chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist referring to an 82 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 08-MAR-2018, the patient was vaccinated with PNEUMOVAX 23 injection, intramuscularly for vaccination (strength, dose, lot # and expiration date were not reported).  On the same date, reported as "almost immediately", the patient developed severe pain at the injection site (injection site pain). The patient sought medical attention and went to emergency room where she was given unspecified medications for the pain and was sent to home. At the reporting time, the patient was not recovered from injection site pain. The causality assessment between the event and  PNEUMOVAX 23 was not provided. Injection site pain was considered to be disabling by the pharmacist.
Initial reticulated rash in first several days and 1 wk later polyarthralgia x 2 and wks. No fevers.
11/18/2019:   from 8:30 pm till about 8:30 am the next morning I experienced a very rapid heartbeat, extreme muscle and joint pain and just an overall feeling of being "unwell".  I was confined to bed most of the day 11/19/2019.  Feeling slightly better on 11/20/2019 I was able to perform my duties.  However on 11/21/2019 while showering I scratched an area on my right shoulder that turned out to be Hives.  I have a picture.
Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rash). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, RASH (Rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
First part of February I started to get a cough and it got so bad I had to go to the E.R. They diagnosed me with bronchitis and my lungs were clear. After about a week I went to see another Dr. and they told me I had an ear and sinus infection. I continue to have pain below my left rig cage and we are uncertain if it is from coughing soo hard. The ear infection was so bad  couldn't hear out of my left ear very good for a month. I am being observed by the Clinic at this time. Ct scan of my chest and abdomen area.
Aching shooting pain into left upper arm and forearm tolerable no rash 3 day post ZOSTAVAX.
Was notified by a third party that patient died on morning of 3/15/2021.  No other information available.
Patient developed fever, myalgias, headache, and tachycardia the day after his vaccine. He was taken to the ED by his mother for concern about myocarditis. He was discharged in stable condition and followed up with me outpatient the next day. His symptoms were resolved when I saw him.
swelling, redness and itching 4.5" x 2.5" to vaccine site starting approx 2-3 days after administration
RECEIVED THE INFLUENZA VACCINE AT 11:30AM, FELT WARM AND FLUSH FACE AT 1300. AT 1330 MILD TINGLING ON THE BACK OF TONGUE AND THROAT. DENIES PROBLEM BREATHING OR SWALLOWING OR ANY OTHER ISSUES. TEMP 97.7 AT 14:30PM.
Global soreness(36 hrs from 9pm 3/11 to 9am 3/13) Vomiting multiple episodes 9am 3/12 ending around 11:30am 3/12 Nausea (8am 3/12 ending 11pm 3/12) Migraine (steady from 8am 3/12  to 11pm 3/13)
Pt had a 5x9mm area of swelling, redness, itching, and warmth at the injection site on the left deltoid. No streaking, or s/s systemic infection.
fast heartbeat; shortness of breath; dizziness; This is a spontaneous report from a contactable consumer (patient). An 18 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EP7533), via an unspecified route, administered in Left Arm on 20Apr2021 at 12:00 (18-year-old at vaccination) as a Dose 1, Single for COVID-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history and concomitant medications were not reported. No prior allergy was diagnosed. Facility type vaccination was reported as Health Clinic. The patient had not received any other vaccine in four weeks prior to vaccination. The patient was not diagnosed with Covid prior to vaccination. Since vaccination the patient was not tested for Covid. On 20Apr2021 at 18:00, the patient had experienced fast heartbeat, shortness of breath, dizziness. These adverse events resulted in Emergency room/department or urgent care. The patient underwent lab test and procedure which included heart beat: fast on 20Apr2021. The patient received IV antihistamines, Bronchodilator infusion as treatment for the resulted events. The outcome of the events was recovering.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Pain, redness, and swelling at injection site Severe abdominal cramps (woke me early from sleep) Body aches High fever (103.5*)  Chills  Sweats Fatigue
I tested positive for covid-19 on an at home Covid test 01/01/2023 I started having chills and a low-grade fever that did not go over 102. My body ached from the joints to my muscles. Also accompanied by a headache and a lack of appetite. I did have a telehealth appointment the same day I tested positive, and the doctor prescribed me PAXLOVID. I took it for 4 days due to the horrible taste. Day 1-2 I started to feel almost normal, and days 3-4 I felt horrible again. All my symptoms had come back. 2 weeks after the PAXLOVID I started to have a rash form in random areas on my body. I am currently still going to a dermatologist to figure out what the rash could be connected too. Also I realized when I am not walking my daily walk or I'm sitting down I feel winded, not so much a shortness of breath but I just feel winded.
This spontaneous report as received from a medical assistant refers to 4-year-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 21-SEP-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # L050956 with expiry date on 17-DEC-2017; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received.; Sender's Comments: US-009507513-1610USA010748: US-009507513-1610USA004609:
large red oval, about 3" x 2", near injection site.  i just noticed it this afternoon, but it may have been there earlier.
Headache, Myalgia, Arthralgia, sweating and sore throat Narrative: 2 days missed work
Systemic: Flushed / Sweating-Mild, Additional Details: Patient complained of feeling hot, sweating noted.  Skin cool and clammy.  Vital signs 98.1, 72, 18, 110/90.  Patient states that he does have anxiety and seeing the other incident in store caused reaction.  Patient seen by EMS, refused transfer to ED for further evaluation.  Patient given water to drink, tolerated well.  Observed for 15 additional minutes and patient stated that he felt better.  Then patient left store, appeared to stable, no further symptoms noted.
fever; severe joints aching; severe headache day two; severe fatigue; Severe stinging down to my finger tip on left arm at time of injetion; Dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 03:00 (Lot number: FH8027) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII, administration date 06Oct2021. Past drug history included: Sulphur, reaction(s): "known allergies: Sulphur". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Left, Vaccine Administration Time: 12:00 AM), administration date: 06Mar2021, when the patient was 59 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6207, Location of injection: Arm Left), administration date: 30Mar2021, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021 03:00, outcome "unknown", described as "Dose number: 3"; PYREXIA (non-serious) with onset 16Nov2021 13:00, outcome "recovering", described as "fever"; ARTHRALGIA (non-serious) with onset 16Nov2021 13:00, outcome "recovering", described as "severe joints aching"; HEADACHE (non-serious) with onset 16Nov2021 13:00, outcome "recovering", described as "severe headache day two"; FATIGUE (non-serious) with onset 16Nov2021 13:00, outcome "recovering", described as "severe fatigue"; PAIN (non-serious) with onset 15Nov2021 03:00, outcome "recovering", described as "Severe stinging down to my finger tip on left arm at time of injetion". Therapeutic measures were not taken as a result of pyrexia, arthralgia, headache, fatigue, pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient not been tested for COVID-19.   Follow-Up (22Nov2021): Follow-up attempts are completed. No further information is expected.
Female  with throat pain, chills, and generalized body aches x3-4days. Patient denies any fever, cough, shortness of breath, nausea, vomiting, or abdominal pain. She states that she received the COVID-vaccine on 10/23/2022. Patient reports compliance with medication regimen
Information has been received from a health professional concerning a 11 year old male pt who on 22-AUG-1995 was vaccinated with a dose of varicella virus vaccine live. Subsequently, on approximately 14-APR-2004, the pt developed breakthrough chickenpox with less than 50 lesions. Follow up information indicated that "there was no single report of adverse reaction following varicella vaccination". The reporter indicated that 49 other patients developed breakthrough cases of chickenpox (WAES0404USA02615, WAES0405USA00572, WAES0405USA00573, WAES0405USA00574, WAES0405USA00575, WAES0405USA00576, WAES0405USA00577, WAES0405USA00578, WAES0405USA00579, WAES0405USA00580, WAES0405USA00581, WAES0405USA00582, WAES0405USA00583, WAES0405USA00584, WAES0405USA00585, WAES0405USA00586, WAES0405USA00587, WAES0405USA00588, WAES0405USA00589, WAES0405USA00590, WAES0405USA00591, WAES0405USA00592, WAES0405USA00593, WAES0405USA00594, WAES0405USA00595, WAES0405USA00596, WAES0405USA00597, WAES0405USA00598, WAES0405USA00599, WAES0405USA00600, WAES0405USA00602, WAES0405USA00603, WAES0405USA00604, WAES0405USA00605, WAES0405USA00606, WAES0405USA00607, WAES0405USA00608, WAES0405USA00609, WAES0405USA00610, WAES0405USA00611, WAES0405USA00612, WAES0405USA00613, WAES0405USA00614, WAES0405USA00615, WAES0405USA00616, WAES0405USA00617, WAES0405USA00618, and WAES0405USA00619). No additional information is expected.
