chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Is totally miserable; High fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Is totally miserable), PYREXIA (High fever) and MYALGIA (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jun-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) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced FEELING ABNORMAL (Is totally miserable), PYREXIA (High fever) and MYALGIA (Body aches). At the time of the report, FEELING ABNORMAL (Is totally miserable), PYREXIA (High fever) and MYALGIA (Body aches) outcome was unknown.            No concomitant medications reported.  Treatment medications was not provided by the reporter
SAME DAY, TENDERNESS AT SITE OF INJECTION.  LATER THAT DAY AND FOR NEXT SEVERAL DAYS , ALL OVER BODY PAIN AND INTENSE SHOULDER PAIN.  ABOUT A WEEK LATER HER BALANCE WAS OFF TO A DEGREE THAT IT CAUSED HER TO FALL AND RESULTED IN A TRIP TO CLINIC FOR SORENESS FROM THE FALL.
Patient reported "don't do well with injections", she was escorted to the wait area. She appeared nervous and denied symptoms. After ~10 mins she because anxious, reported feeling light headed to employees. Patient was assisted to gurney in supine position, O2 applied via nasal cannual by employee, Patient calm and appears in no distess laying supine. She was observed for additional 30 mins. She voiced no complaints and was asymptomatic. She was discharged without difficulty or incident. Patient was instructed to request laying down for second injection.
This pt had a tetanus shot on the 23rd and developed severe left arm pain generalized joint pain, stomach ache, and a temperature to 102 degrees with some difficulty breathing post vaccination. I had talked to the parents over the weekend and advised Benadryl and Motrin which seemed to have substantial benefit. Physical examination: The pt presents today afebrile with the arm still red and warm, but less swollen and painful. The majority of the other symptoms are improved, although the pt still feels a bit punk. Assessment: This is an Arthus type reaction to the vaccination, it appears.  Plan: I am going to refer this pt to Dr. to delineate whether it is the horse serum or other preservatives in the vaccination which need to be avoided in the future.
Fatigue, muscle aches, chills. Pain, induration, and rash at injection site.
The Patient noticed nodules in her bottom lip; Patient re noticed swelling, little by little, in her top and bottom lip; Initial information was received on 09-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (healthcare professional).  This case involves a 53 years old female patient who experienced nodules in her bottom lip (skin mass) and swelling, little by little, in her top and bottom lip (lip swelling), while she received vaccine INFLUENZA VACCINE and while treated with VENLAFAXINE HYDROCHLORIDE [EFFEXOR] and HYALURONIC ACID [RESTYLANE].  The patient's past medical treatment included JUVEDERM VOLBELLA WITH LIDOCAINE on 28-JUN-2019.  The patient has NKDA (No known drug allergies) and no medical history.  Past vaccinations, concomitant medication and family history were not provided.  On 30-Sep-2020, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer), lot number and expiration date not reported via unknown route at an unknown administration site for prophylactic vaccination.  On 30-Nov-2020, the patient started taking RESTYLANE (HYALURONIC ACID) 1 mL (Solution for injection and route was not reported) (lot - 18404) for Dermal filler injection.  On an unknown date, the patient started taking VENLAFAXINE HYDROCHLORIDE (dosage, route and batch number were unknown).  On an unknown date, the patient developed a non-serious nodule in her bottom lip (skin mass), (unknown latency), following the administration of INFLUENZA VACCINE and following the first dose intake of VENLAFAXINE HYDROCHLORIDE and HYALURONIC ACID.  On 25-Jan-2021, the patient developed a non-serious swelling, little by little, in her top and bottom lip (lip swelling), three months 26 days following the administration of INFLUENZA VACCINE, one month 26 days following the first dose intake of HYALURONIC ACID and unknown latency following the first dose intake of VENLAFAXINE HYDROCHLORIDE.  Laboratory data was not reported.  It was reported that the patient had the flu vaccine around 2 months ago.  The action taken for VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE) and HYALURONIC ACID (RESTYLANE) was unknown.  The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL) for Skin mass and Lip swelling.  The patient was not recovered from the events at the time of reporting.
patient received a dose of Boostrix that had already expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2ZF9N, expiry date 24-SEP-2023) for prophylaxis.   On 27-SEP-2023, the patient received Boostrix. On 27-SEP-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: patient received a dose of Boostrix that had already expired).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 27-SEP-2023 A nurse reported that earlier that day, a patient received a dose of Boostrix that had already expired on 24 September 2023 which led to expired vaccine used.  The reporter did not consent to follow-up.  This case was linked with case US2023133461 with same reporter.; Sender's Comments:  US-GSK-US2023133461:Same reporter 2nd patient
Patient was vaccinated on 1/12/21.  She developed symptoms of COVID and diagnosed on 1/22.  She was hospitalized for moderate coronavirus pneumonia and hypovolemic hyponatremia
Sudden vision loss  Saw retinologist, not an eye problem Saw PC doctor who ordered mri (scheduled) Have appt scheduled with cardiologist
Patient presenting with fatigue, numbness L lower cheek and decreased respiration s/p vaccination.  Patient exhibited choking/gagging.  Pt did not desat but placed hands at throat.   c/o chest pressure later, EKG not done by time paramedics arrived.  Paramedics given report of chest pressure.    Benadryl 50mg x1 at 4:30 Epipen administered at 4:30.   Solumedrol 40mg given at 4:43.   Pt placed on 2 L/min of O2.
It was reported that a female pt received a dose of flu vaccine in December 2000 at a flu clinic where she resides. Lot number for vaccine is not available. Pt was diagnosed with Transverse myelitis shortly after she received vaccine. This information was reported by the pt's sister in behalf of the pt. When asked to provide more information, she stated that she would prefer her sister to call directly to provide additional information. The patient reported that she was 36 years old when this event occurred. Vaccine received was fluzone lot# U0345AC, date administerted 11/21/00. On 12/17/00 symptoms of back ache between shoulder blades, massive headache bagan. By the next day, pain radiated to right hand (numbness also present), difficulty breathing, legs became numb, she thought it was ashtma attack but her inhalers would not work. She was tranported to the hospital by ambulance. She was admitted on 12/19/00 and was in ICU on ventilator for two months. She was released to a rehabilitation facility approximately two months later, still on ventilator with tracheostomy. On 7/17/01 she was released from rehabilitation. Currently she still has limited use of her arms (right is worse than her left. She can walk with a quad cane and leg brace. She has a foley catheter, and her sensory perception is very limited from her shoulders down through her legs. From correspondence received at manufacturer on 5/13/02, it was determined that the code for difficulty breathing needed to be added to the COSTART listing.
MILD FLU-LIKE SYMPTOMS (FEVER, CHILLS, FEELING HOT, SWEATING) AND RASH ON SKIN ON BOTH RIB CAGE AREAS THAT DOES NOT ITCH. TOLD PATIENT TO TAKE BENADRYL AND SEE IF THAT HELPED.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 11-NOV-2014, the patient was inadvertently vaccinated with an expired dose of MMR II lot # H017027, expiration date: 14-SEP-2014, albumin status: HSA, 0.5 ml, subcutaneous. No adverse effects were reported. Additional information has been requested.
Patient developed rash in lower arm below injection site within 1 hour of receiving vaccine. Ice pack placed on skin and rash disappeared. Patient verbalized relief.
One and a half month gone after my first Dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (One and a half month gone after my first Dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-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 PRODUCT DOSE OMISSION ISSUE (One and a half month gone after my first Dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (One and a half month gone after my first Dose) 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.
FELT HORRIBLE; This spontaneous report received from a consumer concerned a 59 year old male. 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, and batch number were not reported) 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 patient experienced felt horrible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt horrible was not reported. This report was non-serious.
3/25/2022 at 0911 Employee called the Nurse Vaccine Support line to report symptoms post COVID-19 booster vaccine. Vaccine Name - Pfizer Vaccine Date - 3/23/2022 Booster Dose - Yes Location - Left Deltoid Date of Symptom Onset - 3/24/2022 Symptoms - Chills, Headache (Head feels heavy), Body aches, Fever (TMax 103.1F today at 0600) Last Day of Work and Shift - 3/23/2022  Home Remedies - Motrin 600 mg alternating with Tylenol 1000 mg (Last dose today 0600) Any Improvement - No (Body aches and Fever continue)
On February 27, 2021, I experienced monoparesis  in left leg which caused me to be hospitalized for 11 days, in a physical rehab facility for 20 days and 2 months of outpatient physical and occupational therapy.  Monoparesis of leg / paresthesia of left lower extremity CVA TIA
Post flu shot, developed tingling tongue and chest tightness. Increased shortness of breath. 911 called - EMT gave IM BENADRYL. Refused ER transport.
Pt was given varicella and PROQUAD at the same time. Pt was only to give the PROQUAD, No adverse reactions.
THIS MORNING TD VACCINE GIVEN SUBCUTANEOUSLY IN ERROR INSTEAD OF TB TEST.
Client report receiving first COVID vaccine on 03/11/21, right away began to have burning sensation at injection site.  Later that day, body felt warm and face noticed to be swollen.  On Saturday 03/13, face continued to be swollen, got hives all over her face, arm continued to be sore and throat started to close.  Client went to the ER later that evening about 2100,  treated with steroids, Benadryl and an Epi-pen.  After two days face decreased in swelling but face continued to be irritated x 1 week.  Client report not having symptoms anymore.
Rash at injection sight approximately 4cmX5cm, cortisone to site for itching, Benadryl Child strength.
I received the booster shot on Monday afternoon. At first, I only felt a mild tingling at the injection site, and a cooling sensation. On Tuesday evening, however, I began to have trouble breathing, tingling in my arms, and pain in my chest. I took a Tylenol to settle the spasms in my arm, but I am still under the belief that I have experienced anaphalaxis and I am concerned that this is still going on 24 hours after injection. My arm is still jelly and my chest still feels heavy and I am having trouble taking deep breaths. I have not gone to the hospital. I took a COVID-19 test on Monday and it came back NEGATIVE today. My symptoms are the direct result of the Tdap booster.
Upset stomach; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included cancer (She has had cancer like 3 times). It was reported that the patient had upset stomach on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Patient called today stating that after her vaccines on Wednesday she had some numbness in her arm. Thursday she had racing heart and chest soreness all day. Friday morning heart racing and chest soreness continued. She went to work. After work went to the ER at 3:30pm. After normal EKG and lab work she signed out of ER at 7:30 pain free. Saturday ran 2.5 miles without any difficulty or symptoms. She canceled her trip and refuses to get vaccine boosters. She was thankful for the call and discussion.
No adverse effect and will monitor.  The patient is 3 years old and 7 months. She was given Quadracel 5 month earlier.
Patient had latex sensitivity - Pharmacist counseled on potential risk based on type of syringe used. Vaccine administered on 9-27-11 at 6:50pm. Patient states a few hours later, the arm was itchy and red at injection site. She called Pharmacy at 9:15am 9-28-11, her arm was swollen by then. I told her to use ice, take BENADRYL and contact MD if worse.
Swollen part in the mouth; Tingling part in the mouth; Hurts in small part of side in the mouth; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (Swollen part in the mouth), PARAESTHESIA (Tingling part in the mouth) and ORAL PAIN (Hurts in small part of side in the mouth) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced MOUTH SWELLING (Swollen part in the mouth), PARAESTHESIA (Tingling part in the mouth) and ORAL PAIN (Hurts in small part of side in the mouth). At the time of the report, MOUTH SWELLING (Swollen part in the mouth), PARAESTHESIA (Tingling part in the mouth) and ORAL PAIN (Hurts in small part of side in the mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Patient had taken Diphenhydramine for the event.
Varicella - Information has been received from a registered nurse concerning a 6 year old female patient who on in August of 1995 was vaccinated with varicella virus vaccine live.  On approximately 05 apr 2000.  the patient developed chickenpox.  The patient has not been seen by a physician.
Sore, red, inflamed bicep all along upper arm (armpit to elbow), painful when extending arm.
TIP VARIANT OF FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS); This spontaneous report was received from literature. This report concerned a 45 year old male. The objective of this study was to describe tip variant of focal segmental glomerulosclerosis post COVID-19 vaccination with one case report. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no past medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. Age at time of vaccination 5 decade old. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, 1 week after receiving vaccine, the patient presented with progressive worsening lower extremity edema. He was not taking any prescribed or over the counter medications. His physical exam showed BP (blood pressure) of 160/90 mmHg and plus 2 lower extremity edema. Laboratory studies revealed that, BUN (blood urea nitrogen) 97 mg/dL, serum creatinine 6.7 mg/dL (baseline 0.8 mg/ dL), serum albumin 1.8 g/dL and 24-hour urine protein of 6.5 g. Serological workup was negative. A kidney biopsy showed focal areas of segmental glomerulosclerosis (FSGS), associated with endocapillary foam cells and epithelial cell capping, predominantly involving the takeoff point of the proximal tubule. The areas of segmental sclerosis herniated into the proximal tubule. Immunofluorescence was negative and electron microscopy revealed diffuse epithelial foot process effacement. The patient was diagnosed with tip variant of FSGS (focal segmental glomerulosclerosis) and started on oral prednisone 80 mg daily. He required initiation of dialysis and has no evidence of renal recovery to date. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tip variant of focal segmental glomerulosclerosis (FSGS). The authors emphasized on new cases and relapses of GN's (glomerulonephritis) can present shortly after mRNA COVID-19 vaccination. IgA nephropathy, FSGS and minimal change disease have been reported. The tip variant of FSGS usually presents as a primary podocytopathy and had the best prognosis among the various forms of FSGS due to its high response to steroid therapy and low risk of progression. This report was serious (Other Medically Important Condition). This case, from the Others is linked to 20221220276.; Sender's Comments: V0- 20221218638- A tip variant of focal segmental glomerulosclerosis-The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the Agency Causality is considered indeterminate. The company causality is considered related.
Nausea, Fatigue, Chills, Weakness        Had to Stay lying down.  Sips of water..crackers.    2days    3rd day able to eat "mild foods" and get up.  Day 4 Seemingly back to normal....with usual LONG COVID symptoms.
Red, raised, warm area 2-3" by 6 inches at the site of the injection of yellow fever vaccine. Adv palliative local treatment with cool compresses. No medical treatment at this time.
pt recv vax 24JUN97 & 24hr post vax pt devel a 4x3 inch induration @ the inj site;the induration was red & raised;pt has completely recovered from the adverse event;
02/20/2005- Rash started at night. 02/21/2005 went to MD's office and diagnosed with chicken pox. Vaccine Failure.
While patient was waiting in the post vaccination area (after receiving Pfizer COVID-19 vaccine), he started feeling cold and his face was pale. He was sweating a lot (his clothes were all wet covered in sweat). Patient never had difficulty breathing nor any sign of allergy. He was conscious at all time. I took his blood pressure and it was 114/77 and his pulse was 83. We monitored the patient and called 911.
Client experienced near-syncopal event approximately 5-10 minutes post vaccination. Client has history of syncope with blood donation. Client diaphoretic, exhibiting pallor, weak, shivering. Vitals taken q15 minutes x 3. Client signs/symptoms resolved over next 30 minutes. Client able to walk with steady gait out of vaccination site, accompanied and driven home by spouse.
I had a TIA/mini stroke on 12/29. I went to the ER that same day and received a bunch of tests. They determined there was no neurological damage or visible cause for the TIA. The only thing they found was a congenital heart defect. I was in the ER for 2 days and was discharged with a blood thinner. Soon after that I started taking a high cholesterol.
Extended menstrual bleeding and spotting after receiving COVID vaccine. Recieved second Pfizer vaccine on day three of monthly period and heaviest day had passed. Typically have heavy bleeding/cramps on day #2 ONLY. After receiving vaccine, menstrual bleeding continued for longer/heavier than occured during Pfizer vaccine #1. Seeing spots of bleeding and clots on day 8 which has never occurred during my cycles, even during periods of extreme stress. Menstrual bleeding is typcially noticable for me for 5-6 days and have never seen clots this far into my cycle.   Only other physical side effects were feel of malaise day after receiving injection + headache + soreness in left arm injection site + pain on outside of left breast under arm and next to rib cage (no extreme tenderness to right breast).
Patient developed large area of cellulitis around injection site.  Was seen in our office and treat with Keflex and resolved.
I dont have a taste no more; Chest feels tighten; I keep getting chills; My head is still being hurting; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (I dont have a taste no more), CHEST DISCOMFORT (Chest feels tighten), CHILLS (I keep getting chills) and HEADACHE (My head is still being hurting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (I dont have a taste no more), CHEST DISCOMFORT (Chest feels tighten), CHILLS (I keep getting chills) and HEADACHE (My head is still being hurting). At the time of the report, AGEUSIA (I dont have a taste no more), CHEST DISCOMFORT (Chest feels tighten), CHILLS (I keep getting chills) and HEADACHE (My head is still being hurting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) increased..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment information provided.
The evening after the shot developed severe arm pain (L) unable to raise arm beyond 90 degrees of shldr flexion, abduction. Unable to rotate arm, also arm weakness.
Covid infection despite vaccination  Admitted 8/29. SARS-CoV-2+ on admit.  Pt has received 2 doses of Pfizer  3/17/21, 5/3/21.