chrisvoncsefalvay/vaers-outcomes huggingface dataset:
11:00AM Pt vaccinated. Took a seat in the observation area following injection. 11:25 Reported feeling dizzy,nauseous, and shaky. Pt assisted to a cot and into supine position with her legs elevated on a chair. Initial vital signs 122/78, P-61 O2Sat 99%. Skin cool and dry. States she feels clammy. Denies SOB, medical problems. Reported she had a vegetable smoothie for breakfast. 11:34 Remains supine. Reports still feeling dizzy. 11:41 132/74, P-52-60 Slightly irregular. Pt reported she is taking medication for LTBI. Stated her CXR showed no sign of active disease. She takes 2 pills of the same kind daily. 11:50 118/66, P-60. Reports she feels better. Assisted into sitting position on cot. 11:59 106/78, P-72, O2Sat 9(11:59 continued) Pt given a breakfast bar to eat and water to drink. She ate entire breakfast bar and drank 8 oz H2O.  12:12 128/70, P-73 O2Sat 99%. Denies SOB. Assisted to standing position.  12:18 States she feels much better and that she feels able to go home. Declines to call someone to pick her up as states it is not necessary. Pt walked approx 40 yards to her car accompanied by this RN. At car reported she felt better and able to drive. Pt instructed to avoid strenous activity today, to drink plenty of water and eat regular meals. Pt agreed and was Dc'd home
Information has been received from a pharmacist referring to a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX, subcutaneously (dose, lot number not provided) and at the reporting time, she was experiencing multiple sclerosis flares. She saw doctor for medical attention and was not given treatment for the adverse event. The outcome of multiple sclerosis flares was unknown. Additional information has been requested.
Patient states that she had a flu shot to the left deltoid area and the next day she had swelling at the site that radiated up her arm to her post neck area.
started vomiting @ approx 6AM p/bottle;had a sz & then lost consciousness;began crying;seemed to have trouble breathing;head was ice cold & was very pale;bein dx for cerebral palsy
Patient received Vaxelis after it received temperature excursion of 8.5 degrees for 30 mins; This non-serious spontaneous safety report with Agency reference# 02080037 was received by a partner on 22-Dec-2021 from a Health Care Professional, and forwarded to Agency on 23-Dec-2021.  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-002953, 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 to Agency 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 Vaxelis and the reported event of 'Patient received Vaxelis after temperature excursion of 8.5 degrees for 30 min' remained not applicable.  No further information is expected.
Red, blotchy, itchy rash below injection site appeared 6 days after shot.  Alcohol prep wipes and hydrocortisone ointment helped rash come and go until about 16 days after shot.
Janssen Covid-19 vaccine eua   Chills, body chills, sore body, headache
Patient became very ill quickly, low grade fever, bilateral arm pain, chills and crying that he "didn't feel right". Sent to ER for eval. (Dx: Allergic reaction.
I've had loss of taste, and loss of smell for three days. At the 24 hr post vaccination mark, I started having a severe head cold, stuffed up nose, headaches, eye pain, cough, diarrhea. This has lasted now for 96 hours. Shortness of breath. Sleeping 10-12 hours a day. Lethargic. Etc.
on 6/3/22 Pediatric patient received dose of ADULT vaccine that had been drawn into syringe on 6/2/2022 but had not been administered during the adult clinic. Child was not an existing patient of clinic but was receiving his shots at the facility as his pediatrician was not administering them.  no symptoms at time of vaccine, Dr called and spoke with parents approx one hour later after nursing spoke with pharmacy and Pfizer. parents reported child seemed fine at that time.  they were advised to call back at any point if he started to have any concerning issues, or to call their pediatrician
One day after vaccination, Fatigue.  10 days after vaccine, shortness of breath and pain while breathing.  This happened both times with both shots.   Fatigue the day after, shortness of breath/pain breathing on day 10 lasting 3-4 days.
PATIENT STATES SHE HAD A BUMPY RASH START IN ARMPIT AREA AND GROIN AREA - EXTENDING DOWN INNER ARMS AND INNER THIGHS. PATIENT WILL CONTACT HER PCP FOR FOLLOW UP.
chills; body aches/aching all over; headaches; tired; not resting well last night/didn't rest well last night; a temperature of 99.9F/ fever; where he got the shot was achy; feels like he has a bad case of the flu; tremoring; muscles are achy; This is a spontaneous report from a contactable healthcare professional (patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302 and expiry date: unknown), via an unspecified route of administration on 13Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing high cholesterol since 90s and was taking medication to keep it down, and ongoing neuropathy in the feet back in the 90s. Patient seemed to be okay after the vaccination until he didn't rest well last night on 13Jan2021. The morning of 14Jan2021, he had chills and was aching all over. He has a headache, and he was pretty tired on 14Jan2021. His temperature was 99.9. and wanted to make sure he was okay. They gave him the sheet of side effects but was wondering how long it was going to last. He also had fever and chills on Jan2021. He has been just resting all day long which was all he felt like doing. Patient felt he has a bad case of the flu. When his chills started, he noticed he was tremoring and shaking and his muscles are achy on Jan2021. He usually waits until his temperature is over 100 to take something and noticed where he got the shot was achy on Jan2021. During the night he went to aching more. He was not too excited about getting up and doing anything now. He was tired on 14Jan2021, because he didn't rest well last night and slept in late today. He finally got around, and ate cereal and stuff. He has just been sitting. He would still get the second vaccine, which was not exciting. Outcome of the events aching all over, headaches, and tired are not recovered while for the remaining events was unknown.
Around 730-8 I got a really bad headache. Throughout the night my back tightened up and my hips. I got up tp get ready to go to work, I felt really  light headed while I was brushing my teeth but went in to work. I started felling shortened of breathe and achy. I started feeling  bad and told my Head Nurse and he took my BP and I have a fever. My heart beat was rapid. I went home, slept and had no appetite . The I ended up going to the Hospital  my chest was hurting bad in my lung area, everything about me just hurt I couldn't take it anymore.  They did xray on my lungs, they were clear, my BP was still high, my heart rate had calmed down. They had me sit and relax. The next day I woke up and was ready to put my scrubs on, it was like nothing has ever happened to me. I felt worse with the vaccine then I did when I got the Covid, all I had with Covid headache.  Everything hit so rapid and fast after the shot.
Information has been received from a physician and a healthcare worker concerning a 67 yr old female with a penicillin allergy who on 27Sep05 was vaccinated SC in the left arm with a 0.5mL second dose of pneumococcal 23v polysaccharide vaccine (lot 650453/0791P). In the evening on 27Sep05, the pt's left arm was itchy and swollen. By the next morning, The swelling worsened. On 28Sep05, the pt presented to the physicians office and was treated with fexofenadine hydrochloride (Allegra), a methyl prednisolone (Medrol) dose pack, and levofloxacin (Levaquin). A follow up visit was scheduled on 30Sep05. No diagnostic lab tests were performed. The physician requested a lot check. Results are pending. Left arm itching and swelling were considered to be other important medical events (OMIC) by the reporter. Additional information has been requested.
adult dose of Engerix-B from lot number D23D3 (expiration date 15Mar2025) on 12Jun2023 to a 1 year old female patient; adult dose of Engerix-B from lot number D23D3 (expiration date 15Mar2025) on 12Jun2023 to a 1 year old female patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 14-month-old female patient who received HBV (Engerix B adult) (batch number D23D3, expiry date 15-MAR-2025) for prophylaxis.   On 12-JUN-2023, the patient received the 1st dose of Engerix B adult. On 12-JUN-2023, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: adult dose of Engerix-B from lot number D23D3 (expiration date 15Mar2025) on 12Jun2023 to a 1 year old female patient) and adult product administered to child (Verbatim: adult dose of Engerix-B from lot number D23D3 (expiration date 15Mar2025) on 12Jun2023 to a 1 year old female patient). The outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 12-JUN-2023 The reporter declined to provide patient initials. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The reporter reported that a staff member administered an adult dose of Engerix-B to a patient, which led to overdose and adult product administered to child.
pt stated that w/in 1hr p/vax devel sore throat & t101;pt coughing up large amounts of phlegm;since then has temp of 101 in morning-lower towards evening;advised to see PMD;
sudden onset of h/a, fever @ 630AM on day p/vax;T101 some aching & severe h/a;relieved by APAP;sx dec by MN;pt is afeb w/o h/a now;
Approximately two weeks after receiving my first COVID vaccine, the frequency, intensity and duration of my migraines increased dramatically. For about 20 years I've had one or two migraine headaches per month, usually associated with my menstrual cycle.  Since March 20th until now (July 13th) I have averaged 19 headache days per month.  I have now been diagnosed with chronic migraine with a MIDAS score (Migraine Disability Assessment test) indicating severe disability.
Information has been received from a physician concerning a 9 year old male with no medical history or allergies who on 22-JUN-1998 was vaccinated with a 0.5 ml dose of Varivax. Concomitant therapy included MMR II, Hib conj vaccine (OMPC) (manufacturer unknown) and diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid. There were no other concomitant medications. In November 2005, the patient experienced breakthrough chickenpox. Unspecified medical attention was sought but no labs were done. At the time of this report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
The day after the vaccination my upper left arm was a little sore and tender. I had some joint aching  in arms and hips, not too bad. A few inches below the injection site there was a large (3 inches x 2.5 inches) itchy red patch of skin. it is still there, still itching, 48 hours later. Have not treated it with anything, but took 12.5 mg of Benedryl sleep aid last night to relieve the itch. Have not consulted a doctor.
Lt. leg erythema, edema & tenderness. Edema of 10 cm x 11 1/2 cm in area.
Itching started on my neck around 4pm.  Then noticed after undressing that I had a rash with hives on my neck, torso, back, and upper thighs.  Took benadryl 25mg x 1 dose and went to bed.  Around 6am the next day the rash was completely gone.
I was hospitalized a few days after receiving the vaccine. I was having severe inflammation reaction that caused my joints to be in severe pain and was unable to move. The pain spread to my arms, legs and even jaw where I couldn?t eat solid foods. My inflammation level raised to 20,000 and need help was moving, eating and bathing.
Myoclonic jerks with fever approx 102 lasted about 1 hour. Neurologist evaluated and felt might be from vaccine
Initial unsolicited report received from a physician on 27 April 2016. This case involves a four-year-old female patient who was vaccinated with a dose of DAPTACEL (batch number C4709AA, expiration date: 24 February 2017, via intramuscular route, dose, dose in series and site of administration was not reported) and a dose of IPOL (batch number L1001-1, expiry date: 14 January 2017, via intramuscular route, dose, dose in series and site of administration was not reported), both on 18 March 2016. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was not reported. Concomitant medications were not provided. On an unspecified date following the vaccination, the patient developed abdominal pain and returned to the physician's office on 23 March 2016 who requested that the child be taken immediately to the emergency room. It was reported that there was no information on what medical facility the patient was taken to or whether the patient was actually taken. On 24 March 2016, six days following vaccination, the patient died. Lab data and corrective treatment were not reported. Patient had not recovered from abdominal pain event at the time of death. It was reported that autopsy was pending. List of documents held by sender: none. Sender's Comments: This is a poorly documented death case of a child who was vaccinated with diphtheria-15/tetanus/5 AC pertussis vaccine and IPV (VERO). Five days after vaccination, patient experienced abdominal pain and died the next day. Patient was taken for physician consultation on having abdominal pain, however was referred to emergency room and no further details were provided. No information regarding any previous history of abdominal pain, relevant medical and birth history, underlying cause of death and any diagnostic testing reports were provided. Autopsy result was not available. Due to the very limited available information, causality cannot be assessed for now. Reported Cause(s) of Death: abdominal pain; death nos.
Starting the day after receiving the vaccine, I was very tired in the morning and my arms were very sore. It wasn't until the early afternoon that I really felt poorly. I felt extremely tired, my joints were achy and upon awakening from a nap, my joints on the right side of my body were agonizingly painful. It was difficult to move due to the severity of the pain. I called my son (an ER doctor) and asked for advice/medicine. I took some oxycodone (that was already in the house from a previous surgery) and TYLENOL which helped. When I woke up the next morning, I felt much better. I did not need to take any additional dose of oxycodone.
Rash on my arms/groin/chest After my second Pfizer Covid-19 vax, I noticed this slightly red rash developed on my arms/groin and some on my chest. not very itchy, but noted that it fills with clear fluid if scratched.
1:00pm started having hip pain and was waking slow and painful. Drove home from work around 3:30 and when I got home could hardly get out of car. Got inside and tried to ice, heat, and shower. Also took Tylenol. By 5 pm right hip and leg hurt to the touch and I could not walk. Felt like an ra flareup. Called rheumatologist and she said she was concerned and this reaction hasn?t been seen. She told me to go to ER. They gave me pain medication and steroids which are helping.
