chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via a company representative refers to a 3 months, 12 days old male patient. There were none concurrent conditions or medical history. On 23-MAY-2014, the patient was vaccinated with the first dose of ROTATEQ 2 ml, orally (lot#, expiry date unspecified). None concomitant medications were reported. On 22-JUN-2014, the patient developed diarrhea. The patient was evaluated in an unspecified emergency room on 28-JUN-2014 and was then admitted to an unspecified hospital on 29-JUN-2014 for the treatment of dehydration. The patient was rehydrated and was discharged from the hospital on 30-JUN-2014. The patient was evaluated in the office on 07-JUL-2014 and was found to have "slimy stool without blood". The patient had also developed vomiting and was prescribed PEDIALYTE. On 07-JUL-2014, a stool culture was ordered which revealed "lactoferrin positive", indicating inflammation. Further stool culture results were pending at the time of report. The outcome of events was reported as not recovered/not resolved. The relatedness between all the events and ROTATEQ was not reported. Additional information has been requested.
Severe Leg pain (especially calves.  Both legs equally) Major Leg swelling Elevated D-Dimer Low platelets Elevated Liver enzymes General Body Aches. Shortness of breath Fever Rash Fatigue / Malaise
Woke up and felt off balance, severe nausea and dizziness. Happened one week after second dose of vaccine. Reacted to the vaccine one day after the second dose as well with fever symptoms. Tylenol treated the fever symptoms and I felt fine until the nausea and dizziness one week later.
Fever of 102, vomiting, body aches all over, weakness, dizzy, headache. Started 12 hours after injection and got worse that same day.
Developed chest pain 2-3 days post vaccine which continued to increase until it became extremely severe on 2/19/21. I finally sought medical care in Urgent care on 2/22/21 where i was doagnosed with costochondritis. I experienced chest pain intermittently all the way until June. In addition my entire body felt swollen and i had pain everywhere different and increased from my normal pain. All of my symptoms started to decrease in May and finally improved in June 2021
Left sided jaw soreness 3/10 then 2/10, no radiating pain No itching, swelling, SOB, tachycardia, diaphoresis, dizziness.  h/p PCN allergy resulting in throat and mouth swelling  Vitals @1424 HR 97, BP 174/105, O2 97, @1427 HR 93, BP 161/98, O2 97,  @1434 HR 93, BP 152/99, O2 97, @1440 sitting HR 92, 157/88, O2 97, standing @ 1446 HR 97, BP 159/86, O2 99  Pt discharged to home, self, at 1447
HEADACHE; This spontaneous report received from a consumer via other company (Novavax) concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced headache for about three months after vaccination with the second dose (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache. This report was non-serious.
my lips broke out in fever blisters and swelling.  I am still dealing with these symtoms
After first Pfizer dose, I was just feeling really tired. After the second dose, around that afternoon/evening I started feeling my mouth feeling weird. The next day I saw blisters filled with yellow/whiteish puss in my tongue. I went to the ER later i felt a lump under left shoulder while showering. On 28 MAY 3 AM I suddenly felt my face feeling numb and tingly along with my legs. Mind you I have been in the field emplacing howizters for the past few days in a field exercise. I also jammed my finger on an 80 lb metal bar on 26 MAY and got my finger poked with a hot device that also drained the blood after getting an xray. I called medical ER  at 242 and spoke to Dr.(?) Doctor did not give me his name spelling after I asked for the spelling and he told me that I could always come in to the ER. I told him whether the finger pricking and blooding draining could cause the left facial numbness and legs tingleness. He said no so i am now assuming it is an adverse side effect. I am a smart guy have bachelors in journalism but right now I cannot concentrate and filling out htis form hastily just i case the effects get worse and I have to go to hospital er. Talking to the Dr. (?) was harder than normal and he asked if my breathing was normal, I said i am breathing heavily, which I did not have much control over. He said breathe normally and I will be better from the tingliness. I can write well I am a journalism major but this is hard to write for me . I am also feeling chills and I am also not feeling well. I was able to get this link from my local online meeting and I am glad I can contribute to the research and science in general. I wish the doctor had tested me for possible problems when I had an adverse effect from the first vaccine but the doctor told me to come back if the "viral infection" gets worse after I breathe normal. I did take a PT test and my 2 mile run time increased and it was much harder to run than the 2 mile run. Time went up by at least 3 minutes.
Fever; Whenever she stand up she got dizzy; Headache; Body ache feel like somebody beat me up; This is a spontaneous report from a contactable consumer (patient herself). A 66-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration, administered in Arm Right on 25May2021 as single dose for COVID-19 immunization. Medical history included constipation and arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had not received any other products. It was reported that on (yesterday) 25May2021 she received Pfizer COVID-19 vaccine and after that she had fever and whenever she stand up she got dizzy." Further it was stated that, "She also want to know if she could not put towel on her head something like that, she wanted some medical advice. She stated, she called because she had fever, headache and body ache feel like somebody beat her up. She inquired what could she do. She had the vaccination. She further stated, "All she wanted to know what she going to do with the pain, headache, body ache and fever. She was informed about Pfizer contact resources and informed about the timings as 8 AM to 8 PM from Monday to Friday and 9 AM to 3 PM Saturday and Sunday. Therapeutic measures were taken as a result of fever, she stand up she got dizzy headache, body ache feel like somebody beat me up as a Ibuprofen received yesterday (unknown date) about 12'o clock in the morning. There was not any investigation assessment. The outcome of all events was unknown.  Information on the lot/batch number has been requested. Additional information has been requested.
Had 2 shingle vx and today got shingles again/ Suspected vaccination failure; And today got shingles again; This case was reported by a consumer via (Shingrix interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (occurred on an unknown date, refer case US2021AMR210315).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On 9th October 2021, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received 2 shingle vaccines and again on the day of reporting got shingles.  The reporter asked was there something wrong with vaccines. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR210315:Same reporter.
Nausea, vomiting, fever 101.5, chills, fatigue for the first 24 hours. Severe headache 24 hours after vaccine. Symptoms lasted 36-48 hours. Fully recovered after 2 days
Information has bee received from a physician concerning a female who was vaccinated with a dose of GARDASIL. Subsequently the patient was taken to an emergency room. The reason the patient was taken to the emergency room was unspecified. At the time the outcome was unknown. This is one of several reports receiving from the same source. Additional information has been requested.
pt recv'd vax & c/o feeling tired, aching & sleepy; w/in couple of hrs after vax, pt  had knot at inject site; t 101 till 2am & chills; took apap;
10 minutes after vaccination, patient noted onset of dizziness, feeling "strange", tingling in her left hand, and palpitations.  At 15 minutes after vaccination, her blood pressure was found to be 200/84 LA and HR90 .  O2 sat 98% on RA.  T 98.2 F. Pt remained alert and in no distress, but continued to feel dizzy and unwell.  Her repeat blood pressure was 184/84. EMS was notified and patient was transported to the emergency room.
site was itching; Arm was hurting; Body is warm; excruciating Headache; Hypertension; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer-BioNTech COVID-19 vaccine, lot/ batch number and expiry date were not reported), via an unspecified route of administration on 20Jan2021 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Jan2021, she had an excruciating headache and her body was warm. She had hypertension. On Thursday (21Jan2021) her arm was hurting. Today (23Jan2021) the site was itching. She did not take a temperature. The outcome of events was unknown.  Information on the Batch/Lot number has been requested.
Heat, redness and swelling at injection site.  Mouth ulcers throughout the mou5th
Discharge Provider: MD Primary Care Provider: DO Admission Date: 4/7/2023 Discharge Date: Apr 9, 2023  PRESENTING PROBLEM: Chronic obstructive pulmonary disease, unspecified COPD type (HCC) COVID-19   HOSPITAL COURSE: 76-year-old male with a past medical history significant for diastolic congestive heart failure on Lasix at home as well as chronic obstructive pulmonary disease with home oxygen utilizing 2 L occasionally but not continuously who presents to the hospital with complaints of cough and shortness of breath.   In the emergency department patient is found to be tachycardic but normotensive.  Oxygen level is low and he required 4 L of oxygen to maintain adequate oxygen saturation.  Labs were obtained and remarkable for a white blood cell count of 10.84.  High sensitivity troponin I was elevated at 47 with repeat check found to be decreased at 39. NT proBNP was found to be 486, within normal limits.  Respiratory viral swab came back positive for COVID-19.  Chest x-ray was read as concerning for subsegmental atelectasis or pneumonia within the left mid lung field and left lung base.  Patient was given a dose of Lasix, methylprednisolone, DuoNebs, and thought to warrant admission to the hospital.   Patient fell much improved shortly after admission to the hospital.  He is continued on remdesivir as well as dexamethasone.  Oxygen was able to be weaned off.   By 4/9, patient was able to maintain adequate oxygen saturation while on room air and at rest.  With activity, patient did not significantly desaturate.  As the patient was feeling much better, he was allowed to be discharged home with prescription for 5 more days of oral dexamethasone and recommendation to continue with home oxygen with activity as he normally does.  He was discharged in stable condition on 04/09.
Patients reported having an episode of Shingles approximately 1 week after receiving the First Pfizer COVID 19 vaccine dose.
Immediately after shot child had clonic/tonic seizure with pallor, no incontinence.
tient is a 71 yo female with a history of CAD, morbid obesity, who reports AE after COVID vaccine #1 (PFR 6206) receipt 04 MAR 2021. She reports no immediate reaction in her first 15 minutes. She states as they were driving away, she noted  increasing site pain and then developed vesicles on the roof of her mouth, bumps on the back of her tongue, in addition to HA, felt feverish,  and discomfort to the side of her neck. She denies urticaria, pruritis, lesions at the injection site, SOB, CP, n/v/d, although notes she takes nightly benadryl and Claritin.  On day 1, the lesions on the roof of her mouth became pustular,. She reports her HA and injection site discomfort were improved. On day 2 she developed HA, chills, dizziness, and the tongue papules improved but the vesicular/pustules lesions were more painful. She slowly improved over time and mostly resolved in three weeks. She still has erythematous papules on her tongue. She denies other dermatitis, pruritis, SOB, angioedema, CP, diarrhea. Event was not reproduceable with dose #2.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-AUG-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0079AE, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Child given vaccine that may have had temperature excursion (Data Logger Failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination  Child had no ill effects thus far
Breakthrough case admission after 3 vaccines Pfizer 2/20/21 Lot# EN6200;  Pfizer 3/13/21 Lot# EL9267;  Pfizer 11/5/21 Lot# FH8020
Cause of Death: Septic shock due to Fungemia due to Infected sacral and bilateral ischial wounds with osteomyelitis Other contributing factors: paraplegia, severe protein calorie malnutrition
Severe and persistent inflammation, numbness, shifting pain, headaches all over body. Intermittent and sometimes continuous. Limiting cognitive abilities. Severe loss of motivation, focus and concentration. Drains energy and makes me extremely tired, lethargic. Pain shifts throughout the body intermittently. Inflammation and numbness more severe in legs and head area.
severe leg and foot cramps/spasms. every night and sometimes during the day time. toes point downwards like a ballerina's foot, calf muscles get hard and very painful.  sometimes my foot shakes when this happens
The location of the injection is very sore. I'm also experiencing mild shortness of breath and fatigue.
Headache fever 100.7  Chills  Diarrhea  Joint pain  Pain on site of vaccine
Redness left deltoid, small amount of swelling, warm to touch. Non tender. Treatment with Zithromax  1 tsp today; 1/2 tsp next 4 days. Benadryl 1.5 tsp PO.
RN began injection at 5:16pm and when depressing plunger of syringe realized plunger was already at stopper, indicating the syringe was empty at time of injection. RN then removed needle and gave full dose of vaccination in same arm at 5:17pm. Because there was no way to confirm there was no dose in the first injection, the guest was given education on the possibility of having received two doses and information on Vsafe. Guest was without any initial side effects and left site to home after 15 minute  observation.
