chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vaccine was given Thursday, 10/13/2005 about 12:00pm. Friday 10/14/05 I was cold and sluggish all day. About 6:00pm I went to bed and did not wake until Sat 10/15/05 about 9:00am. I woke up with a headache, my entire body was aching, muscles, joints, fingers, feet, shoulders. I could hardly get out of bed, I was bent over as I moved slowly to the bathroom. Chills were running up and down my muscles. The arms, hands and wrist were so swollen I could not make a fist, wring water out of my bath cloth or dish cloth, neither could I turn on my shower. When I moved my bones made loud cracking sounds. Pain to move my neck. My gums were sore and aching event though teeth had been pulled out years ago. Elbow ached, made cracking sounds. I would wake up about 5:00am with aching fingers, wrist, joints. Feet were aching, the toenail on right foot was split down the middle. Right eyelid is dropping (noticeable). Lumps or swelling are under the skin in my arms and hands. I had to take one step at at time, could not squat. Had difficulty getting out of bed. Weakness in my knees.
Dose 1 received 4/1/2021 and Dose 2 given in error on 4/8/2021
tired every time afterwards, "I feel so crappy; low blood sugar; low blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "low blood sugar", "tired every time afterwards, "I feel so crappy"", "low blood pressure". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tired every time afterwards, "I feel so crappy"; BLOOD GLUCOSE DECREASED (non-serious), outcome "unknown", described as "low blood sugar"; HYPOTENSION (non-serious), outcome "unknown", described as "low blood pressure". Relevant laboratory tests and procedures are available in the appropriate section. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient complained of right swollen arm and slight temp of 99.  She also complained of a headache. This was initially relieved with aspirin and Benadryl but later spiked to 102. Consulted PCP who advised current treatment in which temperature did go down. FYI Patient received HPV vaccine at civil surgeon's office and not at facility.
Pt sitting upright in chair in recovery. A/Ox3. Fell from sitting position to floor on left side. Once on floor pt started jerking movement which lasted less than 1 minute.  Head held until jerking stopped. Pt opened eyes per verbal and tactile stimuli. V/S obtained w/b/p 134/64 HR 58 O2 99%.  No acute distress noted at the time. Pt refused EMS at this time.   Girlfriend contacted per pt request of pt. Assisted to sitting position in chair.  A/Ox3.  Held an extra 30 minutes.  After 30 minutes pt was able to leave with girlfriend.  V/S obtained with b/p 126/56 HR 64 Ox99%.  Ambulated with a steady gait out of building.
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 22-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (MRK INJ) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004379:Original Case : 1808USA001261, US-009507513-1808USA004376:Original Case : 1808USA001261, US-009507513-1808USA004377:Original Case : 1808USA001261, US-009507513-1808USA004378:Original Case : 1808USA001261, US-009507513-1808USA004380:Original Case : 1808USA001261, US-009507513-1808USA004381:Original Case : 1808USA001261, US-009507513-1808USA004382:Original Case : 1808USA001261, US-009507513-1808USA004383:Original Case : 1808USA001261, US-009507513-1808USA004384:Original Case : 1808USA001261, US-009507513-1808USA004385:Original Case : 1808USA001261, US-009507513-1808USA004386:Original Case : 1808USA001261, US-009507513-1808USA004362:Original Case : 1808USA001261, US-009507513-1808USA004387:Original Case : 1808USA001261, US-009507513-1808USA004388:Original Case : 1808USA001261, US-009507513-1808USA004363:Original Case : 1808USA001261, US-009507513-1808USA001261:Original Case : 1808USA001261, US-009507513-1808USA004389:Original Case : 1808USA001261, US-009507513-1808USA004390:Original Case : 1808USA001261, US-009507513-1808USA004391:Original Case : 1808USA001261, US-009507513-1808USA004392:Original Case : 1808USA001261, US-009507513-1808USA004365:Original Case : 1808USA001261, US-009507513-1808USA004393:Original Case : 1808USA001261, US-009507513-1808USA004394:Original Case : 1808USA001261, US-009507513-1808USA004395:Original Case : 1808USA001261, US-009507513-1808USA004396:Original Case : 1808USA001261, US-009507513-1808USA004397:Original Case : 1808USA001261, US-009507513-1808USA004366:Original Case : 1808USA001261, US-009507513-1808USA004367:Original Case : 1808USA001261, US-009507513-1808USA004368:Original Case : 1808USA001261, US-009507513-1808USA004398:Original Case : 1808USA001261, US-009507513-1808USA004399:Original Case : 1808USA001261, US-009507513-1808USA004400:Original Case : 1808USA001261, US-009507513-1808USA004369:Original Case : 1808USA001261, US-009507513-1808USA004370:Original Case : 1808USA00126.
