chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 18 hours after the injection, rash over upper arm developed/The associated skin broke out; High fever; severe body aches; headache; nausea; fatigue; weakness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 17Jun2022 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 12Jun2021, when the patient was 57-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 08Oct2021, when the patient was 58-year-old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 17Jun2022 at 15:00, outcome "recovering", described as "About 18 hours after the injection, rash over upper arm developed/The associated skin broke out"; PYREXIA (non-serious) with onset 17Jun2022 at 15:00, outcome "recovering", described as "High fever"; FATIGUE (non-serious) with onset 17Jun2022 at 15:00, outcome "recovering"; HEADACHE (non-serious) with onset 17Jun2022 at 15:00, outcome "recovering"; NAUSEA (non-serious) with onset 17Jun2022 at 15:00, outcome "recovering"; PAIN (non-serious) with onset 17Jun2022 at 15:00, outcome "recovering", described as "severe body aches"; ASTHENIA (non-serious) with onset 17Jun2022 at 15:00, outcome "recovering", described as "weakness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that about 18 hours after the injection, rash over upper arm developed. The associated skin broke out. High fever, severe body aches and headache, nausea. Persisted for 48 hours. Then fatigue and weakness. No other vaccine in four weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 10:08 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:08 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) 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 51.89 for dose administered on 03-Apr-2021.  Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit at 9 am. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-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 degrees Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No concomitant and treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Vaccine is for 65years and older, given to patient who was 63 yars old
Narrative: Per facility computer system, death notification report on 02/02/21. Per report, wife reported patient expired at home. No other information has been provided.
On 5/6/2023, I woke up with a sore throat. I took a home antigen test that day and got a negative result. I began to feel achy and tired during the day. On 5/7/2023, I took another home antigen test and got a positive result. I had sore throat, body aches, fatigue, and fever. On 5/8/2023, I had all the same symptoms, plus a cough. I took TYLENOL and a cough syrup. I did a video visit with my doctor, who prescribed PAXLOVID. On 5/9/2023, I still pretty much had the same symptoms. Today, I finally feel like I'm getting better. I still have a little bit of a scratchy throat and an occasional cough. The body aches, fatigue, and fever are gone. I feel radically different from how I felt yesterday.
It was reported that a 47 year old male pt received a Fluzone SV vaccination on 10/19/2001 at a hospital. Reportedly 6 weeks later, the pt developed cognitive changes and had "flu-like" illness at end of December. On 01/21/2002, pt was admitted to intensive care unit at hospital. The reported diagnosis was acute disseminating encephalomyelitis(ADEM), unresolved, pt remains hospitalized.
I have a fever of 102F, starting around 2pm, 24 hours after vaccine administration. I am at home, drinking fluids and taking Tylenol. I just wanted to report it. Additionally, I have aches and chills, but I know that is expected.
Red spot on L thigh where he rcv'd DTaP & HIB. Erythematous area 10cm in dia on anteroir of L thigh. Local reac to DTaP/HIB.
Soon after receiving this vaccination, she started reporting that her mouth was itching.  The itchiness progressed to various places mostly around her head and upper torso.  She took 50 mg diphenhydramine about 10 minutes after first reporting the symptoms.  She reported feeling fine about 1 hour later.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 06-OCT-2012 13:31, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 13-year old female patient, with no known drug allergies and no illness at time of vaccination. The reporter informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot# J008423,e expiration date 21-JAN-2016, in the right arm, route not reported), on 04-FEB-2014 at 3:40 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). Parents were informed and were going to revaccinate at no charge. The reporter wrote date of recovery as 27-APR-2014 but did not specify if revaccination occurred. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Hospitalized - for induction of labor;  COVID positive;  fully vaccinated PLUS booster; BRIEF OVERVIEW: Admission Date: 4/27/2022; Discharge Date: 4/28/2022 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Encounter for induction of labor [Z34.90] Post-dates pregnancy [O48.0] INTRAPARTUM COMPLICATIONS: Medical Problems (from 04/27/22 to present) No problems associated with this episode. PROCEDURES PERFORMED:  Vaginal delivery Tubal ligation:  No HOSPITAL COURSE: Patient underwent an uncomplicated vaginal delivery and was discharged home in stable condition. Delivery Details DELIVERY TYPE: Vaginal, Spontaneous ESTIMATED DUE DATE: Estimated Date of Delivery: 4/20/22 GESTATIONAL AGE AT DELIVERY: 41w0d  G4P3013 DELIVERY PROVIDER: ASSISTING PROVIDER(S):  FINDINGS: NEWBORN STATUS: Living  NEWBORN SEX:  girl Baby Girl A [19141623] Delivery Date/Time:  4/27/22  4:54 PM WEIGHT: 3.56 kg APGAR: 1 minutes 5 minutes 10 minutes  8  9  H/P: ASSESSMENT / PLAN: is a 35 y.o. G4P2012 female at Unknown who presents with: Active Problems: AMA (advanced maternal age) multigravida 35+ Plan: 1. Induction of labor: PEDD- Initial SVE: 2/60/-2- Intact  - Contractions rare - Admit to labor and delivery - IV access - LR 125 ml/hr - Clear liquid diet - CBC, type and screen, syphilis - Cytotec for cervical ripening 2. Fetal well being: -   FHT Category 1 - Cephalic by bedside ultrasound - EFW 7 lb - Pelvis appears adequate and proven to 3.22 3. Maternal well being:  - Stable condition - AMA  -endorses taking baby ASA -COVID +-+ 4/24/2022 -Sniffly nose and mild cough, otherwise asymptomatic -recommend sending placenta  - Hgb on admission: pending.
