chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she started to feel sick so she went to see her doctor who diagnosed her with hyperthyroidism; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: EW0153) at the age of 46 years, in left arm and on 06May2021 as dose 2, single (Lot number: EW0169), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroidism", start date: Oct2021 (ongoing), notes: Hyperthyroidism Caller states she is not taking any medications for this condition. There were no concomitant medications. The following information was reported: HYPERTHYROIDISM (medically significant), outcome "unknown", described as "she started to feel sick so she went to see her doctor who diagnosed her with hyperthyroidism". Clinical course: The caller mentioned that in October she started to feel sick so she went to see her doctor who diagnosed her with hyperthyroidism, for which she received treatment for a month and a half (6 weeks) and that she has and has returned to normal values. She presented that with no family history of hyperthyroidism  No follow-up attempts are possible. No further information is expected.
Information has been received from a RN concerning a 11 year old male who was vaccinated with varicella virus vaccine live. On 29Mar04 the pt developed chickenpox with 300+ lesions. The mother stated that her son was vaccinated but the physician was unable to find any vaccination records on the pt. No product quality complaint involved. There were also three other cases reported (WAES0404USA01771, 0404USA01827, and 0404USA01828). Additional information has been requested.
5 minutes after the vaccine, patient started  feeling dizzy, change in vision and sweating. Taken the the patient to the exam room, and made him lie down with elevated legs. Given some water to drink. Checked BP -110/68 , HR-51, and O2 stats-96%, never loss consciousness, alert oriented during the time of incident. Skin looks pale  with profuse sweating. Denies any shortness of breath. Watched the patient for another 30 minutes and send home with after all the symptoms completely resolved/
Narrative:  Patient received first dose of Shingrix and developed a blister at the injection site the next day. Patient reported this to provider. Patient developed no further symptoms, blister resolved on it's own, no treatment necessary.
Patient came to the office to get his second COVID vaccine, and instead of that, patient was giving the Booster Bivalent vaccine.
Pt developed tender bumps and/or itching hives intermittently in area where vax was given.
Arm was more swollen than first shot. Also had stiff neck this time. In morning, I was OK, but I had sudden onset of diaphoreses, was going to vomit/diarrhea/pass out at the same time. Lasted 15 minutes. Then I had a high fever, headache and aches for a few hours. Fever is low grade now (26 hours post injection) with typical flu-ish symptoms. Took a Tylenol and nap at noon.
ON 12/02/2021 4 HOURS AFTER RECEIVING THE VACCINE I DEVELOPED BELLS PALSY ON THE LEFT SIDE OF MY FACE. I CALLED 911 AND PARAMEDICS CAME AND ASSESSED ME. THEY SAID THEY DID NOT THINIK IT WAS A STOKE AND A POSSIBLE REACTION THE THE COVID VACCINE (PFIZER). AND TO TAKE SOME BENYADRL. WHICH I DID. THEY DIDNT THINK IT WAS VERY SERIOUS AND DIDNT REQUIRE HOSPITAL TREATMENT. SINCE ALL HOSPITAL IN MY AREA ARE IN A CODE RED SITUATION.  THEY LEFT AND SAID IF I FELT LIKE I NEED TO GO THE HOSPITAL I COULD CALL BACK AND THEY WOULD TRANSPORT ME. THE NEXT MORNING  12/03/2021 I WENT TO THE URGENT CARE/EMERGENCY ROOM NEAR MY HOUSE AND GOT REAVALUATED BY A DR AND HE DIAGNOSED ME WITH BELLS PALSY STATED HE THOUGHT IT WAS CAUSED BY THE  COVID VACCINE (PFIZER) AND PRESCRIBED AND ANTIVIRAL AND STERIROID MEDICATION.
General body aches with a mid right muscle ache that radiated to the right lower lobe lung. Body aches increased as the week went on until 10/28/2012 had chest pressure/pain with bad leg aching. Went to the ER, then home.
