chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6/27/05- MMR given.  &/13/05- Called to report a fine rash on chest, back and legs.  Also c/o some lethargy and achy joints.  no meds had been taken.  Suggested she avoid ASA products.  May take acetaminophen for discomfort.  Stay in contact.  7/17/05- Called to report rash gone.  Feeling much better.
PUNCTURED VACCINE STORED IN REFRIGERATOR FOR LONGER THAN 6 HOURS APPROXIMATELY 24 HOURS PASSED; ADMINISTERED VACCINE STORED LONGER THAN 6 HOURS APPROXIMATELY 24 HOURS HAD PASSED; This spontaneous report received from a health care professional concerned a 24 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: 212A21A, and expiry: 21-DEC-2021) dose was not reported, administered on 02-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-OCT-2021, the patient experienced administered vaccine stored longer than 6 hours approximately 24 hours had passed. On an unspecified date, the patient experienced punctured vaccine stored in refrigerator for longer than 6 hours approximately 24 hours passed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered vaccine stored longer than 6 hours approximately 24 hours had passed and punctured vaccine stored in refrigerator for longer than 6 hours approximately 24 hours passed was not reported. This report was non-serious. This case, from the same reporter is linked to 20211015057.
Pain in left arm started later that day. Have had almost constant pain in the left arm/shoulder since the injection. A few months later it developed into frozen shoulder, along with bouts of Complex Regional Pain Syndrome (CRPS), in my left wrist and hand. I have had an X-ray, an MRI, along with many sessions of physical therapy. The MRI confirmed the frozen shoulder.  It has been extremely painful, and has limited a great amount of activities, along with daily life and being able to sleep.
Mother states 12 hours. post vax, child developed 102.5 fever, w/foul smelling diarrhea. Tylenol given, temp decreased to 96. (rectal). Temp returned to normal within 2 days. Diarrhea resolved after 10 days. Mother felt problems related to
Patient states that after receiving the vaccine she felt lightheaded and dizzy.  In the days following the vaccine she has experienced periods of vertigo and photosensitivity.
HIGH FEVER, DIARRHEA, VOMITING, DEHYDRATION, LETHARGIC, APPETITE LOSS. LASTED APPROXIMATELY 2WKS. ER VISITS FOR IV TREATMENT.
Sweeling on left arm with no fevers, and small rash on chest. No EMS needed. Checked on her 09-26-2022 and she stated that rash is gone and swelling has got smaller.
Large red area and warm to touch on the left thigh.  Also vomited 3 times the day after 1st thing in the morning.  No fever per mom.
On April 21, 2022 I had my first episode of Raynaud's phenomenon where my fingers turned white, pink and purple. On April 23, 2022 it happened to my 1st digits on both of my feet. I had other similar episodes subsequently. In July, prior to my next internal medicine appointment, I informed my internist,  Dr., that this had occurred. He recommended further testing and found that I had a highly positive ANA and referred me to the rheumatologist. I am awaiting the results of further more detailed testing. I mention this as a potential vaccine adverse effect solely because I did not have COVID (that I am aware of) and I read today that autoimmune disorders can be a part of long term COVID.  As this is a new problem for me, I thought that you might be interested in it in order to monitor others who have a potential autoimmune disease without COVID infection yet had the COVID vaccines and booster. In essence, I wanted to make you aware of what is happening to one of the people who obtained the vaccine. Thank you.
The main thing is that I think the vaccine weakened my immune system. I had pneumonia and I have never had pneumonia that bad before or pneumonia that lasted for over a month. I am still coughing because of it. They gave me antibiotics and that made me feel better within 3 days but the cough lasted for 2-3 weeks. I started coughing up mucus from my chest so they gave me more antibiotics. They did a Covid test, which was negative.
Patient was given the COVID vaccine though he does not meet the age requirement per the EAU guidelines.
PFIZER COVID #3 VACCINE GIVEN 9/30/21, LOT #FE3592; pt had a positive COVID test on 1/24/22 at the clinic; saw PCP and was given Molnupipavr x 5 days; SOB worsened along with cough; pt to ED 2/1/22; O2 supplement placed; continued to worsen; ABX given; transferred to ICU in critical condition; placed on BiPAP; pulmonary fibrotic changes and multifocal infiltrates notes on CXR; intubated; sedated; ventilated; tube feedings; corticosteroids; failed weaning (O2) trial; DNR; Severe COVID pneumonia; pt passed away in the hospital
soreness to Lt shoulder; tingling down Lt arm; later not wanting to move arm as much due to pain so stiffness of shoulder and ongoing pain
Left thigh, red with inner aspect discolored. Firm to touch, 2.5 x 3" area. No fever.
