicates 18 military personnel exp this event. Not presently identifiable.
Fever of 101.3, Myalgias, Cough, and Sore arm.
Information has been received regarding a case in litigation, from a lawyer, concerning a decedent patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-SEP-2012, the patient was vaccinated with ZOSTAVAX, due to health care professional recommendation, for permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided). On an unknown date, the decedent was diagnosed with herpes zoster ophtalmicus and postherpetic neuralgia and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine (vaccination failure). On 28-DEC-2016 and on 06-MAR-2017, the patient was treated for herpes zoster ophtalmicus and postherpetic neuralgia. On unknown date, the patient was diagnosed with shingles (herpes zoster) and/or other related injuries after and despite being inoculated with the ZOSTAVAX vaccine. It was also reported that, on unknown dates, the patient suffered serious physical, emotional and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering (Emotional distress and pain), 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 and diminished quality of life. At the time of report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster ophtalmicus, postherpetic neuralgia, herpes zoster and quality of life decreased was unknown. The reporter considered the adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-treathening and medically significant.
Mom noted swelling to left upper arm @ 7pm on 12/4/08 but did't think much of it until swelling had increased the next morning.  Child seen in health department by nurse practitioner then referred to hospital received dignosis soft tissue infection/cellulitis and started on antibiotic.
My throat closed up for about 30-40 seconds about 30 minutes after shot; This is a spontaneous report from a non-contactable consumer. This 53-year-old female consumer (patient) reported that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER 8732) via an unspecified route of administration into the left arm on 27Mar2021 at 04:00 PM (at the age of 53-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No other vaccine in four weeks, no treatment. No covid prior vaccination and no covid tested post vaccination. No known allergies. On 27Mar2021 at around 04:30 PM, the patient experienced her throat closed up for about 30-40 seconds about 30 minutes after shot. Outcome of the event was resolved.  No follow-up attempts are possible. No further information is expected.
Saliva build up in mouth, light headed and difficulty breathing.  Patient responded to BENADRYL 25mg IM and observation.
-Day after shot: adverse effect was severe joint pain like someone was drilling into my joints with a drill; aside from that I had a fever of 102.5, severe flu like symptoms (fatigue/muscle ache/nausea/fever/migraine) but all those were expected although they were worst than the first 2 shots I had.  If helpful I had a very bad reaction to the first shot where I had severe flu like symptoms for several days.  The 2nd shot was better but I had a very sore arm (not slightly but very sore) for 2 weeks. -2nd day after shot: adverse effect was chest pain/tightness for 2 hours and when that ended I got extremely severe and sharp continuous stomach pains (lower abdominal) for 10 hours non stop. The chest pain and severe abdominal pain had me reach out to my Dr the next weekday.  Aside from that a fever of 101; continuation of flu like symptoms but less severe.  Joint pain still bad but not quite as severe. -3rd day after shot: fever of 99-100 varying throughout day but only remaining symptoms were a migraine  -4th day after shot: no more fever or flu like symptoms but still moderate joint pain and a migraine that I had since the day after my shot.  Aleve would help but not get rid of it just made it less intense. Migraine went away on 6th day.  Still have brain fog and mildly achy joints but migraine gone.
Nausea  Sore arm, not at injection site just overall Cramps  Tired
THE FOLLOWING DAY AFTER ADMINISTERING THE VACCINE STARTED APPEAR "RASH" ALL OVER THE BODY, ITCHING, FELT WARM (TEMPERATURE WAS NOT TAKEN) AND PAIN IN BOTH LEGS FROM THE KNEE TO THE ANKLE. FEELS BURNED SENSATION IN BOTH HEELS AND CAN'T WALK WELL. IN ADDITION TO GENERAL DISCOMFORT. A TABLET OF ATARAX WAS TAKEN AND BENADRYL OINTMENT WAS APPLIED, COLD WATER COMPRESSES WERE APPLIED BUT IT DOES NOT IMPROVE. STILL HAVE THE "RASH"
Patient developed some virus,3 weeks after receiving the vaccine the patient got the infection; This spontaneous case was reported by a physician and describes the occurrence of VIRAL INFECTION (Patient developed some virus,3 weeks after receiving the vaccine the patient got the infection) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Cancer. Concomitant products included OMEPRAZOLE for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VIRAL INFECTION (Patient developed some virus,3 weeks after receiving the vaccine the patient got the infection). At the time of the report, VIRAL INFECTION (Patient developed some virus,3 weeks after receiving the vaccine the patient got the infection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was in her mid 40's and was healthy.  Concomitant medication included med infusion and cancer treatment. No treatment medication was provided.
