chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bruising and redness at the vaccine site; severe hypersensitivity reaction at the vaccine site/Urticaria, Severe reddness and Swelling; bruising and redness at the vaccine site; sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE BRUISING (bruising and redness at the vaccine site), VACCINATION SITE HYPERSENSITIVITY (severe hypersensitivity reaction at the vaccine site/Urticaria, Severe reddness and Swelling), VACCINATION SITE ERYTHEMA (bruising and redness at the vaccine site) and VACCINATION SITE PAIN (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J0A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy and Allergic reaction to wasp sting. Concomitant products included EPINEPHRINE (EPIPEN) for Shellfish allergy.  On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced INJECTION SITE BRUISING (bruising and redness at the vaccine site), VACCINATION SITE HYPERSENSITIVITY (severe hypersensitivity reaction at the vaccine site/Urticaria, Severe reddness and Swelling), VACCINATION SITE ERYTHEMA (bruising and redness at the vaccine site) and VACCINATION SITE PAIN (sore arm).   At the time of the report, INJECTION SITE BRUISING (bruising and redness at the vaccine site), VACCINATION SITE HYPERSENSITIVITY (severe hypersensitivity reaction at the vaccine site/Urticaria, Severe reddness and Swelling), VACCINATION SITE ERYTHEMA (bruising and redness at the vaccine site) and VACCINATION SITE PAIN (sore arm) 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.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: New adverse events added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
20 yr old female here to receive her 2nd dose of COVID vaccine. She stated no reactions after 1st dose. After receiving dose she went to sit in chair as instructed before leaving. Two minutes later RN was notified by pharmacy staff, pt not feeling well. On approaching, pt was very pale and resting her head on friends chest. RN asked if she was having trouble breathing, she stated "A little." 911 was called and an Epi pen was brought to scene. RN asked if pt wanted to lay down and assisted her to the floor, lifting her legs up on a chair. She was very weak and had urinated on herself. She stated she had not eaten anything today and only had a little water. She was given water but only had a small sip. RN stayed by her side while waiting for paramedics to arrive. Paramedics stated BP was low and took her to Medical Center.
Heart palpitations body shaking lost of weight headache. Went to the emergency room on 4/19/2001 I was the diagnosed with Graves  disease I am now on medication. I now have suffered with burning and swelling in my arms and hands I am back in the hospital. I have been very sick since vaccine was administered
Trouble breathing, feelings of throat closing. Occurred hours after vaccine given. Treatment Benadryl 100mg IM and Decadron 10mg IM.
High fever, hallucinations, went unconscious and hit my head on the floor leaving bruising on my head, unable to stand.. fever lasted 3 days. Throwing up. Symptoms listed 4 days, severe headaches that continue every day since the second shot
On 08Mar2021, patient reported that she had right shoulder stiffness along with right facial numbness and tingling x2 days after getting vaccinated. Patient reported that she did not do anything for it. She monitored the symptom and it eventually went away after 2 days of getting the vaccine.
Overhead lights flickered and he froze mid-activity and his eyes rolled up for approx. 10-15 sec., now seizure evaluation/testing by neurologist.
Reports full fecal incontinence 2-3x/day beginning day of vaccination or day after vaccination (GM can't remember) which has been daily and not present prior to vaccination.  She has also had change in stool which is now hard and pebble like.
I have dermatographia with pruritus. It started one week after I got my first shot, but I did not care. After three months, it started with severe symptoms, and I shared it with my provider. I tried many different medications and saw different providers and specialists, but they finally told me that they had no solution.
This case was reported by a nurse and described a 4-year-old female subject who experienced an injection site reaction after inadvertently receiving a dose of diphtheria and tetanus toxoids and acellular pertussis adsorbed hepatitis B recombinant and inactivate poliovirus vaccine combine (Pediarix). On 20 June 2005, the subject inadvertently received a dose of Pediarix (lot number and site of injection not specified) rather than the intended fourth dose of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). Approximately tow days after vaccination with Pediarix, on 22 June 2005, the subject developed a red lump and swelling at the injection site of Pediarix and was seen at a physician's office. The injection site reaction resolved on an unspecified date on or after 22 June 2005 and on or before 03 August 2005.
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 57-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 medications were reported. No Treatment information was reported. It was reported that patient's facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter also stated that no adverse reactions were reported by any patients.
approx. 4 hours after vaccine pt started stumbling around and felt weird. Bones hurt with body aches and felt tired ever since s/p vaccination booster dose.  DX with polymyalgia rheumatica developed after her last booster per provider.
