chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Black and blue mark at the injection site; Itching at the injection site; Redness at the injection site; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), INJECTION SITE BRUISING (Black and blue mark at the injection site), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced PRURITUS (Itching). On an unknown date, the patient experienced INJECTION SITE BRUISING (Black and blue mark at the injection site), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). On 22-Jan-2021, PRURITUS (Itching) had resolved. At the time of the report, INJECTION SITE BRUISING (Black and blue mark at the injection site), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; 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.
Initial arm soreness, followed by a sensation that his legs were "not there". Patient suffered leg pain and had difficulty standing and walking. Patient had no other symptoms. Patient called MD, but did not see MD. Issues all resolved over a 5 to 7 day period.
SWOLLEN ARM, HEADAHCE, NAUSEA, BODY ACHES, FATIGUE, CHILLS
Product storage error; No adverse event; Given vaccine which was beyond the 30 day use by date; Given vaccine which underwent temperture excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion). On 19-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant products reported. It was reported that the lot number underwent temperature excursion on 15 to 17-Aug-2022 and was administered to the patient post temperature excursion.  No treatment products reported.
Dizziness for 11 days beginning day after the injection and 11 days of dizziness starting 2 weeks later. LOSS OF HEARING IN RIGHT EAR.
Fever, malaise, "feeling of allergic reaction:, body aches, injection site pain, swollen glands Narrative:
right half of abdomen is red and hot. patient realized it upon waking up this morning. patient will be contacting PCP today.
did not feel good; lethargic; achy; body aches/achy; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel good), LETHARGY (lethargic), PAIN (achy) and MYALGIA (body aches/achy) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced MALAISE (did not feel good), LETHARGY (lethargic), PAIN (achy) and MYALGIA (body aches/achy). At the time of the report, MALAISE (did not feel good), LETHARGY (lethargic), PAIN (achy) and MYALGIA (body aches/achy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications and treatment information were not provided by reporter.  Events were lasted for 21/2 days.   This case was linked to (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Dec-2021: Non-significant follow-up: No new information was added.
Lost central vision in left eye, day after vaccine. Ophthalmologist started aspirin therapy. Had extensive lab work, MRI of Brain, Carotid Scan, saw several specialists - Will be having Nuclear thyroid scan and sonogram.
I was sick most of March and was diagnosed with pneumonia on the 29th of March via an X-ray and CT scan at hospital. I tested negative for Covid and was put on an antibiotic. I was feeling OK when Dr (Primary Care Physician) said it was OK to get vaccinated. I was vaccinated with my first Pfizer vaccine on April 21st. After a week I could not breath and went to Emergency Room on April 29th. I was admitted to the ICU on the 29th and transferred to hospital as there were no beds in other hospital. I stayed 5 nights in ICU and was discharged from the hospital on the 6th of May. I had a significant amount of blood clots in my lungs and was put on Heparin in the hospital and was sent home on Eliquis. I am still taking the Eliquis. The clots were gone with a had my third CT scan on the 11 of August. I was then diagnosed with emphysema, and this is the reason I am seeing a pulmonologist. I was tested 6 or 7 times for Covid, but all were negative. I had an antibody test in September and was above 20
Chills, fever, body aches, swollen and irritated arm  54 hours so far
My injury is in the muscle of my left arm where the shot was given. I continue to be in pain to this date, wakes me up at night and minimal usage of arm.  The vaccine did not make me sick, just the site and after affects of the pain which is daily.