My arm got progressively sore. within the week it migrated to the muscle next to my breast and up my neck. Two weeks later it settled in my shoulder and was very painful. It was akin to bursitis which I have never had in that shoulder but years ago I had bursitis in my other shoulder so I know what it feels like. But, now it has migrated to a sore neck and  causing stiffness when I try to turn my head.  It seems to hurt worse when I lay down and try to sleep than it does when I am sitting or standing. I have not gone to the doctor so I cant answer item 19. Driving is too painful so I probably wont go to the doctor and hoping it will get better. But, I am wondering if I should get my second shot in June or not.
Fever 100.6 Chills Headache Body ache Dizziness Fatigue
This case was reported by a nurse an described the occurrence of generalized tonic clonic seizure in a 11 year old female subject who was vaccianted with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, absorbed (Boostrix) for prophylaxis. Previous and or concurrent vaccination included meningococcal Group A C Y and W 135, polysaccharide diphtheria toxoid conjugate vaccine Menactra given on 5/26/2006. On 5/26/2006, the subject received the 1st dose of Boostrix (unknown, right arm). On 5/26/2006, at an unspecified time after vaccination with Boostrix, the subject experienced a generalized tonic clonic seizure after going to sleep. The subject was hospitalized overnight and is currently doing fine. At the time of reporting, the event was resolved.
Rashes began breaking out all over my body just under 2 weeks after receiving my 3rd dose of Moderna Covid-19 vaccine. The rashes were accompanied by intense itching. The rashes appeared on my neck, back, feet, hands, legs, arms, and chest. The rashes would appear randomly without warning and in locations on my body that had recently experienced amounts of friction. Rashes would seemingly grow in intensity later in the evening.   My nurse practitioner diagnosed me with dermatographia as a result. Treatments included Zyrtec daily in the morning and Benadryl as needed at night.  Over the course of the next several months, the rashes began declining in frequency and intensity.   As of about February 2022, rashes and itching have effectively resolved.
Pt felt faint, dizzy, hot shortly after being vaccinated. Had pt sit in chair where he rested, received cold compresses and was manually fanned. Pt recovered after approximately 30 min. Was given vitamin H2O to drink.
Believes Injection went into the joint not the muscle; Unable to move arm; lost sleep/lack of sleep; severe pain in arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Believes Injection went into the joint not the muscle), HYPOKINESIA (Unable to move arm), INSOMNIA (lost sleep/lack of sleep), PAIN IN EXTREMITY (severe pain in arm) and HEADACHE (headache) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event (No reported medical history).   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Believes Injection went into the joint not the muscle), HYPOKINESIA (Unable to move arm), INSOMNIA (lost sleep/lack of sleep), PAIN IN EXTREMITY (severe pain in arm) and HEADACHE (headache). On 11-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Believes Injection went into the joint not the muscle) had resolved. At the time of the report, HYPOKINESIA (Unable to move arm) and PAIN IN EXTREMITY (severe pain in arm) was resolving and INSOMNIA (lost sleep/lack of sleep) and HEADACHE (headache) outcome was unknown.            This case was linked to MOD-2021-061635 (Patient Link).; 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, Headache, Hypokinesia, Pain in extremity and Insomnia, a causal relationship cannot be excluded.  This report also refers to a case of Incorrect route of Product administration for mRNA-1273, lot # 030A21A.
itching on nose and back. No urticaria, no angioedema, no throat tightness. 50 mg benadryl given. pt reassessed and symptoms resolved. informed pt to go to ER or call 911 if symptoms worsened and to follow-up with doctor.
