chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a back office lead and refers to a 19-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 11-FEB-2016, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (1ml, left deltoid, route of administration: intramuscularly, dose number not reported, lot number: L035881, expiry date: 26-JUN-2017). Concomitant therapy was not reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received a pneumonia polysaccharide vaccine on 01/12/2006 at 2:30pm.  Patient reports that left arm became sore and could not use arm about 3 hours after receiving vaccine.  Patient also reports pain in left shoulder and elbows and weakness in knees.  Patient also reported having a fever that night with nausea and reporting having flatulence.  Patient evaluation on 01/13/2006.  Temperature of 99.2 degrees.  No swelling in left arm, but tenderness noted in the left bicep and tricep.  Patient reports still having nausea and aches, but no diarrhea or vomiting.  Patient reports fatigue, but may be related to lake of sleep due to previous night.  Patient has a history of hear disease requiring 2 coronary artery bypass grafts surgeries and is currently being treated for hypertension.  Medications include:  Vitron, Niacin, Lopressor, Hydrochlorothiazide, Calcium, Aspirin, Potassium, Multivitamin, Ibuprofen.  Patient is to take ibuprofen as directed, as needed for inflammation and pain.  If symptoms persist or worsen, patient is to followup with emergency care immediately.  Patient agrees to plan of care.
Extreme Chest pain in heart region, 103 degree fever, extreme chills, nausea, and high heart beat
This case was reported by a physician (subject's brother) via a sales representative and described the occurrence of seizure in a female subject of unspecified age who was vaccinated with HAVRIX (GlaxoSmithKline). In 2010, the subject received an unspecified dose of HAVRIX (administration site and route unknown, batch number not provided). In 2010, at an unspecified time after vaccination with HAVRIX, the subject experienced seizure. The subject was hospitalised. At the time of reporting, the outcome of the event was unspecified.
The patient had flu-like symptoms with nausea, body aches, fever and chills. The main reason for this report is she has a 10 cm X 9 cm hive/whelp reaction left arm at the site of the needle stick vaccine. Area is warm to touch and itching and painful. Patient advised to use cool compress, ibuprofen or Tylenol for pain, Benadryl 1-2 Q 6 hours PRN and given IV infusion of Vitamin C 1500mg, mg/zinc/copper/selenium and B-complex.
onset of hives all over the faces..converted to rashes all over the body in next two days with itching, chills and nightly low grade fever. lastly the red patches moved to the extremities with touch sensitivity and itching.
afebrile status epilepticus the day p/vax requiring intubation for apnea induced by Benzodiazipines
Spoke with clients guardian about adverse event. Guardian reported nurse calling her after she went back to school after vaccine due to a rash on chest, lower abdomen, and from inside of arms from elbows to wrist on client. Mother took client to ER to be checked out. Per report of Guardian, ER doctor said, "this rash shouldn't stop client from receiving second vaccine." Guardian also reported ER doctor prescribing Prednisone for 5 days and Benadryl as needed. Guardian did not say what ER doctor ended up diagnosing the rash cause.  Guardian reported client reporting rash was itchy, but Guardian reported she did not see client actively itching. Guardian also reported client very nervous about vaccine and was being told mixed messages about vaccine from peers from school. Per CDC guidelines instructed Guardian to have client evaluated by allergist before receiving second Covid-19 Vaccine. Guardian reported client is doing well now.
Pt reported feeling dizzy, weak, and feverish several hours after vaccine administration. No reaction at injection site.
