chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient fainted after receiving the vaccine. Staff gave water, monitored heart rate, oxygen level and took blood pressure Q15 minutes. Patient stated they forgot to tell us that they faint during some medical procedures especially after seeing blood. Patient returned to baseline approximately 30 mins after fainting.  Color was good 99% oxygen pulse 67 BPM 12 blood pressure was 130/70.  Offered an ambulance - patient declined, offered to take patient to the emergency department patient declined.  Offered to drive patient home and patient accepted. Patient was dropped at residence with a friend meeting there. Patient was counseled on adverse affects to look for and to call 911 or go to the emergency room if condition got worse.
Patient states that she woke up at 3am on 3/26, about 12 hours after her injection experiencing nausea. She got out of bed and describes feeling dizzy and passing out. By 12pm on 3/26, she was experiencing dizziness, headache, body aches, and a fever of 101 degrees F. She also describes significant swelling in the arm where she received her injection, with swelling extending towards her chest. She called her PCP and the health department information line, and decided to go to an urgent care facility at 2pm on 3/26. At the urgent care, per patient report she was assessed to have a temperature of 101.8 degrees F, and a "low BP," value uncertain. Per patient, she was referred to ER for further evaluation of the swelling in her arm/chest and hypotension. In the ER, per patient report, she was given IV fluids and toradol and released the same day. The next day, 3/27, she reports that her symptoms began to decrease. She still had a headache, fever (99.8 degrees F) and body aches. The swelling in her arm began to decrease at this point as well. As of 3/29/21, patient describes mild headache, body aches, and no fever. She is taking tylenol and ibuprofen periodically.
patient felt tingling in their neck, arms and hand and then few days later it went to their feet; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number and Expiration Date: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient felt tingling in their neck, arms and hand and then few days later it went to their feet (medically significant). The clinical outcome of the event was unknown.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Terrible headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Terrible headache) and PYREXIA (Fever) 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 02-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Terrible headache) and PYREXIA (Fever). At the time of the report, HEADACHE (Terrible headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Treatment information was not provided.
The nurse who gave me the shots in the line I was in, gave me 2 shots and when I asked her why she gave me 2 shots, she mumble something that I could not understand. By 20:00, that same day, my body was covered with hives from my neck to my feet. My genitals, legs, ankles and feet were all very swollen. There was no itching, but I felt "unwell" and uncomfortable and very frightened, to say the least. I have been getting the flu shots every year for the past 10 years and have never had an allergic reaction before. On 11/17/00, I called the clinic and explained what had happened and she said I must have received a pneumonia shoe, as well, however, I did not sign the form for a pneumonia shot, I did not pay the extra $2.00 for a pneumonia shot and I was not in line for the pneumonia shot. My physician prescribed Benadryl, which did not help. My body was so puffed up that I gained 15 pounds in 3 days. I was then prescribed Prednisone, which seemed to help and my body weight gradually returned to normal and the hives are slowly fading. However, as of this date, 4 weeks, post vax, of the 2 flu shots, my ankles and feet are still swollen and I still have red hives on my feet and I still do not feel well. I have gone to several different doctors and none have any definitive answers as to how long this is going to last and what I can do about it. I am getting desperate. Is there someone in your organization who can help me?
Got taste in mouth after I left the place and went Home I got flash of red in neck and face . Headache. Nauseated. Arm hurt a lot next day. Headache wouldn?t go away. Day offer shot I got sick. Fever, sore throat.
