chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not provided. On multiple unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection (lot number: M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided). The reporter stated that the administered doses of VAQTA of lot number: M039202 were stored at temperature of 17.6 degrees Celsius (C) for 1 hour 38 minutes on an unknown date. Previous temperature excursions included storage at the temperature of 13 degrees C for 72 hours 30 minutes. Data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA012519: US-009507513-1704USA014783.
This case was reported in a literature article and described the occurrence of systemic lupus erythematosis flare in a subject of unspecified age and gender who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). Subject's medical condition included Systemic Lupus Erythematosus. On an unspecified date, the subject received an unspecified dose of Influenza vaccine unspecified (unknown route and injection site, batch number not provided). 12 weeks after vaccination with Influenza vaccine unspecified, the subject experienced systemic lupus erythematosus flare (SELENA-SLEDAI defined disease flare). Plasma samples were obtained from the subject on the day of influenza vaccination and at 12 weeks post vaccination. Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. Summary of the article: This literature article referred to 28 Systemic Lupus Erythematosus (SLE) patients (age and gender not specified) who exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. Subject's medical history and concomitant medications at the time of the event were unknown. Twenty-eight SLE patients exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. These 28 patients were part of a study conducted to understand mechanisms and identify biomarkers of flare to help prevent damage and improve management. Plasma samples were obtained from SLE patients on the day of influenza vaccination (BL) and at 6 and 12 weeks post (FU). Each SLE patient was matched to a unique SLE patient who did not flare (NF), and to a healthy control (HC). Samples from 13 SLE patients with flare were compared to samples from a non-flare year (self nonflare, SNF). Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. SLE patients who exhibited disease flare had significantly (p < 0.01) higher levels of BL pro-inflammatory mediators, including Th1, Th2 and Th17-type cytokines compared to NF/SNF SLE patients and HC. Regulatory cytokines, including IL-10 and TGF-Beta were increased (p < 0.01) at BL in SLE patients not exhibiting disease flare (NF/SNF) compared to SLE flare and HC. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased at BL in SLE flare patients. Select serum cytokines and chemokines are elevated in patients before SLE disease flare, providing important pathways to dissect for mechanism of flare, therapeutic selection or development.
This spontaneous report as received from a nurse via a company representative refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (subcutaneously, lot # L044524 (also reported as LO: 44524), expiration date 09-NOV-2017; dose was not reported). On an unknown date, the patient experienced local reaction, swelling, redness and pain. She sought medical attention via speaking with the nurse. The outcome of the adverse events was reported as recovering. The relatedness between the adverse events and VARIVAX (Merck) was not provided. This is one of two reports received from the same reporter. One of the patients (unspecified) received an unspecified imaging test (results were unavailable at the time of this report). Additional information is not expected as the reporter did not provide her contact details.
Began feeling very weak with a constant headache that later led to blurry vision on March, 2, 2021.  On the morning of March 4, 2021,  I was still experiencing a right sided headache as well as double vision.  I was no longer able to drive at that point.  I took my blood pressure digitally at the local pharmacy twice where it was 200/104.  I went home to call my physician and also have my wife take my blood pressure manually.  My blood pressure at that time was 214/106.  I went to the hospital where they examined me and then discharged me with a General Headache without a know cause.  I contacted my PCP and he advised me to quadruple my Lisinopril until my BP came down to normal range and see him the morning.  My visit the next day showed an elevated blood pressure, double vision, and a continuing headache.  My meds were adjusted to Lisinopril 10 mg qd and an addition of Norvasc 5 mg qd.  Later that day my blood pressure was down, but still not in the normal range.   The following day, March 6, 2021, I was still having the same issues despite the changes in medication.  I took my blood pressure at 6 pm and it was 199/104.  I immediately went to another hospital where I was admitted as  a "stroke alert" patient in hypertensive emergency.  I am presently being followed as an inpatient in order to get these issues under control.
burning itching hands, and feet; burning itching hands, and feet; burning itching hands, and feet / Itching hands, palms, and webbing in fingers; Dizziness; blurrie vision; tingling in feet, hands, and legs; intense pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Nov2021 12:00 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Syringomyelia" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: BURNING SENSATION (non-serious), BURNING SENSATION (non-serious) all with onset 03Nov2021, outcome "not recovered" and all described as "burning itching hands, and feet"; PRURITUS (non-serious) with onset 03Nov2021, outcome "not recovered", described as "burning itching hands, and feet / Itching hands, palms, and webbing in fingers"; DIZZINESS (non-serious) with onset 03Nov2021, outcome "not recovered", described as "Dizziness"; VISION BLURRED (non-serious) with onset 03Nov2021, outcome "not recovered", described as "blurrie vision"; PARAESTHESIA (non-serious) with onset 03Nov2021, outcome "not recovered", described as "tingling in feet, hands, and legs"; PAIN (non-serious) with onset 03Nov2021, outcome "not recovered", described as "intense pain". Therapeutic measures were not taken as a result of burning sensation, burning sensation, pruritus, dizziness, vision blurred, paraesthesia, pain.  Additional Information: The case was reported as non-serious. Facility where the most recent COVID-19 vaccine was administered was reported as pharmacy or drug store. The patient reported that about known allergies that "Not that I know of". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The list of any other medications the patient received within 2 weeks of vaccination was reported as yes. It was reported that, 24 hours after vaccine burning itching hands, and feet. Really bad at night. Itching hands, palms, and webbing in fingers. Dizziness. Blurrie vision. Tingling in feet, hands, and legs. Comes and goes all day. Can be very intense pain/burning. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that patient received dose 2 (lot number: Ff2590) in right arm (date not reported). Device date was reported as 04Nov2021.  Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
Tongue swelled up and was very tender; Speech impairment; Metalic taste; Anxious; Tender arm of the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SPEECH DISORDER (Speech impairment), DYSGEUSIA (Metalic taste) and ANXIETY (Anxious) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol, Hypertension, Hypothyroidism, Osteoporosis (Imrpoved to Osteopenia 12/2019) and Breast cancer. Concomitant products included TAMOXIFEN from 12-Jul-2017 to an unknown date for Breast cancer, ROSUVASTATIN for Cholesterol, LISINOPRIL for Hypertension, LEVOTHYROXINE for Hypothyroidism, DENOSUMAB (PROLIA) for Osteoporosis.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 17-Feb-2021, the patient experienced ANXIETY (Anxious). On 26-Feb-2021, the patient experienced SPEECH DISORDER (Speech impairment) and DYSGEUSIA (Metalic taste). On 28-Feb-2021, SPEECH DISORDER (Speech impairment) and DYSGEUSIA (Metalic taste) had resolved. At the time of the report, ANXIETY (Anxious) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medication was provided. Action taken with mRNA-1273 in response to the event was unknown   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Add patient demographics. Add medical history, concomitant products, dose 2 information. Add events like anxiety and metallic taste.
6 inch diameter around injection site with red swollen rash with bumps and now two areas with bruising.
pain; chills; fever; ear infection; stabbing pain on it's ears; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (ear infection), EAR PAIN (stabbing pain on it's ears), PAIN (pain), CHILLS (chills) and PYREXIA (fever) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03M20A and 03AK20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced EAR INFECTION (ear infection) and EAR PAIN (stabbing pain on it's ears). On 02-Mar-2021, the patient experienced PAIN (pain), CHILLS (chills) and PYREXIA (fever). On 04-Mar-2021, PAIN (pain), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, EAR INFECTION (ear infection) and EAR PAIN (stabbing pain on it's ears) had resolved.            Concomitant medication not provided. No treatment but doctor prescribed Tylenol and did not clarified if took it or not.  Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Almost 24 hours later developed fever, chills, body ache, headache which lasted a full day then 48 hours later developed a rash on abdomen, both arms, neck, back, and upper thighs
fever; chills; joint pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), ARTHRALGIA (joint pain) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills), ARTHRALGIA (joint pain) and HEADACHE (headache). At the time of the report, PYREXIA (fever), CHILLS (chills), ARTHRALGIA (joint pain) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment details were reported.
