chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial solicited report received on 10 August 2018 from an investigator participating in the study. This case involves an 11-week-old male subject who developed congestion and breathing problem during the study participation. The subject's medical history was not reported. The subject's concomitant therapies were not reported. On 23 July 2018, seven days after receiving an intramuscular dose of blinded therapy in the upper right thigh (dose number: 1367126), the subject developed congestion and breathing problem. The subject also received non-investigational products i.e. an intramuscular dose of PENTACEL in the upper left thigh (batch number: C5461AA), an intramuscular dose of PREVNAR 13 in the lower left thigh (batch number: T88778), an oral dose of ROTATEQ vaccine (batch number: N021101) and an intramuscular dose of ENGERIX B in the lower right thigh (batch number: 52X7T) on 16 July 2018. The event appeared after visit 1. On an unspecified date the subject was hospitalized. The event was MAAE. The lab data was not reported. The subject had no corrective treatment. The event congestion and breathing problem was resolved on 09 August 2018. According to the investigator, the event was not related to the study vaccine or trial procedures. Relationship to non-investigational products according to investigator: not reported. Relationship to investigational product according to company: not reportable. Relationship to non-investigational products according to company: not reportable. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by sender: none. Sender's Comments: Follow-up information received on 08 September 2018: A 11-week-old male subject who developed congestion, seven days after receiving a dose of study product. Based on the available information, the sponsor assesses the event as not related to study product or trial procedure, in agreement with the investigator.
numbness on left side described as stroke like symptoms/ ruled out for a stroke; paresthesia; Chest discomfort; could be inflammation of her muscles; Headache, after the second vaccine; Nausea; This is a spontaneous report from a contactable consumer (patient).  A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in arm left on 15Apr2021 16:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and investigation assessment was reported as none. Concomitant medications included ongoing products for birth control from 2 years ago. No prior vaccinations within 4 weeks. No patient medical history and family medical history relevant to events. No relevant tests. No additional vaccines administered on same date of the Pfizer suspect. The patient previously received first dose of BNT162B2 in left arm on 18Ma2021 16:00 and experienced headache and nausea. The patient experienced headache on 16Apr2021 6:30 am and nausea on 16Apr2021 in the afternoon. She had to go to the emergency room yesterday. Patient had numbness on left side described as stroke like symptoms and paresthesia on 20Apr2021 9:30 am, went to the urgent care first, and they wanted her to go to the emergency room. She was ruled out for a stroke, after they did some testing. They could not diagnose her, so they referred her to a neurologist. She has heard the name Bell's Palsy, when she was on the internet. On 20Apr2021 9:30 am she also felt chest discomfort when she went to the emergency room and in the morning today, but they thought it could be inflammation of her muscles. They gave her methyl prednisone and she still had chest discomfort, but it was not as bad. She was noting improvement. She was released from the emergency room. Events numbness and chest discomfort required a visit to emergency room. Outcome of the events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
sx started w/in a few hr of vax 20MAY97? 6PM? high pitched scream-inconsolable, will not eat;mom called 22MAY no elevation of temp;
Second Pfizer Covid vaccine received 4 February 2021, later she had dental surgery, a post was placed (to prepare for implant), Eliquis was held for 2 days prior and then restarted post procedure, and shortly thereafter she noted acute onset of severe left calf pain  Further work-up revealed 7 May 2021 ultrasound showing acute occlusive deep vein thrombosis of the left calf and paired peroneal veins without extension to the femoral or popliteal veins  Ultrasound 16 August 2021 showed persistent occlusive DVT in one of the left peroneal veins, a second peroneal vein is now patent with improvement in thrombus burden  Due to age greater than 90, and weight less than 60 kg with recently having held Eliquis for her dental procedure (also recently having received Covid vaccines) she was continued on 2.5 mg twice daily Eliquis.
