chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse practitioner and refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JAN-2017, the patient was vaccinated with the improperly stored dose of VARIVAX, subcutaneously (dose was not reported) (lot # M036292, expiration date 17-AUG-2017) for prophylaxis. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion greater than 5 degrees Fahrenheit and less than 14 degrees Fahrenheit (6.1 degrees Fahrenheit) for 41 hours and 20 minutes. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested; Sender's Comments: US-009507513-1702USA004122: US-009507513-1702USA004127: US-009507513-1702USA004124: US-009507513-1702USA004125: US-009507513-1702USA004126: US-009507513-1702USA004121: US-009507513-1702USA001032: US-009507513-1702USA004176:
c/o tightness in chest and throat. ( took Tylenol sines with ibuprofen when got home, did chores, Noticed the tightness in throat. Took Claritan, Called DR and went to ER.
This case was reported by a other health professional via call center representative and described the occurrence of loss of consciousness in a 12-year-old female patient who received BEXSERO (batch number 156801, expiry date 31st August 2017). Concurrent medical conditions included anxiety. Concomitant products included GARDASIL 9. In July 2016, the patient received the 1st dose of BEXSERO 1 ml. In July 2016, 1 min after receiving BEXSERO, the patient experienced loss of consciousness (serious criteria GSK medically significant) and syncope vasovagal. In July 2016, the outcome of the loss of consciousness and syncope vasovagal were recovered/resolved. The reporter considered the loss of consciousness and syncope vasovagal to be unlikely related to BEXSERO. Additional details were provided as follows: This case was reported by an office manager. The patient received both the vaccines on the same day in her arms. The patient experienced an episode of syncope and vasovagal reaction (loss of consciousness, low blood pressure and heart rate) after receiving BEXSERO. The patient did not sustain any injury. She was monitored in the office for 30 minutes following the event and sent home with no sequelae. The vaccination date was unclear, it could be 26th or 27th July 2016. This was the second or third dose of HPV vaccine. The other healthcare professional felt that the events were due to anxiety and not due to vaccines.
Information has been received from a physician concerning a 19 year old female who in 1988 was vaccinated with a dose of MMR II. In 1988, the patient experienced ITP symptoms and was admitted to the hospital. Subsequently, the patient recovered. Additional information has been requested.
2nd dose given >35 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given >35 days after 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 044D21A and 3002179) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given >35 days after 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given >35 days after 1st dose) outcome was unknown.  Concomitant medications were not reported. Treatment medications were not reported.
her pulse ox was 76; shortness of breath; had a high resting heart rate the whole next day, 120-140; a very bad headache; supraventricular tachycardia; lightheaded; This is a spontaneous report from a contactable other healthcare professional (patient). A 36-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, via an unspecified route of administration, administered in left arm on 12Apr2021 10:00 (Batch/Lot Number: Unknown) (at age 36 years old) as single dose for covid-19 immunisation in a pharmacy or drug store. The patient's medical history includes allergies to sulfa drugs. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19 and tested negative post vaccination by nasal swab on 26Apr2021. No other vaccines received within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. On an unspecified date, the patient had a high resting heart rate the whole next day, 120-140 and a very bad headache. She got lightheaded once with shortness of breath when driving and her pulse ox was 76 and she had to pull over and breathe deep. She stated maybe it was supraventricular tachycardia. She did not pass out. The patient recovered from the events.  Information on the lot/batch number has been requested.; Sender's Comments: The association between the event "pulse ox was 76" with BNT162b2  can not be fully excluded based on the limited information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
rt arm became swollen, tender & painful to bend elbow from 1-4 days p/vax;
Patient felt extremely sleepy for the two days following the immunization, and is still experiencing sleepiness, but not as marked as the first couple days.  Pt states he has received flu immunizations in the past without incident.  Pt requested us to inform his physician, the prescriber and complete a VAERS.
Between 24-36 hours-injection site became red, swollen, painful and warm to touch. Patient called at 96 hours post vaccination complaining that pain is still severe and arm is still swollen. Patient went to private MD
From initial information received on 2/25/03 from a nurse regarding an adverse event occurring in the USA, it was reported that a 60 year old female patient received her first dose of YF-VAX, lot number UB234AA, administered SC in the left arm on 1/22/03. on 2/2/03,. 11 days post vaccination, the patient reported having moderate to severe pain in her left arm and generalized aches, fatigue, nausea and vomiting. The patient declined an appointment with the physician at the facility and was seen by her primary care physician, date of doctor visit was not reported. The patient was taking PULMICORT and MAXAIR at time of vaccination for silent asthma. Reportedly, it is unknown if the patient recovered from the events.
mom noted swelling to upper lt arm w/in 1 hrs p/vax; arm swelled to twice the nl size; no temp c/o sl pain in arm; arm was still swollen 18MAY94;
massive stomach sickness, puking, diarreaha, dehyrdration, massive pain in arm  neck and back.  massive pain and dehydration, dry heves for hours,.  Fever above 102 degrees for 3 days. loss of muscle mass, messed up my thyroid, loss of potassium, no focus, and mental ability very impaired, naseaua.
Information has been received from a registered Pharmacist concerning a male pt in his 30's who on 04/07/04 and on 05/19/04 was vaccinated with a first and second dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the pt developed redness, swelling and soreness in the injection arm. The arm was also reportedly warm to touch, however there was no fever. Unspecified medical attention was sought. No product quality complaint involved. Additional information has been requested.
Patient got dizzy right after I gave the shots, he might have lost consciousness for a second. He fell down from the chair and hit his forehead on the floor.
Both vaccines given in the same arm.  Swelling and redness that warranted patient to go to the ED.
My wife went to the local pharmacy to get the PREVNAR13 vaccine based on the advice of our primary care doctor. She took the PREVNAR13 shot in the arm about noon on December 17, 2015. We went home had lunch, watched TV, and talked awhile until she decided to take a nap. About 5:45 P.M. that evening, I went to the bedroom to wake her up and I returned to another room. I went back to check on her twice until the third time of no response; I tried to get her to get out of bed. She was not responsive to my directions, disoriented, and confused. At this time, I called 911 for an ambulance. When the medics arrived her body temperature was 101.5 F degrees. I told them about the vaccine that she had earlier that day. They gave her TYLENOL and started an IV and took her to hospital. At hospital she was treated in the ER after drawing blood and getting urine samples. About 10:00 P.M. the nurse said that she had some type of infection. While in the ER she was given MOTRIN and various antibiotics (ZOYSN). It was decided later that she needed to be admitted for at least one day. About 1:20 A.M. December 18, 2015, she was admitted into the ICU Unit for treatment. Patient was treated here at hospital from 12/17/2015-12/28/2015. My first meeting with Dr. we talked about why she was brought to the hospital and her medical history. During the time she was at this hospital her medical diagnosis and conditions were changed several times such as rapid heart rate, unknown virus, rhinovirus, atrial fibrillation, fluid in lungs, high blood pressure 189/107, bleeding mouth, blood in the urine, low blood count, diffused pneumonia, and common cold. Numerous lab test were done while she was being treated here. She was also given blood while she was here. During my visits with patient, I have noticed that she is having difficulty remembering things. It appears that this may be as ongoing problem. On December 28, 2015, she was transferred to another hospital. Patient was cared for from 12/28/15-01/11/2016. While at hospital, she continued treatments to clear the fluids in the lungs and started the initial physical and occupational therapies. On January 11, 2016, she was transferred to Skilled Nursing and Rehabilitation. During her stay here, she is receiving her follow-up medications for the heart and lungs. She is also doing occupational and physical therapy. The Nurse Practitioner has noticed that patient is having memory issues. Last week, the nurse practitioner asked me about her memory and if it was like it is now before she became sick or if it is worse. It is possible that, she may be released to go home next week after this long ordeal.
A report was received from a health care professional on 11/26/03 concerning a 44 year old female vaccinee who was administered Fluvirin vaccine in the buttocks on 11/5/03. On 11/5/03, the vaccinee requested Fluvirin be administered in the buttocks instead of the deltoid. The vaccinee had not exhibited any signs or symptoms of an adverse event at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
expired dose of ACTHIB was administered to a patient, no adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via Global Medical Information (GMI) (Reference number- 00725700) and transmitted to Sanofi on 16-Aug-2021.  This case involves a one-year-old female patient who was administered an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for prophylactic vaccination.  On 16-Aug-2021, the patient received a fourth dose (0.5ml) of suspect HIB (PRP/T) VACCINE (lot number: UJ351AAB; expiry date: 09-Aug-2021) via intramuscular route in the right deltoid for prophylactic vaccination.  It was case of actual medication error due to expired vaccine used (latency: same day).  It was reported, "Caller states that an expired dose of ACT-HIB was administered to a patient on 16AUG2021 and needed to report it. Caller sought information on how to proceed."  No adverse events were reported at the time of this report.  The outcome of the event was reported as 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 by the regulatory authority. 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.
