chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 15 minutes after receipt of the vaccine, I experienced tachycardia and mild throat swelling.  I was placed in the Immunizations Clinic treatment room, had my airway assessed, and vital signs taken.  My initial vital signs at 0950 were BP 197/99, HR 106, O2 sat 99%, temp 98.3 F, and 0/10 pain.  Over the course of the next 2 hours, I repeatedly had my vital signs taken, was monitored, was provided with water, and remained hypertensive and tachycardic, although down-trending.  I also experienced cottonmouth and bilateral blurred vision/dry eye.  At the end of the 2 hour monitoring, the throat swelling seemed to subside, my systolic BP in the mid 140s and diastolic BP was in the mid 90s.  At time of release from monitoring, I felt better, but dry eyes and dry mouth continued without difficulty swallowing.  I was instructed to report to the ER if my symptoms worsened and to consult by primary care manager about the incident.  Upon walking back to my office, I realized I was experiencing dizziness as well and a mild headache.  I attempted to submit this form online but I received an error message, so I completed the fillable version to upload, in case a partial duplicate record appears.
Pt. c/0 of itching about 7 minutes after injection.  Benadryl 50mg po was given  15 minutes later, pt c/o chest tightness.  Rapid REsponse team called.  Epi Pen was given.  Vital signs were stable.  Pt. transferred to ER. Subsequential dose of EpiPen was given 2 hours later for chest tightness.
dizzy/ lightheaded; migraine attacks; Inappropriate schedule of vaccine administered; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Feb2021 03:30 (Batch/Lot number: unknown) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Product=COVID 19, brand=Pfizer, lot unknown=False, administration date=13Jan2021, administration time=03:30 AM, vaccine location=Left arm, dose number=1), administration date: 13Jan2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 09Feb2021 16:00, outcome "not recovered", described as "dizzy/ lightheaded"; MIGRAINE (non-serious) with onset 09Feb2021 16:00, outcome "not recovered", described as "migraine attacks"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 03Feb2021 03:30, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The events "dizzy/ lightheaded", "migraine attacks" and "inappropriate schedule of vaccine administered" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of dizziness, migraine, inappropriate schedule of product administration.  Additional information: Patient has not been vaccinated with 4 weeks of COVID-19 vaccination. Patient has not been tested for COVID-19 test. Patient has not been tested for COVID-19 test post-vaccination. No known allergies reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Adverse event: ; event 1: chest pain after 1st dose - occurred 2 days post injection with resolution 6 days post Event 2: after 2nd dose: Chest pain, SOB, fatigue - 3 days post injection without resolution Treatment:  telemedicine visit with primary care with recommendation to see cardiology; appointments with cardiologist Dr. for further evaluation; electrocardiogram and physical examination with follow-up appointment 06-23-2021 and echocardiogram scheduled for 6-24-2021
1/15/21: site pain in the afternoon, ~3p 1/16/21: site pain; fatigue  in the afternoon ~1p 1/17/21: extreme fatigue and extreme cold ~10:45am. Extreme cold was inability to warm up inside the home. Dressed in pants, socks, longsleeve shirt, winter hat, feather down vest, turned on fireplace and when took a nap slept with all of that plus 3 blankets. Extreme cold symptoms did not subside until 5p that day.
Had chicken pox as a child and got the shingles vaccine to prevent/lessen an outbreak event. Within a few days I had full blown case of chicken pox from head to toe. Never had shingles before the vaccine but since have had one minor outbreak a month mainly located to the small of my back but has shown elsewhere. When given the vaccine I was in good health. No known allergies.
Reaction/PROQUAD Rt side swollen, redness, slight wheal. Given BENADRYL  dsed swelling/wheal was noted around point of delivery of vaccine. Redness noted around the area of delivery of vaccine.
Fine papular, follicular rash on both thighs. Prescribed BENADRYL 2 mls p.o. tid prn with hydrocortisone cream 2.5 % tid. Follow up in 1 week.
12JUN95 pt had vax 8JUN95 mom stated pt c/o itching & a rash on 9JUN95 PM; areas are red, raised & appears like whelps; rash appear
Pt noticed dry throat and tickling in throat, came to staff in Observation area, noted to have dry constant cough with audible wheeze, hives to lower face/neck.  Pt A&Ox3, calm, skin warm and dry Given Benadryl 50mg PO at 1335 Given Epi pen 0.3mg to R)thigh at 1336 Used own Albuterol MDE, 2 puffs at 1338 using a spacer. BP-138/92, P-125, R-18, O2 sat-98% RA at 1338 1345-O2-98%, R-20, P-125, Local fire Department and paramedics on scene.  Pt awake and alert, reports breathing felt easier.  Ambulated to Medic cot, and was transported to Hospital
BODY ACHES; CHILLS; TIREDNESS; This spontaneous report received from a consumer concerned a 59 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced tiredness. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, body aches, and tiredness. This report was non-serious.
Woke up with body aches and migraine. Migraine took me out all day. Serve lightheadedness, pass out (full on collapse, woke up laying on ground with hand twitching). Serve  lightheadedness continued for next 5 days, where would become dizzy just sitting and if moved would need to stop and let body catch up.
I tested positive for COVID 19 in January of 2021 (I think I had it the first time in March, but never tested). On August 27 2021 at 6pm I received my first Pfizer shot. Immediately after the shot I felt the pressure and pain in my chest. The chest pain/ pressure are still persisting. The cardiologist I saw on 9/10/2021 suggested 600mg Motrin every 3 hrs. The outcome remains unknown  My body had already fought off COVID 19 naturally and with exposure to it again from the first shot the physician I saw suggested he thinks because I already had COVID-19 my body became hyper reactive from post viral and the autoimmune response was inflammation of the sac around my heart.
Repeated vomiting, inability to retain food or fluids. NO FEVER or other adverse events.  11/16/09 Medical records recieved for DOS 10/30/09. Final DX: febrile seizure. Presented early am w/tonic clonic febrile seizure x6 min. Post ictal sleep. Occasional jerks. Not eating. Fever 102.9r.  PE WNL.
Diarrhea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.
Initial report received from a health care professional on 12 October 2009. A female patient (age reported as 40's) with no concurrent illness but who had a history of seasonal allergies, had received an injection of FLUZONE (route and site not reported), lot number U3202AA on 09 October 2009 and one hour later, she developed red eyes and she felt a lump in her throat. The patient had taken "ALLEVERT" one hour before vaccination and was reported to have felt hypotensive after vaccination (onset not reported). The patient's recovery status was not reported; however per the reporter, the patient "now feels congested". The events did not require a doctor's visit. A few years prior, the patient experienced a similar event with symptoms of red eyes and a feeling of a lump in her throat following receipt of unspecified Influenza vaccine (manufacturer and lot number not reported). No additional information was provided at the time of the report. Documents held by sender: None.
This is a spontaneous report from a contactable nurse. A 16-years-old male patient (weight 59cm, height 170 cm) received TRUMENBA (lot R45100), intramuscular on 08May2017 at 0.5 ml, single for immunisation.  Relevant medical history was none. There were no concomitant medications. On 08May2017 the patient experienced chills, stiff neck, like shaking all with outcome of recovered.  Therapeutic measures were taken as a result of events and included diphenhydramine hydrochloride (BENADRYL), Epinephrine and dexamethasone (DECADRON).
Janssen Covid 19 EUA the patient felt light headed in Observation after his vaccine. He denied treatment or transport and an AMA was ran through Grossmont ED. Inc# 2021-00021998
Red swelling at site of vaccine - swelling started disappearing after one week. But area now bruised & small red rash evident oozing this is day 9 - rash itchy & painful.
Moderna COVID-19 Vaccine EUA given at 10:10 on 12/30/2020.  At 10:20 began to experience weird metallic taste in mouth near base of tongue.  At 11:05 began feeling pins and needles sensation on left cheek of face. Then radiated to left forehead and chin at 11:15. Then felt pins and needles sensation I. Left arm at 11:30. Went to the ER at that point.
red, itchy swollen injection site reaction on her left arm; red, itchy swollen injection site reaction on her left arm; red, itchy swollen injection site reaction on her left arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 38-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2019-2020 season) (batch number FX77G, expiry date 30th June 2020) for prophylaxis.   On 2nd April 2020, the patient received Fluarix Tetra 2019-2020 season (intramuscular). On 2nd April 2020, less than a day after receiving Fluarix Tetra 2019-2020 season, the patient experienced injection site erythema, injection site itching and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site itching and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching and injection site swelling to be related to Fluarix Tetra 2019-2020 season.  Additional details were provided as follows: The patient received vaccine in left arm. It was reported that the patient was still having red, itchy swollen injection site reaction on her left arm. The  reaction was still persists at the time of reporting. The reporter did not consent to follow-up.
Tinnitus started intermittently approximately 5 days after the vaccine.  It then became constant on 3/5/2021 (approximately 4 weeks after the 2nd dose of the vaccine).  No previous history of hearing loss or hearing issues.  It has not yet resolved.
"Mandatory flu vaccine was administered on Friday, Nov. 9, 2018. On Saturday after only a breakfast of an egg and ham omelet noticed around 1300 hrs my face was extremely dry. I looked in the mirror and noticed this rash on my face. I have never broke out on my face. My face is still scared with a rash." No known treatment given.
Three weeks after this patient had his Influenza shot, sickness of retro-orbital pain, headache, progressive SOB and flaccid paralysis. The patient now on a ventilator, with acute disseminated Encephalomyelitis.
Feeling dizzy; Low graded fever; Feeling tired; Arm Hurting; Feeling sluggish; Spending most times in bed; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Hurting), SLUGGISHNESS (Feeling sluggish), HYPERSOMNIA (Spending most times in bed), DIZZINESS (Feeling dizzy) and FATIGUE (Feeling tired) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm Hurting), SLUGGISHNESS (Feeling sluggish), HYPERSOMNIA (Spending most times in bed) and FATIGUE (Feeling tired). On 02-Mar-2021, the patient experienced DIZZINESS (Feeling dizzy) and PYREXIA (Low graded fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm Hurting), SLUGGISHNESS (Feeling sluggish), HYPERSOMNIA (Spending most times in bed), DIZZINESS (Feeling dizzy) and FATIGUE (Feeling tired) outcome was unknown and PYREXIA (Low graded fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported.
got infected with covid and died yesterday; Looks like the vaccine may not be as effective with the new variants.; This is a spontaneous report from a non-contactable consumer. A male patient (infectious disease doctor) received two doses of BNT162B2 (Solution for injection, lot number: unknown, Expiration date: Unknown) on unknown dates . The patient travelled and got infected with covid and died yesterday (02May2021). The reporter stated that it looked like the vaccine might not be as effective with the new variants. After two Pfizer vaccines shots , this doctor travelled to see his parents and succumbed to the new variant. Outcome of the event was fatal.  No follow up attempts are possible; Information about Lot and batch number could not be obtained. No further information is expected.; Reported Cause(s) of Death: got infected with covid and died yesterday.
Both my first and second vaccines I have and am now experiencing heart problems and troubles breathing. I'm having chest pain and my arm feels like the achy pain of putting ice on a broken bone. The first vaccine I felt the pain start in my collar bone in the vein and move down. 2nd vaccine I feel like I've been running a marathon and feel pain in my chest. Fatigue both times.
To be very clear, this is in regards to my second booster, 4th in the series of Covid shots.  All shots were Moderna.  Within a few hours of receiving the booster I started feeling a little dizzy.  The following day, Tuesday, July 26th, I was very dizzy and my right ear started to feel a little like I had water or an ear plug in it.  I had not gone swimming or showered so it could not have come from another source.  I was on the swim team in High School and College and never had any issues with water getting trapped in my ears.  I had a large, red raised area on my left arm, near the injection site.   On Wednesday, July 27th I had my annual exam with Dr. at a local HCF.   I told her how I was very dizzy the previous day and she felt that might be a temporary reaction to the vaccine.  The dizziness had gotten better and the ear issue was not severe enough at that time to mention.  My arm was still very red.  This had not happened with any of the previous 3 shots I received.  On Thursday the dizziness had pretty much resolved but the right ear hearing had gotten worse and is still present.  I purchased ear drops to clear "swimmers ear" and they have not helped.  I tried  warm compresses and that has also not helped.  I googled if this was somehow perhaps related to the vaccine, as I had never heard of this being a side effect, and saw that some people have reported it.
Case number PHEH2016US028566, is an initial spontaneous report received from a health care professional on 26 Oct 2016. This report refers to a patient of an unknown age and an unknown gender. Medical history and concomitant medication was not reported. The patient was vaccinated with one single dose of FLUCELVAX (lot number: 185887, expiry date: Apr 2017) at a dose of 0.5 ml subcutaneous on 24 Oct 2016. On 25 Oct 2016 the patient experienced 7 cm patch of erythema around the injection site. The patient used cold compresses and ice for the erythema. It was unknown if the erythema was improving. Final outcome of the event was unknown. Seriousness of the event was reported as non serious and causality was not reported.
Joint and muscle stiffness.  Could barely walk.  Had trouble lifting legs and arms.  (5-6 hours) Hallucinations (1 hour) headache (2 hours) nausea (1 hour) chills (1 hour) fatigue (5-6 hours) Memory Loss.  Could not remember the ride home or things I had said that afternoon (5-6 hours)
After 12 hours the start of flu like symptoms: aches, chills, fever.  Progressed to intense chills and fever, aches.  24 hours later chills subside, aches remain, headaches persist.  36 hours later symptoms largely subsided.
Information has been received from a medical assistant referring to a 16 months year old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 02-NOV-2018, the patient received an improperly stored dose of PROQUAD (lot # R012417, expiry date: 28-OCT-2019; dose, frequency and route were not reported) for prophylaxis (product storage error), which was reconstituted with properly stored sterile diluent (STERILE DILUENT). No adverse effects were reported. There was no previous temperature excursion. It was also reported that temperature was from 15 fahrenheit to 46 fahrenheit for 8 hours and the data logger was involved.; Sender's Comments: US-009507513-1902USA007537: US-009507513-1902USA007536: US-009507513-1902USA007539: US-009507513-1902USA007538: US-009507513-1901USA008772: US-009507513-1902USA007541: US-009507513-1902USA007542: US-009507513-1902USA007543: US-009507513-1902USA007544: US-009507513-1902USA007545: US-009507513-1902USA007546: US-009507513-1902USA007547: US-009507513-1902USA007548: US-009507513-1902USA007549: US-009507513-1902USA007550:
ER admission for dehydration on 10/28/2021. Patient was found to have a urinary tract infection.  First dose of nitrofurantoin was given in the emergency department with remaining prescription sent to the pharmacy. ED to hospital admission on 11/9/2021. AKI - resolved with hydration, stable off IV fluids although PO Intake is poor. ER visits and hospital admission within 6 weeks of receiving the COVID vaccine.
Suspected vaccination failure; I've got shingles after the 2 dose vaccination.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.  Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by patient for himself/herself. The age at vaccination was not reported. The patient reported that he/she received 2nd dose of Shingrix and experienced shingles. This case was considered as suspected vaccination failure as details regarding laboratory confirmation were unknown at the time of reporting. No other information was provided.
One of their patients may have been administered expired Moderna booster of .25 mL, that was in refrigerator for greater than 30 days.; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (One of their patients may have been administered expired Moderna booster of .25 mL, that was in refrigerator for greater than 30 days.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (One of their patients may have been administered expired Moderna booster of .25 mL, that was in refrigerator for greater than 30 days.). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (One of their patients may have been administered expired Moderna booster of .25 mL, that was in refrigerator for greater than 30 days.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.  The patient was well over 18 years of age.the vial was initially stored in the refrigerator on 07 APR 2021. expiration date 31 DEC 2069.
TOOK ALL UNREFRIGERATED DOSES OF VIVOTIF; This spontaneous case (PVX2019-1487) was received from a pharmacist on 10-Jun-2019. It describes a 22-year-old adult female consumer who "took all unrefrigerated doses of Vivotif". The consumer was receiving oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took all the unrefrigerated doses of Vivotif last week. She had a planned trip on 13-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took all unrefrigerated doses of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took all unrefrigerated doses of Vivotif" was considered as not applicable.
No adverse event. Patient received 1st dose of Rotateq at 4 months of age which is over th recommended age of 12 months
Patient came to pharmacy 14 days after receiving vaccine and had a very large bruise on her arm, from her deltoid almost down to her elbow.
Within hours started having a seizure. I went on to have seizures for 8 days straight, often time having several seizures per day. Posturing, memory loss. Had a CRPS flare for several days after the shot. Hands were swollen and were red and purple looking, I broke out in hives around my jaw line.