chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable physician received via a sales representative who reported the same events for 3 different patients. This is the 1st of 3 reports. A 13-year-old patient of an unspecified ethnicity and gender received TRUMENBA on an unspecified date at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced chills, fever, headache, malaise, all on an unspecified date with unknown outcome. Sender's Comments: Linked Report(s): US-PFIZER INC-2016450423 Same reporter/drug/events, different patient; US-PFIZER INC-2016449750 Same reporter/drug/events, different patient; US-PFIZER INC-2016449750 Same reporter/drug/events, different patient.
Left sided chest pain, shortness of breath, exertional tachycardia, radiating chest pain to the back x 7 days.  Treated with rest, Medrol Dose pack and improved over 3 days.  Diagnosis from cardiolgist  -myocarditis
This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. The office manager reported that the patients received unspecified doses of PNEUMOVAX 23 (lot # M006141 with expiration date: 28-MAY-2017 and lot# M006922 with expiration date: 21-JUN-2017) that were improperly stored (freezer: temperature of 31 F for 5 hours; refrigerator: temperature of 54F for 7 hours; there was a data logger in combination with manual monitoring system). Route of administration was not reported. Vaccinations occurred between 15-SEP-2016 and 16-SEP-2016. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
positive antigen test on day 10 and day 11; positive antigen test on day 10 and day 11; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 08Jan2021 as dose 2, single (Lot number: EK9231), in left arm and on 29Sep2021 as dose 3 (booster), single (Lot number: EW0183) at the age of 48 years, in left arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient's relevant medical history included: "Type 1 DM" (unspecified if ongoing); "s/p partial thyroidectomy on thyroid replacement" (unspecified if ongoing). Other medical history included Type 1 DM, s/p partial thyroidectomy on thyroid replacement and patient had no known drug allergies (NKDA). Concomitant medication(s) included: HUMALOG; SYNTHROID; VITAMIN D NOS. Patient received other medication in 2 weeks which included Humalog insulin, Synthroid, Multivitamin and Vitamin D.  The following information was reported: VACCINATION FAILURE (medically significant) with onset Apr2022, outcome "unknown", COVID-19 (medically significant) with onset Apr2022, outcome "recovered" (2022) and all described as "positive antigen test on day 10 and day 11". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: On Day 11 with positive  antigen test on day 10 and day 11, following a negative antigen test on day 7; Positive, notes: On Day 11 with positive antigen test on day 10 and day 11, following a negative antigen test on day 7; Positive, notes: On Day 11 with positive antigen test on day 10 and day 11, following a negative antigen test on day 7; unknown result. Anti-viral details included COVID 19 Treatment with Paxlovid started on 23Apr2022 and ended on 05May2022 with indication as treatment of COVID-19. Patient experienced rebound symptoms like congestion, fatigue on day 11 with positive antigen test on day 10 and day 11, following a negative antigen test on day 7. Therapeutic measures were taken as a result of covid-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the events Covid 19 and the suspect product BNT162B2 cannot be completely ruled out.
Severe itching all over body, vomiting , body aches, feeling weak sleeping all day
can hardly move his arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (can hardly move his arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (can hardly move his arm). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (can hardly move his arm) outcome was unknown.            No concomitant medications reported. No treatment medication was reported.  Patient mentioned their son had a third dose of the vaccine and can hardly move his arm even after a month. Also added their son had covid-19 after the second dose of the vaccine and before this third dose. He was in hospital and received a drug cocktail, and went home after 2 days.   This case was linked to MOD-2021-419252, MOD-2021-418444, MOD-2021-419308, MOD-2021-418432, MOD-2021-418640 (Patient Link).
patient felt light headed and his bp was extremely high. pt wanted something to drink  and was given orange juice. pt felt better and bp came back down to normal and he felt better after 20-25 minutes
First shot in right arm on Jan. 8th, broke out with tiny  blister like pimples all over my face. They cleared up in 2 days after shot. Second shot in left arm Feb. 5th, broke out again but on my bottom lids of eyes and a sty in my left eye. The pimples on lids are cleared up, but the sty is still there.
