chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered outside of allowed storage and handling guidelines; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered outside of allowed storage and handling guidelines) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered outside of allowed storage and handling guidelines). On 27-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered outside of allowed storage and handling guidelines) 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.   Concomitant medications details was not reported by the reporter. Treatment details was not reported by the reporter.
05/04/05- Mother reported child had red, golf ball size swelling on right upper arm. First seen 05/03/05. Initially some fever. None today. Aches and tender to touch. Mother stated she would take child to MD. Unable to contact to verify.
Initial unsolicited report received from a Consumer on 02 September 2015. This case involves a 36-year-old female patient, who had received first dose of Imovax (batch number, route and site of administration were not reported) and a dose of IMMUNOGLOBULIN HUMAN ANTIRABIES (RIG) (batch number, route and site of administration were not reported) on 19 August 2015. It was reported that patient also received second dose (day 3) dose of Imovax polio on 22 August 2015 and third dose (day 7) on 26 August 2015. Illness at time of vaccination was reported that patient had exposure to bat in her house (non bite). Pre-existing physician diagnosed allergies, birth defects, medical conditions were provided as that patient was scheduled for In vitro fertilization or fertilization (IVF) in next week. Other medical history and concomitant medications were not reported. On 21 August 2015, 2 days after vaccination patient experienced tingling in her fingers and toes. Laboratory investigations and corrective treatments were not reported. Patient continues experience tingling in fingers and toes after the vaccination. Hence patient was not recovered from the event. Documents held by sender: none.
Had synovitis secondary to the Moderna COVID19 vaccine; A spontaneous report was received from a pharmacist concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced synovitis.  The patient's medical history, as provided by the reporter, included had 2 artificial knees. No relevant concomitant medications were reported.  On an unspecified date, the patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On an unspecified date, the patient experienced synovitis secondary to the Moderna COVID19 vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, synovitis secondary to the Moderna COVID19 vaccine was not reported.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Critical details such as the dosing date, onset date of the event is lacking. The patient's has a significant history of  2 artificial knees. Further information has been requested.
This spontaneous report as received from a registered nurse refers to a 5 year old patient. The medical history, concurrent conditions and concomitant medications were not reported. On 28-OCT-2016 the patient was vaccinated with improperly stored PROQUAD lot # M032497 22-Jan-2018. No adverse effects were reported. Additional information has been requested.
The patient said that her doctor told her she has small fiber neuropathy ever since the Moderna  vaccine that we gave her on 6/14/21. She has nerve pain (tingling, shock type pain) all over her body including arms and legs. Her doctors recently linked the neuropathy pain to the Moderna shot she got a couple years ago. She has been seeing multiple doctors for the treatment of the neuropathy, and this is still an ongoing problem.
CHEST PAIN; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received 2 doses of BNT 162 (Dose number in series 1)(suspension for injection, route of admin and batch number were not reported) dose was not reported, start therapy date were not reported for prophylactic vaccination. After Pfizer doses, the patient had Chest pain and difficulty in breathing for about one week. The patient parent's were both physicians and they suspected that he had myocarditis from Pfizer vaccine but diagnosis was not confirmed. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Janssen, dose number in series 2)(suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 24-DEC-2021 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 24-DEC-2021, within 5 hours of booster dose, the patient experienced chest pain again. They did not seek medical attention this was based off their own clinical judgment, they were monitoring him at home. (Dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chest pain was not reported. This report was non-serious.
One spot on lower leg; New spot /wondered if booster covid caused the spot on lower left leg; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (One spot on lower leg) and SKIN DISORDER (New spot /wondered if booster covid caused the spot on lower left leg) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2022, the patient experienced SKIN DISORDER (New spot /wondered if booster covid caused the spot on lower left leg). On an unknown date, the patient experienced SKIN DISORDER (One spot on lower leg). At the time of the report, SKIN DISORDER (One spot on lower leg) had resolved and SKIN DISORDER (New spot /wondered if booster covid caused the spot on lower left leg) had not resolved. Not Provided    No concomitant medications were reported. Patient had one spot on his lower left leg that had come back within the last 6 weeks.Patient did not knew this but would like to know the answer of whether the COVID booster caused the spot to come back. It was unknown if patient was enrolled in a COVID-19 Vaccine trial. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Pain at injection site began as mild pain, progressed to moderate and severe pain that lasted from about 2 hours after injection on 03Dec2018 until 11am on 05Dec2016. Also experienced, fever that rose on 03Dec2018 to 99.8 by 7pm. Then 102.4 at 2:30am and 104.2 at 4:45am, and 101.8 at 8:24am on (04Dec2018), gradually reducing to a temperature of 97.6 by 6:00pm on 04Dec2018.  As of 05Dec2018 temperature remains normal. Adverse symptoms that also occurred were headache, fatigue, nausea, and loss of appetite. Took extra strength Excedrin for fever and pain throughout the day on 03Dec and 04Dec2018, and maintained clear fluid intake. All AE's resolved as of 05Dec18. No intervention other than self care needed.
This spontaneous report was received from a nurse refers to currently 9-year-old patient. The patient's concurrent conditions, medical history and drug reactions and allergies was unknown. The patient's concomitant therapies included sterile diluents. On 20-FEB-2018, the patient was vaccinated with improperly stored the patient was vaccinated with improperly stored VARIVAX (Lot # N012619 and expiration date 21-APR-2019), (Lot # N025932 and expiration date 19-SEP-2019) for prophylaxis. The nurse stated that she has spoken to someone at Merck who determined that VARIVAX (lot # N012619) could still be used. Temperature excursion details were provided. Temperature/Time frame was -14 degree Celsius to -10 degree Celsius (-14.3 degree Celsius) for 1 hour 6 minutes. There were no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported. This is one of the six reports linked via same reporter link. Sender's Comments: US-009507513-1802USA007855.
Morbilliform, itchy rash all over his body starting 10 days after his 3rd Covid booster vaccine
Left side neck & jaw lymphadenopathy and swelling; Left side neck & jaw lymphadenopathy and swelling; Left side neck & jaw lymphadenopathy and swelling; This is a spontaneous report from a contactable consumer (patient). A 54-years-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number not reported, patient was not pregnant and 54-years-old at the time of vaccination), via an unspecified route of administration in Arm Left on 01Mar2021 at 15:00 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced left side neck & jaw lymphadenopathy and swelling. reported that patient not received other vaccine in four weeks, reported that left arm injection site is normal, no treatment received for AE. Patient had not COVID prior vaccination and not tested COVID post vaccination. Reported that NKDA (No Known Drug Allergy). The outcome of reported events was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
only 1- 1 1/2cm lump under skin;no bruise or discoloration or other reactions noted;
rt arm inj site red, warm, swollen, stiffness in neck;mobility dec;
Sensitive to the touch; Arm of injection was very sore days 2-4; vaccination site erythema; Injection site is red, warm, and swollen days 2-4, still a little red and swollen today, but improving; Injection site is red, warm, and swollen days 2-4, still a little red and swollen today, but improving; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Oct2021 10:30 (Lot number: EW0217) at the age of 52 years as dose 3 (booster), single. for covid-19 immunisation; influenza vaccine (FLU), administration date 27Oct2021 (Batch/Lot number: unknown) as unk, single. Relevant medical history included: "Congestive heart failure" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "polyarthralgia" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE; PREGABALIN; TORSEMIDE; METOPROLOL; ASPIRIN [ACETYLSALICYLIC ACID]; CYCLOBENZAPRINE; FELDENE; VITAMIN D2. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9269, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM, Route of Administration: Intramuscular), administration date: 17Feb2021, when the patient was 52 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318, Location of injection: Arm Right, Vaccine Administration Time: 06:00 PM, Route of Administration: Intramuscular), administration date: 27Jan2021, when the patient was 52 years old, for Covid-19 immunization. The following information was reported: SENSITIVE SKIN (non-serious) with onset 28Oct2021 12:00, outcome "recovered" (Oct2021), described as "Sensitive to the touch"; VACCINATION SITE PAIN (non-serious) with onset 28Oct2021 12:00, outcome "recovered" (Oct2021), described as "Arm of injection was very sore days 2-4"; VACCINATION SITE ERYTHEMA (non-serious) with onset 28Oct2021 12:00, outcome "recovered" (Oct2021), described as "vaccination site erythema"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 28Oct2021 12:00, outcome "recovered" (Oct2021) and all described as "Injection site is red, warm, and swollen days 2-4, still a little red and swollen today, but improving". Therapeutic measures were not taken as a result of sensitive skin, vaccination site pain, vaccination site erythema, vaccination site warmth, vaccination site swelling.  Additional Information: No other vaccine in four weeks. No Covid prior vaccination. Covid not tested post vaccination. No known Allergies.   No follow-up attempts are possible. No further information is expected.
pt recv vax 16DEC97 & approx 2wk p/later 29DEC97 pt devel thrombocytopenia;
This study was received from the investigator on 21 November 2011. A 24 year-old male subject with a history of high blood pressure and a family history of elevated cholesterol and DM (diabetes mellitus) was found to have an chest pain, unspecified 11 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 18 March 2009. The subject was evaluated in the ER (emergency room) and was hospitalized (dates not reported). The subject's discharge diagnosis was myocarditis. Relevant laboratory data on 29 March 2009 included: an abnormal Troponin I with the highest recorded value of 6.19, a normal ECG and a normal Echocardiogram. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Information has been received from a RN and mother concerning a 15 month old well appearing white male with a sulfa allergy who on 01/13/04, at 11:00 was vaccinated SQ in the thigh with the 1st dose of varicella virus vaccine, live. Concomitant medications on that same day  and time included the 1st  dose SQ in the thigh of the MMR, and the 4th dose IM in the thigh of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine (crm197) (Prevnar). There was no illness or other concomitant therapy at the time of vaccination. The RN reported that on 04/16/04 (also reported by the pt mother as 02/2004), the pt developed a rash characterized by papules on the back of both hands and face. On 04/17/04, the pt presented to an MD with a papular rash suggestive of chickenpox. The pt was treated with diphenhydramine hydrochloride (Benadryl), PRN and was instructed to follow up with the pediatrician as needed. Subsequently, the pt recovered. The pt's mother also reported her other son also  developed chicken pox after being vaccianted with varicella virus vaccine, live. (WAES#0405USA01245). Additional information is not expected.
No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
pt left clinic c/o eyes watery & red face & sneezing;went to MD was given 2 shots
Pt was given the second shot 10 days later instead of 28 days apart. pt reported having 24 hours of the side effects associated with vaccine--fever, chills, aches, headaches.
patient received the vaccine janssen  at 2:12 pm . At 2:13 pm patient complaint of experiencing dizziness , nausea, sweating , blurry vision  dry mouth , difficulty swallowing saliva . per Dr order administer the Epi-pen . 911 was called . Paramedics  transport patient to the nearest hospital
Anomia; Elevated heart rate/felt like it got to over 100; Tachycardia; Paroxysmal atrial tachycardia (PAT); Uncomfortable feeling on the nervous system, like it's overactivated; Adrenaline feeling/hormonal or neuorchemical feeling; Brain fog; Tingling in the mouth; Feel so tired, and is having a hard time sleeping; Feel so tired, and is having a hard time sleeping; Arm sore; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of APHASIA (Anomia), HEART RATE INCREASED (Elevated heart rate/felt like it got to over 100), TACHYCARDIA (Tachycardia), ATRIAL TACHYCARDIA (Paroxysmal atrial tachycardia (PAT)) and NERVOUS SYSTEM DISORDER (Uncomfortable feeling on the nervous system, like it's overactivated) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced APHASIA (Anomia), HEART RATE INCREASED (Elevated heart rate/felt like it got to over 100), TACHYCARDIA (Tachycardia), ATRIAL TACHYCARDIA (Paroxysmal atrial tachycardia (PAT)), NERVOUS SYSTEM DISORDER (Uncomfortable feeling on the nervous system, like it's overactivated), FEELING ABNORMAL (Adrenaline feeling/hormonal or neuorchemical feeling), FEELING ABNORMAL (Brain fog), PARAESTHESIA ORAL (Tingling in the mouth), INSOMNIA (Feel so tired, and is having a hard time sleeping), FATIGUE (Feel so tired, and is having a hard time sleeping) and VACCINATION SITE PAIN (Arm sore). At the time of the report, APHASIA (Anomia), HEART RATE INCREASED (Elevated heart rate/felt like it got to over 100), TACHYCARDIA (Tachycardia), ATRIAL TACHYCARDIA (Paroxysmal atrial tachycardia (PAT)), NERVOUS SYSTEM DISORDER (Uncomfortable feeling on the nervous system, like it's overactivated), FEELING ABNORMAL (Adrenaline feeling/hormonal or neuorchemical feeling), FEELING ABNORMAL (Brain fog), PARAESTHESIA ORAL (Tingling in the mouth), INSOMNIA (Feel so tired, and is having a hard time sleeping), FATIGUE (Feel so tired, and is having a hard time sleeping) and VACCINATION SITE PAIN (Arm sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Heart rate: 125 (High) heart rate was 125 bpm. On 27-Feb-2021, Antinuclear antibody: positive (High) Positive ANA so high, highest possible..     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment includes Cold showers, Compression stocking, Fluid intake.
