chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered pharmacist referring to a 72-year old female patient. The patient's current conditions included allergic to sulfa and codeine. Historical drugs included sulfa and codeine. Medical history and concomitant medications were not reported. On 13-NOV-2018, the patient was administered with PNEUMOVAX 23 (Lot: R018741, expiry date: 06-APR-2020) intramuscularly and unspecified influenza vaccine. On 13-NOV-2018, the patient experienced nausea, lightheadedness, swelling and redness at the injection site. No treatment was received for the events. On an unknown date in November 2018, the events was resolving. Causality assessment was not reported for the events.
This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. It was reported that on an unknown dates the patients were administered improperly stored dose of COMVAX (lot # J013884, exp. 19-AUG-2016, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Raised red warm, itchy 2 in area around site of VAR given. Treated with ice, Ibuprofen PRN, vitals, monitor youth.
1 and 2 days after DTaP vax, left upper arm red, swollen, painful, and itchy.
Patient reported to the pharmacy 2 days after vaccination stating her arm was turning red and became painful and warm to the touch about 1 day after vaccination.  Patient showed back of arm where vaccination was given and there had devoloped a red rash on skin that was warm to the touch.  Rash was about 8 inches x 3 inches in size.
About 12 hrs after receiving flu vaccine had temp > 103 with witnessed convulsing for < 1 min. For about 1 hr after he was way "out of it."
NO AE REPORTED, HOWEVER, DOSE WAS ADMINISTERED IM INSTEAD OF SQ. PER BAVARIAN NORDIC, NO REPEAT DOSE IS REQUIRED
First one muscle ache, head ache, itchy at vaccine site, fatigue and inflammation. Second one First one muscle ache, head ache, itchy at on buttocks and leg a site, fatigue and inflammation. To off work slept 12 hours.
Mom states child ran t104 from 7JUN91PM until taken to ER despite giving Tempra q4hrs; States child had vomit, diarrhea; c/o child legs jerking at intervals;
large dark spot on the top of her hand.; as if "I hit my hand and got a large bruise on it."; resembles a large bruise when you hit yourself.; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (large dark spot on the top of her hand.), CONTUSION (as if "I hit my hand and got a large bruise on it.") and CONTUSION (resembles a large bruise when you hit yourself.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced SKIN DISCOLOURATION (large dark spot on the top of her hand.), CONTUSION (as if "I hit my hand and got a large bruise on it.") and CONTUSION (resembles a large bruise when you hit yourself.). At the time of the report, SKIN DISCOLOURATION (large dark spot on the top of her hand.), CONTUSION (as if "I hit my hand and got a large bruise on it.") and CONTUSION (resembles a large bruise when you hit yourself.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Patient with chronic fatigue who had improved in terms of the fatigue level reports that she developed recurrence of ongoing daily fatigue impacting daily activities approx. Dec 20, 2018.
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case is linked to cases 2018SA279973, 2018SA281633, 2018SA281638, 2018SA281635, 2018SA281636, 2018SA281637, 2018SA281634, 2018SA281632, 2018SA279979, 2018SA281687 and 2018SA281692. (Same reporter). This case involves an 11 years old male patient who he received vaccines MENACTRA and ADACEL which were in below freezing for 4 hours from 11-Sep-2018 through 13-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 11-Sep-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5875AB expiry date: 14-Feb-2020 via unknown route in the left deltoid. On 11-Sep-2018, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6015AA Expiry date: 06-Oct-2019 via unknown route in the right deltoid. It was case of actual medication error due to incorrect product storage. No adverse event was experienced. 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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Information has been received from a health professional concerning a 3 year old patient who was vaccinated with a dose of haemophilus b conjugate vaccine. A few hours later, the patient experienced seizures. The patients outcome was reported to be unknown. Upon internal medical review, the patients seizure was considered to be an other important medical event. No further information is available.