This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173), via an unspecified route of administration in the left arm on 14May2021 at 12:00 (at the age of 49-years-old), as a single dose of COVID-19 immunisation. The patient did not have any other medical history. The patient had no known allergies. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 23Apr2021 at 12:00 (at the age of 49-years-old), as a single dose for COVID-19 immunisation and experienced tinnitus. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021 at 04:00, the patient experienced tinnitus in left ear, extremely difficult to sleep. This is 2nd night with rigging in ears and it was hard to take. Praying it gets better when inflammation decreases. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events tinnitus in left ear, 2nd night rigging in ears and it's hard to take, extremely difficult to sleep and it gets better when inflammation decreases were not resolved at the time of this report. No follow-up attempts are needed. No further information expected.
patient received expired Flublok vaccine with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via Media Information (under the reference 00814672).  This case involves a 41 years old female patient who received expired INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  The patient's medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  Patient had no other vaccines.   On 03-Sep-2021, the patient received a dose of suspect FLUBLOK QIV (0.5 ml, total, lot QFAA2017 and expiration date: 30-jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was reported "they gave 15 patients expired Flublok vaccine, and wants to know what to do."  At time of reporting, the outcome was unknown for the reported 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Hot flashes; Dizziness; Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced HOT FLUSH (Hot flashes) and DIZZINESS (Dizziness). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HOT FLUSH (Hot flashes) and DIZZINESS (Dizziness) outcome was unknown.            Concomitant medication use was not provided by reporter.  Treatment information was not provided by reporter.  Very limited information regarding this patient's death has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Followed up Received on 29-jun-2021 that includes TCR: patient passed away.; Sender's Comments: Very limited information regarding this patient's death has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death
Hematoma - swelling of left arm and bruising. TYLENOL 3/codeine.
This spontaneous report was received from a medical assistant referring to a 83 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 23-MAY-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # N003997 and expiration date 20-OCT-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA011654.
Dizziness/ lightheadedness, pulsing sensation through body, epigastric sore/cramp-like 8pm-present
UNDILUTED VACCINE DOSE (20MCG) GIVEN TO PATIENT, INSTEAD OF 10MCG 5-11 AGE DOSE
DOSE GIVEN OUTSIDE OF THE 2 HOUR WINDOW (VIAL WAS PUNCTURED AT 10 AM AND THE DOSE WAS GIVEN TO THE PATIENT AT 1 PM); This spontaneous report received from a pharmacist concerned a 44 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: 23-JUN-2021) dose was not reported, administered on 18-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported.  On 18-MAY-2021, the subject experienced dose given outside of the 2 hour window (vial was punctured at 10 am and the dose was given to the subject at 1 pm). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dose given outside of the 2 hour window (vial was punctured at 10 am and the dose was given to the patient at 1 pm) was not reported. This report was non-serious.
Nurse that administered vaccine stated "patient received vaccine then shortly after walked with mother to check out window.  While standing at window with mother patient had a syncopal episode, mom caught patient and they sat on the floor.  Doctor was notified and after evaluating patient, patient stood up and walked with mother to a room.  After further evaluation, Dr. determined patient had a vasovagal response.  Patient was stable and walked out of office with mother.
excessive chills, temp 103 x 6hr, body aches, h/a, dizzy, nausea;
pt recv vax & devel some swelling & discoloration @ site p/1st DTP;
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe
pt was given Moderna Monovalent Covid 19 vaccine for ages 6 mos to 5 yrs  O.5 mls IM
3 days after getting both vaccines at same time patient experienced some lip tingling and question some numbness in lips. No facial weakness, no lip swelling, no breathing issues or rashes.
Patient received second dose Pfizer after receiving 1st dose Moderna at another provider.  Patient did not present vaccination card and stated this was first dose.
Patient experienced sore throat, cough, wheezing, red, itchy eye, hoarseness, sore. Went to see care doctor & being prescribed steroid & allergy medication. Patient felt better after the medication treatment after couple days. (Called pt on 12/17/12 follow-up).
Sore arm at injection site bruised,chills,upset stomach,headache very tired stayed in bed took tylenol
lymphadenopathy, parotitis, sore throat, fatigue, itching, began 8Feb91 & got worse, started Amoxicillin 500 mg tid 11Feb91, Sx resolved except for one lymphnode which is enlarged 19Feb91
It was reported that an 18 month old male received DTaP vaccine on 7/29/02. Pt developed an 11.5cm x 8.5cm erythematous annular area at site of injection, area non-tender. Pt is not limping. Reactions initially noted on 7/30/02 and increased in size and became warm on 7/31/02.
Rash at hip and urticaria for 2 days and was taking BENADRYL 25mgm every q12h.
Client received HPV & Pfizer vaccine during immunization clinic @ 0830. Client was in observation area when he started c/o nausea. He had one vomiting episode, per RN. He was given an ice pack, blue emesis bag, water, and fan for supportive measures. He was in the observation area w/ his grandmother & sister. At approximately 0900, he reported feeling better and walked out of the clinic with his grandmother. EMS was not called. Client had vasovagal reaction.
Myalgia, Fever, Injection site pain, fatigue, chills Narrative: