chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ARM SORENESS; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (ARM SORENESS) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (ARM SORENESS). At the time of the report, PAIN IN EXTREMITY (ARM SORENESS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   The patient had some congestion and allergies. She was placed on a steroid and antibiotic. She had received  allergy injections. She did not take injection on the same day as Skyrizi. She had hearing loss and also had  aids. She had arm soreness with first Covid-19 vaccine injection.  The reporter's causality for the events of hearing loss, allergies, arm soreness, congestion was not provided.  Opinion is that the events of hearing loss, allergies and congestion are not assessable. Opinion is that there is no reasonable possibility that the events of arm soreness are related to Skyrizi (risankizumab).  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to.
Hives around the injection site down R) leg and to her arms 24hrs after injection.
ringing in the left ear (tinnitus); This is a spontaneous report from a contactable Other Health Professional. This Other HCP reported same events for himself and other two patients. This is second of three reports, reported for the other one of two patients. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was mentioned that caller's patient and his coworker experienced this ringing in the left ear (tinnitus). Outcome of event was unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021007848 same reporter/drug/event, different patient;US-PFIZER INC-2021009439 same reporter/drug/event, different patient
Pt came to ER for headache, shortness of breath, fatigue, myalgias, congestion, and diarrhea.  Pt found to have acute hypoxic respiratory failure and an abnormal EKG.
warmth at injection site; Maternal exposure during pregnancy; raised bumps at injection site; tenderness at injection site; redness at injection site; fatigue/tiredness; body aches; headache; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (warmth at injection site), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), VACCINATION SITE SWELLING (raised bumps at injection site), VACCINATION SITE PAIN (tenderness at injection site) and VACCINATION SITE ERYTHEMA (redness at injection site) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 001C21A) 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 OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 06-Apr-2021 and the estimated date of delivery was 11-Jan-2022. On 14-Apr-2021, the patient experienced HEADACHE (headache). On 13-May-2021, the patient experienced VACCINATION SITE WARMTH (warmth at injection site), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), VACCINATION SITE SWELLING (raised bumps at injection site), VACCINATION SITE PAIN (tenderness at injection site), VACCINATION SITE ERYTHEMA (redness at injection site), FATIGUE (fatigue/tiredness) and MYALGIA (body aches). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifth week of the pregnancy.  On 17-Apr-2021, HEADACHE (headache) had resolved. On 13-May-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, VACCINATION SITE WARMTH (warmth at injection site), VACCINATION SITE SWELLING (raised bumps at injection site), VACCINATION SITE PAIN (tenderness at injection site), VACCINATION SITE ERYTHEMA (redness at injection site), FATIGUE (fatigue/tiredness) and MYALGIA (body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received the first dose was before she was pregnant and the second dose was when she was 5 weeks pregnant. Her last menstrual was 06-Apr-2021.   This case was linked to MOD-2021-132161 (Patient Link).
pt devel H. Influenza B meningitis 3 wks p/vax;
This spontaneous report as received from a healthcare worker refers to unspecified number of patients. On unknown dates, the patients were vaccinated with GARDASIL exposed to 25F for over 3 months, which was an excursion that was unsupported by in-house stability date. The reporter was unable to provide administration dates, however provided the lot #/expired date as follows: lot # H021608/expire date 13-APR-2015, lot # H01523B/expire date 11-APR-2015, lot # H20002/expire date 08-AUG-2015). No adverse symptoms provided at the time of report. This is one of several reports received from the same source. Additional information has been requested.
Patient received Moderna vaccine (1st shot) and Pfizer vaccine (2nd shot); This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received Moderna vaccine (1st shot) and Pfizer vaccine (2nd shot)) in a 101-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received Moderna vaccine (1st shot) and Pfizer vaccine (2nd shot)). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient received Moderna vaccine (1st shot) and Pfizer vaccine (2nd shot)) 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.   No concomitant medications were reported  No treatment information was provided
Severe nausea, diarhea, stomach pains, beginning 48 hrs from vaccination lasting 4 days
Patient reported a lump over her left upper arm just about 4 weeks after the COVID vaccine, an ultrasound was ordered followed by an MRI and myositis was confirmed. Ice and compression were advised and the symptoms resolved.
