chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Accident that required an admission to ER; Felt ill; Extremely unusually tired; A spontaneous report was received on 18 Feb 2021 from a consumer concerning a 54-year-old, female patient who received Moderna's COVID-19 vaccine and felt ill, felt unusually tired and had an accident.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Jan, 2021, patient received her first of two planned doses of mRNA-1273(BATCH/LOT # 011L20A) injection in the left arm  for the prophylaxis of COVID-19 infection.  On 12 Jan 2021, After receiving the vaccine, the patient felt ill and unusually tired. Treatment for the events were not provided.  On 05 Feb 2021, the patient had an accident and  was admitted to ER (emergency room) and required an intervention on her arm and leg. The patient  received pain shots for the intervention he underwent.  The patient had an appointment for the second dose of the Moderna's COVID-19 vaccine on 14 Feb 2021, but  the vaccine facility,  sent back the patient due to the pain shots she received for the intervention on arm and leg.  Action taken with the second dose of mRNA-1273 in response to the events unknown.  The outcome of the events, are patient felt ill and unusually tired.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Epistaxis, and 8 days of fever, myalgia, cough, and, emesis, concerning for actual contraction of Influenza, versus concomitant flu-like illness by coincidence.
About 8 hours after injection patient experienced a headache followed by achiness all over body. Also experienced shivers & muscle spasms on left side for 45 minutes. Patient went to sleep & woke up with no more adverse reaction.
Slight lightheadedness; Blurry vision; Fatigue and weakness; Fatigue and weakness; Headache; Cold sweats; Dehydration; Sat down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Jun2021 13:30 (Lot number: EW0177) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergy" (ongoing), notes: Additional Information for Other Conditions: From: Caller states since he was 8 or 9 years old. Concomitant medication(s) included: ADVIL [IBUPROFEN] taken for seasonal allergy, start date: May2021 (ongoing); FLONASE [MOMETASONE FUROATE] taken for hypersensitivity (ongoing). The following information was reported: DIZZINESS (non-serious) with onset 30Jun2021 13:45, outcome "recovered" (30Jun2021), described as "Slight lightheadedness"; VISION BLURRED (non-serious) with onset 30Jun2021 13:45, outcome "recovered" (30Jun2021), described as "Blurry vision"; FATIGUE (non-serious), ASTHENIA (non-serious) all with onset 30Jun2021 13:45, outcome "recovered" (30Jun2021) and all described as "Fatigue and weakness"; HEADACHE (non-serious) with onset 30Jun2021 13:45, outcome "recovered" (01Jul2021), described as "Headache"; COLD SWEAT (non-serious) with onset 30Jun2021 13:45, outcome "recovered" (30Jun2021), described as "Cold sweats"; DEHYDRATION (non-serious) with onset 30Jun2021 13:45, outcome "recovered" (30Jun2021), described as "Dehydration"; FALL (non-serious) with onset 30Jun2021 13:45, outcome "recovered" (30Jun2021), described as "Sat down".  Additional information: Patient received first dose of Pfizer vaccine and started to experience side effects. Patient said he got lightheaded so he sat down then got blurry vision, along with feeling fatigue and weak. Patient said Pharmacy Tech gave him water because he felt dehydrated and had a headache. Patient wanted to know how he should treat the side effects and if he should get his second dose of the Pfizer vaccine. No Relevant Tests done. No Family Medical History Relevant to Events. No events following prior vaccinations. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). Time the Vaccination and onset of events Was Given was between 1 and 2 PM. Patient stated he was hearing about the new Delta variant, and he wanted to get the vaccine to protect other people. Patient stated he felt really dehydrated after the vaccine, and drank 3 glasses of water. Patient stated he has not felt any effects after that time, and now feels fine. Patient declines to provide for report, as he states he does not have a primary care doctor.   No follow-up attempts are possible. No further information is expected.
Symptoms were minor--soreness at injection site for 2 days, loose stool the day after injection, and minor headache and fatigue on the day after injection through the following day (2 days after injection).
Began having soreness in left upper arm approx. 2 hours, post vax. By 18:00, the pain was worse and noted swelling of the arm. It also felt hot to touch. Now is experiencing itching which started at noon today.
Injection 11am, 6pm unwell. 9:30 pm brassy cough, temp 101.6, nausea, next morning to void, nausea, felt strange, faint, lay on floor, no temp crawled to bed. BP 97/58, pulse 68. Better now.
pt recv vax 5OCT97 about 7 days later 12OCT97 pt exp sx of a stroke;pt was hosp;f/u conversations w/the initial report 2NOV97 indicated that in all probability the stroke was not associated w/flu vax;pt was reported as d/c from hosp;
bled at the injection site; This is a spontaneous report from a contactable pharmacist.  A 4-decade-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported.  It was reported a female in her 30's bled at the injection site and in unsure if she got the full dose of the vaccine. Information on the lot/batch number has been requested.
By the 15th, I had discomfort under my ribs which I thought might be a UTI. By the 16th, I was really hurting. I went to the doctor on the 18th. The rash from the shingles was prominent by then. The doctor was able to look at me and already diagnose it. I was given a steroid pack and gabapentin for nerve pain. I also had a urinary tract infection which I was given antibiotics for. I took the medication for about a week.  The shingles lasted for 3-4 weeks but 2 weeks was extremely painful.
This literature report, initially received on 23-Jul-2018, was reported by other health professional and concerns a 65-year-old, elderly, male patient. The patient's current conditions included human immunodeficiency virus (HIV) infection (CD4 count 533/uL), hypertension, diabetes mellitus type II and blindness (since an unspecified date). On an unspecified date, the patient was administered Influenza Vaccine (dose, route of administration, batch number, anatomical location and expiry date, manufacturer and trade name: not reported). On an unspecified date, 03 days after vaccination, the patient was admitted to the hospital for acute weakness of all extremities. Initial laboratory workup was performed and showed elevated protein in cerebrospinal fluid and no evidence of infection was noted. Anti-nuclear, anti-VGCC (voltage-gated calcium channel), anti-MUSK and anti-GQ1b antibodies were found to be negative. The patient was treated with intravenous immunoglobulin and steroids for possible Guillan-Barre Syndrome, however his condition deteriorated, and he developed respiratory failure which required mechanical ventilation. The patient also experienced complete quadriplegia, nystagmus and multilobar pneumonia. Electromyography (EMG) showed a severe diffuse demyelinating pattern. On 16th day of hospitalization, magnetic resonance imaging (MRI) of brain showed innumerable foci of T2 flair hyperintensity involving brain and spinal cord. On 17th day of hospitalization, the patient died and permission for autopsy was granted. The autopsy was performed and neuropathologic examination showed multiple soft lesions with tan discoloration throughout the brain and spinal cord, predominantly involving periventricular white matter, bilateral basal ganglia, corpus callosum, cerebellar white matter, pons, medulla and upper cervical spinal cord. Microscopic examination showed discrete areas of demyelination surrounding vessels, with patchy macrophage aggregation, sparse CD8+ lymphocyte infiltration and mild reactive gliosis at the periphery. In a few of the lesions, the infiltrate was composed of neutrophils. Inflammation was perivascular or in the brain parenchyma and did not involve the vessel wall. No hemorrhage or viral inclusions were identified. Luxol fast blue stain demonstrated loss of myelin within the lesions. Neurofilament Immunohistochemical stain highlighted relative preservation of axons, although spheroids and axonal disruption were also present. The findings were more consistent with diagnosis of acute disseminated encephalomyelitis (ADEM). The outcome of the events respiratory failure, multilobar pneumonia and symptoms of ADEM (acute weakness of all extremities, complete quadriplegia, nystagmus, elevated protein in cerebrospinal fluid and severe diffuse demyelinating pattern) was not reported. The reporter assessed this case as serious (death and hospitalization).
OBSTRUCTIVE SLEEP APNEA 4/22/2021 ANEMIA DUE TO CKD  OBSTRUCTIVE SLEEP APNEA 4/22/2021 ANEMIA DUE TO CKD  OBSTRUCTIVE SLEEP APNEA 4/22/2021 ESRD (END STAGE RENAL DISEASE)  OBSTRUCTIVE SLEEP APNEA 4/22/2021 ANEMIA DUE TO CKD
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 54-year-old female patient received BNT162b2 (COMIRNATY), on 27Oct2021 as dose 2 (initial Pfizer dose), single (Lot number: FH8020) at the age of 54 years for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen (Dose 1), administration date: 15Mar2021, when the patient was 53-year-old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 27Oct2021, outcome "unknown"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Oct2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She tested positive for COVID-19 with an at home test"; PAIN (non-serious), outcome "unknown", described as "body aches"; PYREXIA (non-serious), outcome "unknown", described as "fever"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; FATIGUE (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. No follow-up attempts are possible. No further information is expected.
2-3 hrs after vaccination - flush and rash on face. Flushing cleared up overnight. No rash at injection site. Fever blister (1) on lip - appeared 24 hrs after injection.
6/11 at 3:00am, baby woke up. I picked her up and she was incredibly hot. Took her temperature and it was 103.5. Put her into a bath and she screamed. Gave her acetaminophen and took her to hospital. At 4:30 am they gave her Advil. She had to have a catheter put in to take a urine sample. We went home at 5am. At 9am we went to the pediatrician office to follow up. He took temp and it was 102.9. She continued with high temps all day (between 102 and 103.5). Acetaminophen and Advil/Motrin did not help to bring fever down. It finally broke around 9am Tuesday 6/12. Tuesday she had a few bumps. She did not sleep during the day and woke up at night from midnight until 5am. Screaming. She was also constipated and all around uncomfortable. We went back to the doctor Weds as she had a lot of spots and some that looked like blisters. Doctor diagnosed her with chicken pox.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about concomitant medications, and medical history and drug reactions was not provided. On an unknown date the patient was vaccinated with VARIVAX (lot # and expiration date were not reported) for prophylaxis and PROQUAD (lot # and expiration date were not reported) (inappropriate schedule of drug administration). No adverse symptoms were reported.
Patient assessed due to complaint of redness to right upper arm at site of PPSV23 vaccine which was administered in the clinic yesterday. Right upper arm is indurated, red, and warm at deltoid in area approximately 3x3 cm; with another 3 x 1 cm linear area which is also indurated and warm, extending around arm toward axilla. Patient reports overnight pain in arm and headache. Denies fever, cough, or respiratory difficulty. No other symptoms. Will give KEFLEX 250 mg QID for apparent localized infection. Patient may apply cool compresses for comfort.
COVID arm, according to websites. After initial redness and pain at injection site went away, redness returned, accompanied by itchiness, hot skin, mild swelling, and a hardness under skin. A circle about 2 inches in diameter. Not very painful. Occurred about 1 week after injection.
28OCT95 x 3 days severe sinus h/a, congestion, drainage & very stiff neck;partial recovery for about 4 days, then extreme weakness, fatigue, achiness, fever 101.6, h/a x3 days or so;during this period, 4 working days were missed;
Severe esophageal reflux that lasted for months, convulsion like movements, crying for 2 weeks straight. He was completely inconsolable. It eased up after this period, but the crying continued for quite some time. I called the nurse about swelling and a hard knot in the area of the vaccine that lasted 1-2 weeks. I was told it was normal.
Right leg redness and swelling/firmness across entire thigh x 2 days. After- redness and edema at injection site-knot felt upon exam, no tenderness to touch or drainage.
passed out; This case was reported by a nurse via sales rep and described the occurrence of passed out in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo .5 ml. On an unknown date, unknown after receiving Menveo, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was unknown.   It was unknown if the reporter considered the passed out to be related to Menveo.  Additional information was reported as follows: This case was reported by the registered nurse. The age at vaccination was not reported. After vaccination, the patient had passed out. The reporter wanted know if that was normal. This case is 1 of 4 cases reported by the same reporter.
Site: Pain at Injection Site-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: numbness noted around lips/mouth, as well as both hands and arms after receiving the vaccine in the pharmacy by the pharmacist. pt admits to feeling anxious/nervous, likely cause of symptoms. symptoms self resolved within a day.
Rigor, chills, fever 104.9 onset 6-8 hours after injection  Treated with acetaminophen, ibuprofen, cold packs, lukewarm bath to bring down fever.
This spontaneous report was received from a physician via field representative refers to a 16 year old female patient. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided. On an unknown date, the patient was vaccinated with GARDASIL. The patient experienced amneorrhoea since an unknown date after vaccination. Outcome of the event was unknown. Reporting physician did not assessed the causality of the event with respect to vaccination with GARDASIL. Additional information has been requested.
4/20/21 ER HPI 30 y.o. female who presents with history of asthma in ER with complaint of shortness of breath and substernal chest pain since yesterday.  Chest pain is nonradiating and is associated with coughing.  Cough is productive of clear sputum.  No nausea vomiting, no fever or chills, no abdominal pain.  Patient said her asthma only flares of around this time of the year that is during the spring season
Fever and chills all night long, he took a tylenol. Tired, headaches, nausea, and had flu like symptoms. Bad arm pain for 3days. Called doctors office and informed  nurse.
menstrual cycle has been off and then it restarted with brown clotting old blood/her period was not due for another 10 days; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), intramuscularly on the left arm, on 07Jan2021 10:30, at single dose, for covid-19 immunization. Medical history included thyroid cancer. Concomitant medication included thyroid (ARMOUR THYROID). The patient previously took hydromorphone (DILAUDID) and metaxalone (SKELAXIN) and experienced allergies to both. The vaccine was given at the hospital. The patient stated that her menstrual cycle has been off and then it restarted with brown clotting old blood on 09Jan2021 (also reported as 24Jan2021); her period was not due for another 10 days. She added that her cycles have never been off, and she has never had issues with her menstrual cycles or any female problems. The adverse event resulted in doctor or other healthcare professional office/clinic visit on 27Jan2021. Unspecified treatment was received for the adverse event. The outcome of the adverse event was unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination.
