chrisvoncsefalvay/vaers-outcomes huggingface dataset:
an allergic reaction/broke out on jawline/ face breakout; Hives; stress body was under; terrible joint pain; itching spread through out the body; big read rash on the arm; top arm tender; top arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (top arm swollen), PRURITUS (itching spread through out the body), TENDERNESS (top arm tender), ALLERGY TO VACCINE (an allergic reaction/broke out on jawline/ face breakout) and URTICARIA (Hives) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034A21A and 034A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for Seasonal allergy, ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PERIPHERAL SWELLING (top arm swollen) and TENDERNESS (top arm tender). On 24-Apr-2021, the patient experienced PRURITUS (itching spread through out the body) and RASH ERYTHEMATOUS (big read rash on the arm). On an unknown date, the patient experienced ALLERGY TO VACCINE (an allergic reaction/broke out on jawline/ face breakout), URTICARIA (Hives), STRESS (stress body was under) and ARTHRALGIA (terrible joint pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergic reaction, at a dose of 1 UNK. At the time of the report, PERIPHERAL SWELLING (top arm swollen), PRURITUS (itching spread through out the body), TENDERNESS (top arm tender), ALLERGY TO VACCINE (an allergic reaction/broke out on jawline/ face breakout), URTICARIA (Hives), STRESS (stress body was under), RASH ERYTHEMATOUS (big read rash on the arm) and ARTHRALGIA (terrible joint pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-255663 (Patient Link).
Hives on upper torso after getting flu shot few days. Managed with OTC products.
Dad states child's leg started swelling approx. 2 hours after vaccine administered. It was red and swollen.  I instructed dad to put cold compress on leg and give IB Profin.  Instructed to take to dr if it gets worse.  Mom called back the next day and said leg had swollen to 2x it's normal size, they had taken her to ER.  ER dr said it was bacterial infection from shot given.  Ordered antibiotics and warm compresses.  Followed up with child's dr. the next day. This dr said it was a reaction to dtap.  2 days lated mom states leg is back to normal size.
This spontaneous report was received from a Nurse refers to 3 unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 02-MAR-2016, 1 unspecified patient was vaccinated with improperly stored PROQUAD (Merck) lot # L030587 (10-FEB-2017) (dosage not reported). It was stored at 20F temperature and time frame was 599 hours. There was no previous temperature excursion. No adverse events reported. No product quality complaint reported. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
headache, nausea, fever, chills, achyness, no appetite or taste, malaise . Tylenol, clear liquids and bedrest. 24 hours later most symptoms gone except tiredness
hives on both her forearms, mid to lower back, general stomach area, and on the left area of her chest going into the left arm; This case was reported by a consumer via call center representative and described the occurrence of hives in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hives (experiences hives when gets anesthesia).   On 29th September 2020, the patient received Shingrix (intramuscular). On 1st October 2020, 2 days after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with Shingrix on right deltoid. On 1st Octomber 2020 patient experinced  hives on both her forearms, mid to lower back, general stomach area, and on the left area of her chest going into the left arm. Hive was part of patients past medical history, she usually experiences hives when she gets anesthesia. The reporter consent to follow up.
Syncope, dizzy, pallor, abdominal cramps.  Pharmacy check BP x2., gave water, had sit in chair for 30 minutes.  Symptoms resolved within 5 minutes.
Seven days post first dose of Havrix, pt experienced diarrhea. On 03/18/99, the received second dose and experienced a positive rechal seven days later. The most recent information received on 04/26/ does not provide an outcome.
Information has been received from a healthcare worker concerning a female patient who on 19-APR-2012, was sprayed in the eye and mouth with some of her child's VARIVAX (Merck) dose (lot # not reported). The patient experienced irritation in the eye, and sought treatment at an emergency room on 19-APR-2012. It was reported that the patient was not admitted to a hospital. At the time of the report the outcome of the event was unknown. This is one of several reports received from the same source. Follow-up information has been received from the registered nurse (R.N) provided a new information about the 28 student, who on 18-APR-2012 (previously reported on 19-APR-2012) was sprayed in her right eye with some of her child's VARIVAX (Merck) dose (lot # 11410AAV). Additional information is not expected.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Patient received vaccines past its 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccines past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022 at 2:05 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022 at 2:05 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccines past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccines past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details were not reported by the reporter.
Pain on arm within minutes, redness on shot place within 1/2 hour, then  a hard rash within hours, next day rash was even bigger (close to her palm of hand).
The day of the vaccine I had full body aches which went away. Three days after the vaccine I started to get soreness in my upper back, the left side of neck stretching to the left shoulder and down my  left arm.  It feels like a muscle pain it is on a 5-6 on the pain scale. The pain is worse about midday and in the afternoon and early evening. I have tried Tylenol and I was prescribed some Muscle Relaxants which I haven't tried yet. I have had a couple of occasions of pain on the right side but not much. I have been referred to PT and Massage Therapy. It has been there now for four weeks and the pain is still the same and happening daily.
Blood sugar elevated again after second dose. BG reading of 325 on 15Mar2021,and patient claims their diabetes is usually controlled with BG levels normally around 120.; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood sugar elevated again after second dose. BG reading of 325 on 15Mar2021,and patient claims their diabetes is usually controlled with BG levels normally around 120.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B2HA and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (diabetes is usually controlled with BG levels normally around 120). Concomitant products included INSULIN, PREGABALIN (LYRICA), ROPINIROLE HYDROCHLORIDE (REQUIP) and VITAMINS NOS for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugar elevated again after second dose. BG reading of 325 on 15Mar2021,and patient claims their diabetes is usually controlled with BG levels normally around 120.). At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugar elevated again after second dose. BG reading of 325 on 15Mar2021,and patient claims their diabetes is usually controlled with BG levels normally around 120.) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked; Sender's Comments:  US-MODERNATX, INC.-Case for first dose
This case was reported by a consumer via call center representative and described the occurrence of injection site induration in a adult male patient who received SHINGRIX. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, several hours after receiving SHINGRIX, the patient experienced injection site induration, injection site erythema, injection site warmth, injection site pain, injection site rash, headache and blood pressure high. The patient was treated with Blood Pressure Medicine (Unknown). In April 2018, the outcome of the injection site induration, injection site erythema, injection site warmth, injection site pain, injection site rash and headache were recovered/resolved. On an unknown date, the outcome of the blood pressure high was unknown. It was unknown if the reporter considered the injection site induration, injection site erythema, injection site warmth, injection site pain, injection site rash, headache and blood pressure high to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On approximately 12th April 2018, about ten to twelve days before the date of reporting, the patient received SHINGRIX in unknown arm. With the pass of the hours, the injection site place got harder and the area got much more reddish. The reddishness started to expand and create a larger and larger reddish area which was hot, painful, and was burning. Immediately after the vaccination, he had a headache. With the passing of the hours and the days, that reddishness disappeared, the rash disappeared, and the headache disappeared. On the day of reporting, his arm showed no evidence where anyone could see or recognize that in that place had been such a reaction and when he touched his arm, he did not feel the symptoms either. These symptoms were described as occurring within the first five days after having the vaccination. On Saturday night about nine or ten days approximately after having the vaccine, he had a headache again. On Sunday, the headache became stronger and stronger. He took his blood pressure which was described as being very, very high (latency less than a month). The patient notified his doctor and was prescribed blood pressure medicine and a full and complete lab test was ordered. The patient had the shingles vaccination. No information beyond what was already documented could be gained during the call, as the reporter decline to answer any reporting questions. He was referred to his healthcare professional during the call.
hard to figure out what to eat; stomach tenderness; nausea; slept a lot first couple of days; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (hard to figure out what to eat), SOMNOLENCE (slept a lot first couple of days), ABDOMINAL TENDERNESS (stomach tenderness) and NAUSEA (nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History was reported.  Concomitant products included TRAMADOL, TRAZODONE, OMEPRAZOLE, METHOCARBAMOL and DULOXETINE for an unknown indication.   On 16-Apr-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 17-Apr-2021, the patient experienced SOMNOLENCE (slept a lot first couple of days). On 20-Apr-2021, the patient experienced FEELING ABNORMAL (hard to figure out what to eat), ABDOMINAL TENDERNESS (stomach tenderness) and NAUSEA (nausea). On 18-Apr-2021, SOMNOLENCE (slept a lot first couple of days) had resolved. At the time of the report, FEELING ABNORMAL (hard to figure out what to eat), ABDOMINAL TENDERNESS (stomach tenderness) and NAUSEA (nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment includes Bland deit.
