chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Boostrix expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 13-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number c5jl7, expiry date 28th November 2021) for prophylaxis.   On 8th December 2021, the patient received the 1st dose of Boostrix. On 8th December 2021, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The medical assistant reported that, an expired dose of boostrix was given to the patient, which led to expired vaccine used. The reporter consented to follow up.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 04-AUG-2016, the patient was administered PROQUAD, subcutaneously, lot # L016394, expiry date 08-NOV-2016 (strength, dose and site of administration were not reported). The vaccine was reconstituted with an expired sterile diluent (manufacturer unknown), lot # L010589, expiry date 15-MAY-2016. Additional information has been requested.
Loose stools for 5 days following the vaccine; This is a spontaneous report from non-contactable consumer as a patient. A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: unknown) via an unspecified route of administration on 03Mar2021 at 12.30 pm in the left arm as a first dose for COVID-19 vaccination (at the age of 41-years-old). Medical history included moderate asthma and thyroid nodules. Concomitant medication was not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was at a pharmacy. Since the vaccination, the patient had not been tested for COVID-19. On 04Mar2021 at 09:15 am (following the vaccine), the patient experienced loose stools for 5 days. No therapeutic measures were taken as a result of the event. The outcome of the event was recovered on an unknown date. Information about lot/batch number cannot be obtained. No further information is expected.
Initial misuse report received from a health care professional on 28 October 2013 and at GPV on 21 March 2014. A 12-year-old patient of unknown gender had received FLUZONE ID on an unknown date. No adverse event was reported. The patient received FLUZONE ID at incorrect age. The list of documents held by sender: none
3RD DOSE COVID VACCINE GIVEN 11/15/21, LOT #30155BA;  pt to ED with SOB; O2 supplementation; had a positive COVID test on 8/18/22; tested positive as well in hospital; admitted; given Dexamethasone, Remdesivir, Albuterol Inhaler; pt is DNR without aggressive interventions; NSTEMI - heparin given; A Fibrillation with RVR - medication given; pt's condition worsened and she passed away in the hospital
New onset atrial fibrillation; Shortness of breath; Very tired; Her arm was sore; Headaches; A spontaneous report was received from a nurse concerning a 54-year-old, White, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm, headaches, atrial fibrillation, very tired, and shortness of breath.  The patient's medical history was not provided. Concomitant product use was not provided.  On 04 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) in the left arm for prophylaxis of COVID-19 infection.   On 04 Jan 2021 the patient experienced headaches after vaccination.  On 05 Jan 2021 the patient's arm was sore.  On 14 Jan 2021 at 6:00 am the patient's heart rate started at 136 and went as high as 180. She reported having heart palpitations, shortness of breath, and headaches. The patient went to the emergency room and was hospitalized for 14 hours. She was diagnosed with new onset of atrial fibrillation. While in the hospital she was started on a Diltiazem and Heparin.   On 17 Jan 2021, the patient reported she was now in sinus rhythm but was very tired. Her cardiologist prescribed Rivaroxaban and Metoprolol.   Action taken with mRNA-1273 in response to the events was not provided.   The events, sore arm, headaches, atrial fibrillation, and shortness of breath, were unknown. The event, very tired, was considered not resolved.; Reporter's Comments: This case concerns a 54 years old female patient, who experienced a serious unexpected event of atrial fibrillation and non-serious unexpected event of dyspnea, and non- serious expected event of injection site pain, fatigue and headache. The event of headache occurred 1 days after first dose of mRNA-1273, lot # 039K20A. The event of injection site pain occurred 2 days after first dose of mRNA-1273, lot # 039K20A. The event of atrial fibrillation, dyspnoea, and fatigue occurred 11 days after the first dose of mRNA-1273, lot # 039K20A. Treatment included Cardizem drip, heparin, Xarelto and Lopressor. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Pregnant female (approximately 2 months) given 1/2 dose of nasal flu vaccine prior to nurse noting that recipient pregnant. Flu immunization completed with approved for pregnant women vaccine.
A report was received from a health professional on 10/10/01, concerning a 64 year old male patient who experienced chest pains, dizziness and headache immediately after receiving Fluvirin vaccine on 10/05/98. The events resolved 24 hours later. There was insufficient information to determine the reporter's causality assessment.
Red rash; Raised rash; Viral rash; Painful rash; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of RASH ERYTHEMATOUS (Red rash), RASH PAPULAR (Raised rash), VIRAL RASH (Viral rash) and RASH (Painful rash) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Red rash), RASH PAPULAR (Raised rash), VIRAL RASH (Viral rash) and RASH (Painful rash). The patient was treated with PREDNISONE (oral) for Symptomatic treatment, at a dose of Took it for 2 days. In February 2021, VIRAL RASH (Viral rash) and RASH (Painful rash) had resolved. At the time of the report, RASH ERYTHEMATOUS (Red rash) and RASH PAPULAR (Raised rash) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: inconclusive (Inconclusive) Biopsy which showed viral rash.     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.   Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: No newinformation was provided.
Forty hrs post vaccine (DTaP), left thigh swelling, erythema, very warm to touch extending over full antero-lat thigh and very tender.
Severe injection site pain. Generalized body aches. Loss of appetite. Head ache. Nausea. Fatigue. Chills without  fever. Started a few hours after injection with arm pain. Next day all symptoms kept me from working. Following day symptoms seem to be fading.
Patient presented with rash on 6/13/13 on back of left shoulder. Approx 5 inches by 4 inches. Patient said no pain associated w/rash. Mild itching. Told to use diphenhydramine cream by pharmacist.
Patient stated that she became very nauseated in the middle of the night. She was short of breathe and her chest was  tighten. This only lasted for a few seconds, After that patient went in to a sweat. Caused a lot of tension in the back of the neck.
pt recv vax 350PM & returned to office 640PM saem day covered w/large hives & itching;no breathing diff noted;
Patient states that after receiving the vaccine later that night, he started experiencing cold; shivering and went to bed early. The next morning he woke up experiencing dizziness and could not function. He was very thirsty, he drunk 10 glasses of water and felt very sick and his stomach could not digest water. He states he was experiencing intense sweats, very warm and very cold, tension in the head, feeling dizzy, coughing and loss of appetite in the past 4 - 5 days. Patient states that last night he was cold and had 2 - 3 layers of clothes and a blanket. He went to see his PCP for the severe thirst and they ran blood work. The results of this blood work are still pending as of this morning of 10/23/18 and patient stated feeling better today.
improperly stored administered ROTATEQ; This spontaneous report as received from a consumer referring to a female patient of unknown age.   Information of the patients' pertinent medical history, concomitant medications, concurrent conditions, and drug reactions or allergies were not reported.   On 20-JUN-2023, a rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot number 1968385, which had been verified to be a valid lot number for this vaccine, with an expiration date reported and upon internal validation established as 22-MAY-2024) experienced a temperature excursion of 34.9 degrees Fahrenheit (F) for 6 hours and 34 minutes. On 03-JUL-2023, the vaccine experienced a temperature excursion of 51.4 F for 7 hours and 33 minutes. On 04-JUL-2023, the vaccine experienced another temperature excursion of 51.1 F for 24 hours; and on 05-JUL-2023, another one of 50.7 F for 9 hours and 27 minutes.    On 07-JUL-2023, the patient was vaccinated with an improperly stored (product storage error) of the previously mentioned rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 2 mL (indication, strength, frequency, and route of administration were not provided).
Shortness of breath; Fast heart rate; blood pressure was at 180; chest flushed; started to feel funny; A spontaneous report was received from a consumer concerning a female patient of unknown age ,who was administered with Moderna's covid-19 vaccine and experienced faster heart rate,increased blood pressure at 180,shortness of breath,chest flushing,feeling funny and pale look.  Parient's medical history was not provided.No relevant concomitant medications were mentioned.  On 21-JAN-2021,prior to the onset of events,the patient received the first of two planned doses of mRNA-1273(Lot number:unknown)for prophylaxis of covid-19 infection.  On 21-JAN-2021,after administering mRNA-1273 vaccine ,the patient was told to sit down to be monitored for 15 minutes.After 3 minutes,patient started feeling funny.Patient started to feel heart pound out of chest and going really fast along with shortnes  of breath.Nurse told the patient that she looked pale and her chest was flushed.After an hour and half of monitoring blood pressure and heart went down.Patient scheduled for second dose on 15-FEB-2021.Patient was put on oxygen by nurse ,after an hour heart rate and blood pressure went down.  There was no change planned to the dosing schedule of mRNA-1273 in response to the events.  Outcome of events were considered unknown.
In July, my wife noticed my face was drooping. I thought I had  stroke. On 8/20/2021 - I went to the General Hospital ER and found out it was Bells Palsy on the right side of face.  Treatment -aspirin; Methylprednisolone;  Vaclyclovir - I'm finished with that. Now taking aspirin and Ibuprofen for keeping the swelling down. I'm still in process of recovering. Still have it.
The patient received the COVID-19 vaccine at 11:26.  Within 15 minutes, the patient developed light-headedness, chills, shortness of breath, palpations, diaphoresis, and chest pain (described as "pressure on chest").  She was sent to the emergency department for observation/treatment.  In the emergency department, she received diphenhydramine 25 mg IV push at 12:58.  She was discharged to home at 1417 after it was determined she was stable.
fever on the lt thigh;redness on inj site next day child was in crib unconscious fix eyes;pt very cold like died mom reports;had were like cripple;no cry;
cardiac arrest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2021SA394468 (Sanofi).  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC ARREST (death, medically significant), outcome "fatal", described as "cardiac arrest". The patient date of death was unknown. The reported cause of death was cardiac arrest. It was not reported if an autopsy was performed. The clinical course was reported as follows: To prevent one covid-19 related death, Pfizer admits their vaccine kills at least three people by causing cardiac arrest.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101767784 same reporter/drug/event, different patients;US-PFIZER INC-202101767783 same reporter/drug/event, different patients; Reported Cause(s) of Death: cardiac arrest
Patient informed me that she had previously fainted due to vaccination. I told her that she would have to remain seated for a minimum of 15 minutes after vaccination in the vaccination area and be monitored closely. She agreed and decided to go ahead with the injection. I cleaned her arm and placed a barrier bandage on her arm then injected a dose of Fluzone Quad vaccine into her left arm. Within 20 seconds she had lost color in her face and asked to lie down. She was turned on her left side across the chairs by myself and her boyfriend and then both arms and both legs and her neck became very stiff and patient was unresponsive to voice and touch stimulation for about 15 seconds. After the stiffness occurred, her boyfriend called emergency services and Ambulance service was dispatched to the store about 10 minutes later. The EMT took patient's vital signs (pulse, blood pressure)  and also her blood sugar. Patient asked for a cold pack because she said it sometimes helps her after this type of reaction and she was provided an instant cold pack by the EMT.  The EMT recommended that patient be transported to the hospital by ambulance or private vehicle due to low blood pressure (93/64 and 110/64 ) to be carefully watched until full recovery. Patient declined to be transported and left the store with her boyfriend about 12:15 PM.
Severe flare of multiple sclerosis symptoms. Has lasted five weeks so far.  Neurologist says many complaints from other patients,  post-vaccine.
Inadvertent administration.  Novavax only authorized as a 1st booster dose, and patient has already received booster dose.
Chills; Fever; achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 28Feb2021 as dose 2, single (Lot number: EN6201) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pacemaker" (unspecified if ongoing), notes: Eliquis: been taking this for years, she has a pacemaker. If stopped or ongoing unknown; "Heart medication" (unspecified if ongoing); "plaque" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: COVID in the very beginning. Concomitant medication(s) included: ATORVASTATIN taken for oropharyngeal plaque; ELIQUIS taken for cardiac disorder; LOSARTAN taken for cardiac disorder; SYNTHROID taken for cardiac disorder. Vaccination history included: BNT162b2 (Dose-1, Lot: EL9265, NDC/Expiry: Unknown, not on the CDC Vaccine record card., Dose: Unknown strength/volume/dose injection to right arm), administration date: 07Feb2021, when the patient was 72-year-old, for Covid-19 immunization, reaction(s): "Chills", "Fever", "Achy". The following information was reported: CHILLS (non-serious), outcome "recovered"; PYREXIA (non-serious), outcome "recovered", described as "Fever"; PAIN (non-serious), outcome "recovered", described as "achy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, pain.  Additional information: With the first 2 doses she was achy, had chills, fever for about 24 hours.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201279824 Same patient, different dose, different AE;US-PFIZER INC-202201279870 Same patient, different dose, different AE;US-PFIZER INC-202201279869 Same patient, different dose, different AE;
Systemic: Tinnitus-Medium, Additional Details: pt noticed a couple days after recieving 2nd dose that his ear started ringing and was a little hard of hearing. he had a headache for a couple days. describes the sensation as constantly hearing quiet \"cricket\" sounds. he first noticed when tying to talk on the phone and had a hard time hearing. pt unsure if due to shot but will be following up with provider
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 30-MAR-2017, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # M036056 with expiry date 18-MAY-2019 (exact dose and route of administration were not reported). The dose was exposed to the temperature between -3 and 0 degrees Celsius for 4 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA002166: US-009507513-1704USA003054: US-009507513-1704USA003052:
The headaches began in the fall of 2003, but I did not directly associate them to my last vaccination until much later.  I am not sure if they are directly related.
Body aches at 9:00am Chills at 9:00 am  Headaches at 9:35 am Stuffy nose 11:00 am Fever of 100.5 at 1:00pm Last from 12/22/2020 - 12/24/2020
This spontaneous report as received from a nurse refers to unknown number patients of unknown age and gender. The nurse reported that an unknown number of doses of ROTATEQ (dose and lot# not reported) that were improperly stored (outside of the range specified in the prescribing information) might have been administered oral. ROTATEQ was exposed to 30F then 48F for 72 hours. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Within 2 hours of injection severe fatigue, diffuse aching and painful lt shoulder, left neck and left scapular muscles. Pain and fatigue persisted 24 hours. Had to go to bed at 7pm day of shot due to fatigue no fever.
This spontaneous report as received from a medical assistant refers to a 13 years old female patient with no pertinent medical history and no drug reactions or allergies who on 23-APR-2012 was vaccinated with the first 0.5 ml dose of GARDASIL intramuscularly (lot number not reported) and on 26-JUN-2012, was vaccinated with the second 0.5 ml dose of GARDASIL intramuscularly (lot number not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on 29-JUN-2012, the patient developed swelling on her lips. No lab diagnostics studies were performed. No treatment was given for the experience. The patient recovered on an unspecified date. It was stated that on 29-JUN-2012, he patient was seen in the office and the physician did not feel that the reaction was due to GARDASIL. The medical assistant added that the patient did not experience any adverse effects after receiving the first dose of GARDASIL. Additional information has been requested.
Moderate generalized joint pain that affected functional activity, requiring medication of tylenol 500mg po and then ibuprofen 400mg po that finally relieved symptoms temporarily. The joint pain lasted for approximately 36 hours.
Can't lift arm. Severe pain in arm when moving across chest.Pain started about 3 days after shot. Pain in shoulder.
Systemic: Flushed / Sweating-Mild, Additional Details: Patient had a syncope for a few seconds, due to nerveousness on the new vaccine.  Patient laid on the floor and felt better afterward.  The ambulance came into the store and checked on the patient.  He was fine when the ambulance arrived and denied medical service.
inject site & surrounding area red & swollen, hot to touch, tx Advil PRN & Duriced 250mg BID x 10d to prevent infection;
Pt presented to office 5/17/2000 with a 11 cm x 8 cm bright red, indurated area right upper arm extending downward toward elbow. Arm was hot to touch. Dx'd with cellulitis. Treatment Augmentin.
Zoe's symptoms started 5pm on 8/16/16 same day as vaccine was given. First she felt dizzy and was light sensitive-she felt a headache coming on. Then feeling of chills and fever, but was afebrile. When she woke up the next morning she started with headache 7/10, light sensitivity and sore throat. Zoe took MOTRIN and TYLENOL, pushed fluids but no relief from headache. Symptoms continued into 08/18/16-same symptoms as stated above. Headache did not resolve till 8/19/16.
Received a dose from a vial that was expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a dose from a vial that was expired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a dose from a vial that was expired). On 22-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received a dose from a vial that was expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.
Infection; This is spontaneous report received from a contactable consumer (parent). A 17-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: RN6202; Expiration Date: 30Jun2021), via an unspecified route of administration on 28Feb2021 at a single dose for COVID-19 immunization. Medical history included asthma. The patient's concomitant medications were not reported. Parent of the patient stated that the patient received first dose of the Pfizer BioNTech covid vaccine on 28Feb2021 (lot number: RN6202 expiry date 30Jun2021) when she was 16 and she's 17 now. Patient had an infection on an unspecified date in 2021 and was taking 5 days of prednisone. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.