chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report was received from a health care professional on 13OCT2003, concerning a 28 yar old female vaccinee who developed a red,hot, painful injection site, and a rash on her left leg on the same day as receiving Fluvirin on 10OCT2003. On 10OCT2003 the vaccinee developed a red, raised , hot to touch, painful area about 1-1.5 inches in diameter at the site of injection, and a rash on her left leg after receiving Fluvirin on the same day. The vaccinee was improving at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1, 18MAR2004: A follow up report was received from a health care professional indicating that the vaccinee also experienced itching and flu-like symptoms. The time to onset was reported as 8 hours. The vaccinee recovered after 72 hours. The outcome of the events reported initially was not reported except for the rash which was reported as resolved. No follow up pending, all information received. References: PJP200300801, PJP200300803.
7cm itchy, red, warm to touch and swollen patch around the injection site within 24 hours. Has been present since date of injection on 10/01/2020. No treatment currently.
headache, chills, body aches, nausea causing me to stay in bed for one whole day
initial bruising and sore arm. 7 weeks later vertigo and then bells palsy  chronic dizziness and left sided facial paralysis
received the 1st Moderna vaccine 29Dec2020 and the 2nd vaccine on 27Jan2021 and is Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (received the 1st Moderna vaccine 29Dec2020 and the 2nd vaccine on 27Jan2021 and is Pregnant) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20-2A and 039K20-2A) for COVID-19 vaccination.     The patient's past medical history included Factor V Leiden carrier since 2012. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, ACETYLSALICYLIC ACID (BABY ASPIRIN), DOXYLAMINE and PYRIDOXINE HYDROCHLORIDE (VIT B6) for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 12-Nov-2020 and the estimated date of delivery was 19-Aug-2021. On 29-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (received the 1st Moderna vaccine 29Dec2020 and the 2nd vaccine on 27Jan2021 and is Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixth week of the pregnancy.  On 29-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (received the 1st Moderna vaccine 29Dec2020 and the 2nd vaccine on 27Jan2021 and is Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Dec-2020, Pregnancy test: positive (Positive) Positive.         The date of positive pregnancy test was 08-Dec-2020.  The patient has an established prenatal care.  No treatment information provided.
severe reaction to the booster shot; heart started to race; Tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (severe reaction to the booster shot), PALPITATIONS (heart started to race) and TACHYCARDIA (Tachycardia) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced PALPITATIONS (heart started to race) and TACHYCARDIA (Tachycardia). On an unknown date, the patient experienced VACCINATION COMPLICATION (severe reaction to the booster shot). On 08-Jan-2022, PALPITATIONS (heart started to race) and TACHYCARDIA (Tachycardia) had resolved. At the time of the report, VACCINATION COMPLICATION (severe reaction to the booster shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2022, Heart rate: 145/150 bpm (High) 145/150 bpm.         On the night of 07-Jan-2022, the patient's heart started to race and it took around 15 hours for the patient to return to the normal state.  No concomitant medication reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jan-2022: Significant Follow-up - adverse events like palpitation and tachycardia added
approx 6 1/2 hr p/receiving vax began throwing up (projectile) until 4AM next morning; ran fever but didn't get thermometer reading;
Received vaccination at Pharmacy: random all over body itch-burn sensation. Not a dermatitis, more like a nerve irritation. I scratch and scratch causing my skin to get bright red, hot, sore, and whelp, but after a few hours, the redness goes away. I've tried taking benadryl and gabapentin, oatmeal baths, and Cortisone 10. Nothing helps.
Pt presented to the er on 3/12/2021 with c/o 5 days of worsening chest pain and sob. found to have a inferior STEMI and transported to different hospital for urgent angiogram.  acute lateral MI found on angio resulting in placement of drug eluding stent
Migraine all over pain in head. Nausea. Weakness. Sore Body.
patient received an expired dose of Boostrix today. Vaccine expired on 24-SEP-2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2ZF9N, expiry date 24-SEP-2023) for prophylaxis.   On 26-SEP-2023, the patient received Boostrix. On 26-SEP-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: patient received an expired dose of Boostrix today. Vaccine expired on 24-SEP-2023).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 26-Sept-2023 The case was received from the registered nurse. The reporter consented to follow-up. The patient received an expired dose of Boostrix, which led to expired vaccine used.
