chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Recently diagnosed with cancer after receiving both doses of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Recently diagnosed with cancer after receiving both doses of Moderna vaccine) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Recently diagnosed with cancer after receiving both doses of Moderna vaccine) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (Recently diagnosed with cancer after receiving both doses of Moderna vaccine) outcome was unknown.            The concomitant medications were not reported. The treatment information was not provided.  Company Comment :Very limited information regarding this event has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt has redness, swelling and pain to lt deltoid area and also warm to touch. Pt saw md 05/04/08 and was started on oral abx
Fast heart rate twice approximately 2 hours after vaccine. Once more in late evening after going to bed.  Each instance only lasted less than one minute.
Patient reports raised area post vacc. to where 7 days later post injection site became warm and pruritis set in. Pt reports reddened area began to form. Pt took benadryl to where reliet was reported. Reddened area still remains 2x1.5 on 1/19/21 patient reports warm area still remaining. Pt did not seek medical attention.
On 5/5/21 patient developed an erythematous rash with large urticaria, warm to touch on his left upper arm at the site of injection.  He has been having intermittent paresthesia of his left upper/lower arm and hand.
Pt called with c/o lump red, hot to touch, "not angry". Advised to take BENADRYL.
Fine through the shot. About 3 minutes after the shots, her legs started shaking and she passed out.
She was diagnosed with Shingles 2 days ago/ shingles are on the left side of her shoulder and neck; This is a spontaneous report from a contactable consumer (patient). An 84-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 10:30 (Batch/Lot Number: EN6199; Expiration Date: 30Jun2021) as 1ST DOSE, SINGLE for covid-19 immunisation, at 84 years old. Medical history included  arthritis, atrial fibrillation, blood cholesterol (abnormal), blood pressure (abnormal), insertable cardiac monitor; all from unspecified dates and ongoing. No vaccines administered on the same date with bnt162b2 and no other vaccines within 4 weeks. Concomitant medications included apixaban (ELIQUIS) taken for atrial fibrillation; pravastatin taken for cholesterol; diltiazem hydrochloride (DILTIAZEM) taken for blood pressure; acetaminophen taken for arthritis, all from an unspecified start date and ongoing. The patient experienced she was diagnosed with shingles on 27Mar2021. The shingles are on the left side of her shoulder and neck. Patient had no fever. Events did not require emergency room or physician office visit. Patient wanted to know if she can still get the 2nd dose. Outcome of the event was not recovered.
Fever, headache, body aches for 36 hours. Menstrual cycle started 2 weeks early
I had a fever, chill and aches after receiving the vaccine for about 24 hours.  On 10/16/2022, I had congestion, nausea and vomiting. I test for COVID-19, and it was negative. On 10/17/2022 I tested positive for COVID-19. On 10/18/2022 I went to the emergency room for nausea and vomiting. I was there for two hours, and they gave me medicine for nausea and fluids.   On 10/18/2022 I was initially scheduled for a meeting with my doctor to discuss taking Paxlovid but was unable to go. The emergency room doctor did not recommend Paxlovid because it could make me nauseated.  On 10/28/2022, I went to an urgent care center and given the prescriptions Prednisone, Benzonatate, an antibiotic, an antifungal to be pretreated for pneumonia. I also got a prescription for an inhaler. On 11/02/2022 my cough seemed to be moving to my chest. I had an appointment with my doctor on 11/03/2022 and was advised that I would have it for about another two weeks.
patient felt SOB, coughing and having sensation as if something was in her throat.  Epinephrine epi-pen administered VS 130/70  HR 106, O2 Sat = 99% after epi administration
AFTER BEING SCREENING, CLEARED AND RECIEVING BOTH STANDARD ANTHRAX AND TYPHOID IM VACCINES IN THE L ARM, PT, PROCEDED TO THE CHECKOUT SECTION WHERE HE LOST COLOR AND STOP RESPONDING TO VOICE. MEDIC! WAS CALLED BUT THE PT FELL TO THE FLOOR STRIKING THE L SIDE OF HIS FACE IN THE PROCESS. UPON TOUCHING THE PTS BACK AND CALLING HIS NAME HE JUMPED UP TO HIS KNEES. A .25 CM ABRASION WAS NOTED ON THE L BROW, NO DEFORMITY, EDEMA OR DISCOLORATION EVIDENT. PT WAS AOX3 GCS15. PT WAS GUIDED TO A WAITING STRETCHER AND TAKEN TO PRIVATE ROOM WERE HE WAS EXAMINED BY PA AND FOUND TO BE STABLE. VSS WNL. PT WAS RELEASED WITH THE INSTRUCTIONS TO PROCEED TO THE ED IF HIS SYMPTOMS WORSEN. NO FURTHER ISSUE WAS REPORTED.
c/o weakness w/some pain & swelling in joints;pt presented to ER 18OCT98 & was adm for weakness etiology unk;elevated WBC 47,000, no fever,abd bloating & workup was started;
Severe pain after shot, cried excessively that evening, afterwards parents noted personality change, different temperment, reflux worsened, symptoms persisted for three to four months after the vaccination.
Contracted virus; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted virus) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Contracted virus). At the time of the report, COVID-19 (Contracted virus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
patient was inadvertently administered a dose of IPOL intramuscularly into one of his legs that had expired on 30 Nov 2020 with no adverse event; Initial information received on 30-Dec-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 6 months old male patient who was inadvertently administered third 0.5 mL dose of poliomyelitis vaccine (inactivated) [IPOL] on 29-Dec-2020, (lot: P1F491M, expiry date 30-Nov-2020) via intramuscular route in leg for prophylactic vaccination (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No concomitant vaccines were administered   This was an actual medication error case due to the event expired product administered (latency: unknown).  At the time of reporting, no adverse event was reported.  Disclaimer: 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 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.
Pharmacist did not properly dilute the pediatric Pfizer vaccine prior to administration of patient's second dose thus patient received a higher than approved dose. Error was not realized until days later when pharmacy manager noticed there was an extra diluent vial and pharmacy security tapes were reviewed. Patient's guardian and physician were contacted. Per patient's guardian patient was doing well and had no ill effects from the vaccine. Patient's physician saw no need for further follow up.
During administration of influenza vaccine, plunger would not advance after needle was in patient's deltoid. Needle was removed and thus patient needed to receive an additional needle stick in order to receive influenza vaccine.
Systemic: Body Aches Generalized-Medium, Systemic: stopped lactating-Medium, Systemic: Headache-Medium
contracted covid; could not get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted covid) and PRODUCT DOSE OMISSION ISSUE (could not get the second dose) 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 01-Apr-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 COVID-19 (contracted covid) and PRODUCT DOSE OMISSION ISSUE (could not get the second dose). At the time of the report, COVID-19 (contracted covid) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (could not get the second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment was reported.
A spontaneous case report was received from a pharmacist on 27-Jun-2018 for two consumers. Based on the information obtained from the pharmacist, two individual case safety reports PVX201806-000641 (PVX2018-2075; female) and PVX201806-000642 (PVX2018-2091, male) were created and cross-linked in the database. This case report describes a male consumer who "took VAXCHORA in spite of being among an unapproved age group to take it". The consumer was receiving VAXCHORA for cholera prophylaxis. It was reported that the consumer administered VAXCHORA but she was over the age of 64 years and under 81 years of age. The action taken with VAXCHORA with respect to event "took VAXCHORA in spite of being among an unapproved age group to take it" was not applicable. The clinical outcome of the event "took VAXCHORA in spite of being among an unapproved age group to take it" was unknown. Sender's Comments: Company's Comment: The causality of the event "took VAXCHORA in spite of being among an unapproved age group to take it" was considered as not applicable.