More pain upon injection than usual.  Noticed the site of injection became red and hot to the touch withing an hour/hour and a half from injection and continued to increase in size throughout the day.  Placed a cold pack on it that night, 9/23/14, and again on 9/24/2014.  Reported to a nurse at LPH department where vaccine was administered, on 9/24/14 and then to the Immunization Charge Nurse at LPH Dept. on 9/25/2014.  When Immunization Charge nurse inspected site, noted by patient that size, pain and temperature had gone down significantly since previous day, 9/24/14, but were still more than just a local reaction.  Site appeared to Immunization Charge nurse to be lower than the deltoid muscle and apperared by observation to be closer or in the tricep muscle.
Patient describes feeling like he has a "heavy chest and shortness of breath" three days after his first vaccine. Patient describes that is has continued on and off. Seen by provider, unremarkable exam, EKG ordered, patient encouraged to continue with vaccination series.
Family reported that upon return to daycare after Dr's visit, pt developed high fever, had a seizure, fell & hit her head, stopped breathing and lost consciousness she was revived via CPR by staff & transported to ER via ambulance.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 17-MAY-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
On December 13th I woke up and found blood in my urine. A good amount. I reported that right away to my primary doctor. She did a urine test and she also ordered an x-ray of my kidneys and bladder and an ultrasound. And those showed several stones in my kidneys, one which was quite large 8mm. She referred me to a urologist, who had me have an OCT scan of my kidney and bladder and showed the same thing. On March 21st I had a procedure where they filled up my bladder with water to pee out the stones. And I am still recovering from this.
heat at the injection site; swelling at the injection site; tenderness at the injection site, it went away little by little but it was very tender the first week; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (heat at the injection site), VACCINATION SITE PAIN (tenderness at the injection site, it went away little by little but it was very tender the first week) and VACCINATION SITE SWELLING (swelling at the injection site) in a 67-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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (tenderness at the injection site, it went away little by little but it was very tender the first week). On an unknown date, the patient experienced VACCINATION SITE WARMTH (heat at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). On 07-Feb-2021, VACCINATION SITE PAIN (tenderness at the injection site, it went away little by little but it was very tender the first week) had resolved. At the time of the report, VACCINATION SITE WARMTH (heat at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Hypertension-Severe
shortly after receiving the vaccine the patient passed out briefly in the waiting area,  He quickly came to and did not want us to call 911
covid vaccine breakthrough   dose 1 2/20/21  Moderna  030M20A dose 2 3/20/21  Moderna 002B21A
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients were vaccinated with a dose of RECOMBIVAX HB (lot number not specified). Route was unknown. The reporter stated that up to 10 patients had received improperly stored vaccines during the time period of 17-SEP-2012 through 02-OCT-2012. Vaccines involved were MMR II, VAQTA, RECOMBIVAX HB and GARDASIL. No symptoms were reported. Follow up information as received from the medical assistant refers to a 6 months old patient. The patient was vaccinated IM with improperly stored RECOMBIVAX HB (lot # 666600/0319Z, Exp. Date: 08-OCT-2012) at left thigh on 17-SEP-2012. Concomitant medications administered on the same day included PENTACEL (lot # C2869AA, Exp. Date: 08-OCT-2012, intramuscularly at right thigh), PREVNAR 13 (lot # F62923, Exp. Date: August 2013, intramuscularly at left thigh) and ROTATEQ (lot # 0277AE, Exp. Date: 20-SEP-2013, PO). This is one of several reports received from the same source. Additional information has been requested.
Large rash on right arm; Sore on right arm; Sore on right hand knuckle; Stunk when washed hands; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0162) via an unspecified route of administration in the left arm on 13Apr2021 at 15:30 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history included allergic reaction to bee sting. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received unspecified medications within two weeks of vaccination. On 22Apr2021 at 17:00, the patient experienced a sore on her right-hand knuckle, and it stunk when she washed her hands, Cleaned it out with peroxide. The patient went to bed at 23:00. On 23Apr2021 at 04:00, the patient woke up and went into the bathroom turned on the light and saw another sore on her right arm and large rash on her right arm. She went back to bed and woke up about 8:00 and rash had shrunk to half its size. It doesn't itch. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore on right hand knuckle, stunk when washed the hands, sore on right arm and large rash on right arm were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Gangrene of right foot. ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
pt exp emesis, nausea & rigors on 20JUL96 6hr p/vax;pt was also taking drug for malarial prophylaxis;pt went to ER tx w/IV fluids, observed, & sent home;feeling fine next day 21JUL95;MD felt event poss result of either vax or malaria drug;