chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The night after the covid vaccine, the patient started experiencing left-side facial numbness and tingling of the V2 and V3. Patient also started experiencing ear pain. Patient also had uncontrollable drooling and dry eye. The next day, the patient went to work and there the adverse events started worsening. Patient went to the ER and did a full workup. CT scan to rule out stroke and full blood work. As per the neurologist (MD), patient is developing mild Bell's Palsy. No course of treatment was given.
Flu symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced flu symptoms after vaccination and asked if could take ibuprofen.
Patient was administered vaccine on 09/26/2012.  By night time (several hours later), she experienced a swollen arm that she could not lift, was dizzy and disoriented.  The following Saturday she was seen at a local urgent care clinic and was diagnosed with cellulitis and was prescribed cephalexin and steroids. She saw a resolution of symptoms by Monday.
Accidentally left Vivotif unrefrigerated for three days and then took two doses of unrefrigerated Vivotif on consecutive days; Accidentally left Vivotif unrefrigerated for three days and then took two doses of unrefrigerated Vivotif on consecutive days; Spontaneous report received on 24AUG2020.  Based on the information obtained from the female consumer two individual case safety reports 20000452SP (wife) and 20000453SP (husband) were created and cross-linked in the database.  The female consumer reported that she "accidentally left Vivotif unrefrigerated for three days and then took two doses of unrefrigerated Vivotif on consecutive days" (PT: Product storage error/Inappropriate schedule of product administration). She was receiving Vivotif (lot number: 3003320 and expiry date: Nov 2020) for immunization. She stated that Vivotif was left unrefrigerated for three days (Tuesday to Friday) at 72-degree Fahrenheit. She put back Vivotif in the refrigerator on Friday. Later, she took two unrefrigerated doses of Vivotif on consecutive days that was on 22AUG2020 and 23AUG2020, respectively. Action taken with Vivotif with respect to the reported events was not applicable. The outcome of the reported events was unknown.  Company Comment: A consumer accidentally left Vivotif unrefrigerated for three days and then took two doses of unrefrigerated Vivotif on consecutive days (product storage error, inappropriate schedule of product administration). Vivotif should always be stored in the refrigerator at the recommended temperatures and should be taken every other day. The causality of product storage error, and inappropriate schedule of product administration is assessed as not applicable to Vivotif due to the nature of the events which were due to human error.; Sender's Comments: A consumer accidentally left Vivotif unrefrigerated for three days and then took two doses of unrefrigerated Vivotif on consecutive days (product storage error, inappropriate schedule of product administration). Vivotif should always be stored in the refrigerator at the recommended temperatures and should be taken every other day. The causality of product storage error, and inappropriate schedule of product administration is assessed as not applicable to Vivotif due to the nature of the events which were due to human error.
No other AE reported; The product was stored outside of the recommended storage range and administered to patients; PROQUAD administered to an adult patient over the age of 13 years; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided.  On 02-JUN-2021, the patient (reported as adult and over the age of 13 years)  was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status rHA) (dose and route of administration not reported, lot # T028139, expiry date reported as 15-APR-2022 but upon internal validation established as 15-FEB-2022) for prophylaxis(inappropriate age at vaccine administration). The administered dose of vaccine was stored outside of the recommended storage range, in temperature of 43 degree Fahrenheit (F), for 21 days (product storage error). Digital data logger was not involved. The vaccine did not experience any previous temperature excursions. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA003759: US-009507513-2106USA003760: US-009507513-2106USA001912:
Initial misuse report received from a nurse on 11 November 2013. The 2 months old patient had received 0.25 ml FLUZONE. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
pt claims cont to have pain of shoulder lt upper arm, not elbow lower arm & middle/ring finger lt hand;
41F rec'd second dose of Moderna 4/30/21 Took APAP 650 x 6 tabs over 8 hrs following vaccine for side effects  Presented to ER on 5/3/21 with labs notable for AST/ALT 7000/2800, INR 9, lactate 14  Elevated LFTs at baseline in setting of 4 glasses wine/d Also on adderal at baseline for ADHD No other medications/herbals/drugs  underwent liver transplantation on 5/8/21 for acute liver failure Pathology findings below Recovered following liver transplantation  explant and clinical picture otherwise consistent with Tylenol toxicity except that the dose of Tylenol was below the usual threshold that would lead to acute liver failure.  Patient is inquiring whether ALF was a result of vaccine
My first shot was May 4, 2021. After the first shot I had chest pains but they went away. After the second vaccine I was okay for about a day. June 2-3 I experienced strong chest pains. It was very severe that I felt pressure close to my heart, and this is why I went and sought care from a doctor. I have been having chest pains for about three weeks now.
