chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax & devel sz disorder @ 11mos of age; pt presently is 9 yrs old; szs persist & are not entirely controlled by medication; pt has been hospitalized in past for testing (nl EEG); etiology of szs unk;
Customer stated he had shoulder pain that ran down to his hip. Counseled to speak with his doctor.
This case was reported by a consumer via call center representative and described the occurrence of anaphylactic reaction in a 39-year-old female patient who received FLUARIX QUADRIVALENT (batch number 7FF3N, expiry date 30th June 2017). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, 30 min after receiving FLUARIX QUADRIVALENT, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). The patient was treated with EPI PEN, BENADRYL, ZYRTEC and steroids NOS. On an unknown date, the outcome of the anaphylactic reaction was recovered/resolved. It was unknown if the reporter considered the anaphylactic reaction to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient was admitted to the emergency room (ER). The patient stated that no other vaccines were taken that day and all symptoms have since resolved. No further information was reported regarding the event.
Around 1730: Patient was found unresponsive in the bathroom by a patron who alerted PHN. Patient was unresponsive, breathing, and had a pulse. 911 was called for EMS and further medical staff came and patient's head and neck was stabilized. Patient woke up and was A&Ox1, to self. EMS then arrived and transported patient to local emergency department.
Patient's body became covered in hives the next day. Went to the ER where he was treated with oral Benadryl and oral steroids.
Patient reported pain in upper arm, 'all over' and under shoulder of right arm where she had the injection. Pain was intolerable and would wake her up at night. No redness, heat, or swelling at the site. Reported taking IBU & FLEXERIL to no avail.
Patient got a flu shot at approximately 7:45am and by 8:00am was having a reaction. RN gave Benadryl in pill form which did not help. She continually got worse. MD was called and EMS was called. MD ok'd Benadryl, Prednisone and Epi shots. She was transported to hospital as a precaution.
Pt received vaccine and reported feeling flush and shaky. Pt was escorted via wheelchair from a vaccination pod to an observation unit where she was observed and monitored for +30 minutes. Vitals were 114/74, O2 94%, HR 80. Pt reported using albuterol as a rescue inhaler and G Breo regularly.  Pt verified symptoms had subsided and was escorted via wheelchair from the premise.
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium
More than 24 hours after first puncture.; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (More than 24 hours after first puncture.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 031B21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (More than 24 hours after first puncture.). On 23-Dec-2021, EXPIRED PRODUCT ADMINISTERED (More than 24 hours after first puncture.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Neither of the patients had reported any symptoms.
Having tingling sensation on my right hand, starting shoulder and radiating in finger. I am taking Tylenol 500 mcg to relieve pain.  Also as soon as I received vaccine I felt dizzy and felt hot and sweaty. I was given cold water and i felt ok after that.
Patient made an appointment for the COVID-19 vaccine (Pfizer). Patient let us know that he has medical induced anxiety. He has passed out from random medical appointments in the past. Patient was sitting within eye view of the pharmacy. A passing by gentleman said "Dude, are you ok?". I looked over and the gentleman was no longer in his chair. Customer helped gentleman into the chair. The nurse who administered the shot and myself (pharmacist) ran out with the emergency kit. Patient was conscious, but had no color in his face. We gave him water, orange juice, and moist towel for his forehead. Nurse took pulse, it was within normal range. Called 911, EMTs arrived. Patient declined any more help. He walked out of the pharmacy area. Total time of event: 15 minutes.
left lymph nodes swelling; sore; Low grade fever; Injection site swelling; Muscle pain; Joint pain; Chills; loss of appetite; Loss of taste; Injection site pain; Tiredness; Weakness; Headache; This is a spontaneous report from a contactable consumer (patient).   A 62-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6208; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in arm right on 12Mar2021 at 10:30 (at the age of: 62-years-old) as dose 1, single for covid-19 immunisation at hospital. The patient medical history included ongoing arthritis (was diagnosed when she was in her late 30'S), ongoing osteoarthritis and ongoing degenerative joint disease (diagnosed 20 years ago at age 42). She was tested positive for Covid in Dec2019 and on 10Dec2020. She had all the minor side effects except for nausea and site redness. Concomitant medications was not reported. She took medications for arthritis and pain medication. Declines to provide further details. Patient did not receive any other vaccine within four weeks prior to vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect was mentioned as none. Additional vaccines administered on same date of the Pfizer Suspect was mentioned as none. On 12Mar2021, the patient experienced loss of appetite, loss of taste, injection site pain, tiredness, weakness, headache and chills. On 13Mar2021, the patient experienced injection site swelling, low grade fever, muscle pain and joint pain. On 14Mar2021, the patient had sore. On 15Mar2021 the patient experienced left lymph nodes swelling. Caller received the Covid-19 vaccine on 12Mar2021. She had side effects that were bad and did not think she should get the second dose. She had a lot of muscle and joint pain. The next day she was sore. She felt her lymph nodes while reading the paperwork and discovered hers were swollen. The patient clarified that the lymph nodes on the left side were swollen instead of the right side. The outcome of the event low grade fever was recovered on 14Mar2021. The outcome of the event loss of appetite was recovered with sequelae on 15Mar2021 and muscle pain and joint pain was recovered on 15Mar2021. The outcome of the events loss of taste, injection site pain, tiredness, weakness, headache and chills were recovering. The outcome of the events injection site swelling and lymph nodes swelling were not recovered. The outcome of the event sore was unknown.   No follow-up attempts are possible. No further information is expected.
Site reaction/swelling, increased heart rate, increased respiration, rash along legs, belly, chest, neck, face, and ears. Fever of 99-100.3.
PER MOTHER PT HAD TONIC CLONIC SEIZURE LASTING LESS THAN 30 SECONDS. PT WAS DROOLING. HAD POST-ICTAL STATE AFTERWARDS. ONE HOUR LATER HE DEVELOPED FEVER OF 101 F. PT DOES HAVE H/O HAVING SEIZURES IN THE PAST. MOTHER DID NOT TAKE HIM TO ER. HE IS DOING WELL NOW. HE HAS BEEN REFERRED TO NEUROLOGIST SINCE HE HAS NOT FOLLOWED UP IN ALMOST 1 YEAR. THIS WAS OUR FIRST TIME SEEING PT AT OUR OFFICE.
Severe pain at injection site with some swelling, lethargy, and fever to 101.6 degrees F the day after the injection. He was given acetaminophen, which reduced fever to normal. Low grade fever (99-100 degrees F) two days after vaccine.  On the third day after vaccine, on 12/31, he became confused and anxious. Temperature was 104.8 degrees F. He was given acetaminophen and oral hydration overnight. He continued to have a fever to 102 on the following day and was taken to the ED. He was COVID-positive and admitted to the hospital for treatment of COVID-19.
Acute onset of headache vomiting and fatigue about 12 hours after vaccine. No sign of local reaction at site of vaccine. Headache and fatigue and nausea lasted about 72 hours with associated fever to 102 one nosebleed. Seen in office x 2 negative strep normal UA.
About thirty minutes after the vaccine, strong dizziness for about 5 to 10 minutes. It became quickly less prevalent  and mostly went away after an hour. I was glad that I walked back to my school after the vaccine as I had a class 45 minutes after my second shot. Driving would have been impaired for the short amount of time I experienced the dizziness.
severe chills and headache 24 hours after vaccine administered inability to lift arm over head 12 hours after vaccine administered
FEVER 99-102.8. BODY ACHES,CHILLS, MALISE STARTING APPROX 12 HOURS AFTER INJECTION. 20 HOURS AFTER INJECTION - 3 DOSES OF TYLENOL, TEMP 97.8. CONTINUED MALISE AND FATIGUE
headache; Bad fatigue/a lot of fatigue; sore arm/little soreness in the arm; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 38-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot Number: EM9809, Expiration date: 30Jun2021), via an unspecified route of administration, administered in Arm Left on 10Feb2021 (age at vaccination 38-year-old) as dose 2, single for COVID-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot Number: EL324, Expiration date: 31May2021), on 20Jan2021 (age at vaccination 38-year-old), as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 10Feb2021, the patient experienced sore arm/little soreness in the arm. On 14Feb2021 the patient experienced headache and bad fatigue/a lot of fatigue. Caller stated she had a question, stated she got the second dose of the Pfizer vaccine on 10Feb2021, did not feel anything but a little soreness in the arm when she got the vaccine, stated this past Monday, she started to feel like she had a headache and a lot of fatigue that lasted through Wednesday, stated it was a little better on Thursday, and today, Friday, felt a lot better. Caller wanted to know if it was possible to have a delayed reaction to the vaccine. Outcome of the events headache and bad fatigue/a lot of fatigue was recovering and for sore arm/little soreness in the arm outcome was unknown.   No follow up attempts are possible. No further information is expected.
Breakthrough case after three vaccines: Pfizer 2/18/21 Lot# EM9810;  Pfizer 3/10/21 Lot# EN6206;  Pfizer 9/29/21 Lot# EW0150.
Vaginal Bleeding: Menstruation began 1 day after the vaccine, which was normal and expected based on cycle tracking. 9 days after the vaccine I experienced spotting that was random for about 1 week. 21 days after the vaccine I had heavier bleeding (what I consider medium flow) and large blood clots were passed on days 26 and 27 after the vaccine. The blood clots were usually the size of a grape but two of them were golf ball sized, which is unusual for my body. I have bled for a total of 16 out of the 31 days since I had the vaccine. The frequency, amount, and consistency is not normal for my body.
area around inject site lt deltoid red raised, warm to touch almost to elbow; also noticing red, raised area which appear & disappear over entire body; hives subsided 23FEB94;
I have developed a big (3 inch) reddish swelling locally where the vaccine shot was given. I had swinging fever, generalized moderate-sever body ache, particularly back pain.  I developed nausea and vomiting. I went to clinic and they asked me to pay a Co-Payment , and of course, I will pay for the medicine as well, so I refused to be seen by a doctor because buying non inflammatory pain relief medicine is much cheaper over the counter.
In the middle of the night I am waking up feeling dizzy. The whole room is spinning. To the point where I feel like I?m going to black out. Then I am unable to sleep after this happens. Lots of restlessness. I used to sleep 8 hours straight no problem before. I also experienced numbness in my legs during the first 24 hours.
10 hours after second shots : huge fatigue, muscles aches and light headache. Those symptoms faded after 3 days. However the day after the shot, I got my menstruation. It was not the time. I have my menstruation only two to three times a year usually and very light . They last 2-3 days with no pain. One day after the shot, I was bleeding heavily and for seven days . The pain in my lower abdomen was bad.  Once my menstruation stopped that migraine / headache came . It is located right on top of my right eye.  It feels like I bumped my head . The bump has been there for one month now. The migraine comes and goes. I use bc powder for migraine but now even bc powder doesn't come to the end of it. When the migraine is there the whole right side of my skull hurt.
Info has been received from a physician concerning a male who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 641115/1159L). Within 24 to 48 hours post vaccination, the pt developed redness, swelling and pain at the injection site. The pt sought unspecified medical attention. Additional info has been requested.
This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: Apr2021), via an unspecified route of administration on 12Jan2021 08:00 at a single dose on left arm for COVID-19 immunization. Medical history included diabetes, stent, and cholesterol. Concomitant medication included metformin for diabetes, atorvastatin from 2009 (also reported as Jan2020) for cholesterol, ticagrelor (BRILINTA, NDC: 01860776-60, LOT: MM0189, EXP: Apr2023), saxagliptin hydrochloride (ONGLYZA, NDC: 0310-6105-90, LOT: MJ0731, EXP: Feb2023) for diabetes, and terbinafine. The patient experienced felt bad the first day, chills, wooziness/ woozy, felt wobbly all on 12Jan2021. Then experienced feeling like has a big weight on him, blood sugar has been lower than normal, it is usually normal at 110-120, it is lower today at 96/ checked his blood sugar again later and it was 153, which is not through the roof on 14Jan2021, and he is real tired on Jan2021. Patient says he got the Pfizer vaccine, clarified to Pfizer BioNTech COVID-19 vaccine, a couple days ago and the first day he felt bad and had chills and felt wobbly and woozy. He says yesterday (13Jan2021) he felt pretty good, and even worked out. He says he also worked out today, but he has had chills and feels like he has a big weight walking on him, he doesn't know the right word. He says he is also a diabetic, and he noticed today that his blood sugar has been lower than normal, it is usually normal at 110-120, it is lower today at 96. He says he is careful with his diet and eats the same thing. He says he hasn't taken his meds today, and he checked his blood sugar again later and it was 153, which is not through the roof, even without his medication so he would like to know does the vaccine affect your blood sugar? He says he got his first dose of the vaccination on Tuesday at 08:00AM, in his left arm. He clarifies that he has had chills today and then feels like there is a big heavy weight on him, he is real tired and his sugar is low, that was odd. The outcome of the events was unknown.
Redness, swelling lasted 3 wks for lump to go away. After shot around evening time she noticed redness and swelling.
This spontaneous case reported by a consumer, describes the occurrence of increased heart rate (in reference to the heart rate acceleration the caller experienced: "she had for 2-3 days") in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced increased heart rate (in reference to the heart rate acceleration the caller experienced: "she had for 2-3 days"). At the time of the report, increased heart rate (in reference to the heart rate acceleration the caller experienced: "she had for 2-3 days") outcome: unknown. Diagnostic results: On an unknown date, Heart rate: increased (high). Heart rate acceleration. The action taken with mRNA-1273 (Moderna COVID-19 vaccine):  unknown. Concomitant medication and treatment information not provided. Sender's comments: This case linked to MOD-2021-132767 (case for patient first dose), MOD-2021-133049 (case for patient second dose) and MOD21-090778 (E2B linked report). This case also linked to MOD-2021-133270 (patient link).
Flu-like fatigue, slight nausea, all-over achiness - debilitating enough to keep me out of work one day.
