chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller states that the man who gave her the first shot gave it too high she thinks; and that's why it hurt more.; sore arm; Caller states that the man who gave her the first shot gave it too high she thinks; and that's why it hurt more.; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: GN6199) via an unspecified route of administration, administered in left arm on 04Mar2021 (at the age of 67-year-old) as dose 1, single for covid-19 immunization. Medical history included COPD (chronic obstructive pulmonary disease) from 2009 and ongoing, h1n1 from 2009 to an unknown date and was on a ventilator because it attacked her lungs, ongoing diabetes and had Covid on an unspecified date in Nov2020 and she had lost of taste and smell with Covid. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. Family history not provided. On an unspecified date in Mar2021 the patient stated that the man who gave her the first shot gave it too high she thinks and that's why it hurt more, had a sore arm. It was reported that Sore arm after the first dose of the vaccine. Caller states that she had her first dose of the vaccine on 04Mar2021. Her arm was sore for maybe 4 days. Sore arm after the second dose of the vaccine. Her arm was not as bad with the second one.  Says it was sore for maybe half of a day. Caller states that the man who gave her the first shot gave it too high she thinks; and that's why it hurt more. The AEs does not required a visit to emergency room and physician office. The patient wanted to know if the vaccine that she got was a placebo as she has COPD, so she needs the real vaccine, not a placebo. caller stated that sometimes a sore arm was to be expected if you have a shot that goes in a muscle.   Outcome of the event sore arm was resolved on an unspecified date in Mar2021 and outcome of rest of events were unknown.
Patient reported mild fatigue and arm soreness until the following  afternoon when her left eye began to burn which progress to the right eye.   Later in the evening the left  upper eye lid began to swell extending into the lower lid along with right upper lid swelling.   She contacted medical through our COVID hotline where I was notified around 9 pm Thursday night ( 03/04/2021).     She denied an respiratory or cardiac symptoms and was mostly concerned about the periorbital edema.   She did not feel she needed to go to the hospital.    She was advised to take Benadryl 50 mg every 6-8 hours and apply cold packs.   A follow up call was made by me at 07:30 am on Friday and was instructed to contact  her PCP.      Later that day she called me indicating she went to Urgent Care and was seen by Dr.
LAB-TESTED POSITIVE, 09/26/2022, FOLLOWING A NASAL SWAB 09/24/2022.  SYMPTOMS INCLUDED UPPER CHEST CONGESTION AND MODERATE DIFFICULTY BREATHING.  TREATED WITH MOLNUPIRAVIR DUE TO POTENTIAL INTERACTION WITH XARELTO. FEVER VARIED FROM 99.0º TO 103º FOR 3 DAYS. PER CDC GUIDELINES, HOME-ISOLATED 5 DAYS AND MASKED UP IN CROWDS FOR 2 WEEKS FOLLOWING DIAGNOSIS.
Headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Approximately 7pm on Aug 28th my BP crashed due to an extreme autoimmune reaction to the vaccine causing me to pass out and loose consciousness for nearly 10 minutes.  My wife called 911 and EMTs monitored my vitals for about 45 minutes after I came to.  Since then my resting heart rate has been 10-20% lower than normal and my BP has been extremely high.  I am very easy to tire and very weak overall.
71 year old with HTN, HLD, CAD s/p CABG, ischemic cardiomyopathy, AAA s/p EVAR, and COPD presented for elective left heart cath without intervention. Allergy consulted due to anaphylactic reaction several hours after procedure. Patient was stable on RA at time of presentation and vitals were normal and stable during the procedure from 8-9 AM. Procedure log reviewed. He received fentanyl, versed, heparin, omnipaque, and xylocaine during the procedure. No immediate reactions noted and no change in vitals during procedure. He tolerated procedure well and was transferred to the cardiac recovery room on RA with normal vitals.   At 1217, patient received percocet and at 1 PM, desaturations noted on flowsheets (84% from RA). Noted pain level of 10/10. HR increased to 130s-150s and BP did drop as low as 99/87. Per notes, he developed shortness of breath, rash, and itching with this. Given albuterol, racemic epinephrine, diphenhydramine IV, famotidine IV, and solumedrol. After developing nausea, he was given IM epinephrine at 2:10 pm. Then, symptoms rapidly improved and he was transferred to CVICU. He was shortly weaned from BIPAP (briefly hypercarbic) to nasal cannula and eventually 1-2L NC.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 at 12:00 as dose 1, single (Lot number: EN6207), in left arm, on 31Mar2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 30Sep2021 at 16:00 as dose 3 (booster) single (Lot number: F2589) at the age of 23 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Allergic Rhinitis" (unspecified if ongoing); "Inverse Psoriasis" (unspecified if ongoing); "Eczema" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST SODIUM, start date: 01Jul2021; FLUTICASONE PROPIONATE, start date: 01Jul2021; CETIRIZINE HYDROCHLORIDE, start date: 01Jul2021; PANTOPRAZOLE SODIUM, start date: 01Dec2021.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Body temperature: 100 Fahrenheit; 102 Fahrenheit; SARS-CoV-2 test: Positive.  Additional information: Anti-viral Paxlovid was given from 20Jul2022 to 24Jul2022 for treatment of COVID-19. Patient experienced COVID rebound after taking the Paxlovid anti-viral drug as prescribed. Paxlovid was administered within the first 24-hours of symptoms onset. The patient took his last dose of Paxlovid on the evening of Sunday, 24Jul. His symptoms improved during the day Monday and were nearly gone by Tuesday. He returned to work on Wednesday and noticed that symptoms began to return Thursday night. By Friday, symptoms including fever, sore throat, congestion, and body aches returned albeit with perhaps less vigor than before. For example, his maximum fever during initial treatment was 102F whereas his maximum fever during the rebound was 100F. His sore throat was severe during the first round and is minor to moderate during the rebound. His body aches were painful during the first round and are best described as somewhat uncomfortable during the rebound. He made this report on Saturday, 30Jul with all rebound symptoms continuing.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pain in left arm starting 10 days after injection but not at injection site; pain disrupted activity and sleep; blisters on left arm but not at site of injection; CRNP prescribed CIPRO 250mg two times a day for 7 days.
5/2/11 Phone call from mom stating "bug bite" looking rash all over body. Not ill. No fever. Probably, per mom, related to old sunscreen.
Complaining of chills, fatigue and muscle aches and "flu-like" symptoms.
Arm soreness at injection site; soreness / armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Arm soreness at injection site"; AXILLARY PAIN (non-serious), outcome "unknown", described as "soreness / armpit". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a health professional concerning a 13-year-old female who on 05-SEP-2007 was vaccinated subcutaneous in the left arm with her second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657941/0851U). On 07-SEP-2007, the patient developed 1/2 dollar redness and tenderness, as well as warmth to touch and slight pruritic (site unspecified). At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested.
This spontaneous report was received from a licensed practical nurse and refers to multiple patients of unknown age and gender. Information regarding medical history and concurrent conditions were not provided. The licensed practical nurse noted that on multiple unspecified dates, patients were vaccinated with improperly stored vaccine (temperature of 62.2 degrees F, time frame of 3.75 hours) of RECOMBIVAX HB lot # L038018 with expiration date 13-SEP-2017, lot # L033343 with expiration date of 13-SEP-2017 and lot # L027733 with expiration date 13-SEP-2017 (dose and route were not reported). No known adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
expired Moderna vaccine administered past 12 hours puncture time; expired Moderna vaccine administered past 12 hours puncture time; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time) and PRODUCT STORAGE ERROR (expired Moderna vaccine administered past 12 hours puncture time) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired Moderna vaccine administered past 12 hours puncture time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time) and PRODUCT STORAGE ERROR (expired Moderna vaccine administered past 12 hours puncture time) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received 2nd booster dose. It was reported that first booster dose of Moderna COVID-19 vaccine was administered to the patient with more than 12 hours after the vial was first punctured. The vial was initially stored in the refrigerator on 04-Apr-2022. The vial was first punctured on 04-Apr-2022 at 1:55 PM and vaccine was administered on 05-Apr-2022 at 9:00 AM - 1:40 PM EST. The vial was stored in refrigerator post puncture.   Total amount of time the vial was exposed to room temperature range was reported as unknown, the vial was not exposed to room temperature for >24 hours.  The vial did not undergo any temperature excursions.  No concomitant medications was provided. No treatment medications was provided.
