chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Expired product administered (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired product administered (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 07-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired product administered (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired product administered (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired product administered (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine).    Concomitant product use was not provided by the reporter.  Suspect vaccine was Bivalent BA.4-5 Blue Cap. It was reported that suspect vaccine might administer on another date in Jun-2023. Vial size was 2.5 ml. Vial was initially stored in the refrigerator on 07-Jul-2023 which was less then 30 days of administration of vaccine. Vial did not undergo any temperature excursions. Expiry date was reported as 01-Jun-2023. Dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 2nd out of 5 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-732775 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732775:Master case
I had a sore throat, nasal congestion, chills and a mild fever. I went to urgent care and she gave me medication for it. She gave me Claritin tablets for nasal congestion and medicine for cough and sore throat.  She gave me a medical excuse to be away from work for 5 days. I am doing okay now.
Developed itching rash behind knees and on top of thighs about two weeks after first injection.  Rash waxed and waned for about three weeks before subsiding.
Information has been received from an unknown receptionist at a physician's office concerning a 6 year old patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed a mild case of varicella. Unspecified medical attention was sought. No additional information is available . No product quality complaint was involved. It was also reported that a 4.5 year old female was vaccinated with a dose of varicella virus vaccine live and developed a full blown case of chicken pox. Additional information has been requested.
Patient stated that next morning 2/11 she woke up with fatigue, chills, swollen under Left  arm (lymph node area on same side shot was given), also complained of headaches. chills went away on 2/13. On 2/14 felt weakness with SOB with walking. she saw Dr. on 2/12, her Blood pressure was elevated and they did EKG. she left crying office and went home. Dr. told her to fill out a Vaers form for the vaccine but she has no access to internet at home. So she came in to health department to report. She also developed a couple itchy bumps on bilateral ribs.
Information has been received from a physician concerning a male patient who on 19-APR02007 was vaccinated with a dose of Proquad (Lot # 656312/0297U). It was reported that the patient developed redness, swelling, tenderness and induration at injection site on an unspecified date after vaccination approximately April 2007. Additional information has been requested. This is one of several reports received from the same source.
Information has been received from a nurse concerning a 4 year old male with no drug allergies and no pertinent medical history who on 04-MAY-2009 during kindergarten physical was vaccinated subcutaneously into left thigh with a 0.5mL dose of VARIVAX (Merck) (LOT# 662188/1401X). Concomitant therapy included montelukast sodium(MSD) and PULMICORT. After vaccination, the patient experienced a local reaction. On 06-MAY-2009 the patient experienced a red lesion 1cm x 2cm on his left thigh. No lab diagnostics were performed. The patient was seen in the office. On 07-MAY-2009, the patient's mother called to report that the patient was doing better. Follow-up information has been received from the nurse concerning the 4 year old male who on 04-MAY-2009 at 10:00 AM was vaccinated subcutaneously into left thigh with the second 0.5mL dose of VARIVAX (Merck) (LOT# 662188/1401X). On 06-MAY-2009 the patient experienced local reaction--a 1cm x 2cm red lesion on his left thigh. He had recovered on 07-MAY-2009. No further information is available.
9 AM Flu Vaccine administered. 1015 AM In class at school - felt confused + jittery. Was in Math Class + couldn't answer question as he Normally would. Went to Nurses STation. BP slightly Elevated. Mom Took Home after 2 hrs. Felt Normal.
who received two cortisone shots in the knee yesterday.; severe allergic reaction; This is a spontaneous report from a contactable consumer (Daughter) via Pfizer sponsored program. A female patient (mother) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 01Apr2021 as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported.  Reporter called in for her mother received two cortisone shots in the knee yesterday. She wants to know if her mother can go ahead and take the second dose of the Pfizer BioNTech COVID-19 vaccine due today 20Apr2021. The first dose was given 01Apr2021. She asked if the vaccine could still be administered as planned. She then said she wanted to verify with Pfizer because her mother's orthopedic doctor stated the vaccine may be less effective. As per response, it was reported that she should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of this vaccine from CONS-who should not get the vaccine. It was reported that individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. The outcome of the evets was reported as an unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
She began to develop a rash. It started on both arm with minimal hives, then, it was localized on the area around her knees seemed to have been going to the joints, then I wen to her hip area and worsened and then it went throughout her legs and was; This spontaneous case was reported by a consumer and describes the occurrence of RASH (She began to develop a rash. It started on both arm with minimal hives, then, it was localized on the area around her knees seemed to have been going to the joints, then I wen to her hip area and worsened and then it went throughout her legs and was) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 1998, Allergy to molds, Dust allergy, Adhesive tape allergy (Allergy to K-tape adhesive) and Latex allergy. Concomitant products included TAMOXIFEN from 15-Feb-2016 to 11-Mar-2021 for Breast cancer, UBIDECARENONE (COQ10 [UBIDECARENONE]) and RESVERATROL for Cardiovascular disorder NOS, OLMESARTAN and HCTZ for Hypertension, CALCIUM CITRATE;MAGNESIUM;VITAMIN D NOS for an unknown indication.   On 19-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (She began to develop a rash. It started on both arm with minimal hives, then, it was localized on the area around her knees seemed to have been going to the joints, then I wen to her hip area and worsened and then it went throughout her legs and was). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Rash, at a dose of 1 and 4 per day. At the time of the report, RASH (She began to develop a rash. It started on both arm with minimal hives, then, it was localized on the area around her knees seemed to have been going to the joints, then I wen to her hip area and worsened and then it went throughout her legs and was) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Although patient was on Allegra the rash continued to advance for another 4 weeks despite of increase in  dose of Allegra.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow-up a received on 16-JUL-2021 and contains significant information updated physician contact details,patient demographics, past  medical history, concomitant and treatment medications and updated event outcome.
Hot and cold sweats, Terrible headaches, Itchiness and nausea, Fatigue
L arm severe pain at time of vaccination, worsened over the next couple days. Continues and plans to see orthopaedist.
TOO SICK; NOT FEELING WELL; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (TOO SICK) and MALAISE (NOT FEELING WELL) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.  No Medical History information was reported.   On 13-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 14-Apr-2022, the patient experienced MALAISE (NOT FEELING WELL). On an unknown date, the patient experienced ILLNESS (TOO SICK). At the time of the report, ILLNESS (TOO SICK) and MALAISE (NOT FEELING WELL) outcome was unknown.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  It was unknown patient enrolled in COVID-19 vaccine trial.
Very high fever. 104.5. Cool cloth on forehead, cold water to drink, Tylenol given. Called doctor's office, advised to not seek emergency treatment.
pain and swelling at the injection site the for a couple days post injection started on day of initial injection; tender lymph nodes in my left armpit starting on day 5 after the initial injection; itching and slight rash surrounding the injection site starting on day 7 after the initial injection; pain and swelling at the injection site has subsided; still have tender lymph nodes and itchy rash on day 7 post the initial injection
Chills, fatigue, body aches, high grade fever (103.7), swollen lymph node in left armpit (3 inches in length), night sweats, lower back pain, headache.
Pt recv vax on 11/5/97; on 8/18/98 pt exp herpes zoster rash.
Patient is a 76 y.o. female patient of MD with a PMHx of PE on warfarin, HTN, HLD, T2DM, CAD, MDD presenting with URTI sxs.   Acute hypoxic respiratory failure d/t COVID-19 infection P/w cough, congestion, nausea, diarrhea, HA x5d. Vaccinated x2. Husband/son +COVID Afebrile on arrival, HDS. Dropped to 88% on RA, now on 2L NC (no home O2) Initial CBC with mild leukopenia (WBC 4.08). Trop 7. D-dimer neg. +COVID-19 CXR (my read): No vascular congestion or consolidation Cont supplemental O2 to maintain goal SpO2 > 88-90% Decadron 6mg PO daily for 10 days. Hold off on Remdesivir Obtain baseline inflammatory markers Albuterol, robitussin-DM, tylenol PRN. Scheduled Mucinex Encourage IS/PEP Contact precautions PT/OT/SW Daily labs   T2DM, fair control Last A1c 7.6% in 4/2023, will repeat Home regimen: Basaglar 46 units qHS, Glyburide Start Lantus 40u qHS, accuchecks w qAC/HS SSI Hypoglycemic protocol. Hold home oral meds Consider diabetic educator consult   Hypokalemia K+ 3.4 40 mEq of KCl  Additional repletion for goal K > 4, Mg > 2 Daily RFPs to monitor   PE on Warfarin INR 1.5 on admission Consult pharmacy for dosing   Stable chronic comorbid conditions  ? HTN ? HLD ? MDD  After 1 day the pateitn was mainting sats on RA and was discharged to home
2 d after immunizations pt developed > 10cm allergic rash on R ant thigh, a temp of 105 and subsequent seizures, both at the hospital. Records not yet dictated at this report completed.
About 12 hours after my 2nd shot, I experienced fatigue, slight fever, chills, and a burning of the epithelial lining of my trachea and bronchial tubes, which lasted for another 12 hours. I felt great on day 3 and 4. In the evening on the 5th day, I experienced chest pain and heaviness, which caused me to become anxious and panicked. I settled down that evening, but the chest pain and heaviness lasted for another 10 days until subsiding.  I felt as if there were fluid around my heart, and when I laid down the pain would move, as well as the feeling of fluid. In the middle of this, about 5 days into the symptoms of chest pain and heaviness, I went to the ER to receive scans of my chest.
