chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart attack ( heart attack (10019250), Myocardial infarction (10028596)); This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack ( heart attack (10019250), Myocardial infarction (10028596))) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    No Medical History information was reported.   On 17-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 18-Dec-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack ( heart attack (10019250), Myocardial infarction (10028596))) (seriousness criteria death and medically significant). The patient died on 18-Dec-2021. The reported cause of death was heart attack ( heart attack(10019250), myocardial infarction (10028596)). It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDIAL INFARCTION (Heart attack ( heart attack (10019250), Myocardial infarction (10028596))) to have an unknown relationship.    No concomitant medication were provided.  Patient received JANSSEN COVID-19 vaccine as their 1st dose vaccine.  No treatment information were reported.  Company Comment: This spontaneous case concerns a male patient, of unknown age, with history of co-suspect administration of the Janssen COVID-19 vaccine, who experienced the unexpected, serious AESI of myocardial infarction. The event, which resulted in a fatal outcome, occurred 1 day after administration of the second dose of the Moderna mRNA-1273 vaccine. On 18Dec2021, the patient experienced a heart attack and died. No further details were provided. It is unknown if an autopsy was performed. The history of co-suspect administration of the Janssen COVID-19 vaccine remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient, of unknown age, with history of co-suspect administration of the Janssen COVID-19 vaccine, who experienced the unexpected, serious AESI of myocardial infarction. The event, which resulted in a fatal outcome, occurred 1 day after administration of the second dose of the Moderna mRNA-1273 vaccine. On 18Dec2021, the patient experienced a heart attack and died. No further details were provided. It is unknown if an autopsy was performed. The history of co-suspect administration of the Janssen COVID-19 vaccine remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Heart attack ( heart attack(10019250), Myocardial infarction (10028596))
Patient developed a bruise at injection site and reported itchiness. Right below injection site, patient developed a crescent shaped rash that was warm to touch. Patient noticed the reaction the day after vaccination. Four days after vaccination patient took TYLENOL and did not have any addition comments. Area looked improved.
Red arm and swelling after vaccination that subsided after 3 to 4 days. No previous history of reactions to vaccines.
Patient presented to the ED and was subsequently hospitalized several times within 6 weeks of receiving COVID vaccination. Dates include: 2/24/21, 3/2/21, 4/17/21. Patient presented to the ED on 4/29/21 with NSTEMI and 5/7/21 with dizziness.
Patient had large bruise and still has pain and soreness 1 1/2 months later.
Pt recvd MMR vax on 17JUL90; On 23JUL90 pt devel eczematous looking skin on buttock area; 24JUL90 fever; 27Jul90 t102.4 r, devel rash on genital area & spread to face & legs also exp loose stools, cranky & somnolent @ times, neck stiffness;
On 12/23/14, patient received inactivated influenza vaccine 1:34 pm (right deltoid), and pneumo23 vaccine ~5:30pm (left deltoid).  On 12/24/14 ~1am, woke up with severe 10/10 new left shoulder pain, morning vitals temp 100.4, HR 112, BP 147/107. 12/25/14 Fever resolved ~3am.
Fever of 103 p/7 days; cont now p/3 days; examined by MD who could find no cause;
"Husband" received Dryvax on 2/10/03. Area on husband's wife (subject of this report) appeared 2/17/03. A single, slight tender pustule about 3 mm, with a concave center, appeared at right wrist. Developed swollen LN's on 2/14/03 submandibular area 12-24 deg. No other rash noted.
