chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediate tenderness unlike any vaccination I've received since polio vaccine when I was 6 and the doctor administering the shot bent the needle in my arm. Sensitivity mostly resolved after a day or so. Within 24 hours, sensitivity on my right side at or just below the waistline. Day 8, itchy upper arm, swallow, red, warm, firm around injection site.
From initial information received on 09/29/2004 and follow up information received on 10/05/2004 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 55 year old female patient received a dose of Tetanus Toxoid, lot number U1048CA, administered intra-dermally in error instead of Tuberculin PPD on 09/15/2004.  The site of administration was not reported.  Two days later, on 09/17/2004, the patient developed an allergic reaction with blisters, papular lesions and induration at the site of injection.  The patient was not seen by a physician and reportedly recovered from these events.
She was in the shower with mom and all of a sudden fell backwards.  Mom picked her up and she kept falling again.  She was then stiff, eyes rolling to the side, had whole body shaking and stiffness.  Mom took her after the shower and watched her.  She remained unresponsive for about 10 minutes.  They called EMS.  They checked her blood sugar in the ambulance and it was 130.  She was drowsy for about 1 hour after the event.    They transported her to ED where she was evaluated and felt to be fine.  She was discharged home in good condition.
I had dose 4 of the vaccine and experience muscle ache sever joint pain ache with headache.
Egg-sized lump next to injection site. Quarter-size purple bruise, surrounded by egg-size red rash.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age 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 PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Local swelling (arm bled quite a bit when she injected the vaccine - nurse said, "well, we have a bleeder."  Arm pain spread to shoulder and then up neck to occipital lobe under skull.   Resembles feeling of pinched nerve.   Massive headache and unable to rotate head in normal range.
swollen lymph nodes in armpit; swelling is sore also; muscle was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (muscle was sore), VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes in armpit) and AXILLARY PAIN (swelling is sore also) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (muscle was sore). On 13-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes in armpit) and AXILLARY PAIN (swelling is sore also). On 11-Jan-2021, VACCINATION SITE PAIN (muscle was sore) had resolved. At the time of the report, VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes in armpit) and AXILLARY PAIN (swelling is sore also) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.    Treatment for the events are not reported but she used heating pad; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
felt lethargic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EP7534) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "Ductile carcinoma", start date: 2021 (unspecified if ongoing), notes: 2021 diagnosed with ductile carcinoma of the left breast in site 2; "She completed 6 weeks of radiation followed by a year" (unspecified if ongoing), notes: She completed 6 weeks of radiation followed by a year. The patient's family history included: "metastasis of melanoma" (unspecified if ongoing), notes: Mother passed away from metastasis of melanoma; "congestive heart failure" (unspecified if ongoing), notes: Her father passed away at 100 from congestive heart failure, Relevant Tests: No. There were no concomitant medications. Past drug history included: Tamoxifen, notes: she started a 5 years regimen of tamoxifen. Vaccination history included: Shingles shots (She also had the shingles shots a year ago affect her for 24 hours), administration date: 2021, for immunization. The following information was reported: LETHARGY (non-serious) with onset 2021, outcome "unknown", described as "felt lethargic".  Additional Information: Was report related to a study or programme was reported as No. Investigations: No. Other Products: No
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 28-SEP-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2016, 0.5 ml (route and anatomical location of administration were not reported). The vaccine had three temperature excursions one of 328 hours with a lowest recorded temperature of 29 Fahrenheit (F) (-1.6666667 Celsius (C)), the other one of 264 hours with the lowest recorded temperature of 33 F (0.555555556 C) and the third one of 64 hours with a highest recorded temperature of 48 F (8.888888889 C). The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Presented as abd pain, cramping and bloody stools and when initially in outside facility seen sent home with formula change and returned because of worsening symptoms and admitted and with BE diagnosis of intussusception doc and transferred to hospital for surgery.
Large red spot (size of baseball) around injection site. Hot, slightly itchy, tender. Ibuprofin minimizes the pain and swelling.
After 12 hours of being vaccinated was bed ridden, high fever,  unable to walk for 12 hours. , skin color turned grayish and very pale for 24hours. Broke out in hives, particularly on back and chest area. Several bumps per sq/in., unbelievably itchy. 5 days later hives seriously affect sleeping habits and can barely sleep at night. Have had mild eczema for years, 95% out breaks occur on hands and forearms, never back. Vaccine cleared up eczema on fingertips and one small spot on forearm.  Now 30% of body covered in hives (ie, small itchy bumps). 5 days later still have slight headache, thinking still a little cloudy.
