chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt bled through bandage, cleaned up and gave new band aid.  pt then got up and walked to front of store and passed out and hit her head on the floor, tried to get up then and passed out again and hit her head again.  at this time a store member came and got me and when I got there she was pale and lying on the floor.  we inclined her legs and I took her blood pressure (130/75).  this occured within 10 minutes of getting the immunization.  we called 911 and when they arrived she was stating she was feeling good and didn't want to go to the hospital.
Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Child male patient for whom expired dose was administered was reported, while he received vaccine ACTHIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation; and DTAP for Immunisation. On 23-Oct-2018, the patient received a 0.5ml dose of suspect HIB (PRP/T) VACCINE lot UI805AA expiry date 23-Sep-2018 via unknown route in unknown administration site. Child was given was given an expired ACTHIB today. No specific AE reported. This case is actual medication error due to Expired vaccine used. Final diagnosis was expired dose was administered. Outcome of the event was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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. Documents held by sender: none.
CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, and seasonal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, administered on 10-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-DEC-2021, the patient experienced confirmed covid-19 infection. On 12-DEC-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection. This report was non-serious. This report was associated with a product quality complaint: 90000206767.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
I felt very lightheaded and woozy roughly 5 minutes after injection. I was found passed out on the bathroom floor shortly after, with no recollection of entering the bathroom. It was estimated I was out for a couple minutes. I personally wondered if it caused blood pressure to drop, but I had no way to test it and was more focused on sitting up at the time. I stayed in the waiting area until I was confident I was able to walk on my own. A second wave, though less intense, happened roughly 30-45 minutes after the first. I left the store after 2 hours with fatigue, arm pain, and the hand of the opposite arm shaking on its own. The hand stopped shaking roughly 3 hours after the injection.  Fatigue was mostly gone in a day. I could not raise my arm above chest height without pain the 1st day. Today is day two and I can raise it up properly again with mild stiffness and slight twinges of pain.
After 4 wks, raising my right arm is still hurting from shoulder to elbow. I am right handed, but had a fatty tumor on left arm. Went to drs. She said to put ince on it. Didn't work.
Fever 102.0 degrees fahrenheit, chills, hot flashes, dull headache, upset stomach, extreme grogginess.  Severe symptoms lasting one day.  Grogginess lasting into the second day after vaccination.
May 5th - had a stroke - I was not hospitalized. It was a minor stroke and only proved by an MRI. I had multiple symptoms - terrible back ache and eventually unable to walk and numbness and tingling in hands and arms  as of July 1st they started -  Guillain Barre syndrome - Diagnosis - when I went to the hospital - on August 4th -  Paramedics took me to ER. I was in the hospital for 8 days. Then I went to Rehab hospital for two weeks and a day.  Gabapentin - was what I was sent home with and I am doing physical therapy currently. I had had occupational therapy too. I used the walker and I used walking sticks and now I can go without but it's agonizing. It is slowly improving. Every day is better. I think I had a light case.  Recovering now - it's continuing.
Case number PHEH2015US026882, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 66-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 07 Oct 2015 which was stored out of recommended temperature range (temperature excursion at 34 degrees). The nurse stated that, the reason was unknown for the refrigerator to be out of temperature range. There was no any further problem since the temperature excursion problem. No further information was provided. No adverse event was reported following this medication errors. Follow up report received from a nurse on 26 Jan 2016: Updated reporters comments.
swollen glands in neck; This is a spontaneous report from a contactable health care professional, the patient. A 57-year-old non-pregnant female patient received an unspecified dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 24Mar2021 at 16:00 (at the age of 57 years old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within two weeks of vaccine. On 26Mar2021, patient experienced swollen glands in neck. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event swollen glands in neck was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Infant had a fever of 101-102 within 6 hours after his vaccines. He screamed uncontrollably for 4-5 hrs. Fever did not respond to Tylenol but did decrease with Motrin. Mild erythema on right thigh. Eating and drinking ok.
