chrisvoncsefalvay/vaers-outcomes huggingface dataset:
16 year old previously healthy male presented with chest pain consistent with cardiac chest pain that developed 24 hours after the initial vaccination. On presentation, EKG with findings consistent with myocarditis vs pericarditis. Troponin peak was approximately 5.2 on 7/22 and subsequently downtrended. Echocardiogram obtained which showed normal EF, no pericardial effusion, and no wall motion abnormalities. He was observed on cardiac telemetry with serial EKGs and troponins and was cleared for discharge by cardiology and infectious disease. Symptoms were treated conservatively--NSAIDs PRN. He is currently in the recovery phase from the myocarditis and will follow outpatient with cardiology.
Patient experienced some facial swelling while in the observation area. Patient didn't realize there was any swelling until he looked in the mirror. He also reported feeling a little flushed and light headed. No diaphoresis noted.  EMS called to assist, asked him allergic to anything, he said no known allergies but suffers a lot from seasonal allergies.  I offered, and he took one 25 mg PO Benadryl with water @ 11:32 a.m.  EMS took @ 11:33 BP: 160/110, HR 70, R 16, Pulse Ox 97% he said this BP was high for him. Second reading @ 11:44 BP 144/104, HR 62, R 16 Pulse Ox 97% Third reading @ 11:48 BP 130/88, HR 64 R 16 Pulse Ox 97%, vitals back to more normal for him.  Glucose 77 @ 11:42. We kept him for 30 minutes post vaccination, and he was said he was feeling fine, no additional symptoms, swelling above eyebrows decreased and no more flushing symptoms.  EMS offered to take him to the hospital, he refused said he was a physician and was feeling better after given the Benadryl.
AT APPROXIMATELY 15:33 PATIENT THINKS HER THROAT IS SCRATCHY. NO APPARENT DISTRESS IS PRESENT. AT 15:35 PATIENT FEELS LIKE A LUMP WHEN SWALLOWING. REPORT CALLED TO MEDICAL CONTROL AT 15:45. AT 15:57 NOW PATIENT STATES THROAT IS TIGHTENING. PATIENT DECLINED MED CONTROL AND DROVE HERSELF TO EMERGENCY DEPT ESCORTED BY MEDIC.
I had my eyes checked at 9:30 am. 9-25-16. Then went and got my flu shot around 11:00 a.m. Went home and watched TV and relaxed. Woke up the next day tired and wore out. Can sleep no problem can't wake up.
Child moved here from another state, getting enrolled in school. Received shots 3/19/08 prior to move. These shots were not noticed until after the client had left the clinic. Received additional IPV. Mother notifed by telephone. To call nurse if child had any local reactions. No reactions reported.
Patient had redness and swelling to right thigh, soft, no drainage. Pt had no limping, was playful.
Fever 101.2, chills/rigors, severe body aches. (L) arm - entire upper arm red, hot, swollen, painful -> went on to cellulitis -> required KEFLEX 7 days P.O.
I experienced a rash/hives/redness on my chest after 10-20 mins. My breathing was fine, but the rash was starting to spread and my chest felt a hot and cold sensation.
12 year old patient administered expired dose of MENACTRA vaccine with no reported AE; Initial information received on 07-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional via Physician.  This case involves a 12 year old and unknown gender patient who was vaccinated with an expired dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation.  On 28-May-2021, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6575AB and expiry date: 08-May-2021) (Frequency: once) via an intramuscular route at an unknown administration site (expired product administered) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  It was also reported Caller stated that a dose of MENACTRA was given on 5/28/2021 but it had expired on 5/8/2021. If baby was delivered: delivery date and if baby experienced an adverse event. Inform that they will be receiving a follow up questionnaire. If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is an FDA requirement. Product used: Used  At the time of reporting, no adverse event was reported.  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 the 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.
suspected vaccination failure; shingles; it hurt to much; had a total of three singles vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and extra dose administered. On an unknown date, the outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient received total of three doses of Shingles vaccine which led to extra dose administered. After receiving Shingles vaccine, the patient got shingles above right hip and he/she could not lay down on right side when went to bed and it hurt too much. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.
