chrisvoncsefalvay/vaers-outcomes huggingface dataset:
immobile; weakness; inability to walk; lack of mobility; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMOBILE (medically significant), outcome "unknown"; ASTHENIA (non-serious), outcome "unknown", described as "weakness"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "inability to walk"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "lack of mobility". Clinical Course: The caller was calling about the Pfizer-BioNTech Covid-19 vaccine. He was reporting on behalf of his mother. He wanted to know if there were other reports of neurological symptoms happening like weakness, lack of mobility, inability to walk? Are there reports of this happening with other people and if there were any possible treatments for this? He stated they are immobile now. He stated the HCPs do not have any explanation for why this is happening. He stated "that" is the only connection because his mother and brother-in-law are not related and this all happened after getting the vaccines. Explained that Pfizer is unable to make treatment recommendations and that the patient's HCP would be in the best position to provide treatment recommendations.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
injection site was pink and faded; injection site was itching; injection site was red; red welt on her arm, welt on her chest; red welt on her arm that was itching, chest was itching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (red welt on her arm, welt on her chest), PRURITUS (red welt on her arm that was itching, chest was itching), VACCINATION SITE DISCOLOURATION (injection site was pink and faded), VACCINATION SITE PRURITUS (injection site was itching) and VACCINATION SITE ERYTHEMA (injection site was red) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (niacin), Penicillin allergy, Drug allergy (Erythromycin) and Latex allergy.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced URTICARIA (red welt on her arm, welt on her chest) and PRURITUS (red welt on her arm that was itching, chest was itching). On 08-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (injection site was itching) and VACCINATION SITE ERYTHEMA (injection site was red). On 15-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (injection site was pink and faded). The patient was treated with CORTISONE for Erythema urticarial and Itching, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching and Welts, at an unspecified dose and frequency. At the time of the report, URTICARIA (red welt on her arm, welt on her chest), PRURITUS (red welt on her arm that was itching, chest was itching), VACCINATION SITE DISCOLOURATION (injection site was pink and faded), VACCINATION SITE PRURITUS (injection site was itching) and VACCINATION SITE ERYTHEMA (injection site was red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that injection site was about the size of a 1/2-dollar. Concomitant medications were not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Event outcomes were updated. Permissions for further follow up was updated.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 3/17/2023 Discharge Date: 03/23/2023 PRESENTING PROBLEM: Hypoxia Acute respiratory failure with hypoxia Altered mental status, unspecified altered mental status type Pneumonia due to infectious organism, unspecified laterality, unspecified part of lung COVID-19   HOSPITAL COURSE: Patient is a 76 year old man with hx of CVA with LUE and bilateral lower extremity weakness and hydrocephalus with a VP shunt since 2013. He lives in LTC. He presented with AMS. He had a + covid home test at LTC on 3/13. He had O2 sat in the 70's while at his facility. On arrival to emergency department patient was found to be hypoxic at 88 %, he is placed on 3 L of nasal cannula.  Otherwise patient was hemodynamically stable.  Labs were unremarkable. \Chest x-ray was done showing infiltrate in the retrocardiac left lower lobe suspicious for PNA. CTA was neg for PE, it showed bl lower lobe consolidations.    Patient was given Rocephin and azithromycin in the E.D.  Procal was negative.  CT brain without contrast showed diffuse low-density subdural fluid collection overlying the cerebellar hemispheres and along the interhemispheric falx are larger compared to prior with mild mass effect upon the subjacent brain parenchyma.  Likely due to hygromas and/or chronic hematomas. As well as hyper densities within the paranasal sinuses.   He was admitted for neurosurgery eval. Nsx ordered MRI brain which was unremarkable aside from chronic cva and concern for overshunting. Neurology changed his VP shunt settings from 2.5 to 1.5. He was treated with D5W for hypernatremia due to free water deficit. He was monitored off antibiotics but treated with decadron and remdesivir x 5 days. His hypoxia resolved to room air and mental status normalized.   He was made npo on 3/18 after choking on one of his meds. SLP evaluated and recommended meds in puree otherwise thin liquids and general solids. As sodium normalized, D5W was discontinued. Discharged was initially planned on 3/20 however he had nose bleed and poorly able to cough and clear the blood in his pharynx resulting in worsening respiratory status. He was changed to npo. Unasyn was started due to CXR showing left sided consolidation. SLP was consulted and video swallow was  completed on 03/21/2023 showing mild to moderate oral dysphagia and moderate to severe pharyngeal dysphagia and his diet was changed to a dysphagia diet. He was weaned to room air and transitioned to oral augmentin to complete 5 total days of antibiotics for aspiration/CAP. He discharged back to LTC on 3/23. Decadron was discontinued at discharge (initially started on 3/17) as the patient had been weaned to room air.
redness, swelling, and "fluid in the arm."; redness, swelling, and "fluid in the arm."; redness, swelling, and "fluid in the arm."/ arm felt spongie; arm felt "spongie and hard at the same time"; her arm hurt; This spontaneous report was received from a 72-year-old female patient who refers to herself. The patient had an allergy to penicillin. Her current conditions included ileostomy and unspecified thyroid issues. The patient's medical history included acute ulcerative colitis. Concomitant medications included levothyroxine sodium, unspecified allergies pills and unspecified nasal spray.  On 11-APR-2013, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot #, expiration date, strength, dose, frequency, route of administration were not provided) for prophylaxis. She did not report any adverse effects after receiving the vaccine. On 09-OCT-2019, she was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot #, expiration date, strength, dose, frequency, route of administration were not provided) for prophylaxis and also received unspecified flu vaccine; both were administered in the left arm.  The patient stated that since receiving the vaccines her arm hurt. On 11-OCT-2019, the patient additionally developed redness, swelling and fluid in the arm; her arm was spongy and hard at the same time. On an unknown day in October 2019, the patient went to an unspecified emergency room for medical attention and later she was sent to home. She received cephalexin (KEFLEX) as a treatment for the events. On an unknown date, she had unspecified laboratory tests to rule out cancers (results were not provided). The outcome of the events was reported as recovering.  The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
patients administered Moderna vaccine while temperature excursion assessment was ongoing; patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 26-year-old female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown.
No additional AEs or PQC reported; vaccine administered after temperature excursion; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 22-SEP-2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (2 milliliter, lot # 1742080 with expire date 14-JUL-2022) orally for prophylaxis (product storage error). The vaccine experienced temperature excursion of 0.9C for 47 hours and 52 minutes. There was no previous temperature excursion. No additional adverse effects reported.
Child seen in office at 14:30 on 9/15/04 and had normal exam. Received immunization in box 13. At 19:30 child began running a fever, never above 103. About 5:30 on 9/16/04, child experienced generalized seizure lasting about 5 minutes.
death Narrative:  Patient was admitted to the ER on 12/26/20 with worsening shortness of breath and was admitted to acute care services. On 12/29/20, a hospice consult was placed for end stage CHF, EF 20%. On 12/30/20, he transferred to the facility and was a DNR. On 1/7/21, he was noted to have increased secretions in throat and was given atropine gtts sublingual and ondansetron for nausea. He also had issues with insomnia and was given trials of hydroxyzine, trazodone and melatonin. Lorazepam remained on profile as well as part of hospice care. On 1/9/21, he was noted to be more confused, tachypneic and had anasarca (furosemide was ordered). Later on that same day he began to decline rapidly to the point of unresponsiveness other than to verbal stimuli and was determined to be imminent. On 1/10/21, he remained unresponsive and not able to tolerate oral meds. That same day at 1020 when nursing did rounds, he was found to be pulseless and without respirations. An autopsy was declined.
Information has been received from a physician concerning a 65 year old female who on an unspecified date was vaccinated SC with a dose of Zostavax (lot # 652936/0981F). It was noted that the patient was on other unspecified medications. One of two weeks after vaccination, the patient experienced a breakout of chickenpox. The physician reported that he swabbed the pocs. sent the cultures to a laboratory, and referred the patient to a dermatologist. A product quality complaint was not involved. Additional information has been requested.
14:25 Patient stated to RN he is lightheaded. RN took patient to gurney, had him lay down and gave him water.   14:27 vitals  BP 135/96 HR 72 o2 99% Denies pain   14:30 Patient states he is feeling better but not 100% yet. No other complaints.  14:39 vitals  BP 135/89 HR 67 o2 98% Denies pain   14:44 Patient states he feels back to normal. States he has to go to work here at facility now. I advised him to seek immediate medical care if he begins feeling worse. Patient agreed. Discharged from nursing care.    Electronically signed by: RN 2/25/2022 2:48 PM
This spontaneous report as received from a pharmacist refers to a 70 year old female patient. The patient has drug reactions/allergies with penicillin. There was no pertinent medical history reported. On 25-MAR-2014, some where around 10:15am-10:30am, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous, lot# J008435, expired date 11-OCT-2014. No concomitant medications reported. It was reported that after vaccination on 25-MAR-2014 the patient experienced baseball size raised area that was bright red at the injection site and it was warm to touch and also had headache at the same day night (25-MAR-2014). The over the counter unspecified cortisone cream was given as treatment for the adverse events. The patient sought medical attention (patient called pharmacist). Lab diagnostics were reported as none. The outcome of the events warm to touch, baseball size raised area that was bright red at the injection site and headache was reported as not recovered/not resolved. Additional information has been requested.
Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Shakiness-Mild, Systemic: Tinnitus-Mild, Systemic: Weakness-Mild, Additional Details: few minutes after given the covid pfizer vaccine, patient felt like he was going to black out and had ringing in his ears. He was having chills and sweats. his face was becoming more pale than normal. Pt was given orange juice and a protein bar. After 911 was called, his face seemed to have gotten its color back and he did state that he did felt better than before. EMT took him away to the hospital. the patient came back few hours later, and he stated that he felt better and is doing okay now.
Dry mouth; Left arm sore/ All the body is sore; chest, shoulder, and back; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth) and MYALGIA (Left arm sore/ All the body is sore; chest, shoulder, and back) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Aug-2021 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced DRY MOUTH (Dry mouth) and MYALGIA (Left arm sore/ All the body is sore; chest, shoulder, and back). At the time of the report, DRY MOUTH (Dry mouth) and MYALGIA (Left arm sore/ All the body is sore; chest, shoulder, and back) outcome was unknown.            No concomitant medication were reported. No treatment information was reported.
Child came to office 3/27/06. Dx Erythema Multiform. ? Egg, milk allergy or reaction to varivax, Prevnar given 3/23/06.
inability to sleep Fever Chills Muscle aches Joint aches Headache Nausea
The day after vaccination I noticed a rash on my torso arms and legs. It is a blotchy rash that is itchy but not warm to touch. I plan to take some Benadryl. I got first dose and had no reaction.
Dizziness; Chills; Everything I eat and drink tastes like chemicals/I tried other peoples food items as well they all tasted, off; This is a spontaneous report from a contactable Other HCP. A 37-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL9264), via an unspecified route of administration single dose left arm on 10Feb2021 07:30 for covid-19 immunisation. The patient received the first dose (Lot # EL3249) left arm on 20Jan2021 07:30 AM. Medical history included type 2 diabetes mellitus. Concomitant medication included metformin, insulin glargine (LANTUS). The patient experienced dizziness on 10Feb2021 20:00, chills on 10Feb2021 20:00, everything I eat and drink tastes like chemicals/i tried other people food items as well they all tasted, off (ageusia) on 10Feb2021 20:00. The events outcome was not recovered.
