chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 4/14/2021 pts sugar dropped to 40.  EMT was called.  They gave him some meds to bring it back up.  He was still not feeling well that night he took some more sugar meds and went to bed.  Next morning he was foaming at the mouth and unresponsive.  EMT was called again.  On 4/15/2021 Pt was taken to the ER. He was intubated and transferred to another ER.  He has a trach, has a feeding tube and has swelling of the brain.
Initial misuse report received from a healthcare professional on 28 June 2013. A 12-month-old patient had received ACTHIB vaccine mixed with sterile water. No adverse event was reported. Documents held by sender: none.
** The adverse event/outcome not felt to be secondary to the immunizations administered on  8/31/2021. Was notified on 9/1/2021 that the baby expired ER on 8/31/2021
symptoms included nausea, dizziness, headaches, malaise/fatigue, diarrhea, chills hives. tretament included medrol dose pak
throat tightening/dry; tongue tingling, thickening; 1 minute headache, 1 minute of dizziness
Complaint of "Chest Arrhythmia" since Saturday, was advised to go to ER for further evaluation.
Lack of Efficacy/Test Nasal Swab -Positive; Lack of Efficacy/Test Nasal Swab -Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 16:00 as dose 4 (booster), single (Lot number: GJ2524 (also reported as GJ2529)) at the age of 60 years intramuscular, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Lot number: EL3248), as dose 2, single (Lot number: EL3248) and as dose 3 (booster), single (Lot number: FF8841) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyrodism" (unspecified if ongoing); "Known allergies: Penicillian" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Oct2022, outcome "recovering" and all described as "Lack of Efficacy/Test Nasal Swab -Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Oct2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
This spontaneous report was received from a pharmacist and refers to an unknown number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients who were on immunosuppressive therapy with prednisolone (manufacturer unknown) 5 mg once daily, were vaccinated with a dose of ZOSTAVAX and sterile diluent (DILUENT MRK) (dose, route, anatomical location, lot # and expiration date were not reported for both products) for prophylaxis. No adverse effects were reported. Additional information is not expected because the reporter refused additional contact.
Rash, nonspecific, migrating - duration of at least 2 months.  Red marks, possible Zoster infection.
After a week, pt developed small hives, itching, welt, reddness and  hot.  MD prescribed cephalexin.
Jan 1, 2014. Pain, bruise 6 cm diameter. Pain is ache. Worse with movement. Current bruise/hematoma is 1.5 cm, throbbing pain.
Grandmother reported child had "temp of 104, lifeless, difficulty carrying leg" patient was taken to Dr., who referred child to ED. Per GM child had spinal tap and was infused for dehydration.  Unable to rule out meningitis or adverse event post vaccination.
She passed out for few seconds. Called 911 and paramedic. BP and glucose was normal. drank some water and laid down for 20 minutes till paramedic came.
On 01/10/2022 - SOB and fatigue. and continued on the 01/11/2022. On 01/12/2022 severe SOB, sever fatigue, sharp chest pains.  01/13/2022- leg pain and swelling, added to what was already existing, shoulder pain and back pain and that kind of continued. On 01/24/2022- I was sent to the ER,  by my doctor. I was admitted immediately and I had deep Vein thrombosis, blood clot on my right leg and pulmonary embolism in the lungs. 4 days of heparin through IV in the hospital from 01/24 - 01/27/2022, I was in the hospital.  I would say unknown . I am under going current treatment for 6 months. I have to go every week to get images done.
BAD REACTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: slight polyethylene glycol allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced bad reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad reaction was not reported. This report was non-serious.
Patient received the Meningococcal vaccine on 01/19/21. Patient received the vaccine on 8/18/2015 as well.    Patient's mother reached out to the office two days later on 01/21/21 to report that patient had reported "feeling hot" after going to bed the night of 1/19/21. Patient had then broken out in hives all down her arm on 1/20/21. Patient's mother could not tell me which arm had broken out. Patient was given OTC Bendaryl which relieved the hives. Hives returned on 1/21/21 on patient's leg, mother unable to say which leg, at which point she reached out to patient's doctor's office.  CNP advised patient's mother to use OTC antihistamines for symptom control, and to reach out if symptoms do not resolve or if they worsen. Patient's mother also instructed to call 911 in the event patient experienced any breathing issues.
Circular reddened area approx. 3-4 cm in diameter with approx. 1-2 cm of blistered vesicular area inside of reddened area. Located on left leg at varicella injection site.
expired adult dose administered to pediatric patient; expired adult dose administered to pediatric patient; expired adult dose administered to pediatric patient; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 12-months-old male patient who received HBV (Engerix B adult) (batch number G99R4, expiry date 20th May 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd May 2022, the patient received the 1st dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 23rd May 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose, expired vaccine used and adult product administered to child. On an unknown date, the outcome of the overdose, expired vaccine used and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-MAY-2022 Reporter's Comments: The LVN (Licensed Vocational Nurse) reported that an adult dose of Engerix B was given to the pediatric patient in the morning of day of reporting and it was already expired. The reporter consented to follow up by postal. Additional supportive information: The use of an adult dose of Engerix B to pediatric patient which was already expired on 20th May 2022, which led to overdose, adult product administered to child and expired vaccine used.
Urticaria on the wrists developed approximately 10 days after first vaccination. It continued to increase in severeity and spread throughout my body over the following 2 weeks.  Severe urticaria developed on my torso, arms, feet, and legs after the second vaccine dose and has persisted in severity.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 22Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 15Jul2021 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Bronchopulmonary aspergillosis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient received Paxlovid as treatment. The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300334580 same reporter/patient/product, different AE;US-PFIZER INC-202300334579 same reporter/patient/product, different AE;
HEADACHE, sore arm, right bicep twitching, body aches, very tired.
Acute onset of spinning; Acute onset of dizziness; This is a spontaneous report from a contactable nurse, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 17Apr2021 at 11:00 (at the age 54-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, pre-diabetic, pituitary adenoma, vertigo, migraine, uveitis and hyperlipidemia. Concomitant medications included acetylsalicylic acid (ASPIRIN), amlodipine besilate (NORVASC), rosuvastatin (MANUFACTURER UNKNOWN), multivitamin injection (MANUFACTURER UNKNOWN), gummy vitamin (MANUFACTURER UNKNOWN) and escitalopram oxalate (LEXAPRO) all for unknown indications from unknown dates and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 18Apr2021 at 08:30, after the 24 hours of vaccination, the patient experienced acute onset of spinning and dizziness. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events acute onset of spinning and dizziness was unknown at the time of report.  No follow-up attempts are needed. No further information is expected.
hives/hives on her lower legs with sporadic patches on other places of her body including her upper legs, some on her arm, some on her torso and her upper chest; soreness (a little bit); This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Unknown lot number and expiration), intramuscular in left upper arm on 31Dec2020 at a single dose for COVID-19 prophylaxis.  Medical history included cat allergy/seasonal and animal allergies. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for cat allergy. The patient previously received flu shot for immunization on unspecified date.  The patient reported that she received the first dose of vaccine on 31Dec2020 and experienced soreness (a little bit) but was no difference from the flu shot. Last night (18Jan2021), hives started to appear. She took a Zyrtec this morning (19Jan2021) that she usually takes at night to alleviate the symptoms. She takes Zyrtec because she has a cat allergy and also reported to have changed her laundry detergent. The patient was wondering if there have been any reports of delayed allergic reactions to the COVID-19 vaccine. She said that she just got hives on her lower legs with sporadic patches on other places of her body including her upper legs, some on her arm, some on her torso and her upper chest last night. She may have some on her back, but she has not looked yet. She has had this type of reaction before with an antibiotic in the past. She is supposed to get the second dose on Thursday 21Jan2021. She noticed the hives last night and they seem to have gotten a little bit worse overnight but are about the same since she has gotten up. She said that she has allergies, but they are seasonal and animal allergies. She has also been using the same body wash and laundry detergent and stated that nothing has really changed with her. She also said that her partner that lives with her has not had any skin issues. The patient had not yet recovered from the event hives, while unknown outcome for the remaining event.   Information on the lot/batch number has been requested.
Information has been received from a nurse referring to a 40 year old patient of unknown gender. There was no information about concurrent condition, concomitant medication and medical history. On 24-FEB-2017, the patient was vaccinated with a dose of PROQUAD (lot# L040411, expiration date 13-APR-2017, dose, frequency and route unknown) for prophylaxis (Inappropriate age at vaccine administration). No adverse effect was reported. Additional information has been requested.
Information has been received from a nurse concerning a 12 year old female with drug hypersensitivity who on 10-Jul-2008 was vaccinated IM with her first dose of GARDASLI and her second dose of VARIVAX and on 30-Sep- 2008 was her second dose of GARDASIL since receiving the first dose of GARDASIL. She has had a variation of menstrual cycle. Her first menstrual period after the first dose of GARDASIL lasted 8 days. She then had a 2 menstrual periods 20 days apart. She has had a regular cycle for one year prior to receiving her first dose of GARDASIL. At the time of reporting, the patient was not recovered. No additional information at this time. The medical attention was sought in office, Additional information has been requested.
Index finger of the rt hand got bluish. After several months still it did not get back to normal color.If that finger is used it goes back to bluish color and throbbs.
Not feeling myself since the vaccination, Body aches, terrible episodes of chills/shakes, No energy, very tired, no appetite, headaches Began getting worse @ April 1, 2021
Erythema around injection site; Blistering around injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site erythema and injection site blisters. On an unknown date, the outcome of the injection site erythema and injection site blisters were unknown.   It was unknown if the reporter considered the injection site erythema and injection site blisters 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 the patient experienced erythema and blistering around injection site. No demographic details were provided. No lot number or expiration dates were provided. No additional details provided. The healthcare professional did not wish to file adverse event. This case has been linked with cases US2019193803 and US2019194494, reported by the same reporter.
