chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At approximately 3:30 am on 4/2 I began experiencing moderately-severe muscle aches and muscle cramping throughout my body including hips, knees, fingers, thighs, and back. Accompanied with fever, cold sweats, and hot flashes. These symptoms lasted through 10 PM 4/2. Headache present from 7 am to 12 pm 4/5. Arm soreness and fatigue present from 4/2-present. Poor appetite from 4/1-4/5.
Antigen / reconstituted with sodium chloride / was administered to patient; Antigen / reconstituted with sodium chloride / was administered to patient; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amza417a, expiry date 30th September 2021) for prophylaxis.   On 29th June 2021, the patient received the 1st dose of Menveo. On 29th June 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details provided as follows: The patient was administered Menveo in which the powder component of menveo was reconstituted with sodium chloride solution and not the provided diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021142845:Same reporter
Myalgia, Arthralgia, ErythemaMultiform, UrticariaPruritus, NauseaVomiting, fatigue Narrative:  Other Relevant History:
This spontaneous report as received from a medical assistant refers to a 13 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 13-JUN-2014 the patient was vaccinated with first dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # J013324, expiry date: 12-FEB-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
Red, raised rash on extremities, trunk which started evening of- went to bed after taking Benadryl- Awoke to find rash much worse the next day, plus, hands and feet swollen, went to ER and RX'd Prednisone, Benadryl, kept for observation and sent home on above meds plus Zantac.
I right after noticed sensitivity to loud sound and within 2-3 weeks noticed tinnitus in my ears, mainly in my right ear and continues currently.
Client started spiking elevated temperature of 103F and would not keep medication down; vomited on every attempt to keep Tylenol down, approx. 10-15 times. Leg started swelling and redness occurred on 4/13/01, approx. 2 1/2"; then mother took infant to ER, after calling PMD. Client's mother states that the ER physician dx'd cellulitis and administered medications for signs and symptoms; Tylenol and an antibiotic in ER.
This infant developed hives all over his body, eyes swollen, no respiratory involvement. Diagnosed with ear infection when taken to the ER. No fever.
PT HAD ANTHRAX #5 24 FEB 2000; FOR ANTHRAX 1-5 HAS HAD SLIGHTLY INCREASING AMOUNTS OF SWELLING AT INJ SITE. THEN HAD ANTHRAX #6 ON 1 APR 03, AND THE FOLLOWING MORNING NOTED VERY RED/SWOLLEN ARM 110MM X 130 MM. NO SYSTEMIC SYMPTOMS. GIVEN NSAIDS AND DIPHENHYDRAMINE.
Severe acid reflux symptoms for two weeks now, starting a few days after the second shot in the series of varicella/ chicken pox immunizations. The symptoms are making me unable to sleep at night. I have never experienced any acid reflux symptoms before this in my life.
Mom called to report fever of 106 last night (9-1-2016) at 1130pm. Fever this morning of 102 (9-2-2016) MOTRIN given at 830am. Appointment scheduled with physician 9/2/2016 1045am. Temp 98.2 at 11am at physician appointment.
I have a large red ring around my injection site ( left deltoid) that occurred around day 11. I had arm discomfort initially from the vaccine, but that when away.   I am on day 13 since injection. I feel normal other than the  red ring that continues to spread.  I have been taking photos and making the site.  The area inside the ring is warmer compared to my other deltoid on the right side. I am schedule for the next vaccine on the 1/26/21.  I just wanted to make sure I would still qualify to get the second dose/ safe? I can send pictures as well. I just wasn't able to attach an image.
