chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Event: Vasovagal syncope with mild post-syncopal convulsions - patient caught by parent, no head trauma. Was unconscious for 15 seconds. Drowsy, weak on floor for another 10 minutes. Able to sit up in chair after 10 minutes. Treatment: pulse ox checked - normal. Blood pressure checked - ok. Given cool water to drink, cool washcloth to forehead. Given granola bar to eat. After about 20 minutes was able to carefully walk to the car and go home with parent.
Swelling and tenderness of lymph nodes in neck and groin areas that lasted for 5 days following the flu shot.  Lots of discomfort with the swelling such as pain and the back of my head and neck would be very painful when I would cough or laugh due to how tender the areas were.
I developed a moderately severe headache, body aches, fatigue and nausea within a few hours of the vaccine. These symptoms persisted into the next day, but had decreased in severity after about 24 hours. I still had a mild headache and body aches (specifically back, neck, and R shoulder pain) the next two days. Three days after, I started feeling worse. The headache again became moderately severe, as well as the neck and back pain,  fatigue and nausea.  This has continued through today (day 8 post-vaccine).  I still have a moderately severe constant headache (dull with throbbing with exertion or movement in neck), back and neck pain and stiffness, mild nausea, and fatigue.
Began sz @ home @ 730PM brought to ER for eval; continued seizing for 1 hrs total; t101 in ER; pt given meds in ER;
Diagnosed with hypertension in July2021, check from home. Lisinopril was given by doctor .  After 24 hrs of the 2nd dose I had sore arms , fatigue and body aches and within 24 hrs
Information unavailable.  Patient diet at home.  Covid 19 listed as a cause of death on death certificate.
stated that he hurt his back; This is a spontaneous report from a contactable consumer(patient). A 56-year-old male patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on 19-MAR-2021 at the 56 years old at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The patient stated that hurt his back last week in Apr2021 and his appointment was Friday of last week for the second shot. Wanted to know what to do about second shot. Stated that he worked and wanted to know if there was somewhere that he could go. Wanted to how long to wait to get the second one. Stated that he had the first one on 19Mar2021 and the second one was scheduled for 09Apr2021. Wanted to know if it was too late. Stated that he was just getting ready to go back to work. Stated that he thought that he was a He-man. The outcome of the event was unknown. Clarified hurting his back was not from the vaccine.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information, the event Back injury is most likely related to an intercurrent or underlying condition which is not related to the suspected drug.
Onset small red asymptomatic bumps on left arm the evening after receiving first time ZOSTAVAX vaccine in left deltoid. Takes baby aspirin every other night, also on COZAAR, omeprazole, and ZOCOR. Examined on 07/20/2012 and noted to have non-palpable petechiae on left medial arm, dorsal forearm, and anterior lower legs. No ecchymoses. Afebrile. No other reports of bleeding including gums or GI. Remote history pancreatic cancer, pulmonary emboli in 2007 without any complications from anticoagulation treatments. CBC all normal, platelet count 156,000. Rechecked on 7/25/2012, all lesions resolved, no symptoms. Stopped taking aspirin as instructed on 07/20/2012.
Severe headache, Nausea, Weakness, Numbness in fingers, arms, joint pain, myalgia - symptomatic treatment
SHORTNESS OF BREATH (Shortness of breath, Dyspnoea) THROAT SWELLING (Throat swelling, Pharyngeal swelling) The spontaneous report received from a patient concerned a female 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: Unknown) dose was not reported, administered on Right arm on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced shortness of breath, and was hospitalized (date unspecified). On MAR-2021, the subject experienced throat swelling. The patient was treated every 4 hours .Treatment medications (dates unspecified) included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the throat swelling and shortness of breath was not reported. The reporter did not provided causality between covid-19 vaccine ad26.cov2.s and throat swelling and shortness of breath was possible. This report was serious (Hospitalization Caused / Prolonged).
PATIENT FELT DIZZY BUT WITH NO NUSEA AND VOMITING WAS ANXIOUS AFTER FIRST SHOT
Headache; Chills; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization.  The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; CHILLS (non-serious), outcome "unknown", described as "Chills".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from an office manager refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unspecified number of doses of M-M-R II lot# L015279 with expiration date 30-APR-2017 (dose and route of administration were not reported). Administered doses of M-M-R II experienced a temperature excursion at 47 Fahrenheit degrees for 1 hour, with a prior excursion at 33 Fahrenheit degrees for 15 hours. No adverse effects were reported. Product quality complaint (PQC) was not reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA008787: US-009507513-1612USA003962:
19 days after received below vaccines, pt developed post-vaccination Varicella-like rash which was generalized.  (Started at injection site).
