chrisvoncsefalvay/vaers-outcomes huggingface dataset:
(1)Large (golf ball size) lump at injection site. Hot, sore, itchy. Lasted 3 weeks before starting to shrink very slowly. (2)Week 2, right arm began to seize several times per hour (opposite arm of injection), couldn't write or type. Continued for 3 more weeks. (3)Week 4, right leg began to seize numerous times per hour. That all continued to May 10, 2013 when I suffered a focal seizure on right side (head to toe). I've never had a seizure before. The emergency room doctor put me on Keppra until I could meet with a neurologist. Five more focal seizures on right side (head to toe) occurred over the next five days. Neurologist added Tegretol and the seizures stopped as did the inability to write. I am still suffering with strange tingles and pains on my right side and also my left side. It took two months for the lump at the injection site to disappear. In addition, I will add that my menstrual cycle became unpredictable. I cycle every 28 days every month without fail for my entire adult life. (Not on birth control) I was due my period on April 1, four days after the Dtap shot, it was 12 days late. I got a full period again 10 days later, and the next cycle was late.
Forceful repeated vomiting and high fever up to 102 or 103 F.
Patient arm is red, warm to touch, bruised at the injection site, arm swollen near the elbow. Patient reports pain at injection site and near elbow, headache. No other symptoms.
sensorineural hearing loss; tinnitus; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or around 12-AUG-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route of administration, lot # and expiration date were not provided). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered hearing loss in left ear, balance problems and loss of taste. The patient was diagnosed with sensorineural hearing loss and tinnitus. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events of sensorineural hearing loss and tinnitus was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of sensorineural hearing loss and tinnitus were considered to be disabling. Upon internal review, the event of sensorineural hearing loss was considered to be medically significant.
HBP confirmed that none of the patients involved have reported symptoms or adverse reactions; HBP calling to report adverse event for improperly stored and administered VARIVAX.; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      Since 07-AUG-2023, the varicella virus vaccine live (oka/merck)(VARIVAX) lot numbers W039689, X006980, W031810 and X000999 with expiration dates 13-DEC-2024, 07-MAR-2025, 05-OCT-2024 and 09-JAN-2025 respectively had a temperature excursion (product storage error) an after that, 0.5 milliliters were administered to the patient (route of administration not reported and lot number of the vaccine administered not specified) for prophylaxis. No adverse event was reported.
Information has been received from a nurse practitioner concerning a class of 15 students who within the past few weeks were exposed to chickenpox. On an unknown date, each had been vaccinated with one dose VARIVAX (Merck) and all had breakthrough cases of varicella. The nurse practitioner is waiting one more week to see if anyone else in the school district will have breakthrough after having one dose of VARIVAX (Merck). Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information has been requested.
This is a spontaneous report from a contactable pharmacist communicated to a Pfizer sales representative. The pharmacist reported same event for 2 patients. This is the first of two reports. A 65 years old age or older female patient of an unspecified race received PREVNAR 13, via an unspecified route of administration at 0.5 ml, single on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced swollen arm in Jul2016 with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016561791 Same product/event/reporter, different patient.
Patient came into office for well child check.  Patient family all got COVID vaccines at same time.  Patient was given one as well before staff realized that she was only 10 years old.  We notified the parent that this was a mistake.  Parent thankful that daughter got vaccinated even though she wasn't supposed to.  We have not recieved any notification that there was any harm to Patient and she didn't have an adverse reactions.
Patient thought he was light headed 5 minutes after receiving the shot whilst sitting on chair during observation period. Patient felt he needed to lie down and we decided to call ambulance for further follow up. After further evaluation by paramedics he was able to leave on his own accord
This is a prospective pregnancy case. This 28-year-old female subject was enrolled in an open label study. The subject received BOOSTRIX .5 ml on 23rd February 2014. The subject's last menstrual period was on 5th June 2014 and estimated date of delivery was 26th March 2015. The subject received BOOSTRIX during the second trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.
Redness and swelling at the injection site, abdominal pain and diarrhea, and exhibited fits of rage and refused to wear clothing for three days after receiving the vaccine. She exhibits sensory processing concerns that appear to intensify after each round of vaccines given.
2 days after second does experienced numbness of tongue and face. Referred to PCP for further evaluation.
