chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects; Patient was inadvertently administered an expired dose of MMR; MMR vaccine given intramuscularly; This initial spontaneous report was received from an office manager concerning a 75-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 09-MAY-2019, the patient was inadvertently vaccinated with and expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II), with lot number N013296 and expiration date 28-APR-2019, intramuscularly (incorrect route of product administration) for prophylaxis (strenght, dose and anatomical location were not reported); reconstituted with sterile diluent with lot number R032161 and expiration date 18-JUL-2021.  No adverse events or product quality complaints (PQC) were reported.
received expired dose as second booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired dose as second booster) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired dose as second booster). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired dose as second booster) outcome was unknown. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2022-593310 (Patient Link).
pt recvd vax & 1-2 days p/vax exp flu-like sx, high fever, red throat, bronchitis, chest pain, enlarged heart, orchitis (non-infectious); pt was treated w/Amoxicillin & sx resolved very quickly p/that;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 06Jan2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunization. The patient had no relevant medical history and no Known allergies. There were no concomitant medications.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound of symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 13May2022 and stopped on 18May2022. Clinical course was reported as, Rebound symptoms on 21May2022 at 14:00. No treatment received for symptoms and patient was not recovered from symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The patient experienced LLR after the 2nd anthrax dose. This occurred 4-5 days later and lasted 10 days.
I recieved my injection at 1:00pm.  My arm became sore around 3:30pm as expected.   I became very tired  around 5pm.  Around 6:30 I experience heat on the left side of my neck up to the back of my left ear.  Also tingling,  mild swelling,  and drooping on left side of face that lasted a couple of hours.   The next day I still experienced the heat feeling in left side of neck up to the back of left ear, fatigue, and soreness in arm.   But by 3pm I felt fine and haven't had any problems since.
Patient here for vaccine only appointment . Vaccines given at 3:45P Due to receive today per  Shots & checked by employee: Flulaval, TD, Hep A, Hep B, HPV, IPV. PTID x 2 Allergies reviewed. VIS given to parent & after care of vaccine discussed. Vaccine checked by provider. T emp 98 RN Child fell off bed suddenly after vaccines were given at & fell onto scale floor face down. Child had just spoken to Uncle & myself & gave no signs of fainting. Child placed on bed ,lying on back in trendelenburg by uncle & myself. Bleeding noted from under left nostril & right bottom lip. Child responding & denied any pain with red area on top of right hand & right temporal area. . Seen by employee & Dr. BP 110/80, P 59,RR 20 & O2 sat 99. Given juice & tolerated well. Kept for observation. V/S at 4:10P BP 110/54,P 87, RR 24 & O2 sat 99. Child denies nausea,dizziness,blurry vision,headache or any other pain. Staes a bit sleepy. Seen by DR at 4:25 P . Child still denies pain sleepiness at this time or any other sx. Child is living with Uncle,as parents are in another country. Instructed to watch for child unable to stay awake (except during night time, when he will wake child every 2 hrs) , nausea vomiting, headache,blurry vision,dizziness. Please take to ER if he has any of these sx. Given antibiotic oint to use on cut under nostril. If any pus is seen for either cut please have checked. Given appointment for 11/12/19 3:30P with Dr for follow up. Aware he can call our office 24 hrs per day & there will be a covering doctor he can speak with. Uncle voiced understanding. RN
pt recv vax;aching in upper arm; burning sensation when arm is touched by clothes or rubbed; sharp pain at inside elbow & base of thumb;
Mother called stating child was breathing funny. Once arrived temperature 102.1 to 105 to 106 degrees. Tx Nebulizer, pulse Ox, U/A, C&S, CBB blood culture, chest X-ray. Dx bronchitis 4/7/03.
Headache, NauseaVomiting, CHILLS, LOSS OF APPETITE Narrative:
Within 12 hours had a headache and stuffy nose. About 12 hours later experienced intense itching in four areas on body, mostly hands and foot. Another 12 hours later and after a small breakfast had very loose stools with extreme abdominal pain off and on for about 90 minutes and ending with bloody stool. This time frame also included vomiting
Patient's wife called and said husband had bad reaction to shot. Said he was itching, covered in welts and vomiting. Said his heart rate was elevated. She took him to their family doctor but she was on vacation and Dr was filling in. Said they gave her husband prednisone for reaction. His heart rate was still elevated so they referred him to hospital for more tests. She said he was feeling better and they were waiting for test results.
The patient called the pharmacy in the morning on Saturday 3/2 stating she had slept all day Friday following the 2nd SHINGRIX dose and had just woken up with double vision, puffy eyes, puffy lips, and sores in her mouth. She was referred to urgent care, but when I followed up with her Sunday 3/3 she said she couldn't find one that was open and didn't want to go to the ER but was feeling a little better. I suggested BENADRYL which she denied because she was already too tired. I'm uncertain if she tried ZYRTEC which I suggested next. On 3/4 she followed up with her PCP then called me to let me know they were aware and that they wanted a copy of VAERS report if I did one. She said she was still pretty tired on 3/4, but other symptoms were seeming better.
Pt recvd vax & w/in 8 hrs post vax devel fever (104-105), hives & exp severe muscle aches;
elevated BP; 102 fever; severe uncontrolled chills lasting 3 hours; headache lasting 5 days; This is a spontaneous report from a contactable other healthcare professional (patient, self-reporting). A 51-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: en6200, expiration date was not reported), via an intramuscular route of administration in arm left on 18Feb2021 at 07:15 as single dose for COVID-19 immunisation (at the age of 51years and the patient was not pregnant) at Hospital. The patient had medical history of COVID-19. Concomitant medication included ibuprofen and acetaminophen taken for an unspecified indication, start and stop date were not reported (both as other medications in two weeks). Tested covid prior vaccination. No other vaccine in four weeks, no covid tested post vaccination and no known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ek9231, expiration date was not reported), via an intramuscular route of administration in arm left on 28Jan2021 at 16:00 as single dose for COVID-19 immunisation. On 18Feb2021 at 21:00, the patient had 102 fever, severe uncontrolled chills lasting 3 hours, headache lasting 5 days and elevated BP (blood pressure). No treatment was given for these events. The patient underwent lab tests and procedures which included blood pressure with result elevated and body temperature as 102, both on 18Feb2021 at 21:00. The outcome for all events was not recovered.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unspecified dates, the patients were vaccinated with improperly stored dose of VARIVAX, lot # reported as L022868, expiration date: 27-JAN-2017 and lot # L029467, expiration date: 16-AUG-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
difficulty breathing; heart racing; This is a spontaneous report from a non-contactable other healthcare professional. A 74-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6205, Expiration date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single (at the age of 74-years-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, during her 15 minutes waiting period after the injection, patient began to experience difficulty breathing and heart racing. Patient denied rash, hives, welts, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Patient was monitored in bay for approximately 40 minutes. Patient received water and snacks, as a treatment for the events. Patient reported great improvement after snack and feels well. Suspect stress response to vaccine. Patient had no dizziness, lightheaded or palpitations/SOB with ambulation. Follow up response to treatment was good and at discharge, patient was stable to go home and follow up with PCP. Differential Diagnosis was Red flag symptoms (CP, SOB (shortness of breath), NVD, Visual/Neuro concerns). Patient would like to go home. Husband was with her today (08Mar2021) and was able to be with her. Patient left in her seated walker, pushed by husband. Accompanied out by staff member. Follow up with PCP if not improving. Discussed reasons for Emergency department (ED) visit. The outcome of both the events was resolving.  No follow-up attempts are possible. No further information is expected.
Death; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 Unknown Manufacturer), for COVID-19 immunization. The following information was reported: DEATH (death), outcome "fatal". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201322761 Same reporter/ drug/ AE, different patients;; Reported Cause(s) of Death: Unknown cause of death
About one hour after shot, I fainted while going up stairs to go to work. I woke up on stairs. No head injury. This was around 1200pm on 12 JAN. I began to feel ill. Arm hurt, headache, weight on chest. Body hurt. I went to bed early. I woke up on 13 JAN and felt worse. I stayed in bed until around 1300. I got up and went and sat in my office to work. At around 1700, I went to go get my children from a neighbors yard to bring them for supper. I made it to my back yard before feeling to tired to continue. I went inside and laid down. At around 1900 or 1930, I was putting my kids to bed. I then fainted once more. I don't know how long I was out each time. I don't think I hit anything with my head. I got up and went to my bed and texted a Doc.
2 Days after receiving my 2nd Pfizer shot, I began to have blurred vision in only my right eye.  For the first week, it began to get worse a little bit each day making it difficult for me to see out of my right eye.  By the end of the first week (February 22 - February 28), my eye sight had gotten so blurred/darkened with my vision in my right eye that I was uncomfortable operating a vehicle.  During the week of March 1 - March 7, I did not drive and went to the  Eye Institute on March 1st assuming it was a retinal tear or something more serious due to the lack of vision in one eye.  There was blurred vision with a darkness that covered the center part of my eyesight.  It was very difficult to see if it was bright outside and there were little floaters here and there.  I explained this to the urgent care doctor at Eye Institute and they completed retinal scans and various other tests/scans.  The doctor did not see anything physically wrong with the eye.  For that next week (March 1 - March 7), my vision continued to remain exactly the same where there was a large, dark spot constantly when I looked out of my right eye.  As I stated above, it was also very sensitive to light.  I went on Monday, March 8th to get a second opinion, but they also could not tell me what was wrong.  Exactly 2 weeks after the vision issue started, my vision began to return normally.  During the week of March 8th, my right eye regain its vision back to its normal eyesight.  By the end of the week (March 13th-ish), I would say my vision was at least 75% back to normal.  It is 100% back to normal now and has been for a few weeks now.
- Spike in inflammation (Calprotectin)  levels and symptoms related to Crohn's Disease. Calprotectin levels increased from 162 to 1,700 which was more than triple what it has ever reached in the t 7 years since she's been diagnosed.  - Test results showed that her system stopped responding to Vedolizumab in the months following the Covid vaccination. (Test/lab results PRIOR to Covid vaccination showed that her system was responding positively to Vedolizumab and her Calprotectin levels were acceptable).  - At this time she has failed to respond to new treatments.  (New treatments were tried in efforts to bring the inflammation back under control. These included increasing the dosage of Vedolizumab, trying Stelara,  and taking Budesonide. None of these have produced the desired results or brought symptoms undercontrol.
Patient without prior otologic history noticed left sided hearing loss and tinnitus 1-2 weeks after second dose of Moderna vaccine. No vertigo.
NO SWELLING OR REDNESS NOTED AT INJECTION SITE ON LEFT ARM. LOW GRADE TEMP OF 100. CHILD COMPLAINED OF A MILD HEADACHE. NO PHYSICAL IMPAIRMENT NOTED.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "autoimmune thyroid" (unspecified if ongoing); "migraines" (unspecified if ongoing); "allergies" (unspecified if ongoing); "raynauds" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; PRISTIQ; L-METHYLFOLATE.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 12Oct2022 to 16Oct2022.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Test positive for the  Dimer test for blood clots; The ebv test  for herpes virus; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (Test positive for the  Dimer test for blood clots) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2022, the patient experienced THROMBOSIS (Test positive for the  Dimer test for blood clots) (seriousness criterion medically significant) and HERPES VIRUS INFECTION (The ebv test  for herpes virus). At the time of the report, THROMBOSIS (Test positive for the  Dimer test for blood clots) and HERPES VIRUS INFECTION (The ebv test  for herpes virus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2022, Epstein-Barr virus test: (Positive) Positive. On 23-Apr-2022, Fibrin D dimer: (Positive) Positive.         Concomitant medications were not reported. No treatment information was provided by the reporter. It was reported that patient wanted to know why people had to take the Dimer test for blood clots and the ebv test for herpes virus, after getting vaccinated, because 80 percent of people were going to test positive after getting vaccinated.  Company Comment: This is a spontaneous case concerning a male patient of unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) AESI of Thrombosis and the non-serious event of Herpes virus infection. Approximately 1 year after receiving the primary series of mRNA-1273 vaccine, the second dose given one month after the first dose, patient tested positive for the Dimer test for blood clots and the ebv test for herpes virus. There is no available information regarding the clinical course and treatment medication. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) AESI of Thrombosis and the non-serious event of Herpes virus infection. Approximately 1 year after receiving the primary series of mRNA-1273 vaccine, the second dose given one month after the first dose, patient tested positive for the Dimer test for blood clots and the ebv test for herpes virus. There is no available information regarding the clinical course and treatment medication. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
developed at injection site redness, swelling, warm to the touch, sensitive to the touch and itchy.
Information has been received from a physician, concerning a 17 years old female patient. On an unspecified date, the patient was vaccinated with a dose of GARDASIL (dose and route were not reported) (lot # and expiration date were not reported). On an unknown date four days after vaccination the patient experienced migraine headache. In addition, at the site of injection, her arm was tingling and pain was radiating distally. At the time of the report, the patient's outcome of migraine headache, pain was radiating distally and tingling arm at the site of injection was unknown. The relatedness for migraine headache, pain was radiating distally and tingling arm at the site of injection was unknown for GARDASIL. Additional information has been requested.
Redness, blistering and itching of 7 of my 10 toes. Symptoms began on 2 bd toe of left foot late evening of Monday, January 18; involved 2 more left toes by Tuesday evening; Wednesday morning (January 20) involved 3 toes on right foot. Benadryl seems to help the itching. Could not comfortably wear shoes. Friday afternoon, January 22, symptoms appear to be easing a little. No visible signs of pus or infection. Reported this to my physician.
Patient received 11yo vaccines and flu vaccine last week, the following day had fever and symptoms of panic attack, seen at ED, was new patient but does have history of anxiety, motor tic, sleep disturbance. I had already placed referrals for Neuro and Psych at his well check appointment. He was stable in clinic today. Thanks.
She reports on 12/28/2020 feeling fine. On 12/29/2020 she noted a lump at injection site with swelling, she reports extreme body aches through 1/1/2021 to the point that if she would have been scheduled to work that she would have not been able to perform her job duties.  She denied any fever or chilling. She reports that the vaccine gave her side effects similar to when she had the Covid but more severe. She reports on 1/7/2021 that her sense of smell seems like it is not as it was after receiving the vaccination.
Sleepiness; Fatigue; Body aches; Low grade fever; This is a spontaneous report received from a contactable consumer or other non-health care professional reported for himself.  A 66-year-old male received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: ER8737), via an unspecified route of administration, in left arm on 07Apr2021 at 11:00 (at the age of 66-year-old) as dose 2, single for covid-19 immunization at doctor office/urgent care centre. Medical history included prostate cancer in 2020. Patient reported known allergies as no. Concomitant medications included dietary supplements; patient receive any other medications within two weeks of vaccination was reported as yes. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6204), via an unspecified route of administration, in left arm on 13Mar2021 at 13:00 (at the age of 66-year-old) as dose 1, single for covid-19 immunization at doctor office/urgent care centre. On 17May2021 at 10:00, 6 weeks post vaccination of second dose, patient experienced fatigue, body aches, low grade fever and sleepines. These events resulted in doctor or other healthcare professional office/clinic visit. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient underwent lab tests and procedures which included body temperature resulted in low grade fever, on 17May2021. Therapeutic measures were reported as no. The outcome of the events which began 30 hours ago, was not recovered.  Follow-up attempts completed. No further information expected.