chrisvoncsefalvay/vaers-outcomes huggingface dataset:
p/vax pt devel numerous sx which feels have been triggered by vax including stiff neck & h/a 2 days p/vax w/in next several weeks devel progressive weakness, fatigue, dry mouth, swollen tongue, worsening pre exist palpitations & dizziness;  tingling sensation top of head & toes, swollen abdomen (no pain), occasional diarrhea, tremor, difficulty concentrating, and hair loss. Also c/o occasional knee and thumb pain.
m blood pressure increased and went up very high to 146/106; hive on stomach for one day; headache; red blotch on arm; pressure on back of head; pain in back of eye; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (m blood pressure increased and went up very high to 146/106), URTICARIA (hive on stomach for one day), HEADACHE (headache), VACCINATION SITE RASH (red blotch on arm) and HEAD DISCOMFORT (pressure on back of head) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included CELECOXIB (CELEBREX), LISINOPRIL, WARFARIN, ALLOPURINOL, METOPROLOL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (m blood pressure increased and went up very high to 146/106), URTICARIA (hive on stomach for one day), HEADACHE (headache), VACCINATION SITE RASH (red blotch on arm), HEAD DISCOMFORT (pressure on back of head) and EYE PAIN (pain in back of eye). The patient was treated with SUMATRIPTAN SUCCINATE (IMITREX DF) at an unspecified dose and frequency. On 31-Jan-2021, URTICARIA (hive on stomach for one day) outcome was unknown. At the time of the report, BLOOD PRESSURE INCREASED (m blood pressure increased and went up very high to 146/106), HEADACHE (headache), VACCINATION SITE RASH (red blotch on arm), HEAD DISCOMFORT (pressure on back of head) and EYE PAIN (pain in back of eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
pt recv vax in AM c/o pain around 1PM of same day & next day tx w/APAP; Tuesday PM mom noted whelps/rash approx the size of fifty cents piece around inj site & red swollen area 6-8" in diameter around the rashy area; tx DPH; denied itching
pt states after getting the shot in her right arm then later that evening she developed some itching in right arm, both forearm and upper arm.   The next day both arms were red and itching and as a result from scratching she developed bumps.  The next day she only had these symptoms in her left arm and that night she took a Benadryl.  She says her symptoms are better but still has some redness and slight itching that seems to be improving.  She contacted her PCP and was instructed to take Benadryl as needed.
Pt recvd 3 doses of Engerix-B & 3JAN92 it was determined that pt did not respond to the vax series;
Within seconds of receiving vaccine, I felt like I was going to pass out, nurse instructed me to lie down on table, she left and I passed out.  This occurred probably within 30 seconds total after receiving vaccine.  Ambulance arrived and while being transported to hospital, I felt tingling in hands and fingers and also felt incredibly nauseous. Also felt I was going to pass out again, but didn't.  Arrived at hospital, still feeling nauseous and had many tests.  Due to having a history of seizures and syncope, gynecologist and doctors at hospital dismissed symptoms as being anxious over having shot.  I have given blood several times in the past few years and never passed out from that.  It has been 8 months since vaccine and no other symptoms have occurred.
Patient received his Janssen Covid-19 immunization.   The patient arrived at 11:00am on 6/1/21 and completed his pre-screening questions and temperature check.  The patient then completed his "Patient Questionnaire and Consent Form."  The patient was administered his Janssen Covid-19 vaccine around 11:05am.  About 2 minutes after administration, the patient appeared pale and sliding out of his chair.  The pharmacy technician responded and held the patient under his arms.   The patient  convulsed and then became unconscious.  We called 911, checked the patient for breathing and responsiveness.  The patient didn't stop breathing and became conscious about 1 minute after losing consciousness.  We placed the patient on the floor and placed cold compresses under his neck and on his wrists.  EMTs arrived and evaluated the patient and made sure the patient was stable.  EMTs offered to take the patient to the hospital but the patient declined.
within 5 min after administration of vaccine, around pt eyes became red around eye lid, rash developed over body,
Within 14 hours of receiving flu shot, pt awoke with severe red, swollen, itchy hives from head to toe.
5min heart racing, flushing 20 min rash on chest, dizzy, thirsty Resolved after 1 hr 3 days fatigue Patient reports declined ED at time of reaction
I have been having severe headaches, that have been limiting my activities.   I have also starting having "Hot Flashes" again, since the vaccine.  I am  an active, and I haven't had these issues for at least 12 years when I was going through the post menopausal, time in my life.
Information has been received from an approximately 34 year old female with an allergy to artificial sweeteners who on an unspecified dates, was vaccinated with the first and second doses of Gardasil. The date that therapy was started was "about 6 months prior to receiving the third dose. On 04-APR-2007, the patient was vaccinated with the third dose of vaccine by injection. Concomitant therapy included Yasmin. On an unspecified date, the patient experienced muscle soreness after being vaccinated. On 21-MAY-2007, all three injection sites became visible. The patient thought it might be due to being out in the sun and being involved in physical activity. She sought unspecified medical attention. At the time of reporting, the patient was recovering. No further information was provided. Additional information has been requested.
Felt lethargic 1 day after vaccine.  Broke out with hives 3 days after receiving vaccine - on face, neck and upper thigh.  Self medicated with Benadryl.
Received PREVNAR shot, shortly afterwards felt SOA, chest pressure, dizzy and tired. Tremors. Diphenhydramine 25 mg once, methylprednisolone 125 mg Q week, aspirin 325 mg once.
Injection site soreness; stiff neck and sinus issues; stiff neck and sinus issues; This is a spontaneous report from a contactable consumer or other non-HCP. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced injection site soreness and  stiff neck and sinus issues. The outcome of event was unknown.    No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
MENVEO, vial 1 (Men CYW-135) was not mixed with vial 2 (Men A Lyophilized). Only vial 1 was given.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 29-JUN-2012, the patient was  was vaccinated at physician's office by the physician with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-JUL-2016, the patient was treated for a vesicular outbreak that was diagnosed as shingles. The patient was prescribed valacyclovir hydrochloride(VALTREX), prednisone, and  benzonatate(TESSALON) to attempt to manage and relieve her painful symptoms. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
Information has been received from a physician concerning a 77 year old Japanese female with hypertension and a hx of atrial fibrillation, congestive heart failure, and lung cancer who on 18OCT2003 at 11:30 am was vaccinated SC in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included Procardia, Counadin, Lanoxin and nitroglyceria.
patient became dizzy about 5 minutes after covid moderna in jection and felt a little hot but is much better now
Woke up itching all over, with red rash. Took benadryl. At work approximately 12 hours later began feeling itching, rash in several areas (under breast, waist, around inner thigh, and back. Got home and took benadryl to help with discomfort.
She reports regular menses until this month (April 2023) when she had two almost back to back.  Her menses prior were very regular
she died from a blood clot that ran into her heart; felt very very tired; nauseas for the first couple of days; nauseas for the first couple of daysdidn't eat well for the first couple of days; This spontaneous case was reported by a consumer and describes the occurrence of INTRACARDIAC THROMBUS (she died from a blood clot that ran into her heart), FATIGUE (felt very very tired), NAUSEA (nauseas for the first couple of days) and DECREASED APPETITE (nauseas for the first couple of daysdidn't eat well for the first couple of days) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced NAUSEA (nauseas for the first couple of days) (seriousness criterion death) and DECREASED APPETITE (nauseas for the first couple of daysdidn't eat well for the first couple of days) (seriousness criterion death). On 04-Apr-2021, the patient experienced FATIGUE (felt very very tired) (seriousness criterion death). On 08-Apr-2021, the patient experienced INTRACARDIAC THROMBUS (she died from a blood clot that ran into her heart) (seriousness criteria death and medically significant). The patient died on 08-Apr-2021. The reported cause of death was she died from a blood clot that ran into her heart. It is unknown if an autopsy was performed.            As per source document the patient received the 2nd dose on 4 or 5 April 2021 and she died from a blood clot that ran into her heart on 8Apr2021.  Treatment medication was not reported.  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.  Relevant concomitant medications were not provided by the reporter.; 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.; Reported Cause(s) of Death: she died from a blood clot that ran into her heart
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The patient's pertinent medical history and drug allergies were not reported. On 11-JUL-2016, the patient was vaccinated with improperly stored dose of PROQUAD (lot # I017140 and expiry date: 13-NOV-2016). No adverse reactions were reported. No product quality complaint (PQC) was reported. Additional information has been requested.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021 at 12:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 3:53 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 58.68. Concomitant products were not provided. On 02-Mar-2021 Excursion time was reported at 09 am, 10 am, 11 am, 12pm, 2pm and 3pm with temperature as 27,29,32,33,35and 36 degrees Fahrenheit respectively, total doses given for the day was 177, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 02-Mar-2021. 16 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021. On 30-Mar-2021 Excursion time was reported at 09 am temperature as 33 degrees Fahrenheit respectively, total doses given for the day was 173, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 30-Mar-2021. 03 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
No additional AEs were reported; a patient received less than the recommended dose; it leaked from the needle due to human error; This spontaneous report was received from a pharmacist referring to a patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.     On 21-DEC-2021 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # U010533, expiration date 29-OCT-2022; strength, dose and route were not reported) for prophylaxis, which was less than the recommended dose because it leaked from the needle due to human error during the administration (accidental underdose, needle issue). The pharmacist also stated that some were splashed onto his (pharmacist) skin on his hand (split as another case). No additional AEs were reported.  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2112USA009520:
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. In March 2017, the patient was vaccinated with the improperly stored dose of VARIVAX (dose, route and anatomical location were not reported) (lot # reported as M034485 and expiration date 27-JUL-2018) for prophylaxis. Additionally, a propped stored sterile diluent (manufacturer unknown) (lot # and expiration date were not reported) was used to reconstitute the vaccine.  There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion between 6 to 14 degrees Fahrenheit for 480 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004456: US-009507513-1704USA004454: US-009507513-1703USA013275: US-009507513-1704USA004452: US-009507513-1704USA004453:
Extreme myalgia, diffuse swelling and erythema from upper left arm to left elbow nearly circumferential around left arm. Myalgia near injection site nearly resolved, erythema and swelling unimproved two days post vaccination with myalgia extending down inner left arm to left thumb and left pinky finger.
Left knee swelled up; Burning of throat; Lump in the throat; Stiffness in left knee; felt miserable; This case was reported by a consumer via call center representative and described the occurrence of swelling of knees in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included INFLUENZA VACCINE with an associated reaction of joint swelling (patient received inflenza vaccine quadrivalent 2020-2021 season for tolerance, refer case US2021AMR013009).   On 19th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a week after receiving Shingrix, the patient experienced swelling of knees, burning in throat, lump feeling in throat, stiff knees and feeling miserable. On an unknown date, the outcome of the swelling of knees and stiff knees were not recovered/not resolved and the outcome of the burning in throat and lump feeling in throat were recovered/resolved and the outcome of the feeling miserable was unknown.   It was unknown if the reporter considered the swelling of knees, burning in throat, lump feeling in throat, stiff knees and feeling miserable to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine and felt miserable afterwards.  The patient stated that within a day or two her left knee swelled up, developed a lump in her throat, and there was also burning in the throat.  The patient described the lump as the size of a large grape that was located right in the middle where the Adam's apple would be and that it was no longer there, but it did take a long time for it to go away.  The patient was still had stiffness in the left knee that says was better, but not back to normal.  The patient never had any reactions like this before and was otherwise healthy.  The patient did visit her health care professional where they did an ultrasound and was also sent to an endocrinologist but a diagnosis was never made. The reporter did not consent to follow up. Not all information was available and did not give permission to follow up with their HCP.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR013009:same reporter
Intense anger feelings; Feeling super energized; did not feel completely back to normal two hours after injection; feel super energized yet extremely tired; Had a bad headache; This spontaneous case was reported by a consumer and describes the occurrence of ANGER (Intense anger feelings), ENERGY INCREASED (Feeling super energized), FEELING ABNORMAL (did not feel completely back to normal two hours after injection), FATIGUE (feel super energized yet extremely tired) and HEADACHE (Had a bad headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021 at 10:25 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced ANGER (Intense anger feelings), ENERGY INCREASED (Feeling super energized), FEELING ABNORMAL (did not feel completely back to normal two hours after injection), FATIGUE (feel super energized yet extremely tired) and HEADACHE (Had a bad headache). At the time of the report, ANGER (Intense anger feelings), ENERGY INCREASED (Feeling super energized), FATIGUE (feel super energized yet extremely tired) and HEADACHE (Had a bad headache) outcome was unknown and FEELING ABNORMAL (did not feel completely back to normal two hours after injection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; 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.
pt recv vax; c/o excessive irritability p/ vax;pt only consoled p/ bath,feeding; no fever, lasted approx 48 hr;
Thrombocytopenia, SkinRash, Rash & ElevatedBunSCr Narrative: Petichial rash. Patient had IV contrast dye 1/19 no reaction. Patient on Apixiban for a. fib.
This spontaneous case, initially received on 25-Oct-2016, was reported by a non health professional and concerns a 65-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received Afluria for Flu vaccination from 18-OCT-2016 to 18-OCT-2016. Dose regimen: 0.5mL, single dose, Route of administration: Intramuscular in the left arm. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: Between 21-Oct-2016 and 22-Oct-2016, the patient experienced Complete hearing loss in left ear and it was starting to return (Medically Significant, outcome: Not recovered / Not resolved). Reporter comments: the reporter assessed the event as serious. Sender's Comments: Listedness: Assessment according to the CCDS for CSL's Inactivated Influenza Virus Vaccine, unilateral deafness is unlisted. Causality: Unassessable. Time to onset is within 4-5 days following vaccine administration. However there is insufficient information such as  medical history, concomitant treatment, concurrent illness, investigations into cause of deafness for causal assessment.
At about 24 hrs after vaccine I was running a fever of 103.0, body aches, headache, red sore arm. The next day temp was between 101-102 degrees, felt dizzy and uncoordinated, achy and headache. The following day (today) my temp is hovering around 100.0-100.5 and I?m achy and tired, parts of my lips/mouth feel tingly. Arm is still sore, itchy and very red.
The patient was vaccinated on 7/29/2021 at around 2:45pm. Within 5 minutes of receiving the vaccine, the patient stated that he felt as though he "was going to faint" and started sweating profusely. 911 was immediately called. Continued patient monitoring until paramedics arrived. Patient's pulse was monitored and blood pressure (reported by paramedics) was 90/60 mmHg. Patient refused to be transported to hospital. Patient was monitored at pharmacy until blood pressure normalized and patient was stable.