No additional AE reported; an expired VARIVAX was administered to the patient; This spontaneous report has been received from a medical assistant concerning a 12 months old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 12-JUL-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (0.5 milliliter, lot# S021322 has been verified to be a valid lot number and expiration date was 09-JUL-2021; strength and route were not reported) for prophylaxis (expired product administered). This vaccine had no prior temperature excursions. There was no additional adverse event reported. The outcome of the events was unknown.
Provider ordered a Pfizer bivalent booster to be administered.  Patient received vaccination then when he got home is mom told he had already received Moderna bivalent and did not need another booster.
This case was reported by a nurse via sales rep and described the occurrence of numbness in a male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced numbness. On an unknown date, the outcome of the numbness was unknown. It was unknown if the reporter considered the numbness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Few days after receiving SHINGRIX, the patient experienced numbness in arm, and left ankle.
59 yo was given his first Shingrix vaccine documented subcutaneously in the right arm on 6/21/22 (Z4G59) and second dose IM in same arm (lot # DP2X9) on 11/23/22. Seen by neurology for evaluation of new onset of persistent numbness which had spread caudally from right side of chest (between xiphoid and nipple level, about T4-T5) down to his right foot. At that time, he was uncertain if the symptoms were present before or after first Shingrix vaccine. He also began to experience intermittent weakness of the right leg. About 2 months after onset, he had a fall and injured his right index finger. He was diagnosed with thoracic transverse myelitis with a contrast-enhancing lesion at T5, and report of a questionable small lesion at T11. Patient concerned there could be a relationship between worsening of symptoms and vaccines. Patient had subsequent falls. As of 5/23, it appears symptoms may be improving in reverse fashion. NOTE: Patient's PMH is NKDA and cervical spondylosis with myelopathy s/p multilevel posterior decompression and fusion, HTN, BPH, chronic Lyme, prediabetes, lumbar stenosis s/p posterior decompression/laminectomy. Patient has complex cervical and lumbar history noting several "chronic nerve injury" and surgical interventions including C3-7 posterior cervical decompression as well as fusion at C3-C6 and pedicle screws at T1 and T2.
DEATH; This spontaneous report received from a consumer via a company representative concerned a male of an unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total was administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient died (death) after vaccination. The patient died from an unknown cause of death. It was not reported whether an autopsy was performed or not. It was reported that "serial killers, killed his father with the chemical injection for the renamed common flu/ cold, and it will never stop the body from detoxing itself, like it should do to keep a body healthy, unlike the method of "healing" witch we know was nothing more than slowly poisoning people for money". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0-20230455597- Death-Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Information has been received regarding a case in litigation, from a lawyer, regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On 12-OCT.2016, the patient was vaccinated with ZOSTAVAX (strength, dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the pharmacist. On unknown date, the patient experienced shingles and on 03-MAR-2017, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages, as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Mild fever (99.5), slight chills, flush face. Still ongoing after 2 hours with 1000 mg Tylenol  taken promptly after symptoms started.
Mother of pt noted a rash on her daughters abdomen and neck around 1930 hr. Took her to ER where she was evaluated and sent home with BENADRYL. On 9/4/08 mother took child to Hosp. she was told she had hives, given BENADRYL and TYLENOL.