Worsening left shoulder pain/discomfort, unable to do full ROM. Patient has done active ROM exercises with no positive effect. Has taken Tylenol as directed with minimal effect. Patient is planning on seeing primary provider some time this week. 4/26-Patient states she may not get an appointment with MD until next week.
Patient waited in parking lot 15-20 minutes .  She noted a headache when she got home.  About 3 pm she developed tingling in her face and lips (lasted 3-4 hours), increased heartrate (lasted about 3 hours), increased blood pressure (for about 2 hours),  The next day she noted dizziness and weakness, lower extremity redness (redness lasted about 3 days).
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 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03May2021 as dose number unknown, single (Lot number: ER8736) at the age of 36 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative; (May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: I tested negative after finishing the Paxlovid treatment. Four days later I had a sore throat and had a positive COVID test again. It is 3 days later and I still have cold symptoms. No other medication in 2weeks.  No follow-up attempts are possible. No further information is expected.
Patient started by having fever, chills and vomiting. The next day, he started having chest pain and shortness of breath. Mother took him to Urgent care and then was asked to go to the ER. He was admitted to the ICU for positive cardiac inflammatory markers and diagnosed with Myocarditis.
Case number# PHEH2016US027892, is a report initially received from a consumer (patient) through phone via a Patient Oriented Program on 26 Oct 2016. This report refers to a 77 years old female patient. Historical condition was not reported. Current condition included heart block. The patient was polymedicated. On 03 Sep 2016 the patient was hospitalized due to heart block and had a stent placement. The patient received ENTRESTO 24/26 mg for the treatment of an unknown indication in Sep 2016 at a dose of 50 mg, Q12H (oral) during the hospitalization. 08 Sep 2016, the patient was discharged. The patient reported that she was very happy with the ENTRESTO and does not feel that she had been experiencing any side effects. The patient received Influenza Virus Vacc Seasonal Inn on 16 Sep 2016, (route: injection NOS). Patient was advised by her doctor to get flu shot because he said that she may not survive if she catches the flu. On an unknown date, the patient developed flu symptoms off and on (influenza) and cough. Patient reported the same to her physician who prescribed her Azithromycin 250 mg, a cough syrup with codeine, and prednisone 10 mg. After about two days, getting the flu shot the patient began to feel nauseous. Patient reported that she does not feel well (malaise) and was having a hard time with her appetite (decreased appetite) and has not been eating much just drinking a lot of water and juice. Therapy with ENTRESTO was ongoing. The outcome of the events was unknown. The seriousness of the events was not reported. Seriousness assessment of the event, influenza (medically significant) was upgraded based on the information available in the source documents. The consumer assessed influenza as not suspected to treatment with ENTRESTO and was reported as suspected to Influenza Virus Vacc Seasonal Inn. Follow up report received from a consumer (patient) through phone via a Patient Oriented Program on 10 Jan 2017: Added co suspect drug (Influenza Virus Vacc Seasonal Inn), medications (azithromycin, prednisone, codeine and Vitamin A, D, E), events (cough, malaise and decreased appetite), history (heart block) and procedure (stent placement).
headache; ear neck back pain; ear neck back pain; ear neck back pain; chills/shivers; sweaty; nausea; vomiting; diarrhea; dizzy; weak; sore muscles; heavy feeling in both arms; tingling in lower legs; This is a spontaneous report from a contactable Nurse reported for herself. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, EK5730), intramuscular on 21Dec2020 08:30 AM at single dose for covid-19 immunization. Vaccine location was Right arm and it was the first dose. The COVID-19 vaccine was administered at Hospital. Medical history included rheumatoid arthritis and high blood pressure. Concomitant medication included quetiapine, metoprolol succinate, cyclobenzaprine, levothyroxine, omeprazole, tofacitinib citrate (XELJANZ). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's Known allergies included Iodine, Morphine. The patient experienced headache, ear neck back pain, chills, shivers, sweaty, nausea, vomiting, diarrhea, dizzy, weak, sore muscles, heavy feeling in both arms, tingling in lower legs on 21Dec2020 11:00 AM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date in Dec2020.
