chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tingling on my face and jaw; 10th day post vaccine the redness came back.; Fatigue; Red circle on injection site arm; Arm got sore; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling on my face and jaw), MYALGIA (Arm got sore), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE ERYTHEMA (Red circle on injection site arm) and VACCINATION SITE ERYTHEMA (10th day post vaccine the redness came back.) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced MYALGIA (Arm got sore) and VACCINATION SITE SWELLING (Swelling at injection site). On 09-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red circle on injection site arm) and FATIGUE (Fatigue). On 17-Jan-2021, the patient experienced PARAESTHESIA (Tingling on my face and jaw) and VACCINATION SITE ERYTHEMA (10th day post vaccine the redness came back.). At the time of the report, PARAESTHESIA (Tingling on my face and jaw) had not resolved, MYALGIA (Arm got sore), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE ERYTHEMA (10th day post vaccine the redness came back.) and FATIGUE (Fatigue) outcome was unknown and VACCINATION SITE ERYTHEMA (Red circle on injection site arm) had resolved.            This case was linked to MOD-2021-017852, MOD-2021-079605 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: The patient took the second dose therefore action taken is changed to not applicable. The outcome of the event tingling on my face and jaw was changed from unknown to not recovered/resolved .
Blood in stool no Tx given.  1 wk post Rotateq.   Pt well at time of exam.
Information has been received from a medical assistant concerning a 14 year old female patient with allergy to OVCON and a history of irregular menses and pelvic pain who on 16-MAR-2009 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot number 659184/0843X). On 14-MAY-2009 the patient was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot number 661953/1130X). On 17-SEP-2009 the patient was vaccinated IM with the third 0.5 ml dose of GARDASIL (lot number 661953/1130X). Concomitant therapy included TRI-SPRINTEC. Sometime after the second dose the patient developed warts in her genital area, her hip and elbow. On 17-SEP-2009 the patient saw a doctor in the office. There were no lab studies performed. The patient was prescribed ALDARA cream. At the time of the report, the patient had not recovered. Follow-up information has been received from the medical assistant concerning the female patient who on 14-MAY-2009 at 14:06 pm was vaccinated IM in the right deltoid with the second dose of GARDASIL (lot number 682953/1130X). Subsequently the patient developed warts on genitalis, hip and elbow. It was reported that the patient experienced loss of consciousness after the first dose of GARDASIL. The outcome of the patient was not reported. Additional information has been requested.
Back pain, chills, cough, general body discomforts, headache, pain rt shoulder, loss of appetite, tightness and heaviness of upper chest, depression, stuffy nose and congested throat.
Dizziness, Myalgia & NauseaVomiting Narrative:  for treatment for nausea and vomiting
Mom called on 11/08/05 and stated child broke out on Saturday with chickenpox on face, chest , back and legs.
patient describes neuropathy as injection may have been given too high on arm per workers comp physician and caused nerve injury. Will get followup apptment 10/18/2022 and additional ultrasound/PT
I was vaccinated on 11/20.  I experienced a significant headache and fatigue for 3 days after my vaccination.  I noticed a slight dip in my supply beginning on 11/21, but it wasn't significant.  I then began to notice some slight tenderness and what felt like a clogged milk duct in my right breast on Wednesday 11/24.  By Thursday evening (11/25), I began to experience significant pain, increased tenderness, and redness in the same area. I also experienced body aches, a headache and a fever.  By Friday 11/26, I noticed a significant drop in my milk production (from approximately 15 ounces per pump, to approximately 8 ounces per pump).
COVID+ 11/11/22 .  Vaccination status - moderna x4 Discharge Summary   BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider at Discharge: DO  Admission Date: 11/11/2022 Discharge Date: 11/16/2022  Discharge Disposition: Home DISCHARGE DIAGNOSIS: 1. COVID-19 infection 2. Respiratory insufficiency with hypoxia (still present) 3. Hypertension 4. Hyperlipidemia 5. History of CVA 6. Prostate cancer DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Shortness of breath   HOSPITAL COURSE: Patient is a 94-year-old male who was admitted on 11/11/2022 for COVID-19 infection with acute hypoxia.  Patient initially presented with chills, malaise, nausea, cough, shortness of breath since 11/09 though he noted a cough for the past 6 weeks.  Patient was hypoxic requiring 1-2 L of oxygen. Patient was treated with remdesivir receiving 5 days worth, Decadron 6 mg orally daily, prophylactic Lovenox, and supportive care.  Patient subjectively has improved he is sleeping better at night with the Tylenol 3 in coding I have prescribe set discharge.  He is still requiring oxygen 1.5 L at rest and 3 L with activity, physical therapy worked with him and patient is safe for discharge to home.  Care management has set up home health care, PT, and OT.   Vitals are stable patient is medically clear for discharge.  No changes made to patient's chronic disease treatment plans.
As stated by patient-started around 530 pm. Tightness with need to cough - By 6pm felt like huge cement block on center of chest- felt like I needed to cough - felt like filling up with fluid immediately wheezing attack-when tried to talk had convulsive coughing fitts. Used Vicks rub - hot bath soak - up 3 times during night reapplied Vicks laid in bed - hurt so bad - night sweats with chills - brought on migraine gone by morning - exhausted on Friday - slept all day. Hurt so bad from waist down.
Full body muscle aches Sore upper arm Delayed in menstruation  by 2 weeks (negative pregnancy test - at home)
Pt recv vax on 1/14/99; on 2/3/99 pt exp crusted lesion at vax site
Diarrhea for about 1.5 weeks; hives throughout body during the 2nd week (arm, leg, chest, cheek)
spasms in her head; tightened muscles in her whole neck; breathing was difficult; This is a spontaneous report from a contactable consumer. A 75-years-old female patient received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 10Feb2021 (Batch/Lot Number: EL3249; Expiration Date: May2021) as single dose for COVID-19 immunisation. Medical history included quadriplegia from 1992 and ongoing which leads to disability, where patient doesn't have a lot of mobility and need a wheelchair. Concomitant medication(s) included baclofen taken for muscle relaxant therapy from 1997 and ongoing. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date in Feb2021, the patient experienced spasms in her head, tightened muscles in her whole neck and breathing was difficult. The events were considered as non-serious. Reporter state that patient does not want to repeat the same experience as patient was due for second dose of vaccine and unsure if it would be advisable for patient to get the second dose. The outcome of all the events was unknown.
Currently 37 weeks pregnant, 2nd shot, will be induced June 3, due date June 11. Shot administered at 11:20am, I waited 15 minutes, no reaction. That night I took tylenol at 9pm for my headache (recommend and approved by pharmacist who administered my shot), then I took my prenatal vitamin. Around 9:30 I had trouble breathing. It lasted throughout the night. I had to sit up all night. I had to take off my necklace due to my neck swelling. I couldn't take any deep breaths. I was able to fall asleep around 5am when it subsided a bit. I have continued to be short of breath today, neck still looks a bit puffy. It's hard to know whether the more mild difficulty breathing is due to pregnancy or not. I haven't had trouble breathing with this pregnancy unless I am active. This morning I was sitting on the couch and it was hard to breathe (but more mild than last night). No other side effects, my headache is gone and went away after I took the tylenol that night.
No adverse reaction from patient. Medication dose was not reconstituted with diluent at time at administration. Diluent for Menveo was only administered, not reconstituted.
Coughing, SOB, Wheezing, Hives and vomiting occuring within minutes of receiving vaccine. Was given EPI, BENADRYL, Albuterol and oxygen in office.
55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2021-418964 (Patient Link).
it says detected, which means positive, on the nasal swab; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (it says detected, which means positive, on the nasal swab) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced COVID-19 (it says detected, which means positive, on the nasal swab). At the time of the report, COVID-19 (it says detected, which means positive, on the nasal swab) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Polymerase chain reaction: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
has a rash from her elbow to her wrist with little bumps that are itchy, also on her left arm; having trouble lifting left arm; This is a spontaneous report from a contactable consumer (patient) received from a Call Center. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 24Feb2021 at 14:00 (Batch/Lot number was not reported) (at the age of 71-years-old) as dose 1, single for COVID-19 immunisation. The patient had no medical history. The patient had no concomitant medications. The patient experienced having trouble lifting left arm on 24Feb2021 and had a rash from her elbow to her wrist with little bumps that are itchy, also on her left arm on 26Feb2021. The outcome of events was recovering.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained. No further information is expected.
The jail still had some Janssen vaccine that had expired in December.  They misunderstood about the extension and thought that they could still use it.
Covid Arm - 8 days after injection I woke up with a oval shaped red area around the injection site.  It was very puffed up, a bit hard, sore and itchy.  I had no previous side effects except a slight sore arm for a day or two after the injection.  Since I was a bit concerned, I looked up the effect online and found that this is a less common reaction, but does exist.  I plan to keep an eye on it and call my doctor if it hasn't resolved in a couple of days
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. It was reported that an unspecified number of improperly stored doses of ROTATEQ (lot # K010642, expiration date 14-MAY-2106) were administered to the patients (dose and route were not reported) on unknown dates. No adverse events were reported. Additional information is not expected since the physician asks not to be contacted.
Swollen lips evening of 3/15/21. Swollen left side of face including pressure in ear and eye morning of 3/16/21. Treated with Benadryl
Patient received vaccine in left deltoid. The next day had fairly sizeable local swelling that resolved. On 20 July started to get pain in left shoulder; it was minor and not concerning but on 22 July (Sunday) awoke and had markedly limited ROM. This was initially investigated with ER visit where there was a normal X-Ray. Subsequent exam in my office showed inability to activate rotator cuff; and initial diagnosis of frozen shoulder made but then was found to have full passive ROM. MRI of shoulder showed normal structures and tendons; EMG was then ordered but there was a delay in getting study done; this was completed on 13 October and showed only mild Carpal tunnel but by then all her symptoms had resolved and exam in my office 26 October confirmed that there was no further residual shoulder weakness.
Daughter had a fever around 102 degrees and was clingy and fussy for 4 days.  After the fever broke on 11/6/11, she developed a rash.
Blood in Urine, High Fever, Low BP, 12lb loss, Dehydrated.
Swelling & redness at inj site. Patient assessed and given cold compress to area. Pt denies any other complaints.  Pt told if any other symptoms arise to seek emergent medical attn.
adverse event; This case was reported by a other health professional via sales rep and described the occurrence of adverse event in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABX749AA, expiry date unknown) for prophylaxis.   On 14th June 2019, the patient received the 1st dose of Bexsero. On an unknown date, between 1 and 2 months after receiving Bexsero, the patient experienced adverse event. Bexsero was discontinued. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Bexsero.  Additional details were provided as follows: This case was reported by the patient's mother who herself was a Medical Assistant (MA).  The patient received Bexsero and experienced a terrible reaction. The patient's mother decided to not to go with 2nd dose. The reporter agreed to be followed up.
After my booster shot I got stereo tinnitus screaming in my head most of the day. However, there are a couple hours during the day that is is less noticeable.
pt called hospital call center reporting side effects after dose 1. Pt reports she had her 1st dose of Moderna on 09/22/21, next day woke with fever and noticed S/E 10-12 hrs started sharp abdominal pain,  she took medical charcoal . During this 9/25/21 call, pt reports still has abdominal discomfort, states concerned abut her worse rash on hands, noticed blisters and itchy. Pt was advised to be reevaluated at ED
on 3/10/22 patient recieved a second dose of the pediatric (5-11yr/old formulation) Pfizer COVID vaccine 0.2ml into the left deltoid at 2:09pm. Patient was observed by the vaccinator for 15 minutes post injection without any adverse reactions and released at 2:25pm. At approximately 3:30pm the vaccinator realized that an error had occurred and the diluent had not been added to the vaccine vial as instructed by the manufacturer. Vaccinator immediately notified Nurse Manager who then notified the Medical Director. Nurse Manager and Medical Director reached out to the Health Department for advice. Please see continuation page.  The Public Health Department recommended monitoring for any adverse reactions and to make no alterations to their vaccine schedule at this time. They suggested that there may be increased redness, swelling, and pain at the injection site and to monitor for a fever. After recieving advice from the Health Department, Nurse Manager called to noify parents, relay the advice, and offer a follow-up visit.
This non-serious initial spontaneous case was received from other health professional on 04-Oct-2017, concerning a 26-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 04-Oct-2017, the patient was administered expired vaccine that expired in April of this year FLUVIRIN Thiomersal (dose: 0.5 ml, batch number: 1618621, expiry date: Apr-2017, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded to expired vaccine used). No adverse effect was noted. It was reported that the patient had revaccination with the current season. The reporter assessed the report as non-serious. Significant case correction received with IRD 04-Oct-2017: The event coding was changed from no adverse event to no adverse effect. The narrative was amended accordingly. Follow-up report received on 08-Nov-2017: The age and gender of the patient was added. The anatomical location and route of administration were added. The narrative was amended accordingly.
Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022; Patient was administered with vaccine after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the patient was vaccinated with vaccine after the 30 days beyond use date. The date the vial was initially stored in the refrigerator was 10-Jun-2022. It was also reported that the vial didn't undergo any temperature excursions. Reportedly, no adverse reactions were reported.  No treatment information was provided by the reporter.
breast tenderness; irregular periods; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from a sales representative.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, 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: BREAST TENDERNESS (non-serious), outcome "unknown"; MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "irregular periods".  Additional information: It was reported that the event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200053735 same report/product/ae, different patient;
ultrasound the left lower extremity shows extensive occlusive lower extremity DVT involving multiple veins.  Labs otherwise unremarkable, patient appears well, denies chest pain or shortness of breath. He had the J+J vaccine less than 3 weeks ago.
within 15 mins of injection slight headache lasting one hour followed by runny nose, cold like symptoms with muscle pain. Following day in the AM, experienced nausea with diarrhea.  Nausea symptoms proceeding until PM on September 14, 2021, 5 days.  Nausea symptoms were elevated by drinking carbonated water.
pt recv vax 3FEB97 & pregnancy confirmed by test 19FEB97;pt exp fever @ 25wk;during pregnancy, labor, or delivery pt exp a lot of psychological problems;a triple screen was positive for inc risk for down's which was reason for the amnio;
This spontaneous report as received from a pharmacist via field representative refers to two patients of unknown age and unknown gender. The patient's pertinent medical history was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX 1 shot subcutaneously. Concomitant medication included other unspecified vaccines. On an unknown date, the patients developed a rash that spread across the body. It was stated that the rash "was not a big deal" and that it was clearing on its own. The patient had sought medical attention. The outcome of rash was reported as recovering (reported as improving on therapy). The reporter could not single out ZOSTAVAX, as the cause since the patient's were also administered with other unspecified vaccines. No product quality complaint was reported. Additional information has been requested.
soreness in muscles; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (soreness in muscles) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concomitant products included VENLAFAXINE, EZETIMIBE (ZETIA), OMEPRAZOLE, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ) and USTEKINUMAB (STELARA).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced MYALGIA (soreness in muscles). On 02-Apr-2021, MYALGIA (soreness in muscles) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-109734 (Patient Link).