Scratchy throat, flushed, urticaria, dizziness, nausea for 3 days
1st + 2nd shots - got sore arm - after 1 week ok; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Jan2021 11:00 (Lot number: EL2347) as dose 1, single and intramuscular, administered in arm left, administration date 08Feb2021 13:00 (Lot number: EL9265) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Bronchithisis (COPD)" (ongoing), notes: Onset date: 4 years ago , Pertinent details: in care of a pulmonary Dr.; "Asthma" (ongoing), notes: Onset date: decades ago; "High cholesterol" (ongoing), notes: Onset date: long ago; "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST SODIUM taken for hypersensitivity, asthma (ongoing); ERGOCALCIFEROL (ongoing); ALENDRONATE SODIUM taken for osteoporosis (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "1st + 2nd shots - got sore arm - after 1 week ok".  Clinical course: I phoned the clinic where the shot was given. They said to take Tylenol and Benadryl. I did not take Tylenol knowing this does not help the itching. Treatment drug : Benadryl and Canadryl.  No follow-up attempts are possible. No further information is expected.
brain fog; tiredness,fatigued 24/7; his whole body feels like he worked out 24/7; muscles felt like a full body workout; his whole sinus is stuffed for 10 minutes at a time; cannot breath out his nose and only can breathe from mouth; goes to bathroom everyone 30 minutes and can't sleep,sleep pattern is off and evening is off; drinking more fluids; dreams are very vivid; none of the symptoms are going away,It's getting worse, progressively worse.; cannot breathe and cannot do anything; cannot do anything; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Oct-2021 and was forwarded to Moderna on 01-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain fog), FATIGUE (tiredness,fatigued 24/7), DISCOMFORT (his whole body feels like he worked out 24/7), MUSCLE DISCOMFORT (muscles felt like a full body workout) and PARANASAL SINUS DISCOMFORT (his whole sinus is stuffed for 10 minutes at a time) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Aug-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 FEELING ABNORMAL (brain fog), FATIGUE (tiredness,fatigued 24/7), DISCOMFORT (his whole body feels like he worked out 24/7), MUSCLE DISCOMFORT (muscles felt like a full body workout), PARANASAL SINUS DISCOMFORT (his whole sinus is stuffed for 10 minutes at a time), NASAL DISCOMFORT (cannot breath out his nose and only can breathe from mouth), SLEEP DISORDER (goes to bathroom everyone 30 minutes and can't sleep,sleep pattern is off and evening is off), POLYDIPSIA (drinking more fluids), ABNORMAL DREAMS (dreams are very vivid), CONDITION AGGRAVATED (none of the symptoms are going away,It's getting worse, progressively worse.), DYSPNOEA (cannot breathe and cannot do anything) and IMPAIRED QUALITY OF LIFE (cannot do anything). At the time of the report, FEELING ABNORMAL (brain fog), FATIGUE (tiredness,fatigued 24/7), DISCOMFORT (his whole body feels like he worked out 24/7), MUSCLE DISCOMFORT (muscles felt like a full body workout), PARANASAL SINUS DISCOMFORT (his whole sinus is stuffed for 10 minutes at a time), NASAL DISCOMFORT (cannot breath out his nose and only can breathe from mouth), SLEEP DISORDER (goes to bathroom everyone 30 minutes and can't sleep,sleep pattern is off and evening is off), POLYDIPSIA (drinking more fluids), ABNORMAL DREAMS (dreams are very vivid), CONDITION AGGRAVATED (none of the symptoms are going away,It's getting worse, progressively worse.), DYSPNOEA (cannot breathe and cannot do anything) and IMPAIRED QUALITY OF LIFE (cannot do anything) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Received the first vaccine on January 2.  Developed URI symptoms/sinus infection.  On January 29th went to medical clinic related to ringing in the right ear.  Was placed on Amoxicillin-Clav and told to visit ENT if ringing did not stop.  Ringing did improve but never went away.  Received second dose of vaccine on Feb. 2nd, 2021.   Tinnitus increased after second vaccine.   Went to ENT received prednisone for 21 days.  Hearing test showed mild hearing loss on first ENT visit  and worsening hearing loss on second visit.   Currently, in treatment with ENT to investigate all cause of tinnitus and hearing loss.
Patient reported on 8/21/12 that after receiving Tdap on 8/17/12 in (Lt) Deltoid pt reports on 8/18/12 had a fever of 102.9, headache body aches, nausea, dizziness, cough, sore throat, stiffness, and hard time breathing. Reports all symptoms went away within 48 hours after onset.