Arm pain 4/2 at 2pm, dizziness 4/3 at 7am, fever 4/3 at 9am until 4/5 at 8am, rash 4/5 at 7am, swollen lymph nodes 4/4 at 10pm.
my hands and feet go numb / Most of the day I cannot feel my extremities at all; they hurt and it's so painful; I can't walk in the morning for a bit; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Jun-2021 and was forwarded to Moderna on 06-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (my hands and feet go numb / Most of the day I cannot feel my extremities at all), PAIN (they hurt and it's so painful) and GAIT DISTURBANCE (I can't walk in the morning for a bit) 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 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced HYPOAESTHESIA (my hands and feet go numb / Most of the day I cannot feel my extremities at all), PAIN (they hurt and it's so painful) and GAIT DISTURBANCE (I can't walk in the morning for a bit). At the time of the report, HYPOAESTHESIA (my hands and feet go numb / Most of the day I cannot feel my extremities at all), PAIN (they hurt and it's so painful) and GAIT DISTURBANCE (I can't walk in the morning for a bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications was reported. Patient stated that the reaction was so bad that they did not wanted to get the second dose.  Treatment information was not provided.
Patient given Moderna booster, had received Pfizer 1st and 2nd doase anaphylaxis history warranted 30 min observation period 2;20p, c/o tingling in lips, able to swallow comfortable\u 2;27p c/o difficulty swallowing, pale , diaphoretic. 0.3 ml epinephrine administered. Left deltoid Symptoms resolved within minutes, patient returned to her desk
Within the first 12 hours I developed a fever of 102 - 103 degrees farenheit and chills with headache and substantial fatigue. The chills went away after the first day. The 2nd day I still had a fever. Day 3 I had significant nausea in conjunction with headache. These symptoms have continued from days 4 - today, day 11 post vaccine. While they are improving, after the initial fever/ chills my symptoms translated to into seemingly hormonal with nausea, strong food aversions, headaches (that felt hormonal) and 4+ days with substantial constipation and fatigue. It has mirrored the sickness I experienced with both pregnancies however I am not pregnant. I am still experiencing a mixture of fatigue,  headaches, nausea and food aversions (food still does not taste normal).
Approximately one week post vax pt developed erythema a size of a quarter and a hard knot.
I received the pfizer vaccine on 12/19/20 and 1/9/21. I am a physician. My only immediate reaction was some pain at the site of injection which subsided within a day. About 2 months after the vaccine I began to notice severe itching which did not respond to local steroid creams or antihistamines. At about 3 months post vaccine the pruritis became intolerable and I saw a dermatologist and later an allergist. By that time I was starting to develop bullous lesions and I was started on prednisone, which relieved the symptoms but every time I tried to come off the prednisone the itching would recur. I had a punch biopsy which diagnosed "epidermolysis bullosa acquisita. Currently I am taking prednisone 20 mg/d and dapsone 50 mg 2x per day with good results. I never had an autoimmune disease before and thing that the vaccine may heave triggered this reaction. I have had multiple vaccines in the past, including yearly flu vaccine without incident, but this was the first rna based vaccine for me, obviously.
During administration, needle was advanced into deltoid. Approximately half of the vaccine liquid was administered however remainder seemed to shoot out outside the patient's skin.
Client stated that about 20 minutes after immunizations she felt tightness in her chest and palpitations. Informed supervisor. Supervisor called 911. Paramedic did assessments on client and recommended client to be further checked at hospital. Client declined.
Fever for about 48 hours beginning on 10/25. Highest was 101.9 armpit temperature. On 10/29 He woke with a rash on his forehead that became itchy over the course of the day and spread to the rest of his head. Splotchy pink patches. Also, pink spots developed on his torso by afternoon. He was very uncomfortable, scratching his head and about ripping out his hair.