Headache for 48 hours, fever x 12 hours, fatigue x 5 days, severely enlarged lymph nodes to left arm started Monday 12/28, continues today 12/29
Constant head aches; Fever; Tiredness; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Constant head aches), PYREXIA (Fever) and FATIGUE (Tiredness) in a 45-year-old male patient 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 HEADACHE (Constant head aches), PYREXIA (Fever) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Constant head aches) outcome was unknown and PYREXIA (Fever) and FATIGUE (Tiredness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) No reasons of headache were found. On an unknown date, Magnetic resonance imaging head: normal (normal) No reasons of headache were found.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HEADACHE (Constant head aches) to be related. No further causality assessments were provided for PYREXIA (Fever) and FATIGUE (Tiredness).    It was reported that the headaches were not so bad as to take medication, except in some situations when the patient got some Tylenol.  No concomitant medications were reported.   This case was linked to MOD-2022-441554 (Patient Link).
After the administration of flu vaccine, pt had a 15-20 second fainting spell. Pt was brought down to the floor safely, head protected on a  sweater, legs elevated, and arms/legs massaged to increase cerebral perfusion. During the episode, pt had a cervical pulse and was clear air entry throughout the lungs. Vital signs during the episode (BP: 117/88, pulse:50, RR 18, 02 sats 97% on room air. Post episode, pt was alert and oriented X4. Mom was given supportive counselling re possible side effects and reactions to vaccines as part of the VIS information provided to mom.  Pt was observed for 15-20 minutes post episode. 5 minutes post episode Vital Signs (BP:113/82, Pulse:62, RR18, 02 sats 97% on room air, A&O X4) 10 minutes post episode Vital Signs (BP: 114/87, Pulse:65, RR: 19, 02 sats 98% on room air, A&O X4).  Plan to monitor for fever >100.4, poor appetite, headache, lethargy, vomiting, dizziness or worsening symptoms and go to nearest ER. RTC the next day for follow-up.
Devoped a fever of 99.0 approximately 24 hours after the injection.  Took a 600 mg Tylenol at my home.
Grand Mal Seizure, called 9ll, went to hospital,took mri and cat scan.  Appointment with neurologist on going.  Meds perscribed.
Pt. came to the ER via ambulance with the c/o SOB 12-14 hours after the COVID Vaccine.  Went in to cardio pulmonary arrest   CPR unsuccessful and patient expired.  Emergency contact stated that he had been ill and not been eating much for at least 1 1/2 weeks.  Other family members have/had COVID. He was exposed to them.
Had recent diagnosis of epilepsy - was begun on Keppra and Lomotrigine. Complained of severe headache post vaccine (pain 5/10, but spoke very little English - so interpreter was used) .
Pain and stiffness at injection site that radiated down arm and into chest. Red Blotchy areas on skin on left arm. Patient states started day of administration and then area affected continued to spread for the next few days. Now it is 2 weeks later and patient is still experiencing stiffness, and pain, and still some blotchy redness on sking of left arm.
terrible skin reaction; it is all over his body; really bad skin issues on back, head, arms, legs, not itchy but stinging and painful; it's an itch but not a mosquito itching, its not like a normal itch; its interfering with his daily life/was having a problem getting through the day because it was so bothersome and painful.; "to the point that he was going crazy"; This is a spontaneous report from a contactable consumer (husband) via Pfizer- sponsored program COVAX SUPPORT. A male patient of an unspecified age received BNT162B2 (BNT162B2 Covid-19 Vaccine, Solution for injection, Batch/lot number: Not provided, NDC number: Not Provided, Expiry Date: Not Provided) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. The caller was calling about Pfizer COVID injection on behalf of her husband. Caller and patient both got the COVID injection, but the patient had a disturbing reaction. The patient had a terrible skin reaction- it was all over his body, chest, arm, legs and it was not blisters or anything, it was an itch but not a mosquito itching, it was not like a normal itch, its interfering with his daily life. Caller's husband was having terrible side effect "to the point where he was going crazy" he had been to 3 doctors with bad skin issues on back, head, arms, legs, not itchy but stinging and painful. Caller stated husband was having a problem getting through the day because it was so bothersome and painful. The caller wanted to know has Pfizer had any incidents regarding the epidermis or something else in our system like this. The caller declined to file a safety report, no further information or details were captured at this time. The caller declined the department contact information. Outcome of the events was unknown. Investigation Assessment: Not Provided.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.