chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives; the rash is from her head all the way down to her ankles and it is very itchy; the rash is from her head all the way down to her ankles and it is very itchy; diarrhea; vomiting; The rash started in a small section on her arms and now it's moved down to her chest and up to her neck and head and down to her legs and ankles.; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6198) via an unspecified route of administration, administered in Arm Left on 12Mar2021 11:00 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Patient previously received BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6201) via an unspecified route of administration, on 19Feb2021 as dose 1, single for COVID-19 immunization. It was reported that Patient was calling about the Covid 19 vaccine. She received her second shot on Friday, 12Mar2021. By Saturday,13Mar2021 she had broken all out. She had hives, a rash, diarrhea and vomiting. And now the rash was from her head all the way down to her ankles and it was very itchy. The rash started in a small section on her arms and now it's moved down to her chest and up to her neck and head and down to her legs and ankles. On Sunday, 14Mar2021 the diarrhea and vomiting was bad. Monday, 15Mar2021 she had diarrhea. The vomiting had stopped on Sunday 14Mar2021. She went to the emergency room on Sunday, 14Mar2021 and was discharged from the emergency room. On Monday, 15Mar2021 she went to her primary care physician. Benadryl take 2 pills she doesn't know the dosage, she was also prescribed Prednisone, when querying dosage, she states she doesn't have the package with her. The outcome for the rash started in a small section on her arms and now it's moved down to her chest and up to her neck and head and down to her legs and ankles was unknown, for event diarrhea was recovering and for event vomiting was recovered on 14Mar2021 and rest all events was not recovered.  No follow-up attempts are possible. No further information is expected.
vaccine exposure via breast milk; Diarrhea; Not feeling well; fussiness (abnormal for patient); spitting up a lot; not eating regular amount; threw up; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (vaccine exposure via breast milk), DIARRHOEA (Diarrhea), MALAISE (Not feeling well), ABNORMAL BEHAVIOUR (fussiness (abnormal for patient)) and GASTROOESOPHAGEAL REFLUX DISEASE (spitting up a lot) in a 16-week-old male infant exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) , while the mother received the product for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding since 05-Mar-2021.    MEDICAL HISTORY (Patient): The patient's past medical history included No adverse event.    On 05-Mar-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 05-Mar-2021, the infant was diagnosed with EXPOSURE VIA BREAST MILK (vaccine exposure via breast milk), DIARRHOEA (Diarrhea), MALAISE (Not feeling well), ABNORMAL BEHAVIOUR (fussiness (abnormal for patient)), GASTROOESOPHAGEAL REFLUX DISEASE (spitting up a lot), POOR FEEDING INFANT (not eating regular amount) and VOMITING (threw up). The Infant was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 05-Mar-2021, EXPOSURE VIA BREAST MILK (vaccine exposure via breast milk) had resolved. On 11-Mar-2021, DIARRHOEA (Diarrhea), MALAISE (Not feeling well), ABNORMAL BEHAVIOUR (fussiness (abnormal for patient)), GASTROOESOPHAGEAL REFLUX DISEASE (spitting up a lot), POOR FEEDING INFANT (not eating regular amount) and VOMITING (threw up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
Severe arm swelling, redness, 3d after Pneumovax given. Hospitalized. IV antibiotic given.  1/15/08 Reviewed hospital medical records which reveal patient experienced fever, redness, rash & tenderness at RA injection site x 2 days & HA.  Admitted 8/11-8/13/07.  Tx w/IV antibiotics.  ID consult done.  D/C to home on condinued oral antibiotics. FINAL DX: none provided but ID consult states right arm cellulitis s/p pneumovax injection.
RIGHT SIDE OF FACE Numb: forehead, cheek, jaw, tongue Pain: eyelid, eye, eye socket, front of ear, jaw, teeth Changes in sensation varied: burning, sharp, numb, taste Swelling upper eyelid Mild asymmetry Double vision with rapid decline in 48 hours followed by recovery Muscle spasms after 2 weeks Extreme exhaustion\fatigue  Began improving after 2 weeks, most symptoms resolved except: numb forehead, occasional pain\spasms, mild fatigue.   Following 2nd vaccination: currently 6 hours post injection and R side of face is completely numb again.
I had some abdominal pain and nausea the first night...two days after first vaccinaton I fell...a friend caught me and helped me sit..no warning sign...same thing happened a couple more times that day...it happened again at work Monday, April 26, 2021...I caught myself...again no warning signs and then I collapsed at work in front of my manager...saw primary care April 27, the ER April 30th ans again on May 3rd at ER....blood work snd vitals were and are good ...missed work April 27the, 28th, 30th, May 3rd, tried working May 4th and left early...they called an ambulance...anotjer employee took me home. Missed that whole week. Saw Neurologist May 5th, missdd all week and returned to work, Monday May 10th, 2021. I am still in a brain fog and light headed/dizzy since vacation. I feel like I am going to collapse/pass out sitting or standing. My head as far as light headed /dizzy is getting worse...I also drank over 2 gallons of water for a little over two weeks after vaccination. It has also made me constipated.
On February 14th our dayshift staff arrived at work and upon approach to Patient's room approximately 0700 noted her to very warm and flush. Her temp was taken. She was at 103F. On-call nurse was called. Tylenol was advised and recheck.  Prior to recheck Patient's roommate came out stating Patient's was shaking. Staff immediately went to her room to find her actively in a seizure of unknown duration. 911 was called d/t the seizure not ceasing/fever.  Squad arrived and Patient was still having tremors. Staff followed to the ER.  Patient was intubated and placed on a ventilator. Covid test negative.  She is currently at Hospital x3 days.
10 hours after vaccine pale T 101.6 chills & shaking left work 2 hours early.
Received the smallpox vaccine on 7/15/2010. She had a normal take with resolution of the lesion, but twice a week for the last year she has swelling, papules and pruritus of the site. Symptoms are confined to the scar, last a day or so and are gone. No drainage or systemic symptoms. Advised to see Dermatology.
patient had full body rash,especially in warm areas of body. pharmacist advised to keep cool take benadryl or zyrtec, and calamine for itch.  dr called in prednisone and loratadine on 6/26/20.
Woke up on third day after second shot with bells paulsey type symptons on left side of face and coudn't feel anything on left side of throat when I swallowed. Left eye lid drooping and side of face. Immediately called primary care doctor.  Did blood work and cat scan. Saw eye doctor for drooping eye after 3 months of no change in drooping and impaired vision because of it. Surgery performed to lift eye lid. Still can't feel anything on left side of throat when swallowing. Still have viewing issues because of eyelid.
12/30/2020 Four hours after vaccination - left arm soreness, mild headache above right eye.  Client improved that evening. 1/20/2021 Four hours after second vaccine dose - Body aches, intense headache over right eye,  The evening of the same day - Heaviness to left arm, increased pain to left arm radiating to hands, tightness to the left arm with a feeling of "electricity" in the arm.  The pain increased in intensity to the left arm during the night.  Unable to sleep due to intense pain to the left arm and axilla. 1/21/2021 In the morning, client experienced abdominal pain and diarrhea once (loose stool).  She noted swelling to the left axilla, intense pain, swelling below the left jawline. 1/22/2021 Early morning nausea without emesis, itching of the right forearm and nape of the neck, throbbing pain to left axilla with itching, throbbing to the left ear, which has not been sensitive to pain due to deafness.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Information about concurrent condtions and medical history were not providd. The healthcare worker reported that an unspecified amount of doses of GARDASIL that underwent a temperature exursion was administered to an unspecified amount of patients (0.5 ml, intramuscular, lot# not reported) on unspecified dates. No adverse effect reported. The outcome of the event was not reported. Additional information has been requested.
pt recvd vax 830AM @ 2PM started to itch all over especially eyes;no rash or redness; called MD & started on Pred
diagnose with UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (diagnose with UTI) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included vitamins occasionally and tylenol if in pain for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced URINARY TRACT INFECTION (diagnose with UTI). At the time of the report, URINARY TRACT INFECTION (diagnose with UTI) 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.
Onset erythema/warmth on left; anterior -> medial thigh in evening after vaccines administered. No fever N/D/SOB/Pain. Walking well and active
she got COVID; Side effects; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (she got COVID) and VACCINATION COMPLICATION (Side effects) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (she got COVID) and VACCINATION COMPLICATION (Side effects). At the time of the report, COVID-19 (she got COVID) and VACCINATION COMPLICATION (Side effects) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested for COVID and was tested positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided. Patient got first vaccine and a week later was got side effects so got tested for COVID and patient was tested positive.  Company comment: This case concerns a female patient, unknown age, with no medical history reported, who experienced the non-serious unexpected events of Covid-19 (AESI) and vaccination complication on unknown date after the first dose of mRNA 1273 Covid-19 vaccine. The patient was said to be having side effects after the vaccine. A week after the vaccine, she got tested for Covid and was positive.  The patient's Covid-19 infection may be a confounder to the side effects that patient was having after the vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient, unknown age, with no medical history reported, who experienced the non-serious unexpected events of Covid-19 (AESI) and vaccination complication on unknown date after the first dose of mRNA 1273 Covid-19 vaccine. The patient was said to be having side effects after the vaccine. A week after the vaccine, she got tested for Covid and was positive.  The patient's Covid-19 infection may be a confounder to the side effects that patient was having after the vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
No adverse effects; irnproperly stored MMR II was inadvertently administered; This spontaneous report as received from a medical assistant refers to a 12-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 07-OCT-2019, the patient was inadvertently vaccinated with one improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (rHA) lot # R028003, expiration date 01-OCT-2020 (dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted in properly stored sterile diluent. There was no adverse event reported. The administered dose of vaccine experienced temperature excursion of above 47 degrees Fahrenheit (F) (52 F) for 10 hours. There was no previous temperature excursion The data logger was involved.
Rash/hives all over body  Stiff neck  Sharp pains in joints  Stomach ache  Stiffness in joints
Right side of face, neck and chest broke out in hives. I had numbing in my lips and tingling on the right side of my body.
In the middle of the night I passed out while walking from the bathroom. I broke my front tooth in half and smashed in 2 other front teeth. Also bruised cheek, lip, and knee. I had been feeling chills, aches, and flu-like symptoms throughout the night. It required a dental surgeon, dentist, and probably braces. The advice nurse advised going to the Emergency Room due to her concern about a head injury.
Large, angry welts-red and very itchy-appear alternately on face, back, legs, arms, throat. No response to BENADRYL, ZYRTEC, ALLEGRA or oral steroids. No response to anti-itch cream. A month has passed and it still continues.
BlurredVision, Dizziness, Myalgia, Fever, chills
20OCT96 evening lt arm sore, red ache;23OCT96 swollen neck & glands;24OCT96 3AM breathing diff SOB didn't feel good;25OCT96 saw MD started Ibuprofen for pain, swelling ap/3 days still swollen glands;28OCT96 started ATB;4NOV96 still SO
On July 6, 2021 I went to Family Practice for first shot of Moderna Covid-19 vaccine at 1pm. Within approximately 12 minutes of receiving the vaccine, I started to feel my tongue swell and had difficulty swallowing my own saliva. I alerted the nurse and was given an oximeter. Oxygen levels ranged between 97-99 but heart rate went up to 143. As tongue became enlarged I was unable to close my mouth and it became dry so they gave me water to try to sip on as well as liquid Benadryl. EMTs were called and upon their arrival, it was determined that I needed to get epinephrine shot. I was given epinephrine .03mg and IV was started and another round of Benadryl (50mg) was administered.  By 1:40pm pulse rate had gone down to approximately 115. Wheezing was noted by the EMTs.   On the way to hospital, I was given 125mg of Solumedrol. Upon arrival at the hospital I was also given famotidine. I was monitored for approximately 3 hours and discharged feeling stable with swelling of tongue and throat resolved. No prescriptions given.   On July 7th at approximately 1am, I started to feel the swelling of the tongue and narrowing of the throat re-appear as well as chest pressure and pain and went to Medical Center. Treatment there included a second round of IV Benadryl and another epinephrine shot. Symptoms improved and I was in observation for approximately 4 hours and discharged with symptoms having been resolved. Prescription for prednisone, famotidine, and epinephrine pen given. Instructions to also continue Benadryl every 3-4 hours given as well as follow-up with allergist and primary care doctor.
Fatigue for 2 days after shot.  Headache starting 8 days post vaccination. Lasted 2-3 days (4/7-4/9/21) Dizziness, blurred vision, almost fainted on 4/9/21
I woke up and I had pain in my lower jaw on my right side. It was pretty intense pain. I was going to the orthodontist that day so I was thinking it might be a tooth. The pain started to go towards my outer ear. As the day progressed, I went to the ortho at 10:15AM. As I'm sitting there trying to deal with my appointment and talk, every 3 minutes I wanted to jump out the chair. I had excruciating pain shooting through my, it felt like a hot ice pick being stabbed through my ear and, then, it would go away. They got me an emergency dental appointment. I went to my dentist within the hour to see if we were dealing with a dental issue. I'm still experiencing the same pain. Talking makes it worse but even when I'm not talking, it's coming and going. I've given child birth and this was worse than child birth pain. She took x-rays and didn't see anything except a tiny, possible root issue. She didn't think so but in trying to see if it may be what it was, she sent me to an endodontist. The next day. I went to the endodontist. Now, the pain is in my lower jaw up the right side of my face. It goes all the way up my temple to the top of my head. It's only on the right side and it comes and goes and nothing is making it better. That afternoon, I did go to my doctor to rule out an ear infection or anything she could see. The endodontist did a panoramic scan and other x-rays and some cold spray tests on my teeth to see if it was a tooth issue like a root canal or an abscess. He said that there was no issue with my teeth or anything. He referred me to a Dr. He specializes in trigeminal neuralgia. I went to see that doctor on the 18th of October 2021. He listened to all of my symptoms and did his physical exam. He said I needed to have an MRI with and without contrast. That was scheduled for Monday, 10/25/2021. I had that done and I was sent the results. There were 167 scans. In following up with him and seeing everything, there's a vein that lies over the nerve and it was inflamed. He said trigeminal neuralgia can be aggravated by the wind blowing, brushing your teeth, it's very unpredictable. This nerve had become inflamed. He said I may never have another episode. By the time I came back in for the results, it wasn't hurting at all. I wasn't having any issues. I haven't had any other issues until this latest episode that started 05/06/2022 and that was after my COVID-19 vaccine.
Information has been received from a licensed practical nurse concerning a 10 year old white female student with no medical history and no drug allergies, who on 20-NOV-2007 at 10:37 was vaccinated intramuscularly in the left arm with a second dose of Gardasil vaccine (Lot# 659437/1266U). Concomitant suspect vaccination included a second dose of Varivax (Lot# 658414/1026U) administered subcutaneously in the left arm at 10:30. There were no illnesses at the time of the vaccination. On 20-NOV-2007, at 10:40 the patient experienced ringing of ears and lightheadedness. The patients blood pressure was 90/60 and her pulse was 70. The patient recovered on 20-NOV-2007. Additional information is not expected.
Breast feeding 6 months old son; breast feeding 3-month-old son; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Dec-2020 and was forwarded to Moderna on 04-Jan-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE VIA BREAST MILK (breast feeding 3-month-old son) and EXPOSURE VIA BREAST MILK (Breast feeding 6 months old son) in a 3-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The mother's past medical history included Gestational hypertension. Concurrent medical conditions included Alcohol use (occasional glass of wine) and Maternal exposure during breast feeding.    MEDICAL HISTORY (Patient): The patient's past medical history included Fetal growth restriction (IUGR). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and FISH OIL (OMEGA 3 FISH OILS) for an unknown indication.    On 24-Dec-2020 at 7:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) 1 dosage form. On 24-Dec-2020, the patient experienced EXPOSURE VIA BREAST MILK (breast feeding 3-month-old son). On 25-Mar-2021, the patient experienced EXPOSURE VIA BREAST MILK (Breast feeding 6 months old son). On 24-Dec-2020, EXPOSURE VIA BREAST MILK (breast feeding 3-month-old son) had resolved. On 25-Mar-2021, EXPOSURE VIA BREAST MILK (Breast feeding 6 months old son) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary), the reporter did not provide any causality assessments.   Concomitant medications were not reported  This is a case of product exposure during breastfeeding with no associated AEs. The mother of the child will continue to be contacted for further monitoring of AEs in the child.    This case was linked to MOD-2020-041455, MOD-2020-041455, MOD-2020-001985 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: No specific follow-up information recorded. On 25-Mar-2021: No specific follow-up information recorded. On 25-Mar-2021: No specific follow-up information recorded.; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs. The mother of the child will continue to be contacted for further monitoring of AEs in the child.
On 02/27/2021, that was my breaking point I did an emergency appointment with my doctor and therapist. I was basically having a mental break down. Dr.'s colleague put me up on different medication, a higher anti-depression medication, and anti-anxiety medication, and therapy sessions. I have not recovered 100 percent from my AEs I would say I am recovered 60 percent.
Pt seen for well pt check @11AM 27FEB92 exam nl & pt given DTP/OPV @ 1130AM; 1230AM mom stated pt blue & hand & legs shaking;  pt seen by MD 115PM & noted to be pale w/flushed red rash, lethargic & appeared to have post ictal state;
The patient experienced no symptoms.; The patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medication, and drug reactions or allergies was not provided.   On 01-JUN-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) (lot number S035108, which has been verified to be valid, expiration date reported and validated as 03-MAY-2021) (dosage regimen, route of administration and anatomical location were not reported) as prophylaxis (product storage error). The sterile diluent (MERCK STERILE DILUENT) concomitantly used for reconstitution of the vaccine was properly stored.   The vaccine was exposed to a temperature of 7.9 degrees Fahrenheit (F) for 1 hour and 8 minutes as recorded by the data logger. There were no previous temperature excursions. The patient experienced no symptoms.