Arm soreness, fatigue, headache, fever, significant delayed chronic spontaneous urticaria (hives), increased allergic reactions
G47.33 OBSTRUCTIVE SLEEP APNEA 12/8/2021 SEPTIC SHOCK I95.9 HYPOTENSION 10/5/2022 SEPTIC SHOCK
Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Severe
itching, swelling, heat & pain @ site of inj;relieved by DPH by mouth as ordered by MD;
This initial spontaneous report was received on 18-SEP-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and indication not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. Later in 2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as a severe herpes zoster or shingles for the long term prevention of shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
headaches; dizziness; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches), DIZZINESS (dizziness) and NAUSEA (nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) and LISINOPRIL for Thyroiditis.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced HEADACHE (headaches), DIZZINESS (dizziness) and NAUSEA (nauseous). At the time of the report, HEADACHE (headaches), DIZZINESS (dizziness) and NAUSEA (nauseous) outcome was unknown. Not Provided        The action takren with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. Treatment products included Tylenol and advil.   Reporter did not allow further contact
Patient experienced swelling of lips and tongue was having trouble breathing. Pharmacy called 911 and administered one 0.3 mg EpiPen to right thigh. 911 arrived and took over-patient did not go to ER via EMS but was going to go to hospital on her own (mom was with her)
Info has been received from an office manager concerning a female pt who on 10/21/2002 was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent. The pt had received a 1st dose of pneumococcal vaccine 23 polyvalent approx 5 to 6 years "with no problems". Post vaccination with the 2nd dose, the pt developed swelling from her shoulder to her elbow. The reporter indicated that a pt was treated with antibiotics, but did not specify if it was this pt or a 2nd pt (WAES #0210USA02676) that experienced an adverse event post pneumococcal vaccine 23 polyvalent vaccination. Unspecified medical attention was sought. Additional info has been requested.
Severe myalgias and arthralgias, fever (101.5) and diarrhea (brief and transient.  Myalgias and arthralgias were severe.  Orthostasis.  Onset of symptoms within a few hours of vaccine.  No local reaction at injection site.
Patient received COVID-19 vaccines on 1/21/21 and 2/18/21. He was diagnosed with COVID-19 infection, requiring hospitalization, 8/29/21 at local hospital. Those records are not available to this writer at this time.
potential medication error due to the administration of only the liquid DTAP-IPV portion to a patient, not the ACTHIB portion with no reported adverse event; Initial information received on 13-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 5-month-old male patient who had potential medication error due to the administration of only the liquid dtap-ipv portion to a patient, not the acthib portion with no reported adverse event after receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ (pneumococcal conjugate vaccine); rotavirus vaccine and Hepatitis B Vaccine all for Prophylactic vaccination.  On 13-Feb-2023, the patient received suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE at a dose of 0.5 ml once (lot U7331AA, expiry date: 16-Sep-2023) via intramuscular route in the left thigh for immunization.  On 13-Feb-2023 there was administration of only the liquid dtap-ipv portion to a patient, not the acthib portion with no reported adverse event (single component of a two-component product administered, same day latency) of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  Action taken: Not applicable.  Outcome: Unknown.   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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Information has been received from a certified medical assistant concerning a 5-year-old patient with no pertinent medical history or allergies who on 03-JUL-2007 was vaccinated subcutaneous with 0.5 mL dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # 654691/1026F). There was no concomitant medication. On approximately 05-JUL-2007, (within 2-3 days), the patient developed raised, red bump at injection site. Symptoms were described as "itchy, very hard, and warm to the touch." The patient sought unspecified medical attention and was treated with BENADRYL CREAM for itch. No diagnostic labs were performed. On approximately 19-JUL-2007, (2 weeks later), the patient symptoms resolved. A product quality complaint was not involved. This is one of several reports from the same source.
patient experienced onset of subjective and eventually objective fevers 4 days after receiving the second Moderna vaccination.  He experienced malaise, and fatigue as well and some shortness of breath with chest tightness and was ultimately diagnosed with pericardial effusion and pericarditis.
9 week old male given rotavirus IZ. 1st IZ (before any shots). Child immediately had decrease respiration and transient cyanosis and 5-10 mild decreased LOX. Looked stunned. No intervention NO O2, simple stimulation and holding, then fine other IZA given next day. Prof simple choking but did not have typical choking symptoms.