At 11 days after the first shot, I developed a large raised hive at the injection site (1.5" x 2.5").  The hive lasted for a couple days, with redness remaining for about 5 days.  At 27 days after the first shot, I developed an unusual, widespread, bumpy, itchy rash across stomach (I am unsure if this is related to the vaccine).  At 29 days after the first shot, I received my second dose.  At 3 days after the second dose, I have a 3" diameter raised welt at the injection site (that has been growing since the injection).  More importantly, as of this morning I now have a large C-shaped rash encircling my left torso at my armpit, with swollen lymph nodes.  I have a similar rash on the right side, although much smaller.  The C-shaped rashes do not itch.
Pt recvd vax & exp numbness & heaviness in the arm; no treatment;
She can't do her normal activities; joint pain in neck; feet are cold; knee pain; cold chills on and off; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021 and was forwarded to Moderna on 19-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (She can't do her normal activities), NECK PAIN (joint pain in neck), PERIPHERAL COLDNESS (feet are cold), ARTHRALGIA (knee pain) and CHILLS (cold chills on and off) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Meniscus injury (Patient had meniscus -years ago but hadn't been a problem for long time). Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced NECK PAIN (joint pain in neck), PERIPHERAL COLDNESS (feet are cold), ARTHRALGIA (knee pain) and CHILLS (cold chills on and off). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (She can't do her normal activities). The patient was treated with CORTISONE at a dose of shot. At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (She can't do her normal activities) and CHILLS (cold chills on and off) outcome was unknown and NECK PAIN (joint pain in neck), PERIPHERAL COLDNESS (feet are cold) and ARTHRALGIA (knee pain) had not resolved.            Patient visited Ortho-surgeon, Endocrinologist and Primary doctor. She went to ER- ran multiple Laboratory tests from Lyme disease to checked for blood clots(all tests came back normal) and blood work(normal).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up Information Received on 07-JUL-2021  contains No New Information.
Chest pain, shortness of breath. SOB 94%. Examination significant for pain on the costochordcal margin.
Report 2001003774-1 describes "achy knees" in a 51 year old male who received Lymerix for the prevention of Lyme disease. This report was received from the vaccinee and has not been verified by a physician or other health care professional. During the spring of 1999, the vaccinee received his first and second dose of Lymerix. In autumn, 2000, he received his third dose of Lymerix. Subsequently, he experienced "achy knees". The vaccinee has not been evaluated for this event, and no treatment has been given. As of 02/12/01, the outcome of this event is ongoing. The adverse event of "achy knees" does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Headache, SkinRash, sore scratchy throat and tongue swelled a little, chills, hot and cold Narrative:  headache severe and had some tongue swelling
Moderna Covid -19 Vaccine EUA  Fever 100.5 Took 2 Tylenol 325 mg
Patient is a 84 y.o. female patient of a MD with history of CADm HF, CKD stage 4, hepatic cirrhosis and splenomegaly, hx GIB w/ PUD 7/2022, influenza A infection in December 2022 presented to a local Hospital on 3/13/2023 with complaints of polyuria.  Found to have mild hypoxia, COVID-19 infection  Acute respiratory failure with hypoxia Covid-19 Virus Infection Date of onset of symptoms: 3/10/2023 Symptoms present on admission: Myalgia, generalized weakness, chills Date of covid positive test: 3/13/2023 Vaccination status: vaccinated Imaging: Chest x-ray?no infiltrate or fluid overload Oxygen requirements on admission: 89% on room air, 94% on 2 L nasal cannula Current oxygen requirements: RA Medical therapy: steroids Consultants following: ID consulted Anticipated special isolation end date: 3/23/2023 Doing well, still c/o weakness but stable respiratory status off O2.   Chest pain Self limiting CP. Resolved at present. H/o CAD s/p LHC 1/4/22 with PCI On ASA, Plavix, Coreg and statin EKG showing new QT/ QRS prolongation 03/15, improving Had chronically elevated troponin in the setting of CKD, stable Has repeat episodes of chest pain since 3 days on 3/18.  EKG without any acute changes, troponins mildly elevated. Cardiology consult.GDMT in place including dual antiplatelet therapy.  