My daughter was fine and her normal self at 1:30 pm was her appointment they did her shots around 2 pm as soon as we left the dr office she fell asleep and slept a while. The rest of the day she wasn?t really her playful she had a slight fever so I gave her infant Tylenol the was around 4 pm. Around 10:30 she dozed off and woke up like 5 minutes later breathing funny and acting dazed like none coherent so me, her godmother, her son, my son and another friend just stood watching her for about 30 minutes talking to her and looking at her chest and breathing pattern. She finally started acting normal and breathing good. So my friend was like take her home give her a breathing treatment and watch her. When we got in the car I gave her her inhaler and buckled her in and we left. Me and my son who is 11 left and it took us all of 15 minutes to get home so we were home around 11:30 my timing may be a little off but we got home got out I grabbed her bag and car seat thinking she was sleep. Went in the house sat the car seat down unbuckled her and it looked like her nose was running so I took her baby rag wiped her nose and noticed blood so I grabbed her up so fast and ran in my brother room and said she has blood coming out her nose he then asked was she breathing I said no and called 911 he said we not waiting cause the hospital up the road so we left she had no heartbeat when we got there and they tried everything possible They pronounced her dead at 12 something am April 9th
Experienced coughing early on Saturday, the day after I received the vaccine. Then in the afternoon, I started feeling nausea and headache with fatigue. I then vomited and had diarrhea Saturday evening and all through the night. On Sunday, I experienced nasal congestion and a pounding headache along with the fatigue.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 26-JAN-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
Dose of the Ipol was given to a patient after having an excursion at 60 F for 65 hours, No AE; Initial information received on 07-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a five years old female patient who was vaccinated with IPV (VERO) [IPOL] after having an excursion at 60 f for 65 hour.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included Daptacel (DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID) and Fluzone preservative-free 0.25 mL (influenza vaccine)  On 07-Oct-2019 around 9:30AM, the patient received a fifth dose of suspect IPV (VERO) (0.5 ml) (lot number: P1A25 and expiry date: 02-May-2019) via intramuscular route in the left thigh after having an excursion at 60 f for 65 hour.  It was an actual medication error due to product storage error.  At the time of report no adverse event was reported.  It was actual medication error due to incorrect product storage. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Never had a reaction, other than tenderness at injection site nothing real significant; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, LOT: FL9265 or maybe EL9265), administration date: 26Jan2021, when the patient was 78-year-old, for COVID-19 immunization, reaction(s): "tenderness at injection site". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Never had a reaction, other than tenderness at injection site nothing real significant".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PT recd series of 3 Engerix-B vaxs (20mcg) on 13SEP90, 19OCT90, & 27MAR91 & was a non-responder;
left arm is sore; it's warm and itching; it's warm and itching; arm was swollen and red; arm was swollen and red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm is sore), VACCINATION SITE WARMTH (it's warm and itching), VACCINATION SITE PRURITUS (it's warm and itching), VACCINATION SITE SWELLING (arm was swollen and red) and VACCINATION SITE ERYTHEMA (arm was swollen and red) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (left arm is sore), VACCINATION SITE WARMTH (it's warm and itching), VACCINATION SITE PRURITUS (it's warm and itching), VACCINATION SITE SWELLING (arm was swollen and red) and VACCINATION SITE ERYTHEMA (arm was swollen and red). At the time of the report, PAIN IN EXTREMITY (left arm is sore), VACCINATION SITE WARMTH (it's warm and itching), VACCINATION SITE PRURITUS (it's warm and itching), VACCINATION SITE SWELLING (arm was swollen and red) and VACCINATION SITE ERYTHEMA (arm was swollen and red) 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.  No treatment information was provided.
Pt. had diarrhea during nap.  Increased Immodium, no other complaints following.  Patient was found deceased 9:30 AM 10/22/2014. Was normal with no problems 5 PM previous evening.
Severe nausea; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PFIZERER8733) via an unspecified route of administration in the left arm on 02Apr2021 at 12:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021, the patient experienced severe nausea and diarrhea. It was unknown whether the adverse event resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the event severe nausea and diarrhea was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
fibromyalgia; muscle pain; super achy; This is a spontaneous report from a contactable nurse reporting for herself. A 65-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (reported as PNEUMONIA SHOT), via an unspecified route of administration on an unspecified at single dose for immunization, influenza vaccine (INFLUENZA), via an unspecified route of administration on an unspecified date at an unspecified dose for immunization. The patient medical history and concomitant medications were not reported. In 2018, she had ovarian cancer, it came back and she was on chemotherapy then maintenance chemotherapy, she developed a complication. The patient had blood clots in her lungs so she stopped chemotherapy. She was treated to at a city. She needed to be on apixaban (ELIQUIS) 5mg twice a day and also take a diuretic because she had a blood clot. The patient had to take a shot when white cells drop, platelet drops, it correlated with ibuprofen (MOTRIN). The patient had taken influenza and pneumonia shot. She took both of those without any issues. She had fibromyalgia and had muscle pain, super achy, for a day or two after those vaccines. The outcome of the events was unknown.  Pfizer is a marketing authorization holder of [Pneumococcal 13-Val Conj Vac] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Pneumococcal 13-Val Conj Vac] has submitted the same report to the regulatory authorities.  Information about lot/batch number has been requested.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 06-JUL-2014 the patient was vaccinated with improperly stored MMRII, 0.5 ml, subcutaneous (lot number and expiration date not reported). The vaccine was exposed to 49F for 20 minutes. No adverse effect was reported. Additional information has been requested.
pt recvd flu vax in OCT92; On 28FEB93 pt devel the flu;
24 hours after Vaccine... injection site pain, chills, fever, fatigue, headache, feeling unwell,  awoken lymph nodes. Stayed in bed 16 hours. All symptoms disappeared in 24 hours.
Developed "bronchitis" diagnosed at Urgent Care with eye closed at that time but was seen in ER 3 days later and diagnosed with Bell's Palsy thereafter and also had rash at the time. Bell's Palsy improved but developed barking cough 3 weeks later, treated for possible pertussis but they found to have vocal cord dysfuntion.  Later developed shoulder and hand movements and now concerned and workup in progress and treatment for Tourette's Syndrome.