chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Acute onset abdominal bloating and cramps, rapidly worsening. Inability to eat or drink for 6 days. Malaise, weakness.  Attempted visit to urgent care center, was turned away,   EMT came to the house to put in IV access, got several liters of saline. Had labs drawn at home. ABDOMINAL XR  done. After 6 days abdominal distension and cramps started getting better. Started drinking. Careful solid foods after 7 days Noticed for about 10 days after recovery that I was free of chronic pain from tendinitis (probably due to overwhelming immune response -  HAD EXTREMELY HIGH ANTIBODY TITERS AT THE TIME OF VACCINE WHICH WAS DISREGARDED BY MY EMPLOYER , QUOTING "MANDATE" TO VACCINATE)
Patient given Rotarix on 5-18-11, 2nd dose, at 9 months of age.
Irritable bowel syndrome; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome) and COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis (Moderate to severe ulcerative colitis).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK (Citrate Free). On an unknown date, the patient experienced IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome) and COVID-19 (COVID-19). At the time of the report, IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome) was resolving and COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was provided by reporter.  It was unknown if patient was enrolled in COVID-19 vaccine trial. The formulation for Humira was reported as Solution for injection in pre filled pen.  No treatment medication was provided by reporter.  Company comment: This is a spontaneous case concerning a male adult patient with no reported medical history and with co-suspect medication of Adalimumab (Humira) for moderate to severe ulcerative colitis, who experienced the unexpected non-serious  event of Covid-19 and the unexpected non-serious event of irritable bowel syndrome. The events occurrence was unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. No other information surrounding the events was reported. The outcome of the event Covid-19 was reported as resolved while the event irritable bowel syndrome the outcome was reported as resolving. The current Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2022: Live follow up received wherein outcome of event COVID-19 updated, the event verbatim COVID exposed might be covid positive was updated to Covid-19 and narrative updated. Sender's Comments: This is a spontaneous case concerning a male adult patient with no reported medical history and with co-suspect medication of Adalimumab (Humira) for moderate to severe ulcerative colitis, who experienced the unexpected non-serious  event of Covid-19 and the unexpected non-serious event of irritable bowel syndrome. The events occurrence was unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. No other information surrounding the events was reported. The outcome of the event Covid-19 was reported as resolved while the event irritable bowel syndrome the outcome was reported as resolving. The current Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Dizzy, unsteady gait. BP 149/94 (pulse 81), O2 sat 98%. Final BP 145/97 (pulse 75), O2 sat 97%. Crackers, juice given. Patient admitted to taking Norco 150 mg, Ativan, and Marijuana before arriving at stadium.
Hives, itching for 2 weeks. Treated with Benadryl, steroids, Zyrtec, Axid and epi shots; 2 days. Our family physician and her dermatologist felt like it was probably not the vaccine, but the Dynacin that she was taking that caused this reaction. However, we were advised to put in this report in the event they are mistaken and she reacts to her 3rd dose the same way.
Information has been received from a physician concerning a female who on approximately 21-FEB-2008, "about three weeks ago" was vaccinated with an unspecified dose of GARDASIL (lot number unspecified).  The patient fainted.  The patient came to and was fine.  The lot number was unknown.  The patient recovered.  No further information was provided.  Additional information has been requested.
Cough, runny nose, fever 103, multiple discrete diffuse papular rash head to toe. No seizure. The rash remains 02/19/2003
FATHER STATES THAT BABY HAS BEEN VOMITING "A LOT" AFTER EACH FEEDING,  MAYBE ALL OF FEEDING (BOTTLE FED).  NO CRYING, STILL HAS WET DIAPERS, STOOLS SOFT, NO TEMPERATURE.
Pt had 2 previous pregnancies that were terminated because of embryonal inviability secondary to ectopic implantation; 1 was extrauterine, the other was cornual. Pt, on 5/10/99 & 6/4/99 had 1st & 2nd dose of Lymerix, respectively, for
Pt was noted to be scratching in the evening. Inspection of person revealed blotches of different sizes over torso and arms (generalized). MD contacted by caregivers and told to give her Benadryl. Pt eased. No other symptoms presented over 3 days, post vax.
Nasal smell bad like spicy and not pleasant. Smell issue usually night and continuous during day. Need to get fresh air open windows. Take DoTerra breathe Respiratory Drops to get relief from the smell. Thought it would go away.
Myalgia, Arthralgia, Fever, anxiety was seen by outside provider for c/o anxiety - received Zofran 4mg
Vial was stored in the fridge since 23JAN2023 and administered on 15MAR2023; No adverse event; 1 dose of Moderna COVID-19 Vaccine Bivalent was administered BUD on 15MAR2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna COVID-19 Vaccine Bivalent was administered BUD on 15MAR2023.), PRODUCT STORAGE ERROR (Vial was stored in the fridge since 23JAN2023 and administered on 15MAR2023) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H22A) for COVID-19 prophylaxis.     no known allergy or relevant medical historical conditions, concomitant diseases and risk factor.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1) on 23-Dec-2020 and PFIZER BIONTECH COVID-19 VACCINE (Dose 2) on 08-Jan-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 15-Mar-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 15-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna COVID-19 Vaccine Bivalent was administered BUD on 15MAR2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in the fridge since 23JAN2023 and administered on 15MAR2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna COVID-19 Vaccine Bivalent was administered BUD on 15MAR2023.), PRODUCT STORAGE ERROR (Vial was stored in the fridge since 23JAN2023 and administered on 15MAR2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna COVID-19 Vaccine Bivalent was administered BUD on 15MAR2023.) and PRODUCT STORAGE ERROR (Vial was stored in the fridge since 23JAN2023 and administered on 15MAR2023).    The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Dosage text of suspect Spikevax Bivalent was reported as Initial booster.  No concomitant medications was reported.  Vial was stored in the fridge since 23-Jan-2023. No AEs were reported.  No treatment medications was reported.
Onset of right arm soreness, 4 hours, post vax of pneumococcal vaccine. Progressed to right arm, swelling and malaise, chills and feverish. Saw own MD, 2 days, post vax, and treated with amoxicillin. Fully recovered by 10/25/00.
I developed Bell's Pallsy on the left side of my face 11 days after my first vaccine shot. I was diagnosed and given medications for the Bell's pallsy at Hospital, on March 4, 2021.  I have had no history of Bell's Pallsy, nor has anyone in my family that I am aware of.  I don't know whether the vaccination may have been a causal event or not but Dr. who is on our town Board of Health said that I should report this  event via the VAERS.
pt recv vax 29SEP98 & 29SEP98 pt devel petechial rash that was nonpruritic & not painful;also had bruised on arms & legs which did not heal;dx thrombocytopenia;tx med;platelet count 18,000;bone marrow aspiration r/o leukemia but poss ITP
Spoke to Pt who Pt who states unusual diarrhea, headaches, leg pain, and abdominal pain since obtaining Pfizer Covid Vacc on 4/8/2021. Pt reports onset of symptoms as of 4/8/21. Pt states headache is different than her normal headaches. Pt states headaches are located in the front of her head. Pt also states diarrhea is only right after eating. Pt reports bilateral leg pain which responds to Tylenol but both leg pain and headache return after dose has worn off. Pt reports she noticed one leg more swollen and tender than the other. Pt denies SOB, CP, or hemiparesis.
On Monday I started having runny nose and a cough not really tired just restless. I also had sore muscles and I tested the next day in which I was positive for COVID-19. I started having a headache Aleve and it did eliminate the pain. I called the doctor, and they did prescribe Paxlovid, and I haven't taken because everything is kind of going away on their own. Its really strange how I got it I have been wiping everything down and staying away from people.
A report from a physician concerns a 13 year old male. Generally the patient was healthy and not taking any special medications. During 2009 the patient received an inactivated vaccine and a month later was hospitalized due to pancreatitis. On 23-Nov-2011 the patient was vaccinated with FLUMIST (intranasal). One month later he was hospitalized again due to pancreatitis. At the time of reporting, the patient was improving from pancreatitis. The reporter assessed the event as serious due to hospitalization. Corrected Report on 14-Aug-2014: Initial unit changed to MedImmune case and drug type corrected to vaccine, form completed date and administered by added, vaccine related fields completed for FLUMIST, concomitant vaccine and relevant history added, narrative amended.
Back of clients left upper arm was red & swollen 70mm width x 60 mm length. It was warm to touch, and hurt her. T/C was made to her Dr., but she had never been there to establish Dr - they told her to go to ER. This office gave her ice & told her to take BENADRYL (per someone before this nurse saw her) 12/15/11.
Narrative: The patient received two doses of Moderna COVID 19 vaccine. The patient tested positive for COVID 19 on 31 Dec 21. The patient was admitted with DKA, covid pneumonia, tachycardia, sepsis on 31 Dec 21. The patient was treated with remdesivir, oxygen, and dexamethasone. The patient was discharged on 6 Jan 22 on oxygen.
Site erythema, swelling, firm, increasing in size.  Went to Emergency Room 10/5/08.  *Obese girl.
titers drawn on an unknown date indicated insufficient antibodies; This spontaneous report was received from a female patient of unknown age, who is also a physical therapist and was reporting on herself. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions or allergies or medical history provided.   On an unknown date the patient was vaccinated with hepatitis b vaccine (manufacturer unknown) 10mcg/1.0 ml, intramuscularly (dose, frequency, lot #, expiration date and thimerosal status were not reported) for prophylaxis. It is unknown if the patient received one or more doses of the vaccine. On an unknown date, titers drawn indicated insufficient antibodies. On an unknown date, the patient received an additional dose of hepatitis b vaccine (manufacturer unknown) to boost her immunity. Current antibody levels were not known.  The causality assessment of the event was not provided.
