chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe rash on face, it was itching, uncomfortable, and painful; severe rash on face, it was itching, uncomfortable, and painful; severe rash on face, it was itching, uncomfortable, and painful; severe rash on her chest; severe gastrointestinal issues/really bad gastrointestinal pain; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0151, Expiration date and NDC number was unknown), via an unspecified route of administration on 16Apr2021 as dose 2, single (at the age of 55-years-old) for covid-19 immunisation. Patient had no medical history. Patient had no food allergies. Concomitant medication(s) included iodine (131 I) (bovine, it is a natural supplement) taken for thyroid from an unspecified start date and ongoing. Historical vaccine included female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER2613, Expiration date and NDC number was unknown), via an unspecified route of administration on 26Mar2021 as dose 1, single (at the age of 55-years-old) for covid-19 immunisation. On Apr2021, 10 days after the second dose, maybe, patient had really bad gastrointestinal pain. At first patient did not think it was from the vaccine. Patient had this for a week or 2 and eventually subsided. They never found anything, and it was eventually going away and patient thought it could have something to do with the vaccine. Patient went with her husband to get the shots.  On 26Apr2021, patient saw her doctor. On 28Apr2021, patient had severe rash/ severe rash on her chest started after the second dose, she does not typically have skin problems, and went to the dermatologist. On 30Apr2021, patient had a virtual appointment for the rash. The dermatologist said sometimes they don't know what causes things like this rash. Several ointments later, patient's rash had finally subsided. If the rash comes back, she had another ointment to put on it. Patient stated gastrointestinal pain was back in April it only lasted about a month. It was very strong for a very long time and then subsided and patient noticed she did not have it anymore. It did not matter what the caller ate, broth or a sandwich. On 08Jul2021, patient got a second rash on her face a few weeks later and saw her dermatologist. This wasn't life threatening but it was itching, uncomfortable, and painful. The rash on the patient face looked just like the one on her chest. Now the rash on the patient face was healing. The caller had to get ointment that was different from the chest ointment that was not as severe for her face. Patient wanted to know if anyone had a similar reaction. The outcome of severe gastrointestinal issues/really bad gastrointestinal pain and severe rash on her chest recovered on an unspecified date of 2021, severe rash on face, it was itching, uncomfortable, and painful (rash pruritic) was recovering and unknown for rest of the events.  Follow-up attempts are completed. No further information is expected.
About 10 minutes after the shot, I began to feel warm all over. About 15 minutes after the shot, my feet became numb. About 20 minutes after the shot the numbness spread to cover both feet, both legs up to the hip joint, the left arm, both cheeks, and my tongue became heavy. About 30 minutes after the shot, I was unable to walk and could not lift either leg more than an inch off of the table. I could feel my doctors touch, but I had no control of my legs. I felt like I had be shot up with Novocain throughout my body. About 1 hour in, my numb legs began to twitch uncontrollably. This was very scary. About 2 hours after my shot, the numbness in my body turned to pins and needles. At this point I could walk again so I went home. My doctor told me he had not seen that kind of reaction before. The pins and needles lasted until I went to sleep. In the morning ,I woke up feeling like I was on a ship and off balance. It feels like I am having inner ear issues. The pins and needles come and go.
RED, PAINFUL, AND SWOLLEN ARM. DIAGNOSED WITH CELLULITIS IN ER AND PUT ON ANTIBIOTIC ON 9/16/17.
Information has been received from a physician concerning a 5 week old female with no known drug allergies or relevant medical history who was vaccinated with a first, second, and third dose of hep B vaccine recombinant on 04/03/99, 05/07/99, and 01/05/00, respectively. It was reported that the pt was "intense and screaming" on all office visits and for an emergency room visit. The pt was diagnosed with autism at the age of 3. The pt sought unspecified medical attention. Upon internal review, the pt's autism was considered an other medical event. Additional info has been requested. The follow up states the pt was born with jaundice and was seen in the practice at 4 days of age with continued jaundice. The jaundice resolved within a few weeks. The pt was a healthy infant with no known drug allergies or significant past medical history. The pt had may well visits documented, and a few sick visits for otitis media.
