chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax 15NOV95 & exp pain & swelling that noc, called clinic day @ noon, told to apply warm compresses & return if worse the next day;pain, swelling, redness cont to worsen pt had fevers;extensive induration, erythema & pain
Infant had 18 hours of inconsolable severe screaming, beginning within minutes of receiving vaccine. By the time they reached our facility's parking lot.
Muscle Aches to the point where my heart and chest hurt. Never had heart issues before. Felt like rapid heart rate. Happened with my 2nd shot and now my buster.
Information has been received from a nurse concerning a 24 month patient who on an unspecified date was vaccinated with the second dose of VARIVAX (Merck) (lot # 664719/0804Y). On an unspecified date the patient experienced a large area of swelling and pain at the injection site and may have developed some blistering which may have scarred. It was unknown if the patient sought medical attention. The outcome was not reported. This is one of several reports from the same source. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Drug Evaluation and Research and was released. Additional information has been requested.
Patient came in on 2/21/21  to show us her arm and she had a red circle 2"x3" large around the injection site. It did not feel hot. She did say it had itched some and she had used hydrocortisone cream and took Benadryl. She was worried that after 10 days of first shot, it was a red circle. It was not raised.  We instructed her to watch it and let us know if got worse to decide about getting second dose.
SUSPECTED COVID-19 INFECTION; OFF LABEL DOSING FREQUENCY; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via a company representative through social media concerned a patient of unspecified age, sex, race and ethnicity.   The patient's height, and weight were not reported. The patient's concurrent conditions included: immunocompromised. On an unspecified date, the patient previously received 2 doses of covid-19 vaccine (unspecified manufacturer)(dose number in series 1) (form of admin, route of admin, and batch number and expiry date were not reported), dose was not reported (dose number in series 1), for covid-19 prophylaxis. It was unknown whether patient had any adverse event following vaccination with 2 doses of covid-19 vaccine (unspecified manufacturer) (dose number in series 1). The patient previously received first booster with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2). The patient received second booster with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 3), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis which was a revaccination with different covid-19 vaccine and off label dosing frequency (Off label use) (Dose number in series 3). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19 infection twice (Dose number in series 3). First time patient had a bad cold and a fever, and second time with coughing and a headache.  It was reported as "I've had all my shots and two boosters and I've had COVID twice. And I'm immunocompromised. First time it was like a bad cold and I had a fever and I have it again now with coughing and a headache. I am so glad that I had those immunizations are I probably be sitting in a hospital bed". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of off label dosing frequency and revaccination with different covid-19 vaccine was not reported. This report was non-serious. This report was associated with product quality complaint: 90000264370.
Muscle swelling, tender to touch above the heart. Days after the vaccine small lump appeared.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients medical history, concurrent conditions and concomitant medications was reported. On unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 lot # L016429, expiry date 09-SEP-2017 (dose, route of administration and anatomical location were not specified). Administered doses of GARDASIL 9 underwent temperature excursion at 48.6 Fahrenheit degrees for 1 hour and 45 minutes. It was reported that the vaccine underwent previous temperature excursion at 48.9 Fahrenheit degrees for 1 hour and 15 minutes. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a medical assistant referring to a 2 year old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 16-OCT-2018 the patient received an improperly stored dose of PROQUAD (lot # R012417, expiry date: 28-OCT-2019; dose, frequency and route were not reported) for prophylaxis (product storage error), which was reconstituted with properly stored sterile diluent. No adverse effects were reported. There was no previous temperature excursion. It was also reported that temperature was from 15 Fahrenheit to 46 Fahrenheit for 8 hours and the data logger was involved. Sender's Comments: US-009507513-1902USA007536: US-009507513-1902USA007538: US-009507513-1901USA008772: US-009507513-1902USA007539: US-009507513-1902USA007540: US-009507513-1902USA007541: US-009507513-1902USA007542: US-009507513-1902USA007543: US-009507513-1902USA007544: US-009507513-1902USA007545: US-009507513-1902USA007546: US-009507513-1902USA007547: US-009507513-1902USA007548: US-009507513-1902USA007549: US-009507513-1902USA007550.
