chrisvoncsefalvay/vaers-outcomes huggingface dataset:
some itching too; All of those areas are red and slightly raised; Red patch on back; Spots of rash on her belly; rash has presented in various areas; flu-like symptoms; Feverish / feeling hot; was uncomfortable; tossed / redness also presented that evening with a knot / areas are red; Injection site knot; was restless; turned throughout the night; arm is still sore; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in January 2020, on left ear, left side of neck and over collarbone).   On 24th June 2020, the patient received the 1st dose of Shingrix. In June 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 24th June 2020, the patient experienced influenza-like symptoms, feeling hot, discomfort, injection site erythema, injection site mass, restlessness and sleeplessness. On 26th June 2020, the patient experienced rash, itchy rash, raised rash, skin red and spot-like rash. On an unknown date, the outcome of the influenza-like symptoms, injection site erythema and restlessness were recovering/resolving and the outcome of the feeling hot, discomfort, injection site mass, sleeplessness, raised rash, skin red and spot-like rash were unknown and the outcome of the rash, pain in arm and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, feeling hot, discomfort, injection site erythema, injection site mass, restlessness, sleeplessness, rash, pain in arm, itchy rash, raised rash, skin red and spot-like rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm. The reporter stated that, after vaccination, the patient felt feverish but did not had fever. In the evening after vaccination, the patient was uncomfortable, felt hot  restless and tossed and turned throughout the night. The patient also had redness at injection site and injection site knot in the evening after vaccination. The reporter stated that, the area started out the size of a quarter. On 26th June 2020, it was 5 inches across arm and flu like symptoms were better. The reporter stated that, the arm was still sore and had rash presented in various areas. Less than a week, the patient had pain in arm. 2 days after vaccination, the patient had rash, pruritus, swelling, skin red and spot-like rash. The rash was along the line of her chest where the bottom of a sports bra would be. The reporter stated that the rash on chin below lip in the area that the man might had a gotee and also had on fore head between eye brows. The patient had spoty rash on belly and 3 red patches on back. all of those area were red and slightly raised with some itching too. The reporter stated that, the patient was on intermittent fasting and was in 20 hours of fasting currently. The reporter consented to follow up.
Had symptoms of tightness in chest high fever chills rapid heartbeat fluttering of heart nausea vomiting difficulty breathing lightheaded and tingling of fingers and lips severe migraine
I felt kind of bad, so I tested on Sept 21, 2022, and the results were negative. Then on the 22of September had head congestions and I tested again and was still negative. Then on the 23rd I was having congestion in my chest, a weird metallic taste, coughing, a low-grade fever, and head was full of congestion, and I tested again for COVID-1 and the results were positive. I have asthma so I called my doctor?s office, and they sent a script for Paxlovid, and I stared ed it the September 23. It totally cleared up my chest and head congestion, but I was having foggy brain like loss of memory. Not so much congestion and I was having a difficult time going to sleep. I was tired but couldn?t completely relax. On the September the 26 I started having diarrhea. After completing the medication, I felt better but it was a total of 14 days before I was feeling 100%.
Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Severe, Additional Details: Patient did not have observable reaction while in store, she called 2 hours post vaccination to report full body hives and itching. Patient did not have any itching/swelling/tightness of face/throat/chest. Instructed to take oral benadryl at home and go to ER if ANYTHING CHANGES. Will call at home tomorrow AM to check in on progress. No previous reactions of any kind to first 3 covid vaccine doses.
11 days after primary vaccination, patient developed a subcutanous furuncle, pain, swelling at site of vaccination.  Pt treated at local Emergency Room where moderate amount of pus was expressed.  Pt relates working out a lot with a lot of sweating around vaccine site prior to boil developing.  After expression of pus, wound was dressed and pain & swelling symptoms resolved.  Pt was otherwise without significant symptoms.
