chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via other manufacturer and described the occurrence of hives in a adult female patient who received Influenza vaccine. Co-suspect products included Tetanus vaccine. The patient's past medical history included cesarean section, hysterectomy, appendectomy, cholecystectomy, thyroid neoplasm, colostomy closure and cardiac catheterization. Concurrent medical conditions included bipolar disorder, Addison's disease, atrial flutter, hypothyroidism, arthritis multiple joint (both knees and left shoulder), leg edema, muscle spasm, chronic insomnia, esophageal acid reflux, type II diabetes mellitus, gastric bypass, diabetic neuropathy (both feet), multiple allergies, urinary incontinence, migraine headache and essential tremor. Concomitant products included DEPAKOTE, ZYPREXA, hydrocortisone, digoxin, LOPRESSOR, COUMADIN, SYNTHROID, CYTOMEL, oxycodone, ZANAFLEX, FLEXERIL, LASIX, trazodone, ranitidine hydrochloride, NEXIUM, potassium chloride, metformin, MAXALT, SYMBICORT, SUDAFED, BENADRYL Allergy, IMODIUM, BENGAY Cream, CENTRUM, Vitamin C, Vitamin D3 and Vitamin B12. On an unknown date, the patient received Influenza vaccine at an unknown dose and Tetanus Vaccine at an unknown dose. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced hives and pain in arm. On an unknown date, the outcome of the hives and pain in arm were recovered/resolved. It was unknown if the reporter considered the hives and pain in arm to be related to Influenza vaccine. Additional information: The patient developed hives, very painful arm for many weeks.
Itching; Mild lightheadedness; Burning stinging generalized; Burning stinging generalized; Confused/disoriented; Chills; Bug crawling sensation generalized but especially on scalp; Couldn't remember; Extreme fatigue; In a fog; Some GI upset; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO169) via an unspecified route of administration in the right arm on 23Apr2021 at 11:30 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid, benign hypertension, heartburn, back surgery and kidney stones. The patient was allergic to shrimp, skeletal and Computerized Tomography (CT) scan dye. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included levothyroxine sodium (MANUFACTURER UNKNOWN), lisinopril dihydrate (PRINIVIL), hydrochlorothiazide (HCTZ), vitamins nos (MVI) and aluminium hydroxide gel, dried, magnesium carbonate (PEPCID). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received progesterone (MANUFACTURER UNKNOWN), ibuprofen (MOTRIN), prednisone (MANUFACTURER UNKNOWN), metaxalone (MANUFACTURER UNKNOWN), celecoxib (CLEBREX) and tramadol (MANUFACTURER UNKNOWN) and experience allergy to all the medications. The patient previously received hydrochlorothiazide (HCTZ). On 23Apr2021 at 16:30, 5 hours after dose, the patient experienced itching, mild lightheadedness, burning stinging generalized, the patient woke up confused /disoriented to day and time, chills and crawling sensations generalized but especially scalp. There was no fever or shortness of breath (SOB). The confusion continued for 4 to 5 days. On an unknown date in Apr2021, after 5 days when driving, the patient became confused and couldn't remember how to get home from local store for several minutes. On an unknown date in 2021, the patient felt extreme fatigue, lightheadedness and was in a fog because of which the patient couldn't break out for a week. The patient also had gastrointestinal (GI) upset on occasional days. Blood pressure was stable and there was no temperature. Therapeutic measures were taken as a result of itching which included treatment with CLARITIN once daily. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events itching, lightheadedness, burning stinging generalized, confused/disoriented, itching, chills, bug crawling sensations generalized but especially scalp, couldn't remember, extreme fatigue, in a fog and gastrointestinal (GI) upset was resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
p/vax pt c/o lt arm pain, swelling 3-4mm high width of deltoid, redness & hot to touch of inj site;
cervical lymphadenopathy on right side; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (cervical lymphadenopathy on right side) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (cervical lymphadenopathy on right side). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (cervical lymphadenopathy on right side) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD21-076122, MOD21-076477 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD21-076122:dose 1 MOD21-076477:
DEVELOPED THICK HARD DRY SKIN ON TOP OF FOREHEAD INTO THE BEGINNING OF MY HAIRLINE VERY ITCHY, PAINFUL, IRRITATED, SWOLLEN, RED, OOZING PUS, BLOODY, CRUSTY, THE RASH/LESION CHANGED DRASTICALLY DAY BY DAY. I HAVE PLENTY OF PICTURES TO SHOW WHAT IT LOOKED LIKE AT DIFFERENT STAGES.  IT DID SPREAD AT ONE POINT TO MORE SPOTS ON THE TOP OF MY SCALP. THE FIRST LESION STILL HASNT GONE AWAY, ITS BEEN ABOUT 6 WEEKS NOW. I HAVE REPEATEDLY GONE TO MY DOCTOR, THE ER, AND TWO DERMATOLOGISTS WHO HAVE JUST BEEN HANDING DIFFERENT MEDICATIONS FOR MY "RASH/LESIONS" AND THE TWO DERMATOLOGISTS REFUSED TO TAKE A BIOPSY. I HAVE BEEN ASKING SINCE THIS LESION DEVELOPED, TO RUN SOME TESTS TO FIND OUT WHAT IT IS BECAUSE NO ONE REALLY KNEW OR HAD ANY ANSWERS FOR ME. NONE OF THE MEDICATIONS AND OINTMENTS HAVE WORKED. I EVEN BROUGHT A FEW SAMPLES OF THE THICK HARD LARGE CHUNKS OF SKIN THAT CAME OFF OF MY SCALP.  THE UNKNOWN "RASH/LESION" STARTED TO CAUSE TERRIBLE HEADACHES, WHICH I HAVE NEVER HAD 5/11 TRIAMCHOLONE 0.1% OINTMENT 30MG 5/20 MUPIROCIN CREAM 2% 30MG 5/28 DICLOFENAL SODIUM 50MG - PRESCRIBED FOR PAIN SWELLING OF LESION - DID NOT HELP AT ALL 5/31 GABAPENTIN 100MG CAPSULES - PRESCRIBED FOR PAIN  6/4 BETAMETHASON DIP 0.05% LOTION 6/4 DOXYCYCLINE MONOHYDRATES 50MG
BODY ACHE; NAUSEA; CHILLS; VOMITING; HOT FLASHES; MIGRAINE; This spontaneous report received from a patient concerned a 19 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced vomiting. On 12-APR-2021, the subject experienced hot flashes. On 12-APR-2021, the subject experienced migraine. On 12-APR-2021, the subject experienced chills. On 12-APR-2021 18:00, the subject experienced nausea. On 13-APR-2021, the subject experienced body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, and the outcome of vomiting, hot flashes, body ache, chills and migraine was not reported. This report was non-serious.
R thigh (site of immunization) became red and inflamed 5 days after DTaP.
A few days later, I developed a rash on my chest. It started as a few pimples, then turned into a painful and itchy rash (similar to chicken pox). I used Benadryl cream on it. The itching stopped after about a week.
This spontaneous report as received from a nurse refers to a 1 year old patient. A one year old patient inadvertently received first dose in series for each vaccine: VARIVAX (Merck) (0.5 ml, subcutaneous, once, lot # were not reported), M-M-R II (dosage, route, lot # and indication were not reported) and PROQUAD (Merck) (dosage, route, lot # and indication were not reported) on 22-MAY-2014. No adverse effects reported. Additional information has been requested.
Three days later I developed a large rash that looked like a welt and it itched.  It lasted for approximately 4 or 5 days.  All I did was ice it and use hydrocortisone cream on it.  I didn't even contact my physician because I looked it up and figured it was "Covid Arm".
fever presented in the middle of the night about 5 hours after injection - swelling at injection site noticed this morning  - achy/malaise during the night though the next day  contacted DR. this morning 10/25 - - prescribed and antibiotic and steroid
I had high blood pressure the day after receiving the vaccine. As high as 165 over 102. It has now been three days. It's still a bit higher than normal. But working its way back down.   My usual reading, for many years now, has been 120 over 80.  Not surprisingly, I had chills, a headache, and night sweats. But the high blood pressure was by far the most concerning.  I do not regret getting the vaccine. But wish I had known.
lt facial paralysis (bells palsy) starting evening of day of vax;seen @ hosp 1AUG96 by MD;seen by neuro 6AUG96;hosp overnoc; home on rx prednisone & APAP;
THREW UP; This spontaneous case report (PVX2019-2223) was received from a consumer on 30-Aug-2019. It described a female consumer who "threw up" (PT: Vomiting), after administration of third dose of oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer threw up after taking the third dose on 26-Aug-2019. The fourth dose was taken on 28-Aug-2019.  The action taken with Vivotif with respect to the event was not applicable.  The consumer had recovered from the reported event on 26-Aug-2019.  Company's comment: In this case, a female consumer who "threw up" after administration of third dose of oral Vivotif. There is lack of information regarding medical history, concomitant medication and intake of any unhygienic food and water. Hence, the causality has been assessed as not assessable.; Sender's Comments: Company's comment: In this case, a female consumer who "threw up" after administration of third dose of oral Vivotif. There is lack of information regarding medical history, concomitant medication and intake of any unhygienic food and water. Hence, the causality has been assessed as not assessable.
