chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial case received from a health care professional on 06 November 2009. A six-month-old male infant received the following vaccines on 06 November 2009: a first intramuscular left thigh injection of PENTACEL (lot number C3479AA); a right thigh injection of PREVNAR (Wyeth, lot number D93212); and an oral dose of ROTATEQ (Merck, lot number 06514). The patient had a history of eczema, and had bilateral ear infections at the time of vaccination. Approximately 30 minutes post-vaccination, the patient returned to the office with head-to-toe hives, tongue thrusting, repetitive movements of the right arm, and bright red areas on his right ear and diaper area. He was treated with BENADRYL in the office, and transported to the emergency department. A flu test was negative. At the time of the report, the patient had not yet recovered. Documents held by sender: None.
diarrhea, headache, body ache, , soreness at injection site, eyes felt hot, forehead pounding, left hand tingling and numb, couldnt open door, both lips tingling, and tongue/top of mouth
Difficulty breathing, heart racing, throat and mouth dry, lips, and fingers numb, hives.  Had stomach flu symptoms.
Information has been received from a health professional concerning a male who on 30-AUG-2000 was vaccinated with a dose of Varivax (Oka/Merck) (Lot # 635188/0761K). On 04-JAN-2006, the patient developed a generalized rash of <50 lesions. The duration of the rash was 1 week. The patient was not hospitalized. This was noted to be vaccine failure. This was MD documented/evaluated. Follow up information indicated that no further information was available. No additional information is expected.
had 1st pallid breath holding spell 1 day p/3rd DPT; had momentary loss of consciousness; had 2nd pallid breathing holding spell 27APR94;
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age. The patients were vaccinated with a dose of VARIVAX (Merck) on unspecified date (lot number, dose and route not reported). The medical assistant reported that the office did not monitor the temperature of the freezer and refrigerator from 18-JUN-2012 through 01-JUL-2012 so the office did not know for sure if their vaccines were stored at the proper temperature. No symptoms were reported. This is one of several reports received from the same source. Additional information is not expected.
Little warmer at injection site; Solid at injection site; red rash the size of a silver dollar and solid; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Little warmer at injection site), VACCINATION SITE INDURATION (Solid at injection site) and VACCINATION SITE RASH (red rash the size of a silver dollar and solid) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20) for COVID-19 vaccination.     Concomitant products included Blood pressure meds for Blood pressure management, Thyroid meds for Thyroid disorder, PANTOPRAZOLE SODIUM for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Little warmer at injection site), VACCINATION SITE INDURATION (Solid at injection site) and VACCINATION SITE RASH (red rash the size of a silver dollar and solid). At the time of the report, VACCINATION SITE WARMTH (Little warmer at injection site), VACCINATION SITE INDURATION (Solid at injection site) and VACCINATION SITE RASH (red rash the size of a silver dollar and solid) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: follow up received on 20-JUN-2021 and contains no new information.
Within 12 hours, red/indurated tender nodule at vaccination site.  Now on day 8 post-vaccine, I now have a 5x4 cm indurated, pruritic, erythemic, hot lesion that is growing.  I?m an MD And do not feel this is cellulitis but am surprised this itchy lesion is continuing to grow/itch.  I have photos of the progression if you?re interesting in seeing.  I need to know if after this I should still get dose 2.  Thank you.
Approximately 8-10 hours post dose #2 Covid-19 Vaccine experienced headache, enlarged lymph under arm (resolved within 72 hours with ice pack use). chills, elevated temp of 102°. Severe back pain the following day (day 2). Took Motrin for good relief after 3 hours,
felt a little sick; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously had first dose of BNT162B2 on unspecified date for COVID-19 immunization and experienced sore arm. The patient previously took Tylenol for back pain and not feeling well; and cortisone injection for her back pain. The patient had a sore arm after the first dose and felt a little sick after the second dose in Mar2021. She explained 2 weeks before the vaccination series, she had a cortisone injection for her back pain; and the day of the first injection, she took a Tylenol "for back pains". She specified she never takes Tylenol and since she was not feeling well, she took it to feel ok because she wanted to drive to her first vaccination appointment. She explained she read about the intake of Tylenol and cortisone prior to vaccination and how it may render the vaccine less effective. She asked how can she find out the effectiveness/how much protection she got from the vaccine? She explained CDC recommended antibody tests, but she was also referred to Pfizer from her department of health. The patient had both of her shots she thinks the second one was completed 03Mar2021. Before she took the first shot she had a Cortisone shot 2 weeks before the day of shot and she took Tylenol before for some  back pain she was having and since then she has found out that both of those things can make the drug ineffective. She talked to the CDC and they recommended an antibody test and they also recommended she call Pfizer. The outcome of the event was unknown. An unspecified treatment was given to the patient for the event.  Information on the lot/batch number has been requested.
first Moderna COVID-19 dose on 23Apr2021, and hasn't received the second dose yet as she is afraid of needles; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first Moderna COVID-19 dose on 23Apr2021, and hasn't received the second dose yet.) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first Moderna COVID-19 dose on 23Apr2021, and hasn't received the second dose yet.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first Moderna COVID-19 dose on 23Apr2021, and hasn't received the second dose yet.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment was reported. No concomitant medication was reported. Patient is afraid of needles which is why she hasn't gotten the second dose.
12/03/21 patient presents to EC ED for "shortness of breath/cough and diarrhea". PMHx of "dementia, HTN/HLP, atria fib, DM type II and BPH"
Mother reported swelling in right thigh and knee after having vaccination.  Child seen in our office for evaluation upon assessment right thigh 1/4" > in diameter than left.  No redness no tenderness, full weight bearing on extremity.
On the 2nd night after receiving the 1st shot of Moderna vaccine, I experienced intense abdominal pain. It was like if someone was pulling and twisting my intestines. The pain was acute  for about 1hr, then it started fading with renewed but shorter periods of more intense pain. I thought of peritonitis, and if the pain didn't subside I might have called an ambulance. I just decided to lay low  and let the pain pass. It was scary.  The next day on May 3rd, I awoke with rush over my upper body,. Little bubbles was dispersed across my abdomen, shoulders, sides but were few and not dense, so I let it pass. Currently the rush is still on, thankfully don't have the abdominal pain any longer.  However, I am not sure that I shall get the 2nd Moderna shot. I won't survive the intestines twisting pain if increased.
About 12 hours after my 2nd vaccination I developed a fever, chills and severe headache. This continued for 2 full days with fever breaking then coming right back, repeatedly, even with taking Tylenol every 6 hours. The headache was unbearable day 1 but mild day 2.  Fever got up to 102.4 at one point but was between 100-101 most of the time during those two days. I was not able to function or get off the couch at all day 1 and at about 50% day 2. By day 3 post vaccination I felt completely back to normal besides a very sore and swollen arm still. This continued for about 6 days post shot.
Patient called VA line on 5/3/2021 complaining of shortness of breathe and chest pain/discomfort developing after J&J vaccine on 4/30/21. Patient described chest pain as similar to muscle ache/soreness when sick. Patient initially had left arm pain at site of injection that resolved previously. Patient denied fever, chills, fatigue. Patient was referred to local ER for evaluation to rule out potential pulmonary embolism. ER records reviewed, CXR unremarkable with np acute process, no lab abnormalities- troponin, D-dimer negative. Patient discharged from ER with no further interventions than those listed above.
fever, headache, body aches, chills nausea, chest pain and anxiety X 1 week
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Brief < 10 second syncope episode after flu vaccine administration today. EMS activated, patient able to recover in clinic after approximately 15 minutes. Discharged home in stable condition. Patient refused EMS transport to hospital.