My COVID-19 symptoms started on 10/18/2022 at night around 09:00PM. I had a stuffy nose. The next day I lost my voice from 10/19/2022-10/20/2022. I had cough, headaches, weakness, and sneezing. I did a COVID-19 home test on 10/19/2022 which was positive. On 10/20/2022 I went to the pharmacy to  do anther COVD-19 test since they did the test wrong. I had to go back again  to the pharmacy to retake the COVID-19 test on 10/21/2022. They provided me with the positive COVID-19  result on 10/22/2022.  I ask the Pharmacist what to take for my cough they advised me to take Ricola Lozenges as per needed. I also took Theraflu and Alka seltzer plus Cold & Flu.  I even took Tylenol for headaches. I didn't go to my doctor because I treated it like a cold.  My symptoms are gone as of now but I get tired easily and I can't do any work . It didn't happen before this is something I am experiencing now after having COVID-19.  After COVID-19 I started experiencing heart  palpation it goes up and stays up 5-6 hours. The Cardiologist put a Holter Monitor. They said I was going into Atrial Fibrillation. The Cardiologist prescribed me with Moprolol 1/2 per day  and Aspirin  1 per day.  I have an appointment for Echocardiogram  and Stress test on 01/24/2023.  On 02/06/2023 the doctor will go over the result with me.
Emergency department course: Patient lists an allergy to doxylamine and so she was not given Benadryl.  She was medicated with Pepcid and Solu-Medrol.  She did develop itching while in the emergency department however no rash.  She is observed.  On reexam after treatment is feeling better is ready for discharge home.  She will follow-up with her primary care provider.  She is given prescription for prednisone.  She will take Pepcid for the next week.  Return the ER for any persistent worsening symptoms or any other concerns.  She is agreeable with the plan.  Questions were answered.
Intense headaches starting night of injection, lasted for days. I felt weak, pains in my legs ankles and arches. Stomach pain, and feeling lethargic. I took Tylenol but i think that disturbed my stomach. Still having soreness in my legs and ankles and still don't have energy today.
Swelling and tenderness of left lower leg; Swelling and tenderness of left lower leg; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 20Feb2021 at 13:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included transient small bowel obstruction, low grade uterine cancer s/p hysterectomy and tibia/fibula rod placement in 1991 s/p MVA. 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 receive any other vaccines within four weeks prior to the vaccination and did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 30Jan2021 at 15:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. On 23Feb2021 at 08:00, the patient experienced swelling and tenderness of left lower leg, starting 3 days after second COVID vaccine was given. This was at the same site of a prior surgical rod insertion for fracture tibia/fibia which occurred in 1991. Swelling and pain have persisted over the past 3 weeks. The patient was able to ambulate and weight bear but leg continued to remain painful. There was no redness, or discharge, not had fevers, only swelling and tenderness at the surgical site. The patient had not had swelling of leg prior to this event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling and tenderness of left lower leg was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a licensed practical nurse refers to a male patient of unknown age who had not eaten. In August 2016, "last week", the patient was vaccinated with a dose of GARDASIL 9 (dose, route and lot # not reported). Concomitant therapies included MENVEO. The nurse reported that in August 2016, the patient seemed fine when waiting after the vaccine, but then stood up and passed out. The patient did not receive any type of medical treatment or hospitalization and recovered right away. The patient did not seek medical attention. Additional information has been requested.
ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/17/2022 CHF EXACERBATION, UNSPECIFIED ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/17/2022 ABNL LUNG FIELD FINDING
Patient watched sibling receive vaccine. Patient then received HPV #1. Advised by RN to stay sitting on table for a time then when able to wait 20 min. Nurse then turned around to write note in chart. Patient then fell off table, after fainting, hit face onto floor. Was pale and sweaty. Injury to mouth and teeth. Patient with braces. No other apparent injury. Patient then was alert with pain. Patient still pale and lightheaded. Approximately 15 min with thready pulse. 1st BP 96/50 2nd 104/60. On O2 approximately 10 min. Called EMS to transport to ER to evaluate mouth. Patient alert and awake when EMS arrived.
Information has been received from a nurse concerning a 13 year old female who was vaccinated with a second dose of VARIVAX (Merck). One day or two after the second vaccination, the patient broke out with chickenpox in the mouth, around neck and face. On 26-AUG-2008 the patient was seen at the office for a second follow-up. No laboratory or diagnostics tests were performed. At the time of this report, the patient was recovering. Additional information has been requested. Follow up information has been received from a physician by a complete questionnaire concerning a 13 year old female patient with allergic reaction to SEPTRA and CEFZIL, who on 26-AUG-2008 was vaccinated with a second dose of VARIVAX (Merck) (Lot# 659204/1470U) intramuscularly. On 26-AUG-2008 the patient developed a rash. On an unspecified date in 2008 the patient's symptoms disappeared. Additional information is not expected.
patient experienced a rash after the 1st dose of SHingrix; This case was reported by a physician via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient had rash after vaccination. The reporter was unsure about the location of rash and if it had subsided. The reporter was in a hurry. No patient details provided. The reporter did not consent to follow up.
