chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient fainted 4 days after vaccination per mom's report: with HPV vaccine patient was getting up from sitting down on couch when she fainted.  Mom was in other room and heard her.  Patient got up right away and has been acting fine.  No fever, no cold symptoms.
DISCOMFORT; ACHY HERE AND THERE; FEVER; SWOLLEN ARM AT THE AREA OF VACCINATION; REDNESS AT THE SITE OF THE INJECTION; HEADACHE HERE AND THERE; This spontaneous report received from a parent concerned a 30 year old male. The patient's height, and weight were not reported. The patient's past medical history included stroke, and covid-19, and concurrent conditions included immunocompromised, and low immunoglobulin g (igg). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 06-JUL-2021 for prophylactic vaccination. Concomitant medications included immunoglobulin human normal for low igg. On FEB-2021, Laboratory data included COVID-19 virus test positive (NR: not provided) Positive. On 06-JUL-2021, the subject experienced discomfort. On 06-JUL-2021, the subject experienced achy here and there. On 06-JUL-2021, the subject experienced fever. On 06-JUL-2021, the subject experienced swollen arm at the area of vaccination. On 06-JUL-2021, the subject experienced redness at the site of the injection. On 06-JUL-2021, the subject experienced headache here and there. On 14-JUL-2021, treatment medications included paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, swollen arm at the area of vaccination, discomfort, redness at the site of the injection, headache here and there, and achy here and there. This report was non-serious.
Arm went to itching; Redness /has a pretty good size red; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm went to itching), ERYTHEMA (Redness /has a pretty good size red) and MYALGIA (Arm was sore) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced PRURITUS (Arm went to itching) and ERYTHEMA (Redness /has a pretty good size red). In August 2021, the patient experienced MYALGIA (Arm was sore). In August 2021, MYALGIA (Arm was sore) had resolved. At the time of the report, PRURITUS (Arm went to itching) and ERYTHEMA (Redness /has a pretty good size red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that her arm was sore for 3 days and on the 11th day, it went to itching, red and has a pretty good size red. She only put alcohol on it, she did not take any medications. She was due to receive the second dose of the vaccine on 01-Sep-2021 and wanted to know if she should receive it.
Sore left arm for 3 days after injection.; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 24Feb2021 at 10:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, asthma, diabetes and known allergies to silk tape. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), triamterene (MANUFACTURER UNKNOWN) and citalopram (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received codeine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 24Feb2021 at 13:00, the patient experienced sore left arm for 3 days after injection. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the adverse event. The clinical outcome of the event sore left arm for 3 days after injection was resolved on 27Feb2021, 3 days after injection.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient received vaccinations and immediately felt dizzy. Laid patient down on exam table for 5-10 minutes and he began to feel better he stated. BP 125/59. Patient sat up and stated he felt fine. He then stood up BP 116/75. Walked with patient to car and notified parent if he got any worse to go to ER.
About 6 hours after being vaccinated,  right hand got hot and was itching between the fingers. Lasted about 10 minutes.
recurrent fever x 1 day; swollen of arm secondary to DTP, fever varied;
COVID-19; COVID-19; Sinus congestion; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4421537-00.  A 58-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), from 27Apr2022 to 12May2022 at unk, (citrate free), subcutaneous for psoriasis, rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 2022, outcome "recovering" and all described as "COVID-19"; SINUS CONGESTION (non-serious) with onset 2022, outcome "unknown". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "covid-19" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "covid-19" and "sinus congestion" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
3 days of vertigo nausea and Diaerria 2 weeks following small Pox administering Sy Resolved in 5  May 2007
Vaccination after a temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a child female patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient received a kinrix vaccine after a temperature excursion, which led to incorrect storage of drug. The reporter consented to follow-up. This case has been linked to US2022039273, US2022039274, US2022039271, US2022039278 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022039273:same reporter US-GLAXOSMITHKLINE-US2022039274:Same reporter US-GLAXOSMITHKLINE-US2022039271:same reporter US-GLAXOSMITHKLINE-US2022039278:Same reporter. US-GLAXOSMITHKLINE-US2022039277:same reporter
Oth complications following immunization, NEC, init on 2017-01-09.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 25-MAR-2019 the patient was vaccinated with ROTATEQ, lot # R002805, oral for prophylaxis. On 25-MAR-2019, 1 day after onset of therapy the patient experienced product storage error. On an unknown date the patient experienced no adverse event.
This spontaneous report as received from a pharmacist refers to a 71 year old male patient with no drug reactions or allergies who on 27-JUN-2013, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # H011048, Exp. Date: 05-SEP-2013). Concomitant therapies included chlorthalidone, lisinopril (manufacturer unknown), potassium, LIPITOR, COREG and NIASPAN, the patient took antihypertensives and medications for high cholesterol. It was reported that on an unspecified time in June the patient received MEDROL for an unknown reason. The pharmacist reported that the patient developed rash at unspecified time and went to family physician. The physician wrote for patient to receive ZOSTAVAX to help reduce symptoms. On 27-JUN-2013, the patient came to pharmacy with no mention any symptoms and was vaccinated. On 28-JUN-2013, the patient came back to pharmacy and reported that he broke out this morning. The patient developed a rash (rash was all over) and burning, no burst blisters. No treatment was given for the experience. At the time of the report, the patient's outcome was unknown. The relatedness for rash all over and burning and ZOSTAVAX was unknown. Additional information has been requested.
Information has been received from a health professional concerning herself who reports that every time she administered the Gardasil vaccine to a patient her lips swelled.  No other information was available and the physician can not be contacted.
PATIENT RECEIVED THE VACCINE ON 12-29-2019.  SHE STATED TODAY (2-11-2020) BY PHONE CALL THAT 3 DAYS AFTER RECEIVING THE VACCINE IN HER LEFT ARM, SHE DEVELOPED A SKIN BACTERIA, OR SKIN CELLULITIS.  SHE SAID THAT SHE HAS BEEN IN SEVERE PAIN SINCE SHE RECEIVED THE VACCINE AND HAS BEEN SEEN BY 2 DIFFERENT DOCTORS.  SHE ALSO STATED THAT HER HUSBAND RECEIVED THE SAME VACCINE ON THE SAME DAY WITHOUT ANY INCIDENT.
Fever x 2 days (documented 40.2 rectal).  Rash erythema, papules on face, chest right thigh nonblanching.
This was an immunocompromised patient and he had received 3 doses of the Moderna Covid vaccine 0.5 ml doses.  He was returning for his first booster and should have received 0.25 ml, but I mistakenly chose the box on the protocol stating that he had only received 2 doses prompting me to give this dose as a 0.5 ml dose when it should have been a 0.25 ml dose as his first booster.  It was discovered on 8/4/2022 when he came for his 5th dose, or 2nd booster at 0. 25 ml.  He reported that he had no adverse effects and no issues with his 4th dose of the vaccine and he received his 5th dose without issue.
1 week after receiving vaccine, sudden onset of burning, itching, stinging and redness at injection site. Redness is a large oval shape about 2"X3:5"
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Moderna product on 03/01/2021 and 03/29/2021. They presented to Emergency Dept on 10/01/2021 after 4-5 days of illness. They had been staying at a nursing home for a short-term stay after a hip fracture, and were discharged to home approx 09/27/2021. They were informed their room-mate at the nursing home had COVID-19. The individual tested positive for COVID-19 on 10/01/2021 upon hospital admission. The individual experienced complications for COVID-19 pneumonia and delirium. They died in the hospital on 10/13/2021.
SWOLLEN FACE; RAPID HEARTBEAT; DIFFICULTY WALKING; EYES ARE BLURRY; RIGHT EYE TWITCHING/LIPS SHAKE WHEN SMILE; FEELS LIKE AN ANXIETY ATTACK IN COMING; WEAK MUSCLES; SORE MUSCLES; NAUSEA; HEADACHE; FACE FEEL TIGHT; DIZZY; SHORT OF BREATH; TEETH FEEL FUNNY; JAW FEEL TIGHT; FACE IS DOING WEIRD MOVEMENT; This spontaneous report received from a patient concerned a 57 year old female. 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, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 14-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-SEP-2021, the patient experienced dizzy. On 14-SEP-2021, the patient experienced short of breath. On 14-SEP-2021, the patient experienced face is doing weird movement. On 14-SEP-2021, the patient experienced teeth feel funny. On 14-SEP-2021, the patient experienced jaw feel tight. On 14-SEP-2021, the patient experienced face feel tight. On 14-SEP-2021, the patient experienced headache. On 15-SEP-2021, the patient experienced swollen face. On 15-SEP-2021, the patient experienced rapid heartbeat. On 15-SEP-2021, the patient experienced difficulty walking. On 15-SEP-2021, the patient experienced eyes are blurry. On 15-SEP-2021, the patient experienced right eye twitching/lips shake when smile. On 15-SEP-2021, the patient experienced feels like an anxiety attack in coming. On 15-SEP-2021, the patient experienced weak muscles. On 15-SEP-2021, the patient experienced sore muscles. On 15-SEP-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizzy, and short of breath, and the outcome of swollen face, rapid heartbeat, nausea, sore muscles, difficulty walking, face is doing weird movement, eyes are blurry, right eye twitching/lips shake when smile, teeth feel funny, jaw feel tight, headache, feels like an anxiety attack in coming, weak muscles and face feel tight was not reported. This report was non-serious.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown), on 29Mar2021 as dose 2, single (Batch/Lot number: unknown), on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; ezetimibe (ZETIA), (Batch/Lot number: unknown); atorvastatin calcium (LIPITOR), (Batch/Lot number: unknown). The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: LEVOTHYROXINE SODIUM. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Aug2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Aug2022) Positive, notes: first positive test; (24Aug2022) Negative, notes: Tested negative for Covid; (25Aug2022) Negative, notes: Tested negative for Covid; (30Aug2022) Positive, notes: Tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.COVID 19 Treatment start date was 18Aug2022 and stop date was 23Aug2022 with antiviral drug.  Clinical course: Patient took other medications in two weeks. Ongoing (although somewhat improving) fatigue since first positive test result on 18Aug2022. Sore throat returned overnight on 27Aug2022 and 28Aug2022 but went away after getting up both mornings and drinking. No sore throat the next day, but nasal congestion increased markedly overnight on 29Aug2022. Fatigue getting better but still not back to pre-Covid energy. Tested negative for Covid on 24Aug2022 and 25Aug2022. Tested positive again on 30Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
broke out in flat rashes in the back of his neck and right ear; This is a spontaneous report from a contactable physician.   An infant male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), at single dose, diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), in right thigh and hepatitis b vaccine in right thigh, all via an unspecified route of administration on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced broke out in flat rashes in the back of his neck and right ear on an unspecified date with outcome of unknown.  The information on the lot number has been requested.
