chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red rash at injection site; Swelling (puffed-up) at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Red rash at injection site) and VACCINATION SITE SWELLING (Swelling (puffed-up) at injection site) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE RASH (Red rash at injection site) and VACCINATION SITE SWELLING (Swelling (puffed-up) at injection site). At the time of the report, VACCINATION SITE RASH (Red rash at injection site) and VACCINATION SITE SWELLING (Swelling (puffed-up) at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications not included. Patient treatment information was not provided.
Diffuse erythematous indurated reaction from shoulder, mid-way down to elbow.  This reaction was mostly resolved in 3 days.
2nd dose pfizer vaccine was given to patient on 07/07/2021. We found out on 07/09/2021 vaccine was stored outside the recommended 31 day expiration window. We reached out to pt on 07/15/21 to discuss incident but we were unable to talk to pt.
A non-serious, spontaneous report of secondary transmission of flu, muscle cramps, headache and chills has been received from a consumer concerning an adult female, subsequent to second hand exposure to FLUMIST. No medical history or concomitant medication information was provided. The patient's sister took her two children to receive FLUMIST on 09-OCT-2008. The children then spent the week-end starting 10-Oct-2008 away from home. On an unreported date in mid 0ct-2008 the patient experienced muscle cramps, headache and chills. The patient picked up her children from school on 15-Oct-2008. She went to the urgent care center for chills, headache and muscle cramps. The reporter states "She said the doctor there told her she probable got the flu from her kids." No outcome was reported.
Left upper arm just distal to shoulder, reddened area roughly 4cm in diameter with another 1cm border which is lightly reddened. The area is very warm to touch, painful. Injection received 12/22 seen in ER 12/24/08. Treatment of 300mg CLINDAMYCIN Q10 for 7 days and to apply ice or hot packs to the area.
I am like struggling; I am just lethargic as hell after I got my 1st Pfizer shot, at the following day I slept like 13 hours straight; I have been gaining weight ever since I had it and I am still like, I am not losing weight, I  started gaining weight; I am just on blood pressure pills; the following day I slept like 13 hours straight.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Lot number: EW0182) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Nov2020 (unspecified if ongoing), notes: I had Covid in early November. The patient took concomitant medications. The following information was reported: LETHARGY (non-serious) with onset 2021, outcome "unknown", described as "I am like struggling; I am just lethargic as hell after I got my 1st Pfizer shot, at the following day I slept like 13 hours straight"; WEIGHT INCREASED (non-serious) with onset 2021, outcome "unknown", described as "I have been gaining weight ever since I had it and I am still like, I am not losing weight, I  started gaining weight"; BLOOD PRESSURE ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "I am just on blood pressure pills"; HYPERSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "the following day I slept like 13 hours straight.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lethargy, weight increased, blood pressure abnormal, hypersomnia. Additional information- It was reported that patient recently got a shot, he had Covid in early November and he got Pfizer the 1st shot probably 2 and half month ago and he  was just  don't know what the side effects could be from it, like he  was trying to walk like,  like 5 miles a day and he  was like struggling and he had been athlete his whole life and he usually bounce back like very quick and he just can't get out his way, he  was just lethargic as hell after he got  1st Pfizer shot at the store, at the following day he slept like 13 hours straight No follow-up attempts are possible. No further information is expected.
Patient was given higher dose then recommended.  The vaccine was not diluted.  There was no adverse event that happened to the child..
FULLY VACCINATED IN MARCH FOR COVID-19  TYPE AND DATE NOT DOCUMENTED ADMITTED TO FACILITY 7/7/2021 WITH RESPIRATORY DISTRESS HX OF ESRD WITH DIALYSIS
This case was reported by a healthcare professional and described the occurrence of myelitis in a 60-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). There were no concurrent medications. On the morning of 26 September 2011 the subject received a dose of FLUARIX at 0.5 ml in the left arm. On 1 October 2011, 5 days after vaccination with FLUARIX, the subject experienced myelitis. A CT scan performed on an unknown date showed myelitis of C7 and T1. It was reported that at one point, the subject could not use his hands. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention). The subject visited his doctor's office and the emergency department. He was treated with Steroids. At the time of reporting the events were improved. The healthcare professional considered the events were possibly related to vaccination with FLUARIX.
Patient states she experienced: nausea, redness, soreness and bruising at the injection site.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 07-SEP-2011, the patient was administered with a dose of VARIVAX (Lot # 0345AA expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.
Hurting, red. unable to sleep. 10/21 red, warm, swollen, edema approx 15x19cm. Red around arm.
My toes started turning blue on both feet . After 2 days my left pinky toe started hurting and could not touch it. A small blister came up stayed for about a week. I went to my primary dr and the blister had busted. Treatment was antibiotic. 2 weeks later toe was worse turning blue and burning so I went back to the dr and he sent me to a podiatrist. Went 2 or 3 times with no treatment just xray. Podiatrist referred me to vascular surgeon. Vascular did tests on my vascular system ct scan showed no vascular disease.  Toe is now turning black and Grey like a bad scab but had no trauma to toe prior. Vascular dr said it was a blood clot on top of my toe. So vascular dr said to amputate my toe or go to wound care. I have been to wound care 2 times and still no treatment plan and  now I am seeing a podiatrist surgeon at wound care Friday aug.6th to amputate my toe. The pain in my foot is excruciating. I feel like I have no choice. I have been dealing with all this since the first of March. I am still experiencing purple toes fingers and nose when I get cold which ache and burn.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose past 12 hour post puncture) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 29March2022, Date and time vial was first punctured on 29 March 2022 at 10am, Date and time of administration of vaccine 30 March 2022 at 10:35AM.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Mar-2022 at 10:35 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2022 at 10:35 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose past 12 hour post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 29March2022, Date and time vial was first punctured on 29 March 2022 at 10Am, Date and time of administration of vaccine 30 March 2022 at 10:35AM.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose past 12 hour post puncture) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 29March2022, Date and time vial was first punctured on 29 March 2022 at 10Am, Date and time of administration of vaccine 30 March 2022 at 10:35AM.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant drug reported. No treatment information was provided by the reporter. Vial was stored post puncture at Room temperature. Vial didn't undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 24hr.
Fever; headache; nausea; aches and pain; joint pain; she feels like she has the worst flu ever; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. A female patient of an unspecified age (age: 62 (unspecified unit)) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), at single dose for COVID-19 immunisation and did not feel any symptoms with her first dose. Caller reported that she received second dose yesterday (27Jan2021). Caller was experiencing the following symptoms today (28Jan2021): Fever, headache, nausea, aches and pain, joint pain. Caller states that she feels every single side effect she has. Caller reports that she feels like she has the worst flu ever. Caller states that she has taken Tylenol. Caller would like to know how long her symptoms will last. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
FEVER, SORE AND SWOLLEN ARM, ERYTHEMA AT SITE, NAUSEA.
During his regular taekwondo class 12/1, patient felt short of breath and had to bend over and "breathe in a football player position" multiple times to catch his breath.  He has never reported that in his 5 years of taekwondo.  That evening at home he was breathing with intermittent deep breaths and said it was hard to breathe, especially when he lay down to try to go to bed.  He said it hurt in his left chest (pointing to heart area), and that pain felt worse when he lay down or took those deep try-to-catch your breaths.  His at home heart rate and pulse ox were normal, and once he went to sleep his breathing pattern appeared normal.  The next morning he had the same symptoms but still normal heart rate and pulse ox. I started him on ibuprofen assuming this could be a vaccine related mild case of peri or myocarditis.  He went to school 12/2 but avoided physical activity, and pediatrician recommended he come to office for an EKG.  EKG was done and was read as normal.  Vitals all normal.  Exam normal except the strange intermittent deep breaths were observed, and patient was a little tender in both his chest wall and his upper back.  Since EKG was normal doctor said to just continue ibuprofen and observe him, go to ER if worsening symptoms.  It was not 100% clear if this was a vaccine reaction vs costochondritis, although patient had no known precipitating factors for costochondritis or unusual activities for him.
RED RASH ABOUT SIZE OF SILVER DOLLAR ON LEFT DELTOID REGION WHERE VACCINE WAS GIVEN; RED AND PUFFY.
