chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports that approximately ~10 days after receiving vaccine, she developed red spot on arm at site of injection. She reports it was tender and warm to touch. Patient was advised to seek medical care; however, she refused as she does not like going to the doctor. Advised patient to take ibuprofen to help with inflammation. Followed up with patient 12 and 24 hours after she reported ADR. She reports improvement.
As soon as I received the shot my arm felt like lightning went through it. I began having shortness of breath. I walked to get some water and started having more trouble breathing. I was sweating, I felt dizzy. The EMS came and took me to the hospital where I was for 4-5 hours. I was given Benadryl. I was going to get medicine for nausea, but I felt better and was afraid to take anything because of the reaction. I was very lightheaded, dizzy and nauseous. At the hospital, I was observed. I was getting better but I was still itchy. The Doctor was going to prescribe some prednisone but wanted to hold off on any medication to allow the vaccine to do its job. I was given a prednisone pack and a Benadryl pack. I felt better so I didn't take the prednisone. I was told to continue taking Benadryl and if that did not help, I was to take prednisone. Currently, I still experience extreme achiness and fatigue. This is something I have never experienced before. I am on medication for the achiness that my doctor believes to be arthritis but it is not helping. I was able to run 3 miles a day but now I am unable to even walk it. It is difficult getting up and down stairs which the medication has helped with some.
@ approx 4PM, eyes became swollen, pt cried continuously (lasted approx 4 hrs); & later that afternoon became disoriented-did not seem to recognize mom or dad; Taken to ER for eval-no tx given; pt recovered;
Patient experienced significant pain in the right arm and could not raise arm. Patient was advised to take any pain medication she normally is allowed to take by primary care physician. Pain subsided over several days.
Patient was standing by the counter after receiving her vaccine. While Mom was holding her brother, the patient slumped to the floor and Mom shouted "She's having a seizure". Both of us immediately picked the child up and mom held her. The patient was not shaking; she was stiff and very pale. She came to and said "I had a seizure".  Mom then reported that patient has a history of pain-induced seizures. No injuries were reported. Patient was given a bottle of water and Mom held her for about 10 minutes in the clinic room. Patient walked out with Mom about 10-15 minutes after the incident.
First dose of Shingrix 2 years ago; This case was reported by a other health professional via Shingrix GSK and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination
This spontaneous report as received from a nurse and refers to a female patient of unknown age. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. Reporter reported that the patient in the office received her first dose patient GARDASIL 9 quadrivalent which was administered 4 years ago on unspecified date, lot # and expiration date unknown. Patient was administered second human papilloma virus (HPV) dose of GARDASIL 9 on 18-AUG-2017 (inappropriate schedule of drug administration). No adverse effects were reported and no additional information was given. The outcome of events was unknown.
Patient recieved her first set of immunizations on 05/19/04.  On 06/03/04 the patient's parents noted a few petechiae thinking it was a simple rash.  On 06/08/04 when the patient had progressive petechiae over numerous body surfaces, they came to my office for an appointment.  A CBC was obtained and the patient's platelet count was 4,000.  This result was reviewed by a pathologist.  The patient was referred to a hospital.  Upon her arrival there, her platelet count was 10,000.  She received one infustion of IVIG.  Her platelet count increased to 60,000.  Nurse follow up on 07/22/04 states: "ITP."
Information has been received from a medical assistant referring to a 6 month old male patient. No relevant medical history or concurrent conditions were reported. On 01-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
High blood pressure, over 180;  Pulse rate over 115,  Sweating, Dizziness, Chest pressure, Difficulty Breathing
- passed out in car, seizure like activity x 2 diaphoretic. Transferred to - ER per ambulance. Dx: Syncopal episode with fear of needles
No adverse event; 44-year-old patient received Bivalent Moderna COVID-19 vaccine instead of Monovalent first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (44-year-old patient received Bivalent Moderna COVID-19 vaccine instead of Monovalent first dose) and NO ADVERSE EVENT (No adverse event) in a 44-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (44-year-old patient received Bivalent Moderna COVID-19 vaccine instead of Monovalent first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (44-year-old patient received Bivalent Moderna COVID-19 vaccine instead of Monovalent first dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (44-year-old patient received Bivalent Moderna COVID-19 vaccine instead of Monovalent first dose).    Relevant concomitant medications were not reported.  Patient received Bivalent Moderna COVID-19 vaccine instead of Monovalent first dose.  Treatment information was not provided.
I received the PNEUMOVAX vaccine 08/18/16 and had extreme pain in my arm. It has swollen up and bubbled up. I have been up all night vomiting.
