chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Elevated blood sugar, after first vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "disabled" (unspecified if ongoing); "Diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "Elevated blood sugar, after first vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: This consumer (patients Niece) reported for patient (reporter's aunty) number and Expiry Date of Pfizer Covid 19 Vaccine was not provided. She reported that patients' blood sugar levels were normally around 90-130.After first vaccine, patients blood sugars were over 300 and it had been difficult to control the levels and bring the blood sugar levels down. She stated that patient was scheduled for second vaccine but she was feeling hesitant to take it. Reporter seriousness for Elevated blood sugar, after first vaccine was unspecified.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nothing happened to patient. No symptoms, signs at time of administration. Needlestick (employee) happened after administration.
Patient just came in today stating he had "hard lymph nodes starting on 6/20/18 but never called our pharmacy to inform us and just informed us today 6/28/18. But, he did call his DR. as soon as it happened and Dr. states he told him this is rare but can happen with the injection. Dr. advised pt to take Ibuprofen and not to get second vaccination until 5 to 6 months after first vaccination. Patient states he only called physician on phone and Dr. stated he did not need to see patient in office regarding this. I called Dr. today and spoke with office that states Dr. did tell patient it is from the vaccination and he is not concerned about it at this time and will subside with time. Dr. does want pt to still get 2nd vaccination but not for 5 to 6 months after first vaccination.
On 3/21/22 Patient was administered covid vaccine booster after he stated that he had not received any prior booster and providing different year of birthdate. He was administered booster dose of moderna. Patient stated no hx of allergies, health risks, or being immunocompromised. After 15 minutes of being monitored he left clinic, and stated feeling well; no adverse effect reported.
Rash, dizzy, swollen lips and eyes.  Within 2 weeks broke out in Shingles rash and had light sensitivity and severe GI distress.
Sunday morning,(5/23) I woke up with severe back pain, vomitting and low grade fever.  Monday, vomitting and fever was gone but severe back pain still present.  I was unable to roll over in bed, stand or sit.  The pain was present on the right low back radiating into the hip.  Skin pain and sensitivity is present on right side of my lower stomach and groin area.  I was unable to stand or sit for over a week.  (the following tuesday).  No pain medication, massage, accupuncture, chiropractor gave any relief.  As of today 6/2, I still have pain but I am able to sit with minimal discomfort, but standing and walking still difficult and uncomfortable.
Administered adult formulation of Hepatitis A vaccine vs pediatric. Error of medical staff administering vaccine.
a patient who received the first shot in February and wants to get the second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (a patient who received the first shot in February and wants to get the second shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 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 PRODUCT DOSE OMISSION ISSUE (a patient who received the first shot in February and wants to get the second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (a patient who received the first shot in February and wants to get the second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medication was provided.  No treatment medication was provided.
accidentally gave Pediatric/Adolescent Havrix; 24 yo patient got pediatric havrix; This non-serious case was reported by a nurse via sales rep and described the occurrence of underdose in a 24-year-old patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced underdose (Verbatim: accidentally gave Pediatric/Adolescent Havrix) and adult use of a child product (Verbatim: 24 yo patient got pediatric havrix). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 14-MAR-2023 The Sales representative reported via on behalf of a nurse whom accidentally gave Pediatric/Adolescent Havrix to a 24 year old adult on an unknown date, which led to underdose and adult use of a child product. No additional adverse event (AE) information available at this time.
This report has been received from the nurse reported that VARIVAX (Merck) (lot# H020587, expiration date 13-NOV-2014) and PROQUAD (MARRS# 1311USA012185) were through unsupported temperature excursions on 26-JUN-2013, 01-JUL-2013, 22-JUL-2013 thru 31-JUL-2013 and the entire month of August 2013. On 20-SEP-2013 the patient (age and gender not reported) was administered the unsupported VARIVAX (Merck) (dose and route not reported). No adverse effects reported. This is one of several reports received from the same source (MARRS# 1311USA002616, 1312USA003307, 1312USA003308, 1313USA003309, 1312USA003306, 1312USA003310, 1312USA003312, 1312USA003313, 1312USA003314, 1312USA003315, 1312USA003316, 1312USA003317, 1312USA003399, 1312USA003400, 1312USA003401). Additional information has been requested.