5.5 hours after vaccination: heart pounding intensely, palpitations, chest tightness. Best way to describe is that it felt like my heart was going to beat out of my chest and explode. This started very suddenly, continued for a few minutes intensely, and for now (~1 hour after onset) seems to have leveled off. Less intense but chest still feels tight.
The patient states that she noticed increased hair loss which has gotten worse over time...to the point the patient is thinking of cutting her hair short
Right pneumothorax sp chest tube placement. ED visit and hospital admission within 6 weeks of receiving the CVOID vaccine.
Initial and follow up information has been received from a health professional concerning a 78 year old female who on Oct 26 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 649111/0287P). On Oct 26 2004 the patient experienced redness, soreness and pain in the arm where she was vaccinated. The symptoms subsided after one week, on approximately Nov 01 2004. The healthcare worker also reported that the patient notified the doctor office of symptoms via telephone, no diagnostic work up was performed on the patient in the hospital or as an outpatient. The patient was told to call the office or come in for a follow up visit if the reaction got worse. Additional information is not expected.
It has grown a little each day and is spreading out. It is not as red today, but has expanded about half an inch since yesterday; 3 inches below the injection site she has a thick lump that is red and it is growing; 2 inches above the injection site she got a large swelling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78-year-old female patient received BNT162b2 (BNT162B2), on 14May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 78 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: covid-19 vaccine (First dose: , Date: 19Mar2021, Lot number: ER2613, Expire: 31Jul2021), administration date: 19Mar2021, when the patient was 77-year-old, for Covid-19 immunization, reaction(s): "The previous Covid vaccines affected her tachycardia"; covid-19 vaccine (Second dose: , Date 16Apr2021, Lot: ER8730, Expire: 31Jul2021), administration date: 16Apr2021, when the patient was 77-year-old, for Covid-19 Immunization, reaction(s): "The previous Covid vaccines affected her tachycardia". The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 15May2022 at 12:00, outcome "recovering", described as "2 inches above the injection site she got a large swelling"; VACCINATION SITE MASS (non-serious) with onset 16May2022 at 06:30, outcome "not recovered", described as "3 inches below the injection site she has a thick lump that is red and it is growing"; PERIPHERAL SWELLING (non-serious) with onset 16May2022 at 06:30, outcome "not recovered", described as "It has grown a little each day and is spreading out. It is not as red today, but has expanded about half an inch since yesterday".  Additional Information: Caller reported she had a weird reaction to the booster of the Pfizer Covid 19 Vaccine that she didn't have to the other two doses. Per caller she experienced swelling about 2 inches above injection site the next day. The swelling has gone down quite a bit but its still there. About 3 inch below site she developed a thick lump that is red and growing. It's extremely warm and sensitive to touch. Caller marked the area with a black marker to monitor the swelling. It appears to have grown each day and is spreading out. Caller wanted to know if there have been reports of the issue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (18May2022): This is a spontaneous follow-up report received from the same contactable consumer. This 78-year-old female consumer reported that: Updated information included: Reporter information (salutation added).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Exactly 8 days after first vaccine an approx 3? red circle rash appeared around the injection site.  It didn?t hurt but was tender to the touch and itched non stop.  I took Benadryl by mouth and bought topical Benadryl to help control the itching.  After 1 day after a week the rash was totally gone.
Patient brought into the ED via EMS on 7/6/2022 for fever, vomiting, dry cough, and sneezing. He has a history of diabetes and DKA, and was concerned that he might be developing DKA. COVID PCR test completed in the ED was positive. Patient was admitted from 7/6-7/8/22 with COVID pneumonia with severe dehydration. Patient vaccinated with most recent vaccine administrated 1/28/22. This meets criteria for vaccine breakthrough case review.
