chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash; constant runny nose; pain in the ear; shortness of breath; torn labrum; clicking sound in the hip joint; chest pain; cold infection; This is a spontaneous report from a contactable other HCP and a consumer. A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on Apr2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Ibrance 125mg tablet by mouth daily for 21 days on and 7 days off in conjunction with femara (letrozole) as prescribed by MD. Patient reported after the start of therapy patient received covid 19 vaccination. Second dose was received in Apr2021. Since vaccination patient has been experiencing a rash, constant runny nose, pain in the ear and shortness of breath (date of onset not provided). Reported on an unknown date in May2021 patient was seen by an orthopedic specialist for a torn labrum and clicking sound in the hip joint. An unknown injection was given to help with symptoms. Symptoms have now resolved. MD aware. Patient was seen in the emergency room "about 2 and a half months ago" due to shortness of breath and chest pain (date of onset unknown). Patient received multiple tests - chest x-ray and covid 19, which all came back unremarkable. Patient was diagnosed with a cold infection and was placed on prednisone, doxycyline, and cough syrup with codeine. Therapy was placed on hold "about one month". Symptoms still persist and MD was aware. The events reported as other serious (Important Medical Events). The outcome of the events rash, constant runny nose, pain in the ear, shortness of breath, chest pain, cold infection was not recovered, of other events was recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events rash, constant runny nose, pain in the ear and shortness of breath, chest pain are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. However, The event s torn labrum, joint clicking and cold infection are most likely related to inter-current condition, thus unrelated to the suspect drug.  This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
On 9/8/2022 pt received both Fluzone HD and the Pfizer bivalent vaccines at around 1:30pm and reported no side effects. On 9/9/22 he states that at 6:30am he woke up and started having some vertigo. He also said that he was feeling fatigued and was trying to take some steps and tried not to fall forward. Pt took ondansetron and has been feeling better. Has been resting in his chair since time of call at 10:00am.
Rt. thigh site infected, on ABT for infection.  Very red, swollen, central papule with 1 vesicle, s/ itches of erythema.
died p/being hospitalized for interstitial pneumonia; day p/vax felt SOB & started to cough; 5OCt admitted;
pt recv vax & pt eyes rolled back & body went out in, supine position, pt appeared to lose consciousness, but no ER required;pt conscious w/in a few seconds;
approx 36 hrs p/vax pt had limp, pale episode, breathing stopped off & on never turned blue; no fever taken to ER:
a 3-year-old received Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number Y297N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th April 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 6th April 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 07-Apr-2022 Reporter's Comments: The reporter stated that a 3-year-old patient received Kinrix.  The reporter consented to follow-up. Additional Supportive Information: The reporter stated that a 3-year-old patient received Kinrix, which led to inappropriate age at vaccine administration.
Administered covid bivalent unnecessarily. The FDA pulled the bivalent covid vaccine from the market in the middle of my daughter's vaccination. My daughter received the first dose of the covid bivalent vaccine and we schedule her second. Our appointment for the second dose was canceled a few days prior because the FDA pulled the bivalent vaccine from the market without any recommendations or alternatives. As parents we have been trying to do what is best for our daughter, but the government makes it tougher and tougher. We wanted to get our daughter vaccinated finally and tried, as that is the suggestion of most doctors and the government so why would they pull the vaccine from market and not allow children in the middle of vaccination to receive their second or final doses and get fully vaccinated. This is ridiculous isin't something better than nothing. Further the newest vaccine is not available and is not yet fully tested, but approved only for emergency use for children. To make it even worse the FDA made these changes and has never tested the effectiveness or safety of administering the bivalent vaccine with the newest vaccine so you have no clue whether or not this will increase any risks or whether it will be effective at all. This is sad, what type of circus is being run. No common sense. Our daughter today has also missed her window to get a second dose as it should be administered within 8 weeks, but who can we complain to...the government. Our daughter continues to be a high risk for covid going into the fall and unable to get fully vaccinated because the FDA does not know what they are doing. What a joke!
-Rash, swelling, warm (left arm) around site of injection (appears as mild case of shingles). Started within 24 hours after vaccine; still present 4 days later.
