chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm following his vaccination; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm following his vaccination".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 13-Feb-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 13-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 13-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 13-Feb-2022) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2022 at 12:07 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 13-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 13-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 13-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 13-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. It was reported that vaccines went into 2-8 degree Celsius on or about 24-Dec-2021. It was reported that the MFG Expiry date of vaccine was 04-April-2022.   This case was linked to MOD-2022-542869 (Patient Link).
Reported pain at the injection site , extreme fatigue, muscle aches and pain, fevers of 102 for two days fever of 101 for two days, chills, nausea, swollen lymph nodes and a rash on my left arm.
REDNESS IN FACE, NECK AND SUPERIOR EXTREMITIES. HIGH FEVER (103F) AND PRURITUS. WAS RECOMENDED THAT SHE GO TO THE EMERGENCY ROOM BUT REFUSED. TOOK BENADRYL.
A report has been received from a Health Professional concerning an 11 year old, Male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 13-Jan-2014. The patient received expired FLUMIST which started on 13-Jan-2014. The outcome of the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious by the reporter.
I was pretreated for the vaccine; within about 10 minutes after getting my vaccine, my throat and tongue began swelling a bit. I stayed for about 30-40 minutes after so they could monitor me so I wouldn't go into anaphylactic shock or anything. About 4 hours later, I walked into the bathroom and saw my face broke out in hives and had a bad cough. I called my allergist but left a message. I took Benadryl and double dose of one of my prescribed medications to see if it'll help with my current reaction. The next morning, I had a slight difficulty labored breathing. I spoke to my physician, the doctor who suggested for me to take double of my prescribed medications for the morning and evening as well as Benadryl 4 times a day (400mg total). After 4 days, I would go down to 200mg and then after the first week, I went down to 100mg for the next week (I took them for 2 weeks total) to help with my airway problems. My airway problems are still occurring today and take as needed to help me sleep. I still have some swelling in my throat that I've become accustomed to; sometimes, it causes me to wake up gasping. Since receiving the vaccine, my mast-cell activation triggers random hives in the week.
Cellulitis; feel weaker/weakness in wrist and shoulders; whole arm blew up; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulitis) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, PARACETAMOL (TYLENOL A) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant), ASTHENIA (feel weaker/weakness in wrist and shoulders) and VACCINATION SITE SWELLING (whole arm blew up). At the time of the report, CELLULITIS (Cellulitis) and VACCINATION SITE SWELLING (whole arm blew up) had resolved and ASTHENIA (feel weaker/weakness in wrist and shoulders) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Doctor gave antibiotics as treatment. Patient taken drug for blood pressure, cholesterol patient had an adverse effect. Cellulitis in left arm, the whole arm blew up. They told patient it was not related (the doctor at facility). doctor told him it probably was and gave him an antibiotic for a week. She said if it does not clear go the hospital. It cleared up.  Company comment: This is a spontaneous case concerning an 82-year-old male patient with no medical history reported who experienced the unexpected and serious event of cellulitis. The event occurred on an unknown day after a first dose of mRNA-1273 vaccine was administered. The rechallenge was not applicable since outcome of the event is not clear. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-404954, MOD-2021-404954 (Patient Link).; Sender's Comments: This is a spontaneous case concerning an 82-year-old male patient with no medical history reported who experienced the unexpected and serious event of cellulitis. The event occurred on an unknown day after a first dose of mRNA-1273 vaccine was administered. The rechallenge was not applicable since outcome of the event is not clear. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Prior to flu shot I was perfectly healthy, no issues, playing sports weekly and exercising. Since I had the flu shot that same afternoon I felt tired, headache, swollen left gland, runny nose, achy body symptoms.   I feel terrible and never had issues prior!
Itching on hands; Rash on back and chest; Sore Throat; soreness of the joints. Symptons still evident after 6 days.
Patient felt dizzy and fainting  2-3 minutes after vaccine. Her breathing was normal. Pharmacist gave her 5 ml of benadryl ( 12.5mg/5ml). Patient start responding within 1 min, Mean while pharmacy call 911. Paramedics arrived and check all symptoms ,BP and ECG. BP was little elevated and ECG came normal.