Patient returned to office this c/o itching noted to scattered  areas of his body.  Patient noted with scattered red, slightly raised areas to back of thighs, behind bilateral knees, one area to right forearm (inner), noted to left antecubital area as well.  Patient also noted with some patchy areas of redness to abdominals folds and below navel area. Patient alert and oriented. Denies shortness of breath. Talking to staff without difficulty. Benadryl 25mg administered in doctor's office.
Yesterday had a 1/2 dollar size area of redness where she got her immunization and now today that area is more red and hard and with a softball size area of itchy erythema. She has no behavior changes, fever or any other sxs.
weakness, palor, sweating, headache and localized redness at site of injection IN RIGHT ARM.
No adverse event; Wrong dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patient post temperature excursion; Moderna COVID-19 vaccine administered to patient post temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Wrong dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced WRONG PRODUCT ADMINISTERED (Wrong dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Wrong dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Wrong dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion).    This case was for patient 52 out of 104. Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26-May-2022 to 30-Sep-2022 and lot AR5186C was affected between 08-Sep-2022 to 27-Sep-2022. AR5186C was previously reported. Wrong dose was given to adults mistakenly and were reported to VAERS and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case
Woke up on 02/14/2021 and had no sense of taste or smell. 2 negative covid tests.  Also extreme fatigue, shortness of breath, increased HR with little to no movement noticed.  Occasional chest pains.  To this date, the symptoms still exist.
Started out with my shoulder blades being sore that night. I woke up the next morning and was sore all over, my head hurt, and my temperature was anywhere from 100.3-101. I checked it various times thru out the day. By the time I was ready for bed I felt a little better, but not up to normal standards.  I slept thru the night and woke up fine. I wasn't sore anymore and my twmp was 98.2.
mild diarrhea post shot; This is a spontaneous report from a contactable consumer (patient). A 21-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3302) via an unspecified route of administration on the left arm on 14Jan2021 13:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 20Jan2021 05:00 AM, the patient experienced mild diarrhea post shot. No treatment was received for the event. Event resulted to a doctor or other healthcare professional office/clinic visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the vaccine was administered was in a hospital in a Military Base. Post vaccination, the patient has not been tested for COVID-19. Outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
nausea; Really bad chills; shaking; fever; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), CHILLS (Really bad chills), TREMOR (shaking) and PYREXIA (fever) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced NAUSEA (nausea), CHILLS (Really bad chills), TREMOR (shaking) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NAUSEA (nausea), CHILLS (Really bad chills), TREMOR (shaking) and PYREXIA (fever) outcome was unknown.            Concomitant medication were not reported/unknown.
Patient received the Janssen vaccine in the left arm in the immunization room. She then got up and walked over to chair to stay for observation. Within 5 minutes she walked to pharmacy counter and stated she did not feel well. Immediately myself and one technician ran over to help. She stated she felt hot and like passing out. We elevated her feet initially, she did become unresponsive for 1-2 minutes. Other technician called 911 at this time. We then put her flat on the floor and monitored her blood pressure, heart rate and O2. She did begin to talk.  A nurse was in the store and offered her assistance. Patient never stopped breathing but was hot, clammy and slight gray in color. Ambulance arrived within 10 minutes from call.
PER PT- STARTED W/ SORENESS AT SITE THE NIGHT AFTER VACCINE ADMINISTERED. NEXT DAY PT C/O ERYTHEMA & SWELLING FROM LOWER DELTOID TO ELBOW.
Pt lethargic, with non custodial parent out of town. Febrile 11-8-09 -> 11-9-09. Found unresponsive. Died in AM 11-9-09. ? foul play.
Patient was given an adult  dose, (0.3mL) of Pfizer Covid 19 Vaccine.  Anyone 12 years old and up gets 0.3mL of the vaccine.  Children 5-11 years old get 0.2mL.  Father of Patient insisted that the patient was 12 years old while giving information to office staff and nurse administering the vaccine. Once the nurse had given the dose of 0.3mL, she was reviewing the paper work and saw that that the date of birth given would make the child 11, not 12.  After questioning the father again, he said the correct date of birth was 02/05/2011, making the child 11 years old, not 12 years old.  Everything was explained to the father, and the child waited in the clinic 30 minutes after receiving the vaccine to ensure there were no problems or reactions. There were no issues noted, father was instructed to monitor child for normal possible side effects of the vaccine.