chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient fainted after receiving vaccine; Information has been received from a physician via a field representative referring to a female patient of unknown age. The patient's medical history, concomitant medications and drug reactions/ allergies were unknown by the reporter.  On 18-JUN-2019, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (frequency, anatomical location, route of administration, batch/ lot number and expiration date were not reported) for prevention of human papillomavirus (HPV) and the patient had nothing to eat or drink before receiving vaccine.   On the same date, the patient fainted in physician office after receiving HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). The patient had to be taken to emergency room, however it was unknown if the patient was admitted. On an unknown date in June 2019, the patient was recovered.   No product quality complaint (PQC) was involved. Information about treatment given for adverse event and lab diagnostics/ studies performed was unknown by the reporter. The patient sought medical attention.   The causality between the event and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) therapy was not provided.  Upon internal review, the event of faint was determined to be medically significant.
On the day of he got a fever of 105 degrees. He also received the PCV13 shot as well. Following the day after the shot he got red itchy blotchy skin and now has eczema.
the temperature was above 46 Fahrenheit degrees (F)  (46.73F)  for 46 hours, 5 minutes 0 second; No additional AE/PQC reported at this time; This spontaneous report was received from a nurse, concerning a 6-month-old patient of unknown gender. The patient's historical drugs, historical conditions, and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with the third dose of improperly stored temperature excursion rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error) (lot number 1707585 and expiration date 21-FEB-2022 were verified as valid) taken orally for prophylaxis.   Moreover, the temperature was above 46 Fahrenheit degrees (F) (46.73F) for 46 hours, 5 minutes 0 seconds, which was detected by digital data logger; with no previous temperature excursion. The recommended range temperature was 36°F to 46°F (2 degrees celsius (°C) to 8 °C).   This is one of the multiple case reported from the same source.; Sender's Comments:  US-009507513-2104USA002044: US-009507513-2104USA002043: US-009507513-2104USA001947: US-009507513-2104USA002045: US-009507513-2104USA002041:
Patient expired on 08/20/2021.  1st dose 02/09/2021     2nd dose 03/06/2021
Every year patient got the flu; Initial information was received regarding an unsolicited valid non-serious social media case from a consumer via social media on 14-Oct-2020 .  This case involves patient with unknown demography who got the flu every year (influenza), while he/she received Influenza vaccine.  Medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine (Produced by unknown manufacturer, lot number and expiration date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient who got the flu every year (influenza), (unknown latency) following the administration of Influenza vaccine.  Laboratory data was not reported.   It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  There will be no information on the batch number for this case.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: Itchiness at injection site and fingers on the same day. Progression of rash to hands within 3 days.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of ROTATEQ (lot #, expiration date, dose and route were unknown) (Incorrect product storage). No adverse events were reported. This is one of two reports from the same reporter. Additional information has been requested.
The patient is a 50 y.o. female who presents to the Emergency Department with 3 days of a low abdominal discomfort with nausea and vomiting just today.  She says that she had decreased oral intake today due to her other symptoms and she had a low blood sugar of 65 earlier today.  She did not take her evening Lantus because of this.  She had already taken her usual Metformin and glipizide. She denies any fevers, denies any diarrhea.  Her last bowel movement was this morning and normal.  Denies any blood in the stools.  Denies any significant cough or breathing difficulty. Denies urinary symptoms, dysuria, hematuria. She reports that she is also had about 2 weeks of a left arm pain that comes and goes, and it seems to radiate to her trapezius.  She says that when the pain comes she feels a lump in her left outer arm.  She did see her PCP for this and was started on diclofenac about 1 week ago.  She says that this does help some.
He gave a Pfizer shot to a child and forgot to dilute it; He gave a Pfizer shot to a child and forgot to dilute it; Sore throat; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 7 year-old male patient received bnt162b2 (COMIRNATY), administered in deltoid left, administration date 29Jan2022 11:00 (Lot number: FL0007, Expiration Date: Sep2021) at the age of 7 years as dose 1, 0.2 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 29Jan2022 11:00, outcome "unknown" and all described as "He gave a Pfizer shot to a child and forgot to dilute it"; OROPHARYNGEAL PAIN (non-serious) with onset 29Jan2022, outcome "not recovered", described as "Sore throat".  Additional information: The reported confirmed the patient was administered with the Pfizer COVID19 vaccine, the paediatric formulation with an orange cap. The patient had a sore throat which didn't need to be sent to a doctor or anything. The patient's sore throat began later on during the day on 29Jan2022. The reporter confirmed the expiration date on the bottle is Sep2021 but mentions there was an extended expiration date which says 08Mar2022. The patient did not visit emergency room or physician office.Patient's Medical History was none (no allergies, nothing).Other Products was reported as no  No follow-up attempts are possible. No further information is expected.
