chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3248), via intramuscular route of administration in right arm on 01Mar2021 at 12:00 (at the age of 39-year-old) as dose 1, single and via intramuscular route of administration in left arm on 23Mar2021 at 12:00 (at the age of 39-year-old) (Batch/Lot Number: EP6955) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included omeprazole, sertraline hydrochloride (SERTRALINE A), generic multi vitamin; all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. No COVID prior vaccination and tested with COVID post vaccination. It was reported that the patient was vaccinated in Mar2021. On 01Jul2021, the patient began experiencing COVID symptoms. On Saturday, patient went and got tested and on "Sunday", the patient got the positive result for COVID 19, "I am currently". On 01Jul2021 at 12:00, the patient had experienced horrible fever swings and body aches with no taste or smell. The patient received confirmed test results on "Sunday" 04Jul2021. Adverse events were resulted in doctor or other healthcare professional office or clinic visit. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included SARS-COV-2 RNA, QL, RT PCR(COVID-19): positive on 04Jul2021 (Nasal Swab). The outcome of COVID-19 was reported as not resolved.  Follow-up attempts are completed. No further information is expected.
loose stool/patient still with diarrhea; ear pulling; low grade fever of 99.5 F; decreased appetite; This spontaneous report has been received from a nurse practitioner and a nurse via a company representative, referring to a currently 17 month old patient of unknown gender. The patient's concomitant medication and drug reactions or allergies were unknown by reporter. The patient had no pertinent medical history.  On 07-JAN-2019 and 13-MAR-2019, the patient had received two doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) as per the dosing schedule, orally, (dose/lot/expiration date: #1 lot# R013289 with expiration date reported as 03-OCT-2019,  but upon internal validation established as 10-MAR-2019, #2 lot#R017926 with expiration date: 30-APR-2020, strength was unknown) for prophylaxis (reported as normal childhood vaccine schedule), along with diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (PEDIARIX) (dose, frequency, strength, route, lot# and expiration were unknown), haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (dose, frequency, strength, route, lot# and expiration were unknown) and pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (dose, frequency, strength, route, lot# and expiration were unknown).   On 14-MAY-2019 (reported as at 6 months of age), the patient received the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) as per the dosing schedule, orally, (lot# R022223 with expiration date: 24-MAY-2020; strength was unknown), along with diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (PEDIARIX) and pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) were given with rotavirus vaccine, live, oral, pentavalent (ROTATEQ).  On 01-APR-2020, the patient was seen on for loose stool, low grade fever of 99.5 degrees Fahrenheit (F) and ear pulling. No ear infection present. On the same day, a stool swab was done and was positive for rotavirus on 03-APR-2020. A follow up with the patient's parents on 03-APR-2020 found the patient still with diarrhea and decreased appetite and fully recovered on 07-APR-2020. Treatment was given for adverse events with oral hydration and ibuprofen. The patient had sought medical attention. The outcome of low grade fever of 99.5 F and ear pulling was unknown. The causality assessment between the events and the suspect therapies was not reported.  Upon internal review, the event diarrhea (positive for rotavirus) was determined to be medically significant.  This is one of 3 reports received from the same reporter.; Sender's Comments:  US-009507513-2004USA004637: US-009507513-2004USA004625:
Shortly after receiving this vaccine, I had shaking and severe nausea to the point where I couldn't really get out of bed for several days. I missed work for these days. The nausea has persisted and I am on day 19 after the vaccine and am still having severe nausea. No chance of pregnancy
shaking and chills; no energy from Saturday 1:00 am until Sunday sometime between 1 and 3am  when I broke out in a sweat; I did not have a fever; took one 325 mg. Tylenol every 4-6 hours starting at 4:00am Saturday; chills would periodically subside but continued off and on until early Sunday morning.  When I woke at 8:00am on Sunday I felt great - a little weak, but normal.  To reiterate: Was up and restless, chills the night after the shot; during the day slept off and on; slept 12 hours on Saturday night. Very unusual to need so much sleep and to have chills that were uncontrollable at times.  Arm was very sore and remained red for 4 days.
employee mixed vaccine incorrectly with only .6ml of diluent instead of 1.8.  prolonged monitoring occurred,. no adverse outcomes. no reported issues from patient
Height: she shrunk; aching in shoulders and uppers arms; aching in shoulders and uppers arms; her whole body has felt colder; She does not feel good; She has been pretty depressed with the pain; crying; This is a spontaneous report from a contactable consumer. An 85-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3248), intramuscular in upper left arm on 13Jan2021 13:15 at single dose for covid-19 immunisation (prevent covid).  There was no medical history. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She got the flu shot and shingles shot way before the covid vaccine. The patient got her Pfizer covid vaccine last Wednesday on 13Jan2021. She had been aching in her shoulders and upper arms hurting real bad on 14Jan2021. She had some chills. She did not feel good and it did not seem to be letting up. The first day she was fine. She clarified that she did not experience chills, she felt colder on her whole body on 14Jan2021. She took ibuprofen (ADVIL) about 2.5 to 3 hours ago earlier as treatment. Height: she shrunk. She still had a good appetite. She had been pretty depressed with the pain, she was hurting and crying from the pain. No emergency room or physician office visit required. She was scheduled to get her second dose at the same facility. The outcome of events aching in her shoulders and upper arms hurting real bad, felt colder on her whole body was not recovered. The outcome of other events was unknown.
58 y.o. man with hx of long standing low back pain, repaired thoracic AVM, hx of PE/DVT on Xarelto, HTN, HLD, and possible CVA with facial cranial nerve palsy resolved with iv-TPA presents for evaluation of bilateral lower extremity weakness x 2 months. LP today with cytoalbuminologic dissociation indicative of Guillain Barre. His symptoms began shortly after receiving the Johnson and Johnson vaccine
7 1/2 x 5 cm area of redness and swelling of (R) mild thigh-mildly tender. Two shot punctures seen. No fever, chills, hives, HA, wheezing, cough
ANCA Positive Vasculitis; adverse event of vasculitis; This is a spontaneous report from a contactable consumer reported for a male patient received from a Pfizer sponsor program. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number and Expiration date: unknown), via an unspecified route of administration on an unspecified date, as single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date, as single dose for covid-19 immunisation. Medical history included vasculitis. The patient concomitant medications were not reported. On an unspecified date, following second dose of vaccination, the patient experienced adverse event of vasculitis and, ANCA positive vasculitis (anti-neutrophil cytoplasmic antibody positive vasculitis). It was reported that the patient had ANCA Positive Vasculitis and ended up getting a recurrence of it after getting the vaccine and they were not sure if it was related or not. The reporter mentioned that she was calling to see if there have been any other examples of this happening. The outcome of the events was unknown.  Information about lot/batch number can be obtained. Additional information has been requested.
His side effect are ''cold and cold''; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Lot number: 8020) at the age of 16 years as dose number unknown, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NASOPHARYNGITIS (hospitalization) with onset 2021, outcome "recovered" (2021), described as "His side effect are ''cold and cold''". The patient was hospitalized for nasopharyngitis (start date: 2021, discharge date: 2021).  No follow-up attempts are possible. No further information is expected.
Swelling and Bruising of L Upper Arm. Pt stated arm swelled up and throbbed. Upon examination 10/18/18 at 3pm - still noted quite a bit of bruising and yellowing. Still tinder and sore. Pt stated that dose last year did NOT have any problems. Pt will follow up if conditions worsens.
vaculitis; GI symptoms; This case was reported by a physician via sales rep and described the occurrence of gastrointestinal disorder in a 6-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   The patient's past medical history included premature birth (Patient was born 6 weeks premature).   On 16th October 2020, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 26th October 2020, 10 days after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced gastrointestinal disorder. On 29th October 2020, the patient experienced vasculitis. On an unknown date, the outcome of the gastrointestinal disorder and vasculitis were unknown.   It was unknown if the reporter considered the gastrointestinal disorder and vasculitis to be related to Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient along with her mother returned to physician's office on 26th October 2020 with gastrointestinal symptoms and was seen. The patient was seen again by physician on 29th October 2020 and presented with vasculitis. This was 1 of 3 case reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR047386:same reporter US-GLAXOSMITHKLINE-US2021AMR022342:twin´s case
Over the past week and a half I have experienced lots of side effects: light headedness, fatigue, shortness of breath, slight fever, feeling off balance, sore throat and tongue.