fever, cough, aches - lasting 2 days fatigue - lasting 3 days
diagnosed with new variant of COVID-19; Low grade fever; Can't breath/Can't always clear my airway; Cough that is different than it normally is; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Can't breath/Can't always clear my airway), COUGH (Cough that is different than it normally is), COVID-19 (diagnosed with new variant of COVID-19) and PYREXIA (Low grade fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to animal (Allergy to horses) and COPD. Concomitant products included VALSARTAN (DIOVAN), OXYCODONE HYDROCHLORIDE (OXYCONTIN), OXYCODONE, METHOCARBAMOL (ROBAXIN), TIZANIDINE HYDROCHLORIDE (ZANAFLEX) and GABAPENTIN for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jul-2021, the patient experienced DYSPNOEA (Can't breath/Can't always clear my airway), COUGH (Cough that is different than it normally is) and PYREXIA (Low grade fever). On an unknown date, the patient experienced COVID-19 (diagnosed with new variant of COVID-19). At the time of the report, DYSPNOEA (Can't breath/Can't always clear my airway), COUGH (Cough that is different than it normally is), COVID-19 (diagnosed with new variant of COVID-19) and PYREXIA (Low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jul-2021, SARS-CoV-2 antibody test: positive (Positive) Patient was diagnosed with new variant of COVID-19.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment information was reported
2/15/22- Arrived to ER with complaints of SOB upon exertion, weakness and pelvis pain after a fall three weeks ago . Has had to ambulate with walker, Cane is baseline for her. RA sat at home 80's. Covid + test on admission.  2/16/2022- Admitted Covid 19, hyponatremia and pubic rami fracture. RA sat 88% place on 2LNC.  BP-222/88 given IV hydralazine. Sodium- 121. Baricitininb,IV decadron,  IV Rocephin , IV azithromycin , Lovenox and Remdesivir if increased o2 requirements. Continue BP medications: Amlodipine, clonidine, lisinopril and metroporolol. Chest x ray- right basilar infiltrate  and pelvis xray- unoffical read pubic rami fracture.  2/17/2022- Official read pelvic xray negative. Requiring now 0.5L of o2NC., 2/18/2022-  No longer requiring any supplemental oxygen, 92% on RA. BP-143/62. Sodium 124. Discharged to home, continue current medications cefdinir added for pneumonia.
Shot given on 12/02/2005. On 12/03/2005 itching at site where shot were given along with a morbilliform rash that spread to all of patient body parts.
arm nearly paralyzed and very painful for about 35 hours post injection; fever 101 for 24 hours: chills and mild night seat occurred during evening for 2 nights post; 2 days of tolerable fatigue; now, while almost 3 full days after injection, i'm feeling about 95%  recovered, experiencing only very mild pain at injection site only. tested positive for covid on 10/22/2021 qualitative naat; tested negative on 11/05/2021 qualitative naat;  symptoms worse with injection then with actual infection with covid 19 virus.
I had swelling in my right armpit lymph node and a mild rash that developed on the 4th day. I also developed Bell?s palsy in the right side of my face. I went to the ER where I was prescribed prednisone and valacyclovir. These medications both helped a little. On June 25th the rash got worse, and the doctor prescribed a steroid cream which has helped. The rash has gone away from under my arm, but my lymph node is still swollen. On June 25th the doctor also said my face was more symmetrical, but I still have weakness and pain on my jawline and lip area. The pain is like a nerve pain and still comes and goes but it is not as bad as it was initially.
Received MMR 9-14-06.  Developed diarrhea that evening on 9-15-06 student developed fever and itching on trunk of body.  Site of injection painful, swollen, and erythematous.
Mom reported that Sat. mid-morning she had low grade fever (99-100F) and headache. Mom gave Ibuprofen. At 8pm Sat. night her T. was 102F. Sunday, she developed a rash on her face and hands ans she continued to have fever. By Monday she had rash over her entire body. Fever continued. Mom called MD for an appt. on Tuesday.  Tues. morning her face was swollen. She saw the doctor at 2:45 PM. Mom reported that her oxygen saturation was 78%. The doctor gave her oxygen, benadryl and ibuprofen.
Pain at injection site has continued.  Currently have limited range of motion.  Doctor diagnosed as tendonitis.  Exercises prescribed are making pain in shoulder/arm worse.  Constant pain in shoulder/arm.  Pain, tingling, numbness radiates down arm and into clavicle.  Have limited ability to lift & use left arm.
Type of vaccine is listed as HIB PRP-T -- I am not sure which one to select in the drop down. On August 22nd, 2016 patient began a fever at 3 PM that climbed to 102.9 by 8 PM. On August 23rd, 2016 the fever continued and a rash began all over his body. We went to the ER. Which they gave him suppositories to reduce the fever.
Tachycardia, chest pain, EKG changes Referral Cardiology ED visit Death
Numbness, chills, headache, tiredness in response to second shot after about 1 day . All faded but still sleeping far more than usual 2 days after shot (when I am reporting). Took NSAIDS, no need for professional attention (or if there was need, no professional attention was sought).
Low grade fever 3 days, fuzzy headed, lethargy, joint aches & pains (2 days) , exhaustion, trouble remembering names of things (2nd day - then resolved). Bronchial pain, can hear heartbeat in head especially upon exertion (climbing stairs- would resolve in 2 minutes upon sitting or laying down). Spent 4 days in bed. A lot better today 12/9/22/
Onset itching, warmth, and redness, discomfort within minutes after receiving vaccine. Itching continued over 2 day period & redness increased to 5x7 cm size. Area of erythema minimally raised and mildly tender at left upper arm on 10/22 (2days after flu shot).
Dizzy  dizzy spells; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy  dizzy spells) and VACCINATION SITE PAIN (Sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concomitant products included ALLERGY MEDICATION.    On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 28-Jan-2021, the patient experienced DIZZINESS (Dizzy  dizzy spells). At the time of the report, DIZZINESS (Dizzy  dizzy spells) and VACCINATION SITE PAIN (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Con meds include blood pressure and anxiety pills.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt recvd vax 21OCT94 in AM; in PM, pt had fever 105.2, given APAP & motrin;MD visit-pt appeared fine; temp not taken;meds for treatment cont; recovered;
Received third dose Pfizer vaccine at 16:45 in the left arm. Lot# 3045BA. Patient was directed to observation area.   At 16:55 lightheaded, metallic taste, and dry mouth.  Patient skin was warm and dry.  Patient respirations were not tachypneic or dyspneic. Reported that she hadn't anything to eat since breakfast.  HR:  78   BP:  130/80   RR:   16   O2Sat%:  99      17:00  Had a cup of water which seemed to help, dry mouth, and metallic taste going away. Declined EMS.   17:06 Feeling much better but still slightly lightheaded. Patient ate some food that she had brought with her in her purse.   HR:  64   BP:  110/72   RR:   16   O2Sat%:  97   17:10 Feeling better and slowly got up without any lightheadedness and wanted to go home. Declined calling anyone to come to get her. Stated that she was fine to drive.  17:15 - Care Practitioner educated on home discharge/adverse reaction instructions and escorted attendee to her car. Patient was steady on her feet and denied any dizziness/lightheadedness.
accidentally administered a dose of diluent to a patient, and no vaccine/no AE; Initial information received on 08-Apr-2019 regarding an unsolicited non-valid non-serious case received from a consumer/non-health care professional.  This case involves a 18 months old male patient who accidentally received a dose of diluent of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE INACT (HAVRIX) for Immunisation.  On 08-Apr-2019, the patient received a 0.5 ml single dose 3 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5444AA via unknown route in the left leg.  It was a case of actual medication error because active ingredient not added to diluent.  It was reported that patient experienced no symptoms.  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 and Module VI of the 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.
Covid positive test 9/8/21 approx 4pm testing time medium to heavy cold symptoms, nose throat and some chest congestion Monoclonal antibodies treatment on 9/10/21 heaviest symptoms on 9/5/21 Medications Administered Name Date     REGEN-COV (EUA) 60 mg-60 mg/mL intravenous solution Inject 10 mL by intravenous route. Notes: 2.5 mL given SC x 4 doses; R upper arm, L upper arm, R lateral abd, L lateral abd
PATIENT APPEARED TO BE UNRESPONSIVE ABOUT 5 MIN AFTER SHINGRIX VACCINE. LOWERED PATIENT TO THE FLOOR, THEN SHE STARTED TO BE RESPONSIVE, TOOK BLOOD PRESSURE WHICH WAS LOW 58/32 HR 65 AND SHORTLY THERE AFTER PARAMEDICS ARRIVED. PLACED PATENT BACK IN CHAIR AND THEY OBTAINED A 12 LEAD EKG AND LEFT WITH THE PATIENT
Dizziness, PVCs of the heart confirmed in the ER at local Hospital, with chest pain. Went to the emergency room in July and received a referral to a cardiologist. Was hooked to a holter monitor for 3 days, did EKG stress test and sleep tests. Nothing was found.
