chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reaction to "something "; very itchy; Red; Looked like measles; both hands/both legs; both arms; "all over rash"; eczema on left arm; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (eczema on left arm), ADVERSE REACTION (reaction to "something "), PRURITUS (very itchy), ERYTHEMA (Red) and RASH MORBILLIFORM (Looked like measles) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced ECZEMA (eczema on left arm). On 23-Feb-2021, the patient experienced ADVERSE REACTION (reaction to "something "), PRURITUS (very itchy), ERYTHEMA (Red), RASH MORBILLIFORM (Looked like measles), RASH (both hands/both legs), RASH (both arms) and RASH ("all over rash"). At the time of the report, ECZEMA (eczema on left arm), ADVERSE REACTION (reaction to "something "), PRURITUS (very itchy), ERYTHEMA (Red), RASH MORBILLIFORM (Looked like measles), RASH (both hands/both legs), RASH (both arms) and RASH ("all over rash") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No Treatment information provided
Information has been received from a nurse practitioner (N.P.) concerning a 54 year old female patient with a history of chickenpox as a child. The patient's concurrent conditions included hypertension, diabetes (non insulin dependent), hypothyroidism, hypercholesterolemia and smoker "smokes half pack per day". On 28-MAR-2012, the patient was vaccinated with a dose of ZOSTAVAX (dose, route was not reported) in the right arm(lot #:672557/1601AA; expiration date: 13-JAN-2013). Concomitant medications included verapamil, lisinopril (manufacturer unknown), metformin, ACTOSE, JANUVIA, levothyroxine sodium, and LOVASA. N.P. reported that in "late" MAY 2012 the patient developed a rash on her face. Patient sought medical attention and went to the emergency room (E.R.) Unspecified antibiotics and cream were given as treatment for the event. It was reported that the rash "comes and goes". N.P. stated that she had "given hundreds of ZOSTAVAX doses and had not seen this type rash before". No lab diagnostic studies were performed. At the time of the report, the patient's outcome for rash on her face was unknown. Additional information has been requested.
Daily headache for 10 days. Entire left arm muscle extreme soreness for 14 days.
Headache, Myalgia & Fever Narrative: 0830 immunization. 2200. Shivering so bad she couldn't fall asleep until 03:00. Then sweats. Real bad sweats. Aches & pains all over. Bad retro-orbital headache. T-max 100.0 First dose in series had only significant local soreness
All happened within 24 hrs of shot. Shortness of breath. Headache. Fever of 102.5. Joint pain and muscle aches.
102 degree fever 8 hours, head ache 24 hours, nausea, weakness for 24 hours
right sidedness weakness; numbing in her arms and legs; tingling in her arms and legs; she couldn't feel the right side of her face or her tongue; crushing stomach pain; Inappropriate age at vaccine administration; This is a spontaneous report received from a contactable reporter nurse from medical information team.  A 6 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEMIPARESIS, outcome "unknown", described as "right sidedness weakness"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbing in her arms and legs"; PARAESTHESIA (non-serious), outcome "unknown", described as " tingling in her arms and legs"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she couldn't feel the right side of her face or her tongue"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "crushing stomach pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and Hemiparesis, hypoaesthesia, Paraesthesia, Feeling abnormal, Abdominal pain upper cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Red itchy rash at and around injection site. Looks and sounds exactly like "covid arm" that has been reported after moderna vaccination. Warm to touch and slightly swollen.
the next day 4/9 after the shot, had severe chest tightness where I had to go to the ER & was found to have abnormal EKG findings
I was driving, getting off the interstate and evidently had a seizure.  I remember very little of the next 8 or so hours in the trauma center.  I had no warning.
AT AROUND 9 PM PATIENT STARTED FEELING NUMBNESS RIGHT BELOW THE INJECTION SITE. THE FOLLOWING MORNING THE PATIENT NOTICED REDNESS OF THE SKIN BELOW THE INJECTION SITE . THE REDNESS HAS STAYED THE SAME SINCE THE TIME IT DEVELOPED. HE REPORTS NO PAIN OR ITCHING. HE HAS NOT ATTEMPTED ANY TREATMENT AND HAS NOT SOUGHT ANY MEDICAL HELP FROM HIS DOCTOR.
Patient did not have any symptoms at the time of covid vaccination or during the observation period. Patient started having left arm and foot numbness the day after moderna covid vaccination. He developed left facial droop 2 days after vaccination and went to local ER on 02/28/2021. CT/MRI revealed acute right occipital and right thalamic infarct and old left occipital infarct. Carotid US showed fully occluded left carotid. Patient smoked for 40 years and quit March 2021 and previously used crack cocaine and quit 1 year ago. He was discharged from hospital on amlodipine, clopidogrel, atorvastatin, and aspirin, which were new medications. Patient has returned to work for over 2 weeks.
Case number PHEH2015US022674 is an initial spontaneous report received from a pharmacist on 28 Oct 2015. This report refers to a 61 year old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) multi dose vial (MDV) on 28 Oct 2015. It was reported that the vaccine administered was pre-drawn into a syringe from multi dose vial for 10 days and held at proper temperature. No adverse events were reported following the maladministration.
My 15 year old was mistakenly given the Moderna Vaccine - first dose on Saturday. We need to know what to do now regarding a second dose.
got delayed allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (got delayed allergic reaction) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced ALLERGY TO VACCINE (got delayed allergic reaction). At the time of the report, ALLERGY TO VACCINE (got delayed allergic reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Have not yet sought out medical attention, joint pain, fatigue (had these issues, but they were exacerbated). Pain in knees, back, and hands (marked increase in pain). Depression has been getting much worse, have sought therapy (father died recently, so can't point to vaccine specifically, may be a coincidence).
T 101 degrees legs feel like "rubber". Back of neck aches. Generalized aches. Pneumonia - Rt. Flu Lt arm.
cough, fatigue, HA, body aches. starting on 8/29/21
Pt returned to clinic with large area of erythema at the injection site with 86x80mm measurement with warmth to touch. Also a satellite area of erythema with measurements of 50x45mm. These were located at the injection site of Anthrax #4. Pt was given topical steroid, Motrin, no RTC if 5x5 increase.
Within 15-minutes of vaccination, patient reported headache, nausea, dizziness, and near-syncopal episode. Emergence response crew reported negative orthostatic blood pressures. Patient stated they felt like the "room was spinning", but never became syncopal. Patient reported mild reaction to first vaccine 21-days prior. Patient was administered 4mg Odansetron PO prior to EMS arrival. Patient refused EMS transport and was monitored on-site.
Headache, Myalgia, NauseaVomiting, Chills  Other Relevant History:
Patient was given vaccination on 4/13/22. Expiration date on COVID vaccine was 4/12/22.  Patient had no adverse reactions or symptoms.
I had vaccination on 04/14/2022. In 2022 I had five episodes with heart when I went to bed at night. I went to cardiologist 11/2022 and was put on a Holter monitor for 8 days. The results came back showing I was having atrial fibrillation. I was given a CT scan and nuclear stress test. Dates are unknown for testing. I am going to see an Electrophysiologists in 04/2023 and inquiring if I can have an ablation. I was put on a blood thinner.
After receiving the first shot I went home and had an alcoholic beverage and experienced an AFIB event.  I had never before experienced AFIB but my Apple Watch diagnosed it.  I subsequently saw my cardiologist and wore a monitoring device for two weeks which recorded another AFIB event.    When I had the second shot I did not experience an event directly but have experienced about 6 or 7 events in the past 10 months.  The most recent was two days after I received a booster shot but seemed to be triggered by my being dehydrated as well after a long bike ride.  Triggering of an event also seemed to be related to consumption of alcohol which I have now ceased to consume.  After stopping alcohol I had gone 4 months without an event culminating with the booster-related event mentioned above.
Bruising after injection that became tender & firm about 3 weeks later & slight atrophic skin at base of (L) deltoid developed.