ED to Hosp-Admission Current 9/26/2021 - present (18 days) COVID-19 Principal problem   Hospital Problems          POA   * (Principal) Toxic metabolic encephalopathy Yes       Coronary arteriosclerosis Yes       Multi-infarct dementia with delirium Yes       Bipolar affective disorder, depressed, in full remission Yes       Stage 3a chronic kidney disease Yes       Essential hypertension Yes       Polyneuropathy associated with underlying disease  Yes       VP (ventriculoperitoneal) shunt status Not Applicable       Ambulatory dysfunction Yes            Medical Problems                Plan: Admit patient to MedSurg under observation status. PT evaluation to gauge patient's mobility as the wife is able to take care of him as long as he is able to walk with a walker Toxic metabolic encephalopathy has resolved, patient is at baseline, wife is at bedside to confirm. Continue home medications Avoid benzodiazepines and opiates to prevent delirium, frequent reorientation, maintain sleep-wake circadian rhythm. Consult infectious diseases the patient has a history of VRE in the urine looks infected however it is difficult to gauge if the patient is actually symptomatic.  He does have mild leukocytosis. Addendum: spiked fever overnight, will switch abx to linezolid. Culture reviewed, only sensitive to linezolid. ID consult is pending.    VTE prophylaxis: Heparin Full Code     History of Present Illness    Chief Complaint Patient presents with ? Altered Mental Status   Patient is an 78 y.o. male.    Past medical history of VP shunt, dementia, ambulatory dysfunction dependent on a walker, BPH status post proctectomy complicated by urinary incontinence.  Patient is accompanied by his wife who is at the provider of history.  She states that he was in his usual state of health and he was sitting in his recliner in the garage which he normally does.  She went out to go check on him and asked him to come inside so she can change his diaper at that point the patient would not get out of the chair and look like no one was home.  She denies seeing any tonic-clonic like activity.  She called over a neighbor to help get patient out of the chair and when they were not able to, they called EMS.  Patient is pleasantly demented and is symptom free.  He is seen eating a sandwich and appears to be very comfortable.  Wife is at bedside who states that he is back to his baseline mental status.  She does straight cath him every other day.     In the ER labs are notable for mild leukocytosis with urine that appears to be infected.  He was given ceftriaxone in the ER.  Labs and imaging reviewed.
devel red, itchy rash on abd & back 2 days p/vax;It progressed until it covered all extremities & face;on 9/10/99 visited local ER;
Rash beginning on the patient's waist  that progressed to involve the upper and lower extremities. A dermatology NP gave the patient topical triamcinolone cream, but the patient never used it. Selenium sulfide wash didn't work but made the patient's skin itchy. The rash was not itchy until the selenium sulfide cream. As of 4/22, the patient was started on erythromycin and hydrocortisone lotion, with unknown current outcomes. Diagnosis thought to be pityriasis lichenoides chronica.
Swollen, Arm is bigger than normal; It is itchy; Arm was pink red Blotch; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen, Arm is bigger than normal), PRURITUS (It is itchy), MYALGIA (arm was sore) and RASH MACULAR (Arm was pink red Blotch) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02AL20A) for COVID-19 vaccination.     The patient's past medical history included Shoulder replacement.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced MYALGIA (arm was sore). On 05-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen, Arm is bigger than normal), PRURITUS (It is itchy) and RASH MACULAR (Arm was pink red Blotch). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. On 02-Feb-2021, MYALGIA (arm was sore) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen, Arm is bigger than normal), PRURITUS (It is itchy) and RASH MACULAR (Arm was pink red Blotch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment details included  Ice, Exercise.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow up received on 19-JUN-2021 contains no newinformation.
LEFT SIDE NUMBNESS ON FACE, ARMS, AND LEGS; DIZZINESS; NUMBNESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 56 year old female. 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 not reported, batch number: 205A21A, expiry: not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced left side numbness on face, arms, and legs. On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced numbness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on APR-2021, and had not recovered from left side numbness on face, arms, and legs, and numbness at injection site. This report was non-serious.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On unknown dates, the patient were vaccinated with LIQUID PEDVAXHIB lot number K025005, expiration date 31-JUL-2017 and lot number L042258, expiration date 18-AUG-2018 (route was not provided). Concomitant therapy information was not provided. On unknown dates, there was incorrect product storage as multiple unspecified patients received improperly stored LIQUID PEDVAXHIB. The temperature was 47.98 F and the timeframe was 63 house. No adverse event was reported. At the time of the report, the patients' status was unknown. Additional information has been requested.