pt recvd vax 2FEB94 t106.3 R 1 wk later 9FEB94 w/mild congestion & rhinitis, neg sepsis workup; today 103.6; mild URI sx only;
My right upper arm got sore & is still very sore to the point I have trouble moving it. It at first swelled up but went down but stayed tender to touch.
Low grade fever; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A female patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (ongoing). Concomitant medication(s) included: OCRELIZUMAB. The following information was reported: PYREXIA (non-serious) with onset 05Sep2021, outcome "recovered", described as "Low grade fever".  Additional information: patient age was reported as 36 (no units provided).   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Upper R arm is swollen, 1 - 1 1/2 below the injection (1 x 1 1/2" in size) welt painful when moving R arm.
Severe right side face pain encompassing temple, ear, cheek bone, molar and nose. Suspected Trigeminal nerve pain. Treated with Butalbital-Acetaminophen-caffeine to no effect.
Approximately 3 minutes after receiving vaccination, patient experience seizure in waiting room. Seizure lasted approximately 45 seconds-1 minute. Regained consciousness. 2 inch laceration to chin and chipped tooth post seizure. EMS called. Patient transported to local ER for further treatment.
09/12/22 presents to ED for "physically attacking staff at nursing facility". PMHx of "COPD, diabetes mellitus, hemorrhoids, generalized anxiety disorder, history of prostate cancer status post RT on finasteride, hypertension, former alcohol abuse"
This spontaneous report as received from a medical assistance refers to two patients of an unknown gender and age. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL 9 lot # L037554, expiration date 25-DEC-2017 (strength and route were not provided). There were no concomitant medications and adverse events reported. No product quality complain was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a nurse concerning a female patient who was vaccinated with Hepatitis B vaccine recombinant (yeast) (manufacturer unknown). Fifteen minutes post administration, the patient developed hives, shortness of breath, became red and blotchy, agitated and experienced chest of tightness. Unspecified medical attention was sought.  Additional information has been requested.
A day after the vaccine I developed 4 bumps inside my lips (like cold sores).  But this report is about developing Covid Arm 8 days after the vaccine.  My arm started aching and my muscle felt tight.  When I looked I saw a big red circle around the injection site.  It was warm to the touch and sore.  I looked it up and found out that it was something that some people get.  I have not recovered yet, but expect to in a few days.
Patient was fine for a few minutes after receiving vaccine and then got up to move out of chair. After standing a few moments, she was walking away from table and appeared to have tripped. When we asked her if she was okay, she didn't respond and so I ran over to check on her. Her eyes were rolling around and she was non-responsive. After about a minute, she blinked a few times and then started to cry stating she didn't know what happened. She bit her lip to which we applied ice and monitored her for about 20 minutes further with no further incident.
