chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt went to ER after vaccines were given with red, itchy skin all over body. Treated with oral med for allergic reaction. Pt called to day to inform us of this.
Sudden onset on nausea following the vaccine at 5:40pm.   Stabbing pain in head sporadically and left side of face twitching.  12/30/20 stabbing pain in head continues sporadically.  Nausea, chills, joint pain and lack of energy throughout the day.  Rash all over body at 8:00pm and head pain..  3:00am extreme nausea and heart palpitations.  Felt like I was being kicked in the chest.  12/31/20  Lack of energy, body aches and headache.  11:00am leg cramping like dull  charlie horses not able to be relieved.  Subsided after 30 minutes.
Information has been received from the customer concerning a female subject of unknown age enrolled in an unknown study. On an unknown date the subject was vaccinated with GARDASIL. As per the subject self-reported, she did not know if she finished all the doses of GARDASIL during the study period. The subject wanted to report that she was diagnosed with systemic lupus erythematous and myasthenia gravis after she participated in the study. No further information about the adverse events was provided. The reporter was inquiring about the records from the study that the subject participated back 10 to 12 years ago. No subject number, site number or investigator's name was reported. It was attempted to reach the subject to not avail to get her full demographics. Both events were considered medically significant. Relatedness between the event and the study therapy was not reported. Additional information is not expected.
diarrhea, fever, skin on the inside of lips and mouth felt loose; diarrhea, fever, skin on the inside of lips and mouth felt loose; diarrhea, fever, skin on the inside of lips and mouth felt loose; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (diarrhea, fever, skin on the inside of lips and mouth felt loose), DIARRHOEA (diarrhea, fever, skin on the inside of lips and mouth felt loose) and PYREXIA (diarrhea, fever, skin on the inside of lips and mouth felt loose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 008B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, the patient experienced MOUTH SWELLING (diarrhea, fever, skin on the inside of lips and mouth felt loose), DIARRHOEA (diarrhea, fever, skin on the inside of lips and mouth felt loose) and PYREXIA (diarrhea, fever, skin on the inside of lips and mouth felt loose). On 27-Nov-2021, MOUTH SWELLING (diarrhea, fever, skin on the inside of lips and mouth felt loose), DIARRHOEA (diarrhea, fever, skin on the inside of lips and mouth felt loose) and PYREXIA (diarrhea, fever, skin on the inside of lips and mouth felt loose) had resolved.            No concomitant medications were reported.  Treatment information was not provided. Before patient received the booster dose of Moderna COVID-19 vaccine Patient had diarrhea, fever, skin on the inside of the lips and mouth felt loose. 3 days after the booster dose patient felt fine.   This case was linked to MOD-2021-405759 (Patient Link).
Felt dizzy and nauseated 10-15 minutes after receiving the influenza vaccine. Had the same sensation 10 yrs ago upon receiving influenza vaccination. Received H1N1 vaccination 2009 without adverse reaction. Brought to ER and discharged home.
Headache,Fever, body aches, joint pain, nausea, extreme fatigue , lumps in legs , leg cramps and numbness, shooting burning feeling in left arm
Patient stated that there was redness around the site of injection and it has heat to it.  It is a little bigger today than it was yesterday.  No pain, but some tenderness.
Patient received the COVID vaccine. Patient stood up to allow the next person to sit for vaccination.  Within a minute, client loses consciousness  and falls, hitting his head on the wooden floor. Client was evaluated by our emergency medical technician, vital signs within normal limits. Client presented with palor, coloring resolved prior to leaving the site.  Client was transferred to the cot. Client alert and oriented on all spheres but states he is tired and wants to sleep. Medic unit called for further evaluation.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received SHINGRIX. Concomitant products included quinapril. On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd May 2018, less than a day after receiving SHINGRIX, the patient experienced chills. On 4th May 2018, the patient experienced fever. On an unknown date, the outcome of the fever and chills were not recovered/not resolved. It was unknown if the reporter considered the fever and chills to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The patient received the vaccine on the left arm. The patient's body temperature went as high as 101.3 on the next day of vaccination. The husband reported that his wife planned to follow-up with her physician on an unknown date.
No additional AE details provided. No additional AE reported; MMR II was administered intramuscularly instead of subcutaneously; This spontaneous report was received form a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications, and drug reactions or allergies was not provided.  On 02-SEP-2022, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) intramuscularly instead of subcutaneously, with lot# T031436 with expiration date 15-SEP-2022 (albumin status rHA) for prophylaxis (dose and frequency not reported), together with sterile diluent lot # U005104 with expiration date 01-JUL-2023. No additional adverse event (AE) details provided or reported.