COVID+ 10/26/22.  Vaccination status - Moderna x3 BRIEF OVERVIEW:  Admission Date: 10/26/2022 Discharge Date: 10/29/2022   Active Hospital Problems   Diagnosis Date Noted POA ? Dyspnea 10/27/2022 Unknown ? Acute asthma exacerbation 12/28/2020 Yes ? COVID-19   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Dyspnea Acute exacerbation of mild persistent extrinsic asthma COVID-19 Acute asthma exacerbation   HOSPITAL COURSE: The patient is a 44 y.o. male with PMH of asthma who presented to the ED due to shortness of breath for 2 days. He complains of accompanying fever, chills, sweats. Also recalls body aches. Also recalls wheezing and pleuritic chest pain left-sided. Self-medicated with NyQuil, DayQuil, vitamins, airborne. He also continued to use a his to inhalers. Despite this, remained short of breath.   Presented to the emergency department, found to be wheezing. Chest x-ray negative. COVID-19 positive. Breathing treatments and steroids given. He was admitted for further medical management.   He received IV remdesivir for COVID 19 and prednisone for asthma exacerbation. He received supportive care. He should follow up with his PCP as an outpatient. He was discharged home in stable condition on 10/29/2022.     BP 135/94  | Pulse 95  | Temp 36.6 °C (Oral)  | Resp 18  | Ht 1.829 m  | Wt 129.3 kg  | SpO2 95%  | BMI 38.65 kg/m²    Physical Exam Constitutional:      General: He is not in acute distress.    Appearance: He is obese.  HENT:     Head: Normocephalic.  Eyes:     General: No scleral icterus.    Conjunctiva/sclera: Conjunctivae normal.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: No wheezing.  Abdominal:     General: Bowel sounds are normal. There is no distension.     Palpations: Abdomen is soft.     Tenderness: There is no abdominal tenderness. There is no guarding or rebound.  Musculoskeletal:     Right lower leg: No edema.     Left lower leg: No edema.  Skin:    General: Skin is warm and dry.  Neurological:     Mental Status: He is alert.
Neck (and left arm) pain; (Neck and) left arm pain; This is a spontaneous case initially received from agency (case ID: SEQ19-04122) by pharmacist on 08-Oct-2019, concerning a 78-year-old, female patient.     The patient's current medical condition and concomitant medication were not provided.   On 03-Oct-2019, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, anatomical location: left deltoid, route of administration: intramuscularly, batch number: P100110680, expiration date: 15-May-2020) for prevention of influenza.  On 04-Oct-2019, one day after the vaccination, the patient experienced neck and left arm pain.   The outcome for the events of neck and left arm pain were not reported.   The reporter did not provide seriousness and causality assessment.; Sender's Comments: The patient experienced neck pain and vaccination site pain, one day after administration of the suspect product, Afluria Quadrivalent. Chronology is plausible. Information regarding underlying medical history and concomitant drugs was not provided. Based on provided information, causal role of the suspect product is assessed as related for both events.
On call doctor was called on 10/23/06 that the pt was brought to ER (hospital) and pt was dead already. History of diarrhea and vomiting.  11/14/06 Received medical records from PCP including med record from OB/GYN of mother which reveals Mom was 23yo, g4, p2 with PMH of gonorrhea & chlamydia, HSV I & II, Grp B strep.  Developed thrush on 8/25/06 visit & treated. On 10/17 date of vax visit weight was 12 lbs 9 oz, length 23, head 15.5.  Child was noted to be healthy at that time. 6/12/07 Received autopsy report which reveals COD as dehydration due to gastroenteritis & manner of death as natural.  Dehydration from severe diarrhea was contributing factor.  Parent reported patient had been vomiting along w/diarrhea since 10/21 (received vaccines on 10/17).  Parent also admitted to use of drugs (crank) up until her 5th month of pregnancy when prenatal care began.  Parent reported that allergy to formula may have been contributory as patient was on his 3rd type of formula.  Coroner investigation reveals no milk allergy was reported in pcp medical records.
pt adm to hosp for apneic episode; recvd vax 1130AM 10APR92; 4PM mom noted pt was blue from waist down & limp; ran for help; back less than 60 secs; baby blue all over & limp; went to ER;
Second dose one week after first; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a 6-month-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 3393T, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLULAVAL QUADRIVALENT).   On 10th October 2022, the patient received the 2nd dose of FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 10th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's comments: A physician had called to ask for information about the administration of Flulaval vaccine to a 6 month-old patient one week after the first dose administration instead of waiting at least 4 weeks as written in the Product Information (PI). Reporter mentioned that patient did not suffer from any adverse reaction and she wanted to know how to proceed with the patient vaccination. Additional supportive information: The patient received the second dose of Flulaval vaccine earlier than the recommended interval, which had led to shortening of vaccination schedule.
Vaccines were stored after beyond use date and CDC expiry date; Vaccine was administered after beyond use date and CDC expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after beyond use date and CDC expiry date) and PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and CDC expiry date) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after beyond use date and CDC expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and CDC expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after beyond use date and CDC expiry date) and PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and CDC expiry date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   It was reported that patient took vaccine on 08-Apr-2022, after the CDC expiration date i.e on 02-Apr-2022.The BUD date was reported as 02-Apr-2022. All 45 patients were adults, who received the Moderna vaccine beyond the 30-day use by date and no additional information provided.  Date Stored in Standard Freezer for the lot 068H21A was 2 degrees F high, -1 degrees F low on 04-Jan-2022.   No treatment medication was reported.  This case contains information for the 36th of 45 patients described by the reporter.
5/16/21 - experienced tingling in lips and dizziness within 5 minutes; drank some water and waited.  Shooting pains down left side arm and leg for 2 weeks began about 2 hours after the injection. Then the shooting pains spread to the other foot and arm.  I began to experience hot feet sensations, which continue to be present as of January 17,2022. Difficult to stand, walk, and even sit (as the pain persists). There are also shooting pains down both right and left legs - intermittently. Occasionally there are shooting pains down arms. However, the most persistent pain is in the right foot which aches most of the time (but not aways). I also have additional food allergies (wheat allergy is more intense, and allergic to red wine).
sleepy/ just wanted to sleep most of the time but it was not that bad; lethargic; loss of appetite; flu; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy/ just wanted to sleep most of the time but it was not that bad), LETHARGY (lethargic), DECREASED APPETITE (loss of appetite), INFLUENZA (flu) and NAUSEA (nausea) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A and 037F21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: flu vaccine. Past adverse reactions to the above products included No adverse event with flu vaccine.   On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, 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 experienced SOMNOLENCE (sleepy/ just wanted to sleep most of the time but it was not that bad), LETHARGY (lethargic), DECREASED APPETITE (loss of appetite), INFLUENZA (flu), NAUSEA (nausea) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (sleepy/ just wanted to sleep most of the time but it was not that bad), LETHARGY (lethargic), DECREASED APPETITE (loss of appetite), INFLUENZA (flu), NAUSEA (nausea) and PYREXIA (fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No information on concomitant medication were reported. patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient was asking if she will die from getting the Moderna Covid-19 vaccine. She had friends and friends of friends who died ad were dying after getting the vaccine. She was scared that she will also die. She wanted to know what the long-term effects of the vaccine are. She was forced to take the vaccine. After the 1st dose, she felt very sleepy and lethargic. She just wanted to sleep most of the time, but it was not that bad. This lasted for 2 days. After the 2nd dose, she had nausea, fever, was lethargic and had loss of appetite. She felt like she had a bad case of flu, and it was intense. This lasted for 3 days, and she had to take Tylenol.
Suspect - weekness, off-ness, when walking, feel better laying down....no energy, unable to drive
5/15/2021-Had instant sharp pain in Rt Calf below Knee and inflammation throughout Rt foot 5/26/2021-Evaluated by Orothepedic Dr  as I had both knees replaced 2014, 2016-Knee and Hip Joints were good, nerve issues were suggested as being an issue-MRI of lower back was scheduled 5/28/2021-MRI of lower back suggested consultation with Doctors 6/16/2021-Evaluation with Dept referred me to Pain Management evaluation 7/14/2021-Evaluation with Pain Management Dr -recommended Epidural treatment after a Venous Doppler Scan 7-21-2021-US Venous Doppler Scan performed-no evidence of vein thrombosis involving right lower extremity-left common femoral vein-Possible baker's cyst noted on Rt
my arm be red and hot and feel thicker 3 inches below where my shot was given; my arm be red and hot and feel thicker 3 inches below where my shot was given; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm on 20Apr2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced arm be red and hot and feel thicker 3 inches below where my shot was given. The outcome of event was of unknown.  Follow-up(23Apr2021): This is a follow-up contained no new safety information.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
24 hrs post injection, felt itchy all over body, rash in patches all over. 48 hrs later symptoms exist, took Claritin (10mg) tablet.
This spontaneous case, received from a pharmacist on 15-Oct-2018, (initial and follow-up 1 combinedly processed), concerns a 47-year-old, adult female patient. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 56F for 8 hours following a power outage. On 14-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 30-Jun-2019) which was stored inappropriately. No adverse event was reported. The reporter assessed this case as non-serious. This case 201804547 was cross-linked to the case 201804533 reported by the same reporter.
relative died; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: DEATH (death, medically significant), outcome "fatal", described as "relative died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: The reporter mentioned her 2 relatives died when they took the vaccine and her husband became sickly when he took the vaccine too.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300141645 same reporter/vaccine/event, different patients;; Reported Cause(s) of Death: relative died
I had a pain in my lower middle back right side and in pain and swelling in my lower left leg from my ankle to mid thigh
About a week after being vaccinated I started experiencing bad headaches, chest pains and pains in my leg. I went to the emergency department at Hospital to get checked out. They took blood and I had a high d dimer test result. They did an Ultrasound of both legs, and a CT with contrast of the lungs and a CT of the head. No blood clots were evident at the time. Over the next couple of weeks my left leg has continued to swell and hold fluid. On 5-11-2021 I had another ultrasound of the left leg again to rule out a possible blood clot. Again they did not find anything. After reviewing blood work from a coag profile all results were elevated but not worrisome per the dr. I continie to have more swelling in the left lower extremity, muscle aches and pains in that leg along with more busted blood vessels. I have experienced pains in places that I have never had before. Example a sharp pain started around my left pelvic area and shot up to the left shoulder and then burned for several minutes.
A non-serious spontaneous report of administration of H1N1 over 49 year of age was received from a registered nurse/health professional concerning a male adult patient. The patient did not have any medical history and was not on any concomitant medications. On 13-Oct-2009, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered resolved. Additional information was received on 17-Dec-2009 and incorporated into the narrative: medical history, concomitant medications and reporter's type.
On receiving the flu shot this year in my left arm, I experienced a very sharp pain unlike what I've experienced on previous vaccinations. The pain and soreness in my left arm did not subside, and 2 weeks later I visited occupational health for the first time. I was advised to take ibuprofen three times daily and apply ice. About 3 weeks after my first visit, I returned to occupational health when the pain had not subsided. I was treated with a MEDROL dose pack and experienced some relief of the pain. The pain returned about one week after completing steroid course, and I returned to occupational health. An MRI of the left arm was completed, and the results are pending. 2 months after vaccination, the pain and soreness in my left arm continues.
Information has been received from a registered nurse (also reported as certified medical assistant) concerning a 71 year old female patient with hiatus hernia, seasonal allergy, ibuprofen causes shortness of breath, glaucoma, arthritis and hyperlipidaemia and a history of helicobacter pylori infection that had been corrected who on 20-JAN-2009 was vaccinated intramuscularly into the right arm with a 0.65ml dose of ZOSTER vaccine live (Oka/Merck) (Lot #663196/1417X).  Concomitant therapy included ACTONEL, aspirin, calcium (unspecified) (+) vitamin D (unspecified), chondroitin sulfate sodium (+) glucosamine sulfate, vitamins (unspecified), NEURONTIN, NEXIUM and simvastatin (MSD).  The medical assistant reported that after vaccination (on unspecified date) the patient experienced a local reaction to the right arm.  The area was red, warm and slightly raised area that was 2 by 1 and 1/2 inches.  The patient was told to apply a cool compress to this area.  The patient sought medical attention by phone on 23-JAN-2009.  At the time of reporting the patient was recovering  This is one of two cases from the same source.  This is a consolidation of two reports concerning the same patient.  Additional information has been requested.
Extreme fatigue, dizziness, and sore arm within 6 hours of receiving shot. Started feeling feverish a couple of hours later. Sweated off fevers continuously for the next 2-1/2 days. Headaches came and went during this time. Took Aleve every 4 hours until this all stopped.
pt recvd vax; a few hrs later pt began sounding "out of it";(would not respond to simple questions) then whole body contracted & tension lasted about 15 mins;pt went into sourd sleep for several hrs p/ episode;also had varicella 2 wks prior