chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administration of ROTATEQ after temperature excursion; This spontaneous report was received from a consumer, who was also a patient of an unknown age and gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and the patient's pertinent medical history was not provided. On 18-JAN-2021, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml, orally, for prophylaxis, lot # 1691141, expiry date was not reported, but upon internal validation was established as 01-NOV-2021 (formulation, concentration, dose number, frequency were not reported). The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent a temperature excursion at 1. 3degrees of Celsius (C) for 19 minutes, as recorded by the data logger. There was no previous temperature excursion. No product quality complaint (PQC) was involved.
A patient received his first dose of Moderna Covid-19 vaccine in Feb2021, which exceeded thelength of vaccination for second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (A patient received his first dose of Moderna Covid-19 vaccine in Feb2021, which exceeded thelength of vaccination for second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (A patient received his first dose of Moderna Covid-19 vaccine in Feb2021, which exceeded thelength of vaccination for second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (A patient received his first dose of Moderna Covid-19 vaccine in Feb2021, which exceeded thelength of vaccination for second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.   Reporter did not allow further contact
soreness, irritability, diarrhea, mental fog, loss of cognition, death occurred ~10 days after vaccine administered
Swelling of right arm around injection site at approximately 7:30pm 3/19/2021. Uncontrolled vomiting for 15 minutes began at 12:00am on 3/20/2021. Rigors, profuse sweating, two episodes of urinary incontinence  during the vomiting. Soap like/chemical taste in mouth shortly prior to vomiting. Full body myalgias, lethargy, fatigue, and mild headache.
?Moderna COVID-19 Vaccine EUA? Pain throughout the left arm that goes up to the left side of my neck and down to my arm. Around injection site is red, hard,  and a patch of bumps and itchy. Fever, headache, nausea, body ache, joint pain, chills, very tired, and sleepy. I have had increased lower back pain.  All these symptoms started at around 03:00 am on 2/4 and continue but not as bad as the first day.
Initial unsolicited report received from a consumer via other company (Pfizer, Manufacturer report number: 2017118436) on 30-MAR-2017. This case involves a female patient (unknown age) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported), on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient developed allergy to flu shot. Lab data and corrective treatment were not reported. The outcome of the event was unknown. List of documents held by sender: none.
pt had first dose of Moderna on 3/12/2021 pt recieved a second dose of pfizer on 4/21/2021
This spontaneous report was received from a 27 year old male consumer concerning himself. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date the patient started the vaccine series of GARDASIL (doses, dose numbers, schedule, route, anatomical location, lot number and expiration date were unspecified). The reporter stated that he was unable to complete the GARDASIL series because he turned 27 last month. It was not confirmed if or when the patient began the GARDASIL therapy. No adverse event was reported. No concomitant therapies were reported. Additional information is not expected, no contact details were provided.
Fever, swelling, redness @ injection site, and general aches. Pt developed a productive cough within 24 hours of receiving the shot.
Employee came to office on 09/22 at 1530 to rcv Tdap shot.  At 1540 she developed difficulty breathing, itching, and hoarse throat.  She spoke to her office coordinator and they sent her to the ED.  She was treated with IM Benadryl, monitored and sent home.
BRIEF OVERVIEW:  Discharge Provider: MD Primary Care Provider at Discharge: MD  Admission Date: 4/22/2021;  Discharge Date: 4/23/2021  Active Hospital Problems - Admitted for bilateral PE ? Acute pulmonary embolism without acute cor pulmonale, unspecified pulmonary embolism type (HCC) 04/22/2021  DETAILS OF HOSPITAL STAY: Patient is a 87 y.o. male with psoriatic arthritis, essential hypertension who presents today with right-sided chest pain.  He reports onset starting yesterday. The pain radiated around to his back into the center of his chest. Thought he had pulled a muscle was having heartburn. Taking a deep breath made the pain worse. He tried Tums but no significant relief. It was not associated with shortness breath. Denied any, lower extremity swelling or calf pain.  Today the pain was acutely worse so presented to the emergency department for evaluation. No prior DVT, PE, no FH of DVT/PE. No weight loss. No recent prolonged trip. On arrival to the emergency department his pulse was noted to be elevated to 120 but otherwise vitals unremarkable.  CT angiogram thorax had significant findings of multiple bilateral pulmonary emboli involving segmental and subsegmental vessels.  There was no evidence of right heart strain.  He was started on heparin drip and transferred to another facility for ongoing care. He was switched to Eliquis 10 mg bid for 7 days, then 5 mg bid for 3 months.  He has not sign of any malignancy, no weigh loss. He received Moderna COVID-19 vaccine on 3/4/21 and 4/1/21. It is conceivable that this PE could be complication of COVID-19 vaccine. He should follow up with PCP in 1 week.              CTA also showed partial visualization of gas fluid collection within the right upper quadrant, likely reflecting a duodenal diverticulum which was present on 8/20/2012 CT abdomen, incompletely assessed. There is a small hiatal hernia. PCP to follow. Discussed with wife, and with daughter over the phone.  Patient discharged home.
Both eyes swollen & puffy evening of inject, only 1 eye involved by AM; completly resolved in 2 days;
p/vax pt exp local reaction; health dept exam revealed swollen rt deltoid; warm to touch; slight redness; suggested tylenol; ice pack or cool h2o pack; also benadryl
his wife is in the ICU and is dying; had three covid shots and is dying and had double covid and was vaccinated three times with the Pfizer Covid vaccine; had three covid shots and is dying and had double covid and was vaccinated three times with the Pfizer Covid vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TERMINAL STATE (hospitalization), outcome "unknown", described as "his wife is in the ICU and is dying"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had three covid shots and is dying and had double covid and was vaccinated three times with the Pfizer Covid vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: had double covid.  Additional Context: Caller states he is trying to figure out why his wife is in the ICU and is dying and had three covid shots and is dying and had double covid and was vaccinated three times with the Pfizer Covid vaccine and he wants to know who is responsible for lying and saying the vaccine is effective and who lied to the FDA; states he knows the vaccine is not effective and states what is the point of a safety report and it is pretty set up for no recourse. Reporter details: Caller declined to provide any contact information or verify further details so this report filed as consumer. Caller aware RA has no information to speak from and declined transfer to RA agent; states he wants to know who is responsible for selling fake medication and all of it is bad and is garbage; caller was asked for any lots, expiry dates or NDC numbers of the Pfizer Covid vaccine and declined to provide and states you can put that it is all garbage. Asks for agent to tell him who is responsible for lying to the FDA.   Description of Product Complaint: Description of complaint: Caller states he is trying to figure out why his wife is in the ICU and is dying and had three covid shots and is dying and had double covid and was vaccinated three times with the Pfizer Covid vaccine and he wants to know who is responsible for lying and saying the vaccine is effective and who lied to the FDA; states he knows the vaccine is not effective; states he wants to know who is responsible for selling fake medication and all of it is bad and is garbage; caller was asked for any lots, expiry dates or NDC numbers of the Pfizer Covid vaccine and declined to provide and states you can put that it is all garbage; full report details not able to be obtained due to caller declined report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
ADMINISTRATION ERROR:  2ND DOSE OF PRIMARY SERIES WITH PFIZER COVID-19 MONOVALENT VACCINE WAS GIVEN TOO SOON.  IT WAS ONLY 13 DAYS AFTER 1ST DOSE.  1ST DOSE ON 10/26/22 AND 2ND DOSE ON 11/8/22.
With vaccines 2-5 we had considerable body aches; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYALGIA (With vaccines 2-5 we had considerable body aches) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A and 009C21A) for COVID-19 vaccination.     Concurrent medical conditions included Environmental allergy and Cholesterol. Concomitant products included ROSUVASTATIN for Cholesterol.   On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In 2021, the patient experienced MYALGIA (With vaccines 2-5 we had considerable body aches). The patient was treated with IBUPROFEN at an unspecified dose and frequency. In 2021, MYALGIA (With vaccines 2-5 we had considerable body aches) had resolved. re      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient height was reported as 6 feet and 4 inches.  It was reported that patient received two primary and 3 booster vaccines, all Moderna vaccines.   From vaccine 2 and 3 patient had considerable body aches with onset about 12 hours after the injections. Patient body aches lasted for 2 days.  Patient was healthy and active.  Patient did not seek medical care for AE cause. Patient did not experienced a similar event in the past.   This case was linked to MOD-2022-658061, MOD-2022-658071, MOD-2022-658065 (Patient Link).
Arm - swollen & sore. Back - charley horse like feeling in middle of back. Vocal cords - sore, inflamed, swollen.