Vaccine given April 5, 2021. On April 5, 2021 around Midnight/April 6, 2021 12:01am, I became very chilled and a very uncomfortable headache started; I remained cold for about 1 hour; headache lasted for 7 hours - subsided after I took one 200 mg Advil softgel; aches and pains in head, both sides of jaw, knees, and ankles from Midnight to 4:00am; very tired and didn't feel like walking or moving around much from Midnight to Noon (April 6, 2021); felt nausea on and off from 1am to 7am; perspired from 2am to 4am (didn't get up to take my temperature so don't know if I had one but pretty sure I did since I sweated for so long).
Numbness and tingling in feet, hands and lower legs.  Heart rate over 130 even after taking Adavan.
Flu like symptoms. Fever. Sweating. Body Aches. Stuffy nose. Headaches.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Healthcare consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with the agency on a compliance improvement plan and has been reinstated vaccination privileges.
The following information gathered from patient on 4 July while in hospital:  Patient reported to HC on 2 July/ Day #8 after receiving SPX Vaccination on 24 June complaining of chills and tunnel vision, feeling 'off', sweating profusely temp was 102 degrees with BP of 160/120.  Patient also revealed prior sun exposure on 1 July with some reddened areas.  Physician sent to Hospital. Patient stated that the vaccination on his arm appeared about the Day #10 picture when shown pictures of normal reaction timeline and described, "bruised yellow on perimeter...continued oozing... sunken a bit...too yellow to be a scab".  Spoke with house Doctor.  During hospitalization CRPs elevated to 5-6, patient had diarrhea, received fever reducing medications, blood cultures and SPX vaccination site was removed by surgeon.  When asked if tissue samples were taken it was unknown.  Per patient the skin area around the vaccination site was cleansed with rivanol 0.1%.  10/27/2008 MR received for OV 7/8/2008 with Dx:  Cellulitis. Pt seen in f/u for foreign hospital visit for viral fever and smallpox vaccination site infection. Tx-antibiotics. Pt is now well
Seizure, New onset focal, one sided, still seizing after rectal valium, resolved after IV valium transferred.
Patient came in for his 3rd Hep B vaccine. Pulled vaccine from fridge, check vile date, within date. Double checked with other nurse "this the correct vaccine" she to glanced at the vile in hand and stated, "yes". Peeled label and placed on consent form for patient to sign to receive vaccine. Administered vaccine to patient with no incidents. Upon putting vaccine information in under patient name, lot number come up for "PEDS dose". Went to fridge to check box, box had "up to age 19" on it. Was not aware the adult and peds where together in same basket (only box of Hep B vaccines in fridge), actual vile of the vaccine did not list it was a PEDS dose. Notified vaccine coordinator of what happened and what my next step was.
Swollen gland under arm that had injection 24 hours later.  Swelling was visibly noticable lump.  Underarm slightly tender 7 days later.  A lot of body aches and pains, hurt to roll over from 24-48 hours post-injection.
Stroke approximately 3 Weeks after 2 dose; This is a spontaneous report from a contactable consumer(patient). A 56-year-old male patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration in APR-2021 at the 56 years old at single dose for COVID-19 immunisation.  The medical history included previous heart attack 4 years ago. The concomitant medications included Other medications in two weeks. There was no other vaccine in four weeks. The Historical Vaccine was first dose BNT162B2 in Mar2021 12:00 PM at 56 years old for Covid-19 immunisation. The patient experienced Stroke approximately 3 Weeks after 2 dose on 09May2021 14:30. The patient was Hospitalized due to it from May2021 to May2021(duration 2 days). There was Emergency Room Visit, department or urgent care. There was treatment for this event.  The event was assessed as Life-threatening. There was no covid prior vaccination. The patient underwent lab tests and procedures, which included Nasal Swab on 09May2021: unknown. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Soreness in arm from shoulder to elbow; swollen post 24 hours.  48 hours out, soreness lessening.
Flushed skin, body heated, hives and tingling in hands. Given 25 mg of Oral Benadryl and drank 16.9 ounces of water. All symptoms went away within 15 minutes of taking Benadryl. No further symptoms occurred.