Headache, Myalgia & Fever Narrative: missed two days work following second dose of vaccine due to flu like symptoms
Circumstance or information capable of leading to a medication error; No adverse event; Pharmacist has vaccine for 6 to 11 year old patients The Pharmacist feels that the labeling is confusing enough that she almost made a mistake because the labeling says "booster doses" only on the box.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT LABEL CONFUSION (Pharmacist has vaccine for 6 to 11 year old patients The Pharmacist feels that the labeling is confusing enough that she almost made a mistake because the labeling says "booster doses" only on the box.), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to a medication error) and NO ADVERSE EVENT (No adverse event) in a 6-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2023, the patient experienced PRODUCT LABEL CONFUSION (Pharmacist has vaccine for 6 to 11 year old patients The Pharmacist feels that the labeling is confusing enough that she almost made a mistake because the labeling says "booster doses" only on the box.). On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to a medication error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT LABEL CONFUSION (Pharmacist has vaccine for 6 to 11 year old patients The Pharmacist feels that the labeling is confusing enough that she almost made a mistake because the labeling says "booster doses" only on the box.), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to a medication error) 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 PRODUCT LABEL CONFUSION (Pharmacist has vaccine for 6 to 11 year old patients The Pharmacist feels that the labeling is confusing enough that she almost made a mistake because the labeling says "booster doses" only on the box.) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to a medication error).    No concomitant medications were reported. Expiration date is not known. No other adverse events were reported. No treatment medications were reported.
On Tuesday 02/24/2020 I went to bed with severe chills. Woke up at @3am and while walking to the bathroom I was disoriented and then passed out TEMPORARILY and hit my backside and head on the floor. My wife came to my aide and I was profusely sweating and felt drained and light headed. I made my way back to my bed and my wife administered cold compresses to my head. Within @ 15 minutes I started to feel a bit better, but very tired. I fell asleep and woke the next day feeling like I had the Flu. We drove to the medical center Hospital and went to the Emergency Room where I was seen by Doctors. All vitals were taken and I had a fever of 101.2 and a low blood pressure. Blood and urine was taken and I was put on an IV DRIP. I was released after @ 5 hours and went home. That evening my temp spiked to 104. I took Iboprophen and after a couple of hours it started to come down. Now after 1 week from the vaccines my symptoms are very Flu like.
Fever for 24 hours - high was 102 degrees. Started 6 after injection  Chills - 20 hours on and off.  Started 10 hours after injection  Sore at injection site - 96 hours. Started 3 hours after injection  Dizzy - 2 hours. Started 18 hours after injection
Injection site and a decent sized circle underneath it has what looks like cellulitis. The rash is hot to the touch and swollen. It has now been a whole day that it has been there.
I have had headaches on and off for a couple of days since I got the vaccine. I took some tylenol which would help a little bit and then return
Lost sight while sitting- vision went white screen, 2 - 3 seconds later felt surge of blood in head and vision returned to normal.  Sat several minutes to access situation- no SOB, no palpitations, normal pulse, normal respiratory rate.  Followed up with Electrophysiologist (submitted pacemaker trace- identified approx 4 hour Afib that transitioned into Ventricular tachycardia with 195bpm rate and heart stopping for 4 seconds unable to maintain rate.  Cardiologist, whom I had follow-up appt with said Pacemaker restarted heart and he and new Electrophysiologist- placed me on Flecainide Acetate 50mg bid on 6/25 and all issues resolved.
While I was asleep I woke up to my left am moving all over the place 0n it's own and there was no feeling in the arm at all.  Next morning I could not open the door with my left hand. it took me a couple months to relearn how to tie a tie to go to church.
Four hours after shot was dizzy and had a pretty constant headache. Still today 6/24/21 am having bouts of dizziness headaches ranging from noticeable to very painful.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: cellulitis-Mild, Additional Details: pt report white puss, dx with cellutilis on abx treatment today
I think it's a sinus infection; my throat feels weird; sleepy a lot; there's mucus starting from my sinuses; feeling out of it; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (I think it's a sinus infection), THROAT IRRITATION (my throat feels weird), SOMNOLENCE (sleepy a lot), SECRETION DISCHARGE (there's mucus starting from my sinuses) and DISORIENTATION (feeling out of it) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, SERTRALINE, BUPROPION, LEVOCETIRIZINE, LOSARTAN, ALPRAZOLAM, ALBUTEROL SULFATE, EZETIMIBE, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and DICYCLOMINE [DICYCLOVERINE] for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced SINUSITIS (I think it's a sinus infection), THROAT IRRITATION (my throat feels weird), SOMNOLENCE (sleepy a lot), SECRETION DISCHARGE (there's mucus starting from my sinuses) and DISORIENTATION (feeling out of it). At the time of the report, SINUSITIS (I think it's a sinus infection), THROAT IRRITATION (my throat feels weird), SOMNOLENCE (sleepy a lot), SECRETION DISCHARGE (there's mucus starting from my sinuses) and DISORIENTATION (feeling out of it) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication information was reported.