pt recv vax 24JAN97 & on 25JAN97 pt exp numerous generalized sz;the events prolonged existing hosp, & remained hosp for more than 10 days;all lab values were nl;pt recovered;
can tell me if this label is actually mislabeled and it actually wasn't adult dose that got a child label sticker on; He was supposed to receive the adult formulation but believes he got the pediatric formulation; Received the Pfizer COVID-19 Vaccine, it should be an adult dose but on the label of the vaccination card where it's written like the pediatric dose was administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Dec2021 (Lot number: FL0007, Expiration Date: Mar2022) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart condition" (unspecified if ongoing), notes: Medical Condition and Concomitant Medication: Consumer stated, "Yes, I have heart condition. The patient took concomitant medications. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 21Dec2021, outcome "unknown", described as "He was supposed to receive the adult formulation but believes he got the pediatric formulation"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 21Dec2021, outcome "unknown", described as "Received the Pfizer COVID-19 Vaccine, it should be an adult dose but on the label of the vaccination card where it's written like the pediatric dose was administered"; PRODUCT LABEL CONFUSION (non-serious), outcome "unknown", described as "can tell me if this label is actually mislabeled and it actually wasn't adult dose that got a child label sticker on".  Additional addition: Vaccination card which was typically had to be peeled off the vaccination vial indicates it's a pediatric Pfizer 5 to 11 its a 0.2ml, Pfizer age 12 plus 0.3. The patient received the Pfizer COVID-19 Vaccine, it should be an adult dose but on the label of the vaccination card where its written like, the pediatric dose was administered or the sticker on the vaccination card that has been given to him apparently was a Pediatric Pfizer vaccine 5 to 11 years old. The patient had no recent lab work. The reporter related to a study or programme.  Follow-up attempts are completed. No further information is expected.
FELT WEIRD; FEVER; CHILLS; This spontaneous report received from a patient concerned a male of an unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (suspension for injection, route of administration, batch number and expiry were not reported) dose was not reported, for prophylactic vaccination (dose number in series 1). No adverse events reported with dose number in series 1. The patient received additional covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, batch number and expiry were not reported) dose was not reported, 01 total, administered on 14-DEC-2021 for prophylactic vaccination (dose number in series 2). The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-DEC-2021 (Tuesday) the patient felt weird and patient experienced fever and chills, and it was most likely from booster (dose number in series 2). Patient informed that events duration was weird. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt weird, fever, and chills on 16-DEC-2021. This report was non-serious.
CC:  Urticaria and headaches following receipt of AVA                                            IMMUNIZATION  Vaccine Date Onset Date  SYMPTOMS Anthrax #1 3/19/2003 @4/19/2003 One month after receiving his first anthrax vaccination this service member's back developed a fine red pruritic rash that peeled requiring medical attention. This rash was also noticed about both ankles, groin and waist where elastic touched. He reports onset of migraine like headaches after his first anthrax vaccination that persist today along with the rash. Each anthrax vaccination makes the rash last longer with increasing pruritis and headaches. See HPI. Anthrax #2 4/2/2003 @4/19/2003  Anthrax #3 4/16/2003 @4/23/2003  Anthrax #4 12/10/2003 @12/17/2003  Anthrax #5 2/3/2004 @ 2/10/2004   History of Present Illness:    This 38 year-old received his first anthrax vaccination on March 19, 2003 prior to deployment.  Approximately one month later, he states his back began to itch fiercely. His buddies told him his back was covered in red bumps that later cracked and peeled.  The rash spread to both ankles, groin, and where ever elastic or a constricting piece of clothing touched his skin. He was seen by medical, diagnosed with first an allergy to detergent/chemical in his clothing and later a "heat rash." He was given Allegra and a skin cream.  It took two weeks for this rash to resolve.  He states he is now very sensitive to detergents and soaps.   He received his second anthrax vaccination on April 2, 2003.  While trying to sleep that evening he states he felt a "crawling sensation all over."  After two days of continued itching and reoccurrence of the rash he returned to medical where he was diagnosed with "sand fleas".   He was given some Allegra and advised to "clean his gear."  The rash persisted and he returned to medical questioning the rash in conjunction with his second anthrax vaccination.  The medic agreed he had a mild systemic reaction and treated with Allegra.  The rash resolved after 4 days.  He reports the onset of a 4/10 throbbing "migraine-like" headache located over his temples and forehead after the first anthrax vaccination.  He states his eyes became itchy and he felt "woozy in the mornings" as if his equilibrium is off.  He states the sensation is like trying to "cross your eyes" and you feel woozy.  This sensation lasted a few seconds up to five minutes resolving spontaneously.  Nothing caused the sensation and it occurred at anytime of the day or night. He reports a history of having a rare headache, if any, that sleep would resolve prior to receiving his anthrax vaccinations.  He reports the headaches continue to occur 1-2 times a month requiring Tylenol for relief.  Sequential anthrax vaccinations produced similar symptoms with increasing duration and intensity of discomfort.  The rash continues to occur 3-4 times a month lasting for 4-5 days intermittently as of October 26, 2004.
sick...flu symptoms started thursday following vaccine...continue with stuffed up & blah feeling as of today 12/5/19 1st & last Last time i get a flu shot!