Dry mouth; Weak; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth), ASTHENIA (Weak) and FATIGUE (Feeling tired) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced DRY MOUTH (Dry mouth), ASTHENIA (Weak) and FATIGUE (Feeling tired). At the time of the report, DRY MOUTH (Dry mouth), ASTHENIA (Weak) and FATIGUE (Feeling tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment details included Tylenol.
Arm pain after immunization. Pt. received a Pneumovax vaccination approximately 24 hours ago.  He is not complaining of pain and swelling in the left arm.  He denies any fever or chills.  He denies any airway compromise or other complaints.  He has received pneumococcal vaccination in the past twice (as he reports) without any problems.
Red hot itchy arm from shoulder to elbow.  Low grade fever.  Sleepy. Lasted three days already.
Patient received 0.5 ml instead of 0.3 ml. Patient had no unusual adverse effects, only sore arm and swollen lymph nodes in armpit.
DEVELOPED DIZZINESS AND NAUSEA SHORTLY AFTER VACCINATION. WAS BROUGHT BY PRIVATE VEHICLE TO EMERGENCY ROOM. SYMPTOMS LASTED ~1 HOUR.
Fully vaccinated employee developed symptoms 9/1/21 and resulted positive for Covid-19.
This spontaneous report was received from a health care worker refers to an approximately 62 year old female patient (physicians mother). The patients medical history included allergy to penicillin and allergy to DEMEROL. On 19-NOV-2013 the patient was vaccinated with ZOSTAVAX 19400 PFU (lot # J007209; expiration date: 20-SEP-2014) (dose and route of administration were not reported). Concomitant therapies included amitriptyline hydrochloride (manufacturer unknown) and citalopram. On 19-NOV-2013, reported as the same day of vaccination, the patient was seen at the office for urinary tract infection and was prescribed with BACTRIM. On 20-NOV-2013, the following day, the patient experienced shingles. It was reported that the patient had sought medical attention. There was no product quality issue involved. The outcome of urinary tract infection and shingles was unknown. The causality of the event was not provided. Additional information has been requested.
After the second dose he had the same pain but worse; This is a spontaneous report received from a contactable reporter(s) nurse  (Other HCP) from medical information team.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "multiple myeloma" (unspecified if ongoing); "a fracture and a tumor in the pelvis" (unspecified if ongoing), notes: He had a fracture and a tumor in the pelvis; "tumor in the pelvis" (unspecified if ongoing), notes: He had a fracture and a tumor in the pelvis. The patient took concomitant medications. The following information was reported: PAIN (non-serious), outcome "unknown", described as "After the second dose he had the same pain but worse".  Additional information: He passed away after receiving the second dose of the Pfizer COVID-19 vaccine. He had multiple myeloma. He had a fracture and a tumor in the pelvis. He has been on chemo treatment and steroids. Patient got the vaccine in the early part of chemotherapy. He received the first vaccine and three weeks later received the second. After the second dose he had the same pain but worse. He had a red arm, sleeping problem and it created a lot of problems where he couldn't walk and needed a walker. He was diagnosed with ischemic bowel disease caused by SRS. He got radiation for the pain and he had ischemic bowel which causes the intestines to not get blood. It started with an inflammation and soon after he died. .  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About an hour after the vaccine I began to show a red rash on my face that was hot to the touch. I also experience high blood pressure.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Jun2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Kidney stones" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid taken as treatment, Treatment start date: 27Sep2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Covid Postive; tested positive for COVID-19; loss of taste and smell; loss of taste and smell; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Covid Postive) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced COVID-19 (Covid Postive) (seriousness criterion medically significant), DRUG INEFFECTIVE (tested positive for COVID-19), AGEUSIA (loss of taste and smell) and ANOSMIA (loss of taste and smell). At the time of the report, COVID-19 (Covid Postive), DRUG INEFFECTIVE (tested positive for COVID-19), AGEUSIA (loss of taste and smell) and ANOSMIA (loss of taste and smell) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jun-2021, Body temperature: 97.9 (Inconclusive) 97.9°F. On 24-Jun-2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included a thyroid medication (not further specified). Treatment information was not reported. Based on the current available information and lack of scientific plausibility for the occurrence of the event causal relationship is considered unlikely related to mRNA-1273.; Sender's Comments: Based on the current available information and lack of scientific plausibility for the occurrence of the event causal relationship is considered unlikely related to mRNA-1273.
after the vaccination, I was coughin sporadically, chronic Fatigue, then got Diagnosed with Pneumonia on 08/2021 the doctors noticed the kidney function was at its lowest in record but considered it normal due to the pneumonia, I was prescribed 2 types of antibiotic. recovered from the pneumonia but the fatigue and coughin continued In november I started noticing dots of blood in my cough by December 23, 2021 the fatigue was extreme, I was short of breath and the blood every time I coughed was evident and constant, so I called my primary physician who instructed me to go to the ER where I was diagnosed with Covid Acute Kidney injury and ANCA Vasculitis
This spontaneous report was received from a consumer referring to her daughter, a female patient of unknown age. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown day in 2013, the patient was vaccinated intramuscularly with the first dose of GARDASIL for prophylaxis (strength, dose, units and lot number were not reported) and on 16-MAR-2015, the patient received the second dose of GARDASIL. On an unknown date, the patient experienced full body aches, shortness of breath, loss of appetite, and loss of hair. The patient was admitted to an unknown hospital for unknown adverse event. The patient sought medical attention and received treatment fot the adverse events. Therapy with GARDASIL was discontinued. The outcome of full body aches, shortness of breath, loss of appetite, loss of hair and unknown adverse event was reported as not recovered. The relatedness between the event and GARDASIL was not provided.
Vasovagal syncope immediately after vaccine administration. Patient fell forward, hitting her nose and forehead on chair in exam room. Appropriate mental status and blood pressure. Patient was given some juice and a dose of MOTRIN for pain after which she felt well enough to walk to the car.
Patient got the Moderna vaccine and have had 3 more boosters; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got the Moderna vaccine and have had 3 more boosters) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (patient received Pfizer vaccine and 5 booster shots). Past adverse reactions to the above products included No adverse event with Pfizer.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got the Moderna vaccine and have had 3 more boosters) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got the Moderna vaccine and have had 3 more boosters) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.  It was reported that the patient had received Pfizer vaccine and 5 booster shots, then the patient went down and got the Moderna vaccine and had 3 more booster shots and in the next month, the patient would be getting the Johnson and Johnson vaccine and after a month, the patient would start getting more boosters again.  It was reported that in January, the patient would start all over again because the patient wanted to be sure that the patient was safe and all of patient's family and friends remained safe. The patient expected that everyone should be vaccinated and boosted atleast 10 to 20 times every year and people should not forget to get at least 4 or 5 flu vaccines either.  No treatment information was reported.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. In 2015, between February 2015 and 13-APR-2015, the patients were vaccinated with a improperly stored doses of GARDASIL lot # K007264 and expiration date on 02-MAR-2017. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Feels like have fever in it; Itch; 4 in x 4 in Red; Rash; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feels like have fever in it), PRURITUS (Itch), ERYTHEMA (4 in x 4 in Red) and RASH (Rash) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy and Drug allergy (Amoxicillin allergy.).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced FEELING HOT (Feels like have fever in it), PRURITUS (Itch), ERYTHEMA (4 in x 4 in Red) and RASH (Rash). The patient was treated with HYDROCORTISONE at a dose of Cream. At the time of the report, FEELING HOT (Feels like have fever in it), PRURITUS (Itch), ERYTHEMA (4 in x 4 in Red) and RASH (Rash) 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. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feels like have fever in it), PRURITUS (Itch), ERYTHEMA (4 in x 4 in Red) and RASH (Rash) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy and Drug allergy (Amoxicillin allergy.).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced FEELING HOT (Feels like have fever in it), PRURITUS (Itch), ERYTHEMA (4 in x 4 in Red) and RASH (Rash). The patient was treated with HYDROCORTISONE at a dose of Cream. At the time of the report, FEELING HOT (Feels like have fever in it), PRURITUS (Itch), ERYTHEMA (4 in x 4 in Red) and RASH (Rash) 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.
Patient received the pediatric 5-11 year old vaccine instead of the 12 and up Pfizer vaccine like he should have. The date of birth was entered incorrectly into the computer and he received the child vaccine instead of the correct Pfizer vaccine.
5 minutes later, subjective throat tightness and headache. Lasted a few minutes. Tolerated second dose.
No adverse event; Dose administered after 30-day Use by Date to patient; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to patient) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine and also unknown if had any of the medical history or condition.     On 23-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 23-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to patient) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to patient).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported. Treatment medications were not provided.  This case was reported for patient 6 out of 7.   This case was linked to US-MODERNATX, INC.-MOD-2023-721391 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721391:Patient 1 out of 7 patients