chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies or reactions or concomitant medications. On an unknown date, the patients were vaccinated with improperly stored VAQTA lot # M031696 with expiration date of 26-MAY-2017, lot# M034896 with expiration date of 26-MAY-2017, lot# M039202 with expiration date of 11-MAR-2018, and lot# N005274 with expiration date of 03-APR-2018, for prophylaxis (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 47-77 degrees Fahrenheit (°F) for 3 hours. There were not previous excursions. Data logger was involved.  No adverse symptoms were reported. No product quality complaint was involved. No further information was provided.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA001229: US-009507513-1705USA001009: US-009507513-1705USA001232: US-009507513-1705USA001230: US-009507513-1705USA001231: US-009507513-1705USA001228:
Partially lost smell; Partially lost taste; Headache; Short time "everything come black"/ short time "black down"; Sore arm; Night time sweat; Short time "lost control of muscle of neck"; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Short time "everything come black"/ short time "black down") in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Short time "everything come black"/ short time "black down") (seriousness criterion medically significant), PAIN IN EXTREMITY (Sore arm), NIGHT SWEATS (Night time sweat), MUSCLE DISCOMFORT (Short time "lost control of muscle of neck"), DIZZINESS (Dizziness) and HEADACHE (Headache). On 11-Apr-2021, the patient experienced HYPOSMIA (Partially lost smell) and DYSGEUSIA (Partially lost taste). On 10-Apr-2021, LOSS OF CONSCIOUSNESS (Short time "everything come black"/ short time "black down") had resolved. On 11-Apr-2021, NIGHT SWEATS (Night time sweat), MUSCLE DISCOMFORT (Short time "lost control of muscle of neck"), DIZZINESS (Dizziness) and HEADACHE (Headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), HYPOSMIA (Partially lost smell) and DYSGEUSIA (Partially lost taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications use was unknown.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Pt had vaccines administered 01-08-08. Became congested with runny nose approx 1 week later. On 01-19-08 pt became more fussy and tired and developed a rash over bilateral upper extremities and across trunk. Pt taken to Stat Care 01-20-08 and was diagnosed with "Viral Exanthem." Family was instructed to keep pt out of child care for up to 1 week while rash still visible. Also instructed to administer infant Tylenol or Motrin as needed. Pt developed low-grade temperature of 100.0F on 01-21-08. Rash still present at this time.
Deceased Narrative: Patient was outpatient, there is no information about reactions, underlying or active conditions between the time they came in for their first Pfizer dose and their death.
Patient developed firm, tender papules and pustules to hands and feet with a few to arms and legs measuring from 3-7 mm in size 2 days ago and states he had his smallpox vaccination 2 weeks ago. He will be treated with atarax for itching and motrin for pain. He has been warned against further rubbing/scratching and to wash all clothing and bedding and to prevent cutaneous contact with others. He was placed on quarters and I will follow up with him in 2 days. He was also consulted to preventive medicine doctor for further follow up and reporting.
Self reported allergic reaction to MRNA COVID vaccine - Nonspecific dizziness, brain fog, seizure like episodes.
Fever body/joint ache. fever - 102.0, took tylenoL.
Information has been received from a nurse practitioner concerning a 64 year old female consumer with hypertension, hyperthyroidism, osteoporosis and no known allergies who on 07-APR-2008 was vaccinated SQ in the right upper arm with a single dose of zoster vaccine live (Oka/Merck) (lot # 659268/0158X). Concomitant therapy included LOTREL, MAXZIDE, BONIVA, NEXIUM and SYNTHORID. On 08-APR-2008, the patient developed soreness at the injection site. On 09-APR-2008 the patient was examined in the office. There was no lab studies performed. The exam revealed a 4X4 cm area of redness at the injection site. There were no lesions. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
MMR, Varivax, Hepatitis A, and Fluzone given on 9/4/07. 9/14/07 awoke with rash on torso, neck and face - blotchy, papular. 1 tsp Benadryl given.
