chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From initial information received on 5/7/04 from the patient regarding an adverse event occurring in the USA, it was reported that a 43 year old female patient received second dose of IMOVAX RABIES vaccination, lot number W1419, administered IM on 1/12/04 (on or about 2:00 PM). Six days later on 1/18/04 at6:00 PM the patient developed facial itching and a reddened rash and hives which progressed over the entire body. The patient did not have tongue swelling. She began using 1% Cortaid creme locally on Saturday morning. She felt immediately hot then the itchiness stopped. She popped some Benadryl Q4 hours over the weekend and by Sunday evening, the rash was subsiding and the itchiness resolved. By Monday, the rash was fading and lighter. The patient did not experience any fever throughout the episode. The patient recovered from these events.
Patient felt lightheaded a few minutes after the flushot.  Over a few hours, it progressed into an allergic reaction and the patient went to an emergency room for treatment.
Migraine, high blood pressure spike, tinnitus, general fatigue.  24 days later: tinnitus still ongoing, extreme fatigue (not able to walk slowly for more than 15 minutes or perform daily tasks), head pressure, ear pressure. Unable to work in computer for more than an hour.
#1 Moderna vaccine 1/22/21 @1210hours  at right deltoid Date of second shot was not recorded for report 2nd vaccine caused side effects started the next day - woke up feeling very weak, headache, eyes hurting, fever not measured, felt confused, dizzy, vomited x2
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was supposed to receive ZOSTAVAX received VARIVAX (Merck) (Lot #, dose, route unspecified) instead of September 2011, "1 year ago". The patient was not experiencing any known symptoms. No treatment information was reported. The outcome was unknown. Additional information has been requested.
blood clots; calf pain; headaches/head pain; swelling; This is a spontaneous report received from a contactable reporter (Other HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "blood clots"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "calf pain"; HEADACHE (non-serious), outcome "unknown", described as "headaches/head pain"; SWELLING (non-serious), outcome "unknown", described as "swelling". Additional information: Patient stated that her job requested booster vaccine or she will lose her job. Due to the adverse reactions that she had with the first 2 vaccines, and now calf pain and blood clots ruled out, she felt that Pfizer should hold her exempt from receiving this injection (Booster). She was fully vaccinated. She had swelling, head pain, and when she gets headaches it was so severe that she had to call out of work.    The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202200249143 same patient/drug, different dose/AE
Information has been received from a nurse concerning a 61 year old male who on 16-JUL-2009 was vaccinated with a dose of VARIVAX (Merck) (lot # was reported as 1739) instead of ZOSTAVAX (Merck) in his left arm.  Human error.  No adverse effect noted.  At the report time the outcome was unknown.  No further information is available.
Dizzy shortly after, passed out. Slept for 12 hours straight, fever and red swollen rash appeared on upper arm where shot was given. Extremely painful and hot to touch and lasted for over a week. I still feel very exhausted and irritable.
ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPERCAPNIC RESPIRATORY FAILURE HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXIA 2/24/2022 -- RECURRENCE OF SAME SYMPTOMS
48 hrs after immunization mother noticed L deltoid area red, warm & swollen.  Skin is very tight.  Brought child back to clinic =~72 hrs p imms.  L deltoid is as described above c ara extending from 1/2" down deltoid to approx. 1" below.  Afebrile, goo ROM.  will see PCP.  Has used ice & ibuprofen since yesterday.  PCP advises it is a local reaction.  Observe.
Patient called stating she is having flu like symptoms, nausea and fatigue after receiving the immunization. Slightly red at sight, minimal swelling
This spontaneous report was received from a pharmacist and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with a dose of improperly stored M-M-R II lot# L032181 with expiration date: 25-AUG-2017 (dose and route of administration were not reported). Administered dose of M-M-R II underwent temperature excursion at 77 Fahrenheit degrees, for 1 hour. Data logger was not involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
This is WAAAAAY to comprehensive.  I can see why people don't follow through and complete the.  And what is the facility on the previous page?  facility for what - my doc visit, where I got the vaccine, where I went for my kidney stone diagnosis (er)?
Had a seizure.  EEG normal CT scan normal lab normal went to ER by ambulance. Had another seizure on 08/31/2010.
Urticaria 8/23/16; Hydroxyzine prescribed 8/29/16.
Report body chills x 2 days that has completely resolved. Cough and sore throat started 4 days post vaccination. Treatment: OTC Robutussin with little improvement. Outcome: Symptoms are improving does not interfere with ADLs.  (Employee tested positive for covid 2 months ago).  Instructed to monitor symptoms.
Numbness on left arm (injection arm, spreading to left hand); This is a spontaneous report from a non-contactable consumer, the patient.  A 59-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 06Apr2021 at 16:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 07Apr2021, the patient experienced numbness on left arm (injection arm, spreading to left hand). 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. The clinical outcome of the event numbness on left arm (injection arm, spreading to left hand) was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
low grade temp-101, muscle ache across hips, vomited food, dark yellow urine, fatigue;
13 X 15 cm erythematous, raised welt below injection site, warm to touch.
pt child in clinic for DTP/HIB vax -mom to recv flu shot; mom inadvertently recv child dose of DTP/HIB instead of flu vax;
Vomiting, diarrhea, fever, chills, aches, exhaustion.
Tachycardia, HR 130's, tremors, shortness of breath. The medical record received on 2/17/04 states arm numb.
Reactions to Moderna booster; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Reactions to Moderna booster) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reactions to Moderna booster). At the time of the report, VACCINATION COMPLICATION (Reactions to Moderna booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.
I experienced headaches, tiredness, cough, sore throat, pain in my body, joint pain, muscle pain, vomiting, nausea and fever.
Hospitalized 2/2/22-2/7/22 fall, weakness, confusion, head injury, decreased appetite, diarrhea,
Soreness at injection  site. Fever of 100.6 Fahrenheit. Achy and tired.
No additional AE was reported; Improperly stored vaccine(s) were administered; This spontaneous report as received from a registered nurse refers to a 4-month-old patient of unknown gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On 30-MAR-2021, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number: 1691299, expiration date: 25-DEC-2021, dose and route of administration not provided) and haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot number: T020616, expiration date: 16-MAR-2023, dose and route of administration not provided). The vaccines were stored in temperature 50.7 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. Digital data lodger was involved.  No adverse event was reported.  This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-2104USA000392:
Mom reported onset of 4 inch circular red raised area at site of HPV vaccine. Lasted 1.5 weeks - resolved on its own with no action taken by parent. Reported to provider after resolution.
bad h/a, eyes blurred, rash;treated w/Pred;was hospitalized on 9SEP94 for cephalgia;r/o rabies;seen in office on 12SEP94;well as of 11OCT94;while jogging, unprovoked bit by stray dogs
Mild fever; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient got the first shot of the COVID-19 vaccine and is experiencing a mild fever. The event was considered non-serious. The outcome of the event was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
I started getting migraines the day after the vaccine and lasted for 4 weeks. They finally went away after going to massage therapist and chiropractor 3 times. In January I went to urgent care I felt like I had a cold and they found white spots in my throat. I was given antibiotics. A few days later I took a Covid test and came back positive. I had sinus pressure and congestion and about a week and a half later it went away.
Joint pain and swelling that began the morning after first Hep B in a series of three required for job as vol. fire dept. worker. The vaccine was given May 15 and symptoms not reported until June 3/02. Tx with Celebrax but would not take. Seen at another provider. Hep B panel neg-put on prednisone x 6 days. 6/6/02. pt has hypersensitivity with adverse effect from hepatitis vaccine. Labs: drew hypatic profile.
This spontaneous report as received from a physician, via company representative, refers to a male patient of unknown age (who is also the physician's son). Patient's pertinent information on medical history, concurrent conditions and concomitant therapies was not provided. On 29-SEP-2016, the patient was vaccinated with an unidentified Merck HPV vaccine. Patient received either a dose of GARDASIL 9, 0.5 ml once (route of administration, lot number and expiration date were not reported) or a dose of GARDASIL 0.5 ml once (route of administration, lot number and expiration date were not reported), both to prevent HPV (Human Papilloma Virus). On an unknown date in 2016, after receiving the vaccine, the patient experienced complex regional pain syndrome (CRPS). On 08-OCT-2016, the patient needed to use a wheelchair. He was, at the reporting time, able to walk with a cane but "on bad days", the patient still needed to use a wheelchair, which the reporter considered a disability. The patient sought medical attention and received the physical therapy needed, reported as "236 visits to a physical therapy". It was unknown by the reporter if treatment was given for the adverse event. The physician also reported that there was a study done, where an unspecified number of people who received the vaccine, also developed complex regional pain syndrome (CRPS) (recorded in case # 703621). The outcome of the patient's complex regional pain syndrome (CRPS) was reported as recovering. The causality assessment between the patient's complex regional pain syndrome (CRPS) and the administered vaccine was not assessed. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1801USA005286.
Soreness at vaccination site, shivering, muscle and joint aches over entire body, headache, rash on entire RIGHT arm, no appetite.  Spent two days bedridden.  Used acetaminophen to treat symptoms.
arm is red; center of injection is red, hard, and warm; center of injection is red, hard, and warm; center of injection is red, hard, and warm; injection site sore; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported that.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 for covid-19 immunisation. The patient experienced arm is red, center of injection is red, hard, and warm (vaccination site erythema, vaccination site induration, and vaccination site warmth), and injection site sore on an unspecified date. Caller is calling about the Pfizer Covid19 vaccine because she had her second shot on Monday, and she did not have any side effects except that her arm is red and has an area about the size of two coins. Adds that the center where she got her injection is hard and red, and hot. She is wondering if this is a common side effect. The area was red and warm where she touched it and wanted to know if that is also a common side effect. Caller is worried the vaccine did not go in properly. The injection area is sore when she moves it and today it was sore when she touched it. She tried to put ice on it a few days and it really did not help. Caller would like to talk to somebody to make sure the vaccine is going to be effective, because she is concerned that it did not go in properly, and she would like to see if this is a common result of the vaccine. Caller asks who would be answering if she was transferred. Caller does not want to complete safety report. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Itching with irritation and  blistery rash starting with a hive on my lower lip then clusters of itchy patches under my left arm spreading to my  neck, chest , stomach and inner thighs over a course of 4 days. (Basically from my neck to my knees front side only) Was seen at Clinic on Monday 3/29/21. Prescribed Triamcinolone & Zyrtec D.