15APR94 onset of diarrhea & fever (101 to 102) 16APR94 diarrhea fever, vomiting, red blotches sx gave by afternoon 17APR94; 18APR94 red blotches reoccurred; appt made to see MD today; 3PM 18APR94 telephone call from parent saw MD;
I experienced very heavy bleeding on days 2 and 3 of my menstrual cycle and some irregular light bleeding between cycles.
Fatigue all week, dizziness, site tenderness that spread into abdomen.  Ultimately today 04/18/21,  I was forced to seek medical attention after hyper elevated blood pressure (212/138), disorientation,  and severe headache. I tested positive for Covid-19 after rapid test, contrary to negative EKG, labs, x-ray and urinalysis for other conditions.
AFIB; This is a spontaneous report from a contactable consumer (patient). A 76-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in Arm Left on 15Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 15Feb2021 (Batch/Lot number was not reported) for covid-19 immunisation. Concomitant medications included valsartan (DIOVAN) taken for an unspecified indication, start and stop date were not reported; clonidine (CLONIDINE) taken for an unspecified indication, start and stop date were not reported; carvedilol (CARVEDILOL) taken for an unspecified indication, start and stop date were not reported. The patient experienced afib (resulting in hospitalization) on 15Apr2021 with outcome of unknown. The patient was hospitalized for afib for 3 days. The adverse event resulted in Emergency room/department or urgent care, Hospitalization. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown on Nasal Swab. Therapeutic measures were taken as a result of event (Medication blood thinners, BP meds). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
It's listed in the notes that are attached. I had tetanus vaccine 01August 2020 and had an adverse reaction. Patient had a HA August 1, 2020 at clinic. I had a tetanus vaccine shot that was due and had in injected on my left arm that day. As far as I remember, I've never had a reaction like I did this vaccine. The next day my arm was little sore and I expected it to be. I did have tingling sensations a couple of days after the shot and didn't think much of it. At times it felt like it was falling asleep. My arm felt a little stiff but nothing I couldn't handle. The week went by and my arm persisted. It wasn't until August 8 on a Saturday that my lower back on the right side began to cramp and tighten up. I had difficulty touching my toes and putting on my socks and shoes. The next three days got worse. I had trouble getting out of bed. It would take me a few minutes to get warmed up in order to put my clothes, shoes, and move around. I had trouble squatting. I would get cramps on my lower right back and couldn't squat all the way down. I almost went to the doctor, but I was going to see if it would get better by Wednesday August 12. On August 13 I was going to participate in a exercise that was on August 14 and 15. My back got a little better and I was able to walk and put on my shoes with some pain. At the exercise, I met a healthcare worker. She was in the medical center where I participated earlier that month. I told her about my incident, and she told me that I need to document this and see a doctor. I asked her if it had to be a specific doctor and she said no. I could use my doctor in my hometown. So, Monday August 24, 2020, I went to the healthcare clinic and saw Dr. I told him about my issue and that I need to be examined and have documentation in case this tetanus had given me bad side effects. He examined me and took blood and urine samples. He also suggested to be checked from the COVID 19 virus. The samples and tests were done. The results were given to me Friday August 20, 2020. I was tested negative on the COVID 19 virus and the rest of the blood and urine samples seemed normal. My back has almost zero stiffness and my arm has slight tingles now and then. I'm documenting this so that it can in the medical record in case I may have re-occurring effects in the future. I will be at work until December 31, 2020 with the COVID 19 mission. I'm ready to get back into exercising like before and teaching. I will keep physically fit as much as I can. This was a very unusual experience because this has never happened to me before where I cannot move or do any form of hard exercise unless I'm very hurt or very sick.
This child had an area 2 1/2 x 3 1/2 erythema initially, then it increased to 3 1/2 x 4 1/2, no itching at visit on 01/15/01. At visit on 01/17/01, redness greatly faded, still can see a shadow of reaction. Never complained of muscle pain. Treated with Keflex for 2 days.
Information has been received from a physician and a consumer concerning the consumer's 31 month old daughter with no known drug allergies who on 03/22/2001 was vaccinated with varicella vaccine in the right thigh. At the time of vaccination, the pt had an upper respiratory infection and "adenitis." The pt's mother reported that about one week after, she took off the pt's bandaid and there were "2 small red hard bumps where they gave the shot." She reported that about two weeks later "it's not red now and the bumps are nearly gone." In follow-up, the physician's office reported that the onset was 04/10/2001. The physician's office reported that the pt's mother called and was told,to apply ice at site of injection, if continues to break out to call for appointment. In follow-up, it was reported by the physician's office that the pt recovered.
