chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ITCHINESS; RASH; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a parent via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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, administered on 06-MAY-2021, dose was not reported, administered on 06-MAY-2021, and dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 06-MAY-2021, the patient experienced itchiness, rash, off label use, and inappropriate schedule of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash, itchiness, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
End of July I noticed swelling and pain in my left leg. I was away from home so when I returned, I made an appointment with my doctor on 8/2. He was concerned about a blood clot in the leg. I had a venous ultrasound which showed an extensive venous thrombosis in the left leg. I was started on oral coagulants, Eliquis. I am still on that. I saw the doctor again on 8/27 and I have another follow up appointment at the end of this month. The pain is better, the selling is gradually getting better. The swelling is still present but improved.
Myalgia, Arthralgia, NauseaVomiting, fatigue, joint pain all symptoms both doses Narrative:  Other Relevant History:
I felt bad within a couple of hours. The upper part of my arm hurt on movement. The next morning it had a visible circle around the injection site. The whole arm was swollen for three or four days. There is still a mark on my arm with a shadow of the bruise.  General fatigue and muscle soreness in arm which radiated into my back.  Lingering weakness in my arm and pain on movement.  I took Ibuprofen and used ice.
Patient had the 2nd Moderna covid vaccine dose on 3/11, had flu like symptoms on 3/12, and then on 3/13 she developed left sided head/neck lymphadenopathy. Her flu like symptoms resolved. The lymphadenopathy is persisting
Persistent pain at injection site. (L deltoid 0.25 ml preserv free - pregnancy).
Some pain and soreness in his arm; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14May2021 (Batch/Lot number was not reported, expiry date not reported) as second dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 on an unspecified date at first dose, single for COVID-19 immunization. The patient experienced some pain and soreness in his arm on 15May2021, and asked if it was safe to take Tylenol. Clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Developed redness and swelling to left upper arm where Kinrix was administered.  Seen at Dr. was given rx for antibiotic on 7/31/2015.
Information has been received from a 20 year old female medical assistance with a history of live birth who on 01-MAR-2007 was vaccinated with her first dose of GARDASIL. On an unspecified date, the patient was vaccinated with her second dose of GARDASIL. On 25-SEP-2007, the patient was vaccinated with her third dose of GARDASIL. On 21-NOV-2007 the patient found out she had a cyst on the ovary. The patient reported that she is getting the cyst removed. No further information was expected.
Injection site is red, swollen and tender to touch.  Started breaking out in patches close to wrist and four close to elbow.  Ruby red in color and painful, shortness of breath.
super dizzy; heart rate dropped; Low blood pressure; vomiting; This is a spontaneous report from a contactable consumer (patient's mother). A 20-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6203, NDC number, UPC number and expiry date were reported as unknown) via an unspecified route of administration on 02Mar2021 (at the age of 20-years-old) as a single dose for covid-19 immunization. Medical history included congenital adrenal hyperplasia from an unknown date and unknown if ongoing. Concomitant medication included prednisolone (PREDNISOLONE) taken for congenital adrenal hyperplasia, start and stop date were not reported. It was reported that two minutes after her first shot, she got super dizzy, started vomiting, heart rate dropped and had low blood pressure. They had EMS at their site and paediatrics doctor happened to be on call. Her mother asked If she still going to take the second shot and they did not know what to do. The patient had underline medical condition (congenital adrenal hyperplasia) so she was steroids dependent, three times a day. After vomiting they gave her emergency medicines (emergency steroids). Reporter stated they increased her steroids because if someone had adrenal problem and when they vomit, they lose the steroids so that become the problem, so they triple the dose of medication in the site. The reporter stated that their doctor wanted them to figure out if the events were severe reaction, she asked what events are consider severe and do they recommend the second vaccine. The reporter stated that they were curious if the events were severe allergic reactions, so they wanted to know the next step. The patient underwent lab tests and procedures which included blood pressure measurement: low and heart rate: dropped on 02Mar2021. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Chills, fever, pain at injection site, abdominal cramps evening of vaccination. Rash on stomach at 24 hours. Body covered with hives at 48 hours.
Patient called pharmacy to say he had developed a Rash and Hives the evening of his vaccine (vaccinated in the morning). Patient treating at home with hydrocortisone 1% and oral benadryl.
nausea; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Patient received 2nd dose of the covid vaccine and was still experiencing nausea on unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a physician and refers to a 55 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications and it was stated that the patient did not have any allergies. On 20-APR-2018, the patient was vaccinated with an unspecified dose of VARIVAX injection, lot number N027627 with expiration date on 04-OCT-201, as the patient was a not immune healthcare worker (strength, dose, route of administration and anatomical location were not reported. Other suspect therapies included sterile diluent (MERCK STERILE DILUENT) injection (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported). On 05-MAY-2018, the patient experienced 50 vesicular lesions on chest spreading over body with unspecified fever (rash vesicular and pyrexia), therefore, the patient was placed under an unspecified therapy treatment. On an unspecified date in May 2018, a varicella Immunoglobulin M (IGM) test was performed and the result was negative, 5/9 (units not provided) (antibody test negative). On approximately 08-MAY-2018, reported as "since last week", the patient's lesions were fading and there were no new outbreaks. The outcome of antibody test negative was not reported and the reporter did not assess the causal relationship between therapy with VARIVAX or sterile diluent (MERCK STERILE DILUENT) and the aforementioned events.
This literature marketed report as received from the authors of a published article, refers to an 11-year-old with a history of failure to thrive, febrile seizures, and a vesicular rash following the varicella vaccination (manufacturer unknown) (strength, lot number, expiry date, dose, route and date of administration were not reported). The patient presented with one week of occipital headaches and hypertensive urgency. She developed fever and vision loss in the left eye two days after admission (reason unspecified), with new reports of a partial right visual field deficit for one month. Magnetic resonance (MRI) findings were consistent with meningoencephalitis. The cerebrospinal fluid revealed 34 (units not provided) white blood cells and a positive vaccine strain varicella (VZV) polymerase chain reaction (PCR). Serum cytomegalovirus (CMV) IgG was greater than 10,000 u/mL. Ultimately, the patient was diagnosed with meningoencephalitis and left optic neuritis secondary to VZV and right eye CMV retinitis. Due to the patient's multiple opportunistic infections, an immune work up was initiated. Her HIV antigen and antibody tests were positive, and her CD4 count was 0 cells/mm3 leading to the diagnosis of AIDS. The outcome of vesicular rash, meningoencephalitis, positive vaccine strain varicella (VZV) PCR and left optic neuritis was not reported. Upon internal review, the events meningoencephalitis and left optic neuritis were considered medically significant.
Initial and follow-up information has been received from a physician concerning a 15 year old female with no pertinent medical history or drug reactions/allergies who on 26-JUL-2007 was vaccinated with a first dose of Gardasil (653735/0688F) 0.5mL IM in the left deltoid muscle. There was no concomitant medication. On 26-JUL-2007 the patient experienced severe pain at the injection site of the left deltoid muscle immediately after administration of her first dose of Gardasil. The pain radiates down the left arm and the patient stated that she os unable to bend arm at the elbow. Medical attention was sought. The physician prescribed ibuprofen hcl and ice compresses. At the time of reporting the patient had not recovered. No further information was available. Additional information has been requested. Follow-up information was received. On 27-JUL-2007, the patient had recovered. Additional information is not expected.
1. Swollen, red, and sore injection area, lasting approximately four days, decreasing daily. 2. Approximately 12 hours of lethargy, general body soreness, and a headache (treated with two doses of ibuprofen every 4 hours). 3. Brief (30-60 minutes) numbness on top-front of head and forehead, and in between my nose and upper lip around 10am day after injection.
trouble breathing; throat felt like it was closing; sternum hurt; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration (patient age at the time of vaccination was 33 year and patient was not pregnant at the time of vaccination), administered in arm right on 30Apr2021 at 14:30 as single dose for COVID-19 immunisation. The patient's medical history included down syndrome. Patient not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient previously took penicillin and experienced allergy. Patient was not received any other vaccine prior four weeks of vaccination. Patient received other medications two weeks prior of vaccination. About 12 hours after the vaccine, on 30Apr2021 at 03:00, the patient began with trouble breathing, throat felt like it was closing, and sternum hurt. The patient visited to emergency room/department or urgent care for the events. Since vaccination patient not tested for COVID-19. Therapeutic measures were taken as a result of the events with oxygen, tyelnol and hydroxyzine. Pfizer have permission to contact your/the patient's healthcare provider about this report. The outcome of the events was reported as recovered on unspecified date in 2021.  No follow-up attempts are needed. No further information was expected.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: Patient was seated at observation area, she sais she was feeling throat tighentess. she says she had got other reacctions in the past and she always carries an epipen. Epipen was taken for emergency kit and administered. 911 was called, she was feeling bettter after 20 minutes but emergency personal recommeneded to take her to the er as the vaccine can do another reaction. pt was talking to us all the time with a gaspy voice.
no energy for about two days; did not feel like eating much; nausea; tired; Did not want to do anything but sleep that day; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no energy for about two days), SOMNOLENCE (Did not want to do anything but sleep that day), DECREASED APPETITE (did not feel like eating much), NAUSEA (nausea) and FATIGUE (tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced SOMNOLENCE (Did not want to do anything but sleep that day), NAUSEA (nausea) and FATIGUE (tired). On an unknown date, the patient experienced ASTHENIA (no energy for about two days) and DECREASED APPETITE (did not feel like eating much). At the time of the report, ASTHENIA (no energy for about two days), SOMNOLENCE (Did not want to do anything but sleep that day), DECREASED APPETITE (did not feel like eating much), NAUSEA (nausea) and FATIGUE (tired) had resolved.            No concomitant and treatment drugs were reported.   This case was linked to MOD-2021-047191 (Patient Link).
MODERNA COVID-19 VACCINE EUA Pt received 1st dose of vaccine on 24 JUN and received 2nd dose 7 days earlier than recommended time frame which is on 15 JUL. Pt reported slight dizziness but no adverse reaction.
felt fine day of & immed following vax; 2 days p/vax devel rash @ site of flu shot, fever, stomach cramps; 19OCT93 rash had spread to hands, scalp & trunk; site of flu shot is darkened & covered w/a fine rash;
-- Lethargic, 84 hours -- Fever over 103 F, 84 hours -- Fever over 104.5 F, 12 hours -- Vomiting all foods, liquids, and medicines, 84 hours -- All foods taste bad, still has symptom -- No appetite, still has symptom -- White "Covid" tongue, still has symptom -- Nausea, 84 hours -- Fatigue, 84 hours -- Ear infection, unknown duration
HEADACHE, BACK PAIN, FELT WEAKNESS.  CURRENTLY FEELING FINE
Chills; Had some congestion; This is a spontaneous report from a contactable consumer. An 82-year-old male patient received first dose of BNT162B2 (Lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 23Jan2021, the patient had some side effects, he took the shot, the first shot on Wednesday and he is having chills even last night and then of course he has had some congestion. The consumer asked if how long do this normally last. No treatment received for both events. The outcome of the events was unknown.  Information about lot/batch number has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 04Mar2021 as dose 2, single (Lot number: EN6199), in left arm, on 16Aug2021 as dose 3 (booster), single (Lot number: FA7485), in left arm and on 06Apr2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "hyperthyroidism" (unspecified if ongoing); "Hashimoto's disease" (unspecified if ongoing); "allergy to antibiotics" (unspecified if ongoing). The patient took concomitant medications which included medications for blood pressure and thyroid. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), all described as "COVID 19 Treatment". Therapeutic measures (paxlovid) were taken as a result of vaccination failure, covid-19. Outcome of the events was unknown.
1. PT reports numbness in feet and lower legs when running; onset MAY 2021. 2. PT reports multiple painful joints, no history of direct trauma to these areas; onset MAY 2021. Pt reports dull joint ache in bilateral elbow, wrist, knee, shoulder and ankle; dull ache in back; bilateral Achilles tendon ache. 3. PT reports dry, mildly itchy skin rash on bilateral forearms, upset stomach, and diarrhea; onset AUG 2021. PT states that GI issues resolved but continues to have rash. 4. PT reports frequent headaches; onset JUN 2021 with frequent trouble sleeping 5. PT reports NEW ONSET decreased penile erection; onset JUN 2021 with frequent urination and occasional painful urination. PT states that erection "isn't full" and also notice "no morning erections." PT states that he didn't have this issue prior to deployment.
Horrible debilitating non stop migraine like headache for three days following 1st dose of vaccine starting  12 hours after dose.  Extreme tiredness, muscle pain, nausea three days duration.  All symptoms resolved  3 days after vaccine
3/28/08 3:30pm received call from patient.  States nausea, dizziness and weakness developed 1/2 hour after HPV injection.  Symptoms have persisted.  Appt offered to evaluate, patient declined.  Per MD push fluids, Tylenol.  Monitor.
In the beginning of December 2022, I had some positional vertigo, which went away with exercises designed to treat it. On 12/24/2022, I had my first aura, though I didn't have any pain. I still think it was probably a migraine, though. On 12/28/2022, I had a very severe headache. I have a history of neck injury, so I'm used to getting headaches, but this was different. The pain started above my right eye and radiated to my right temple and around my right ear. The headache eventually went away, but on 12/29/2022, I got an appointment with my PCP. My doctor said I was having a ramshorn headache with auras. Since this was a new experience and there were auras, she arranged for me to get an MRI. She also took me off birth control on account of an increased risk of stroke with auras. I then underwent the brain MRI on or about 1/12/2023. On 1/13/2023, I was notified that they suspected that an abnormality detected on the MRI was an aneurysm. I was referred to get a CTA test, which I underwent on 1/25/2023. The test confirmed that I had a 4 mm aneurysm in my brain. It was a superiorly directed paraclinoid ICA cerebral aneurysm. On 2/2/2023, I had a consult with a neurosurgeon, who suggested surgery to treat the problem. On 3/6/2023, I underwent endovascular surgery to place a flow-diverting stent in the artery affected by the aneurysm. A week before the surgery, I started taking PLAVIX (75mg) and full-strength aspirin once a day. I am still taking them and will continue to do so for the next six months. At the sixth month, the neurosurgeon will perform an angiogram to see if the stent is working. I am currently recovering from the surgery. For the most part, everything is fine. The incision in the femoral artery has caused me to have pain and discomfort and some physical limitations, but it's healing as well as expected.
per patient "I took the Moderna vaccine yesterday morning.  By mid morning i had a few red blotches on my face, some itching on my extremities and tingling in my lower lip. I stopped back past the vacccine area this morning to let them know i had a very small reaction and i was told to complete an injury report."
Describe Event, Problem, or Product Use Error: [Moderna COVID vaccine] use for COVID -19 under Emergency Use Authorization (EUA): Per hospital reporting system "pt advised me he needed to make his follow up for 2nd Moderna Vaccine. That triggered me to question his 1st vaccine he had just received. (we do not offer 1st of 2nd Moderna vaccine at our facility at this time, only Moderna booster) I looked at the order in his chart for future which did in fact say Moderna. I went and consulted with Nurse Lead and she checked and pt did in fact receive the "Moderna booster" but was treated as vaccine #1 in error. She consulted with precepto and it was determined that patient would receive another injection with the remaining portion of the booster to complete Moderna vaccine #1. Patient agreed and then was advised to get the 2nd Moderna at an outside vaccine location per our current guidelines.
this was a booster shot, after receiving J& J in March of 2021. No adverse event, but patient received vaccine that was expired beyond the BUD by 27 minutes. Manufacturer was contacted and BUD was ok per Pfizer's extended stability data.