Received H1N1 injection on 12/19/09 @ 10:30, @ 12:15 felt "faint" but did not faint for a couple of seconds and then resolved. Felt "itchy" for about 12 hrs - no rash. Also had intermittent c/o nausea - with vomit. Refused to HD 12/18/09
5MAY93 mom called to report swelling rt leg; requested bring pt to clinic; area of edema approx size of quarter or so;
It hurts when I lift my left arm - where I received the vaccine shot.   Ibuprofen relieves most of that pain.
12 hours after injection, got a severe migraine which resulted in a visit to the ER.
Elevated temperature, blood pressure & pulse.  Began during night of 4-6-21.  Sent to local ER where he received IV fluids & Tylenol.  Upon return to facility was prescribed Benadryl & Prednisone Dose Pack. Question #20 answered unknown as patient recently started the prescribed medications.
Patient stated Pain in left hand finger tips, swelling in left  wrist, body shaking, teeth chattering and Patient states she was forgetting were she was.  Patient stated Shortness of breath./  Treatment:  Gave Oxygen, and sat with her and calmed her down and she felt good to leave one hour later.  Pt currently is feeling good and no symptoms currently as of today.
caller received his first dose of the covid-19 vaccine in January, caller states 10 days later tested positive for covid-19; This is a spontaneous report from a Pfizer-sponsored program Covax  Support. A non-contactable male consumer, the patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date in Jan2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, consumer stated 10 days later tested positive for covid-19, caller was questioning second dose. The outcome of the event was unknown.  Information about the lot/batch number has been requested.
I saw the buildings around me tilt as I walked away from vaccination site, 3 minutes after waiting 15 minutes. I called ou tto people near me that I was fainting, so they grabbed my arm. I supported myself on teh building, which was 3 feet away. The sensation of a tipsy world left immediately. But they still called a nurse, who wheeled me in to the vaccination site to take vital signs.
Exactly a week after the chicken pox vaccine patient started with fever of 101. Sudden onset. Did not have any cold symptoms that day. Then he was fussy, when walking he was just stumbling around and would fall over. Then on 05/18/2013 he started with slight wheezing, cough and rattling in chest. Was taken to doctor's office on 05/20/2013.
This spontaneous report as received from a pharmacist refers to an adult female patient. The patient was vaccinated with the first dose of RECOMBIVAX HB (dose, route and lot number not reported) on 17-JAN-2012 and would "now" like to received her second dose "today", on 02-OCT-2012. No adverse symptoms reported. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. At the time of report, the patient's outcome was unknown. Additional information has been requested.
None, no ADR. Pt was just double dosed a PREVNAR. Received 4/1/15 also.
Chills. Lots of chills. Fever. Felt like I was hit by a train, only the night of getting the vaccine tho. Also was extremely tired and my head felt foggy, even the next day too.
Skipping heart beats.  Not "irregular" -- very regularly skipping exactly every third beat.   This kept on for hours.   By late evening, it had gone to skipping only maybe every 6th or 8th beat.    After sleeping well all night, in the morning the heartbeat was fine -- no recurrence in almost 2 weeks since then.     (Because of heart surgery 20+ years ago, on other nights I do have occasional skipped beats -- just one "miss" at a time -- but nothing at all like this continuous series.)  Had NO OTHER  after-effects, none like the ones reported in the news and by acquaintances.
Pt experienced itching & redness on the arm vaccine was administered. Not at the administration site but along the forearm. She didn't know if she got poison ivy or if this was a reaction.
2/28/2018 Per Hospital ED report-At around 2200, when parents went to wake child from nap, child was noted to appear off and parents observed generalized tremors. Pt was noted to have a fever earlier today and was given APAP at 1800. EMS stated that it lasted approximately 30 minutes. The child was not convulsing upon presentation to the emergency department but had a right gaze deviation and was rigid. 2.5 mg of rectal VALIUM and the seizure was arrested. He subsequently had another seizure and a second dose of rectal VALIUM taken the rest of the seizure. T: 37.4 degrees C (Rectal) HR: 140 (Monitored) RR: 35 BP: 89/51 SpO2: 90% WT: 8.4 kg. Patient was transferred from Hospital ED to another Hospital. Per second hospital notes-presented to first hospital with fever and seizure characterized by left arm twitch and staring, episode lasted 15 min at home and continued in EMS. Pediatric neurology recommended an EEG which was normal, patient did have another 2 seizures post EEG. Pediatric neurology recommended sending the patient home on KEPPRA 20mg/kg/day divided BID due to having 4 seizures within a 48 hour period. Patient also prescribed 2.5 mg rectal DIASTAT rescue medication for seizures greater than 3 min or greater than 3 episodes in 30 minutes. Patient was discharged home 3/2/2018 with recommendation to follow up with primary care provider in 2-3 days and Ped Neurologist in 2-3 months.
I have had headaches, what felt like toothaches, one sided facial pain, ear aches, jaw pain, a lot of fatigue, sinus problems and I have had sever pain on the left side of my face, ear and pain. I went to the dentist and he could not find anything wrong with me, he sent me to an Endodontist, and he took and x-ray and test and could not find anything with the x-ray or scan, he did a heat and cold test and he did a root canal on my tooth, but that did not solve the pain at all. I went to urgent care with sever pain on the left side of my face and the Dr. stated I had TMJ and an ear infection and she prescribed a muscle relaxer and an antibiotic. The antibiotic cleared the ear infection, the muscle relaxer did not help at all but the pain. I was till feeling a lot of pain so a couple of days later I went to my primary care and the NP that saw me was concerned and she ordered a CT scan, and she disagreed with the diagnosis of TMJ but said that I l had a lot of fluid behind my ear, and the CT Scan did state that I had TMJ Arthritis but no infection, they set up an appoint for me to see someone for arthritis. I have also been referred to an oral surgeon for neuralgia, I was also advised to see an ENT which I saw on yesterday and she said I had hearing loss in both ears but no infection, she recommended hearing aides, and she also recommended that I go to an oral surgeon to look at the TMJ closer and come back to see her after that.
Pt recv vax on 10/30/98; 10 min post vax pt exp LA swelling (knot)/ sore/ bruising; rash on neck w/itching; tx=cold compress, Prednisone, Atarax
Fever; Chill; Body Aches; This case was reported by a consumer via sales rep and described the occurrence of fever in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 8 hrs after receiving Shingrix, the patient experienced fever, chills and general body pain. On an unknown date, the outcome of the fever, chills and general body pain were unknown.   It was unknown if the reporter considered the fever, chills and general body pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's Comments: The reporter reported that the patient experienced fever, chill, body aches starting approximately 8 hours post administration. The reporter did not consent to follow up.
Patient received flu shot and walked away to look at stuff in the store. Shortly the patient started to experience some dizziness and vision went black. Patient had to sit down and rest. Patient was also feeling hot. Patient had not eaten prior to receiving vaccine. Patient was able to get up and leave the store for home.
Patient passed out after COVID vaccination. Became alert and oriented within 1 minute after vaccine. Gently lowered to floor. Wet washcloth placed to forehead. Given sip of water by parent at 11:00am. At 11:03am patient felt normal and was able to stand without problems. Parent declined any further treatment or EMS notification. Left building ambulatory with parents.
Fever- 102.5, severe headache, severe arm pain(right arm), nausea, diarrhea, severe fatigue, chills, body aches- all symptoms lasted at least 36 hours. Nausea for 3-4 days
headache; Dizzy; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to case 2019SA297782.  This case involves a 25 years old female patient who experienced headache and dizzy, while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 17-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious headache and dizzy (dizziness) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was dizzy and headache.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for headache and dizzy.  Batch number was requested.
Developed episodes of chest pain on February 25, 2021; received diagnosis of pericarditis and initiated treatment with ibuprofen on March 9..  Ibuprofen was discontinued March 12 because of elevated creatinine; Colchicine begun on March 10, 6 week regimen. Symptoms gradually resolved by mid-May.  Creatinine returned to baseline.
When I first got the 2nd vaccine. within a minute, I got a headache and it carried out about 4 hours after. A few weeks later I noticed a lot of Lymph nodes swelling under my arm. My blood sugar started to register abnormally higher. In May I noticed I started getting short of breath. My doctor found I have Aortic Stenosis. I did not have this before the vaccine. My doctor did not think it was related. I was sent to a Cardiologist to check the stenosis to see if I need heart surgery.  I was tired as time has went on.
Rash all over my body. It causes a sharp, burning itch. The rash is raised, full of liquid that then oozes.