After 2nd dose of the Moderna shot, my wife had body aches, lethargy/fatigue, chills and a headache that would come for about 6-10 hours and then leave for 2.5 weeks straight.  There were some days where only some of those symptoms would show (e.g. fatigue and chills) but not the others - all symptoms were coming and going in waves (all these symptoms, except the headache/migraine, which has now lasted continuously day/night without stopping for 72 days straight,  would actually last for a full 5 weeks). On April 25, she woke up with a strong headache, which has now lasted continuously for 72 days straight in varying degrees.  When the migraine pain was at its' peak, her thinking was very foggy, she has trouble speaking and she started losing motor control.  She could not get out of bed for days and needed full time care.  After a few weeks of intense pain, during which she was hospitalized for 3 days/2 nights, the pain lessened and she was able to get out of bed and take care of her personal needs.  She has had light sensitivity and noise sensitivity since this migraine began.  During these 72 days, the pain went down to a 2 on a 1-10 scale for 10 days and we thought we were making progress only to see it spike again and again.  It seems to go down for 8-10 days then spike for 7 days or so - but it never goes away.
feeling tired after second Moderna Covid-19 vaccination; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (feeling tired after second Moderna Covid-19 vaccination) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (feeling tired after second Moderna Covid-19 vaccination). At the time of the report, FATIGUE (feeling tired after second Moderna Covid-19 vaccination) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter No treatment medications were provided by the reporter.   This case was linked to MOD-2021-361761 (Patient Link).
patient initially complained of nausea &  feeling lightheaded, fatigue & body aches along with swelling in right arm the evening of vaccination.  She still did not feel well on Saturday (day after) Right arm continued swelling down to & including fingers. Sunday (2nd day after) Mom called the pharmacy. She stated that patient had taken ibuprofen, she still did not feel well but swelling in arm had gone down.  I advised her to watch closely for any other signs of allergic reaction (ie trouble breathing) and seek emergency medical attention as needed.  Patient went to ER, and was flown to hospital to seek treatment.
DIZZINESS; ARM PAIN; CHILLS; FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 69 year old female. 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 not reported, and batch number: 99205A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced dizziness. On 12-APR-2021, the subject experienced arm pain. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, chills, fever, and nausea, and was recovering from arm pain, and headache. This report was non-serious.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX injection, lot # reported as L048462, expiry date 02-DEC-2017 (dose, route of administration and administration site were not specified). Administered doses of (Oka/Merck) VARIVAX underwent temperature excursion at 75 Fahrenheit degrees for 1 hour and 10 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
3 second generalized tonic clonic sz; Resolved spontaneously; No sequelae;
incorrect product storage; This spontaneous report was received from a registered nurse referring to a female patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was not provided.      On 02-NOV-2020, the patient was vaccinated with one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (1 injection, lot # T027110, expiration date 23-MAR-2022; strength and route were not reported) which underwent a temperature excursion for prophylaxis (product storage error). The facility had a power outage due to a storm in the area, pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was stored in their refrigerator when the power went out, and reached a temperature of 56 Fahrenheit degree for 5 hours outside of the recommended storage conditions as outlined in the prescribing information. There was no previous temperature excursion. Data logger was involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T027110; expirationdate: 23-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Swelling on lt side of neck & jaw; Tender to touch; Seen by MD on 13MAR91 & dx as mumps disease;
Fever, Chills and a softball size around swelling at the injection site (hot, red, and inflamed)
Pfizer Vaccine bottle was expired after June 30, 2021. No adverse reactions observed or reported.
Headache, Myalgia, Arthralgia, HA, joint pain, body aches, fatigue, chills Narrative:  Other Relevant History:
Painful right arm began at 6:00 p.m. On 9-26-11 headache began on 9-27-11 a.m. Resolved on 9-28-11 a.m. Red sunburn like itchy rash - full body began on 9-28-11 at 9:00 am. 9-26-11 left arm injection site pain.
Felt sore in my arm; arm started getting real real sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm started getting real real sore) and INJECTION SITE PAIN (Felt sore in my arm) in a male patient of an unknown age who received mRNA-1273 (batch nos. 020B21A and 010A20A) for COVID-19 vaccination.     No relevant medical history provided.  The patient's past medical history included No adverse event (no medical history provided).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm started getting real real sore). On an unknown date, the patient experienced INJECTION SITE PAIN (Felt sore in my arm). At the time of the report, PAIN IN EXTREMITY (arm started getting real real sore) and INJECTION SITE PAIN (Felt sore in my arm) outcome was unknown.            Patient was taking concomitant medications for blood pressure and blood thining. Treatment information not provided.