11/29/2021: heart palpitations/myocarditis diagnosis is being assessed; confirmed by testing (ECO, MRI, blood). 12/28/2021: muscle tightening/soreness on left-side of body (calf, neck and lower back). 12/29/2021: anxiety; and "hot"/burning skin feeling in both forearms, colon area on stomach and under right armpit. 12/24/2021: constant insomnia.
chills; feels like a "chill pain" going up her spine and pain in her spine; out of breath; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received first dose of BNT162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that she received the first dose of the Pfizer Covid 19 vaccine, she felt chills that night and the following days, she didn't have a fever but she states she feels like a "chill pain" going up her spine and pain in her spine. Also, since receiving the vaccine she felt like she was out of breath but took a deep breath and she felt better. She described them as "anxiety-like" symptoms but stated she does not have anxiety. She had not seen a doctor about this symptoms. The patient wanted to know how long will the chills last. She enquired if the vaccine could trigger any dormant conditions upon vaccination and there are any recommendations for receiving the second dose of the vaccine 20 days after the first dose instead of 21. She asked regarding lymphatic drainage massages or infrared sauna, is that something she should avoid due to the vaccine. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fatigue, unable to stay awake x 3 days , felt hot and cold, severe body pain, lump r side of neck then lump under arm pit , Bells Palsy
Case PHEH2016US024027 is an initial spontaneous report received from pharmacist on 16 Sep 2016. This case refers to unknown demographic patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose FLUAD (batch number: 165803) at a dose of 0.5 ml intramuscular on an unknown date. The pharmacist was reported that, the FLUAD syringe leaked when administering vaccine to a patient. The pharmacist did not know the date of occurrence did not have any patient information or expiration date. No adverse event was reported following this medication error.
Patient got a swollen arm from the shoulder to the elbow. It is also red and painful.
Patient experienced chest pain, stomach ache, and diarrhea the afternoon after the vaccine was administered.  The patient has no history of chest pain and believed that the symptoms were due to the shot, which was given earlier in the day.  The symptoms continued for 2 days.  The patient appeared to have fully recovered after two days, and no longer experienced the previously described symptoms.
I have a rash/itching on my neck into my earlobes that are swelling. This began a week after the first vaccine and got worse after the second one. I also started itching in my belly button and it is all red and looks like it has some tiny blisters inside of it. I've been taking generic claritin and did take some generic Benadryl - but not every night.
Pt was scratched by her cat in the eye (right). MD advised TD. Given and reaction occured 12/06/2001. Left deltoid area with redness, slightly swollen.
Redness, swelling getting worse in past 24 hrs. Low grade fever. Site is warm to touch. Reaction on Right leg. Tx: Erythromycin.
10 hours after Sever Diarrhea, almost passed out twice with lightheadedness for about an hour.  Day 1 fever ranged from 100-103.  Day 2, Fever ranged from 99-101.  Day 3 low grade fever, day 4, no fever.  Chills and body aches severe day 1, moderate day 2.   Headache moderate day 1, mild days 2 and 3 Fatigue Extreme through day3, moderate on day 4 when it tapered off through day 10 Arm pain Local resolved after day 6.
Patient was given a flu vaccine by my immunizing technician. She was advised to stay in the store but she went outside and waited in her car. She came back in after 15 minutes presenting with itchy legs, arms and chest, heart racing, scratchy throat and SOB. She could talk with no difficulty and didn't appear to be in respiratory distress. I had the patient sit in the immunization room, I gave her two 25mg diphenhydramine then observed her (with epi-pen ready) for another 15 minutes until her mother (who's a nurse) came and picked her up. She asked us not to call 911.  In those 15 minutes her itchiness, heart rate and scratchy throat were better. She stated she was a nursing student and her mother was a nurse and they had an in-date epi-pen at home.  I advised the patient to follow up with emergency services or a clinic as symptoms could re-occur within 24 hours.
Patient experienced right side chest pain ten minutes post vaccine. PR 20, HR 78, 97% Sat, 130/70, Blood glucose 124. 0 SOB, 0 dizziness, 0 headache. EMS evaluation: EMS and NP recommendation to go to local ER for evaluation. Pt refused transport to local hospital. Patient advised on side effects/adverse reactions after vaccine.
Patient started three hours after the Flu Mist was administered with fever of 101.5, body aches, diarrhea, sweats, headache and loss of appetite.  It lasted 36 hours.  The fever returned to normal, but the diarrhea and body aches still persist almost 72 hours later.
pt recvd vax 26OCT denies fever, no localized rxn, devel rash groin area, which progressed stomach & back;seen by MD 3x & family given cortisone inj w/improvement of rash; pt denied any allergy to eggs-able to eat eggs in baked/cooked foods
A report has been received from a Health Professional concerning a 4 year old, female patient. Height 41.75 in; Weight 38.0 Pounds, who had been receiving nasal FLUMIST Quadrivalent, 0.2 milliliters, once/single administration. FLUMIST Quadrivalent started on an unknown date. The patient experienced had a fever on 02-DEC-2015, stuffy nose and runny nose, which started on 30-NOV-2015 and congestion which started during 2014. The outcome of the event of stuffy nose, runny nose, had a fever and congestion is unknown. The reporter's description of the event(s) was as follows: Patient was born one month prematurely. The report was considered to be non-serious by the company physician.
6 cm x  cm erythema with 5 cm circular induration at insertion site.
Full dose of the vial, enough for 6 doses/ 3 milliliters; It won't come back up the way it's supposed to/drop foot; Numbness on the whole left side of my body; Incontinence; Malabsorption; Eye pattern disorder; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Full dose of the vial, enough for 6 doses/ 3 milliliters) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hysterectomy.    On 17-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced ACCIDENTAL OVERDOSE (Full dose of the vial, enough for 6 doses/ 3 milliliters) (seriousness criterion hospitalization). On an unknown date, the patient experienced PERONEAL NERVE PALSY (It won't come back up the way it's supposed to/drop foot), HYPOAESTHESIA (Numbness on the whole left side of my body), INCONTINENCE (Incontinence), MALABSORPTION (Malabsorption) and EYE DISORDER (Eye pattern disorder). The patient was hospitalized from 17-Mar-2021 to 18-Mar-2021 due to ACCIDENTAL OVERDOSE. The patient was treated with Physical therapy for Peroneal nerve palsy and Physical therapy for Hypoaesthesia. At the time of the report, ACCIDENTAL OVERDOSE (Full dose of the vial, enough for 6 doses/ 3 milliliters), PERONEAL NERVE PALSY (It won't come back up the way it's supposed to/drop foot), HYPOAESTHESIA (Numbness on the whole left side of my body), INCONTINENCE (Incontinence), MALABSORPTION (Malabsorption) and EYE DISORDER (Eye pattern disorder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter. The treatment information was not provided. It was said that the patient was hospitalized for a day and a half on 17-Mar-2021 to 18-Mar-2021. Again was hospitalized on 24-Mar-2021, then again on 19-Jul-2021. The patient was struggling with a lot of things.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Pt recvd Engerix-B & p/1st dose devel fibromyalgia;
patient tested positive for COVID-19 virus after first dose of Moderna COVID-19 Vaccine; patient received second Moderna COVID-19 dose over 37 days after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (patient tested positive for COVID-19 virus after first dose of Moderna COVID-19 Vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received second Moderna COVID-19 dose over 37 days after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced COVID-19 (patient tested positive for COVID-19 virus after first dose of Moderna COVID-19 Vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received second Moderna COVID-19 dose over 37 days after first dose). At the time of the report, COVID-19 (patient tested positive for COVID-19 virus after first dose of Moderna COVID-19 Vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received second Moderna COVID-19 dose over 37 days after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.     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.   no concomitant medication were reported no treatment was reported
With in less than 5 minutes after the vaccine, the room was spinning and I was super dizzy. I could never have stood up if I tried. My body felt the way it did when I had a CAT scan with contrast. Like something through my body in addition to the dizziness. I got super nauseous too. The dizziness subsided in about 10 minutes. The nauseous stayed for about 12 hrs. Anti-nauseous meds did help throughout the day. I was fine the next day
12 hours after the  vaccine was administered I experienced chills, nausea , headache, and all over body ache.  The duration was about 6 hours until symptoms subsided. No medications were taken for symptoms, just bed rest.
Had Dtap/Hib vaccine to left thigh on 1/23/07. Several hours later mom noted increased volume to anterior thigh, erythema and increased tonsil temperature. No fever, patient playful with normal gait and eating well. Seen in clinic on 1/26/07 improved without antibiotics.