chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022; dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022) in a 36-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     Patient had no allergies, acute/chronic illnesses and daily medications. Patient not tested positive for COVID within last month.     On 13-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The product expiration date was 25 Mar 2022.   It was reported that HCP confirmed the patients did not experience any side effects yet.  On 25-Feb-2022 the vial was initially stored in the refrigerator, its 30 day used by date was 25-Mar-2022 and expired. The vial did not undergo any temperature excursions.  Treatment information was not provided.
This spontaneous report has been received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date the patients was vaccinated with M-M-R II (strength, dose, dose number, route and lot # not reported) which was improperly stored. The temperature excursion for M-M-R II was not supported with in-house stability data. It was reported that there has been two episodes of temperature excursion, after the second excursion , doses of improperly stored vaccines were administered to patients. No adverse symptoms reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Fever, chills, slight nausea, insomnia.  From about 8pm until about 8am
More than 35 days between doses; Watery eyes; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between doses), LACRIMATION INCREASED (Watery eyes) and PAIN IN EXTREMITY (Pain in the arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Blood pressure abnormal. Concomitant products included OXYGEN for an unknown indication.    On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between doses), LACRIMATION INCREASED (Watery eyes) and PAIN IN EXTREMITY (Pain in the arm). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between doses), LACRIMATION INCREASED (Watery eyes) and PAIN IN EXTREMITY (Pain in the arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, SARS-CoV-2 test: positive (Positive) Patient tested positive for COVID-19..         Concomitant medications included sugar pill, blood pressure and COPD medication.  Treatment information was not provided.   This case was linked to MOD-2021-299964 (Patient Link).
Freezing; Stomach cramps; Nausea; A spontaneous report was received from a consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced freezing, nausea and stomach cramps.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Batch#: unknown) for COVID-19 infection prophylaxis.  On 30 Dec 2020, next day after receiving vaccine, the patient stated that they experienced freezing, nausea, and stomach cramps. No additional information available at this time. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, freezing, nausea, and stomach cramps were unknown.; Reporter'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.
pt lost vision and had headaches.  On 4/17/2021 she went to Hospital.  They did multiple test.  They did blood work and took MRI.  She was diagnosed w/ subarachnoid hemorrhage.  Pt was given a surgical procure on her head. She was discharged after five days to FU w/ PCP and surgeon
24 hrs post vaccination developed temp 101 degrees F, nausea, vomiting, wheezing, dyspnea, pruritus (generalized), localized redness/tenderness at injection site.
Patient's wife called pharmacy at 8pm reporting that the patient had chills and was vomitting.
had a sore throat; bad cough; symptoms of a bad cold; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via Social media and transmitted to Sanofi on 01-Nov-2020.  This case is linked to cases 2020SA308140, 2020SA308110 and 2020SA308037.  This case involves an unknown age patient who had a sore throat (Oropharyngeal pain), bad cough (Cough) and symptoms of a bad cold (Nasopharyngitis), while he/she received vaccine INFLUENZA VACCINE.  The patient's past vaccinations included INFLUENZA VACCINE and never had any problem.  Medical history, medical treatments, concomitant medications and family history were not provided.   On an unknown date, patient reported that he/she was never had a problem with the regular INFLUENZA VACCINE but the two times he/she got the high dose shot of INFLUENZA VACCINE for seniors, within two days patient was sick with a bad cough, had a sore throat and symptoms of a bad cold (respiratory symptoms) that lasted over three weeks.   After that patient never received influenza vaccine after that for the last two years and had no problem. Patient reported that he/she leaves alone and go out to the grocery store about once a week. There are no children and no people that visit he/she.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as resolved on an unknown date for all the events.  There will be no information regarding batch number for the case.
fell asleep during ride home when awaken for dinner mom noted lethargy, arm twitching, fingertips blue & cold & fever 104.8 ax; antipyretic adm by mom & temp @ 10PM was 103.6 ax & pt slept remainder of noc p/APAP; hx of  OM 2 wks prior;
The patient is positive for COVID-19 requiring hospital admission with supplementary oxygen and administration of dexamethasone. Symptoms of COVID-19 began on 2/15/21 and hospital presentation occurred on 2/18/21.
