chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to a 39 year old male patient. The patient's pertinent medical history included Crohn's disease, diverticulitis and history of elevated liver function tests. He did not have any drug reactions or allergies. Concomitant therapies included HUMIRA, albuterol, amlodipine, aspirin (manufacturer unknown), atenolol, IMURAN, SYMBICORT, CELEXA, clonidine, FLEXERIL, VALIUM, LASIX, LOPID, GLUCOPHAGE, PERCOCET, potassium (unspecified), simvastatin (manufacturer unknown) and DIOVAN HCT. On 15-SEP-2016 at 15:00, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # M020521, expiration date 17-NOV-2017, intramuscularly; site and dose were not reported, indication provided as "based upon patient's condition"). On the same day, immediately after vaccination, the patient experienced shortness of breath, chest tightness, severe back pain and stiffness in all extremities. He received epinephrine and the symptoms quickly subsided. The outcome of the events was recovered in approximately September 2016. The relatedness between the events and PNEUMOVAX 23 was not reported. The reporter determined shortness of breath, chest tightness, severe back pain and stiffness in all extremities to be medically significant as they required an intervention to prevent a serious outcome (it was reported that without epinephrine, the adverse events could have been life threatening). Additional information has been requested.
RASH STARTED APPEARING AT CHEST AND NECK AND FACE WITH ITCHING,  FATIGUE, PAIN AT INJECTION SITE, NUMBNESS AND TINGLING IN THE ARM SHOT GIVEN, HEADACHES, JOINT PAIN, BODY ACHES, CHILLS, FEVER OF 99.9 BY TUESDAY. STILL HAVING SEVERE JOINT AND BODY ACHES WITH HEADACHES AND LOW GRADE FEVER CURRENTLY.
Information has been received from a physician concerning a 74 year old female who on 24-SEP-2007 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot# 657765/0585U). On 25-SEP-2007 the patient experienced a localized allergic reaction on the left arm at the injection site with a 5 inch induration, urticarial wheal without systemic urticaria and edema. The patient was treated with oral BENADRYL. Additional information has been requested.
Charley horse (dull) left leg, sore arm (like punched) Neck pain,  excruciating stomach pain for 45 minutes-1 hr that just went away.  Mild headache
Information has been received from a pharmacist concerning a patient who had negative titers after receiving a dose of MMR II. The pharmacist did not know if the patient was given 1 or 2 doses of vaccine in the past. The pharmacist also did not know if the patient was negative to measles, mumps or rubella. No further information is available. Correspondence attempts were unsuccessful.
I am feeling very weak.; headache; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old male patient received BNT162b2 (COMIRNATY), on 23May2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer, Caller states that he did not have any side effects with his other Covid19 vaccines.), for COVID-19 immunization. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "I am feeling very weak."; HEADACHE (non-serious), outcome "unknown"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 59 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Dysautonomia" (unspecified if ongoing); "Orthostatic hypotension" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "a-fib" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lyrica, reaction(s): "Known allergies: Lyrica". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Customer ordered ADACEL and FLUZONE HD, Customer declined ADACEL Due to cost, ADACEL was administered in place of FLUZONE.
I have Constant Ringing in my ears. It never goes away; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 29Mar2021 at 13:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication was not reported. The patient had no known allergies to food, medication or other products. On 30Mar2021 at 13:00, the patient experienced constant ringing in ears and it never gone away. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event constant ringing in ears were not resolved at the time of this report.
Pfizer 3/18/21, 4/8/21. Positive on 12/8/22
Patient woke up with pain in right and left shoulders.  Pain went across shoulder blades and into his neck.  patient reported that left arm improving but right arm he has difficulty lifting things with.
7AUG92 pt recvd Engerix-B & 8AUG92 devel generalized itching, swollen upper lip, feeling of palpitations, heartburn & pain @ site; 10AUG92 seen by MD; prescribed Hydroxyzine;
Dose given ~5:20 pm.  @~5:40 pm: pt came to counter, R arm was red from fingers to elbow (red to purple). no signed or sxs of itching and observed lips and tongue: normal. @~5:47 pm: gave pt Benadryl 25 mg PO and bottle of water, pt took the tablet. Pt was asked to sit and wait so we can monitor. @~6:00 pm: arm was returning to normal color. redness almost come @~6:05 pm: arm nearing normal color. no complaints of itching. observed lips and tongue: normal.  @~6:10 pm: Sat W/pt. color of arm back to normal. pt had no complaining of itching or SOB.  @~6:20 pm: released pt. told father to call EMS if Sxs return (Swelling of lips & tongue, SOB, rash returns or worsens)
Swelling, redness, warmth in L arm (arm in which pt received vaccine. I was called by pt's family, advised warm compresses, elevation, Tylenol prn pain, and to ER/call 911 prn sxs worsen.  Called again 8/26 am by pt's family, I asked them to bring her to clinic as walk-in pt--> I examined pt, saw ~ 20 x 10cm area of warmth, erythema @ pt's upper arm;no axillary LAD (though pt c/o L axillary pain), no streaking, and pt afebrile (98.8F). I rx'd Bactrim DS bid x 10d in case of cellullitis, advised call/ rtc prn sxs worsen.
