chrisvoncsefalvay/vaers-outcomes huggingface dataset:
One week after second shot - severe IBS which hadn't happened in about 15 years.  Lasted about 6 weeks now my digestive system is slowly getting back to normal.  Met with my gastrointestinal doctor who saw nothing wrong after viewing my last colonoscopy and examining me.  Saw other examples of this on the internet.  Nothing else has changed in my diet or lifestyle, just the vaccine.
Migraine, Vision blurred.  This case was reported by a healthcare professional and described the occurrence of migraine headache in a 25-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions include migraine headache.  Her prior migraine was three months prior to the vaccination with Engerix-B.  The subject's migraines normally lasted only one day. The subject had no reported illness at the time of vaccination.  Co-suspect medication included medroxyprogesterone acetate (Depo Provera). On 09 May 2006, the subject received the 1st dose of Engerix-B (unknown, right arm).  On 10 May 2006, 24 hours after vaccination with Engerix-B, the subject experienced migraine headache and blurred vision.  At the time of reporting, the migraine headache was resolved. The outcome of the blurred vision was unspecified.
Inappropriate age at vaccination; inappropriate schedule of vaccine adminstration; Unspecified blood test which came back negative for measles, mumps or rubella immunity; This spontaneous report was received from a nurse refers to a 48-year-old female patient. The patient's pertinent medical history, concurrent conditions, allergies/drug reactions and concomitant medications were unknown. On an unknown date (reported as: when the patient was child), the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) (product administered to patient of inappropriate age) (strength, dose, route, anatomical location, lot# and expiration date were not reported) for negative titers. On 14-JAN-2020, the patient underwent unspecified blood test which came back negative for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live immunity (antibody test negative). On 15-JAN-2020, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR II) (route, dose, anatomical location were not reported) lot # R030806 and expiration date 24-OCT-2020 for negative titers. On 03-MAR-2020, the patient was vaccinated with second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR II) (inappropriate schedule of vaccine administration). The outcome of the event antibody test negative was unknown. The causality assessment between the event antibody test negative and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR II) was not reported.
pt recvd vax & child stiffened-up; became very red & stopped breathing; 1st episode the noc of vax;2nd & 3rd episodes the next day; last only a few secs
repeat vomiting, t101-103, aches, pains, could not walk or be touched, cranky, could not be touched, h/a, runny nose, cough, could not eat;
5mins p/vax pt sitting on chair, then fell off chair fainting-immed reacted to pt w/ammonia inhaler;
Physician diagnosed varicella on 10/15/07.  10/15/07-Fever, restless, runny nose x2 days.  10/24/07-4 pox marks currently with scabs.
HIVES ALL OVER MY BODY BEGAN ON 01/01/2022. SAY ALLERGIST ON 01/10/2022. HE GAVE TOLD ME TO USE OTC MEDS: ZYRTEC, BENADRYLM AND HYDRO-CORTISONE CREAM. HIVES HAVE LASTED AND ITCHED FOR 4 WEEKS. AT 5 WEEKS NOW THEY ARE GONE FLAT AND DON'T ITCH AS MUCH.
Began having painful needle like pricks in nerve endings in various parts of my body. After a couple of days of this, the feeling continued mostly in my feet & calves of both legs. There is a lot of feeling of pins & needles, painful burning sensation as well as some numbness in my feet. It is still continuing.
Within 5-10 minutes pt got immediate erythema & histamanic reaction (L) deltoid - injection site. Overnite had chills. Temp 101 myalgias & arthralgias. BENADRYL 12.5-25 1 PO QID x 3 days. If symptoms worsen to hosp. IV BENADRYL & aggressive hydration.
Febrile seizure and stopped breathing  prior to this his arms and face turned red.  This started at 8:30 am on 4/27/2021 He was in the emergency room by 9am. They gave him an IV, bloodwork, urinalysis, ct scan, x-rays. They transported him to Hospital. He continues to run a fever 7 days later.  The following is from his discharge papers Patient was seen at hospital for a sudden episode of shaking in his arms and legs and fluttering of his eyes. We understand that his lips turned blue and  vomiting associated with this episode, and was found to have a temperature of 103. Seizure was triggered by the fever.
