chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt got vaccines on 6/12/01. The next day, both thighs were swollen and red, left more than right.
Mom states red, swollen right upper arm started 11/17/12 morning. Mom gave BENADRYL which helped. Rt. arm swollen at site of vaccines today 11/19/12.
he is infected with COVID-19; he is infected with COVID-19; This is a spontaneous report from a contactable nurse (patient). A male patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient called to find out if there should be a delay in the second dose because he was infected with COVID-19 on an unspecified date. His second dose was scheduled on 13Jan2021 and he was wondering if he should continue in 2 days. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.
Immediate dizziness and nausea. Became tachycardic within an hour. This is still an issue 3 weeks out. Day after vaccine I felt mild flu symptoms all day and was struck with a severe chest pain and intense nausea in the afternoon. I went to the hospital emergency room and had multiple tests run. No cause was found for the chest pain. It began in the center of my chest and moved to the right side of my back.  I have been dizzy, nauseous and extremely fatigued as well as a headache for the last three weeks. The doctor didn't know what caused the pain. He checked me for a pulmonary embolism  because my clotting factors were slightly elevated.  They have not been rechecked,  though I requested my doctor have them and my platelets rechecked. I still do not feel well. My brain is foggy, my vision gets blurry at times, and I still have the dizziness,  fatigue and nausea. I am no longer achy and I have not had another chest pain like the one I had on the 26th.
WART; This spontaneous report received from a patient via a company representative 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced wart. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of wart was not reported. This report was non-serious.
Bells Palsy - Paralysis Right Face - Right Eye will not shut completely and dries out quickly. I have little control of my right eye. Hard to breathe through right nostril.
rapid heart beat; slight dizziness; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at injection site), TACHYCARDIA (rapid heart beat) and DIZZINESS (slight dizziness) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site). On 29-Apr-2021, the patient experienced TACHYCARDIA (rapid heart beat) and DIZZINESS (slight dizziness). At the time of the report, VACCINATION SITE PAIN (soreness at injection site), TACHYCARDIA (rapid heart beat) and DIZZINESS (slight dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment details were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-099182 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-099182:Same reporter
mom came to clinic 14JUL92 pt had indentation rt thigh; states began p/last vax; had not noticed rt away; seen by MD fatty necrosis rt thigh 1 x 1.5cm;
Headache, Myalgia, CoughWheeze, Rash, FATIGUE Narrative:
Patient experienced what initially looked like a bruise but has since developed into what looks like an age spot at the site of injection.
Pt recvd 3 doses of Hep B vax & blood work showed that pt was neg for Hep B antibodies; recvd 2 Engerix-B booster doses on 24APR91 & 31MAY91, respectively for protection against Hep B; 09JUL91 titer was neg;
Severe pain in arm from about a few hours after injection, eased up some after 24-36 hrs. Lifting arm was more painful than I?ve remembered any other shot or vaccine being. Starting the next day (if not sooner), I also experienced an acute depressive episode that has lasted since vaccine almost continuously. Have had symptoms each day at least once, but most days throughout most of day that included crying, extreme sadness, and some suicidal ideation. The things I?m feeling upset about don?t feel rational. Different from normal depressive episodes for me and feels very much like something is happening chemically and that I don?t have control over emotions. Also have experienced headaches each day from 4/11 through today. Waking up with headaches and lasting throughout most of day. I did experience exacerbated migraines when I was suffering from Covid-19 symptoms.
Post vaccination and while in recovery experienced itchy eyes, proceeded by swelling of upper lip, itchy throat and coughing. Remained alert and oriented to person, place and time.  Rapid Response Team called, vaccine recipient transported to Emergency Room.  Release to home post recovery.
