chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 07/05/2006 a white male presented to the health department with a 12-year-old girl with an immunization record.  The girl's mother was present.  The girl and her mother do not speak English.  The white male, interpreted for them and signed the immunizations.  The 12-year-old girl required to have an MMR, VZV, Hepatitis A and B, and Menactra.  The MMR and MENACTRA was given in the right arm.  The MMR subcutaneous and the MMR intramuscular.  I gave the VZV subcutaneous in the left arm and TWINRIX intramuscular in the left arm.  After the immunizations were given, the client was sitting in the chair and I told him that I would put them into the computer and moved to the other side.  A woman came around and asked me how many immunizations the 12-year-old girl received and I stated four and then realized that she needed an IPV.  The immunizations were given approximately at 2.50 pm on 07-05-2006.  Approximately 2:55, I heard a woman screaming and walked over to the 12-year-old girl lying on the floor. A registered nurse stated that when she started to fall out of the chair, a male caught her and laid her on the floor.  At this point, the registered nurse was checking her blood pressure.  I told the woman to call 911.  The vitals were 125/80, pulse 100, and respiration were 20.  When I was checking her pulse, her eyes were open and she was having some jerking motions in her lips.  The emergency medial services arrived approximately 3:00 P.M. and assessed the client.  No medications given.  The male declined for her to be taken to the emergency room.  I called the male on 07-06-2006, and he stated that the 12-year-old girl is fine.  She did not have any problems.
Tested positive for covid-19 after 1st dose; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Apr-2021. The most recent information was received on 23-Jun-2021 and was forwarded to Moderna on 23-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for covid-19 after 1st dose) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid-19 after 1st dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for covid-19 after 1st dose) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, COVID-19: positive (Positive) Positive. On an unknown date, COVID-19: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No Treatment Medications were provided. He stated that he had never been positive for Covid-19 and did not remember reporting this or other events.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Significant Follow up received on 23 June 2021. Added new laboratory data.
Possible hematochezia, mucously stool after each IPV vaccine, both in combo (PEDIARIX at 2 mos. PENTACEL at 4 mos) and singly on 12/19/16.
syncope, leading to fainting and mild seizure. Patient woke up without need for epinephrine and was alert and oriented. Paramedics called to check out patient. Patient declined ambulance.
The patient was given the Pfizer vaccine on 2/16/2021 and was given Moderna vaccine on 3/9/2021.  No unusual symptoms was noticed.
Chest Pain; Dizzy; Hard time breathing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Aug2021 19:00 (Lot number: FC3182, Expiration Date: 31Oct2021) at the age of 29 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHEST PAIN (non-serious) with onset 19Sep2021 20:00, outcome "not recovered", described as "Chest Pain"; DIZZINESS (non-serious) with onset 19Sep2021 20:00, outcome "not recovered", described as "Dizzy"; DYSPNOEA (non-serious) with onset 19Sep2021 20:00, outcome "not recovered", described as "Hard time breathing". The events "chest pain", "dizzy" and "hard time breathing" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of chest pain, dizziness, dyspnoea. Additional information: The patient did not receive any other vaccine within four weeks and patient did not receive any other vaccine within two weeks. The patient has not been tested for covid prior to vaccination. The patient was not covid prior to vaccination. No follow-up attempts are possible. No further information is expected.
itching / still get itchy; hands are stiff; cannot move my second finger on right hand; both legs are numb; bit swollen; dizziness; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PAIN IN EXTREMITY (sore arm), PRURITUS (itching / still get itchy), MUSCULOSKELETAL STIFFNESS (hands are stiff) and HYPOKINESIA (cannot move my second finger on right hand) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     patients has a history of taking blood thinners.  The patient's past medical history included Diabetes.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 02-Apr-2021, the patient experienced DIZZINESS (dizziness) and PAIN IN EXTREMITY (sore arm). On 03-Apr-2021, the patient experienced PRURITUS (itching / still get itchy), MUSCULOSKELETAL STIFFNESS (hands are stiff), HYPOKINESIA (cannot move my second finger on right hand), HYPOAESTHESIA (both legs are numb) and PERIPHERAL SWELLING (bit swollen). At the time of the report, DIZZINESS (dizziness), PAIN IN EXTREMITY (sore arm), PRURITUS (itching / still get itchy), MUSCULOSKELETAL STIFFNESS (hands are stiff), HYPOKINESIA (cannot move my second finger on right hand), HYPOAESTHESIA (both legs are numb) and PERIPHERAL SWELLING (bit swollen) outcome was unknown. Not Provided          Reporter did not allow further contact
Right Deltoid swollen two days after administering the Tdap. Some itching noted. Parent not sure when swelling started noted 2 days later.