Passed out; Seizure; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) and SEIZURE (Seizure) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).  No concomitant medication were reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form Lot # 040A21A..  On 10-Mar-2021, the patient experienced had a fever, passed out and had a seizure  On 07 Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form Lot # 045A21A. After 12 hours he passed out and had a seizure.  The patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), SEIZURE (Seizure) (seriousness criterion medically significant) and PYREXIA (Fever).   The outcome of passed out, seizure and fever is resolved.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) is not applicable as both vaccines had been administered.   Description: On 10 Mar 2021, the patient had a fever, passed out (medically significant) and had a seizure (medically significant).  No treatment information was provided.   This case was linked to (E2B Linked Report).; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded. Fever is consistent with the known safety profile of mRNA-1273. MOD-2021-072699:2nd dose case
I had some palpitations for the first six weeks after the second dose. Three weeks after the second dose of the vaccine I got a rash all over my upper and lower extremities with a few on my trunk. It was mildly popular and red. Some looked like hives, and some had swelling around. It was very itchy. I did not have any on the soles of my feet, but I did have itching. It was static in the areas where it existed. I took Allegra for the itching, and I used Hydrocortisone cream. The cream worked and I used a cream Anti itch CeraVe. The rash lasted three weeks. The skin peeled off in large areas and then it improved. The palpitations also resolved about one week later
First day 4/8/21 pain at site, extreme headache, extreme body aches, chills and low grade fever. 4/9/21 substantial swelling under right eye.
Began with fever and feeling "achy". First lesions appeared on chest, then spread to back, arms, face, and around ears. Doctor instructed patient to take baking soda baths and over the counter Benadryl as needed for itching.
significant swelling up and down the arm that had the injection; pain in the elbow; A low fever of 100.8 F; body aches in the lower back and knee; body aches in the lower back and knee; painful lymph node swelling in the same arm as the injection is present with significant fluid (more than a golf ball size); painful lymph node swelling in the same arm as the injection is present with significant fluid (more than a golf ball size); This is a spontaneous report from a contactable consumer (patient). A 42-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0170, Expiration date: not reported), via an unspecified route of administration in arm left on 09May2021 at 10:15 AM (at the age of 42-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included birth control. Past drug event included oxycodone hydrochloride;oxycodone terephthalate;paracetamol [PERCOCET] and experienced allergy. The patient's concomitant medications in two weeks included ethinylestradiol, norethisterone acetate (JUNEL), taken for birth control. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8731, Expiration date: not reported), via an unspecified route of administration in arm left on 18Apr2021 at 10:30 AM (at the age of 41-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, the patient was not pregnant at time of vaccination. Other vaccine in four weeks was reported as no. No covid prior vaccination and no covid tested post vaccination. On 10May2021, the day after the vaccine, significant swelling up and down the arm that had the injection, with pain in the elbow. A low fever of 100.8 F and body aches in the lower back and knee occurred. 48 hrs after receiving the vaccine, painful lymph node swelling in the same arm as the injection was present with significant fluid (more than a golf ball size). This pain has persisted even with 400 mg of ibuprofen taken daily. Treatment was not received for the events. On 10May2021, the patient underwent lab tests and procedures which included fever (body temperature), resulted as 100.8 Fahrenheit, low fever of 100.8 F. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Uncomfortable Tinnitus in both ears; This is spontaneous report from contactable consumer, the patient. A 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208), via an unspecified route of administration in left arm on 09Mar2021, at 14:30 PM, (age at vaccination: 55-year-old) as a single dose for COVID-19 immunisation. Medical history included heart murmur, mitral valve prolapse and hashimotos thyroiditis. The patient report that she is allergic to penicillin. 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 received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in left arm on 16Feb2021, at 13:00 PM, (age at vaccination: 55-year-old), as a single dose for COVID-19 immunisation. Concomitant medication included NP Thyroid 45 mg (MANUFACTURER UNKNOWN), Vitamin D (MANUFACTURER UNKNOWN), Melatonin (MANUFACTURER UNKNOWN). On 18Mar2021 at 9:00 AM (started about 9 days after second dose), patient experienced uncomfortable tinnitus in both ears. It was reported that no treatment measures were taken for the events. The clinical outcome of tinnitus was not recovered at the time of this report.   No follow-up attempts possible. No further information expected.
Within 12 hours of vaccine had and continue to have persistent significant headaches that are not relieved by NSAID or other agents. Also body fatigue that was never experienced prior to the vaccine. Swelling and rash at injection site that dissipated over next 3-4 days after vaccine.