devel neuropathy (parasthesias) one leg w/in 24hr;progressed slowly to mild weakness, parasthesias arm;w/in 1wk all extremities involved;sent to neurologist;
I had pain when the injection was given. Five days later I had a headache, stiff neck, muscle spasms, and insomnia.
chills; Fever; today is the first day he has had an appetite; nausea; headache; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 85-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration as dose 1, single for covid-19 immunisation. Medical history included asthma and COPD from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date Feb2021, the patient experienced Extreme chills, nausea, headache, and loss of appetite. It was reported that, first dose of the Pfizer Covid 19 vaccine 10 days ago and he developed the following symptoms: Extreme chills, nausea, headache, and loss of appetite.  The patient reported that a day or two after the first dose, he started developing chills and a fever. The patient said his symptoms went on from days and were getting increasingly worse. He said a day or two later, he started developing chills and a fever. He said his symptoms went on from days 2, 3, 4, 5, 6 and 7, getting increasingly worse. He said on day 7 he started taking Tylenol because he didn't know what else to do. He said he took Extra Strength Tylenol 500mg. He said the took 5 Extra Strength Tylenol 500mg a day (or 5 Extra Strength Tylenol 500mg within a 24-hour period). He said today is the first day he has had an appetite. The patient stated that he had suffered for the last 10 days and today is the first day he has had an appetite. The patient said he was going through all the COVID-19 Vaccine literature, and none of the symptoms are supposed to occur until the second COVID-19 Vaccine dose. The patient said since he experienced symptoms with the first COVID-19 Vaccine dose, he was concerned about what he would experience with the second COVID-19 Vaccine dose. The patient said on the plus side, the Extra Strength Tylenol 500mg lessened his symptoms. The patient said he has been drinking juices, but today was the first day he had a little bit of food. The patient said his health being what it is with the COPD and asthma, he was wondering if that contributed to more of the symptoms he experienced with the first COVID-19 Vaccine dose. The caller asked if Pfizer has heard of any other cases like his with people have symptoms after receiving the first COVID-19 Vaccine dose. The Reporter asked if Pfizer could provide him with an answer as to if he was taking the proper dose of Tylenol to treat his symptoms. The outcome of the event appetite impaired was recovering and other events were unknown.   Information about lot and batch number was requested.   Follow-up attempts completed. No further information expected.
606 doses were given after expiration date; Placed in refridgerator on 21 Sep 2021, Vaccine expired on 03 Oct 2021 and Administered on 07 Oct 2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Placed in refridgerator on 21 Sep 2021, Vaccine expired on 03 Oct 2021 and Administered on 07 Oct 2021) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Placed in refridgerator on 21 Sep 2021, Vaccine expired on 03 Oct 2021 and Administered on 07 Oct 2021). On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Placed in refridgerator on 21 Sep 2021, Vaccine expired on 03 Oct 2021 and Administered on 07 Oct 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported. Date of placed in refrigerator was on 21 Sep 2021. Vaccine did not undergone any temperature excursion. No  adverse events were reported for patient. No Treatment information was reported.
hives, sweating and  vomiting  for 2-3 days. no treatment
Headache aches, chills Narrative:  employee states: approx 15 hours after injection experienced headache the 22 hours after injections had aches and chills at hour 39 was symptom free
gradually gotten worse; it hurt to even lift the arm; swollen lymph node; Felt pain in his right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt pain in his right arm), CONDITION AGGRAVATED (gradually gotten worse), LIMB DISCOMFORT (it hurt to even lift the arm) and LYMPHADENOPATHY (swollen lymph node) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PAIN (Felt pain in his right arm) and LYMPHADENOPATHY (swollen lymph node). On an unknown date, the patient experienced CONDITION AGGRAVATED (gradually gotten worse) and LIMB DISCOMFORT (it hurt to even lift the arm). At the time of the report, PAIN (Felt pain in his right arm), CONDITION AGGRAVATED (gradually gotten worse), LIMB DISCOMFORT (it hurt to even lift the arm) and LYMPHADENOPATHY (swollen lymph node) outcome was unknown. Not Provided          Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Extreme diarrhea; vomiting; sore throat; dizziness; headache; chills; tiredness; low grade fever; body aches; This is a spontaneous report from a contactable consumer (Patient).  A 71-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: EN6199) via an unspecified route of administration on 03Mar2021 at 11:45 am, in the left arm (at the age 71-year-old) as a single dose for COVID-19 immunisation. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: EN5318) on 10Feb2021 at 11:45 am in the left arm (at the age 71-year-old) as a single dose for COVID-19 immunisation. Patient's medical history included Irritable bowel syndrome, allergy to Amoxicillin. Patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's 2 weeks prior medication included Bupropion, Atenolol, butalbital, red yeast rice. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. On 04Mar2021 at 1:00 am, the patient experienced extreme diarrhea, vomiting, sore throat, dizziness, headache, chills, tiredness, low grade fever, body aches. The patient did not take any treatment medication for the events. The outcome of events was not recovered.  No follow-up attempts are possible; No further information is expected.
