chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse outcome identified, however Gardasil vaccine given in error to patient who is 16 weeks pregnant.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unspecified dates between 01-JUL-2016 and 06-SEP-2016, the patients were vaccinated with improperly stored doses of VAQTA, lot # L048456, expiration date: 25-MAY-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 15.8 degrees Fahrenheit (reported as low temperature) for 148 hours and 50.7 degrees Fahrenheit (reported as high temperature) for 1 hour and 30 minutes. The temperature excursion was captured using digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter (linked with MARRS# 1609USA013203, 1609USA013449, 1609USA013450). Additional information has been requested.
Information has been received from a nurse practitioner concerning a 29 year old female smoker with allergies who on 17-FEB-2009 was vaccinated IM with her initial dose of RECOMBIVAX HB (Lot # not reported) 1.0ml in deltoid.  Concomitant therapy included ZYRTEC.  On 17-FEB-2009, within 30 minutes of receiving the RECOMBIVAX HB, the patient developed dizziness.  The patient's dizziness persisted.  The patient called the office on 19-FEB-2009 to report the ongoing dizziness.  The nurse practitioner was considering discontinuing the series.  It was reported that the patient sought medical attention:  called the office.  Additional information has been requested.
Chills 8am morning after. Aches and pains all next day.  Day 2 only brain fog - heavy  Day 3 back to normal
SWOLLEN BREAST AFTER THE VACCINE; This spontaneous report received from a consumer concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced swollen breast after the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen breast after the vaccine. This report was non-serious. This case, from the same reporter is linked to 20220610772.
Pt vaccinated @1430. 1436 pt c/o Itching, tingling to mouth and nose and one side of throat, nausea. Pt given Benadryl 50mg PO. Bp 166/81, P 98, SPO2 99%, mild wheezing auscultated. Car seat leaned back, MD consulted. Pt has hx blood clot Oct 2021, currently on Lovenox BID. Pt used her personnal inhailer she had in car. Hx of anaphalaxis with bee stings, Fentanyl, Hydrocodone. EMS called, on site <5min, care transfered, pt being taken to local ER. Pt advised to consult PCP to determine if she should get 2nd dose. RN
Patient reports she got up out of be early the next morning after receiving her COVID vaccine and took 2 of her morning pills and then had an episode where she passed out for a few minutes and spilled the water down her clothing.  She felt weak and tired  after this episode and so went back to bed for several hours.  Later that day she had another episode of feeling lightheaded as if she might pass out, while sitting at a hair salon waiting for her appointment, but did not actually pass out, just felt a wave of heat and slight nausea, but did not faint.  She had one further near syncopal episode at home later that night when she also noticed she was a little "jittery" and noted a strange smell that the rest of her family did not notice.    She also reports that she has had near syncopal episodes in the past and thinks she may have been a little dehydrated the day these incidents occurred.
MULTPLE SEIZURES, STOPPED BREATHING, BRAIN HEMORRHAGE, CPR, RETINAL BLEEDING, COMA, SEIZURE MEDICATIONS.
Vaccinee rec'd 1st does of Engerix-B (deltoid) on 20AUG90; Developed itching, rash on arms & legs 22AUG90; Tx SUS-PHRINE;
This spontaneous report as received from a pharmacist refers to a 40-year-old female patient. It was reported that the patient had no allergies and drug reactions. No information regarding the patient's pertinent medical history and concomitant medication was provided. On 07-MAR-2019, the patient was vaccinated with GARDASIL 9 intramuscular, lot # N032284, expiration date 22-SEP-2020, for human papilloma virus (HPV) prevention (exact dose was not provided). On 08-MAR-2019 (reported: starting day after injection), the patient experienced injection site pain "on and off". On 13-MAR-2019 (reported as 6 days after injection), the patient sought medical attention by contacting pharmacy due to the fact, that she still experienced injection site pain. It was reported that no bruising at the site and no fever were recognized. No treatment was given and no intervention to prevent serious criteria was performed. The outcome of the injection site pain was reported as not recovered. The relatedness between the injection site pain and the GARDASIL 9 was not provided.
Developed pain, eczema, erythema (R) deltoid at site of injection. Used ice for treatment.
pt returned 2 days later with rash at injection site. pt stated that it was small in size between elbow and shoulder i advised this was normal and to contact pcp if getting worse. patient returned 12/24 to state they had chills headache and cold like symptoms stated they had never had any feeling like this after any vaccine and asked if it was possible we gave an expired product. stated these are normal side effects and the patient should follow up with physician
mistakenly received a third dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date received, first dose) and Shingrix (On an unknown date, received second dose).   On an unknown date, the patient received the 3rd dose of Shingrix (intramuscular, unknown deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: mistakenly received a third dose of Shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 31-JUL-2023 The reporter stated that the patient mistakenly received a third dose of Shingrix because she forgot she had already received two doses. Nothing else was reported. The reporter consented to follow up. The reporter reported that the patient mistakenly received a third dose of Shingrix because she forgot she had already received two doses, which lead to extra dose administered. The case had been linked to the case US2023104118  reported by same reporter.
reported on 04Jun2021 /first dose / administered on 16Sep2019 / second dose on /day as reported it; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 92C34, expiry date 4th June 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 16th September 2019).   On 4th June 2021, the patient received the 2nd dose of Shingrix. On 4th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received the second dose of Shingrix later than the recommended schedule which led to lengthening of vaccination schedule. The second dose was given on the same day of reporting. The reporter consented to follow up.
About 10 minutes after the vaccine the patient complained of headache/lightheadedness.  We supplied the patient with a bottled water and he drank some. About 3 minutes later the patient complained of not feeling well/right.  His eyes then rolled back in his head and he began to shake. He did slump to the side in his wheelchair.   He was breathing although it seemed a bit labored. He was not responsive verbally when w asked him if he was ok. After about 2 minutes, the episode seemed to end.  He moved and  straightened up. His eyes opened and he was able to answer questions. He complained of feeling tired. He wanted to lay down and he said his stomach was a bit upset. 911 was called while the patient was not responding. They arrived after he awakened. He was given oxygen and eventually placed on a gurney and taken to the ER.
The left arm was red at injection site; A bump at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (The left arm was red at injection site) and VACCINATION SITE SWELLING (A bump at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (The left arm was red at injection site) and VACCINATION SITE SWELLING (A bump at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (The left arm was red at injection site) and VACCINATION SITE SWELLING (A bump at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.     Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Follow up received, contains event outcome as recovered.
I experienced headaches, dizziness, fever, chills, fatigue and muscle aches.
Vaccine adulterated due to temperature excursion.  No adverse events experienced/reported by patient.
Pregnant and got the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and got the vaccine) in a 26-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in October 2020 and the estimated date of delivery was 01-Aug-2021. On 21-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and got the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and got the vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Nov-2020, Pregnancy test: positive (Positive) Positive.     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.   Treatment information not provided. The patient's estimated date of conception was 01-Aug-2021.  The patient had one previous full term birth on 06-Apr-2019.
Muscles hurt and weak; Fatigue; Muscles hurt and weak; Strong chills; Fever; Arm painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm painful), MUSCULAR WEAKNESS (Muscles hurt and weak), FATIGUE (Fatigue), PYREXIA (Fever) and MYALGIA (Muscles hurt and weak) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism since 1998, Anxiety (worsen) since 1996, Insomnia (worsen) since 1989, High cholesterol, Drug allergy (Codein), Drug allergy (Aspirin) and Drug allergy (Sulfa.). Concomitant products included CLONAZEPAM for Anxiety, ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol, LEVOTHYROXINE for Hypothyroidism.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm painful). 23-Feb-2021, the patient experienced PYREXIA (Fever). On 24-Feb-2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced MUSCULAR WEAKNESS (Muscles hurt and weak), MYALGIA (Muscles hurt and weak) and CHILLS (Strong chills). At the time of the report, PAIN IN EXTREMITY (Arm painful), MUSCULAR WEAKNESS (Muscles hurt and weak), PYREXIA (Fever) and MYALGIA (Muscles hurt and weak) outcome was unknown and FATIGUE (Fatigue) and CHILLS (Strong chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count (150-450): 154 (normal) Blood platelets in the low range and other (Borderline) Blood platelets towards the low end of the normal range.         Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: First dose details added, event added, lab data added, concomitant medication added, medical history added, vaccine facility details added,  event details updated
Pt experienced muscle twitching in right arm around previous injection site post vax, lasting for approximately 10 days. This is a reoccurring event happening each time the pt receives vax.   Muscle twitching is almost continuous post vax and lasts about one week. This vax was in left arm but twitching occurred in the right around injection site.
pt brought to ED with change in mental status; slurred speech with LE weakness; CT of head showed no acute changes; CXR showed cardiomegaly and either pulmonary edema or bilateral pneumonia; positive for COVID; given ABX and steroids; pt's condition worsened; sepsis; acute organ dysfunction secondary to COVID pneumonia; increase in O2 needs; family changed pt status to DNR, comfort measures; medications dc'd; transitioned to inpatient hospice; pt passed away in the hospital
From initial information received on 5/11/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a two month old female patient received her first dose of ActHIB, lot number UE096AA, administered in the left thigh, her first dose of Daptacel, lot number C1612AA, administered in the left thigh and her first dose of IPOL, administered in the right thigh on 2/10/04. At approximately 5:00 AM the next morning the patient was found dead.  An autopsy was performed, the physician's office is sending a certified letter requesting results. The physician's office will forward a copy to the manufacturer once it's received. Reportedly, the local sherriff's office quarantined the sharps container and the vaccine lots involved.  Follow up on 11/01/04 states: "From additional information received on 11/01/04 from the initial reporter, it was reported, "Reviewed, no additional information at this time." From additional information redceived on 11/8/04 from the initial reporter, the information has reportedly been reviewed on 11/4/04 and additional information is availale at this time.