Moderna vial does not have an expiration date on the vial.  Nursing scans vial agency auto fills.In lot # field click on magnifying glass for drop down of lot numbers.  Normally when lot number is chosen expiration date auto fills. The lot number of this vaccine was not found. So lot number was manually entered and beyond use date (BUD) that was written by pharmacy on packaging was entered in as expiration date because patient was waiting. Vaccine was administered and message sent for a lot # to be entered into system. Recieved reply back that this lot was expired on 3/25/22. Imm. coordinator and NM notified and Moderna contacted for advice.
Got the shot in the morning (at grocery store pharmacy) and at night in bed back seemed stiff.  Awoke next morning to a lot of soreness and some pain in lower back; wasn't present before. Hadn't done any heavy lifting, etc. to bring that on.
burning tongue; Tiredness; chills; Patient got1st dose of moderna vaccine on 5thFEB2021. On 26th feb 2021 got her second dose; A spontaneous report reported by a consumer concerning a female patient of 52 years of age who received Moderna's COVID vaccine and experienced the events like tiredness, chills, tongue with hypersensitivity and inappropriate schedule of product administration.  The patient's medical history was not provided and there was no concomitant list provided.  On 5 Feb 2021, prior to the onset of the event, the patient received first of two planned doses of   mRNA-1273 (lot number- unknown)  via unknown route of administration for prophylaxis of COVID 19 infection.  On 26 Feb 2021, prior to the onset of the event, the patient received second of two planned doses of mRNA-1273 (lot number- unknown)  via unknown route of administration for prophylaxis of COVID 19 infection.  On 27 Feb 2021, the patient experienced events like tiredness, chills, tongue with hypersensitivity and inappropriate schedule of product administration. The treatment medications were not provided.   Action taken with mRNA-1273 in response to event was unknown.  Outcome of the events  like tiredness ,chills and inappropriate schedule of product administration were considered as resolved . The outcome of the event tongue with hypersensitivity.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, frequency and route were not reported) (lot# K010215 and expiration date 05-MAY-2017) and confirmed not GARDASIL. M-M-R II and (PNEUMOVAX 23 appeared on the product list, because stability questions were asked about these products and no doses of improperly stored M-M-R II and PNEUMOVAX 23 were administered. No adverse effects were reported. No Product Quality Product (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Right deltoid-red with mild induration 8 cm x 9 cm non tender.  Tylenol, Benadryl
her arm was very sore (at the injection site).; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   The reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix shot and had pain at the injection site. The patient warned him that if planned on getting the shot that was not going to want to go to work the next day.  No further information was known. The reporter provided limited information. This case linked with US2020219735, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020219735:same reporter
Pt felt faint, no loss of consciousness.  Pt felt nausea, no vomiting, no resp. problems.  1 min pt down, offered crackers, with PB, water, BP 90/60, increased to 100/70.
Pt developed a temp to about  105 degrees F approximately 24 hrs after vaccines and then had a seizure for approximately 15 seconds. Medical records state vomiting. msv
Symptom onset afternoon of 4/7 while playing golf,  with feelings of fatigue and leg weakness,  worsening leg weakness in the evening while taking a bath, followed by inability to get out of tub, but eventually able to drag self to bed where he passed out. Woke hours later and called EMS.
Pt received Pfizer vaccines on 4/1/21, 4/21/21, 10/22/21, 5/23/22. She came in for her bivalent booster dose on 10/18/22. Due to mix up of the Pfizer monovalent and bivalent vaccine- she may have gotten either the monovalent or bivalent Pfizer vaccine.
edema in rt hand beginning same day as inject; 8OCT92 nodules in rt hand, nodules in rt shoulder; SOB, angioedema, fatigue, arthritis, fever, rash;
Pt rec'd vaccine on 7/12/11, within 1 hr her arm began to hurt & swell up. By the next day, 7/13/11 the pt. was seen by her PCP & he prescribed levofloxacin x10 days for cellulitis. The pt is now recovering.
Woke up with a very swollen and red and hot left arm. Ask pharmisist at Walgreens and she said ice packs and Tylenol for pain.
Narrative:  Pt was an 88 YO male with PMH of seizure, lung nodules, HTN, HLD, and psychological issues. Facility was notified of pt's death by agency.
This spontaneous report was received from a Registered nurse regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
Muscle tenderness on injection site (upper left arm) after about an hour - lasted 3 days Body aches all over - took already prescribed Oxycodone - lasted 5 days Tired/Weakness - rested & slept - lasted over a week
Employee reported burning sensation at the site of IM injection Left Deltoid immediately after administration at 1555 on 09/23/2019.  Employee started to complain of feeling "dizzy" at 1600 Blood pressure obtained 104/70mmHg , HR 89bpm , regular respiration rate , no signs of respiratory compromise  or distress noted. Employee stated she had nothing to eat today 09/23/19. Employee provided with cheese crackers x6 and 12 ounces of electrolyte fluid. Employee remained in office #2 for observation , at 1618 employee now reports abdominal cramping rates a 9 out of 10  on a 0-10 scale with 10 being the most pain. At 1620 Blood pressure obtained 100/67 mmHg and HR 87bpm , no changes in respiration pattern. No signs of anaphylatic reaction ,no facial swelling, no hives, no swelling throat noted, employee denies difficulty breathing. Employee states "dizziness feeling is only when she lifts her head up and not when my head is lying down "Employee reports no other symptoms experienced and no changes in intensity for symptoms of dizziness, abdominal cramping. employee requested ibuprofen for pain for abdominal cramps employee and reports no changes with cramping with food and fluid. employee did consume all of the crackers and electrolyte drink provided . Employee did stated burning sensation to left arm at IM site stopped . 1630 after re-evaluation of employee's response to treatment the employee took medication two 200 mg tablets of Ibuprofen by mouth provided from first aid kit .  Employee remains under MSA /MCS observation post administration of Hepatitis B  vaccine.  1720 BP 98/61 mmHg HR 84 bpm Respiratory rate 20 breaths per minute. employee remains awake and alert.  No redness or swelling noted to site.  CMD notified and stated for employee to transfer to the hospital.  911 dispatched at 1750. 1755 EMS arrived, employee walked independently to ambulance with paramedic to go to Hospital ED.
Narrative:  Pt was a 55 YO male with PMH of alcohol associated cirrhosis c/b varices, HTN, GERD, and Aflutter presented to the ED on 10/8/21 with nausea/vomiting/hematemesis after stopping drinking for 2-3 days. Patient passed at 0452 on 10/24/21 from multisystem organ failure due to sepsis in the setting of decompensated cirrhosis. Pt received the Moderna COVID-19 vaccine on 2/6/21 and 3/1/21; it does not appear that death was related to the vaccine.
As of 8/8/2021: Pui is currently hospitalized with no infusion and no date of being released. Pui has been diagnosed with pneumonia. Pui wife would not disclose place of employment, however did state that pui rarely goes anywhere besides work and home. Pui is asthmatic and started coughing on 08/04/2021.
pain in the muscle; headache; fatigue; nausea; fever; little vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain in the muscle), HEADACHE (headache), FATIGUE (fatigue), NAUSEA (nausea) and PYREXIA (fever) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included HYDROCHLOROTHIAZIDE for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced MYALGIA (pain in the muscle), HEADACHE (headache), FATIGUE (fatigue), NAUSEA (nausea), PYREXIA (fever) and VOMITING (little vomiting). On 07-Mar-2021, MYALGIA (pain in the muscle), FATIGUE (fatigue), PYREXIA (fever) and VOMITING (little vomiting) had resolved. At the time of the report, HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a female nurse of unknown age referring to herself. On an unknown date the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot #, dose and route were not reported). No adverse effect reported. Additional information is not expected since the reporter does not want to be contacted.
I went into labor 2 weeks after receiving the vaccine at 26wks gestation. I also had a short cervix and uterine abnormalities (septate and bicornate).
On 6-13-11 received VARIVAX #2 (R) arm and Hep A #2 (R) deltoid. On 6-14-11 developed swelling & pain that increased on 6-15-11. On 6-15-11 (R) deltoid area of warmth, redness, tenderness 13cm x 8cm. Treated with KEFLEX.
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Previously administered products included shingles (received 7 years ago before the date of reporting). In October 2017, the patient received the 1st dose of SHINGRIX. In December 2017, the patient received the 2nd dose of SHINGRIX. In May 2018, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient having an episode of Shingles in May as well as a second episode that is currently ongoing. The batch number was unavailable as the reporter was the patient. Adeverse event obtained through chat, in which both consumer and agent had connection issues. During reconnection consumer stated that, the patient was the greatest advocate of shingles vaccines because she had the old vaccines 7 years ago but she would no longer encourage people to go through the expense of getting the new vaccines. The agent requested full demographics and consent to follow up. Follow-up consent provided however only an email address and telephone number was provided.
I felt the vaccine flowing through my entire body. I felt very warm and had a bitter taste in my mouth.
Itching, redness, hives - resembles a map, on vaccine site- left arm. Itching began on 10-9-09.
PATIENT SEEN AT EMERGENCY DEPARTMENT: PER PATIENT'S FATHER, PATIENT HAD LEFT LEG SWELLING WITH A RASH AFTER DTAP SHOT ON FRIDAY 9/24/10
Patient found unresponsive in recovery area at 6pm.  Patient skin color gray, cool, unresponsive, no pulse noted by writer.  Writer sternal rubbed patient and called name multiple times.  Staff arrived to assist and writer sent one to call 911 and one staff member to get wheelchair to tranport patient to recovery area.  While waiting for wheelchair after about 2 minutes patient regained consciousness, but still gray and not fully responsive.  Patient stated she could see me but vision very blurry.  Writer and  LPN tranported patient to recovery and took vitals.  Patient awake at this time.  VS 110/80, 95%SpO2, pulse 76 at 6:06pm. Recheck of BP 132/110 at 6:14pm. Patient skin PWD.  EMT's arrived assessed patient, took EKG-WNL, VSS stable, BP slightly elevated.  EMT's offered to transport patient via amb to ER, patient declined.  Writer released patient to boyfriend to drive her home.
101.7 temperature  starting at 12 hours after 2 vaccines in same arm.  Chills  and body aches. Full body inflammation. Severe right arm pain until rash started spreading. Right arm below injection sites swollen then day 3 after fever broke growing warm red underskin redness  3 inches below inje tion site.
Hives began as small spots around 8:30 pm.  Benadryl was given.  Hives grew to cover much of her arms, legs and torso by morning.  Benadryl continued as prescribed.  Hives persisted for several days.
Pt. noticed pain in arm quickly after receiving immunization. Stated pain got worse and she became dizzy through the night until 5 AM the next morning. Eventually felt back to normal 24-28 hours after time of immunization.
Red rash consisting of small red bumps.  Started on face and spread over entire body.  It has now been three days and it is starting to improve, especially on the face.
PATIENT STATES LEFT ARM WEAKNESS AND TINGLING. PATIENT VITALS ARE BP 134/78, HR 76, RR 18. PATIENT STATES FEELS FINE AFTER MORE OBSERVATION AND DOES NOT WANT ANYMORE INTERVENTIONS.
ACUTE ST ELEVATION MI, LEFT ANTERIOR DESCENDING CORONARY ARTERY 6/15/2021 HTN (HYPERTENSION)
i slept most of the day; very bad chills; Headache; Muscle aches; loss of appetite; Dizziness; overt weakness; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), DIZZINESS (Dizziness), ASTHENIA (overt weakness), SOMNOLENCE (i slept most of the day) and CHILLS (very bad chills) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Flu. Concurrent medical conditions included Factor V Leiden mutation since April 2007. Concomitant products included CALCIUM from 01-Jan-2015 to an unknown date, MAGNESIUM from 01-Jan-2016 to an unknown date and POTASSIUM from 01-Jan-2018 to an unknown date for an unknown indication.    On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced SOMNOLENCE (i slept most of the day). In September 2021, the patient experienced DECREASED APPETITE (loss of appetite), DIZZINESS (Dizziness), ASTHENIA (overt weakness), CHILLS (very bad chills), HEADACHE (Headache) and MYALGIA (Muscle aches). On 08-Sep-2021, CHILLS (very bad chills) had resolved. At the time of the report, DECREASED APPETITE (loss of appetite), DIZZINESS (Dizziness), HEADACHE (Headache) and MYALGIA (Muscle aches) outcome was unknown and ASTHENIA (overt weakness) and SOMNOLENCE (i slept most of the day) had resolved.            no treatment medication were reported.   This case was linked to MOD-2021-322614 (Patient Link).