Left deltoid local reaction 5 centimeter swelling resolving by 3rd day. Considered an other important medical event.(OMIC)
Headache, body aches, felt hot, but not fever.  Fever developed to over 101 degrees by 6pm and childrens Motrin was administered (1 tsp) along with a bath to reduce temp.  Provided Motrin again in the morning on 11/14 to reduce fever and help with the headache.  She woke up with swollen blood shot, green goobered eyes. When Motrin wore off and fever was gone, her face was flushed red, her eyes and feet swelled, rashes on her back and legs appeared and she felt itchy on her legs and feet. We provided children's Benadryl around 5pm on 11/14.  She woke up feeling much better on 11/15, but the rashes were still present and stayed for several days.  This is probably unrelated, but she seems to have pulled a muscle possibly on her right thigh when I grabbed her out of her booster seat on 11/17, but it was the leg opposite of the injection. She has been limping and favoring the leg since then.
My left upper arm, where the injection was given, became very hot, achey, and swollen.  The entire area became red and extremely sensitive to touch.  I came down with a fever, headache and chills,and became very fatigued, with a low appetite.  The only medication I took was asperin, to relieve my fever and headache.
This consumer report (initial receipt 16-Jan-2013) concerns a female patient. The patient always received a flu shot in previous years and never had an issue. The patient was in perfect health prior to receiving this flu shot. In the fourth week of Nov-2012 the patient received AFLURIA (batch number not specified). After receiving the vaccine the patient felt extreme exhaustion and body and muscle aches that were severe enough to wake her up in the night. The patient stated that her pharmacist suspected that the symptoms were related to Guillain-Barre syndrome however her primary care physician did not suspect this. The patient received a full physical in Jan-2013 and had various unspecified blood work, the results of which did not reveal a possible diagnosis. No further information was provided. FUP (30-Jan-2013): After internal case review, events of extreme exhaustion, body and muscle aches, waking up in the night were changed from listed to unlisted with change in overall case listedness.
Headache, body ache, drowsiness, sweats, chills,  and ACNE. All other symptoms except acne went away after 48 hours. Acne has been persistent for THREE MONTHS now and has spread from face to neck, back, and chest as well. Went to dermatologist and allergist in order to get rid of the acne and see what I am allergic to.
no adverse event-- just mixing error --multi dose diluent vial was used more than twice to mix with covid
SWELLING ON BOTH  LEGS; RASH ON  INTERIOR LOWER LEGS ALL OVER THE BOTTOM PART; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included breast cancer, renal failure, non alcohol user, non smoker, fish allergy, and sulpha allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, Laboratory data included: Renal function test (NR: not provided) Abnormal. On 06-MAY-2021, the subject experienced swelling on both legs. On 06-MAY-2021, the subject experienced rash on interior lower legs all over the bottom part. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on interior lower legs all over the bottom part, and swelling on both legs. This report was non-serious.
1 patient received Monovalent shot on 06-Apr-2022 from vial shipped in 02-Mar-2022 and thawed in a cooler while being transported; No adverse event; Received Expired Monovalent vaccine after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (1 patient received Monovalent shot on 06-Apr-2022 from vial shipped in 02-Mar-2022 and thawed in a cooler while being transported) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (1 patient received Monovalent shot on 06-Apr-2022 from vial shipped in 02-Mar-2022 and thawed in a cooler while being transported) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (1 patient received Monovalent shot on 06-Apr-2022 from vial shipped in 02-Mar-2022 and thawed in a cooler while being transported) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (1 patient received Monovalent shot on 06-Apr-2022 from vial shipped in 02-Mar-2022 and thawed in a cooler while being transported).    Concomitant medication was not reported.  Patient received Monovalent vaccine on 06-Apr-2022 Lot 046L21A which was shipped on 02-MAR-2022 and thawed in a cooler while being transported. Vial did not undergo any temperature excursions. Vial size 5.5 ml red cap. Reporter stated that, since they did not notice the vaccine was expired, some of these patients received another Monovalent dose after the expired dose within recommended time. They are still investigating and does not have any patient identifiers at this point.  Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2022: Live Significant Follow-up received: Reporter added and narrative updated.
I was preparing to draw up a Pfizer dose when I was called away to assist a patient at the register. I had already prepared the syringe to stick in into the vial by pulling in the correct amount of air when I was called away to assist a patient at the register. I proceeded to help that patient and went back to my vaccination. In my haste to get to the patient I grabbed the syringe that was full of air and administered it to the patient, not realizing I had not drawn up the vaccine. I immediately realized my mistake when I pushed the plunger and withdrew the needle. I apologized to the patient and explained my error and asked him if he would allow me to administer the vaccine. He was very understanding and he allowed me to inject him with his Pfizer dose.
Injection site arm swelled from shoulder to elbow. Stiffness due to swelling. Also C/O fatigue but poor sleep due to arm discomfort. No fever.
A needle malfunction caused a patient to receive less than a full dose.  Vaccinator was unable to determine the dose amount.  I counseled the patient in accordance with the CDC Interim Clinical Considerations.  Patient decided not to receive an additional dose.
On January 13, 2022 patient received their Pfizer Covid- 19 booster vaccine at our satellite location. About 2 weeks later (1-18-22) she developed an itchy rash on her scalp, neck, and shoulders bilaterally. She states the rash is very itchy and she puts Vaseline on it which helps with the itching. It has not gotten worse over the last couple of days. No further complaints and denies needs. Encouraged her to follow-up with her primary care physician for his/her opinion if rash doesn't go away and she VU.
Blood Clot, lower leg (left calf muscle).  MD. recommed Xeralto 20mg
Case number PHHY2011US27085 is an initial spontaneous report received from a health care professional on 29 Mar 2011 with combine follow-up from a nurse on 28 Apr 2011. This report refers to a 17-year-old male patient. he was vaccinated with MenA lyophilized conjugate component of MENVEO (batch number 024011, expiry date: Apr 2012) reconstituted with sterile diluent instead of Men CWY liquid conjugate component intramuscularly on 12 Mar 2011. This was found during an inventory on 29 Mar 2011. No other adverse reaction was reported. The patient was advised for re-vaccination. Follow-up received on 28 Apr 2011: Updated reporter information.
Patient received Tdap on 5/4/06, and then received another dose of Tdap, inadvertently, on 11-14-07.
Pt. states had temperature of 105 degrees.  Afebrile at time of visit to Health Center.
One Day after receiving Flu shot, my father experienced extreme pain throughout his entire body along with fatigue. Soon after, fevers began with night sweats and chills.  He returned to Dr. who prescribed several antibiotics over the course of weeks with no relief.  Symptoms continued and he was hospitalized at a hospital on 12/20/06 - 12/22/06.  Fevers continued to come and go, mostly at night with sweats and chills.  He continued to loose weight and was anemic.  He changed doctors and began seeing another Dr. who noted there was infection but could not determine the cause.  My father was hospitalized again on 01/17/07 - 01/23/07 and was seen by several doctors and administered several tests but doctors have yet to determine the cause of the infection.  On 02/08/07, he visited with a Dr.  who requested I contact CDC b/c he believes the symptoms are related to his Flu Shot of 11/14/06. His blood work continues to be very abnormal and the muscle fatigue/pain, anemia, and fevers continue. My father has been unable to work since this began and had to unwillingly retire due to above events. He has trouble climbing steps and walking even a small distance.  Prior to this he was very active and completely different.  My father had had prior Flu shots in the past but hadn't had the vaccine in about 4 years. He never experienced any reaction like this.  03/05/2007 MR received from PCP. Multiple OVs from 12/08/2006 to 01/03/2007 for c/o fever. Temp 101.8 on 12/15/06 and 101.1 on 12/29/06.  Fatigue and malaise noted on 12/29/06. DX: FUO.  04/27/2007 MR received for 2 hospital admits 12/20-22/2006 and 1/17-23/2007. Initial admit for c/o cough, generalized aches and weakness. PE: WNL. Prinicipal Dx:  1) Acute Bronchitis. 2)  Malaise/Fatigue.  2nd Admission for c/o fever on and off x 2 months. C/O chills, generalized aches and fatigue. PE: WNL. Principal DX: 1)  Fever of Unknown Origin. 2) Anemia with Thromobocytosis, mild colitis.