Narrative:  COVID infection following COVID vaccine series 03/05 COVID vaccine dose #1 03/26 COVID vaccine dose #2 12/16 pt c/o non-productive cough, headache, myalgia, requested to be tested for COVID; COVID positive 12/17 pt c/o fever, fatigue, myalgia, nausea, vomiting 12/20 pt meets criteria for regeneron, reports desire to receive from community source
neuralgia; This case was reported by a consumer via interactive digital media and described the occurrence of neuralgia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st August 2020, the patient received Shingrix. On 10th September 2020, 20 days after receiving Shingrix, the patient experienced neuralgia. On an unknown date, the outcome of the neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the neuralgia to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported but was selected as adult as per the vaccine indication. The patient was experiencing side effects after the dose of Shingrix. He/she visited the doctor with ongoing symptoms and now was diagnosed with Neuralgia.
Systemic: None- Fridge excursion-Mild, Additional Details: Fridge excursion a few degrees too cold for a few hours on 10/29 discovered 1/9
Patient developed rash on face (chin and near eye), warm upon touch, swelling on the face, urticaria. Patient went to PCP for check up and was prescribed Medrol dose pack. Itchiness, redness and swelling has reduced after starting Medrol dose pack.
Delayed local injection site reaction starting about a week after injection - large erythematous splotch on upper left arm, deltoid area. Not pain, fever, or itching. Resolved within 24 hours.
Approximately 6 hours after receiving 4 immunizations he deveolped a macular-papular rash on both arms.  No fever.  No other complaints.
Bad stomach problem; stomach was hurting; I wasn't able to sleep all night; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 10Feb2021 at 11:00 (Batch/Lot number were not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history included food poisoning (after the patient went clean up his system for hours he was fine) Concomitant medication were not reported. On 10Feb2021 at 19:30, the patient experienced bad stomach problem and stomach was hurting. He wasn't able to sleep all night on 10Feb2021. It was reported that on 10Feb2021 about 19:30, the patient started to have bad stomach problem and when he went to the bathroom it was a blood but then there was an interval between that. The patient wasn't able to sleep all night. He reported that he had same experience before when he had food poisoning (similar experience but then after he went clean up his system for hours the patient was fine). It was stated that he done a probably couple of times with blood but this time it looks like it has been 24 hours on my system. The patient was not sure whether or not it was the effect of the medicine or he have another food poisoning. The patient do not know why his stomach was hurting and he was curious if whether or not somebody had reported the same situation as him. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient received IPOL from a punctured vial after it was exposed to a temperature excursion with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received via health professional on 07-Oct-2022. Agency number: 01312677.  This case involves a 6-month-old female patient received IPV (VERO) [IPOL] from a punctured vial after it was exposed to a temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2022SA416564, 2022SA416822, 2022SA418179, 2022SA419029 and 2022SA417858.   The temperature excursion situation occurred due to fridge malfunction Max/Low Temperature reached 16.6C, 8.9C, +9.6C, +8.6C, +12.8C for 1st excursion 6 HOURS and 17 MINUTES 2nd excursion 23 MINUTES 3rd excursion 15 MINUTES 4th excursion 8 MINUTES 5th excursion 6HOURS and 16 MINUTES. Human error was not involved.  On 12-Sep-2022, the patient received punctured vial suspect IPOL suspension for injection from a at dose 0.5 ml (lot V1B901M; Expiration Date :22-Jun-2024) via unknown route in unknown administration site for immunization post temperature excursion with no reported adverse event (poor quality product administered) (latency; same day).  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.
Within several hours of receiving vaccine patient fell "sleepy, dizzy, like I wanted to throw up", denies fever.  Three days later developed fluid filled itchy rash on right arm.( Public health department noted on 9/5-scaly area on right arm) on 9/4 rash spread to chest. Public health department noted few maculopapular areas on right arm-antecubital area and on upper right side of chest.  Public health department advised to see medical doctor for rash.
lump developed in injection arm 3 days after vaccine injection.  As of 1 week later, it has not gone away or gotten larger.  Diagnosed as possibly nodular fasciitis; lump developed in injection arm 3 days after vaccine injection.  As of 1 week later, it has not gone away or gotten larger.  Diagnosed as possibly nodular fasciitis; This is a spontaneous report from a non-contactable consumer. A 28-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN 6205, Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 03Mar2021 (age at vaccination 28 years) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced lump developed in injection arm 3 days after vaccine injection. as of 1 week later, it has not gone away or gotten larger. diagnosed as possibly nodular fasciitis on an unspecified date. The patient underwent lab tests and procedures which included ultrasound scan with unknown results. Therapeutic measure were taken as a result of events which includes ultrasound, multiple doctor/surgeon visits. The outcome of event was not recovered.   No follow-up attempts are possible. No further information is expected.