Sore arm; wants to sleep all the time/sleepiness; a little nasal stuffed up; a little coughing; lost her taste; joint pain; Muscle ache/all these aching; Real fatigue/"very very tired"/tiredness/tired all the time/has to lie down after doing some chores; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (wants to sleep all the time/sleepiness), NASAL CONGESTION (a little nasal stuffed up), COUGH (a little coughing), AGEUSIA (lost her taste) and ARTHRALGIA (joint pain) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No patient history information was provided.  Concomitant products included MIRTAZAPINE (REMERON), LISINOPRIL and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (wants to sleep all the time/sleepiness), NASAL CONGESTION (a little nasal stuffed up), COUGH (a little coughing), AGEUSIA (lost her taste), ARTHRALGIA (joint pain), MYALGIA (Muscle ache/all these aching), FATIGUE (Real fatigue/"very very tired"/tiredness/tired all the time/has to lie down after doing some chores) and PAIN IN EXTREMITY (Sore arm). The patient was treated with IBUPROFEN for Muscle ache and Fatigue, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (wants to sleep all the time/sleepiness), NASAL CONGESTION (a little nasal stuffed up), COUGH (a little coughing), AGEUSIA (lost her taste), ARTHRALGIA (joint pain), MYALGIA (Muscle ache/all these aching), FATIGUE (Real fatigue/"very very tired"/tiredness/tired all the time/has to lie down after doing some chores) and PAIN IN EXTREMITY (Sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient was given 0.2ML Pfizer-Biontech Covid-19 (5-11 Yr) Vaccine Vial (unapproved) instead of Comirnaty Covid-19 Vaccine Vl. Patient came in with 2 other younger siblings.  Pharmacist verified with dad that he will be given 3 pediatric doses to the pt.'s. Dad agreed and did not mention that one of them just turned 12. There was no adverse reactions reported during the 15 minutes observation period.
About 16 hours after injection I was struck with chills so bad that I could  feel my bones hurt..  piled on the blankets  put leggings on sweatshirt and went to bed under four heavy blankets with a heating bag.  Lasted about three hours!
Seizure; Felt dizzy; Eye sight was blurry; Shake and jerk; Shake and jerk; Skin turned pale; Heart rate was high; Nauseous; This is a spontaneous report from a contactable consumer. A 17-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 28Apr2021 16:00 as unknown, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included fish oil; magnesium [magnesium citrate]; vitamin d [vitamin d nos]; probiotic [bifidobacterium lactis]; vitamin b complex (VITAMIN B). The consumer stated, approximately 20 minutes after receiving the vaccine (28Apr2021 16:15) the patient felt dizzy, eyesight was blurry, and he began to shake and jerk. It resembled a seizure. His skin turned pale, heart rate was high, and he felt nauseous. It took him approximately 5-10 minutes to feel "normal" again. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in emergency room/department or urgent care. There is no treatment for AE. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was resolving.  Information about Batch/Lot no. has been requested.
TO DATE SINCE 11/14/2021....INJECTION SITE IS SORE AND IS RED. UNDERNEATH MY ARMPIT FEELS LIKE IT IS SWOLLEN, NIT SURE IF THE LYMPH NODES ARE SWOLLEN, BUT I HAVE PAID ON MY ARMPIT, AND IT IS KIND OF SWOLLEN COMPARED TO MY RIGHT ARMPIT  LAST FEB 2021, AFTER MY 20D DOSE, I HAD COVID ARM AND I ALSO REPORTED THAT ADVERSE REACTION ON THIS SITE AS WELL.  BUT THIS BOOSTER SHOT OR 3RD DOSE, LONGER SPAN OF SORENESS, INJECTION SITE IS RED AND ROUND AND PAIN BY MY ARMPIT, MAYBE LYMPH NODES
CHIEF COMPLAINT:   C/O SOB, cough since Covid Booster on 12/31. Home albuterol tx x5, DuoNeb and decadron x1 vis EMS.   HISTORY OF PRESENT ILLNESS:     This patient is a 67-year-old female presents emergency department with complaints of cough and shortness of breath.  Patient states that she received a Covid booster on 12/31.  Patient states that she has been having symptoms since then.  Patient states she has a history of asthma and has used her home albuterol treatment 5 times today.  Patient called EMS and was given a DuoNeb and Decadron.  The patient denies any chest pain but does complain of significant shortness of breath stating that she saw oxygen saturation levels as low as 77%.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 06-FEB-2018, 19-APR-2018 and 22-JUN-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N003984 and expiration date 19-NOV-2018; lot# N024295 and expiration date 24-MAR-2019; lot# N028258 and expiration date 30-MAY-2019) orally for prophylaxis, respectively. The sterile diluent (MERCK) (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Ongoing right shoulder pain for 2weeks, began 1 day after vaccine. 5 out of 10 achy pain.
About a week after the injection, "I" felt pain in the muscles on the left side of neck. It hurt to turn "my" head to the left/  "I" still feel mild muscle pain down "my" neck and in "my" upper arm. It hurts to put down heavy items.; The pain ran down from "my" neck to triceps. "I" stretched and slept with a neck pillow and was able to turn "my" head after a few days.; It feels like a pulled muscle maybe; This is a spontaneous report from a contactable other healthcare professional, the patient. A 23-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, depression/anxiety and environmental allergy. Concomitant medications included montelukast (MANUFACTURER UNKNOWN) and bupropion (MANUFACTURER UNKNOWN); both for unknown indications from unknown dates and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, about a week after the injection, the patient felt pain in the muscles on the left side of her neck. It hurt to turn her head to the left and the pain ran down from her neck to triceps. She stretched and slept with a neck pillow and was able to turn her head after a few days. She felt mild muscle pain down her neck and in upper arm at the time of report. The patient reported that it hurt to put down heavy items and it felt like a pulled muscle might be, but that was at the injection site. The patient also reported that she never had experienced that before and had not done anything to aggravate that muscle. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events patient felt pain in the muscles on the left side of neck/mild muscle pain down neck and in upper arm, the pain ran down from neck to triceps and felt like a pulled muscle was resolving at the time of the report.    No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Developed angioedema - tongue swelling. Seen in ER, given IM SOLUMEDROL and diphenhydramine, SXS resolved.
I administered the patient a booster moderna vaccine and he immediately passed out. came to in a few seconds and was ok. did not require any medical treatment.
Fell and broke femur; Fell and broke femur; flu like symptoms; Felt lousy; This is a spontaneous report from a contactable consumer (patient). A 77 year old female patient received bnt162b2 (BNT162B2, Lot Number: EL9262), Dose 2 via an unspecified route of administration, administered in the left arm on 12Feb2021 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. There were no concomitant medications. The patient previously received the first dose of BNT162b2 on 22Jan2021 (Lot Number: Unknown) via an unspecified route of administration in the left arm for COVID-19 immunisation. On 12Feb2021, after the second dose of bnt162b2, the patient experienced felt lousy and flu like symptoms. On 27Sep2021, the patient fell and broke her femur; medically significant events.  The patient recovered from the events, after 6 hours. The patient was recovering from the fall and broken femur. The patient previously received the first dose of BNT162b2 on 12Oct2021 (Lot Number: FF2590) via an unspecified route of administration in the left arm for COVID-19 immunisation.   Follow-Up (19Oct2021): Follow-up attempts are completed. No further information is expected.
pt got an abscess in the location of the injection - he required an incision and drainage procedure as well as antibiotics
SWEATING; VOMITING; TREMBLING; SEVERE MIGRANE; LIGHT HEADEDNESS; WEAKNESS; CHILLS; FEVER; This spontaneous report received from a parent concerned a 25 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. no drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced light headedness. On 09-APR-2021, the subject experienced weakness. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.8 F. On 10-APR-2021, the subject experienced sweating. On 10-APR-2021, the subject experienced vomiting. On 10-APR-2021, the subject experienced trembling. On 10-APR-2021, the subject experienced severe migrane. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, vomiting, trembling, severe migrane, light headedness, weakness, chills, and fever on 10-APR-2021. This report was non-serious.
65mm x 65mm erythema area around left deltoid.  Painful to touch.  Occurred today, 4-1-08.  Mother applied cold compresses.  Informed mom to continue with compresses and give Tylenol for pain.  Return to clinic if worsens.
TOOK UNREFRIGERATED DOSE; This spontaneous case report (PVX2019-1847) was received from a pharmacist on 17-Jul-2019. It describes a 62-year-old adult female consumer who "took unrefrigerated Vivotif" (PT: Product storage error), while being on oral Vivotif capsule (one dose every other day) (lot no: 3003276) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif on 05-Jul-2019, then left it out at room temperature. On next day, she realized that it was unrefrigerated for around 24 hours at 70-75-degree Fahrenheit. Later, she took all the remaining doses. She took the last dose on 11-Jul-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took unrefrigerated Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated Vivotif" was considered as not applicable.
receive Rotarix via intramuscular instead of oral; This case was reported by a nurse via call center representative and described the occurrence of inappropriate route of vaccination in a 10-week-old male patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 6th October 2021, the patient received Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On 6th October 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination. On 6th October 2021, the outcome of the inappropriate route of vaccination 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 details were provided as follows: The patient received Rotarix via intramuscular instead of oral, which led to inappropriate route of vaccination. The patient was evaluated in the hospital.  No further details provided. The reporter consented to follow up.
3 of her coworkers also experienced hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (3 of her coworkers also experienced hives) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (3 of her coworkers also experienced hives). At the time of the report, URTICARIA (3 of her coworkers also experienced hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Stomach pains; sore throat; Weakness; Nausea; Rash at a previous surgical site; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pains), OROPHARYNGEAL PAIN (sore throat), ASTHENIA (Weakness), NAUSEA (Nausea) and RASH (Rash at a previous surgical site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia, Familial tremor, Spinal fusion (Cervical fusion), Gastric bypass (roux en y gastric bypass), Ankle reconstruction (multiple ankle reconstruction) and Brittle bone disease (brittle bones). Concurrent medical conditions included Latex allergy (Latex) and Drug allergy (RX Mini-press).    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pains), OROPHARYNGEAL PAIN (sore throat), ASTHENIA (Weakness), NAUSEA (Nausea) and RASH (Rash at a previous surgical site). The patient was treated with HYDROCORTISONE (CORTIZONE [HYDROCORTISONE]) ongoing from 18-May-2021 for Rash, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pains), OROPHARYNGEAL PAIN (sore throat), ASTHENIA (Weakness), NAUSEA (Nausea) and RASH (Rash at a previous surgical site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
8/16/21: Patient arrived at the ER due to shortness of breath, increasing dyspnea, left-sided chest pain, and diarrhea. Patient states they had symptoms for the past 7 days. Patient tested positive for COVID on 8/8/21. Patient was prescribed Decadron and empiric antibiotics after testing positive from outside facility.  He subsequently became hypoxic with desaturation to 90% and was started on high-flow nasal cannula. diagnosed with COVID-19 pneumonia 8/24/21: intubated and ventilated, requiring sedation and paralytics  8/30/2021: patient still admitted at the time of this report submission. Note: patient previously vaccinated with Pfizer COVID-19 vaccine in January 2021.
Rapid heart rate 110-135 bpm (baseline heart rate is 80s), frequent heart palpitations (some in a row), heart rate speeds up and slows down intermittently / seems irregular at times/ seems to beat harder and softer intermittently in the same minute, dizziness for 2 days especially when rising from laying even if slowly, severe joint pain in all joints (feet, ankles, hands, wrists, knees, hips, entire spine from neck to sacrum, Ovary pains off cycle time, nausea, anorexia, headache, lymph node swelling and pain, body aches, malaise, fatigue, general sense of doom as if something bad is very wrong, anxiety, standing and walking is painful and takes all energy to perform. Mild Skin rash on hands (possible flare of eczema or psoriasis, however this condition became much worse since having COVID19 in 01/2021 and vaccines 08/31/21 and 10/13/21).  Some breathing changes, such as more mucus production and was unable to take as deep of a breath and noted voice changes. Injection site hot, swollen, red, very painful and unable to use arm for most activity.