Initial information received on 22-Mar-2019 regarding an unsolicited valid non-serious case received from a non HCP. This case involves a female patient of unknown age was exposed to vaccine ADACEL lot number, Exp. Date, dose, route and site of administration were not reported on 22 Mar 2019 while she was pregnant of 36 weeks and also received same vaccine few months ago. Data for this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The gestation period was 36 weeks. The date of last menstrual period was not reported. The estimated due date was not reported. The actual date of delivery was not reported. The data regarding previous pregnancy/ies not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was also an actual medication error case due to extra dose administered. It was unknown whether the patient experienced any adverse event. At the time of reporting, pregnancy outcome was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder' compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
The patient called for an appointment complaining of pain, itching, and welts on right deltoid are where the PNEUMOVAX shot was given.
heart issues/experiencing some irregular; Chest pain, Heart pain; felling a quarter size discomfort on the left side of the chet and had the felling of it "jumping out of his chest; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (heart issues/experiencing some irregular), CHEST PAIN (Chest pain, Heart pain) and CHEST DISCOMFORT (felling a quarter size discomfort on the left side of the chet and had the felling of it "jumping out of his chest) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced CHEST DISCOMFORT (felling a quarter size discomfort on the left side of the chet and had the felling of it "jumping out of his chest). On an unknown date, the patient experienced CARDIAC DISORDER (heart issues/experiencing some irregular) and CHEST PAIN (Chest pain, Heart pain). At the time of the report, CARDIAC DISORDER (heart issues/experiencing some irregular), CHEST PAIN (Chest pain, Heart pain) and CHEST DISCOMFORT (felling a quarter size discomfort on the left side of the chet and had the felling of it "jumping out of his chest) outcome was unknown.            Patient stated  had a CAT scan for blockages and heart attack (this diagnose is was discarded) and was concerned about the myocarditis and decided to go to the emergency room  11Nov2021. He was administered no treatment. Concomitant medications was not reported.  Treatment medications was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received event added. On 17-Nov-2021: Nonsignificant follow up append and contact information added
Shingles erupted after about 10 days of first dose of vaccine. Shingles then led to Ramsey Hunt Syndrome. Lost complete hearing in left ear still to this date.  Face was paralyzed on left side but is; Shingles erupted after about 10 days of first dose of vaccine. Shingles then led to Ramsey Hunt Syndrome. Lost complete hearing in left ear still to this date. Face was paralyzed on left side but is; Face was paralyzed on left side; Lost complete hearing in left ear still to this date.  Face was paralyzed on left side but is; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient reported for himself that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0168), via an unspecified route of administration, administered in left arm on 21May2021 at 03:00 PM (age at the vaccination was 56 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history includes heart attack in November of 2020. No known allergies. Concomitant medication included atorvastatin, prasugrel and acetylsalicylic acid (ASPIRIN LOW); All were taken for an unspecified indication, start and stop date were not reported and the patient received within 2 weeks of vaccination. The patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was reported as other. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Jun2021 at 12:00 AM, the patient experienced shingles erupted after about 10 days of first dose of vaccine.  Shingles then led to Ramsey Hunt Syndrome. Lost complete hearing in left ear still to this date.  Face was paralyzed on left side but is now getting back movement.  Still out of work and dealing with shingles after 6 weeks.  In pain constantly from the shingles. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. For adverse events given medication to try and deal with nerve pain. The serious criteria was reported as disabling/incapacitating. Outcome of the events was not recovered.
PATIENT RECVED VACCINATION DOSE, THEN WENT HOME AND WENT TO BED AND AROUND 11PM ON 10/6/22 HAD ITCHING  THAT STARTED ON LOWER LEGS/ANKLES. She awoke next day to find the hives on ankles, arms, backside, shoulder and rib area. No fevers were reported by patient, she only showered to help relieve itching. Patient presents to clinic for evaluation on 10/08/2022 for hives and itching and for treatment. Currently in no acute distress despite the itching. reports no swelling of throat, face, or difficulty swallowing.  Patient examined and only pertinent finding was skin condition with hievs on noted places above, other Review of systems were negative. Pt instructed to take benadryl to help with hives, and monitor for any more s/s such as fever, anayphylaxis and worsening of hives.
I experienced irregular heartbeat, rash, hives, severe nausea, dizziness, itchy throat and vomiting.
An expired booster was given to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired booster was given to a patient) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired booster was given to a patient). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (An expired booster was given to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were reported.
Rash on both feet, more noticable on left foot. No itchiness until next day
Patient appeared nervous to be receiving vaccine. Immediately after receiving the vaccine, patient said she felt clammy. She asked me if she looked pale. Then she told me that she thought she was going to pass out. The patient then passed out. Her head was on my arm. I called for help from a technician. Checked that patient had a pulse and was breathing. She was. Technician called 911. Patient was out for maybe 30 seconds. She was alert and responsive to all our questions. The paramedics arrived and evaluated her. The paramedics said it was caused by anxiety about receiving a vaccine. I checked patients BP it was 119/80. Patient declined to go to with paramedics. We called patients family and waited. Update: Patients husband came by pharmacy and reported that patient was fine. They took her to ER and said that the MD told them that patient passed out due to anxiety about the vaccine. She has been released and is fine. 2-19-19 at 1pm.