chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She broke her leg severely in September; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 33 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Mar2021, for COVID-19 immunization. The following information was reported: LOWER LIMB FRACTURE (medically significant) with onset Sep2021, outcome "unknown", described as "She broke her leg severely in September". Therapeutic measures were taken as a result of lower limb fracture. Patient was taking a muscle relaxer, VALIUM, and gabapentin for her leg. She stated she has not had a reaction in the past so she was not sure if she should take those medications that day. She asked if they should apply heat or cold to it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna COVID-19 Vaccine  MUSCLE PAIN-FULL BODY, EXTREME FATIGUE,  HEADACHE, NAUSEA, FEVER (101.0 reduced with 400mg ibuprofenx1).  Symptoms began with muscle pain/fatigue @0600 Feb 10th.  Headache/fever @ 1300 Feb 10th resolved with Ibuprofen, Nausea (mild) Feb 11 for < 4h.  Fatigue lasted from 0600-Feb 10th through roughly mid-day Feb 12th.
p/vax pt exp mild clinical varicella w/about seven pox, a couple of which had blistered;reporter thought spots may have been a result of a bug bite;pt sought unspecified medical attention;
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe
12/30: noticed redness, warmth, soreness to left upper arm (injection site) Since 12/30 to current, the left upper arm is still tender to touch with the same redness. Taking over the counter meds.
Body aches and pain; headache; joint pain; pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the right arm on 23Mar2021 at 11:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes, obesity and high blood pressure. Concomitant medications included metformin (MANUFACTURER UNKNOWN), NEXIUM, LIPITOR, allopurinol (MANUFACTURER UNKNOWN) and MICARDIS. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP3247) via an unspecified route of administration on 04Mar2021 as a single dose for COVID-19 immunisation. The patient did not have any allergies to food, medications, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced body aches and pain, headache, joint pain, pain at injection site on 23Mar2021 at 23:45. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the general body pain, headache, joint pain and vaccination site pain was not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of blackout in a 70-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 20th August 2018, refer case US2018218417). On 30th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 1st December 2018, 1 days after receiving SHINGRIX, the patient experienced blackout (serious criteria GSK medically significant), nausea, pain in arm, headache, excess sweating, fall, blood pressure decreased, pulse decreased and friction burn. On an unknown date, the outcome of the blackout, nausea, excess sweating, fall, blood pressure decreased and pulse decreased were recovered/resolved and the outcome of the pain in arm and headache were unknown and the outcome of the friction burn was not recovered/not resolved. It was unknown if the reporter considered the blackout, nausea, pain in arm, headache, excess sweating, fall, blood pressure decreased, pulse decreased and friction burn to be related to SHINGRIX. Additional information received as follows: The patient stated that in the next morning after receiving SHINGRIX he experienced nausea, pain in left arm and a massive headache. The patient stated that around 10:00 am the day after receiving the 2nd dose, he started sweating profusely and when he attempted to get up from the chair, he blacked out and his wife found him on the floor. The patient checked his blood pressure and it was 92/40 with a pulse of 68. The patient laid down in the bed and 30 minutes later when he rechecked his blood pressure, it was 113/59 with a pulse of 78. The patient stated that later that day (on 1st December 2018), he went to visit his family physician. The patient stated that his physician noticed that he had a rug burn on his left forearm that was approximately 8 inches in length that he developed as a result of him blacking out and falling on the floor. The reporter gave consent to follow up. The emergency room visit was required. The contact details of the physician were provided.
Initial report received from a healthcare professional on 25 JANUARY 2013. A 56-year-old female patient, had received a dose of FLUZONE (lot number, route and anatomical site of administration were unknown) on an unspecified date in the end of SEPTEMBER 2012 at 5:00 PM. The patient had no significant past medical history (PMH). The patient's son was diagnosed with strep throat. The patient's concomitant medication included Amoxicillin which was taken to avoid contacting strep throat from patient's son. The patient had denied any illness at the time of vaccination. On an unspecified date in SEPTEMBER 2012, the patient developed acute cough with shortness of breath and hypertension. The patient went to emergency department for evaluation and treatment. Corrective treatment details were not reported. Laboratory details included allergy tests for antibiotics (Amoxicillin) and protein based foods (Ovalbumin) were performed. All test results were negative. At the time of this report, the cause of the patient's symptoms was unknown. At the time of this report, the outcome of the events was unknown. Documents held by sender: none.
TEMP 101+,  48 HOURS JOINT PAIN, SLEPT FOR TWO DAYS, COULD NOT THINK STRAIGHT, FELT LIKE HAD COVID, HAD COVID IN SEPT. OF THIS YEAR. INJECTION SITE RESEMBLED CELLULITIS, SAW @ DOCTORS OFFICE AFTER DAY THREE. TOOK FOUR DAYS TO START TO GET BACK TO NORMAL. RIGHT ARM REMAINS TENDER BUT RED AREA  RIGHT DELTOID RESOLVING FROM TENNIS BALL SIZED (DIAMETER), INDURATED OUTWARD ~ 1 CM.  FRANK RED.
After receiving the shot in L arm... immediately 1. dizzy and lighthead 2. tingling/numbness in L fingertips  within 30 min 1. numbness on L side of face 2. MD assess weakness on L UE  Next day...continue to feel numbness on L side of face
Bleeding & bruising happened instantly as the injection was given.  Within 2 minutes (walking to the waiting area) she was feeling dizzy.  By the time we sat down she said she felt like she was going to be sick.  She began sweating - it was dripping off her head and neck and her eyes kept closing.  She was extremely pale and her lips were white.  She was like this for approximately 10 minutes.
Asymptomatic: Tested COVID-19 positive on routine admission screening test. Admitted 9/6/2022 following hospital stay r/t GI bleed.
Within 2 hours red circle around/below injection area. 2 night later pink ring around red, raised area. Warm to touch.
General "achiness", then numbness in face.  Physician Visit, DX. Bells Palsy R/T influenza vaccine.
pain; had the vaccination and still got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. In June 2021, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not reported. The patient had a Shingles vaccine and still got shingles about 2 months ago from reporting date. The patient stated that still not over the pain completely. The doctor said they would had been much worse without the shot. The follow up would not be possible as no contact details were available. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule and time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Redness, swelling at site 7.5 cm x 8 cm. Cold compress, BENADRYL.
Check all the documents from VA clinic. Report of confirmed degenerative joint disease, hypertension, Diabetes Type II September 2003. Additional problems include thyroid nodule, gastric reflex, osteopenia, and acne. Receives partial compensation for service related problems.
Patient stated on the evening of 11/19/2015 that her arm felt sore and came back to the pharmacy on 11/21/2015 at 3 PM with pain, redness, and swelling at the injection site. Counseled the patient to take ibuprofen, Benadryl, and to ice the area and to call her physician.  Also advised the patient to seek urgent care if symptoms worsen.
Temp 103 after immunization (11/4/08).  11/6/08 phone call still with fever, headache, eye pain and tenderness @ site.  Offered office visit.
I developed a rash on my arm a week after the 1st dose.  It was itchy and red and about 6 inches long.  It went away gradually after 4-5 days.
On March 27, 2023, I started having a sore throat and I was extremely cold. I turned the heat up all the way and was still shaking as if I was cold. I also couldn't walk or talk normally, but those symptoms only lasted a couple days. My husband managed to make an appointment for us to test at a pharmacy at 10:15am. The doctors wouldn't prescribe Paxlovid because of the medications I was taking so they gave me Tylenol instead. I had a headache, and my temperature was up to 102 degrees Fahrenheit. I also took Dayquil and Nyquil, but I did not take any extra Tylenol after the two I received in urgent care. Then I contacted my hematologist, and then she prescribed me Paxlovid which I started on April 1, 2023. I still take the Nyquil at night at this point. I'm still weak, but I rarely cough. I'm still having to blow my nose. My temperature went away within three days.
