chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started breaking out with hives/I still have them; Headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Started breaking out with hives/I still have them), HEADACHE (Headache) and VACCINATION SITE PAIN (Sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, COPD, Anxiety and Tremor.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced HEADACHE (Headache) and VACCINATION SITE PAIN (Sore arm). In June 2021, the patient experienced URTICARIA (Started breaking out with hives/I still have them). At the time of the report, URTICARIA (Started breaking out with hives/I still have them) had not resolved and HEADACHE (Headache) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.            concomitant medications include High Blood Pressure medication,COPD Medication,Anxiety Medication,Medication for Tremors. patient  Went to an allergist and they took 11 vials of blood to check on allergies, etc. Nothing jumped out. patient also know someone that has gotten the 2nd shot and started in June with rashes, she just have the hives.Allergist said it could be possible side effect. Patient is also unsure if she will get a third dose.   This case was linked to MOD-2021-325579 (Patient Link).
I woke up one morning and was having heart papitations. At first I didn't schedule to see doctor but it kept happening. Then I scheduled to see my primary care. I am in bigemy every other heart beat is irregular. I went to primary care, then cardiologist, he ordered labs, I had echo. I have had to have hoelter monitor for 48 hrs and I am scheduled for stress test march 11th.
Prior to getting this vaccine I was not sick now I have heart palpitations, severe headaches (I never get headaches), sweats and chills, muscle cramps in legs and arms, shortness of breath, cramping and diarrhea for 5-weeks. I was getting ready to go to my primary care physician but the symptoms have mostly subsided except for occasional erratic heart palpitations and headaches that come out of nowhere be it relaxing (sleeping) or physically working i.e. hauling wood which I always do! I have been always been healthy and physically fit so what's wrong with this vaccine?  I hope I don't die from this vaccine!
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL (dosing details unknown). No concomitant medications were reported. On an unknown date the patients were administered improperly stored GARDASIL. No adverse events were reported. Outcome of administering the improperly stored GARDASIL was unknown. There was no product quality complaint involved. This is one of the two cases received from the same reporter. Additional information has been requested.
Hives; Migraine; Body aches; Fever; This spontaneous case was reported by a non-health professional and describes the occurrence of URTICARIA (Hives), MIGRAINE (Migraine), MYALGIA (Body aches) and PYREXIA (Fever) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced URTICARIA (Hives), MIGRAINE (Migraine), MYALGIA (Body aches) and PYREXIA (Fever). On 31-Mar-2021, URTICARIA (Hives), MIGRAINE (Migraine), MYALGIA (Body aches) and PYREXIA (Fever) had resolved.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In February 2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. Later in July 2018, the patient was treated at a medical facility for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Pt. received Tdap and MMR and within 10 min. began to have red spots on neck, chest and back with itching. Pt. took Bensdryl 25 mg.  Remained in office for 15 min.
Case number PHEH2014US020232 is an initial spontaneous report from the health care professional (patient) received on 01 Oct 2014. This report refers to an adult female patient. She was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date. On an unknown date, after vaccination her arm was swollen, red and hot. The outcome of the events was not reported. The patient received FLUVIRIN for the next 7 years and experienced similar events (see cases: PHEH2014US020234, PHEH2014US020235, PHEH2014US020236, PHEH2014US020237, PHEH2014US020238, PHEH2014US020239 and PHEH2014US020240).
shingles that progressively spread; red/itchy/small and big splotchy areas on leg, back, arm; red/itchy/small and big splotchy areas on leg, back, arm; red/itchy/small and big splotchy areas on leg, back, arm; very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick), HERPES ZOSTER (shingles that progressively spread), ERYTHEMA (red/itchy/small and big splotchy areas on leg, back, arm), PRURITUS (red/itchy/small and big splotchy areas on leg, back, arm) and RASH MACULAR (red/itchy/small and big splotchy areas on leg, back, arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 011A21A) for COVID-19 vaccination.     No medical history reported by the patient.  Concomitant products included LORATADINE and FLUTICASONE for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced ILLNESS (very sick). On an unknown date, the patient experienced HERPES ZOSTER (shingles that progressively spread), ERYTHEMA (red/itchy/small and big splotchy areas on leg, back, arm), PRURITUS (red/itchy/small and big splotchy areas on leg, back, arm) and RASH MACULAR (red/itchy/small and big splotchy areas on leg, back, arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-Apr-2021, ILLNESS (very sick) had resolved. At the time of the report, HERPES ZOSTER (shingles that progressively spread), ERYTHEMA (red/itchy/small and big splotchy areas on leg, back, arm), PRURITUS (red/itchy/small and big splotchy areas on leg, back, arm) and RASH MACULAR (red/itchy/small and big splotchy areas on leg, back, arm) outcome was unknown. Not Provided          This case was linked to MOD-2021-169604  (Patient Link).