Came in the ER with complaint of fever, low appetite, vomiting, had seizure in ER and unstable. Transport to other facility was arranged and pt expired during transport. Pneumococcal sepsis and meningitis.
This is a spontaneous report from a contactable other-HCP (patient). A 55-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# EN6202), at the age 55, via an unspecified route of administration, in left arm, on Feb 25, 2021, single dose, for COVID-19 immunization. The patient's medical history not reported. Historical vaccine included received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EL9262), at the age 55, via an unspecified route of administration, in left arm, on Jan 27, 2021, at 08:30, single dose, for COVID-19 immunization. The patient has no known allergies. The patient did not received any other vaccines within 4 weeks. Reportedly, patient took other medications in two weeks of vaccination. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. On Feb 26, 2021, patient developed tender and swollen lymph nodes in left arm pit, fatigue and slight dizziness. The patient did not received any treatment for the events. The outcome of events: recovering. Follow-up attempts completed. No further information expected.
Gave ProQuad MMR/V on left leg, left room to get AVS, when I came in the room mom stated left leg started to get red after shot. Noticed and reported findings. Benadryl given PO observed x 30 min after med.
No adverse symptoms reported; improperly stored vaccines were administered to patients; This spontaneous report was received from a nurse referring to a 4 years-old, patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not provided.   It was reported that on 03-DEC-2019, varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R018138) was under temperature excursion at 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees centigrade (C) to -10 degrees C) (8.7 F), for a time frame of 50 minutes, and the previous temperature excursion was at 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees centigrade (C) to -10 degrees C) (6.9 F) for a timeframe of 50 minutes. On 12-DEC-2019, the patient was vaccinated with improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R018138 has been verified to be a valid number; expiration date 25-JUN-2020) for prophylaxis (strength, dose, frequency, route of administration, anatomical location were not reported). It was reported that the call was due to data logger. No adverse symptoms were reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1912USA001555:same reporter US-009507513-2006USA003314:same reporter US-009507513-2006USA005620:same reporter US-009507513-2006USA005618:same reporter US-009507513-2006USA005616:same reporter US-009507513-2006USA005617:same reporter
Information has been received from a pharmacist concerning an 84 year old female with cardiac disease, penicillin and ampicillin allergy who on 01-JUN-2009 was vaccinated SQ with a 0.5ml dose of PNEUMOVAX 23 while hospitalized at a hospital with cardiac diagnosis. It was unknown if this was the patient's first dose of PNEUMOVAX 23. On 01-JUN-2009, 2 hours after administration, the patient developed an area of redness, swelling, tenderness and warmth at injection site of the right upper arm. The unspecified physician has prescribed BENADRYL, ice compresses and ordered a venous Doppler study. At the time of this report, the patient was not recovered. Additional information has been requested.
PATIENT COMPLAINS OF TWO DAYS OF "ITCHINESS AND REDNESS" AND WARMTH TO THE SITE OF INJECTION. OBSERVATION REVEALS NICKEL SIZED ECCHYMOSIS AT LEFT MEDIAL DELTOID REGION. TWO AREAS OF ERYTHEMATOUS ELEVATED WHEALS DISTAL TO ECCHYMOTIC AREA. WARM TO THE TOUCH WITH BLANCHING NOTED. BORDERS OF ERYTHEMATOUS AREA MARKED FOR FUTURE REFERENCE. PATIENT TOLD TO TAKE 800MG MOTRIN PO EVERY 8 HOURS FOR TWO DAYS. APPLY HEAT OR ICE COMPRESS WHEN POSSIBLE AND FOLLOW UP IN 48 HOURS IF SYMPTOMS PERSIST OR SOONER IF SYMPTOMS WORSEN.
Patient began feeling like there was a Vasoline like substance under her eyelid on the morning of 9/4/18. She went to the ophthalmologist and was told the optic nerve was swollen. The patient's husband reported the incident to me, to see if it might have been due to the vaccine (SHINGRIX) given on 8/18. I called GSK, spoke with employee, and reported the incident. He informed me that this side effect was not reported in any studies which included greater than 29,000 patients.
Patient states she received the MMR vaccine on 9/3/08 at 12:20pm.  She felt fine all evening and at 2:45am got up to use the rest room.  She became "hot, dizzy, and lightheaded."  Upon sitting, some of these symptoms resolved, however when she stood back up she felt as though she "might pass out."  She went back to sleep after incident and states she is feeling better today.  She did not receive medical treatment for this.
twitching  every minute throughout their body, in different places all day long; has not gotten the second dose yet; heavy pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (heavy pain in the arm), MUSCLE TWITCHING (twitching  every minute throughout their body, in different places all day long) and PRODUCT DOSE OMISSION ISSUE (has not gotten the second dose yet) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced PAIN IN EXTREMITY (heavy pain in the arm). On an unknown date, the patient experienced MUSCLE TWITCHING (twitching  every minute throughout their body, in different places all day long) and PRODUCT DOSE OMISSION ISSUE (has not gotten the second dose yet). At the time of the report, PAIN IN EXTREMITY (heavy pain in the arm) and MUSCLE TWITCHING (twitching  every minute throughout their body, in different places all day long) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (has not gotten the second dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
This case was reported by a consumer (also the subject) and described the occurrence of sudden weakness in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received a dose of FLUARIX (details unknown). Immediately after vaccination with FLUARIX, the subject experienced sudden weakness. At the time of reporting the outcome of the event was unspecified. The consumer refused to provide any further information.
05/25/2005 - five maoular rash - prescription - vasiwound. 05/20/2005 - CBC with platelet # of 75K. 05/25/2005 - CBC with platelet - # of 208K.
Within 1 week of receiving the vaccine, I had cardiac arrhythmias that required me to see a doctor.  I have also had headaches every day since receiving the vaccine.
PT HAD ONE VARICELLE VACCINE. SHE HAD CHICKEN POX 09/27/2007
Patient received TD vaccine about 03/20/2006, left arm was sore next 2 days.  Had muscle fasciculations left arm next day.  Developed joint pain in knees, ankles, shoulders and hips around 03/25/2006 which continued to today.  Had red splotches on legs yesterday.  Has chest tightness with respirations.  Prescribed prednisone for 12 days.
Could not keep anything down; Chills; Tired; Fevers; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Could not keep anything down), CHILLS (Chills), FATIGUE (Tired) and PYREXIA (Fevers) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A. and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced DISCOMFORT (Could not keep anything down), CHILLS (Chills), FATIGUE (Tired) and PYREXIA (Fevers). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DISCOMFORT (Could not keep anything down), CHILLS (Chills), FATIGUE (Tired) and PYREXIA (Fevers) outcome was unknown.            Concomitants were not provided.
itchy rash. He described it to be like a poison ivy-like rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash. He described it to be like a poison ivy-like rash) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-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 RASH PRURITIC (itchy rash. He described it to be like a poison ivy-like rash). At the time of the report, RASH PRURITIC (itchy rash. He described it to be like a poison ivy-like rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported No treatment information was  provided   This case was linked to US-MODERNATX, INC.-MOD-2021-068340 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068340:
The patient is an  85 y.o. female with past medical history of idiopathic pulmonary fibrosis/ hypothyroidism, hyperlipidemia, trigeminal neurology, history of recurrent syncope status post pacemaker placement, asthma. Presented to the emergency department at hospital with chief complaint of shortness of breath and was found to have acute COVID-19 infection and a large pericardial effusion.   Patient was discharged from Hospital 4/2/22 at that time she was admitted for acute on chronic hypoxic respiratory failure, and findings or pericardial effusion on CT scan, echocardiogram showed only trivial pericardial effusion.   She presented back to hospital with an acute onset of shortness of breath and dyspnea on exertion. Workup revealed a CT scan of the chest showing large pericardial effusion and COVID-19 positive.  She was transferred to hospital for further evaluation. A repeat echocardiogram revealed a small pericardial effusion is noted, predominantly adjacent to the mid to apical right ventricle. No tamponade physiology. This measures 1.2 cm in maximal dimension.  She remained on her home O2 settings of 2L. Given she is asymptomatic and with relatively small appearing pericardial effusion, she was discharged home in stable condition with plan to follow up with PCP and Cardiology. She will a follow up Echo to assess progression of pericardial effusion.   The patient has h/o recurrent UTI and due to her underlying pulmonary disease, our Pulmonary team recommended avoiding nitrofurantoin in the future due to her diagnosis of interstitial lung disease.
Lymph node swelling around collar bone, dizziness within hour of receiving, fever & fatigue.
