chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Around November I started having extreme fatigue vomiting and weight lost. I did a video visit with my doctor, she stated I might have COVID and she didn't encourage me to come in so I waited through the holidays. I returned Jan 20 I still had nauseous, vomiting, weight loss (down 17 pounds in total). Dr. scheduled test. Ultrasound= nothing. EGD =irritation from the vomiting. CAT Scan that showed nothing. I have an upcoming appointment with a surgeon that wants to put a flap at the end my esophagi.
Within 2 hours of DTAP, very irritable, fever and persisted > 24 hours.
UrticariaPruritus Narrative:  not puritic , scattered and continuing to occur 6 days post
This is a spontaneous report from a contactable reporter who reported for 4 patients via a sales representative. This is 4th of the 4th report. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration at single dose on an unspecified date. The patient medical history and concomitant medications were not reported. The patient experienced red swollen arm on an unspecified ate with outcome of unknown.
12midnight severe chills started. Excessive urination once an hour although I wasn't taking in any fluids. 630am 4/10/21 headache (felt like a sinus headache on steroids) chest pain when breathing. Excessive tiredness and  body aches.
VACCINE WAS ADMINISTERD IN RIGHT DELTOID. LOCAL REACTION DEVEOPLED IN TO CELLULITIS WITH STREAKING DOWN RIGHT ARM. AREA IS PAINFUL, HOT TO TOUCH, RED, AND RAISED. AREA THE SIZE OF A BASEBALL. CELLULITIS BEING TREATED WITH KEFLEX.
Erythema and mild pluritis at injection site (right deltoid), onset 9 days after vaccination L/W delayed hypersensitivity
Site: Bruising at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild, Additional Details: Patient did not tell me that already receive booster, and relative booked another appointment
BLOOD PRESSURE UP AND DOWN. PATIENT STATES "FEELING REALLY BAD" ON 2/25/2010. C/O FATIGUE, DIZZINESS, AND BEING LIGHTHEADED. PATIENT STATES ON 2/28/2010 SHE EXPERIENCED CHEST PAIN AND HEART RACING. AT THAT TIME SHE WENT TO THE LOCAL ER. SAW PRIMARY DOCTOR ON 3/4/2010 WHO GAVE ROCEPHIN AND B12. WORE HOLTER MONITOR 3/15/2010 AND 3/16/2010. PATIENT STATED NO ABNORMAL RHYTHM JUST OCCASSIONAL PVCS.
experiencing fever of 101 degrees F; muscle aches; chills; This is a spontaneous report from a Pfizer-sponsored program, received via a contactable consumer. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), dose number 1, via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was experiencing fever of 101 degrees F, muscle aches, and chills on 05Jan2021. The outcome of the events was unknown.  Information about Batch/Lot number has been requested.
I developed a severe case of facial shingles; suffered great pain; anguish; severe loss of hearing; fear of loss of vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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. Vaccination history included: Covid-19 vaccine (Primary series immunization complete but manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (1st booster), for COVID-19 Immunization; Both shingles boosters (I did previously have both shingles boosters in 2018), administration date: 2018. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "I developed a severe case of facial shingles"; PAIN (non-serious), outcome "unknown", described as "suffered great pain"; ANXIETY (non-serious), outcome "unknown", described as "anguish"; HYPOACUSIS (non-serious), outcome "unknown", described as "severe loss of hearing"; FEAR (non-serious), outcome "unknown", described as "fear of loss of vision". The events " i developed a severe case of facial shingles", "suffered great pain" and "anguish" required physician office visit.  Additional Information: patient stated that, after my 4th corona booster patient developed a severe case of facial shingles, suffered great pain, anguish, suffering. numerous visits to numerous doctor's fear of loss of vision and severe loss of hearing. Patient previously had both shingles boosters in 2018 and patients hearing was fair. Your vaccine was poison and causing great pain and suffering shame on Pfizer. immune from lawsuit Pfizer made billions in profits injuring people. your cure worse than the disease.  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 nurse refers to a 4 month old patient of an unknown gender. On 16-JAN-2015, the patient was vaccinated with improperly stored ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
2 1/2 days after immunizations, pt got rashes/hives on both thighs some were flush with skin surface others were welts. They didn't disappear until 2 weeks later, 11 days after  immunizations, he c/o severe pain in > Arm and joints. He got the shakes, and vomited. Lasted 1/2 day.
Resident tested positive for COVID 01/06/2021. Resident received outpatient IV fluid bolus of D5NS 1 liter on 01/13/2021.
