chrisvoncsefalvay/vaers-outcomes huggingface dataset:
child was administered an expired Daptacel, No AE; Initial information was received on 19-Feb-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 3 year old male patient who was received an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment, vaccination and family history were not provided.   On 18-Feb-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5366AA, Expiry date 07-Feb-2020) via intramuscular route at an unknown administration site for prophylactic vaccination  It was a case of an actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  The patient was administered an expired Daptacel but did not know the site.  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.
fainting, sweating, eyes rolled back, slouched over in chair then perked back up. still complained of dizziness and sweating.  called 911 within 1 min of episode and paramedics came to take over. Patient was talking and coherent but sweaty.
Needle malfunction during administration of second dose which did not need to be re-administered, as patient received > 50% of the dose.
Sore throat; Nausea; Headache; feeling very heavy; Pain at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 at 12:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. The patient believed she had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included ethinylestradiol, norethisterone acetate (MICROGESTIN), ibuprofen (MANUFACTURER UNKNOWN), paracetamol (TYLENOL) and pseudoephedrine (MANUFACTURER UNKNOWN), all from unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 09:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 07:30, the patient experienced sore throat, nausea, headache, feeling of very heavy and pain at the injection site. Therapeutic measures were not taken as a result of the events. The events did not result  in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event sore throat, nausea, headache, feeling of very heavy and pain at the injection site was resolved with sequelae on 18Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
when I had my shots I was sick 3days both times; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (when I had my shots I was sick 3days both times) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (when I had my shots I was sick 3days both times). At the time of the report, ILLNESS (when I had my shots I was sick 3days both times) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-286336 (Patient Link).   Reporter did not allow further contact
A non-serious spontaneous report of severe projectile vomiting and fever has been received from a registered nurse concerning a 24-month-old patient of unknown sex subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 to 59 months of age for FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST along with Hepatitis A vaccine an unknown date. The patient received a total of one dose of FLUMIST before the onset of the event. The patient experienced severe projectile vomiting and fever five hour after FLUMIST and Hepatitis A vaccine administration. The symptoms of severe projectile vomiting lasted approximately four hours. The events of severe projectile vomiting and fever were resolved. Reporter assessed the events of severe projectile vomiting and fever as related to FLUMIST and Hepatitis A vaccine. All follow up attempts have been completed per company SOP's.  No further information is available. 19-Feb-2010.
Based upon the date of the vaccine and the onset of Covid, I seriously doubt the event is related to the vaccine. I felt unwell evening of 6/30/22.  Husband had tested positive for Covid on 6/26/22.  I tested negative on 6/26/22 and 6/28.  I tested positive 7/2/22.  Symptoms included mild fever (100.5), muscle aches, headache, sinus and chest congestion and coughing. My sinuses were swollen, ears had pressure and by 7/4, I had green drainage.  Cough was productive and I coughed up quite a bit of phlegm.  Did a tele-visit with my doctor on 7/5.  Doctor called in cough medicine and amoxicillin/clavulanate potassium.  Remaining remaining sinus infection symptoms abated by 7/16/22.
1601- Pt. given HPV. Pt. became diaphoretic, increased breathing pale which lead to syncope. Pt. resting on exam table with doctor present. Vitals monitored. 1630- Doctor admin Hep A with no adverse reaction. 1635 Pt cleared by doctor and released -1645.
Sor arm with loss of range of motion in shoulder. Red then large bruise at injection site. Fatigue for 3 days. First shot only.
Information has been received from a physician concerning a 5 year old patient who on 11/1/2001 was vaccianted with varicella virus vaccine live. Concomitant vaccine administered together with varicella virus vaccine live included a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). It was reported that the patient seen on 3/3/2005 with breakthrough varicella with one lesions that was still on the chest. The patient was treated with acyclovir. Subsequently, the patient recovered. Follow up information from a physician indicated that the patient experienced chickenpox, described as mild with only 10 to 15 skin lesions. Additional information has been requested.
Severe pain on the arm, swollen and red area.  Slight fever. Started approximately at 7pm yesterday and continues today.  Today has some dizziness and feels exhausted.  I put some ice on the arm and took 2 Panadol to lower the fever.
Around 1 week after my vaccine I experienced  the Covid arm. It was on my left arm on the injection site on the top. It was sore, then it started turning hot. It looked like a large hive. It was hot to the touch & itchy. It lasted about a week. I seen my doctor they prescribed me a antibiotic. But then after when I seen it wasn't getting better I went to the ER.
PATIENT HAD SX 1 DAY AFTER VACCINATIONS GIVEN LASTING 7 DAYS TOTAL. SHE HAD CONSTANT FEVERS X1WK RANGING FROM 99-104 DEGREES. MALAISE, NAUSEA, ANOREXIA, SORE THROAT, DEHYDRATION, GRAY COLORED MEMBRAINE ON THROAT ON DAY 5 OF 7, DEVELOPED CANCRE SORES IN MOUTH, INFLAMED GUMS, RECEIVED IV FLUIDS AS OUTPT X3 (1000CC BAGS), USED IBUPROFEN & ACETAMINOPHEN FOR FEVER, USED LIDOCAINE SWISH FOR SORE MOUTH, HYDROGEN PEROXIDE/H2O 50-50% SWISH FOR SORE GUMS,  COMPAZINE FOR NAUSEA, ZITHROMAX RX ON DAY 5 OF 7.
