chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fully vaccinated patient who admitted through ED for ongoing nausea and vomitting.  Provider discharge note below:  "Per HPI, a 70 YO female with past medical history of GERD, HLD, HTN presenting to Hospital with from ED with complaints of generalized weakness and diarrhea that began 2 weeks ago, she came to the ED and was tested for COVID-19 on 10/31/21 and results were positive. Per daughter the patient has been nauseous and unable to eat or drink much. She is able to take her blood pressure medication and ""keep it down."" However, her symptoms have been progressing and this week she developed non-bloody vomiting and blurry vision. She denies noticing any blood in her stool. Today she endorses feeling weak and having abdominal pain. She denies chest pain, shortness of breath, headache, dizziness, fevers, chills or diaphoresis.    At ED her vitals were stable but her labs came back for significant values for extremely elevated Cr 15.7, BUN 131, hyperkalemia 5.6, proteinuria and leukocytosis. She was given 2L of NS. She was transferred to Ed for evaluation and possible emergent dialysis.    Nephrology was consulted and she was admitted under our services for management of all her chronic conditions. She received zofran for nausea and had one episode of brown colored emesis in the ED. She was also started on more fluids here. Chest xray and CT head was negative for any acute process. EKG negative for any acute changes.    Hospital Course:  1. AKI: likely due to ATN from volume loss. Improving with good UOP. S/p HD 11/5, 11/6 with significant improvement. No indication for further HD, access discontinued. Follow up with nephrology as an outpatient    2. COVID-19: patient afebrile, maintaining adequate saturation on RA. Having diarrhea, improved   3. HTN - Restarted lisinopril - Holding HCTZ for now.   4. Sinus bradycardia: asymptomatic - Hold metoprolol for now   5. Normocytic anemia: stable "
Pt developed redness, slight swollenness with warm to the touch to the upper right arm.
After giving patient vaccine and I handed him his vaccine card he fainted and fell out of chair face first  and started convulsing. I told technician to call 911  I proceeded to turn him over to check for pulse and breathing to see if CPR was needed. He came to and sat up and I asked him questions if he had had any reaction to his first dose of Pfizer vaccine. He said no. As I was talking to him he fell backwards and passed out again. He regained consciousness after a few minutes. EMS arrived on site shortly there after and  administered aid. Since his blood pressure was very low and pulse was high he was transferred to hospital
DIZZINESS WITHIN THE FIRST 10 MINUTES OF INJECTION FOLLOWED BY NAUSEA AND VOMITING.
Information has been received from a physician who is the father of a male child who was vaccinated "at 15 months old" with a dose of varicella virus vaccine live. In 2002, "in the past year," the pt developed necrotizing pneumonia, rales and had no lesions. It was noted that the father called the child's pediatrician and ordered an "unamed antibiotic." There was no culture obtained. Unspecified medical attention was sought. There was no product quality complaint involved. It was also noted that the pt's condition resolved. Upon internal medical review the necrotizing pneumonia was considered an other important medical event (OMIC). The reporter also mentioned his two other children who were not vaccinated but developed chickenpox. Additional info has been requested.
F/U symptoms Red, hot, swelling on shoulder area, next day the back on bicep was very sore to touch, swelling above elbow. Next day elbow swollen, red, hot. The next day below elbow water on elbow, trip to doctor for anti-bacterial meds.
12-29-20 the night of the shot I had cold chills,alittle headache,just alittle facial tingling, joint pain,hot flashes and very tired and sore arm. Day 2 started with sore arm and with back radiating in different part of my back and hot flashes, very tired Day 3 starting with more back pain and some mood swings and very tired. Day 4 to present back pain a lot more and joint pain.
1:22 pm Varicella and Measles Mumps and Rubella vaccines->given almost immediate urticarial lesion (2 cm) around site of injection, resolved within 1-2 minutes of giving oral BENADRYL referred to allergist for evaluation.
Vein in left arm forearm swollen discolored 5inches below the index! And thumb area.  Went to the hospital on memoral day.  Between 830 11am.  Xray wa done and pain in the groin left side area doppler was done on bothe legs because extreme cramping in the calf muscles in both  as well.
2 cm - redness, around vaccine site, right thigh, itchy. No fever, chills, eating cooperatively. Rx - KEFLEX 125/5 ml 10 ml daily QID for 5 days. Warm compress. Rx Ibuprofen 100/5 ml 2.5 ml q6h prn fever, pain.
Patient contacted the pharmacy on 1/20/23. Reported receiving a 1st dose Shingrix vaccine on 1/18/23. Patient experiencing swelling and pain at the injection site on the left arm. Pharmacist advised patient to contact prescriber and to take OTC products to relieve symptoms e.g. tylenol
Approx. 5 minutes after vaccine given Pt. felt weak and like she was going to pass out. She was sitting in chair and we gave her water and she put her head between her legs. After approx. 2-3 minutes she felt better and sat up drank water. After about 2 more minutes she felt dizzy and she went limp, she was diaphretic, pulse 50, bp 80/palp. Pt. arroused and was able to speak approx. 2 minutes later but was very weak and states "I cannot see anything". Squad was called they arrived and assumed care. Pt. was alert and oriented and was able to talk. Pt. Mom was with the patient the whole time
Heavy and Painful periods; Heavy and Painful periods; This spontaneous case was reported by an other health care professional and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Heavy and Painful periods) and DYSMENORRHOEA (Heavy and Painful periods) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy and Painful periods) and DYSMENORRHOEA (Heavy and Painful periods). At the time of the report, HEAVY MENSTRUAL BLEEDING (Heavy and Painful periods) and DYSMENORRHOEA (Heavy and Painful periods) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant Product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-209189 (Patient Link).
Information has been received from a medical assistant, on 02-JUL-2015, concerning a patient of an unknown age and gender. On 13-MAY-2015, the patient was vaccinated with a dose of PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that underwent 159 hours temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Penis numb and occasionally tingling. Urge to urinate nearly constant through day, on occasion waking to need with little output. Discomfort while urinating.
Vaccine administered at 1000 am. Patient had syncope episode at 1001 after vaccine administration. Patient stood up immediately after vaccination administration and was walking to the waiting room for his 15 minute wait period. While walking patient stopped, and collapsed falling backwards and hitting his head. Patient had lost consciousness for about 2 minutes. Patient regained consciousness at 1003 and seemed alert but had difficulty recalling events leading up to him falling and could not recall falling. Patient's vital signs were taken at 1004 BP at 85/56 HR 67 and SPO2 at 100%. Pediatrician was called to respond and performed her assessment. Vitals were rechecked at 1012 BP 92/59 HR 69 SPO2 100%. Patient stated that he was feeling better but still felt a little dizzy. Patient was moved from supine to sitting position at 1024. Vitals rechecked at 1034 BP 94/59 HR:77 SPO2 100%. Patient was moved from sitting to standing at 1040. Patient still had difficulty recalling events but was able to stand and walk properly. Patient was discharged from clinic with concussion precautions and will be reevaluated on 18SEP2020 for progress following event.
pt to ED with c/o decreased oral intake and increasing SOB; O2 sats 72% in ED; placed on NRB mask; COVID pneumonia; BiPAP; transferred to ICU; long complicated course; pt's condition worsened; acute on chronic renal failure; pt experienced bradycardia and coded; pt died in the hosp
Client received the 1st or 2nd COVID vaccine (Pfizer Lot # EW0185 expiration 05/22/2021) at 1312. RN vaccinated the client at 1312, the client then told her that she was feeling lightheaded and dizzy. RN alerted and they responded. EMTs alerted PHN at 1315 and vital signs were taken (blood pressure 102/60, oxygen 98, pulse 62). Skin color was appropriate to skin tone, client was alert and oriented. Client?s mother was with her and sated that the client as anxiety to needles and has passed out before from receiving a vaccine. Client stated that she did eat today. She has no medical conditions, no allergies, and is not taking any medications. Client refused Benadryl. At 1320 client stated that she was feeling a ?little better? and was escorted to zero gravity chair when dizziness and lightheadedness subsided. Client given juice which she accepted and drank. Vital signs taken at 1325 (blood pressure 118/74, respirations 18, heart rate 72, oxygen 97). Vital signs taken at 1335 (heart rate 76, oxygen 96, respiration 18, blood pressure 122/76). Client and mother provided education to seek emergency services if life threatening symptoms appear, and to follow up with primary care provider. Vital signs taken at 1345 (oxygen 97, heart rate 82, blood pressure 118/78). At 1347 client stated that she was doing fine and did not have any more symptoms. Client left with her mother at 1347 unassisted with a steady gait.
Pain at the injection site; Body aches; Temperature of 98.9; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site), PAIN (Body aches) and BODY TEMPERATURE (Temperature of 98.9) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03m20a) for COVID-19 vaccination.     Concomitant products included Blood pressure meds and Cholesterol meds for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site), PAIN (Body aches) and BODY TEMPERATURE (Temperature of 98.9). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site), PAIN (Body aches) and BODY TEMPERATURE (Temperature of 98.9) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Within 5 minutes of receiving dose  I developed a bounding pulse. My heart was racing and I started sweating. It resolved on its own with no treatment in about 5 minutes.
I have bad tinnitus now. It gradually started after my first dose and has been constant since receiving my 2nd dose.  It is really bad.
Large rash on injections site, 5 inches long and 2 inches wide. Very warm to the touch and itchy. It?s still there 3 days later.
angioedema; This is a spontaneous report from a contactable physician. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Mar2021 17:15 (at the age of 43years) as single dose for Covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. No known allergies. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced "uvula/soft palate/posterior oropharynx angioedema 5 days post vaccine" on 21Mar2021 (10:00AM). The adverse event resulted in Emergency room/department or urgent care. The patient was treated with Epinephrine, Benadryl, Solu-Medrol. The patient has not been tested for COVID-19 since the vaccination. The outcome of event was recovering.  Information about lot/batch number has been requested.; Sender's Comments: Based on the available information and on the compatibility with the product's known safety profile, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of angioedema cannot be excluded. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
I95.9 HYPOTENSION 6/6/2023 REPEATED FALLS
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Multiple Patients received expired dose of the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21-2A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Multiple Patients received expired dose of the Moderna vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Multiple Patients received expired dose of the Moderna vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant medication was not provided. Treatment information was not provided.
Pt received 1st dose of Pfizer vaccine on 3/2/2021. Pt was positive with COVID on 3/22/2021. Pt was admitted to the hospital on 4/7/2021 for chest pain
Headache; Fever up to 100.5; Extreme fatigue; Muscle aches; Nausea; Lack of appetite; Immediate arm pain - swelling, tender to touch; Immediate arm pain - swelling, tender to touch; Immediate arm pain - swelling, tender to touch; This is a spontaneous report from a contactable Nurse.   A  26-year-old female patient patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3246) intramuscular, on 08Jan2021 at 16:00 on left arm at single dose for COVID-19 immunization. Relevant medical history included that patient had a Covid diagnosis on early October. Vaccination history included first dose of BNT162B2  (lot number: EK5730) on 18Dec2020 at 10:00 AM, Intramuscular on Left arm .Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20). The patient was not pregnant. On 08Jan2021 at 16:00 the patient experienced Immediate arm pain - swelling, tender to touch. On the same day at 22:00 the patient experienced Fever up to 100.5, extreme fatigue, muscle aches, nausea and lack of appetite. Treatment received included Tylenol. The patient recovered from Immediate arm pain - swelling, tender to touch on an unspecified date, from other reported events, recovered on 10Jan2021.
3x3 induration on right upper arm. Developed reaction on 7-20-07. Saw MD 7-20-07. MD instructions: cool packs, motrin and make report.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Medical history and current conditions were not reported. On 05-FEB-2015 (also reported as today), the patient was vaccinated with an expired dose of ZOSTAVAX (subcutaneous, dose 0.65 ml, lot # 672558/1600AA, expiration date 13-JAN-2013). No adverse experience was reported. Additional information has been requested.
Patients received expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. The treatment information was not provided.
THE PATIENT EAS SUPPOSED TO GET FLU VACCINE BUT THE TECHNICIAN GAVE HER COVID VACCINE BY MISTAKE. THE PHARMACIST COUNSELED HER MOM THE GIRL WAS FINE. NEXT DAY THE PHARMACIST CALLED THE DAD TO FOLLOW UP . THE FATHER SAID THE GIRL WAS LITTLE TIRED BUT NOW SHE IS FINE.
PATIENT'S DOCTOR REFERS: SEVERE LOCALIZED REACTION TO THE VACCINE EVIDENT BY EDEMA AND PUSTULES.
The day after vaccination pt ran fever.  Started shaking, apnea and bluish discoloration of face.
Patient called stating she began having pain in her left arm two days after her flu shot. The pain worsened & radiated into her chest & back. Went to ER & was given scripts for LORTAB & naproxen. Patient denies recent injury. Patient came in for follow-up with MD on 10-25-11 c/o pain in arm & shoulders after shot. Waited a week before going to ER for evaluation.
This case was reported by a nurse via other manufacturer and described the occurrence of systemic inflammatory response syndrome in a 18-year-old female patient who received BEXSERO for prophylaxis. Co-suspect products included TRUMENBA for prophylaxis. On 31st July 2017, the patient received the 1st dose of BEXSERO. On 1st June 2017, the patient received the 1st dose of TRUMENBA. On 31st July 2017, 4 hrs 30 min after receiving BEXSERO, the patient experienced systemic inflammatory response syndrome (serious criteria GSK medically significant), fatigue, injection site pain and interchange of vaccine products. In August 2017, the patient experienced appetite absent, sore throat, cold sweat, joint pain and enlargement of lymph nodes. On an unknown date, the outcome of the systemic inflammatory response syndrome, fatigue, appetite absent, sore throat, cold sweat, joint pain, enlargement of lymph nodes, injection site pain and interchange of vaccine products were unknown. It was unknown if the reporter considered the systemic inflammatory response syndrome, fatigue, appetite absent, sore throat, cold sweat, joint pain, enlargement of lymph nodes and injection site pain to be related to BEXSERO. Rerun: Additional details were provided as follows: This case was reported by a Nurse Practitioner. The nurse practitioner did not mention if the patient was on any other medications at the time of the events or if the patient had any other medical conditions to report. The patient received 1st dose of TRUMENBA first on 1st June 2017. The patient for her 2nd dose of TRUMENBA was given BEXSERO instead in error, which led to interchange of vaccine products.  TRUMENBA and BEXSERO should not be given together as per the reporter. The patient was given BEXSERO around 9.30 in the morning and by 2pm that afternoon, the patient was complaining of extreme fatigue and injection site pain. The patient returned to the office and was seen by the nurse practitioner on 4th August 2017. At that time, in addition to the extreme fatigue, was having no appetite, sore throat, swollen lymph nodes, joint pain, and cold sweats. The nurse practitioner ran blood work and blood cultures to rule out mono. Cultures came back normal but the blood work did show patient was having an acute inflammatory response. Reporter stated one of the test results was 21.9 which indicated the acute inflammatory response. The nurse practitioner also mentioned that 4th August 2017 was day 1 of the patient's menstrual period. The nurse practitioner did not say if there was any additional need for follow-up and had informed the reporter that the patient was told to get back in touch or come back in if continued to have issues and they had not seen since 4th August 2017.  The nurse practitioner was unable to provide outcomes for the reported events. As per the nurse practitioner the office would have any product information that might be needed, provided consent for follow-up.
Second dose I had aches, fatigue nausea headache; Second dose I had aches, fatigue nausea headache; Second dose I had aches, fatigue nausea headache; Second dose I had aches, fatigue nausea headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Second dose I had aches, fatigue nausea headache), FATIGUE (Second dose I had aches, fatigue nausea headache), NAUSEA (Second dose I had aches, fatigue nausea headache   ) and HEADACHE (Second dose I had aches, fatigue nausea headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 012M20A) for COVID-19 vaccination.     Concomitant products included SERTRALINE for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Second dose I had aches, fatigue nausea headache), FATIGUE (Second dose I had aches, fatigue nausea headache), NAUSEA (Second dose I had aches, fatigue nausea headache) and HEADACHE (Second dose I had aches, fatigue nausea headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, PAIN (Second dose I had aches, fatigue nausea headache) outcome was unknown and FATIGUE (Second dose I had aches, fatigue nausea headache), NAUSEA (Second dose I had aches, fatigue nausea headache) and HEADACHE (Second dose I had aches, fatigue nausea headache) had resolved.            The patient reports experiencing headache, nausea, fatigue. Symptoms have resolved    This case was linked to MOD-2021-370969, MOD-2021-371024 (Patient Link).
Body aches, fever, headaches, sore throat, shortness of breath, chest pain, fatigue x 6 days since having 2nd Pfizer vaccine.