chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner concerning a 15 year old female with no pertinent medical history or history of drug reactions/allergies, who on 13-APR-2007 was vaccinated with the first dose of Gardasil, 0.5 ml, IM, right deltoid (lot # 653978/0955F). There was no concomitant medication. The patient was in the waiting room for 5 to 10 minutes post injection when she experienced loss of coloration and had difficulty breathing and swallowing. The patient felt like her throat was closing up. The patient was administered an EPI (epinephrine) injection and stayed in the office for 45 minutes. The events improved after the epinephrine injection and was considered to have recovered from loss of coloration, difficulty breathing, difficulty swallowing and throat closing up. The nurse practitioner considered the events to be an other important medical events and to be life threatening. Additional information has been requested.
myalgia at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site muscle pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comment: The pharmacist reported that the patient received first dose of Shingrix and experienced myalgia at the injection site and two weeks later the patient still had it. The reporter consented to follow up by email.
Received PNUS on 11/16/10. Experienced pain & swelling with redness x 2 weeks. Returned to clinic today 11/30/10. No c/o soreness. Left posterior are hardness noted with some discoloration (dark) no pain noted with touch or palpation. Pt stated "treated heat alternate with ice and applied alcohol as needed".
The pt received vaccines on 5/8/01 and on 5/8/01 PM the pt developed fever, shaking episode and brought to the ER. The pt was admitted to rule out sepsis.  Diagnosis was fever only.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. ON an unknown date, the patient was vaccinated with GARDASIL. On an unknown date, the patient complained that there was pain at injection site. The outcome of pain at injection site was unknown. This is one report of several from the same source. Additional information has been requested.
Woke up on 4/10 (day after administration) with bone and muscle aches, blurry vision, headache that felt like it was in eyes on both side. Also had hot sweats during the night. Took tylenol and drank a lot of water, as advised, at vaccine facility. Treated with bed rest; All symptoms resolved on Mon 4/12
TIRED; BODY ACHES; This spontaneous report received from a patient concerned a 50 year old, male.  The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included patient had no abuse drug/ illicit use and known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the patient experienced tired. On 11-MAR-2021, the patient experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, and body aches. This report was non-serious.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 26-MAY-2021) dose was not reported, administered on MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine  was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210557803.
This spontaneous report as received from a physician refers to a 53 year old female patient with no pertinent medical history/drug allergies or drug reactions reported. On an unknown date, "when the patient was child" the patient was vaccinated with a dose of MMR II (route, dose, lot# and expiration date were not provided). On 24-FEB-2015, the patient was vaccinated inadvertently with a "booster dose" of MMR II, intramuscular (dose, lot# and expiration date were not reported). On the same date, after received the vaccine, the patient experienced vomiting. Concomitant therapies included ZOLOFT and MOBIC. The outcome of vomiting was reported as recovered/resolved on 24-FEB-2015. The reporter physician considered that the vomiting was related to the concomitant medications, and not related with MMR II. Additional information is not expected since there is not authorization to contact the physician.
Presents with Seizure this morning. Per EMS, Pt was increased on Depakote, and hadn't gotten a refill on his prescription which caused back-to-back seizures, each lasting approx 30 seconds and entire episode lasting 3-5 minutes. Pt who has a hx of seizures currently is back to normal and has no complaints or pain at this time.  Patient was recently hospitalized at our MC for concerns of possible CVA.  He and his wife report that he had a full inpatient workup, including MRI and ultrasounds which were negative for acute stroke.  Patient was determined to have had seizure activity leading to his neurological symptoms, and he was increased on his Depakote to 500 mg b.i.d..  Patient's wife states that they have not
Case number PHEH2016US023454, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 61-year-old patient of an unknown gender. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with one single dose of FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscularly into right arm on 01 Dec 2015. It was reported that, the patient received FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error (incorrect product storage).
On 7/13/04 vaccine administered. on 7/14/04 client's daughter called to say client's arm was "red, warm and swollen to the elbow". On 7/15/04, she called again and said "It's alright now."
Very sore arm, could barely lift it.  Very painful at injection site and entire shoulder/arm area after 1st shot and couldn't sleep on side of shot, and got a headache. Needed to rest or sleep the 1st & 2nd day.   After 2nd shot, injection site hurt but not as bad as 1st shot, however, this time the injection site turned red, itched and had a raised rash about size of a fist. By 2nd day, it spread to about size of my hand and still hurt and itched.  By 3rd day, which was actually about 48 hrs later, it started to really calm down, the rash was no longer raised, and it wasn't as red.  Pain had also subsided. Also, on the 2nd day, had the chills, laced in a car at about 115-120 degrees, slept about 45 mins, came into the house and sweat like crazy. Chills were gone and felt better, and after about 3 hrs, felt much better.  Still tired but was able to carry on as usual. By 3rd day felt more normal.
This is a spontaneous report from a non-contactable consumer (patient). A 33-year-old male patient received BNT162B2 (BNT162B2), via an unspecified route of administration on 17 Feb 2021 (Lot Number: EL3247) as single dose (at age of 33-year-old) for COVID-19 immunization. Medical history was reported as none. Concomitant medications were not reported. No known allergies and no COVID-19 prior vaccination. No other vaccines in four weeks. On 17 Feb 2021 patient experienced injection site soreness, mild lethargy. No treatment was required for the events. Patient was not tested for COVID-19 post vaccination. Patient recovered from the events on 17Feb2021. No follow-up attempts are possible; Information about lot/batch number could not be obtained. No further information is expected.
We tested positive We must have already had covid when we got the shot although we didn't know it; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (We tested positive We must have already had covid when we got the shot although we didn't know it) 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 18-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced COVID-19 (We tested positive We must have already had covid when we got the shot although we didn't know it). At the time of the report, COVID-19 (We tested positive We must have already had covid when we got the shot although we didn't know it) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. The patient received anti-body on 26-Aug-2021.   This case was linked to MOD-2021-319706 (Patient Link).
patient described feeling itchy as injection went in, lightheadedness, dizziness, face feels puffy, possible lip swelling
Fever of 100.7F, body aches specifically upper and mid back pain, soreness at site of injection,  chills,  general discomfort, difficulty falling asleep
onset 2-3 days after injection - no symptoms at injection site - pain and weakness limited from shoulder to elbow increased over a few days and remain unchanged over past 6 weeks - normal range of motion of arm - pain lifting objects and raising arm - muscles painful to pressure - NO rash, swelling, sensory loss or atrophy  outpatient doctor appointment scheduled
The very next day I woke up to diarrhea. I experienced diarrhea for 5 weeks. I did attempt some over time counter medication; did not work. I went to my primary care physician and advised to change my diet but that did not help the diarrhea.
pt presented to ER @ local hosp w/fever up to 106 then status epilepticus, generalized sz, no cyanosis;no apnea-lasted approx 40min;no response to IV valium, IV ativan but good response to IV Dilantin;
Shortly after receiving vaccine she began to have a scratchy throat with some mild increase work of breathing. No distress. Transported to ED for further evaluation and discharged to home approx. 2 hrs later.
extreme fatigue, mono, chronic strep throat, Hashimoto's, extreme face and body swelling, aching muscles. Got first vaccine 7/10/09 Lot 0072X in conjunction with Menactra vaccine. Second vaccine 12/22/08 Lot 1311X. Went to college on cross country scholarship. Started off season great. She said she started noticing that she was having trouble running mid October and that her legs felt heavy. Starting getting facial swelling second week of January. Went to doctor and they said it was allergic reaction. Got sick in February - dx with strep. Didn't get better. Went to ER end of March with extreme facial swelling. Told her it was allergy and gave her prednisone. Re-dx with strep again in early April and then mono April 9th. Got really sick and could not get better. Extreme facial and body swelling. Dx with Hashimoto's June 29th. and started thyroid treatment. Was not able to return to college in August and is still home. Started getting muscle soreness in July. Made Gardasil connection 2 weeks ago and is going to begin treatment by doctor who has helped several other gardasil patients.  10/13/09 Medical records received, Dates of Service 4/19/09-8/10/09.  Dx:  Other Specified Acquired Hypothyroidism, Abnormal Weight Gain, Oligomenorrhea, Fatigue, Thyromegaly. Presenting Sx:  Pt. experienced an approximately 40 lb. weight gain over a 1 to 2 month period,  additionally she c/o fatigue, trouble sleeping and staying asleep, facial swelling, swelling around eyes, acne, one terminal hair periumbilical, headaches and a heavy period.  Pt. saw a nutritionist and was put on a diet plan.  She experienced menarche at age 13 and had irregular periods for several years (approximately 6 periods/yr.).  Ortho Tri-Cyclene-Low was initiated which she took for several years, but stopped early this year after missing several pills.  She re-started the pill a few months ago.  Concomitantly, she takes Synthroid, Cosyntropin and furosemide.  She was diagnosed with mononucleosis in April, and tested positive for Epstein-Barr Virus in May.  Her thyroid function testing has been essentially normal, with the exception of T-3 which has been testing slightly low.
97.8 nl temp; late afternoon on 9OCT95 devel t102 by 2nd day w/APAP q 4 to 6 hrs;red arm-ice to are starting 11OCT95; 12OCT95 redness less some congestion, asthma;
pt recv vax OCT97 & exp localized cellulitis w/redness @ the inj site & lumps & bumps;Md had been giving vax for years & siam had never seen anything like it;
Information has been received from a physician concerning a child who was vaccinated with a dose of varicella virus vaccine live and in approx May 2005 developed chickenpox. It was noted that an outbreak occurred in the child's elementary school. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
after each one became hot; tachycardic; lightheaded; weak-feeling starting approx. 10 minutes after the injection, lasted about 30 mins; This spontaneous case was reported by a physician and describes the occurrence of FEELING HOT (after each one became hot), TACHYCARDIA (tachycardic), ASTHENIA (weak-feeling starting approx. 10 minutes after the injection, lasted about 30 mins) and DIZZINESS (lightheaded) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 929904, 001B21A and 006M20a) for COVID-19 vaccination.     The patient had no allergies (medications, food and other products). The patient never had COVID positive test or diagnosis. The patient had no acute and chronic illnesses at the time of vaccination.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (weak-feeling starting approx. 10 minutes after the injection, lasted about 30 mins). On an unknown date, the patient experienced FEELING HOT (after each one became hot), TACHYCARDIA (tachycardic) and DIZZINESS (lightheaded). In October 2021, ASTHENIA (weak-feeling starting approx. 10 minutes after the injection, lasted about 30 mins) had resolved. At the time of the report, FEELING HOT (after each one became hot), TACHYCARDIA (tachycardic) and DIZZINESS (lightheaded) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient did not receive other vaccines which was given within 1 month prior to Moderna COVID-19 vaccine.  Concomitant medication of the patient was not reported.  The adverse events did not cause the patient to seek medical care (office visit, Urgent care, ER, hospitalized).  No treatment information was provided by the reporter.  The patient decided to try Pfizer as second booster and did not develop those reactions.   This case was linked to MOD-2022-566669, MOD-2022-566610 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2022: Upon live follow-up, significant information was reported which included addition of reporter's details (contact number and address), patient demographics (height, age, DOB and gender), suspect product information (date and lot number of all 3 doses), medical history information and event details (prior history and outcome for 3 events (except Feelings of weakness)). Event description was updated accordingly.
Rash and low grade fever starting morning of 2/20/2015.  Fever reaching 105.4*F and still rising the evening of 2/21/2015.  No appetite.  Fever lowered with Ibuprofen.  Fever and rash started to subside on the morning of 2/22/1015.
Swollen lymph nodes in arm receiving shot was a new reaction not seen in previous shots.  All shots current and past resulted in muscle aches, joint pain, chills and slight headache.
Pt fainted just after the shot was given. She was given some water and some candy. No loss of consciousness. She was speaking the whole time. She was able to leave with her mother in aproximately 20 to 30 minutes after she fainted. Mom stated after the fact that patient was extremely anxious about having to get the shot and in years past had to be restrained when getting shots. I attempted unsucessfuly to reach mom on 8/12/18.
Briefly, patient is a 16 year old with Evans syndrome who presents to the ED with low-grade fever (Tm 100.4), muscle aches, and left-sided chest pain.  Symptoms began yesterday and chest pain today.  Patient received third dose of COVID vaccine yesterday.  Pfizer vaccine.    ROS: All other systems of a 10 system review are negative.  Medical history: reviewed, and no relevant medical conditions Immunizations: up to date Surgical history: reviewed, and non-contributory Social history: lives at home with family    Exam: My examination of the patient revealed the patient to be active, alert, and in no distress. The HEENT exam was clear, the neck was supple, the lungs clear to auscultation, no abnormal cardiac sounds,     Briefly, patient is a 16 year old with Evans syndrome who presents to the ED with low-grade fever (Tm 100.4), muscle aches, and left-sided chest pain. Symptoms began yesterday and chest pain today. Patient received third dose of COVID vaccine yesterday. PFIZER vaccine. ROS: All other systems of a 10 system review are negative. Medical history: reviewed, and no relevant medical conditions. Immunizations: up to date. Surgical history: reviewed, and non-contributory. Social history: lives at home with family. Exam: My examination of the patient revealed the patient to be active, alert, and in no distress. The HEENT exam was clear, the neck was supple, the lungs clear to auscultation, no abnormal cardiac sounds, the abdomen was nontender throughout. Normal skin color and perfusion. No rashes. Neurologic examination is normal. ED course: Patient with fever, muscle aches, left-sided chest pain 1 day status post PFIZER Baxi #3. ECG obtained which was normal with no ST elevation. D/W hematology who follows patient for Evan's syndrome. Troponin sent. Patient is well appearing, and well hydrated. No focus of infection on examination. I transferred care to colleague at change of shift at 23:36. I performed a history and physical exam was involved in the initial care and management of the patient. Signed out to me at 11 PM change of shift.  In summary, this is a 16-year-old male past medical history of Evan syndrome who presents the emergency department low-grade fever and chest pain after his third COVID vaccine. EKG is reassuring. Troponin is 0.01. Discussed with cardiology feels that it is safe for him to go home. Will discharge home with outpatient follow-up as needed. Cardiac MRI pending as of 9/11/2021.
Allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction). At the time of the report, HYPERSENSITIVITY (Allergic reaction) 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.  Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-064545 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. MOD-2021-064545:Son
headache, muscle aches and pains, night sweats, fever, arm very sore at site of injection 3 days later
Soreness after shot. Pain worsened and am now unable to raise my arm or bear weight using it. Constant pain, especially at night. Appointment with an orthopedic doctor tomorrow.
SHOT WAS STRESS; POUNDING HEART/ THREE EPISODES OF HEART PALPITATION; This spontaneous report received from a parent concerned a 42 year old female. The patient's height, and weight were not reported. The patient's past medical history included: congestive heart failure, and other pre-existing medical conditions included: Patient wears an implanted heart rate monitor to record heart rate. The patient reported that the symptoms of heart palpitations were still ongoing due to existing congestive heart failure, but the frequency of episodes is now similar to what it was prior to vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 02-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included metoprolol for congestive heart failure, hydrochlorothiazide for drug used for unknown indication, and venlafaxine for drug used for unknown indication. On 03-AUG-2021, the patient experienced pounding heart/ three episodes of heart palpitation. On an unspecified date, the patient experienced shot was stress. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pounding heart/ three episodes of heart palpitation, and the outcome of shot was stress was not reported. This report was non-serious.
Patient received Pfizer Covid19 vaccine on April 9, starting having symptoms of fever (101 degrees F), chills, body aches, muscle soreness. On April 13 experienced throat soreness and called/saw personal physician. Physician prescribed Amoxicillin 500mg tabs for 7 days.  On Wed. Apr 14 got blister on lip.  On  Apr. 15
Pt recv vax on 11/18/98; on 11/19/98 pt exp red/ edema/ tenderness of LA; tx=Tylenol & ice
Irritability.  Redness of 75x80cm and swelling of 115x125cm noted.  Tenderness, pt c/o pain.  Area warm to the touch.
Hives following morning arms/legs (disappearing by afternoon). Pt. warm to touch (per mother) eating and active. Allergies: environmental.