chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blood pressure went up to 157/80; Bad hives; Chills; Very tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (blood pressure went up to 157/80), URTICARIA (Bad hives), CHILLS (Chills) and FATIGUE (Very tired) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced CHILLS (Chills) and FATIGUE (Very tired). On 27-Feb-2021, the patient experienced URTICARIA (Bad hives). On an unknown date, the patient experienced HYPERTENSION (blood pressure went up to 157/80). On 28-Feb-2021, URTICARIA (Bad hives) had resolved. At the time of the report, HYPERTENSION (blood pressure went up to 157/80), CHILLS (Chills) and FATIGUE (Very tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 157/80 mmHg (High) when she was seen at the yearly check up..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications included aspirin.   Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2021: Added medically confirmed to yes, lab data and new event.
Sudden onset of chills 24 hours after vaccine. Developed violent rigors while driving car home from grocery store (had felt fine when entered store). Arrived home barely made it to couch due to being dizzy/lightheaded. Had violent shaking chills for 3.5 hours, so intense unable to reach bottle of water or cell phone that were 18 inches away on coffee table.
a child was / given the adult (1440 EL.U.ml) of Havrix.; a child was accidentally given the adult (1440 EL.U.ml) of Havrix.; This case was reported by a physician via call center representative and described the occurrence of adult product administered to child in a 19-month-old patient who received HAV (Havrix 1440 adult) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On an unknown date, the patient received Havrix 1440 adult. On an unknown date, unknown after receiving Havrix 1440 adult, the patient experienced adult product administered to child and accidental overdose. On an unknown date, the outcome of the adult product administered to child and accidental overdose were unknown.  Additional details were provided as follows:  This case was reported by a medical doctor (pediatrician). The age at vaccination was not reported. The patient was accidentally given the adult (1440 EL.U.ml) of Havrix, which led to adult product administered to child and accidental overdose. The reporter consented to follow-up. This was 1 of the 9 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021120532:same reporter US-GLAXOSMITHKLINE-US2021120528:same reporter US-GLAXOSMITHKLINE-US2021120526:same reporter US-GLAXOSMITHKLINE-US2021120525:same reporter US-GLAXOSMITHKLINE-US2021120521:same reporter US-GLAXOSMITHKLINE-US2021120516:same reporter US-GLAXOSMITHKLINE-US2021AMR121314:same reporter
Uncontrollable blood sugar for several weeks since getting initial shot.; This is a spontaneous report from a contactable consumer or other non hcp.  A 24-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Lot Number: Unknown) at the age of 24 years, as DOSE 1, SINGLE for COVID-19 immunization.  Medical history included Juvenile Diabetes (Type I). It was unknown if the patient had any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. It was reported that the patient experienced uncontrollable blood sugar for several weeks since getting initial shot, on an unspecified date. The event was reported as non-serious. No treatment was received for the event. The clinical outcome of the event was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Pt recv vax on 8/5/98; on 8/6/98 pt exp pain, edema, nausea
Immediately following injection pt had a dystonic reaction - slurred speech, rt sided facial droop, followed by no speech, unresponsive to verbal & tactile stimulation. VS: BP 139/87 P 131 R 20 O2 100% transported to ED, then to floor on observation status.
Pt recv vax on 10/27/98; on 10/28/98 pt exp headache, joint pain, malaise, fever (100.1), nausea &vomiting
on July 3rd, 2 days after vaccination , child had 10 second episode of stiffening up, and eyes rolling back followed by post ictal state for approximately 30 minutes ( drowsiness). Did not have any fever at the time, but had been more sleepy than usual for the previous 2 days. Mother brought child to be seen at  emergency room where reportedly he had some blood tests done which were normal. Mother was told to have him seen by a pediatric neurologist. He has an appointment coming up  next week at the neurologist, and has since otherwise been well. I saw him for follow up in office 07/31/2019.
Four days after the shot, I started having a sore throat. On Saturday, I started having congestion, on Sunday I had chest congestion and a really bad cough. On Monday, I had diarrhea and did a at home COVID 19 test and it was negative. I went to the urgent care on the 31st of May, no prescription was given; was told to rest and drink plenty of fluids. A flu test and COVID 19 test was given at the urgent care and my results were negative.
Patient put on consent being 18 years old but calculating the year of birth, patient is 17 years old
Several hours after the injection I experienced persistent itching at the vaccination site. Going on 3 days now, but symptoms seem to be improving.
On 6/24/00, the pt developed a confluent rash on chest, face, abdominal, and trunk. Treated with Benadryl and prednisone.