Initial report received from a healthcare professional on 16 July 2013.  A 31-year old female patient had received an intramuscular dose 1 of ADACEL vaccine (batch number: UA567AA) in the right deltoid on 16 July 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was reported as unknown. The estimated date of delivery was unspecified date of September 2013. At the time of the report, the patient had not experienced any adverse events. It was reported that patient didn't indicate anything specific for health during pregnancy and risk factors. Concomitant medications and past medical history was not reported. As per reporter treatment for infertility was reported as no indicated. Follow-up information received from a healthcare professional on 09 September 2013. The patient had one previous pregnancy-spontaneous abortion prior to 20 weeks gestation. The patient's last menstrual period date was on 30 December 2012 and estimated delivery date was reported as 06 October 2013. Documents held by sender: none.
Tested positive on 9/19/2021.  This is a very pleasant 78-year-old male with a past medical history of atrial fibrillation, mild Crohn's, occasional dysphagia, gout, hyperlipidemia, hypertension, coronary artery disease, chronic kidney disease stage 3-4, osteoarthritis, obstructive sleep apnea, anemia, ankylosing spondylitis, who presents to the emergency room complaining of fever, chills and shortness of breath.  States his symptoms have been going on for approximately 24 hours.  He has received 2 vaccinations for COVID the last was in February 2021 but tested positive in the emergency room.  He also states he was recently diagnosed with hypothyroidism and just started on medications yesterday.   In the emergency room he had a temperature of a 100.9°, heart rate 157, leukocytosis of 10, TSH of 25, GFR of 31 and a chest x-ray that read bilateral pulmonary haziness may represent pulmonary edema versus bilateral pneumonia.  Mild cardiomegaly.  Patient treated with antibiotics, diltiazem drip and Lasix.  Sepsis fluids were held in light of COVID and possible pulmonary edema.  We do not have a 2D echo on record.  By the time I assessed patient he was feeling better.     Patient denies any  cough, rhinorrhea, sore throat, chest pain, palpitations, orthopnea, paroxysmal nocturnal dyspnea, nausea, vomiting, diarrhea, constipation, hematuria, dysuria, frequency, melena, hematochezia or focal neurological complaints
Within the first 24 hours of receiving my Moderna booster (vaccine #3) I developed painful and swollen lymph nodes in the armpit of the arm that received the injection. This lasted approximately 5-6 days. On day 3 an itchy rash developed on my collarbone and then significant full body itching progressed from there. The itch spreads throughout my body intermittently and is intense.
it was a muscle and joint pain and it was the same type of pain she experienced with the 1st dose; it was a muscle and joint pain and it was the same type of pain she experienced with the 1st dose; This is a spontaneous report from a contactable consumer (patient) via  Regulatory Authority. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6200), via an unspecified route of administration, in left arm on 02Mar2021 17:00 (at the age of 45-years-old) as dose 1, single for COVID-19 immunization. Medical history and concomitant medications was reported as none. The patient experienced muscle and joint pain after the first dose in Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Patient developed myalgia and fatigue 2 days after the receipt of his vaccine, which have been persistent since, impacting his daily activities Labs at PCP on 7/2 showed eosinophil count of 1700, referred to ID where repeat AEC is 1570 today
7/26/08 - raised red pruritic papule, dime size, at injection site; 7/27/08 - Flat red mark left cheek (Non-pruritic); 7/27/08 - Flat red mark right cheek (Non-pruritic); Flat red oblong mark 4" length, abdomen - pruritic; All faded gradually by 8/2/08. No treatment needed.