Pt recv'd flu shot & 4 days later developed tingling from the hips down.Nerve conduction study was consistant w/GBS.Pt last seen 11/15 w/ resolution of tingling in leg but now has tingling in fingertips.
Next day I had a sore throat, headache, hot flashes, chills, fatigue, nasal congestion and drainage.
AREA AROUND VACCINATION SITE IS SWOLLEN, PAINFUL, SORE AND ITCHY.  PATIENT ALSO HAS 2 RED, RAISED AREAS A FEW INCHES BELOW THE VACCINATION SITE THAT WERE  NOT THERE YESTERDAY, THE DATE OF THE VACCINATION.
Hives began three days after booster shot. They have continued to this day. The hives move to new location daily. Legs, arms, back, chest, belly, neck, head, feet, earlobes, etc. Red, itchy bumps. I took a course of steroids for 1 week prescribed by my doctor. That didn't help. I now take Allegra every morning and Benadryl at night when the itching is too bad to sleep.
tested positive for COVID; This is a spontaneous report from a contactable consumer (patient). A 50-years-old male consumer reported for himself that he received the first dose of the Pfizer COVID-19 vaccine (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection; Lot number/expiry date: unknown) via an unspecified route of administration as a single dose for COVID-19 immunization on 23Feb2021. The patients past medical history and concomitant medications were not reported. The patient reported that he received the first dose of the Pfizer COVID-19 and was tested positive for COVID on 01Mar2021." He received monoclonal antibodies via IV. Patient was scheduled to receive the second dose tomorrow. He wants to know if he can still receive the second dose as scheduled.  E-transmitting AE due to long hold time, requested a call back.  Information regarding lot/batch has been requested.
Mom reports t103 & very lethargic p/DTP being very irritable; "laid around for 3 days";
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered maintained activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Agency consulted with the Dept of Public Health and Environment and did not recommend repeating this dose in question. No ill effect post administration was reported.
Pt stated 2 day post vax, she is very sick, c/o fever, chills, difficulty breathing, dizziness and weakness.  Pt was encouraged to come to Health Center to see MD.  She failed to come in.60 day follow-up dated 9/26/00 provided no additional data.
Fever, nausea, sore throat, chills, inflammation, muscle aches, and swelling around the knees
Pt called clinic on 08/14/19 approx 2:00 pm, stated she had a reaction to the vaccine administered the previous day.  Pt stated the reaction was that she had lost her eyesight to her rt eye earlier in the day and had already been examined by a opthalmologist.   The Dr had diagnosed the incident as optic neuritis/optic migraine,caused by reaction to the vaccine.  The pt returned to the opthalmologist on 08/15/19 and after being examined again he advised pt to continue to take her BP meds and to finish the vaccine series.  The optic nerves were a 6.5 and had been 8 at first visit.  I advised pt  to allow the nursing staff to research if she should finish vsccine series and that we would call her back
Breakthrough varicella infection. Rash started 5/19/22 and spread along trunk and back. No other symptoms noted. Improvement with acyclovir treatment.
chills; tiredness; periodic dry heaves over 2.5 day period; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, SINGLE), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; RETCHING (non-serious), outcome "unknown", described as "periodic dry heaves over 2.5 day period".  Additional information: She did not become aware of the side effects until after the 24 hour period.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
no adverse event - patient received gray top (adult) vaccine, and received 0.3mL rather than the correct volume of 0.2mL
Received my vaccine on November 23, 2021 exactly 10 days later I experienced itchiness on my scalp chest neck palms and hands. Until this date I still have the symptoms which will now be seven weeks. Have been taking an anti-histamine which I have had side effects from so it has been very difficult for treatment. I am still the same no improvement.
Hoarse voice. Started about 24 hrs after the Johnson shot, I still have it.
Arm soreness which came up within hours of injection, slightly limited range of motion , got slightly worse into the night but was gone by morning.  Pain would be described as minor.
Arm started swelling day after injection of 11/09/16. Swelling has moved to elbow and it itches like crazy. Taking BENADRYL has been helping.
Tachycardia, dizziness, feeling shaky, reports eating prior to getting vaccine, right arm felt slight tingling, HR 98 at 11;45am, Blood pressure 146/100, patient brought to stretcher to lay down and be monitored for 30min, tachycardia felt better 20min after, mother came in and sat with patient. Was monitored for an extra 20min until all symptoms resolved. Bp upon departure 120/64
Swollen left axillary lymph node one day after. Tenderness at injection site.
Left eye started swelling day after vaccine (profuse redness and edema almost swollen shut), full body aches.
This is my 2nd dose of Pfizer. I got sick both times. After my fever was gone,  still have stiff neck for a few more days. Today is 2 weeks after the second dose, I feel like I got covid all over again but only feeling shortness of breath for a number of times a day for everyday. I had to inhale long oxygen to feel better every time .
When identifying the patient, the mother was unclear which child was which despite the identification process and placed the wrong child in the chair for her shots, despite a second check in indicating the type of shots she was getting that day.
vomiting; does not feel good; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 14Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received a 1st shot of Pfizer vaccine yesterday (14Jan2021) and has been vomiting since this am (morning) (15Jan2021) and does not feel good (exact date unspecified; Jan2021). The outcome of events was unknown. This case is non-serious.  Information on the lot/batch number has been requested.
Around 12:45pm today (1/28/21) I fainted after getting up from using the restroom. My partner was with me and said that after I got up I began shaking and he helped me to the ground where I continued to "shiver", as he called it, for another few seconds before going limp. Once I came to (a few seconds later) I felt very confused at where I was and had a pounding headache and my ears were ringing loudly. It was all I could focus on. After that my partner helped me to bed where he continued to check on me and I slept for 5 hours.
Patient presented to the  emergency department this morning for symptoms of shortness of breath, anxiety, and mental status changes. Patient was immediately placed upon 10 L oxygen mask supplemental oxygen.  Patient was started on broad-spectrum antibiotics and small bolus of fluid was administered after patient was noted to be hypotensive. Treatment and discharge. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Information has been received from a doctor of pharmacy concerning a female patient who on approximately 04-NOV-2008 was vaccinated intramuscularly with a dose of PNEUMOVAX (lot # 662662/0979X).  It was not known if the patient had been previously vaccinated with PNEUMOVAX.  The pharmacist reported that the patient developed swelling, pain and redness and required no treatment and had recovered.
I have an immune disorder, CBID and I'm very high risk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNODEFICIENCY COMMON VARIABLE (medically significant), outcome "unknown", described as "I have an immune disorder, CBID and I'm very high risk".  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Decreased overall energy and right calf muscle pain/soreness. These symptoms started the day after receiving the vaccine.
5 days after receiving the injection I began experiencing significant dizzy/vertigo pells that continue to this day.  I have been examined by doctors and PTs who have determined that my dizziness/vertigo spells do not appear to be inner ear related and my brain scans are vascular scans of the neck are normal.  The dizzy spells are impacting my ability to function daily, am unable to drive most of the time, and my work is doing their best to accommodate me at this time by allowing me to connect work from home.
Boby aches, muscle aches, over all not feeling well, then started having ringing in my ears get louder and louder. I went to the ER about a week ago 6/10/23 over my heart, I blacked out, was unresponsive and shocking on my own vomit. ER diagnosis was I was in AFIB, my jaws and arm was killing me. I was treated with aspirin and various medication  then able to go home with medication. I the new  cardiologist/APN  on  6/12/23
Body chills/body aches/fever 103.7 was the highest/headache/neckache/pain down entire left side.
day 9/10 R arm began to itch and red rash appeared.  Became hard and swollen and painful to touch.  Day 11 chills and rigors but afebrile.  Took Zyrtec and Tylenol day 11 and by day 13 all s/s resolved but R arm was still slightly sore and swollen for a few more day.
sore arm x one week, right axillary lad on 1/2/21 Narrative:
After injection patient got up from chair and preceded to exit the administration area and fainted. Father at the time did have a hold of him so he did not fall. Offered to call 911 but father refused. Patient did regain conscious after a 20 seconds. Was able to respond and after a couple of minutes slowly sat him on a chair where he waited with his father until he felt well enough to walk on his own.. approx 10 to 15 minutes. During that time kept on looking in on how he was doing.
Patient had an episode of 1 minute  unreponsiveness days after receiving COVID vaccine. Was hospitalized and admitted. More than likey due to hyponatremia which led to hypotension.
symptoms have been constant since 8/28 or 8/29. Initially headaches and sore arm also, but arm soreness has subsided although headaches still occur. I have been taking advil/aleve or an OTC pain relief. Also turmeric supplements. I have been coming to work and we are monitoring at this point in time