chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial solicited report received from an investigator in a trial on 02 March 2017. A 20-year-old male subject with no significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000, (lot number and route, site of administration not reported) on 20 April 2016. On 10 May 2016, 22 days after vaccination the subject was diagnosed with angina pectoris. On 29 April 2016, 09 days after vaccination the subject was diagnosed with Non-ST elevation (NSTEMI) myocardial infarction. The lab data included on 29 April 2016, the Troponin I was 0.06 (abnormal) and ECG was abnormal, Echocardiogram, MRI (heart, brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a 20-year-old male who developed angina pectoris and Non-ST elevation (NSTEMI) myocardial infarction with favorable temporal association post vaccination with ACAM2000. Myocardial infarction is listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccines. The company has assessed the event as possibly related to study vaccine.
Difficulty in breathing; Body tingle; Nausea; Fatigue; Swollen at the site of injection; Fever; Chills; Redness at site of injection; Pain at the site of injection; Vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Difficulty in breathing), PARAESTHESIA (Body tingle), NAUSEA (Nausea), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Swollen at the site of injection) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure management. Concomitant products included LEVOTHYROXINE, IOVERSOL (IVERSENSE) and DILTIAZEM HYDROCHLORIDE (DILT-XR) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Difficulty in breathing), PARAESTHESIA (Body tingle), NAUSEA (Nausea), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Swollen at the site of injection), PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Redness at site of injection), VACCINATION SITE PAIN (Pain at the site of injection) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Difficulty in breathing), PARAESTHESIA (Body tingle), NAUSEA (Nausea), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Swollen at the site of injection), PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Redness at site of injection), VACCINATION SITE PAIN (Pain at the site of injection) and VOMITING (Vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included blood pressure medication. The patient underwent Covid-19 test at work and results were not available.
This spontaneous report as received from a medical assistant refers to a 23 years old patient. The patient was vaccinated with a dose of GARDASIL (lot # H012973; exp date 05-MAR-2015) on 12-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. The medical assistant reported that GARDASIL was exposed to 72 degrees Fahrenheit for 120 hours and the vaccine was administered to the patient after the temperature excursion. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Arm very sore 4 days then very red about 5 inches down towards elbow- slightly itchy- 4-5 days.
Post vax, the pt could not sleep. He complained of dizziness the morning after vax. He complained of pain in left side of neck and ear, headache, and generalized aches. Took ibuprofen and rested. Symptoms lasted 12-18 hours, felt better on 3rd day post vax.
Vomiting, severe pain, intussusception. Surgery to fix intussusception performed 12-22-2022
on 9/19/ 2021 was hospitalized and diagnosed  with non epileptic seizures  .Discharged on the 20th . had a seizure on the parking lot and was admitted to hospital for 1 day
First my upper arm felt like it had a 5 pound brick in it. and then I couldn't raise my arm above horizonal to floor.  It did resolve but took 12 weeks  to get back to normal. Two weeks after my shot I developed an ache in my vagina.  It seemed to resolve in 12 hours but now continues to com back intermittently for short periods of time.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 18-MAY-2015, the patient was vaccinated with ROTATEQ which had been improperly stored (oral, lot # reported as: K020183, expiry date: 25-JUN-2016, dosage not provided). The product had not been supported with in-house stability data. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Body aches, muscle soreness, sore throat, chest congestion and cough, with symptoms increasing over past 7 days and not resolving.
Transverse myelitis, marked hypotonia, all 4 extremities, lethargy. Irritability added from Discharge Summary rec'd 11/10/2003/sr
Right half of face swelled and broke out in hives.  The white of the right eye turned solid pink.  Infant was extremely fussy and crying.  Unable to be consoled but only the right half (which was facing away from me initially) broke out.  Hives and the pink eye lasted for just over an hour.  Once she calmed down, I took a few pictures of the remaining hives.
24 hrs p/shot t103, shakiness & loss balance, unable to walk for an hr;
This spontaneous report was received from a nurse and refers to a 72 year old patient of unknown gender. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medications were not reported. On 20-JAN-2017, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX23 via intramuscular route in the right deltoid (lot # L012215, expiry date: 13-JAN-2017) for prophylaxis. No adverse effects were reported. Additional information has been requested.
pt started crying about 130PM-uncontrollable nonstop crying;pt was taken to ER about 330PM & cried another hr;ER MD according to mom felt this crying was d/t the vax;pt seen next day by MD & told DTAP or DT should be given instead DTP
This spontaneous report was received from a pharmacist refers to a male patient of unknown age. The patient was vaccinated with a dose of PNEUMOVAX 23, (lot number was reported as 0595AA, expiration date 30-AUG-2012) on 26-SEP-2012. Concomitant medications were not reported. No adverse event was reported. This is one of the reports received from the same reporter. Additional information has been requested.