?Covid arm? appeared approximately 8 days after getting first moderna shot? very itchy upper left arm at site of injection, within a few hours became a raised lesion-type area approximately 4 inches long and 3 inches across, hot to touch, hard
have her second dose in July on July 9th, she tested positive for COVID on the 21st of the December; have her second dose in July on July 9th, she tested positive for COVID on the 21st of the December; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the parent.  A 17 year-old female patient received bnt162b2 (BNT162B2), administration date 09Jul2021 (Lot number: FA6708) at the age of 17 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose no:1, Lot no: EW0217), when the patient was 17 years old, for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 21Dec2021, outcome "unknown" and all described as "have her second dose in July on July 9th, she tested positive for COVID on the 21st of the December". The patient underwent the following laboratory tests and procedures: covid-19: (21Dec2021) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Advil. Clinical course: This consumer reported that her daughter is the patient who had 2 doses of the Pfizer Covid-19 Vaccine, so she had like her last dosage was 09Jul caller did not provide year and was unwilling to complete this report so unable to clarify further. Caller's question is when is she eligible for the booster of the Pfizer Covid-19 Vaccine relative to her testing positive for COVID; should she wait 90 days
4" x 6" swelling and redness around shot area generating temperature of 101 degrees two and three days after being administered, headache lasting 2 days, joint pain lasting one day
PNEMONIA, ARDS, VENT REQUIRED 4 DAYS DOD3/19/21
Initial information received on 31-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 35 years old female patient  who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE instead of QUADRIVALENT INFLUENZA VACCINE expiry date May-2019 (lot number, route and site of administration was not reported) on an unknown date while she was 7 week pregnant. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered, Inappropriate age at vaccine administration and overdose. It was also a case of vaccine exposure during pregnancy. It was unknown whether patient experienced any adverse reaction. 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 party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Pt developed bursitis in (L) upper arm. Pain in shoulder a few hours after injection. Pain continued x 10 days with limited range of motion of shoulder. Saw orthopedic surgeon at home. Rx with prednisone orally and PT. Sx resolved after 5-6 weeks. No disability.
Information has been received from a licensed practical nurse concerning a seven-year-old male patient with no allergies or pertinent medical history, who on 10-NOV-1998 was vaccinated SC with a dose of varicella virus vaccine live. There was no concomitant medication. On 25-OCT-2005 the patient was diagnosed with chickenpox with 20 lesions. He was afebrile. There were no laboratory studies performed. The patient is recovering. There was no product quality complaint reported. The patient sought unspecified medical attention. Additional information has been requested.
Pt fainted after receiving the vaccine, then vomited.  911 was called, EMTs checked his O2 (98-99), BP (98/58), and Blood Sugar (104).  Pt slowly started to feel better, no extra measures were needed.  Pt was given water and walked out to his car with his mother.
25 minutes after recieving injection. Red rash to upper torso, arms, neck and face.  Hot flash.  Treated with atarax 50mg.  Watched by paramedic for 30 minutes. Rash subsided. released to go home with strick instructions to call EMS if rash worsened or any difficulty breathing.
Case number PHEH2014US020749 is an initial spontaneous report received from a pharmacy technician on 14 OCT 2014. This report refers to a 47 years old female patient. Her medical history and concomitant medications were not reported. She was inadvertently exposed to FLUVIRIN 2014/2015 (batch number: 1411001) splashed in her eyes on 14 OCT 2014 when she was drawing up a dose of FLUVIRIN for a patient. It was reported that her affected eye burned, experienced hurt causing some swelling. She was wearing contact lenses at the time of vaccine splash then removed her contacts and used the eye wash on the affected eye. After eye wash, she noted that her eye was puffy and warm under the eye. Her vision had not been impaired and she was wearing her glasses. The outcome of the events was reported as unknown. The seriousness and causality of the events were not reported.
Post vax, the patient developed hives which started under the left arm and continued to spread until her body was covered. The patient saw a physician on 07/27/2001 through 08/01/2001 each day.
On 11/28 patient contacted doctor and later visited the office. Diagnosed with Bell's Palsy affecting left side of face. Patient has history of head trauma so uncertain whether vaccine caused problem.
Patient felt lightheaded, nauseated and complained of numbness in tongue. Patient did not have any further symptoms of allergies. After a few minutes, she developed a headache and was tired. She was released after 30 minutes.
Pfizer-BioNTech COVID-19 Vaccine EUA. Sharp/throbbing pain into underarm and left breast. This is day two after getting the second dose. It just started this morning when I woke up at 8 am.
patient developed hives 4 hours after vaccination, started taking antihistamines every 4 hours to manage symptoms, came to clinic on 8/22/21 and got dexamethasone 8mg IM, called on 8/23/21 that symptoms were returning, was prescribed prednisone taper pack.
Information has been received from a physician concerning a 14 year old female with no pertinent medical history or drug reactions/allergies who on 16-AUG-2007 was vaccinated with a first dose of Gardasil (lot# 0469U) 0.5mL IM in the gluteus. There was no concomitant medication. On 16-AUG-2007 the patient had a short seizure and then fainted shortly after being vaccinated with Gardasil series for approximately 20 seconds. Medical attention was sought. The patient was treated with an ammonia inhalant and oral fluid (Gatorade). On 16-AUG-2007, the patient had fully recovered. Follow-up information was received from the medical assistant. The patient had no injection site reaction. The patient was adopted so a medical history of the patient was not available. Upon internal review, short seizure is considered to be an other medical event. Additional information is not expected.
Nausea; Feeling like I wanted to throw up; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (Nausea) and VOMITING (Feeling like I wanted to throw up) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LIRAGLUTIDE (VICTOZA), PHENTERMINE, ROSUVASTATIN, FAMOTIDINE, IBUPROFEN (DUEXIS) and ESTROGENS CONJUGATED (PREMARIN) for an unknown indication.    On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea) and VOMITING (Feeling like I wanted to throw up). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency. At the time of the report, NAUSEA (Nausea) and VOMITING (Feeling like I wanted to throw up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-184719 (Patient Link).
Huge headache and felt very weak for the entire next day; Huge headache and felt very weak for the entire next day; Nausea and massive feeling of imbalance.; Nausea and massive feeling of imbalance.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 19Apr2021 at 18:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. Concomitant medications taken within two weeks of vaccination included escitalopram oxalate (LEXAPRO), bupropion hydrochloride (WELLBUTRIN) and Probiotics; all from unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 29Mar2021 at 18:00 (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 19Apr2021 at 21:00, the patient experienced nausea and massive feeling of imbalance. The patient experienced huge headache and felt very weak for the entire next day on 20Apr2021. 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 events nausea and massive feeling of imbalance, huge headache and felt very weak for the entire next day was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Husband and wife had a adverse re-action to the Pfizer covid-19 shot given all within the same week. We was both labeled with having a stroke. Mine was a stroke in hospital for 2 days. Had a MRI done and said to have been a stroke. The store I had my covid-19 shot is pharmacy.
arm is warm; arm is swollen; arm is red (red spreads down to her elbows); arm is itchy; fever; uncomfortable feeling within a few hours; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (uncomfortable feeling within a few hours), INJECTION SITE WARMTH (arm is warm), INJECTION SITE SWELLING (arm is swollen), INJECTION SITE ERYTHEMA (arm is red (red spreads down to her elbows)) and INJECTION SITE PRURITUS (arm is itchy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history reported).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced MALAISE (uncomfortable feeling within a few hours). On 09-Apr-2021, the patient experienced INJECTION SITE WARMTH (arm is warm), INJECTION SITE SWELLING (arm is swollen), INJECTION SITE ERYTHEMA (arm is red (red spreads down to her elbows)), INJECTION SITE PRURITUS (arm is itchy) and PYREXIA (fever). At the time of the report, MALAISE (uncomfortable feeling within a few hours), INJECTION SITE WARMTH (arm is warm), INJECTION SITE SWELLING (arm is swollen), INJECTION SITE ERYTHEMA (arm is red (red spreads down to her elbows)), INJECTION SITE PRURITUS (arm is itchy) and PYREXIA (fever) outcome was unknown.
fever & mild upper airway sx, then lower resp problems w/dec 02;dx influenza, r/o pneumonia;deteriorated;required intubation, ventilation support;dx pneumococcal pneumonia;devel shock, father req no aggressive tx-pt died; father ref autopsy
Intense pain at site for over 24 hrs. Fever, chills, sweats,headache,sore muscles, aches
Admitted to hospital with sob upon exertion that started prior to vaccine. Hx COPD, HTN, CKD, hyperlipidemia, bladder cancer in remission.  Stated he has been taking Eliquis and Xarelto between renal doctor and cardiologist Dr.  Anticipating going home 2/5/21 but then turned blue and stopped breathing under a DNR. COVID test negative.  Labs show acute on chronic renal failure with an elevated troponin likely from demand ischemia.