Large local inflammatory reaction over right deltoid. Pink discoloration, warmth, no tenderness.
Difficulty breathing, rapid heartbeat, dizziness, weakness, short of breath, severe headaches and body aches.
Patient experienced viral like symptoms beginning 5 days after immunization. They included: bronchitis, conjuctivitis, and temporary hearing loss which resolved. He continues to have a sore throat and nerve pain in his neck. He is currently taking prednisone (Taper) and thinks he is improving.
This case was reported by a nurse via sales rep and described the occurrence of high temperature in a 16-year-old male patient who received BEXSERO. Concomitant products included MENACTRA. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown receiving BEXSERO, the patient experienced high temperature, weakness generalized and joint pain. On an unknown date, the outcome of the high temperature, weakness generalized and joint pain were recovered/resolved. It was unknown if the reporter considered the high temperature, weakness generalized and joint pain to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced higher temperature than normal, pain in joints and general weakness. The patient went to emergency room (ER) but the reporter did not know if patient stayed overnight.
I had numbness in my lips, tongue was numb and felt swollen, throat felt itchy. Had some shortness of breath. I got home took. Benadryl 50 mg. I was at the ER for about4 hours. I left the emergency room it was busy and I felt better the numbness in my throat,tongue, and lips had gone . I took an additional dose of Benadryl at bedtime.
lingering erectile dysfunction for 72 hours; Weakness; Diarrhea; light chills; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ERECTILE DYSFUNCTION (lingering erectile dysfunction for 72 hours) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 26-Jun-2021.    On 14-Sep-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 ERECTILE DYSFUNCTION (lingering erectile dysfunction for 72 hours) (seriousness criterion medically significant), ASTHENIA (Weakness), DIARRHOEA (Diarrhea), CHILLS (light chills), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, ERECTILE DYSFUNCTION (lingering erectile dysfunction for 72 hours), ASTHENIA (Weakness), DIARRHOEA (Diarrhea), CHILLS (light chills), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jun-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was mentioned by reporter. No treatment medication information was mentioned by reporter.  Company comment: This case concerns a 30-year-old, male patient with no previous relevant medical history, who experienced the unexpected event of erectile dysfunction. The event occurred on unknown days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The reporter assessed the event as possible. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 30-year-old, male patient with no previous relevant medical history, who experienced the unexpected event of erectile dysfunction. The event occurred on unknown days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The reporter assessed the event as possible. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Noticed severe bruising on arm morning after injection. Appx. 4-5 days after noticed muscle deterioration at injection site. Appx. 1 week after began having pain that has progressively gotten worse.
Patient received MMR vaccine on 06/10/16. 2 1/2 weeks later developed petechial rash on extremities. Platelet count of 29,000, was hospitalized for ITP.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 19 year old female. 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: 202F21A expiry: 07-FEB-2023) dose was not reported, administered on 09-FEB-2023 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. Age at time of vaccination 19 years old. No concomitant medications were reported. On 09-FEB-2023, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Memory loss/Ask her a question, she does not remember the answer; Feels like a headache is coming but it is not but she does not have a headache; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (Memory loss/Ask her a question, she does not remember the answer ), FEELING ABNORMAL (Feels like a headache is coming but it is not but she does not have a headache) and MYALGIA (Sore Arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced AMNESIA (Memory loss/Ask her a question, she does not remember the answer ), FEELING ABNORMAL (Feels like a headache is coming but it is not but she does not have a headache) and MYALGIA (Sore Arm). At the time of the report, AMNESIA (Memory loss/Ask her a question, she does not remember the answer ), FEELING ABNORMAL (Feels like a headache is coming but it is not but she does not have a headache) and MYALGIA (Sore Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reportedly, patient did not feel tired or fatigued.  Patient's consent to follow-up was affirmative.  Concomitant product use was not provided.  Treatment product information was not provided.