This spontaneous report was received from a licensed practical nurses (LPN) and refers to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 15-APR-2017, the patient was vaccinated with a improperly stored dose of GARDASIL 9 (lot # L037554, expiry date: 25-DEC-2017) (dose and route of administration were not reported). No adverse event was reported. Temperature excursion and time frame were 31.3F for 2 hours and 39 minutes; 32F for 3 hours and 36 minutes; 52.5F for 2 hours and 17 minutes. The was no previous temperature excursion. Data logger was involved. Additional information has been requested.
a little warm to the touch/warm and raised; a little sore/felt like the muscle was a little sore; itch/noticed it was huge/itchy; Huge rash; red/red mark from shoulder to arm/It is walking it's way down to her elbow; pretty big; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (a little warm to the touch/warm and raised), VACCINATION SITE PAIN (a little sore/felt like the muscle was a little sore), VACCINATION SITE PRURITUS (itch/noticed it was huge/itchy), VACCINATION SITE RASH (Huge rash) and VACCINATION SITE ERYTHEMA (red/red mark from shoulder to arm/It is walking it's way down to her elbow) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078CZ1A and 078CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical History was reported.  Concomitant products included VITAMINS NOS for an unknown indication.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (a little warm to the touch/warm and raised), VACCINATION SITE PAIN (a little sore/felt like the muscle was a little sore), VACCINATION SITE PRURITUS (itch/noticed it was huge/itchy), VACCINATION SITE RASH (Huge rash), VACCINATION SITE ERYTHEMA (red/red mark from shoulder to arm/It is walking it's way down to her elbow) and VACCINATION SITE SWELLING (pretty big). The patient was treated with GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORINE) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (a little warm to the touch/warm and raised), VACCINATION SITE PAIN (a little sore/felt like the muscle was a little sore), VACCINATION SITE PRURITUS (itch/noticed it was huge/itchy), VACCINATION SITE RASH (Huge rash), VACCINATION SITE ERYTHEMA (red/red mark from shoulder to arm/It is walking it's way down to her elbow) and VACCINATION SITE SWELLING (pretty big) outcome was unknown.
Patient fainted after receiving the vaccine. Patient was placed in the Trendelenburg position and recovered quickly within 5 minutes.
Patient had Varivax, DTaP, IPV 11:30 Mom came out 5 minutes later stated patient with hives, head pain, hard time breathing. Epi-pen given left thigh, I.V. placed normal saline fluid given. Vital signs taken - per order doctor. Patient transported to hospital via ambulance. Stable at time of d/c to hospital.  06/04/2007 ER record received for chief c/o shock.  Child received 5 yr vax and within minutes he developed scratching in his throat sneezing, and a rash over his entire body.  Epipen was administered in the PCP's office and he was transported via EMS to hospital for further tx.  PE notable for generalized erythderma over the entire body. Anaphylaxis protocol was initiated. Assessment: Anaphylaxis.  Immunization reaction.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) and in Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "asthmas" (unspecified if ongoing), notes: Other medical history: asthmas. Concomitant medication(s) included: BENZONATATE, start date: 09Jul2022, stop date: 15Jul2022; FLOVENT HFA, start date: 09Jul2022, stop date: 23Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient received treatment of Paxlovid from 11Jul2022 to 15Jul2022 for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt started with temp of 102 approx 2 1/2 hours after administration of influenza vaccine. Temp up to 105 the following day.