Numbness of the entire left side of the face. From the ear to the mouth. 2nd vaccine shot received in left arm today.
This spontaneous report as received from a physician assistant via company representative refers to a 65 year old male patient. Pertinent medical history, drug reactions or allergies were unspecified. On 08-OCT-2014 the patient was vaccinated with PNEUMOVAX23  (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. On 08-OCT-2014 (also reported as later that day), the patient experienced significant pain and swelling at the injection site. On 05-OCT-2014 (also reported as the next day), the patient went to reporter's office and the physician's assistant stated that the swelling was raised about 5" in diameter and was uncomfortable to the touch for the patient. The patient was prescribed with BENADRYL and instructed to apply an ice pack. The reporter stated that she thought the swelling  would resolve itself and expected the patients to recover. None laboratory diagnostic studies were performed. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX23 was not reported. Additional information has been requested.
on Friday 03/18/21 I woke at 6:00 AM with itching and upon inspecting my body found I had a red itchy rash on the trunk of my body front and back. Very, very little rash on my upper arms and upper thighs that didn't seem to present until Sat. morning 3/19/21. I did have allergy testing within the month prior which  reaffirmed my cat allergy but saw improvement from testing 5 years ago. I also received my regular allergy shots 2/23/21 and 3/15/21. I was given ordansetron for nausea at the ER after gall stone diagnosis on 3/13/21 of which I took two tablets spaced according during the day 3/17/21.  I was feeling well on 3/18/21 when I received my shot and was excited to get my Covid 19 vaccination.
Increased mucus production. Pt has never had this problem before but claims after flu shot she has had a marked increase in mucus production.
The day following my second vaccine I started having chest pain on the right side of my chest where my lung is. I felt it was my lung so I assumed it was because of my asthma and me having been outside a lot the day prior. It persisted so I made an appointment with my primary health provider, but I couldn?t get an appointment for a month.  The chest pain lasted the entire month and occurred every day, but wasn?t constant. Besides the chest pain I could breath fine except I felt like I couldn?t fully empty my lungs.  She listened to my lungs and they sounded fine, but ordered an X-ray. The X-ray showed just a little fluid in them so she ordered an ECHO. The echo showed cardiomyopathy so she referred me to a cardiologist.   All my bloodwork is fine. Dr said I had significant heart failure with EF less than 30% alone with the cardiomyopathy with mild enlargement of left ventricle. I don?t have high cholesterol and my BP is only mildly elevated when I go to the dr, but at home it tests fine.  I am obese. I had a cardiac MRI a month later (was the earliest they could get me in).  The mri already showed EF improvement to 45% and nothing was enlarged.  I had a stress test a couple weeks later and it showed no blockages. The cardiologist has put me on Entresto for the heart failure and a beta blocker to slow my heart to give it time to heal. She put me on these right after I had the ECHO.
Pt reports rash started on lower back a week after vaccine. Spread to underarms, legs, hips, groin, chest, arms.
Within days of the first shot on July 11, I had a small itch bumps on my hands and small itch bumps on the back of my ankles, similar to hives I have previously experienced. These remained for weeks and I had some itching on my legs. Within days of 2nd shot on August 11, 2021, I had severe rash developing on my legs.  I used anti-itch creams that did not help. The rash was itchy, bumpy, red dots that bled easily and some filled with white fluid. The rash covered below my knees by August 28 and continued to move up my body until it has covered legs, arms, shoulders, abdomen, rump, chest, neck. I contacted my doctor Sept 1 about the spreading rash. She prescribed 20 mg prednisone for 5 day, which I started on Sept 3.  Rash continued to spread during this time. Last week it was difficult to do daily tasks and sleep because clothes irritated the rash.  I am still covered with rash and calamine lotion is helping some.
Exacerbation of psoriasis to generalized body. Was only at site of elbows at time of visit. Rash to entire back, abdomen, and arms and legs bilaterally following injection. Patient was seen by his Dermatologist who started phototherapy.
seizure; Stroke like event; This is a spontaneous report received from a contactable consumer (Patient) reporting for himself. A 50-year-old male patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 29Mar2021 01:00 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunization. Medical history included rheumatoid arthritis from an unknown date. The patient's concomitant medications were not reported. The patient experienced seizure and stroke like event on 22Apr2021 at 11:00. The patient was hospitalized for seizure and stroke like event for 5 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Apr2021. Outcome of the events was unknown  Information on Lot/Batch number was available. Additional information has been requested.
Fever, chills, body aches, stabbing/pinching pains in feet, itching
Patient received the Moderna Bivalent, Influenza, and Tdap vaccinations at a home visit provided by a Public Health Nurse on 10/06/2022 at 3pm and was found by his wife in bed at 5am 10/07/2022 shaking and flailing around like he was having a seizure.  CPR was started at home, a officer arrived on the scene and placed an AED on patient, no shock advised and continued CPR.  Ambulance crew arrived and placed an eye gel and the Lucas device. Pt continued to have no organized rhythm or spontaneous breathing.  On arrival to Hospital, lucas device was in place and EMT's were bagging patient through the eye gel device.
Pt mom called on 11/8/23 stating her son had vaccines on Monday 11/6/23 woke up Tuesday 11/7/23 with leg hurting little swollen not wanting to walk but mom didn't think much of it at the time and gave him Motrin which got him throughout the day. Then on Wednesday 11/8/23 his leg is more swollen red and painful. Mom was concerned it may be from vaccines. Senn Dr. on 11/9/23 and per note "Swelling of left lower extremity - Fever, leg swelling and redness are most likely due to vaccines (vaxelis, PCV)  - Reassured, can use ice/cool packs, tylenol/motrin PRN - Low concern for infectious cause of rash/swelling at this point - Reviewed red flag symptoms and when to seek care - Recommended daily photo documentation in case swelling worsens"
9/14/12 localized swelling, redness, pain at inj. site. Pain c/o while inj. given. 11/09/12 reports decreased mobility of arm that vaccine was given in, which has been present since inj. given. C/O swelling, puffiness, pain at all times. Grip strength less in affected arm. C/O pain keeps her awake at noct. Has been seen 1x by chiropractor & has another appt. scheduled. Was advised by this reporter to see PCP also.
Sore arm - Strong pain on first day vaccination. Symptoms started approximately 6 hours after vaccination. The pain is bearable after taking tylenol next day. treatment- tylenol
MAJOR Insomnia beginning at 1:30 AM, lasting for 6 hours,  Slight chills, Major aches and fatigue. Struggle to get out of bed to perform simple tasks (brush teeth, etc).  Events lasted until about 1:00 PM
This is a spontaneous report from a contactable consumer. A 17-years-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EP7534), via intramuscularly, in Left arm on Mar2021 as single dose (at the age of 17-year-old) for COVID-19 immunization. The patients medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. It was reported that, on Apr2021 at 08:00 AM 2 weeks after the 1st COVID vaccine dose, patient developed COVID symptoms. The patient underwent lab tests and procedures which included sars-cov-2 test resulted as positive on Apr2021 Nasal Swab. Patient waited for the symptoms to go for 2 weeks and then we scheduled her 2nd shot until 26May2021 (2 months after her 1st dose). No treatment was received. AE resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was recovered.  Follow-up attempts are completed. No further information is expected.
Immediately after administration, flushed face, tingling in hands and feet, mild shortness of breath. Resolved after 15 minutes.
Administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter  It was reported that the dates of vaccine administration were 3MAY2022, 4MAY2022, 9MAY2022, 11MAY2022, 17MAY2022, and 20MAY2022  Patient was received 2nd booster  No treatment medications were provided by the reporter
Breakthrough case admission after two vaccines Moderna 3/10/21 Lot# 023M20A ; Moderna 4/7/21 Lot# 025B21A
11/16/10 Tonsils painful at 6:00 PM; 11/17/10 Tonsils painful continued; 11/18/10 12:00 AM awaken with severe tonsil pain, can no longer swallow due to pain, 7:00 AM continued pain and felt dizzy almost blackening out and nausea. Went back to bed, reawakened at 10:00 AM symptoms were mild - so I went on about my normal business. Returned home at 6:00 PM directly went to bed, slept from 6:00 PM until 8:00 AM 11/19/10 (day 4)
"I feel sick"; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS ("I feel sick") 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS ("I feel sick"). At the time of the report, ILLNESS ("I feel sick") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Chills. Woke up uncontrollably and violently shivering with entire body despite being under normally sufficient blankets. Difficult to walk or do anything until I piled more blankets on and threw over head to get warm again. Also nausea and dizziness. Morning after general malaise and low fever, but chills are gone.
66-year-old female brought into the emergency room history of diabetes difficulty with breathing, nausea and vomiting last 2 to 3 days.  Patient a little more awake and alert than on admission.  Patient is still confused about how long she has been in the hospital.  History of camping with their motor home in Park the week of 24 July.  There for 3 to 4 days with her grandchildren.  Apparently one of the grandchildren started to feel ill on the way home 27th 28th.  Patient has been home with some respiratory distress.  Patient was tested at home 8/10 tested positive they called primary care and was given a prescription for Paxlovid. Patient states she took it on the 10th 11th and 12th and on the morning of admission here.  Patient had progressive nausea and vomiting over the last 2 to 3 days.  Patient was noted to require O2 in the ER placed on 2 L with progression over the next 24 hours.  Patient has been evaluated by MICU, currently on 6 to 7 L.  Breathing better.  Patient maintained on the floor.  Infectious diseases been asked to assist.  Patient able to call her husband to verify dates.  Infectious disease has been asked to assist.  Patient has cough shortness of breath does not require home O2 normally. She was found to have COVID and was in DKA. She received dexamethasone 6 mg daily, now complete.
Itchy - burning rash - legs - abdomen - arms - neck. No medical treatment used lotions - (no rash on feet or back).
Wrong vaccine administered; No Adverse Event; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Wrong vaccine administered) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.   No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Wrong vaccine administered) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Wrong vaccine administered) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Wrong vaccine administered).    No concomitant medications were reported.  Patient states that he was required to get a COVID-19 vaccine for immigration purposes. Patient went to a drug store and was administered a dose of the Moderna COVID-19 bivalent vaccine. Patient then mentioned that had not previously received the primary series or any doses of the Moderna COVID-19 vaccine. Patient wanted to know if this was the only vaccination needed or did he need any additional doses were needed.  No treatment information was provided.   Reporter did not allow further contact
BILATERAL BLOOD CLOTS IN LEFT AND RIGHT LOWER LUNGS; This spontaneous report received from a patient via a company representative concerned a 46 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 08-APR-2021, the patient experienced mild chest pain and dyspnea. On 14-APR-2021, the patient visited to emergency room and diagnosed with bilateral blood clots in left and right lower lungs. The patient had no prior medical history of blood clot and pulmonary issues. On 14-MAR-2021, treatment medications included: rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bilateral blood clots in left and right lower lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a 46 male patient, unspecified ethnicity who was noted, at the emergency room (ER), to have bilateral blood clots in left and right lower lungs 9 days after receiving the covid-19 vaccine ad26.cov2.s. Weight and height were not reported. Medical history, smoking history and concomitant medications were not reported.  Six (6) days prior to the visit to the emergency room, the patient experienced mild chest pains and dyspnea. Patient was sent home from the ER with Rivaroxaban. Based on the available information and considering the temporal causality, this is assessed as indeterminate per WHO causality classification of adverse reaction following immunization.
PT RECEIVED BOTH VACCINES IN ONE ARM (LEFT ARM) AND REPORTED HARD KNOT HAS DEVELOPED.