This spontaneous report has been received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II injection (albumin status unknown; lot number, expiration date, dose and route of administration were not reported). Concomitant therapy included sterile diluent used to reconstitute. The M-M-R II was stored at -0.24 degrees Celsius for 124 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint was involved. As of 26-MAY-2017, all telephone attempts to obtain follow-up information have been unsuccessful. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA000920: US-009507513-1705USA000822:
Injection site immediately swelled up and bled and bruised. Applied cold pack and had pt remain seated and gave her 10ml of benadryl liquid. Pt also complained of a headache
Information has been received from a registered nurse concerning a child who was vaccinated with varicella virus vaccine live (Oka/Merck). Subsequently the patient developed lesions starting in the hairline, face, chest and abdomen. The child was diagnosed with a viral rash, but the nurse believed that it was chickenpox. As of 05-DEC-2006 the patient had not recovered. The registered nurse also reported on other childrens' experiences with varicella virus vaccine live (Oka/Merck) (WAES#0612USA00711). No additional information is expected.
nausea after second dose; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea after second dose) in a patient of an unknown age and gender 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(s). On an unknown date, the patient experienced NAUSEA (nausea after second dose). At the time of the report, NAUSEA (nausea after second dose) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
Pt developed large swollen, tender, erythematous area at site of DTaP injection. Reaction occurred within 12 hrs of injection. Treated with ice/Zyrtec/Benadryl.
4 days s/p Covid Pfizer Vaccine 5-11, Patient c/o of "heart feels like it wants to jump out chest", mom brought Patient to ED where she had a cardiology work up, cleared for discharge after 1 day observation. No issues since discharge.
pt recvd vax; approx 6-8 hrs after vax, pt devel generalized redness w/ moderate itching of upper body, & mild tingling; approx 12-16 hrs following vax pt devel diuresis;
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions or concomitant medications were not reported. On 07-FEB-2017, the patient was inadvertently administered with an expired dose of PNEUMOVAX 23 intramuscularly (lot # L024129, expiration date: 21-JAN-2017), for prophylaxis. No adverse events were reported. Additional information has been requested.
2 weeks of abdominal pain & nausea,  documented weight loss of 10lb, prolonged malaise limiting his scholastic learning, all associated with having the first covid-19 (pfizer) vaccine on 6/7/21  He had  fever  lasting several days that began within 2 days of vaccination (but that resolved within several day ).   Labwork done  at that time showed modest nonspecific elevations of inflammatory markers CRP of 42,  (normal < 8), ESR 50, calprotectin 285 (120 limit).  SARS covid-19 antibody semiquant to spike protein RBD was 64.4 U/mL (<0.8, Labcorp).  Other tests did not identify another specific etiology, and an evaluation by another physician for myocarditis was reportedly normal.  As of 7/17 he feels better with a resolution of all symptoms, labwork repeated this past week (7/15) showed a resolution of those same inflammatory markers to normal levels .
I have been vomitin for the last 4 days with a lot of abdominal pain.. Can keep sips of liquid down but increases pain. I have 2 sisters that have had reactions to this, also. One is very similar to my reactions.
This is a 27 year old male, with a history of irritable bowel syndrome and lactose intolerance, who received FluMist for the first time on 10/5/06. On 10/6/06 the pt developed a fever of 102 and fatigue two days later, on 10/8/06, the pt was having trouble breathing and was admitted to the hospital. Upon admission, the pt was given a diagnosis of pneumonia. The pt was treated for his symptoms and was discharged on 10/10/06. For the next two weeks, the pt returned to work despite having a persistent mild fatigue. In the following month, the pt was hospitalized two more times for other serious medical problems. There is no further information regarding course of events. lab diagnostic testing results, treatments, and event outcome. The reporter was requested to forward all pertinent pt medical information to product safety at manufacturer. The provided reporter causality is definite. 05/15/07-records received from facility for DOS 11/9-11/22/06-DX DX: Mycarditis. Initially treated for pneumonia. Subsequently developed chest pain found to be in complete heart block with a troponin of 4 and CK of 140. Cardiac cath clean, spontaneously converted to junction rthythm. Cardiac MRI showed inferolateral LV wall and epimyocardium was involved sparing the endocardium. Developed pulmonary edema. tiring tachypneic, ultimarely intubated. Extubated. Developed bradycardia and progressed to left bundle branch pattern wide complex with palpations and dizziness. Pacemaker placement. Echocardigram showed normal LV size decrased function and a PASP of 38%. RPR, blood culture, urine cultue negative. Brochoscopy culture negative. Interesting that his FluMist vaccination was temporarily related to the beginning of what looked like a URI episode and ultimately developed in his first initial experience of chest pain and shortness of breath. Per annual follow up: Reporter indicated that the patient had finaly recovered from the event with a pacemaker. 07-Mar-08 Follow up: Has pacemaker. Top part of heart does not work, only bottom with pacemaker. On blood thinners. Low endurance. Heart races at times. SOB at times. Prior to vaccine he was in good health. His job as an EMT fire fighter required frequent physicals.
