chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a licensed practical nurse and refers to unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. Follow up information has been received on 08-MAY-2016 from the nurse and refers to 8 weeks old patient of unknown gender. On 29-AUG-2016, the patient received improperly stored dose ROTATEQ. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1608USA012794:
Case number PHEH2014US005824 is an initial spontaneous report from a nurse received on 13 Mar 2014. This report refers to a patient of unknown demographics. Past medical history and concomitant medication were not provided. The patient was vaccinated with first dose of MENVEO (batch number: unknown) intramuscularly at age of 13 years old and second dose at age of 15 yrs and 10 months. No adverse event was reported following this medication error (inappropriate schedule of vaccine administered).
Local injection site reaction: swelling, warmth, soft tissue edema. No fever, systemic symptoms.
8/21/2013 appt for vomited x 1. 8/20, fussy, tired. Given Pedialyte & Ibuprofen. 8/22 called MD. Rash since 8/21. ? fever. 8/22 appt for rash all over. Red dots. Itching: Rx'd Triamcinolone cream.
Information has been received from a registered nurse concerning a 6 week old female who, "about one month ago", on approximately 01 Nov 2006, was vaccinated with a 2 ml oral first dose of Rotateq. Concomitant vaccines administered on the same day included a dose of Prevnar and a dose of Pediarix. "Later in the day", on approximately 01 Nov 2006, the patient experienced fever of over 103 degrees. The patient went to the emergency room and was hospitalized overnight. It was noted that the patient had a spinal tap and blood work done. The patient improved the next day and was sent home. The patient was considered to be recovered a couple of days after receiving Rotateq by the reporter. No product quality complaint was involved. The patient's experience was considered to be immediately life threatening and disabling. Additional information has been requested.
General Itchiness, runny nose, and throat scratchy. She did mention symptoms prior to vaccine but after receipt of vaccine feels exacerbated.  Evaluated in ER and d/c home.
Patient began with a fever yesterday night of 101.0. Two occasions of vomiting without coughing. Also has swelling, and redness with local warmth around the site of the new season influenza vaccine.  Pt was given ibuprofen here in the office. Dr. examine patient and prescribed her Ibuprofen, Pedialyte, cetirizine, Albuterol. Pt has a follow-up on  12/20/2022 to see how she is doing.
Case received from a healthcare professional (physician) on 17-Mar-2014. Three unidentified patients (no details provided), with no reported illness at the time of vaccination, no reported pre-existing diagnosed allergies, birth defects or medical conditions, and no reported concomitant therapies, had received an intramuscular dose of ADACEL (batch number U4689AA, anatomical site of administration not reported) on unspecified dates in 2014. On an unspecified date in 2014, post-vaccination, the patients experienced cellulitis, induration and redness at the injection site. It was not known whether the patients' symptoms resolved. No relevant diagnostic tests/laboratory data were conducted. This case was reported as non-serious. Upon internal review, the seriousness was upgraded to serious, i.e. important medical event.
Lumbosacral radiculopathy L5 S1. Severe pain, muscle spasm, unable to walk. Use of crutches, walker, hospitalized. Use of narcotics and muscle relaxants. The patient is a 12-year-old female without significant past medical history seen here on February 5 for complaints of left low back pain. She reportedly had fallen to her knees while playing basketball on Saturday. Her pain started on Sunday and then she was seen here on that Monday. She had a urinalysis performed in the ER that was normal. She was given ibuprofen, NORCO, and VALIUM for her discomfort. She was discharged with prescription for VALIUM and Ibuprofen. On Wednesday she had an ultrasound of her kidneys which was normal. Since then she has seen her doctor and changed to cyclobenzaprine since VALIUM wasn't working. Today she has increased pain in the left SI joint with complaints of numbness in her left leg and inability to walk. No fever. No nausea, vomiting or diarrhea. She denies any incontinence or difficulty urinating. No saddle anesthesia.
Patient presented to ER in 10/2021 with chest pain x 2 and was admitted with chest heaviness on 10/17/2021 with a pericardial effusion of unclear etiology.  Admitted again on 10/22/2021 for continued chest pain.  Admitted again on 10/30/2021 with sepsis and dx with pericarditis.  Received Pfizer covid booster on 11/30/2021 and was admitted again to constrictive pericarditis with effusion on 11/9/2021.  Back in ER on 4/25/2022  and 6/9/2022.  The latter date complicated with COVID diagnosis.  She is being followed and treated by cardiology.
Monday 4/5/21 5:15 pm vaccine  5:15 slight lower back pain and headache  5:45 growing illness 6:45 pm  -  Tuesday 4/6/21 6:30 am - full systems, high fever, body aches, naseua, fatigue  Tuesday 4/6/21  7 am - 8 pm - slight headache and body aches but overall feeling ?better? Wednesday 4/7/21 -  7 am - diarrhea and severe stomach pain and gas 12 pm - fever and body aches coming back  3 pm - more fever and fatigue, body aches, and headache  (no more stomach pains)  7:30 pm - took my temperature 100.65 Went to sleep  4/8/21 - 7:30 am - 98.55 temperature  still body aches and pain but feeling ?better? again
I had a mri and x-ray unregards to my excoriating pain from the vaccine in my arm and it was horrible. I was on the ground crying for a week rescue my arm was so sore.
After second shot, rapid heart rate within 30 minutes, lasted off and on through the second day; Bouts of dizziness; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non-pregnant female patient received second dose of BNT162B2 (COVID 19, Pfizer, Solution for injection) via an unspecified route of administration, administered to her left arm on 06Mar2021 10:45 AM (at age of 70-year-old) (Lot unknown reason: Misplaced/discarded) as single dose for Covid-19 immunization. Facility type vaccine: School or Student Health Clinic. The patient's medical history included atrial fibrillation and congestive heart failure (CHF), catheter ablation on 21Apr2021 (successfully cured) and implanted heart monitor. No Covid tested prior or post vaccination. No known allergies reported. Concomitant medications were reported as none. The patient previously took first dose of BNT162B2 (COVID 19, Pfizer, Solution for injection) via an unspecified route of administration, administered to her left arm on 13Feb2021 03:00 PM as single dose for Covid-19 immunization and experienced rapid heart rate, 99, palpitations, high blood pressure within two hours after first shot (on 13Feb2021 05:00 PM) which lasted about 36 hours (treatment received: No). Second shot, rapid heart rate within 30 minutes, lasted off and on through the second day. Bouts of dizziness started about 12 hours after injection, still experiencing off and on. Heart rate issues recorded on her watch. The patient did not receive any treatment in response to the events. Outcome of the events was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot been obtained.
Pt received vaccine around 0950,  tolerated well. Pt and mother sent to lobby, and within approximately 10 minutes nurse was called that mother had reported patient had a rash. Immediately nurse called code blue, noticed patient in mothers arms, awake, alert in no distress. Patient mother was told to come in  to vaccine room to be assessed. Head to toe assessment was done by nurse, patient is awake and alert, no respiratory distress noted, skin warm, dry to touch. Nurse noted hives to upper and lower body excluding face. Pt  mother denied any previous allergic reaction of any sort. Pt was monitored for 30 minutes,  mother voiced she would take patient to pediatrician (Dr.) to be evaluated  today. Pt mother advised to seek medical care to E.R or call 911 if s/s worsen. Pt mother voiced understanding of all discussed. Pt was calm, in no respiratory distress, no itching noted upon leaving clinic.. Will follow up with mother.....
pericarditis; This is a spontaneous report from a non-contactable consumer reported for another male patient (reporter's boss's husband). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at unknown age) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient developed pericarditis months after his second dose. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received booster dose (0.25 ml) 17 days too early.  Called patient when discovered error, she said she felt fine, no issues.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 13-NOV-2015, the patient was vaccinated with an improperly store dose of MMRII (lot # K024036 exp date 26-NOV-2016) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
I have had sparatic stomach pains, fatigue , Severe Headache , Muscle pain, Nausea and Pain in joints. The fatigue, knee pain and chronic headache still remains constistent since vaccination.
BREAKTHROUGH COVID 19 INFECTION.  PT WITH MILD TO MOD SX.  SHE IS 3 WEEKS OUT FROM THE ORIGINAL RSV INFECTION.
Dizzy; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Apr2021 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 21Apr2021, the patient felt dizzy. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dizzy was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Mild headache within 1 hour of vaccine.  Fatigue in evening  necessitating early to bed.  Slept through the night and awake in am without symptoms. Getting out of bed sudden drop in BP with weakness, feeling faint, nausea, sweating.  Drop in BP to 68/52.  Unable to go to work. Improved with upright resting in am  with BP at 10:30 am 119/69 (low as my usual BP averages 130's/mid 80's).  Still slightly nauseous.  Able to have toast and tea. Felt better as am progressed and able to drive to work at 11:45 am.  Worked until 6 pm without further symptoms.
w/in 4 hrs devel rash cont to recover w/pruritus & welts covering hips, ribs, & elbows; also saw dentist that afternoon & had dental work
wrong vaccine administered; This spontaneous report was received from a pharmacist via Pfizer refers to a patient of unknown gender and age (age also reported as 53 with units not reported). The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date (also reported as "within a month"), the patient was wrongly vaccinated with second dose of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) instead of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, anatomical route of administration, lot/ batch number and expiry date for both the vaccines were not reported) (wrong product administered). It was reported that on an unknown date in September (year not specified), the patient received first dose of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13). The reporter also enquired about when would the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) be given after two doses of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13). The outcome of wrong product administered was unknown.
No adverse reaction, however patient received 4th dose of HIB in error, should have received 3rd dose of Hep B vaccine. No harm to patient.
Patients states he has a sore arm that lasted for more than a month and is having a hard time sleeping
pt developed cellulitis, warmth and redness in the arm the vaccination was received.   Pt to start oral antibiotics to treat.
Breakthrough case admission after two Janssen vaccines Janssen 3/11/21 Lot# 180525;  Janssen 11/3/21 Lot# 213D21A
Had vaccine at 2:15 in the afternoon on 4/1/2021. That night in bed had mild itching on tops of both legs, thought it was dry skin.  Next morning I noticed red splotches on both legs from top of thigh to just below knee, front and sides (not on back of legs). That night about 10:30 I woke up with severe itching and hives on the same areas of both legs.  Bumps and red splotches and very hot.  Called Hospital and told me to take a Benadryl and go to ER if I experienced swelling of tongue or difficulty breathing.  I had neither.  I only had Cetirizine Hydrochloride 10 mg so I took one of those. Itching went away in about 1/2 hour.  Got Benadryl next day and Cortisone cream.  Red splotches are lessening each day but definitely still there.  It doesn't itch during the day only at night. So I am still taking the Benadryl before bed.  I had no other side effects besides the hives.  No fever, no headache, no body ache, no pain at injection side, no chills.  The vaccine did sting when going in and lasted a few minutes after.  I had no other changes that might cause this. Didn't work outside, clothes the same, eating the same, nothing different that would trigger this.
Information has been received from a physician concerning a 15 year old male who on 26-FEB-1998 was vaccinated with a first dose of MMR II (route, site, dose and lot number not reported). On 27-MAR-1999, the patient was vaccinated with a second dose of MMR II (route, site, dose and lot number not reported). On 10-NOV-2009 the patient experienced mumps (the date diagnosed was reported as 14-DEC-2009). Lab results for 14-DEC-2009: IgM was <1:10, IgG was 9.38 and Serum Amylase was 327. The patient was afebrile. He presented swollen neck for a day. The outcome for mumps was not reported. Follow-up information was received from a physician concerning the 15 year old patient (also reported as 14 years old). It was reported that the patient was diagnosed with mumps on 16-NOV-2010 (previously reported as 14-DEC-2009). The patient had stomach symptoms, headache and was afebrile. On 16-Nov-2009 the following laboratory test results were obtained: serum immunoglobulin G test 8.99; serum immunoglobulin M test which was negative and serum amylase test 112. At the time of reporting the patient's final outcome remained unknown. This is one of several reports from the same source. No further information is available.
1. Seborrheic dermatitis rash on forehead. Treated with one week of Lotrimin cream.  2. Missed period. No pregnancy, period resumed as normal following month.
My brother Received Moderna covid booster shot (3rd shot) and 2 weeks after, hives presented on his skin all over my body. The problem still persists 4 months later. The hives are very itchy and uncomfortable.
arm was in pain; head felt funny; she felt off for a few days; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (arm was in pain), FEELING ABNORMAL (head felt funny) and DEPRESSED MOOD (she felt off for a few days) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-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 PAIN IN EXTREMITY (arm was in pain), FEELING ABNORMAL (head felt funny) and DEPRESSED MOOD (she felt off for a few days). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm was in pain), FEELING ABNORMAL (head felt funny) and DEPRESSED MOOD (she felt off for a few days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that she did not took any medications post dose 1.  No treatment information was provided.  No concomitant medication was provided.     This case was linked to MOD-2021-019076 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: This follow-up was received on 25-MAY-2021 which did not update any new information.
On the morning of Jume 20 I woke up and didn't know where I was. I was given a diagnoses of transent global amnesthia.
pt recv vax 7 2 days p/vax pt began bleeding & since normally is on a shot to stop period MD thought may had exp a miscarriage however pregnancy was never confirmed;pt also devel SOB, hypoxia & now is very ill w/varicella pneumonia;cough;
Repeated vomiting and diarrhea Stomach cramps Stomach aches Chills Fatigue  I called the doctor on the phone. They recommended for her to go to Urgent Care. She was given a prescription of Zofran.
Moderate redness, one large circle around injection site approx 4" across x7 days. No itching, pain, swelling.
Parent stated her daughter has measles from getting the MMR vaccine.  She has a generalized rash, low grade fever, itching.  She was seen by her family doctor and Dx'd with measles.
It was pain not only in the injection arm but also on my other arm. It felt like I had been injected in both arms. It lasted for like 10 days. I did a telehealth visit around 03/21. They said it was Covid arm. They told me to take Tylenol and to apply heat. It resolved after the 10 days.
Diabetic ketoacidosis without coma associated with type 1 diabetes mellitus - started on DKA protocol with insulin drip.  She corrected quickly and that her acidosis and ketones cleared.  Transitioned off the drip to subcutaneous insulin.  She was taking p.o.  Lethargy resolved and she really turned to her baseline mentation.  ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Patient fainted within minutes after receiving vaccine.  Fell out of chair and blacked out.  She woke up immediately but felt very confused and shakey.  911 was called and vitals were taken by EMTs.  Patient was picked up by her parents.
MOTHER NOTED REDNESS AT THE SITE OF INJECTION. PATIENT COMPLAINED OF TENDERNESS AT THE SITE. THE AREA OF REDNESS SPREAD BY THE NEXT MORNING TO 12CM.
Headache, Sedation, Arthralgia, Erythema and swelling @ injection site Narrative:
Case number PHEH2012US014453 is an initial spontaneous report received from a nurse on 20 Jul 2012. This report refers to an 18-year-old female patient. She was vaccinated only with MenCYW-135 component of MENVEO vaccine (batch number: X11032) intramuscularly on 20 Jul 2012. No adverse event was reported.
Patient received first dose Pfizer in January 2021, second dose Moderna on 6/13/2021. Troubleshooting: pt checked Pfizer in the computer as 1st dose. Scribe and vaccinator did not look at card to see what was given prior; first vaccine out of state, so no clear record. Counseled by staff that he had received two doses of mRNA vaccine and advised to check with his doctor whether additional vaccine  is needed, since the first vaccine was given so far outside the recommended 42 days between the 2 doses.   Vaccinator and scribe both counseled.
Pt vaccinated with Pneumovax 23 developed pain & tenderness at the site of injection & asthenia.
Pt developed staggering wide based gait, loss of balance, needs to hold on for support to walk, and dizziness.  Follow up on 09/07/04 states: "New onset tremor.  This is a follow up report with form completed date of 03/13/00."
LTCF Pfizer Vaccine clinic conducted 12/29/2020 Vaccine lead received a call indicating that a staff member deceased somewhere between 1/3/2021 and 1/4/2021.   Cause of death is unknown, and an autopsy is being performed.
Narrative: Patient received Moderna COVID-19 vaccine on 1/13/21. Patient was transferred to outside facility for CABGx5 on 1/19/21. Patient developed atrial flutter, AKI, acute pancreatitis, serratia bacteremia, and acute blood loss anemia. Patient died on 2/13/21.
20 minutes after injection - tingling in throat. Tingling subsided about an hour after injection 1 hour after injection - right forearm tingling , numb and feels heavy and welt on right hand
3/24 medical facility, admitted day after covid vaccine with syncope. Male with a history of PVCs  who is coming into the hospital after a syncopal episode;  patient reports in usual health, he had a second covid vaccine on 3/23, and start getting dizzy especially with movement on  3/24. On 3/24, he woke up and was going to the bathroom and then turned around to walk out of the bathroom and all of a sudden became lightheaded and dizzy.  He said he ended up falling onto the ground not sure exactly how long he was out for but did not lose control of bowel or bladder function he had no chest pain. Stable course in the ER vital signs reviewed slightly elevated blood pressure.  Extensive work-up was done.  Normal saline bolus given. Chemistries unremarkable save for creatinine 1.32.  Rest labs reviewed.  He did meet gap alert criteria so CT C-spine CT head done no acute findings. EKG sinus tachycardia as ventricular trigeminy.  No ST elevation. Discharged in stable condition.