Cold sore in mouth, right side of lip; This spontaneous case was reported by a patient and describes the occurrence of ORAL HERPES (Cold sore in mouth, right side of lip) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced ORAL HERPES (Cold sore in mouth, right side of lip). At the time of the report, ORAL HERPES (Cold sore in mouth, right side of lip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-032370 (Patient Link).   Reporter did not allow further contact; Reporter's Comments: 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.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored ROTATEQ (lot # L023870, expiration date 20-APR-2017, dose was unknown) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I have COVID; I have COVID; hard to breath; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had COVID and it is hard to breath. It was reported that the patient took the shots and still got it. The event COVID was assessed as serious (medically significant). The outcome of the events was unknown.  The information about the batch number has been requested.
COUGH; CHEST HEAVINESS; VACCINE HURT GOING IN; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's past medical history included allergy shots, and concurrent conditions included bronchitis in oak and cedar season, and allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included fexofenadine hydrochloride for allergy. On 08-APR-2021, the subject experienced cough. On 08-APR-2021, the subject experienced chest heaviness. On 08-APR-2021, the subject experienced vaccine hurt going in. Treatment medications (dates unspecified) included: guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cough, had not recovered from chest heaviness, and the outcome of vaccine hurt going in was not reported. This report was non-serious.
Fever and body ache. Was at work by the end of the day I started feeling VERT fatigue and body ached real bad. No strength to move. Drank water, Gatorade, and took Tylenol, started feeling better the next day about mid day.
The pt developed extremely swollen, red, and hard right thigh started off within four hours after vaccination that progressed over next 2 days. Given Tylenol. Child limping left leg also red in the small area.
This spontaneous report as received from a nurse who refers to an unspecified number of patients of unknown age and gender for which their concurrent conditions, medical history and concomitant medications were unknown. It was reported that improperly stored doses of GARDASIL (strength, dose, and route were not reported) were administered to an unspecified number of patients on an unknown date. No adverse effects were reported. Additional information has been requested.
Information was received via telephone call from a pharmacist regarding a 76 year old female who 5 years ago was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) and experienced an exacerbation of an unspecified health condition. The pharmacist stated that the exacerbation of the patient's health condition had nothing to do with pneumococcal vaccine, polyvalent (23-valent). Permission to follow up with the patient's physician was denied. No further information is available.
Patient reports tightening in her throat about 20min after receiving vaccine. She also reports Itching for 24hours and the development of blisters.
Event described on 1st page, treatment: lots of sleep, drank water and Gatorade, lasted only lasted 24 hours
No adverse events; patient received one dose of MMR II inadvertently intramuscular, instead of subcutaneous; This spontaneous report was received from a pharmacist referring to a 62-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 13-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), (strength, dose, frequency were not provided) administered intramuscularly, for prophylaxis. The Lot No. R036583 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported as 17-DEC-2020.  But the reporter stated that the patient received the dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) inadvertently via intramuscular, instead of subcutaneous (incorrect route of product administration), on this date. No adverse effects were reported. And no additional information provided or product quality complaint (PQC).
This case was reported by a physician via sales rep and described the occurrence of low blood pressure in a 18-year-old female patient who received BEXSERO (batch number 168401, expiry date February 2019) for prophylaxis. On 7th September 2018, the patient received the 2nd dose of BEXSERO. On 7th September 2018, less than a day after receiving BEXSERO, the patient experienced low blood pressure, chills, fever, weakness, sweating and muscle cramp. On an unknown date, the outcome of the low blood pressure, chills, fever, weakness, sweating and muscle cramp were unknown.  The reporter considered the low blood pressure, chills, fever, weakness, sweating and muscle cramp to be related to BEXSERO. Additional details were reported as follows: The vaccine given at 11 am, and the patient was brought back 4 hours later with a fever of 103 degrees  fahrenheit , slightly low blood pressure. The provider believes it was related to the vaccine. The reporter agree to follow up from GlaxoSmithKline.
Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; This is a spontaneous report from a contactable Nurse (the patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL0140, expiration date unknown) via an unspecified route of administration on 29Dec2020 at 12:30 PM (at the age of 30-years-old) at an unspecified dose in the right arm for COVID-19 vaccination. The patient's medical history was not reported. No information was reported regarding allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient answered "yes" when asked to list any other medications she had received within two weeks of vaccination but did not list those medications. The patient stated that she experienced lightheadedness on 29Dec2020  "immediately after vaccine." About twenty-four hours later, on 30Dec2020 at 13:00  she experienced "SEVERE" diarrhea/urgency, nausea, fatigue, fever of 101 and migraine. The patient did not receive any treatment for the events. The clinical outcomes of lightheadedness, severe diarrhea/urgency, nausea, fatigue, fever of 101 and migraine were reported as recovering. The patient underwent lab tests and procedures which included body temperature: 101  on 30Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19.