Information has been received from a registered nurse concerning an 18 year old female who a few days ago was vaccinated IM with the second dose of GARDASIL (lot# 656607/0153U). Subsequently the patient experienced hives down her injection site arm within thirty minutes of receiving the vaccine. Unknown medical attention was sought. It was reported that the hives lasted for about days and then the symptoms resolved. no product quality complaint was involved. Additional information has been requested.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No medical history was reported. The patient was vaccinated with GARDASIL (lot#, expiry not reported) on the following dates: 20-SEP-2010, 30-JUL-2012 and 01-OCT-2012. No adverse effect reported. No concomitant medications were reported. Additional information has been requested.
Initial report was received from the Nurse on 29 Jan 2010: This patient (under four years of age) was vaccinated with 0.5 ml of H1N1, (batch number 102136P1) intramuscularly on an unknown date.  The outcome of patient's condition was reported as not available.  The seriousness criteria of the patient was not reported.
Information has been received from a registered nurse, concerning a male patient, who on an unknown date, was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot number not provided). The nurse reported that the patient had varicella twice (dates not reported). The patient's outcome was unknown at the time of reporting. It was unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Headache; light headedness; nausea; tired; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the arm left on 16May2021 at 15:45 as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EW0161) in the left arm on 18Apr2021 at 15:45 as a single dose for Covid-19 Vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced headache, lightheadedness, nausea and tired. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events headache, lightheadedness, nausea and tired was recovering at the time of this report   No follow-up attempts are needed. No further information is expected.
Patient with an unspecified autoimmune disease was vaccinated with PNEUMOVAX 23/ Patient had recent blood work done that did not show an immune response/resistance to pneumococcal disease; This spontaneous report has been received from a company representative and refers to a 45-year-old female patient.  The patient's pertinent medical history, other drug reactions or allergies were not reported. The patient's concurrent conditions included and autoimmune disorder. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and anatomical site of administration were not provided).  On an unknown date, the patient had recent blood work done that did not show an immune response/resistance to pneumococcal disease (vaccination failure). The patient received treatment for the adverse event.  The outcome of the event was not provided.  The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).
Hives covering entire body. Red raised welts on legs, abdomen, chest, arms, and cheeks. Somewhat itchy, but child has been remaining calm. Mom is wondering if it may be from flu shot. Flu shot on 10/25/17. Hives began 10/30/17. Known allergy to coconut.
Child received HIB vaccine and next morning mom noticed large hard purple and red area over most of upper arm.
I have had muscle aches the past two days; I have had dizziness immediately when I move my head backwards or too much forward, the past two days; I have had nausea the past two days; I have had sight problems the past two days; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (I have had muscle aches the past two days), DIZZINESS (I have had dizziness immediately when I move my head backwards or too much forward, the past two days), NAUSEA (I have had nausea the past two days) and VISUAL IMPAIRMENT (I have had sight problems the past two days) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced MYALGIA (I have had muscle aches the past two days), DIZZINESS (I have had dizziness immediately when I move my head backwards or too much forward, the past two days), NAUSEA (I have had nausea the past two days) and VISUAL IMPAIRMENT (I have had sight problems the past two days). At the time of the report, MYALGIA (I have had muscle aches the past two days), DIZZINESS (I have had dizziness immediately when I move my head backwards or too much forward, the past two days), NAUSEA (I have had nausea the past two days) and VISUAL IMPAIRMENT (I have had sight problems the past two days) outcome was unknown.         No relevant concomitant medication was reported. The treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Uknown) was not applicable.
pt recv vax 12JUL95 & 11APR(7 pt exp vax failure/chickenpox & was dx w/mild varicella;
I was still recovering from COVID when I received the second dose. I was still experiencing fatigue, shortness of breath (with activities) but no cough or fever. It was about 1PM on the day of the vaccine that I started feeling weird. I spiked a fever (102F) and felt extremely weak, I could not walk without my husband's assistance. I started having severe headaches (not like the ones with the 1st dose, these were regular severe headaches). My heart rate was elevated (lasted about 72 hours). I also noticed that my 1st injection site (1st dose) started getting read and hot to the touch again, it came back, like it reacted to something. Then, a little lower I had about the size of an orange a very hard and red area, like someone had beaten me with a baseball bat and you could see the separation of both areas of both shots. The second one was huge. I called my PCP's office but they could not see me so I went to Urgent Care (02/08) and the physician there was concerned about the possibility of cellulitis.  I was concerned about pneumonia because of my cough and shortness of breath. He sent me to get a chest  X-ray at Radiology, no pneumonia. He treated me with antibiotics for my arm. My arm was really bad. Everything lasted until 02/09. Arm got better on 02/10 (I was on antibiotics for 10 days). It took me a while to gain my strength back and not feel so fatigued. I want to say in fact I started feeling myself again around 03/15/2021.
This case was reported by a other health professional via other manufacturer and described the occurrence of rash in a female patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to Hepatitis B vaccine. Additional details were provided as follows: This case been linked to other case which contains pharma suspects linked to respective allergies.
Died due to his many medical conditions; could not administer second vaccine; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of GENERAL PHYSICAL HEALTH DETERIORATION (Died due to his many medical conditions) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rehabilitation therapy (Patient was in rehabilitation center) and General physical health deterioration (It is reported that patient had history of many medical conditions, unspecified.).    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 GENERAL PHYSICAL HEALTH DETERIORATION (Died due to his many medical conditions) (seriousness criterion death) and PRODUCT DOSE OMISSION ISSUE (could not administer second vaccine). The patient died on an unknown date. The reported cause of death was medical conditions. It is unknown if an autopsy was performed. At the time of death, PRODUCT DOSE OMISSION ISSUE (could not administer second vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: This is a male patient of unknown age who received mRNA-1273 vaccine (batch no. unknown) who died on an unknown date after receiving first dose of vaccine. Patient had history of many medical conditions. No conmeds were given. Reporter could not administer second vaccine. Very limited information has been reported at this time. No further information is expected.; Reported Cause(s) of Death: medical conditions
Rash all over body with autoimmune response including extreme fatigue, lack of hunger, etc.
He was dehydrated; He experienced upset stomach; He experienced fatigue; He vomited; This spontaneous case was reported by a patient and describes the occurrence of DEHYDRATION (He was dehydrated), ABDOMINAL DISCOMFORT (He experienced upset stomach), FATIGUE (He experienced fatigue) and VOMITING (He vomited) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Lyme disease.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced FATIGUE (He experienced fatigue) and VOMITING (He vomited). On an unknown date, the patient experienced DEHYDRATION (He was dehydrated) and ABDOMINAL DISCOMFORT (He experienced upset stomach). At the time of the report, DEHYDRATION (He was dehydrated), ABDOMINAL DISCOMFORT (He experienced upset stomach), FATIGUE (He experienced fatigue) and VOMITING (He vomited) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Pt became ill on 27JUL91 w/103.8 ax temp; Mom called MD; given APAP & sponged w/cool water; 945PM had sz or convuls & was taken to Hosp & admitted; t105.8 R; given ASA suppositories, ATB, & Phenobarb;
Child has Down's Syndrome. Child given vaccines 3/2/12. On 3/3/12 had first infantile spasm. Evaluated in ER 3/4/12 due to many spasms. Continues to have spasms (infantile spasms).
nasal congestion, runny nose.   COVID positive PCR on 08/02/2021
rash and hives in the arm of shot, chest, and legs for a few hours, benadryl was taken twice before it went away
Patient was NPO for fasting labs, with blood drawn around 11 AM. Following phlebotomy, he received 2 vaccines and felt faint. As the final two vaccines were given he passed out briefly with urinary incontinence. He quickly revived. Blood sugar and BP were normal.