chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt vaccinated, taken to high obs due to anxiety, RN assessed, VS wnl, left observation in no distress. as per pt was in parking lot, was driving, felt "heavy and dizzy" he notified operations staff and 10:45am sent two RN out to assess. BP elevated 140/101, 98% o2 sat, Hr 86, R 20, no sob, denies chest pain, facial symmetry present. EMS arrived 10:50am, BP improved 128/90, pt refused hospital evaluation, family arrived. Pt instructed not to drive, and to call 911 should symptoms worsen or recur. Left site driven by family member. Medical director made aware.
Severe pain in right leg, hip, foot. Rash - burning - like pins sticking me - now itching - still nerves hurt. Still on pain med.
My ankles were bright red, extremely itchy, and swollen with a eczema like rash formed around them.; My ankles were bright red, extremely itchy, and swollen with a eczema like rash formed around them.; My ankles were bright red, extremely itchy, and swollen with a eczema like rash formed around them.; My ankles were bright red, extremely itchy, and swollen with a eczema like rash formed around them.; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL1283), at age 45 years, intramuscular on the right arm, on 29Jan2021 09:00 at single dose, for COVID-19 immunisation. Medical history included allergy to red wasp bee stings. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient's concomitant medications were not reported. On 30Jan2021 01:00, patient's ankles were bright red, extremely itchy, and swollen with a eczema like rash formed around them. Patient soaked her ankles and took some diphenhydramine (BENADRYL) and ibuprofen (MOTRIN). She also applied triamcinolone acetonide cream usp. and oatmeal (EUCERIN ECZEMA RELIEF BODY CREAM). She mentioned that it is not resolved by Tuesday, she will visit urgent care. Facility where the most recent COVID-19 vaccine was administered was at a hospital. Since the vaccination, the patient has not been tested for COVID-19. The adverse event resulted in emergency room/department or urgent care. The outcome of the events was not recovered. Case was reported as non-serious.
Info has been received from a CMA concerning a 13 month old male with no medical history or allergies who on 9/16/05 was vaccinated, SC in the left arm, with the 1st 0.5mL dose of varicella virus vaccine live (lot 650230/1113P). Concomitant vaccinations on that same day, included the 1st, SC dose in the left arm of MMRII (lot 647562/0573R) and the 4th, IM dose in the left thigh, of Prevnar (lot A74406B(. There was no other concomitant therapy. The CMA reported that on 10/14/05, the pt developed chickenpox characterized by 12 lesions. It was noted that there was no known exposure to wild-type varicella. On 10/17/05, the pt was seen in the physician's office. No treatment or lab/diagnostic tests were required. At that time, the pt was also noted to have a secondary case of impetigo which was treated with Bactroban ointment and cephalexin. In 2005, the pt subsequently recovered from the chickenpox and impetigo. Additional info is not expected.
Extreme bouts of  nausea first few days after vaccine.  Estimated that patient died at home within 3-4 days after receiving the vaccine.   Last phone call to daughter expressed extreme nausea and seemed to have altered mental status.  Found dead  by daughter on 01/04/2021.
After the first vaccine it seem like things were ok. The worst thing I had was not being able to breathe. I also had fatigue, headaches, and weakness. It progressed. I started using my inhaler more and then it was kind of fine. Then my inhaler did not work. It became painful to breathe. My chest would hurt like there was not enough room in my lungs. I went to urgent care on 09/28/2021. They thought it was my heart so they did an x-ray and they referred me to a pulmonologist. They ruled out pneumonia with the x-ray. I missed a week of work.  I continued to not be able to breathe, in fact I am still having trouble to breathe right now. After the second shot I had a more severe headache and vomiting but I did not go to the doctor. I also had trouble visually and trouble concentrating and I was losing my train of thought. I had a foggy brain. I was very fatigued. I would sleep more than I would normally sleep. More than 8 hours.
EMS transported pt to hospital with c/o SOB; O2 sats in 50s on RA; placed on NRB and O2 sats were in the 70s; pt intubated; positive for COVID; treated with remdesivir, decadron, lovenox; per death certificate pt died in the hospital
The adverse event was to the HPV vaccine, which was the second dose in a series started when I was much younger and administered in my left arm. The day after the injection site was red, slightly swollen and painful to the touch.  Some time after, some type of slightly raised painful bump formed in the injection site.
an expired dose of IPOL was administered to one patient today with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (Reference number- 00798411) and transmitted to Sanofi on 05-Oct-2021.  This case involves a 16-year-old male patient who vaccinated with fourth 0.5 mL (once) dose of expired IPV (VERO) [IPOL] (lot R1F973M, expiry date 03-Oct-2021) via intramuscular route in the right deltoid on 05-Oct-2021 for prophylactic vaccination (expired product administered).  Medical history, medical treatment, past vaccination and family history were not provided.  Concomitant medications included HPV VACCINE and MENINGOCOCCAL VACCINE for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  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 guidelines. 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.