Apr11: Ache began in Rt. arm, aprox. 3PM, and traveled through whole body by late evening followed by chills so intense that I could not stop shaking. The chills began shortly before 8:30PM. (Some nausea, not too bad though); Apr 12: Woke up feeling better, just not myself yet, so took it slow all day. Apr.13: Woke feeling much better, took shower and while drying off my lower back started being very painful with any movement to the extent that I could barely walk without hanging onto something. This lasted all day. I have experienced spasms in that area before, but never this severely. Apr 14: I was much improved and began feeling like my body belonged to me once again. I took it easy being cautious. I will see Dr. Apr 24th.
dysentery, feels like I'm having a colonoscopy; a little disoriented; This spontaneous case was reported by a consumer and describes the occurrence of DYSENTERY (dysentery, feels like I'm having a colonoscopy) and DISORIENTATION (a little disoriented) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     The patient's past medical history included Migraine. Concomitant products included ALPRAZOLAM (XANAX) and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced DYSENTERY (dysentery, feels like I'm having a colonoscopy) and DISORIENTATION (a little disoriented). At the time of the report, DYSENTERY (dysentery, feels like I'm having a colonoscopy) and DISORIENTATION (a little disoriented) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported taking migraine medications. No product name was given. No treatment information for the events was reported.  Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
After shingles vaccine, redness, soreness, swelling, itching, rash.  Rash started 12/23/2011 still persisting on 12/27/2011.
Nausea/vomiting/dry heaving since midnight , started feeling better around 4:30 pm.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Shellfish allergy" (unspecified if ongoing), notes: Known allergies- Shellfish. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Now testing positive again with symptoms within 60 days of having Covid paxlovid treatment; (May2022) Negative, notes: Completed full series and tested negative after 7 days in Early May2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course included no other medication in 2weeks. Treatment of COVID-19 included Paxlovid.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Brain Fog; dizziness; unsteadiness; inability to think; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain Fog), DIZZINESS (dizziness), BALANCE DISORDER (unsteadiness) and THINKING ABNORMAL (inability to think) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced FEELING ABNORMAL (Brain Fog), DIZZINESS (dizziness), BALANCE DISORDER (unsteadiness) and THINKING ABNORMAL (inability to think). The patient was treated with DIHYDROERGOCRISTINE, LOMIFYLLINE (ANTIVERT [DIHYDROERGOCRISTINE;LOMIFYLLINE]) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Brain Fog), DIZZINESS (dizziness), BALANCE DISORDER (unsteadiness) and THINKING ABNORMAL (inability to think) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Significant: Patient is feeling better nowfrom events
Patient received Pfizer/BioTech COVID booster shot at approximately 12:30pm on 10/13/21.  Patient stated that right arm was slightly sore and that she experienced some mild hallucinations the same evening.  The next morning (10/14/21) she noticed what appeared to be an "X" on the right arm where the injection had been administered.  She thought it may have been a contact irritation (mentioned possibly a latex reaction) but I advised the patient that we only use non-latex bandages and nitrile gloves during administration of vaccines.  The patient continued to monitor the area which was warm to the touch, itchy and continued to grow in size.  She presented mid-day to the pharmacy on 10/17/21 to ask the pharmacist their professional opinion of what to do about the reaction.  The pharmacist advised the patient that the incident needed to be reported to VAERS for documentation but that the patient could treat the area locally with over the counter antihistamines (i.e. Benadryl, Claritin) and 1% Hydrocortisone.  I advised the patient to draw around the borders of the rash to monitor the response to the OTC treatments and that as a precaution she should follow up with her PCP Monday morning 10/18/21.
intestinal disturbances; 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 ABDOMINAL DISCOMFORT (intestinal disturbances) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (intestinal disturbances). At the time of the report, ABDOMINAL DISCOMFORT (intestinal disturbances) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up received on 25-May-2021 included no new information.
Report a temperature excursion involving PROQUAD and VARICELLA. Excursion occured on 2 separes dates/ Several patient were administered PROQUAD during this temperature excursion; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were not provided.      On 08-DEC-2020, the patient was inadvertently administered with an improperly stored dose (product storage error) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) at a dose of 0.5 milliliter for prophylaxis (strength, route of administration, and anatomical location were not reported; lot number  T021302, had been verified to be a valid number; expiration date 19-DEC-2021). The  temperature  excursion was at -5 degrees Celsius (C) for 10 hours, for a time frame of  20 hours, and no had the previous temperature excursion. It was reported that the call was due to data logger. Additionally, it was reported a varicella vaccine (manufacturer unknown) with a temperature excursion on 2 separate dates with the exact same temperature condition, however this vaccine was not administered to the patient.
This spontaneous report was received from a medical assistant referring to a 16 year old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 08-MAR-2018, the patient was administered an improperly stored GARDASIL 9 (lot: N026814; Expiry date: 15-JUL-2020 and lot reported as "N021572"; Expiry date: 01-MAY-2020) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 47 °F to 77°F (67.3°F) for 10 hours, 30 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several reports linked via same reporter link.
I had tachycardia, neuropathy, restless legs, headaches, fatigues, dizzy spells and my heart skipping beats.
UNIT HAD AN EXCURSION THAT WAS OVERLOOKED. PATIENT HAS BEEN MADE AWARE BY PROVIDER.
Arm is severely bruised extending past injection site and down the left arm. Left arm is tender and swollen. Persistent headache and dizziness. Pain starting to extend up towards the neck.
Breakthrough case of COVID-19; I had extremely congested head and coughing, and extreme tiredness as well.
Patient received a Moderna COVID-19 booster dose (0.25ml) on 11/29/2021.  She stated for two weeks following the booster dose, she experienced a racing heartbeat.  Ten days after the booster dose she went to the doctor, an EKG was performed and Afib was noted from the EKG.  The racing heartbeat has now stopped as of 12/15/2021.
Pt received Flu vaccine on 10-8-03- Pt noticed knot and bruise on 10-10-03. Pt returned to health department on 11-10-03, bruise measured 1 1/2 inch long by 1 1/2 inch wide, hematoma 1 inch long by 1 inch wide.
Chest discomfort, body aches, joint pains, day that was seen in the ER Shortness of breath with chest pain that radiated to the back, headaches,  chills,
Discharge Provider:  Primary Care Provider: DO Admission Date: 2/23/2023 Discharge Date: Mar 2, 2023  PRESENTING PROBLEM: Vasculitis (HCC) [I77.6] AKI (acute kidney injury) (HCC) [N17.9]   HOSPITAL COURSE: 77 y.o. who has a past medical history significant for mitral regurgitation, PSVT, HTN,  DOE, OSA, and positive ANCA/ RF. She had undergone work-up outpatient in the setting of blood tinged sputum for one week with productive cough for over a month and AKI with hematuria. She was transferred to the ED with concerns for vasculitis. Patient had positive p-ANCA, elevated MPO (8.0), mildly elevated PR3 (0.4) antibiody. Bronchoscopy performed with BAL on 2/24 with bloody secretions throughout. No ongoing hemorrhage was appreciated.  Culture notable for 50-100k normal upper respiratory flora.  Incidentally positive for COVID -19. Patient was treated with 5 day course of abx for CAP. Hypoxemia worsened and required BIPAP. Pulmonology consulted. Due to impending respiratory distress pulse dose steroids had to be started prior to a renal biopsy on 2/23 and 2/25 with marked improvement in her hypoxia and respiratory status, and patient was weaned to nasal cannula and eventually RA. IR performed renal biopsy on 2/27/23 with prelim pathology showing RBC bases, but no crescents- appears to be pauci immune vasculitis. Nephrology consulted and following for AKI and vasculitis. She was started on prednisone 60mg on 2/28, with plans to continue this for likely a few months. TB test obtained at time of discharge, with plans to follow-up in nephrology clinic in a week for TB test results and likely consideration of starting rituxan. Pulm following and to arrange outpatient follow-up and pentamidine treatments for PCP ppx. Pulm rehab evaluated patient and patient without any oxygen needs at rest or ambulation. Patient medically stable for discharge home on 3/2, with close nephrology follow-up and outpatient pulmonology follow-up.