Headache, Myalgia, Arthralgia, NauseaVomiting, pain at inj site Narrative:
Initial and follow up information has been received from Merck pregnancy registry through a Nurse concerning a 21 year old female with no previous medical history, who on 14-SEP-2007 was vaccinated IM with a first 0.5 ml dose of GARDASIL. Concomitant medication included FOCALIN 15 mg QD intermittently just until pregnancy known for ADHD and ZOFRAN 4 mg TID PRN for nausea/vomiting. It was reported that the patient received the vaccination while she was pregnant. Medical attention was sought. In follow up the nurse stated that on 28-May-2008, the patient delivered a normal live born female infant weighing 8 lbs and 9 Oz with an apgar score 9/9. There were no complications or abnormalities and no congenital anomalies. There were no infections or illnesses during pregnancy. It was reported that patient had a caesarean section since the baby was in breech presentation. Pediatric medical records were received and reviewed and the following experience was identified. On 02-JUN-2008 baby came to doctor's office and was found to have jaundice. Baby's bilirubin was 16.7 mg/dL and she needed photo therapy. She was seen on 03-JUN-2008 and it was reported as physiologic jaundice and was admitted to the hospital. On 06-JUN-2008 the baby was seen in the doctor's office for follow up hospitalization for jaundice. It was reported that on examination baby had "?questionable hip dysplasia". A follow up phone call was made to the doctor's office and information was received that the baby was referred to an orthopedist. The nurse reported that as per the doctor's note the baby had an examination with the doctor. It was reported that "physical examination showed the hip to be slightly lax, but there was no evidence of any dislocation and it appeared the hip was tightening". The mother cancelled the follow up visit for the baby with the doctor but reported that the baby was doing well. On 11-JUN-2008 the baby went to the doctor's visit. In the record it was reported that the baby had eye drainage and diarrhea after amoxicillin. The baby was reported to be improving after amoxicillin (date of therapy not reported). It was reported that the baby had poor weight gain. On 18-JUN-2008 the baby visited doctor's office. It was reported that she had positional plagiocephaly. The skull x-ray was negative. On 10-JUL-2008 the baby came to doctor's office. It was reported that the baby was started on 15 mg PREVACID and her plagiocephaly was stable. On 04-AUG-2008 the baby visited the doctor's office for immunization and found to have nasal congestion. Gastro Esophageal Reflux Disease and upper respiratory infection. The outcome was unknown. The baby also had events after she was vaccinated with ROTATEQ (MSD), ACTHIB, PEDIARIX (WAES # 0811USA02267). Upon internal review baby's breech presentation which required a caesarean section delivery was determined to be an other important medical event. Additional information has been requested. All medical records will be provided upon request.
The patient experienced no symptoms; patient was administered a dose of PROQUAD and a dose of VARIVAX at the same time; patient was administered a dose of PROQUAD and a dose of VARIVAX at the same time; This spontaneous report was received from a registered nurse, and refers to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.       On 24-JAN-2020, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # R035226, with an expiration date in 04-DEC-2020) (strength, dose, frequency and route were not provided) for prophylaxis. On the same date (reported as "at the same time"), the patient was also vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot #S021325, with an expiration date in 05-JAN-2021) (strength, dose, frequency and route were not provided) for prophylaxis.   Other suspected therapy included sterile diluent.
This spontaneous report was received from a registered nurse concerning an unspecified number of patients of an unknown age and gender. The patients relevant medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in October-2015, unspecified number of patients received improperly stored VARIVAX, lot number reported as K002918 with expiration date on 26-FEB-2016 (dose, strength and frequency were not provided). No doses were administered past the expiration date. No symptoms reported. According to the reporter, there were no previous temperature excursions and the temperature and time frame excursions were reported as: -11.2C for 360 hours, -11.1C for 480 hours and -10.7C for 1296 hours. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. On 07-NOV-2016, All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
1/2 hr after injection became nauseated and dizzy. Next day started vomiting, 2 days after developed hives, pt states she took Benadryl at that time. Went to ER when throat and tongue started going numb. They started IV and gave her steroids and more Benadryl, symptoms relieved at that time. States she started with hives again this morning. Will call private physician for medical advice.
2 days after pt received the shingles vaccine she developed right-sided upper abdominal pain, then 2 days after shot, she developed an erythematous, vesicular rash along the T10-T12 distribution on the (R) side. She is being treated with VALTREX and gabapentin.
At the very beginning I ended up with a bad cold as part of the symptoms. I was rushed to the ER with a Kidney and Bladder infection. The ER doctor prescribed antibiotics to treat the infections. I was in bed for three days because of the infections. I'm afraid to take the 2nd dosage because I do not want the same thing to happen.
Pt reported that approximately 24hrs after receiving the vaccinations she had a headache, dizziness.  Went home, took shower, slept through the night.  The next day she didn't remember much of the previous day.  Feels she continues to have trouble absorbing subjects at school.  Feels she is gradually getting better.
PATIENT STATES THAT HE FIRST EXPERIENCED SORENESS IN THE ARM WITHOUT REDNESS, TREATED WITH ICE... ABOUT 6 HOURS LATER (4PM) HE STARTED HAVING FLU-LIKE SYMPTOMS, INCLUDING HEADACHE, PAIN IN JOINTS, COLD HANDS... BY 11PM THAT EVENING, PT FEELING SOMEWHAT BETTER BUT STILL HAVING JOINT PAIN. WHEN PATIENT CALLED THE NEXT DAY TO REPORT THE REACTION, HE SAID HE FELT SOMEWHAT "HUNG OVER" BUT BETTER THAN PREVIOUS DAY.
Patient development shoulder and arm pain within 3 days of receiving booster COVID vaccine. Pain radiated from middle of scapula down arm and through breast.  Patient was incapacitated for several weeks. She received medrol dos pak to decrease inflammation. She alternated Tylenol with advil and also used lidocaine patches. She ended up getting x-ray of neck and back. Ultimately the pain stopped at about 6 weeks after the shot.
iritis; painful headache like a migraine; soreness in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of IRITIS (iritis), MIGRAINE (painful headache like a migraine) and VACCINATION SITE PAIN (soreness in the injection arm) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     Concurrent medical conditions included Collagen-vascular disease. Concomitant products included Retro Vials for HIV for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced MIGRAINE (painful headache like a migraine) and VACCINATION SITE PAIN (soreness in the injection arm). On 21-May-2021, the patient experienced IRITIS (iritis). The patient was treated with PREDNISONE (drop) for Light sensitivity to eye and Eye redness, at an unspecified dose and frequency. At the time of the report, IRITIS (iritis), MIGRAINE (painful headache like a migraine) and VACCINATION SITE PAIN (soreness in the injection arm) outcome was unknown.            Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
pt recv vax 26MAR98 & about 6 to 8hr p/vax pt had cellulitis @ the inj site;pt also had some hip pain;
Blinding in right eye 2 days post-vaccination. Diagnosed with optic neuritis. The following months after many more tests I was diagnosed with vaccine-induced multiple sclerosis.
Pt right arm deltoid swollen, warm to touch and red given Benadryl and was told to put warm packs on arm to reduce swelling also to take Benadryl and Motrin.
Janssen on 3/23. Positive on 8/28 admitted 8/29 to current
Sore at site night of vaccination - also redness and swelling increased next day (10/8) with itching and warmth too. 10/9 - increased down arm to elbow - no induration. 10/10 - Swelling started to decrease. 10/13 - Back to normal.
PATIENT STATED THAT SITE BRUISED THAT EVENING, THEN TURNED INTO RED RAISED AREA, WARM AND HARD TO TOUCH.
Patient was administered a Pfizer Covid 19 vaccine booster at our off site clinic on 12/11/2021. This was approved by the provider on site.  There were no adverse effects after the injection. Mother of child was insistent that he receive his booster due to his history of asthma and his pediatrician recommended he receive it.
His arm is still shaky; Has difficulties with function in his had doing daily activities; He has trouble getting out of bed; Patient is worried he will lose function in that arm as well and eventually die; did not receive the second dose; Arm is very painful; Patient describes full paralysis in that arm; This spontaneous case was reported by a consumer and describes the occurrence of MONOPLEGIA (Patient describes full paralysis in that arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, AMLODIPINE, EZETIMIBE, ALOGLIPTIN and METHYLPREDNISOLONE SODIUM SUCCINATE (PREFORIN) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced MONOPLEGIA (Patient describes full paralysis in that arm) (seriousness criterion medically significant). On an unknown date, the patient experienced TREMOR (His arm is still shaky), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has difficulties with function in his had doing daily activities), VACCINATION COMPLICATION (He has trouble getting out of bed), ANXIETY (Patient is worried he will lose function in that arm as well and eventually die), PRODUCT DOSE OMISSION ISSUE (did not receive the second dose) and VACCINATION SITE PAIN (Arm is very painful). At the time of the report, MONOPLEGIA (Patient describes full paralysis in that arm), TREMOR (His arm is still shaky), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has difficulties with function in his had doing daily activities), VACCINATION COMPLICATION (He has trouble getting out of bed), ANXIETY (Patient is worried he will lose function in that arm as well and eventually die) and VACCINATION SITE PAIN (Arm is very painful) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not receive the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included exercise nerve tests with electricity.   The patient has been to his hospital and has not seen any success in his treatments.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pain starting in right eye and continuing deep into throat. I thought it was a nerve infected by tooth/gum issue.
Injection site is red, hard, feverish and sore, and this began 10 days post injection
Experienced hearing loss (left ear) early morning, ringing sounds. Made an appointment with the doctor, referred to specialist. Hearing tests were conducted and concluded I lost 40% of my hearing. Now working on getting hearing aids.  Very expensive to get, working with company to get hearing aids. They requested a MRI to discard tumor. Appointment is today for the MRI. Will return to company with results to get hearing aid.
Started running a fever as high as 102F the next day after first shot, with extreme fatigue.  Had this same fever every day for 2 weeks.  Fever would drop slightly with Tylenol or ibuprofen, but every day would rise again to 102F.  Went to urgent care on August 20.  Doctor prescribed stronger ibuprofen and said to continue to push fluids.  After 2 weeks the fever has gone away, but still feeling fatigued.
Transient measles no nausea, vomiting diarrhea or fever. No other symptom except rash.
Started with neck stiffness, that was very uncomfortable to start off with, then the stiffness worked its way thru my entire body. With the left side ( the side I got the shot on) becoming extremely stiff and to the point painful.  Night sweats.  It took two days to feel better sort of.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 27-OCT-2014, an unspecified number of patients were vaccinated with improperly stored ROTATEQ lot # K001716, expiration date: 24-NOV-2015, oral (dose was not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Ma gave a Tdap to Pt. instead of the correct Dtap. She than gave the correct immunization to Pt. the correct Dtap was given before Pt. left the office.
Impact to Menstrual Cycle. I had two periods this month - both heavier than usual. One period (my expected period) began on 4/21/2021.  It lasted four days (normal).  The second period began on 5/2/2021 and is still ongoing at the time of this submission. Both were heavy flow with clotting.  I experienced breast tenderness and fatigue with both periods (which is normal for me).
Information has been received from an office manager via field employee referring to a 68 year old female patient. On an unknown date in October 2010, the patient received her first shot of ZOSTAVAX (lot#, expiration date, dose, route unspecified). On 02-MAR-2015 the patient was vaccinated with the second dose of ZOSTAVAX (lot #, expiration date, dose unspecified, route was reported as injection). The second dose of ZOSTAVAX was given in error by an unspecified clinician when the patient was supposed to receive a different unspecified vaccine on that date instead (wrong vaccine administered). Product confusion was not reported by the reporter. No adverse effects were reported. The patient had not sought medical attention. Additional information has been requested.
5/12/03 temp 99.3, unable to move limbs or stand; alert and talking. Admitted by doctor to medical center; testing treatment. Diagnosed Transverse Myelitis. Some improvement daily; transferred to hospital rehab 5/21/03 for further therapy. 5/14/03 School nurse called health department saying student in hospital. The 60 day follow up received on 8/6/03 states per family doctor's office nurse, will continue to take therapy for "fine motor skills" next few months. The medical record states per review of initial hospital record, diagnosis at that  time was cervical radiculapathy.
Pt received the influenza on 11/21/2018 at 1350. Pt went to the waiting room and sat down for 5 mins. Employee looked over and pt was very pale, and lethargic. Pt also cool and clammy. Pt is awake and did not lose consciousness. Pt provided water and ice pack for comfort. Pt placed on a bed and recovered with no other interventions.
Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium
pt recv vax 21JUN96 930AM & had a sz 11:15AM;t103 @ ER;sz felt to be a febrile seizure;
Patient presented to ED 3 days after Moderna vaccination with chest pain.   EKG and blood work reflective of possible Pericarditis.
was administered by another pharmacist. pt was sitting & started to feel dizzy 5 minutes after her 1st dose. her father recognized her dizziness & called help. pt was given water and dad elevated her leg by placing them on the chair. Pt stated thae she was dizzy because she got the dose empty stomach. & her dad reported prior history of dizziness after immunization in doctor's office. symptoms improved in 5 mins & she was monitored for further adverse events for another 30 mins
Headache & Diarrhea  Narrative:  HEADACHE REMAINS BUT IMPROVED. NEW SYMPTOM OF DIARRHEA
Patient reported dizziness after vaccines. Patient reported tingling in face (one side). Also had tingling on tongue and in throat. Mild SOB. Dryness in mouth. Given Prednisone and BENADRYL.
Painful/swollen/firmness x 1 week, red/itchy starting day 7, diffuse redness day 8,  resolved day 9