large area of induration/redness of rt deltoid p/DT vax given; 15cm in diameter
Loosing hair; This is a spontaneous report from a contactable consumer or other non hcp.   A 12-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: ER8735; Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 17May2021 (at the age of 12-years-old) as DOSE 1, SINGLE, and second dose via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot number and Expiration date was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. The patient experienced loosing hair on an unspecified date. Reporter was calling because her son got the vaccine the first dose on 17May2021(confirmed) had been noticing that he was losing hair, and didn't know if this might a be side effect of the vaccine, planning to take him to the doctor and calling on Monday to schedule an appointment but just wanted to ask if it could be a side effect of the vaccine. The suspect product was confirmed as Pfizer COVID-19 Vaccine. Reporter stated, thought the patient height was about 4 feet 9 inches. Reporter didn't know an exact date of event because reporter just noticed after patient took (incomplete sentence), not the exact date but reported as about a week. On the week of this report, reporter noticed after the shower and saw a lot of hair on the mat. For facility name, reporter stated, could not find the card right now but it was a hospital in. Anatomical site where COVID-19 vaccine was administered reported as right arm for both the shot. No treatment received in response to event. Reporter just noticed and was wondering that's why called to see if it might be a side effect a reaction to the vaccine. It was concerning, yesterday after patient took a bath, reporter noticed a lot of hair and that's not normal and will call the doctor to schedule an appointment but again wanted to call to ask. Patient took no other vaccine prior to the first dose. Reporter stated, it just if patient passes the comb through his hair you know the hair will come off and it's a lot of hair it's not one or two hair it's several, and stated reporter did not know the time event started. Clinical outcome of the event was unknown.  Information on the lot/batch number has been requested. Additional information has been requested.
Patient received her first Janssen Covid 19 vaccination on 11/01/2021. She received the injection high in her left deltoid. Starting the evening of the shot she has had toothache-like pain in her muscle and tingling and numbness down her arm and in to her fingers. It is severe enough to wake her up in the middle of the night. She resolves this by shaking and massaging the arm and using a stress ball. She also takes tylenol for the pain. This is consistent with an injection going in to the bursa of the muscle, or possibly the tendon. I suggested she see her provider, and ask them if a course of steroids may be helpful. She refused as she is skeptical of steroids. We talked about her continuing her tylenol regimen, and revisiting the idea of a provider's visit an the three month mark, of not resolved. She was satisfied with the phone consultation.
Hypermotility of boewls began 1-2 days after injection and has persisted for 8 days. No fever, chills sweats. Mo blood in stool or other discoloration. Profound gaseousness and flatus
24 hours after receiving pneumovax. I felt sick chilled, my left arm swelled and was red and hot. Over nite my fever was 101.3. I called telephone nurse, she said to put warm compress, antibiotic cream and report to Dr in am. Urgent care diagnosed cellulitis and put me on Amoxicillin after a shot of antibiotic.
Immediately became very dizzy, and my heart started racing. I started to feel discomfort in my throat. and tongue felt lazy in my mouth. I also felt my arms and legs very heavy and a wave like sensation going up and down my body.  These symptoms were strongest 2-3 minutes after the shot for about 15 minutes. Then they seemed to fade away, and come back for the next hour. They eventually resolved on their own, and were not severe enough for me to need medical help or treatment, although I did stay in the emergency room in case the throat and tongue discomfort became worse, by the time they got to me, the symptoms had resolved themselves.  I woke up the next day with a sore arm,  and it remained sore for the next three days. And I also woke up for the next three days with extreme nausea.   I would also like to add that I am currently breastfeeding a 5 month old, in case that is important.
tiredness and pain in both his knees and legs; tiredness and pain in both his knees and legs; tiredness and pain in both his knees and legs; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (tiredness and pain in both his knees and legs), PAIN IN EXTREMITY (tiredness and pain in both his knees and legs) and FATIGUE (tiredness and pain in both his knees and legs) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011a21a and 016m20a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL and VITAMINS NOS for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced ARTHRALGIA (tiredness and pain in both his knees and legs), PAIN IN EXTREMITY (tiredness and pain in both his knees and legs) and FATIGUE (tiredness and pain in both his knees and legs). At the time of the report, ARTHRALGIA (tiredness and pain in both his knees and legs), PAIN IN EXTREMITY (tiredness and pain in both his knees and legs) and FATIGUE (tiredness and pain in both his knees and legs) had not resolved.            Treatment information was not provided.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-395985.
around 30 minutes after vaccination, patient experienced vomiting, diarrhea, chills, and muscle spasms. 6 days later she says she is still so ill that she cannot leave her bedroom/bathroom and cannot even drink water without vomiting around every 3 hours. she has not taken any medication because she can't keep anything down
Child developed fever 104.6 one day after vaccine (Dtap, Varivax). Went to urgent care, then hosptial. - Motrin given.
Patient describes loss of function in left arm since PREVNAR vaccine; patient has trouble lifting arm and reaching.