Mild Headache lasting 4 days. Increase in perceived volume of previously existing tinnitus (doubling of volume, has not changed since  shortly after the 2nd shot)
Pt had  the second Pfizer covid shot Mid April.  By end of April, he was starting to put out very Dark urine which I think because was accumulating bilirubin in his system.  Two weeks after that started to notice that he was Jandiced.   I saw him in the Emergency room on May 30.  Hi Bilirubin total was 20.   He had Cat Scan of the abdomen reveiling dilated intrahepatic ducts.  He had a MRCP,  by the GI doctor .  had a swelling or tumor at the out flow to the intrahapatic ducts.   Brushings were taken.  Brusings were taken an examination under microscope.   Some atypical cells that were but no mention of cancer.  These same cells sent for staining to an outside lab.   With the stain they were favored, but not definatly called cancer cells.    At the time that I saw the pt,  his impression ( the pt ) was that his new symptoms were a direct result of having the Pfizer Covid shot.
Received first dose of Moderna on Sunday, January 17, 2021 around 11:00am, no reactions to the vaccine that day. On Sunday January 24, 2021 at 6:15pm, noticed at the injection site a big fist size red itchy rash. The rash is very hot and itchy, must be a slowed allergic reaction the the vaccine.
limited use of shoulder; This case was reported by a consumer via interactive digital media and described the occurrence of joint range of motion decreased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced joint range of motion decreased. On an unknown date, the outcome of the joint range of motion decreased was not recovered/not resolved.   It was unknown if the reporter considered the joint range of motion decreased to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got the Shingles vaccine over 2 years ago (the day before reporting) and still had limited use of shoulder. The patient asked so weigh your opinions. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Some injection site discomfort in first 12 hours.   24 hours later increasing headache that became severe and lasted for two days. ( I am not prone to headaches,  just mild sinus discomfort or slight hangover from alcohol)    This headache was much worse.  Arm pain increased as time progressed and spread farther in arm and even neck and lasted for 5 days.   I felt tired for about 5 days.  I had some mild headaches more than normal after the five days and until present.  Added note.  I don?t get sick often.  I worked as a flight attendant for 28 years and exposed to lots of whatever.  I don?t get sick with more than a little cough or something but never miss work.  I felt pretty bad for 5 days after this vaccine.
Information has been received from a physician concerning a 14 year old female with no pertinent medial history or drug reactions/allergies, who on 17-AUG-2006 was vaccinated intramuscularly with HPV rLI 6 11 16 18 VLP vaccine (yeast) (lot#653650/0702F).  There was no concomitant medication.  On 17-AUG-2006, 15 minutes after receiving the vaccination, the patient "passed out" in the car on her way home.  The patient was driven back to the physician's office, where she "woke up and was given soda and cold compresses".  There was no reactions at the injection site and the patient had no additional reactions.  Additional information has been requested. 01/05/2007 Initial and follow-up information has been received from a physician concerning a 14 year old female with no pertinent medical history or drug reactions/allergies, who on 17-AUG-2006 at 10:00 AM was vaccinated intramuscularly in the arm with the first dose of GARDASIL (lot # 653650/0702F). There was no concomitant medication and no illnesses a time of vaccination. On 17-AUG-2006, at 10:10 AM, the patient "passed out" in the car on her way home. It was reported that following vaccination, the patient went to her car and as her mother was driving, the patient passed out. The mother drove right back to the physician's office with the patient, and the patient was carried into the office by a physician at which time she was awake. The patient lied down and was given soda and a cold compress to her forehead. It was reported that the "patient was only out a matter of 2 minutes before coming to". There was no reaction at the injection site and the patient had no additional reactions. No further information is expected.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On an unspecified dates, the patients received an improperly stored doses of ROTATEQ orally (dose was not provided) (lot number: K007244, expiration date: 16-MAR-2016; J015689, expiration date: 11-NOV-2015; K016261, expiration date: unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Developed 101F fever, painful right arm, malaise 2 days later. Went to UC 6 days later and diagnosed with cellulitis. BACTRIM and Cephalexin have helped cellulitis to resolve, but continues to have 5/10 right deltoid pressure/pain.
I don't know if this is an adverse effect or something that has just happened. I have two masses/lumps under my left arm (near the breast) and am going for further evaluation (mammogram and ultrasound) on June 29, 2021.
High Fever; chills; cough; vomiting; Pneumonia; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 23May2021 18:00 (at the age of 59 years old), dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the has not patient been tested for COVID-19. On 26May2021 15:00, the patient experienced high fever and chills, cough and vomiting. He reported to his doctor. Chest x-ray on 09Jun2021 showed Pneumonia. Pneumonia was reported to have lasted more than 30 days and not getting better. A CT scan was done on 09Jun2021 and waiting for report (unknown results). The adverse events resulted in doctor or healthcare professional office/clinic visit. The adverse events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered.   Information on the batch/lot number has been requested.
The mRNA Moderna vaccine triggered an HSV-2 outbreak.  My first vaccine shot was May 6th, I experienced an outbreak at the end of May and have been experiencing monthly outbreaks since my first Covid /Moderna vaccine.  I previously experienced outbreaks 4 times a year.
I have been getting hives ever since my second dose. Every day at the same time, my torso and back break out in hives. Although I do have allergies, this event is new. I have take Benadryl everyday to relieve the hives. Taking Beanadryl on a consistent basis has caused my blood pressure to skyrocket and I am now unable to control my blood pressure unless I cease taking Bemadryl. If I stop taking Benadryl, the hives remain making it impossible for me to sleep at night and causes excessive and untolerable itching.
p/recvd vax pt mom noticed rash on neck & chest; notified MD who suggested oral anti histamine for itching & call if sx worsened 22DEC92; 23DEC92 to MD dx german measles prob secondary to the MMR;
Site: Bruising at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
15AUG92 t103-104, rash starting on head &progressing downward, h/a given APAP; 17AUG92 visit MD t103, >=pulse 110; scattered red papules; 21AUG pt adm to hosp-pt comatose;
About 5 days after the vaccine I felt dizzy and I still feel dizzy at day 15 after my vaccine on March 25; I felt tired next day; My left arm was sore; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 25Mar2021 at 13:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. The patient had no known allergies to medications, food or other products. Concomitant medications included erenumab (AIMOVIG) for an unspecified indication, from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021, the patient felt tired the next day and left arm was sore. On 30Mar2021, at 20:00, i.e. 5 days after the vaccination the patient felt dizzy and at day 15 after vaccine the patient still felt dizzy. The patient was concerned about dizziness. No therapeutic measures were taken as a result of reported events. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures, which included nasal swab test (rapid test) on 06Apr2021 and tested negative. The clinical outcome of the events patient felt tired, left arm was sore and patient felt dizzy and at day 15 after vaccine the patient still felt dizzy was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
shortly after receiving the vaccines I got a tingly sensation starting from my left arm, up into my shoulders and it traveled all the way down my spine where it caused me to not be able to stand or walk and my heart started irraticly beating and pounding in my chest.  Thankfully there was a doctor there with her mother getting vaccinated and she watched me for about 20 minutes or more until the feelings passed. It was VERY scary!!!  I thought I was being paralyzed!!!
feverish; terrible headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and headache. On an unknown date, the outcome of the fever and headache were unknown.   It was unknown if the reporter considered the fever and headache to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had a bad reaction, feverish and terrible headache but this one was a little different. For the tolerances of 2nd dose, refer case US2019AMR220078, reported by same reporter for the same patient.
broke out with red itchy welt of the injected (left) arm /  similar welt on his right arm; broke out with red itchy welt of the injected (left) arm /  similar welt on his right arm; This case was reported by a consumer via call center representative and described the occurrence of erythema urticarial in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (mild case).   In September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, several days after receiving Shingrix, the patient experienced erythema urticarial and pruritus. On an unknown date, the outcome of the erythema urticarial was unknown and the outcome of the pruritus was recovered/resolved.   It was unknown if the reporter considered the erythema urticarial and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The reporter did not provide lot or expiry date.  A couple of days after the receiving the shot ,the patient broke out with a red itchy welt of the injected(left) arm. The size of the welt started as quarter sized and grew to 3 inches. A couple days after that he developed a similar welt on his right arm which also started as quarter sized and grew to 3 inches. Both areas had resolved, but on 3rd February 2021 after having a blood pressure cuff squeeze his left arm he developed a small welt again. The patient's physician had advised not to get the second Shingrix shot.  The reporter did not consent to follow-up. This case has been linked with US2021029247, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021029247:same reporter
It almost kill me/I'd rather be dead than to deal with this; When I get up, I feel like I'm wearing a suit made of lead; It was sickening.; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (It almost kill me/I'd rather be dead than to deal with this), DISCOMFORT (When I get up, I feel like I'm wearing a suit made of lead) and MALAISE (It was sickening.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (It almost kill me/I'd rather be dead than to deal with this), DISCOMFORT (When I get up, I feel like I'm wearing a suit made of lead) and MALAISE (It was sickening.). At the time of the report, FEELING ABNORMAL (It almost kill me/I'd rather be dead than to deal with this), DISCOMFORT (When I get up, I feel like I'm wearing a suit made of lead) and MALAISE (It was sickening.) had not resolved.        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.   No concomitant medication was reported. On 28-Mar-2021, patient got 1st shot of vaccine. It almost killed him. It ruined patient's life. Patient stated vaccine facility owe him 10 million dollars for what they did to his life. Patient used to be a triathlete just 3 days before. Nobody was trying to fix them & help them. They just want to take money from the government. It was sickening.  No treatment information was reported.
Isolated redness of nose, mouth, and inner ear, nose running, 10ml Benadryl given PO 3:30pm. No difficulty breathing, no swelling of mouth or tongue.
I got the vaccine and didn't have any side effects until 7 or 8 days later, at night i felt my arm itch when I woke up I had a 6 inch raise and growing and hot to touch. I saw my primary doctor about 12 hours later and was on steroids for 12 days and went away quickly after i started it was 10mg start it was a taper pack started at 60mg. Within the first 24 hours of being on them the rash went away and i had no complications on my second does.
Pt presented to ED on 8/24/21 with complaints of shortness of breath and falls. Tested positive for COVID-19 on 8/24/21. Progressive respiratory decline in ED requiring intubation .  Currently in ICU on mechanical ventilator and receiving remdesivir and dexamethasone
The first night I experienced chills.  The next day I had muscle aches and symptoms similar to having a kidney stone.  I  felt constipated.  Overall I was miserable.   After 48 hours all symptoms had subsided and the following day were gone.
Injection site pain persisted for about 5 days, with a red raised patch about 5 inches by three inches around site. On Saturday morning (vaccination was Thursday afternoon) I woke with bright red patches on neck, inner arm, under breasts.   Not highly itchy; hot and slightly swollen.  Look just like "Hives" similar to those I got previously with ibuprofen, and after some foods, possibly shrimp and fish.  Improved by topical antihistamine cream and by 25 mg benadryl at bedtime on first day of symptoms; took 25 mg three times on second day of symptoms and repeated application of antihistamine cream.   Fading by Tuesday, no longer visible by Thursday.
Pt. was given Dtap vs. Tdap or TD booster after an updated vaccine was needed.
PATIENT CAME IN REQUESTING THE UPDATED MODERNA VACCINE AND WAS ADMINITERED MODERNA BIVALENT VACCINE 02/13/2023. HOWEVER, PATIENT WAS ALREADY ADMINISTERED WITH THE MODERNA BIVALENT BACK IN 09/2022. IN TOTAL THE PATIENT DID RECEIVED 2 MODERNA BIVALENT DOSES (09/2022 AND 02/2023).
Breakthrough COVID confirmed by PCR; Breakthrough COVID confirmed by PCR; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 11 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17Jan2022 (Lot number: FE3594) at the age of 11 years as dose 3 (booster), single, administration date 02Jun2021 (Lot number: EW0179) as dose 2, single and administration date 14May2021 (Lot number: EW0179) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Feb2022, outcome "recovering" and all described as "Breakthrough COVID confirmed by PCR". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Feb2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. No covid prior vaccination.  No follow-up attempts are possible. No further information is expected.
Employee reported on 4/16 that after receiving the J&J vaccine she was having uterine contractions and pelvic pain. She went to her primary which put her on baby aspirin. Employee then called out for chest pain on 4/20. She went to the ER on 4/19/21 . ER stated she did not have a blood clot and it was muscle related. She was put on medication. She was put out of work for 3 days. Upon her return on 4/23 she returned to work and stated she was advised by her primary to get an MRI.