This spontaneous report was received from a Registered Nurse refers to a 16 year old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. On 18-JAN-2018, the patient was vaccinated with improperly stored GARDASIL 9, lot # N017686 (expiry date: 02-FEB-2020) for prophylaxis (incorrect product storage) (dose not reported). The vaccine was concomitantly reconstituted with properly stored sterile diluent. The vaccine underwent a temperature excursion of 35.30 F for 0.25 hours. No adverse effects were reported. The call was because of a data logger. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA000815: US-009507513-1809USA002916: US-009507513-1809USA002917: US-009507513-1809USA002918: US-009507513-1809USA002919: US-009507513-1809USA002921: US-009507513-1809USA002922: US-009507513-1809USA002923.
About two weeks after 2nd booster, my daughter started tremors in her hands and legs. Unrollable small shakes in both arms and legs.   The termers got stronger, and we visited hospital ER at the end of November. All blood and urine test were normal, but she kept shaking in the morning. On January 1st, 2023 she had a seizure and we ended up in another hospital.
Pt developed localized rash to tricep area. Rash was itchy and irritating. Developed 2 days.
Patient said he developed a bump at injection site a couple of days after the shot. It is still there and hasn't gone away yet. No regular MD so has not been looked at.
The vial was initially stored in the refrigerator on 20-Jan-2022 and was administered more than 30 days after; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 20-Jan-2022 and was administered more than 30 days after) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson & Johnson vaccine (Patient has received a primary Johnson & Johnson vaccine) on 08-Jul-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson vaccine.    On 22-Feb-2022 at 11:45 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2022 at 11:45 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 20-Jan-2022 and was administered more than 30 days after). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 20-Jan-2022 and was administered more than 30 days after) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient received the booster dose. Vial didn't undergo any temperature excursions. No symptoms were reported.  No medications, treatments, or additional doses had been administered at the time of this report.   This case was linked to MOD-2021-054280, MOD-2021-042747, MOD-2021-060758 (Patient Link).
Had TDap 4/12/06 in left arm.  Also had TwinRX LD, requested specifically because is a teacher and needed right hand to right.  For one month after, though no redness or swelling, pain in upper arm so excruciating initial suspicion was for a ripped rotator cuff, had xrays.  She had done nothing other than have those two shots in that arm.  Pain lasted over one month, and now she can only lift her left arm shoulder high and is in some discomfort still doing that.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/3/2021, 3/3/2021, and 9/28/2021. Bedbound s/p stroke presented to the emergency department for altered mental status and hypoxemia. Amitted for respiratory failure with COVID-19, septic shock, UTI, and altered mental status. Patient received antibiotics, dexamethasone, and remdesivir. Status declined rapidly with multiorgan failure w/increasing O2 demands. Expired 1/9/2022.
Sore arm, headache, fever 102 degrees, shakey, dizzy, weak, muscle aches.
Vaccine was predrawn into syringes and these were administered after the 6 hour expiration time limit
Not reconstituted with antigen; Only adjuvant was administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number 24R7T, expiry date 26th January 2024) for prophylaxis.   On 28th November 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 28th November 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 19-Dec-2022 Reporter's comment: No other information was provided. The reporter did not consent to follow-up. This is 2 of 2 linked cases reported by same reporter. Additional supportive information: The patient received only received adjuvant vial of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022189761:Same reporter
The first night I had aches and fever and some congestion in the chest. The aches lasted a day or two. The fever lasted 2 days the most. The congestion lasted 10 days, it wasn't bad. I was given an antiviral LAGEVRIO for 5 days.
I believe it was just an immune response to the vaccine and did not affect or interfere with my routine, but I haven't seen it listed anywhere and thought I should report it. About 18 hours post-vaccination, I noticed I had four styes developing in my eyes. There were two on the eyelash line of each of my lower eyelids. I used warm compresses to soothe the slight pain/irritation, and reduce the inflammation, and over a period of 3-5 weeks they healed on their own without medical intervention, though one does seem to have left a tiny scar on my left lower eyelid.
Information was received from a pharmacist concerning a patient of unknown age and gender. The pharmacist reported that an expired dose of ZOSTAVAX (lot # L040443, expiration date 15-JAN-2017) was administered to an unspecified patient on 02-MAR-2017 (dosage and route of administration not provided). No adverse effects. No further information to report. Additional information has been requested.
got the shingles shot, shingles symptoms/suspected vaccination failure; Can I still get shingles? I seem to have symptoms; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the shingles shot several years back. The patient asked if it was still possible to get shingles. The patient seemed to have symptoms. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.