Malaise within 5 hours, low fever within 12 hours,high fever (102.5) within 20 hours, headache, joint pain. Itching. Rx-Allegra, chlortremiton, calomine lotion.
On 5/29/21 vomiting, on 5/30/21 noticed fatigue, nausea and dark urine, on 6/1/21 went to urgent care who referred to ER. 6/1 labs bilirubin 4.2, alkaline phos 186, ALT 396, AST 142. Performed CT and MRCP on 6/1 and 6/2 and found no blockages. Liver biopsy on 6/4 (see detail in Item 19). Labs relatively stable during hospital stay 6/1-6/4. Repeat labs 6/12: bilirubin 7.4, alkaline phos 186, ALT 184, AST 80. Diagnosed on 6/16 with "autoimmune cholangitis" started high dose steriods (60mg) on 6/16 and naltrexone 50mg for itching on 6/16 and ursodiol 300mg 3x times a day. Submitted report on 6/17.
On day of: after 8 hours, intense chills of body. Muscle aches from shivering due to chills. Lasted about 4-6 hours, with no residual effects the next day.  7 days after administration: rashes all over body, including both arms, legs, and sides. Rashes were prominent and itchy during the morning, and slowly got better over the day. Daily Claritin was taken in morning.
Right upper arm redness, warmth, swelling and tenderness starting within 12 hours of vaccination. Ice and ibuprofen used. Redness and swelling spread to elbow. Started to improve after 48 hours and was seen for follow up visit.
Patient broke out into a macular papular rash 10 days after the vaccines were administered.  The patient had a low grade fever for 2 days prior to the onset of the rash.  The temperature never was greater than 100.3.  Patient also had URI symptoms.  The rash started on the face and the trunk of the body and has spread to cover the entire body.  The rash is mild and non-pruritic.
On 8-22-16 patient states she "felt like something was in my eye". She went to see OD, on 8-25-16 and was diagnosed with "shingles L eye with cornea involvement". She was given Rx homatropine gtts to the eye and p.o. Rx famciclovir 500 mg T.I.D. #21. She was told to take p.o. Tylenol OTC prn for pain. She states that she "forgets" to take the Tylenol and that the pain is not too bad now. She has f/u appointments with ophthalmologist, on 8-30-16 and she also has an appointment for f/u with her PCP on 9-1-16.
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (606 doses given after expiration date) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 008C21A) for COVID-19 immunization. No medical history reported. On Oct 27, 2021, patient received the 3rd dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 27, 2021, patient administered expired product (606 doses given after expiration date). At the time of the report, administered expired product (606 doses given after expiration date) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reportedly, there was confusion between the expiration date printed on the carton and when vial was scanned. No adverse event reported. Vial did not undergo any temperature excursion. Vial was placed in refrigerator on Nov 18, 2021.
SARS-CoV-2 positive 5/4/21. Had symptoms including productive cough 4-5 weeks, fatigue for 4 weeks, exertional dyspnea for 3 weeks, anosmia for 6+ weeks (ongoing), mild myalgia for 1 week, mild headache for 1 week.
5:00 pm 10/24/2011 rash on back of both arms 7:00 pm 10/25/2011 rash on butt & front of legs 5:00 am 10/26/2011 rash on ankles.
7.5 x 9 cm redness and induration; surrounding injection site at 72 hours
My arm/shoulder muscle is messed up.  Since the vaccine, I can no longer lift 3 lbs over my head with that arm without extreme pain.  I work out a lot and I can normally lift at least 20lbs.
The above patient received a COVID-19 vaccine on 03MAR21 @ 1440.  He came to the EH&S office on the morning of 04MAR21 complaining of left arm pain, fatigue, headache, muscle pain, joint pain, chills, and nausea/vomiting.  He was evaluated by a healthcare provider who noted mild swelling and a small knot was felt in his left arm.  He is to follow-up with our onsite nurse or his medical provider if his condition worsens.
My adverse event started with the dosage 1 of the Pfizer Vaccine. On April 1st, I had eaten dinner and didn't feel right (within an hour and 15 minutes I felt a weird sensation in my throat and my blood pressure stated to climb up to 192/122 and I was rush to the ER by ambulance and they gave me a baby aspirin. The Doctor performed a CT Scan and found that the protein in my blood was elevated via blood test performed and upon being released from the hospital, I went to see my PCP because my blood pressure was spiking daily (been on blood pressure medication and my blood had never spiked before). I had 4 or 5 total episodes where my blood pressure would spike too high and I could feel pulsation in my neck and the hospital could not pinpoint. I took my medication and it would go away but would return 10 hours later (face would also become flesh). My Doctor put me on a beta-blocker 30 gram per day and am on Lytensopril was doubled on 20 grams instead of 10 grams. I am also on Propranolol 10 mg tablets 3 times per day (beta-blocker),  and Spironolactone 25 mg twice per day. It's very disturbing because I'm on 7 medications and a heart monitor (on my 9th day...mail in on June 21st to get the results). I will be having a stress test done at the end of June and a possible Angio-gram which I am holding off on.
Patient reports feeling lightheaded, felt her heart was racing. EMS assessed patient, BP:172/104, pulse 64 (patient did not take her BP meds in the morning). Patient reports feeling better,  symptoms improved. Cleared by EMS
Pain,  swelling, redness @ injection site, extreme fatigue next day, month later (April 7th) , developed total body rash
Primary Care Physician contacts Call Center on 06DEC10 re 34 y/o male patient with an onset of itchy red welts, appearing initially on patient's upper arms 1-2 months after the SM's receipt of Anthrax #4 (25APR07) and AVA # 5 (14MAY07). SM also received his 2nd Smallpox Vaccine on 26APR07 and Typhoid ViCPS on 20JUN07. SM continued to have recurrent, intermittent bouts of "red bumps" not associated with any known food or environmental trigger and no h/o atopy. Pt was dx'd with "chronic papular urticaria" (20JUL09) by Dermatologist. Pt. also exhibited marked dermatographism one exam. The Dermatologist, felt the etiology was consistent with "a hypersensitivity to some kind of trigger, difficult to pinpoint". Rx'd with TEMOVATE 0.05% topical TEMOVATE cream BID and po Loratadine, which was changed to daily ZYRTEC 10mg po qd at subsequent visit. Patient continued with chronic bouts of "itchy red bumps" on upper arms, spreading to thighs, back and buttocks and lasting minutes to hours. SM received AVA # 6 on 12NOV10 in preparation for upcoming 2011 deployment abroad and expressed concern for his recurrent itchy red bumps to his PCP, who referred the SM for a second opinion to a Civilian Allergist in Nov of 2010. When the SM saw the Allergist, the red bumps were not present, but he showed the Allergist photos he had taken. The Allergist felt the photos of the bumps did not appear allergic in nature, but like nodules and suggested they may be related to receipt of the Anthrax and Smallpox vaccines. The patient's second SPV was 26APR07 and AVA # 6 & Typhoid ViCPS were on 12NOV10. The patient has had ongoing, intermittent bouts of the red itchy bumps since MAY/JUN 2007. They are a "nuisance" but do not affect his ability to perform his work or cause any sx of anaphylaxis- no breathing or swallowing difficulties, no facial or periorbital edema. No shellfish, Latex allergies.
tested positive for covid 9/21/2021, done r/t sx congestion, exposure to positive household member
Patient experienced moderate (5/10) headache 20 minutes post-injection, self-medicated with Advil about 4-5 minutes ago, is awaiting relief.
Two weeks after the vaccine, I developed a sharp pain at my lower back pain on the right side. About 3 days later, I broke out in a rash on my back. I immediately the next morning went to the doctor, and he diagnosed me with shingles. I was prescribed an antiviral. Blistering lasted about 3 weeks and extreme fatigue which lasted about 4 weeks. Assumed it was a routine outbreak of shingles. I had not been vaccinated for shingles.
pt recvd vax;devel redness & swelling of arm & fever;to md, had fallen twice & devel aphasia;by am redness reduced;md & rn agreed fall due to myalgia
This spontaneous report as received from a nurse refers to an unspecified number of patients unknown age and gender. On an unknown date the patients were vaccinated with first dose of GARDASIL (lot number and expiry date unknown) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. On an unknown date the patients returned to the office over 1 year later after receiving the first dose of the GARDASIL (inappropriate schedule of drug administration). No adverse events were reported. The action taken with the therapy with GARDASIL was unknown. There was no product quality issue reported. Additional information has been requested.
6x5cm well circumscribed macular -papular rash at L upper arm at injection site/onset ~ 4d post vaccination. No systemic symptoms.