PT first was very sensitive, screamed, loss of appetite, and then lethargic. Onset of sleeping and arm twitching (seizure) is what caused the referral of PT to the ER. Symptoms slowly occurred. Treated with subdural hematoma and retinal hemorraghes. Discharge summary on 05/05/04 states: Non-accidental injury, subdural hematoma
This case was reported by a nurse via call center representative and described the occurrence of pain in a adult female patient who received RABAVERT (batch number C2A011A, expiry date April 2020). On an unknown date, the patient received RABAVERT. On an unknown date, immediately after receiving RABAVERT, the patient experienced pain, burning sensation, eyes tearing, muscle pain and inappropriate preparation of medication. On an unknown date, the outcome of the pain, burning sensation, eyes tearing, muscle pain and inappropriate preparation of medication were unknown. The reporter considered the pain, burning sensation, eyes tearing and muscle pain to be related to RABAVERT. Additional information was reported as follows: The age at vaccination was not reported. At 9 am the patient received only the diluent portion of the RABAVERT which led to inappropriate preparation of medication. Immediately after the diluent portion was given, the patient reported pain, burning, muscle hurts and tear to eye. As of 10:40 am, the patient was still experiencing the symptoms. The patient received the correct RABAVERT dose in the right arm, after the incorrect dose was given. Lot number or expiry date was not given for the correct dose given. The patient went home. No additional information was provided.
24MAR92 @ 145PM pt devel local rxn @ inject site lt thigh, about 2 1/2" circumference red & swollen; Mom described as every 2 hrs; pt  devel more hives, head, ears, torso, arms, legs, everywhere per mom w/itching, fever 101; MD visit 26MAR
This spontaneous case was reported by a  and describes the occurrence of PAIN IN EXTREMITY (sore arm), TENDERNESS (tenderness), SWELLING (swelling), ERYTHEMA (redness) and CHILLS (CHILLS) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), TENDERNESS (tenderness), SWELLING (swelling), ERYTHEMA (redness), CHILLS (CHILLS), PYREXIA (fever) and MYALGIA (aches and pains). At the time of the report, PAIN IN EXTREMITY (sore arm), TENDERNESS (tenderness), SWELLING (swelling), ERYTHEMA (redness), CHILLS (CHILLS), PYREXIA (fever) and MYALGIA (aches and pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment details were provided.  patient does not think a follow-up is required as the reaction seems to be brought by a change in detergent.     Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: TCR Form     updated the follow-up consent of patient
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     No Medical History information was reported.     Concomitant product use was not provided by the reporter.  The facility had a temperature excursion in the freezer. They had an inspection and saw that their DDL was not recording the temperatures.  At the time of the excursion, the vaccine was in frozen storage. The vaccines were in broken cartons with vial size of 2.5 mL and 5.5 mL.  Because only manual recording was done twice a day, the maximum and minimum temperatures reached by the vials were unknown.  The excursion duration was unknown. The vaccine was returned to the freezer.   The visual inspection showed the vaccine state as still frozen.  The vial underwent temperature excursion for the first time.  Treatment information was not provided.
It began (11pm on the day of injection) with sever pain in both injection site (Covid vaccine in left shoulder & Flu vaccine in right shoulder) that prevented my ability to sleep until 4:30 am.  In the morning  additional symptoms developed (continual pain in both shoulder, chest congestion, general body ache, mild headache, persistent smell of cigarette smoke (no one smokes) and low grade cough.   Symptoms present at time of reporting.
Headache LIGHTHEADEDNESS, CHILLS, FATIGUE, SORE ARM, MALAISE  Narrative:    Other Relevant History:
The patient received Monovalent Moderna (6 months - 5 years) at 25 mcg/0.25 mL. This is a lower-than-authorized dose administered to the patient. Patient received 6-11y Moderna vaccine on 12/13/2022.