About 5 minutes after the vaccine, I felt like the vaccine going through my body, mu fingers kept tingling, heart rate started to race. They game me some orange juice and monitored me for about 15 minutes. I went back to work and I felt shaky for about 3-4 hours. I then had a terrible headaches and back ache. That same night I got some hives and chest tightness with increased in throat production and the headache continued that night.  The next day I still felt tired and achy, felt like a mild flu. I had chest tightness with difficulty breathing.  I continued to feel sick Saturday and Sunday and Monday I had a Covid test done, which was negative.  On Monday I had rashes on my arms and legs and continued to have the hives and on Tuesday I started to feel a bit better with a dry cough.  On Tuesday 01-12-220 I had a chest x-ray which was negative.  On Wednesday, I woke up and felt much worse and that's when I called the NP and she prescribed three inhalers for my breathing issues. On 01-27-2020, since I was still feeling not better I called off work.  As now, I am slowly getting better, but I still continued with the hives.
Patient described the day after receiving the injections that redness and pain at the injection site.  He has had fever and chills, highest recorded temperature reading is 100.3F.  The patient had a virtual visit on 10/31.  It was requested to draw around the redness and if increases to be seen.  He came in on 11/1 due to increase in size.  The redness covered from mid deltoid down to an 1/2 inch to the elbow.  it is warm to the touch.  A couple of raised areas like welts, but mainly flat.
Child complained of dizziness immediately after receiving flu vaccination; skin color pale. Recovered within 15 minutes after episode with no further complaints.
EXPOSURE TO COVID-19; OFF MEDICATION AFTER BEING EXPOSED TO COVID; NEEDLE STABBING/PRICKLE STABBING FEELING; VACCINATION SITE PAIN; SWELLING OF LEGS; PAINFUL R ARM; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included there was no reported medical history.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included upadacitinib for rheumatoid arthritis.  On 01-APR-2021, the subject experienced painful r arm. On 30-APR-2021, the subject experienced swelling of legs. On an unspecified date, the subject experienced exposure to covid-19, off medication after being exposed to covid, needle stabbing/prickle stabbing feeling, and vaccination site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful r arm, and swelling of legs, and the outcome of vaccination site pain, exposure to covid-19, needle stabbing/prickle stabbing feeling and off medication after being exposed to covid was not reported. This report was non-serious.
Moments after receiving vaccine patient passed out. Mom and Dad were with her. Pharmacist had dad lay her on the floor, pharmacist lifted legs and patient immediately regained consciousness. Pharmacist asked patient to stay in the waiting area until she felt better. Patient was given frozen water bottle wrapped in paper towel (store was out of immediately cold ice packs). When patient indicated she was ready to leave, pharmacist instructed parents to walk near in case she felt faint again. Pharmacist called patient a few hours later to check but no answer. Left message but no return call.
Patient reported heart racing and blood pressure rising rapidly - she noticed about 4 hours after and it got increasingly worse in the early afternoon - she called Dr. to report it and ask if she should go to the ER because she was becoming very worried about it.The Dr. told her to calm down and continue monitoring at home for a few more hours by 9pm it had resolved.
has COPD a Chronic Breathing Lung Disorder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  An 89-year-old male patient received BNT162b2 (BNT162B2), in Feb2022 as dose number unknown (second booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (First booster, unknown manufacturer), for Covid-19 Immunization. The following information was reported: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "has COPD a Chronic Breathing Lung Disorder".  Additional information: Caller had COPD a Chronic Breathing Lung Disorder and had his Pfizer Covid-19 second Booster 5 months before (Feb2022). He wanted to know if he still needs to get another booster shot because if he gets covid, he will probably die.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
62 years old patient received the Fluzone High-Dose in error not the standard dose that was ordered, no AE; 62 years old patient received the Fluzone High-Dose in error not the standard dose that was ordered, no AE; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 62 years old patient who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number and expiry date not reported) on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  It was reported that the age of 62 years old patient received the Fluzone High-Dose in error not the standard dose that was ordered. Nurse inadvertently gave high dose flu vaccine.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Recurrence of pancreatitis requiring hospitalization, with abdominal pain, lipase to 6740, D-dimer to 4516, without flare of primary symptoms of MCTD (no arthritis, myositis, dyspnea, worsening of Raynauds, photosensitive or vasculitic rashes).  Still hospitalized on d4 after admission, anticipate d/c in next 24-48 hours
Exposure to COVID-19 virus  Fatigue, unspecified type  Nasal congestion  Cough
NIGHT OF VACCINATION DEVELOPED FEVER, CHILLS, BODY ACHES AND LIMITED MOBILITY IN ARM THAT RECEIVED INJECTION
Patient states she started with hives on 03/17/21 around 8pm. She states the hives initially started on her stomach and chest and gradually spread to her back/legs and head.  Currently hives are present all over her body and she c/o hives are itching. She has not taken any OTC medication for the hives. Patient also c/o headache, chills and muscle aches and nausea that started on 03/17/21 and resolved on 03/19/21.
