chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CLOT IN LEGS; ESCALATING PAIN IN LOWER BACK; ESCALATING PAIN IN LEG; This spontaneous report received from a patient via news story concerned a 4 decade (early 40s) male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. In APR-2021, the patient experienced clot in legs and was hospitalized. The patient was improving and scheduled to leave the hospital in few days. On 16-APR-2021, the Patient experienced escalating pain in lower back and leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from clot in legs, and the outcome of escalating pain in lower back and escalating pain in leg was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: - Clot in legs (PT-Thrombosis). This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
C/o nausea. It lasted about 20 minutes. Pt left @ 10:05AM
Information has been received from a physician concerning a female with an allergy to "tetanus shot" who was vaccinated with the first dose of Gardasil.  On 24-AUG-2007, the patient experienced an allergic reaction described as hives.  The patient's hives persisted.  Additional information has been requested.
Headache, itching and redness began the following day, shortly after experienced severe pain stemming from the injection site, up the back and to the hand, immediate loss of function of left arm (injection arm) and respiratory problems, coughing, congestion, throat irritation and elevated heart rate. 103.5* fever recorded at home and was sent to the emergency room. Was hospitalized from 1/21/2013 - 1/25/2013. Since then as until today is still experiencing some congestion and respiratory problems, severe pain in injected arm, pain and pressure in the chest and throat and loss of mobility and use of injected arm. Physical therapy has had no effect in helping resolve these issues. No medicines have been administered but cortisone steroids were advised but not taken.
This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received PEDIARIX. Co-suspect products included BOOSTRIX. On an unknown date, the patient received PEDIARIX at an unknown dose and BOOSTRIX at an unknown dose. On an unknown date, am unknown time after receiving PEDIARIX and BOOSTRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage was unknown. Additional information received: Patients were possibly vaccinated with PEDIARIX and BOOSTRIX that was deemed unusable because of a possible temperature excursion.
Cause of death undetermined at this time. Reported from a doctor with a mother who refused vaccine due to 2 deaths she heard about after children received vaccines. Only information available at this time.  2/21/08 Reviewed autopsy report which states COD as sudden unexplained & unexpected death in infancy. Manner of death as undetermined (co-sleeping).  2/29/08 Reviewed vax record & database updated w/same.
17years 9months at time of vaccination Minimum recommended age for COVID19 (Janssen) is 18  Organization has been requested to enter all COVID vaccines into the Immunization Registry. .   Organization is assisting with entering information into immunization registry and VAERS.
In mid May, 1999, the pt received her first treatment with Lymerix. Sometime thereafter, she experienced a slight redness at the injection site which resolved. In mid June 1999, she received the second dose of Lymerix and one day later she was bitten by a tick. Approximately one week after the second dose, she experienced an arthritis attack, with joint pain, stiffness, and difficulty walking.  No treatment was given. The most recent information received on 6/29/99 reports the symptoms are ongoing.
The child developed a red raised rash all over body. Looked like chicken pox as stated by mother, but never developed blisters. Rash appeared 10 days after being given vaccines.
Initial information received on 21-Dec-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA395251 (same reporter). This case involves a four years old patient (gender not reported) who was vaccinated with a dose of wrong vaccine FLUZONE QUADRIVALENT (lot number, Exp. Date, route and anatomical site of administration not reported) on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and concomitant medications were not reported. It is an actual medication error case due to wrong vaccine administered. It was unknown whether the patient experienced any adverse event. 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 interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Beginning in afternoon on day of injection: whole body pain, weakness, minor balance problems, nausea, very thirsty, left arm pain (barely able to lift arm, rash around injection site (down to almost elbow and inside arm), minor chills, sweating, loss of appetite. Due to weakness, stayed in bed most of the day following injection. Gradually better over next few days. Mild irritability over (10 ?-day period).
I woke up in the middle of the night with a terrible migraine. I don't usually get headaches. It got to the point that I was being woken up every night with migraines that lasted about 45 mins. This lasted for 23 days exactly. I finally contacted my PCP. She said that she thought I should get my 2nd dose. I didn't have fever, chills, or any other symptoms. I did feel really tired. My doctor gave me some sleeping pills to take because I was getting up 2-3 times a night because of my headaches. I decided not to take them though. I never took any of them. I just sucked it up and prayed that it would end soon. After the 23 days, my headaches finally gradually slowing. I pretty much just sucked it up until about the last 5 days and that is when I contacted my PCP. I just couldn't take it anymore. They gradually started to go away after that. I started getting them twice during the day, and once at night. I was getting them 3-4 times during the day and 2-3 times at night. The migraines were so bad that I would get very dizzy. I was very disoriented. After about 27-28 days total, I did not have them anymore.
This spontaneous case, initially received from a pharmacist on 29-Oct-2018 concerns 63-year-old, adult, female patient. The patient's current condition included diabetes. The patient's concomitant medications were reported to be unknown. On 24-Oct-2018, the patient under age of 65 years was accidentally administered FLUAD (TIV) [dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number: 250798, expiry date: 31-May-2019] (explicitly coded as inappropriate age at vaccine administration). No adverse event was reported. The reporter assessed the event as non-serious.
bodychills; headache; heavy sweats; low fever; no appetite; losing weight; lethargic; heavy head; tired; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received the first dose of BNT162B2 (Lot number: En6205), via an unspecified route of administration, administered in left arm on 08Mar2021 11:00 (at the age of 65-year-old) as single dose for COVID-19 immunization. Medical history included high blood pressure and high cholesterol. No Covid prior vaccination. Concomitant medications included amlodipine besilate; benazepril; and gemfibrozil. No other vaccine in four weeks. On 08Mar2021 15:00, the patient experienced body chills, headache, heavy sweats, low fever, no appetite, losing weight, lethargic, heavy head and tired. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was hospitalized due to the events on unspecified date. There was no treatment given for the events. The outcome of the events was not recovered.
Information has been received from a pharmacist concerning her 63 year old female mother with no drug reactions/allergies, who on 13-NOV-2008 was vaccinated intramuscularly with a dose of ZOSTER (Oka/Merck) at another office.  There was no concomitant medication.  On 13-NOV-2008, the patient developed red, swollen and painful area at the injection site.  It is unknown if the patient
an 8 year old was inadvertently administered a dose of adacel with no reported Adverse event; an 8 year old was inadvertently administered a dose of adacel with no reported Adverse event; the patient is behind in her vaccinations with no reported Adverse event; Initial information received on 12-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 8 years old female patient who was inadvertently administered a dose of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported adverse event and reported the patient is behind in her vaccinations with no reported adverse event.  The patient's past vaccination(s) included DTAP on 10-JAN-2014  at age of 2 months, DTAP on 16-MAY-2014 at age of 7 months and DTAP on 01-MAR-2018  at age of 4 Years. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included hepatitis B vaccine, hepatitis A vaccine ,  measles vaccine, mumps vaccine, rubella vaccine (MMR) ,  varicella zoster vaccine (varicella vaccine) for immunisation.  On 30-Jun-2022, the patient received 0.5ml  dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (unknown strength) (lot C5828AA; Expiry date 30-Mar-2023) via intramuscular route in the left deltoid for immunization.  On 30-Jun-2022 It was reported that 8 year old was inadvertently administered a dose of adacel with no reported adverse event (accidental exposure to product) (product administered to patient of inappropriate age) and patient was behind in her vaccinations with no reported adverse event (inappropriate schedule of product administration) (latency; Same day). It was asked that this dose will count as a valid dose for her DTAP series  Action taken : not applicable.  Outcome : Unknown.  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 the 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 interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
High fever (102 deg) and excessive crying for 2 days following vaccinations-was admitted in the hospital for 24hrs. The medical records received on 1/23/04 states not eating.
Patient reports mild itching to L arm. Feels like hot flashes, slight dizziness. S/SX ongoing for hot +, itching at site. No hives. No SOB. Site appears fine. No flushed. at 09:30-symptoms resolving.
11:48.  Patient received vaccination at 11:45.  In observation area, she reports to RN she has developed Blotchy red spots on her arms and her face feels hot. Patient moved to treatment area.  She is exhibiting erythemic macular anular areas to the inner aspects of both forearms measuring approximately 2-4 inches in size.  There is no elevation of the reddened area.  No hives, rash or itching noted.  Denies shortness of breath.  Lung sounds are clear bilaterally.  Heart rate is 78 BPM, Resp. Rate 16/min.  B/P 178/100, Pulse ox 97% on room air.  12:53 Recheck vital signs:  B/P 170/96, Pulse 76 BPM, RR  16/min, Pulse ox 94% RA.  She denies SOB.  Redness and blotchy appearing area's persist. Noted redness to palms of hands.  Patient states they do not feel tight or swollen.  Will continue to monitor.  It does not appear that this reaction is anaphylactic in nature.  Continues to have clear breath sounds through all lung fields.  Denies any sensations of tightness or swelling to throat, tongue, lips or eye lids. 13:15:  B/P 160/96.  Pulse 77, RR 16 Pulse ox 97% on Room Air  Patient states she is feeling better.  Redness appears to be fading slightly. Will continue to monitor 13:55:  B/P 154/86. Pulse 77, RR 16 Pulse ox 97% on Room Air.  Blotches faded.  Palms of hands returned to flesh tone. Denies any SOB, swelling to face, lips, tongue. 14:00:  Patient states she feel fine.  She does have a friend here who will driver her home.  She will come back later for her car as a matter of precaution.  Pt states she will take OTC Benadryl at home.  Recommend no more than 25 mg by mouth every 4-6 hours for next 24 hours.  If she starts have a return of symptoms or worsening symptoms, she is instructed to call 911 and go to the nearest emergency room.  Patient verbalizes agreement.  Leaves ambulatory, in satisfactory condition accompanied by friend.
This spontaneous report as received from a health professional refers to a 13 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
5 1/2 hrs after injection c/o  itchy eyes; took BENADRYL .25 mg. Following morning woke with eyes swollen shut. Called MD who advised to take 50 mg BENADRYL @ 9A-1P-6P. AT 6 pm, lips began to swell + burn.  Developed rash on face + groin. Went to ER + treated with IV BENADRYL + Steroids. 3 days following vaccine, but (L) eye + cheek still rashy + slightly swollen. NB: Recalls during an environmental site test on 11/13. Friend/calleague has similar symptoms.
Patient received a vaccine after the Moderna vial had been punctured 20 times. Patient was the 23rd patient to get vaccinated from the vial. Moderna was contacted and informed of the incident.
pt recv vax 9JUL96 & initial lab eval in December 1996 revealed a positive test for varicella antibodies;subsequent eval on 3NOV97 revealed a lack of seroconversion;
After immunization of H1N1 2, HAV 2 a few minutes later while child was standing fainted and fell down. After elevated legs resumed normal condition.
9 days after injection: Developed a rash that was warm to the touch and itching at the injection site. Rash was accompanied by swelling and soreness. The onset was early in the morning when I noticed slight itching and mild soreness. The symptoms slightly worsened, nothing extreme, throughout the day and then stayed steady for a few days. Treated with benadryl and tylenol, which helped. Cleared up in 2 or 3 days.
"I received my booster on Tuesday and I woke up yesterday very sore, which I expected, but it has made my whole left side very sore. As the day went on yesterday I started hurting a little more and it felt like my heart was hurting. Last night I applied a heating pad on the area I was hurting. I woke up this morning and you can feel my lymph nodes are swollen under my left arm. I am hurting at the top of my left breast all the way around it just like my heart is hurting and the pain goes down my left side to my back. The pain in my arm is from my elbow all the way to my armpit. I wasn't able to put deodorant on due to the pain under that arm. Is this something I should be worried about? When I received my 2nd dose My left side hurt and the left side of my breast was sore, but this is worse so I wanted to reach out since it has been 2 days. I have also been taking ibuprofen for the pain and swelling. "
Localized redness, measuring 10'x5 1/2" irregular shaped surrounding the injection site.  Warm to the touch and patient report pain 5 out of 10 to the area.  Patient encouraged to apply ice pack throughout the day.  This nurse outlined the redness with ink pen.  Appointment scheduled with doctor 10/1/15.  Encouraged patient to seek help at Urgent Care clinic if the redness continues.
Had flu shot for several years with no reaction. Woke up the next day with uncommonly sore arm, nausea, dizziness, and muscle soreness. Never sought treatment.
Pt developed chills, aches the evening after receiving vaccine. A few day later developed left-sided chest pain radiating to left shoulder.
Patient admitted as inpatient on 9/1 due to acute respiratory failure with hypoxia due to COVID pneumonia. Patient was tested for COVID-19 and was positive on 9/1.
This spontaneous report was received from a pharmacist, who also happens to be the patient's daughter, via a company representative, and refers to her mother a female patient (age unknown). The reporter indicated that, the patient was administered with pneumococcal 13v conj vaccine previously (date unknown) and she had no reaction for that. The patient's concurrent conditions or concomitant therapies were not provided. On an unspecified date, the patient received a dose of injectable PNEUMOVAX23 for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported). On an unspecified date, the patient developed unspecified cellulitis after receiving the injection. The reporter indicated that she advised the patient to go back and showed the lesion to her physician, but the patient refused. No treatment was given for the event, and it was unknown whether laboratory diagnostics studies were performed. It was reported that the cellulitis lasted approximately 5 days and the patient recovered from it on an unspecified date. The relationship between the event and PNEUMOVAX23 was not provided. Upon internal review, the event cellulitis was determined to be medically significant. Additional information has been requested.
Patient is only 4 months old.  Nurse went into wrong exam room with the wrong patient and administered vaccines intended for the 15 month old in the next room.  The patient also received Vaqta, MMR and Varivax which was the correct order.  PNP consulted with RN which is the Immunization Nurse Consultant.  Instructed that patient may experience a slight rash or reaction but to watch the child for adverse reactions and if any problems go to ED.  Patient brought back the next day for follow-up.  Mom stated patient was smiling active and playful without fever.  Minimal redness and swelling at injection sites.  No problems at this time.
Ringing in ears / tinnitus, began a few days after first dose but has increased significantly after the second dose and is constant.
Patient is a 76 y.o. male patient of  PA-C with history of HTN, sarcoidosis, COPD presented to Hospital with SOB.   Acute respiratory failure with hypoxia COVID19 pneumonia COPD w exacerbation Dx with pneumonia (neg covid) on 8/4 at another facility; improved with doxy Now w/ SOB, cough, fatigue x 3 days (+) covid test and hypoxia at rest at urgent care today  Currently on 2L NC; only on home O2 at bedtime CT chest (8/23) RLL patchy airspace opacity w/ consolidations  Afebrile, WBC normal, procal < .06 Started on IV dexamethasone at  hospital Continue home inhalers, spiriva, singular, add albuterol Does not qualify for Remdesivir, hypoxia resolved, breathing at baseline Stable for discharge, on home inhalers, Continue home inhalers, spiriva, singular, add albuterol Does not qualify for Remdesivir, hypoxia resolved, breathing at baseline Stable for discharge, on home inhalers, and chronic prednisone dose   HTN Stable, continue home lisinopril   Sarcoidosis Stable Home regimen: Prednisone 20mg every other day Cont dexamethasone for now
Dizziness waking up, 2 days after vaccination. Lasted 3 hrs., stayed in bed. Weakness for a few hours after that. After looking at reaction list, realized that red eyes & hoarseness the day believe could be related. No more dizziness or vertigo, but head did not heal "right" for several days.
Swollen, tender supra clavicular lymphadenopathy.  Also some milder adenopathy in brachial region.  Both were in left arm, which had received DTAP.
headaches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches). At the time of the report, HEADACHE (headaches) outcome was unknown.            No concomitant and treatment medications were not provided.
Experienced shortness of breath for roughly 24 hours. This began about 6 hours after receiving my vaccine.
Client reported that about 40 minutes after each dose she developed, ?slight throat closing.? The client stated the symptoms lasted one hour each time. The client denied any other signs or symptoms of anaphylaxis. The client didn't take any medications for the symptoms.
Left arm soreness; Chills; Headache; Bodyache; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Left arm soreness), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Bodyache) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Left arm soreness), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Bodyache). At the time of the report, PAIN IN EXTREMITY (Left arm soreness), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Bodyache) had resolved.        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 treatment information was provided.  No concomitant medication was provided.
Pt was w/sister @ home; Was due for snack & was playing; went limp & fainted; aroused easily but has felt weak; t99 today, spoke w/pvt MD last evening;
1hr post vax lightheaded, dizzy, problem breathing, loose congestion, cough w/mucus-progressed over weekend;
01/04/22 presents to Surgery for " L2-L5 posterior lumbar laminectomy fusion". PMHx of "HTN, sleep apnea without CPAP use, GERD, CKD stage III, anxiety, and depression"