Miscarriage of pregnancy. 11/30/09 Medical records from OB office received for DOS 11/19/2009  Presented with vaginal bleeding and cramping. G 1, P 0, 5 weeks gestation. DX: Abortion spontaneous/complete
Following vaccine, given left thigh 8/30/2006 RTC on 9/1/06 with erythematous, tender, indurated left ant thigh area at least 10x12cm, uncharacteristically beyond localized inj site reaction. Tx Keflex antibiotics, warm compresses, re evaluated 9/5/06 Asymptomatic.
RAISED RASH DOWN ENTIRE ARM WITH ITCHING.  PATIENT DESCRIBED AS MANY MISQUITO BITES OR A CONTACT TYPE RASH
Headache, nauseous, dizziness, 101 degree fever, body aches
Severe chills - vomiting - aches and pains diarrhea - light headed.
Information has been received from a registered nurse concerning a 21 year old female patient with no allergies or drug reaction history, who on 31-JUL-2008, was vaccinated with the first dose of GARDASIL (lot number # 660557/0072X) (route not reported). On 24-MAR-2009, was vaccinated with the second dose of GARDASIL (lot number # 660616/0570X) (route not reported). On 23-MAR-2011, the patient was vaccinated with the third dose of GARDASIL 0.5 ml, intramuscular, (lot number # 667194/1081Z exp date unknown). There was not concomitant medication. On 24/MAR/2011 the patient developed headache, fever and dizziness. It was noted no laboratories were performed. At the time of the report the patient was not recovered. The patient contacted the office by phone. Additional information has been requested.
feels sick to her stomach/pretty sick; arm pain, can't even touch it; upset stomach; arm  is very sore; chills; it wasn't a good reaction; was in bed all day and the next day; could not function; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (feels sick to her stomach/pretty sick), PAIN IN EXTREMITY (arm pain, can't even touch it), VACCINATION COMPLICATION (it wasn't a good reaction), MOBILITY DECREASED (was in bed all day and the next day) and DECREASED ACTIVITY (could not function) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 015M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (it wasn't a good reaction), MOBILITY DECREASED (was in bed all day and the next day) and DECREASED ACTIVITY (could not function). On 02-Dec-2021, the patient experienced ILLNESS (feels sick to her stomach/pretty sick), PAIN IN EXTREMITY (arm pain, can't even touch it), ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (arm  is very sore) and CHILLS (chills). At the time of the report, ILLNESS (feels sick to her stomach/pretty sick), PAIN IN EXTREMITY (arm pain, can't even touch it), VACCINATION COMPLICATION (it wasn't a good reaction), MOBILITY DECREASED (was in bed all day and the next day), DECREASED ACTIVITY (could not function), ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (arm  is very sore) and CHILLS (chills) outcome was unknown.            No concomitant medications were reported No treatment medications were reported It was reported that patient had a little bit of problem before with Moderna about a year ago.   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2021: Non significant follow up received, contains No new information On 08-Dec-2021: Followup information received  Added new events pretty sick, it was not a good reaction, was in bed all day and the next day could not function.
This spontaneous report was received from a registered nurse via pharmacist via office manager refers to a 04 year old male patient. The patient's relevant medical history and concurrent condition were not reported. On an unknown date, patient was vaccinated with first dose of VARIVAX injection (lot number and dosage not reported). On L035127 (expiry date: 14-SEP-2017) (dosage not reported), which had previously undergone a supported temperature excursion. Concomitant therapies included M-M-R II, it was administered but according to the prescribing information it never left proper storage conditions (negative 58 to positive 46 degrees Fahrenheit). It was unknown if there was any relevant laboratory data. As of 04-MAY-2016, it was unknown if the patient continued to take VARIVAX and the outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Solid red oval going 3cm laterally each way from injection site, and 5cm above and below injection site. Heat and minor swelling around injection site. Pain in armpit, almost unnoticeable while resting. upon raising armpit pain worsens. Swelling in the armpit as well. Headache. (NO fever).
Very sore arm and hot to the touch.  The muscle (deltoid?) felt very tight, like the size of a tennis ball.  My head felt like it was on fire, however, I never broke out in a sweat.  During the night of February 25th, I had chills.  I awoke every hour to hour and a half.  I took one Tylenol before going to bed, then another at 3:30am.  Also, during Friday, Feb.26, I took 1 Tylenol about every 4 hours, which helped.  I felt tired/fatigued during the 26th, but not the kind of tiredness from lack of a good night's sleep.  During the night of Friday, Feb.26th, I had night sweats and chills.  On the evening of Feb.26th, after I ate dinner, the left side of my mouth began to swell.  I took a Zyrtec to counteract the allergic reaction.
Received adult dose of Hep B when he should have received the pediatric dose.  No physical side effect symptoms occurred.  This was a booster vaccination as he did not have immunity from previous series.
Patient was in the observation area after his second Pfizer COVID-19 vaccine dose.  Shortly after, patient was observed to be shaking and then fell out of his chair and hit his head on the ground.  Patient sat up immediately afterwards.  Patient was coherent and able to respond to questions when addressed by the healthcare team.  Patient was diaphoretic and was bleeding slightly from injury on his head from falling.
Dizziness, Headache,  WARM ALL OVER, ROOM MOVING, FELT HEART BEAT , LIGHTHEADED Narrative:  1550-SYMPTOMS STARTED 20 MINUTES AFTER INJECTION.PT SEEN BY AGENCY MD. RESTING ON A MONITOR. VITAL SIGNS ALWAYS WITHIN NORMAL LIMITES OF 114/91-88-20-100%. 1630- PER EMPLOYEE "I FEEL A LOT BETTER" ONLY A LITTLE LIGHTHEADED. 1700-EMPLOYEE D/C HOME WITH PARENTS. EMPLOYEE HOME TODAY DUE TO HEADDACHE AT 0300 TODAY.  Other Relevant History:
S.ymptoms: fever 2/14, 2/15  Muscle back pain severe 2/15, Diarrhea 2/14,2/15.  Weakness, tired 2/14, 2/15, 2/16, 2/17
Leg of the injection site broke out in bright red hives that were more than 2 inches away from injection site. Symptoms have remained to date (5 days), with color of breakout turning from bright red to pale gray. On second day post-vaccine, patient was mildly lethargic.
01/13/2022: Event occurred after 2nd vaccine.   78-year-old female who presents to the emergency department with COVID.  The patient states that she called EMS because she was getting readings in the 70s on her pulse ox at home.  She does not normally wear oxygen.  She does wear CPAP at night.patient states she has been sick for the last 2 weeks.  She had an outpatient test that was positive for COVID.   She has had a cough.  She denies any nausea, vomiting or diarrhea Continue with albuterol, Remdesivir, Decadron 6 mg daily
Mother states 4 x2 inch redness of left arm on 4/9/08.  States pain from shoulder to elbow with tender to touch until 4/12/08.   Ring effect redness on lateral side of Lt arm.  Kept child awake at night. Seen by family physician on 4/10/08.  Benadryl and ABT prescribed.
Client age 18y 9m, given an adult dose of Hepatitis A. No adverse reaction noted.
pt recv vax 21NOV96 & 26NOV96 pt devel a rash @ inj site w/5-10 small bumps;it was noted that rash did not seem to bother pt & was not itchy or painful;
I became severely nauseated, lost my appetite for 3 days but I had to force myself eat in order to take the antibiotics my Dr prescribed. Sinuses became infected, urine changed color from lite yellow to dark brown, my body ached so badly, severe headaches, terrible chest congestion and severe coughing, eyes felt like they wanted to bulge out of the sockets because they hurt so bad.
Patient is a new resident at a facility.  Patient consented initial COVID dose and wanted the CDC COVID CARD.  Even discussed initially she isn't a witch and knows about these things.  Per Interim director she stated initial check in database showed never received.  When processing database doses it was noticed using the wildcard patient has 2 accounts and received 2 doses of Pfizer COVID in March 3  and March 24 20201 - database ID created by the HCF and spelled patient first name when her real name is spelled differently.  Logged COVID Moderna dose under database ID and administered as 1st dose moderna 3/28/2022  It is possible this isn't the patient as well. But needed to document in case