About 1-2 weeks following flu shot, child experienced off/on severe headache, low grade fever, nausea and fatigue. On night of 12/25/2016, child experienced 103 degree fever, chills, fatigue, body aches, red cheeks, loss of appetite. Fever broke roughly by 12/27/2016. Child had loss of appetite for next few weeks. Child awoke on 1/11/17 with sudden, severe, debilitating OCD like symptoms and would not touch objects due to severe fear of germs. OCD gradually increased to the point of seeking emergency treatment on 2/4/17. Child would not step on floor in the morning to get out of bed, stating she can't do it because it is "dirty". She also had severe separation anxiety, inconsolable crying, tantrums, refused food although hungry, daytime urinary incontinence and would not let anyone touch her (never experienced any of these symptoms in past). ER staff bewildered. Recommended inpatient or partial hospitalization psych services. Parents declined as it was explained neither inpatient or partial psych hospitalization does not treat OCD. Child enrolled in outpatient therapy and OCD improved within 3 weeks to about 95%. Pt again awoke on 3/31/17 with severe debilitating OCD like symptoms, more severe than the last episode. This time, she also experienced motor facial tics with mouth, chorea like movements in arms and shoulders, severe headaches, dilated pupils in broad daylight, extremely fidgety, ADHD type symptoms, impulsivity, constantly putting hands in mouth in odd manner, vocal throat clearing tics, repeating same word three times, occasional knee pain, loss of math skills, decline in handwriting abilities at school, extreme defiance, irritability, inability to sleep due to involuntary movements of legs at night, severe separation anxiety, inconsolable crying, mild regression for 1-2 week period  thumb sucking, baby talk, playing with baby toys. The focus of the OCD obsessions switched from "germ fears" to "doing everything perfectly and repeating each little task", such as walking up and down the same step for hours, walking in and out of doorways for hours trying to get it "just right". Pt saw therapist who mentioned possible PANDAS/PANS diagnosis. Child's symptoms have somewhat subsided, but are still present to date and fluctuate day to day. Child still experiences motor tics of face and arms and repeats odd behaviors stating she can't make herself stop. Child did 3.5 hours of cartwheels nonstop yesterday as she cried hysterically that she could not make herself stop. Child lost the ability to handwrite clearly and lost math skills, dropping three grade points in school since this began. On 5/22/17 child was diagnosed with PANDAS/PANS as result of vaccine injury that triggered an autoimmune response which is attacking the brain.
Developed severe shaking, teeth chattering, freezing body feeling, nausea, vomiting, headache and very high fever 104.3 at 5pm.  Fever decreased with Tylenol and ice packs to 100. Fever of 100 lasted until 9/14/2021 mid afternoon. He feels OK today, 9/15/2021
Narrative:  COVID infection following COVID vaccine series 12/29/2020 , Pfizer, dose #1 01/19/2021 Pfizer, dose #2 08/23 COVID swab, result: detected 08/21 pt cc: cough, dyspnea, fatigue exposure: unknown 08/23 pt admit to medicine cc: General fatigue and shortness of breath dx: Acute hypoxic respiratory failure LOS: 5 days 08/23 CTA PE impression: Negative study for acute pulmonary embolism. Multifocal pneumonia, with the largest opacity in the RIGHT lower lobe. Recommend PA and lateral chest radiographs in 6-8 weeks after appropriate treatment to document resolution. 08/23 CXR impression: No acute pulmonary finding. 08/25 FIBRINOGEN result: 491 08/25DDIMER result: 0.99 08/25 ESR result: 41 08/26 FIBRINOGEN result: 378 08/26 DDIMER result: 0.6 08/26 ESR result: 30 08/27 FIBRINOGEN result: 326 08/27 DDIMER result: 1.56 08/27 ESR result: 21 09/05 pt traveled and was readmitted non-agency hospital LOS: unknown 09/09 COVID-19 ANTIGEN(BINAX) result: not detected 09/09 ESR result: 7 09/09 CTA PE impression: No pulmonary embolus. Since prior CT dated 8/23/2021, some worsening of multifocal airspace and groundglass opacities, consistent with known viral pneumonia, again most pronounced in the right lower lobe. 09/09 BNP result: 106.3 09/09 procalcitonin result: <0.05 09/09 pt admit to cc: General fatigue and shortness of breath dx: COVID Pneumonia LOS: 1 day 09/10 FIBRINOGEN result: 250 09/10 DDIMER result: 1.41 09/10 ESR result: 10
Good Morning!  I am an RN working for ,  wound treatment clinic.  I got the CoVid vaccine through my work place.  I got my first Moderna got on 03-22.  I am concerned that I may be having a delayed reaction to the vaccine.  The past 3 days I have had hives/itching/rash intermittently.  Symptoms are the worst at night.  They resolve with Benadryl.  Last night was the worst.  Around 6 PM I started developing rash and hives.  BY 9 PM I was covered from Head to the bottom of my feet with hives and severe itching.  I took Benadryl 50 mg and applied topical triamcinolone cream to the worst areas and had improvement of symptoms within an hour.  This morning when I woke up, the hives were completely resolved.  I reported the incident to our Infection Control nurse and she advised I file this report and follow up with my PCP.
Diagnosed with/tested positive for COVID-19 on 2/2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Diagnosed with/tested positive for COVID-19 on 2/2022) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A, 021B21A and 094F23A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypercholesterolemia since 2000 and Hypertension since 2000. Concomitant products included SIMVASTATIN for Hypercholesterolemia, LOSARTAN for Hypertension.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2022, the patient experienced COVID-19 (Diagnosed with/tested positive for COVID-19 on 2/2022). At the time of the report, COVID-19 (Diagnosed with/tested positive for COVID-19 on 2/2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received dose 4 of Moderna Vaccine on 09-Jul-2022 with Batch no. being reported as 017B22A.   Treatment information was not reported.   This case was linked to MOD-2023-725105 (Patient Link).
Within 5 minutes of injection, Dr. complained of a sensation of coldness going down the arm to the hand.  When checked on roughly 15 minutes later, reported numbness that started at anterior crease of the elbow that continued to the palm of the hand and the posterior aspect of the hand.  Mobility not affected.  Followed up roughly one hour post injection.  Reported no change.
Gave 0.5ml for the 3rd dose instead of 0.25ml.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 at 12:15 as dose 1, single (Batch/Lot number: unknown), in right arm and on 09Apr2021 at 15:30 as dose 2, single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 26Dec2021 at 13:30 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 26Dec2021 at 13:30, outcome "unknown", described as "vaccine brand other=Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Oct2022) Positive, notes: Rebound within a week of completing paxlovid course of treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Expired vial 10/24/2021 administered 10/26/2021.
First soreness at injection site.  Next day severe muscle pain in arm pit and severe headache on left side of head.  Muscle pain has subsided over 3 days, but still some there.  Headache on and off for 2 days.
3 hrs post vax; awoke from nap w/gasping respirations; appeared pale in color; breathing irregular episode lasted 5 mins; went to local ER; t101; color improved adm to hosp for observation;
following #2 dose of vax pt was inconsolable for 2 days w/t104 for same interval;
WHEN PATIENT WENT HOME AFTER VACCINATION, STARTED FEELING PAIN IN LEFT ARM THAT STARTED TO SWELL.PATIENT SAYS SIDE EFFECTS THAT INCLUDE HARD TIME WALKING AND CONFUSION LASTED FOR 20-24 HOURS AFTER GETTING VACCINATED.  PATIENT STATES THAT SHE WASN'T ABLE TO DO ANYTHING ON SATURDAY 07/13/19 AND FELT THE PAIN WAS GONE BY SATURDAY NIGHT.  PATIENT STATES THAT SHE DIDN'T HAVE ANY SORENESS IN HER RIGHT ARM OR EXPERIENCED ANY OTHER SYMPTOMS. THERE WAS NO FEVER INVOLVED BUT PATIENT FELT LETHARGIC AND WEAK.
Presented to the ED for evaluation of heart palpitations, bilateral lower leg pain, bilateral arm pain, and headache onset two weeks (6 weeks from vaccine) Patient got a CT angiogram of the chest which indicated faintly visible peripheral subsegmental emboli within the left greater than right lower lobe pulmonary arterial distribution.  Patient received 0.9% sodium chloride 250 mL and apixaban 10 mg.
Temp: 103.3; extreme pain in vaccinated arm resulting in inability to move or lift arm; nausea, headache; symptoms unset less than 24 hrs after injection. TX: Tylenol and bedrest
This case was reported by a pharmacist via call center representative and described the occurrence of breast cancer in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving Shingrix, the patient experienced breast cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the breast cancer was unknown. Additional details were provided as follows: This case came via email into Medical Information's queue. The age at vaccination was not reported. The patient had SHINGRIX vaccine approximately 1 month before the reporting date. On 7th August 2018, the patient was scheduled for breast cancer chemotherapy, and had been advised by her oncologist to avoid any vaccines. The healthcare professional reported it as a possible adverse event. The timing of breast cancer diagnosis was unspecified in relation to when the patient received SHINGRIX.
Wednesday morning I noticed server loud pitch noise in both ears, tinnitus.  I still have it over a week later though I do have short periods of low pitch ringing now
pt had a positive COVID test on 8/27/22 and passed away in the facility on 8/30/22
This case was reported by a consumer via call center representative and described the occurrence of pain in extremity in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in extremity. On an unknown date, the outcome of the pain in extremity was recovered/resolved. It was unknown if the reporter considered the pain in extremity to be related to Shingrix. Additional details were received as follows: The age at vaccination was not reported. The reporter mentioned in a very casual statement that she knew a patient that experienced a sore arm for couple of days and recovered. When the reporter asked for detailed information, reporter did not want to provide information without the consent of people involved. This is one of four cases reported by the same reporter.
This case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, 14 hrs after receiving SHINGRIX, the patient experienced sickness, nausea, pain, headache and fatigue. On an unknown date, the outcome of the sickness was unknown and the outcome of the nausea, pain, headache and fatigue were not recovered/not resolved. It was unknown if the reporter considered the sickness, nausea, pain, headache and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was very sick 14 hours after receiving vaccine and asked how long it would last. The patient also experiencing nausea, aches with a headache, fatigue and was on bed most of the day.
Pt called & complained of severe muscle aches & numbness in her arm (3 days after administration). She could hardly move it. Was told to take ADVIL or ALEVE for it.
Two days after red dots on chest, welts at injection sight,  went away.  Nine days later woke up, injection sight looked like  a bee sting before I got into shower.  After I got out of shower, my whole body was itching, injection sight was welted up three times as big,  and felt nauseous. Also had the red spots on chest again.
Patient reported itching sensation through body. Patient ported noting Hives.  Patient airway clear.  Assessed by NP on site, given 10 mg Zyrtec PO.  Hives resolved, patient felt better. Disposition to home.
She adds that she has a very uneasy feeling about getting the 2nd vaccine, she will not g; she is fearful,; She is worried that she only has 1 vaccine on the card, is Pfizer able to provide an excuse not for her ?; This is a spontaneous report from a contactable consumer reported for herself. A 55-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. She had the covid virus last year on 13Mar2020, she again confirms it was in 2020 when she came down with it. She was moderately to severely sick, but she just had telehealth appointments there was no hospitalization, she has asthma and diabetes, it lasted 3 weeks, and she did not have long lasting effects from the virus. She was Allergic to tree nuts. The patient's concomitant medications were not reported.  The patient stated that she has a very uneasy feeling about getting the 2nd vaccine, she will not get it, she is fearful, she feels like she would be hospitalized with the second, she though it would kill her, she doesnt know how to be protected. She is scheduled for the second dose on 19Apr2021 at 10:15. She had the positive covid result in Mar2020, it was a deep nasal swab. She has had 3 covid test in total, being the 1 positive one last year and she did 2 this year. Caller clarifies that the 2 tests this year were not due to symptoms or anything. She only took the test to be able to visit her mom in the group home. Outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021404399 same reporter/patient/drug, different event in separate dose
Injection site sore, tiredness, muscle pain all over body (especially my back), chills, sweats, joint pain all over (even my fingers), nausea and just not feeling well.  All symptoms was really bad the day after the vaccine.  The second day there was some relief and on the third day I was still having most of the symptoms but feeling better than I did the first and second day.
Maternal exposure during pregnancy, third trimester; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Oct2021 (Lot number: Ff2588) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergy: penicillin" (unspecified if ongoing). The patient was 36 weeks pregnant at the event onset. The patient is expected to deliver one baby. The patient took concomitant medications. Past drug history included: Aspirin, reaction: "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: El 3247, Location of injection: Arm Left), administration date: 02Feb2021, when the patient was 33 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: El1284), administration date: 10Jan2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 23Oct2021, described as "Maternal exposure during pregnancy, third trimester"; IMMUNISATION (non-serious) with onset 23Oct2021, described as "Booster".  The patient delivered a child with Congenital anomaly or birth defect  Follow up information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101724262 Mother/baby case
9 days after the shot my right shoulder is sore and sensitive to touch, but it is not at the injection site. I have some swelling above my right collar bone and a swollen gland.