This is the second time patient was getting VN after receiving the COVID vaccine; This is the second time patient was getting VN after receiving the COVID vaccine; Really messing with patient's like and equilibrium; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), VOMITING (non-serious), outcome "unknown" and all described as "This is the second time patient was getting VN after receiving the COVID vaccine"; BALANCE DISORDER (non-serious), outcome "unknown", described as "Really messing with patient's like and equilibrium". Additional information: This is the second time patient was getting VN after receiving the COVID vaccine. It happens within 2 days of the shot. Really messing with patient's like and equilibrium.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300180437 same patient/different dose;
Urinary tract infection; This is a spontaneous report from a contactable consumer (patient).  This 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3302, Expiration Date May2021), via an unknown route, on 21Jan2021 at single dose for COVID-19 immunisation. Relevant medical history included urinary tract infection for years. Relevant concomitant medications included apiaxaban (ELIQUIS). On 23Jan2021, the patient developed urinary tract infection (UTI). The patient stated ''I have urinary tract infection for years, so it's not something, it's not unusual". Therapeutic measures taken as result of the event included antibiotics. The patient had not recovered from the events.
Day 2:  fatigue throughout day, chills between 4-10 pm Day 4:  vertigo upon awakening
I experienced a sore arm and tiredness, breakthrough case of COVID-19 which led to me having the following symptoms: congestion, sore throat, runny nose, nausea, brain fog, fever, my joints and muscles felt like rubber and I could not stand or walk without holding on to furniture, my sense of taste left and a cough.
FEELS LIKE GETTING A HEART  ATTACK; STOMACH PAIN; SORENESS AND BODY ACHES; CHEST PAIN; SHORTNESS OF  BREATH; CHILLS; WEAKNESS IN THE LIMBS; SIGNIFICANT SEVERE PAIN AT INJECTION SITE; DIARRHEA; FEVER; This spontaneous report received from a patient concerned a 37 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: 1822811, expiry: UNKNOWN) dose was not reported, administered on 11-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2021, the patient experienced feels like getting a heart attack. On NOV-2021, the patient experienced stomach pain. On NOV-2021, the patient experienced soreness and body aches. On NOV-2021, the patient experienced chest pain. On NOV-2021, the patient experienced shortness of breath. On NOV-2021, the patient experienced chills. On NOV-2021, the patient experienced weakness in the limbs. On NOV-2021, the patient experienced significant severe pain at injection site. On NOV-2021, the patient experienced diarrhea. On NOV-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the significant severe pain at injection site, diarrhea, stomach pain, fever, soreness and body aches, chest pain, weakness in the limbs, shortness of breath, chills and feels like getting a heart attack was not reported. This report was non-serious.
Heart beat irregular and quick; Heart beat irregular and quick; Excessive sweating; Dizziness; Headache; Fever; Body and joint pain; Body and joint pain; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Jan2022 09:00 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Surgery" (unspecified if ongoing), notes: Surgery and chronic pain, with anxiety; "chronic pain" (unspecified if ongoing), notes: Surgery and chronic pain, with anxiety; "anxiety" (unspecified if ongoing), notes: Surgery and chronic pain, with anxiety; "known allergies nsaids" (unspecified if ongoing), notes: known allergies Zofran and nsaids; "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient took concomitant medications. Past drug history included: Zofran, reaction(s): "known allergies: Zofran", notes: known allergies Zofran and nsaids. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unknown , Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 10Jan2022, when the patient was 43 years old, for Covid-19 Immunization.  The following information was reported: HEART RATE IRREGULAR (non-serious), HEART RATE INCREASED (non-serious) all with onset 31Jan2022 13:00, outcome "recovered with sequelae" and all described as "Heart beat irregular and quick"; HYPERHIDROSIS (non-serious) with onset 31Jan2022 13:00, outcome "recovered with sequelae", described as "Excessive sweating"; DIZZINESS (non-serious) with onset 31Jan2022 13:00, outcome "recovered with sequelae", described as "Dizziness"; HEADACHE (non-serious) with onset 31Jan2022 13:00, outcome "recovered with sequelae", described as "Headache"; PYREXIA (non-serious) with onset 31Jan2022 13:00, outcome "recovered with sequelae", described as "Fever"; PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 31Jan2022 13:00, outcome "recovered with sequelae" and all described as "Body and joint pain"; FATIGUE (non-serious) with onset 31Jan2022 13:00, outcome "recovered with sequelae", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of heart rate irregular, heart rate increased, hyperhidrosis, dizziness, headache, pyrexia, pain, arthralgia, fatigue.  Additional Information: If other vaccine in four weeks was reported as no. Other medications in two weeks was reported as yes. If covid prior vaccination was reported as yes. If covid tested post vaccination was reported as yes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Symptoms began 12/4/2021. Headache for 5 days, Tylenol did not help, Nausea, Diarrhe for 5 days, too weak to get out of bed, , fever,   Came to local Health Dept 12/8/2021  Bp 170/110.  I referred to her Primary care Dr.. I called to check on her today 12/9/2021.  She said Dr said her bp was wnl now and did no changes to her meds.
