chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness and blister all over body after vaccines administered after getting home from clinic. Physician determined reaction was from varicella vaccine.
Periorbital edema, urticaria, pruritis 3 hrs. post injection. IM and PO Diphenhydramine and Albuterol inhaler. Symptom duration: 5-6 hrs.
itchy rash on face 3 hrs after vaccination, seen at urgent care and prescribed oral prednisone
Brief swelling on left side of lips.  Swelling went away, after patient took Benadryl.  Physician was notified.  Patient feels fine and has no other reactions.
Pt vaccinated with Tetanus Deiptheria developed fever/chills, generalized myalgia, malaise & headache.
Patient received a Chicken Pox vaccination on 11/20/02.  Beginning on 11/28/02, she had a high fever, up to 103 degrees, on and off until 12/2/02.  She also had 2 "pox".
Received #2 H1N1 injection on 12/02/2009.  On 12/09/2009 Mother reports child c/o of bilateral toe pain.  12/10/2009, child c/o bilateral foot numbness. Mother of child, called HD 12/10/2009 3:50 pm regarding the above information.  Mother instructed to call pediatrician at once for evaluation.  Child seen 12/10/2009 pm. Was told to continue to moniter and be reevaluated if condition worsened. 12/14/2009 Mother states child c/o of continued pain bilaterally at toes and balls of feet.  12/23/2009  Mother states child continues to have bilateral toe pain.  Will continue to moniter.
Patient came in for a well child check and was due for multiple vaccines. Patients parents agreed with provider to get Varicella, MMR, and Pediarix. Varicella was administered on the right vastus lateralis, MMR and Pediarix was administered on the left vastus lateralis. Patient got vaccinated on 7/18/23 and went to ED on 7/23/23 because of a rash.
The day after 2nd Moderna vaccine: Syncope (suspect seizure) shortly after wife got him up from bed, minutes later saw him slumped over in chair, pale,  prolonged loss of consciousness about 20 min, EMS called and took him to ER.  Had bowel incontinence with this;  no tonic/clonic activity, no tongue biting.
8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload.  Nephrology was consulted with management of hemodialysis while hospitalized.  Infectious disease was consulted.  He was started on IV steroids, IV remdesivir, and daily inflammatory markers.  The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula.  He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021.  Critical care was consulted for management.  Palliative care was consulted for goals of care discussion with no changes in plan of care.  On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation.  He was placed in the prone position due to hypoxemia.  He developed severe acidosis.  Temporary HD catheter was placed.  This evening, he had continued acidosis with increasing vasopressor requirements.  The case was discussed with nephrology and he was started on CVVHD.  There were complications with initiation of CVVHD as multiple filters clotted off after initiation.  The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine.  He received a total of 6 A of sodium bicarb.  The patient's deteriorating condition was discussed with his daughters.  He was transitioned to a DNR CCA.  The patient expired cessation of vital signs on 9/4/2021 at 1:10am.    Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP
urinary incontinence (peed herself) while awake; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 16:00 (Lot number: FK5127) at the age of 5 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: Patient had covid prior vaccination. The patient's concomitant medications were not reported. The following information was reported: URINARY INCONTINENCE (non-serious) with onset 12Nov2021, outcome "unknown", described as "urinary incontinence (peed herself) while awake". Therapeutic measures were not taken as a result of urinary incontinence.  Additional information: The Lot was not available/provided to reporter at the time of report completion. The facility type vaccine was pharmacy or drug Store. Patient did not take other vaccine in four weeks.  Daughter (age 5) received first vaccine on 11Nov2021. This morning (12Nov2021) she experience urinary incontinence (peed herself) while awake. Patient did not tested Covid post vaccination. Patient had no known allergies.   Follow-up attempts are completed. No further information is expected.
W/I 48 hrs- Erythema warmth induration right UE to elbow. Fever/ Myalgias/ Malaise
facial swelling, NO tongue swelling or difficulty breathing. Treated with cool compresses, benadryl 25 mg at night, Claritin, low dose hydrocortisone
First and foremost I never even scheduled or authorized the vaccine for the shingles vaccine that I was given only the other three vaccines I gave my consent and authorized. On the first evening at 9:00 pm is when I first started feeling bad headaches,chills ,and fever I was also very fatigued went to bed and next day on the tenth and eleventh I was feeling very I'll still vomiting , constipation,headaches severe nausea,face pale and eyes cyanotic,vomiting ,Very fatigued.soreness severe bilateral arms.