Extreme fatigue for over 3 months. Alleviated by steroid shot. Then, October felt heart pain. Tested blood showed heart damage and blood clot Waiting for MRI
at 10:33 chest feeling full like could stop breathing any second along with a weird headache, then dizzy head through chest, down arms, legs and toes.  at 10:40 Hard pain started  in a wide band from  right side of back and went to left .  at 11:10 Tongue and tip of tongue went numb and metal taste. then upper lip went numb. 11:20 Outer upper mouth numb and  still weird taste, but now strange smell. 11:29 Nose now numb  and upper chest feels icy cold and numb inside. 11:36 Now cheeks numb and chin. Still weird feeling in chest and down arms. some nausea now. 12:31 Really bad left eye pain for about  10 seconds. 1:30 Now only tongue and upper lip still numb. 1:35 heart pounding in chest and head . pounding stopped at 1:55. At 2:15 All stared going away, face turned bright red with heat. at 4:00 still have left eye pain and headache, other all gone
This spontaneous report as received from a medical assistant refers to a 16 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 25-JUN-2014 the patient was vaccinated with first dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J005010, expiry date: 23-OCT-2015) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, , 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA01304 (same reporter link).
i woke up at 3am with chest pain on 01-11-2021. I went to the hospital and was diagnosed with pericarditis. At the hospital, an EKG, echocardiogram, US of the abdomen, MRI of the chest, lab work, cardiac marker series , CRP and a scheduled exercised test was done that picked up arrhythmia.  I am now recovering and I am still taking Colchicine, a gout medication that treats inflammation and pericarditis. I am on this medication till mid April 2021 when I see my cardiologist for follow up.
Pt had numbness and tingling in arms after vaccination. No treatments given besides monitor for 1 hour and tingling went away. No difficulty breathing, swallowing or chest pains.  Vitals normal with slightly elevated  (168/78) blood pressure which he stated was normal because he felt anxious.  Sats 98% on room air, RR 16, HR 68. He was comfortable and wanted to go home after an hour of observation and tingling resolved .
Positive COVID test on July 1st Congestion began on July 2nd along with a cough, low-grade fever, dizziness/fatigue
Systemic: Allergic: Swelling of Face/Eyes/Mouth/Tongue-mild, Systemic: Body aches generalized-Mild, Systemic: fainting/Unresponsive-mild, Systemic: Fever-mild, Systemic: headache-mild.
Patient received her second dose of the coronavirus19 vaccine at our facility at 11:54 am. on 4/19/21.  At approximately 1220, patient complained to nurse about mild itching located on scalp, chest, and upper left arm.  No visible hives or rash were identified.  Patient denied SOB, difficulty breathing, difficulty swallowing, tongue swelling, chest pain.  Patient was given fexofenadine 60 mg. PO.  Patient was monitored and observed for another 30 minutes with no new or worsening symptoms.  Patient was warned about new or worsening symptoms to monitor for and when to seek emergent care. Patient verbalized understanding.
This spontaneous prospective pregnancy report as received from a healthcare worker, refers to a 35 year old female patient. The patient's medical history included drug reaction to sulfonamides. On 08-MAY-2013, the patient was vaccinated with GARDASIL lot # H019495 and expiry date 15-AUG-2015, intramuscular. Concomitant therapies included prenatal vitamins. The patient became pregnant with LMP of 19-OCT-2012 and EDD of 26-JUL-2013. Initial exposure to GARDASIL was at 28 week(s). On 08-MAY-2013, the patient is 35 years old and the patient received 1 GARDASIL dose in error. The patient's last menstrual period was on 19-OCT-2012, and the patient is pregnant. No known adverse effects. The outcome of patient is pregnant, no known adverse effects, patient received 1 GARDASIL dose in error and patient is 35 years old is unknown. The reporter considered patient is pregnant, patient received 1 GARDASIL dose in error, patient is 35 years old and now known adverse effects to be not related to GARDASIL. Additional information has been requested.
Pt experienced a fever of 100 for 4 days.  Arm was very swollen and sore. 5 X 5 mm induration at injection site.
Needle used for administration of vaccine.  During administration, needle and hub broke off from syringe and vaccine squirted out on patient?s arm.  Unclear how much went into arm.   Needle and hub removed from arm.  No adverse effect for patient.   Dr. contacted- advised to re-administer full dose.
Patient stated that her finger went numb like four days after taking the vaccine. In June she started gaining a little feeling in her fingers. Patient stated that her index finger still has not gain full sensation. Patient took a nerve test on 7/26/2021.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: PATIENT CALLED THE PHARMACY ON 9/20/21, STATING THAT SEVERAL DAYS EARLIER HE STARTED TO DEVELOP A LARGE SWOLLEN AREA, PURPLE COLORED ON HIS CHEEK, SEVERE SINUS AREA PAIN AND BLURRED VISION.  PT WAS REFERRED FOR IMMEDIATE ATTENTION.  UNKNOWN AT THIS TIME IF ISSUE IS DETERMINED TO BE VACCINE RELATED.
Patient into pharmacy stating that his arm is still sore from the flu shot he received on 9/15/18. He asked if it was normal to still be painful. He can move his arm but states it's sore in the shoulder area when he reaches up.
Redness, soreness, swelling, heat and itching. During a routine check up patient's doctor prescribed KEFLEX and ADVIL. He thought it may lead to cellulitis.
My daughter was given the flu shot at around 11:45 a.m. on Saturday, November 25.  Within hours, she broke out in hives on her face, stomach and chest. She has been extremely irritable for the last two days.
Patient is a 93 y.o. male admitted to the hospital on 12/3/2022 for an unwitnessed fall.  Hospital course complicated by delirium and fevers related to UTI and COVID. Discharged to long term care facility.    Discharge Diagnosis and Associated Hospital Course   Toxic / Metabolic encephalopathy with baseline dementia - Delirium likely related to fall, dehydration, head trauma, infection - suspected vascular + alzheimer's dementia as baseline  - Behavioral medicine evaluated 12/6 - continue Seroquel 25 mg nightly, depakote sprinkles 250 mg nightly, melatonin 1mg nightly - If pt unable to take PO, consider IV Haldol dose for agitation - More alert today. Has not required PRN seroquel past 24 hours.   COVID-19 - New fevers 12/6 (resp pcr wasn't collected until 12/10) - no respiratory symptoms, only attributable symptom is encephalopathy  - did not require O2 support - Supportive care for covid at this point, isolation ended12/20   Acute kidney injury on ckd 3a, resolvd - Likely prerenal with altered mental status and no intake - Baseline CR 1.2, AKI resolved with IVF - continue ACEi - BMP with stable renal function as of 12/19   Acute cystitis - resolved - Urine culture > 100k E coli, sensitive to cephalosporins - completed 3 days of rocephin   Fall - likely mechanical in setting of dementia, unwitnessed - Trauma signed off with no major injury, PT/OT/CM   Permanent AFib - S/p PPM in 2019 - continue increased toprol xl 50 daily for bp, eliquis 5 bid   Hx of right MCA Embolic Stroke - Cardio embolic in setting of A. fib not on AC - Presented with: Left-sided hemiparesis and dysarthria - Interventions: S/p mechanical thrombectomy on 10/13/2022 - On atorvastatin 10 mg daily, eliquis 5 bid   Hypertension - Labile BP due to periodic agitation - continue increased toprol xl to 50 mg and new lisinopril 5 as of 12/7, can be followed up OP   DM2 - Home regimen on outpatient records indicates Lantus 20 units with SSI - Glucose levels acceptable - Continue lantus 5 U nightly,  SSI   Chronic HFpEF - Monitor volume status   Prostate cancer - Per history, underwent prostatectomy and artificial urinary sphincter  - continue op follow up   Coronary artery disease - S/p ballooning of RCA 1998 with CABG in 2000. - continue Lipitor, AC, BB, not on AP   Hyperlipidemia - Continue home atorvastatin
This spontaneous report as received from a pharmacist refers to a 64 year old female patient. On 12-OCT-2013 the patient was vaccinated with ZOSTAVAX VIAL 19400 PFU (lot # J004266, exp date 12-JUL-2014) 0.65 ml (dose # unknown), subcutaneous for immunization. Concomitant therapies included SINGULAIR. Pharmacist reported that patient came back to pharmacy today (15-OCT-2013) and reported that she developed swelling, about size of a lemon, redness and itching around injection site (onset date reported as 15-OCT-2013). There were no treatment informations and no labs performed. The patient sought medical attention by spoke to pharmacist. The outcome was reported as not recovered/not resolved. Additional information has been requested.
pt states that she developed a swollen arm and lymph nodes the Sat after the vaccination was given. This lasted several days.  On advice of physician she took Benadryl. The problem was resolved
Severe nausea- unable to eat. Noticed around 30 minutes after the vaccine was given, and did not subside until the next day. Slept for 10.5 hours and woke up with minimal/moderate nausea that disappeared by about 24 hours after injection.