SORENESS/ACHE IN LEFT LEG; TINGLING IN LEFT LEG; NUMBNESS IN LEFT LEG; This spontaneous report received from a patient concerned a 36 year old male. The patient's weight was 170 pounds, and height was 70 inches. The patient's concurrent conditions included: seasonal allergy, smoker, and alcohol user, and other pre-existing medical conditions included: Patient had no medical history. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 202A21A-H expiry: UNKNOWN) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-AUG-2021, the patient experienced soreness/ache in left leg. On 30-AUG-2021, the patient experienced tingling in left leg. On 30-AUG-2021, the patient experienced numbness in left leg. Treatment medications (dates unspecified) included: gabapentin. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from tingling in left leg, soreness/ache in left leg, and numbness in left leg. This report was non-serious.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 3 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Sep2021 as dose 1, single (Lot number: 301258A), in left arm and on 30Mar2022 as dose 2, single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300008782 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;
Bilirubin is 2.3; Red purpura type rash on his trunk and arms; Red purpura type rash on his trunk and arms; Flat red lessions; Itchy; This case was reported by a consumer and described the occurrence of red rash in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included glaucoma (does not take any meds except eye drops). Concomitant products included antiglaucoma preparations and miotics (Eye Drops For Glaucoma-Name Unknown).   On 13th September 2019, the patient received the 1st dose of Shingrix. On 14th September 2019, 1 days after receiving Shingrix, the patient experienced red rash, purpuric rash, skin lesion and itchy rash. On 24th September 2019, the patient experienced bilirubin increased. On an unknown date, the outcome of the red rash, purpuric rash, skin lesion, itchy rash and bilirubin increased were unknown.   It was unknown if the reporter considered the red rash, purpuric rash, skin lesion, itchy rash and bilirubin increased to be related to Shingrix.  Additional case details were provided as follows: The reporter reported adverse event experienced by their father. The age at vaccination was not reported but it could be 85 years or 86 years.  The patient did not take any medications except eye drops for glaucoma for many years. The patient developed a red purpura type rash on his trunk and arms, had flat red lesions and was itchy. The patient's lab work for a physical exam was performed on 24th September 2019 and his bilirubin was found to be 2.3. The reporter stated, after some research they found that, the hepatitis B vaccine has an adjuvant AS01B. According to an FDA (Food and Drug Administration report), this agent can temporarily cause elevated CRP (C reactive protein), bilirubin, monocytes, leukocytes, and neutrophils among other issues. When searched for Shingrix, it also had same adjuvant. So, the reporter asked, could the AS01B in Shingrix also cause the same elevations. The patient would have an abdominal ultrasound in coming week, but the reporter wanted to ask if this was a possibility.
Metallic Taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 at 12:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. Concomitant medications included propranolol (MANUFACTURER UNKNOWN) and gabapentin (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Apr2021, the patient experienced metallic taste in mouth. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were not taken as a result of reported event. The clinical outcome of the event metallic taste in mouth was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Non-Arteritic Anterior Ischemic Optic Neuropathy event, unspecified laterality, no treatment available, partial loss of sight in left eye.
Shingles flare following vaccination.  Office Visit with provider on 5/13/21
Patient was referred to me after his chiropractor noted that he had swelling to the inner left ankle. The swelling started about 02/13/2022. He had negligible discomfort and swelling to the medial posterior left ankle. No pretibial edema was found in either leg. Calf and ankle circumferences were the same on both legs. Normal pedal pulses. No skin changes. An upright venous Doppler done by me revealed an occlusive DVT from the left proximal femoral vein to the popliteal area into the upper calf. The left small saphenous vein was thrombosed from the popliteal area to the distal calf. A DVT ultrasound done the next day confirmed these findings. He was prescribed Eliquis 5 mg, 2 tabs 2x/day for 7 days then 1 tab 2x/day. He was fitted with 20-30 mmHg graduated compression hose, knee high, which are to be worn daily during the day. He has been limited to normal light activity and will follow up on 3-11-2022. He is contacted by phone every 1-2 days. He will follow up 3-11-2022.
injection site pain which doubles the pain he experienced on his first shot; This is a spontaneous report received from a contactable consumer (reporting on himself) via Pfizer-sponsored program. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number and Expiration Date was not reported), via an unspecified route of administration on 27Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 for COVID-19 immunization and experience injection site pain. It was reported that patient received his second dose today (27Feb2021) and he experienced injection site pain which doubles the pain he experienced on his first shot. He was asking if he can apply ice or compress to the injected site. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Report A0355776A describes an injection site reaction in a 4 year old male who received Infanrix. Medical history, concurrent conditions, and concurrent medications were not specified. On 11/27/2001, the vaccinee received his first injection of vaccinee received infections of inactivated poliomyelitis virus vaccine and MMR vaccine. On 11/30/2001, three days after receiving Infanrix, he experienced an injection site reaction at the site of Infanrix administration, characterized by a hard, red, itchy lump measuring 1.5 inches in diameter; the area was hot to the touch. The vaccinee provider considered the events to be mild in severity and were related to Infanrix administration. The events resolved on 12/06/2001.
Patient alleges she received her vaccine in the bursa/rotator cuff area, resulting in a possible small tear and pain. She is unable to lift her arm without assistance of her other hand.
Got it 25 years ago and I I got the flu; Initial information regarding an unsolicited valid non-serious case received from a consumer via media and transmitted to Sanofi on 08-Dec-2020.  This case involved an unknown age patient who reported influenza vaccine got it 25 years ago and got the flu (Influenza).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported.  On unknown date, (latency unknown) patient reported influenza vaccine got it 25 years ago and got the flu (influenza).   It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.
8/29/07-2:30-4:00 pm-achy; sore, swollen arm, headache: 6:00 pm- neck and back pain, headache worse; crying; paresthesia, worse to the touch; chills, low grade fever -> went to immeidate care 8/30/07-evening-severe pain "10 on pain scale"-neck into lower back; vomiting; 102 deg F temp -> went to ER-neurologist consulted-given IV morphine, Ativan