Patient described fatigue, ocassional fever, chills, headache and body aches for 4-5 days after immunization. No localized reaction.
Since the vaccination, has the patient been tested for COVID-19?:Yes/Date: 01Jan2022/Result: positive; Since the vaccination, has the patient been tested for COVID-19?:Yes/Date: 01Jan2022/Result: positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing); "If covid prior vaccination: Yes" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jan2022, outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19?:Yes/Date: 01Jan2022/Result: positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2022) Positive, notes: Nasal Swab.  Additional information: Facility type vaccine was Hospital. Patient received other vaccine in four weeks and other medications in two weeks. Patient had no known allergies.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available, the events Drug ineffective and COVID-19 are assessed as related to BNT162B2 administration.
Initially a sore arm at injection site about 2 hours after vaccine. At 15 hours after  2nd dose, nausea and vomiting started at about 20-30 minute intervals. When stomach contents were empty, vomiting bile and any water I sipped. I would have gone to the ER, butI have a supply of anti-nausea/anti-emetics from radiation therapy, I used them from 5/4 to 5/8 in order to retain any fluids. Accompanied by whole body weakness/ fatigue and lightheaded/dizzy spells. Took last anti-nausea med on Sat 5/8 evening.  Began to try solid food (BRAT diet-like) in Sun 5/9.  Body weakness and fatigue noticeable through 5/13. Also very constipated after resuming normal diet.
Narrative: She has a extensive allergy to environmental and food allergens. received her first dose of Pfizer COVID19 vaccine 6/2/21. about 10min after, she felt left arm tingling that progressed to her legs and feet tingling. she had some nausea. then her tongue felt swollen and she could tell her BP was elevated. EMS was summoned. she received dph IM and declined epinephrine. she was transported to th ED. She is feeling better. No difficulty breathing or swallowing. no rash. no vomiting. has a headache. 0841: first dose Pfizer COVID vaccine given w/ 30 minute wait; tolerated well 0850: Pt reports anaphylactic symptoms V/S: 185/93BP , 102HR , 20RR , O2 100% RA 0852: 1ml bendryl IM given to left deltoid; tolerated well 0855; MD notfied; advised 911 transport 0900: 911 called 0905: PT reports decreased symptoms; no trouble swallowing/breathing 0905: PT declines epi-pen 0913; Fire EMS on scene 0916; Fire EMS transported PT and serum tryptase orderd. Was skin tested prior to vaccine by outside allergist and cleared to get vaccine.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (lot #, dose and expiration date were not reported) subcutaneous. Concomitant medications were not reported. On an unknown date, 3 weeks after vaccination, the patient experienced shingles. The outcome of shingles was unknown. The relatedness between shingles and ZOSTAVAX. Additional information has been requested.
About 3 ½ hours after receiving dose, patient went to bathroom, passed-out on floor after urinating. His wife found him upper body shaking on the floor. He woke-up shortly after and did not remember falling. Able to get up and walk to couch. Felt nauseous and very tired.
Employee was scheduled by manager to receive second dose of vaccine. Employee presented to clinic, didn't have vaccination card and received the Pfizer vaccine. Afterwards it was found that this employee's first dose was Moderna and was given on  12/29/2020. Employee did not have any adverse effects, just received second dose too soon and with the wrong manufacturer.
I realized while at work the next day (1/25/11) that my arm, where the shot was administered, was swollen in the shape of a band aid.  I kept taking Tylenol & even took Advil that night to ease the pain, and applied an ice pack that night, but I could not sleep on my right side due to the swelling and pain. I realized the next morning (1/26/11) that the area was red and swollen even higher and wider than it was before. I then called the PCP's office to see if this was normal, or if I needed to be seen again.  I went to the dr's office and saw Dr. who advised I may have an infection and prescribed antibiotics and hot compresses.
Patient's mother scheduled an appointment for patient because he had a "hard, red, hot lump" on his right thigh where his influenza vaccine was administered.
None adverse reaction. Pt given vaccine expired on 7/27/11 not aware of exp at time of injection.