Nearly 12 hours on the dot post injection I began having intense chills and shaking.  Within 30 min from that all of my joints in my body had pain 9-10/10 and my pain threshold is high--it flet like i was being dismembered.  I Spiked a fever of 102, muscle pain began which felt like acid was eating them away from the inside out--I thought I could have necrotizing fasciitis--I had to take 2 vicodin every 4 hrs, 1000mg tylenol every 8 hrs, ibuprofen 600mg q 6 hrs, and CBD chew plus CBD cream on my joints--I cried in pain for 4 hours--by 9 am I called my Nurse colleague to ask for ideas as I was still crying and I took an antihistamine--Claritan--and I finally slept for 2 hours.  This lasted for 2 days and then I had severe headache, nausea, fatigue, and continued off and on arthrigia through day 4.  Day 5 I was able to return to work.  Arm swelling and pain lasted 5-6 days.  FYI I had Covid in early January 2021.  First inj sx were mild--fatigue and migraine.  I will not take a booster ever again.  Most painful experience of my life and I have had an ovarian cyst rupture, and an awake frozen shoulder reduction,
Information has been received from a certified medical assistant concerning an 18 year old female. It was reported that the patient fainted after receiving her first dose Gardasil. Lot number was not available. The patient recovered and no further information was given. Additional information has been requested.
break through infection / covid test result=Positive; break through infection / covid test result=Positive; Inappropriate age at vaccine administration; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 9 year-old male patient received bnt162b2 (BNT162B2), administration date 11Dec2021 (Batch/Lot number: unknown) at the age of 9 years as dose 2, single and administration date 20Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.There were no other vaccine given in four weeks. The covid was not there prior vaccination. The covid tested positive post vaccination.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 03Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 03Jan2022, outcome "recovering" and all described as "break through infection / covid test result=Positive"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Inappropriate age at vaccine administration". The symptoms included coughing.The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive, notes: Test type: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This is a 95y.o. female with significant past medical history of HTN, GERD, dementia, CAD, and osteoporosis  that presented to the hospital with chief complaint of shortness of breath. Found to have confirmed COVID-19 infection, acute hypoxic respiratory failure, septic shock with hypotension, AKI, hypernatremia, L femur fracture and NSTEMI. Given the patient's advanced age, history of dementia/blindness, and additional co morbidities the family has opted to pursue comfort care only. She has been enrolled under hospice services for end of life care.
7/26/04: red, itchy, blood shot. 8/02/04 9:15AM P.C. from client. He received an MMR on 7/15/04. ON 7/26 he had a fever of 99 and felt achy. His eyes became blood shot, slightly itchy, no changes in vision. An MD thought it was viral, but could be due to a vaccine. Eyes are clear now. On 7/28/04 he developed red dots on upper back and neck, 90%gone on 8/1 all gone on 8/2/04. 7/29 and 7/30 his right knee became stiff and sore mid thigh to midcalf, limited range of motion, no swelling or heat. 8/2 its resolved. Additional comments: Client is 47 and does admit to history of arthritis in elbows and shoulder 2 sports in youth. Plan: Call if other symptoms appear. Addendum: Does have seasonal itchy eyes.
Dose 1:10Mar2021, Dose2: 26Mar2021 (duration between the doses is 16 days); Itchy rash from injection site to elbow; This is a spontaneous report from a non-contactable consumer, the patient. A 62-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Mar2021 (at the age of 62-years-old) as a single dose for COVID-19 immunisation (inappropriate schedule of vaccine administered). Medical history was included known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO), for an unknown indication from an unknown date and unknown if ongoing.  The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Mar2021 at 08:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. On 28Mar2021 within couple of days, the patient experienced itchy rash from injection site to elbow which lasted for 2 weeks. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event, itchy rash from injection site to elbow was resolved on an unknown date in Apr 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Speech difficulty, Mental fogginess on 4/2. Presented to hospital on 4/4. Diagnosed with Left ACA stroke on MRI on 4/6.
Two days after receiving the meningococcal vaccine, my son experienced a hives type of rash circling the injection site on his left deltoid. The area was itchy and  white welts swelled up against a red rash on the skin. It started off as a small hive on one side of the arm then it spread all around the area of the injection site within an hour. I did not have an allergy cream so I used cortizone 10 cream on the rash. I applied it the evening it appeared and thankfully it was gone by morning.
Initial and follow up information has been received from an office manager in a physician's office, concerning a 16 year old black female patient with no known drug allergies, oral herpes and asthma who on 18-JAN-2007 at approximately 3:30pm, was vaccinated IM in the right gluteal, with the first dose of Gardasil (Lot #654540/1163F). The patient experienced some pain during the administration of the vaccine (previously reported as no symptoms), but subsequently recovered (date unspecified). The patient's mother, who was a nurse, had questioned the office3 about the effectiveness of the vaccine, after she received training of correct Gardasil administration. On 19-MAR-2007, at approximately 3:45pm, the patient received the second dose, IM in the right deltoid, of Gardasil (Lot #654702/0011U), with no problems reported. No further information is expected.
35 patients exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patients exposed to vaccine from which vial may have been punctured more than 20 times) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patients exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patients exposed to vaccine from which vial may have been punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided. Patient DOB was reported was 1945.
I became very nauseas and tired around 7:00 P.M. and started to have diarrhea.    I was sweating profusely and having constant diarrhea for 36 hours.  I was unable to eat and I drank sips of water and Gatorade as I could but I didn't want much.  I had horrible stomach cramps the entire time.  I was unable to go to work on Friday.
16 year old female inadvertently given the first dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old female inadvertently given the first dose) in a 14-year-old female patient who received mRNA-1273 (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old female inadvertently given the first dose). On 28-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old female inadvertently given the first dose) had resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: NNI
1-23-16 developed headache, shoulder, neck, muscle discomfort: resolved by Sat night. 1-24-16 3 red area near site of injection 12 x 10 cm red/warm to touch.
Nausia, headache, dizziness, fully body aches especially of shoulders, neck and lower back over the course of the day, getting mildly worse with physical activity day after vaccination.  After a day of rest, pain was more manageable the next day.
Hives all over back of neck, facial swelling, and eye swelling, sore throat, headache
Headache and fatigue.  Difficulty sleeping   Took naproxen?s for headache.  Gone but still fatigued
The pt experienced a seizure on 10/2/98. He appeared to be choking and it lasted for approximately 1 minute. EMT's checked the child and told us to contact the MD. The child experienced another seizure 12 hours later. The child was taken to the ER. He then began having a seizure every 12 hours for the next 5 months until the correct medications were found. Seizures are now under control, but the child has a severe developmental delay.
Female Pt missed her menstrual cycle for 3months and then starting bleeding heavily after that.; Female Pt missed her menstrual cycle for 3months and then starting bleeding heavily after that.; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (Female Pt missed her menstrual cycle for 3months and then starting bleeding heavily after that.) and HEAVY MENSTRUAL BLEEDING (Female Pt missed her menstrual cycle for 3months and then starting bleeding heavily after that.) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced MENSTRUATION DELAYED (Female Pt missed her menstrual cycle for 3months and then starting bleeding heavily after that.) and HEAVY MENSTRUAL BLEEDING (Female Pt missed her menstrual cycle for 3months and then starting bleeding heavily after that.). On 19-Jul-2021, MENSTRUATION DELAYED (Female Pt missed her menstrual cycle for 3months and then starting bleeding heavily after that.) and HEAVY MENSTRUAL BLEEDING (Female Pt missed her menstrual cycle for 3months and then starting bleeding heavily after that.) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided by the reporter.   No treatment information was provided by the reporter.
exacerbation of chronic graft versus host disease; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allogeneic haematopoietic stem cell transplantation (HSCT)" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: CHRONIC GRAFT VERSUS HOST DISEASE (medically significant), outcome "unknown", described as "exacerbation of chronic graft versus host disease".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported event and suspected vaccine BNT162B2 cannot be completely 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.,Linked Report(s) : US-PFIZER INC-202200611693 Same reporter/product/event, different patient
Severe ataxia requiring hospitalization. Treated with 5 days of IVIG. Normal gait when not fatigued but recurs, mildly, in late afternoon. when fatigued.  Continues with bilateral upper extremity tremors.
A roughly one-degree Fahrenheit higher body temperature starting Monday night, 1.5 days after shot, and lasting until Thursday. Said higher temperature was not noticeable to me consciously, however the sleep monitor I wear at night detected it. Higher body temperature appears to have started about the same time that the mild local right-arm soreness around my Pfizer injection site subsided.
tongue swelling started the following day after vaccination. Complains of SOB for 2 weeks and went to ED. Client was provided with Lasix 40 mg and 3.5 L O2  Chest x-ray moderate enlargement of cardinal pericardial silhouette and pleural effusion, CHF
This spontaneous report was received from a pharmacist referring to two separated patients of unknown age and gender. Concomitant therapies included sterile diluent (DILUENT MRK). The patients' concurrent conditions and medical history were not reported. On 03-JUL-2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # M041086 with expiration date of 03-JAN-2018, for prophylaxis (route, anatomical location and frequency were not reported). No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 15 to 46 degrees Fahrenheit for 40 hours 16 minutes. Previous temperature excursion was reported as 15 to 46 degrees Fahrenheit for 60 hours (worst case). The call was not because of a "data logger". No further information was provided. Additional information has been requested.; Sender's Comments: US-009507513-1707USA006623: