chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Throat hurting; Headache; Little lightheaded; She knows it is not like a sore throat, she hasn't had a sore throat and she is not sick. It doesn't feel like that, it is like a weird tingly sensation.; now she is experiencing a dull ache in the same area. The dull ache started just recently maybe a week or 2 ago and is now moving down to her hand.; she had a hurt arm for a couple days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021766605 (Pfizer).  A 28 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12May2021 16:00 (Lot number: EW0185) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 21Jun2021 19:00, outcome "not recovered", described as "Throat hurting"; HEADACHE (non-serious) with onset 21Jun2021 19:00, outcome "not recovered", described as "Headache"; DIZZINESS (non-serious) with onset 21Jun2021 19:00, outcome "not recovered", described as "Little lightheaded"; PHARYNGEAL PARAESTHESIA (non-serious) with onset 21Jun2021 19:00, outcome "not recovered", described as "She knows it is not like a sore throat, she hasn't had a sore throat and she is not sick. It doesn't feel like that, it is like a weird tingly sensation."; PAIN IN EXTREMITY (non-serious) with onset May2021, outcome "recovered" (2021), described as "she had a hurt arm for a couple days"; PAIN (non-serious) with onset Jun2021, outcome "not recovered", described as "now she is experiencing a dull ache in the same area. The dull ache started just recently maybe a week or 2 ago and is now moving down to her hand.".  Additional information: The patient's concomitant products women's multivitamin. She just takes women's multivitamins daily. There were none additional vaccines administered on same date of the Pfizer suspect. She did not visit emergency room and physician visit. There were none any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). Patient's Medical History (including any illness at time of vaccination), other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. Illness/AE was none. Family Medical History Relevant to AE(s) was none.  Follow-up attempts are completed. No further information is expected
A nurse  reported that a pt received vaccine on 3/7/2000 and on 3/8/2000, the pt developed transient fever, malaise, hypotension, nausea, and arthralgia. The pt recovered.
26SEP95 t103ax MD notifief (not seen by MD);27SEP t103;28SEP 101;29SEP t100; temp x 4 days;
Patient received a 3rd dose of Moderna. Staff was not aware she has received a second dose at her previous facility so they ordered a 2nd dose at the new facility and when we entered the information into IRIS we saw it was her 3rd dose.
During administration of the vaccine, the needle separated from the hub of the syringe partially. Most of the vaccine leaked out onto patient skin. Followed up with patient and Dr.
My son had a fever saturday morning October 31st. Later that day my son had a febrile Seizure. He was rushed to the hospital.
I was having a headache and I had been made aware that I was exposed to someone who tested positive for COVID-19 so I was anticipating I may be at risk. I was then having body aches, a cough, fever and a major fatigue. I tested positive three days later on the 13th. I have not had the fatigue leave and it has been a problem. I did see my healthcare provider recently and they stated that I had fluid buildup in my sinus and was put on an antibiotic. I have also had an elevated heart rate in the mornings and had an EKG to look into this. Other than the sinus issue and the heart rate I am mostly recovered.
At 1000, RRT was called in the post-vaccine recovery area for a 65 y/o female who complained of itchy throat and swollen upper lip. 2 RNs responded with stethoscope, pulse ox, and emergency kit. Head-to-toe assessment completed. Assessment WNL. Vitals: 02: 96%, HR: 65, manual BP: 180/100. Client took Losartan 100 mg in the AM, only. Fire Chief on site, activated 911 response. Paramedics arrived and completed their work-up. Vitals stable, client AA0x4, assessment continues to WNL. Client speaking in full sentences with no labored breathing. 2 RNs determined to have client wait in recovery area for 15 more minutes. EMS did not transport client to hospital. After 15-minute period, client was stable and left AMA.
Within 1 and 1/2 hours headache, nausea, diarrhea, cold sweats.  Lasted for about another hour and 1/2.  Now feel weak.  All other symptoms are gone.
This case was reported by a healthcare professional and described the occurrence of vaginal yeast infection in an adult female subject who was vaccinated HAVRIX, (GlaxoSmithKline).  Concurrent vaccination included TYPHOID vaccine, (manufacturer unspecified) given on 12 June 2008.  On 12 June 2008 at 17:00 the subject received 1st dose of HAVRIX at 1.0 ml.  On 18 June 2008, 6 days after vaccination with HAVRIX, the subject experienced vaginal yeast infection.  A systemic reaction.  At the time of reporting the events were unresolved.  The healthcare professional considered the events were unresolved.  The healthcare professional considered the events were possibly related to vaccination with HAVRIX.
Hives: red rash over trunk, arms, legs, neck, face Felt like skin on fire, Nausea, Fever, Internally itchy. Felt like throat was closing up, Headache, Heart racing.