Rash on stomach and legs.  Started as small red bumps, then began to itch.  Saw a Nurse Physician Assistance at Hospital Emergency Room that evening.  Treated with Prednisone and Atarax.
After 1st dose:  Sick for two days.  Fever, chills, body aches, headache, nausea.  After the 2nd dose:  Sick for only one day with the same systems, but more severe.
started with chills, sore arm, progressed to fever, muscle aches, twitching muscles in left leg, fatigue, red splotches in right arm, terrible pain in right arm, headache, jabs of pain at different times, different parts of body (chest and legs), tightening of chest
I have no history of headaches. Starting the week after my second vaccination, I started waking up in the middle of the night with headaches so severe that they brought me to tears and I felt like I was going to vomit. The first headache was the worst. I'd give it a nine in severity with 10 being the worst. Since that first episode, I've continued to have headaches in the middle of the night about every second to fourth night, the last one occurring last night with a severity I'd rate at 7.  These headaches are accompanied by body aches all over and fatigue, which may be from a lack of sleep. I can find nothing different in my life to account for these episodes
After giving vaccines, pt reported that his stomach was hurting and that he was feeling like he was going to pass out. Pt did not have a syncope episode but just felt like he was going to faint. Pt's skin turned very pale and he was holding stomach, complaining of nausea after vaccines were given. Pt did report before vaccines that he did not like getting shots and that it had been a while since he has received any vaccines. Pt was given a cool cloth to apply to neck and head,  a bottle of water and cool fan placed in front of patient. Pt was instructed not to make any sudden movements or stand up and to sit in office for 15 minutes for observation. Pt's symptoms resolved within 15 minutes and pt was escorted to lobby where mother was waiting for him. Pt did not drive to office and was instructed not to after this visit. Mother and patient verbalized understanding.
I did not have an adverse reaction to the vaccine. I noticed a change in my pulse one day while out driving. I contacted my doctor, and it was determined that I have a heart arrythmia. On 04/13/2023, I had to go to the emergency room for observation. I am scheduled to see a cardiologist on 04/26/2023.
My arm started itching at the injection site a week after receiving the vaccination. Today there is redness, irritation, and discomfort.
THE 2ND DAY I FELT VERY SICK I STAYED IN BED ALL DAY I HAVE ASTHMA & MY INHALER WASNT WORKING SO I HAD TO GO TO ER & THEY PUT ME ON THE NEBULIZER  & WHILE I WAS IN ER I NOTICED MY EYESIGHT WAS BLURRY . SO I WENT HOME & STILL FELT SICK & MY EYES STAYED BLURRY SO I MADE APPT TO SEE MY PCP ABOUT A WEEK LATER & HE STATED I WAS HAVING ADVERSE REACTION TO VACCINE.
Pt. received 1st dose of Jannsen vaccine at 1503 by EMT. Approximately 25 min post vaccine administration she started to feel a "burning sensation" in her throat, similar to the reaction after her first dose of Moderna on 1/29/21. We observed her for another 10-15 min and then she c/o of dryness in her throat, no compromise to airway, but concern about possible delayed reaction to this vaccine admin. Decision was made to call 911 and have her evaluated at Medical Center. Transported via ambulance by FD
09/02/22 presents to EC ED for "fevers". PMHx of "hyperlipidemia, AAA, dementia, CAD, carotid artery stenosis"
PT CAME TODAY AND REPORTED  THAT SHE HAS STARTED EXPERIENCING PAIN ON HER HAND WHERE SHE RECEIVED VACCINE ON 09/13 . SHE STATED SHE DID NOT HAVE ANY PAIN WHEN SHE RECEIVED VACCINE ON 8/6.