chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture; No adverse event; patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture), EXPIRED PRODUCT ADMINISTERED (patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2022, 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 16-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture), EXPIRED PRODUCT ADMINISTERED (patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture) 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 PRODUCT STORAGE ERROR (patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture) and EXPIRED PRODUCT ADMINISTERED (patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture).    No relevant concomitant medications were reported. HCP stated that 2 patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture. Date the vial was initially stored in the refrigerator was on 14 DEC 2022. Vial was first punctured on 15 DEC 2022, 2:00 PM and administered on 16 Dec 2022 at 09:42 AM. The vial haven't undergone any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree Celsius = 46 degree to 77 degree Fahrenheit): Approximately 18 hours. No treatment medication reported.
I had my second injection on Sunday morning 1/24/21 at 9:00 AM.  I was fine through the day.  The previous dose (dose #1) was on 12/29/20 and I became symptomatic the following day.  I had aches, malaise and fevers of 102.7 on 12/30/20.  The fevers lasted approximately 12 hours and resolved with Tylenol.  My left deltoid was very swollen and quite painful.  The swelling and pain resolved within 24 hours after the first injection.  Prior to dose #2 and through the day on 1/24, I used Tylenol and Celebrex, both medications were ingested at 8:45 and the tylenol wa again ingested at 11pm prior to going yo bed.  By 12:15, I had severe bilateral calf pain.  Fever started shortly after that.  Severe Headaches and Photophobia began at around 1 am.  I had a vey difficult time walking and was quite dizzy through the night.  Unable to sleep more than a couple of minutes at a time.  By 6:45 am, my fever was around 103.5.  I have used Tylenol and Ibuprofen since 1/25/21, 6:45 am.  both medications have been utilized around the clock on TID basis.  Fever dissipated by 1/25/21 evening.  Only a mild headache is present.  The injection site was swollen, indurated and painful to touch similar to cellulitis.  I have not used antibiotics, drew a line and have monitored the redness, it is slowly resolving.    By 17:30 on 1/26/21, I have a mild headache, mild malaise and chills.  No fever.  Arm is still swollen red and hot. I have not had respiratory or GI symptoms and have no history f Covid Exposure and have tested negative on multiple occasions.
I began having a fever, with coughing and feeling really bad. I was not able to get up and move around. I had bone aches. I contacted my doctors office and they advised me to isolate. I work in the dental field so I was advised to quarantine for 10 days. I drank a lot of fluids and laid in bed and rested. I did not test to see if I was positive. We had issues getting test. My symptoms dissolved after 10 days. My taste and smell still comes and goes and the rash that I initially got the 1st time I got COVID-19 worsened. The rash worsened on every dose of the vaccine. I have an upcoming appointment at the dermatologist to look at the rash.
Patient admitted to hospital due to hyperkalemia; called to come to hospital based on labs from hemodialysis session a day prior- 3/21/21. Patient also complaining of bright red blood with bowel movement and weakness. Patient reports non compliance with medications and diet. Hyperkalemia treated and resolved. Evaluated by cardiology for halter monitor- will follow-up as an outpatient.
Trouble sleeping, Pounding headache, severely swollen eyes pain all around eyes down to lower cheekbones.  Swelling has not gone down and has been more than 24 hours.
Day after vaccines when putting child to bed mom noted area around vaccine site red and slightly raised. Mom gave benadryl and was instructed to continue benadryl as needed and apply cool compresses
Initial case received on 12 January 2010 from a healthcare professional. A 39 year old female received the following vaccinations on 12 October 2009: Right deltoid injection of ADACEL (sanofi pasteur Inc. lot number UF551BA, sanofi pasteur Ltd. lot number C1359), right deltoid injection of IPOL (lot number D0120-2), left deltoid injection of TYPHIM VI (lot number E0213) and left deltoid injection of TWINRIX (GSK lot number AHABB167AA). The patient was reported to be 28 days pregnant at the time of the vaccinations with an estimated date of confinement of 29 June 2010. On an unspecified date she had one ultrasound with no results provided. Her last menstrual period was not reported. She had no previous pregnancies, no known allergies, no medical conditions and no concomitant medications. Follow-up information was received 23 August 2010 from a health care professional. Based upon new information received, it was determined this case now meets serious criteria and it has been upgraded from non serious to serious. The patient's last menstrual period occurred in September 2009 and her current pregnancy history was reported as "N/A". Prenatal testing had not been performed (previously reported as one ultrasound performed with no results provided). The patient had no pregnancy complications; however, she did experience complications during labor which consisted of + Placental abruption and fetal intolerance. An emergent C/S (cesarean section) was performed on 25 June 2010 at which time, a single live female infant was delivered at 39 and 3/7 weeks gestation weighing six pounds with no congenital anomalies. Apgar scores were 9/9 at one and five minutes respectively. An outcome for the event of + Placental Abruption was not reported. No further information was provided at the time of the report. Documents held by sender: None.
In 10/98 the pt developed varicella and sought unspecified medical attention. No further information is available.
This spontaneous report was received from a registered nurse and refers to a 17-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB thimerosal-free, lot # R001530, expiration date 07-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 2/24/2023 Discharge Date: Feb 26, 2023  PRESENTING PROBLEM: Hypoxia [R09.02] COVID-19 [U07.1]   HOSPITAL COURSE: Pt is a 69 yr old F with PMHx of  chronic diastolic CHF (LVEF 62% on TTE in 2022), prior pulmonary embolism on Xarelto, pulmonary hypertension, status post left lower lobe lobectomy, OSA with obesity hypoventilation syndrome on nightly BiPAP, hypertension, restless leg syndrome, insomnia, morbid obesity presented to ED with shortness of breath that started on 2/23.    Her shortness of breath is associated with nasal congestion and dry cough. She was found to be COVID positive on a in home test. In ER, noted to be tachycardic, T-max 102.7° F. Briefly desaturated to 88% on room air.  EKG unremarkable.  Labs unremarkable.  Found to be COVID-19 positive.  UA with few bacteria, 19 WBC, small leukocytes.  CXR unremarkable.     Admitted for close monitoring, symptomatic control and Decadron. Her symptoms improved though she still continued to have non-productive cough. CBC and procalcitonin were stable.   I offered to monitor her 1 more tonight given her symptoms of cough, congestion but patient felt ready to discharge. I recommended she follow up with PCP within 1 week and monitor oxygen levels at home with pulse oximeter (pt has this at home).   She is discharged home in stable condition
clogged duct/mastitis right breast along with fever, chills, body aches, joint pain x 48hrs
VACCINES ADMINISTERED IN AM ON 3/24/2009.  T/C FROM MOC 3/27/09 AT 9:15 AM TO REPORT CHILD C/O HER LEFT ARM ITCHING.  aRM IS RED, INFLAMMED AND WARM,ABOUT THE CIRCUMFERENCE OF AN ORANGE, NO PAIN.  MOC ADVISED TO APPLY WARM COMPRESSES TODAY, AND THAT IT IS USUALLY SELF LIMITING AND SHOULD START TO RESOLVE BUT IF GETS WORSE TO CALL PMD.
Mother reports rash on patient's face all over with redness, swelling, itching starting 2-4 weeks after immunizations. Condition is persistent and mother reports worsening over time. Pediatrician diagnosed as questionable allergic reaction. Prescription: Benadryl PRN and Prednisone 20 mg BID x 7 days. Unresolved.
Nausea; loose stools; This is a spontaneous report from a contactable other nurse. A 34-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscular in left arm on 23Dec2020 14:45 at a single dose for covid-19 immunization. The vaccination was done in a hospital. Medical history included Acid reflux, depression, and B12 deficiency. The patient was not diagnosed COVID-19 prior to vaccination. Concomitant medication included drospirenone, ethinylestradiol (SYEDA), cyanocobalamin (B12-VITAMIIN), and venlafaxine hydrochloride (EFFEXOR). The patient experienced nausea and loose stools on 03Jan2021 04:00. The outcome of the events was not recovered. The event was assessed as non-serious. The patient was not tested for COVID-19 post vaccination. There was no treatment for the said events.  No follow-up attempts are possible. No further information is expected.
Patient returned to office 3-23-09, after vaccine 3-20-09 with rash.  Reviewed sx and hx with MD who also saw patient.  Diagnosed with viral EXANTHERN, unrelated to vaccine.
COVID-19 + 1/11/2021, EXPIRED ON 1-24-2021
Patient called the pharmacy after talking to her physician's office and stated that he told her to go to the emergency room after complaining of vomiting, swollen tongue and throat closing. She states that she believes it is from the flu shot as she had a similar reaction last year but did not report it to anyone. She stated she took BENADRYL but did not relieve the symptoms.
Patient was given Moderna as covid 19 booster shot instead of Pfizer. Patient had no adverse reaction to different vaccination during 15 minute observation time and was released.  Dr. was contacted and ok'd that Moderna was fine as 3rd vaccination. Several attempts have been made to contact patient to notify her that she was given Moderna instead of Pfizer and she has not answered the phone nor contacted us back.
Chills and fever were accompanied by sharp joint pains,  severe throbbing and pulsating headaches (primarily on the upper right side) and migraines that developing into throbbing and pulsing in the entire body lasting for 10 hours; three fever cycles and the first lasted 10 hours before the fever broke in a sweat; I could not sleep the entirety of the first night and experienced hourly urination and intense dehydration. After first fever cycle I was alert for an hour before second cycle began; after third cycle symptoms changed to nausea and dizziness that prevented me from being mobile without assistance or upright for more than a few minutes, by Saturday evening symptoms went away and I could resume eating, drinking, and walking again
During post vaccine monitoring, at 14  minutes, patient began c/o feeling faint, tingling, heart racing and hot.  When asked she described her tongue as tingling and her heart racing.  Heart rate at this time was in the 130s-150s, o2 sat 97-99%, BP 180/100 in L arm.  Patient appeared pale and reported that she felt like she was going to faint.  Pharmacist administered 50mg of Benadryl, cool towel was placed on patients neck.  Continued to monitor for 15 more minutes.  HR began to decrease, patient drinking water, color appeared to return to face.  After 14 more minutes, she c/o faint feeling returning, with chest pain.  HR spiked again 120s-150s, BP 168/108, EMS was called, O2 sat remained 97-99%, EMS advised to administer 325mg ASA.  Patient chewed ASA as instructed and drink water.  EMS arrived at the 26 minute mark.  Patient reported sharp chest pain 7/10 at that time, BP, EKG and glucose were normal per EMS.  EMS advised ER visit for further tests and evaluation.
This spontaneous report as received from a healthcare worker (immunization official) refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concomitant medication were not reported. On an unknown dates, the patients were vaccinated with an improperly stored VARIVAX (Merck) (lot #J013907 with expiry date 30-OCT-2015; lot # K026385 with expiry date 15-DEC-2016; dose and route of administration were not provided). Exact number of doses administered was not specified. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Upper arm swelled and was sore X 1 day with no redness. Went away on its own.
The reaction starts out as a rash and within hours it was hives all over my body.  For the next 2 1/2 days, it continued to produce hives and continual itching all over my body (including my scalp).  Benadryl would relieve the itching temporarily, but not completely.
1208 - patient in general observation and states she feels lightheaded. Declined w/c and ambulated to private observation area with gait steady. EMT on site in attendance.  BP 122/80; HR 68; O2 99% on room air. Denies numbness, tingling anywhere. Denies nausea. States she did eat this morning.  1212 - patient still experiencing mild lightheadedness. Offered water - declined. Offered snack and agreed to some cookies.  1223 - Patient ate all cookies and states she feels better. Denies lightheadedness. BP 110/70; HR 60; O2 99%. Left ambulatory with steady gait to personal vehicle.
Fatigue; This is a spontaneous report received from a contactable consumer. A male patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on an unspecified date, as a single dose, for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient experienced fatigue on an unspecified date. The patient did not receive any treatment for the reported event fatigue. The clinical outcome of event fatigue was resolving at the time of this report. No follow-up attempts are needed. Information about lot/ batch number cannot be obtained.
Patient came in for vaccine. After vaccination, I had patient sit in a chair in case of any adverse reactions. About 5 minutes after vaccination, another patient came over and said that was not feeling well. When going out to patient I noticed he was very pale and sweating.  The patient then proceeded to pass out. I was able to hold the patients head and the other customer was able to hold his shoulders to make sure he did not fall out of the chair. The patient then got very stiff and proceeded to push back in his chair, after about 10 seconds he relaxed. The patient was passed out for about 3 mins, during that time I was able to remove his mask and hold his head. After gaining consciousness, I was able to make sure he was ok. We were able to give him some water and he stated he felt better. I asked the patient to stay for another half hour to monitor. After giving the patient another bottle of water, and having him sit he was able to get up and leave.
Intense pain on left side of head near temple lasting 5 days after the 2nd dose.; Vertigo started 2nd night of the 2nd dose. Vertigo lasted for days before clearing out with body movement exercises; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18May2021 18:30 (Lot number: EW0185) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "IBS-D" (unspecified if ongoing); "vertigo" (unspecified if ongoing), notes: Last episode of vertigo was 10 years ago for unrelated reasons. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose number=1, product=COVID 19, lot number=EW0171, administration time=06:15 PM, vaccine location=Left arm), administration date: 27Apr2021, when the patient was 29 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 19May2021, outcome "recovered" (24May2021), described as "Intense pain on left side of head near temple lasting 5 days after the 2nd dose."; VERTIGO (non-serious) with onset 19May2021, outcome "recovered" (2021), described as "Vertigo started 2nd night of the 2nd dose. Vertigo lasted for days before clearing out with body movement exercises". Therapeutic measures were not taken as a result of headache, vertigo.  Additional information: Intense pain on left side of head near temple lasting 5 days after the 2nd dose. Vertigo started 2nd night of the 2nd dose. Vertigo lasted for days before clearing out with body movement exercises. Asked medical professional for guidance and was told to rest. Last episode of vertigo was 10 years ago for unrelated reasons. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient wasn't tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Itching, swelling eyes-like conjunctivitis. Tightening of throat. Flu-like symptoms; Resolved overnight then just felt weak, tired. No local Rxn at injection site.
Shortness of breath; Confused; Tightness in chest; Chest pain; Blood pressure high; Blood pressure increased from 106/72 mmhg to 140/90 mmHg; Headache; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of breath), CONFUSIONAL STATE (Confused), CHEST DISCOMFORT (Tightness in chest), CHEST PAIN (Chest pain) and HYPERTENSION (Blood pressure high) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESTRADIOL and GABAPENTIN for an unknown indication.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced DYSPNOEA (Shortness of breath), CONFUSIONAL STATE (Confused), CHEST DISCOMFORT (Tightness in chest), CHEST PAIN (Chest pain), HYPERTENSION (Blood pressure high) and HEADACHE (Headache). 27-May-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure increased from 106/72 mmhg to 140/90 mmHg). On 27-May-2021, DYSPNOEA (Shortness of breath), CONFUSIONAL STATE (Confused), CHEST DISCOMFORT (Tightness in chest), CHEST PAIN (Chest pain), HYPERTENSION (Blood pressure high), BLOOD PRESSURE INCREASED (Blood pressure increased from 106/72 mmhg to 140/90 mmHg) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2021, Blood pressure measurement: 140/90 mmHg (abnormal) following the first shot of vaccine BP  was 140/90. On 27-May-2021, Electrocardiogram: normal (normal) normal. On an unknown date, Blood pressure measurement: 106/72 mmHg (normal) her normal blood pressure was 106/72.     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.   The patient reported 20 minutes after vaccination shot she experienced the reported adverse events for 30 seconds. The patient was transported to the ER and was discharged within 2 hrs.  The treatment medications relevant to events were not reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Immediate pain upon injection.  As the days continued area became red, swollen, painful and got worse over the next 5-7 days.  Swelling and coloring has improved but pain and hard lump at injection site is still present.
I noticed a little redness after and thought it was from the bandage.   Sunday, 3/28, I noticed that the site was itching. The redness has spread and the itching continues .  It?s almost like a bee sting.  The redness is at least 2 to 3inches in diameter.