Forty hours after vaccine, right arm became red, swollen and painful. Patient was taken to the emergency room and diagnosed with cellulitis and treated with oral antibiotics, with resolution.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns an 86 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 13-Sep-2016, the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 13-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.
red large circle, swollen, and very hot to touch on injection  site, put ice on it for two days
After one week from first dose I noticed some chest pain but it went away. Noticed chest pain again approximately one week after second dose and it went away but came back periodically. Each time a little worse. Then had difficulty breathing and severe chest pain for or five months after the second dose. I thought it would go away like it normally did but it got worse and I went to the hospital. I couldn't breathe and had severe chest pain and irregular heart beat.
In the few weeks before my Urgent care center visit I had lost strength, had irregular bowell movements and loss of appetite.  I was put on Miralax at the Urgent care center visit.  I had all the side effects with no benefits so I discontinued use after two and one half weeks.  I met with my PCP on 20MAR2023 I was given a blood profile, ultrasound and a  CT scan. Pancreatic cancer was diagnosed.
Red, raised, fevered area that is painful to touch and child states that sometimes it itches.
Patient with 2 Moderna COVID vaccinations who admitted to the hospital with incidental COVID positive test found during admission testing, admitting diagnosis Tubo-ovarian abcess on CT-Scan with subsequent surgical resection.  No respiratory issures during stay.
4/10/21: nose bleed wouldn't stop with giant clots coming out and has never had a nose bleed in life. Due for 2nd vaccine Friday 4/23/21.
Client had received 1st dose of moderna on 8/27/21. Client reported afterwords that he had minor throat swelling when he arrived home and took expired Benadryl.  Client had contacted health dept multiple times wanting to receiving the 2nd dose of Moderna.  He told us about his "minor throat swelling" and we instructed that we would not give the 2nd dose of Moderna since he had a minor anaphylatic event .  He could try J/J.  Client came in on 10/4/21 and filled out his paperwork for 2nd dose of Moderna. He put on paperwork that he did not have an adverse reaction to the 1st dose and denied it when asked by staff.  2nd dose of moderna was given by staff because they did not know he had a previous reaction.   Client hung around in clinic from 2:40pm until 4:04pm and then c/o throat swelling. Dr assessed patient. 99% on room air. EMS was called at 4:15pm. Client refused epi and benadryl. Pt stated he wantedf to sign a refusal for tx/transport to hospital. At 4:35pm pt denied shortness of breath or any problems swallowing. Discharged home.
One week after Covid shot, red itchy rash at injection site. It is warm to the touch. This is second day of reaction.
Information has been received from a physician concerning an 18 or 19 year old female patient who on unknown dates was vaccinated with three doses of GARDASIL (dose, route and lot # were not reported). The physician reported that on an unspecified date a patient found to be positive for HPV after receiving all 3 doses of GARDASIL. At the time of reporting the patient had not recovered. The patient sought unspecified medical attention. Laboratory diagnostics studies included Papanicolaou smear. Additional information has been requested.
Debilitating headache and nausea. In bed, eyes closed, in a dark room for 24 hours.
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Autoimmune Disease (diagnosed by MD)-Medium, Systemic: Cardiac Disorder (diagnosed by MD)-Medium, Systemic: Confusion-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Heart Attack-Severe, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Severe, Additional Details: Death cetificate stated that patient had a hyperactive immune response which led to hyper coagulation which resulted in cardioac thrombosis
Treatment 9 days after the shot on January 22, 2021.  Bacterial Infection
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 13-AUG-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# R006216 and expiration date 28-AUG-2019) for prophylaxis (Incorrect product storage). The Merck Sterile Diluent was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001959.
Patient had sore arm with heat radiating, fever, nausea, but no vomiting or difficulty breathing.
Patient presented to vaccination site and requested Pfizer COVID vaccine additional dose. Patient received Pfizer 1st dose on 3/5/21, Pfizer 2nd dose on 3/26/21, and Pfizer booster dose on 10/14/21. RN 1 submitted a medical consult to Clinical Project Coordinators requesting to proceed with Pfizer COVID vaccine additional dose. Clinical Project Coordinator RN 2 elevated request to medical consult team. MD 1 from medical consult team approved request for Pfizer COVID vaccine additional dose. On 3/21/21, patient received Pfizer COVID vaccine (LOT# FK9894) additional dose at 1634. EMT 1 educated patient on signs and symptoms of adverse reactions, when to seek emergency care, and to register on V-Safe. At approximately 1650, patient left facility with unlabored respirations and steady gait.
Pt c/o arm swollen, rash onto shoulder with body aches. Tender to touch.
PT EXPERIENCED RECTAL AND VAGINAL BLEEDING STARTING THE DAY AFTER THE IMMUNIZATION AND LASTING FOR 24 HOURS.
Patient received vaccine in her left arm. It was made aware to the immunizing technician prior to vaccinating that the patient had a history of dizziness after vaccines. Patient was seated when receiving shot and after stayed seat. About 30 seconds after the shot patient lost consciousness and fell out of the seat hitting her head on the way down. The pharmacist and mother helped patient back to her seat. As she came to consciousness patient reports a little headache and dizziness. Pharmacist took blood pressure which read 84/52, temp 97.9 and gave patient some water and 911 was called. As EMS arrived patient reported still some dizziness but was feeling better.