6 days after receiving vaccine member experienced pain and numbness in left arm. Now just occasional pain and no more numbness.
Pt had a severe headache beginning within 30 min of this first dose of anthrax vax. It lasted 8 hrs. Pt also had sob associated with this and resolved w/albuterol. No ER visit w/this.
The patient received the Janssen shot on 05/20 and contacted the Pharmacy via phone 05/30. She complained that since her Janssen shot she is experiencing sore arm and occasional numbness.
tested positive for COVID-19 virus; Patient slept day and night for 3 days after the vaccination; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and slept day and night for 3 days/hypersomnia and tested positive for COVID-19 virus.  The patient's current medical condition included COVID-19 since 05MAR2021.  Concomitant medication history was not provided.  On 25JAN2021, prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (lot/batch not available) intramuscularly for prophylaxis  of COVID-19 infection.  On 29JAN2021, following the vaccine administration, the patient slept day and night for 3 days after the vaccination, was taken to the hospital, where he tested positive for COVID-19 virus. Patient was still in the hospital at the time of this reporting and he tested positive for COVID-19 again on 05MAR2021.   Treatment information were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events, hypersomnia and COVID-19 were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However , the mRNA-1723 does not contain a virus capable of causing infection and with the occurrence of Covid-19 positive test after vaccination, is unlikely related to mRNA-1273.
prone to headaches; severe migraine; Fever/Fever this morning of 102F; This is a spontaneous report from a contactable consumer (patient's husband) via Pfizer sponsored program. A 59-year-old female patient received the second dose of bnt162b2 via unspecified route of administration on 11Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 12Apr2021, his wife was experiencing severe migraine. His wife had a prescription medicine butalbital, caffeine, paracetamol (FIORICET). The patient asked if there any contraindication to taking with Pfizer COVID 19 vaccine. She had fever of 102F in the morning on 12Apr2021, it is down right now, but still had migraine. She did take paracetamol (TYLENOL), but it didn't do anything, she is prone to headaches. The outcome of the event migraine was not resolved. The outcome of the event fever was resolved. The outcome of the other event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a nurse and refers to a currently 14-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # N032284, expiration date: 22-SEP-2020 (dose and route of administration were not provided) for prophylaxis. Temperature and time frame were reported as: below 0 degrees Celsius (-0.6 degrees Celsius) for 7 hours and 38 minutes and 9 degrees Celsius to 25 degrees Celsius (13.3 degrees Celsius) for 1 hour and 14 minutes. Previous temperature excursion was reported as: 9 degrees Celsius to 25 degrees Celsius (11.7 degrees Celsius) for 3 hour and 53 minutes and 9 degrees Celsius to 25 degrees Celsius (23 degrees Celsius) for 11 hours and 21 minutes. Digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1811USA007952: US-009507513-1811USA007948: US-009507513-1811USA001303: US-009507513-1811USA007950: US-009507513-1811USA007951: US-009507513-1811USA007946: US-009507513-1811USA007945: US-009507513-1811USA007947.
Rash after receiving Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash after receiving Moderna COVID-19 vaccine) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash after receiving Moderna COVID-19 vaccine). At the time of the report, RASH (Rash after receiving Moderna COVID-19 vaccine) outcome was unknown.            Patient details was mentioned as Unknown group. Concomitant and treatment medication was not reported.   This case was linked to MOD22-005566 (Patient Link).
pt recvd vax & arms would not straighten out; demo of elbows & wrist bent placed close to body;
Discharge Provider: MD Primary Care Provider: DO Admission Date: 4/2/2023 Discharge Date: Apr 4, 2023  PRESENTING PROBLEM: Weakness [R53.1] COVID-19 virus infection [U07.1]   HOSPITAL COURSE: Patient is a 87-year-old man who presents to the emergency department due to fevers, chills, generalized weakness, coughing, dyspnea and chest pain.  He was very weak and unable to go home and take care of himself.  He was tested for COVID-19 and positive.  Most of his symptoms were attributed to COVID-19 infection.  He had a CT abdomen and pelvis with contrast which revealed esophagitis but was otherwise grossly unremarkable.  He was seen by Physical therapy and Occupational therapy and was independent in his room.  He says that he was feeling much better after some rest.  His chest pain improved.  It seemed only be with coughing and was likely costochondritis.  Troponins were stable and EKG was unremarkable.  He was then discharged home in stable condition.