No additional AEs were reported; An expired MMR II was administered to a patient.   MMR II had a temperature excursion in 10/2022 and it was given on 5/15/2023.   The diluent did not have temperature excursion and was not expired.   No additional AEs were reported. No further inform; MMR II had a temperature excursion in 10/2022; Description: An expired MMR II was administered to a patient.   MMR II had a temperature excursion in 10/2022 and it was given on 5/15/2023.   The diluent did not have temperature excursion and was not expired.   No additional AEs were reported. No further information provided.  No PQC.  This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      In October 2022, the vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot number u013036, expiration date 23-APR-2023 had a temperature excursion and was administered on 15-MAY-2023 (dose and route of administration not reported)(product storage error and expired product administered). The sterile diluent used to reconstitute the vaccine had no excursions and was no expired. No adverse event was reported.  The excursion was of 50 degrees Fahrenheit for 4 hours. No previous excursions were reported.
Bilateral tingling which morphed into peripheral neuropathy legs and feet including twitching and hands included as well. Also increased liver enzymes and decreased thyroid tsh levels
Pain in right arm at injection spot, more than just feeling of soreness, 3 hours after injection.  Nausea 12 hours after shot, vomiting 15 hours after shot, headache started at 6 am day after shot (or 17 hours after shot). Headache continued for 29 hours - advil and tylenol not effective at getting rid of pain.  Nausea still continuing 48 hours after shot.  Sweating 14 hours after shot and continuing for 12 hours - could be due to fever (was not able to check temperature but was feeling warm)
Fever of 102F, within 6 hours, post vax, and 5 hours of non-stop crying, irritability and unable to sleep. Fever has been sporadic for nearly 10 days. Doses of children's Motrin used for fever.
70 y/o with past medical history of C4/C5 compression who presents with shortness of breath post vaccination. Patient states that this is the second vaccination in the two-dose Pfizer series. Patient denies reaction to previous vaccinations. Patient received the vaccination to the right arm. Patient denies sore throat, difficulty swallowing, chest pain or rash. NP and Paramedics at patient side. Patient with noted elevated BP (184/91) and remaining vitals normal (99% O2, 82 HR). EKG normal. Patient placed on 2L O2 by NC.  Patient provided with water bottle. Patient monitored for 25 mins with resolution of symptoms. BP normalized to 145/72 and patient weaned off O2 with no further complaints of shortness of breath. Remaining vitals within normal limits. Patient aware that if symptoms persist or worsen to seek further medical care. Patient discharged in stable condition
Severe side effect post 2nd covid vaccine.  Started about 9-10 hours post vaccine. Fever (101.9+ F) Rigor Severe body aches Severe headache Nausea
After being given flu shot (combiant/inactive) (eating regular diet with no other medications) at 1:30 PM...at 8:PM starts Severe itching and burning skin, large hives, whelps all over body beginning on back, stomach, face..quickly spread to all other body parts. Went to ER. Given Benadryl 2tsp every 6 hrs all night. On 03/18/2016 at at 10:00 PM severe itching and painful feet...given 2 tsp Benadryl..feet are completely red on soles and warm to touch. Tried to soak feet but water burns her (warm or cold water has same reaction) and child screams in pain. We dry feet, lay her comfortably with feet propped up for apx 45 min. apply dermisil lotion. Redness fades except for toes, heel and pad under big toe after 2 hours. Still painful to touch. Will go to clinic in AM, 03/21/2016 if nothing else occurs before that requires emergency visit to hospital again.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6205), in right arm, on 31Mar2021 as dose 2, single (Lot number: ER8732), on 29Sep2021 as dose 3 (booster), single (Lot number: FF8839), in right arm and on 04Apr2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Valley fever w/pneumonia", start date: Apr2021 (unspecified if ongoing); "Valley fever w/pneumonia", start date: Apr2021 (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Aug2022, outcome "recovered" (11Sep2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (11Sep2022) Low grade fever; SARS-CoV-2 test: (01Sep2022) Positive; (02Sep2022) Negative; (05Sep2022) Positive; (11Sep2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Patient did not received any other medication within 2 weeks of vaccination. On 03Sep to 04Sep still had runny nose headache sore throat and tested on 05Sep2022 Positive. Patient had increased symptoms until tested Negative n 11Sep2022 and symptoms included low grade fever, headache, sore throat runny nose, sore heavy chest, sneezing, coughing, sore runny eyes, hot and cold flashes, tired. Treatment received for the adverse events include administration of drug Paxlovid on 26Aug2022 which is stopped on 30Aug2022.