chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received form a nurse refers to a patient of unknown age and gender. On 27-SEP-2013 the patient was vaccinated with M-M-R II (reported lot # H018950 corresponding with lot # 1483AA: expiration date: 18-OCT-2014). The vaccine was exposed to temperature exposures of 50F for 85 minutes, 47F for 15 minutes, 48 F for 35 minutes, 52F for 95 minutes, 48 F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter linked). Additional information has been requested.
10 days after receiving the MMR, the pt ran a high fever of 105F and would not eat solids (got sick). He had a rash on his body and face, swelled (cheek area), screaming and we could not comfort him. Called MD and gave Tylenol and fever would not break. Was told to take him to the ER. Diagnosed with Autistic Spectrum Disorder.
Significant rash to face and trhink-raised red popular exanthem highly concentrated to face; sporadic on extremiter. Mild nasal congestion; fatigue/lethargy, constipation all started with rash. 8/3/19 when constipation started, 8/4/19 when fatigue started with low grade fever. 8/5/19 when rash started
Severe cold after day 2.  Day 3, I have a stuffy and very runny nose, runny eyes, cough, tight chest and slight chills.
allergic reaction (anaphylactic); This is a spontaneous report from a contactable pharmacist (patient). A 52-years-old female patient received second dose of BNT162B2 (BNT162B2), Via an unspecified route of administration, administered in Arm Right on 05Apr2021 09:15 (Batch/Lot Number: ER8737) as single dose for covid-19 immunisation. Medical history included hypersensitivity. There were no concomitant medications. The patient experienced allergic reaction (anaphylactic) (anaphylactic reaction) on 05Apr2021 09:15 few seconds after the second dose had taken Claritin the night before both shots and Benadryl 30 min before and on 2nd shot. 3 h later the reaction repeated and I took 2 more Benadryl Therapeutic measures were taken as a result of allergic reaction (anaphylactic) (anaphylactic reaction). The patient had recovered from the events.  No follow-up attempts are possible. No further information is expected. .; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event anaphylactic reaction and the suspect vaccine BNT162B2.
About 5PM after injection, I started feeling like I had a spider web across my face and eye. The next morning red splotches appeared on my face and eye lid all on the left side of my face. As it progressed it turned into red bumps then later scabbed over. I have a red, swollen area under my eye. The MD diagnosed it as shingles. I have had the shingles shot years ago
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent condition, concomitant drug and drug reactions/allergies were not reported. On 11-JUN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route was not reported) lot # r024023, expiration date of 22-AUG-2019 for prophylaxis (product storage error). Other suspect therapies included sterile diluent (strength, dose, route of administration, lot/batch# and expiry date were not reported). No adverse effects were reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter.
***PATIENT DID NOT HAVE AN ADVERSE EFFECT, BUT RECIEVED A 4TH DOSE OF PFIZER VACCINE ON 9/8/21****
I developed a severe sore throat, aching, fatigue, a cough, chills and runny nose. I completed a COVID-19 home test on Sunday January 15, 2023. I contacted my doctor through the portal and the doctor call prescribed PAXLOVID. I began taking the medication the next day. On Thursday of that week, I was still tired and was getting dizziness with activities. The fatigue, cough and sinus stuffiness remained after the I had completed the PAXLOVID. The cough remained for a long time. By March 5, 2023, I felt completely recovered.
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female who on 02-MAR-2010 was vaccinated with the first dose of GARDASIL when she was pregnant. The patient had not been given any other of GARDASIL. The patient was 20 weeks pregnant at the reporting time. The patient's LMP was approximately on 17-DEC-2009. EDD was on 23-SEP-2010. The patient sought medical attention. No adverse reactions reported. Follow up information has been received from the registered nurse concerning a 25 year old female who on 02-MAR-2010 was vaccinated with the first dose of GARDASIL (lot # 663452/0671Y). Concomitant therapy on 02-MAR-2010 included a 0.5ml dose of H1N1. On 05-APR-2010, serum alpha-fetoprotein test (MSAFP) for screening was performed and the result was negative. On 22-APR-2010, ultrasound for dating and anatomy test was performed and the result was normal. The patient had 2 previous pregnancies and 2 full term deliveries with no pre-term deliveries, no spontaneous abortions, no elective terminations, no fetal deaths. There were no birth defect nor infant complications in previous pregnancies. The patient's LMP was 17-DEC-2009. EDD was 23-SEP-2010. At the time of the report, the outcome was unknown. Follow up information has been received from the nurse practitioner who reported that estimated conception date was 06-DEC-2009. The patient experienced proteinuria and preeclampsia during pregnancy. On 14-SEP-2010 the patient was vaccinated with a 0.5 ml dose of influenza virus vaccine (unspecified). On 14-SEP-2010 the patient delivered a female normal infant (weight 3600, length 19, apgar score 9/9, weeks from LMP 40 weeks 2 days, head circumference 35). There were no congenital anomalies. Other complications or abnormalities included: retained placenta, velamentous insertion site - placenta uneven villus maturity, thick chorionic plate. Additional information has been requested.
