chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She noticed her arm being very sore and she became nauseated late in the evening of 10/25/2010.  On 10/26/2010, she noticed her arm still being very sore, red colored from the shoulder to the elbow and felt hot to the touch.  On 10/27/2010 she called the doctor's office and was told to use cold packs and take Benadryl as directed.  The arm stayed red, sore and feverish until 10/31/2010. She did use cold packs and Benadryl until 10/31/2010.
1 day p/receiving flu vax, pt exp sleepiness & c/o not feeling well; vomiting 2 days p/vax & the vomitus was noted to be brown; pt died on 17OCT91; COD congestive heart failure;
lethargic, malaise, diarrhea, pruritic rash to both arms inside elbow. referred to primary provider. Patient states she will make an appointment with dermatologist. Patient took Benadryl to relieve itching which has helped somewhat.
This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 9-month-old male patient who received ENGERIX B (batch number 9554M, expiry date 30th May 2020). Concomitant products included nystatin and PREVNAR 13. On 17th April 2018, the patient received the 4th dose of ENGERIX B (intramuscular) .5 ml. On 18th April 2018, 1 days after receiving ENGERIX B, the patient experienced injection site swelling, injection site erythema, rash and runny nose. On an unknown date, the outcome of the injection site swelling, injection site erythema, rash and runny nose were unknown. The reporter considered the injection site swelling, injection site erythema, rash and runny nose to be possibly related to ENGERIX B. Additional details were provided as follows: This case was reported by the site manager. On 17th April 2018, the patient concomitantly received 3rd dose (0.5 mg)of PREVENAR 13 on the right side. At 14:08, the patient received ENGERIX B on the right side. The patient's parent called after hours and reported that the patient experienced a red swollen area where the shot was given, has a runny nose and a rash patch the size of a 50 cent piece, but had no fever.
This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a female patient who received Flu Seasonal TIV Dresden for prophylaxis. On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, less than a year after receiving Flu trivalent vaccine, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown. It was unknown if the reporter considered the erythema to be related to Flu trivalent vaccine. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient developed redness after receipt of a flu vaccine (unknown brand) several years in a row. The vaccine was not given in pharmacist's facility. This case has been linked to the US2018169158, reported by the same reporter.
Severe edema and erythema to R deltoid; No systemic reactino; Pain to arm when raising; warmth in area of edema and errythema. Instructed caregiver to alternate warm and cold compresses; Resolved in three days
was given an expired FLUZONE HD QIV with no adverse event; Initial information received on 19-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 67 years old male patient who experienced was given an expired fluzone hd qiv with no adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 VACCINE (COVID-19 VACCINE) for Immunisation.  On 19-Oct-2022, the patient received a  0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ768AC; expiry date: 30-Jun-2022) via intramuscular route in the deltoid NOS for immunization.  On 19-OCT-2022 the patient developed a non-serious event was given an expired fluzone hd qiv with no adverse event (expired product administered) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Within 10 minutes post vax, the patient experienced heart arrhythmia, her airway was tight, she was nauseous and sweating. Patient was treated with Epipen and taken to ER. Doctors determined her reaction was due to lactose intolerance.
Information has been received from a nurse referring to a 34 year old female patient. Information about medical history, concurrent conditions and concomitant therapies were unknown by reporter. On 19-JUL-2018, the patient was vaccinated with first dose of RECOMBIVAX HB (lot # M040422, expiration date 07-JUL-2019) (route and dose were not reported) for prophylaxis. On 29-AUG-2018, not knowing the patient was two weeks pregnant (vaccine exposure during pregnancy), the patient received the second dose of RECOMBIVAX HB (lot # M040422, expiration date 07-JUL-2019, for prophylaxis; route and dose were not reported). The last menstrual period(LMP) was calculated as 15-AUG-2018 and expected delivery of date(EDD) was calculated as 22-MAY-2019. The treatment was not given for the event. Information about lab diagnostics/studies performed was unknown by reporter. The pregnancy outcome was outcome pending. The fetal outcome was unknown. No adverse effects reported.
Initial unsolicited report received from a consumer (patient's parent) on 06-APR-2017. This case involves a 14 years old male patient who was vaccinated with a first dose of MENACTRA (batch number, expiry date, dose was not reported) intramuscularly in an unknown site on 03-APR-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as refused to provide and Illness at the time of vaccination was reported as denied. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 03-APR-2017, same day of following the vaccination, the patient had developed pain at the injection site with redness and swelling which is accompanied by High fever, nausea and dizziness. The patient required emergency room (ER) or doctor visit on an unknown date. Laboratory investigations were reported as none. The patient received analgesics and took rest as corrective treatment. The outcome of the event was reported as not recovered. List of documents held by sender: none.
after getting the vaccine, her taste and smell came back which has been gone since Oct2017 when she had shingles in her mouth and right side of face; This is a spontaneous report received from a contactable consumer (patient). A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 lot number: EK9231, expiry date: 30Apr2021), via an unspecified route of administration on the left arm, on 24Jan2021 15:30, at 0.3 mL, single, to protect her husband and her neighbor/COVID-19 immunization. Medical history included shingles in her mouth and right side of her face in Oct2017; and has not been able to taste or smell since 2017. There were no concomitant medications. The patient had shingles in her mouth and right side of her face on Oct2017 and she lost her taste and smell from it. She has not been able to taste or smell since 2017. The patient called to report a positive thing that happened after she got the COVID-19 vaccine on 24Jan2021 15:30. By the morning of 25Jan2021, the patient fixed her coffee and when she drank her coffee, she tasted it. She was like, 'wait a minute'. So, she took another sip. She can taste and smell. She smelled and tasted everything. After the coffee, she fixed an egg and put extra salt and pepper and she could taste it. After getting the vaccine, her taste and smell came back which has been gone since Oct2017 when she had shingles in her mouth and right side of face. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
5 hours after SQ vaccine administered patient developed soreness, redness, raised, itchiness at injection site. No fever. (+) nausea. Ice applied to (R) arm, hydrocortisone and ADVIL PRN.
Mild headache; Body soreness; Fatigue; Mild swelling of lymph nodes; Soreness of right arm; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 06Apr2021 at 12:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as no. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 16Mar2021 at 12:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 00:00, the patient experienced mild headache, body soreness, fatigue, mild swelling of lymph nodes and soreness of right arm. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events mild headache, body soreness, fatigue, mild swelling of lymph nodes and soreness of right arm was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Pt's sister, called pharmacy to notify us about the patients reaction. Sister asked to remain contact with any questions. Pt received both Fluad and Pfizer Comirnaty (Lot: HF9275, EXP: 12-1-24)  on 10/10/23 IM in the right deltoid. ***Please note, the option box above did not have the Pfizer Comirnaty Covid-19  vaccine as an option and when I tried to select "Other vaccine" and type in the information, the form kept stating I had an error and had to select from the listed options.  4 days after vaccination the patient woke up in the morning with severe pain in the right hand and numbness in the index and middle finger. I instructed sister to have her sister evaluated by a physician and we would report the reaction via VAERS.  Upon follow up with sister on 10/20/23, patient has not seen the doctor. The patient is taking a "wait and see" approach. Per sister, patient said the pain has gone away and she is experiencing more a tingling sensation in the affected fingers that comes and goes. Sister stated she will encourage sister to see a physician if the symptoms do not subside.
Fatigue, major headache, aches, chills, minor fever.  Essentially being fully sick for about 36 hours
Around the end of September or first of October had a itch (bad-breakout) on left back just above waistband. Finally cleared up then around first of December broke out in rash (itching) and (hurting) on left side in front. Still itching and hurting.
This spontaneous report was received from a physician and refers to a 4 year old male patient. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 26-JUN-2018, the patient was vaccinated with VARIVAX (lot #, expiration date, dose, frequency and route of administration were not provided) for prophylaxis. Other suspect therapies included M-M-R II (lot #, expiration date, dose, frequency and route of administration were not provided) and SHINGRIX intramuscularly (lot #, expiration date and dose were not provided). Concomitant therapies included sterile diluent (STERILE DILUENT MRK INJ). The reporter stated that the patient was vaccinated in February 2018 and could not clarify which vaccines were administered, VARIVAX and M-M-R II could not be ruled out. The patient did not experienced any adverse events.
Client presented to Public Health Center to receive Pfizer PEDS dose one. Vaccinator was vaccinating client, when Client moved arm and Vaccinator was unable to give full dose. Vaccinator also stated some of the vaccine had leaked from syringe while vaccinating. Incident was elevated to Operations Lead  and Med consult and was submitted. Per CDC guidelines approved for client to be revaccinated on opposite arm
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient was fainted and was unresponsive.  EMS was called.  Father stated this was a known issue.  It was more of a phobia.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 31-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (1 drink/week) on 15-May-2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 14-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 on 16-May-2020 and the estimated date of delivery was 20-Feb-2021. On 14-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fourth week of the pregnancy.  On 14-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2020, Pregnancy test: positive (Positive) positive. On an unknown date, Glucose tolerance test: normal (normal) normal. On an unknown date, Prenatal screening test: normal (normal) Normal   Quad screen  (also known as the quadruple marker test, the second trimester screen or simply the quad test  is a prenatal test that measures levels of four substances in pregnant women's blood). On an unknown date, Ultrasound scan: normal (normal) normal.     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.   No relevant concomitant medications reported.  Estimated date of conception reported as 01-Jun-2020. Previous pregnancy was ended on 22-Jan-2019 with full-term live birth without any complications.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 31-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Moderna COVID 19 vaccine eua, lip swelling approximately 12 hours after injection, chills, fatigue and hardness at injection site approximately 10 hrs after injection
Received the second dose of the shot at 4pm on Tuesday. Woke up at 2am the next morning with severe chills and fever. Tossed and turn unable to sleep because of body aches. The next day (Wednesday) I suffered from low grade fever, headache, body ache, chills, hot flashes, and slight nausea. By the next day,(Thursday) I still had slight fever and headache and sore arm. The next day (today- the third day) I've continued with fatigue and headache but much less severe.