This spontaneous case, initially received on 05-Oct-2018, reported by other healthcare professional (nurse), concerns a female patient of unspecified age. The patient's current condition included unspecified immune disease (since an unspecified date). On 03-Oct-2018, the patient was administered AFLURIA QUADRIVALENT [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 03144611A, expiry date: 30-Jun-2019]. On 04-Oct-2018, 1 day after vaccination, the patient developed a red circle of 5 cm. On 05-Oct-2018, 2 days after vaccination, the patient visited emergency room due to the swollen arm. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as serious (medically significant).
received the Johnson & Johnson COVID-19 vaccine; Patient 2nd Dose past 42 days; itchy throat; itching in eustachian tubes; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient 2nd Dose past 42 days), THROAT IRRITATION (itchy throat), EAR PRURITUS (itching in eustachian tubes) and INTERCHANGE OF VACCINE PRODUCTS (received the Johnson & Johnson COVID-19 vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Anaphylactic reaction (40 years earlier).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced THROAT IRRITATION (itchy throat) and EAR PRURITUS (itching in eustachian tubes). On 08-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient 2nd Dose past 42 days). On 03-May-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (received the Johnson & Johnson COVID-19 vaccine). On 11-Jan-2021, THROAT IRRITATION (itchy throat) and EAR PRURITUS (itching in eustachian tubes) had resolved. On 08-Feb-2021, PRODUCT DOSE OMISSION ISSUE (Patient 2nd Dose past 42 days) had resolved. On 03-May-2021, INTERCHANGE OF VACCINE PRODUCTS (received the Johnson & Johnson COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was reported.  No treatment information was provided.     This case was linked to.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Patient received another manufacturer's vaccine after Moderna vaccine.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  The causality for the event of missed dose is assessed as not applicable.
Fever/chills/erythema/lymphangitis/adenopathy. Tx: Tylenol po q4-6hrs. Motrin po q 8 hrs bed rest.
Seriousness criteria other medically significant (OMIC) Initial report received on 3/28/2006 from a health care provider. A two month old female patient, with a medical history of premature birth at 26 weeks gestation and bronchopulmonary dysplasia, had received on 2/25/2006, a dose one, left thigh injection of Adacel, lot number C2340AA, a dose one site unknown injection of IPOL, lot number unknown, a dose one, right thigh injection of Hib vaccine, lot number 0717R, and a dose one, right thigh injection of Hepatitis B vaccine, lot number 0143R. The patient had been hospitalized since birth (birth weight 580 grams) in the Neonatal intensive care unit. Per the reporter, the patient was administered Adacel in error. At an unspecified amount of time post immunization, the patient experienced an episode of tachycardia and decreased oxygen saturations. At the time of the events, the patient was already receiving oxygen, and secondary to the event, her oxygen administration was increased. There was no separate hospitalization for this event. The patient subsequently recovered from the event.
Patient began with RLE, below the knee numbness, tingling, and weakness. Progressed to include RUE at time of admission. Also described aphasia, which began the same evening,  Admitted to the hospital with normal MRI, CTA head and neck, and no other obvious culprits to account for symptoms.
This spontaneous report as received from a field employee via a physician's assistant refers to a female patient in her 70's. On an unkonwn date when the patient was in her 60's, she was vaccinated with PNEUMOVAX 23 (also reported as unspecified manufacturer). No concomitant medications were reported. On an unknown date the patient experienced pneumonia. The outcome of pneumonia is unknown. Additional information has been requested.
VERY TIRED/LETHARGIC FOR NEXT 6-7 HOURS; ACHY; CHILLS; NOT FEELING WELL; LOW GRADE FEVER OF 100F; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 128 pounds, and height was 64 inches. The patient's past medical history included: ulcerative colitis, and concurrent conditions included: immunocompromised, and bactrim allergy/sensitive to sulfa drugs, and other pre-existing medical conditions included: Patient experienced anaphylactic reaction when treated with IV dyes. The patient experienced anaphylactic reaction when treated with promethazine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 24-AUG-2021) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the patient experienced very tired/lethargic for next 6-7 hours. On 19-MAR-2021, the patient experienced achy. On 19-MAR-2021, the patient experienced chills. On 19-MAR-2021, the patient experienced not feeling well. On 19-MAR-2021, the patient experienced low grade fever of 100f. On 19-MAR-2021, the patient experienced headache. On 19-MAR-2021, the patient experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 100 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very tired/lethargic for next 6-7 hours, achy, chills, not feeling well, low grade fever of 100f, headache, and fatigue on 21-MAR-2021. This report was non-serious.
6/20/05 4:50pm Onset of nausea within 3-4 minutes post vaccination. Felt "tired, droopy". B/P 104/70 P.100 reg,R. 20. No dyspnea, rash or swelling. Slight pallor, alert and oriented. States she had similar reaction (nausea) following shots, but only last 5 minutes. 5:10pm After lying down felt less faint. B/P 115/72 P. 82. R. 22. Nausea unchanged. 5:32pm No longer faint. Less pallor, nausea unchanged. Seen by M.D. ok to drive home. Called in sick 6/21/05. Told supervisor she still didn't feel well. 6/21/05 1:45pm Called employee at home. States she feels much better this afternoon. States she vomited once last night. Felt very dizzy this morning so did not go in to work. Feels much better after sleeping most of morning.