chrisvoncsefalvay/vaers-outcomes huggingface dataset:
08/07/05 Raised red rash started to appear.  08/08/05 Rash had spread to entire trunk and extremities, no fever. Rash itches.  08/08/05 Seen by doctor - he feels not related to immunizations
This spontaneous report was received from a Registered  Nurse referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not reported. On 26-FEB-2016, the patient was vaccinated with an improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of VAQTA (lot # L023232 and expiration date: 25-FEB-2017 (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Vomiting, diarrhea, low blood pressure. Someone "said this was a seizure" family did not take her to ER.
This spontaneous report as received from a nurse refers to a patients of unknown age and gender. A nurse reported that an unspecified number of unknown patients have been administered doses of ROTATEQ, oral, lot # I009745, expiration date 17-FEB-2016, orally that was stored at both 47.1 Fahrenheit degrees for 96 hours and -5 Celsius degrees for 48 hours. ROTATEQ lot # K009745 was given on 14-NOV-2014, 24-NOV-2014 and 20-JAN-2015. No adverse effects reported. Additional information has been requested. This is one of several reports received from the same reporter.
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.) and EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.) in a 59-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.). In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.) and EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant product was provided by the reporter. No treatment medication was provided. The Nurse reports no adverse reactions or side effects to the Moderna Covid-19 vaccine. The temperature excursions occurred on 4-MAR2-022, 5-MAR-2022, 7-MAR-2022, 8-MAR-2022, 9-MAR-2022, and 10-MAR-2022. It was reported that the vial was moved to refrigerator on 03-Mar-2022. Proposed desired use by date was reported to be on 16-Mar-2022.
Flu-like with diffuse aches (mostly musculoskeletal about lower back and joints) and tiredness and myalgia  Lasted 24 hours
Patient c/o "tightness in chest" denies SOB. Patient stated that drinking water help her feel better. V/S stable obtain EKG NSR patient was release in stable condition by MD onsite.
Vasovagal response with near syncope. After injection, patient with nearly immediate dizziness, lightheaded, feeling of near fainting, nausea. Given water, snack. Vitals stable. Laid patient down with feet elevated on chair. Ice pack to back of neck and cool compress to forehead. Denied any SOB, chest discomfort, or difficulty breathing at any point. Had marked improvement of symptoms except remaining lightheaded/dizzy feeling. Observed total of 60 min then discharged to home with daughter as driver. Instructed not to drive and to seek emergency medical attention if symptoms worsened at home.
administer an expired adacel with no reported adverse event; Initial information received on 06-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 year old female patient and reporter reported that an expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI)  and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Prophylactic vaccination.  On 06-Jun-2023, the patient received a dose 1 at a dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE suspension for injection (Strength: Standard and expiry date: 10-May-2023, lot C5882AA) via intramuscular route in unknown administration site for Immunization and administer an expired vaccine with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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.
Confusion, Dizziness, Headache, Dizziness and confusionX 24H, H/A lasted 5 days Narrative:
muscle aches; extremities cold; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle aches) and PERIPHERAL COLDNESS (extremities cold) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle aches) and PERIPHERAL COLDNESS (extremities cold). At the time of the report, MYALGIA (muscle aches) and PERIPHERAL COLDNESS (extremities cold) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
Narrative: 13:30 After Patient received Covid 19 shot, he started complaining of dizziness and nausea. Pt remained AAOx4, appeared diaphoretic and pale. He denied having any chest pain, shortness of breath. Charge nurse was notified, Vital signs obtained: B/P 78/43 pulse 47 and spo2 97%RA. 13:22 Rapid response called. 13:36 Pt sitting in chair, remains AAOX4. Nursing staff and wife at side. Pt reports dizziness, lightheadedness, nausea. Denes chest pain, sob, difficulty breathing. Rapid response respiratory team arrived B/P rechecked: 91/54, pulse 56, spo2 98%RA. Pt reports he feels a little bit better. Report given to RRT nurse. Pt assessed by the RRT team and was advised to go to the ER. Patient was hesitant to go but his wife encouraged him to go and he agreed to . Patient taken to the ER via wheelchair by RRT team nursing staff. Care relinquished to RRT team nursing staff.
Patient's mom stated he ran a fever of 103.9 last night and was nauseated. The fever came down with Ibuprofen and Tylenol but he was still nauseated this AM, got up and threw up and then went back to bed. She hasn't checked his temp this AM but he did say he felt better.
Chills, Nausea, Dizziness, Headache, and Upset Stomach. Most symptoms went away within 36 hours. Took tylenol for headache and chills.
Itchy rash started in legs on 2/18/15 after 2nd dose. Rash has spread to arms and chest.
Only side effect that she got that's on her arm; This is a spontaneous report from a contactable consumer (patient's sister). This is the second case out of two cases.  A female patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The reporter stated her sister got her vaccine at her hospital and also side effects was ''on the arm'' (not clarified). She got this shot in ''the organ'' (not clarified), also had ''organ'' (not clarified). The only side effect that she got that's on her arm. Outcome was unknown. Information on Lot/Batch number has been requested.
Patient noted hives on his chest and abdomen and inner thighs on 12/28/09. Pt self treated with OTC calamine lotion and hives lasted less than 24 hours, pt could not recall exact time.
This case was reported by a nurse via sales rep and described the occurrence of shortness of breath in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included FLUARIX QUADRIVALENT for prophylaxis and PNEUMOVAX 23 for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX, FLUARIX QUADRIVALENT and PNEUMOVAX 23. In September 2018, less than a day after receiving SHINGRIX and FLUARIX QUADRIVALENT, the patient experienced shortness of breath, cold sweat, tremor and drug interaction. On an unknown date, the outcome of the shortness of breath, cold sweat, tremor and drug interaction were unknown. The reporter considered the shortness of breath, cold sweat, tremor and drug interaction to be related to SHINGRIX and FLUARIX QUADRIVALENT. Additional details were provided as follows: In September 2018, the patient received administered influenza vaccine (brand or manufacturer unknown, dose unknown) and PNEUMOVAX-23 at the same time as SHINGRIX (co-administered during same office visit). In the same evening after receiving the SHINGRIX, influenza vaccine, and PNEUMOVAX-23, the patient went to the emergency room with symptoms of shortness of breath, cold sweats, and shaking really bad. The emergency room health care professional was caring for her told her that the reactions were due to her receiving all 3 vaccines at the same time. On the date of reporting, the outcomes of the reactions are unknown. The reporter considered the shortness of breath, cold sweat, tremor and drug interaction to be related to PNEUMOVAX 23.
Pt had facial swelling/eyes almost swollen shut. Treated at hospital with BENADRYL. Pt treated for next 24 hrs with scheduled BENADRYL.
Pfizer vaccine was diluted prior to administration of 0.3 mL IM dose, but was realized after dose provided to patient the insufficient diluent amount was used. Vaccine vial was mistakenly diluted with 0.8 mL rather than advised 1.8 mL, therefore patient received more potent dose. Pt was informed of this discrepancy, she completed 30 min wait after dose without any adverse reaction in office setting. Provider was informed of dosing error as well. Pt did report next day having soreness to injection site area, body aches, fever, lump in axilla-this persisted for about 48 hrs then resolved. Home care measures were reviewed/advised. Upon already scheduled follow up with provider 8/19/21 (appt for other reason) patient had recovered fine.
New onset seizure activity diagnosed in month of July while patient at home with family.; EEG demonstrated "focal" seizure activity.; This is a spontaneous report from a contactable physician. A 85-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot Number: IR8731)via intramuscular, route of administration, administered in left arm on 01Apr2021 at 10:00  as Dose 1,Single for COVID-19 immunization. Medical history included high blood pressure, a fib (Atrial fibrillation), high cholesterol, TVAR (Transcatheter aortic valve implantation), hx CHF (cardiac failure congestive), seizures and anxiety from an unknown date and unknown if ongoing. Concomitant medications included metoprolol (METOPROLOL), diltiazem hydrochloride (CARDIAZEM (AVENTIS)), rosuvastatin calcium (CRESTOR), celecoxib (CELEXA [CELECOXIB]), furosemide (LASIX [FUROSEMIDE]), potassium chloride (POTASSIUM CHLORIDE) and apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported. The patient previously took Bactrim and flourecin contrast and experienced known allergies for bactrim and flourecin contrast. The patient experienced new onset seizure activity diagnosed in month of july while patient at home with family and EEG demonstrated focal seizure activity on 06Jul2021 at 19:00. The patient received treatment for the events. The patient was hospitalized for eeg demonstrated focal seizure activity (partial seizures) for 5 days. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. The outcome of the events was unknown.
Pt was admitted with COVID-19 pneumonia on 4/15 that has progressed to COVID ARDS, DKA, AKI on CKD, NSTEMI
This spontaneous report was received from a pharmacist concerning an unspecified number of patients of unknown age and gender. On an unknown date the patient was vaccinated with a dose of (Merck) VARIVAX. No other co-suspect therapy was reported. Concomitant medications were not provided. The pharmacist reported that (Merck) VARIVAX, stored at an overall average temperature of minus 14.5C for five months, may had been administered to unspecified patients. No adverse effects reported. Additional information has been requested.
Initial misuse report received from a healthcare professional on 26 March 2014. A male patient received an expired dose of TD vaccine of unknown brand (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
shortness of breath and wheezing starting 24 hours after her booster immunization of Pfizer covid vaccine, requiring ER visit, nebulized albuterol and prednisone, having a history of asthma but no recent flares until this immunization.  ER visit was on 1/19/2022, 2 days after her booster shot.
Information has been received from a physician concerning a 12 month old female who was vaccinated SC with a dose of Proquad (Lot # 651814/0771R). Subsequently, 7-10 days post vaccination, the patient experienced a fever, rash at the injection site, and irritability. Subsequently, the patient recovered. There was no other information. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Pain and swelling at the injection site, Fever, body aches, headaches, and nauseousness lasting a full day after receiving vaccine and following. I didn't take any treatments, just rested and waited it out. Ended up getting better by day two.
Lightheaded; Possible neurological issue; High Blood Pressure; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheaded), VACCINATION COMPLICATION (Possible neurological issue) and HYPERTENSION (High Blood Pressure) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Lightheaded), VACCINATION COMPLICATION (Possible neurological issue) and HYPERTENSION (High Blood Pressure). On 20-Mar-2021, DIZZINESS (Lightheaded), VACCINATION COMPLICATION (Possible neurological issue) and HYPERTENSION (High Blood Pressure) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.  It was reported that the patients all the issues were resolved themselves within approximately one week after the second shot.      Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Non significant follow up. Narrative description was updated.
Shoulder/arm pain at the injection site; Nausea; headache; general soreness; Shoulder sourness; Flu-like symptoms; This is a spontaneous report from a contactable consumer. This consumer female patient reported that she received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patients past medical history and concomitant medications were not reported. On an unknown date, the patient experienced fatigue, nausea, headache and general soreness. Flu-like symptoms (moderate- described as feeling awful) until 24 hours after the second dose was administered. The reporter mentioned that these symptoms did not require any require any treatment or attention by an HCP. These effects were reported to me at 12 PM and 8 PM today. The patient was presently recovering from the events. Information on lot/batch number has been requested.  Followup(14Apr2021): This is a spontaneous report from a contactable consumer. This consumer (patient) reported that: The report of shoulder soreness was sent via text message.  No follow-up attempts are needed. Information on lot/batch number cannot be obtained.
Hair Loss/Massive Shedding. Not breakage. Abnormal hair shedding started in June and progressively getting worse. Have lost about 45% of normal volume
A non-serious spontaneous report of H1N1 Mist squirted in eye was received from a registered nurse concerning a child (age and gender not provided). The patient's medical history and concomitant medications were not provided. On 19-Oct-2009, the patient received H1N1. During administration, part of the dose of H1N1 mist squirted in the eye of the patient. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event was considered resolved.
Patient received Pediatric Pfizer dose instead of Adult Pfizer dose. Mom was notified and per CDC guidelines was instructed that redose was not necessary.
None - just reporting given Tdap on 11/10/11 and 6/11/13.
I got Covid after Dose 3 experienced  a little fever, sinus headache, fatigue. I tested on Day 5 (positive results)through Day 10 tested positive.
DIZZINESS (MORE LIKE LIGHT HEADEDNESS); Leg pain; Nausea; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies or any medical condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced dizziness (more like light headedness). On APR-2021, the subject experienced leg pain. On APR-2021, the subject experienced nausea.  Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, dizziness (more like light headedness) and leg pain was not reported. This report was non-serious.
"Throat closing, tongue swelling, nausea, eyes watering" Pepcid 20mg IV, Solu Medrol1 25 mg IV, Benadryl 50 mg IV
Significant itching around and including injection site. Got vaccine 9 days ago and still have periodic significant itching in that area
I contracted covid. At first I thought it was allergies, but my sinuses were really bothering me. I had troubling breathing, congestion, sore throat. No fever, but I did have a cough. I was not even tired, actually I felt like I had enough energy to even run a marathon. I lost my appetite, had diarrhea , was really thirsty, and I had a lot of sinus pressure.
Caller who got all four shots of the Pfizer covid-19 vaccine was prescribed Paxlovid and after taking it for five days he still tested positive; Caller who got all four shots of the Pfizer covid-19 vaccine was prescribed Paxlovid and after taking it for five days he still tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller who got all four shots of the Pfizer covid-19 vaccine was prescribed Paxlovid and after taking it for five days he still tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Prescribed Paxlovid and after taking it for five days he still tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 18-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot# L013428, expiry date 03-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): lasting for 88, 136, 24 and 72 hours, with the lowest recorded temperature of 30, 31, 34 and 33 degrees Fahrenheit, respectively. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
the patient was due for the Hep B vaccine but  he was given then Meningococcal B vaccine the patient had no adverse affects the doctor was notified and the doctor had no reccomendations  she stated that he would still have to receive the vaccine when it it due the patient mother was giving the VIS of the Meningococcal B vaccine that he received
A mother reported that the child has a rash on abdomen, arms and legs, was fussy. The pt had a temp of 99.6, raised lump at left leg injection site. The pt is eating ok. On 1/5/01 the mother reports that the rash has improved and the lump on left thigh is smaller and the pt is less fussy.