This spontaneous report as received from a consumer refers to his/her 12 year old granddaughter. The patient's pertinent medical history and drug allergies were unspecified. On an unknown date, the patient was vaccinated with first dose of GARDASIL (dose, frequency, route and lot# were not reported) and on the same day, the patient received a booster shot, unknown vaccine name. Concomitant medications were none. From 15-AUG-2015, the patient experienced back to back menstrual cycles (polymenorrhoea). The outcome of the event was unknown. The relatedness of the event with GARDASIL was not reported. Additional information is not expected as the reporter did not wish to contact.
Patient felt flushed then cold and throat felt cold. No SOB nor difficulty breathing.  Within ~22 minutes patients symptoms resolved and patient felt back to normal, leaving the clinic without further issues
swollen rt arm, very red & tender;swelling noted in armpit;arm is bruised;(used ice packs)
Had a sore arm for a couple of days; Patient did not receive their second dose of the Moderna COVID-19 vaccine for more than 36 days.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Had a sore arm for a couple of days) and PRODUCT DOSE OMISSION ISSUE (Patient did not receive their second dose of the Moderna COVID-19 vaccine for more than 36 days.) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included ATORVASTATIN, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN + HIDROCLOROTIAZIDA), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), MONTELUKAST, ACARBOSE, AMLODIPINE, FUROSEMIDE, GABAPENTIN and GLIMEPIRIDE for an unknown indication.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Had a sore arm for a couple of days) and PRODUCT DOSE OMISSION ISSUE (Patient did not receive their second dose of the Moderna COVID-19 vaccine for more than 36 days.). At the time of the report, PAIN IN EXTREMITY (Had a sore arm for a couple of days) and PRODUCT DOSE OMISSION ISSUE (Patient did not receive their second dose of the Moderna COVID-19 vaccine for more than 36 days.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided
Patient denied any adverse reactions.  Patient was in the clinic with guardian for 15 mins and denied any adverse reactions.  Patient guardian was informed by the community health nurse about the wrong brand vaccine administered and grandmother denied any adverse reactions.
rash on your legs; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as an unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the reporter just wanted to know if it was a normal reaction from Pfizer Vaccine to get a rash on your legs and all that. The reporter seriousness for the event was reported as unspecified. The reporter was informed about Pfizer Medical information department and was provided with the number. QR Comment included it could not be clarified if the caller was calling for self or for some other user, hence was the patient also the reporter. The outcome of the event was unknown.  Information on batch/lot number is requested.
I have had tinnitus since about a week after my vaccination.  This ringing in my left ear only is sometimes so loud it wakes me up at night.  There are times when I do not hear it.  It is always worse as the day goes on.
SHE STARTED FEELING ILL THE NEXT DAY AND THEN 4 DAYS LATER SHE STARTED GETTING LARGE RED SPOTS WENT TO URGENT CARE AND THEY INFORMED US THAT SHE HAD SHINGLES...AND IT WAS CAUSED BY THE COVID SHOT.
Patient's wife called and claimed that she noticed a rash same as hers on the left arm. Patient had to go to urgent care and doctor suspected of cellulitis. Patient came in on 03/24/2018 and showed me the area, arm appeared to be bruised rather than a rash. Patient claims he takes COUMADIN.
This spontaneous report as received from a Licensed Practical Nurse on behalf of an unspecified patient's mother refers to a patient of unknown age and gender about the "binding agent" in M-M-R II. The patient was vaccinated with a dose of M-M-R II (lot# 12376, expiry date: 28-AUG-2010) (dose, route and location unspecified) in 2008. The reporter stated that she was unsure if the patient had any reactions to the M-M-R II but stated that the patient will be seeing unspecified specialist for an unspecified reason on an unspecified date. At the time of report, the outcome of the event was unknown. Additional information has been requested.
Developed fever 99.0 chills, diarrhea and vomiting within 24 hours after taking 1st dose.
The patient received Vaxelis after it experienced a temperature excursion 8.5 degree for 30 minutes; This non-serious spontaneous safety report was received by regulatory agency reference# 02080012 on 22-DEC-2021 and forwarded on 23-DEC-2021 from a Health Care Professional.  Due to the nature of the event, the causality between Vaxelis and the reported event of 'Temperature excursion' was not applicable.  For reference purposes this case is linked to MCM-002954, MCM-002956, MCM-002957 due to same reporter.  Further information is expected.  FOLLOW-UP INFORMATION was received by Fax from a HCP on 27-Jan-2022. On 28-Jan-2022 additional information was received by the partner from the same HCP and forwarded on 31-Jan-2022. The case is maintained as non-serious.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "Patient received Vaxelis after temperature excursion of 8.5 degrees for 30 min" and Vaxelis remains not applicable.  No further information is expected.