received Fluzone HD 3 weeks ago and he went to the doctor received another dose / no AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown demographic patient who had received two doses within  3 week of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number and Exp. Date not reported) via unknown route in unknown administration site, on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to extra dose administered.   It was reported that received Fluzone HD 3 weeks ago and he went to the doctor received another dose.  At the time of reporting, the patient had no adverse reactions.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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 on the batch number was requested.
the patient received two doses of RabaVert and for the other two didn't show; Case reference number US-BN-2021-000708 is a spontaneous case report initially received from a pharmacist on 05-Apr-2021, and concerns a male patient.  The patient's medical history was not provided.  The patient's concomitant medications included Immunoglobulin (immunoglobulin human normal).  On an unspecified date, the patient received the initial dose of RabaVert (Inactivated Rabies Virus Vaccine, Batch no. not provided) at an unknown dosage regimen for post-exposure prophylaxis.  On an unspecified date, the patient received the second dose of RabaVert (Inactivated Rabies Virus Vaccine, Batch no. not provided) at an unknown dosage regimen for post-exposure prophylaxis.  On an unspecified date, the patient was supposed to receive the other two doses according to the vaccination schedule, but the patient was out of the town and did not show up on time for the other two doses (product dose omission issue).   At the time of this report it was not known whether the patient developed any adverse event.  Further information was not provided.; Reporter's Comments: Product dose omission issue is listed by convention. Reportedly, the patient received two doses of RabAvert for post-exposure prophylaxis instead of four. No adverse events were reported. Product dose omission issue is not related to the suspect product but to a human action.; Sender's Comments: Product dose omission issue is listed by convention. Reportedly, the patient received two doses of RabAvert for post-exposure prophylaxis instead of four. No adverse events were reported. Product dose omission issue is not related to the suspect product but to a human action.
Patient started experiencing a pressured headache; Patient started experiencing a painful headache; This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT (Patient started experiencing a pressured headache) and HEADACHE (Patient started experiencing a painful headache) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A, 048B21A, 045J21A and 010H22A) for COVID-19 prophylaxis.     It was reported that patient had received other vaccine in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Flu vaccine fall 2021 (Flu vaccine fall 2021) in 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine fall 2021.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced HEAD DISCOMFORT (Patient started experiencing a pressured headache) and HEADACHE (Patient started experiencing a painful headache). The patient was treated with GABAPENTIN at a dose of up to 2700 mg; AMITRIPTYLINE at an unspecified dose and frequency and LAMOTRIGINE at an unspecified dose and frequency. At the time of the report, HEAD DISCOMFORT (Patient started experiencing a pressured headache) and HEADACHE (Patient started experiencing a painful headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  It was reported that patient started experiencing a pressured and painful headache, 8 days after the dose 1 which had not gone away. The pain initially started over left eye and later in summer f 2021, it started to move a little bit to the crown of head from front to back. The base pain and pressure had not gone away, but pain flared up at times. Patient had spoken to a neurologist and had taken Gabapentin.
his feet feel like they are 4 times their size, and it was not like that before; ringing in his ears; numbness in his feet; coldness in his feet; her feet getting more nerve; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), via an unspecified route of administration, administered in Right Arm in 2021 (at the age of 66-years-old) at dose 1, single and via an unspecified route of administration, administered in Arm Left in 2021 at dose 2, single for covid-19 immunization. Medical history included allergies, hay fever, allergic to sodium nitrate in all meats, allergic to gin. There were no concomitant medications. The patient previously took statins and experienced drug allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He got the vaccines six months ago. After first dose, patient reported that he had ringing in his ears and his feet were numb and cold, he felt his feet were 4 times the size they really were, and these got worsened after the second dose of the vaccine. He described that he has extreme numbness and coldness in his feet and his doctor has not been able to do anything to help it. He was asking if there was any information on those side effects and if there was anything that could help. He also stated that his feet felt like they were 4 times their size and was not like that before. He also experienced a worsening of his feet getting more nerve. He already had the issue, but it got worse. It was a nerve thing just like his ears. His feet were numb and cold. It was getting worse. It is about the same feeling. He didn't realize it was related. With the numbness and coldness in feet, his feet felt 4 times the size they really were. They were getting worse instead of better. He has received acupuncture and went to a chiropractor, and nothing has made it better. He went to a neurological doctor who couldn't get anything better either. The vaccine was not administered at military facility. The events resulted in physician office visit. Patient underwent lab tests and procedures included brain MRI with unknown results. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
chills; general body aches; fatigue; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first single dose of BNT162B2 (Solution for injection, lot number: el9262, exp date not reported), via an unspecified route of administration (Vaccine location: Left arm) on 22Jan2021 15:00 for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Other (not specified). Prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant at the time of vaccination and was not pregnant at the time of reporting. The patient had no allergies to medications, food, or other products. There were other medications patient received within 2 weeks of vaccination (not specified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021, the patient experienced severe chills lasting for another 24 hrs; then general body aches and fatigue lasting for 3 days. The events were considered as non-serious by the reporter. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on an unspecified date in Jan2021.