Arm tingling, numbness, pain, with increased pain when moving fingers into a fist.
started with a "Parkinson's freeze" the same day, next day developed trouble breathing and admitted for bilateral pneumonia and sepsis.
My wife the virus first and she got sick and tested positive and we were on a trip we cut the trip short and come home and the next day I started developing symptoms and I tested positive.
Information has been received from a 32 year old male consumer with a pcn allergy who in August 2001 was vaccinated with a dose of hep A vaccine. There was no concomitant medication. Subsequently, two weeks after being vaccinated, the pt developed a "hot burning sensation" all over his body and also had a fever. It was reported that six months later, in approximately February 2002, the pt received a booster dose and two weeks later, had the same symptoms. The pt did not seek medical attention. Additional info has been requested.  A 15-day follow up report received 6/3/2003 adds: Follow-up information from the doctor's office reported that they "are not aware of this adverse event, the pt did not notify the doctor." Additional follow-up info from the physician reported that there are "no reports of this pt having received hepatitis A virus vaccine inactivated or having a reaction to it." No further info is expected.
felt weak; Dysentery; violently sick; throwing up; dehydrated; dry heaving; This is a spontaneous report from a contactable consumer. An 84-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: E18982, expiration date was not reported), intramuscular on the left arm (also reported as left shoulder) on 15Jan2021 at single dose for COVID-19 immunization.  The patient medical history was not reported. It was reported that the patient was taking an unspecified blood thinner and other unspecified products. It was reported that patient got the first dose on 15Jan2021 and everything was fine. The following Friday, exactly a week later, on 22Jan2021 at 930am he got violently sick as far as throwing up and dysentery. He was asking if it could be from the shot. He got sick and was heaving for 7 hours, then he was dry heaving after throwing up so much, it was green bile. He knew he was getting dehydrated and drank a bottle of Pedialyte at 7pm that night. He had to stay a half hour after getting the vaccine since they wanted to monitor him a little longer since he takes blood thinners an other crap. He did not specify the other medications that he takes. On Saturday he felt fine but he felt weak. The patient recovered from dysentery and throwing up on 23Jan2021, while outcome of the remaining events was unknown.
Tiredness, sore back of neck, shoulders,  and lower back All occurred about the same time (~18h after vaccination)
lightheadedness - 1 week and continuing. Have appointment 2/18/2021 with primary care doctor.
5/18/21 rash hands, wrists, forearms, trigger finger both hands, hands and arms going numb at night, restless leg. Told  Dr. about Trigger finger on 6/30.  Aug, Sep, Oct, Nov daily headaches. Took sumatriptan daily.  8/24/21 hypersensitive skin on hands and wrists. Tender touch felt like slice with razor blade. Facility prescribed mentholated hand cream. No relief.  11/5/21 Dr. office visit. Suggested Shingles vaccine for hands. I declined. Hand still extreme pain.
104 degree fernhait fever; under 16 and over 12 years of age/received the Pfizer COVID-19 vaccine; Received the second dose of the vaccine 2 weeks apart instead of 3 week from dose 1; This is a spontaneous report from two contactable consumers (patient mother and father). A adolescent male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took the first dose of BNT162B2 in May2021 for covid-19 immunisation. The patient was under 16 and over 12 years of age. The son of reporter (patient) received the Pfizer COVID-19 vaccine one week earlier then recommended time. The patient received the second dose of the vaccine 2 weeks apart instead of 3 weeks from first dose. Reporter stated the second shot was supposed to be the 07Jun2021. That was when he was supposed to receive is second vaccine. The patient was experiencing 104 degrees fernhait fever. The reporter did not want him to die and asked what could they did. The doctor asked they to call Pfizer as he didn't know anything about the vaccine. The outcome of events was unknown.   Information about lot/batch number is requested.
presented on 9/28/2021 with headache and joint pain for 5 days. Patient is fully vaccinated in February of this year. She is mostly at home, denies recent travels. She goes to her doctor's appointments regularly. She has underlying liver cirrhosis, Pt says she was in a funeral 10 days ago, crowded and no masks were on.Her husband and son live with her, both asymptomatic but getting tested symptoms got worse she came to the ER and the screen was positive for COVID infection with pneumonia, she denies any shortness of breath. But she noted a pulse oximetry was low while in the ED it has been within normal limits on 2 L of nasal O2.she is now admitted for further management.
Patient experienced tenderness at injection site in the first 24hrs after. Then 48hrs later experienced arthralgia in left shoulder joint which continues to worsen.
Vaccine was given on 12/10/02. Same night (12/10/02) child started screaming; doctor consoled in her. Then child went limp and couldn't wake up for half an hour. Sweating increased. Rescue called and resucitated.
Upper (L) leg erythemic warm area to touch 16 cm x 9 cm from injection site. No fevers, c/o pain, tenderness, no streaking.
This initial spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patient were inadvertently vaccinated with improperly stored GARDASIL injection (Dose, lot number and route not provided). A total of 32 doses were administered. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd MMR vax JUN90 & following vax became pregnant subsequently, underwent a therapeutic abortion; no further details were provided;
Hair started to fall out; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair started to fall out) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Patient has allergy to Ciprofloxacin.) and Drug allergy (Patient has allergy some generic drugs.). Concomitant products included COLECALCIFEROL (VITAMIN D3), LEVETIRACETAM (KEPPRA XR), BIOTIN, PROBIOTICS NOS and CIPROFLOXACIN for an unknown indication.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2021, the patient experienced ALOPECIA (Hair started to fall out). At the time of the report, ALOPECIA (Hair started to fall out) outcome was unknown.            Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: received FU document it does not contain newinformation.
05/20/2005- Presented in office with rash on face and wrist. DX: with varicella (post vaccine)
Information was received from a registered nurse regarding males who were vaccinated with GARDASIL. She stated that males feel GARDASIL is a painful vaccination. No further information is expected.
10AUG96 listless, earache, eyes puffy-watering (hurt), mucus very yellow from runny nose, stomachache;devel cough then started limping-could not walk;sx lasted until about 12SEP96 then re-occurred 5FEB97 through 9SEP97;
Pt received single steroid injection 9/24/09 and then vaccinated with Zostovox 5 wks later on 10/29/09. Began to feel poorly 2d later and developed classic shingles rash on 11/5/09. Was seen at local walk-in clinic and treated with VALTREX x 1 1/2 weeks. Rash is resolving and pain has decreased by 50%.
Information has been received from a physician concerning a 9 month old female patient who on 02-MAR-2010 was vaccinated with the first dose of ROTATEQ (lot # not reported), on 01-APR-2010, patient received the second dose of the vaccine (lot # not reported) and 07-JUN-2010, the patient was vaccinated with the third dose of the vaccine (Lot # 665275/0301Z). The physician reported that the patient presented to doctor's office on 29-SEP-2010 and was tested for Rotavirus due to presenting with a fever, blood in the stool as well as diarrhea. Upon culture results received on 30-SEP-2010, it was determined she was positive for having Rotavirus despite receiving all the recommended vaccinations. The patient's outcome was not reported. Upon internal review blood in the stool was considered to be an other important medical event. Additional information has been requested.
Pt. cough and shortness of breath for six days. In patient. Treatment Rendesivir injection and Tylenol. Allergic to penicillin.
Grand mal seizure that lasted 5 minutes. Occurred 1am the day after vaccine given
Immediately after receiving the vaccine GARDASIL, my vision blurred and went dark. I had to receive help walking to the car as I felt I was about to faint. Over the next 3 weeks, I experienced extreme fatigue and a weakened immune system. Frequent nose bleeds occurred which has never happened before.
21NOV96 pt recv vax to lt thigh on 22NOV96 daycare reported hives-as of 11:50 on this day more hive were present;tx none;