Patient felt dizzy after receiving vaccine, vitals signs checked and stable, BP 134/84, HR 80, RR 18, Temp 98.0, SPo2 98%. He drank water and was monitored for 30minutes. No acute ditress noted.  He stated he was ok after 30minutes observation and ready to leave.  Accompained  by Mom.
CLIENT CALLED TODAY (2/21) STATING SHOT WAS GIVEN ON 2/3/20 AND HE EXPERIENCED DISCOMFORT IN HIS ELBOW LATER THAT SAME DAY BUT ON 2/13 HIS ARM WENT NUMB EVEN DOWN INTO HIS HAND.  THREE OF HIS FINGERS STILL REMAIN NUMB TO THIS DAY.  HE WENT TO THE ER ON 2/14 AND THE DR FELT IT WAS R/T A PINCHED NERVE IN HIS NECK.  HE HAS BEEN USING ICY HOT EVER SINCE AND HIS WIFE READ THE SIDE EFFECTS OF GETTING HEP A AND THINKS IT COULD BE RELATED SO HE CALLED  IN.
Per patient report:  about once a week since my second vaccine I have had like a chill up my entire back.  Starts at bottom works up.  Tiny spasms of skin.
a lot of swelling in my leg; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (a lot of swelling in my leg) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (a lot of swelling in my leg). At the time of the report, PERIPHERAL SWELLING (a lot of swelling in my leg) outcome was unknown.            Concomitant product use was not provided.  Treatment information was not provided.
Patient started getting a rash on the left arm, which developed on the right arm and lower back too. She took diphenhydramine with no improvement. She was prescribed Methylprednisone 4 mg dose pack for 6 days on 12/27/2017 and Hydrocortisone 0.2% cream on 1/9/2018.
erythematous, swollen macule at site of injection on left upper arm and pain with movement or palpation of arm self- improving without seeking medical evaluation until about 3 weeks afterwards . Mild erythema and some pain at arm remain to date but overall improved
Patient began projectile vomiting and having severe diarrhea a few hours post vaccine. He became lethargic and almost unresponsive that night and into the following day and was severely dehydrated. He could not keep breast milk down. We took him back to Doctor's office on 3/20/19 and they gave him pedialyte which was all he kept down for the next 12 hours. The next day he continued to vomit and have severe diarrhea and only had 3-4 wet diaper in 48 hours. We took him to the ER at Hospital on 3/21 where they did X-rays and ultrasounds to rule out intussusception. He was given fluids and sent home to rest and we were instructed to keep up the pedialyte until he began producing more wet diapers and then slowly introduce breast milk again.
My adverse event at 03:00AM. I was feeling pain in my head and went completely blind.  used my watch to call 911. They took me to the ER where they did MRI, it showed there was a mass but it showed there was brain bleed ( inflammation).  I had a  brain surgery done for it on 01/05/2023. I was in the hospital for approximately 22 days not  100% sure. I was transferred  from ER to ICU then to rehab. I am still in rehab getting treatment.  They also did another MRI which showed a little blood on Feb. The doctors said it will  to be determined. I will be in the rehab for awhile. I also went to  a Oncologist on 03/29/2023  they are still trying to find out the cause of my brain bleed. I will be going for a follow up again on April.  i will be doing another MRI on 05/22/2023.
11YO PT GIVEN 12+ PFIZER INSTEAD OF 5-11 PFIZER.
Fatigue, fevers, nausea, body aches, chills, sore throat, swollen lymph nodes. Symptoms started on 1/28/21 and are ongoing.
"didn't feel quite right" (2ND dose); This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL ("didn't feel quite right" (2ND dose)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 002A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: FLU VACCINE VII (Annual Flu Vaccine intramuscular route) in 2021. Past adverse reactions to the above products included No adverse event with FLU VACCINE VII. Concurrent medical conditions included Allergy to antibiotic (ampicillin), Sulfonamide allergy (sulfa), Drug allergy (Indocin) and Irritable bowel syndrome (Recent change in Status: No change) since 2010. Concomitant products included VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (VITAMIN D3), UBIDECARENONE (COQ-10), LUTEIN [XANTOFYL] and GARLIC [ALLIUM SATIVUM] for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 01-Apr-2021, the patient experienced FEELING ABNORMAL ("didn't feel quite right" (2ND dose)). At the time of the report, FEELING ABNORMAL ("didn't feel quite right" (2ND dose)) outcome was unknown.            Patient never had COVID positive test or diagnosis. There was no recent change in status such as improvement or worsening. Other Concomitant medicine includes flex for knees and joints and antioxidant for unknown indication. No treatment information were reported by the reporter.   This case was linked to MOD-2022-515150, MOD-2022-513916.