Approximately one hr. after receiving vaccinations c/o itching to left cheek then progressing to right cheek, chin and ankles.  Red raised "pimple-like" rash.  Progressively subsided after approx. five days.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 07-OCT-2013, the patient was inoculated with ZOSTAVAX at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 10-JUN-2014, she was treated by a physician at a clinic for the onset of a severe vesicular rash accompanied by weakened immune symptoms and eye interference, which was diagnosed as severe herpes zoster that had spread to the retina and optic nerve. Between the dates of 29-DEC-2014 and 05-JUL-2017, the patient received consistent treatment at the clinic for serious complications of zoster infections of the eye including detachment of her retina and permanent vision loss. She was prescribed VALTREX, prednisone, and gabapentin for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of permanent vision loss was considered not recovered. The outcomes of the other events were unknown at the time of reporting. Causality assessment was related. Upon internal review, zoster infections of the eye, retinal detachment and permanent vision loss were considered to be medically significant. Additional information has been requested.
Feeling worn; Felt tired; sore at the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of DEPRESSED MOOD (Feeling worn), FATIGUE (Felt tired) and VACCINATION SITE PAIN (sore at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer (treatable).   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced DEPRESSED MOOD (Feeling worn), FATIGUE (Felt tired) and VACCINATION SITE PAIN (sore at the injection site). At the time of the report, DEPRESSED MOOD (Feeling worn), FATIGUE (Felt tired) and VACCINATION SITE PAIN (sore at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Treatment information was not provided.
ACUTE PULMONARY EMBOLISM 11/17/2021 HYDRONEPHROSIS ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 11/17/2021 HYDRONEPHROSIS HYPOTENSION 9/24/2021 HYDRONEPHROSIS ACUTE RESPIRATORY FAILURE 11/17/2021 HYDRONEPHROSIS ACUTE PULMONARY EMBOLISM 11/17/2021 ADENOCARCINOMA, HEAD OF PANCREAS ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 11/17/2021 ADENOCARCINOMA, HEAD OF PANCREAS HYPOTENSION 9/24/2021 ADENOCARCINOMA, HEAD OF PANCREAS ACUTE RESPIRATORY FAILURE 11/17/2021 ADENOCARCINOMA, HEAD OF PANCREAS
Arm was sore at bedtime. By the morning, I could barely move my right fingers.  Very sore and tired the day after.  I was incredibly sore everywhere - back,chest, hips, legs, neck... very hard to move. Around 5 PM the day after the vaccination, I became violently ill.  Diarrhea, chills, feverish, sweating. etc.  This lasted until about 3 AM on the 18th.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Bad Headache"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "slightly achy"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore left arm". Additional information: Event took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Numbness and tingling in the ring finger and little finger on left hand. Treatment included OTC anti-inflammatory, and stretching to reduce common symptoms of ulnar nerve entrapment. Condition has not lessened in 28 days.
Diarrhea; Severe muscle and joint pain; Severe muscle and joint pain; Fever; Headache; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea), MYALGIA (Severe muscle and joint pain), ARTHRALGIA (Severe muscle and joint pain), PYREXIA (Fever) and HEADACHE (Headache) 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 COVID-19 (took 5 weeks to have negative covid test) and Pneumonia (2 months ago). Concurrent medical conditions included Iodine allergy, Blood pressure high and Vascular disorder NOS. Concomitant products included ATENOLOL for Blood pressure high.    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), MYALGIA (Severe muscle and joint pain), ARTHRALGIA (Severe muscle and joint pain), PYREXIA (Fever) and HEADACHE (Headache). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) on 22-Jan-2021 at a dose of UNK dosage form and PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, DIARRHOEA (Diarrhea), MYALGIA (Severe muscle and joint pain), ARTHRALGIA (Severe muscle and joint pain), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: systolic 170 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
One week following the first vaccination, Patient started experiencing swelling in her right knee which has progressed to both knees and accompanied by fatigue, stiffness, and pain. . In the several months that have followed, she has been diagnosed with Juvenile Idiopathic Arthritis. While we do have data to support the presence of this autoimmune disease prior to the vaccinations, the recent significant flair occurred right after the shots and has had significant impact. We still have not been able to control the symptoms months later.
Arm hurt; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREDNISONE (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm hurt".  Additional information: This patient had a short hospital stay, but also came on a high dose of prednisone. Patient has been  taking over a month. Patient was still on 5mg Prednisone, at which patient said her pulmonologist allowed her to get the vaccine if she was taking 5mg or less. States that none of these patients reported any side effects from the vaccine, except their arm hurt  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Our pharmacy mistakenly scheduled the patient for his second Moderna dose for 6/14/21, only three weeks after he received his first dose on 05/24/21, and he received the second dose on 6/14/21. The error was discovered on 6/16/21, and I spoke with the patient to notify him of our error. He said he has not had problems in terms of adverse effects and feels fine. I asked him to notify our pharmacy if he has any problems, and I provided him with the Agency telephone number to use if needed.
Pt. states that after receiving the 1st dose of Moderna 07/05/2021, started experiencing severe pain through the left side of the body, frequent migraines, and extreme fatigue. ER visit 07/10/2021 due to limbs feeling numb and recommendations were made to visit with Primary. Observation/Discharged.