Infanrix given instead of Boostrix; Infarix given to a 37-year-old; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 37-year-old female patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 15-MAR-2064) for prophylaxis.   On 06-FEB-2023, the patient received Infanrix. On 06-FEB-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Infanrix given instead of Boostrix) and inappropriate age at vaccine administration (Verbatim: Infarix given to a 37-year-old). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 13-Mar-2023 A nurse practitioner called in to report that a dose of Infanrix was given instead of Boostrix. The information for the adverse event was collected and the reporter accepted to be transferred to second line. The reporter consented to follow up. The patient received dose of infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Patient slept after the first one and came home and passed on and slept all day and patient is sleeping a lot.; This spontaneous case was reported by a physician and describes the occurrence of HYPERSOMNIA (Patient slept after the first one and came home and passed on and slept all day and patient is sleeping a lot.) in a 65-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect products included non-company products RSV VACCINE for an unknown indication and INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   On 28-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form, dose of RSV VACCINE (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 28-Oct-2023, the patient experienced HYPERSOMNIA (Patient slept after the first one and came home and passed on and slept all day and patient is sleeping a lot.). At the time of the report, HYPERSOMNIA (Patient slept after the first one and came home and passed on and slept all day and patient is sleeping a lot.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.  Company comment: This spontaneous case concerns a 65-year-old, female patient with no medical history information reported, who experienced the unexpected non serious AESI of hypersomnia. The event occurred on the same day after a dose of SPIKEVAX 2023-2024). As reported, patient got three shots on the same day RSV, flu, and Spikevax and slept a lot after the first one. Reportedly patient came home and passed on and slept all day. Patient reported that she never takes naps and now is sleeping a lot. No further information about the events was provided. Concurrent administration of RSV and influenza vaccines remains a confounder for the event. The benefit-risk relationship of SPIKEVAX 2023-2024 is not affected by this report.
Received hepatitis A and typhoid vaccine on 8/22/03.  Received PPD and anthrax vacicne on 8/27/03.  On 8/27/03 was admitted for profound pericardial effusion requiring drainage and pericardial window. Patient currently still admitted and improving. Nurse follow up on 05/19/04 states: Per review of hospital d/c summary, diagnosis of cardiac sarcoma (cancer) again confirmed and has already been coded. (This was a case that resulted in the death of the patient and was followed by nurse as well. Case was complete, but this d/c summary from the patient's last hospitalization just arrived.) Discharge summary states dyspnea, edema, chest pain.
June(ish) 2015 stopped birth control. October 2016 period stopped. December 2016 diagnosed with Premature Ovarian Failure.
Sore left arm; tiredness; This is a spontaneous report from a contactable consumer (Parent). A 12-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/Lot Number: EN5318) via an unspecified route of administration, administered in Left Arm on 12May2021 (at the age of 12-years-old) as Dose 1, Single for COVID-19 immunization. The patient's medical history was not reported. The Concomitant medications included  fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) loratadine (CLARITINE) vaccine in two weeks. No other vaccine administered in four weeks. No Known allergies were reported. The patient did not test for covid post vaccination. The patient did not suffer from covid prior vaccination. On 12May2021, the patient experienced sore left arm and tiredness. Patient did not received ant treatment. Query included Drug safety unit recently received the attached report submitted via a web site. Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events. Response received I first became aware of this event on 12May2021. Please let me know if you need anything else. The outcome for the events was recovering.
patient received an expired dose of Daptacel, NO AE; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old male patient who expired dose vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  Concomitant vaccination included Prevnar and ActHIB.  On 25-Oct-2019, the patient received a 0.5 ml fourth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5307AA Expiry Date 23-Oct-2019 via intramuscular route in the left thigh.  It was an actual medication error due to patient received an expired dose of Daptacel. It was reported that the Nurse states that they gave an expired Daptacel to a patient.  At the time of reporting, the patient had no adverse 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 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.
Information has been received from a physician concerning his 4 year old white son who on 1/19/01 was vaccinated at 1 year of age with a first dose of varicella virus vaccine live (lot # 632387/1238K). There was no illness at the time of vaccination. Concomitant therapy included cetirizine hydrochloride syrup. Subsequently, on 6/1/04 at 9:00 AM, the patient developed chicken pox. It was noted that the child was exposed to his cousin (non-vaccinated) who had a full blown case of the chicken pox. The child had a total of 12 pox and a low grade fever. No other information was available. Unspecified medical attention was sought. There was no product quality complaint. Follow up information received from a physician indicated that the patient developed 14 vesicles that progressed through typical stages. He was also noted to have a fever to 102 degrees and was irritable. The outcome was reported as recovered. There were no relevant diagnostic tests or laboratory data. No further information is expected.
I got a rash and welts on my skin. I was itching profusely and it eventually went away. My blood pressure was extremely  and unusually high.
Temperature 104 onset, carried 103 x 2 days. Hot red swollen left arm, Red area 4x4 size on 5/22, 5x6 size on 5/23/04. Arm very sore, hurt to touch and move arm. Vomited x2. Treated with Tylenol and Motrin.