whelps on rt side, rt arm & rt axillary area;denied itching;pt put menthol & TMC on whelps;come down w/sore throat, cough, & congestion lasting 7 days;
fever, muscle aches, headache,  tylenol within 30 hours I was back to normal with no symptoms or signs
This spontaneous prospective pregnancy report was received from a registered nurse, regarding a 21 year old female patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unspecified date, the patient was vaccinated with the first two doses of GARDASIL 9 for prophylaxis (frequency, route, anatomical location, lot # and expiration date were not provided). The patient's last menstrual period was approximately 31-MAY-2018, based on the due date reported. On approximately 14-JUN-2018, the patient became pregnant.  On 06-JUL-2018, the patient was vaccinated with third dose of GARDASIL 9 intramuscularly, lot # R000301 with expiration date 29-AUG-2020 for prophylaxis (frequency and anatomical location were not provided). On 13-JUL-2018, the patient returned for intrauterine device (IUD) placement and the nurse discovered patient was pregnant (exposure during pregnancy). The estimated date of delivery (EDD) was 07-MAR-2019. No information about  prenatal tests performed was provided, no treatment was given for the event and no adverse effects were reported.
She recalls that when she had the injection, it "was very painful going in" and pain increased in severity over time, after a few weeks "the pain morphed" from injection site pain to more profuse anterior shoulder and arm pain, pointing from the R AC joint down biceps region. She states "pain is 24/7" and "it does not go away", though it does improve at rest. She describes a constant, dull ache, with worst when lying down in supine with the arm unsupported at her side
red blister like eruptions on the right side of my torso (about 10 sites); Itching; swelling; hives; rash on my torso; cough; muscle weakness; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EM9810, Expiry Date: Not reported) via an unspecified route of administration, administered in arm left on 07Feb2021 at 12:15 (at the age of 77-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included hypertension from an unknown date and unknown if ongoing. The patient concomitant medication included benazepril, baclofen, hydrochlorothiazide, cyanocobalamin (B-12) and nicotinic acid (B3 NIACIN) taken for an unspecified indication, start dates and stop dates were not reported. The patient previously took diphenhydramine and experienced drug hypersensitivity. The patient did not receive other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On day 10 after the first shot (07Feb2021), the patient began taking cholecalif 25 mcg as prescribed by VA doctor. Then on an unspecified date in Feb2021, the patient experienced a rash on torso, cough, muscle weakness and was advised to stop on day 12. All reactions ceased by day 15. However, on day 24 from 1st shot, on 02Mar2021 at 7:00 the patient developed red blister like eruptions on the right side of his torso (about 10 sites). The PA dermatologist thought hives, recommended zyrtec. Itching and swelling began to cease immediately. The adverse events resulted in physician office visit. The patient received treatment for hives and did not receive treatment for rest all events. Outcome of event rash on my torso, cough, muscle weakness was recovered on 22Feb2021 for all other events outcome was recovering.  No follow-up attempts are needed. No further information is expected.
10-15 minutes after tingling lips then numb, 10-15 minutes after feet tingling like pins and needs numb then hands too. Called provider within one hour and took two hydroxoxine  palmonate 25 mg. One and a half hours later feet snd mouth were still numb but not tingling as much, then developed hives on back and was itching on head, back and legs. It took three hours for itching to stop and then by 7:30pm most symptoms stopped but lips still numb and felt swollen but did not look swollen. Took loratadine over night also per primary care recommendation. Woke up at 7am on 9/11/21, lips still numb feeling, chest is tight and heavy, but no wheezing and arms and back itch slightly.
This study case was received from the investigator in a trial on 20 August 2013. A 24 year-old male subject with no significant past medical history was found to have unspecified disease of pericardium 15 days after the subject had received the following vaccines on 11 July 2013: an injection of ACAM2000 (lot number, route and site of administration not reported) and TYPHIM VI (lot number, route and site of administration not reported). Troponin I, ECG, and echocardiogram were not available. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
1 day after GARDASIL developed fever, myalgias, swollen eyes; diagnosed with "mono". Monospot (+) however EBV titers all negative. Never felt completely well -> recurrent myalgias, swollen glands, headache. EBV IgG titers (+) 11/08. Multiple complaints myalgias, knee pain; erythema nodosum diagnosed 4/09.
Moderna vaccine given expired 10/24/2021-  monitoring- vitals stable, no complaints
First dose gave me redness, itching, burning in the area where I was Vaccinated was small. Second dose redness, itching, burning in the area where I was vaccinated bigger. Third dose redness, itching burning, hot area and secretion of clear liquid where I was vaccinated started there and then the elbow, neck, left chest and armpits.
Dtap was given expired 2 weeks ago to a patient who is 15 months old; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 15 months old patient (gender unknown) who received expired dose of vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site On an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Expired vaccine used.  At the time of report no adverse event was reported.  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 Directive and Module VI of the 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.  Information on the batch number was requested.  Documents held by sender: none.
