chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diarrhea/ loose bowel movements; depressed; does not feel well; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). a 73-years-old female patient received BNT162B2 (pfizer-BioNtech covid-19 vaccine, formulation solution for injection, batch/lot number was not reported) via intramuscular, administered in arm left on 03may2021 at 12:00-13:00 as dose 2, single dose for covid-19 immunization (at the age of 73-years-old). Medical history included ataxia, which was a genetic abnormality, diagnosed 5 years ago she got the diagnose but she had symptoms since 2008 and irritable bowel syndrome which was diagnosed prior to receiving the vaccine and patient upped her medication for that because her system is being irritated. The patient's concomitant medications were not reported. the patient previously received first dose BNT162B2 (pfizer-Biontech covid-19 vaccine) on an unspecified date, as single dose for covid-19 immunization and received flu vaccine on Feb2021 for flu vaccination. It was reported that on 03may2021 patient received second dose of vaccine and stated that on 04may2021 she experienced diarrhea/loose bowel movements, was depressed and does not feel well. the patient stated that after receiving vaccine she was having diarrhea, no ER or physician's office required. She stated that she had a family physician visit on Friday after the vaccination and she said she had diarrhea that had not stopped. Her doctor told her to go to the ER. she told her it was not that bad and did not go. she has irritable bowel syndrome, and she upped her medication for that because her system is being irritated. it helped somewhat. she was still having loose bowel movements and it was not watery or explosive but just draining. she was getting depressed and she does not feel well and has been drinking lots of fluids so that she does not get dehydrated. She mentioned that she was diagnosed with irritable bowel syndrome prior to receiving the vaccine. The medication that she increased was dicyclomine 10 mg capsules. She stated it was in a pharmacy vial and she does not have a lot or expiration. She just empties the bottle into another bottle and no longer has it. The count size was 270 capsules. There was no seal on the bottle and she would be willing to send a sample. She has a new bottle, but she has not used any out of them yet. She gets them from (pharmacy name) and they get from different placed. The directions are for her to take one 10 mg capsules three times daily. She was now having to take 4 pills daily and that has helped somewhat. instructions on bottle say she can double dose with acute episodes. She has not doubled it, just taken an extra dose. product strength and count size dispensed was 10mg, 270 count. The outcome of the event diarrhoea was not recovered and outcome was unknown for rest of the other events.  Information on the Lot/batch number has been requested.  No follow-up attempts are possible. No further information is expected.
Fever,  headache , body aches, tried  Ibuprofen and acetaminophen  lots of rest.  Lasted about 36 hours
No signs or symptoms reported; temperature excursion on PROQUAD that was administered; This spontaneous report was received from the medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 21-APR-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (1 time dose), lot number T027115 and expiration date of 07-FEB-2022 for prophylaxis (dose, route of administration and anatomical location were not reported).  Administered dose of vaccine experienced temperature excursion of 6°F to 14°F (13.8°F) for 1 hour 45 minutes 0 seconds; 15°F to 46°F( 14.5°F) for 2 hours 30 minutes 0 Seconds, with a time frame of Time frame: 4 hours 15 minutes 0 seconds. No signs or symptoms were reported. Data logger was not involved. There were no previous excursions reported.  This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA007568: US-009507513-2104USA007341: US-009507513-2104USA007516: US-009507513-2104USA007569:
Pain in the arm dow to fingers for 2 days. Fever on day 2 to day 4. Headache that was from day one and has not left.
PT complained of chest pressure, not feeling right. PT was found to have rapid heart rate in the observation room post vaccine.
Went on cruise 11/06 felt sick began feeling sick 11/05 took home test 11/08 morning with positive result of covid, 11/08 went to minute clinic prescribed Lagevrio,  11/14 symptoms subsided.
Woke up in the middle of the night with some common side effects like chills and aches, but the part that worries me is that I feel like there are bugs crawling all over my skin and I?m really scare. I can?t get comfortable and although I?m exhausted, I can?t sleep because of this feeling.
Pain in (R) arm, pt was stuttering and ditzy. Pt. seen at a chiropractor's office, because of all the pain. 8/23 Pt. Mom states arm feels heavy, ditzy, stuttering, running a temp. 100.4.
Patient is a previously healthy 16 year-old M presenting with acute onset chest pain, shortness of breath, nausea, vomiting, malaise, fever and myalgia to ED on 5/6/2021 at 20:44.  He started experiencing symptoms on 5/6/2021 morning a t06:07 AM.  He received his second dose of  Pfizer COVID-19 vaccine on 5/4/2021 10:: AM.  In the ED, CBC, CMP and UA was within normal limits. EKG at 20:46  and again at 21:14 showed  ST segment elevation in inferolateral leads with possible myocardial injury, ischemia or pericarditis.  Troponin 0 hour was 835 and at 2 hours 1674.  Patient was admitted to the PICU for further evaluation and management. Echo on 5/6/2021 showed normal LV systolic function with SF 31%  . Cardiac MRI on 5/7 showed contrast enhancement of inferolateral wall consistent with myo-pericarditis with small pericardial effusion.  Troponins were trended every 12 hours and plateaued in the 1800's on 5/8/2021. Patient was diagnosed with acute myo-pericarditis. Respiratory viral PCR and COVID-19 PCR on 05/06/2021 were negative. Thyroid studies were normal. ANA titer is pending. Viral serology for HbsAg was negative and HIV was non-reactive. Results for additional viral serologies for Coxsackie viruses, EBV, CMV and HHV6 are awaited. Patient was treated with  NSAIDs and Colchicine. IVIG was not given based on clinical judgement. Pediatric Cardiology was involved in patient's care and clinical decision making. Patient remained hemodynamically stable on room air throughout his PICU course. He was discharged on 5/9/2021 with Pediatric Cardiology outpatient follow up in 2-3 weeks. He will continue Ibuprofen 600 mg every hours and Famotidine 20 mg 2 times daily until his follow up.
1. 6:30 PM: Started getting chills. 2. 8:30 PM: Evolved into shaking, chills, could not get warm, bones ached, ears hurt, severe headache.  Note:  The patient did not take his temperature. 3.  Between 12 AM and 2 AM symptoms did not improve.  Patient took 2 tablets of Tylenol 650mg ea. 4.  Around 3 AM all symptoms resolved except for Headache.  Patient fell asleep. 5. When patient woke up at about 8 AM on 12/23/15, all symptoms were resolved.
Dose was administered 2 days earlier than allowed  on day 15 vs day 21.
Within 15 minutes, light headed and slight nausea, deeveloping small rash on right arm Within 60 minutes,  migraine, nausea, slight chest pain, HBP, fever Within 8 hours, migraines, nausea, body aches, fatigue, fever With 24 hours, migraines, nausea, body aches, fatigue,on/off fever
At 2:35 pm, patient fainted. His friend caught him and called me over as the patient had slumped over in his chair. Patient regained consciousness quickly, after around 30 seconds had passed (2:36pm). Patient stated that his ears were ringing and that he felt nauseous. He recalled feeling a cold flash prior to fainting. Per the patient, this was his first time receiving a vaccine of any type. He had never fainted before. Patient stayed an extra 10 minutes in addition to the 15 minute wait and was given water. He was able to leave on his own.
From initial information received on 12/9/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that an 11 month old female patient received her first dose of FLUZONE, lot number U1468AA, administered in the left thigh, a dose of MMR, lot number 0313P, administered in the right thigh and a dose of VARIVAX, lot number 1350N, administered in the left thigh on 12/3/04. The routes of administration were not reported. Two days later, on 12/5/04, the patient experienced a febrile seizure. The patient's body temperature at the time of the seizure was unknown as per the reporter. The patient was hospitalized for three days and discharged on 12/8/04. The patient has recovered from this event.
A non-serious spontaneous report of administration of expired FLUMIST was received from a registered nurse concerning an 11-year-old female patient. Neither relevant medical history nor concomitant medications were reported. On 01-Sep-2009, the patient received FLUMIST that expired in April 2009. Follow-up with the reporter on 15-Oct-2009 showed "the patient was doing fine with no problems after taking the expired FLUMIST. She has been re-vaccinated for the flu and had no problems or reaction of any kind. The patient is doing great". There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information received on 15-Oct-1009 and incorporated in the narrative: outcome of the adverse event.
Tightness in both thigh muscles - most noticeable in mornings.  Tightness never goes away.  Ongoing
Approximately 5-10 minutes after receiving injection patient became faint and collapsed while browsing store.  Did not appear to hit his head or significantly injure himself in any way but reported headache and some confusion on regaining consciousness.  Slowly moved to sitting position and allowed to recover.
recieved booster dose of 0.25ml instead of third dose for immunocompromised of 0.5ml. patient returns same evening and received second dose of 0.25ml for total of 0.5ml though. no adverse effect reported
Severe pain in my arm from the time I received the shot. Could not use my entire left arm at all for a month. Tingling down to my fingertips. Required multiple trips to an orthopedic specialist. Multiple courses of medication.  First diagnose' was SIRVA, followed by frozen shoulder.  Still having pain and issues to this day. Limited use of my left shoulder. Injection site was too high.
My arm was very red, had pains in arm for 3 weeks. One of the men told me to buy allergy pills - it did help me some. Pharmacy had no other complaints.
Wrong vaccine given. Gave 3rd dose of primary Pfizer BioNTech Monovalent given instead of Pfizer Booster. Patient notified and open to receiving correct vaccine when the time is right.  Pt states feels fine and will notify clinic if develops any symptoms.
Pt recv vax on 3/8/99; on 3/9/99 pt exp red/ tender/ hard area; tx=ice, Tylenol
Next day post vax, the pt developed a fever, chills, and redness at the injection site.
Pt administered Varivax. On 03/28/2003 developed disease Dx on 06/10/2003
Patient was given MMRV (Proquad) instead of MMR. This was realized on 3/21/22 during a vaccine count.  Lot # of vaccine administered was  determined to be MMRV and not MMR. (The packaging on MMR and MMRV are very similar and the vaccine locations were switched in the fridge on accident.) Patient's father was called as soon as mistake was realized. Patient's father said that she was doing fine and had no adverse reactions or concerns.
A few hours noticed redness and itching at site of injection. Aching and low grade fever for a couple of days a very painful headache for a few days.
Initial dose: sore at injection point until evening of the following day. Chills starting 5 days after shot lasting one week. Tired for 3 days beginning 5 days after shot.
Flu vaccine given 1/20/14, pt states next day woke up left arm very painful difficulty lifting arm, left rib cage area painful - she went to ER 1/20/14.
Patient fainted about 5-10mins after shot.  Was sweating profusely and seemed very weak. Could sit up and was conscious and could answer his name and where he was.    Paramedics were called and hooked him up to heart monitor and then took him to hospital.
constitutional fatigue, general weakness, achy, sore arm;not painful;had initial local itching;will probably not continue series & check titer;28JUN94 follow-up recovered
10.00pm day of vaccine.... feverish, tired went bed.  Next day awoke  feeling Nauseous, unable to eat or drink anything. Debilitating headache.... took Advil.... no relief...  kept awaking  and felt no better... slept hoping the next time I awoke I would be back to normal. This continued through 24 hours. I believe  the vaccine is incompatible with my DNA  None of my friends had any problems with it.... I did not consult with a Doctor but I am not looking forward to the 2nd dose tomorrow. Thank you.
chest pains; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pains) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced CHEST PAIN (chest pains). At the time of the report, CHEST PAIN (chest pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported. No concomitant medication was provided.
I experienced extreme dizziness, diarrhea, headaches, and heart palpitations and worsen a couple days following the vaccine. I went to the ER on 09/29/2021 at 02:00AM and the ER Doctor did an EKG and CT Scan. I was advised to follow-up with my PCP. My PCP ordered a heart monitor on the same day during my appointment (awaiting approval from my insurance company). I am still experiencing the same symptoms and am contemplating going back to the ER.
Fever off and on for several weeks following vaccination. fever 6/6/15 103.7. Excessive crying for several days following with lethargy and decreased LOC. Vomiting 6/8/15. 6/9/15 crying for 6 hours straight, back arching, no eye contact. Saw pediatrician and was sent to hospital. 6/10/15- unable to hold head up, walk, or stand. Continued abnormal posturing, back arching, scissoring of legs, excessive screaming/crying, lethargy, no eye contact. 6/12/15- symptoms began improving. 6/15/15- back to baseline.
I have had two menstrual periods/my sister is having similar symptoms; I have been spotting now/my sister is having similar symptoms; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for a female patient (reporter's sister). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No known allergies were reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had not received any other vaccine within 4 weeks. Other medications in two weeks: Yes, too many. On an unspecified date the patient experienced I have had two menstrual periods/my sister is having similar symptoms and I have been spotting now/my sister is having similar symptoms. The reporter reported that patient did not receive treatment for events (not on any meds or birth control). The outcome for the events were unknown. Follow-up attempts are completed. No further information is expected.
Flu shot given on 1/26/2011, in his right thigh. The next day on 1/27/2011, mother noted some redness at the injection site and drew a line around it (bigger circle than the redness area). On 1/28/2011, the redness has come up to the line and in one place the redness spreaded outside of the circle a little. No fevers, and is acting well. On 2/1/2011, the update is no increased redness and is currently fading. The redness is more of a "brown color". No treatment needed. (Mother had KEFLEX abx in case, but there was no need to start it).
pt reports flushed face, severe headache, nausea, swollen injection site- looks like a "boiled egg",  injection site hurts and itches, feels lousy, arm swelling/pain woke her up overnight.
Both feet are swollen, both feet the top part are puffy; Red face and hands; Shooting pain; Feet are still red; red feet and red hands that has been ongoing for three months that goes away and comes back; Feeling bad; Sore arm (left arm- second dose) for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHROMELALGIA (red feet and red hands that has been ongoing for three months that goes away and comes back), FEELING ABNORMAL (Feeling bad), PERIPHERAL SWELLING (Both feet are swollen, both feet the top part are puffy), ERYTHEMA (Red face and hands) and PAIN (Shooting pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Polymyalgia rheumatica and Blood pressure high. Concomitant products included TOCILIZUMAB (ACTEMRA) for Polymyalgia rheumatica.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced FEELING ABNORMAL (Feeling bad) and VACCINATION SITE PAIN (Sore arm (left arm- second dose) for 3 days). On an unknown date, the patient experienced ERYTHROMELALGIA (red feet and red hands that has been ongoing for three months that goes away and comes back), PERIPHERAL SWELLING (Both feet are swollen, both feet the top part are puffy), ERYTHEMA (Red face and hands), PAIN (Shooting pain) and ERYTHEMA (Feet are still red). On 05-Mar-2021, VACCINATION SITE PAIN (Sore arm (left arm- second dose) for 3 days) had resolved. At the time of the report, ERYTHROMELALGIA (red feet and red hands that has been ongoing for three months that goes away and comes back) and ERYTHEMA (Feet are still red) had not resolved, FEELING ABNORMAL (Feeling bad), PERIPHERAL SWELLING (Both feet are swollen, both feet the top part are puffy) and PAIN (Shooting pain) outcome was unknown and ERYTHEMA (Red face and hands) had resolved.            No treatment information was provided by the reporter.  The patient had her feet is still red for about four months especially the bottom of the feet. Her doctor was informed.   This case was linked to MOD-2021-107064 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Non-significant follow up received, Reporter details added. On 07-Aug-2021: Followup document received on 09-AUG-2021 and the start date of vaccine was changed to 03-FEB-2021. New events added. outcome of the events updated.
pt recv vax 18APR; On 25APR pt devel large red swollen, itchy area around inj site & other red raised areas distant to upper arm;
Attended an engagement dinner on 12/18/21 where all had received at least 2 doses of the COVID vaccine. My household which consist of 5 members where 4 out of 5 tested positive for COVID-19 by 12/23/21. I started coughing with a slight fever and body aches on 12/20/21. Tried getting a COVID test but wasn't able to get into a location until 12/22/21.
Tingling, numbness, pins and needles feeling throughout entire body several hours after vaccine. These symptoms were sporadic and then intensified and became constant 6 days after the vaccine when I felt chest tightness.
Developed left lower leg discomfort on day 5 post-vaccination with dose 1 of Moderna COVID-19 vaccine.   Developed worsening pain, swelling and mild erythema of the left lower leg distal to the knee over the next 48 hours.  Seen on 1/05/2021, and STAT venous duplex ultrasound ordered, which revealed a prominent deep vein thrombosis partially occlusive, partially nonocclusive extending from the left femoral vein distally.   Started on anticoagulation with apixiban.  No signs/symptoms of pulmonary embolus.  No precipitating event that would raise risk of acute DVT (He does not have any open areas of his skin concerning for infection in the leg.  No recent injury to the leg.  No recent surgeries or period of immobility.  No prior personal history of DVT, provoked or unprovoked.  He does not smoke.  He does drink alcohol in small amounts, to moderate amounts on occasion.  No history of alcohol misuse or abuse.).  He has chronic HIV infection, well controlled.  He does have a family history of DVT (his mother had 1 provoked and 1 non-provoked DVT).
PAIN IN ARMPIT WHERE VACCINE WAS ADMINISTERED; DISCOMFORT IN ARMPIT WHERE VACCINE WAS ADMINISTERED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced pain in armpit where vaccine was administered, and discomfort in armpit where vaccine was administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in armpit where vaccine was administered and discomfort in armpit where vaccine was administered was not reported. This report was non-serious.