I received my first Moderna booster for COVID-19 on 11/19/2021. On maybe 11/21/2021, I noticed that the lymph nodes in my left armpit were swollen and tender. The lymph nodes remained in this condition for maybe 3 or 4 months. I did not seek medical care, because I had heard that this was a possible side effect of the vaccine, so I didn't think it was necessary. On 11/20/2021, I experienced a fever, which I think was 101. This is high, but it wasn't as high as the temperature I experienced after getting the first dose of Pfizer vaccine for COVID-19, which was 103. I began getting mild chest pains. I don't recall when they began, but they occurred mostly in the late afternoons and evenings. The pain was usually in the left side of my chest, though sometimes in was more in the center. They were mild at first, but with each episode, the pain grew ever more intense. On the late afternoon of 4/13/2022, I began having chest pains at work; there was nothing in particular at work that triggered the episode, but it just started happening. I then went home and took 2 aspirin in the hope that the pain would go away. The pain kept getting worse, though. When my daughter came home, she insisted that I to the ER, which I did. At this point, the pain was beginning to radiate from my chest to my neck and left shoulder. When I got to the ER, I underwent an EKG, a chest X-ray, and blood work. The results of the blood work and chest X-ray indicated that everything was normal, though there was something slightly different on the EKG, but they said that it was nothing indicating a heart attack or other emergency. I was given a diagnosis of acute chest pain with no known cause. They then gave me a referral to a cardiologist. After I got home from the ER, I went to bed, fell asleep, and woke up in the night with continuing chest pains. I then went back to sleep. I woke up again a while later drenched in sweat, and the chest pain at that point was totally gone. When I went to the cardiologist on 4/29/2022, I underwent an EKG. An echocardiogram was done 6/28/2022 and a stress test was done 5/26/2022. The results of all the tests done by the cardiologist were normal. The cardiologist gave me nitroglycerin to try in case the pains were caused by arterial spasms, but the medication did not help the pains. The pains became less frequent, less intense, and of shorter duration. At the time of this writing, it has been at least a month since the last episode occurred, during which the pain was very mild and very brief.
may have received wrong dose/may have received wrong vaccine presentation; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (may have received wrong dose/may have received wrong vaccine presentation) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 017B2AA) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (may have received wrong dose/may have received wrong vaccine presentation). At the time of the report, INCORRECT DOSE ADMINISTERED (may have received wrong dose/may have received wrong vaccine presentation) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant information were reported by the reporter. It was reported as two patients with COVID-19 vaccination card from another vaccination provider and Moderna lot number is written on each of the patient's vaccination cards. The nurse was unsure which Moderna vaccine presentation the patient's received based on the lot number (age group 6 months through 5 years, 6 years through 11 years, or 12 years and older). The nurse stated there was a potential that each patient received the wrong vaccine presentation and dose, but she isn't sure. She was going to call the vaccination provider to confirm which presentation and dose the two patients received.   Reporter did not allow further contact
Soreness around injection area/ unable to move left arm freely; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 24Feb2021 at 09:15 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to jackfruit and shrimp from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Feb2021 at 19:00, the patient experienced soreness around injection area and unable to move left arm freely. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event soreness around injection area and unable to move left arm freely was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Patient was to receive Bivalent COVID 12 years and up at visit. Patient actually received Monovalent COVID 12 years and up
Went to Employee Health Services to received Annual Flu Vaccine (Flublock). The vaccine was administered by a nurse and within 5 minutes the site area of the injection began to itch. The nurse provided a cold pack to put on the injection site. The nurse ask me a series of questions about how I felt and if I had problems breathing. I stated, I did not have any problems breathing , only the site of the injection was itching and it was visibly red. The nurse stated she wanted me to wait before leaving to ensure that I was feeling okay. After waiting for 20-25 minutes. I stated that I felt fine- just that I was itching in the area. I went back to work and eventually home. Once I arrived at home, the itching became worse, but with a cold pack and wiping the area rubbing the area with alcohol it felt better. On Wednesday, October 28, 2020 EHS was administering flu vaccines to the staff at the facility were my office is housed. I decided to go see the nurse and have her to look at my arm. She measured my left arm (site of the vaccine) and measured my right arm, comparing the two. The left arm was visibly larger than the right. She suggested that I contact my PCP and complete this form. I mentioned to her that I took pictures of my arm Monday night and she asked that I email them to her.
All body joints began to ache. Fatigue and body weakness began. Started having dry eyes. These symptoms went on for months.
Swelling at site; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), lot number and expiration date were not reported, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced swelling at site on an unspecified date. The outcome of the event swelling at site was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Right bicep started itching, and bicep and triceps became swollen. Arm almost back to normal on 10/31/18.
vaccine is really taking a big toll on her brain function; feels just weird, like everything is in slow motion/feeling really weird; dizzy/lightheaded; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in left deltoid on 02Feb2021 at single dose for COVID-19 immunization. The patient's medical history was not reported.  There were no concomitant medications. The patient got the COVID vaccine a couple hours ago on 02Feb202 and was very lightheaded. When the patient was asked to provide her mailing address, she stated she was feeling really weird, the vaccine was really taking a big toll on her brain function, she was super dizzy and feels just weird, like everything is in slow motion. Lightheadedness started probably about 20 minutes after she had the shot, they made her wait for 15 minutes, now she just feels really weird. The patient was healthy, she just got blood tests back and everything said she is healthy. She thought they said to call if she was having a side effect of dizziness or weakness, as they are more serious, but she called her doctor and they said to call Pfizer. The outcome of the events was unknown. The patient underwent lab tests and procedures which included blood test: unknown results on unspecified date.
pt had a positive COVID test on 6/9/22; pt passed away at home on 7/6/22; no medical records received on this patient
Allergic reaction/swollen face / puffy eyes / numbing of left side / tingling on upper and lower lips.