chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician referring to a 15-month-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 06-JUN-2017, the patient was administered improperly stored PEDVAXHIB (lot reported as: N00236, expiry date: 24-OCT-2019). On 06-SEP-2017, the patient was vaccinated with improperly stored doses of VAQTA which had the lot # N005274, expiration date 03-APR-2018) (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA007325: US-009507513-1709USA012768.
headache/migraine which is typical with vaccinations like flu vaccine; headache/migraine which is typical with vaccinations like flu vaccine; This is a spontaneous report received from a contactable consumer (patient). A 59-years-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6199, patient was not pregnant and 59-years-old at the time of vaccination), via an unspecified route of administration in Arm Left on 05Mar2021 at 15:45 as UNKNOWN, SINGLE DOSE for COVID-19 immunisation. The patient's medical history included allergies (known allergies: Yes). The patient's received unknown concomitant medication. On 05Mar2021 at 21:00, the patient experienced headache/migraine which is typical with vaccinations like flu vaccine. Facility type vaccine reported as other. Reported that patient not received other vaccine in four weeks. Reported that other medication was taken in two weeks but not reported any medicine. No treatment received for the event. Patient had not COVID prior vaccination and not tested covid post vaccination. The outcome of reported events was not recovered.  No follow-up attempts are possible. No further information is expected.
PT RAN 101 FEVER AND LOST SIGHT IN EYES DAY AFTER VACCINE AND HAD TO LEAVE WORK--WIFE CALLED TODAY (NEXT DAY) AND COMPLAINED ABOUT PROBLEM--PT IS FEELING BETTER AND EYE SIGHT IS BETTER BUT NOT RESOLVED
Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA302580 (same reporter). This case involves a seven years old female patient who was vaccinated with a 0.25 ml dose of FLUZONE QUADRIVALENT (lot UT6262NA, expiry date: 30-Jun-2019 via intramuscular route in the right deltoid) on 25-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not It was a case of actual medication error due to vaccine underdose. It was reported that 2 sisters ages 7 and 11 received 0.25mL's each of FLUZONE QUADRIVALENT in error. The patient didn't experience any adverse events following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Friday about 10am I started with chills by the time I got home I had a temp 0f 99.0.  I had fever and chills all day Friday.  Saturday at 2:30 I was awakened with chills and a fever.  I fell back to sleep finally woke back up at 5:30am....got up out of bed at 5:40.  I was out in the kitchen at 5:45 I started to feel bad so I headed back to the bedroom to get my cell phone to call my sister to let her know that I was feeling strange but blacked out.  Not quite sure how long I was out but I hit my head, knee and shoulder.  After regaining conscious, I was able to get to my phone to call my sister for help.  Due to my fever and chills we decided to not go to the ER.  I went to my family doctor on Monday.......I have a concussion from passing out
Heart Problems.  Though I was having a heart ache.  Nothing on tests went away after 3 days.
Sore arm; Was tired that night/ I'm exhausted still; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Was tired that night/ I'm exhausted still) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   In 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. In 2022, the patient experienced PAIN IN EXTREMITY (Sore arm). 2022, the patient experienced FATIGUE (Was tired that night/ I'm exhausted still). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown and FATIGUE (Was tired that night/ I'm exhausted still) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  It was reported that the patient took Moderna and flu shot last year and was tired that night and had a sore arm, the next day. The patient was in bed since Wednesday and went to bed early on Tuesday evening. At the time of report the patient was exhausted, except when Motrin was taken.
On Wednesday afternoon, started with a dry cough, hoarseness, chills, sore throat,  no fever.  Had chills the next day but no fever. called the clinic was tested for COVID-19, results came back negative.  On Friday, had weakness and difficulty breathing.  Also had some dizziness and weakness until today which she is doing fine.
R rectus femoris with erythema and swelling at injection site of dtap given on 1-29-10.