Next night I developed a heart rate of 130-160 bpm. Still currently suffering a high hear rate. I was recommended benadryl and ativan by emergency room nurse. My heart hurts and I'm exhausted and light headed all the time.
After feeling better from the expected symptoms of the vaccine I experienced intermittent nausea and a few instances of dizziness. These events would happen about 3 times per day lasting from an hour to two hours for about 3 weeks after my vaccine. The bouts were the worst the first 2 weeks after vaccination and have finally now begun to subside about 5 weeks after. I have never experienced nausea without any other symptoms before in my life. I honestly thought I could be pregnant but I have had 2 periods since vaccination so it definitely was not that.
After vaccination, mother noted baby to have arching of back/ no seizure activity and swelling of cheek/face area and trouble breathing. Symptoms all resolved - vitals and exam were normal except some mottling of skin. POX = 100% RA. HR = 128. RR = 38. Stable, but sent to ER for further evaluation and observation.
POX, LIKE CHICKEN POX.  A FEW ON THE LEGS AT FIRST, THEN MORE APPEARED MOSTLY ON THE ARMS AND LEGS.
Vaccine administered 10/5/10 began having slight dizzy spells in morning - got worse to all day vertigo - taking BONINE as per pharmacist condition still in effect 10/9/10.
Patient received the above vaccines on 7-20-20 along with a PPD skin test. Was fine until 7-26 when Lt upper arm became red, inflamed, waRm, sore. 4 x 4 1/2" inch area induration. Had been outside in the heat most of the previous day. Some confusion about which arm had Bexsero - pt says Left, Nurse charted Right
Patient received a two dose series of Pfizer /BioNTech vaccine. First dose March 30 , 2021 and second dose May 16, 2021. She answered no to all questions including no to pregnancy at both occurrences. There were no requests at either times for a medical evaluator to answer additional questions. The patient returned to the vaccination POD on June 3rd, 2021 claiming that she had a miscarriage some time after the second dose.  She requested information about the POD but did not offer any other information. She requested that we advise people that this happened to her and that she has already alerted the local news agencies and CDC.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose not reported, 1 total administered on an unspecified date for COVID-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The patient received additional dose of non-company suspect vaccine included: elasomeran (Moderna) (dose number in series 2) (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with non-company suspect vaccine elasomeran (Moderna) (dose number in series 2). The patient received tozinameran (Pfizer Biontech) (dose number in series 3) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 08-SEP-2022 for covid-19 prophylaxis which was revaccination with different COVID-19 vaccine.  On an unspecified date, patient had COVID-19 for which patient took non company unspecified suspect (form of admin, route of admin, and batch number were not reported) dose not reported, administered on an unspecified date for COVID-19 treatment. After 6 days of medication, patient tested positive. On 27-FEB-2023, patient had symptoms (confirmed covid-19 infection) (dose number in series 3) which resulted to the confirmed clinical vaccination failure (dose number in series 1). In 2023, Laboratory data included: COVID-19 virus test Positive and COVID-19 virus test Negative. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and tozinameran was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000274483.; Sender's Comments: V0-20230322260-Confirmed clinical vaccination failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Site: Itching at Injection Site-Medium, Systemic: HIVES-HAPPENED DAY AFTER VACCINE ADMINISTRATION-Medium, Additional Details: PATIENT CALLED TO INFORM US AT PHARMACY THAT SHE HAD DEVELOPED HIVES AFTER PFIZER VACCINE ADMINISTRATION SHE HAD TALKED WITH HER DR AND WAS TAKING BENADRYL TO HELP WITH PROBLEM
Redness hard lump 5cm circular area, warm, tenderness and itchy. IBU, Ice and Hydrocortisone cream x 5 days
19Dec97 Pt recv 1dose vax. 8Jan98 Pt devel mild varicella-like rash of approx 20 lesions. Pt exp very little pruritus & no fever.