chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was initially stored in the refrigerator on 07-Feb-2023; No adverse event; she has few Moderna vaccines administered after the 30-day beyond use date. This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (she has few Moderna vaccines administered after the 30-day beyond use date.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-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) 1 dosage form. On 13-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (she has few Moderna vaccines administered after the 30-day beyond use date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (she has few Moderna vaccines administered after the 30-day beyond use date.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Feb-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (she has few Moderna vaccines administered after the 30-day beyond use date.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Feb-2023).    Concomitant medication was not provided.  It was reported that the vial was individual vial and size was 2.5 ml. The vial did not undergo any temperature excursion. Treatment information was not provided.    This case was linked to US-MODERNATX, INC.-MOD-2023-722319 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722319:
Bell's palsy on right side; Numbness of face on right side; Hearing loss in right ear; Buzzing in both ears; Flu like symptoms for 4 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (Hearing loss in right ear) and FACIAL PARALYSIS (Bell's palsy on right side) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis, Blood pressure and Cholesterol.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms for 4 days). On 25-Mar-2021, the patient experienced DEAFNESS (Hearing loss in right ear) (seriousness criterion medically significant) and TINNITUS (Buzzing in both ears). On 27-Mar-2021, the patient experienced FACIAL PARALYSIS (Bell's palsy on right side) (seriousness criterion medically significant) and HYPOAESTHESIA (Numbness of face on right side). On 22-Mar-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms for 4 days) had resolved. At the time of the report, DEAFNESS (Hearing loss in right ear), FACIAL PARALYSIS (Bell's palsy on right side), TINNITUS (Buzzing in both ears) and HYPOAESTHESIA (Numbness of face on right side) outcome was unknown.            She was taking blood pressure and cholesterol medicine as concomitant.  Treatment included steroid infusion.; Sender's Comments: Limited information regarding these events has been provided at this time and a causal relationship cannot be excluded
Per patient, 6 days after she received the Janssen vaccine she developed a rash on her feet and legs.  Initially she thought it was fleas, so she thoroughly cleaned everything but the rash started to spread and on one else in the house was having a problem.   She said the rash is extremely itchy and she is miserable.  She went and saw PA , at the Walk-In Clinic on Sunday, 4/11/21.  She said she started Prednisone that day, now day 4 of taking it she said her rash may be a little better, but not sure.   She said it's still extremely itchy and she's miserable.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 19-JUL-2016 the patient was vaccinated with improperly stored PNEUMOVAX 23 (dosing details were not reported) (lot # L022262 expiry date 05-NOV-2016) which was stored at a temperature of 56.3 F for a time frame of 9 hours. There were no previous temperature excursions reported. It was reported as the call was made because of data logger (therapy type: digital data logger). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
I had a breakthrough case of Covid-19. Nasal and chest congestion with a lot of fatigue low oxygen level.
Sudden dizziness/nausea, fever up to 104, severe body aches, headache, chills, sore throat, pain in jaw, rash all over trunk, pain/tingling/numbness in hands, loss of appetite
Patient received second dose of Moderna Covid 19 vaccine and experienced light headed-ness and vision disturbances upon standing approximately 2 minutes after the injection the patient than proceeded to complain about dry mouth, dizziness, itchiness. Patient was observed for approx. 20 minutes by pharmacist, she never last consciousness during that initial period. BP measured after injection was 149/101 pulse 91bpm. Patient rose after 20 minutes and proceeded to go shopping in the store and returned to the pharmacy approximately 25 minutes later. The patient ate a banana and candy bar and stated she did not feel capable of pushing her cart to her car or driving home. She then stated she had a systemic tingling/itching feeling, was feeling drowsy, tongue felt fuzzy/possibly swollen and decided to lay down on the floor on her own accord due to feeling faint. Patient stated these symptoms were worsening as she was laying down and had a supine BP measurement of 175/103 104 pulse. Patient at one point closed her eyes and did not respond for several seconds and when she came too she consented to Epinephrine injection, which was administered intramuscularly into the right outer thigh. Paramedics arrived and transported patient to hospital. Patient called pharmacy about 2 hours later and was very appreciative of the efforts made by the pharmacist and stated she was being discharged on corticosteroids and all symptoms had resolved after steroids were given at ER.