Flu-like sxs; fever; full body muscle pain; weakness; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 at 12:15 as dose 5 (booster), single (Lot number: HD9835) at the age of 39 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Lot number: Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Lot number: Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Lot number: Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Lot number: Unknown), for Covid-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 04Oct2023 at 18:00, outcome "recovered", described as "Flu-like sxs"; FATIGUE (non-serious) with onset 04Oct2023 at 18:00, outcome "recovered"; PYREXIA (non-serious) with onset 04Oct2023 at 18:00, outcome "recovered", described as "fever"; MYALGIA (non-serious) with onset 04Oct2023 at 18:00, outcome "recovered", described as "full body muscle pain"; ASTHENIA (non-serious) with onset 04Oct2023 at 18:00, outcome "recovered", described as "weakness". Therapeutic measures were not taken as a result of influenza like illness, pyrexia, myalgia, asthenia, fatigue.  Additional Information: It was reported that the patient did not take any other vaccine in four weeks. Flu-like symptoms (fever, full body muscle pain and weakness, fatigue) for approx 24 hours - symptoms started approx 6 hours after injection. The patient was not tested for COVID Prior to and post vaccination.
On 12/07/2022, I started to experience symptoms, but I figured it was just allergies. I took a COVID test and it was negative. I stayed home from work, the following day because I felt awful. I went to an Urgent Care and they did a PCR COVID-19 test and called me on 12/10/2022 to inform me that the test came back positive. I was prescribed Paxlovid, which I feel helped me. I could notice an improvement every day.
Swollen Arm; Arm was hot to touch; Swelling has moved to wrist; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), PERIPHERAL SWELLING (Swollen Arm), INJECTION SITE WARMTH (Arm was hot to touch) and JOINT SWELLING (Swelling has moved to wrist) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced PRURITUS (Itchiness). On 10-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen Arm), INJECTION SITE WARMTH (Arm was hot to touch) and JOINT SWELLING (Swelling has moved to wrist). On 16-Jan-2021, PRURITUS (Itchiness) had resolved. On 16-Feb-2021, PERIPHERAL SWELLING (Swollen Arm) and JOINT SWELLING (Swelling has moved to wrist) had resolved. At the time of the report, INJECTION SITE WARMTH (Arm was hot to touch) outcome was unknown.
swelling of abdominal lymph nodes; he was in so much pain that we took him to ER; They did CT and confirmed mesenteric lymphadenitis; This is a spontaneous report from a contactable consumer (patient). A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EP7534, Expiration Date: not reported), via an unspecified route of administration, in left arm on 26Jul2021 16:15 as dose 1, single for COVID-19 immunization (at the age of 12-year-old). Medical history included acid reflux from an unknown date and unknown if ongoing and had no known allergies. Patient had not experienced any past drug event. There were no concomitant medications. Patient did not receive any other vaccine in four weeks and other medications in two weeks. Patient had no covid prior vaccination and was not covid tested post vaccination. The patient experienced swelling of abdominal lymph nodes, he was in so much pain that they took him to ER, they did ct and confirmed mesenteric lymphadenitis on 10Aug2021 06:00. It was reported that, both times 2 weeks after each vaccine he had experienced swelling of abdominal lymph nodes. The first time he was in so much pain that they took him to ER believing it to be appendicitis. They did CT and confirmed mesenteric lymphadenitis. Pain lasted 2 weeks. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included computerised tomogram: confirmed mesenteric lymphadenitis on an unspecified date. Therapeutic measures were taken as a result of events with prescription medications. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Additional Details: Thirty minutes after shot, patient passed out and urinated on herself. Plus, had what she discribed as a seizure.
27JUL09 about 15 minutes after receiving first AVA, first ENGERIX-B and second TYPHOID VI vaccinations (7/2009) began to "feel bad", felt a "rush going through her arms", was itchy with red flat blotchy flushed skin to arms, neck, and chest that developed into hives, was having difficulty breathing, and was lightheaded. Her dizziness was described as the room spinning with any head movement. She denied any blurry vision, sweating chest pain or tightness in her throat. Staff placed her flat, elevated her feet Her blood pressure was recorded as 146/90 pulse 86. Five minutes later BP was 122/77 pulse 81 (patient thinks her BP is usually 135/74). She was given IM EPI-PEN. She reported immediate improvement to breathing and dizziness following epinephrine. By the time the patient was transferred, the majority of symptoms has resolved. Provider documented shortness of breath with no wheezing and skin with "hives". She was given 10 mg of oral ZYRTEC and was monitored for 3-6 hours before release. A few hours prior to vaccinations and onset of symptoms she ate chicken salad with ranch dressing and diet coke. She has had these items at the same restaurant since without any adverse reaction. No new clothes, detergents, deodorants, perfumes, etc. No pollen, mold, dogs/cats, bee/insect, or latex allergies. She did not exercise prior to this reaction. Her hives gradually resolved over the next 10 days on ZYRTEC. She has had no reoccurrence since. She deployed in 2009 for two weeks and upon return was advised no civilian allergist could evaluate her for a potential AVA vaccine allergy. She was referred to hospital in Jan 2010. Records note further vaccinations in November 2009 with IM influenza and Jan 2010 with H1N1 with no adverse events reported.
Fever, chills, very swollen left arm-entire arm. Fatigue (slept for 3.5 hours as a nap), wheezing, runny nose, painful ears. Rash on left side of face, arms from shoulder to hand. Very sore throat, aching joints, stiffness, shaky, tremors face/hands. Hands cramping, lightheadedness, headaches, spinning sensation. Still has sore throat, fever aching joints, sneezing, coughing
Heart palpitations/arrhythmia, chest tightness, numb fingers so severe I went to the ER.; Heart palpitations/arrhythmia, chest tightness, numb fingers so severe I went to the ER.; Heart palpitations/arrhythmia, chest tightness, numb fingers so severe I went to the ER.; Heart palpitations/arrhythmia, chest tightness, numb fingers so severe I went to the ER.; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 30-year-old female patient received bnt162b2 (brand=Pfizer), dose 2 via an unspecified route of administration, administered in arm right on 10May2021 10:00 (Batch/Lot Number: ER8731) as dose 2, single at the age of 29-year-old for covid-19 immunisation. Dose 1 was received with lot number: EW0176, 19Apr2021 09:00, dose number 1, vaccine location: right arm at the age of 29-year-old for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Facility type vaccine: pharmacy or drug store. No other vaccine in four weeks. Adverse event reported as heart palpitations/arrhythmia, chest tightness, numb fingers so severe patient went to the ER on 24Jul2021 21:00. Events resulted in Emergency room/department or urgent care. Patient recovered with lasting effects. No treatment. No COVID prior vaccination. No COVID tested post vaccination. The outcome of event was recovered with sequelae.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Hypertension-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient received Pfizer Covid vaccine today and presented with swollen, tingling, itchy lips within 15 minutes of the dose.  Benadryl administered to patient.  911 was called and paramedics arrived.  Patient's friend returned to let us know that patient was being monitored at the ER for the next 6 to 7 hours and was doing alright. Mildly elevated blood pressure here and at ER.