Unable to stand without assistance. Shot was Friday morning, slept normally, arose normally, normal morning routine. Resumed normal sedentary activities. After about two hours, I was unable to stand and walk. Eventually rose without falling back in my chair. Tried walking around. Did not fall but moved unstably and slowly. Also was unable to recall how to perform some of the daily activities. Returned to chair for another hour. Again, unable to stand and walk normally. Eventually got a cane for safety. This lasted through Saturday. Sunday morning was walking with about 80% of normal stability. By the end of Sunday I was largely normal..
pt in a nursing home; tested positive for COVID on 9/8/21; moved to an isolation room; some cough and congestion; DNR; given "COVID Vitamin Protocol" and Azithromycin; DNR; poor oral intake; loosing weight; placed on O2 with O2 sats 91% on O2; pt's condition deteriorated and she passed away in the nursing home
Redness, swelling,itching, pain at injection site? about 2 inches in diameter
shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 030B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Adhesive tape allergy (Allergic to tapes.) and Adhesive tape allergy (Allergic to Band aids.).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown.            Concomitant product use was not provided by the reporter.   Treatment information was not provided.
One week after 2nd dose of Pfizer Covid vaccine I was struggling with dizziness, brain fog and mild nausea.  The nausea subsided after the 2nd week but dizziness and brain fog persist - general sense of disorientation at times.  I often found myself standing up looking into the fridge or closet feeling a sense of "where am I and what am I doing?"    Brain fog lifted slightly after 8 weeks but dizziness  / sensation of rocking on a boat persists after 12+ weeks.  The sensation is most pronounced when I am walking inside and/or doing activities that have me moving from side to side / up and down such as unloading dishwasher cleaning, etc.  The sensation is constant except for when sitting or lying down.
Nurse Mgr/APRN discovered that the above mentioned Pfizer vaccine was not properly removed from the regular freezer (-25° to -15°c) on 10/13/2021. The Pfizer vaccine was moved from the ultra cold freezer to regular freezer on 09/28/21 and should have been removed from the regular freezer the end of the day on 10/13/21 and placed in the refrigerator for 31 days. The vaccine was not removed on this day from the freezer. The vaccine is still in the freezer today 10/25/21. It was investigated and found that the vaccine was use in clinic Monday 10/18 through 10/23. NP called Pfizer and spoke with an attendant, walked her through the scenario and she made NP aware that vaccine could not be used past day 17 after being in the regular freezer, voice that vaccine stability could not be determined and that vaccine should not have been used past the 3 day grace or day 17 and should have been moved to the refrigerator on day 14 after removal from regular freezer. Patient was notified of the incident.
Patient developed a rash to B\L upper extremities and back area within 15 minutes of vaccination. Patient also reported having some itchiness in the throat. Patient given Benadryl 50mg IM, VS monitored and all WNL. Discharged when symptoms improved. Patient is flagged for second vaccine and has/will not received from us. Patient informed about not being able to receive 2nd dose.
Itchy rash all over body within 30 minutes of vaccine, worsened; improved marginally with Benadryl, patient needed to go to ER, where he received steroid.
This spontaneous report as received from a Licensed Practical Nurse refers to a unspecified patient. The patient's medical history and current condition are not reported. On an unknown date the patient was vaccinated with 2nd dose of GARDASIL (Lot # and expiry date not reported) of dose 0.5 ml via intramuscular route 1 year after the first dose of GARDASIL and received the third dose of GARDASIL about 60 days after the second dose of GARDASIL. No adverse effects are reported. Product quality complaint is not reported. The outcome of event is unknown. Additional information has been requested.
Moderna COVID-19 Vaccine EUA  Hospitalized for weakness and muscle aches, unable to walk, rhabomyolysis
About 10 red, slightly irritated dots on the abdomen. Mildly itchy, not painful. Mosquito bite-sized.
Hot right arm injection site; Right arm injection site hard lump that has got softer the last few days - injection site feels like a big knot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot right arm injection site) and VACCINATION SITE MASS (Right arm injection site hard lump that has got softer the last few days - injection site feels like a big knot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot right arm injection site) and VACCINATION SITE MASS (Right arm injection site hard lump that has got softer the last few days - injection site feels like a big knot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot right arm injection site) and VACCINATION SITE MASS (Right arm injection site hard lump that has got softer the last few days - injection site feels like a big knot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Patient stated that after first vaccine she said that the injection site at the right arm felt like there was a hard lump that has got softer the last fewdays and felt like a big knot and it is hot.. It was reported that Manufacturer date of suspect drug was Apr2021, Lot number and expiration date of suspect drug was unknown.
(R) upper thigh 1 cm cluster of erythematous papules. Will observe for now, monitor for signs of infection.
Client was here for a TB skin test. We had been giving TB skin tests and covid-19 vaccine in the same room. The vials were in the same cooler. Inadvertently gave pfizer bivalent 0.1 ml intradermally rather than tuberculin. Realized what had happened when I went to write down the lot number. Immediately notified my supervisor, administrator, and patient.  Patient returned to facility and received TB skin test in her other arm. She came to facility on 11/3/22 to have her TB skin test read. The arm where the pfizer was injected was red and a bit swollen. Patient stated it was "getting better." She did have 3 pfizer doses for her actual vaccine in the past. No systemic reaction was noted at that time. Plan is to follow up with patient next week to see how her arm is doing. We are no longer performing the tests and the vaccinations in the same room.
This spontaneous report was received from a Registered Nurse (R.N) concerning multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of LIQUID PEDVAX HIB (Lot # M036058; expiration date 19-MAY-2018), (Lot # M034188; expiration date 20-MAY-2018), (Lot # N007750; expiration date 29-NOV-2019), (Lot # M047666; expiration date 17-JUL-2019), (Lot # N000235; expiration date 26-OCT-2019), for prophylaxis (dose and route not reported). It was also reported that the vaccine was reconstituted with properly stored diluent (Lot # unknown by reporter). The temperature was 9°C to 25°C for 210 hours and there was no previous temperature excursion. The call was made because of a data logger. Adverse effects reported and there was no PQC involved. This is one of several cases from the same source.; Sender's Comments:  US-009507513-1708USA003628: US-009507513-1708USA003629: US-009507513-1708USA003635: US-009507513-1708USA003631: US-009507513-1708USA003632: US-009507513-1708USA003633: US-009507513-1708USA003634: US-009507513-1708USA011937: US-009507513-1708USA003630:
MILD SORE ARM, TIREDNESS, NAUSEOUS WITHIN FEW HOURS.  26 HOURS LATER SEVERE REACTION BEGAN.  RAPID HEART BEAT 154 BMP AND A HARD KNOT (BOUT SIZE OF DIME)  FORMED IN LEFT PALM (ARM OF SHOT).  TOOK FLECAINIDE 150 MG THAT REDUCED RATE TO 90 BPM BY 6 PM THAT NITE.  HEART WAS NORMAL BY NEXT MORNING.  THE HARD KNOT IN LEFFT PALM STILL REMAINS 10 DAYS LATER.
40 y/o female with a hx of recurrent idiopathic pericarditis (11/2019, 7/2020)developed pleuritic and positional CP 5 days after the 2nd dose of Moderna vaccine. Referred to ED by PCP after 4 days of ongoing sx. ER: EKG with diffuse ST elevation and PR depression consistent with pericarditis. HR 91. Bedside ECHO showed no pericardial effusion. Negative troponin. CRP elevated at 3.3. Anemic (not new). Discharged with ibuprofen and colchicine. F/U with PCP on 6-21-2021: Per chart review pain was gone. Inquiring about how long she had to take medications
Soreness in arm of injection for both shots; This is a spontaneous report from a non-contactable consumer (patient) received . A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 26Jan2021 at 11:30 (Batch/Lot Number: EL3247) (at the age of 31 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medications included ibuprofen (ADVIL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced soreness in arm of injection for both shots on an unspecified date in 2021. The patient received no treatment for the event. The outcome of event was recovered on an unspecified date in 2021. The patient also received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in left arm on 16Feb2021 at 13:30 (Batch/Lot Number: EL3247) for COVID-19 immunisation and experienced soreness in arm of injection for both shots, after second shot: severe headache, body aches, tiredness, thirst.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021228721 Same reporter, suspect drug, patient and events; different dose
T/C 10/5 - c/o of fever 101+, myalgia, weakness day after vaccines; cold symptoms (rhinorrhea, cough) started day 2 after vaccines; Day 3 cold symptoms increased with head pressure also Day 4 c/o cont. head pressure, weakness, fever & cold sx. 10/20 symptoms lasted 7-10 days none now/TC today.
This case was reported by a other health professional via call center representative and described the occurrence of hepatic cirrhosis in a 56-year-old female patient who received SHINGRIX for prophylaxis.  In July 2018, the patient received SHINGRIX. In July 2018, less than a month after receiving SHINGRIX, the patient experienced rash. On 1st August 2018, the patient experienced lab test abnormal. On 9th August 2018, less than a year after receiving SHINGRIX, the patient experienced cancer antigen 19-9 increased. In August 2018, the patient experienced hepatic cirrhosis (serious criteria GSK medically significant), ascites (serious criteria GSK medically significant), biliary tract disorder and raised liver function tests. On an unknown date, the outcome of the hepatic cirrhosis, ascites, rash, biliary tract disorder and lab test abnormal were unknown and the outcome of the raised liver function tests was recovering/resolving and the outcome of the cancer antigen 19-9 increased was not recovered/not resolved. It was unknown if the reporter considered the hepatic cirrhosis, ascites, rash, biliary tract disorder, raised liver function tests, lab test abnormal and cancer antigen 19-9 increased to be related to SHINGRIX. Additional details reported as follows: The patient received SHINGRIX in early July and developed a rash sometime in July. In early August the patient developed elevated liver function tests (LFT's), acute hepatitis with ascites and bile duct dilation and evidence of cirrhosis based on imaging. Since August the patient's cancer antigen 19-9 increased (CA 19-9), has been steadily increasing (this was a pancreatic cancer marker). On 9th August 2018 the CA 19-9 was 429, and on 10th October 2018 it was 1281. The healthcare professional did not have information on the SHINGRIX as it was given elsewhere. The healthcare professional stated that the patient's liver lab values have been improving but not the CA 19-9. They were questioning whether the SHINGRIX might have caused a false positive in this marker.
17 year old pregnant patient that was given her first dose; 17 year old pregnant patient that was given her first dose; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPOSURE DURING PREGNANCY (17 year old pregnant patient that was given her first dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old pregnant patient that was given her first dose) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Aug-2021, the patient experienced EXPOSURE DURING PREGNANCY (17 year old pregnant patient that was given her first dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old pregnant patient that was given her first dose). At the time of the report, EXPOSURE DURING PREGNANCY (17 year old pregnant patient that was given her first dose) outcome was unknown and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old pregnant patient that was given her first dose) 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 concomitant medication details were reported. No treatment medication details was reported.  Company Comment: This is a case of product exposure during pregnancy and inappropriate age at vaccine administration with no associated AEs for this 17-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy; Sender's Comments: This is a case of product exposure during pregnancy and inappropriate age at vaccine administration with no associated AEs for this 17-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Pain  at injection site- 1/22/2021, 7PM, eased on 1/24/2021 evening. Swelling at face and all over body- 1/23/2021- resolved on 1/24/2021 morning. Severe body ache, feverish feeling- 1/22/2021, 7PM, eased on 1/25/2021 morning. Swelling at injection site- 1/22/2021, 7PM, still persistent Redness at injection site- 1/22/2021, 7PM, still persistent Itching at injection site- started on 1/25/2021, persistent Nausea and headache- mild
pt recv vax in 1983 & in 1985 tested HIV pos; MD reported in f/u that pt had not been seen for approx 5 yr; No further details were provided;
Myalgia, NauseaVomiting, chills and muscle cramps Narrative:
second day stomach ache, third day:  stomach ache, sore throat, tired, aches, runny nose, cough a little, lungs hurt, dizzy sometimes, problems concentrating, pain at site, shivering.  No thermometer so don't know about a fever.
Patient received injection at 1705, reported lightheadiness at 1715, BP was 172/114, 62. Patient denied any other symptoms, would not allow us to call 911, would not lay down to elevate feet. Patient stated that sometimes his sugar is low and he uses sugar tablets. He ingested one at approximately 1730. Patient left at 1745 and called at 1800 reporting that he was home and felt better.