Patient rec'd vaccines 7-31-13, returned to clinic 8-1-13 with local reaction (red rash extending from injection site to knee and up thigh) mom states she noticed reaction around 10am this morning. Pt. sent home with Rx ATARAX and instructed to return for follow up 8-3-13.
This spontaneous report as received from a healthcare worker refers to a 9 week old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 01-OCT-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Fever up to 102.2, fatigue for 24 hours, extreme arm soreness on injection side
Erythema multiforme; little itchy; very red rash; extreme rash around both ankles; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA MULTIFORME (Erythema multiforme) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M90A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2021, the patient experienced ERYTHEMA MULTIFORME (Erythema multiforme) (seriousness criterion medically significant), RASH PRURITIC (little itchy), RASH ERYTHEMATOUS (very red rash) and RASH (extreme rash around both ankles). At the time of the report, ERYTHEMA MULTIFORME (Erythema multiforme), RASH PRURITIC (little itchy), RASH ERYTHEMATOUS (very red rash) and RASH (extreme rash around both ankles) outcome was unknown.            Concomitant medications included blood thinner medicine. Treatment information not provided. "Patient had a very red and a little itchy, a few months after he completed his 2 doses of the Moderna Covid-19 vaccine. He got the second dose in March and the rash only started 2 days ago. Patient says he did not have symptoms right after the shots, however he never had this kind of rash before. Patient confirms he did not have fever. Patients says that he looked it up online and says the rash is called Erythema multiforme as the images looked exactly what his rashes are. Patient says he only used a rash ointment and he will see his doctor tomorrow."  Company Comment: Very limited information regarding this event has been provided at this time.; Sender's Comments: Very limited information regarding this event has been provided at this time.
Adult patient received a pediatric dose of Hep B. Health Department notified. Patient notified and informed she needs to come back in to receive adult dose of Hep B per the health department. Patient voiced understanding and will make appointment for vaccine.
09/03/22. bleeding at the injetion site, pain. 09/04/22. severe pain, swollen and redness around injection site of the left arm. limit of motion. 09/15/22. painful and  difficult to lift the arm. 09/29/22. visit Dr. and has been diagnosted with rotator cuff tendinitis or frozen shoulder. treated with steroid injection and advil. 10/19-26/22. severe pain and limitation of motion. visit Dr. and had x-ray, MRI, has been diagnosted with rotator cuff tendinitis, adhesive capsulitis and myositis. treated with strong pain killer, muscle relaxer and physical therapy. untill today no improvment
patient developed tinnitus 3 days after receiving her second Pfizer covid vaccine-  It started in the right ear and several days later also had it in her left ear  It has persisted since April 19 on and off
I lost my sense of taste three days after the shot.  So far it has not come back yet a week later.  I am noticing that I can taste salt now, but that is about it.
Pt vaccinated with DTP/OPV dx to have clinical pertussis with course lasting 4 wks.
Extreme fatigue, sweating, diarrhea, nausea. Lasted an hour or two. Followed by body aches/tired rest of day
Arthus reaction of the left shoulder and systemic symptoms such as body aches and pains, intermittent elevated heart rate and fever.
Sore left arm, sore area under left arm, heart palpitations, light headache, fatigue that began on Friday and lasted through Sunday. Palpitations are intermittent and have improved, but are still occurring on 11/24/2021. I had no reaction to the first two Pfizer shots; not even arm tenderness. Saw doctor on 11/24/2021.
Information has been received from an investigator from GLAXOSMITHKLINE (GSK) BIOLOGICS (manufacturer control # B0465767A) regarding a 24 year old female with bipolar disorder, depression, oedema hands and feet, hypertension, sore throat, hypothyroidism and viral infection with a history of 1 pre-term pregnancy and with a normal birth who entered a GSK clinical sponsored trial. On 09-MAR-2007 the patient was vaccinated IM with a first dose of Gardasil. Concomitant therapy included Ortho Tri-Cyclen, venlafaxine HCl, spironolactone, levothyroxine Na, carbamazepine, ibuprofen, diuretic (unspecified) and amoxicillin. On 09-APR-2007, a pregnancy test was positive. Her LMP was on 04-MAR-2007 and Ortho Tri-Cyclen, was used for contraception until 16-MAR-2007. On 01-MAY-2007 the patient experienced spontaneous abortion at 8.2 weeks of pregnancy. She was hospitalized for 2 days and the event was considered clinically significant. She was treated with dilation and curettage and the event resolved on 01-MAY-2007. It was noted that her partner had no abnormal medical or family history. The investigator considered that there was a reasonable possibility that the spontaneous abortion may have been caused by Gardasil because the patient received the injection within 30 days of the pregnancy. The patient was withdrawn from the study due to the spontaneous abortion and subsequent study administration discontinued. No further information is available.