Pneumonia; This spontaneous case was reported by a patient and describes the occurrence of PNEUMONIA (Pneumonia) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PNEUMONIA (Pneumonia) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Company comment:  This is a spontaneous case concerning a female patient of unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) event of pneumonia after the administration of the second dose of mRNA-1273 vaccine. Latency could not be assessed due to lack of information on vaccination date and onset date of event. No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-749833 (E2B Linked Report). This case was linked to MOD-2023-749833 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749833:Same reporter, different product
Pt. received BOOSTRIX and ZOSTAVAX on 10/11/17. Next pt. day broke out in hives. On 10/14/17 was prescribed prednisone taper - hives worsened and pt. returned to doctor and was prescribed a stronger prednisone taper.
Information has been received from a medical assistant concerning a 10-week-old male with allergic rhinitis and an allergy to sulfonamides who on 19-AUG-1993 was vaccinated with his first dose of RECOMBIVAX HB (Lot # 608134/0848W). On 14-OCT-1993 he received his second dose (Lot # 608884/1087W) and on 29-APR-1994 the third dose (Lot # "1325B"). Concomitant therapy included SINGULAIR. On 31-AUG-2007 the patient had a negative hepatitis B antibody titer. The patient sought unspecified medical attention. A product quality complaint was not involved. Additional information has been requested.
The pt experienced a rash, scratching since 8/30/00, was seen in the ER on 8/31/00. Treated with Tylenol and or Motrin and Benadryl.
Approximately 2 weeks after receiving Rubella vaccine developed edema of arms and legs and aching joints all over. Tx by personal physician 4/21/03 with Kenalog IM and Medrol dose pack. Pt reports complete resolution of symptoms.
Hands crack; hands became raw; Hands kept shedding skin/Like a bad case of eczema; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EROSION (hands became raw), ECZEMA (Hands kept shedding skin/Like a bad case of eczema) and SKIN FISSURES (Hands crack) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 013A21A and 046A21A) for COVID-19 vaccination.     Concomitant products included RAMIPRIL for Blood pressure, ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN D NOS, PRAVASTATIN and CALCIUM for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced SKIN EROSION (hands became raw) and ECZEMA (Hands kept shedding skin/Like a bad case of eczema). On an unknown date, the patient experienced SKIN FISSURES (Hands crack). The patient was treated with PREDNISONE on 09-Dec-2021 for Adverse event, at a dose of 20mg prednisone for 7 days. At the time of the report, SKIN EROSION (hands became raw), ECZEMA (Hands kept shedding skin/Like a bad case of eczema) and SKIN FISSURES (Hands crack) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Allergy test: normal (normal) No allergies.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had stated that Due to Crack she couldn't go outside. Patient Had to wrap hands at night by using use steroids.
I was believed to be about six weeks pregnant (first trimester) and have started having heavy vaginal bleeding the day after I was given the vaccine. The day I got the vaccine I felt fine beyond arm pain until 2:30 PM when I began feeling chills and sweaty. I measured my temperature and did not have a fever but took Tylenol as advised due to being pregnant.  I felt poor through today and this evening began having heavy vaginal bleeding most consistent with a miscarriage. I have never miscarried before. I will go get labs drawn at the earliest time when I call my provider tomorrow.
Varicella vesicles - approx 100 located mostly in trunk and extremities; low grade fever, malaise and post partum woman delivered c-section given vaccine prior to discharge from hospital.
adverse vaccine reaction; : A STUDY TO EVALUATE THE SAFETY OF THE PFIZER-BIONTECH COVID-19 VACCINE IN HEALTHCARE WORKERS, THEIR FAMILIES, AND THEIR COMMUNITIES  This is a report from a safety study.  A 33-year-old female subject started to receive study vaccine, BNT162B2, first dose on 23Dec2020, second dose on 15Jan2021, both for COVID-19 immunization. Relevant medical history and concomitant medications were both unknown. On 23Dec2020, the subject experienced adverse vaccine reaction, assessed as serious as an important medical event. The clinical course was as follows: On 23Dec2020, the subject presented to emergency department and stated 10 minutes after receiving the COVID-19 vaccination, she developed funny sensation of the lips and neck and felt as though she had trouble breathing. She was treated with epinephrine, antihistamines and corticosteroids and her symptoms resolved to baseline. No prior history of anaphylaxis. The subject was discharged home the same day. Emergency department discharge diagnosis: Reaction Allergic Initial. On 31Dec2020, subject followed-up at out-patient clinic. The clinic physician notes: The 33-year-old female who experienced an adverse reaction to the Pfizer COVID vaccine on 23Dec2020. The clinical notes suggested that there were no objective findings, and the adverse reaction consisted more of symptoms or subjective findings. It was unclear whether the adverse vaccine reaction represented anaphylaxis or not. The action taken with product BNT162B2 was not applicable. The outcome of the event was recovered on 23Dec2020.  The investigator considered there was a reasonable possibility that the event adverse vaccine reaction was related to BNT162B2, but unrelated to concomitant drugs.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Vaccination adverse reaction. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
The night that followed my vaccine I got cold chills and shakes for about 2 hours.  That was followed by labored breathing for about two hours.  The soreness from the shot was intense and I couldn't sleep for more than an hour or two at a time.  The day following the shot I felt groggy and not myself.  I ended up taking a four hour nap the next day in the afternoon and very unproductive as I didn't feel good the rest of that day.
acute diverticulitis; micro-perforation of the colon; This literature-non-study case was reported in a literature article and describes the occurrence of DIVERTICULITIS (acute diverticulitis) and LARGE INTESTINE PERFORATION (micro-perforation of the colon) in a 41-year-old male patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIVERTICULITIS (acute diverticulitis) (seriousness criterion medically significant) and LARGE INTESTINE PERFORATION (micro-perforation of the colon) (seriousness criterion medically significant). At the time of the report, DIVERTICULITIS (acute diverticulitis) and LARGE INTESTINE PERFORATION (micro-perforation of the colon) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DIVERTICULITIS (acute diverticulitis) and LARGE INTESTINE PERFORATION (micro-perforation of the colon) to be related.    No concomitant and treatment medication were reported. COMPANY COMMENT: This is a literature non-study case concerning a 41-years-old male patient with no medical history who experienced the unexpected (seriousness criterion medically significant) events of DIVERTICULITIS and LARGE INTESTINE PERFORATION unknown days after  3rd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is a literature non-study case concerning a 41-years-old male patient with no medical history who experienced the unexpected (seriousness criterion medically significant) events of DIVERTICULITIS and LARGE INTESTINE PERFORATION unknown days after  3rd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
tired; sore throat (GERDS): Dec. 2 head ache for 3 weeks; Dec 21 more palpatations noted( I have SVT);  started medication for GERDS for 3 months- symptoms better; headache- gone palpations continue - scheduled to visit doctor after the New Year.
Same day of vaccination day later on that night I started having chills, body aches, & fatigue. The next day on 1/26/2021 the fatigue got worst but the body aches & chills got better. On 1/27/2021 I recovered from the fatigue. Also on 1/26/2021 around mid day I also noticed that on the vaccine site it was swollen it was progressing every day. It was very painful, it was very warm, it was more red & slight itchiness. On 1/27/2021 It was the worst day everything increased more, the pain, the swollen, & redness. I took Benadryl & Zyrtec. On 1/28/2021 my symptoms got a lot better.
Chills, slight nausea,  injection site pain and swelling, muscle pain, generally achy. All symptoms still felt the next day (am still experiencing them at time of report). No treatment sought yet.
Pt. due for DTAP but KINRIX was given unintentionally on LVL.
No other adverse events reported; Caller reports that doses of improperly stored vaccines were administered to patients.; This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and geneder. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 17-JUN-2022, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error) oral liquid, 1 dosage form, lot #1742084, expiration date: 05-OCT-2022, administered orally for prophylaxis (dose number and strength was not provided). No other adverse events reported.; Sender's Comments:  US-009507513-2206USA006019: US-009507513-2206USA006096: US-009507513-2206USA006141: US-009507513-2206USA006272: