chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started with chest pain, palpitations, difficulty breathing, sweating, dizziness, and headaches. But sweating went away overtime.  Now I am experiencing joints pain, dyspnea with minimal exertion, persistent chest pain and overwhelming headaches. Also tingling on the medial side of both hands, back pain, and generalized fatigue. I used to be a very healthy person, but right now I am suspended from driving as result of having multiple episodes of syncope that I have never had before. I cannot concentrate on anything; I will never be able to play tennis anymore. I am just desperate for my health and I am convinced that my life will never be the same. I am just praying God to keep me alive!
Shingles; Hurt; Burning under my skin; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles, pain and burning sensation. On an unknown date, the outcome of the shingles, pain and burning sensation were not recovered/not resolved.  It was unknown if the reporter considered the shingles, pain and burning sensation to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient reported that got shingles Vaccine and two weeks later, got the shingles it hurt like hell, still burning under the skin. The follow-up would not possible as no contact details were available.
THIS IS QUALITY EVENT. THIS PATIENT WAS GIVEN PFIZER 12 AND UP GRAY CAP VACCINE (  NO DILUENT NEEDED). THIS WAS DULUTED AS PFIZER AGES 5 TO 12 WITH DILUENT AND GIVEN AT KIDS DOSE 0.2ML ON 02/21/22. STAFF REALIZED ON 02/22/22 AND CONTACTED THE PARENTS ASAP. NO ADVERS REACTIONS REPORTED AT THE TIME FOR THIS CHILD.
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 10-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up).    Concomitant medications details were not reported by the reporter.  Patient ID was reported as 7656467.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Reportedly, In this report the patient was not Eligible for vaccine. Breakdown of doses were reported as 51 doses from batch numberAS7140C and  60 doses from Batch number AS7148B.  Treatment details were not reported by the reporter.
At apprx. 1151 pt reported throat itching and dizziness.  He was moved to cot to lay down.  At 1155  BP 158/92 HR 60 Osat 99%.  At 1200 BP 155/95, HR 66, OSat 100%.  Pt continued with initial symptoms and felt like lips were swelling.  Pt intermiten Trendelenburg. At apprx. 1205 administered 50mg Benadryl IV by paramedic.  At 1220 pt symptoms continued and he was transported by squad to the Hosptial.
Developed hives on arms and chest. Experienced headache, diarrhea, and lethargy.
Patient received the 1st dose of the COVID vaccine (Pfizer Lot # ER8735 expiration date 07/05/2021) at 1738. At 1800, the client walked up to the EMT desk and asked EMT, "can you take my blood pressure." EMT asked the client if she was feeling alright. The client stated, "I feel some tingling in my finger tips and I'm a little hot and sweaty." PHN responded at 1801 and helped EMT escort her to the zero gravity chair. The client denied any shortness of breath, difficulty breathing, or nausea. Vital signs were taken at 1802 (blood pressure 142/84, heart rate 62, oxygen 96%). PHN offered the client Benadryl at 1805, which she refused. Client has no medical history, no allergies and is not taking any medications. Vital signs taken at 1812 (132/84, heart rate 59, oxygen 97%). At 1812, client stated, "the tingling is gone. Maybe I was nervous. My friend passed out and vomited when she got her vaccine." Vital signs taken at 1822 (blood pressure 130/80, heart rate 52, oxygen 97%). EMT asked the client if this heart rate was normal for her, which the client replied, "yes." Vital signs taken at 1830 (blood pressure 122/72, heart rate 51, oxygen 97%). PHN advised client to follow up with primary care provider and an allergist, and provided education on when to seek emergency services. At 1832, client stated, "I feel fine now," and left the facility unassisted with a steady gait at 1832.
Pain and swelling under armpit of left arm.  As of 1/5/21 (day 7) pain and swelling continues.