Mother found child face down in bathtub at home. Child was cyanotic and unresponsive. Questionable seizure diagnosed at ER.
Beginning about 8 p.m. on day of vaccination, I grew fatigued.  Friday, 4/2/2021, I woke up and could barely get out of bed and had the dry heaves for most of the day.  Not able to eat anything.  Stayed in bed (except to dry heave) for the day.  The odd thing about this is that just about a year ago, I had the Covid-19.  It lasted for about 6 weeks.  At the time (March/April) there wasn't any test available.  After I had the worst sore throat EVER, I then had the malaise and dry heaves for a few weeks.  Finally I found that Pepcid helped with the GI symptoms.  That was after about 3+weeks of this.  I literally could not get off the couch and slept much of the time.  I just find interesting that one day of the same type of symptom that I had when I had the active virus was a side effect.  Also, note my antibodies have been positive to date.  I've been getting them checked regularly.
Patient was accidentally given 2 covid vaccines by nurse inted of one covid vaccine and 1 flu shot
Rash (redness and swelling) developed at site of injection and continued to spread over 5 days before patient contacted provider and pharmacy. Patient to follow up with primary care provider for treatment.
Rash on arm a couple of days after vaccination and it lasted about a week.  Arm felt bruised and very sensitive.
On the 8th day I woke up with my left deltoid swollen. I had a red spot at the injection site, the size of a racquetball.  My lymph nodes in my axilla were also swollen and I had no fever. I went to see my PCP and by that day, I was feeling 50% better and by the next morning, my symptoms were gone.
I started noticing that I had chest pain and chest discomfort. I also have been having more shortness of breath than I am used to. When I went to the doctor, they though it was just an asthma attack, but I told them that the discomfort in my chest felt different than what I am used to so the doctor referred me to a heart specialist. They noticed abnormalities of my heart and is going to continue to monitor it. There was some regurgitation with my heart and at those times it causes me to be a little short of breath. I felt like I had to do breathing treatments more frequently now. I had also caught COVID-19 well before getting the vaccine.
19APR95 2hrs p/vax pt blue & limp; mom aroused, eyes glazed further episode w/in 1 h rs to PMD; MD ER-screaming high pitched cry x 4-6hrs-lethargic x 2 days; body felt cold for hrs
Pretreated with 75 mg diphenhydramine PO and 200 mg cimetidine PO 30 minutes prior to injection due to previous reactions to vaccinations in previous years. 20-30 seconds after receiving Flublok, the patient began having difficulty speaking and forming words, as well as a numbing sensation in her feet, but was able to feel when touched. The patient began coughing and having difficulty breathing shortly after, and was administered 0.3 mg epinephrine IM during transfer to the ED.
Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) for 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 and INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) (Intramuscular) 1 dosage form. On 30-Oct-2021, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter considered MALAISE (Malaise) and HEADACHE (Headache) to be possibly related.    The patient had FLUARIX vaccine on right deltoid along with Moderna booster dose.   No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-370135 (Patient Link).
Unexplained heavily menstruation bleeding/ breakthrough bleeding. I had been on my birth control for months prior to the vaccine. My periods were controlled and routine.  I noticed I started have breakthrough bleeding and spotting. It has increased to where i have been bleeding when I should not be and extremely heavy. I spoke to my OBGYN several times. She increased my consumption to three pills a day to stop the bleeding and then recommended a switch in birth control. I switched birth control and the bleeding has continued.  There's no explanation why this is happening because this had not occurred in almost a year of taking this medication.
allergic reaction to the Tdap; rash approximately 5 inches at and around the injection site; chills; muscle soreness; joint soreness and aches; swelling; erythema; Initial information received on 27-May-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 11 years old male patient who had allergic reaction to the tdap, chills, muscle soreness, joint soreness and aches, swelling, erythema and rash approximately 5 inches at and around the injection site while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-May-2022, the patient received a  fifth dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE , (lot:  U7271AA ; expiry date: not reported) via intramuscular route in the left deltoid for immunization.  On the same day,  the patient developed a non-serious event of  allergic reaction to the tdap (allergy to vaccine) , chills , muscle soreness (myalgia), joint soreness and aches (arthralgia), swelling, erythema, rash approximately 5 inches at and around the injection site (vaccination site rash)  following the fifth dose administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient's mother took him to urgent care on 25-May-2022 and they gave medications to soothe the symptoms  Action taken : not applicable for all the events.  The patient was treated with PARACETAMOL (TYLENOL),  DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) , LORATADINE (CLARITIN [LORATADINE])  and IBUPROFEN (IBUPROFEN) for Vaccination site rash, Allergy to vaccine, Chills, Myalgia, Arthralgia, Swelling and Erythema.  Outcome: not recovered for all the events
Information has been received from other source concerning a female (age not reported) who was vaccinated on unspecified date with Gardasil (lot number unknown). On the same date, the patient also was vaccinated with 2 other vaccines. On an unspecified date when administered Gardasil, the patient passed out. The patient recovered from the adverse event. Additional information has been requested.
the Moderna vaccine has cured my Type II diabetes; some arm soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (some arm soreness at injection site) and THERAPEUTIC RESPONSE UNEXPECTED (the Moderna vaccine has cured my Type II diabetes) in a 64-year-old female patient who received mRNA-1273 (batch nos. 047A21A and 021B21A) for COVID-19 vaccination.     The patient's past medical history included Type 2 diabetes mellitus.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (some arm soreness at injection site). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (the Moderna vaccine has cured my Type II diabetes). On 26-Mar-2021, VACCINATION SITE PAIN (some arm soreness at injection site) had resolved. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (the Moderna vaccine has cured my Type II diabetes) outcome was unknown.        For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   treatment information not provided.   This case was linked to MOD-2021-101376 (Patient Link).
NO ADVERSE EVENT REPORTED; BOTH DOSES WERE ADMINISTERED OUTSIDE OF MANUFACTURER EXPIRATION DATE 8/31/22. VACCINE WAS RECEIVED IN SHIPMENT ON 7/22/22 AND PLACED IN FRIDGE WITH BEYOND USE DATE 9/30/22 AND WAS NOT LABELED CORRECTLY TO EXPIRE 8/31/22 ACCORDING TO MANUFACTURE EXPIRATION. VERIFIED WITH MOTHER, NO ADVERSE EFFECTS REPORTED
Patient states the night of 7/18/16 the following symptoms began 101.1 F Temp, Body aches, Chills, sweats, malaise, pain at injection site and lethargy.
Patient presents to medical facility for 2nd booster dose of Moderna Covid vaccine. When documenting in log, lot number states Modera lot 048L21A expiration date of 7/8/2022. Vaccination administered 7/13/2022. No adverse reaction noted during observation window, Follow up scheduled.
This spontaneous report as received from a local nurse refers to a patient of unknown age. The patient's medical condition and current conditions are not reported. On 13-AUG-2014 the patient was vaccinated with RECOMBIVAX HB of 1 ml strength via intramuscular route (lot #H010965 and expiry date 01-JUN-2014). Approximately on an unknown date in 2014 the patient received an expired dose of RECOMBIVAX HB. No adverse events are reported. The outcome of the events is unknown. Additional information has been requested.
Information has been received from a physician referring to a 12 year old male patient with asthma. The patient had no drug reactions/allergies or concomitant medication. On 21-JUL-2015, the patient was vaccinated with his first dose of GARDASIL 9 (lot # K026246 with expiration date 28-JAN-2017; route was not reported). On 09-SEP-2016, the patient was vaccinated with his second dose of GARDASIL 9 (lot # M020103 with expiration date 15-FEB-2018; route was not reported) (inappropriate schedule of drug administration). On the same day, the patient experienced an adverse effect of headache "ever since the second dose". The patient's mother sought medical attention by calling the physician on an unspecified date in 2016, and a treatment of an unspecified dose of "TYLENOL or ibuprofen" was ingested, which improved the headache temporarily. There was no lab diagnostics studies performed. The causality was not reported. Additional information has been requested.
Patient initially noticed an itchy red rash on her back.  During the day on 5/11/2012 at school rash progressed to entire body.  At 3:30pm on 5/11 pt had diffuse erythematous raised plaques, some with central pallor, all over trunk, b/l extremities, palms, soles, face.  Given one dose of hydroxyzine 30mg and Zyrtec 10mg.  Rash resolved.
PT described hive rash and swollen eyes started 2/20/03. Has stated had hives with vax in past, but did not inform nurse at the time. Could not recall which vax had caused past hives.
Rash on torso, back, and arms. Still persist to date. Taking over counter meds to stop itching
pt recv in 1983 & pt exp a positive anti-nuclear antibody & ulcerative colitis;
Patient stated she had tremor like movements for an hour that night and a little redness. Patient is better now.