DIFFICULTY BREATHING; SWOLLEN NOSE(STUFFY NOSE); THROWING UP/VOMITING; PAIN IN SIDE OF NECK; PAIN IN EYE SOCKET; DIARRHEA; TREMOR; WEAKNESS; BIG HEADACHE; This spontaneous report received from a pharmacist concerned a female patient of unspecified age. The patient's height, and weight were not reported.  The patient was not pregnant at the time of reporting and had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: 21-JUN-2021) 0.5 ml, 1 total administered on 05-APR-2021 18:00 to left arm for prophylactic vaccination. Concomitant medications included ascorbic acid, cyanocobalamin, and vitamin b complex. On 06-APR-2021, next morning after vaccination the patient woke up with a big headache, her nose was swollen and stuffy and she had difficulty breathing. On 06-APR-2021 16:00, she threw up/vomited. The patient had difficulty breathing and went to chiropractor who adjusted her pressure points. She still had stuffy nose and headache at the time of this report and difficulty breathing was somewhat better but not completely gone. The patient's nose was blocked and had pain in the left side of neck and eye socket. She also had weakness, diarrhea and tremor after getting the vaccine shot. The nurse came to her house and gave her a bag saline, magnesium and ketorolac each. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from difficulty breathing, and swollen nose, had not recovered from big headache, and the outcome of vomiting/throwing up, pain in side of neck, pain in eye socket, weakness, diarrhea and tremor was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210414709-covid-19 vaccine ad26.cov2.s-difficulty breathing. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
11/4/2021 12:45 am chest pains started, radiating to the back and up the jaw. 11/4/2021 1:00 am arrived at ER. Chest pain "7/10". GI cocktail given at the ER to see if symptoms relieved.  Chest pains persist. EKG performed and came back normal. Bloodwork taken (high sensitivity Troponin among others). Chest x-ray taken and also came back normal. Troponins came back elevated in the 500's. 3 rounds of Nitroglycerine given with no improvement in chest pains. Nitroglycerine paste applied to chest. Chest pains improved to "5/10" pains. Repeat Tropinins drawn and still in the 500's. Repeat EKG came back normal.
Local rash with swelling at the injection site with discomfort into the axillary lymphnodes . The area is ichy and has not changed since the vaccine was given.
Irregular heart beat and chest pain ever since the first vaccine dose. Symptoms began about 2 days after the first dose was administered.  Symptoms seemed to worsen again 3-10 days after the second dose. Still get sharp pains in my chest near my heart today.  Today I looked up my symptoms and they seem comparable with Myocarditis so I decided to make this entry.
29JAN92 pt came home sick & had nocturnal temp 101; Friday both hands & feet & eyes swollen; Monday rt knee swelled; dx arthritis from MMR;
Came down with shingles about five days after, was diagnosed about 9 days after the vaccine
Father states that patient with twitching and jerking movements which began 24 hours after vaccine administration
Vaccine in the left arm of a patient of an unauthorized age; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine in the left arm of a patient of an unauthorized age) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine in the left arm of a patient of an unauthorized age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine in the left arm of a patient of an unauthorized age) had resolved.        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.
SOME UNSPECIFIED PROBLEMS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced some unspecified problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from some unspecified problems. This report was non-serious.
short of breath, mucous drainage, cough, sinus congestion +COVID 19 test
Acute limb ischemia of right leg required an open thromboembolectomy of right common femoral, SFA and profunda artery and a right lower extremity 4-compartment fasciotomy
Patient was observed to be sitting in her chair with head down on knees in 15 minute waiting area after receiving Johnson and Johnson Vaccine. Patient reported light headiness and nausea. Patient was AOX4 and vital signs laying at 11:24 am: HR: 79, O2: 96% RA and Temp: 98.1 F, BP not reading. BP retaken at 11:34 am laying down: BP: 50/29 with thready pulse. Patient denies any chest pain, trouble breathing, itchiness, pain. BP retaken laying down at 11:40 am BP: 95/59 and Heart Rate 71. BP retaken sitting at 11:49 am. BP: 83/49. Blood pressure retaken sitting at 12:06 pm : BP 92/57 , HR: 65. Patient reported she normally runs a low blood pressure.  Per Patient stated she feels better, had a snack. As precaution called friend to pick her up.
heart flutters; Rush feeling almost like adrenaline rush; arm was sore for less than 24 hours; This spontaneous case was reported by a health care professional and describes the occurrence of PALPITATIONS (heart flutters), PAIN IN EXTREMITY (arm was sore for less than 24 hours) and FEELING ABNORMAL (Rush feeling almost like adrenaline rush) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm was sore for less than 24 hours). On 04-Apr-2021, the patient experienced PALPITATIONS (heart flutters) and FEELING ABNORMAL (Rush feeling almost like adrenaline rush). On 03-Apr-2021, PAIN IN EXTREMITY (arm was sore for less than 24 hours) had resolved. At the time of the report, PALPITATIONS (heart flutters) and FEELING ABNORMAL (Rush feeling almost like adrenaline rush) outcome was unknown.        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 medications were not provided by the reporter
Myalgia, Fever, Pain/Discomfort at injection site, chills, fatigue Narrative:
1 wk after shot arm  itch and red at site and below several inches. Arm very warm. Other side arm pit area small lump.
a 16 year old patient received a dose of Fluzone QIV with no AE; Initial information regarding an unsolicited valid non-serious case received from a Pharmacist via Nurse on 24-Oct-2019.  This case is linked to cases 2019SA304586, 2019SA304587, 2019SA304588, 2019SA304580, 2019SA304590, 2019SA304591 and 2019SA304592.  This case involves a 16-year-old patient (unknown gender) who received QUADRIVALENT RECOMBINANT INFLUENZA VACCINE [Flublok QIV]) (Batch No: QFAA1938, Expiry date: 30-Jun-2020) (Product administered to patient of inappropriate age).  The patient s past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the inappropriate age at vaccine administration.  It was not reported whether the patient experienced any 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 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.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 42-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  It was reported that there were no power outages, but the facility was not able to download digital data logger. The data logger was unable to download the data for Dec-2021, Jan-2022 and Feb-2022 No treatment medication information was given.
Initially: Pain at site, limited ROM (couldn't lift my arm up), pain w any ROM, decreased strength in right hand, numbness in rt hand.
headache; chills; fever; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04May2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history included Covid 19. The patients concomitant medications were not reported. It was reported he received the Pfizer COVID-19 vaccine on 04May2021. He was experiencing some symptoms it is been two days headache chills and fever in May2021. He stated he had COVID and received the antibody infusion. A lot of people of ask him why he was getting vaccinated since he had the antibodies. The clinical outcome of the events was unknown.  No follow attempts are needed; information about lot/batch number cannot be obtained.
COVID 19 Pfizer LOT FT9142 was kept in refrigerator BUD. Received 7/26/22. Administered 12/14/22.