Tingling in legs/knees. Swollen left side of face. Swollen and sore left underarm. Swollen and painful left foot. Difficulty walking on left foot. Painfull headache. Chest pain. Extra heartbeats. Heart palpitations. Abnormal heartbeat. Abnormal feeling in chest. Tiredness.  Generally feeling sick/unwell.
Previous to the symptoms that made me go to the ER I had fever (highest 101.4), severe chills, dizziness, fatigue, etc.  Late night on the 26th (in the early morning) I had severe shortness of breath when laying down/difficulty breathing, sitting up made it better but still not normal level. Heart flutters. Brief chest pain and RIGHT arm pain. This lasted a good 30 minutes (the shortness of breath).  Enough so that I called a nurse line, confirmed I needed to go to the ER, went to the ER.   They did EKG, X-ray, gave me pepcin and salt water fluids, blood tests, COVID test, and eventually a CAT scan.  EKG and X-ray came back fine. Blood work indicated ?possible infection? or pulmonary embolism  so they did a CAT scan. CAT scan came up clear for pulmonary embolism but found something else. I think they said something about lymph nodes and one was labeled as a ?priority? RAD4 or something to double check on.   They discharged me after also referring me to mental health services. However, later that day after sleeping (since I hadn?t slept the entire night) I woke up at 2 AM to find a bump on my lower left back (that has been there previously, been there for years) was now inflamed, sensitive and painful, possibly(?) the source of the detected possible ?infection? they mentioned?
Ischaemic stroke; This spontaneous case was reported by a consumer and describes the occurrence of ISCHAEMIC STROKE (Ischaemic stroke) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ISCHAEMIC STROKE (Ischaemic stroke) (seriousness criterion medically significant). At the time of the report, ISCHAEMIC STROKE (Ischaemic stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Reporter mentioned that diagnosis from hospital which included magnetic resonance imaging (MRI), computed tomography (CT scans), and echocardiogram (EKG) did not reveal any signs from where the blood clots were originated. No treatment information was provided by the reporter.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested
Nearly immediately started having joint pain, chills, fever (did not measure temperatuer- it felt low-grade) and lack of energy.  The symptoms have lessened in severity in the 2nd 24 hours but have not yet cleared.  I didn't experience any of these symptoms after the first injection in the series back in May 2019, except pain at the injection site for a day or two I was fine.
8 days after anthrax and smallpox vaccines, developed vesicular rash on trunk, neck, scalp and bilateral upper extremities.  Patient was afibrile and had no other symptoms.  Was see in Emergency Room and diagnosed as generalized vaccinia.  He was hospitalized because he lived in an open-bay barracks and was felt to be infectious. Follow up from Hospital Discharge: headache, nausea, malaise.
Working on scheduling for second dose of Moderna vaccine more than 42 days after first dose; Diagnosed with COVID-19 one week after first dose of Moderna vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Diagnosed with COVID-19 one week after first dose of Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Working on scheduling for second dose of Moderna vaccine more than 42 days after first dose) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No historical conditions were reported.  Concomitant products included DUTASTERIDE (AVODART), PRAZOSIN and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Diagnosed with COVID-19 one week after first dose of Moderna vaccine). On 06-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Working on scheduling for second dose of Moderna vaccine more than 42 days after first dose). At the time of the report, COVID-19 (Diagnosed with COVID-19 one week after first dose of Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Working on scheduling for second dose of Moderna vaccine more than 42 days after first dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 06-Feb-2021, the patient was treated with Lilly COVID-19 antibody infusion.   This case was linked to MOD-2021-068455 (Patient Link).
Pruritis and urticaria one day after Influenza vaccine. Petechiae developed over the next 24 hours to most of body except face and neck, worst on legs. He otherwise felt fine. Probable vasculitis Dx.