chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme burning skin pain; Extreme burning skin pain; Muscle soreness under the burning skin; The burning started on the left back and then each day expanded to left side, right back and side, left stomach side then right stomach side and then chest; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 22Mar2021 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus (diabetes type 2), degenerative disc disease and fusions C4 to C7, arthritis and general body pain (24 hours a day of pain and the patient took no pain medication at all for it in 7m years). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had received unspecified concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 01Mar2021 at 15:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient previously took acetylsalicylic acid (LOPRIN) and lisinopril dihydrate (LISINOPRIL) and experienced swollen face right side; tadalafil (CIALIS) and experienced pain in spine (spin pain); metformin (MANUFACTURER UNKNOWN) and experienced stomach issues and blockage; all taken on unknown date for unknown indication. On 05Apr2021 at 07:00, the patient experienced extreme burning skin pain like a bad sunburn and muscle soreness under the burning skin like the patient got beat up. No visible skin markings, redness, rash and pimples; the burning started on the left back and then each day expanded to left side, right back and side, left stomach side then right stomach side and then chest. The patient also reported that he already had a history of pain through his body 24 hours a day for degenerative disc disease (disability retirement) and about once a year got the skin pain on either (ether) the left or right back side only of his body for 2 weeks at a time but never in the whole torso both left and right front and back all at once and never muscle pain under the burning skin ever, this was a first. Therapeutic measures were taken as a result of the events and included treatment with prednisone (MANUFACTURER UNKNOWN). The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme burning skin pain, muscle soreness under the burning skin and the burning started on the left back and then each day expanded to left side, right back and side, left stomach side then right stomach side and then chest were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Temporary loss of consciousness during administration of vaccines. Pt. reported dizziness, nausea. Reports loss of consciousness has occurred previously with vaccinations and blood draws. Given juice x2, observed x20 minutes. Reported no s/s left facility.
A few minutes after shot, face started feeling hot. Felt light headed. Face and neck started turning red. Medic came out, BP was190/?? Was given water and advised to go to emergency. I declined. They said to take BP medicine and hydrate. Redness disappeared after 4 hrs.
This spontaneous report as received from a nurse refers to a female patient of unknown age. On 11-NOV-2014, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency was unknown), inadvertently administered in the left dorsal gluteal muscle as an intramuscular injection. No adverse events was reported. No product quality complaint (PQC) involved. The outcome of the event was unknown. No further information provided. Additional information is not expected.
pt cried x 3hrs then became limp & whiny x 3hrs;t104.1 o, vomited x hr, shaking all over w/fever;lt thigh & lt knee swelling & tenderness
Patient received Moderna first dose 1/26/21, felt fatigue first few days symptoms resolved. L arm started itching 2/2/21. Called doctor's office 2/3/21 to report L arm has swelling size of "golf ball", redness, warmth.
I received the vaccine on April the 9th had no problems.  I was exposed to COVID in August.  I started a small cough on, and they tested positive test.  The VA offered the antibody infusion.  About an hour after the infusion, I started to have a headache, runny nose, short of breath, high temperature and muscle aches.  My wife called the ambulance, and I was taking to the ER.  I spend the 3 days in the hospital and on the 21st of August my symptoms started to subside.  They released me on the 22nd of August.  I spend the next 5 days at home recovering and I took another test on the 27th and I tested negative for COVID.
no AE; The medical assistant is reporting that a patient received improperly stored vaccine.; This spontaneous report was received from a medical assistant referring to a patient of unknown age. Information about the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On 08-AUG-2023, the patient was vaccinated with improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection (1 dosage form, lot #w017819 was valid for formulation pre-filled syringe, expiration date 27-DEC-2023, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Product storage error).  The suspect vaccine experienced a temperature excursion of 18.8 degrees Celsius for 9 hours. No additional adverse events (AEs)were reported (No adverse event). No further information was provided. There was no previous excursion.
After 2nd day with VAX i noticed my left eye twitching. It has been an almost constant twitch. My left eye is swollen and feel like theis is liquid. My left eye feels strained
A report has been received from a Health Professional concerning a 4 year old, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). FLUMIST QUADRIVALENT (INTRANASAL) started on 20-Dec-2013. The patient was inadvertently given expired FLUMIST QUADRIVALENT. The patient experienced GAVE EXPIRED FLUMIST QUADRIVALENT which started on 20-Dec-2013. The outcome of the event of GAVE EXPIRED FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter. Corrected report 05-Feb-2014: Case medically confirmed box ticked.
On 1/11/2021 (day of first vaccine dose) at approximately 5pm I began experiencing the following symptoms: fatigue, chills, muscle aches, 99.7 temperature. These symptoms lasted throughout the night and did not continue the next day. I also experienced pain at the injection site which lasted for approximately 3 days.   On 1/16/2021 at approx. 3am I woke up feeling itching and stinging on both of my hips. I got up and looked in the mirror and noticed what appeared to be hives or rashes on my left and right hip. The rashes were red, slightly raised and approximately 3 inches long. I took Benadryl which helped to alleviate the itching and stinging. The following day (1/17), the rashes were still present but were no longer raised.  On 1/17, I noticed a smaller hive like rash on both the outside and inside of my right arm. Today (1/18) the rashes on my hips and arm are still present but no longer raised.   When I woke up on 1/18/2021 I had pain and itching on my upper left arm where I had received the vaccine injection. The area is red and warm to the touch. I saw my PCP who described the area as "indurated". The redness, pain and itchiness have persisted throughout the day.   I cannot think of anything else that would have caused this reaction. I have not eaten anything new/different, I have not changed any detergents or body washes/lotions. I have not taken any new medications.
Feverish Feeling; took the Covid-19 home test kit and tested positive; felt increasingly worst everyday; felt shivering in bed; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt increasingly worst everyday), PYREXIA (Feverish Feeling), CHILLS (felt shivering in bed) and SARS-COV-2 TEST POSITIVE (took the Covid-19 home test kit and tested positive) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     Concurrent medical conditions included Back disorder NOS. Concomitant products included VITAMIN B3 and CALCIUM for Back disorder NOS, ATENOLOL, CITALOPRAM, OMEPRAZOLE and AMLODIPINE for an unknown indication.    On 19-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-2021, the patient experienced FEELING ABNORMAL (felt increasingly worst everyday) and CHILLS (felt shivering in bed). On 21-Dec-2021, the patient experienced PYREXIA (Feverish Feeling) and SARS-COV-2 TEST POSITIVE (took the Covid-19 home test kit and tested positive). The patient was treated with GUAIFENESIN (MUCINEX) for Adverse event, at a dose of 3 tablet, q12h. At the time of the report, FEELING ABNORMAL (felt increasingly worst everyday), PYREXIA (Feverish Feeling), CHILLS (felt shivering in bed) and SARS-COV-2 TEST POSITIVE (took the Covid-19 home test kit and tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.         Patient received the booster dose of the Moderna Covid-19 Vaccine and felt shivering in bed on Monday and feverish feeling on Tuesday. Patient felt increasingly worst everyday. Patient took the Covid-19 home test kit and tested positive.  Company Comment: This case concerns a 62-year-old female patient with no previous relevant medical history reported, who experienced the non-serious events of Feeling abnormal, Pyrexia, Chills and SARS-CoV-2 test positive. The events occurred on the following two days after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). Based on the mechanism of action of mRNA-1273 causal association between the event of SARS-CoV-2 test positive and mRNA-1273 product is assessed as not applicable. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.; Sender's Comments: This case concerns a 62-year-old female patient with no previous relevant medical history reported, who experienced the non-serious events of Feeling abnormal, Pyrexia, Chills and SARS-CoV-2 test positive. The events occurred on the following two days after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). Based on the mechanism of action of mRNA-1273 causal association between the event of SARS-CoV-2 test positive and mRNA-1273 product is assessed as not applicable. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.
25min p/vax noticed a rash (hives), itching under chin;referred to ER for tx;med given by MD;by 11:30 itching gone;to f/u w/family MD;
3/27/2023 This started with a cough and a low grade fever.  3/28 the fever peaked at 101.  3/29, Tested with an At Home COVID-19 test, positive.  Televist with doctor, proscribed Paxlovid. Symptoms diminished while on Paxlovid, but once the Paxlovid was over, there was a rebound of symptoms including runny nose, sinus pressure, loss of taste and smell, body and joint aches.  These lasted about 2 weeks.  Chest congestion and runny nose linger to time of reporting.
HYPOXIA 1/10/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Headache 1 hour post, injection site pain 6 hours post, fever chills sweating that night
Welt looking red rash, hot to touch, raised skin, 4" long/ 1" wide- has grown to 12" long/ 3" wide. Extremely sore to touch.
100 degree fever, widespread severe aches, mild nausea, which resolved within 48 hours. Acetaminophen taken helped. This was  followed the next few days by very sore, swollen, red arm at injection site.
Mom called at approximately 10:45 reports infant acting different has not acted like this with previous doses, temp 100, stares. Had reported giving Tylenol early am (approx 6am 09/08/2005) for teething denied fever. To ER told to watch infant EC. Reg Tylenol to control fever. 09/09/2005 reports cont increased temp 103, high pitched cry is giving Ibuprofen with relief but when 6 hrs up temp up again.
Only one vial was administered; Only one vial was administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Only one vial was administered) and inappropriate dose of vaccine administered (Verbatim: Only one vial was administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 25-Apr-2023 The reporter had question, only one vial was given to patient. The reporter asked whether they need to give the whole new dose. It was reported that Vial 2 was given not 1. No credentials provided and no additional information. The reporter stated that only one vial, Vial 2 was given not 1 which led to  inappropriate preparation of medication and inappropriate dose of vaccine administered.
Patient self-reported adverse event involved body ache, low graded fever and itchy rash about 3 inches on injection site developed on same day of injection. She took tylenol 500mg and felt better in two days.
This spontaneous report was received from the patient's mother referring to her daughter of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 21-SEP-2016, the patient was vaccinated with a dose of GARDASIL (Dose, lot number, expiration date, route and anatomical location were not reported). The patient's mother stated that on an unknown date, her daughter's limbs became paralyzed (diplegia) as a result of receiving GARDASIL. At the time of reporting the outcome of diplegia was unknown. There was no product quality complaint (PQC) involved. Upon internal review diplegia was determined to be medically significant. The primary reporter assessed the causality between the event and GARDASIL as related. Additional information is not expected as there is no contactable information available.
Started complaining of not feeling well a few days after the injection onto pin and needles effect in hands & feet. Bells palsy on one side of face then onto the other side onto Severe weakness throughout entire body to being on a ventilator severly paralyzed for over 6 months until death on 5/20/08
Case number PHEH2013US023545 an initial spontaneous report received from a consumer on 08 Nov 2013. This report refers to a 58-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with influenza vaccine (manufacturer and batch number: not reported) intramuscularly on an unknown date, 4 years ago. It was reported that she was so sick after getting the flu shot. She had symptoms of heart beating fast and blurry vision within 10 minutes of getting the flu shot. She also had nausea and was totally sick. She felt awful the whole day during day and night and had a high fever. She took TYLENOL. About a week later she went to doctor and took an antibiotic. The physician told her that she probably had an allergic reaction to something in the flu vaccine. The event outcome was unknown. She skipped a year and then took flu shot in the last year and the vaccine was well tolerated. The seriousness and causality was not reported.
35 minutes after injection - Heart rate increased to 105 bpm and bp elevated. Returned to normal after 10 minutes.
Neck became hot, chills, hot flashes, backache, body aches, knee caps ached, toes ached, nausea, vomiting (night of only), lasted 48 hours.
Night terrors x 2 days, 3-4 a night 11/8, 11/9. Fever, body aches 11/6-7.
Reported itching, redness, swelling at injection site approx 15 minutes after receiving. Given Claritin. After another 15 minutes, reported full-body itching and hives. Sent to ED for further treatment.
Fever, deep, persistent cough, especially at night, lasting 7 days. Anaphylaxis (sweeping in hands, feet, lips, and full body rash) requiring emergency room and prednisone.
both arms got numb; tingly; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPOAESTHESIA (both arms got numb) and PARAESTHESIA (tingly) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021 at 11:37 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced HYPOAESTHESIA (both arms got numb) and PARAESTHESIA (tingly). On 14-Apr-2021, HYPOAESTHESIA (both arms got numb) and PARAESTHESIA (tingly) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.     Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Outcome updated.
headache, chills, body & joint ache, fatigued/lethargic, loss of appetite, fever. at injection site sore, large red oval, hard bump, bruise, heat, itchiness
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 1:03 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 1:09 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 40. for dose administered on 27-Feb-2021 and 40.12 for dose administered on 27-Mar-2021. No concomitant medications were reported.  Batch number 019B21A administered on 27-Mar-2021 underwent temperature excursion with temperature range of 35 degrees Fahrenheit from 09:00 AM to 10:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  Batch number 014M20A underwent temperature excursion on 27-Feb-2021 with temperature 35 degrees Fahrenheit from 01:00 PM to 02:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
45 minutes after flu vaccine pt had onset of several erythematous raised lesions on face & left arm - slightly itchy - no SOB. No local reaction at injection site.
Rash on (L) upper arm since yesterday. No c/o itching. Afebrile Flat rash with central clearing.
Pt devel erythema & induration surrounding the inject site p/receiving Typhoid vax; Pt also exp fatigue, nausea, gasrointestinal distress, & fever; This ADR was previously reported to FDA by the reporter;
Five or six children devel red, swollen lumps @ inject site; All the parents called to report the rxn & two of the pts were seen in office;
Tingling and swelling of tongue for 24 hours. Took Benadryl.
I had COVID-19. The first 2 days, I felt fine. Then on Sunday, I woke up feeling worse. I had watery eyes and sneezing, like allergy symptoms. My doctor told me to start drinking Claritin-D. I had fever of 102.6, chills, I couldn't get out of bed, I felt exhausted. My head and entire body hurt. I just didn't have any energy. I struggled to get out of bed. I also had diarrhea. I started taking day and NyQuil severe. My symptoms lasted for about 2 weeks.
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a health care provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Within 2 hours of injection pt developed fever, emesis. By the next day, he had redness, swelling and pain at the injection site. His fevers persisted though the emesis resolved. He was lethargic and not eating. He was hospitalized on 6/29/17 for IV fluids and labs. His CRP was over 6 with a normal WBC. He had a normal UA and CXR.