This spontaneous report as received from a pharmacist refers to a 64 years old male patient who on 04-SEP-2012, the patient was vaccinated SC with, 0.65 ml of a dose of ZOSTAVAX (lot # and dose were not reported).  No other co-suspects were reported. No concomitant medications were reported. On 08-SEP-2012, the patient developed a "chicken pox like rash, all over his body". The patient sought medical attention by a contact to his pharmacist. At the time of the report, the outcome of he developed a chicken pox like rash, all over his body was reported as not recovered/not resolved. Additional information has been requested.
Right arm pain and deep deltoid muscle pain on palpation. Decreased range of motion to right arm and requires stretching to potentially get full range movement. Deltoid  Muscle pain on passive and active elevation of right arm.
Gave vaccine early afternoon. Around 5 pm, developed wheezing, watery nose and tongue felt funny. Between 6-7 pm, lower jaw, lower lip and tongue felt numb. Wheezing got worse. Took benadryl 25 mg. Wheezing improved. Went to er and received pepcid. Took more benadryl and pepcid at midnight and symptoms resolved next day.
Patient was playing Basketball approximately two hours after vaccination. His friend stated during the seizure-like episode that he had passed out while playing basketball a month ago and almost once before. Once taken to the hospital there was a report of an abnormal EKG. He has been admitted for monitoring.
Edema, dizziness, headaches, itching, pain in joint, skin burning sensation, tingling in hands, numbness on half of the head. Vision loss, muscle aches.
A report has been received from a Health Professional (Registered Nurse) via medical representative concerning a patient of unknown gender. No information regarding medical history, concomitant disease or concomitant medication was provided. A nurse reported that they had a patient who receive FLUMIST QUARDIVALENT and then later test positive for the flu. Action taken with FLUMIST QUARDIVALENT and outcome of the event was unknown. The report was considered to be non-serious by the reporter.
Calling about an adverse reaction to the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Calling about an adverse reaction to the Moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Calling about an adverse reaction to the Moderna vaccine). At the time of the report, VACCINATION COMPLICATION (Calling about an adverse reaction to the Moderna vaccine) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    No concomitant medications were reported. No treatment details were reported.
Marked soreness injection site with heat; left axillary LN tenderness and enlargement; body aches; headache; chills without fever
Lost of Taste, ongoing. Extreme Fatigue, unable to get out of bed for 2.5 months, full,  strength never returned. Right Renal Artery Stenosis, ongoing,   Hypertension, ongoing, medicated. High Resting Heart Rate > 100, ongoing. Left Ventricular Hypertrophy
Beginning the evening of his vaccines, he developed marked redness, swelling, warmth and pain. 4 days post-vaccine he still had redness of 2/3 of his arm with bruising around the inferior vaccine site.
Tired; Arm is lot more sore; Little arm soreness; Couldn't sleep so well; Felt achy like i had the flu; Sweaty; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little arm soreness), INSOMNIA (Couldn't sleep so well), PAIN IN EXTREMITY (Felt achy like i had the flu), HYPERHIDROSIS (Sweaty) and FATIGUE (Tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (Little arm soreness), INSOMNIA (Couldn't sleep so well), PAIN IN EXTREMITY (Felt achy like I had the flu) and HYPERHIDROSIS (Sweaty). On 20-Jan-2021, the patient experienced FATIGUE (Tired) and PAIN IN EXTREMITY (Arm is lot more sore). At the time of the report, PAIN IN EXTREMITY (Little arm soreness), INSOMNIA (Couldn't sleep so well), PAIN IN EXTREMITY (Felt achy like i had the flu), HYPERHIDROSIS (Sweaty), FATIGUE (Tired) and PAIN IN EXTREMITY (Arm is lot more sore) 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 relevant concomitant medications were reported.   No treatment information was provided.