spiked fever of 104 approx 10 1/2 hrs p/vax administered; parents took pt to ER; fever down to 101 approx 10AM;
pt recv vax & devel rash on the upper one half of pt's lt arm; VS pulse 60, resp 24 & BP 100/80; pt explained that the rash felt itchy & hot;
Vaccine on April 11.  April 16 began slight fever, chills, body aches, fatigue...no big deal and expected.   April 20th both hands swelled up, extreme ache in hand n finger joints, could hardly bend fingers.  Other joints as well substantial ache; ankles, knees (shin splints), elbows, wrist, shoulder, all joints, ache very strong but no swelling.  ONLY hands/hand n finger joints substantial swelling.  Took Tylenol 500mg and Motrin 600mg, which helped a little with discomfort.  Slept 13 hours last night, woke today with swelling 50% down.  NEED TO KNOW IF SHOULD GET 2ND DOSE OR NOT. SCARED
On 30-05-2023 lowest temp was recorded at 35.8F) , and on 05-06-2023 the lowest temp. was 33.7 F); After excursion vaccine was administered to patient; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (On 30-05-2023 lowest temp was recorded at 35.8F) , and on 05-06-2023 the lowest temp. was 33.7 F)), POOR QUALITY PRODUCT ADMINISTERED (After excursion vaccine was administered to patient) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7180B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .05 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (On 30-05-2023 lowest temp was recorded at 35.8F) , and on 05-06-2023 the lowest temp. was 33.7 F)), POOR QUALITY PRODUCT ADMINISTERED (After excursion vaccine was administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (On 30-05-2023 lowest temp was recorded at 35.8F) , and on 05-06-2023 the lowest temp. was 33.7 F)), POOR QUALITY PRODUCT ADMINISTERED (After excursion vaccine was administered to patient) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (On 30-05-2023 lowest temp was recorded at 35.8F) , and on 05-06-2023 the lowest temp. was 33.7 F)) and POOR QUALITY PRODUCT ADMINISTERED (After excursion vaccine was administered to patient).    No concomitant information was reported. It was reported that department of health advised vaccine specific refrigerator needed to be used, instead of the dorm-style fridge on site. The vial sat at room temp for 15 mins before admin and then discarded at the end of the day. No treatment information was provided.
Patient stated that she started to have flu like symptoms several hours after administration of SHINGRIX (chills, fever, muscle aches "felt like knives stabbing her in every joint", severe nausea, increased heart rate ->130BPM). After only being able to sleep less than 2 hours, she went to ER where they ran multiple tests including a negative flu test. She stated that they ruled out everything and attributed her reaction to the vaccine. Her symptoms were treated and she covered in the next day or so.
This spontaneous case was reported by a health care professional and describes the occurrence of LYMPHADENOPATHY (armpit is swollen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (armpit is swollen). At the time of the report, LYMPHADENOPATHY (armpit is swollen) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were reported.No Treatment information was reported. Patient had the booster on Tuesday and is  immunocompromised so patient had the full dose not the booster.
A patient received improperly stored VARIVAX; No additional AEs were reported; This spontaneous report was received from a nurse referring to a patient an 11-year-old. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), at a dose of 0.5 milliliters (lot# U016065 with an expiration date on 20-MAY-2023) for prophylaxis (strength, anatomical location, and route of administration were not reported) (product storage error).       The dose of varicella virus vaccine live (oka/merck)(VARIVAX) was exposed to a temperature excursion of 0.3 degrees Celsius (°C) during a time frame of 2 hours and 34 minutes. There was no prior temperature excursion and no adverse events were reported.
received dose reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number AE234, expiry date 12th December 2023) for prophylaxis.   On 15th February 2023, the patient received Hiberix. On 15th February 2023, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 20-Feb-2023 and 21-Feb-2023 Reporter's comment: The nurse reported that a patient (did not know which one cause they did not keep records of the patients) was administered Hiberix diluted using sterile water (that was part of Varivax). The incident was discovered the next day while doing inventory and they realized that one of hiberix vaccines had not powder accompanying.  Did not refer product quality complain. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: The patient received Hiberix which was reconstituted with sterile water, which led to wrong solution used in drug reconstitution.
This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the first dose of ROTATEQ orally (PO) (strength, dose, frequency, lot# and expiration date not reported) for prophylaxis. On 07-FEB-2019, the patient was vaccinated with the second dose of ROTATEQ PO (strength, dose, frequency not reported) with lot# N013992 and expiration date 27-JAN-2019 (expired vaccine used). No adverse effect reported.