Patient fainted about 4 minutes after receiving first Moderna vaccine. Patient admitted that he has had similiar reactions before from immunizations and blood draws. He does not think his reaction was due to the vaccine. He believes it was from fear of getting shots.
had Shingles 7 times since I got vaccine/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the patient had shingles 30 times in the last 8 years from reporting date).   In April 2021, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-MAY-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient got the shingles vaccine in April a year ago.  The patient got 7 out of 30 times shingles since he/she had been vaccinated. The patient stated that, it was horrible. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Pt developed hard lump and redness on her left leg near the area of injection that quadrupled in size throughout the day on Saturday. Taken to the Emergency Room where she was diagnosed with left leg cellulitis.
breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (breastfeeding) in a female patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding.    MEDICAL HISTORY (Patient): The patient's past medical history included No adverse event (No reported medical history.).    In December 2020, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with EXPOSURE VIA BREAST MILK (breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (breastfeeding) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  The patient's medical history and relevant concomitant medications weren't reported Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Added reporter contact information.
strokes; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is 1st of 2 reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization in a hospital.  The patient's medical history reported as none. Concomitant medications were not reported. The physician reported that there were two patients who came in with strokes with no underlying condition/health risks, but they had been recently vaccinated with the COVID vaccine on unspecified date. The event resulted in physician office visit. Outcome of the event was unknown. The event was assessed as serious (hospitalization).   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the implied time association, the possible contribution of suspect vaccine BNT162B2 to the event stroke cannot be excluded. The patient's age and detailed clinical course would be helpful for further assessment.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021163468 same reporter, product, event; different patient
CHILD'S DATE OF BIRTH WRITTEN ON CONSENT DOES NOT MATCH THE DATE OF BIRTH IN IMMTRAC #148965344. CHILD IS TOO YOUNG TO RECEIVE VACCINE.  SEE VAERS #686967 REGARDING FIRST DOSE ON 5/15/2021.
I administered the TDAP and Flu vaccine both intramuscularly in the left arm of patient 1st. He seemed fine, no reaction. Then I administered the Gardasil 9 vaccine in the right arm intramuscularly. Within seconds of the 3rd vaccine, his eyes rolled back in his head, wasn't coherent for a second or two. I called him by name and he seemed to come around just as quickly. I asked was he okay he said he felt dizzy and felt like he needed to vomit so I went and grabbed a trash can with liner for him to puke in if needed. I sat with him and i asked him how he was feeling he said he was still dizzy and nauseated. There wasn't any respiratory issues, breathing was fine, no signs of hives, redness, swelling in the face. No vomit came about at this time either. I sat with him some more and we begin to have small talk, but he was getting paler by the minute and started to complain of tingling in his right hand and fingers and severe nausea and headache. So I opted to call 911 to have them check him out and he said okay. Still no respiratory issues. I called 911, told them the situation. Fire & rescue came, provided treatment and took him on to ER here in town. I called ER to check up on him but they couldn't provide any info over the phone. About an hour later his father called and said they had released him and that he was doing better and headed home.
He got covid after the first dose.; He got covid after the first dose.; This is a spontaneous report from a contactable pharmacist reporting for a patient via Pfizer-sponsored program. A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Jan2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient got the first dose in Jan2021 and he got covid after the first dose on an unspecified date in 2021. The patient wanted to know if he could get the second shot now. The patient underwent lab tests and procedures which included covid-19 (SARS-CoV-2 test): positive on an unspecified date in 2021. The outcome of events was reported as unknown.   Information related to batch/ lot number has been requested.
Headache, Myalgia, Fever, fatigue, chills Narrative:  Other Relevant History:
I have a strange full arm rash/stripped skin discoloration on my right arm. It appeared two weeks after the shot and is still present. It does not itch and is not irritating. It looks like a series of stretch marks almost. It is slightly fading from an angry red to a lighter brown.   My body had a very bad reaction on the next day after the second shot. I anticipated that reaction, but not this skin discoloration / rash. I do not think it is going to go completely away. It is very strange.
Onset approx 2 min post vacc admin of pt stating "I don't feel right". Pt unable to describe how she feels. Denies difficulty breathing, nausea, and/or dizziness. VS BP 140/80 R 20 P 97 SpO2 99% on Rm air. Pt was observed for approx 1 1/2 hours and released. No Tx given. Pt told initial nurse she experienced numbness on Lt side after 1st dose of RABAVERT on 10/1/12 as well as some nausea lasting overnight. Pt did not report this until visit on 10/8/12. Provider talked with state health dept. & Novartis. All in agreement to cont. with pre. exp series. Provider Dx'ed 10/8/12 episode as panic attack.
I received the vaccine on Friday, 10-15-21 around 2:30 pm. I have had pain on the injection site ever since. On 10-16-21 I woke up with swelling on both the left side of my posterior cervical area and on my underarm lymph nodes. Tremendous itch and pain on the underarm area and neck. I also feel a throbbing sensation under the arm area with I have swelling.  I am unable to press my arm against my body.
Information has been received from a woman's clinic regarding GARDASIL in a pre filled syringe. It was reported that the syringe was leaking. No adverse event was reported. In follow up it was reported that the patient received the dose of GARDASIL the same day using a different syringe. The problem was identified before patient was injected so patient never received any of the faulty dose, therefore this reports being deleted from our files, and a healthcare professional did not come into direct contact with the vaccine as a result of the complication. No further information is available.
Moderna COVID-19 Vaccine EUA. Mild fever, fatigue, slight headache.  Arm sore for three days. Slight fever day three. Used OTC meds for fever and body aches.
Received a shingles booster shot this Friday into the back of the left arm.  Experienced localized swelling and redness that progressed over the last 2 days.  Redness progressing down the elbow.
Mom called at 15:30 4/6/06 reporting pt screaming and crying when touched anywhere on body. Lt left Trom hip to knee, red and hot. No fever.
Approximately an hour and a half after getting the vaccine, I noticed my hands swelling, then my jaws started aching, then they felt like they were swelling, along with my cheeks going down my neck, then I got a great deal of pressure, swelling, in my ear drums. I was speaking with a friend, who is a nurse, and she told me to take a Benedryl, so I ate a 12.5 milligrams children's chewable diphenhydramine.  Twenty minutes later I felt normal again.  Later that evening I noticed the palms of my hands were very hot.  I did not have any fever.  That passed the next evening.
A legal complaint was received from an attorney alleging that a child received series of Hib (manuf unk), DTaP (manuf unk), and hep B (manuf unk) vaccines as well as doses of Tetramune and Engerix B vaccines from April 1999 through at least October 2000 and subsequently "developed severe neurodevelopmental disorders with associated high mercury exposure levels as a result of the vaccinations he received, and has suffered serious permanent injury." It is alleged that "As a result of the mercury in the Thimerosal-containing vaccinations that Minor Child received as an infant, Minor Child now suffers, and in the future will continue to suffer, from the toxic neurological effects of mercury poisoning." According to the legal complaint, "the Minor Child has sustained mental, intellectual, developmental and neurological incapacity and associated learning disabilities, affect disorders and impairments." No further info was available at the date of this report.
CLIENT IS COMPLAINING OF MUCH PAIN RADIATING FROM THE INJECTION SITE. IT IS PERSISTING EVEN AFTER USE OF IBUPROFEN.
Moderna vaccine around 2 this afternoon Had initial reaction of flushing and tachycardia; nurse monitored her and symptoms went away about 15-20 minutes later. Around 5:15 pm this evening felt like "a flip switched" and suddenly felt flushing and itching, hives to chest, and became very lethargic.  EpiPen given at 5:50 and all symptoms resolved.
Trihib injected IM L deltoid, Upon returning to room to complete visit, noted unusual redden area at injection site, size of golf ball with small raised area. Notified doctor, who saw pt and advised to apply ice & observe pt. Epil 1.(?) mg for 1st kg ready at nurse's station. Mom informed of necessity to stay and informed of side effects. Pt returned after 1 hr and instructed to use Tylenol & Benadryl.
Patient received Pfizer Booster 3 months early. Patient was observed for 20 minutes and showed no signs of distress after time was done. Informed patient to seek care immediately if showing signs of SOB, chest pain or extreme dizziness.  Patient informed that nurse will follow up with further instructions about possible repeat dose. Patient verbalized understanding.
Starting at 11:30 pm, 9-22-2018: Fatigue, rapid heart rate, shortness of breath, tightness in chest, nausea, muscle pain where vaccines were administered, pain in both shins.
