chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SVT episode with a heart rate over 210 bpm; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on 23Mar2021 16:45 (Lot Number: ER8727) as dose 2, single (at age of 46-years-old) for covid-19 immunisation. No pregnant at time of vaccination. No other vaccine in four weeks. Medical history included allergies. No Covid prior vaccination. Concomitant medications included montelukast sodium (SINGULAIR); levocetirizine dihydrochloride (XYZAL) taken for allergies. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) on 02Mar2021 16:30 administered in Arm Right (at age of 46-years-old) for COVID-19 immunization. The patient experienced SVT episode with a heart rate over 210 bpm (hospitalization) on 21May2021 10:30. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for SVT episode with a heart rate over 210 bpm for 1 days. She never had SVT before or any heart conditions. The event treatment induced medication to slow down her heart and stop SVT. The patient underwent lab tests and procedures which included heart rate: 210 bpm on 21May2021, rapid test: negative Nasal Swab on 19Jan2021. Outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
2 hrs p/vax pt devel a total body rash, & pain, swelling & redness @ inject site; muscles in arm were tight; no fever; react was treated w/DPH;
patient covid test date was on 12May2021; patient covid test date was on 12May2021; Falling; weakness; unable to stand; malaise; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11May2021 13:45 (Batch/Lot Number: Ew0173) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Prostatectomies and high blood pressure both from an unknown date and unknown if ongoing. There was no other vaccine in four weeks. Concomitant medication included levetiracetam (KEPPRA) taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: ER8731), on 20Apr2021, 10:45 AM for covid-19 immunization. It was reported that the patient experienced Falling, weakness, unable to stand, malaise on 12May2021. The event resulted in Emergency room/department or urgent care, Hospitalization. Treatment includes: Oxygen, saline. It was reported that if covid prior vaccination :Yes; and if covid tested post vaccination :Yes. It was also reported that  the patient covid test date was on 12May2021 and with positive result. The reporter considered the event as serious (criteria: Caused/prolonged hospitalization). The outcome of the events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Information has been received from a nurse practitioner reporting that on 01-SEP-2006 a 12 month old male was vaccinated with Varivax (lot #653964/0590F). The patient was also given Comvax. Approximately three months later in approximately December 2006, the patient developed a shingles-like rash on the right leg. Also, the patient was diagnosed with bronchiolitis. The patient was prescribed ACYCLOVIR for the rash. The patient sought unspecified medical attention. The patient was reported to be recovering. There was no product quality complaint. Follow-up information was obtained from the nurse practitioner who indicated that the patient (infant male weighting 22.1 lbs and 30.25 inches in height) came in for a 15 month check up. On 24-JAN-2007, the patient developed a rash on his right leg. The reporter said that the rash was consistent with shingles on right leg. It was reported that the patient is a healthy 15 month old with bronchiolitis. The patient is on therapy with Albuterol. The patient was recently hospitalized for bronchiolitis-RSV. The patient recovered. Additional information has been requested.
Pt developed hives, difficulty breathing - received Epinephrine x 2, Benadryl and IV steroids. Information from medical records states facial edema. msv
Information has been received from a registered nurse concerning her 6 year old daughter, who in 2002 at the age of one, was vaccinated with varicella virus vaccine live (Oka/Merck). In September 2006, her daughter developed a mild breakthrough of chickenpox. Her lesions were located on her shoulder and genital area, .accompanied by a low grade fever. Unspecified medical attention was sought. The nurse reported that chicken pox was going around at the local school. There was no product quality complaint. It was also noted that the patient's two sisters developed after vaccination with varicella virus live (Oka/Merck) (WAES#0703USA00658 and WAES#0703USA00659)
strong pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (strong pain in the arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (strong pain in the arm). At the time of the report, PAIN IN EXTREMITY (strong pain in the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information provided.
This spontaneous report was received from a registered nurse referring to two unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not provided. On 25-JAN-2017, the patients were vaccinated with improperly stored doses of VARIVAX injection (lot# M033904 with expiration date 20-JUL-2018) for prophylaxis (strength, dose and route were not provided). The vaccines were exposed to a temperature excursion between 14 Fahrenheit degrees and 46 Fahrenheit degrees for 3 hours. Prior temperature excursion was registered on an unspecified date, between 5 Fahrenheit degrees and 14 Fahrenheit degrees for 25 minutes. The call was placed because of a Digital data logger. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA009272:
At 3:00 AM stomach pain, nausea. By 10:00AM nausea, migraines, dizziness, fatigue, pain in muscles, difficult breathing.  By 5:00 PM it was better and then the following morning symptoms came back.
Pt awoke early the morning following vaccine with overall shaking, dizziness, and increased confusion and somnolence. Evaluated in ER; Back to baseline at end of ER visit.
Patient received Moderna 0.5 ml at approximately 1115 on 2/27/21. During her 15 minute observation period she became lighted headed and then fainted was lying on floor. Patient was transported to provider area via wheelchair. Where vital signs were monitored. Patient was administered 25 mg Benadryl at 1125 and Tylenol 650 mg at 1213.  during recovery period her vital signs stabilized and she was discharged by the provider at 1225 tom the care of her mother.
Roughly 5 min. after administration patient became white in the face and lips, began to sweat profusely, and then lost consciousness for about 10 sec. Pt. regained consc. for a few min and lost cons. again for about 20 sec. Pt. was asked series of questions to remain alert until paramedics arrived 5-10 min later. Suspected dehydration and hypoglycemia.
Vaccia given 2:45 - on 2/22/07 - for remainder of day. Patient felt increase fatigue, lightheaded, nauseated. Spent day in nurse office sleeping.
Tinnitus in both ears starting approximately one week after the first Pfizer covid-19 shot and continuing since then for over two years.  No treatment.
This spontaneous report was received from a pharmacist and refers to a 56 year old female patient. On 05-JUL-2014 the patient was vaccinated with ZOSTAVAX lot # J014810, .65 ml, subcutaneous, for the prevention of shingles. On 06-JUL-2014, the patient experienced erythema, two inches in diameter, around the injection site, and an injection site that was itchy and sore. No information regarding concomitant medications, concurrent medical conditions, or other pertinent medical history was not provided. Treatment was not given (but it was reported that the patient saw the pharmacist). The outcome of erythema, two inches in diameter, around injection site, and an injection site that was itchy and sore is unknown. Additional information has been requested.
Large erythema at injection site for 2 weeks with swelling and pain. Flu-like symptoms associated.
Had swollen lymph nodes, mouth soars, hives, fever, fever blisters, muscle aches, fatigue, chills
My adverse was more a lung Covid-19. My doctor called it Covid-19 induced asthma. I had low oxygen levels. I had tightness in my chest and hard to breath.
PATIENT EXPERIENCED SWELLING AT INJECTION SITE ABOUT A QUARTER SIZE, IT APPEARED RAISED AND SWOLLEN. PATIENT FELT SICK, HOT AND NAUSEOUS 1-2 MINUTES LATER. SHE SAT-DOWN FOR ABOUT 20MIN UNTIL SHE FELT BETTER.
He tested positive for COVID after he took his first dose; He tested positive for COVID after he took his first dose; This is a spontaneous report from a contactable consumer (patient). A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route on 21Mar2021 at single dose for covid-19 immunisation. Medical history was not reported. The patient's concomitant medications were not reported. On an unknown date, the patient tested positive for COVID after he took his first dose. He inquired about the interval between the first and second dose and how long was the limit between the two doses. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Systemic: Heart Attack-Severe, Additional Details: Family member called 9/12/22 stating patient had heart attack evening prior on 9/11/22.  She said she was in hospital and not doing well, and wanted to know which vaccine she received and what time on 9/10/22 because they weren't sure if there was a link between vaccine and heart attack and were concerned.
--- 3/20/2021 10:39 AM --- Member received COVID-19 Vaccination, while completing 15min wait post vaccination wait period member lost consciousness, fell to ground on Left side, denies head pain, no edema/brusing noted, not tender to palpation on exam, VS Stable, assisted to exam room and supine position with LE Elevated, Abrasion on L hand, member declined dressing.  Completed 20 min wait in exam room, assisted to sitting and standing position with no lightheadedness or dizziness noted, able to ambulate 50 plus feet independently.  Member home in Private vehicle.
Per RN who reported this ADR: "Patient developed a rash after receiving the pneumonia vaccine. He was admitted this morning and is allergic to egg. We are calling the doctor to let him know that". Per RPh conversation with patient's RN on Mon 8/17/15 at 1035 AM: Patient got a dose of PNEUMOVAX 23-standard adult dose on Sunday, then broke out in a generalized rash/hives. Per RN patient is okay and is getting BENADRYL 25mg IV every 8 hours as needed for itching. MD also ordered prednisone 20mg po Q morning (8/16 2130).
Patient complained of feeling very lightheaded and dizzy, he was sitting down when vaccination was given, but then stood up to go to register which was a couple of steps away. Reaction occured within 2-3 minutes of administration. Advised patient to have a seat, set a timer for 15 minutes while seated. Blood pressure was taken by pharmacist, results were 140/85, patient added that was his normal range on a daily basis. As the 15 minutes passed, his lightheadedness decreased but not 100%. His wife was present, and drove him home. Called patient next morning 11/26/18 around 9:45am, patient confirms feeling 100% and the reaction was just at the pharmacy.
Nausea, dizziness, vitals wnl. Lay down, got better.
This spontaneous report was received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates (reported as from 06-DEC-2016 to 04-JAN-2017), the patients underwent the administration of improperly stored doses of ROTATEQ with lot numbers M007301 and M011832; and expiration dates 19-NOV-2017 and 25-JAN-2018 respectively, orally (dose was not provided) for prophylaxis. There were no adverse events reported. Administered doses of ROTATEQ were exposed to a temperature excursion of 35°F for 60 hours. Data logger was not involved. There were no previous excursions reported.   This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1701USA007868: US-009507513-1701USA007869: US-009507513-1701USA007870: US-009507513-1701USA003063:
This spontaneous report as received from a physician via company representative refers to a 22 month old patient, of unknown gender. (Patient attended daycare at the time of the report). Patient had no medical history and no allergies or reactions to the drugs. On 10-SEP-2013, the patient was vaccinated with VARIVAX (Merck) (dose, frequency and anatomical location: not reported, subcutaneous) (lot # J003222, exp date: 15-MAR-2015). There were no concomitant medications. On 08-JUL-2014, the patient experienced chicken pox, diarrhea, fatigue and low grade fever. No laboratory diagnostic studies were performed. The patients sought medical attention (office visit on unspecified dates). The outcome of fatigue, low grade fever, chicken pox and diarrhea was unknown. The medical assistant had no information on recovery of the patient. The reporter stated that the parents never called the office with any health difficulties following office visit on 08-JUL-2014. Treatment provided was palliative-no prescriptions were written. There was no information on the severity or duration of breakouts. Relatedness between fatigue, low grade fever, chicken pox and diarrhea and VARIVAX (Merck) was not reported. This is one of the several reports, received from the same reporter. Additional information has been requested.
Student hit bone and it scared him.  Most of the vaccine spilled out.  I re-administered the vaccine to the patient.  I informed her of the possible side-effects and I called to check on her two days later.  She was fine just had a sore arm.
Left arm is red, puffy, hives, itchy 6 inch x 3 inch  per patient.  Cellulitis.  Cephalexin 500mg three times a day for 10 days.  06/94-vis  Spoke to her 03/31/2003-resolved.
Patient has had no symptoms yet, but he was accidently injected with the 20-21 formulation. We will likely be revacinated with this years shot at a later date.
Initial symptom occurred in March 2022:  small amount of spontaneous bleeding from left breast nipple Further testing in April and June did not indicate a cause or diagnosis Follow-mammogram on December 5, 2022 revealed possible breast cancer Biopsy on December 8, 2022 confirmed Ductal Carcinoma In Situ (DCIS) Stage 0 Treatment has not begun as of this date (12/25/22)
Pt recvd vax 27OCT92 & on 29OCT92 pt devel fever of 104, myalgia, lymphadenopathy, headache, sore throat; temp lasted for 3 days; @ the time of report the pt had sl sore throat & lymphadenopathy;
sore throat; runny nose; fever; slight headache; tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), SARS-COV-2 TEST POSITIVE (tested positive for Covid-19), PYREXIA (fever) and HEADACHE (slight headache) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), PYREXIA (fever) and HEADACHE (slight headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), SARS-COV-2 TEST POSITIVE (tested positive for Covid-19), PYREXIA (fever) and HEADACHE (slight headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, COVID-19: positive (Positive) The patient tested covid-19 positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include, Descovy for PrEP.
Fever, body aches, left arm pain. Fever and body aches resolved but had lingering left arm pain. Arm pain treated with Diclofenac Gel.
A report has been received from a Health Professional concerning a female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 18-NOV-2014. The patient experienced wrongful administration . The outcome of wrongful administration is unknown. The report was considered to be non-serious. The reporter and company physician considered that there was no casual relationship between wrongful administration and FLUMIST.
Numbness feeling inner right ear and tinnitus began 14 hours after HPV #3 - began w/ numbness - then tinnitus 1 hr later - persists to now - later in day - no other sx or illness.
About 12 hours after the injection I started experiencing cold sweats, headache, fever, nausea, diarrhea and body aches. There was a throbbing pain going from the injection site up my arm and into my neck. Haven?t been able to barely eat anything since symptoms started.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain), MYALGIA (Body Aches) and NAUSEA (Nausea) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Allergy, LAMOTRIGINE for Antidepressant therapy, CLONAZEPAM for Anxiety, LISINOPRIL for Blood pressure abnormal, HYDROCHLOROTHIAZIDE for Blood pressure high, TIZANIDINE for Muscle relaxant. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain), MYALGIA (Body Aches) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. On 12-Mar-2021, PAIN IN EXTREMITY (Arm Pain), MYALGIA (Body Aches) and NAUSEA (Nausea) had resolved. 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.
Sx's started evening of 1/13/03 (Mon) with discomfort - mild diarrhea on Wed & Thurs AM. Fever of 103 deg on Sat, Sun, Mon, Tues, & Wed, treated with Motrin to bring down fever. Burning sensation in hands on Sunday, funny metal taste Sat. or Sun. Friday felt ache at work - meek felt tender bone by Tuesday. Take BP medication and periostat daily. Sat MD 1/21/03.
Information has been received from Merck Pregnancy Registry for GARDASIL vaccine from a Nurse practitioner concerning an 18 year old female with AUGMENTIN allergy and no  pertinent medical history who on 06-OCT-2-008 was vaccinated with first dose of GARDASIL vaccine (Lot # not reported). Concomitant therapy included ZOFRAN. On 08-DEC-2008 she received second dose of GARDASIL (Lot # not reported). When she received second dose of vaccine she was pregnant. Patient had last menstrual period on 13-NOV-2008. Estimated date of delivery was 29-AUG-2009. The patient received out patient IV therapy for hyperemesis. Ultrasound was performed to confirm pregnancy. Additional information has been requested.  This is in follow-up to reports (s) previously submitted on 2/13/2003.  Follow up information has been received from a nurse practitioner concerning a 18 year old female, on 15-JAN-2009 and ultrasound was made and showed that the foetus has 8 weeks and 2 days old. Additional information has been requested.
Pt out of town, mom called to report red, hard, swollen warm "saucer-sized" diameter area on (L) leg. no fever, pt. active and alert. R/T pt in another stated, sent to nearest urgent care or ER for eval. Admitted to hosp x 2 days for cellulitis s/p according to mom.  07/02/2007 MR received for o/n hospital stay for L thigh cellulitis.  Child presented with swelling and redness and with c/o itching on the L thigh at the site of vax.  PE WNL except redness and swelling to L thigh.  Asessment:  Left thigh cellulitis.
After the Vaccine- Started feeling under the weather in the evening of day 4, with sore lymph nodes in neck,. On day 5 ~ Fatigue and exhaustion, unable to do daily tasks and a rash/ hives lasting  a few hours.  Day 6-9 still feeling fatigued, mainly evenings, but feeling better and able to exercise and do daily tasks.
This case was reported by a consumer via call center representative and described the occurrence of increased intraocular pressure in a 71-year-old male patient who received SHINGRIX for prophylaxis.  The patient's past medical history included glaucoma. On 19th June 2018, the patient received the 1st dose of SHINGRIX. On 19th June 2018, less than a day after receiving SHINGRIX, the patient experienced shivering, injection site pain and fever. On 29th June 2018, the patient experienced increased intraocular pressure. On an unknown date, the outcome of the increased intraocular pressure was unknown and the outcome of the shivering, injection site pain and fever were recovered/resolved.  It was unknown if the reporter considered the increased intraocular pressure, shivering, injection site pain and fever to be related to SHINGRIX. Additional details were provided as follow: The patient received SHINGRIX vaccine in the left arm. On 7th or 8th June 2018, the patient's eye pressure was 19, 20 or 21 (unit not reported). The patient's eye pressure had increased to 35 (unit not reported) after he had the SHINGRIX vaccine. The patient also experienced low fever and some shivering the same day that lasted approximately 24 hours and had some soreness at the injection site that lasted a couple of days. The patient had denied permission to contact their physician.This case is linked with US2018164427, reported for the patient's wife. Lab Comments: On 7th or 8th June 2018, the patient had eye pressure of 19, 20 or 21.
Headache, body aches (especially legs), extreme chills with extremities shaking, probable fever, injection site considerably more painful/tender than with first dose, inability to sleep all night, a bit light headed, weak and balance problems while walking, dry mouth  After roughly 6 hours, most symptoms gone or greatly improved.  Still had some headache and body aches, felt mildly feverish, injection site still painful, fatigue due to lack of sleept
Vomiting x4 times, headache. Given Tylenol 650mg and Zofran 4mg  x1. PT went home to rest.
Right arm (upper) with redness, swelling, hot, redness (3 1/2 inches wide) itching and soreness, no fever 10-7-10.