RAPID HEART RATE; HOT FACE; WOKE HER UP AT NIGHT; UNCONTROLLABLE CHILLS; FEVER; CONSTANT HEADACHE; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and alcohol user, and other pre-existing medical conditions included the patient had no known drug or non-drug allergies. the patient have no history of drug abuse or illicit use. the patient had no fever history, no rapid heart rate, and no regular medication. The patient was previously treated with influenza vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072) dose was not reported, once a total administered vaccinated on right arm on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: ibuprofen. On 13-MAR-2021, the subject experienced rapid heart rate. On 13-MAR-2021, the subject experienced hot face. On 13-MAR-2021, the subject experienced woke her up at night. On 13-MAR-2021, the subject experienced uncontrollable chills. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced constant headache. Laboratory data included: Body temperature (NR: not provided) 103 F, and Heart rate (NR: not provided) 140 {beats}/min. On 15-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heart rate, hot face, woke her up at night, and uncontrollable chills on 14-MAR-2021, and was recovering from fever, and constant headache. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender who on unknown dates were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dose, route, lot # and expiration date were not provided). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Red rash on left arm; Nausea; Fatigue; Headache; Fever; Chills; Normal red rash; Usual discomfort at injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash on left arm), VACCINATION SITE DISCOMFORT (Usual discomfort at injection site), RASH ERYTHEMATOUS (Normal red rash), FATIGUE (Fatigue) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 001M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE BESILATE (NORVASC), HYDROCHLOROTHIAZIDE, LEVOTHYROXINE SODIUM (SYNTHROID) and LOSARTAN POTASSIUM (COZAAR) for an unknown indication.   On 15-Feb-2021 at 1:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021 at 1:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE DISCOMFORT (Usual discomfort at injection site). On 16-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Normal red rash). On 16-Mar-2021 at 12:30 PM, the patient experienced HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). On 16-Mar-2021 at 9:00 PM, the patient experienced FATIGUE (Fatigue). On 17-Mar-2021, the patient experienced NAUSEA (Nausea). On 15-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on left arm). The patient was treated with MULTIVITAMINS [VITAMINS NOS] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Red rash on left arm), VACCINATION SITE DISCOMFORT (Usual discomfort at injection site), RASH ERYTHEMATOUS (Normal red rash), FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Supplements and vitamins were given as concomitant medications.  Patient reported that no medication was taken to relieve the symptoms of 48 hour duration. Patient woke up next morning at 1230am with headache, fever, chills, and nausea beginning at 430am and normal red rash   This case was linked to MOD-2021-064379 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: significant follow up contains updated narrative (no treatment taken)
This spontaneous report as received from a health worker on 05-NOV-2014 refers to an unspecified 12 month old patient. The patient inadvertently received 2 doses of VARIVAX injection (strength, dose, route and lot# were unknown) on an unspecified date of 2014 within the last week. No adverse effect reported. Additional information has been requested.
Pt previously received 2 Moderna vaccines and due to his age, he should've been given a Moderna vaccine for his 3rd dose but was given a Pfizer.
Two days after vaccination the patient woke up with extreme tinnitus. It is so severe and constant the is disruptive of her daily activities and sleep. She is still experiencing tinnitus with no improvement after two different physician examinations.
Prolonged seizure (> 40 min). Does have h/o febrile seizures. Several days later remained very fussy, overall uncomfortable. Cried most of day on day 3 after vaccine.
PATIENT RECEIVED FIRST DOSE OF MODERNA VACCINE AND HE WAS TOLD TO SIT FOR 15 MINUTES OF OBSERVATION PERIOD. FIVE MINUTES INTO THE OBSERVATION PERIOD PATIENT CAME UP TO THE COUNTER SAYING HE FELT STRANGE AND FAINT. PATIENT WAS OBSERVED TO BE SWEATING, PALE, SHAKY, AND COULD BARELY STAND. AFTER ASKING PATIENT CONFIRMED HE WAS ABLE TO BREATH NORMALLY. I SAT HIM DOWN AND HAD A TECHNICIAN CALL 911. PATIENT ASKEED FOR WATER TO DRINK, HE WAS GIVEN SOME. HE STARTED TO FEEL BETTER AS THE MINITES WENT BY AND WE WAITED FOR EMTS TO ARRIVE. NO EPIPEN WAS ADMINISTERED. EMTS ARRIVED AND TOOK HIM TO THE AMBULANCE TO CHECK HIS VITALS. PATIENT MENTIONED HE FELT MUCH BETTER BUT AGREED TO HAVE HIS VITALS CHECKED.
Within 30 seconds passed out. Woke up and about 5 minutes later passed out again, with eyes open and could hear but couldn't talk. Epi Pen administered by Pharmacist around 8 minutes after shot.  Taken by ambulance to ER
This case was reported by a non-health professional via sales rep and described the occurrence of injection site erythema in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The office manager reported that 5 patients recently experienced injection site reactions as redness and swelling at the injection site. A few of the patients returned to the office for evaluation This was reported to the field rep off the cuff and the reporter provided very little information but said she would compile all the patient's information for follow up. An registered nurse was also present at the time of the report. This case has been linked with 4 cases, reported by the same reporter.
Pt with uremitting crying greater than 3 hours. Pt also with hx of colic per mom's report received dtap thurs at primary pediatrician.
Pt had severe HA, myalgias followed by hyperventilation & paresthesias, no fever or focal neurologic changes on exam * improved with MOTRIN.
the arm that the Trumenba was administered in was puffy.; headache; nausea; chills; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. An 18-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration in arm on an unspecified date at a single dose for immunization. The patient's medical history was not reported. Concomitant medication included meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) for immunization. It was reported that on 29Jul2019, the patient was administered meningococcal group b rlp2086 in one arm and was administered  meningococcal vaccine a/c/y/w conj (dip tox) in the other arm and the arm that the meningococcal group b rlp2086 was administered in was puffy and within 6 hours of administration of the vaccine, the patient complained of headache, nausea and chills and on the next day, the patient came in with her siblings and was seeing the HCP and was still complaining that her arm was puffy and still had a headache. The outcome of the events vaccination site swelling and headache was not recovered while the outcome of the events nausea and chills was unknown.  Information on the batch number has been requested.