Vaccine administered during the day, by evening (before bed) felt sick to his stomach, had a fever of 101.2 during the night, felt better by afternoon of the following day, tx with Tylenol.
Patient arrived at clinic and evaluted by doctor. Mom states on 08/27/2005 received varicella Imm at local health dept. and woke up in the moring with rash over body. Dx. from doctor Varicella induced rash- treated with Benadryl and Cool aveeno bath.
Pt received Varivax immunization on 4/3/03 and was diagnosed with Varicella on 10/9/03.
anaphylactic reaction/she had symptoms of lightheadedness and sensation of throat closure; lightheadedness; throat closure; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic reaction/she had symptoms of lightheadedness and sensation of throat closure) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unk and unk) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Latex allergy. Concurrent medical conditions included Environmental allergy (dust mites).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reaction/she had symptoms of lightheadedness and sensation of throat closure) (seriousness criterion medically significant), DIZZINESS (lightheadedness) and THROAT TIGHTNESS (throat closure). At the time of the report, ANAPHYLACTIC REACTION (anaphylactic reaction/she had symptoms of lightheadedness and sensation of throat closure), DIZZINESS (lightheadedness) and THROAT TIGHTNESS (throat closure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Tryptase: elevated (High) Elevation persisted 3 weeks.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Before her 2nd dose, she pre-treated with Motrin and Claritin.  Concomitant product use was not provided by the reporter. Treatment for the event anaphylactic reaction included EpiPen and intravenous Benadryl.  Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-073832 (Patient Link).; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
to improper preparation and administration of PENTACEL with no adverse event; Initial information was received on 28-Aug-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves 2 months old male patient who reported that improper preparation and administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Aug-2023, the patient received a unknown dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine (Suspension for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for Immunization and mproper preparation and administration of pentacel with no adverse event (product preparation error) (latency : same day) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine. The information on batch number was requested.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event to improper preparation and administration of pentacel with no adverse event.  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 the 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.
24 hours after the shot: chills, low fever, muscle aches for about 12-14 hours 48 hours after the shot:  heavy fatigue for about 8 hours 1 week after the shot: blotchy red area on skin around injection site, slightly itchy.  Lasted a few days.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 30-MAR-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-APR-2016, the patient was treated by a physician for a blistering vesicular outbreak which was then diagnosed as herpes zoster, or shingles. The patient was prescribed valacyclovir 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 the events is unknown. Additional information has been requested.
Headache; Nauseated; Swollen arm of the injection; Red arm in same arm of the injection; Redness; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), SWELLING (Swelling), PERIPHERAL SWELLING (Swollen arm of the injection), ERYTHEMA (Red arm in same arm of the injection) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN, LORATADINE, LEVOTHYROXINE, AMLODIPINE, SERTRALINE, GLIPIZIDE, CALCIUM and VITAMIN D3 for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced ERYTHEMA (Redness), SWELLING (Swelling) and ERYTHEMA (Red arm in same arm of the injection). On 09-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm of the injection). On 11-Apr-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Nauseated). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 08-Apr-2021, ERYTHEMA (Redness), SWELLING (Swelling) and ERYTHEMA (Red arm in same arm of the injection) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen arm of the injection), HEADACHE (Headache) and NAUSEA (Nauseated) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included centrum. Treatment details included paracetamol and ice usage.
tested positive for COVID-19/got COVID; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 31Mar2021 (Batch/Lot Number: EW0150) as 1st dose, single (at the age of 39-year-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received Pfizer-BioNTech COVID-19 Vaccine first dose on 31Mar2021, she was scheduled for second dose on 30Apr2021, however she wanted to know if she is okay to receive her second dose on 30Apr2021because on 08Apr2021 she tested positive for COVID-19, she got COVID and then tested negative for COVID-19 on 18Apr2021. The patient underwent lab tests and procedures which included Covid-19 Test: positive on 08Apr2021, Covid-19 Test: negative on 18Apr2021. The outcome of event was recovered on 18Apr2021.
mom states pt w/high fever not taken-very irritable & crying & describes sz last 1-2mins;seen by pvt MD
Fever of 102.4, later followed by rash that has gotten worse over last 2 months.
Patient experienced hives on her face and back. She is in the process of being treated for idiopathic hives, but had not had a significant outbreak in over a month. She described this particular events as pretty severe. The hives did not start to become a problem until the following night.  The hives resolved after 4 days. Patient was advised by her doctor to refrain from receiving the second dose.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent conditions, medial history and concomitant medications were not reported. On 16-NOV-2015, the patient was vaccinated with improperly stored VARIVAX dose 1, from lot # L015045 (dose and expiry date unknown).  No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Fever ranging from 102-99 from 3/26 until 4/1  Body pain 3/26 until 3/31 Migraine style headaches  3/26 until 3/31 Red and rash in the injection site 3/29-4/5 Swelling in arm and neck