When giving the Pfizer COVID vaccine, the syringe locked up / jammed after giving the patient 0.1mL.  I was not able to complete dose from that syringe, so I gave the patient a full second dose from a different syringe.  The syringe was a vanish point 1 mL 25 g 1 inch syringe
Left eye was slightly swollen; Soreness at her nose; Diarrhea; Nasal congestion; Fast pulse; Nausea; Headache; Fatigue; Muscle pains; Chills; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Left eye was slightly swollen), HEART RATE INCREASED (Fast pulse), DIARRHOEA (Diarrhea), NASAL CONGESTION (Nasal congestion) and NASAL DISCOMFORT (Soreness at her nose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Mitral valve prolapse, MGUS, Overactive bladder, Breast cancer stage I, Lactose intolerance and Thyroid disorder NOS. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), MOMETASONE FUROATE, NADOLOL (CORGARD), AMLODIPINE BESILATE (LODIPINE [AMLODIPINE BESILATE]), SOLIFENACIN SUCCINATE (VESICARE), PHYTOSTEROLS NOS (CHOLESTOFF ORIGINAL) and ANASTROZOLE (ANASTRAZOLE DENK) for an unknown indication.   On 26-Feb-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-Feb-2021, the patient experienced HEART RATE INCREASED (Fast pulse), NASAL CONGESTION (Nasal congestion), NAUSEA (Nausea), HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle pains) and CHILLS (Chills). On 28-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). On 06-Mar-2021, the patient experienced NASAL DISCOMFORT (Soreness at her nose). On 07-Mar-2021, the patient experienced EYE SWELLING (Left eye was slightly swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PREDNISONE at a dose of Taken 2 pills.. On 27-Feb-2021, NASAL CONGESTION (Nasal congestion), FATIGUE (Fatigue), MYALGIA (Muscle pains) and CHILLS (Chills) had resolved. On 28-Feb-2021, HEART RATE INCREASED (Fast pulse) and DIARRHOEA (Diarrhea) had resolved. On 01-Mar-2021, HEADACHE (Headache) had resolved. On 06-Mar-2021, NASAL DISCOMFORT (Soreness at her nose) had resolved. At the time of the report, EYE SWELLING (Left eye was slightly swollen) and NAUSEA (Nausea) outcome was unknown.            The patient's medical history also included dermatological filler injected belowboth eyes one or one and half years ago.    Most recent FOLLOW-UP information incorporated above includes: On 14-Mar-2021: Follow up received on 14-MAR-2021, contains information such as, she has a swelling under her left eye that swelling started a week and a dayafter 2nd shot, taken diphenhydramine and two prednisone pills.
9 months after 3rd vaccine dose, got COVID. Registered a 102.5F fever, then 100-101.8 for 4 days. Upper respiratory issues (coughing, sneezing), headache, body aches and chills, loss of taste and smell, dizziness and fainting.
Outbreak on face, neck, ear, eye, scalp, lips. Nerve pain in ear, on face, in mouth, on scalp and neck. Blood in ear. Office visits: May 15, May 22, June 6, 2018 - prescribed antibiotics, ear drops, nerve pain - gabapentin.
Patient had c/o dizziness and headache. Patient was assessed by immunization team and EMS and taken to hospital for further assessment.
Miscarriage; This is a spontaneous report from a non-contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 19Feb2021 (Batch/Lot number was not reported) as dose 2, single (at the age of 38 years old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 (Lot number: unknown, not available/provided to reporter at the time of report completion) administered in left arm as dose 1, single for COVID-19 immunization. No known allergies. No other vaccine in four weeks and no other medications in two weeks. The patient experienced miscarriage on 19Aug2021. The patient was hospitalized for miscarriage for 1 day. No COVID prior vaccination and was tested post vaccination. The patient underwent lab tests and procedures which included nasal swab/covid test: negative on 14May2021, Nasal Swab/covid test: negative on 24Aug2021. Therapeutic measures were taken as a result of miscarriage, treatment reported as "D and C". The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
IMMEDIATE SORENESS-LATER THAT DAY LARGE INDURATION ON L THIGH OF 5 INCHES. WARM TO TOUCH, SWOLLEN-LASTED 4 DAYS. PT VERY IRRITABLE AND EMOTIONAL.
A spontaneous report was received on 14-NOV-2014 from a pharmacist concerning a female patient (age unknown). In April 2014, the patient received a dose of ZOSTAVAX. On 13-NOV-2014, the patient was inadvertently administered a second dose of ZOSTAVAX. No adverse effects were reported. Additional information has been requested.
Patient has received all 5 doses of Moderna COVID vaccine (primary series, 2 regular boosters, and bivalent booster) & presented to the ED from his outpatient clinic visit on 11/16/2022 for workup of hypotension.  He also had a cough, &  tested positive for COVID, but that is not his chief complaint nor why he was admitted.  He was admitted to the Adult Care Unit on the same day for further evaluation of his cardiac and infectious status (may be another infection in addition to COVID).  Pt is DNR, and does not want to be transferred to another hospital for any reason.  Patient passed away (PEA arrest) on 11/22/22.