Started with burning lips at 1:00 pm (53 hours post shot), took extra Benadryl at bedtime.  Woke up 6:00 am next morning (Good Friday) with palpitations and shortness of breath.  Allergist couldn't get me in, Internal Med doc's on call nurse practicioner told me to go to ER.  Called hospital covid hotline and was told symptoms were not a known reaction to the vaccine.  Self-treated as if it was an allergic reaction with an existing prescription of prednisone.  I  had these symptoms 24 years ago  after 2 Epi pens in one week reacting to allergy immunotherapy shots.  Had full cardio workup then with no problems noted.  Last heart stress test early 2018, no problem.
Swollen Lymph nodes; Nerve pain comes and goes throughout the body.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Aug2021 11:00 (Lot number: FA6780, Expiration Date: 30Sep2021) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gluten" (unspecified if ongoing); "Dairy" (unspecified if ongoing); "Egg yolks" (unspecified if ongoing); "Sulfonamides" (unspecified if ongoing). There were no concomitant medications. The following information was reported: NEURALGIA (non-serious) with onset 08Aug2021, outcome "recovering", described as "Nerve pain comes and goes throughout the body."; LYMPHADENOPATHY (non-serious) with onset 09Aug2021, outcome "unknown", described as "Swollen Lymph nodes". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of neuralgia.  Additional information: No other vaccine was given in four weeks.No other medications were given in two weeks: No. The patient did not had covid prior vaccination. The patient did not tested for covid post vaccination. the patient was queried: The Pfizer Drug safety unit recently received the attached report submitted by you via [Website Name] Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events. The patient responded the patient first became aware of nerve pain symptoms on 09Aug2021.  No follow-up attempts are possible. No further information is expected.
1/20/22     C/o body ache,  since yesterday ,  cold chills, fever ( 100.9 ) fatigue , headache ( hx of migraine ha ) ,slight    St ,   dry cough  ,  X  today   Pt states she  Started with  Migraine headache   Early this am-patient states she has frontal ha -patient states pain level from a headache is about 10/10 /patient states her  headache  Is as with light sensitivity /patient states sometimes headache is associated with nausea and vomiting but she does not have any nausea vomiting today.
SWELLING IN BOTH ANKLES; SWELLING IN FEET; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included bee string allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A2LA, and batch number: 042A2LA expiry: UNKNOWN) dose was not reported, administered on 15-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-JUL-2021, the subject experienced swelling in both ankles. On 15-JUL-2021, the subject experienced swelling in feet. Laboratory data included: Blood pressure (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in both ankles, and swelling in feet. This report was non-serious.
Patient had PO dose of Rotateq #1 and mom nursed immediately after within 4 hours of administration her nipples - very red, painful - developed mastitis. Put on antibiotics.
Nausea, vomiting, vertigo, syncope, chills, headache, body ache
EAR INFECTION; TOOK ANTIBIOTIC WHILE ON VIVOTIF; This spontaneous case (PVX2019-1306) was received from a nurse on 23-May-2019. It describes a 19-year-old adult female consumer who developed ear infection, after the administration of oral Vivotif (one capsule every other day) for typhoid prophylaxis. She also "took amoxicillin while on Vivotif" for ear infection.  Case report: The consumer started taking Vivotif. Later, she developed ear infection, so she started taking amoxicillin for it and stopped taking Vivotif. She would complete amoxicillin course on 28-May-2018.  The nurse reported that she was better now, and she did not take any other medication.  Action taken with Vivotif with respect to the event ear infection was dosage discontinued while with respect to the event "took amoxicillin while on Vivotif" was not applicable.  Action taken with Amoxicillin with respect to the event ear infection and "took amoxicillin while on Vivotif" was not applicable.  The consumer started recovering from the event ear infection while the clinical outcome of the event "took amoxicillin while on Vivotif" was unknown.  The reporter considered the event ear infection unrelated to vaccine.  Company's Comment: In this case, the patient developed an ear infection after receiving Vivotif vaccine. Since ear infection is an infectious condition the causality of the event was assessed as unlikely with Vivotif. The causality of the event "took amoxicillin while on Vivotif" was considered as not applicable. ; Sender's Comments: Company's Comment: In this case, the patient developed an ear infection after receiving Vivotif vaccine. Since ear infection is an infectious condition the causality of the event was assessed as unlikely with Vivotif. The causality of the event "took amoxicillin while on Vivotif" was considered as not applicable.