Pt developed a single 6mm wheal w/ surrounding erythema between eyebrows 15" /p flu vax given, w/o response @ inj site w/ sl upper face flushing. Pt denied difficulty breating & w/o observed SOB. 1 hour post inj pt exhibited 2 additional facial (approx 15mm ea) & one lower back area of erythema (25mm)w/ facial flushing sl increased. Pt continued to deny difficulty breating. Benadryl 25 mg po given w/ decrease in sym. Pt discharged to home w/ mother w/ instructions to call w/ questions or if symptoms return.
This case was reported by a physician and described the occurrence of generalized itchy rash in a 35-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 7 November 2008 at 14:00, the subject received unspecified dose of FLULAVAL (.5 ml, unknown). On 7 November 2008, at an unspecified time after vaccination with FLULAVAL, the subject experienced generalized itchy rash. The subject was treated with BENADRYL. The physician reported that a female subject received a FLULAVAL vaccine during her employer's flu clinic and developed generalized itching rash on her arms and trunk one hour after the injection. The subject may have taken some BENADRYL. The rash was resolving by the time the physician saw the subject in her office. No other symptoms were reported. At the time of reporting the event was improved. The physician considered the event was possibly related to vaccination with FLULAVAL.
completely covered with a rash; I was very tired; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 03Feb2021 at SINGLE DOSE for COVID-19 immunisation. Medical history included thyroid disorder; patient also stated, "I have sinus and allergies because I am allergic to dust. Dust is everywhere. I get the runny nose." Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid. The patient reported "I have the vaccine on 3rd of this month and I had the Pfizer one and I was fine except I was very tired. I ended up going bed around 8 O'clock which is not like me but I was just so tired and then I woke up around 10 O'clock completely covered with a rash. So I took I had and allergy pills that had Benadryl in it so I took that and went to the bed. Next day all of it was gone. It was little bit left on my right cheek and my neck. I don't know if I still go for the other vaccine, this 24 or not. I didn't have temperature or anything." About the start date of the event, the patient further stated, "It was the 3rd between 10 or 10:30 in the night. It was 9 hours after I had the shot. I didn't have reaction right away, I was fine except I was tired, 9 hours later I have the rash." The patient stated that she was fine. Treatment for the event rash includes allergy pills that has Benadryl. The patient also asked if it was okay to go for second shot on the 24th. The patient was recovering from the rash while outcome of tiredness was not yet recovered.  Information about lot/batch number has been requested.
This spontaneous report was received from a pharmacist regarding an approximately 23 month old patient, who is also the reporter's child. Information on patient medical history or concomitant medications was not reported. On 17-FEB-2009, at 18 months old, the patient received a first dose of VAQTA (route of administration, strength, lot number and expiration date were not reported) for prophylaxis. On 04-AUG-2009, 5 months later, the patient received a second dose of VAQTA (route of administration, strength, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported.
A few hours after receiving the vaccine, I began to feel a small sore spot on the exterior in the right corner of my upper lip. This morning, I can see it in the mirror and it appears to have a tiny white spot in the raised area.  I have never had a cold sore before nor experienced a sore like this before.
Mon@11-shot Mon by 8pm-every cell body hurts worse than ever experienced before, freezing to wringing wet all night, terrible migraine.  Cannot sleep, cannot begin to get comfortable. Tues 12:. Slightly better can at least get rest but unable to productivity function Wed evening:. Finally feel human but still have terrible headache Thurs morning:. Headache, light headed, heart rate elevated
This spontaneous report was received from a nurse refers to one-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 06-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045392, expiry date: 17-NOV-2018) for prophylaxis (incorrect product storage). The lot of M-M-R II were reconstituted with properly stored sterile diluent (DILUENT MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000054: Original Case : 1709USA000054