Cry painful x 15 hr (5-15 min intervals sleeping)- Left otitis media
Vial was first punctured on 15-Jul-2022 8.30 and dose adminisitered on 18-Jul-2022 9:30 am; Dose administered more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 15-Jul-2022 8.30 and dose adminisitered on 18-Jul-2022 9:30 am) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jul-2022 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2022 at 9:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 15-Jul-2022 8.30 and dose adminisitered on 18-Jul-2022 9:30 am). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 15-Jul-2022 8.30 and dose adminisitered on 18-Jul-2022 9:30 am) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Vial was initially stored in the refrigerator on 28-Jun-2022. Vial was first punctured on 15-Jul-2022 about 8:30 am. Post Puncture the vial was stored in Fridge.  Vial did not undergo any temperature excursion. Total amount of time the vial was exposed to room temperature range (8 to 25 degree Celsius - 46 to 77 degree Fahrenheit) was unknown, but only taken out when a dose was to be drawn up. Probably less than an hour in total. Vial was exposed to room temperature for more that 24 hours. No treatment information was provided.
Varicella injection given on 12-17-02 in upper right thigh. On 12-31-02 mom noticed swelling and redness at site and also chicken pox lesions appeared on face, head , neck and back with itching. Area of swelling measured 4cm x 4cm at time of office visit.
Pt states has hx of anaphylactictic reactions to meds & c/o feeling dizzy after 30 minutes in waiting area.  Transferred by w/c to oberservation area to cot.  BP 200/80 P64 R16.   When pt started experiencing sever headache when she laid down.  BP 220/80  Pt was in severe hypertension crisis. 7:45pm EMS called 8:12pm Transferred to EMS. BP 210/100
she was admitted to hospital due to big reaction after getting the first shot; nausea; the dizziness hit her/ woke up at 8pm and dizziness was still there and kept on going; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (she was admitted to hospital due to big reaction after getting the first shot) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Epilepsy and Vertigo (Get really dizzy.). Concomitant products included LAMOTRIGINE (LAMICTAL), LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) and CARBAMAZEPINE (TEGRETOL) for an unknown indication.    On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, the patient experienced VACCINATION SITE REACTION (she was admitted to hospital due to big reaction after getting the first shot) (seriousness criterion hospitalization) and DIZZINESS (the dizziness hit her/ woke up at 8pm and dizziness was still there and kept on going). On an unknown date, the patient experienced NAUSEA (nausea). The patient was hospitalized on 19-Jun-2021 due to VACCINATION SITE REACTION. At the time of the report, VACCINATION SITE REACTION (she was admitted to hospital due to big reaction after getting the first shot), DIZZINESS (the dizziness hit her/ woke up at 8pm and dizziness was still there and kept on going) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 20-Jun-2021 patient went to the hospital and had blood work done  but no results were reported. Treatment reported is unknown nausea medication.  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.; 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.
My uncle unexpectedly passed away during the early morning hours of April 13.  He had reported to my aunt that he was having shortness of breath, headaches, and in general not feeling well.  She found him sitting up with a clear liquid pouring out of his nose and then he fell over dead.
Ct rec'd vaccine around 12p-arond 6-7 pm on 10/17/07 mom noticed swelling under (L) eye. hives on (L) side from neck, down arm and legs with itching on day #2 Hives disappeared, but client c/o itching over entire body on Day #3-No symptoms at all-client had no complaints
Injection site infection; Injection site swelling measuring 8 inches by 4 inches; Injection site redness; Injection site heat; Injection site hardness; This case was reported by a pharmacist and described the occurrence of injection site infection in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site infection, extensive swelling of vaccinated limb, injection site erythema, injection site warmth and injection site induration. On an unknown date, the outcome of the injection site infection, extensive swelling of vaccinated limb, injection site erythema, injection site warmth and injection site induration were unknown.   It was unknown if the reporter considered the injection site infection, extensive swelling of vaccinated limb, injection site erythema, injection site warmth and injection site induration to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that he had at least 100 patients this year who had experienced similar reactions like injection site redness, heat, hardness and swelling measuring 8 inches by 4 inches (extensive swelling of vaccinated limb) after receiving the Shingrix vaccine. It was unknown what lot numbers, location or treatment was given to the 100 patients. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020250657:Same reporter
on 3/27/21 Swelling of lips and face. on 49/21 swelling of the tongue