Patient called 11/15 complaining of adverse events from vaccine administered on 10/02/2020. Patient Received Fluzone HD in right arm, complains that when he got home about 1.5 hours later and removed his shirt he had flaky white marks from where immunizer placed hand on arm to administer vaccine.  Patient stated that immunizer was wearing gloves, cleaned the site and administered the vaccine correctly but from where the hand was placed was the white flaky stuff. Patient also stated that where he had the Polio vaccine scar on his Left arm it was red and inflamed when he got home. Patient has been using Ciclopirox on the both sites which had been helping. This morning he woke up with a yellow mark from where the immunizers thumb would have been placed.
This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient, of an unspecified age, received the BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Feb 5, 2021, single dose, for COVID-19 immunization. Medical history included seasonal allergies, from an unknown date and unknown if ongoing. The patient's concomitant medications not reported. Patient reported she received the first dose last Friday Feb 5, 2021. Her seasonal allergies arrived on an unspecified date, which she would normally treat with a Claritin. Reporter indicated she had a root canal tomorrow. Therapeutic measures were taken as a result of seasonal allergies. The event assessed as non-serious, with outcome of unknown. Follow-up attempts completed. No further information expected.
I went into a hypertensive crisis 2 days after receiving the first dose / my blood pressure was 243/167; Also, my heart rate was elevates=d. I spent 4; This is a spontaneous report from a contactable other health professional (patient).  A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FC3182), via an unspecified route of administration, administered in arm right on 01Oct2021 at 13:30 (at the age of 45-years-old) as dose 1, single for COVID-19 immunisation. Medical history included known allergies: Iodine contrast. Concomitant medication included omeprazole (PRILOSEC [OMEPRAZOLE]) taken for an unspecified indication, start and stop date were not reported. The patient went into a hypertensive crisis 2 days after receiving the first dose, on 03Oct2021 at 13:45. Her blood pressure was 243/167 on 03Oct2021 at 13:45, an ambulance had to come get her and give her nitro. Also, her heart rate was elevated on 03Oct2021 at 13:45. She spent 4 days in the hospital and was still having problems. The events resulted in emergency room/department or urgent care and hospitalization. The patient underwent lab tests and procedures which included blood pressure measurement: 243/167, heart rate: elevates on 03Oct2021, SARS-COV-2 test: negative (Nasal Swab) on 07Oct2021. Therapeutic measures were taken as a result of all events. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event hypertensive crisis  and heart rate increased cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
8 days after my  first vaccine shot, on Jan 19th night, I suddenly started having  pain in the chest. The pain was located in the left side of the lower end of the sternum, in the epigastric region. Pain lasted for 3-4 hours. Initially it was severe, pulsating, acute pain as if nerve pressing against chest. Unbearable pain. I was unable to lie down, turn on sides. Pain would aggravate on movements and if I would touch the specific spot in my chest. . Deep breaths reduced the pain to some extent. Pain severity decreased after 4 hours after which I started getting pain in my left arm, radiating to my pinky finger.  The pain also  radiates to left upper back on movements and exerting left arm for long time, especially typing computer keyboard, doing daily chores cooking, washing dirty dishes, sleeping on the side. ,I am unable to sleep on the left side, if I sleep on left side, I start getting tingling and numbness in my left arm. I did not take any pain medications until Jan 26th as the pain did not disappear. Once at night the pain also radiated to my left leg , I felt  numbness when I tried to sleep on my left side. Occasionally, I feel pain in my right arm and right back. The pain near the sternum area reduced significantly when I took two doses of Ibuprofen 600 on Jan 26th in the afternoon and night. The pain in left arm radiating towards left pinky still persists, with numbness and tingling  if I do daily task for longer duration. Ibuprofen helps to relieve pain temporarily.  Mild pain in right arm, neck and upper arm. I will continue to closely monitor my symptoms.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 13-AUG-2013 the patient was vaccinated with VARIVAX (Merck) (lot # G007814, expiration date 10-AUG-2013) injection, 0.5 ml, subcutaneously. The healthcare worker reported that the patient received an expired dose of VARIVAX (Merck). No adverse effect reported. Additional information has been requested.
maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 11-Dec-2020 and the estimated date of delivery was 17-Sep-2021. On 01-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifteenth week of the pregnancy.  On 01-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment medications were provided.  Date of positive pregnancy test was reported as 02-Jan-2021. Estimated date of conception reported was 19-Dec-2020.