Suspect her chest pain may be related to underlying COVID infection or other noncardiac etiology. Rec adding Imdur to GDMT. F/U with primary cardiologist as OP in 2-4 weeks   AKI on CKD stage III/IV  Cr 1.66, Baseline creatinine 1.1-1.3, GFR 45 Very cautious IV hydration in setting of COVID-19. Improved with IVF Cr 1.65> 1.2>1.5 today. Reduce Bumex on dc and start in 2 days with BMP on 3/23. Rec OP f/u with PCP in 1 week.    Hyperglycemia H/o DM but not on medication A1c 6.5, most likely elevated BS secondary to dexamethasone. BS should improve off steroids, will dc on low dose januvia X 1 month. OP f/u with PCP   Pancytopenia Likely infection induced Monitor; If no improvement, consider outpatient hematology follow up Stable for now.  Hypothyroidism Resume synthroid 175 mcg / day    CAD Chronic diastolic HF (congestive) Pulmonary HTN S/P staged PCI 12/30/21 and 1/4/22 after NSTEMI F/w Dr. (Cardio) Resume home regimen: aspirin 81, Lipitor 80, Plavix 75 mg daily, coreg 25 mg BID, Amlodipine 5>10 mg daily Resume Bumex at lower dose and rec OP f/u with PCP    Chronic pain Norco 5/325 every 6 hours as needed resumed   Hx GIB Hx PUD (7/2022) Resuming protonix 40 mg twice daily x 8 weeks (7/18/22-9/18/22), then daily 10/2022. Currently on PPI BID   Dementia w/o behavioral disturbances Currently alert awake oriented x3 Initiate delirium precautions Home regimen: Abilify, Prozac 20 mg daily, Atarax 25 mg 3 times daily as needed, Ditropan
Case number PHEH2014US018318 is an initial spontaneous report from a pharmacist received on 10 SEP 2014. This report refers to a 74-year-old female patient. Past medical history and concomitant medications were not reported. On 09 SEP 2014, she received 5 ml dose of FLUVIRIN 2014/2015 (batch number: 1411201) intramuscularly instead of 0.5 ml dose. No adverse events were reported following the maladministration. No additional information was available.
NURSE INSTRUCTED TO ADMINSTER PFIZER COVID 19 VACCINE. PARENT OF PATIENT LATER REQUESTED TO ADMINSTER MODERNA
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   The patient had take IV Fluids as a treatment medication.
Experienced sore arm after first dose and again after second dose; Patient had a little fever of 100°F, did not have motivation; Tired; Head was kind of hurting but it wasn't headache, it was from the fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Experienced sore arm after first dose and again after second dose), PYREXIA (Patient had a little fever of 100°F, did not have motivation), FATIGUE (Tired) and HEADACHE (Head was kind of hurting but it wasn't headache, it was from the fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history). Concomitant products included MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] and MELATONIN for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Experienced sore arm after first dose and again after second dose), PYREXIA (Patient had a little fever of 100°F, did not have motivation), FATIGUE (Tired) and HEADACHE (Head was kind of hurting but it wasn't headache, it was from the fever). On 03-Apr-2021, PAIN IN EXTREMITY (Experienced sore arm after first dose and again after second dose), PYREXIA (Patient had a little fever of 100°F, did not have motivation), FATIGUE (Tired) and HEADACHE (Head was kind of hurting but it wasn't headache, it was from the fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 100 °F (Inconclusive) 100 °F.         Treatment for the event included ibuprofen.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.
Cough, 104 temperature for 2 days, cough for 14 days, malaise for 10 days
Day after vaccine I had pain in injection site, joint pain, body aches, fatigue. Left early from work. The day after that I was completely normal. Fast forward to today (9 days after vaccine) and my arm is swollen at injection site and painful. I have body aches and fatigue. No fever. The vaccination site is also red and itching.
pt rep  states patient was hospitalized after receiving first dose of moderna vaccine.  he became severely ill and was diagnosed as having 20 bleeding ulcers
No side effects until 1PM on the 18th, hot flashes with dizziness and nausea, then I started feeling like I was going to pass out and then felt like the blood was rushing through my head.  Also head headache. I received a shot of Zofran 4mg. 30 min later I was able to sit up up and 10 min later I was able to stand without being dizzy. Still having waves of nausea. Body aches and flu like symptoms on Saturday. Right now only the nausea. Monday I was fine, but today it started the nausea and dizziness. No intervention needed today.
Patient came into pharmacy the day after she received the vaccine. With redness and a lump at injection site I called manufacturer and was told this was a typical injection site reaction and patient was referred to the prescriber.
This initial foreign regulatory report (GB-MHRA-ADR20746964) received from Regulatory Agency on 25 Nov 2010 has been transcribed from an Anonymised Single Patient Report (ASPR). On 01 Nov 2010, the patient received FLUVIRIN (batch number: 11146001) for flu vaccination. On 07 Nov 2010, the patient developed chest pain, which resulted in hospitalization. The patient also developed bilateral weakness and numbness in four limbs (more on left side than right side) probable Guillain-Barre and was treated with immunoglobulin infusion. The events were also assessed as disability and medically significant. A clinical investigation revealed cerebrospinal fluid glucose of 3.5 mmol/L, and cerebrospinal fluid protein of 934 mg/L. No abnormalities were detected on nuclear magnetic resonance imaging. At the time of the report, the patient's condition was still present and unchanged. The physician's causality assessment was not reported. By convention reports from the agency are considered to have implied causal relationship.
Information has been received from an unspecified reporter referring to a 6 week old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 13-SEP-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Developed numbness and tingling in all 10 digits hands and feet 11/08/2005 at 3am that had progressed to affecting the entire hands, and predominantly plantar aspect of feet. Feels weak. Unstable with Romberg testing. Able to stand and walk.
pt began to have fever to 103 on 28OCT96 & cont to have;31OCT96 mom was shopping w/pt & pt very fussy & felt extremely hot;took pt to ER was given suppository & remained in ER x 2hr;
Patient called at 12:45 to say shot site was swollen and sore. No redness, no rash or other side effects. Feeling soreness down to hand. Advised cool compress and to see doctor if worsened.
(L) ear pain and dysethesia corresponding to check up distribution, no rash; onset shortly after Zoster immunization.
Chest pains and tightening; Chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 29Dec2021 at 17:00 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious) with onset 30Dec2021, outcome "not recovered"; CHEST DISCOMFORT (non-serious) with onset 30Dec2021, outcome "not recovered", described as "Chest pains and tightening". The events "chest pains and tightening" and "chest pain" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of chest discomfort, chest pain. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Additional information: No other vaccine in four weeks, no information patient received treatment for event, no vaccination prior covid vaccination. Patient received covid test post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No Bexsero doses available; This case was reported by a consumer and described the occurrence of product availability issue in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (received 1st dose on 10th August 2021, by Intramuscular route).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced product availability issue. On an unknown date, the outcome of the product availability issue was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was the patient's mother. The age at vaccination was not applicable for this report. The reporter called to schedule the second dose, they advised they did not have any additional doses available as they had just thrown out the remaining vaccines which were not expired.The reporter tried to find other pharmacies with Bexsero but has not had luck and  asked if there was any way to locate Bexsero nearby. The patient did not receive 2nd dose of Bexsero due to availability issue, which led to product availability issue. The reporter consented to follow up.
cough; runny nose; body aches; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 38-year-old female patient received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 37 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EL3247, Route of Administration: Intramuscular), administration date: 17Feb2021, when the patient was 36-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247, Route of Administration: Intramuscular), administration date: 28Jan2021, when the patient was 36-year-old, for Covid-19 Immunization.  The following information was reported: PAIN (non-serious) with onset 19Apr2022, outcome "recovering", described as "body aches"; COUGH (non-serious) with onset 19Apr2022, outcome "recovering"; RHINORRHOEA (non-serious) with onset 19Apr2022, outcome "recovering", described as "runny nose". It was unknown if therapeutic measures were taken as a result of cough, rhinorrhea, pain. No follow-up attempts are possible. No further information is expected.
Headache, Fever, chills, fatigue After 2nd vaccine on 1/11/21, symptoms developed 1/12/21 around 7pm, fever 101.7, chills, h/a, extreme fatigue. took tylenol which helped, symptoms started again last night (1/13/21), fever, headache
No ADR Monovalent formulation administered inadvertently as booster. Incorrect vaccine delivered to facility leading to wrong formulation being administered as a booster dose