chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant concerning three patient of unknown age and gender. The pertinent medical history and concurrent conditions were not reported. On an unknown date (also reported as some doses were administered on  30-JUN-2016 and some doses were administered on unspecified dates), two unspecified patients were vaccinated with GARDASIL injection (lot number reported as M014929, expiration date: 27-MAY-2017)(dose, route and anatomical location of administration were not reported) and one unspecified patient was vaccinated with GARDASIL injection (lot number L040459, expiration date: 06-APR-2017) (dose, route and anatomical location of administration were not reported), which were improperly stored at 32.7F for 5 days. Additional temperature excursions reported maximum temperature 51.3 for 84 hours and minimum temperature 27.7 for 314 hours. The GARDASIL were back in range as reported. It was unknown if a digital data logger was involved. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Flu like symptoms, chest heaviness, anorexia, cough...symptoms have resolved as of 1/29/21
Patient appointment # D10E8SG - arrived in post vaccination room, shortly after being seated, he verbalized feeling dizzy and sweaty.  Presented alert, awake, and oriented, respiration easy and un-labored, color pink, skin warm and dry, no distress noted.  Evaluated by EMS BP 118/76, HR 86.  Discharged from POD at 1:45 PM accompanied with wife, who was also vaccinated today.  Patient  stated he feels ok, observed while ambulating, steady gait, no distress and released from POD at 1:45 PM
Approximately 15 minutes after receiving vaccines developed rash to face. Not itchy, no shortness of breath. Observed for additional 15 minutes for s/s anaphylaxis. Rash still present (pt. had been crying after shots) perhaps slightly increased. Given BENADRYL 12.5 mg orally here. Dad refused further doses.
Slowed time sense/disorientation, followed by euphoria. Overnight, fever, chills, delirium, soreness of arm.
Lump at the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump at the injection site) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Lump at the injection site). At the time of the report, VACCINATION SITE MASS (Lump at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications information were reported.   Reporter did not allow further contact
Immediately after injection, I had an allergic reaction itchiness in my throat and lymph nodes. The vaccine triggered my period the same day which was weird because my menstrual cycle just ended a week prior. I thought it was just spotting, but when I got home, I had a regular flow like a monthly period. The nurse practitioner there told me to take Benadryl. My roommate got me Benadryl and went to get food and went home. I woke up with intense vertigo for the next couple of days. The room was spinning around me; all the way to Sunday, I had severe vertigo and couldn't go to school all the way until 01/31/2022. I went to class on 02/01/2022. I went to class fine on 02/02/2022, but had a sharp headache after dinner that evening. The vertigo returned the following Thursday, 02/03/2022 and I couldn't go to class that Thursday until this Monday, 02/07/2022. I called my doctor who told the nurse practitioner to do a check-up as they diagnosed me with BPPV (benign paroxysmal positional vertigo). No medication would aid proper treatment to aid my recovery; I was given worksheets to exercise my brain for when experiencing vertigo episodes. I was also suggested to see an acupuncturist to help with treatment.
My left shoulder was in severe pain within 2 hours of injection. I couldn?t raise my left arm and was in tears.  I treated with heat but got no relief. I took 2 Aleve once a day. After ten days, with no decrease in pain, I made appointment with Orthopedic doctor.
Myocarditis. Shortness of breath, palpitations. Wore a heart sensor for 2 weeks until symptoms started to subside (took 3 months).
Patient got the first vaccine on Thursday and on these past 2 days, felt all the side effects; Dizziness; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient got the first vaccine on Thursday and on these past 2 days, felt all the side effects), DIZZINESS (Dizziness), HEADACHE (Headache) and NAUSEA (Nausea) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient got the first vaccine on Thursday and on these past 2 days, felt all the side effects), DIZZINESS (Dizziness), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, VACCINATION COMPLICATION (Patient got the first vaccine on Thursday and on these past 2 days, felt all the side effects), DIZZINESS (Dizziness), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not reported.
No additional AE reported; ROTATEQ involved in the temperature excursion was administered to the patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported.  On 04-OCT-2022, the patient was vaccinated with an improperly stored (temperature: 47.1 Fahrenheit (F) degrees for 9 hour and 15 minutes and 35.2 F degrees for 45 minutes) rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 2 milliliter, administered orally, lot #U038864 was found to be valid, expiration date: 22-APR-2023 (strength was not reported) for prophylaxis (product storage error). No additional adverse events were reported. There were no previous temperature excursions.