1 of 4 pts vax from the same lot exp an adverse event; pt recv OPV only 13SEP94 @ well-baby visit; 15SEP parent reported that pt had a fever of 103.8; ofc visit 15SEP-nl exam; no med prescribed;
suffered life threatening bilateral pulmonary emboli; acute cor pulmonale; accompanying gastrointestinal; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (suffered life threatening bilateral pulmonary emboli) and COR PULMONALE ACUTE (acute cor pulmonale) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (suffered life threatening bilateral pulmonary emboli) (seriousness criterion medically significant), COR PULMONALE ACUTE (acute cor pulmonale) (seriousness criterion medically significant) and GASTROINTESTINAL DISORDER (accompanying gastrointestinal). At the time of the report, PULMONARY EMBOLISM (suffered life threatening bilateral pulmonary emboli), COR PULMONALE ACUTE (acute cor pulmonale) and GASTROINTESTINAL DISORDER (accompanying gastrointestinal) outcome was unknown.            Concomitant product was not provided by the reporter.  Treatment information was not provided.  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.
Muscle pain and soreness. Mostly in shoulders and back but pain radiates down hips and up into headaches. Treatment has been warm baths, hot compress, and muscle relaxers. Doctor appointment on 10.20.2021. The pain continues regardless what I do.
Patient received adult dose (30 mcg) of Pfizer COVID 23-24 vaccination instead of appropriate pediatric dose (10 mcg)
This spontaneous report was received from a healthcare worker refers to unknown number of patients with unknown demography. On an unknown date, the unknown number of patients was vaccinated with improperly stored M-M-R II (dose, route and frequency were not reported) lot # J003790. No adverse effect reported. On 22-APR-2014, a phone call was placed to healthcare worker. The phone call went directly to voicemail. A voicemail message was left requesting that the healthcare worker return the phone call. Additionally, a request was made for patient identifiers, lot number and expiration date and date of vaccination. On 22-APR-2014, a phone call was received from healthcare worker. The healthcare worker was able to list the vaccines that experienced a temperature excursion. The healthcare worker stated she would do further research and attempt to fax over the list of patients who received the vaccines that had experienced a temperature excursion, by Lot number and also include the date of vaccination. The event temperature recursion experienced vaccine was considered to be not related to PEDVAXHIB. This case is linked to the case # 1404USA010658, # WAES1404USA010659, # WAES1404USA012083, # WAES1404USA012084, # WAES1404USA012085, # WAES1404USA012086, WAES1404USA012087, #1404USA012088, # 1404USA012089 and #1404USA012090 (same reporter link). Additional information has been requested.
Information has been received from a physician concerning a 61 year old white female (131 lbs., 64 inches) with a history of asthma and a penicillin allergy who on 26-JUL-2007 was vaccinated intramuscularly with the first dose of GARDASIL.  Concomitant therapy included estradiol (ESTRASORB), progesterone (PROMETRIUM), fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (+) salmeterol xinafoate (ADVAIR) and albuterol sulfate (PROVENTIL) "as needed".  On 26-JUL-2007 in the evening, the patient experienced an asthma attack.  The patient took some "Preventolin" and had some hot tea and felt better the next day.  The patient recovered from the asthma attack.  On 28-SEP-2007 the patient was vaccinated with the second dose of GARDASIL.  It was reported that the patient did not have any adverse experience afterwards.  Additional information has been requested.
Migraine that didn?t respond to any medications (tried all available) but Imitfex but wouldn?t get rid of it only took it from a 10 to a 5.  Stem cell IV 3 months later finally resolved it.  Also had flu like symptoms for 48 hours and then had an autoimmune response  to the vaccine and all my diseases flared for over a month despite increased prednisone.  My rheumatologist said all his patients had autoimmune responses to the vaccine.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 20-NOV-2014, the patient was inoculated with ZOSTAVAX by a pharmacist as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated at a medical center for a vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
can't lift arm after 2 weeks from pain, swollen since 3 days after vaccine
Rash ?covid arm?  Dr called it cellulitis  Also extremely swollen lymph node in left armpit
Within 1 hr of receiving flu shot, pt. began having severe gas that turned into diarrhea;which is still present 1 month after injection.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the local on a compliance improvement plan and has been reinstated vaccination privileges.