16 Nov 2004 Itchy rash appeared on elbows, complained of "bad taste" in mouth, began frequent spitting rather than swallowing saliva (continued through Feb 2005). 19 Nov 2004 Wheezing, difficulty breathing, some coughing treated with Benedryl and Albuterol with Nebulizer.  Wheezing seemed to peek on 22 Nov with difficulty making it 3-4 hours between treatments.   23 Nov 2004 Saw doctor.  Started Orapred and wheezing resolved by 27 Nov. 6 Dec 2004 Itchy rash spread to legs saw doctor.  Treated with .05 Hydrocortizone cream. Suggested I could see a neurologist regarding the spitting.  Received second dose of Hepatitis vaccine.    16 Dec 2004 Looks like insect bite on top of left foot, itchy. 17 Dec 2004 Left foot swollen and red, rash spread, many bumps, itchy and painful. 18 Dec 2004 Left foot VERY swollen, red and warm, itchy and very painful, difficulty sleeping.  Treated with Benadryl, Tylenol and Motrin.   19 Dec 2004 Skin on foot actually split open from swelling and oozed.  Elevating foot and ice.  No walking.   21 Dec 2004 Swelling down on foot. 10 Jan 2005 Saw neurologist.  He suggested that the spitting now is a learned behavior that should be ignored.  Yet, this behavior continues to interfere with his speech, he interrupts play to spit, and he has difficulty sleeping if no garbage can is placed near him so he can spit.   14 Jan 2005 Noticed small amount of rash on elbows again, slight itch. 15 Mar 2005 Spitting and rash seem to have resolved. Left foot is scarred.
pt recv vax 30APR97 & exp flushing fever, hot sensation, chills, abd pain, tiredness;pt was seen by school nurse;pt rested a short time & then felt fine;pt seen again by school nurse @ which time PE was nl;pt recovered 30APR97
Dizziness, NauseaVomiting, Bradycardia, Syncope Narrative:
Severe throbbing pain to left arm at injection site radiating up to left neck & behind ear area followed with chills & shivering, site red, swollen, & hard to touch then temperature up to 101.6- took ibuprofen, Tylenol & warm pad place to site.
Fever 101; pain in both thigh; chills; nausea; headache; This is a spontaneous report from a contactable nurse (patient herself). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the left arm on 13Jan2021 13:00 at single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS). Concomitant medications were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. On 14Jan2021 01:00, the patient experienced fever 101, pain in both thighs, chills, nausea and headache. No treatment was received for the adverse events. Clinical outcome of the events was recovered with sequelae on Jan2021.
Symptoms started in the afternoon, fatigue, coughing, and slight fever. Tested positive on an at home COVID-19 test 8/23. Spoke to doctor that day, LAGEVRIO was prescribed. Flu like symptoms continued. About 10 days to 9/2. These symptoms waxed and waned but diminished gradually until 9/7.
Information has been received form a physician concerning an 18 year old male who on 21-SEP-1992 was vaccinated with the first dose of MMR II, on 14-Oct-1994 was vaccinated with the second dose of MMR II. On 02-DEC-2009 the patient experienced mumps. Follow up information has been received from a physician concerning a 16 year old (also reported as 18 year old) female patient who 21-SEP-1992 was vaccinated with first dose of MMR II (dose, route and lot number not reported). On 14-OCT-1994, the patient received the second dose of MMR II (dose, route and lot number not reported). The physician reported that the patient developed mumps on 13-NOV-2009 (also reported as 02-DEC-2009). The patient was diagnosed with mumps on 17-NOV-2009. The patient had parotitis in the both sides and was afebrile. The final outcome for mumps was not reported. This is one of several reports from the same source. No further information is available. Additional information has been requested.
soreness at the injection site on his arm; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 20Mar2021 (Batch/Lot number: unknown) at the age of 46 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 21Mar2021, outcome "unknown", described as "soreness at the injection site on his arm"; FATIGUE (non-serious) with onset 21Mar2021, outcome "unknown", described as "fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a licensed practical nurse concerning an approximately 6 year old patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck). On approximately 28-MAR-2007, the patient developed approximately 10 lesions. At the time of report, the patients' outcome was unknown. This is one of several reports received from the same source. No further information is available.
This is a spontaneous report from a Pfizer-sponsored program, IBCC (Inbound Call Center for HCPs), from a contactable nurse practitioner reporting for her son. This 19-year-old male patient received the first single dose of TRUMENBA intramuscular in the left deltoid on an unspecified date during the summer of 2016 for immunization.  The patient medical history was none, concomitant medications were not reported.  No other vaccines were given the same day or within four weeks. The patient experienced redness (four to five inches redness induration) and pain at the injection site the same day of vaccination. Therapeutic measures were taken as a result of the events and included the administration of ibuprofen (MOTRIN). No Emergency room or physician's visit and no relevant tests were performed. The patient recovered on an unspecified date in 2016 after about one week.
Eyes rolling to side or up and diagonal. Both eyes will go in same direction during episode. It lasts for just a second and then he's back to normal. It happened 7-10 times over the course of 4 days. In addition, three days after shot my son got a high fever (102) and that lasted on/off for about ten days. We went to the pediatrician's office on 4/11 because of the odd eye movement. He recommended we get an EEG. That was completed on 4/14. We are currently scheduled to get a brain MRI done on 5/6/16.
patient developed a hard, red swollen spot on her arm at the injection site 10 days after the injection. advised her to ice it.
I21.3 - STEMI (ST elevation myocardial infarction) (CMS/HCC)
pt recvd vax & began to exp a serum sickness type react consisting of joint pain, weakness, &/or diarrhea; workup has included numerous tests for collagen vascular diseases, & has been non-diagnostic;
Rash immediately following 03/21/1997 hep vaccine with arrested head growth and neurological complications. Arrested growth, eye rolling and blinking. Per 1 year follow up: Pt has not recovered. Seizures- immediately following DTAP (10/16/1996) is on video. Movement disorder. Severe development delay. Mercury poisoning. Autonomic Neuropathy. Special school. Comments: What are you going to do to help my son? We have been to clinics and hospitals and spent thousands of dollars and millions of hours- what will you do?
Information has been received from a registered nurse referring to multiple patients of unknown age and gender. The patient's concomitant medication, medical history and drug reactions/allergies were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L048848 with expiration date 09-AUG-2018, dose unknown) intramuscularly for prophylaxis. The vaccines were exposed to 8.8 degree Celsius for 60 minutes. There was no previous temperature excursion. No adverse effects were reported. Data logger was involved. Additional information has been requested.
Patient was administered an expired dose of FLUZONE QIV from last year with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional and consumer/non-health care professional via Agency (Reference number- 00791011) and transmitted to Sanofi on 29-Sep-2021.  This case involved an unknown age and gender patient was administered an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] from last year (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On an unknown date in September 2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: not reported and expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination (expired product administered).  It was reported "Pharmacy student calling for information regarding the FLUZONE QIV and the caller would like to know if the patient requires revaccination? Caller does not have information on the patient of the event. Caller was unable to provide a lot number, but was able to provide an expiration date for the product".  This case was an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event.  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.  There will be no information available on the batch number for this case.
On March 19, 2021, I had a 2+ hour episode of a heart arrhythmia.  I put on my apple watch and catalogued the heart rate which was between 100 and 162 for most of the time period.  I had once before (in 2019 had a very short episode of a-flutter-- under 10 minutes long).  This was different.
This spontaneous report as received from employee (unspecified) refers to a 66 year old male patient. Patient medical history and current condition was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX. Other co-suspects and concomitant medication was not reported. On an unkonwn date the patient experienced shingles, rash and pain in his left leg after receiving ZOSTAVAX. It was reported that the patient received treatment with Gabapentin (unspecified dose/frequency and manufacturer). Cancer and overdose was not reported. The outcome of the event was reported as not recovered/not resolved. Additional information has been requested.