ARM FEELS A LITTLE WARM; REDNESS; SORE ARM; BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a 47 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: 207A21A, expiry: 14-SEP-2021) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the subject experienced body aches. On 30-JUL-2021, the subject experienced chills. On 01-AUG-2021, the subject experienced sore arm. On 02-AUG-2021, the subject experienced redness. On an unspecified date, the subject experienced arm feels a little warm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and chills on 31-JUL-2021, had not recovered from sore arm, and the outcome of redness and arm feels a little warm was not reported. This report was non-serious.
Starting about a month after the second dose, I developed shortness of breath during hard exercise (ie  running at more than a jog).  After some time, I went to my doctor for review, close to Sept 2021.  I received a full set of tests (bloodwork, ECG, etc.).  I was then diagnosed with Asthma and prescribed an inhaler (Albuterol Sulfate) which has worked to reduce the problems since then.
Pt w/ hx of codeine allergy (Rash). Pt c/o flushing/sweating and nausea 15mins after vaccination. BP 129/80, HR 77, O2Sat 100% RA -- > 133/85, 70.  Pt stable and released from vaccination site 1hr 10mins post vaccination.
Dizziness/vertigo lasting over 2 days.; Dizziness/vertigo lasting over 2 days.; This is a spontaneous report from a non-contactable consumer (patient). A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in Left arm on 09Apr2021 at 12:30 (at the age of 27-year-old) as single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies to medications, food or other products. The patient's concomitant medication included sertraline hydrochloride (ZOLOFT). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in Left arm on 12Mar2021 at 12:15 (at the age of 27-year-old) as single dose for COVID-19 immunization. The patient was not pregnant. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced dizziness/vertigo lasting over 2 days on 11Apr2021 at 11:00. No treatment was received for these events. The outcome of these events was not resolved at reporting time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
C/O pain Wed pm, Thurs. (8/15/02) pain  was worse, temp 99.8-taken Alieve-8/16/02-temp 100.8, red, painful. Used hot compresses and Alieve, 8/17/01 area warm to touch, red, fever. Seen 8/18/02-pain better, no fever itching. Mon. 8/9/02 arm red, warm and swollen, unable to take Benadryl. Benadryl cream and Alieve.
I had covid 19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (I had covid 19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced COVID-19 (I had covid 19). At the time of the report, COVID-19 (I had covid 19) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred in Nov-21, an unknown duration after the unknown dose of mRNA-1273 vaccine administered on an unknown date for the indication of COVID-19 vaccination. At the time of report outcome of the events was Resolved. Further details about the event are not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred in Nov-21, an unknown duration after the unknown dose of mRNA-1273 vaccine administered on an unknown date for the indication of COVID-19 vaccination. At the time of report outcome of the events was Resolved. Further details about the event are not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient received SHINGRIX in clinic on 8/13/18 and within 2 hours developed nausea, vomiting, difficulty swallowing, wheezing, fever, chills, weakness. He was seen  2 days after IZ and he still had wheezing on exam and had been unable to eat that day due to nausea.
mom states pt temp rose to 104 & went limp the evening of the shots; pt held lt hand & arm very tight & stiff; 5JAN93 several episodes of head jerking;
Pt describes extreme pain at injection site. Followed by redness and swelling. 04/01/05-04/04/05. Seen by Dr. No antibiotics needed. Redness and swelling involved arm down to elbow area.
13JUN95 Bell's palsy-lyme titer, ESR, CBC w/diff, SMAC; 15JUN95 lyme confirmed; admitted hosp
Patient describes normal menstrual bleeding before the vaccine. A week after the vaccine, the period was very heavy and irregular. Patient required HOSPITALIZATION and BLOOD transfusion.
Bodyache; Tingling; Chills; Fever; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 28Apr2021 at 10:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 07Apr2021 at 12:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. On 28Apr2021 at 23:00, the patient experienced chills, fever, headache, body ache and tingling. Since the vaccination, the patient had not been tested for COVID-19. The events 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 reported events. The clinical outcome of events chills, fever, headache, body ache and tingling were recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected
Breakthrough case admission after 2 vaccines Moderna 9/16/20 lot# 045A21A;  Moderna 4/15/21 lot# 016B21A
ADULT OBSTRUCTIVE SLEEP APNEA ACUTE RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPERCAPNIC RESPIRATORY FAILURE
At 6:50 the patient went into a generalized tonic-clonic seizure. She seized for 8-10 minutes. She was taken by squad to Community hospital where she was admitted to the ER. They did a chest x-ray, CT scan, and blood work. All came back normal. She was then sent and admitted to Hospital main campus. They did and EEG which also came back normal.