This spontaneous report was received from a nurse practitioner via company representative regarding a 17-year-old female patient (reported as "daughter"). The patient's relevant medical history, current conditions and concomitant medications were not provided. Approximately in 2010 (reported as "9 years ago"), the patient received second dose of GARDASIL (strength, lot# and expiry date were not reported) for prophylaxis. On an unknown date (reported as "two weeks post vaccination"), the patient experienced one hour of leg numbness and could not move her legs. The patient did seek treatment with the pediatrician. It all resolved. The patient was able to walk. It lasted one hour. The pediatrician suspected it could be Guillain-Barre Syndrome and thought it possibly related to the vaccine. There was no negative outcome. The patient could walk at the time of report. No product quality complaint (PQC) was involved. The outcome of Guillain-Barre Syndrome was reported as recovered. The reporter's causality assessment was not reported. Upon internal review, Guillain-Barre Syndrome was determined to be medically significant.
Nondescript symptoms including: stomach ache, fever, intermittent diarrhea, body aches, body rash, swelling of extremities, joint pain, feeling faint.
No additional AEs; Caller reported expired dose of PNEUMOVAX 23 was administered.; This spontaneous report has been received a medical assistant, regarding to patient of unknown age and gender. The patient's pertinent medical history, current conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 16-FEB-2023, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (Expired product administered), injection, intramuscular (IM), at a dose of 0,5 milliliter (ml), administered for prophylaxis (lot number U026796 which was determined to be valid, with an expiration date on 28-JAN-2023) (strength and anatomical sites of injection were not provided).  No adverse event was reported.
05/04/00, one hour post vax, pt became nauseated, chilled, felt like flu. Arm became red and sore for 2 - 2 1/2 hours following injection and lasted several days.
pt states that by noon she developed horrific itching on her face, neck and shoulders.  Pt had severe chills by 3:00 she had a persistent cough, headache, and left arm became numb.   Her left hand got cold and nailbeds turned blue. Pt had body aches and pains. Pt took cough medicine, She wrapped her arm in heating pad and messaged her hand.  She put a topical medication on her skin to help with itching.  Pt had these symptoms for 2 days and then they all subsided.
She felt dizzy after vaccination. BP cuff placed on her to obtain BP and she then had hand twitching and eyes went up. Lasted a few seconds. BP checked x 2 was normal. She was pale around lips. Few minutes later BP systolic dropped to 87. She then ate/drank and was monitored for 30 minutes or more and returned to normal. BP prior to leaving was normal.
Fever within 24 hrs, intense arm pain to fingers/across back/up neck on (L) side, headache, chills. Fever up to 102 degrees. All symptoms x 48 hours (72 hrs from injection). At 48 hrs from injection red blotches appeared. Azythromycin prescribed. Arm increased to red/hot 6 inch diameter. Cleared mostly by 1 week after injection.
Doses were expired 06Jul2022, Date the vial was initially stored in the refrigerator was on 12Jul2022; Gave 4 doses that were expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave 4 doses that were expired) and PRODUCT STORAGE ERROR (Doses were expired 06Jul2022, Date the vial was initially stored in the refrigerator was on 12Jul2022) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave 4 doses that were expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Doses were expired 06Jul2022, Date the vial was initially stored in the refrigerator was on 12Jul2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave 4 doses that were expired) and PRODUCT STORAGE ERROR (Doses were expired 06Jul2022, Date the vial was initially stored in the refrigerator was on 12Jul2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Reporter was wondering what will be the process because last week they had a clinic, and they realized the doses were expired on 06-Jul-2022 and on 12-Jul-2022, the vials were initially stored in the refrigerator. On 13Jul2022, they gave 4 booster doses that were expired, and reporter was confused about the expiration date. The vial did not undergone any temperature excursions. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-609300, US-MODERNATX, INC.-MOD-2022-609296, US-MODERNATX, INC.-MOD-2022-609298 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-609300:Same reporter case US-MODERNATX, INC.-MOD-2022-609296:Same reporter case US-MODERNATX, INC.-MOD-2022-609298:Same reporter case
Swelling and redness at injection site. Arm is sore and itchy. Rash developed days later.
Husband had a bad affect on the first one; Husband being really tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Husband had a bad affect on the first one) and FATIGUE (Husband being really tired) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Husband had a bad affect on the first one) and FATIGUE (Husband being really tired). At the time of the report, VACCINATION COMPLICATION (Husband had a bad affect on the first one) and FATIGUE (Husband being really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Heart attack; A Spontaneous report  was received from a pharmacy intern concerning a patient (age and gender unknown), who experienced a heart attack/myocardial infarction.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unknown date, prior to the onset of symptoms, the patient received one of their two planned doses (dose number not provided) of mRNA-1273 (Lot number not provided) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, 8 days after vaccine administration, the patient experienced a heart attack. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of event, heart attack, was unknown.; Reporter's Comments: This case concerns a patient of unknown age and gender with a serious unexpected event of myocardial infarction.  The event occurred 8 days after first dose mRNA-1273. Treatment not reported. Event outcome unknown. Very limited information regarding this event has been provided at this time.  Further information has been requested.  Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Per the nursing supervisor and medical records, this patient developed chest pressure, dizziness and shortness of breath 3 days after his second moderna vaccination.
screamed for 4 hrs p/DTP/OPV/HBOC given on same day;
Day after my vaccine I felt like I could not focus, I felt really weird. My eyes were dilated. My whole face went numb, like tingly numb. I got a rash above my eye and lips. My whole arm still aches, sudden loss of strength . I went to ER. The doctor said it was like I was having symptoms of a stroke. I still feel very fatigued.
sore arm; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "Arrhythmia" (ongoing); "Arthritis" (ongoing). Concomitant medication(s) included: METOPROLOL oral taken for arrhythmia (ongoing); MELOXICAM oral taken for arthritis. Vaccination history included: BNT162b2 (Dose 1, Time: Morning , Site and route of injection:, Anatomical site of injection: arm (Left), Route of administration: Intramuscular, Batch/lot number: EN6207), administration date: 05Mar2021, when the patient was 62-year-old, for Covid-19 immunization, reaction(s): "Sore arm", "Fatigue"; BNT162b2 (Dose 2, Time: morning, Site and route of injection:, Anatomical site of injection: arm (Left), Route of administration: Intramuscular, Batch/lot number: EW0161), administration date: 15Apr2021, when the patient was 62-year-old, for Covid-19 immunization, reaction(s): "Sore arm", "Fatigue"; BNT162b2 (Dose 3, Date: 31Aug2021, Time: morning, Site and route of injection:, Anatomical site of injection: arm (Left), Route of administration: Intramuscular, Batch/lot number: FA6780), administration date: 31Aug2021, when the patient was 62-year-old, for Covid-19 immunization, reaction(s): "Sore Arm", "Fatigue"; BNT162b2 (Dose 4, Time: morning, Site and route of injection:, Anatomical site of injection: arm (Left), Route of administration: Intramuscular, Batch/lot number: FJ5683), administration date: 28Jan2022, when the patient was 63-year-old, for Covid-19 immunization, reaction(s): "Sore Arm", "Fatigue". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had no adverse events associated with any of vaccine, just sore arm plus fatigue for one day. The patient did not have prior vaccination. No specific relevant test for thromboembolic events with thrombocytopenia  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Information has been received from a patient who was vaccinated with a dose of Gardasil. Concomitant therapy included a dose of DTaP and a dose of Menactra. Subsequently, the patient experienced an instant severe headache and the she was fine. Additional information is not expected.
Typical side effects experienced prior to adverse event. On 3/31/19 the arm given the injection became very itchy 3:00 PM. At 7:00 PM I showered & saw a red rash starting at the bruised injection site going down my arm at an angle. Applied homeopathic gel for itching again at bedtime. In morning the rash was longer so saw Dr. for betamethasone dipropionate cream .05%. used twice daily for 10 days.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 11:51 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 11:51 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 44.20 for dose administered on 15-Apr-2021. No concomitant medications were reported.  Batch number 044B21A administered on 15-Apr-2021 underwent temperature excursion with temperature of 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 06-April-2021 and beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Hives on trunk starting 2 day after immunizations. Grandmother gave Benadryl 9/24/08 in PM after call to nurse and hives had resolved by late 9/24/08. Sulfa stopped by grandmother on 9/24/08 PM.
Onset 11-22-09, presented to ER with sensory/ neurologic complaints affecting left thigh & right thigh & general weakness.  Fell.  Syncope.  Febrile - 105.  Rec'd IVIG & antibiotics (for pneumonia).  Resp. failure.
Pain below the sternum that comes and goes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (Pain below the sternum that comes and goes) 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, the patient experienced CHEST PAIN (Pain below the sternum that comes and goes). At the time of the report, CHEST PAIN (Pain below the sternum that comes and goes) outcome was unknown.            Reporter did not allow further contact
Pt presented with hypoxia, elevation of troponin, found to have COVID-19 pneumonia. Was initiated on Remdesivir and decadron with significant improvement in symptoms throughout her 5 day course. Has been maintained on room air for last 2 days. Cardiology wishes to perform cardiac cath for troponin elevation, cannot r/o NSTEMI vs demand from COVID. Will schedule when pt is out of COVID precautions within 1-2 weeks, pt to call to schedule this procedure. Was cleared from all services and discharged in stable condition. She was started on ASA 81mg daily as well as lipitor 40mg. Heparin infusion for possible NSTEMI was d/ced after 48 hours, can resumr home Eliquis for A fib.
nausea, tachycardia, malaise and headache no specific treatment improved over 24 hrs
p/vax pt felt jittery,buzzed as though had too much caffeine;pt exp jittery, jumpy as if high on caffeine;
Information has been received on 02-OCT-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On 08-OCT-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy for routine health maintenance and for the prevention of shingles. Shortly after receiving ZOSTAVAX, the patient was admitted to a hospital due to a sudden and severe right-sided facial paralysis and was diagnosed with Bell's palsy and later diagnosed with hearing loss. 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, pain and suffering, and other damages. Hearing loss and Bell's palsy were considered to be medically significant. Additional information has been requested.