chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to a 6 months old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 01-OCT-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
hurting arthritis pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (hurting arthritis pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included PREDNISONE for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (hurting arthritis pain). The patient was treated with ACETYLSALICYLIC ACID for Adverse event, at an unspecified dose and frequency. At the time of the report, ARTHRITIS (hurting arthritis pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I was struggling with the acid reflux prior to the vaccine after a bilateral surgery in August 2021. After the 3rd Dose of the Pfizer, I noticed it has gotten worse and it is affecting my voice. I received the flu vaccine on 10/15/2021. After both vaccines, the 3rd dose of Pfizer and the flu vaccine. I noticed 2 days after the flu vaccine, I began having pain on the left side of my jaw. My glands are swollen. I was unable to eat and chew that lasted quite a while. 11/17/2021, when I close my mouth entirely, there is pain, and it is tender on the left side of my jaw around my ear. While I am chewing or eating, I can tell there is some pain and swelling. I went to see NP, on 11/05/2021, who works for Dr. because I started to notice one of my eyes were bothering me, when I would look up or to the side, when I would attempt to look up or move, my eye would hurt. Movement in the eye- I felt pain in the back of my eye. I have swollen glands in my jaw. The NP said it might be TMJ and to put heat on it and see a dentist.  I will see a gastroenterologist on 12/21/20021- to have an endoscopy. 11/17/2021 This is the longest I have ever had swollen glands on the left side under my jaw, close to the joint. I don't know if it could be related to the acid reflux or not, maybe it is.
Shot Received 4:45 pm Wed the 27th; Arm pain 9:30 pm; receded ~8 am; Cold feeling/tiredness/ mild chills 6:45 am; Joint pain 7:30am - focused in ankles; Moderate chills around 9:30 am; Everything sans chills resolved 1030; Chills resolved 11:40; Chills return, moderate 1645; Chills partially recede 1730; Fever spike - 101.62 @ 1735; Chills gone 1800; Fever breaking - 100.5 @1846; Cold sensitivity 2010; Side effects fully resolved overnight
First:  Injection site reaction; swollen, red, painful.  Pustule near injection site.  Also:  respiratory difficulty, swelling in throat, sore throat, shortness of breath.
Minutes after flu vaccine administered developed cough, throat tightness, facial flushing and red blotches on trunk; escorted to E.D. directly adjacent to employee health department; provided with BENADRYL and 4 hours observation; coughing resolved with minutes of initial reaction prior to treatment.
Information has been received from a 59 year old female with allergies to amoxicillin, naproxen (Aleve), shrimp, onion, rice, and dark chocolate who was vaccinated SC with a 0.5ml first and second dose of pneumococcal 23v polysaccharide vaccine in 1995 and 2000, respectively. Concomitant therapy included digoxin (Lanoxin), captopril, flecainide acetate (Tambocor), aspirin, simvastatin and water pills. Subsequently, after receiving two vaccines of pneumococcal 23v polysaccharide, the pt developed bronchitis. Unspecified medical attention was sought. No lab diagnostic studies were performed. At the time of the report the pt had recovered. There was no product quality complaint involved.  The pt's bronchitis was considered to be disabling. Additional information is not expected.
UTI; This is a spontaneous report from a contactable consumer or other non hcp.     A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose single for covid-19 immunisation. The patient medical history and concomitant was not reported. It was reported that, on an unspecified date, the patient experienced urinary tract infection with outcome of unknown. Therapeutic measures were taken antibiotics as a result of uti (urinary tract infection).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Erythematous papular rash over injection site - slightly pruritic is extending approximately 5 x 3 cm.
No additional AE reported; expired PNEUMOVAX 23 (pfs) was administered to a patient; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 20-JAN-2023 (reported also as "today"), the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) injection, lot # U021995 confirmed to be valid with expiration date 13-JAN-2023 (exact dose, route of administration, and anatomical location were not reported), for prophylaxis (expired product administered). The vaccine was stored according to prescribing information through the date of administration. There was no additional adverse event reported.
Spontaneous report received on 14JAN2013 from a female company employee. The female reported that she experienced a large local reaction at the injection site following immunization with BIOTHRAX. Subsequently, she recovered, but declined further immunization with BIOTHRAX due to the reaction. No further information is expected at this time.
I received the vaccine on June 13, 2021 and within 3 hours I had a red itchy rash across my abdomen. Treating with benadryl.
Tingling on the fingertips; Pain in the Shoulder; Numbness all around his Arm; This is a spontaneous report from a Pfizer sponsored program.   A contactable pharmacist reported for a 12-year-old male patient that who received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number and expiry date was unknown) via Intramuscular route of administration at Left Deltoid on an unknown date (Age at vaccination was 12-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. On an unknown date patient has a few areas of painful shoulder. He has tingling in his fingertips and his arm was numb. Outcome of the events was unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.
sick; Initial information regarding an unsolicited valid non-serious case received from a non-health care professional via social media on 22-Nov-2020.  This case involves an unknown age female patient who got sick (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, past vaccinations, family history and concomitant medications were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (illness) every time she had taken the flu shot (non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received HAV (Havrix 1440 adult) (batch number E9G4E, expiry date 29th December 2021) for prophylaxis. Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 5th January 2022, the patient received Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 5th January 2022, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: Pharmacy technician reported that the patient received expired dose of Havrix, which led to expired vaccine used. The reporter consented to follow-up.
Patient came in on 12/06/21 for his 4 months WCC and Immunizations.  Patient came in on 12/07/21 with right thigh swollen and rash all over body Patient was prescribed Prednisolone syrup  15mg/5ml--1.25 ml orally BID 5 days.  Patient came in on 12/08/21 for follow up , with mild rash on lower back, and chest and a right erythema induration less than 1 cm.
sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21-MAR-2023, the patient received Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 24-MAR-2023 The case was received from the patient via interactive digital media. The patient had the shot and had only a sore arm.  The patient had not known anyone that had it, however he/she did not want to write a review about his/her experience if he/she contracted it.  The patient stated that god bless the scientist who discovered it. The follow-up could not be possible as no contact details were available.
"74 year old female with Past Medical History DM II, ESRD on HD, hep A, HTN, HLD, presented to ER with worsening cough and fatigue. She says she completed her covid vaccination series in February 2021. She worsened over the weekend with her symptoms and wen to urgent care and was directed to ER. In the ER she has required 5-6L NC for hypoxia and she was placed on NRB therapy. She denies chest pain, palpitations, abdominal pain, constipation, diarrhea, headache, vision changes, slurred speech"
Systemic: Dizziness / Lightheadedness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: 5 min after vaccine felt hot, sweating, nausea---stated he had this reaction to flu shots in past so typically has not gotten flu shots recently--had him sit w/ head down-gave cold bottle of water he finished-took bp 123/56--put fan on him for cooling---continued to improve every 5 min-after 30 min stated he felt fine & was able to walk out of store
8/6/21: This is a 52 year old Dentist with no Past Medical History.  He is Admitted to PCU for COVID19, Multifocal Community Pneumonia, Chest Pain,  Positive D-Dimer, Elevated CPR Inflammatory, and Low-grade Fever. Patient has been sick with COVID for approximately 11 days.  Has had low-grade fevers Note: Patient previously vaccinated with Moderna COVID-19 Vaccine: First Dose: 01/28/2021 Lot Number 028L20A and Second Dose: 03/04/2021 Lot Number 011J20A. 8/11/2021: patent discharged
6/2/06 Varicella, 2 days of pruritic rash over torso, varying stages of Dev-papules, some crusted. Is recovering.
chills, fever, aches, enlarged lymph nodes, tiredness (0200-2000) 1/8/2021
Trouble Breathing, blood clot, other issues.  Next day. Spent 4 days in hospital
Pt developed sx c/w pericarditis starting 1-2 weeks prior to presentation. EKG showed junctional rhythm, he had (+) CKS and ECHO showing mild decrease EF. He responded well to pain meds and has been doing well post discharge. The hospital discharge summary received on 3/10/04 states chest pain, headache, nausea, vomiting, malaise, palpitations and myalgia.
Pt received Pfizer vaccine dose 1 at 12:05pm, immediately experienced seizure for aproximately one minute. Postictal state symptoms include agitation and confusion. At 12:20 pt is AOx4, BP 188/118, HR 116, O2sat 99% 8 LPM NRB. Pt transported via EMS to hospital to receive further care.
Patient in with reaction noted to (L) arm with redness and swelling noted, warm to touch, no pain, no itching noted, patient advised to see PCP, ASAP (area is golf ball in size). Patient advised to take BENADRYL and call PCP for appointment. No information about autoimmune disorder prior to vaccine given.
Started to get dizzy nearly immediately after vaccine. She says he barely made it home. She developed joint pain, fatigue, headache, hot sweats, nausea and vomited once, which was reported on a 3/31/2021 appointment. The next day she had improvement, but the joint pain, dizziness, and  abdominal cramping persisted. On my 4/21/2021 appt still have significant joint pain and having to stop working due to this pain.
severe joint pain & inflammation for 2wk;exhaustion, lethargy & flu like sx for 1wk;aggravation of asthma for 3-5 days
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 4:57 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 19-Nov-2021 at 4:57 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patients were given doses from vials that were stored in an ultracold freezer which was colder than should had been. Vaccine was stored in an ultra cold freezer at minus 82 degrees Farenheight. Storage condition at the time of the excursion was frozen storage and excursion duration was 1 month.   Date when vials moved from freezer to refrigerator was 19 NOV 2021 and Moderna Covid 19 vials went from the super cold freezer to the refrigerator. No vaccine state changes were noticed and vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported.  There was no concomitant list was provided by the reporter. No treatment medications were provided.   This case was linked to MOD-2021-402935 (Patient Link).
Pt sitting in lobby after vaccine administered for 20 min - pt then got hot and lightheaded transported per Doctor request to the E.R. via wheelchair.
After first shot I had tingling on the back of my tongue. It went away later that day. The second shot I had tingling later that day and had a headache but it went away the next day. April 2 woke up with tingling on my tongue and then I couldn't taste anything plus a bad headache. Around 4 pm I went to ER because my lip started to pull to the side and I still didn't have any taste and my tongue was tingling more. My lips started to feel numb along with the side of my face. I went to ER and was sent to hospital for a MRI by ambulance.I was told I have Bells Palsy and was giving steroids to take for 5 days and to see my dr.
ACUTE RESPIRATORY FAILURE 4/16/2023 BPH (BENIGN PROSTATIC HYPERPLASIA) HYPOXEMIA 4/13/2023 BPH (BENIGN PROSTATIC HYPERPLASIA) ACUTE RESPIRATORY FAILURE 4/16/2023 COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC HYPOXEMIA 4/13/2023 COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC ACUTE RESPIRATORY FAILURE 4/16/2023 CELLULITIS HYPOXEMIA 4/13/2023 CELLULITIS ACUTE RESPIRATORY FAILURE 4/16/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA HYPOXEMIA 4/13/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA
3 HOURS AFTER VACCINATION PT FELT HOT, PRURITUS AND SWELLING OVER INJECTION SITE.  HE WAS SEEN THE NEXT DAY AND TREATED WITH BENADRYL.
This spontaneous report as received from a registered nurse who was the mother of a 12 month old male patient. The patient's medical history included food protein-induced enterocolitis syndrome. No drug allergies was reported. On 08-MAY-2015, the patient was vaccinated with VARIVAX (Merck) (Lot number, dose, unit and route were unspecified). On the same day, the patient was vaccinated with M-M-R II and hepatitis a vaccine (Lot number, dose, unit and route were unspecified) and VAQTA (Lot number, dose, unit and route were unspecified). Concomitant therapies included ZANTAC and PERIACTIN. On 15-MAY-2015, 8 days after onset of therapy the patient experienced pyrexia which she treated with TYLENOL cold sweat, also her son experienced symptoms similar to his preexisting condition (food-protein-induced enterocolitis syndrome) such as diarrhea, mucusy and stringy stool. She also noted that her son has been sleepy, sweaty and clammy although the although the fever had resolved. No lab diagnostics studies were performed. The patient had called pediatrician office and sought medical attention. No product quality complaint involved. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
patient received an expired TENIVAC today, with no reported adverse event; Initial information received on 14-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP.  This case involves a 76 years old female patient who experienced patient received an expired tenivac today, with no reported adverse event after receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 14-Nov-2022, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, Suspension for injection dose 0.5 ml, lot U6852AA expiry date: 07-Oct-2022 via intramuscular route in unknown administration site for immunization (strength unknown).  On 14-Nov-2022 the patient received an expired tenivac today, with no reported adverse event (expired product administered) (latency same day).  Action taken: not applicable  It was not reported if the patient received a corrective treatment for the event   Outcome was 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 guidelines. 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.
Fatigue, low temperature (99.8), very sore arm at injection site and up to an 18? radius
? A new stroke 24 hours after receiving the second COVID-19 vaccination Moderna  On Tuesday April 6, 2021 the patient showered by himself, walked up and down stairs in the home and was able to walk with the assistance of a cane.  He received the Moderna vaccination second dose at 10:00am (I believe this was an adverse event caused by the vaccination)  Wednesday April 7th at approximately 1:30pm I noticed he was unresponsive prompting me to call 911. His MRI at Hospital clearly diagnosed him as having another stroke, causing patient to no longer walk and use the restroom without assistance.  He is still in the hospital. Hospitalization and Physical Therapy is needed to allow patient to continue practicing as an Attorney.
This spontaneous report was received from  a registered nurse and refers to a patient of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On 26-MAR-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (dose, route, lot number and expiration date were not provided). Concomitant medication was not provided. No adverse effect reported. No product quality complaint (PQC) was involved. This is one of nine reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a medical assistant referring to a patient of unspecified gender and age. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On 21-SEP-2017, an improperly stored dose of ROTATEQ 2 ml, once, lot number M045544, expiration date 23-JUN-2018 (dose, route of administration and were not reported) was administered to the patient. The dose was stored in temperature 33.8 degrees Fahrenheit for 20 minutes and in temperature 35.8 degrees Fahrenheit for 2 minutes. No previous temperature excursions were reported. No adverse effects have been reported. Data logger was involved. Product quality complaint was not involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA012899: US-009507513-1709USA012898: US-009507513-1709USA012896: US-009507513-1709USA012897.
Hives that began on groin, stomach, underwear lines, armpits, face, scalp, palms and soles and tops of hands and feet. Lasted 2 days and then became dermatographia on same areas. Still have this today.