bleeding/I bled without end/more serious bleeding events; passing blood clots as big as tennis balls; had cramps that lasted 72 hours; Maternal Exposure During Pregnancy; This is a spontaneous report from a contactable consumer. This consumer reported information for both mother and fetus/baby. This is a mother report. A 36-years-old pregnant female patient received second dose of bnt162b2 (BNT162B2; Batch/Lot Number: ER8735), via an unspecified route of administration, administered in Arm Right on 03May2021(at the age of 36-years) as single dose for COVID-19 immunisation. Medical history included anxiety, irritable bowel syndrome. Concomitant medications included minerals nos, vitamins nos (PRENATAL VITAMINS) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication, start and stop date were not reported. The patient received first dose of BNT162B2(lot Number: EW0153), via unspecified route in right arm, administered on 12Apr2021 at 05:00PM as single dose for COVID-19 immunization. The patient experienced had cramps that lasted 72 hours, bleeding/i bled without end/more serious bleeding, passing blood clots as big as tennis, maternal exposure during pregnancy. Clinical course was reported as I had a subcorionic hemorrhage during my pregnancy. 25 hours after first vaccine I had severe cramping pain that felt like labor and went to the ER for a major bleeding event. The evening of my second vaccine I had cramps that lasted 72 hours and the next two days I had to wear pads because of bleeding. The following weekend I bled without end, checked in to the hospital Sunday night. I continued to have more and more serious bleeding events passing blood clots as big as tennis balls until Monday I has emergency c-section to deliver at 24 weeks. 4 weeks later our preemie baby died in the NICU. The patient was hospitalized for muscle spasms, hemorrhage, thrombosis for 12 days. The mother reported she became pregnant while taking bnt162b2. Last Menstrual date of the patient was 23Nov2020. The mother was due to deliver on 05Sep2021. The patient did not have covid prior vaccination. The patient tested for covid post vaccination. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 17May2021 Nasal Swab. Therapeutic measures were taken as a result of adverse events as bed rest, Magnesium. The outcome of the event maternal exposure during pregnancy was unknown and rest all events were not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100987373 Same reporter/ drug for different patients (baby)
Immediately after the injection I did not feel well. I felt like my post vaccine effects were more significant than anyone else. I was out of it and extremely fatigued. I couldn't get out of bed. My rosacea flared up and it was my whole face. My food sensitivities are way more sensitive now. I have itchy scalp. I am allergic to chicken now, whether it is being cooked or eaten, I have a mass cell reaction to it. Heart palpitations. I am more anxious and allergic to things all the time.
I had odd cold sore like break out on cheeks next to my lip.; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 17Mar2021 16:30 (at the age of 43-year-old) as dose 1, single for COVID-19 immunization at hospital. Medical history was none. There were no concomitant medications. Patient's known allergies was none. The patient did not receive any other vaccine with 4 weeks prior to the vaccination or other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that after the first dose, he had odd cold sore like break out on checks next to his lip. This about 5cm break out and lasted a few days on an unspecified date. The patient did not received any other treatment for the events. Outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
pt recvd vax; pt exp fever, convulsions & respiratory problems; pt had lose of appetite; pt also had rash & swollen on body;
There is a red 4-inch circle where I got my vaccine.  There is no pain or itchiness, so I didn't even know it was there until I noticed it after a bath.  I told my brother about it and he said it was called "covid arm" and only appears with a Moderna vaccine, which is what I had.  I read about it and it suggested I get my second shot in the other arm. I also read it will disappear with time so if that is true I am not concerned.
Worsening of tinnitus. Already had mild case with a high pitched sound in both ears, but mostly my left. About a day or so after 1st phizer shot the volume and intenity of tinnitus increased. Also added a lower octave static like sound in left ear that was not there before.  My 1st shot was March 17 about 9:30 am. My ears still ring almost 2 1/2 weeks now with the increased intensity. Afraid to get second shot, which I am supposed to get on Wed Apr 7.