chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt developed left facial numbness and sensation of heat and numbness in the left arm and numbness into the leg and foot. Symptoms started at 1:36 pm while walking to catch train. Pt noted numbness and felt light headed. Pt had mild headache that he associated with not eating much. Pt returned back to urgent care because of symptoms and RR team called.    Pt had given blood for tests (12 vials) and abdominal ultrasound earlier in the morning as work up for his chronic renal insufficiency. Pt drank several cups of water before the ultrasound.  Symptoms initially improved but did not resolve, so he was sent to ER for stroke. Pt had 3 more episodes of worsening left sided numbness and lost consciousness on 2 of those occasions per the patient. Neurology evaluated patient and said that they were likely thalamic strokes. Pt was unable to have an MRI because of metal in his eye.
Information has been received from a 67 year old female patient allergic to aspirin and sulfa drugs, and with thyroid disorder who on 16-DEC-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Merck) (lot# not provided) 0.65ml. Concomitant therapy included thyroid medication. On approximately 08-APR-2009 ("a little less than a week ago") the patient received a PAP test and results came back that she had HPV. She has been with her husband for 35 years and believe this may have been caused by the ZOSTAVAX vaccine (Merck). Patient sought unspecified medical attention. At the time of this report patient had not yet recovered. No further information is available.
Patient had pain at vaccination area starting on 6/22/2019. On 6/23/2019 he had muscle pain, weakness, tiredness, headache, upset stomach and was shivering.
I was very tired; Couldn't move arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 25Jan2021 09:40 (Lot number: EL9261) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Presumed COVID-19", start date: 05Jan2021 (unspecified if ongoing), notes: Asymptomatic, no symptoms, Fever, Slight Headache, Chills, Vomiting's during time period. There were no concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "I was very tired"; INJECTED LIMB MOBILITY DECREASED (non-serious), outcome "unknown", described as "Couldn't move arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: On 02Jul2020, the patient been tested negative for Covid Antibody Test. On 02Feb-10Feb abnormally ill with Covid like symptoms, followed up with antibody test was negative, also negative for Strep's flu. The patient presumed that asymptomatic Covid 19 had on 05Jan2021. No symptoms/fever slight headache, chills, vomiting's during time period were reported. On 13Feb2021, the patient had Covid symptoms. No Covid testing was available at that time I took an antibody test 02Jul2020 but later became aware time with accuracy of the test was low. The patient's spouse tested positive for Covid on 05Jan2021. The patient was slightly symptomatic (Chills, Vomiting, Headache) and took shot 1 on 25Jan2021 and shot 2 on 18Feb2021, Couldn't move arm after shot 1 and was very tired, after shot 2, the patient had every symptom on the Pfizer info sheet except for injection site redness, was very ill about 3 days. The vaccination facility was provided as hospital and not administered at military facility. The patient did not received any medication and concomitant medication within 4 weeks prior vaccinations.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a nurse refers to "less than 10" patients of unspecified age and sex. The patients medical history and concurrent condition were not reported. On an unspecified date, the patients were vaccinated with doses of improperly stored VARIVAX (Merck) injection (lot # K002918 expiry date 26-FEB-2016). No adverse effects were reported. Additional information has been requested.
her husband did not receive the second dose of the vaccine, after the first dose on 05Apr2021; fever of 104 degrees Fahrenheit; deep redness from wrist to shoulder on injection arm; Chest Pain; deep redness from wrist to shoulder on injection arm; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pain), ERYTHEMA (deep redness from wrist to shoulder on injection arm), PRODUCT DOSE OMISSION ISSUE (her husband did not receive the second dose of the vaccine, after the first dose on 05Apr2021), PYREXIA (fever of 104 degrees Fahrenheit) and VACCINATION SITE ERYTHEMA (deep redness from wrist to shoulder on injection arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced CHEST PAIN (Chest Pain), ERYTHEMA (deep redness from wrist to shoulder on injection arm), PYREXIA (fever of 104 degrees Fahrenheit) and VACCINATION SITE ERYTHEMA (deep redness from wrist to shoulder on injection arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (her husband did not receive the second dose of the vaccine, after the first dose on 05Apr2021). At the time of the report, CHEST PAIN (Chest Pain), ERYTHEMA (deep redness from wrist to shoulder on injection arm), PYREXIA (fever of 104 degrees Fahrenheit) and VACCINATION SITE ERYTHEMA (deep redness from wrist to shoulder on injection arm) had resolved and PRODUCT DOSE OMISSION ISSUE (her husband did not receive the second dose of the vaccine, after the first dose on 05Apr2021) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication provided. On an unknown date, Body temperature: 104 (Inconclusive) 104 degrees Fahrenheit.   No treatment medication provided.  The patient did not receive second dose at all.
Pneumo Conjugate (Prevnar 20) given in error. No known events.
Red rash and swelling at injection site, rash spread to chest, back, and other arm.
Day after vaccine started fevers of up to 100.6 F, throughout following days fevers ranging from 99.6 up to 100.4. After a week still on off fevers tiredness, nausea, and headache also have not gotten my menstrual cycle.  Went to urgent care on April 30, 2021 was checked and Covid Tested, results came back negative.
Patient had history of HSP for which the vaccine triggered recurrence of HSP - purpura to both legs, with moderate hematuria and proteinuria
2/5/2021 thru 2/12,  Started having a red, bumpy rash in Left arm.  Then spread over his entire left side.  Took 2 weeks to go away, used topical cream, Benadryl and took XT.
Intense body aches, chills and severe fatigue.  Persistant vomitting and dirrahea for 8 hours on and off the night of my vaccine. 101-102 degree fever for 24 hours after onset in evening after vaccine. Severe exhaustion, nausea, and overall feeling terrible for 3 days.  I didn't recover and finally feel more like eating until Sunday May 16th, 4 days after my vaccine. Took tylenol, drank fluids as much as I could, and slept and soaked in warm bath.
PATIENT WAS INADVERTENTLY ADMINISTERED THE VACCINE. VACCINE EAU NOT APPROVED FOR UNDER AGE 18. PATIENT WAS MONITORED FOR 1 HOUR WITH NO ADVERSE EFFECTS.
Patient was given the 0.25ml Moderna booster on 1/7/2022.  Patient had received 2 full doses of pfizer previously.
Information has been received from a licensed practical nurse, for the Pregnancy Registry for GARDASIL (Lot # 659184/0843X), concerning a 25 year old female who on 21-AUG-2008 was vaccinated with the first dose of GARDASIL.  There was no concomitant medication.  The patient's last menstrual period was 22-JUL-2008.  35 weeks from her LMP she gave a birth to a healthy baby on 24-MAR-2009.  Currently she is breast feeding the baby.  The patient had sought medical attention.  Follow up information has been received from this practical nurse.  She reported that she did not have any more information than what she had provided.  Additional information is not expected.
very sick the second day; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick the second day) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (very sick the second day). At the time of the report, ILLNESS (very sick the second day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants medication were provided. No treatment medication were provided.
Red warm rash, swollen and hot with pain upon touch, occasionally itches. Rash occurred 48 hours post injection approximately 4 inches below injection site.
20 MINUTES AFTER RECIEVING The COVID VACCINE, THE PATIENT Became PALE, & NAUSEOUS BP 84/57 P  64 Pulse oxcimitry 99%- Rest FLUIDS & & SNACK The PATIENT improved BP 93/65 &was DISCHARGED
Arm has 3" x 2" induration & redness at injection site. BENADRYL cream tid.
This is in follow-up to report(s) previously submitted on 6/13/08. Information has been received from a physician concerning a female with an upper respiratory infection who was vaccinated on an unspecified date with a dose of GARDASIL (lot# not reported).  Subsequently, 12 or more hours after the vaccination, the patient experienced palpitations. The patient also had a cold at the time but had not taken any medication. She also had a low grade fever attributed to the cold. The patient's outcome was not reported.  Additional information has been requested. Follow up information received from the physicians office stated that the patient was never treated with GARDASIL. It was reported that the patient had received "other vaccines not manufactured by Merck" details of the "other vaccines" was not provided. On an unspecified date the patient had an electrocardiogram which was within normal limits and the patient was considered to have recovered from the event.
Dose was injected into left arm approx 1:30 on 4-8.  Resumed normal daily activity including rigorous 1.5 hrs of tennis from 18:00-19:30.  Left arm was a little sore, but no other adverse effects of vaccination.   At approx. 01:00 on 4-9 I was awoken by what felt like severe chills with elevated heart rate.  I tried to walk around my house to see if that would ease the symptoms, it did not.  About 01:45 I started drinking a Brisk ice tea.  That helped & allowed me to fall back asleep.  Felt sluggish all day 4-9 with flu-like body aches & pains, so stayed in bed most of day.  On 4-10 I resumed my normal activity level.
Nose bleed; Body ache; This spontaneous case was reported by a pharmacist and describes the occurrence of EPISTAXIS (Nose bleed) and MYALGIA (Body ache) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 001A21A) for COVID-19 vaccination.     The patient's past medical history included Rhinoplasty. Concurrent medical conditions included Nose bleed.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced EPISTAXIS (Nose bleed) and MYALGIA (Body ache). At the time of the report, EPISTAXIS (Nose bleed) and MYALGIA (Body ache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information provided.  The patient took Ibuprofen as treatment medication.   This case was linked to US-MODERNATX, INC.-MOD-2021-068376 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068376:CROSSLINKED WITH DOSE 1
DISCHARGED. Patient is a 90 y.o. female who presented with complaints of weakness poor appetite and back pain.  CT scans of the lumbar spine and pelvis showed Acute Left/Right L5 transverse process fractures, L4 pedicle fracture and age indeterminate compression deformity of L3 and Nondisplaced bilateral sacral alar insufficiency fractures.  PT OT and orthopedics consulted.  Of note patient had recent COVID infection 12 days ago currently asymptomatic outside of fatigue and remained on room air during hospitalization. Ortho Spine consulted recommended Pt/medical management. If she fails medical management then will consider MRI. Discharged back to Nursing home with additional PT/OT and nursing. Advised close follow up with PCP and ortho spine.
This spontaneous case reported by a consumer, describes the occurrence of pyrexia (slight fever) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 038A21A) for COVID-19 immunization. No medical history reported. On Mar 30, 2021, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; .5 milliliter. On Mar 6, 2021, patient experienced pyrexia (slight fever). At the time of the report, pyrexia (slight fever) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported. Upon internal review on Aug 4, 2021, the age corrected to 38 years.
At 2000 on 1/13/21, I started to experience intense ache at the injection site, which by 2200 progressed to myalgias in my back, especially lower back, neck, and right arm. At 2300,  I started to have fever/chills, up to 39 C orally. This only partially responded to Tylenol. I was not able to sleep.  At 2:30 am I noticed an unusual headache, 8/10, as well as bilateral eye pain on Moving eyes side to side as well as sensitivity to light. Headache was mostly frontal, which came and went every few minutes  until exactly 11:38 am on 1/14/2021, when the fever and myalgias very suddenly got significantly better. Almost exactly 24 hrs to the minute after injection. On 1/15/2021, I still have significant pain in my left arm, swelling, redness and, now, itching at the injection site. My lower back still hurts.
Patient received 3rd dose of Covid19 Pfizer vaccination due to facility not keeping proper records. Patient condition unknown at time of report.
This case was reported by a other health professional via regulatory authority and described the occurrence of suspected vaccination failure in a adult male patient who received Men ACWY-CRM NVS (Meningococcal ACWY Vaccine (potential MENVEO)) for prophylaxis. On 26th June 2008, the patient received Meningococcal ACWY Vaccine (potential MENVEO) (intramuscular). In April 2013, unknown after receiving Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced vaccination failure (serious criteria GSK medically significant), meningitis (serious criteria hospitalization and GSK medically significant), syncope (serious criteria hospitalization), headache (serious criteria hospitalization), fever (serious criteria hospitalization), stiff neck (serious criteria hospitalization), chills (serious criteria hospitalization), photophobia (serious criteria hospitalization), decreased appetite (serious criteria hospitalization), nausea (serious criteria hospitalization), malaise (serious criteria hospitalization) and weakness (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the meningitis, syncope, headache, fever, stiff neck, chills, photophobia, decreased appetite, nausea, malaise and weakness were recovered/resolved. It was unknown if the reporter considered the vaccination failure, meningitis, syncope, headache, fever, stiff neck, chills, photophobia, decreased appetite, nausea, malaise and weakness to be related to Meningococcal ACWY Vaccine (potential MENVEO). Additional details were provided as follows: The age at vaccination was not reported. On 20th April 2013, the patient received tuberculin purified protein derivative (suspect). This case was considered as suspected vaccination failure as the confirmatory lab test, and basic immunization schedule, were not provided.
Patient tested positive on 01/26/2022.  Admitted to the hospital on 01/30/2022 with symptoms: feverish, muscle aches, runny nose, cough, wheezing, shortness of breath, nausea or vomiting, headache, fatigue, diarrhea, olfactory disorder, difficulty breathing.  No date of discharge was listed. Patient has multiple pre-existing health conditions.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. Between 03-SEP-2017 and 11-SEP-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (lot # M003701, expiration date 01-NOV-2019 and lot # N003700, expiration date 01-NOV-2019) (dose and route were not reported) for prophylaxis. The vaccine was exposed to 8.5 Celsius degrees (°C) for 1 hour. There was no previous temperature excursion and also there was no "data logger". No adverse effects were reported. Lot number M003701 is an invalid lot number for haemophilus B conjugate vaccine (meningococcal protein conjugate). This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA009437: US-009507513-1709USA009443: US-009507513-1709USA009439: US-009507513-1709USA009440: US-009507513-1709USA009441: US-009507513-1709USA009442: US-009507513-1709USA005606: US-009507513-1709USA009435: US-009507513-1709USA009438.
Onset of soreness around injection site within two hours; lingering soreness remains after ~60 hours; at peak, pain rating 6/10. Onset of general "ill" feeling within 4 hours (mild fatigue and body aches, sensitivity to sound). Physical discomfort increased overnight, reaching peak ~15-20 hours after injection but remaining severe throughout day 2 (unable to perform daily activities). 400mg ibuprofen every 6 hours helped to alleviate symptoms. ~15 hours after injection, sleep was interrupted by severe body aches along with nausea; followed within 30 minutes by vomiting.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M001579, expiration date 05-OCT-2018 (dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. Administered doses of vaccines experienced the following temperature excursions between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 12 hours. The vaccine experienced the previous temperature excursion between -47 degrees Fahrenheit and 77 degrees Fahrenheit for 3 hours. Data logger was involved. No product quality complaint (PQC) was involved. Additional information has been requested.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 14-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 04-Mar-2012. On 13-Mar-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 16-Apr-2012 and incorporated into the narrative: No late occurring adverse event.
My husband was diagnosed with shingles on 5/06/2021. We aren?t sure if this was caused from the vaccine but since it occurred within a week after receiving, we wanted to report it.
No adverse event; Moderna Dose 1 24-FEB-2021 and Moderna dose 2 7-APR-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Dose 1 24-FEB-2021 and Moderna dose 2 7-APR-2021) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 027B21A) for COVID-19 prophylaxis.     The patient's past medical history included Obesity. Concurrent medical conditions included Hypertension.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Dose 1 24-FEB-2021 and Moderna dose 2 7-APR-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Dose 1 24-FEB-2021 and Moderna dose 2 7-APR-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Moderna vaccine dose 3 given on 11 Nov 2021 with Batch/Lot No: 067F21A and location of injection was left arm. Moderna vaccine dose 4 given on 10 May 2022 with Batch/Lot No: 049L21A and location of injection was left arm. Moderna vaccine dose 4 given on 07 Sep 2022 with Batch/Lot No: AS7140C and location of injection was left arm. Pfizer vaccine was used for treatment of covid 19 on 15-Oct-2022 and had event Symptomatic rebound with positive antigen test result on 24 Oct 2022 with outcome recovering/resolving. The concomitant medication Pharma was taken by 1-Jan-2022 till 24-Oct-2022.
No additional AE reported; a patient was administered an expired dose of MMRII; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 29-SEP-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) 0.5 milliliter, lot number S016678, expiration date 30-MAY-2021 (route of administration not provided) for prophylaxis (expired product administered). No adverse event was reported.
This spontaneous report as received from a consumer (patient's mother) via social media refers to a male patient of unknown age. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. On unknown dates, the patient was vaccinated with GARDASIL, (dose, dose #, route, lot # and expiration date unknown) for prophylaxis. No concomitant medications were reported. The patient's mother reported that she thought this vaccine was great until she had her son vaccinated, knowing he could only be a carrier not get cervical cancer. On unknown dates, he stayed sick shortly after each round of vaccination and had bad headaches. Since an unknown date (reported as now), the patient had been experiencing autoimmune problems. The reporter also stated that, the vaccine only works for five years and it is not worth the fall out of the vaccine as it has too many side effects. The outcome of the events was unknown. The reporter did not provide causality assessment for the events. No product quality complaint was involved. Upon internal review, autoimmune problems was determined to be medically significant. Additional information has been requested.