chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient only receiving the liquid component (DTAP-IPV) and not the ACTHIB component of the PENTACEL vaccine with no reported adverse event; Initial information was received on 28-Feb-2022 regarding an unsolicited valid non-serious case via call center received from physician.  This case involves a 1 months old male patient who experienced patient only receiving the liquid component (dtap-ipv) and not the acthib component of the pentacel vaccine with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.   On 27-Apr-2022, the patient received 0ne dosage form of 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine  (lot UJ62AAA, expiry- 7-dec-22) (strength; unknown) via intramuscular route in the left thigh for immunization.  On 27-APR-2022 the patient developed a non-serious patient only receiving the liquid component (dtap-ipv) and not the acthib component of the pentacel vaccine with no reported adverse event (product preparation error) (latency: same day) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine  Action Taken: not applicable.  At time of reporting, the outcome was Unknown for the event patient only receiving the liquid component (dtap-ipv) and not the acthib component of the pentacel vaccine with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
receiving expired doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving expired doses) in a 26-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 14-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving expired doses). On 14-Dec-2021, EXPIRED PRODUCT ADMINISTERED (receiving expired doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-413275, MOD-2021-411099 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Dec-2021: Follow up document contains non significant information.
Headache; I feel horrible/ feel this bad before this get better; I feel like I got the flu; I got a fever for over a 100; This is a spontaneous report from a contactable consumer or other non-health professional (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and expiration date were not reported), dose 2 via an unspecified route of administration on 20May2021 as 2nd dose, single for covid-19 immunisation. The patient took historical vaccination with BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on an unspecified date for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got second dose yesterday morning, and have all of the regular symptoms headache, fever, felt like got the flu, and got a fever for over a 100 on an unspecified date in May2021. The patient was wondering that how much longer need to feel this bad before this get better. The patient also stated that it really was not that patient felt like hell but felt horrible so some other time. Limited information was available over the call. The outcome of the events was reported as not recovered.  Information on lot/batch number has been requested.
Lymph nodes in underarms swelled up like golf balls and I still have them, although reduced.
Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Patient received the COVID 19 vaccine on March 18, 2021 @6:00pm.  On April 5, 2021 @8:00am the patient began to feel pain in L leg which progressed to area red and tender to touch and increased in pain with each day.  Patient went to the ER on April 9, 2021 and an ultrasound revealed a 10 cm blood clot in left leg.  Patient was not admitted but sent home on Zarelto 15 mg 2x daily.  Patient did see physician as a follow up.
Patient had 2 days of diarrhea, weakness and dizziness. Patient admitted with acute kidney injury, COVID-19, dehydration and diarrhea.
Pain in right arm, fatigue,  and low grade fever began at 11:00 am. Pain in right arm greatly decreased by the following day, low grade fever and fatigue still present. Fever has hovered between 99.2 - 99.6 Fahrenheit.
Itchy hives and swelling of the body, especially of the hands. Taking Zyrtec, lasted 5 days.
Fever to 102.5 followed by multiple tonic clonic seizures. 10/06/06-records received for DOS 9/21-9/22/06. DC DX: Seizure On 9/21/06-had blank stare, fever 101.5 (R), laboraded breathing, episode lasted 45 minutes, tonic clonic jerking movements of the right arm observed by paramedics along with 'strange eye movement'. RX with Valium. In ER temp 102.4, RX with Ativan secondary to persistant staring. No HX URI, no seizures in past, dad with possible URI. PMH: 1 previous ER visit 2 weeks ago for fever 103.5 DX as virus and RX with motrin and tylenol.  PE: awake, alert interactive. TM bilateral with erythema but non buldging. red raised macule 2cm right upper arm. DTR symmetrical, down going Babinski.
COVID-19 TEST POSITIVE; This spontaneous report received from a consumer concerned a 74 year old female. 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 not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-NOV-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This case was associated with product quality complaint: 90000208145.
Between Thanksgiving and Christmas 2021, a growth developed on my left forearm above the wrist.  It kept growing until it stuck up 1/4th inches from the surrounding tissue and had a subcutaneous knot about 1/4th inches circumference.  I was seen at 9:00 am on 1-5-2022 by Dr. who immediately scheduled an appointment for me with a dermotologist for 11:00 that same day.  Dermatologist, initially diagnosed the growth as a keratoacanthoma and immediately biopsied it and sent it for examination.  Results 2 days later came back benign as a skin lesion.
Moderna COVID-19 Vaccine  Extreme dizziness since waking at 5am that persists still.  Only goes away when lying down. Nausea with repeated vomiting earlier.  Feeling somewhat better this evening, but afraid to eat or drink and get sick again. Extreme fatigue; unable to get out of bed.
Lymph nodes on right side of body swollen so large I couldn't move my arm or leg without pain. Neck swelling was less extreme but still painful.
This spontaneous report as received from a licensed practical nurse refers to over 40 unspecified patients of unknown age (no patient information provided). On an unknown date, the patient was vaccinated with, improperly stored outside temperature conditions listed in the product insert, PNEUMOVAX 23 (dosage regimen and indication were not provided). No adverse effects reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Tooth sensitivity that felt like spread through the gums. Lasted several hours. Bad enough to keep awake from sleep and consider going to a hospital. Laying down feels better than sitting or standing up. Tried oragel  to numb the effected area. Did not alleviate pain. Did not try to treat otherwise.
FLUARIX Quadrivalent given IM right deltoid at 1500 / 14 November 2018. Approximately 1700; developed hives on right thigh with localized pain in spreading rash area, very itchy and body chills.   15 November 2018 - no pain or chills and rash is not spreading, but continues to itch. 16 November 2016 - no pain or chills, rash is not spreading and itching is less.
A few hours after vaccinations patient began experiencing sever pain in Left arm where pneumonia shot was given (no redness or swelling), patient saw MD next day. MD gave patient topical VOLTAREN gel to place onsite and instructed to use ice as needed. Patient currently has difficulty raising arm up and has limited range of motion in her arm. Pain is much better but still experiencing pain 10 days after vaccination.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route unknown) on 04-JUN-2013, lot # and expiration date were not provided. No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
shortly after vaccine looks like hives that started on my arm and then it went on to  on my chest and back and stomach and today it is on my legs. Called my primary and was told to take Benadryl and it hasn't helped. its gotten worse
Case number PHEH2015US019570, is an initial spontaneous report received from a health care professional (HCP) on 30 Sep 2015. This report refers to a 29 year old female patient. Historical conditions and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173539) intramuscularly at a dose of 0.5 ml on 23 Sep 2015. The HCP reported that the FLUCELVAX which was stored at room temperature for 24 hours was administered to employees. No adverse event was reported following the medication error.
chest pains; heart palpitations; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pains) and PALPITATIONS (heart palpitations) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pains) and PALPITATIONS (heart palpitations). At the time of the report, CHEST PAIN (chest pains) and PALPITATIONS (heart palpitations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information is provided. No treatment information provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow up received contains information about the event heart palpitations
It started with a headache on Sat. at 11:00. I took Tylenol twice that day. That evening I felt worse and was running a temp. I continued to run a temp until Monday noon w/the highest recorded at 102.8. My arm became more sore and had a large red patch of skin It was very warm to the touch and burned. The patch became much larger and began traveling down my arm. I tried warm compresses and ice packs with no relief. I returned to work on Tues. as a teacher (10-8-19 and had my temp. taken in the morning. It was still at 99.5; I still did not feel 100%. The redness and swelling in my arm was spreading down my arm. By, Wednesday evening (10-8-19) the redness was subsiding and the pain is less. On Sunday (10-6-19), I became worried and phoned call-a-doc to seek medical help. He advised me to take a pic of my arm and send it to them. He then asked me to take a marker and draw a line around the redness and let him know if it continued to spread. He also advised me to take 600mg of Motrin every 6 hrs. I took pictures of my arm again on Monday (10-7-19) after the redness and swelling had spread more than an inch beyond the marked outline. They called me back today (10-9-19) to see how I was doing. I told them that I felt like it was finally getting some better and the pain was getting better. I have never had a reaction to a shot in the past.
Diffuse rash noted on back of neck & cheeks. 7.5 mL BENADRYL given p.o.
Within minutes of the inoculation, I Felt dizzy, faint, and hot. My heart rate jumped to 145. I sat down, asked for help. I was taken to the ambulance with a heart rate of almost 180! My blood pressure was a little high.
No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use) and NO ADVERSE EVENT (No adverse event) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053c21a and 027C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use).    No concomitant medications were reported.  Pharmacist reported that they had more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 days beyond use date.  The lot number for the monovalent vaccines with their corresponding BUD dates were 027C21A (BUD - 21-May-2021), 053C21A (BUD - 01-Jul-2021), 939902 (BUD - 02-Sep-2021), 011F21A (BUD - 04-Nov-2021), 012H21B (BUD - 23-Dec-2021), 056M21A (BUD - 12-May-2022), 082B22A (BUD - 08-Sep-2022).   The lot numbers for the bivalent vaccines with their corresponding BUD dates and the interval period of administration. 052D22A (BUD - 17-Nov-2022), dates of administration 18-Nov-2022 to 28-Nov-2022, 023H22A, (BUD - 15-Dec-2022), dates of administration 16-Dec-2022 to 20-Dec-2022.  It was reported lot 042J21A should had been reported with a BUD of 17-Feb-2022.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live significant Follow-up contains narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
I got my second Pfizer booster on 4/8/2022. I had a stroke on 4/16/2022. On the day of my stroke, I was folding laundry when I had a feeling in my head that was sort like the one you get when your ears pop on an airplane. My body then went weak and my speech began to slur. I then started to vomit. My husband called the emergency number. The medics came and gave me a shot. They sent an ambulance and sent for an ambulance from the Hospital. When the ambulance arrived, they took several CAT scans and checked the vessels in my head. They gave me anti-nausea meds and stabilized me and then took me to the hospital. I stayed at the hospital between April 16 and April 19. While there, I underwent CAT scans, X-rays, and an MRI. After their evaluation, it was determined that it would not be necessary for me to go to a rehab center. At the time of this writing, I receive services at home. I have a nurse who comes to see me once a week. I'm scheduled to soon have a physical therapist evaluation and a speech therapist evaluation.
My arm developed a large red circle that was hot to the touch at the point of the injection. I was seen today by a virtual doctor and started on Keflex for the infection.
My 15 month old was administered three shots. Two were given in one thigh and one in the other. We went home and he was seemingly fine other than being a little grumpy. The next day he had very heavy breathing. I went to put him to sleep and in his sleep he was jumping and it seemed like a tic that he had never ever had before. I went on to find out that was this was is called a febrile seizure. About an hour after him being asleep, he woke up around 10pm puking out of nowhere. He puked almost nonstop for two hours. During the puking episodes he was very lethargic and totally out of it. He was also having more febrile seizures. He went back to sleep around 12 am and slept the rest of the night and had nothing else happen.
Started experiencing severe diarrhea on 9/27 with extreme itching of skin throuout body on 9/28, The itching comes and goes, both symptoms have been very uncomfortable.
Hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Hurts). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that the Shingles vaccine hurts him/her. The patient stated that he/she still have to receive his/her second dose. Follow-up would not possible as no contact details were available.
L side of my face swelled; I could feel my tongue tingling; Tightness in my chest; This is a spontaneous report from a contactable consumer (patient) and other healthcare profession. A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: Not Reported, Expiry Date: Not Reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation and also received complement c1 esterase inhibitor (HAEGARDA), subcutaneous from 14May2021 (Batch/Lot number was not reported) and ongoing, at 5182 iU (q 3-4 days) for hereditary angioedema. The patient medical history and concomitant medications were not reported. It was unknown whether the patient was pregnant. On 26Aug2021, the patient experienced L side of her face swelled due to which the patient had to use Firazyr, she could feel her tongue tingling, and tightness in chest in the context of indication hereditary angioedema prophylactic dosing problems cause by Covid-19 vaccine. The reporter assessed the case seriousness as non-serious. Outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (07Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed and no further information is expected.
SUFFERED 8 DAYS WITH REACTION / UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high risk health concerns.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 subject experienced suffered 8 days with reaction / unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suffered 8 days with reaction / unspecified adverse event. This report was non-serious.
Nausea most of the day; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 11Jan2021 at 18:45 at a single dose for COVID-19 immunization in a hospital.  Medical history included hypertension and stress. The patient has no known allergies. Concomitant medications included atorvastatin, ezetimibe, amlodipine, and irbesartan.  On 17Jan2021 at 13:00, the patient experienced nausea most of the day. The patient did not receive other vaccine in four weeks. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not received treatment for the event. The patient recovered from nausea in Jan2021.   Information on the batch/lot number has been requested.
Client c/o of pain and redness at injection site. Rt arm received Menactra vaccine 6/16/05 also hep B note quarter size reddened area, no fever, advised client to use cold pk on arm, take pain med, call back if she get worse. 9/1/05 Per telephone f/u with reporter, please add to Box 7 that injection site R arm appeared "puffy".
Redness, tenderness and mild pain at the injection site. A few days after the administration it started to look better and the initial swelling went down. However it still looked red and irritated.
Client reported that she had tingling in her arm and her hand was a purplish color. Client stated that her hand just felt weird.  Client stated that she did not have breakfast. Her oxygen levels were 97% and heart rate was 55 bmp. She was given juice and observed.
Employee Health Services was notified that employee was Positive for COVID-19 10/02/2021, MDH requires us to report to VAERS  breakthrough cases.