chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DRY COUGH; SORE LEGS; CHILLS; FEVER; SWOLLEN EYES; BODY ACHES; HEADACHE; This spontaneous report received from a parent concerned a 24 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced swollen eyes. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced sore legs. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced dry cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen eyes on 09-APR-2021, was recovering from body aches, had not recovered from fever, chills, sore legs, and dry cough, and the outcome of headache was not reported. This report was non-serious.
No rash was noted, but later stated whelps were seen on back, immediately following vaccination. Pt experienced dizziness, strange sensation in leg, problems with memory. Pt was given Benadryl in ER.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hyperventilation-Mild, Additional Details: Patient was waiting after getting dose, fainted, ambuelnce was called. Patient awoke, severe sweating and heavy breathing but responsive. Was monitored by EMT but left without further incident.
LEGALLY BLIND/ LOST SO MUCH OF HIS EYESIGHT; MULTIPLE STROKES; SUSPECTED COVID-19 INFECTION; PERMANENT DISABILITY; This spontaneous report received from a consumer via a company representative via social media concerned a 48 year old male of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure no follow-up will be requested for this case. Age at time of vaccination 5 decade old. No concomitant medications were reported.  On an unspecified date, the patient had went through the gauntlet with covid due to his job the patient was fully vaccinated, wore mask and maintained whole 9 yards. The patient had got covid (suspected covid-19 infection) and was hospitalized for unspecified number of days. The patient was put in an induced coma. The patient had multiple strokes and lost so much of his eyesight that he was now legally blind and had been fighting for his permanent disability.  It was reported that "A friend of mine went through the gauntlet with Covid. Due to his job, he was fully vaccinated. Wore masks, the whole 9 yards. Then he got COVID and was hospitalized. I told him before he went in to not let them put him into a coma. They put him in an induced coma. He had multiple strokes and lost so much of his eyesight that he is now legally blind. 48 yrs old and is now fighting for his permanent disability. It breaks my heart for him". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, multiple strokes, legally blind/ lost so much of his eyesight and permanent disability was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case, from the same reporter is linked to 20230103381. This report was associated with a product quality complaint: 90000265459 and 90000265460.; Sender's Comments: V0 : 20230103417-  legally blind/ lost so much of his eyesight, multiple strokes,  permanent disability. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.  20230103417-Suspected covid 19 infection. The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration.
This spontaneous report as received from a consumer refers to a 19 year old male patient. The patient's pertinent medical history was none. In May 2013 the patient was vaccinated with first dose GARDASIL intramuscularly. Concomitant medications were not reported. Approximately in 2013 (reported as with in one week) the patient experienced mood swings and joint pain. On an unknown date the patient was fatigued, his eyes began to swell and sleeping for 2 weeks straight which was unlike him after receiving second shot of GARDASIL on an unspecified date. The outcome of mood swings, fatigue, joint pain, his eyes began to swell and sleeping for 2 weeks straight which was unlike him was reported as not recovered/not resolved. The causality was not reported. The patient sought medical attention by talking to the physician. Additional information has been requested.
Diagnosed with blood clots; DVT; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunisation. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Diagnosed with blood clots"; DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "DVT". Therapeutic measures were taken as a result of thrombosis, deep vein thrombosis. Clinical course: Patient's wife confirmed if the DVTs which patient experienced was related to the recent vaccine booster. He took Eliquis which was very expensive. He was healthy, very active adult.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300048620 same reporter/drug/event, different patient;
Pfizer vaccine in LH arm, arm was sore for 2 days, arm continues to feel tender and has pins and needles feeling, worse when elevated or moved
Client received 1st dose of Pfizer vaccine on 4/20/21 and 2nd dose of Pfizer vaccine on 5/14/21.  Client received 3rd dose of Moderna vaccine 9/17/21.  Monitored client and educated patient on possible side effects.
FLARE UP; NERVOUS; ACIDIC PH; TINGLING; NUMBNESS; SHAKING; JITTERY; ABNORMAL VITALS; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included depression, anxiety, seasonal allergies, social drinker, and smoker, and other pre-existing medical conditions included patient takes allergy shots for her seasonal allergies. no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068JJ and expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 to Right Arm for prophylactic vaccination. Concomitant medications included bupropion for anxiety, and depression, azithromycin for seasonal allergies, cetirizine hydrochloride for seasonal allergies, and montelukast sodium for seasonal allergies. On 07-MAR-2021, the subject experienced tingling. On 07-MAR-2021, the subject experienced numbness. On 07-MAR-2021, the subject experienced shaking. On 07-MAR-2021, the subject experienced jittery. On 07-MAR-2021, the subject experienced abnormal vitals. Laboratory data included: Blood pressure (NR: not provided) 170/110 mmHg, Heart rate (NR: not provided) 106 bpm, and Pulse rate (NR: not provided) 80-90 bpm. On 08-MAR-2021, the subject experienced flare up. On 08-MAR-2021, the subject experienced nervous. On 08-MAR-2021, the subject experienced acidic ph. Laboratory data included: Blood pressure (NR: not provided) 136/97 mmHg, 154/92 mmHg, 114/75 mmHg, 114/75 mmHg, Heart rate (NR: not provided) 80 bpm, 110 bpm, 129 bpm, and (NR: not provided) Acidic pH level. Treatment medications (dates unspecified) included: lorazepam. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abnormal vitals on 08-MAR-2021, was recovering from numbness, jittery, flare up, and nervous, had not recovered from tingling, and shaking, and the outcome of acidic ph was not reported. This report was non-serious.
Patient received vaccine on 10-8-12 and noticed a small blister on arm on morning of 10-20-12 that was where she received injection. No signs of infection and no other symptoms. She said she wouldn't have even noticed it but saw it in mirror.
My arm was in so much pain. I could not move my arm. The treatment was putting a cold towel on it. The pain lasted a couple of days.
Initial unsolicited report received from a pharmacist on 12 October 2016. This case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. (Same vaccine). This case involves a patient of unknown age and gender, who was vaccinated with FLUZONE intramuscularly (batch number: UI669AA, expiry date: 30 June 2017 (dose, dose in series were not reported) in the left arm on 04 October 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions was unknown. Illness at the time of vaccination was also reported as unknown. No further information regarding medical history was available. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On unspecified date and duration following vaccination, the patient developed left arm, red, swollen down not elbow and raised area approximately 7cm by 6 cm ('6 em'), warm to touch, hurt at injection site. On 05 October 2016, one day post vaccination the patient felt ill. The patient needed ER visit. Laboratory data was not reported. Corrective treatment was reported as 'no'. The outcome of the events inflammation localized and vaccination site reaction was reported as unknown and on 06 October 2016 the patient recovered from illness. List of documents held by sender: none.
BLOOD CLOTS; This spontaneous report received from a patient via Social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s  (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose,1 total administered start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The patient reported " one month after I got the J&J Covid shot I was in the hospital with blood clots" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211241127-Covid-19 vaccine ad26.cov2.s -Blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm hurt for 4 days/The 2nd day it hurt worst than flu shot), LIMB DISCOMFORT (It was pretty sore), ERYTHEMA (A little pinkish red color) and INFLAMMATION (A little inflamed) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII (arm hurt for 4 days after COVID-19 vaccine and the 2nd day it hurt worst than flu shot). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), DEXLANSOPRAZOLE (DEXILANT), NEBIVOLOL, MONTELUKAST, ASPIRIN [ACETYLSALICYLIC ACID], LISINOPRIL, LEVOTHYROXINE and OXYBUTYNIN for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (Her arm hurt for 4 days/The 2nd day it hurt worst than flu shot), LIMB DISCOMFORT (It was pretty sore), ERYTHEMA (A little pinkish red color) and INFLAMMATION (A little inflamed). The patient was treated with NAPROXEN SODIUM (ALEVE) for Pain in arm, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Her arm hurt for 4 days/The 2nd day it hurt worst than flu shot), LIMB DISCOMFORT (It was pretty sore), ERYTHEMA (A little pinkish red color) and INFLAMMATION (A little inflamed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient gave consent to safety for Follow-up.
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. The registered nurse stated that doses of ROTATEQ oral (dose, lot number and expiry date were not reported), were exposed to a supported temperature excursion and administered to unspecified patients since the excursion occurred on 17-FEB-2015. No adverse experience has been reported. There was no concomitant medication provided. This is one of two reports received from the same reporter. Additional information has been requested.
Woke in the very early morning With a terrible pain on the top of my right foot. I didn?t look at it at the time. Took Advil and put some ice on it and it took a few hours to get better. I had no injury prior to that. In the morning it appeared red and swollen at my midfoot, more immediately. It was very tender around the proximal first metatarsal.
This spontaneous prospective pregnancy report was received from a 25 year old female patient regarding herself. On an unknown date in August 2013 the patient was vaccinated with a dose of VARIVAX (Merck) (lot #, expiration date and route not reported). The patient reported that she was pregnant when she received VARIVAX (Merck). The patient discovered that she was pregnant on 01-OCT-2013. The Last Menstrual Period (LMP) and Estimated Delivery Date (EDD) is not known. Additional information is not expected.
Tachycardia at 110; chills; muscle pain; fever of 100.4; cough; fatigue; joint pain; wheeze; This is a spontaneous report from a contactable other HCP reported for self. This 38-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via intramuscular at 12Jan2021 11:00 AM at single dose in left arm for COVID-19 immunization. The patient medical history included COVID-19 prior vaccination. The patient concomitant medication was reported as no. The patient had no known allergies. The patient experienced tachycardia at 110, chills, muscle pain, fever of 100.4, cough, fatigue, joint pain, wheeze at 12Jan2021 23:00 PM. The patient received treatment paracetamol (TYLENOL), ibuprofen (MOTRIN), diphenhydramine hydrochloride (BENADRYL). The patient was not diagnosed with COVID since the vaccination. The patient was recovering from the events.  Information about lot/batch number has been requested.