NP had ordered and was administering the HPV9 and Flu vaccine to the child.  The sibling was also with the parent and the parent decided she wanted the flu vaccine for the other child also. The flu vaccines were in different compartments but when NP started administering the vaccines she inadvertantly administerd the other flu vaccine to the same patient.  The first flu vaccine was given in the left arm and the other in the right arm.  The parent was told and educated on what had happened.  She was told to contact our office if any adverse effects were noted.  She was watched for 15 minutes in our office without any adverse effects as of yet.
pt exp nausea, severe regurgitation, cold sweats, fever, flushed, chills;
on getting 2nd shot she said "i think i'm  going to pass out"  Pt has syncopal event after immunizations today. Patient was seated for immz. She vocalized she felt like she was going to pass out. Mom and I layed her down. She has a mild clonus and was "out" for about 10 seconds. Pt woke spontaneously and was not post ictal. Pt was kept supine for 5 minutes during history portion of appointment and gradually head of table was raised to 90 degrees. Pt was completely recovered in 10 minutes and was advised to tell staff in future she fainted after a shot in past
Breakthrough case admission after 2 vaccines Pfizer 5/12/21 Lot# Ew0179;  Pfizer 6/3/21 Lot# EW0183
16DEC98 flu like sx, n, lt arm sore 2 days p/shot;23DEC98 h/a, progressively worse;24DEC fever, severe neck pain & stiffness, h/a;25DEC98 lethargy & neck/h/a, restless, cold feet;29DEC98 color-blue grey;dx poss Reyes synd;weakness,numbness
On Sunday 01/09/2022 at  11am my son got the first dose vaccine of Pfizer on his left shoulder. On 01/10/2022 he felt fatigued, and went to school. He then told me he felt like that his head was moving. I bathed him and he got really cold and had high fever, highest 38 degrees. At 9pm I gave him Tylenol. At 5am, he started to hallucinate. He was telling his father "that  why his dad wanted to kill him". He was screaming that his dad was his friend. At that moment he started to vomit. At 09:30am, he vomited and gastric juices, yellow and liquid. I took him to the pediatric clinic 01/11/2022. Dr. is who saw him at the clinic. He was given pills for the vomiting and was sent home. At 1pm, he was given Tylenol for his hallucinations and he saw everything very big and that he could touch the ceiling. The next day, the vomit went away. His mood changes was that he was excited and talk super fast and then really slow and that his tongue got twisted. The participant states that his tongue was twisted, slurred speech. 01-13-2022,  I took him to Healthcare. My son has sensitivity to the light, photophobia. Before the vaccine he was fine. The Doctor revised him and gave him acetaminophen and continue observation. Up until yesterday, he felt he felt his head really big. I gave him Pedialyte, made him hot soup so he may feel better.  Today he has some lesions in his upper palate. I also spoke with Dr., healthcare. I paid his medical expenses because he does not have health insurance. I told the pediatrician doctor that I will not let my son get his second vaccine due to what he experienced and felt. They told me at the hospital that my sons symptoms are effects of the vaccine.  At this time, he is recuperating at this time and pray that there are no secondary lasting effects from his symptoms from the vaccine.  I am worried of hat effects my son will have in the future and if other exams can be done on my son. If anything changes in my son status, I will report again.
Swelling right underarm, ongoing; minor body ache throughout and felt like cold coming on, no fever, 12 hours. Did not seek treatment.
23OCT92 asthma type attack in middle of noc; 24OCT92 clammy, sweaty feeling, whelpy rash on face, sinus pressure & nasl congestion; 25OCT92 nasal congestion; 26OCT92 sinus drainage, sneezing, chilling;
Shingles infection (rash) manifested itself in the right side of her head, including her eye. Gabapentin. Valacyclovir. Tramadol. Gabapentin and Tramadol have lessened her pain some.
Arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm is sore). At the time of the report, PAIN IN EXTREMITY (Arm is sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was reported.
patient with difficulty breathing, rash/urticaria, diffuse redness, and swelling of the throat. This occurred within 30 minutes of receiving an influenza vaccine. Treatment included epinephrine 0.3 mg IM, diphenydramine 50 mg IV, methylprednisolone 125 mg IVP, famotidine 20 mg IVP.  Patient observed for 3 hours and discharged home.
Per RN telephone encounter on 3/12/21: About 35 minutes after vaccine started having tingling in face and arms and developed red blotchy skin with slight itching in these areas. Red areas not raised or welted.  Benadryl  50 mg does help decrease redness and itching. She had taken Benadryl for 2 weeks, but once she stopped the symptoms returned. Patient had an office visit on 3/26/21 for assessment. She was provided prednisone, omeprazole and Benadryl regimen/taper, but the symptom of facial tingling came back despite this. She presented to the ED on 4/1/21 with facial paresthesia. She was instructed to stop taking the medication regimen, but she was still have tingling on her face that moves around from her eyes to cheeks to temples to jaw.
Hives next day after receiving Fluzone .25 ml. Thimerosol-Free
SADDLE PULMONARY EMBOLISM ACUTE DVT OF LEFT POPLITEAL VEIN
Case completed Covid primary series in March 2021, then was hospitalized for Covid in September 2021.Upon discharge: Had been treated with Dexamethosone and Remdesivir for 5 days. She was discharged on 3.5 liters of Oxygen.
Swelling, erythema, itching @ local site; pt given Hismanal & Tolectin in ER to relieve sx.
Devel severe n/v, chills alternating w/feeling flushed & feverish, & severe abd cramping; Fainted several times over 4-5 hrs then nausea & muscle aches; Did not seek med care @ time of sx; MD advised to discontinue vax series;
Pt recv vax on 11/10/98; on 11/21/98 pt exp seizure
Arm was sore; Rash on the injection Site onset about 1 week after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) and VACCINATION SITE RASH (Rash on the injection Site onset about 1 week after vaccination) in a 70-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore) and VACCINATION SITE RASH (Rash on the injection Site onset about 1 week after vaccination). At the time of the report, PAIN IN EXTREMITY (Arm was sore) and VACCINATION SITE RASH (Rash on the injection Site onset about 1 week after vaccination) had resolved.            No concomitant medications were provided Treatment for the events were not provided   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Patient demographics updated. Additional event was added
Information has been received from a physician concerning a 19 year old female with a history of mental disorder who was vaccinated with Gardasil and fainted.  The patient's outcome was not reported.  No further information is available.
Pt. became dizzy when standing, fell over slowly and had one minor jerking movement. No known loss of consciousness. Pt. recovered quickly after the event and was given a snack and rested as he had not eaten at all that day. Pt. doing very well following the event.
Loss of balance, headache, and stroke; Loss of balance, headache, and stroke; Loss of balance, headache, and stroke.; This is a spontaneous report from a contactable consumer (patient).   A 73-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: unknown), via an unknown route of administration, administered in left arm on 20Apr2021 at 09:00 (at the age of 73-years-old) as dose 2, single for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: En6206), via an unspecified route, administered in left arm on 30Mar2021 at 09:00 (at the age of 73-years-old) for covid-19 immunisation. Patient has no known allergies. Patient received other unspecified medications within 2 weeks of vaccination (name of medications not specified). Patient did not receive any other vaccine within 4 weeks prior to covid vaccine. On 02Jun2021, the patient experienced loss of balance, headache, and stroke. The events resulted in emergency room/department or urgent care. The patient was hospitalized for loss of balance, headache and stroke for 5 days. Treatment was received for events as medical care and medications. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient has been tested for covid-19, sars-cov-2 nasal swab test: negative on 30Jun2021. Outcome of events was recovering.   Follow-up attempts are needed. Further information is requested.
Started getting rash with micro papules. 12-11-05 became increasing worse each day. 12-14-05 increase papules mostly on face, spreading to abd, back and extremities. Given Decadron 6 mg IM and Atarax  10 mg every 6 hr PRN. Getting better still on Atarax with rash fading.
Had a mild fever of 101.3 in morning after second COVID-19 vaccine.  By end of day, fever had gone down to 100.3 and by next day (today) fever gone and felt fine.
Breakthrough case after 3 vaccines Moderna 2/28/21 Lot# 025A21A;  Moderna 3/24/21 Lot# 045A21A;  Moderna 10/25/21 Lot3 017F21A
Pt was administered GARDASIL injection-tolerated well.  Less than five minutes later, while checking out, pt stated she was feeling funny, light headed, was taken into an exam room and sat on the table.  Pt became limp, closed her eyes and made a few strange noises, and began to seize, made sounds 3 more times and urinated on herself.  Dr came in and checked her breathing and took her blood pressure.  Pt regained consciousness after approximately 2 minutes, but remained disoriented for another several minutes.  During this post-ictal period, Dr. arrived.  Pt states she felt like everything was a dream.  Transport was called to take the patient to the emergency department.  7/8/09 ER records received DOS 8/18/08. Assessment: Possible vasovagal episode vs seizure. Patient presents after seizure at MD's office, amnesia for event, urinary incontinence, general body aches. 7/13/09 Neuro consult rec'd dated 8/22/08 with dx: vasovagal syncope. Seen if f/u to above ER visit.  Pt reports being "slow" since episode with some H/A, dizziness and nystagmus.  Seizure activtiy 2' to being upright during syncope episode.  Syncope precipitated by Gardasil shot. Does not think seizure d/o
Patient passed out while in seat and hit her head. She appeared to shake for a few seconds and then came out of it. I asked if patient had epilepsy and partner said she had seizures in the past but not diagnosed. She had a large bump on her forehead. EMS was called and they came and evaluated her
Immediate heat wave felt. Had hives on both arms, flushing. Heat waves intermitant. Difficulty breathing. Given 02 seated. Sent to ER via ambulance. BENADRYL X 2 before reaching hosp. IV's and med. Discharged at MN. HA at MN at home. Rx for PREDNISONE QID x 2 days. Weak today - day after.  HYDROXINE 1 TID PRN at home.
This is an initial spontaneous report from a contactable reporter.  A reporter reported for (age and race unknown) her son, who started to receive PREVNAR 13 (unknown date).  His concomitant medications were not provided.  His medical history included the first dose of PREVNAR 13 at approximately 2 years and 11 months of age.  His physician recommended 2 other doses after that.  His second dose was given approximately 3 months later.  After that dose he experienced an acute reaction, clarified as his eyes were fluttering and jerking but it resolved within approximately 3 days.  He has had several tests including an EEG and a CT.  They have not provided a diagnosis yet but they are considering seizures or epilepsy.  The reporter states the physicians do not feel the events are related to PREVNAR 13.  Physician's Contact: refused.
periods are longer and heavier; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (periods are longer and heavier) in a female patient of an unknown age 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 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (periods are longer and heavier). At the time of the report, HEAVY MENSTRUAL BLEEDING (periods are longer and heavier) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. Her period lasted more than 14 days.
This spontaneous report as received from a nurse refers to a patient of unknown gender, currently 14 year old. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On an unknown date the patient was vaccinated with improperly stored PROQUAD (lot # R013575, expiry date: 10-NOV-2019) (dose and frequency were not reported) subcutaneously for prophylaxis. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F (-9 degree Celsius (C) to 8 C) (25.2F) for 13 hours 36 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA002375: Original Case: 1811USA002232; US-009507513-1811USA002232: Original Case: 1811USA002232; US-009507513-1811USA002374: Original Case: 1811USA002232; US-009507513-1811USA002371: Original Case: 1811USA002232; US-009507513-1811USA002372: Original Case: 1811USA002232.
Patient felt nausea and stomach churning approximately 10 minutes after receiving vaccine.  Shortly after this patient's left ear began ringing and palms started sweating and hands shaking.  Ringing continued for at least 1 hour.  Patient was given Benadryl 25mL PO.  BP = 110/85, P = 86, T = 97.7
This spontaneous report as received from a registered nurse refers to a 17 month old patient. On 27-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (lot# not reported) 0.5 ml intramuscular. It was reported that the patient, who was intended to receive PREVNAR, was inadvertently administered PNEUMOVAX 23 on 27-OCT-2014. No adverse effects reported. Additional information is not expected.