Second dose administered 18 days after the first dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered 18 days after the first dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered 18 days after the first dose). On 17-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered 18 days after the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were not provided by reporter.  No concomitant medications were provided by reporter.
SHARP JABBING PAIN IN BODY; FEELING LIKE STICKING WITH NEEDLE ALL OVER; This spontaneous report received from a consumer concerned a 64 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: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced sharp jabbing pain in body. On 12-APR-2021, the subject experienced feeling like sticking with needle all over. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sharp jabbing pain in body and feeling like sticking with needle all over was not reported. This report was non-serious.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE SWELLING (Vaccination site swelling) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included CHOLESTEROL, ALLIUM SATIVUM, CAPSICUM ANNUUM, CRATAEGUS LAEVIGATA, FOENICULUM VULGARE, UBIDECARENONE (HEART) and LEVOFLOXACIN (LEVOPRIDE [LEVOFLOXACIN]) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE SWELLING (Vaccination site swelling). At the time of the report, VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
got both of her legs amputated because of some malignancies on her legs that developed after getting vaccinated; got both of her legs amputated because of some malignancies on her legs that developed after getting vaccinated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (medically significant), LEG AMPUTATION (medically significant), outcome "unknown" and all described as "got both of her legs amputated because of some malignancies on her legs that developed after getting vaccinated". Clinical information: The reporter mentioned that a young girl from (withheld), (withheld) got both of her legs amputated because of some malignancies on her legs that developed after getting vaccinated (she mentioned she does not know which vaccines were administered to her). She stated she got really scared about this because this young girl was very athletic. The reporter was concerned after hearing this.   The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Passed 6mm Kidney Stone with violent symptoms: extreme pain, nausea, vomiting.  Took in Emergency Care, painkillers including morphine, CAT scan. Discharged few hours later as stone had made its way to bladder
pain upon inject (stinging pain) followed by warm erythma area 1" circular, lasting 4 days; no fever;
Moderna COVID vaccine for the first dose, and now they know the second dose is no longer manufactured. He wants to know what second dose he should take; no adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Moderna COVID vaccine for the first dose, and now they know the second dose is no longer manufactured. He wants to know what second dose he should take) and NO ADVERSE EVENT (no adverse event) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Oct-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Moderna COVID vaccine for the first dose, and now they know the second dose is no longer manufactured. He wants to know what second dose he should take) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Moderna COVID vaccine for the first dose, and now they know the second dose is no longer manufactured. He wants to know what second dose he should take) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Moderna COVID vaccine for the first dose, and now they know the second dose is no longer manufactured. He wants to know what second dose he should take).    No concomitant medication was reported.  No treatment information was reported.   Reporter did not allow further contact
Received #4 Anthrax Vaccine on 15Apr04 at 1400 started getting itching sensation around area on 16Apr04 at night. Notice large redness area around site.
This spontaneous report was received from a medical assistant, referring to a 17 year old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PROQUAD subcutaneously, lot # N020617, expiration date 22-JAN-2019, for prophylaxis (Strength, dose and frequency were not reported). No adverse effects were reported.
Swelling and pain of throat and hernia/chest. Slight fever and sweating/dizziness. It was the hernia that took the brunt of the reaction and was very painful.
48 hrs p/immun given mom reports high pitched screaming, restlessness, high temp but did not use thermometer;
Patient was underage - 5 days away from 18th birthday.  Shot was administered by nursing students.
AFTER RECEIVING VACCINE, LOCALIZED REDNESS AND SWELLING ON LEG CLOSE TO INJECTION SITE. PATIENT REMAINED IN CLINIC FOR 20 MINUTES FOR MONITORING. SYMPTOMS DID NOT BECOME WORSE DURING THIS TIME.
I had the second vaccine dose on 8/3/2021 at 8am. At 11pm I began having fever, chills, and body aches. These lasted 24 hours. 7 days later on 8/9/2021 I began having vaginal bleeding, light, brown colored like the early days of my period. This bleeding was at day 19 of my menstrual cycle. My cycle generally runs 30-35 days, so this bleeding is about 10 -14 days early. It is currently 8/10/2021 and light bleeding persists.
Parent reports diarrhea for 2 weeks post 1st and 2nd dose of RotaTeq.
Some doses that may have been administered past 30 days from being thawed; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed). In 2021, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed) had resolved. In 2021, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter. Expiration dates are unknown, they only have the 30 day mark which was on 16May2021
Felt feverish during the night, felt better the next morning, then became nauseated, fatigued, headache, febrile, leg cramps
Redness, swelling, induration, tender and warm to touch. Measures 4.5x4.8cm. Patient a febrile. Patient is 28 year old pregnant woman at 24.5 weeks gestation.
Headache; This spontaneous case was reported by an other caregiver and describes the occurrence of HEADACHE (Headache) in a 53-year-old female patient 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. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable
rash/redness with slight skin swelling; rash/redness with slight skin swelling; rash/redness with slight skin swelling; This is a spontaneous report from a non-contactable consumer (Patient). A 67-year-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in left arm on 25Feb2021 16:00 (at the age of 67-year-old) as dose 1, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included allergy to PCN, Morphine, Demerol on an unknown date and unknown if ongoing. Other medical history none. No Concomitant medication in two weeks. Prior to vaccination, patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccine in four weeks. It was reported that on 12Mar2021 07:15 (15 days after injection) developed large area-1 1/4 inch wide-of rash/redness with slight skin swelling. Started at 1/2in and over next 24 hrs increased to 1 1/2 in. Patient did not receive any treatment for the event. Outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received bnt162b2 (BNT162B2), on 14Feb2021 at 15:00 as dose 1, single (Lot number: EL9261), in left arm and on 07Oct2021 at 10:15 as dose 2, single (Lot number: EL9261) at the age of 76 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Jun2022 at 14:15 as dose 3 (booster), single (Lot number: 057M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Stage 1 sarcoidosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Simvastatin, reaction(s): "Drug Allergy", notes: Simvastatin minor random muscle pain; Simvastatin, reaction(s): "minor random muscle pain", notes: Simvastatin minor random muscle pain. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Jun2022 at 14:15, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of interchange of vaccine products, drug ineffective, covid-19 which included Paxlovid taken from 15Sep2023 to 20Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300311398 same reporter/patient, different dose/AE;
This case was reported by a consumer via call center representative and described the occurrence of feeling of warmth in a 73-year-old male patient who received SHINGRIX for prophylaxis. On 12th April 2018, the patient received the 2nd dose of SHINGRIX. On 13th April 2018, less than a day after receiving SHINGRIX, the patient experienced feeling of warmth. On an unknown date, the outcome of the feeling of warmth was not recovered/not resolved. The reporter considered the feeling of warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received the dose of SHINGRIX on left arm. The patient reported feeling like he had sunburn. There was no redness just the sunburn feel. The feeling started on his feet a day following the shot and by the 2nd day it progressed to the top of his head down his whole body to his feet. At the time of reporting, the patient rated the intensity as a 3 but prior to it that had been an 8 or 9 at times. The patient was treated in urgent care and also the emergency room but not admitted to the hospital. The patient described it as feeling like his skin had been in the sun all day and was sunburned. The patient had denied permission to contact their physician.
Patient passed out for a few moments a few minutes after getting the vaccine. Patient fell and bit their lip and had some bleeding from lip. Afterwards patient felt better, had some hypotension when standing from sitting position. Paramedics evaluated the patient. She will see the doctor out of caution, although was feeling better after the incident.
Fever: 100.4 Chills Headache Fatigue Body aches Treatment: OTC/naproxen
Patient received shot in arm and stated he felt light headed, lost consciousness and fell forward, was helped to the ground by staff, Started assessing patient, getting vital signs, and called 911. Patient refused to leave with paramedics. Out for approximately 30 seconds.
STates having funny feeling in chest, daaphorectic, would not respond to questions.  Vacant stare.  Sent to ED for further evaluation.
Stated they felt oncoming vasovagal response, patient was diaphoretic and pallor. Patient instructed to lie down  , vital signs taken. After approximately 15 minutes of laying down vitals improved, color returned, and patient felt better.
Fever, severe headache, nausea, chills, muscle aching, fatigue, dizziness