The Wrong dose for the Moderna COVID Bivalent booster was given on 10/14/2022 at 0.25mL (As7146B) instead of the 0.5mL dose.  Another 0.25mL (061F22A) dose was given on 10/26/2022.
post vaccine day 4 developed facial shingles left bridge of nose, day 12 developed sudden onset of left parotid gland edema and left neck lymphadenopathy, days 3-26 intermittent palpitations
Narrative:  72 yo male got covid vaccines on 2/14/2021 & 3/1/2021 from public health source. Pt died at home on 6/12/2021. Facility was notified of the pt's death from the Hospital Advanced heart failure clinic . Pt was newly diagnosed with heart failure on 5/25/2021. Per MD cardiology outpatient initial clinic on 5/21/2021: 72y/o M w/ PMH significant for HTN, T2DM, asthma, and BPH, b/l PE and newly diagnosed b/l cardiomyopathy. Patient was recently admitted to the hospital with complaints of SOB and was found to have b/l PE and cardiomyopathy. LHC was deferred to respiratory status of the patientToday, patient is stil complaining of SOB, fatigue, tiredness. He is using walker today due to his tiredness and fatigue. His assoc symptoms include cough. But denies any chest pain. Patient BP is in the soft range but denies any dizziness/lightheadedness. Likely covid vaccines did not contribute to patient's death given serious heart condition.
Increase temp 101 >. Sore/inflammation to inj site. Nausea.
Has had a dull frontal headache since waking on 2/20/2009 after 1 day of Tdap and still present on 2/24/2009
January 2006, I had an adverse reaction due to the 2nd Anthrax shot.  I had conditions of numbness to my right upper torso, my right shoulder, my right arm, and my right hand.  I was taken to the Medical Center's emergency and monitored for 24 hours, this happened approximately 6 hours after receiving the shot.  I was then released and continued to be treated for the numbness.  Some time in February 2006 I was giving a nerve test and was cleared Fit For Duty, but the numbness on my right hand did not go away (Today's date is 24March2007).
Chills; Fever; Aches and pain; aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), PAIN (Aches and pain) and MYALGIA (aches) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. M014M20A) for COVID-19 immunisation.     No medical history was provided by the reporter.  The patient's past medical history included COVID-19 from 27-Dec-2020 to 10-Jan-2021 and Flu from 27-Dec-2020 to 10-Jan-2021.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever), PAIN (Aches and pain) and MYALGIA (aches). On 04-Mar-2021, CHILLS (Chills), PYREXIA (Fever), PAIN (Aches and pain) and MYALGIA (aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2020, Influenza: (Positive) Positive. On 27-Dec-2020, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Bruising on arms, legs and torso; Dizziness; Fever; Joint pain; Back pain; Headache; Excessive urination; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONTUSION (Bruising on arms, legs and torso), DIZZINESS (Dizziness), PYREXIA (Fever), ARTHRALGIA (Joint pain) and BACK PAIN (Back pain) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced CONTUSION (Bruising on arms, legs and torso), DIZZINESS (Dizziness), PYREXIA (Fever), ARTHRALGIA (Joint pain), BACK PAIN (Back pain), HEADACHE (Headache) and URINE OUTPUT INCREASED (Excessive urination). At the time of the report, CONTUSION (Bruising on arms, legs and torso), DIZZINESS (Dizziness), PYREXIA (Fever), ARTHRALGIA (Joint pain), BACK PAIN (Back pain), HEADACHE (Headache) and URINE OUTPUT INCREASED (Excessive urination) had not resolved.      Treatment information included: Dayquil and Benadryl.
Shortly after receiving 2nd Moderna  within the 15 min. observation period patient said  her arm was itching and upon viewing it was red and little swollen  at the injection site.  Patient was given an ice pack to place on injection site and around 10:12am she was feeling better and she left the pharmacy.
