chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CARDIAC ARREST; This spontaneous report received from a consumer concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, picc line, and diabetic foot ulcer. The patient had no known allergies. The patient had no previous history of heart conditions. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Concomitant medications included Ceftriaxone for diabetic foot ulcer, and Heparin for picc line prophylaxis.  On Saturday, 20-MAR-2021, the patient reported that his chest felt funny but he wasn't sure about the cause. On Monday, 22-MAR-2021 morning; the patient had collapsed when he got out of the shower and yelled for help. The patient was gasping for breath and reading on pulse oximeter dropped into the 70's and also reported that he felt light headed. It was unknown weather the patient died in ambulance or at hospital. It was unspecified if an autopsy was performed. Laboratory data included: Oxygen saturation decreased (NR: not provided) Dropped to 70's.  On 22-MAR-2021, the subject died from cardiac arrest.  The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210342361 -COVID-19 VACCINE AD26.COV2.S- Cardiac Arrest. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY.; Reported Cause(s) of Death: CARDIAC ARREST
to get his second dose but he never came back; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (had 1st dose of shingrix administered on 08 APR 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: to get his second dose but he never came back). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 30-Oct-2023 A pharmacist tried repeatedly to get the patient back in pharmacy to get his second dose but he never came back.  The physician sent in a prescription this week for the Shingrix vaccine so the reporter was not sure whether to just give him a second dose or need to do the series again. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow-up.
Urticaria next day after injection with Dtap & Hib vaccine. Seen at urgent care per mother.
Onset of temp 100.7 at 9pm on 2/20/2021 with rapid chills, body aches and headache within 1/2 hour.  Continues throughout night with peak temp 101.6.  Subsided in am 2-21-2021.  Zero appetite for 2-21 and 2-22 with general malaise noted both days.  Noted tiring by days end into Tuesday 2-23-2021.  No residual symptoms noted except lack of appetite and being tired.  I did not have the vaccine card with me at the time I completed this form.  This was with Employee Clinic.
Shortness of breath, dizziness, headache chills. Whole body felt weak.
I suddenly developed a feeling of a metalic taste from my chest like I was getting bronchitis and a sore throat 36 hours after the 2nd vaccine.I had a slight congested cough. I awoke the next morning with a sore throat, my throat  was white and my tongue was coated with a white and green coating. My tongue was ruffelled on the edges and bumps on my tongue. I called my Dr the next day and felt I had bronchitis, possible sinus infection due to several months of congestion and yeast on my tongue, She prescribed Augmentum antibiotic and Nystatin mouth swish. My chest and nasal congestion cleared but I still have some green coating on my tongue and some bumps. i used the Nystatin swish for 2 weeks.  I was not running a temp but did not feel good.
I am 42 years never had a nose bleed.  Twelve days after my johnson&johnson shot I had my first
This spontaneous report was received from a nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates in the years 2015, 2016 and 2017, the patients were vaccinated with improperly stored doses of PEDVAXHIB (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. There were multiple temperature excursions but the temperature and the time frame were unknown by the reporter. No data logger was involved. No adverse effects were reported. Additional information has been requested. Sender's Comments: US-009507513-1705USA005385: US-009507513-1705USA005386: US-009507513-1705USA005387: US-009507513-1705USA005388: US-009507513-1705USA005389: US-009507513-1705USA005390: US-009507513-1705USA005342.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was status epilepticus. She was then hospitalized for rehab services for 4 days.
Sore arm at injection site through the night. Arm was significantly better the next day, and tenderness completely gone after 2 days.
Mom stated the pt started itching on 3/10/01. Mom noticed the pt broke out in whelps all over the front and back of trunk. On 3/11/01 the pt is still itching and mom denies the pt having a fever, nausea, vomiting.
following symptoms started aout 10-12 hours after receiving vaccine: fever with body aches lasted 2 days, headache and fatigue lasted 3 days, naseau and vomitting lasted 1 day.
Information has been received through the pregnancy registry from a physician concerning a 33 year old female who on 6/18/99 was vaccinated with varicella virus vaccine live. There was no concomitant medication. On 6/30/99, the pt told the physician she was six weeks pregnant. LMP was 5/19/99, EDD is 2/25/00. Follow-up was received which indicated the pt left the practice. The physician stated that he "thinks the pt had an abortion", but he "is not sure".  This report will be classified as lost to follow-up.
I awoke at 5:00 a.m. on 02/25/21, feeling feverish, used the toilet, and returned to bed. Awoke about 3 hours later with fever, chills, slight nausea, and achy. Temperature registered at 37.5. Took acetaminophen (500mg) and returned to bed.  Injection site swelling, redness, soreness. Symptoms lasted all day. Highest temperature was 37.8 at approximately 7:00 p.m.  Fever broke at around 10:30 p.m. Slept thru the night and awoke at 7:00 a.m. on 02/26/21, feeling much better.  Injection site is less swollen and less sore; some redness remains.
Patient was given MMR vaccine intramuscularly. This vaccine is supposed to be given subcutaneously.
Patient mentioned that her vision was starting to get blurry and couldn't see well and she had to sit down. It lasted about an hour.
edema in the right leg; This spontaneous case was reported by a physician and describes the occurrence of OEDEMA PERIPHERAL (edema in the right leg) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA) and DUPILUMAB (DUPIXENT) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced OEDEMA PERIPHERAL (edema in the right leg). At the time of the report, OEDEMA PERIPHERAL (edema in the right leg) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-079122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079122:2nd dose
A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST. The vaccine had and expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Patient fully vaccinated with Moderna COVID19 vaccine with 1st dose on 2/3/21 and 2nd on 3/3/21. Patient reported COVID symptoms of headache, loss of smell and cough starting 8/20/21 and tested COVID positive on 8/23/21
This case was reported by a healthcare professional and described the occurrence of passing out in an adult subject of unspecified gender who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of HAVRIX at 1.0 ml in an unknown arm. Immediately after vaccination with HAVRIX, the subject experienced nausea and then passed out. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. In the reporter's opinion nausea and passing out were probably related to treatment with HAVRIX. It was noted that the occurrence of nausea following administration of HAVRIX happened with three different subjects. The reporter requested replacement of three packs of vaccine (ndc 58160-826-48). All three vaccinations in question had the same lot number and expiration date. Linked cases include A0931346A and A0931347A.
Shortly after getting my first vaccination I had a sore shoulder/arm and body aches.  This continued to get worse during the week, I started getting short of breath and more winded when doing any activity.  My heart would race and pound extra hard.  Exactly a week after my shot I began to get extremely itchy from the injection site, which was spreading up my arm into my neck area.  This also made it more difficult for me to breath.  I took multiple doses of Benadryl at home which seemed to stop symptoms from getting worse.  So I decided to not go to the ER.  I contacted my provider about what to do for the next vaccine dose  later that week.  I did not get the 2nd dose due to the difficulty breathing from the first dose.  I still have asthma like symptoms since this whole ordeal which has required follow up appointments.
Employee came into medical office at 12:30 and vomited. She reports that she looked up in a screening booth and the room spun which made her nausea and then vomit. Employee said she had anxiety and c/o SOB stating I feel like I can't fill my lungs. Called Dr to evaluate and had employee sit down and take deep breaths which resolved the SOB/hyperventilation sx. VS taken at 1237 145/94 with pulse 95 BPM. She reported to seeing spots. SX resolved in > 10 minutes, VS retaken at 1255 129/73 with pulse 62 bpm.
Localized Urticaria at injection site of varivax.  Totally resolved after a dose of Benadryl.
Immediate headache and tongue swollen, headache has continued off and on. Menorrhagia began early Saturday morning and I am going through 10 -12 tampons a day with large clots, heavy bleeding and cramping. My cycle is not supposed to start for another 2 weeks. I keep everything on an app and am still pretty regular.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concomitant medication, medical history and drug reactions/allergies were not reported. On unspecified dates, the patients were administered improperly stored doses of RECOMBIVAX HB (lot # M001578 with expiration date 21-NOV-2018; dose and route were not reported). The vaccines were exposed to 1 degree Celsius (C) for 60 hours and 90 minutes. A data logger was used to log temperatures, and there were no prior excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Breakthrough case admission after 3 vaccines Pfizer 2/24/21 Lot# El9267;  Pfizer 3/17/21 Lot# EN6205;  Pfizer 12/20/21 Lot# FL3197
Mother called 9/15/21 afternoon that the school nurse told her the child's upper arm was red and more swollen than usual at injection site. No fever. Mom accepted apt. for 9/16/21 230pm. Left upper arm injection site red, swollen and warm. No drainage. Able to move arm. Child Autistic and non verbal but mother states" it is uncomfortable.' She is giving Motrin PRN as advised and applying cold to the area.
Received pneumovax Lt deltoid on 12/17/05 (lot # 0371P). 12/18/05 Developed Lt arm erythema from area of injection at Lt deltoid and down distally to hand, red and warm to touch. Cephalexin 500mg one tid x 1 wk - effective.
Myalgia, Arthralgia, Fever, Fatigue and just feeling "off" Narrative:  Other Relevant History:
feeling like she has the flu; pain in shoulder; Middle of night felt tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (feeling like she has the flu), ARTHRALGIA (pain in shoulder) and FATIGUE (Middle of night felt tired) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018F21A, 030A21 and 013M207) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-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 experienced INFLUENZA LIKE ILLNESS (feeling like she has the flu), ARTHRALGIA (pain in shoulder) and FATIGUE (Middle of night felt tired). At the time of the report, INFLUENZA LIKE ILLNESS (feeling like she has the flu), ARTHRALGIA (pain in shoulder) and FATIGUE (Middle of night felt tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medication were reported no treatment medication were reported   This case was linked to MOD-2021-406405 (Patient Link).
Expired Vaccine Used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used). On 24-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication information was provided.  No Treatment medication information was provided.
Information has been received from a registered nurse concerning a 4 year old white female with no allergies or medical conditions who on 2/2/00 was vaccinated SC with a first dose of varicella virus vaccine live (lot # 630678/0426J). There was no known illness at the time of vaccination. The nurse reported that one of her patients may have experienced a mild case of chicken pox even though the patient was immunized. It was noted that in retrospect, the patient's mother seemed to remember the patient having some lesions in her hair some time in August 2003. Therefore, it was assumed that the patient developed chicken pox. No medical attention was sought, a prescription drug was not required, and she appeared to be fully recovered in September 2003. There was no diagnostic tests performed. It was noted that neither the patient or her sibling had any adverse events following prior vaccination. A product quality complaint was not involved. Additional information was received from the registered nurse which indicated that there really was no follow up. Follow up information was received from the registered nurse which indicated that the patient probably did have varicella. It was noted 8/4/03 after the child's sibling had chicken pox, patient had few in scalp. No further information is expected. The nurse also reported a case of chicken pox in the patient's unvaccinated sibling.
Day 1- pain and lack of range of motion at deltoid left arm , existed for about 5 days. Burning in chest, possibly lung. Shortness of breath, scanty urination/dark urine, problems with bowel movements.   Days 2-4: dizziness, disorientation, gait changes, delay thinking, headaches, shortness of breath chest burning, whole body joint pain, neuropathy like sensations in arms, blood pressure spikes/ pulse rates dropped to 42.
Pfizer BioNTech COVID 19 Vaccine EUA 20 hours later Headache. Tired. Body aches. redness and swelling at the site.  1 pm.  At 630 pm low grade fever 100, took Tylenol.  Took a second round at 1 am.   Illness ended.  Swelling and redness grew around site and left armpit.  Continues to grow 2-12-2021
PRESSURE BEHIND LEFT-SIDE OF HEAD; ANXIETY; DEPRESSION; SENSATION RADIATING FROM HEAD TO NECK; HIVES; FEVER; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies the patient did not have any history of illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced hives. On APR-2021, the subject experienced sensation radiating from head to neck. On APR-2021, the subject experienced depression. On an unspecified date, the subject experienced pressure behind left-side of head, and anxiety. Laboratory data (dates unspecified) included: Blood test (NR: not provided) normal, CT scan (NR: not provided) NORMAL, EKG (NR: not provided) NORMAL, Heart rate variability test (NR: not provided) NORMAL, Pulmonary function test (NR: not provided) NORMAL, and Scan with contrast (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hives on 21-MAR-2021, and fever on 14-MAR-2021, and the outcome of sensation radiating from head to neck, pressure behind left-side of head, depression and anxiety was not reported. This report was non-serious. This case, from the same reporter is linked to 20210503208.
About a week after receiving the first injection my arm became itchy and a large red rash developed around the injection site.  It is now  1 week after the rash developed and 2 weeks after receiving the vaccine and the rash and itchiness are still present. The rash is also growing in diameter. It is now covering most of my upper arm.  I have also suffered from neck pain since having the injection. This is subsiding though.
Warm, red skin at injection site (right arm) from subcutaneous MMRV vaccine. It is swollen. Mother of the patient noticed it the next day at bath time since the site was covered with the bandaid. Mom reported that the patient complained of pain and warmth.  Treatment: patient given Ibuprofen 12.5ml in office 3/24/21.
Extreme weakness; pins and needles tingling sensation in both hands; Increased heartrate; tightness between the neck and both shoulders; warm sensation around the spinal cord/ warm feeling has now progressed to both legs; fatigue; This case was reported by a consumer via call center representative and described the occurrence of weakness in a 45-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th October 2021 11:00, the patient received Fluarix Quadrivalent 2021-2022 season. On 6th October 2021, the patient started Fluarix Tetra Pre-Filled Syringe Device. On 6th October 2021 19:30, 8 hrs 30 min after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced weakness, pins and needles, heart rate increased, muscle tightness, feeling of warmth and fatigue. On an unknown date, the outcome of the weakness, pins and needles, heart rate increased, muscle tightness, feeling of warmth and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the weakness, pins and needles, heart rate increased, muscle tightness, feeling of warmth and fatigue to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details were reported as follows: The case was reported by the patient. The patient received Fluarix on 6th October 2021, at approximately 11 am, the patient beginning to experience symptoms at approximately 7:30 pm, on the same day.  The patient first experienced a pins and needles tingling sensation in both hands, next experienced an increased heartrate, developing a warm sensation around the spinal cord.  The patient also experienced extreme weakness that was beyond what they would consider normal fatigue.  The patient also developing a tightness between the neck and both shoulders.  The warm feeling had now progressed to both legs, which began early on the day of reporting on 7th October 2021. The patient reported all symptoms were ongoing and seem to be getting progressively worse. The reporter consented to follow up.
2/25/04 at 1530 presented to Health Department. Left arm red and moderate swelling in a tear drop shape in middle of area from shoulder to elbow. Area not warm to touch.
Puffy eyes, rash on neck, itch 1/2 days later persistent - took BENADRYL beginning 1 wk after shot.