At around 11;30pm the day after my son received his 2nd Pfizer Covid vaccine, he woke me up and was complaining of significant chest pain.  He could not get comfortable.  I called the consulting nurse, as he was not having problems breathing she said I did not need to take him into the emergency room but to continue to monitor him and suggested giving him ibuprofen, I  had already administered one ibuprofen and then gave him another.  After several hours he was able to get comfortable and go to sleep.  We had a routine visit with the pediatrician two weeks later and we discussed what had happened.  Since he appeared to not have any further symptoms we didn't specifically run any test for the doctor order an EKG.  We ended up having to follow up with a cardiologist and when we describe the event she determined based on what she had seen in other patients and that the ibuprofen stopped the symptoms that it is likely he had myocarditis as a result of the 2nd vaccine.
Patient came to the pharmacy today to report that 3 days after he had his flu shot on 10/15/2020, he started experiencing pain at the site of the injection. The pain continued to spread further down his hand. He said he can't easily lift the arm presently. He used some cold/hot compress on the shoulder but that hasn't helped relief the pain. Patient was advised to continue to put hot/cold compress on the site of injection, take some OTC pain  pills and see the Dr on Monday, 11/16/2020 as he made the appointment
pt recvd DTP/OPV/HIB on 29JUL92 aobut 1 wk later, was noted to be very irritable & to startle often; pt's condition's deteriorated since & on 9SEP92 was dx w/infantile spasm; pt on ACTH;
Burns on his palms of his hands , elbow, back of the neck,; skin itched / Sometimes the itching is on the patients face, neck; skin itched and was red all over his upper body and comes and goes; swelling of the face, eyelids, the cheeks.; bumps on the back of his neck and shoulder; Sore right arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (Burns on his palms of his hands , elbow, back of the neck,), PRURITUS (skin itched / Sometimes the itching is on the patients face, neck), ERYTHEMA (skin itched and was red all over his upper body and comes and goes), SWELLING FACE (swelling of the face, eyelids, the cheeks.) and SWELLING (bumps on the back of his neck and shoulder) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Previously administered products included for Product used for unknown indication: Influenza. Past adverse reactions to the above products included No adverse event with Influenza.   On 06-Dec-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 and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. In December 2022, the patient experienced SKIN BURNING SENSATION (Burns on his palms of his hands , elbow, back of the neck,), PRURITUS (skin itched / Sometimes the itching is on the patients face, neck), ERYTHEMA (skin itched and was red all over his upper body and comes and goes), SWELLING FACE (swelling of the face, eyelids, the cheeks.), SWELLING (bumps on the back of his neck and shoulder), PAIN IN EXTREMITY (Sore right arm ) and PYREXIA (Fever). In December 2022, SKIN BURNING SENSATION (Burns on his palms of his hands , elbow, back of the neck,), PRURITUS (skin itched / Sometimes the itching is on the patients face, neck), ERYTHEMA (skin itched and was red all over his upper body and comes and goes), SWELLING FACE (swelling of the face, eyelids, the cheeks.), PAIN IN EXTREMITY (Sore right arm ) and PYREXIA (Fever) had resolved. At the time of the report, SWELLING (bumps on the back of his neck and shoulder) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  It was reported that the patient didn't had COVID-19 infection previously.  No treatment drug information was provided.   This case was linked to MOD-2022-691350 (Patient Link).
PATIENT WAS GIVEN VACCINE AND STATED THAT HER STOMACH WAS HURTING. AFTER RECIEVING VACCINE PATIENT FAINTED AND WAS OUT OF IT FOR ABOUT 2 SECONDS. PATIENT SAID SHE REMEMBERED FEELING WEAK. PATIENT DID NOT HIT HEAD AND EMERGENCY HELP WAS CALLED AND CHECKED HER OUT TO BE FINE.
Started becoming really itchy all over 2 1/2 to 3 hours after the vaccine. Woke up the next morning covered with a whole body rash / hives.
Pt recvd 3 doses of Engerix-B & was determined to be a nonresponder;