Woke up next day with left leg sciatic pain, difficult to move leg. Could not put on socks and shoes. States coworker had similar reaction after her flu shot. Also stated she walked all around BIG E (fair) day before. Attempted accupuncture and could not tolerate. Is improving at time of call without intervention approximately 4 days post shot.
Crying all night 13MAR92; fever 104 & over 13MAR92 & 14MAR92;
Information has been received from a registered nurse concerning an 11 year old female with no medical history or drugs allergies, who on 24-NOV-1998 was vaccinated with a 0.5 mL first dose of VARIVAX (Merck) (lot # 628147/1262H), subcutaneously.  The patient received a second dose of VARIVAX (Merck) (lot # 658286/1096U) on 18-JUL-2009 in her left arm.  There were no concomitant medication.  On 18-JUL-2009 the patient developed chicken pox with less than 50 lesions present.  No laboratories studies performed.  The patient sought medical attention through a phone call.  At the time of this report the patient was recovering.  Follow-up information was received from the registered nurse who reported that the female patient received 2 doses of VARIVAX (Merck) and still contracted varicella disease.  At the time of reporting, the patient had recovered.  No further information is available.
pt states that she felt dizzy and nauseated immediately after getting the vax.  Within 24 hours her left arm became sore and she experienced weakness.  She lost range of motion and had to see her PCP.  She was referred to have physical therapy.  After several months of physical therapy with no improvement was then referred to an orthopedic Dr.  She was given a cortisone injection.  She was told this was from having inflammation from the vaccine.  She states she has had improvement after having this injection but still some achiness and some limitations. Her arm is about 80-90% better at this time.
After having the vaccine 08Jan2021 and 27Jan2021 I tested positive for COVID-19 on April 4, 2021; After having the vaccine 08Jan2021 and 27Jan2021 I tested positive for COVID-19 on April 4, 2021; This is a spontaneous report received from a contactable consumer (patient herself). A 78-year-old female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: El3246) via an unspecified route of administration in arm on 27Jan2021, (at the age of 78-years-old) as single dose for COVID-19 immunization and was previously administered the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: El3246) via an unspecified route of administration in left arm on 08Jan2021 10:00 as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included diabetes, lymphoma, high blood pressure, thyroid from an unknown date and known allergies: Sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Concomitant medications were not reported. The patient tested positive for COVID-19 on 04Apr2021 after having the vaccine 08Jan2021 and 27Jan2021. The patient was sent to the hospital for the events. The patient received antibody infusion as treatment to the event. The outcome of the events was not resolving.  Information related to batch/Lot no. was requested. .
Headache; Vomiting; Stomach pain; She is not breathing; This is a spontaneous report from a contactable consumer. This consumer reported for a 16-year-old female patient (reporter's sister) that: A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 20Aug2021 as dose number unknown, single for COVID-19 immunisation at pharmacy. The patient medical history and concomitant medications were not reported. She was having some side effects. She was having headache; she has vomited and a lot of stomach pain. We only gave her Tylenol (Intent: treatment). She took the vaccine on Friday in the afternoon. She stated having them yesterday (21Aug2021) in the afternoon, but it got worse this morning. She said she was not breathing. We are going to send her to the hospital.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pt received COVID-19 vaccine on 2/23. He felt tired and unwell after. He had a syncopal episode on 3/4 and presented to ED. He was in complete heart block. Pacer placed. No CAD on coronary angiogram. Normal heart function. Discharged home. Presented unwell to ED with chest pain and elevated troponin  on 3/16 found to have cardiomyopathy EF around 25% (medically managed, sent home) Repeat left heart cath done at the time showed no CAD. Presented to ED 3/22 with cardiogenic shock, EF 10%. Proceeded to have multiorgan system failure, impella placed, had cardiac arrest, transferred to another facility for further support. Was placed on VA ECMO. Heart biopsy done 3/25 revealed giant cell myocarditis. Pt is in critical condition and not expected to live d/t sequelae from cardiogenic shock: shock liver, AKI, ischemic bowel with ecoli bacteremia.
First dose of the vaccine was given to a 17 year old; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose of the vaccine was given to a 17 year old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose of the vaccine was given to a 17 year old). On 08-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose of the vaccine was given to a 17 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Patient demographic details were added, updated lot number provided and anatomical site of the dosage.
Acute response to the first dose of the Moderna series was a large raised , warm rash on the arm in which the vaccine was administered about 5 days after receipt of vaccine("COVID arm").  Response to the second dose included nausea/vomiting, muscle aches, joint pain in multiple joints, fever and fatigue.  This response started 9 PM after receiving second dose of vaccine at 4 PM and did not resolve completely until 3 days later.  Also experienced repeat of COVID arm with second dose - not as severe as with the first dose. I have since been diagnosed with DVT in left in December of this year with no identifiable risk factors for blood clots (i.e., age < 65, no personal of family history for clotting disorders, not pregnant, not on hormonal contraceptives, no history for long trips, no injury or surgery, not obese etc).  Clots were described  by provider as being  chronic rather than acute so cannot rule out that these could have been triggered by the vaccine rather than another cause - especially given the absence of any other risk factors for clots.
heart felt like it was fluttering; Had no appetite; felt like something was sitting on chest; Slept all day; felt tired; sore arm/arm hurt very badly; This is a spontaneous report from a contactable consumer. A 12-year-old male patient received bnt162b2, intramuscular, administered in Arm Left on 12Jul2021 17:00 (Lot Number: ew0181) as DOSE 1, SINGLE at age of 12-year-old for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced heart felt like it was fluttering on 13Jul2021 19:00, sore arm/arm hurt very badly on 12Jul2021 19:00, felt tired on 13Jul2021, had no appetite on 13Jul2021 19:00, felt like something was sitting on chest on 13Jul2021 19:00, slept all day on 13Jul2021 19:00. Evening had sore arm. Next morning felt tired and arm hurt very badly. Had no appetite. Evening of next day felt like something was sitting on chest and heart felt like it was fluttering. Slept all day and next day woke up felt ok. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
localized; erythema four centimeters by four centimeters on left tricep immediately following BOOSTRIX vaccine Lot # AC52B029AA. Within 20 minutes responded to BENADRYL 50 mg oral dose.
I experienced dizziness, almost passing out. It was like when you stand up too fast then you sit down and it was more aggressive than that, and I fell down the first time. I fell into the bed and when I opened my eyes I was lying down. I tend to sit down when I get this episodes. I sweat really bad and shake when this happens to me.  I do not know which way is up and down. When the dizziness subsides, my sweating kicks in really bad. I will be seeing Dr. in two weeks on 09-24-2021.
Dizziness, lightheaded, tachycardia tumoritis persisting since May! Patient c/o sf since May 23 (initially seen 5/28/08 for complaints).  2/24/09 MR received from PCP from 3/2008 to 1/2009 for multiple visits with multiple c/o. PE 3/18/08 with normal exam except wrist tenderness from waitressing. HPV and TDaP given. HPV#2 5/120/08.  First seen 5/28/08 with c/o dizziness and lightheadedness x 4 days. Dx:  Dizziness-no clear etiology. F/U 6/6/08, 9/18/08 with continued sx and now with lower abd pain and suprapubic discomfort.  Neuro consult 7/9/08 with normal exam. DX: Transient lightheadedness of unclear etiology. Encouraged increased H2O and vitamins. 8/18/08 presented with SOB and dizziness. anxiety attack noted 9/18/08. Abnormal PAP with colposcopy 11/2008.Sx continue through 1/09.  W/u (-). DX:  dizziness.
This spontaneous report as received from a reporter (details unspecified) refers to a 12 year old female patient. The patient had no medical history. On 30-OCT-2012, the patient was vaccinated with a second dose of GARDASIL 0.5 milliliter (ml), intramuscular. No concomitant medications were taken. On 12-NOV-2012 (reported as day 12 of second dose), the patient experienced headache, vomiting and fever. No laboratory test was performed. The outcome of headache, vomiting and fever was unknown. Additional information is not expected.