chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 1 minute of receiving GARDASIL (last of 4 vaccines given) pts eyes fluttered & she had syncopal episode for a few seconds with several jerks of lower legs concurrent with syncope. Recovered from that in several seconds. No change with pulse, BP or O2 sat throughout
I had some respiratory issues, shortness of breath, one severe issue in December/January.  Dr. did chest x-ray which showed interstitial markings in my lungs.  He did a subsequent CT scan.  He does not believe the vaccine caused the issue.  We are not sure as I don't smoke, etc.  Thought maybe I had COVID and didn't know it due to being vaccinated (mild symptoms) or some other event caused it.  Repeating CT scan in about 3 more months to see if things are the same/worse.  Have 70% of lung capacity.  Also found enlarged liver, spleen, etc.
This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever), chills, myalgia (body ache) and headache in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 21, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 21, 2021, patient had pyrexia (fever), chills, myalgia (body ache) and headache. At the time of the report, pyrexia (fever), chills, myalgia (body ache) and headache outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
Patient was initially given the adolescent Engerix which was 0.5 mL. Upon realizing the error, the provider consulted the vaccine insert which instructed her to give a second 0.5 mL dose so that the patient would receive the full 1.0 mL vaccination which was appropriate for her age group
fever to 103 w/in 24hr of vax;extremely fussy, constant whining, crying, inc fussiness w/touch;
pt recv vax 5JAN96 & devel an inj site rxn, characterized by edema from shoulder to elbow;the area is hot & painful to touch & looks like a giant hive;pt is having diff moving the arm d/t the pain;
soreness at injection site after first dose; did not receive second dose; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (soreness at injection site after first dose) and PRODUCT DOSE OMISSION ISSUE (did not receive second dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History Reported.     On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness at injection site after first dose) and PRODUCT DOSE OMISSION ISSUE (did not receive second dose). At the time of the report, VACCINATION SITE PAIN (soreness at injection site after first dose) and PRODUCT DOSE OMISSION ISSUE (did not receive second dose) outcome was unknown.        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.   Treatment information not provided. Concomitant medications were not provided. Symptom text in narrative included Call warm transferred from Moderna Customer Care, case# 00164205 Nurse calling about herself receiving the Moderna COVID-19 Vaccine (lot: 026L20A, expiration: unknown) on 29Dec2020 in her right arm to prevent COVID-19.  She experienced minor soreness to injection site after first dose.. She was scheduled for her second dose in January but did not receive it. Patient not on any concomitant medication. She wants to know whether she can just get second dose now or if she has to start series over. Caller consent to follow up via email. No primary care physician at the time. She would like the info in writing.
After the patient received the vaccination, her mother spoke to the ARNP about the fact that she was currently pregnant. After talking with the WIC staff, approximately 1 hour later, the patient and her mother left the building and drove away. While in the car, the mother notice that the patient was rigid, shaking, eyes rolling back. She took her directly to the ER. It took about two minutes to get there. In the ER, IVs were started and labs were drawn. The patient responded immediately, but was drowsy for the rest of the day. By the time the patient was discharged she was alert and crying.
pt had no problems immed p/vax;@ approx 9:45 pt had confluent reddened ares on both wrists (inner aspect) L>R;epi given into lt upper arm;EMS was activated;transferred to another hosp;
Pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 21Apr2021 at 12:45 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3) and zinc (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 31Mar2021 at 12:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 20:00, the patient experienced pain at injection site. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain at injection site was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Body achiness, tired starting 11/6/13. Diagnosed with Drug induced Sweets syndrome secondary to flu vaccine.
Slight swelling and redness distal to injection site and medially down to elbow on RA.
Information has been received from a registered nurse concerning a 19 year old female who on 10/10/00 was vaccinated with the 1st dose of Hepatitis B vaccine recombinant. Within five minutes post-vaccination, the patient passed out for about 10 seconds and was cold, clammy and very pale. The reporter stated that the patient's heart rate was 90 and her blood pressure went up to 140/100 for about 5 minutes and then returned to 130/86. The patient was given oxygen until she regained consciousness. The reporter stated that no other symptoms were noted. Additional info has been requested.
Titer for Hepatitis B-borderline per laboratory/ low titer; This spontaneous report as received from a medical student refers to a 15-year-old male patient. The patient had seasonal allergies. The patient had no pertinent medical history, drug reactions or allergies and concomitant therapies.  On 21-NOV-2004, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route of administration, lot # and expiration date were not reported) for childhood immunization. On 21-DEC-2004, the patient was vaccinated with the second dose of hepatitis b vaccine (recombinant) (manufacturer unknown). On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 5/0.5 microgram/ml, as third dose, intramuscularly (dose, lot # and expiration date were not reported) for childhood immunization.  On 21-FEB-2020, the patient had titers drawn to check for hepatitis B immunity and the laboratory results were "borderline" (also reported as low titer). The patient did not seek medical attention.  The outcome of the event was reported as not recovered. The relatedness between the event and the suspect vaccines was not proceeded.
ER/URGENT CARE VISIT: Opening Alert charting for RETURN FROM ER (DX SEIZURE HISTORY OF). resident was sent out to the ER @ 11:54 AM after having trouble breathing following her COVID vaccination. RN administered EPIPEN, emergency services was called and resident was sent out VIA ambulance
Severely Cold 15-20 minutes after shot. Last 12 hours. Had to turn heat up to 75 & wear a sweatshirt to stay warm. Hands felt like ice. Then sever Migraine headache for 6 days. Took  Imitrex those days & Excedrin the 7th day(today). It also feels like menopause is back. Get hot flashes but tingly (needle Like)
breakthrough COVID -19 infection; breakthrough COVID -19 infection; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 5 years as dose 2 (tris), single and (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 05Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 05Jan2022, outcome "recovered" (Jan2022) and all described as "breakthrough COVID -19 infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Jan2022) positive, notes: 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.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the events covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
Low back and thigh pain at 1700. He then did not sleep well. On March 3, 2012 he had fever to 101F, queasiness, upper and lower back pain with some neck pain.
WRONG COVID 19 VACCINES ADMINISTERED,  PFIZER 5-11 FORMULATION ORANGE CAP WAS ADMINITER TO THE PATIENT WHICH IS 12 YRS OLD.
immediate pain in the opposite left arm, as well as neck pain  on the right side from the chin to shoulder, was seen in urgent care on 1/30/21
Very withdrawn, high fever, throwing up, flu/cold symptoms for 2 months - Gave her MOTRIN - Children's: TRIAMINIC.
This spontaneous report was received from a physician refers to an anonymous group of patients of unknown age and gender. ON an unknown date the patients were vaccinated with PNEUMOVAX23, 1 single dose (route and lot # were not reported). On an unknown date the patients experienced red hot spots at the injection site and also experienced pain for one week long as well. They sought medical attention. They saw the doctor. The outcome of the events was reported as recovered/resolved. This is one of two reports received from the same reporter. Additional information has been requested.
pt recvd vax; devel thrombocytopenic purpura w/ platelet count 5000/mm3; subsequently devel pulmonary hemorrhage;
Swollen injection site, severe body aches, and a headache. Lasted from Saturday night at about 6pm and ended the morning of 2/1/21 for the severe body aches, headache is still active. Injection site is still swollen and warm to touch.
patients who received a vaccine which was more than 30 days in the refrigerator/For this patient, the number of days that have passed were 11; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator/For this patient, the number of days that have passed were 11) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jul-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator/For this patient, the number of days that have passed were 11). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator/For this patient, the number of days that have passed were 11) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Site: Redness at Injection Site-Mild, Additional Details: patient stated that she has a 3 inch round/red spot around the site of vaccine administration. the spot is not causing her any pain. she is going to take some benadryl and monitor the area. if it gets worse, she is going to seek medical attention.
PATIENT NOTICED ARM WAS PINK BELOW INJECTION SITE AND GRADUALLY GOT REDDER OVER THE NEXT FEW HOURS, TENDER AND WARM TO TOUCH
Beginning on the evening of the 4th day (Wednesday, 3/3/21) after the vaccination and continuing to present (Sunday, 3/7/21) experiencing symptoms of fever, chills, fatigue, and loss of appetite. Symptoms would seem to worsen through the day. Husband would go to bed by 9pm and remain in bed until 11am the next day, feeling too exhausted to get up.  Diarrhea a couple of times a day since Friday, 3/5/21.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unspecified dates from 01-AUG-2017 to 14-SEP-2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M035828, expiry date 28-MAY-2018 (doses were not reported). Concomitant therapies included sterile diluent. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 13 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1709USA008598:
Syncopal episode, fever in the evening, nausea, soreness. Had stayed under observation in medical office x 20 minutes without any reactions or complaints.
This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. It was reported that improperly stored doses of GARDASIL 9 lot number L026602, expiry date 19-OCT-2017 (dose and route were not reported), were given to unspecified multiple patients on 11-APR-2016. No adverse effects were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
2/9: 11:00am - Onset of high fever (103F), no appetite, moderate fussiness, difficult sleeping, tachycardia (145-178bpm) overnight.  2/10: Fever off and on with poor appetite and fussiness. 103 fever at bedtime. (HR 135-172bpm) while sleeping.
Headache, Myalgia, Fever, chills, fatigue Narrative:  Date of vaccination 1/11/2021 Symptoms: chills, fever (101-102), fatigue, headache, body aches
Pt developed nonfebrile seizures on 3/3/00. Child also had diarrhea with dehydration. Treated with anticonvulsants.
realized the syringe only had about 0.1 mL v. 0.7 mL of medication and reported she used a different syringe/ no AE; realized the syringe only had about 0.1 mL v. 0.7 mL of medication and reported she used a different syringe/ no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional and transmitted to Sanofi on 24-Aug-2021.  This case involves an unknown age and gender patient while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ715AB, expiry date not reported) then reported realized the syringe only had about 0.1 ml instead of 0.7 ml of medication and used a different syringe (underdose and syringe issue) via unknown route at an unknown administration site on an unknown date for prophylactic vaccination (latency was on same day).  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  At the time of report, no adverse event reported.  It was reported, "Caller reported there was no damage on the box or syringe, but the side was a little flimsy. Caller reported the other syringes look okay."  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for both the events.
Patient started having neurological issues approximately 5 days after the vaccine.  Mom reported that the patient started having behavioral issues such as spitting and has had to be put on medication.
At routine 38 week doctor appointment, had high blood pressure. Upon re-check, it was still high and also had protein in the urine. Diagnosed with pre-eclampsia despite never having issues with high blood pressure and none of the associated risk factors. Went straight to labor and delivery and upon monitoring, baby was in distress. Heart rate did come back up; she was born that evening by c-section. Original due date was February 5, 2021 (birth date was January 25).  Birth weight was 5 lbs 12 oz.
Heart pounding, dizziness, exhaustion, tight chest, flushed (no fever), out of breath
NauseaVomiting, HYPERtension, Tachycardia, throat swelling Narrative: Went home after vaccine and starting vomiting, throat swelling. HR and BP elevated Went to ER was given beta blockers, in hospital for observation.
Booster. Same effects as second, fever 101, chills, muscle pain, headache, nausea, red non-raised rash starting at forehead and extending down to belly button.
Patient stated in State Board complaint of widespread bruising in the left arm FOR UP TO 8 WEEKS after vaccine administration. She did not state in her complaint how soon after the vaccine was administered this began. It is unknown as to whether or not medical treatment was sought after, as this information was relayed to the pharmacy through a board of pharmacy complaint, and was not communicated with the pharmacy during the alleged 8 weeks. The patient did not ask for medical treatment from the pharmacy. We will contact the patient's PCP, Dr., about this matter on Monday, August 6th, 2018.
p/vax pt devel an inj site rxn characterized by pain, redness & swelling;the area of swelling measured 5cm w/in 30 seconds of vax, enlarging to 40cm by 40cm w/in 90 minutes;
Information has been received from a consumer concerning her 12 month old son with no pertinent medical history and no reported allergies, who in June 2007,  was vaccinated with a dose ATTENUVAX vaccine (Enders-Edmonston) (dose, route and lot number not provided). There were no concomitant medication. The mother reported that one week after receiving ATTENUVAX vaccine (Enders-Edmonston) approximately June 2007, his son developed asthma and allergies to pineapple, watermelon, crab, shrimp, nuts and trees. At the time of the report the patient had not recovered from the events. No labs studies were performed. The patient sought unspecified medical attention. Follow-up information was received from a nurse practitioner (N.P.). It was reported that the 20 month old male patient who on 08-MAY-2007 was vaccinated into the left thigh with a first dose of ATTENUVAX vaccine (enders-Edmonston) (lot # 654623/0034U). Concomitant therapy included a third dose of TRIPEDIA, lot # C2553AA that was given into the left thigh on 20-APR-2007. There was no illness at time of the vaccination. It was reported that on 12-MAY-2007, the patient experienced a reactive airway disease (RAD). The patient required an ER visit with no admission in Nov 2007, and had 3 office visits for RAD. The patient required neb treatments and prednisone. Lab tests included chest X-ray with a negative result. Subsequently, the patient recovered on an unknown date. It was reported that on 29-JUN-2007 the patient was vaccinated into the left thigh with a first dose of rubella virus vaccine live (Wistar RA 27/31 (MSD, lot # 655408/0036U). No further information is available.
mild symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 27Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Tested pos.: 12Jan2021), administration date: 06Jan2021, for Covid-19 immunization, reaction(s): "Tested pos.". The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "mild symptoms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A month after I received the vaccine pain at injection site and muscle spasms with certain movements, if I tried to lift something heavy I would feel pain, doesn't hurt all the time, with different actions I can still feel the pain localized at injection site.
Information has been received from a RN concerning a 4 y/o who on 27Mar00 was vaccinated with a dose of varicella virus vaccine live. On 24Jul2003, 2 weeks after exposure to a 4 year old child who on 11Jul2003 was diagnosed with shingles (also reported as a child with chicken pox and a child who had chicken pox illness in April 2000), the pt was seen at the physician's office and was found to have a mild case of chicken pox. No treatment was required.  No product quality complaint was involved. It was also reported that 3 other children were vaccinated with a dose of varicella virus vaccine live and developed a mild case of chicken pox. Additional information has been requested.
When patient arrived his guardian was not here so he sat and waited. When dad came, we registered patient as normal asking if he feels ill or not and he stated no. When I brought him back to the room we were talking about school and activities he is in and he seemed normal and answering normally just tired. I cleaned his arm and talked him through things that can happen with the second dose of Pfizer. He seemed just fine and once I injected and bandaged him he went stiff and I tried to talk to him and he did not respond. I called for help and they got his dad. he finally started coming too and was extremely warm. I sat with him for 10 to 15 minutes and rubbed his back and we got him water to drink. we started an incident report right away while talking to the dad. nothing further happened and he was told to go straight to the clinic to be checked out.
24 hours after vaccination patient started running a fever.  Temperature went to 102.5.  Chills. Next day temperature was elevated all day.  Took Tylenol,.