I95.9 HYPOTENSION 10/31/2022 ATRIAL FIBRILLATION, UNSPECIFIED I95.9 HYPOTENSION 10/31/2022 ATHEROSCLEROSIS OF AORTA I95.9 HYPOTENSION 10/31/2022 ACHALASIA
This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-OCT-2016, the patient was vaccinated with a dose of M-M-R II (strength, dose, route, anatomical location, lot number and expiration date were not provided), for prophylaxis. Then, on 01-JUN-2017, the patient was vaccinated with another dose of M-M-R II (strength, dose, route, anatomical location, lot number and expiration date were not provided), also for prophylaxis. Subsequently, on 21-JUL-2017, the patient was vaccinated again with a dose of M-M-R II (lot number reported as N008366 with expiration date of 13-MAR-2019; strength, dose, route and anatomical location were not provided), also for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). No adverse effects were reported.
Welt/hive the size of an apple on her LA arm-warm to the touch, hurt. Fever, vomiting started at about 6-7:00 pm the 6th of October-this welt started as the size of a quarter and then the next day was the size of an apple.
Patient is presenting with shortness of breath/decreased air entry; chest pain began 30 minutes after injection as leaving site to her car; Arm tingling; lip tingling; This is a spontaneous report from a contactable physician. A 47-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), dose 1 via intramuscular route of administration in arm right on 09Apr2021 (at the age of 47-years-old) as single dose for COVID-19 immunisation at other facility. The patient was not pregnant at the time of vaccination. Lot number was not available/provided to reporter at the time of report completion. Medical history included allergies (peanuts) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. List of any other medications the patient received within 2 weeks of vaccination stated as not applicable. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was presenting with shortness of breath, decreased air entry, chest pain began 30 minutes after injection as leaving site to her car, arm tingling, lip tingling on 09Apr2021. Decreased air entry on exam no overt bronchospasm but improved with albuterol no asthma history for her. The events were not serious and seriousness criteria included none. Events resulted in Emergency room/ department or urgent care. Therapeutic measures were taken which included treatment with Aspirin and Albuterol for chest pain and tightness and decreased air entry or dyspnea. Clinical outcome of the events recovered on unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Rash; pruritus of left forearm; headache; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Aug2021 at 15:00 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included postpartum disorder NOS (3 weeks postpartum) and polycystic ovarian syndrome. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included minerals nos, vitamins nos (PRENATAL VITAMINS), pyridoxine hydrochloride (VITAMIN B6), vitamin d nos (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), macrogol 3350 (MIRALAX) and ibuprofen (ADVIL); all from unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Aug2021 at 15:30, the patient experienced rash, pruritus of left forearm and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash, pruritus of left forearm and headache was unknown at the time of the report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Approximately, 10-15 minutes after receiving Tdap in Right deltoid, area began feeling very hot, feverish, notified infection control nurse, said just a localized reaction; at approximately 12:30 PM entire right arm, right shoulder, and neck began itching, areas were red and warm, took Claritin 10mg at approximately 2 PM due to itching continued; site of infection was sore; which progressively got worse over the next 24 hrs, warm to touch, red splotches on neck, arm, shoulder. Temp around 99.7,orally, my usual body temp is 97.0-97.5. 9/26/2013- Right arm remained extremely sore, burning sensation similar to sunburn in shoulder and neck, tired, generalized body aches, nasal congestion started. 9/27/2013- arm continues to have burning sensation, noticed bright red area on shoulder; left forearm to elbow rash apparent, as well as lighter rash on Right forearm; throat sore, nasal congestion, left nare had scant blood in mucus. 9/28/2013- not as achy, rash looks better, right arm burning sensation remains as well as bleb and small red area where injection given, throat really sore, hard to swallow, no appetite, feel tired, no fever, left eye has pink eye upon waking with slight crusty drainage, left nare still producing scant bleeding in mucus, feels like ulcer or sore in nare, throat ticklely feeling, mild coughing beginning.
Abdominal Ascites beginning 3 weeks post 2nd dose Moderna vaccination. Patient treated with paracentesis once weekly at the hospital. Ongoing issue. Unable to receive paracentesis last week due to location of fluid/intestines. Patient was also taken off of Capecitabine and put back on other cancer med used previously, pt does not remember name of this medication. Patient is holding Metformin as well due to alterations of blood sugar.
Usually walks 3 miles a day, day after vaccine went for a walk 150-200 yards out had to take a break lungs on fire very rapid breathing after doctor visit lung irritability had simmered by Tuesday no more side effects.