Moderna COVID?19 Vaccine EUA Timeline for medical treatment 4-13-21 first Moderna Covid Vaccine Lot number 008B21A 5-13-21 second Moderna Covid Vaccine lot number 004C21 5-19-21 Go to Hospital Urgent care. Complaining of shortness of breath and rapid, pounding heart.  Given a Covid test, and ekg and x-ray and sent home, being advised to isolate. 5-20-21 Call my primary care physician to say symptoms are worse.  Asked a series of questions over the phone and advised to go to the ER within the hour. 5-20-21  9:00am Admitted to ER at Hospital after blood oxygen levels test at 84% when walking.  Short of breath and pounding heart.  CT scan with contrast ordered by attending MD.  Found 4 pulmonary Emboli and a damaged RVT heart.  While waiting for admittance, given a shot of anti-coagulant into abdomen.  Transported to Hospital in another city admitted at 9:30pm.   2 day stay in hospital, receiving one more shot in abdomen of anti-coagulant.   5-22-21 released from Hospital.  Prescribed Eliquis for 6-8 month minimum.  Referred to Pulmonologist  and to my primary physician, and to a Hematologist-Oncologist within my insurance provider?s coverage. 5-27-21 Visit PCP Dr.  Advises to keep heartrate BPM under 100, and take it easy, hoping that in 6-8 weeks, I will begin to have more energy and stamina. 6-1-21 Visit Pulmonologist.  She reassures me that the clots will not shift, and that I don?t need to worry about that.  Oxygen level still drops to 92% when walking normally with nurse. Advises to continue with searching for cause of severe Pulmonary Emboli. 6-9-21 Visit Hematologist-Oncologist at Cancer Care Center.  After questions of family history, he orders a CT scan with contrast of Abdomen.  Blood drawn for labs included: Activated Protein C Resistance. JAK2 V617F Mutations, Reflexive. Lupus Anticoagulant Group W.Interp. PNH by Flow Cytometry. Protein C Activity. Prothrombin Mutation (G20210A). 6-19-21 Receive CT scan with contrast of Abdomen at hospital. 6-21-21 Visit Hematologist-Oncologist for consultation of test results.  All blood tests negative.  CT scan showed nothing remarkable in abdomen. It did show a clot in the right femoral vein. Upcoming appointments include follow up echocardiogram and mammogram in July, 2021.  Follow up CT scan of abdomen and ultrasound of heart in November, 2021.
Patient felt dizzy, VS taken, water given. Patient reported she didn't take her medication this morning. BP 149/83, HR 60, 100% room air.
EMPLOYEE STARTED FEELING DIZZY WHEN STANDING FROM A SITTING POSITION APPROXIMATELY 20 MINUTES AFTER RECEIVING VACCINATION. NAUSEA AND ABDOMINAL PAIN APPEARED APPROXIMATELY 45 MINUTES AFTER VACCINATION. B/P:122/80, PULSE 103. EMPLOYEE STATED HE FELT LIKE HE NEEDED TO VOMIT BUT NEVER DID. EMPLOYEE WAS THEN TAKEN TO AN URGENT CARE UPON RECOMMENDATION FROM POISON CONTROL.
injection site and lower on the left arm.  Redness, swelling, soreness,  warm to touch  started 8 days after injection.   Day 9 redness is larger.
Approximately 3 weeks post vaccine I started experiences itching scalp and random hives all over my body. The hives have continued for three weeks and appear daily throught the day. OTC antihistimines such as Zyrtech and Benedryl provide some relief but they still apear. Visited an allergiest yesterday and pending allergy testing. The physician felt strongly that this could potentially be a delayed reaction to the booster vaccine but again other labs are still pending. The allergist is Dr. in city, state.
Patient showed signs of severe hypoglycemia.  Initially he was incoherent and within minutes slipped into being unconscious.  We were able to wake him up and administer glucose tabs to him.  After one tablet, he was still incoherent but responsive.  After two tablets, he was becoming more coherent.  After the administration of a third tablet, he regained coherence.  At this time EMT's arrived.  He recorded a normal blood sugar.
4hours after vaccination  I began to experience a headache Arm hurt General body pains-loss energy Swollen Throat Sweating a lot Joints hurt Eyes hurt Nausea after during and  eating
4 days after injection developed axillary lymphadenopathy with soreness from under the arm extending to the L breast causing pain with sleeping on that side, no erythema or edema, no fever or chills, resolved after 2 days with ibuprofen, cool/ice compresses
started to complain of throat tightness, increased heart rate, mottled skin about 6 min after receiving Moderna booster.
Pain from elbow to shoulder severe enough to cause difficulty sleeping.  Following morning had erythema of upper arm from deltoid to elbow with striations.  He had polyarthritis for 48 hours.