Started with a dull head ache the evening of the vaccine and it's progressively gotten worse. Today it is causing nausea.
Day after vaccine had myalgias, fever Tmax = 100. something but < 101 degrees. Had significant fatigue and "slept for two days straight." Symptoms lasted 3-4 days.
This spontaneous report as received from a physician via a Company Representative refers to a 81 year old male patient. Medical history and concurrent conditions were not reported. In 2009, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (lot number was not reported). Secondary and concomitant therapies were not reported. In December 2013, the patient experienced severe case of shingles. There were massive blisters and low grade fever. Patient was referred to an infectious disease specialist for treatment. Treatment given was an unspecified antibiotic and an unspecified antiviral. At the time of the report, the patient was recovering from the events. It was reported that therapy with ZOSTAVAX was discontinued. Additional information has been requested.
Patient did NOT experience any adverse events, but he did receive 2 doses of the Janssen COVID vaccine 12 weeks apart.  The first dose failed to report, so the administering provider of the 2nd dose was unaware that the patient had received the first dose.  The patient, however, was aware that he had already received the first dose and chose to get a 2nd dose because he had heard people talking about "booster" shots and "figured why not?" (patient's own words).  He disclosed this to me when this error was discovered and I called to assess him for any adverse effects.  Again, he states that he did not experience any adverse effects from the 2nd dose. Lot of 2nd dose was 1820095,  also administered IM in left arm
I had body and joint ache that went away in 24 hours. About 2 weeks later, it came back. I began wake up at nights with server lower back pain. Then it would go away within an hour. I also had groin pain. I went to the doctor about this. He thought it might be a hip ligament. He did an X-ray on my back and said I had arthritis in my back. I also went to my OBGYN about my groin pain. They did a ultrasound. They also did blood work, which was normal.
history from mom-well baby exam approx 9AUG93 given immun DTP/HIB/OPV 14AUG runny nose;
It started out like a sinus head cold and there was a low grade 99 fever. I had no fever after that, and it just went to my chest, and I went to the doctor. I tried over the counter cold medicine, and it didn't really do anything. the doctor said my lungs sounded horrible and gave me an antibiotic and prednisone the first time I went. the second time they gave me an inhaler and extended the prednisone. I'm still taking the inhaler.
Mother specifies that approximately 35 minutes after the vaccination of the baby, she observed a rash on the face, arms, back, and 1 foot.
Patient presented to the ED after a fall.  Denied any shortness of breath but reported chronic cough.  Has intermittent urinary difficulty.  In the ED noted to be hypotensive with blood pressure 73/36, heart rate 120, temperature 97.1°.  BUN was 11, creatinine 1.2.  Lactate was 3.2.  Procalcitonin was 0.08.   Chest x-ray showed stable cardiomegaly and mild pulmonary venous congestion.  No lobar infiltrates.  COVID-19 test was positive.  Patient was given starter dose of IV antibiotics and admitted.  Patient did not require any supplemental oxygen and therefore was not started on any Decadron.  He was afebrile during his hospital stay.  His blood pressures normalized.  Antibiotics discontinued as procalcitonin was not elevated and cultures were negative.  Patient did have inflammatory markers elevated from underlying COVID-19.  Because of COVID-19, patient will not be able to go to any facility for a few more days until he finishes with isolation.  Patient vehemently refused to go to rehab and was discharged home in stable condition. his discharge diagnosis were: Sepsis present on admission secondary to COVID-19 infection-resolved COVID-19 infection without hypoxia Hypotension on admission secondary to above-resolved
I21.4 ACUTE NON ST ELEVATION MI 7/12/2023 ACUTE NON ST ELEVATION MI
Headache, Myalgia, UrticariaPruritus, numbness and tingling on the left side-leg, arm and sides Narrative:
experiencing extreme pain; soreness in the arm that was injected; feel extremely tired; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (experiencing extreme pain), VACCINATION SITE PAIN (soreness in the arm that was injected) and FATIGUE (feel extremely tired) 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 23-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PAIN (experiencing extreme pain), VACCINATION SITE PAIN (soreness in the arm that was injected) and FATIGUE (feel extremely tired). At the time of the report, PAIN (experiencing extreme pain), VACCINATION SITE PAIN (soreness in the arm that was injected) and FATIGUE (feel extremely tired) 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.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
adacel that was given expired/ none symptoms; Initial information received on 17-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse (reporters herself) by phone.  This case involves a 20 months old female patient who was vaccinated with 0.5 ml fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5202AA and expiry date: 16-May-2019) via intramuscular route in the left thigh.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) on an unknown date.  It was a case of actual medication error due to expired vaccine used.  No symptoms were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.