COVID-19 INFECTION/LOSS OF SMELL AND TASTE/RUNNING NOSE/COUGHING/HEADACHE/BODY  ACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, vaccinated in right arm, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced covid-19 infection/loss of smell and taste/running nose/coughing/headache/body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19 infection/loss of smell and taste/running nose/coughing/headache/body ache. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case assessed as non serious.
I got nauseas and clammy.  Then started getting dizzy.  Next morning the 1st, I had vertigo very bad. Still have it today the 2nd.  But tiny but better.  Been online, several people have it after vaccine.  I'm scared to take 2nd shot?
Daughter received the primary series last year. She received the booster in November. Since then, she has not had her period.; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the parent.  A 16-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, 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: MENSTRUATION IRREGULAR (non-serious) with onset 2021, outcome "unknown", described as "Daughter received the primary series last year. She received the booster in November. Since then, she has not had her period.".  Additional information: The patient received the primary series last year. She received the booster in Nov2021. Since then, she has not had her period. Her period was not regular when she received the booster, however, it was non existent at this time. The patient has also gone through some weight loss. The only difference from everyday life was the fact that the patient received the Pfizer BioNTech Covid-19 vaccine booster. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
AFTER a few hours, I came home not feeling well.  I lied down and slept for at least 18 hours.  On 2/9/21, I called my doctors office due to dangerously elevated blood pressure.  I was told to immediately go to the hospital.  My pressure was brought down and was given meds (clonidine).  On 2/28/21, I experienced a similar incident after which I was told to follow up with my cardiologist and primary care physicians.  I was put on losartin, clonidine and hydrochlorothiiazide and monitor my pressure.  I had a follow up on 3/10/21 with my cardiologist.  Blood pressure had remained high.  Although this could be coincidental, a continuous check of BP has shown it going back to normal.
C/o painful arm 7 days after vaccination.  Redness & itching.  No known allergies.  No hives or respiratory symptoms.  Rx with CLARITIN & BENADRYL.  Symptoms resolved after 24 hours.  Mild reaction per ER physician (will note as allergen in file).
Influenza vaccine given at 14:18. Symptoms started at 14:30 - cold sweats, shortness of breath, chest pain, dizziness. Referred to ER. Had EKG done. Medications given: Duoneb, Solumedrol, Benadryl. Observed for 4 hours and then discharged home with prescription for prednisone.
received the full dose instead of the half dose for the booster dose; This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (received the full dose instead of the half dose for the booster dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (received the full dose instead of the half dose for the booster dose). On 28-Oct-2021, ACCIDENTAL OVERDOSE (received the full dose instead of the half dose for the booster dose) 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 medications were reported.
Initial minor Anaphylactic reaction with more severe biphasic reaction approximately 19 hours later. Called emergency and was monitored at hospital. Still feeling symptoms including abdominal pain, nausea, dizziness, lightheadedness, fatigue, pain and itching at site.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a clinic as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2015, the patient was treated at a healthcare facility/clinic (by an unspecified healthcare professional) for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
1/14/09 pt received vaccines (Dtap, Fluzone). No allegeries or cold systems noted or reported. 1/15/09 - mother states noted "bumps" under patient's arms and in peri-area. Red rash progressed to hives over entire body and took on purplish hue along with irritability, fever, and increased lip swelling.  Pt was seen 1/19/09 at ED and discharged then called by PMD to take child to Hospital on 1/20/09 where he was hospitalized for 1 day. After discharge, was followed by Dermotologist and awaiting test results which were received by this office 2/12/09.  2/20/09 Derm consult dated 1/22/09 received as f/u for ER visit for 1 wk hx of fever, irritability, tense painful skin and arthralgias. Periorbital edema and lip swelling noted on arrival to ER.  F/u visit with no DX noted. Still with residual blotchy erythema of the legs which is cyclical in nature.   2/27/09 MR received for DOS 1/20-21/2009 with DX:  Serum sickness. Pt presented with widespread erythema, irritability and fever with lip swelling & erythema.  Admitted for w/u for possible Kawasaki's which was r/o.  Severe itching noted. Tx with steroids and antihistamines and d/c for outpt f/u (above).