chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bowel obstruction; enflamed gallbladder; GI issues; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of INTESTINAL OBSTRUCTION (bowel obstruction) and CHOLECYSTITIS (enflamed gallbladder) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (GI issues). On an unknown date, the patient experienced INTESTINAL OBSTRUCTION (bowel obstruction) (seriousness criteria hospitalization and medically significant) and CHOLECYSTITIS (enflamed gallbladder) (seriousness criterion medically significant). At the time of the report, INTESTINAL OBSTRUCTION (bowel obstruction), CHOLECYSTITIS (enflamed gallbladder) and ABDOMINAL DISCOMFORT (GI issues) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
no additional AE; administration of liquid PEDVAXHIB  dose after expiration; This spontaneous report was received from a licensed practical nurse and refers to a 4-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On 26-MAR-2021, the patient was vaccinated with an expired single dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 ml, lot # R013572 has been verified to be a valid lot number, expiration date reported as 21-MAR-2021 and confirmed, for prophylaxis. The patient had not reported any additional adverse experiences as result. There was no previous temperature excursions on the product.
Very fast heartbeat; Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Very fast heartbeat) and PALPITATIONS (Palpitations) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery (Open heart surgery when she was young).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced TACHYCARDIA (Very fast heartbeat) and PALPITATIONS (Palpitations). At the time of the report, TACHYCARDIA (Very fast heartbeat) and PALPITATIONS (Palpitations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild
Heart arrhythmia; shortness of breath; slight swelling of face and neck; slight swelling of face and neck; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7534) via an unspecified route of administration into left arm on 21Mar2021 12:30 as single dose for COVID-19 immunisation. Medical history included heart disease, food and environmental allergies and diabetes. The patient's concomitant medications were not reported. On 23Mar2021 01:30, patient experienced heart arrhythmia, shortness of breath and slight swelling of face and neck. No treatment was given to the patient. Outcome of events recovered on an unspecified date.
The Medical Assistant preparing and administering the vaccine diluted the vial of the COVID vaccine and administered all three doses from the three dose vial at once.  He received an estimated 9-10 mcg of the vaccine instead of the 3 mcg indicated for his age. He developed moderate postvaccine symptoms the next day including body aches and fatigue. Approx 48 hours after the vaccine he had recovered almost completely excluding the muscular soreness at the site of the injection which lasted about about 24 hours.
Started as hives and turned into rash, even around his eyes; definitely could have caused the allergic reaction; my son developed a allergic rashes over the body/Started as hives and turned into rash, even around his eyes; This is a spontaneous report from a contactable consumer. This consumer (patient's parent) reporting for a 25-year-old male patient (reporter's son) via Medical information team.  A 25-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EW0177, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 02Jun2021 at 12:30 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was reported as none and did not have any other medical condition. Patient did not have prior vaccination within four weeks. Patient did not have any typically allergies. On an unspecified date in Jun2021, the patient experienced my son developed a allergic rashes over the body/Started as hives and turned into rash, even around his eyes, definitely could have caused the allergic reaction. Reporter stated that she and her son went for their first dose of the Pfizer BioNTech Covid-19 vaccine on 02Jun2021, and scheduled for 2nd dose tomorrow. her son developed rash all over his body 19Jun2021. She reported that he doesn't typically have allergies and has not done or had anything new to cause a reaction. Think it may be from vaccine. Rash went away yesterday, so it lasted about 2 days. Urgent care prescribed prednisone, but he did not take it and rash subsided on it's own. Started as hives and turned into rash, even around his eyes. Should he get the second dose after reacting to the first. Reporter stated just have a question, my son and I both went for the Pfizer shot on June 2nd for first one and on the, it would be the 18th my son developed a allergic rashes over the body. So, as send him to the urgent care, Reporter stated can't understand that and there is nothing that could have, he doesn't have allergy and definitely could have caused the allergic reaction you know he had. So, we are wondering if it's the possible side effect from the shot because we were going to get the second shot on Wednesday, tomorrow and I am concerned if he should get it. Rash went away yesterday, so it lasted about 2 days. Urgent care prescribed prednisone, but he did not take it and rash subsided on its own. Patient did not receive any treatment for the events. On 21Jun2021, the patient recovered from the event allergic rashes over the body/Started as hives and turned into rash, even around his eyes (rash all over) and other events were unknown.  Information about lot/batch number cannot be obtained. Additional information has been requested.  No follow-up attempts are needed. No further information is expected.  Follow-up attempts are completed. No further information is expected.
Patient had blisters on medial side of thighs, about a month later after vaccine administration, which slowly crusted over and resolved spontaneously without any intervention.
He passed out; He was convulsing on the floor; This is a spontaneous report from a contactable consumer (patient's wife). A 36-year-old male patient received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 16Aug2021 at 14:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Not even a minute after vaccination the patient passed out (medically significant) on 16Aug2021 with outcome of unknown, he was convulsing on the floor (medically significant) on 16Aug2021 with outcome of unknown. Emergency number was called. No therapeutic measures were taken.   The lot number for bnt162b2 was not provided and will be requested during follow-up.
Fri Jan 10, 2014 12:45 PM Patient, 60 year old. She is calling regarding: had shingles vaccine two days ago. Her left arm is red and swollen from elbow to shoulder and painful. She applied ice, hot to touch. Has body aches and feeling really bad. 149/72 pulse 83. Consulting Nurse spoke to patient directly. She began having headache yesterday morning, neck is supple. Pain is up in forehead between her eyes, no visual changes. Light and noise bothers her head. Never had migraines, not having nausea. She has small little blisters where vaccine given about size of silver dollar, large blister just smaller than a dime. Painful to touch. Current Temp 102.3 and thermometer has not beeped to completion of measuring. The above was copied from a Consulting Nurse encounter today. Pt is currently being cared for by Dr. at Emergency Room.  Dr. called the injection room and spoke to myself and LPN regarding this reaction. Dr. was advised this reaction can occur but it's very rare, pt needs to stay away from pregnant women, infants, anyone immunocompromised etc until blisters crust over and dry up. Dr. states he will treat the pt as though she has shingles.
I start developed pain in my foot. I contact the doctor. I also have swelling and could not wake well. They think it a gait coronation. They did a blood test and ultrasound to rule out blot clot. They gave me Allopurinol 100mg prescription medicine for it.
After Injection performed errands, shopped. 5:00 returned home tired, weak slight headache. Ate cereal, in bed by 7:00 pm Wed. night.  Unable to sleep, extreme sweating (skin wet), chills joint pain (hips, lower back, wrists), rapid heart beat,headache, head swimming. nausea. Got up and had a piece of toast. and 1 xtra strength tylenol. Got up at 2:11 pm Thurs.called Iredell health services. Said ok to take Tylenol and Benedryl  to sleep. Woke up at 5pm most smptoms gone.
muscle aches; fatigue; nauseous/ almost vomiting; had a "brain fog" or was feeling unwell; had a "brain fog" or was feeling unwell; This is a spontaneous report from a contactable Other HCP reported for himself.   A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on unknown date for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 1 day after getting the vaccine the patient experienced muscle aches and fatigue. Then on Sunday, he was nauseous, "almost vomiting," had a "brain fog" or was feeling unwell. The outcome of the events was reported as unknown.   Information on the lot/batch number has been requested.
The patient called today to inform us he has adverse events on Saturday evening, 40 minutes  after getting the Covid Vaccine, he had a sensation of floating, and 4 hours later sharp chest pain which occurred every 3 minutes , lasting 10-15 seconds for a duration of 3 hours, he could not move. then at 2am Sunday morning, he woke up gasping for air, he drank some water and tried drinking coffee which he spilled and blacked out, by Sunday afternoon he felt better, and today he is feeling a lot better
fever 104 and cold also the rarest thing that me and I swell the armpit under the left hand I also have a lot of muscle pain. This is my third day of the vaccine and it seems that the inflammation is decreasing but there is constant pain like a swollen glad.
Week after 1st dose 1/2021, Rapid/intense  heart beat,  severe rise in blood pressure,  which continued thru 2nd dose 2/2021 but along with new frequent fatigue/aches that seem  to only go away by constantly drinking LARGE amounts of bottled waters,  approx. 2 20oz every hour
This was a free flu shot from work... I have had them before at least 3 times. Never had a reaction that I am aware of. I have a cough but no fever or other issues. I am taking MUCINEX DM 1200mg every 12 hours for few days. I have used it before many times and never saw hives or anything from it. Also the hives etc come on almost at the 12 hour mark of using the MUCINEX but I didn't take it during the events just to be sure it wasn't associated. The only thing I can attribute these oddities to was the flu shot I received. I have no explanation otherwise. Hives across entire back very itchy felt like mosquito bites. 12 hours after the shot. Took BENADRYL and they went away. (Almost never get hives ever). 10/20/2016 7:pm 36 hours after shot Upper lip swelled up for no reason and had two hives on lower external eyelids. Went away in an hour or so. 10/21/2016 40 some hours after shot. 230am woke up restless and arms were itching and hands tingling arms and hands felt puffy. Web between fingers was red and itchy subsided on its own. I am not a hypochondriac I almost never go to Dr. I just thought maybe I should report this in case anyone else had these types of side effects. I feel ok just odd things happening nothing that I would consider worrisome or prolonged. The lot for my shot is below if it has anything to do with these oddities: Lot# 9N2x7 EXP. 2017 APR GlaxoSmithKline VIS 8/7/2015.
PRESENTED TO THE HOSPITAL EMERGENCY DEPT. WITH HYPOTENSION AND RAPID HEART RATE
Mild rash around injection site started 10 days post injection , with itching and mild discomfort. No pain . Applied over the counter hydrocortisone and took Claritin . Reaction lasts about 4 days then went away. It was localized to right arm about 3-4 inches in diameter.
FEVER, HEADACHE, MYALGIA, ERYTHEMA, SWELLING Narrative:  FEVER 101  Other Relevant History:
Severe chills, body aches, weak, nauseous, all over sick feeling. Probably had a fever though I didn't take my temperature. I took Advil and the symptoms lessened but didn't go away completely. Had to miss a day of work because I still felt ill in the morning.
This is a spontaneous report from a contactable consumer (patient).    This 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 18Apr2021 (Lot Number: EW0158) as single dose for COVID-19 immunisation; tofacitinib citrate (XELJANZ), route of administration, start and stop date, lot number and dose were not reported for ulcerative colitis. Medical history included ulcerative colitis, nearsighted. Concomitant medication included mesalamine taken for ulcerative colitis, start and stop date were not reported. The patient experienced it lose my body, my bodies ability to find infections , it makes me immunocompromised (as reported) on an unspecified date with outcome of unknown, minor arm stiffness at the injection site on an unspecified date with outcome of recovered, The action taken in response to the events for tofacitinib citrate was unknown. The patient stated that "Well I don't know would you be able to hopefully either may be you can't answer my question. You can direct me to a proper resource. I received my first Pfizer vaccine last Sunday. I didn't have any adverse reaction other than just a minor in arm which gone out. but I am patient with Ulcerative colitis, On Xeljanz for the two years now and I have been trying with to find any sources information or anyone who has the information about the interaction of Xeljanz with the Pfizer, Report Pfizer meds, Pfizer Xeljanz is doing a good job for me, keeping my Ulcerative colitis to  in control, but one of the main concern of Xeljanz it lose my body, my bodies ability to find infections, it makes me immunocompromised, we have been extra care full over the past years COVID until I been able to get my Pfizer Vaccine and I got another one, my Pfizer second one shot scheduled in another two weeks, but I am trying to find some information it says whether I should need to take Xeljanz or I should cut that or stop to I could my second COVID Vaccine shot Pfizer one?" "I did not have any negative reaction. Minor muscle stiffness at the injection site which went away after one day, which was minor. I am not concern about my side effects as I am with efficacy of the Pfizer COVID shot if I am taking Xeljanz, I am concerned that Xeljanz might be reducing the efficacy of the COVID Shot. I would like to know does Pfizer Xeljanz. If any information does the Pfizer has about that. I like to understand if any information about the effectiveness or effect. if I need to change my Xeljanz intake after the shot."
No known adverse events. There were no adverse reactions or events. Therefore there is no date or time.
I am 37 years old, 5' 3", 115 lbs.    An hour after receiving the first dose, I experienced increased rapid heart rate while maintaining a resting position. This lasted for 2 hours. In the couple of weeks that had followed, I experienced heart palpations once or twice a day, often in the morning as I awake.   I received the 2nd shot on March 29, 2021. In early April, I noticed that the superficial veins in my arms had become quite inflamed. Inflamed veins such as these are more typical of those of a bodybuilder, I do not do strenuous lifting at all.  At first, they would appear when it was warm out (about 70 degrees F). Yet as the weeks progressed, the inflammation occurred more frequently, regardless of warm temperatures.   As of this day, Dec. 04, 2021, there is more pooling of blood within the veins of my arms.  They are almost always inflamed. I experience itching and a sensation that something is crawling underneath my skin. The heart palpatations no longer occur. I do not have inflamed veins in any other part of my body.
Patient felt she had a fever, malaise and sores in her mouth.  Patient had no thermometer, so fever is subjective.  Also stated she gets mouth sores each time she gets a fever.
Pt reports localized erythema, warmth, & pain. Onset 1 hour post administration of vaccine, on 10/19. 10/21 presents with 15cm x 6cm area of localized hyperemia, warmth. No resp. symptoms, no urticaria.
She would like to find out if the vaccines involved in the previous excursion would need to be readministered. 31.5 degrees FAHRENHEIT. Vaxelis administered.; This spontaneous safety report,  was received by a partner on 03-AUG-2023 and forwarded to agency on 07-AUG-2023, from a health care professional.  The causal relationship between Vaxelis and the reported event "She would like to find out if the vaccines involved in the previous excursion would need to be readministered. 31.5 degrees FAHRENHEIT. Vaxelis administered" was assessed as not applicable due to the nature of the event.  Further information is expected.
Significant supraclavicular and cervical lymphadenopathy  on vaccine arm side. Still present 14 days status post 2nd Moderna vaccine.
On 11/2/15 11:00 am vaccine administered. 4:00 pm Pain to left deltoid and upper arm. 8:00 pm injection site redness, swelling and unable to move arm, warm to touch, but no fever.
This spontaneous report as received from a clinical medical assistant refers to an unspecified patients of unknown age and gender. There was no medical history, drug reactions/allergies and concomitant medication provided. On 20-MAY-2015, the unspecified patients were vaccinated with an improperly stored doses of GARDASIL (dose, route, lot # and expiration date were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pain radiating up to left side of neck and down arm, sweating, shaking and itchy throat.
Red, raised rash that started on left arm (near injection site) rash spread entire body.  Rash itches and feels hot.
No adverse effect reported; one male patient received improperly stored PROQUAD/ Vaccine administered after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a 5-year-old male patient. There was no information about the patient's concurrent condition, concomitant medication and medically history provided.   On 03-SEP-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot number: R015741, expiration date: 02-DEC-2019 (dose, indication and route of administration were not reported) reconstituted with properly stored sterile diluent. No adverse effect reported.  The administrated dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was exposed to the highest temperature of 6 degree Fahrenheit to 14 degree Fahrenheit for 1 hour and 8 minutes. The previous temperature excursion was 15 degree Fahrenheit to 46 degree Fahrenheit (42.8) for 37 hours and 7 minutes. The digital data logger was involved.
Booster given greater than 12 hours after vial was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Congestive heart failure and AFib. Concomitant products included ATORVASTATIN, PHENYTOIN (DILANTIN [PHENYTOIN]), APIXABAN (ELIQUIS), FUROSEMIDE (LASIX [FUROSEMIDE]) and LACTULOSE for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured) to be not related.    No treatment information was reported.   This case was linked to MOD-2021-416295 (Patient Link).
Initial unsolicited report received from office person medical assistant on 30-May-2018. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of PENTACEL (Batch number: C4976AA, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. It was case of an actual medication error due to inappropriate reconstitution technique. It was not reported whether the patient experienced any adverse events or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Patient received vaccine at 11;04 and stated she felt good.  She left the immediate area and returned approximately at 11:15 am feeling dizzy, faint, muscle aching in arms and legs, High blood pressure of 146/104
w/in 24hr of vax pt devel an inj site rxn characterized by a 3cm by 3cm area of redness, inflammation & tenderness;pt recovered;this is 1 of 5 pt from this facility to have an adverse exp p/vax;