Red banding around (L) arm near injection site approx 1-2 cm on 2-14-11. On 2-15-11 red band faded but brighter red band spread almost to elbow (total of 4cm redness) on 2-17-11 left eye dark like black eye look. No treatment.
He got his vaccine, his arm was a little bit sore.  The next day he was unbelievably tired, wiped out at around 1:00  He also had a headache and also his blood sugar was elevated quite a bit, in the high 200's.   Normal BS's are from 35-150.   This lasted for approximately 8-9 hours after that, and was back to his normal self by 9-10:00 PM.    He has done well since.
Fever; chills; arm pain; lymph node swelling in arm pit of right arm (injection sight); tiredness; headache; Dose 1: Moderna, Dose 2: Moderna; Dose 1: Moderna, Dose 2: Moderna; Booster; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Dec2021 10:00 (Lot number: FJ1620) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII, administration date 03Nov2021. Vaccination history included: Moderna (DOSE 2, SINGLE, Dose brand: Modema, Batch/Lot No: 038B21A, Location of injection: Arm Left, Administration date: 28Apr2021), administration date: 28Apr2021, for Covid-19 immunization; Moderna (DOSE 1, SINGLE, Dose brand: Modema, Batch/Lot No: 016B21A, Location of injection: Arm Left, Administration date: 31Mar2021), administration date: 31Mar2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 10:00, outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 01Dec2021 22:00, outcome "not recovered", OFF LABEL USE (non-serious) with onset 01Dec2021 10:00, outcome "unknown" and all described as "Dose 1: Moderna, Dose 2: Moderna"; PYREXIA (non-serious) with onset 02Dec2021 22:00, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 02Dec2021 22:00, outcome "not recovered", described as "chills"; PAIN IN EXTREMITY (non-serious) with onset 02Dec2021 22:00, outcome "not recovered", described as "arm pain"; LYMPHADENOPATHY (non-serious) with onset 02Dec2021 22:00, outcome "not recovered", described as "lymph node swelling in arm pit of right arm (injection sight)"; FATIGUE (non-serious) with onset 02Dec2021 22:00, outcome "not recovered", described as "tiredness"; HEADACHE (non-serious) with onset 02Dec2021 22:00, outcome "not recovered", described as "headache". Therapeutic measures were not taken as a result of interchange of vaccine products, pyrexia, chills, pain in extremity, lymphadenopathy, fatigue, headache.  Additional Information: The patient took other vaccine in four weeks. Patient was not diagnosed with Covid-19 prior to vaccination, neither tested positive.  No follow-up attempts are possible. No further information is expected.
Healthy patient without immunization records, needing to start catch up immunizations, given PEDIARIX and MENACTRA at age 9.
After being screened to enter the healthcare facility and completing the intake screening for COVID vaccine, patient received the Janssen COVID vaccine at approximately 11:00am.  Several minutes later while sitting in the observation area, patient stated that he felt like throwing up and that he had a headache.  He said he just started feeling tired.  He denied any shortness of breath, swelling in his mouth or throat, or rashes.  He stated he had not eaten breakfast in the morning.  When his vital signs were checked, his blood pressure was 149/94 and heart rate was 90.  He was alert and oriented.  He was transported to the facility urgent care for further assessment and observation. In urgent care, he appeared to become more lethargic, although his vital signs remained stable.  911 was called.   While waiting for the ambulance, staff spoke to the patient's brother (who had been waiting outside for patient).  Patient's brother stated that patient had a fever and stomachache the night before, and that patient had a recent surgery and had not completed his post-op antibiotic course.  Patient's brother stated that he came to clinic anyways for the vaccine appointment because he wanted to get the COVID vaccine so that he could return to work (as required by his employer).   Patient was transported to  Hospital.  Per nurse report, he was released from the emergency room after a brief observation period.
he tested positive for covid after having the vaccine; he tested positive for covid after having the vaccine; Runny nose; Sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administration date 11Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "he tested positive for covid after having the vaccine"; RHINORRHOEA (non-serious) with onset 2022, outcome "unknown", described as "Runny nose"; OROPHARYNGEAL PAIN (non-serious) with onset 2022, outcome "unknown", described as "Sore throat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (unspecified date) positive; (07Jan2022) positive, notes: On 07Jan2022 we tested positive for COVID-19 on a PCR test"; (12Jan2022) positive. Investigations: Then the caller tested again 5 days later, and on 12Jan2022 they were still positive. The caller has had the Pfizer covid vaccine. The caller got his booster on 11Dec2021. The caller tested positive for covid after having the vaccine. The caller had a runny nose and sore throat. don't have additional information on a second dose of the Pfizer-BioNTech COVID-19 vaccine for 5 through 11 years of age formulation (orange cap) being administered in an interval longer than 11 weeks". My symptoms were a runny dose sore throat after vaccination. My wife only has received her two doses of the Pfizer-BioNTech COVID-19 vaccine, after the second dose she experienced side effects like her body ached, night sweats got over her. On 07Jan2022 we tested positive for COVID-19 on a PCR test".   The lot number for bnt162b2 was not provided and will be requested during follow up.
Narrative:  Pt homeless, hx of substance abuse, hep-C & depression received one dose of covid vaccine from outside community clinic on 3/31/21. Pt died on 5/22/2021 per record system. Circumstances of death not noted. Not able to assess if covid vaccine related to patient's death.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration of vaccine include 7th May 2021 No concomitant medication information were provided.
p/vax pt devel pain & weakness in rt arm & large red area about 4 inches below site of inj;no redness @ site of inj;pt only spoke to MD by phone & MD ordered DPH;
Presentees with orthostatic hypotension and + covid; Tx: Rocephin, decadron, Sinulair; usual 20 mg of lisinopril was decreased to 5-10 mg, given IV fluids, stabilized with this. His orthostasis resolved, is ambulatory, his Covid remains stable does not require supplemental oxygen. saturations are holding in the 91-92% saturated range which is his usual. No new complications are seen, his chronic venous stasis changes are unchanged, no new clots are noted, his protime accelerates felt related to his Covid and his Coumadin is held this time but will restart in 2 days.
This spontaneous report as received from a registered nurse via Medical Record refers to a currently 4 years old patient with no known drug allergies (NKDA). On 17-MAR-2010, the patient was vaccinated with the first dose of HepB (unspecified) for HepB. On 06-MAY-2010, the patient was vaccinated with the first dose of PENTACEL for DTP/aP; Second dose of HepB (unspecified) for HepB; First dose of PREVNAR for PCV and First dose of ROTATEQ for Rotavirus. On 13-JUL-2010, the patient was vaccinated with the second dose of PENTACEL for DTP/aP; Second dose of PREVNAR 13 for PCV and Second dose of ROTATEQ for Rotavirus. On 20-SEP-2010, the patient was vaccinated with the third dose of PEDIARIX for DTP/aP; Third dose of ACTHIB for Hib; Third dose of PREVNAR 13 for PCV. On 20-DEC-2010, the patient was vaccinated with the first dose of FLUZONE for influenza. On 01-JUN-2011, the patient was vaccinated with the fourth dose of PENTACEL for DTP/aP; First dose of M-M-R II for Measles; Fourth dose of PREVNAR 13 for PCV. On 15-SEP-2011, the patient was vaccinated with the first dose of HAVRIX for HepA; Second dose of FLUZONE for influenza. On 21-MAR-2012, the patient was vaccinated with the second dose of HAVRIX for HepA. On 26-MAR-2014 at 02:25:15 pm, the patient was vaccinated with the Second dose of PROQUAD (Merck) (lot # J015312, expiry date: 03-JUN-2015) (dose and route of administration not reported) which was stored improperly, exposed to 42F for 4 weeks. It was reported that the patient did not seek medical attention. On the same date, the patient was vaccinated concomitantly with the Fifth dose of DAPTACEL for DTP/aP and the fifth dose of IPOL for Polio. This is one of several reports from the same source. Pediatric medical records were received and reviewed; no adverse experiences related to the prenatal exposure or to other Merck Products were identified. All available medical records will be provided upon request. Additional information is not expected.
Fever, chills, body aches, headache when I got up the day after the shot, around 10am. Got worse as the day went on. Took ibuprofen at about 9pm and felt much better. Felt fine the next day.
CMA administered two Quadrivalent Fluzone injections of 0.5ml to child. One Fluzone was administered to left thigh and second Fluzone was administered to the right thigh.
It started off my smart watch advised me that heart rate was higher than 120 with no activity for 10 min when I checked my heart rate it told me it was beating at 146 beats per min and then it climbed from there to 164, then I was feeling really hot I took my lunch at work and took my temp, which was 101.9 and then from there I just layed down and tried to take a nap but could not I was shivering and my body was completely aching and I had sharp pain in my left hand right below my thumb in between my joint, it would hurt when I tried to sit up or move it was just that one spot that would hurt. I kept having a fever and took ibuprofen and that did not take any effect but hours later I took Tylenol, that helped a little bit and later in the evening my fever went down to 99.4 and stayed down for awhile but came right back. I could not really walk, I was shivering and my body ached, and I would have a headache in and out as well, my heart rate would go back up to like 140 to 150. The next day I woke up to another fever and took Advil Dual action, and it helped some it would go up and down, and then by the middle of the day the fever finally broke and the soreness went away and I have been better since then and everything is back to normal.
This spontaneous report was received from a nurse and a healthcare worker and refers to a 4 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 23-DEC-2015, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of the several reports received from the same reporter. Additional information has been requested.
26OCT93 in eve became pale then started having fussy spells frequently;  mom describes it as flipping out/ (screams, gets red & trembles all over); pediatrician told mom we would decide re giving "P" @ next visit;
22JUL92 recvd Engerix-B & devel a back ache & shoulder pain;
Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: SINUS PRESSURE-Severe
Became lightheaded/dizzy/weak within the first 5 minutes of receiving vaccination. Began sweating and had chest tightness. Began seeing red spots which progressively filled field of vision/everything turned red and couldn?t see anything for a few minutes. Pharmacist checked on me periodically and gave me cold water to drink. Vision slowly returned after drinking water/placing cold water bottle on forehead. This all occurred within 15 minutes of receiving vaccination. I stayed at pharmacy for an hour before I started feeling well enough to drive home.
Information has been received from a certified medical assistant concerning a female (age not reported) who was vaccinated with a dose of ZOSTAVAX and experienced redness about the size of a quarter at the injection site. No treatment was given. No other complications were reported. Additional information has been requested.
I had severe pains in my leg that seemed to travel down over the course of 24 hours. I was extremely nauseous and had a mild to severe headache off and on for a week. 103-degree fever beginning at 7:30 PM the night I got my shot and lasted until 6AM.
Stent insertion NOS; This spontaneous case was reported by a patient family member or friend and describes the occurrence of STENT PLACEMENT (Stent insertion NOS) in a 66-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced STENT PLACEMENT (Stent insertion NOS). At the time of the report, STENT PLACEMENT (Stent insertion NOS) outcome was unknown. Not Provided          No Concomitant  and Treatment medications was reported.
irregular heartbeat; My heart has been beating very fast; All night I couldn't sleep at all; This is a spontaneous report from a contactable consumer (patient). A 28-years-old male patient received first dose of BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 13Aug2021 at 13:00 hours as dose 1, single (at the age of 28-years-old) for Covid-19 immunisation. Patient had no medical history and had no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any concomitant medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. On 13Aug2021, at 16:00 hours, patient stated that his heart had been beating very fast all night, he couldn't sleep at all. On 14Aug2021, now patient do have an irregular heartbeat. The patient did not receive any treatment for the events. The outcome of all the events was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
MMR given on 3/13/03, eye pain with fever (37.8) around 3/24. Noted on 3/25 start of rash on face, which spread to chest and back and thighs. Around 3/27 had severe joint pain in all joints with swelling in wrist. Was placed on prednisone by MD.
HPV Vax #1 given IM (L) deltoid with immediate discomfort in shoulder "fluid expanding the shoulder". Pain increasing over past 5 weeks with decreased range of motion and deep burning pain. Pain to palpation over deltoid and posterior rotator cuff muscles. No redness. No swelling. No drainage. No fevers. Orthopedics to evaluate shoulder joint.
Became very drowsy around 4:00pm on June 1. I felt completely wiped and stayed in bed the rest of the evening and the next day. Symptoms went away around 4:00pm on June 2nd. After my 1st COVID vaccine, I was very lethargic, achy, and had a fever.