Info has been received from an RN concerning a 12 month old female who on 3/21/05 was vaccinated with a dose of varicella virus vaccine live. The RN reported that on 3/23/05, the pt developed full-blown chickenpox. Unspecified medical attention was sought. In March 2005, the pt recovered from the full-blown chickenpox. Additional info has been requested.
Moderna COVID-19 Vaccine EUA Very Itchy, slight redness and very firm swelling in 2 inches  around injection site, started 7days after injection.  Putting Benadryl cream on it for last 2 days
In the evening of Dec. 16, my arm was very tender and hurt to touch or move. It got better by the next afternoon, at which point I shoveled the snow, only to come inside with chills, sweats, low-grade fever (100.5), dizziness and headache. The entire episode was only acute for a few hours and by the next day I felt mostly myself.
I have been diagnosed with PTSD and since the day after the second dose I have a big increase in my depression and anxiety.
Student received H1N1 vaccine ->came to clinic 30 minutes later c/o headache, and SOB, BP 128/82 -> rested x 20 minutes -> SOB better, c/o some chest pressure -> had juice and crackers, rested -> back to class, symptoms resolved.
approximately 2 weeks after vaccine administration developed headache, ataxia, and seizures requiring antiepileptics, steroids, antibiotics.  11/6/07 Received vax records & pcp medical records.  VAERS database updated w/same & date of vax corrected to 10/19/2007. Flu shot not on vax record but ordered on pcp note.  Pcp note of 10/19 indicates patient in good health on day of vax.  Returned to pcp 11/2/07 w/dizziness, fever, HA, slight cough.  Dx w/viral infection.  T/C to provider to clarify vax info.  Received 2nd page of vax record w/flu vax info.  VAERS database updated w/same. 11/30/07 Reviewed hospital medical records which reveal patient experienced HA, vomiting, ataxia & right sided spasticity.  Had HA x 7 days prior to admitl w/increasing ataxia x 3 days.  Admitted 11/2-11/10/2007.  As preparing for LP, patient had seizure & desaturation.  Intubated & admitted to PICU.  Neuro consult done.  Given IV antibiotics & antivirals until cultures came back neg.  Extubated 11/5 & progressed well on antiseizure meds.  FINAL DX: Encephalitis; ataxia; headache.
Had COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Had COVID-19) in a 78-year-old female 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Had COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Had COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       treatment was not provided.
Initial unsolicited report received from a nurse on 30 Sep 2016. This case is linked with 2016SA182127, 2016SA182128, 2016SA182129, 2016SA182130, 2016SA182131, 2016SA182132, 2016SA182133, 2016SA182134, 2016SA182135 (same reporter). This case involves a patient (age and sex not reported) who was vaccinated with a dose of Fluzone Intradermal (Batch number, expiry date, dose, route and site of administration were not reported) on an unspecified date. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were not provided. On an unspecified date, post vaccination; the patient experienced anaphylactic reaction. Lab data and corrective treatment was not reported. The outcome of the event was not reported. Upon internal review the case was considered as serious due to important medical event: anaphylactic reaction. List of documents held by sender: none. Sender's Comments: As with other vaccines, anaphylactic reaction is listed following INFLUENZA QUADRIVAL A-B VACCINE. This poorly documented cases as time to onset is unknown. Additional information including but not limited to the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), information regarding any drug or food intake during the period between vaccination and reaction and allergy testing to identify the culprit allergen are needed to further assess this case. Based on the available information, a role of the vaccine cannot be ruled out.
Increased apneic episodes worsening overnight; increasing lethargy. Infant taken to ER via ambulance; was intubated. Sepsis work out performed; transferred to ICU. The discharge summary received on 4/5/04 notes a full sepsis work-up meaning they were looking for infection and none was found. Add aspiration pneumonia, PDA (duct art pat) and feeding intolerance.
Patient with PMH significant for CKD 4, CHF anemia, CAD, atrial fibrillation, HTN who was admitted due to exertional shortness of breath. He was seen by cardiology and he had L/RHC today showing patent LAD stent, proximal LAD stenosis, normal PA pressure and normal cardiac index. Concerning for low filling pressure. He does not appear fluid overloaded and plan was to hold on further diuretics at this time. Next morning and after the angiogram, patient denies any chest pain and SOB, discharged home. This ED visit and hospital admission was within 6 weeks of receiving the COVID vaccine.