About 30 hrs after my first shot I experienced severe and debilitating vertigo and anxiety started. I thought it was related to how terrible my vertigo was but my anxiety continued to increase over the next 4 days, while my vertigo decreased, to the point of an urgent care and ER visit. During this time I began having panic attacks, for what felt like no reason. I?ve never had these before. The urgent care doctors and ER doctor said it was just anxiety and would go away. I was prescribed lorazepam and took that for a week while trying to regain normalcy. I then got my period again, even though I had just had it right before being vaccinated. The panic attacks began again and I became complete debilitated for 9 months. Have 1 week in the middle of my cycle where I was somewhat functional, but the week before, during my period, and after, I experienced severe anxiety, dread, fear, panic. I wanted to die. Ive tried so many antidepressants, gone to so many doctors trying to figure out what?s wrong, had a brain MRI, a vagina and thyroid ultrasound. Along the way I discovered I have Hashimoto?s but finding my right thyroid hormone dosage did not change my mental health, only fatigue. We also discovered extremely low estrogen and I was put on hormone replacement therapy but that caused back to back periods, and therefor never ending panic attacks, so I stopped it. I am finally on a high dose of 2 antidepressants and I am functional again but not back to my normal self. I still feel on edge and nauseous every day and my anxiety still gets more severe during my period. I was a high functioning worry wort before this but never experienced anything like this. My friends and family would?ve described me as stead and calm. I never got the second dose. I am traumatized and in therapy for a what has happened to me this last year.
Information has been received from a physician via field representative referring to a 72 year old male patient. There was no pertinent medical history. On an unknown date ("several years ago"), the patient was vaccinated with ZOSTAVAX (dose, route, frequency and lot number not provided). There were no concomitant medications reported. On 04-OCT-2015, the patient developed shingles after receiving ZOSTAVAX. He visited the physician's office and was treated with acyclovir. No lab diagnostics studies were performed. The outcome of  the event was unknown. Additional information has been requested.
redness and itchy, in a circle at the injection site 7-8 days after first injection ("Covid-arm")
Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 08-AUG-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) VARIVAX (lot # N029634, expiration date 23-OCT-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# R002715, expiration date 20-FEB-2020). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
redness @ joint areas-especially when exposed to heat of sunlight dx w/dermato myositis;
mom phoned @ 3PM to say pt was laying in floor & body was jerking, potted color; no change in eyes; told to come back to ofc; mom arrived back @ ofc 315PM; blue tinge lips; nails beds blue & skin mottled; MD notified immed; MD examined t103
The pt experienced pruritis, allergic dermatitis at the site of injection (left deltoid) with redness and itching.
pt fainted on way home immediate nausea & then vomited;lethargic 7 sleepy for several hr;did go to basketball practice 8PM ok by 10PM;no problems 4NOV97 or 5NOV97;
I started feeling ill on Monday 12/19 and on 12/20 did a home COVID-19 test which was positive. Symptoms were cough and congestion but no fever, lack of energy body aches and within 5-6 days I started to recover. I did contact my doctor which prescribed PAXLOVID on the 12/23. The cough did linger for a month and a half.
Multiple lesions/rashes throughout the upper arms bilaterally, the back, the neck, the trunk, and bilateral hip trexor areas. The genitalia and lower extremities, plus face and forearms diagonally  had no reaction or rashes.
Developed high level fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Developed high level fever) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Developed high level fever). At the time of the report, PYREXIA (Developed high level fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Constant twitching and pulsing in lower legs and spontaneously throughout the body. Has not stopped since receiving the vaccine.
Started with hoarseness, throat itchy, progressed to labored breathing, shaky. Sought medical attention approx 4-5 hrs after vaccination. Treated at ER with prednisone, Benadryl.
Chest pain began 1 day post vaccine.  ECG with subtle ST elevation.  hs-Troponin 840 and trending down on presentation 12/7.   EF normal. By criteria, probable myocarditis; low risk
ErythemaMultiform, UrticariaPruritus,  1/6 warm to touch injection arm 1/7 mild arm pain, erythema, warm to touch  under injection site 1/10 itchiness 1/11 erythema improving, itchiness.  Narrative:  1/6 warm arm, 1/7 mild arm pain, erythema, warm to touch under  injection site. Each day getting worse 1/10 getting better, but itching. 1/11 itching,  erythema improved getting smaller. Instructed to take claritin, hydrocortisone  applied reports no relief. Will continue to monitor.
Moderna vaccine was placed in the refrigerator on 24APR2022 and had a 30 day beyond use date of 23APR2022/Focusing on the Use by date administered vaccine past the Manufacturers expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was placed in the refrigerator on 24APR2022 and had a 30 day beyond use date of 23APR2022/Focusing on the Use by date administered vaccine past the Manufacturers expiration date) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was placed in the refrigerator on 24APR2022 and had a 30 day beyond use date of 23APR2022/Focusing on the Use by date administered vaccine past the Manufacturers expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was placed in the refrigerator on 24APR2022 and had a 30 day beyond use date of 23APR2022/Focusing on the Use by date administered vaccine past the Manufacturers expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that lot number 068H21A which expired on 02-APR-2022 was placed in the refrigerator on 24-Mar-2022 and had a 30 day beyond use date of 23-Apr-2022. Focusing on the Use by date the vaccine was administered past the Manufacturers expiration date to the patient.  The patient received the booster dose.  It was also reported that the vial had not undergone any temperature excursions.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2022: Significant Live follow-up was received with patient information and suspect drug information.