61 y.o. female who arrived by Home presented to the emergency department for Evaluation of syncopal episode.  Patient reports earlier this morning at 330 she awoke to go get a glass of water, states that she felt significantly weak and felt that she would drop the glass of water she was going to get it.  She describes mild associated lightheadedness but denies vertigo, visual disturbance, chest pain, dyspnea.  She that went to ambulate to the living room so she lied on the couch, but does not exactly remember what happened after this.  She remembers that there is a chair and she thinks she may have fallen forward and hit her head against a chair and fell down to the ground.  She notes that she had currently has a fat lip and feels slight abrasions on her knees bilaterally.  History is notable for hypertension, dyslipidemia, states has been compliant with her medications.  No recent illnesses, cough, colds.  She underwent vaccination 3 days ago for COVID with the majority of vaccine and reported 2 days ago she had mild body aches and myalgias, however at present states she feels largely asymptomatic.  She was encouraged to present to the emergency department at the request of her coworkers  Laboratory work-up largely unremarkable.  CT head no acute process.  EKG my read sinus rhythm, normal PR, QRS, QTc, no ST segment changes or T wave inversions concerning for ischemia.  Discussed the work with the patient recommended that she follow-up as an outpatient with her primary care provider, also provided with a Zio patch and recommend to follow-up with cardiology.  Patient extravascular fat study with plan felt comfortable for discharge home.  Discharged in stable condition
Shivering, violent trembling, fever, chills - lasting nearly 4 days; also complete loss of appetite, achiness, lack of energy, loss of bladder control - lasting about 7 days.
Information has been received from patient's mother who reported that her 17 year old daughter on 12-AUG-2008 was vaccinated with GARDASIL.  There was no concomitant medication.  On 14-AUG-2008, two days after her daughter was vaccinated she began to have an upset stomach which has been ongoing up until now.  The patient's mother said that the stomach discomfort has been occurring approximately 15 minutes after she eats or drinks something.  At the time of the report, the patient had not recovered from her upset stomach.  The patient sought unspecified medical attention.  Additional information has been requested.
now he need to wait 2 weeks before getting his 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (now he need to wait 2 weeks before getting his 2nd dose) in a 43-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (now he need to wait 2 weeks before getting his 2nd dose). On 11-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (now he need to wait 2 weeks before getting his 2nd dose) had resolved. Not Provided          Concomitant medication not provided. Treatment medication not provided.   Reporter did not allow further contact
Pt. received Japanese Encephalitis vaccine and developed acute nausea within 1/2 an hour. No other anaphylactic symptoms.
Pt c/o nausea and vomited 3 minutes after vaccine was administered. Pt has history of nausea and vomiting after all vaccines .  Pt was given cold compress to neck and transferred to stretcher placed in recumbent position. Was accompanied by father and observed for 15 minutes. Pt stable and ambulatory. Was discharged from unit in no acute distress accompanied by father.
Pt got shots, c/o arm pain, got up et sat in chair in the room while sibling got shots. Pt passed out in chair, called for dr to come in room. Arm stiff/calf pain/emesis. Heart rate 60 - recovered to 72.
Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a ten- years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (carton Lot: UI985AC and Pre-filled syringe Lot: UI985AC) expiry date: 22-Mar-2019 via intramuscular route in the right deltoid on 13-Sep-2018 instead of vaccine FLULAVAL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included ACETAMINOPHEN for an unknown indication at a dose of 325 mg. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was not reported whether the patient experienced any adverse events following the vaccination. 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 party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
approx 48hr post vax 1 1/2" in diameter area around shot is red rt leg;pt has no other signs or sx of distress, no fever, not fussy-x/for red area;mom called MD 10JUL98 f/u pt well-redness gone;pt nl;
Patient has red rash, left side of forehead and surrounding Lt eye, consistent with shingles.
Patient was given first Pfizer vaccine. Approximately 5 minutes after injection patient came to the nurses station complaining of some tightness in the throat. He states that it felt difficult to swallow. No complaints of SOB, difficulty breathing, no redness or swelling around the mouth. Nurse alerted the doctor of the day who performed an exam.
Patient developed a case of shingles the day after vaccination according to the doctor.  Rash developed on patient's side.