According to caregiver, site of injection red and hot feeling.  Started day after injection and continues to today.  Recommended she call her doctor.
Physician reported that patient received Prevnar, Acel-Imune, Hib-Titer, and IPV (Aventis Pasteur SA) on 8/21/2000. Within 24 hours post-immunization, she developed vomiting and diarrhea. She also developed redness, swelling, and warmth at an unspecified injection site. The vomiting and diarrhea resolved after 2 to 3 days.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown dates, the patients were vaccinated with an improperly stored dose of ROTATEQ (lot# L013193 with expiration date 20-JAN-2017; lot# L028645 with expiration date 27-MAY-2017; lot# L023866 with expiration date 24-MAR-2017; lot# L035510 with expiration date 13-MAY-2017; dose was not reported; orally). The vaccines were exposed to 4 hours 30 minutes at 47.5 Fahrenheit (F) on the fifth of April (year unspecified), 1 hour 30 minutes at 51.3 F, 2 hours at 56.3 F on the seventh of April (year unspecified), 1 hour and 30 minutes at 48.9 F on the fifth of May (year unspecified) and 1 hours at 51.6 F. This is one of several reports received from the same reporter. Additional information has been requested.
48 hours of body aches; 48 hours of tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (48 hours of body aches) and FATIGUE (48 hours of tiredness) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (48 hours of body aches) and FATIGUE (48 hours of tiredness). At the time of the report, PAIN (48 hours of body aches) and FATIGUE (48 hours of tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment drug details was provided.
PATIENT STARTED HAVING CHEST PAIN AT 1600 ON 10.21.2022 THAT RADIATED DOWN HER LEFT ARM. SHE TOOK A NITROGLYERIN AND CAME TO THE ER. PATIENT WAS ADMITTED DUE TO DYSRHYTHMIAS.
This retrospective pregnancy case was reported in a literature article and described the occurrence of spontaneous abortion in an adult female subject who was vaccinated with H1N1 (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of H1N1 (unknown route and injection site, batch number not provided). The subject's last menstrual period was on unspecified date and estimated date of delivery was not provided. The subject was exposed to the vaccine during the first trimester. On unspecified date, at an unspecified time after vaccination with H1N1 and at unspecified weeks gestation, the subject experienced a spontaneous abortion. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. The authors reported 33 other cases. Summary of the article: The potential serious consequences of maternal influenza infection in pregnancy have long been recognized; pregnant women are at increased risk for influenza-associated morbidity and mortality. As reviewed recently, there are limited data on the safety of influenza vaccine in pregnancy; however, to date, there has been no indication that seasonal influenza vaccines containing inactivated virus pose a risk to the mother or the foetus. This has led to the current recommendation that all pregnant women be vaccinated with the seasonal influenza vaccine regardless of trimester. Despite these recommendations, vaccination rates remain less than optimal. Surveys have demonstrated that mother's concerns about safety contribute to poor compliance with vaccine recommendations. This situation was escalated during the 2009-10 H1N1 season, when lack of safety data about the H1N1 was coupled with intensive public health messaging that emphasized the need for all pregnant women to be vaccinated. Additional safety information on pH1N1-containing vaccines when used in pregnancy was therefore needed. The purpose of this study was to evaluate the foetal risk and relative safety of the pH1N1 influenza vaccine. To assess risks and relative safety of the pH1N1-containing vaccines, the author conducted a prospective cohort study of pH1N1-vaccine-exposed and unexposed comparison women who were recruited during pregnancy and followed to outcome between October 2009 and August 2012. There were 1032 subjects available for analysis; 841 women were exposed to a pH1N1-containing vaccine in pregnancy, and 191 women were unexposed to any influenza vaccine in pregnancy. Nine of 328 (2.7%) first-trimester-exposed pregnancies resulted in an infant with a major birth defect compared to 6/188 (3.2%) in the unexposed. The hazard ratio (HR) for spontaneous abortion was not elevated. Adjusted HRs for preterm delivery were elevated for exposure anytime in pregnancy, specifically with exposure in the 1st or 2nd trimester. However, the mean decrease in gestational age in the exposed pregnancies was approximately three days. In conclusions, no meaningful evidence of increased relative risk or HR for major birth defects, spontaneous abortion, or small for gestational age infants was demonstrated.