chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Pain at injection first injection (R)) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 028L20A) for COVID-19 vaccination.  No Medical History information was reported. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection first injection (R)). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site pain, at an unspecified dose and frequency. On 07-Jan-2021, VACCINATION SITE PAIN (Pain at injection first injection (R)) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. This case was linked to MOD-2021-194165.
The day p/the flu shot was given flu sx began & have continued for over 7 days; h/a, body aches, congestion, stuffy nose, lt ear plugged;
ED to Hosp-Admission Discharged  3/28/2021 - 3/29/2021 (30 hours)    Last attending ? Treatment team Pneumonia due to COVID-19 virus Principal problem  Discharge Diagnosis Hospital Problems          POA   * (Principal) Pneumonia due to COVID-19 virus Unknown       Type 2 diabetes mellitus without complication, without long-term current use of insulin (CMS/HCC) Yes       Obstructive sleep apnea syndrome Yes       Restrictive lung disease Yes       Morbid obesity due to excess calories (CMS/HCC) Yes       Prostate cancer (CMS/HCC) Yes       Status post radiation therapy Not Applicable       COVID-19 virus detected Yes     Hospital Course    COVID-19 Pneumonia Patient presented with headache, chills, diarrhea, dry cough and rash. Patient was maintaining saturation of 91-92% at rest and was desaturating down to 88-89% on slightest exertion. Patient was started on oral dexamethasone 6 mg daily and remdesivir therapy. Patient left AMA on Day 2 admission. Patient was provided 10 days of dexamethasone therapy.    Atopic Rash Likely secondary to COVID-19 infection or allergic reaction. Rash responded well to Benadryl therapy initially.  Patient reported reappearance of rash the next day. Patient was continued on Benadryl PRN.   Chest Pain, Resolved  Heart score of 3.  EKG unremarkable for ischemic changes. Clinical suspicion for angina was low.   Type 2 Diabetes Most recent HbA1c of 7.8 on 11/2020. Patient is on home glipizide therapy. Patient started on 8 units of Lantus nightly and low-dose sliding scale.   Essential Hypertension Patient is on lisinopril 20 mg therapy at home. Home dose of lisinopril resumed   Possible obesity hypoventilation syndrome Possible COPD Previous note by pulmonologist reflects that patient's disease might be restrictive instead of obstructive however as he had responded to inhalers, inhalers were continued. Patient's home Incruse Ellipta was resumed. DuoNebs as needed were given.   Obstructive Sleep Apnea  Patient uses CPAP at night. CPAP ordered to be used nightly during hospital stay   Major depressive disorder Symptoms are well controlled on Prozac therapy. Home dose of Prozac resumed   Hypercholesterolemia Home dose of atorvastatin 40 mg resumed   Morbid Obesity
large swollen, raised, red area (approx.. 4" X 3") on my left upper arm Narrative:  large swollen, raised, red area (approx.. 4" X 3") on my left upper arm. HAS IMPROVED
2 hrs after MMR began screaming, writhing and complaining of arm pain (not at site of injection which was not inflammed) screamed x 3 hrs, had fever. Resolved with TYLENOL at about 4 hrs after injection give today. Spent 3 hrs at office under observation.
The pt experienced a fever of 103.7 and vomiting. The pt was admitted to the hospital and hydrated with IV fluids for 8-12 hours. Pt was admitted 10:00am 8/18/00, D/C'd about 12noon on 8/19/00.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 12-JUN-2015, the patient was vaccinated with a dose of improperly stored M-M-R II, lot number K015374, expiration date 18-SEP-2016 (dose and route were not reported). No adverse symptoms reported. This is one of several reports from the same source. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever, disorientation and incomplete course of vaccination. On an unknown date, the outcome of the fever, disorientation and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the fever and disorientation to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 1st dose of Shingrix vaccine about a year ago and experienced fever and felt disoriented. Till the time of call the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The patient was inquiring about the recommendation for timing of the second dose and the severity of the side effects associated with the second dose.  The patient spoke from Shingrix FAQs content. Provided medical advice disclaimer and referred to HCP. No additional details were provided. The reporter consented to follow up.
She has swelling of gland in her armpits; This is a spontaneous report received from a contactable consumer (patient's friend). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration as dose 1, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter was calling for a friend who received a Pfizer first dose of COVID vaccine and she has swelling of glands in her armpits, and this has been going on for 25 days now. Patient did not receive the second dose they did not want to give it to her before they know what was happening. Reporter wanted to check was this was normal side effect because patient's medical doctors don't know what to say. Patient did not receive any treatment for the event. The patient was not recovered from the event.  No follow-up attempts are possible. Information about. Batch/lot number cannot be obtained.
Right arm (injected with PNEUMOVAX 23) became very sore to the point patient had to make a sling to hold up arm. She tried ADVIL, heating pad and ice, but no help. Feels paralyzed from (R) shoulder to (R) elbow.
5x6 inches in diameter, flesh is hard, red, shoulder and arm very inflamed, itchy, tissue is hot to the touch.
7 hours after immunization, pt c/o dizziness, weakness 12.5 mg Benadryl given- 8 min later dizziness resolved but weakness cont. Mom reports weakness, dizziness cont into next day, but did resolve.
High-pitched ringing in both ears.  More prevalent in right.  Both ears 'popping' constantly.
Extreme sickness, nausea, fatigue, incapacitation to the extreme - could not move or go to work, had to take a sick day which is very rare for me. Almost went to the hospital due to this reaction - very painful and distressing.
EXPLOSIVE DIAHRREA 3/24/21 VERTIGO, DIZZINESS, HEADACHE, NAUSEA 3/25/21 DIZZINESS, HEADACHE, NAUSEA FOR 1 WEEK SYMPTOMS RETURNED 10 DAYS AFTER 2ND VACCINATION 4/8/21, CONTINUING SPORADICALLY SINCE
Loss of taste; Not doing well; Extreme fatigue; Muscle aches; Joint pain; Chills; A spontaneous report was received from a 74 year old male, patient ,who administered first dose of Moderna Covid-19 Vaccine and have experienced loss of taste, malaise, fatigue, muscle aches, joint pains and chills.  The patient's medical history was not provided. His concomitant medications were Purinethol, Losartan, Omeprazole, Metoprolol, Singulair, Metformin, Amaryl, Norvasc, Pioglitazone, Trulicity 0. No information on allergies.  On 28 Dec 2020, prior to onset of events, patient received first of two planned doses of Moderna Covid-19 vaccine for the prophylaxis of Covid-19 infection. (Lot: 039K20A).   Since then patient has been not doing well(malaise) and experiencing loss of taste, muscle aches, joint pains, chills and fatigue. It is not known whether he seek treatment for the events.  Action taken with 2nd dose of vaccine is not reported.  The outcome of the events loss of taste, malaise, muscle aches, joint pains, chills, and fatigue were not recovered at the time of report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Rash around mouth, and on angle of mouth where vaccine drip down, vomiting, diarrhea. Retching. Irritability, diaper rash. After ROTATEQ.
MISSED TO TAKE LAST DOSE OF VIVOTIF ACCORDING TO SCHEDULE; This spontaneous case report (PVX2019-2779) was received from a consumer on 11-Nov-2019. It described a female consumer who "missed to take last dose of Vivotif according to schedule" (PT: Product dose omission), while being on oral Vivotif for typhoid fever.  Case report: The consumer missed to take the last dose of Vivotif, which was due on 10-Nov-2019.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "missed to take last dose of Vivotif according to schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take last dose of Vivotif according to schedule" was considered as not applicable.
Left shoulder and elbow "achy", hurts a lot. Started 1 day, post vax, of 1st Hep-B shot and still continues. Instructed to call PMD.
Patient was  given DTaP vaccine instead of Tdap No adverse effect or reaction but error made in giving wrong vaccine at wrong age Discussed with staff about it and protocol to avoid such errors in future Discussed with mom regarding the error.
It was reported that an 18 year old male pt received a TD Adult on 9/8/00 and on 9/11/00, the pt developed a local reaction of redness and pain at the injection site. Physician treated as cellulitis with Cefadroxil 500mg twice a day for 10 days.
Persistent (more than 3 weeks) mucous in stools; persistent belly pain; required hospitalization of 2 days; diagnosed with COLITIS; could no longer breast feed; had to feed baby only Nutramigen for next 9 months.  7/13/09 Hospital records received DOS 3/6/08 to 3/7/08. Final Diagnosis: Allergic Colitis Suspected, Gastroesophageal Reflux Disease Suspected. Parent reports child has diarrhea, colicky, 'pepper jelly stool', screaming, distended abdomen. Peripheral eosinophilia. Patient presents with irritability and mucoid stools. Cries after feeding. Greenish stools. Regurgitation, spitting up. Gassy.    7/13/09 PCP medical records received DOS 11/19/07 to 9/17/08. Assessment: Colitis Presents with mucousy stool, abdominal pain, colic. Diarrhea. Pasty green yellow stool.
devel fever & brief generallized tonic clonic sz; less than 2 hrs p/receiving DTP/HIB pt underwent LP, blood culture, complete blood count all WNL;
Collapsed, unresponsive, low heart rate and blood pressure, vaccine staff attended and then felt 911 should be called, paramedics attended, did EKG
Pt did not respond to the Engerix-B vax series; 24JAN91 (? 24JAN92) HBSAB neg; 1 booster dose was given;
Administer on 11/04/2022 Pfizer Covid Monovalent, on left deltoid as a Third Dose  No adverse outcome after vaccine administration
It's starting to bruise underneath; severe joint pain; severe muscle pain; headache; it was extremely painful / it was sharp; she had bleeding on the injection site for +15 hs / there was lots of fresh bleeding; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (it was extremely painful / it was sharp), VACCINATION SITE HAEMORRHAGE (she had bleeding on the injection site for +15 hs / there was lots of fresh bleeding), CONTUSION (It's starting to bruise underneath), ARTHRALGIA (severe joint pain) and MYALGIA (severe muscle pain) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 030L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, ACETYLSALICYLIC ACID for Clotting disorder, ETHINYLESTRADIOL, NORGESTIMATE (TRINESSA), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), ESCITALOPRAM OXALATE (LEXAPRO), LEVOTHYROXINE SODIUM (SYNTHROID) and SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced PAIN (it was extremely painful / it was sharp) and VACCINATION SITE HAEMORRHAGE (she had bleeding on the injection site for +15 hs / there was lots of fresh bleeding). On an unknown date, the patient experienced CONTUSION (It's starting to bruise underneath), ARTHRALGIA (severe joint pain), MYALGIA (severe muscle pain) and HEADACHE (headache). On 27-Oct-2021, PAIN (it was extremely painful / it was sharp) and VACCINATION SITE HAEMORRHAGE (she had bleeding on the injection site for +15 hs / there was lots of fresh bleeding) had resolved. At the time of the report, CONTUSION (It's starting to bruise underneath), ARTHRALGIA (severe joint pain), MYALGIA (severe muscle pain) and HEADACHE (headache) outcome was unknown.            No treatment were reported.   This case was linked to MOD-2021-366431, MOD-2021-366435 (Patient Link).
Miscarried found no fetal heartbeat at 3/11 ultrasound. D&C completed 3/19
Was delirious for 2 days; Wasn't feeling good; Had high blood pressure; Had chills; Had fever; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Was delirious for 2 days) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo and Dizziness.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced DELIRIUM (Was delirious for 2 days) (seriousness criterion medically significant), FEELING ABNORMAL (Wasn't feeling good), HYPERTENSION (Had high blood pressure), CHILLS (Had chills) and PYREXIA (Had fever). On 04-Apr-2021, DELIRIUM (Was delirious for 2 days), FEELING ABNORMAL (Wasn't feeling good), HYPERTENSION (Had high blood pressure), CHILLS (Had chills) and PYREXIA (Had fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided. Patient reported that all the possible adverse events subsided by 04-Apr-2021. Patient stated that she took combination medication of nexium, antihistamine, and unspecified third product which alleviated the adverse events. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Malaise, Fatigue, nausea, fever (101.2); arm swelling; leukocytosis.  Final diagnosis: SIRS due to noninfectious process with acute organ dysfunction.  Other final diagnoses for same admit: Fever; primary hyperaldosteronism; paroxysmal atrial fibrillation; nontraumatic acute kidney injury due to dehydration; DM2 with CKD stage 3; left adrenal mass; major depressive disorder (in full remission); GERD; HTN; Hx of thyroid cancer - postoperative hypothyroidism; hyperlipidemia.
blood pressure shot up; pulse went up to 114 beats per minute; felt woozy; sore arm; Weakness; headache; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (blood pressure shot up), HEART RATE INCREASED (pulse went up to 114 beats per minute), DIZZINESS (felt woozy), PAIN IN EXTREMITY (sore arm) and ASTHENIA (Weakness) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information Was Reported.     On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (blood pressure shot up), HEART RATE INCREASED (pulse went up to 114 beats per minute), DIZZINESS (felt woozy), PAIN IN EXTREMITY (sore arm), ASTHENIA (Weakness) and HEADACHE (headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency and IBUPROFEN at a dose of UNK dosage form. On 22-Jan-2021, BLOOD PRESSURE INCREASED (blood pressure shot up), HEART RATE INCREASED (pulse went up to 114 beats per minute) and DIZZINESS (felt woozy) had resolved. On 25-Jan-2021, PAIN IN EXTREMITY (sore arm), ASTHENIA (Weakness) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Blood pressure measurement: increased (High) blood pressure shot up. On 22-Jan-2021, Heart rate: 114 (High) 114 beats per minute.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication information was reported.     Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up Information received on 21-jun-2021and contains no new information.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: 649702), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cancer" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "known allergies: statins" (unspecified if ongoing), notes: known allergies: statins. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Anti-viral treatment for COVID-19 with Paxlovid from 18Oct2022 to 23Oct2022.  No follow-up attempts are possible. No further information is expected.
24-48 hours after having the vaccine, patient noted confusion with decision making and went to sleep, when he woke up, he noted right wrist pain that then moved to the elbow then to the shoulder. By the third day he started having left ankle pain and swelling. He was hospitalized for septic joint, received arthrotomy/synvectomy and IV antibiotics for 6 weeks.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 16May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "High Blood Pressure" (unspecified if ongoing), notes: Other medical history: High Blood Pressure. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: No known allergies. Antiviral details: COVID 19 treatment start date was 06Jul2022.