Initial report received on 30 August 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; lot number C3153BA received on 10 August 2009, C3363AA received on 26 October 2009, C3469AA received on 18 December 2009 and C3731AA received on 19 November 2010 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 26 May 2012, approximately 18 months after the last dose. On 30 May 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 30 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 30 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 12 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 17 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
received dose from vials beyond 30-day use by date; received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (received dose from vials beyond 30-day use by date) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (received dose from vials beyond 30-day use by date). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration was 07-may-2021 No concomitant medications were reported No treatment drugs were reported   This case was linked to MOD-2021-364262 (Patient Link).
injecting expired ACTHIB on a patient/ActHIB was given after the expiration date of the diluent (with no reported adverse event); Initial information received on 26-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and gender patient who was injected expired acthib on a patient/acthib was given after the expiration date of the diluent (with no reported adverse event) while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect HIB (PRP/T) VACCINE lot number not reported  (expiration date :17-Sep-2022 of powder and 15-Oct-2022  of diluent) at an unknown dose for via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date (latency: same day), the patient was injected  expired acthib on a patient/acthib was given after the expiration date of the diluent (with no reported adverse event) (expired product administered).   Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event.   Outcome: unknown   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.
Pt passed out after receiving vaccine. He became pale in color and was talking. Wife provided Gatorade since we noticed he wasn't feeling well. Pt then laid back in the chair and became unresponsive, but still conscious. Pharmacy team, moved patient to the floor, where he immediately became responsive and color came back to skin. It is noted that the patient was sweating at the time of the event, and he stated he does not do well with shots. All of this took place within 15 minutes of receiving the Janssen Covid-19 vaccine.
PATIENT WAS GIVEN PFIZER BIVALENT BOOSTER VACCINE FOR  CHILDREN AGE 5 TO 11 YEAR OLDS. THE PATIENT WAS OK AT THE TIME OF VACCINE. WHEN THE PATIENT WALKED OUT WITH HER FAMILY SHE PASSED OUT. MOTHER BROUGHT PATIENT BACK TO THE PHARMACY. PATIENT SAT DOWN, MONITORED AND WAS GIVEN A GATORADE OR POWERADE TO REPLENISH HER ELECTROLYTES. PATIENT WAS DIZZY, LIGHTHEADED AND WANTED TO SLEEP. PATIENT WAITED 15-20 MINUTES OR SO BEFORE THEY FELT BETTER/RECOVERED AND LEFT THE PHARMACY.
16 year old male at table 4 received booster dose of Pfizer Covid vaccine to left deltoid.  Patient started to rise to go to observation and immediately fainted and fell out of chair onto the floor landing on his left side  rolling to rest on back, his back was pressed against the bottom bar of privacy screen.  Patient did hit his head on floor w fall.  Patient woke immediately slightly disoriented, pale in color and clammy.  No blood or open injuries noted no contusion noted to back of head.  Patient answered questions and stated back of head was a little sore, ice pack applied to area.  No dizziness  stated and pupils equal.  Help to wheelchair taken to Care Room, BP 124/82, P64, R 20, o2 97% Given water, snack and stated feeling better, color returning to face. ice continues to back of head.  States no pain or discomfort .  RN inspected back and a 2 inch red mark noted mid line no bleeding or laceration noted .  Back of head inspected no contusion or bleeding noted.  !4:15 pm BP 117/58, P 70, R 18, o2 99%, pupils Equal reactive to light.  Denies any pain or discomfort,  Father declined EMS to be notified to evaluate patient.  Father and Patient educated to monitor for disorientation, dizziness, headache, nausea, vomiting, and if needed to contact physician or if needed go to a ER.  Left w father at 14:20 pm
Contracted Covid 19, fever, sore throat, wheezing in throat, congestion, vomiting and body aches.
Fever 100.9, swelling of left axillary lymph. 300 mg ibuprofen every 5 hours
Myalgia, NauseaVomiting, Leg aches Narrative: Sore arm morning following injection.  Put ice on it and took Benadryl.
Previously COVID positive 12/15/2020 received Moderna vaccines on 5/29/21, 6/2/21 (Dates probably entered wrong, but this is what is listed in chart) tested positive for COVID by PCR on 10/7/21 admitted to local Hospital on 10/8/21 with COVID pneumonia.
RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/23/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Pt's. grand mom states pt. L-arm was red and swollen. She also states pt. C/O HA, nauseated.
Rash, stiffness in upper back muscles, by next morning and over following days:  increased rash and pain/stiffness in back, foot (area around pre-existing bunion), one shoulder (area around pre-existing bursitis).  Pain dissipated after about a week, first in upper back/shoulder, foot became swollen and difficult to walk, then resolved.