Vaccination administered and patient was observed after 15 minutes for reaction. After 6 minutes patient complained of headache and "feeling a little weird" to clinical support staff. He was observed for the 15 minutes and still reported feeling weird. He was observed for an additional 5 minutes and was asked again by clinical support staff how he was feeling and he reported he was the same. Patient was asked by clinical support staff if he wanted to stay a little longer for observation and he stated he was ok to go. He was instructed by clinical support staff to contact the office with any other complications.
Information has been received from a registered nurse concerning her daughter, a 11 year old female with a history of ventricular septal defect (discovered in 2002), who on 31-JUL-2008, was vaccinated with the first dose of GARDASIL, lot # 660553/0070X, 0.5 ml, intramuscularly in her left arm. Concomitant therapy included MENACTRA. It was reported that following the first vaccination with GARDASIL, the patient developed a rash on the injection site, arm. The rash was described as papular, mildly itchy from the elbow to the shoulder. The onset of the rash was unknown at the time of the report. The rash was reported to have "lasted a while", but no time frame was available. On an unspecified date, the patient recovered. The patient did not seek medical attention. Additional information has been requested.
pt recvd vax & 4 days p/1st dose exp induration (inject site) that lasted 1 wk, that was followed by a blister (inject site) that led to peeled skin & a scab; when scab was removed there was a non-painful ulcerated lesion (inject site);
This case was reported by a physician via sales representative and described the occurrence of hives on chest in a subject of unspecified age and gender who was vaccinated with HAVRIX 720, GlaxoSmithKline.  Concurrent vaccinations received the same day were unspecified, but may have included live attenuated measles, mumps (strain not specified), rubella vaccine (MMR).  In 2007 on an unspecified date within the last two weeks of this report, the subject received unspecified dose of HAVRIX 720 (unknown).  At an unknown time after vaccination with HAVRIX 720, the subject experienced hives on chest.  At the time of reporting the outcome of the event was unspecified.  The physician considered the event was possibly related to vaccination with HAVRIX 720.
Vaccine that was administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that was administered beyond use date after thaw process) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 18-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that was administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that was administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 28 years and 08 months.  No concomitant medications were reported.  On 10-Jun-2022, the vaccine facility staff was notified of an audit that was done and they were made aware of vaccines that were administered beyond use date after the thaw process. Patient had not reported any adverse reactions after the administration of the vaccine.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-542869 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-542869:Master case
Sore throat; Blood pressure elevated to 185/110; sensory reaction developed down into feet and hands; Effected thinking; giddiness effects to the brain; Missed second dose - Did not want to receive second dose; Soreness of the left arm; Fatigue; Low grade fever; This spontaneous case was reported by an occupational therapist and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), BLOOD PRESSURE INCREASED (Blood pressure elevated to 185/110), VACCINATION COMPLICATION (sensory reaction developed down into feet and hands), THINKING ABNORMAL (Effected thinking) and DIZZINESS (giddiness effects to the brain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chemotherapy (chemotherapy for Non-Hodgkin's Lymphoma.) in April 2020. Concurrent medical conditions included Cancer and Kidney failure.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), BLOOD PRESSURE INCREASED (Blood pressure elevated to 185/110), VACCINATION COMPLICATION (sensory reaction developed down into feet and hands), THINKING ABNORMAL (Effected thinking), DIZZINESS (giddiness effects to the brain), PRODUCT DOSE OMISSION ISSUE (Missed second dose - Did not want to receive second dose), MYALGIA (Soreness of the left arm), FATIGUE (Fatigue) and PYREXIA (Low grade fever). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), BLOOD PRESSURE INCREASED (Blood pressure elevated to 185/110), VACCINATION COMPLICATION (sensory reaction developed down into feet and hands), THINKING ABNORMAL (Effected thinking), DIZZINESS (giddiness effects to the brain), PRODUCT DOSE OMISSION ISSUE (Missed second dose - Did not want to receive second dose), MYALGIA (Soreness of the left arm), FATIGUE (Fatigue) and PYREXIA (Low grade fever) outcome was unknown.        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.   No treatment information was provided.  No concomitant medication was provided.
c/o lt elbow pain x 1 days p/vax in lt deltoid;unable to fully straighten elbow;able to fully flex;no swelling, no erythema, no tenderness;
Four days after my second vaccination, I had a severe heart arrhythmia and fainted twice.
This spontaneous report as received from a other health professional refers to a patient of unknown age. The patient was vaccinated with, 0.5 ml VAQTA (lot# unspecified). No other co-suspects were reported. No concomitant medications were reported. The patient received a second dose of VAQTA 1 month after the first dose of VAQTA, and then received a third dose of VAQTA, 6 months after the first dose. No adverse effect reported. It was unspecified if the patient had sought medical attention. This is one of the reports from the same source. Additional information has been requested.
Severe Jaw pain on the left bottom jaw that radiates to my ear. The pain comes and goes. Been having jaw spasms.
PFIZER-BIONTECH COVID-19 VACCINE EUA.  PATIENT SENT TO HOSPITAL FROM NURSING HOME ON 3/15/21 WITH DIARRHEA, VOMITING AND AMS. ADMITTED AND REMAINS HOSPITALIZED ON 3/17.  PATIENT TESTED POSITIVE FOR COVID-19 ON 3/15 AND HAS RECEIVED BOTH DOSES OF VACCINE MORE THAN 2 WEEKS AGO.  HOSPITALIZATION REPORTED TO BE RELATED TO PATIENT SEPTIC WITH GI INFECTION. POSITIVE COVID INFECTION IS INCIDENTAL.  PATIENT ON ROOM AIR. NO FINDINGS ON CHEST X-RAY.
Information has been received from a physician concerning a 50 day old female with no pertinent medical history who on 14-SEP-2007 was vaccinated PO with her first 2.0 ml dose of Rotateq (lot# 657515/0668U). Concomitant vaccinations administered that day included a dose of COMVAX, a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of poliovirus vaccine inactivated (unspecified) and a dose of PREVNAR. On that same day, the patient experienced severe diarrhea, insomnia and uncontrolled crying. Medical attention was sought by contacting the physician by phone. Also, on 17-SEP-2007 the patient was examined in the physician's office and was hospitalized for "a couple of days". On 02-OCT-2007 the patient was seen for a follow-up visit by the physician and was noted to be recovering. No other symptoms were reported and no other information was available. There was no product quality complaint. Additional information has been requested.
pt admitted to hosp with dyspnea, fever, positive for COVID; started on remdesivir, dexamethasone, supplemental O2; hx of CHF, COPD; 8/30 experienced Cardiac arrest, spontaneous circulation after defibrillation; pt was intubated and eventually made a DNR; pt's condition worsened while in the hospital and she expired in the hosp.
I don't think the person angled the shot properly.    Severe Shoulder pain top of shoulder, side, back including rotator cuff even two weeks later.
Was pretty sore for on 2/28 and 3/1 but then was fine. Started being a little itchy on 3/5 in the evening where vaccine site was. Woke up on 3/6 with a very swollen hard lump at the vaccine site and a bit of an itchy red rash.
Had a migraine H/A, dizzy, light sensitivities. Felt like a tight band around the head.  Normal sore arm.  Went to the Dr. and rec'd a migraine cocktail and then got a Rx for the migraine.
pt recvd vax & devel lightheadedness & fatigue following vax w/MMR;
Information has been received from a registered nurse concerning a 5 year old patient who was vaccinated with a dose of ZOSTAVAX (Oka/Merck) instead of VARIVAX (Oka/Merck) by a human mistake at a different facility. No adverse effect reported. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.