Received AVA (4), Hep A (2), and Hep B (3) on 9/28/04. Noted burning sensation for a minute or two during injection and right after receipt of the anthrax vaccine in his right arm. (He had not experienced that sensation with previous anthrax vaccines). He also noted a local reaction around his anthrax injection site-redness, tenderness, and swelling about the diameter of a golf ball and raised about 1/2.
Diarrhea; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had diarrhea since an unspecified date for two weeks after getting the first dose of Pfizer COVID vaccine. She took a whole bottle of Pepto Bismol. The outcome of the event was unknown.   Information on the Lot/Batch number has been requested.
A 3.5-4 inch swollen, red, hot circle appeared at the injection sight that was itchy. We noticed it after school on 3/2/21 and it didn?t increase of decrease in size over night so we took her back to the doctor
Evening after shot, site was sore and couldn't sleep on that side.  During evening (12:30 pm) felt cold, shivering, felt feverish. in morning had fever of 100.  Had to stay in bed and rest on and off.  By Sat. night
I started Sneezing on 1/19 at work and felt run down.  I got a  fever later that night had my throat was sore. Injection site was red and hot during my fever. fevers 101 at night and had trouble sleeping.  I am better now. I got the first dose of the vaccine on 1/12/21.
Confirmed with customer no additional AE.; Dose of GARDASIL 9 that was administered early/Patient who received their first dose of GARDASIL 9 on 1/29/2021, and the patient received their second dose of GARDASIL 9 on 6/2/2021; This spontaneous report has been received from a Registered Nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 29-JAN-2021, the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9)(dose, route of administration, anatomical location of vaccination, lot number and expiration date were not provided).  On 02-JUN-2021, the patient received an early second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) in a 2 dose series regimen (inappropriate schedule of product administration) (dose, route of administration and anatomical location of vaccination were not provided; lot number T008152 has been verified to be a valid lot number and expiration date reported and established as 21-JUN-2022). No additional adverse events were confirmed. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008152; expirationdate: 21-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Dizzy, lightheaded, left arm numb. O2 saturation 98%. HR 68 and strong. No SOB. Color pink. BP WNL. Laying down, drinking juice. After lying flat and drinking juice pt. began to feel better. Symptoms resolved and felt ok to leave. Encouraged to go to ED if symptoms worsen.
This initial spontaneous report was received from a physician via a company representative and refers to a 2 month old male patient. The patient was born a "preemie" at 33 weeks. Concomitant medications included ranitidine hydrochloride (ZANTAC). In January7 2017 (reported as six months ago), at age 2 months, the patient was vaccinated with his first dose of ROTATEQ 2 ml orally for the prevention of rotavirus along with PENTACEL and PREVNAR. In January 2017 (reported as six months ago), the patient experienced severe watery diarrhea which subsided. In March 2017 (reported as at 4 months old), he received his second dose of ROTATEQ and had another case of watery diarrhea but not as severe as the first case. This case of diarrhea also subsided. The physician also reported that the mother who breast fed the baby was on some type of "elimination diet". The patient did not received his third dose of ROTATEQ (also reported that it was withdrawn). The patient recovered from the diarrhea. Causality assessment was not provided. Additional information has been requested.
injection site pain/soreness, fatigue Narrative:  (1) Ache/Soreness in arm/shoulder that vaccine was administered (left arm). Onset approx 3-4 hours after receiving vaccine. Felt similar to soreness after a tetanus shot. Lasted approx 48 hours. (2) Extreme fatigue. Onset approx 12:30pm the day after vaccine was administered. Fell asleep around 6:00PM that evening. Woke up the next day around 6:30AM and felt like normal.
Patient presents to the emergency department with decreased appetite, general feelings of being unwell and severe body aches. She was subsequently admitted for management of COVID-19 pneumonia. She remains hospitalized at this time.
Hives, swelling, high fever, warm at site of injection, and severe pain in entire upper arm.
Pt reports post vaccine she developed rash and arthralgia of fingers. By 3/16 rash had resolved but arthralgia has increased.
After loading my fishing wagon into my truck I closed the tailgate and started towards the door of my truck.  I suddenly became very dizzy and had to hang onto my truck to keep from falling.   It has not happened again but I have felt light-headed ever since.  I am due to get my second shot on 5  FEB 2021.