woke up on second day post vaccine with mild spotting of blood from vagina. Period is not due for another 2 weeks. Also, not pregnant, currently abstinent for 5 months
Rapid heart rate, felt like throat was closing, cold sweat (clothes were wet), Faintlike with black spots  obscuring  vision, ears ringing,nausea, dry heeves,  lasted 10-15 minutes, subsided as I was getting ready to go to ED.  Post episode, shaky, headache, standard flu like symptoms for the day.
Awakened to painful, swollen upper lip. Prednisone and Benadryl taken, symptoms subsided before noon. Developed a light rash to both legs later in the evening. Woke early in the morning with swollen lower lip and hives on abdomen and back, very itchy. More prednisone and benadryl taken. Continued to take low dose prednisone for several days. Reported to nurse on 9/27/21. Reported at doctor visit on 10/5/21, asymptomatic at that point.
pt recv vax 31AUG96 & lab eval on 28MAR97 revealed vaccine failure (negative rubella titer);
I got my 2nd vaccine on 4/30/21 at 10:45 AM.  By 6:00 PM I was dizzy and lightheaded.  I am now on day 5 and still am experiencing these symptoms.  I have been drinking plenty of liquids and eating fine.
Immediately after immunization patient began to feel lightheaded and dizzy and had a strange taste in her mouth.  25 mg of Diphenhyramine was administered by patient as she was alert.  Patient continued to feel ill and fainted.  EMS was called and presented to determine the patients blood pressure was low.
Rigors, Paroxysmal nocturnal dyspnea, Shortness of breath, fatigue - lasted approx 36 hours
Eye swelling; Swelling around his right eye; This case was reported by a physician via call center representative and described the occurrence of eye swelling in a 2-year-old male patient who received Flu Seasonal QIV  (FluLaval Quadrivalent 2021-2022 season) (batch number 2579B, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included FluLaval Quadrivalent (received 1st dose on an unknown date) and FluLaval Quadrivalent (received 2nd dose on an unknown date). Concurrent medical conditions included ear infection (the patient had a ear infection prior to and at the time of the vaccine).   On 3rd January 2022, the patient received the 3rd dose of FluLaval Quadrivalent 2021-2022 season (intramuscular) .5 ml and Flulaval Tetra Pre-Filled Syringe Device. On 3rd January 2022, 5 hrs after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced eye swelling and periocular swelling. In January 2022, the outcome of the eye swelling was recovered/resolved. On an unknown date, the outcome of the periocular swelling was unknown.   It was unknown if the reporter considered the eye swelling and periocular swelling to be related to FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. 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 reported as follows: The case was reported by pediatrician. The patient received the Flulaval in his right thigh.  The reporter reported that the patient received 3rd flu vaccine given over the past 3 flu seasons.  The reporter reported that after receiving Flulaval, the patient developed swelling around his right eye.  The reporter reported that the patient also had an ear infection prior to and at the time of the vaccine that might had caused the eye swelling.  The reporter did not consent to follow up. This case had been linked to the case US2022002796, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022002796:same reporter
Information has been received from a physician concerning a female patient who on an unknown date was vaccinated with a dose of Gardasil.  Subsequently, the patient experienced a coma and is now paralyzed.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Upon internal review, coma and paralyzed were determined to be other important medical events.