chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sent to the emergency room because his doctor thought he was having a stroke.; blood vessels had burst in the brain, the hands, and the neck (describes it looking red, purple, like a chemical burn); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (sent to the emergency room because his doctor thought he was having a stroke.) and PURPURA (blood vessels had burst in the brain, the hands, and the neck (describes it looking red, purple, like a chemical burn)) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not reported.). Concomitant products included DULAGLUTIDE (TRULICITY) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (sent to the emergency room because his doctor thought he was having a stroke.) (seriousness criteria hospitalization and medically significant) and PURPURA (blood vessels had burst in the brain, the hands, and the neck (describes it looking red, purple, like a chemical burn)) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 14-Apr-2021 due to CEREBROVASCULAR ACCIDENT and PURPURA. At the time of the report, CEREBROVASCULAR ACCIDENT (sent to the emergency room because his doctor thought he was having a stroke.) and PURPURA (blood vessels had burst in the brain, the hands, and the neck (describes it looking red, purple, like a chemical burn)) outcome was unknown.            The lot number of the second vaccine was thought by the patient to be 0L161521A but patient was unsure.  The patient was hospitalized for one day due to the events.  Magnetic resonance imaging (MRI) and computerized axial tomography (CAT) scan were performed (results not provided).  Treatment information was not provided. Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-080378, US-MODERNATX, INC.-MOD-2021-080378 (E2B Linked Report). This case was linked to MOD-2021-080340 (Patient Link).; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. -MODERNATX, INC.-MOD-2021-080378:Physician case -MODERNATX, INC.-MOD-2021-080378:
Information has been received from a physician concerning "many patients", with an unknown medical history, were vaccinated with a dose of Recombivax HB (manufacturer unknown).  It was reported that many patients who received the vaccine developed nervous system disorders.  It was unknown if medical attention was sought.  The patients' status is unknown.  No product quality complaint was involved.  In follow-up, the office manager reported that the physician confirmed that this report only concerned one patient. The event happened eight years ago.  The consumer is no longer the physician's patient.  No further information was available.
Information has been received from a registered nurse concerning her nephew who was vaccinated with ATTENUVAX as a child and experienced "red all over". It was unknown if the patient sought medical attention. At the time of the reporting, the patient's status was unknown. This is one of several reports received from the same source. Additional information has been requested.
The day following vaccination, the patient experienced redness, swelling and tenderness at the injection site, described by the patient as the size of "half a tennis ball". On day 4, the injection site is less swollen and red.
Vaccines given approx 3:30PM on 2/15/05 pt broke out in hives, with itching, upper arms, upper back, upper chest, neck and lower face. Zyrtec 1 qd x 2 weeks.
The patient's eyes started to roll back in his head. The patient fell backward on the exam table. The patient's arms started shaking uncontrollably. The patient could not see.
Around 10:00AM received Pediarix vaccine to LAT. Upon leaving clinic parents noticed red spot at injection site. 1-2hr later area had grown to 8x5cm and pt was very fussy. No systemic sx. Left ant and lat thigh with area of violaceous lacey-almost urticarial spot. No mass, not hot. Docs blanche-not ecchymotic.  Pt has follow up 8/2/04
Optic Neuritis - referred to ophthalmology for work-up.  Symptoms started after vaccination.  Unclear specific day/time.  1/30/09 Received PCP medical records of 9/26-11/3/2008. FINAL DX: Optic neuritis Records reveal patient in usual state of good health on 9/26/08 when received vaccinations & depoprovera.  RTC 10/13 w/eye pain w/movement x 1.5 wk, peripheral blurry vision, seeing white spots, frontal HA, bilateral knee pain.  Referred to Ophtho but no report available.
1 1/2 weeks post dose 1, 4/13, I started to have lo grade fever, headache, muscle weakness and body aches. On 4/15 I broke out in a red splotchy rash all over my arms, then my front torso and back torso. I had blood work on 4/17 and my kidney and liver numbers were very elevated, my platelets were very low, and my red blood cells were described as "immature." on 4/19 I repeated the labs and they were worse. My internist referred me stat to a hematology oncologist. On 4/20 I had a series of discreet tests on my blood, and also a bone marrow biopsy. The concern was acute onset leukemia. My tests came back days later ruling out blood cancer, and the doctor says the best guess is an extreme antibody reaction to the vaccine.  My rash began to abate around 4/23. It is now Friday 4/30. I have been unable to work, and my symptoms are continued muscle pain and weakness. I still have some lo grade fever, headaches and dry sinuses. I have never felt sick like this.
The patient's husband reported that after the immunization the patient had an elevated blood pressure, vomiting, and headache which required hospitalization for 2-3 days before resolving
?Covid Arm?, redness, uticaria, raised lesions, mild itchiness, spreading along upper arm and worsening each day/throughout each day. Pain at injection site initially and had a knot under the skin prior to the redness spreading.
warm/fussy for two days, and hives on hands and feet 1 day after vaccine, rash and fever seemed to have resolved on clinic visit at 2 day mark. possible related worsening diarrhea but had mild symptoms before vaccination
Information has been received on 13-AUG-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 26-APR-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a hospital health center as recommended for routine adult health maintenance and for the long-term prevention of shingles and zoster-related injuries. The vaccine did not prevent shingles or zoster-related injuries as intended. On or about 16-APR-2016, the patient was treated at an urgent care for the onset of a rash, which was diagnosed as shingles. The patient was prescribed valacyclovir hydrochloride (VALTREX), ondansetron hydrochloride (ZOFRAN) and ibuprofen for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving the ZOSTAVAX for the long-term prevention of shingles and zoster-related injuries, the patient suffered and continues to suffer painful and ongoing injuries and damages and required and continues to require extensive medical care and treatment. As a further proximate result of ZOSTAVAX the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Itchy lungs, trouble breathing, congestion, angioedema. 50mg Benadryl PO, Epi, albuterol, solumedrol
Itchiness; Injection site sore; Injection site red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), VACCINATION SITE PAIN (Injection site sore) and VACCINATION SITE ERYTHEMA (Injection site red) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PRURITUS (Itchiness), VACCINATION SITE PAIN (Injection site sore) and VACCINATION SITE ERYTHEMA (Injection site red). At the time of the report, PRURITUS (Itchiness), VACCINATION SITE PAIN (Injection site sore) and VACCINATION SITE ERYTHEMA (Injection site red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not provided.
suspects optical Shingles; right eye became very sensitive; Watery eye; eye sensation as having a headache in the eye / Tender to touch; Sensitivity extended on right side of face near cheek; eye sensitivity to light; numbness around eye down to cheek; This case was reported by a pharmacist via call center representative and described the occurrence of ophthalmic herpes zoster in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th March 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 12th March 2020, 3 days after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), eye discomfort, watering eyes and eye pain. In March 2020, the patient experienced hyperesthesia, photophobia and numbness facial. On an unknown date, the outcome of the ophthalmic herpes zoster, eye pain, photophobia and numbness facial were not recovered/not resolved and the outcome of the eye discomfort was recovering/resolving and the outcome of the watering eyes and hyperesthesia were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster, eye discomfort, watering eyes, eye pain, hyperesthesia, photophobia and numbness facial to be related to Shingrix.  Additional details were provided as follows: The patient was a pharmacist and reported receiving 2nd dose of Shingrix in left deltoid.  On 12th March 2020, the patient's right eye became very sensitive and she suspects optical shingles. Her eye started watering and becoming bothersome.  The patient also described eye sensation as having a headache in the eye.  Sensitivity became worse as the day went on.  At night, the patient's eye became worse in that it became tender to touch as if lightly pressing on a bruise.  Sensitivity extended on right side of face near cheek and upper jaw.  The patient used an ice pack last night to help relieve sensitivity. The patient reported eye sensitivity to light and numbness around eye down to cheek.  Her symptoms are not too painful. The reporter consented to follow up.
Patient called into pharmacy on 05/08/2021 @ 1:15 pm stating that upon going into work this morning around 8:00 am and starting her shift that she had weakness and tingling in the arm (left) that her injection was given.  She had burning and it hurt just from the injection itself but understood that to be normal. She was concerned about the burning and tingling that was present. She also stated that it as she tried to use the arm at work ( she is a groomer ) that a weird tingling sensation traveled up to her neck and to the middle of her index finger. She had to leave work because she could not use her arm to do her job.  I advised the patient to seek medical attention.  I called the patient  back @ 6:58 pm on 05/08/2021 and she stated that she was feeling better but has not had time to seek medical attention and was going to wait until Monday.
Information has been received from a registered nurse concerning a 4-year-old male with reflux and no other pre-existing allergies, birth defects, or medical conditions who on 07-FEB-2002 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live.  Concomitant therapy that day included a first dose of measles virus vaccine live (Enders-Edmonston) + mumps virus vaccine live (Jeryl-Lynn) + rubella virus vaccine live (Wistar RA 27/3) administered SC in the left thigh and a third dose of poliovirus vaccine inactivated (Vero) administered SC in the left thigh.  The patient was noted to have hives on his chest and trunk at the time of vaccination.  On 11-JAN-2006 the patient developed herpes zoster.  There were no relevant diagnostic tests or laboratory data.  There were no adverse events following prior vaccinations.  Follow up information indicated that on the evening of 11-JAN-2006, the patient developed a low back ache and vomiting.  The patient was very weak and tired.  On 12-JAN-2006, the patient got worse.  Per the mother, the rash did progress as expected.  It was noted that the rash scabbed over, and the outcome was reported as recovered on 26-JAN-2006.  No additional information is expected.
After receiving a tetanus vaccination on my mid-upper left arm, I had redness, swelling, and bruising around a large part of my arm for 7 days, and was told by a different doctor that it was infected at the injection site. I had a low grade fever (100.2) for 4 days after vaccination was given, along with body aches, chills, and tiredness.
Patient stated she suffered shortness of breath and throat tightening which caused difficulty breathing as well as redness and inflammation of right arm.
This case was reported by a lawyer and described the occurrence of loss of concentration in a 53 year old female pt who received lyme disease vaccine recombinant (Lymerix) injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the pt received Lymerix. At an unk time after receiving Lymerix, the pt experienced severe joint pain, insomnia, fatigue, and memory loss.  Time to onset, treatment, and outcome were not reported.
Post vax, mom states baby couldn't cry, questionable apnea. Called ambulance.
Vaccine administered after temperature excursion; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Apr-2021 and was forwarded to Moderna on 04-Apr-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after temperature excursion) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after temperature excursion). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after temperature excursion) had resolved. 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.   concomitant information was not provided. Treatment information was not provided.   This case was linked to MOD21-068620 (E2B Linked Report).; Sender's Comments:  MOD21-068620:cross link
It looks like I have chicken pox or something; Inside of her legs broke out with a rash/ Her hands did break out; This is a spontaneous report from a contactable consumer (patient). A 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in right deltoid on 25Mar2021 11:15 (at the age of 86-year-old) (Lot Number: EN6206) as dose 1, single for COVID-19 immunization. Medical history included contusion from and infection (patient ran into the bed post with her ankle and skinned it and it bruised and got infected and it was not healing). Concomitant medication(s) included cephalexin (CEPHALEXIN) taken for contusion, infection, start and stop date were not reported. The patient previously took flu vaccine. The patient did not take any other vaccine within 4 weeks prior to COVID vaccine. The patient reported that inside of her legs broke out with a rash and broke out on her hands on 27Mar2021. The patient reported that it looks like she had chicken pox or something on an unspecified date. The outcome of legs broke out with a rash and broke out on her hands was not reported and the outcome of other event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
This spontaneous report was received from a physician refers to an unspecified number of patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose (at a temperature of 10 F for 1 hour) of PROQUAD, therapy type: rHA, lot # M029595 (expiry date: 10-DEC-2017) (dosage not reported). No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Nurse was about to administer vaccine, needle touched patient, then patient changed mind and wanted a different needle (vanish point instead) without administering any portion of vaccine. Due to contamination, wasted vaccine, and administered new vaccine.
Around 11:00pm the night of the injection for dose 2, I started having flu like symptoms. Lasted about 4-5 days
TIGHT BURNING FEELING IN UPPER RIGHT BACK AND RIGHT ELBOW; CRIPPLING CONSTANT PAIN; MUSCLE WEAKNESS TO THE RIGHT ARM; TIGHTNESS ON UPPER RIGHT SIDE ON BACK NEAR RIGHT SHOULDER; INJECTION SITE PAIN; INITIAL BURN WHEN VACCINATED; DISCOMFORT; DID NOT SLEEP WELL AT NIGHT; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included shellfish allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced discomfort. On MAR-2021, the subject experienced did not sleep well at night. On 11-MAR-2021, the subject experienced muscle weakness to the right arm. On 11-MAR-2021, the subject experienced injection site pain. On 11-MAR-2021, the subject experienced tight burning feeling in upper right back and right elbow. On 11-MAR-2021, the subject experienced crippling constant pain. On 11-MAR-2021, the subject experienced tightness on upper right side on back near right shoulder. On 11-MAR-2021, the subject experienced initial burn when vaccinated. Treatment medications (dates unspecified) included: ibuprofen, naproxen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 12-MAR-2021, was recovering from tight burning feeling in upper right back and right elbow, crippling constant pain, did not sleep well at night, discomfort, initial burn when vaccinated, and tightness on upper right side on back near right shoulder, and had not recovered from muscle weakness to the right arm. This report was non-serious.  Additional information was received on 19/Mar/2021. The following information was updated and incorporated into the case narrative. Reporter details added, patient information (date of birth, sex, ethnic origin, race) added. patient allergy details, batch number of suspect, site of administration, Vaccine facility details, events: injection site pain and muscle weakness to the right arm were added.; Sender's Comments: V1:Medical assessment comments not required as per the standard procedure as the case is considered non serious.
Patient began feeling lightheaded and passed out a few minutes after receiving her first dose of Moderna. She quickly recovered, was placed in a Trendelenburg chair and vitals were normal upon being checked. EMS was onsite to evaluate the patient. No further treatment was necessary.
the following morning the patient became unresponsive while taking a shower, became asystolic and died despite about an hour of ACLS and 8 rounds of epi
Patient given second dose of HPV vaccine 2 weeks after receiving the first dose.  No adverse reaction.  No treatment needed.
This case was reported by a physician via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and pain. On an unknown date, the outcome of the fever and pain were unknown. It was unknown if the reporter considered the fever and pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The health care professional reported that the patient experienced fever and aches after the 1st dose of SHINGRIX. No further details were provided.
Pt was seen for well visit with conjunctivitis. 45 minutes post vax, pt experienced Tonic/clonic generalized seizure. Pt was seen in ER with a fever of 104.8, nml exam. Pt was admitted to rule out sepsis, antibiotics were given. Discharged on 4/22/00 with neg cultures, no fever and normal exam.
Pain in joints.  Started in the arm of the injection, stopped hurting in the arm then moved to the chest, then back, hips, knees, and ankles. Pain in the knees lasted three days. My knees had been injured previously.
Injection site pain Narrative: Patient reported a "weird feeling" at the injection site on the left deltoid within about 8 minutes post vaccine injection. She also reported brief and transient nausea. Vitals were normal. Patient was monitored for an additional 15 minutes at Facility and reported feeling comfortable and left. Husband drove patient to Facility and back home again. Patient in vaccine research study.
Dizziness & Headache Narrative: Patient c/o mild headache, dizziness, and dry mouth. Denies any other symptoms.
10/28/99 burning,swelling from should to elbow,pain of rt arm. Chest pains on 10/29/99, increased w/activity and coughing. Pt still has golfball size swelling to back of arm,tender to touch and still has mild ongoing chest pain.
It was administered to an individual who is 17 years old; A spontaneous report was received from a pharmacist concerning a 17 years old patient who received Moderna's COVID-19 vaccine (mRNA-1273).  Medical history was not reported. Concomitant medication was not reported.  On an unknown date, prior to the onset of the events it was administered to an individual who is 17 years old, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  Action taken with mRNA-1273 in response to the event It was administered to an individual who is 17 years old was not provided.  The outcome of the event It was administered to an individual who is 17 years old was resolved.  The reporter did not provide the assessment of the event It was administered to an individual who is 17 years old to study drug.; Reporter's Comments: This report refers to a case of inappropriate age at vaccine administration for mRNA-1273 with no associated AEs.
Tight, heavy chest, trouble breathing.  Lasted  from 8PM until about 1AM.  Fatigue and chills the next day.