Initial report received from a healthcare professional on 30 November 2012. A 73-year-old male patient, whose date of birth, medical history and concomitant medications were not reported, received a dose of FLUZONE HD (lot number, route and site of administration were not reported) on an unspecified date. This patient is a doctor. On an unspecified date, the patient presented fever, malaise and dehydration. Corrective treatment and laboratory investigations were not reported. The patient outcome was not reported. Documents held by sender: none.
Fever (101 - 102.6 occurred 18 hrs after vaccination, lasting 2 days), headache (12 hours after vaccination, lasting 4 days), swollen gland in L arm (24 hours after vaccination, lasting 6 days), body aches, chills, exhaustion, and loss of appetite (12 hours after vacc, lasting 3 days)
This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. On an unknown dates the patients were vaccinated with improperly stored PEDVAXHIB (dosing regimen unspecified) (lot # L030870, expiry 10-JUN-2018). Excursion details are as follows: which were exposed to the following conditions, were administered to unspecified patients: temperature: 31.55 F, Time frame: 45 seconds, there was no previous temperature excursion, It was call because of a data logger. No adverse effect reported. No further information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Onset of fever, generalized aching 24 hour after vaccine given.  Vomited 2 day after vaccine given.
16 SEP-started to get upset stomach 17 SEP- upset stomach 18 SEP- lwr abd cramps, nausea, vomiting, diarrhea, chills, elev temp  19 SEP- lwr abd cramps, nausea, diarrhea, chills,  20 SEP- lwr abd cramps, some diarrhea, seen by doc with dx of viral syndrome- sick in quarters x 1 day. 21 SEP- back to normal 22 SEP- 1st solid stool -AM
Information has been received from a physician concerning herself, an approximately 36 year old female with no known allergies and no medical history, who on an unspecified date in 1996, when she was a resident, was vaccinated with two doses of varicella virus vaccine live (Lot number not available). There was no concomitant medication. The physician reported that recently she was tested and was found to be "titer negative". No additional information was provided. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
Received call from doctor's office at 15:25 on 9/29/00, stating that pt was in the ER having seizures. ER staff stated that mom stated that about an hour after returning home, the baby was making funny noises and jerking all over. After grabbing him up, he starting crying, after calming him down, she laid him down and he started jerking again and called the EMS. EMS stated that when they arrived "the baby was screaming his head off." The pt was admitted to the hospital for observation. No fever reported. He was dismissed from the hospital on 9/30/00.
lit ref-- pt noted arthralgias, lt sided hemi-hypoesthesia, unstable gait & cerebral vasculitis 7 days p/vax;tx=for 2mo w/ methylprednisolone &cyclophosphamide;hypoesthesia  of 2 fingers remains;authors conclude "vaccine-induced vasculitis"Annual follow-up received on 11/27/00 provided no additional data.
Pt stated day 9, wound swelled-10cm patch of "purple" and 30cm patch of "red." Purple patch resolved redness worsened to cover entire anterior and medial thigh. Pt stated L groin lymphnodes were swollen but resolved yesterday. At 1000 L thigh ulceration 1cm with eschar, 27cm of erythema, pos l linguinal tender lymphadenopathy. At 1200 pt returned with rapidly spreading erythema; medial protion spread 10cm over two hours.
Swelling with a red rash and pain and itching, area 5 square inches.
On 2/3, I started to feel an ache in my left armpit, as if I had pulled a muscle. Added to that on 2/4 was an ache and heaviness to my upper left arm. Added to these 2 symptoms on 2/5 was a small light rash that I noticed around 6:30am. This rash grew in size and became hot around noon. I saw my PCP around 4pm on 2/5. After I was examined, it was determined that I was having an allergic reaction at the site of the injection. I was prescribed Amoxicillin-Clav 875-125mg and began taking in the evening of 2/5. The symptoms began to decrease within 36 hours. As of today, 2/11, the rash on my upper arm is barely visible. I will finish the full amount of antibiotics by Friday 2/12.
Woke up in Cold sweat the night after receiving shot. Sore arm the following day. Tested positive for corona virus 01/06/2021
Patient received a dose that had already expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 21-week-old male patient who received DTPa (Infanrix) (batch number 49tm3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st May 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 31st May 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 31-MAY-2022 Reporter's comment The registered nurse reported that the patient received a dose of Infanrix that had already expired. The reporter did not consent to follow-up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: The patient received Infanrix which was already expired, which led to expired vaccine used.
BODY ACHE; INSATIABLE THIRST; FEVER; BAD HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: UNKNOWN expiry; UNKNOWN) dose was not reported, administered on 28-MAR-2021 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. On MAR-2021, the subject experienced body ache. On MAR-2021, the subject experienced insatiable thirst. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, insatiable thirst, fever, and bad headache on 30-MAR-2021. This report was non-serious.
(R) arm became red and swollen. No fever, chills or other constitutional symptoms noted.
Within one minute of receiving the vaccine, I lost consciousness/ passed out. When I came to, it took me awhile to realize where I was and what had happened. I was alone in the room. I eventually realized that I was sweating profusely as of water have been poured all over me, something I have never experienced before. Then I began vomiting violently. I couldn't move because I kept almost passing out and I continued vomiting. The two vaccine workers kept wanting to call an ambulance for me but I didn't see what an ambulance could do for me and it was hard to respond to them. I could not get up or move myself or leave the store by myself. After about a half-hour I contacted my sons to come to the store and help me. When my son's arrived, approximately 15 minutes after all of my Adverse Events began, they helps me out to the car in the parking lot and I continued vomiting violently, even on the drive home. Once at home, I took anti nausea / anti vomiting meds and after an hour or two I could sit up and sip water. By that night, I had fevers and the continued throughout the night along with a migraine like headache. The next day continue taking the anti-nausea meds but I still was not able to move around or eat and I had fevers add headaches severe muscle aches and soreness throughout the day and the next night. For the next several days, I was no longer taking the anti nausea meds and I just constantly felt like I was going to pass out and vomit. It felt like all the blood had been drained from my face. It was hard for me to sit or stand or walk around. I tried to work remotely but even just sitting up in my home to a computer was very difficult. I felt dizzy and light-headed and nauseous constantly. On a Thursday, the 10th, I suddenly became very cold and chilled even though I had not had a fever that day. I laid down on my bed with a blanket to try to warm up but my teeth were violently chattering and my hands and feet were ice cold but profusely sweating like nothing I've ever experienced on my hands and feet. My arms and legs started shaking so badly it was more like Tremors bordering on convulsions. It was a very scary and I would have gone to the hospital but I could not safely drive. This lasted about an hour and after it went away, it never came back. I last had a fever on Sunday, the 13th. It was approximately 101. I have not had a fever for a headache after that day but I still felt light-headed and nauseous until June 18th. I have been feeling basically normal since the 18th. I am hopeful that I will not have any more effects but I'm wondering how and where I should report any others?
Patient experienced level 10 pain (on the numeric pain scale) 10 days after receiving the shot. For two weeks the patient was not able to lift arm over his head. Shooting, electric like pain would come and go over the next 3-4 weeks. The intensity of pain would fade over the course of approximately 6 weeks. By 12/13/18 the patient was back to normal and has not reported any symptoms since then.
After a fews days of taking the vaccine he started feeling bad. His heart rate was going up he had the feeling of being light headed and about to pass out. He was taken to the ER and admitted on 2/23/21
Swollen Lymph node on my left collar bone.  DIdn't notice it for a few days but it lasted about 2.5-3 weeks. Was about the size of a large marble. I was worried about getting second dose then I noticed that people had this as a common side effect on their collar bone. I was very sleepy the day after the shot and very foggy.  I didn't wake up until 10 AM and then worked until about 1230 PM then went and laid back down. It wasn't for several days until I noticed the lump on my collar bone.