Swelling of the tongue and throat, soreness/sensitivity in the mouth, and loss of taste. Condition is slowly subsiding.
During the 15 minutes of the after vaccination waiting time , patient passed out and hit his head on the floor, we called 911 and provided the patient the first aid until EMS arrived and took over patient care, patient was awake after the fall. Mother was present with patient at all time during the event.
Arm was really really sore; Arm swelling further and further to the point the caller struggled to put on a sweater; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was really really sore), PERIPHERAL SWELLING (Arm swelling further and further to the point the caller struggled to put on a sweater) and HEADACHE (Headache) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was really really sore), PERIPHERAL SWELLING (Arm swelling further and further to the point the caller struggled to put on a sweater) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Arm was really really sore), PERIPHERAL SWELLING (Arm swelling further and further to the point the caller struggled to put on a sweater) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medication included acetaminophen.
REDNESS DEVELOPED DAY AFTER VACCINE 2ND DAY: LARGE AREA BELOW INJECTION SITE ON ARM RED, HOT, PAINFUL. PATIENT USED COLD PACK TO HELP WITH PAIN 3RD DAY: 10/29/19 PATIENT CALLED DR. REDNESS SLIGHTLY BETTER
yesterday patient was given a flu vaccine that was last years with no reported AE; Initial information received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case is linked to case 2022SA401825(CLUSTER).  This case involves an unknown age female patient who had received influenza quadrival a-b multidose vaccine preserved [Fluzone] yesterday that was expired with no reported AE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Sep-2022, the patient received a dose of 0.5 ml total of suspect influenza influenza quadrival a-b multidose vaccine preserved suspension for injection standard (lot UJ694AB, expiry date- 30-JUN-2022) via intramuscular route in the left deltoid for Immunization that was expired with no reported AE (expired product administered) (latency same day).  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Regulatory Authority. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Psychosis after the administration of the first dose; This is a literature report for the following literature source(s):   A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, 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: PSYCHOTIC DISORDER (medically significant), outcome "recovered", described as "Psychosis after the administration of the first dose". Therapeutic measures were taken as a result of psychotic disorder.  Clinical course: A new case of psychosis after the administration of the first dose of the mRNA-based COVID-19 vaccine and worsening of psychotic symptoms after receiving the second dose. Hallucinations and delusions were presented within four weeks and resolved in three days after the administration of antipsychotics.; Sender's Comments: As per the available information the causality of the event psychotic disorder with the suspect can not be ruled out completely. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Ras, Ethics committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201355347 Same article/drug/patient and different event;
DTaP #5 given in Rt arm on 8/21/02. 8/23/02 R arm erythema, swollen, and hot to touch. 9x6 1/2cm welling Omnicef 1 1/2 tsp bid x 2 day. Advil given. Apply ice locally.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose03/26/21 2nd dose04/16/21 Diagnosed covid positive:08/28/21 Symptom onset:08/28/21 Exposure: Symptoms:COGH, FATIGUE, FEVER, MUSCLE ACHES,LOSSOF SMELL/TASTE,DIARRHEA,RUNNY NOSE,CHILLS, HA
Received vaccine in left hip on a Thursday; on the second day after the shot, I woke up with redness and irritation at the site.  The third day, I woke up with increased redness, discomfort and swelling around the vaccination site.  I used ice packs that day, and saw a physician on the next day (Monday, 4th day after).  He treated with an antibiotic and Zyrtec and recommended hydrocortisone for the irritation.
Lab results from April 20211 for liver enzymes were elevated. Discontinued methrotrexate treatment.
SWOLLEN LYMPH NODE IN NECK; FREAKED OUT; CALL OUT OF WORK 2 DAYS; EXTREME FATIGUE FOR A WEEK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced swollen lymph node in neck, freaked out, call out of work 2 days, and extreme fatigue for a week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen lymph node in neck, freaked out, call out of work 2 days, and extreme fatigue for a week. This report was non-serious.
Patient received ZOSTAVAX on 11/7 & by 11/10 had redness & swelling at injection site, approx 2 1/2 x 2 1/2 in with some c/o tingling in that extremity. By 11/14 symptoms resolved with ibuprofen, rest, & ice.
11 days after MMR/VARIVAX/PENTACEL, low grade fever, irritability. Day 10, measles like rash, otherwise healthy infant.