Moderna covid-19 VACCINE EUA administered on 3-11-21. The rash first appeared on 3-18-21 Raised red, itchy, bumpy rash at site of injection (muscle of upper left arm). Appeared yesterday, one week after vaccination. This appeared after swollen, painful symptoms of vaccination had been gone for a few days. It is in roughly the same area as the original swelling.
didn't receive the second dose >42 days; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (didn't receive the second dose >42 days) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (didn't receive the second dose >42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (didn't receive the second dose >42 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment details were provided.
i started with a severe headache consistent with sinus pressure and dry cough.  this lasted for 3 days.  i was told by my doctor that it was a sinus infection.  i started feeling much better and on the  5th day, i lost all taste and smell.   i am on my 3rd day of not smelling and tasting as my only symptoms.   no fevers, nausea, diarrhea, no muscle aches, nothing, just NO taste or smell.
Severe nausea, stomach cramps. on and off for 5 hours.  Blacked out while walking to bathroom.  fell and struck chin on table and chipped a tooth.  Wife called EMTs.  they  hooked me to an IV and took me to the emergency room at Hospital.  Was discharged a few hours later.  Nausea and cramps did not return.  Felt of 48 hours later
A report was received from a health care professional on 12Nov03, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 07Jan04. A follow up report was received from a health care professional concerning a 2 year old male vaccine who inadvertently received Fluvirin on 07Nov03. On 07Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experienced any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report cross reference with: PJP200301062, PJP200400063, PJP200400064, PJP200400065, PJP200400066, PJP200400067, PJP200400068, PJP200400069, PJP200400070, PJP200400071, PJP200400072, PJP200400073, PJP200400075, PJP200400076, PJP200400077, PJP200400078, PJP200400079.
BODY IS FIGHTING SO BADLY; SWEATING; CAN NOT FUNCTION; CHILLS; HEADACHE; FEVER; NAUSEA; MUSCLE PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported 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 an unspecified date, the patient experienced body is fighting so badly, sweating, can not function, chills, headache, fever, nausea, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body is fighting so badly, headache, fever, chills, nausea, sweating, muscle pain, and can not function. This report was non-serious.
This spontaneous report has been received from a certified medical assistant referring to 20 patients of unknown age. On unspecified dates, these patients were inadvertently administered improperly stored (Oka/Merck) VARIVAX (Strength: 1350 U, Lot# L001326, Expiration date 13-JAN-2017) subcutaneously (dose unknown). No adverse effects were reported. Additional information has been requested.
Horrible headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Horrible headache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, the patient experienced HEADACHE (Horrible headache). At the time of the report, HEADACHE (Horrible headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 16 Jun2021, post vaccination, the patient reported that she experienced symptoms of a severe headache.   No treatment information was provided No concomitant information was provided
Perspective employee received Varicella for pre-employment on 7/11/17 to L arm and she came to EHSon 7/13/17 stating that L her arm was sore,red and a little swelling at the site. She described sight being painful to touch 3/10. The area measures 70 mm wide and 70 mm long. She denied having any difficulty breathing or swallowing at anytime post vacciantion. She said the site started out with reddness the size of a dime the day of vacciantion and then she showered and the next day it was the size that it is now. Her VS are WNL, she has no fever, and she was given a cool compress to apply to site. She said that she would take something for pain when she return home.She was informed to see medical attention if condition worsens, or return to Employee Health & Safety department.
Pt states started to have a high fever in middle of night last night. No respiratory symptoms. Pt took Tylenol and reduced fever. Pt states had fever or possibly flu the last time had Td vaccine 20 yrs ago.
He started to not feel well again today; Sunday got sicker; had diarrhea; Had a fever of 99.5; Flu like symptoms; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), ILLNESS (Sunday got sicker), DIARRHOEA (had diarrhea), MALAISE (He started to not feel well again today) and PYREXIA (Had a fever of 99.5) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Had a fever of 99.5). On 07-Feb-2021, the patient experienced ILLNESS (Sunday got sicker) and DIARRHOEA (had diarrhea). On 09-Feb-2021, the patient experienced MALAISE (He started to not feel well again today). The patient was treated with LOPERAMIDE in February 2021 for Diarrhea, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) 06-Feb-2021 for Fever, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), ILLNESS (Sunday got sicker), DIARRHOEA (had diarrhea), MALAISE (He started to not feel well again today) and PYREXIA (Had a fever of 99.5) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported.   Reporter did not allow further contact
Worst was nausea and vomiting which developed early evening the second day and lasted about 24 hours or more, eventually controlled by zofran. Some swelling and heat at injection site some joint stiffness and discomfort, but these were not particularly troublesome
I gave vaccine on April 5th and vaccine expired on April 1st.     I was unaware I  was suppose to update the expiration date on the moderna vaccines.   I assumed when I received the vaccines the expiration date was already in ( like the other vaccines).    Patient is feeling normal and no adverse reaction noted.   Contacted moderna, supposed to get back with me on viability.
ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN ACUTE PULMONARY EMBOLISM