Extreme spike in blood pressure 230 systolic. First blood pressure reading since receiving vaccine. I was sent to Emergency Room.  They found none of the usual suspects that cause this spike. Vaccination was my only new experience in many months. Never had near this high of a reading. Is there a connection?
Double pneumonia in the both lungs/fully vaccinated and still got a Delta variant; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (Double pneumonia in the both lungs/fully vaccinated and still got a Delta variant) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 PNEUMONIA (Double pneumonia in the both lungs/fully vaccinated and still got a Delta variant) (seriousness criteria hospitalization and medically significant). At the time of the report, COVID-19 PNEUMONIA (Double pneumonia in the both lungs/fully vaccinated and still got a Delta variant) outcome was unknown.            Concomitant medication was not reported.  Patient received Moderna vaccine. Patient was hospitalized due to double pneumonia in both lungs. Patient was fully vaccinated and still got a Delta variant. Treatment details were not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the unexpected and serious (due to hospitalization and medically significant) AESI of COVID-19 pneumonia, which occurred after the second dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the unexpected and serious (due to hospitalization and medically significant) AESI of COVID-19 pneumonia, which occurred after the second dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Patient refers to  her experience with her two vaccines and explains her reaction to the first vaccine. Due to her health history, the patient suffers from a rare cancer, she has her annual check ups. A mammogram was performed it showed the following, bilateral need replaced sonography normal axillary lymph node are seen. Prominent right axillary lymph are recognized measuring 0.9 and 1.6 cm, most likely associated to COVID vaccination.
soreness in left arm started around 6 hours after the dose. Day after the vaccine, pt woke up with a low-grade fever, fatigue, and full-body weakness, and nausea. Pt admits to sleeping for the majority of the day. No pain reliever or fever reducers were taken. After 26 hours post vaccine, fatigue lessened but low-grade fever and weakness persisted.
Diarrhea FEVERISH, DIARRRHEA X2 DAYS Narrative:
7/10/2022 Woke up with a cough.  7/12 I had body aches and couldn't taste or smell.  I took a home COVID 19 Rapid test and it was positive.  Telemedicine with Doctor who prescribed Paxlovid.  Began to feel better 7/18.  Cough lingers.
Nausea and vomiting 10 min post vaccine - has cold S/S PRIOR to vaccination.
HSV SWELLED UP NERVES; SHINGLES; TESTED POSITIVE FOR HSV LAST WEEKEND; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2023, the patient experienced tested positive for hsv last weekend. Laboratory data included: Herpes simplex test Positive. On an unspecified date, the patient experienced hsv swelled up nerves, and shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tested positive for hsv last weekend, hsv swelled up nerves and shingles was not reported. This report was non-serious.
This spontaneous report was received from a health professional referring to multiple patients of unknown age and gender. The patient's medical history, drug reactions/allergies and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with doses of ZOSTAVAX lot number: M011665, expiration date: 17-MAY-2017 (concentration, dose, frequency and via were not reported), which were improperly stored at 32.5 Fahrenheit degrees for 16 hours. No previous temperature excursion was reported and it was not detected due to a data logger. No adverse effect were reported. Additional information has been requested.
p/vax pt devel an urticaria type rash on abd & groin;pt sought unspecified medical attention;
Cellulitis developed to right arm where received Menveo injection. Treated with cephalexin.
After several hours in pm. pt started vomiting uncontrollably, per pt states she threw up about 40 times. On sat morning pt, started having severe leg pain and couldn't stand to touch them.  Informed pt to go to the ER to be seen.
Overall aches, fatigue, fever and chills for which I took Aspirin 3X's across 24 hours. Initial symptoms lasted 12 hours. Since I was feeling fine by 9:00 the next morning (24 hours after the vaccination,) I resumed my usual busy Saturday morning-activites but by 12:00pm the symptoms had  returned. That is when I took the 3rd dose of Aspirin and slept for 3 hours. Sunday I was pretty much inactive. Since then I have felt fine (if more fatigued than usual.)
Information has been received from a certified medical assistant concerning a female who in June 2008 was vaccinated with the second dose of GARDASIL vaccine. The patient had "trouble getting shots or giving blood." The patient laid down for 15 minutes post vaccination and was monitored. When the patient walked down the hall way the patient fainted, and it took the patient about 30 second to revive. Smelly salts were place under the patient's nose. Subsequently, the patient recovered from faint. The patient sought medical attention at the office. This is one of several reports from the same source. Additional information has been requested.  10/08/08 This is in follow-up to report(s) previously submitted on 7/15/2008. Information has been received from a certified medical assistant concerning a 15 year old female who on 10-APR-2008 was vaccinated with the first dose of GARDASIL (lot# 659182/1757U) at 1900. On 19-JUN-2008 the patient was vaccinated with the second dose of GARDASIL at 10:00. The patient attempted to leave and started to feel nauseated after the second dose at 10:00 on 19-JUN-2008. The patient ran into the wall and passed out. The patient was put on floor and it took the patient about 30 second to revive. Smelly salts were placed under the patient's nose. Subsequently, the patient recovered from faint but still nauseated. The patient did not eat anything prior to shot. The patient was advised to eat prior to the last shot. This is one of several reports from the same source. Additional information has been requested.
pt recvd vax;lt deltoid swollen,red,itchy;entire arm achy;30mar95 dizzy & stomach cramping & n for 1 hr;arm red & swollen & warm to touch from shoulder to elbow;31mar95 achy joints;malaise;d;ice,motrin given;lt arm sl red;3apr95 no redness;
Subjective: Patient is here for rash for 2-3 weeks. It initially started the same night as she received her flu shot. Started on neck, then back, arms. It has mostly resolved but she now has some on her upper forehead.  Previously tolerated influenza vaccine without any issues. No signs of anaphylaxis, no throat/oral swelling, wheezing, SOB, or hive-like rash. Rash described as tiny small bumps, fairly itchy. Not painful. Exposure to new foods, soaps, detergents, or skin care products: No Recent viral symptoms: No MRSA history: No prior history of MRSA or other serious infections. ROS: Has not had fever, rash, cough, difficulty breathing, vomiting, diarrhea or dehydration concerns.  PMHx: Generally healthy since birth, no chronic health problems.
Felt her heart racing and pounding; felt queasy; Felt her heart racing and pounding; This spontaneous case was reported by a consumer and describes the occurrence of the second episode of PALPITATIONS (Felt her heart racing and pounding), the first episode of PALPITATIONS (Felt her heart racing and pounding) and NAUSEA (felt queasy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included Flu like symptoms (The patient may have had a variant of COVID as she had all the symptoms of it, flu like) in October 2019. Concurrent medical conditions included Shellfish allergy and Asthma since October 2019.    On 16-Mar-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced the first episode of PALPITATIONS (Felt her heart racing and pounding). On 16-Mar-2021 at 11:30 PM, the patient experienced the second episode of PALPITATIONS (Felt her heart racing and pounding) and NAUSEA (felt queasy). The patient was treated with CALCIUM CARBONATE (TUMS ANTACID) for Adverse event, at an unspecified dose and frequency. At the time of the report, last episode of PALPITATIONS (Felt her heart racing and pounding) and NAUSEA (felt queasy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-086533, US-MODERNATX, INC.-MOD-2021-086723 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Syncope; Diarrhea; Low pressure; Flu-like symptoms; A regulatory report  was received from a consumer concerning a 72-years-old, male patient who received Moderna's COVID-19 Vaccine, and who experienced flu-like symptoms, head went back, eyes went white, jaw move left to right, made a last breath, thought he died, diarrhea and low pressure.  The patient's medical history included high blood pressure. Products known to have been used by the patient, within two weeks prior to the event, included Metoprolol succinate.  On 24 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (042L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.    On 25 Jan 2021, the patient reported flu-like symptoms. Treatment information was not provided.   On 26 Jan 2021, the patient reported head went back, eyes went white, jaw move left to right, made a last breath, thought he died, diarrhea and low pressure. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.   The event, flu-like symptoms was considered recovered/resolved on 25 Jan 2021.  The events, head went back, eyes went white, jaw move left to right, made a last breath, thought he died, and diarrhea was considered recovered/resolved on 26 Jan 2021.  The outcome of the event low pressure was unknown.; Reporter's Comments: This case concerns a 72 year old male with medical history of hypertension on metoprolol, who experienced a serious unexpected event of syncope and non-serious unexpected events of flu-like symptoms, diarrhea, and low blood pressure. Event onset was 1 day after first dose of mRNA-1273. Flu-like symptoms resolved. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
7-13-09 child received 4 immunizations at Dr office. 7-15-09 site of MMR was red, hot and raised, no fever, no malaise, child acting normally. Went to see physician assistant at the clinic, placed on KEFLEX in case of cellulitis prevention. Pt saw PA 7/16/09 area of infection much better per the PA.
Within 2-3 days, the pt developed an injection site reaction described as cellulitis.
covid arm that is itchy; covid arm that is red; covid arm that is hot; covid arm that is swollen; covid arm that is painful and sore; covid arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (covid arm that is itchy), VACCINATION SITE ERYTHEMA (covid arm that is red), VACCINATION SITE WARMTH (covid arm that is hot), VACCINATION SITE SWELLING (covid arm that is swollen) and VACCINATION SITE PAIN (covid arm that is painful and sore) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included irms for an unknown indication.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (covid arm that is itchy), VACCINATION SITE ERYTHEMA (covid arm that is red), VACCINATION SITE WARMTH (covid arm that is hot), VACCINATION SITE SWELLING (covid arm that is swollen), VACCINATION SITE PAIN (covid arm that is painful and sore) and VACCINATION SITE REACTION (covid arm). The patient was treated with irms at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pt received COVID vaccine on 3/12/2021 at 9:05 AM. At 9:10 AM, pt informed RN she was experiencing itching and hives around injection site on her left arm. Pt experiencing localized reaction at site of COVID vaccine. No symptoms of anaphylactic reaction observed. Pt counseled on localized reaction. 1 Diphenhydramine HCl 25 mg tablet given at 9:13 AM. Per pt report, itching and hives began to resolve within 10 minutes. Upon assessment, hives were resolving 10 minutes post diphenhydramine HCl administration. Pt advised to stay at site for 30 minutes for observation. Pt stayed 30 minutes after diphenhydramine HCl administration. No hives or pt complaints of itching at the site of administration or arm when she left at 9:45 AM.
Chest pains; Fever; Chills; Aches; Joint pain; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration in left arm on 21Mar2021 at 11:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included hydrochlorothiazide (manufacturer unknown), omeprazole (manufacturer unknown) and trazodone (manufacturer unknown), all on unknown dates for unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN via unspecified route of administration in left arm on 28Feb2021 at 11:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. The patient previously received levofloxacin (LEVOQUIN) (manufacturer unknown) for unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 22Mar2021, patient experienced chest pains, fever, chills, aches, joint pain and fatigue. No therapeutic measures were taken for the reported events. The clinical outcome of the events all the events was recovering at the time of reporting.   Information about lot number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: added patient age at first dose.
Pt. had a small pustule form 10 days after VARIVAX given at vaccination of VARIVAX site no other symptom pt.'s mother was advised to use anti-itch cream.
EXPIRED VIAL ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced expired vial administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vial administered was not reported. This report was non-serious.
Patient had episode of projectile vomiting with suspected aspiration and subsequent fever on the night of vaccines.
Redness about half size of fist, mild swelling, hardness at injection site.  Fever up to 100f.  Elevated pulse up to 110.