chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 38 Y female with h/o DM2, HTN, GERD, Mirena IUD in place, obesity, recurrent UTIs, who presented to the ED with 1 day of fever/chills, diaphoresis, generally feeling ill, and tachycardia.    Met sepsis criteria with sinus tachycardia to 170s, tachypnea, fever to 101.7 and WBC 25.9, with lactate 4.7. No clear localizing signs of infection. Covid positive. RSV/flu negative. UA with 24 WBCs, 6 RBCs, 270 squamous cells -- possible contamination. Urine culture no growth. Blood cultures no growth to date. CT chest/abd/pelvis showed no PE but did show scattered areas of consolidation in the lungs concerning for infection/inflammation as well as skin thickening around the umbilicus, although no clinical signs of cellulitis. CT also noted aortic and coronary artery atherosclerosis. Complained of left flank dull pain throughout admission, although urine culture negative and no CVA tenderness. No genital pain or rash concerning for Fournier's gangrene.   Admitted for septic shock and treated with IV fluids and IV ceftriaxone and PO doxycycline (1/29- ) for possible pyelnonephritis vs community acquired pneumonia as well as remdesivir (1/29- ) for Covid without hypoxia. Lactate normalized and WBC downtrending. Patient evaluated for ACAH and was accepted into the program. She appeared well on day of discharge, was walking around without issue, tolerating PO, and wanted to go home.
This report describes joint pain in a male vaccine of unspecified age who received LYMErix. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not provided. The vaccinee reportedly received LYMErix; the number of injections administered was not reported. In a statement of injuries, his attorney alleged that the vaccinee "suffers from pain in his joints, specifically his ankles, knees, elbows, wrists, hips, and groin. He also experienced fatigue and flu-like symptoms. In addition, his physical condition has caused him to be depressed." Time to onset following immunization, treatment, and outcome of the alleged events were not reported.
Sores in mouth . Gray skin color. Boil looking sores in mouth on gum under nose and right cheek.  Cough  that feels like flem in throat
Received call from patient on 1/14/2021.  He stated he developed shingles 2 days after receiving the vaccine.  Rash is on R thorax and under the arm. He saw his PCP and was started on Acyclovir.  The lesions are crusted
The medical Assistant administered a Pentacel and then another IPV instead of PCV. Pt was double dosed with IPV that day.
pt recvd standard dose of Hep B vax & did not achieve protective titer;
Fever within 24 hours. Redness, swelling, warmth at site of vaccine with 48 hours.
immune response; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "immune response".  Additional information: Caller had both doses of the vaccine. She was planning to get the booster dose in January next year, 8 months after her second dose of the vaccine. She mentioned as well after getting the second dose she had an immune response. She was not up to date on a new variant Omicron. She wanted to know the efficacy of the booster dose to the new variant Omicron and what would be the difference of getting the booster for 8 months after the second dose instead of 6 months.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pressure in center area of chest front and back at about 0400 on Oct 30.  This was about 13 hours after the booster shot was received. It was a pressure of about 5 on a scale of 10.   The pressure lasted about 2 hours and then dissipated. After the first episode the pressure was reduced to about a 3 on a scale of 10  and  come and goes and last about 2 hours. I have been taking Ibuprofen.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No medical history was provided by the reporter.  On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018, lot # N010107, expiration date: 28-MAR-2019) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from an other reporter concerning a 12 month old patient. On 10-OCT-2017, the patient vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # N019822, expiration date: 13-JUL-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002098: US-009507513-1709USA002186.
7/7/15 - Pt complaining of left upper arm redness, tenderness, swelling and warm to touch. On 7/10/15 - pt reports onset of fatigue and diarrhea, redness, swelling from shoulder to elbow and site warm to touch. Still present today. Saw Dr. no treatment needed.
pt recvd vax 11AUG95 & 16AUG95 pt exp h/a, myalgias & gen rash; no further details were provided;
Headache for the past 11 hours; severe chills for at least 5 hours (went to sleep and chills were gone); feeling dehydrated since I got the shot; fatigue and restlessness
12 hours post vax, the pt developed a fever of 103.7. She responded to Motrin and the fever was gone after 24 hours.
COVID-19 breakthrough. My symptoms were fatigue, exhaustion, weakness, high fever (102-104 degrees), body aches, chills, headache, and loss of appetite. After I recovered, I had a loss of taste for about a month.
chills, 101.5 fever 24 hr.s, soreness at injection site
He had received a Moderna COVID vaccination this morning and about 5 minutes later he began to feel lightheaded and dizzy, clammy, and had hot flashes.  Denies nausea or vomiting.  Denies chest discomfort or palpitations.  Denies shortness of breath.   Patient presently states that he is feeling much better.
Boostrix admin on 2/27/14. Injection site was visibly reddened. Upon touch there was a hard nodule. Soreness was still in the arm. Advised patient to take Benadryl, Ibu, Tylenol.
The patient sat down for 15 minutes to be observed for any reactions and told us that she had numbness on the right side of her face and right arm as well. She then told us that the numbness was spreading to her neck and right leg as well. EMS was called and took her to the hospital.
Diarrhea; Crushing chest pain that comes and go; Nauseous; vomiting; Fever at 102.4 degrees Fahrenheit; Sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), CHEST PAIN (Crushing chest pain that comes and go), MYALGIA (Sore arm), NAUSEA (Nauseous) and VOMITING (vomiting) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced MYALGIA (Sore arm). On 13-Jun-2021, the patient experienced DIARRHOEA (Diarrhea), CHEST PAIN (Crushing chest pain that comes and go), NAUSEA (Nauseous), VOMITING (vomiting) and PYREXIA (Fever at 102.4 degrees Fahrenheit). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) for Myalgia, Diarrhoea, Nausea, Vomiting, Chest pain and Pyrexia, at an unspecified dose and frequency and ALPRAZOLAM (XANAX) for Chest pain, Nausea, Diarrhoea, Vomiting, Myalgia and Pyrexia, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), CHEST PAIN (Crushing chest pain that comes and go), MYALGIA (Sore arm), NAUSEA (Nauseous), VOMITING (vomiting) and PYREXIA (Fever at 102.4 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jun-2021, Body temperature: 102.4 (High) 102.4 degree Fahrenheit.     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 medication was provided.
Unusually heavy menstrual bleeding. Periods occurring frequently, only 5-9 days apart, with bleeding lasting up to eleven days. This is not normal for her.
Urticaria on chest, back, neck, arms -> developed within 2 hours of vaccine.
Urticarial rash over face, torso and extremities within. Seen by Dr. when rash became pronounced.
patient had covid shot given to her at drive up. she states immediately she started having a headache, labored breathing, tongue swelling and burning in her chest along with being flushed. the physician on site gave her benadryl and epinephrine, and she  was then driven to another ED where she was given IV steroids. she states the vaccine adverse event was not reported by any of the facilities that took care of her that day. she also has had flu like symptoms since she got her shot and she is still recovering.
Information has been received from a physician concerning an approximately 5 year old female patient with no medical history who was vaccinated with a dose of VARIVAX (Merck), injection (lot number 659698/1770U, dose not provided). Concomitant therapy included DTaP, HAVRIX and poliovirus vaccine. The patient received VARIVAX (Merck) and later her left upper arm became red and warm to the touch. The patient also complained of itching at the site. The site of injection was 4 centimeters round and swollen. No complaint of fever or pain was reported. There was no quality complaint. Additional information was requested.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4th Patient received expired booster doses after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 prophylaxis. No Medical History information was reported. On 01-Aug-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4th Patient received expired booster doses after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4th Patient received expired booster doses after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (4th Patient received expired booster doses after manufacturer date of expiry). It was reported that patient was not pregnant. Concomitant medication details were not reported by the reporter. Patient received booster dose. On 29-JUL-2022 vial was initially thawed and stored in refrigerator. Vial did not undergo any temperature excursions. Treatment details was not reported by the reporter.
This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 47-year-old female patient received bnt162b2 (BNT162B2 Formulation; solution for injection), dose 2 via an unspecified route of administration on 11Mar2021 at 16:30 (Batch/Lot Number: EN6207) as DOSE 2, SINGLE (at the age of 47-year-old) for covid-19 immunisation. Medical history included lupus, Mixed connective tissue disease, Auto immune disease, a reaction MRI contrast and Allergy to IV medications from an unknown date and unknown if ongoing. Reporter stated that she was allergic to all IV medications, It's not a certain drug class, the pharmacist told her that it seems like she was just allergic to a additive in the IV medications. Concomitant medications (other products) included prednisone (PREDNISONE) and diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 on 18Feb2021 at 16:30 (Batch/lot number: EN6200, Expiry Not Written) (at the age of 47-year-old) for covid-19 immunisation and experienced Hives, rash and welts. The patient experienced welts/hives, rash on 11Mar2021, reporter stated that within 30 minutes the patient got the hives, rash, welts, but it lasted about a day and a half, however she had took a lot more prednisone before the second dose. She has also Recovered completely form this. When querying to patient, it was stated this was all creepy and scary on an unspecified date. It was reported that the patient was given a high dose of prednisone to take before both Pfizer Covid vaccine doses because she has a history of allergic reaction. She experienced welts/hives within 10 minutes after each vaccine dose. The patient wants to know if there was any information on the efficacy of the vaccine for individuals who have received the vaccine while taking high dose steroids. The reporter stated that she feels the Pfizer website guidance on receiving the second dose after an allergic reaction was not clear. The physician recommended to take high dose prednisone and Benadryl prior to receiving the vaccine. It was reported that prior to the Second dose, she took a total of about 150mg. Then after receiving the second dose the following day she took 40mg in total, then 20mg the next day, and 20mg again the next day after, and then she was done, she didn't have as bad of a rash. It was reported that physician said its fine for the second dose, and to just pre-medicate again. She took more prednisone this time prior to the second dose, got the second dose, she had a rash again. Her physician was indicating that the efficacy of the vaccine was now maybe lower because she had the Prednisone. The patient does not recall if it was Prednisone tablets or capsules, it was little round circle. Therapeutic measures were taken as a result of welts/hives and rash. The outcome of event reported as recovered on unknown date of Mar2021. No follow-up attempts are needed. No further information is expected.
since receiving the vaccine she has had discomfort and decreased ROM in her right arm between the elbow and the shoulder
Atrophy of soft tissue atrophy 4x5cm diameter over (L) medial-lateral thigh at site which would correspond with immunization administration. No underlying abnormalities noted, no inflammation, no tenderness; no functional abnormality.
Patient reported pain, warmth, and swelling down the entire length of left arm. She also experienced generalized weakness, headache and feeling "exhausted". Missed work 2 days because of how she felt. Is better now.
Tingling and partial loss of feeling in left arm within 30 minutes of injection. Tired, severe body aches and chills within 12 hours.
Rash on face and stomach, started after shots per mom, more fussy than usual, and decreased appetite. MD discussed with mom not serious reaction. Continue supportive treatment, fluids, and antipyretics.
Crescent shaped area of induration and redness that persisted until next vax series (2 mts). no signs / Sx of infection. Not tender.
Varicella vaccine administered 4/11/08. Patient called 4/22/08 to report little "acne" like bumps in area of vaccination. Noted more bumps on epilateral side of body. Saw dermatologist, who cultured, given diagnosis of chickenpox. Started on Valtrex. Patient called 4/25/08 to report fatigue and headache.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD subcutaneously, lot # N020615, expiration date 22-JAN-2019, albumin status rHA; and lot # N010246, expiration date 25-SEP-2018; (dose and albumin status were not reported) for prophylaxis; administered along with a properly stored sterile diluent, subcutaneously, lot # L028663, expiration date 29-MAR-2018 (dose was not reported) for prophylaxis. It was reported that the vaccine was exposed to temperature of -9 degrees Celsius to 8 degrees Celsius, for a time frame of 4 hours and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received form the same reporter (MARRS # 1712USA008050, 1712USA008779, 1712USA008780, 1712USA008781, 1712USA008782, 1712USA008784, 1712USA008785, 1712USA008786, 1712USA008787.). Sender's Comments: US-009507513-1712USA008050.
I felt nauseous, extremely tired, headache, muscles ached especially in the arms for a day, enough to be incapacitated.
VACCINE RECIPIENT RCD 2 PFIZER C- 19 VACCINE DOSES PRIOR TO THIS, ON 12-18-2020 AND 1-7-2021, WITHOUT ADVERSE EFFECTS. ON 7-31-2021 AT A SPONSORED HEALTH PROMOTION AT, RECIPIENT WAS TESTED FOR COVID IGM AND IGG ANTIBODIES BY AN OU RESEARCH IMMUNOLOGIST AS PART OF A GRANT-SPONSORED STUDY. HER IGG ANTIBODIES WERE REPORTED AS VERY LOW. AS THE CLINIC WAS CLOSING,  THERE WERE PFIZER C-19 VACCINE DOSES TO BE WASTED.  THE RECIPIENT REQUESTED A 3RD DOSE (BOOSTER) AND THE DRH VACCINE COORDINATOR (VC)APPROVED IT BASED ON RECIPIENT'S LOW IGG RESULTS,  RECENT REPORTED STUDIES AND VACCINE THAT WOULD BE WASTED.  THE VC DID NOT HAVE AUTHORITY TO APPROVE THIS BOOSTER DOSE.
I am a runner who is no longer able to run and train for my September event due to the pain stiffness and slight swelling in my left knee- the same knee that over a year ago was swollen from my first case of shingles that ran down my left leg all the way to my ankle. I am so angry since I asked my dr whether I should wait until after my race to get this shingles vaccine and she said I would not have any adverse effects except the pain in the arm like the Covid vaccine. That is not the case and I am so angry at myself for not putting off this vaccine until November after my international and local running events.
On 12/27/2022 I tested positive for COVID-19. I was prescribed Paxlovid, got better in three days after taking the medication. I had body aches, pain in all my body, cough and low grade fever. I also had mile to moderate headaches.  I went to urgent care on 12/28/2022 where exams and lab work were performed. I have recovered from my symptoms.
This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 14-APR-2015 was vaccinated with an improperly stored dose of GARDASIL lot #K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 72 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Head on left side gradually got heavy, vision went blurry, left side weakness,  and headache. I had been having memory loss and searching for words a few weeks before and just thought it was because I was getting older. Similar symptoms as a TIA. I was driving and more worried about pulling my car to the right and back over from crossing the line.
Vacccinated at 9:30am. On 1/12/2021 7:30am started with flush face, nausea, dizzy, fever, headache and chills
Fever; Body Aches; Body does not feel right; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (Body Aches) and FEELING ABNORMAL (Body does not feel right) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included IBUPROFEN for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), MYALGIA (Body Aches) and FEELING ABNORMAL (Body does not feel right). At the time of the report, PYREXIA (Fever), MYALGIA (Body Aches) and FEELING ABNORMAL (Body does not feel right) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
12/23 within 2 mins after the vaccine I felt light headed and I felt like I was  going to pass out my heart was beating really hard, it started to mellow out and my face swelled up about an hour after. I was told to go to the ER and I took oral Benadryl and it went away and did not return
Severe localized reaction to vaccine. Entire anterior right thigh swollen, erythematous, warm, and tender. Started 24 hours after vaccine. No fever or other symptoms.
Systemic: Fainting / Unresponsive-Medium, Systemic: Hypertension-Mild, Systemic: Nausea-Mild, Additional Details: Patient was slightly dizzy after vaccine, then abruptly lost consciousness, hit head on wall.  She was dizzy for approx 30 minutes, BP was approx 167/88.  Symptoms did not resolve after water so called paramedics to check her over.  They discharged her to home.  I checked with patient after 3 hours and she was feeling normal.
Stated had localized blister appear at old smallpox vaccine site. C/O itching at sight. Instructed not to itch. States blister is gone, now it appears more to be a sore. Was seen by MD who told her to report. Received report on 08/25/10. While interviewing discovered patient admitted to have Graves Disease which is auto immune and she was asked by provider if she had any auto immune disease in which she denied.
patient noticed redness, swelling, warmth and itching at vaccine site on 08/28/22. Vaccine was given 08/25/22. Pt. is unsure whether she has had a fever or not. Pt. also has been fatigued, muscle aches and occasional dizziness but unsure whether this is due to the vaccine reaction or the long covid which she was diagnosed with on 08/25/22.