Symptoms: diffuse dermatographic urticaria  Treatments: 40 mg PO prednisone x5 days, 62.5 mg IM solumedrol x2 doses, 50 mg PO diphenhydramine in evenings, 10 mg PO certrizine in mornings (later switched to 60 mg fexofenadine daily)
Patient was sitting up when vaccine administered and then rose a few seconds after to stand from the exam table. She got up, and then fell face forward onto the floor hitting her forehead. Patient did not lose consciousness.
PATIENT HAD RECEIVED ONE DOSE OF PFIZER ON 12/28/2020. PATIENT WAS UNAWARE OF THE NAME AND TYPE OF THE VACCINE SHE RECEIVED . ON 3/14/2021 SHE SIGNED UP FOR MODERNA 1ST DOSE. THE ERROR WAS NOTICED ON 4/11/21 WHEN SHE CAME FOR SECOND DOSE MODERNA WHILE LOGIN HER 2ND DOSE ON DELVAX. WE CONTACTED PATIENT AND SHE ADMIT THAT SHE DID RECEIVE PFIZER BUT DIDNT KNOW IT WAS COVID-19 VACCINE.
First week in November he woke up one day and had double vision. His right eye started to sag and wouldn't stay close. He went to the eye Dr.
exhaustion, pain,depression,lack of appetite, weakness, couldn't sleep;couldn't work;memory loss;sleeping 16-22hr a day x 6wk;lost over 30 pounds;couldn't work;
Really hot; Sweating like crazy; Intense nausea; Shaking (could not hold phone from shaking); Headache; Intense chills; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 19Apr2021 at 09:15 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 19Apr2021, the patient experienced intense chills, shaking (could not hold the phone from shaking), and headache. On 20Apr2021, the morning, it was really hot for the patient, sweating like crazy, and had intense nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events intense chills, shaking (could not hold phone from shaking), headache, really hot, sweating like crazy and intense nausea were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
patient came down with COVID; fever; chills; headache; myalgia; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (patient came down with COVID), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (myalgia) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014c21a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive on 27-Jan-2021.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (patient came down with COVID), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (myalgia). At the time of the report, COVID-19 (patient came down with COVID), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (myalgia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, SARS-CoV-2 test: positive (Positive) patient came down with COVID.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-226267 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up information  received on 17-Jun-2021 contains the patient details updated and  dosage 2 added in products tab.
12 x 7 cm erythematous edematous rash at site of KINRIX.
Case number PHEH2014US022554, is an initial spontaneous report from a pharmacist received on 10 Nov 2014 and with a combined follow up received from the pharmacist via quality assurance department (QA reference number: 343542) on 16 Dec 2014 and on 17 Dec 2014 respectively, with the follow-up information received from Quality Assurance Department (reference number: 343542) on 27 Feb 2015. This report refers to a 66 years old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145623, expiry date: 30 Apr 2015) intramuscularly in deltoid on 08 Nov 2014. It was reported that the prefilled syringe FLUVIRIN stopper jammed and the pharmacist was only able to administer 2/3rd of the dose to the patient. No adverse event reported. It was reported that there was no damage to package and was stored in the original box until the time of use. It was also reported that there was difficulty to push plunger. The complaint was raised for FLUVIRIN batch 145623 as the stopper jammed. No sample was available for analysis. No root cause was identified during the BD investigation. The most probable root cause is that the needle, not provided by Novartis, was plugged, although no sample available for analysis it is difficult to determine the exact nature of the defect. The root cause has therefore been determined as supplier/material defective due to a blocked needle. Combined follow up received from the pharmacist via quality assurance department (QA reference number: 343542) on 16 Dec 2014 and on 17 Dec 2014 respectively: Updated expired date of vaccine, site of vaccination and reporter comment in narrative. Follow-up information received from the Quality Assurance Department (reference number: 343542) on 27 Feb 2015: Updated FLUVIRIN vaccine batch review report.
Pt had #2 Moderna Vaccine 5/7/2021 which was very painful." Friday night c/o head- ache & today red, raised hot area to the side of injection site. (size of coffee lid)
They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    Patient age was between 6 months to 5-years. Concomitant medication was not reported.  The vaccination clinic received incorrect guidance from the Department of Health in regards to the vaccination, who instructed to order and administer the vials with pink top to 6month-5year previously unvaccinated patients when the switch from monovalent to bivalent happened. This resulted in 24 patients being under vaccinated.  It was reported that 24 pediatric patients were administered underdose bivalent vaccine doses for either their first or second doses. They received 0.2 ml dose from the pink vial instead of the 0.25 ml dose from the blue cap vial. The patients were being contacted and revaccinated with the correct dose. Treatment information was not provided.  This case contains information for the 7th of 24 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
A 14 year old received a BOOSTER Pfizer dose- they were not eligible for a 3rd dose due to age( the second dose was greater than 6 months ago) and both doses were well tolerated, no adverse reactions