Vomiting and diarrhea began 1 day after ROTATEQ administered. Has continued x 11 days.
c/o Feeling Funny-lightheaded, weird taste in mouth right after vaccines given. After 3 min became pale, lips grey-laying down after this. O2 SAT=97% P 77 B/P 116/66. Had better color after 5-10 min. 15 mg after vaccines had swelling of hand and pain that arm. 6:45 PC to parent-slept 1-3:45. No swelling after that.
Patient received 1st dose of HPV on 6/9/09 broke out w/rash.  0 complications pt. recovered.  Patient received 2nd dose of HPV on 09-01-09 w/rash more severe occurring within 2 hours of injection D/C series of HPV per Dr.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vial left in room temperature for over 24 hours) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vial left in room temperature for over 24 hours). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administered with vial left in room temperature for over 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The vial was first punctured on 29-Dec-2021 10:15 AM and was administered to this patient on 30-Dec-2021 11:05 AM. The vial was kept in room temperature after first puncture.
Child & parents came to office 2/29/08 for evaluation of "swelling of face after ingesting peanut butter. Child has known allergy to eggs. Exam with diagnosis of angioedema. During exam ~ 10 cm diameter hive in area of right antero-lateral thigh at site of immunization of DTaP & PCV7 on 2/27/08.
pt recv vax 6MAY94 & 21MAY94 devel mumps which are now subsiding; No further details were provided;
Approximately 10 minutes after injection I started driving home. I began to feel like my mind was foggy and some fatigue, then my lower lip and tongue started to tingle. I stopped driving and waited to see if anything further developed. I then felt flush and my hands became clammy. After maybe 2 minutes these symptoms resolved, I never had any trouble breathing so I continued home and did not seek any medical attention. The whole time frame was about 5 to 10 minutes.
She states that 5 patients were given expired doses. One elderly patient passed away the next day 24Feb2023.; Moderna lot 015B22A that expired 2/12/23. If a dose was given 2/23/23, She states that 5 patients were given expired doses; The vial was expired on 12-Feb-2023 and initially stored in the refrigerator on 23-Feb-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of DEATH (She states that 5 patients were given expired doses. One elderly patient passed away the next day 24Feb2023.) in an elderly male patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 23-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna lot 015B22A that expired 2/12/23. If a dose was given 2/23/23, She states that 5 patients were given expired doses) and PRODUCT STORAGE ERROR (The vial was expired on 12-Feb-2023 and initially stored in the refrigerator on 23-Feb-2023). The patient died on 24-Feb-2023. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, EXPIRED PRODUCT ADMINISTERED (Moderna lot 015B22A that expired 2/12/23. If a dose was given 2/23/23, She states that 5 patients were given expired doses) and PRODUCT STORAGE ERROR (The vial was expired on 12-Feb-2023 and initially stored in the refrigerator on 23-Feb-2023) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported.  The treatment medication was not reported.  No information provided about individual vials or unbroken cartons. The vial size was 2.5 ml but the information was unknown. The vial was initially stored on 23-Feb-2023. The vial had undergone no temperature excursions.  Company comment: This spontaneous case concerns an elderly male patient of unspecified age with no medical history reported, who experienced the fatal unexpected serious (medically significant) event of death that occurred one day after receiving a dose of mRNA-1273 vaccine in COVID-19 vaccination series. It was reported that, an expired product was administered which was initially stored in refrigerator.  Cause of death was unknown. It is unknown if an autopsy was performed. No further details on risk factors, circumstances leading to death, patient's past medical history and additional vaccination details were reported.The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-715165 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715165:Same reporter (4 patient's case); Reported Cause(s) of Death: Unknown cause of death
Hives on arm  that received injection, chills, cough, chest pain when coughing, sore throat general aches all over.
On 9/4/01, received MMR and Mantoux. On 9/16/01, pt complained of severe headache; pain in left leg towards ankle; blood shot eyes and was very dizzy. Went to a doctor. As of 9/27/01, still has severe headache but it does subside towards the end of the day with pain medication. Left leg still throbs.
This spontaneous report was received from a nurse concerning to a 5 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
"My" menstrual cycle was disrupted. "My" period arrived 9 days earlier than usual, on day 18 of "my" cycle.This has never happened to me. My periodaways arrives on day 27, latest day 29. Never before that.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 17:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. 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. The patient did not receive any medications within two weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 19Mar2021 at 17:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 03May2021, the patient's menstrual cycle was disrupted. The patient's period arrived 9 days earlier than usual, on day 18 of the cycle. This had never happened to the patient. The patient's period always arrived on day 27, latest day would be 29 and never before that. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 12May2021, the patient underwent COVID-19 PCR test via nasal swab and the result was negative. The clinical outcome of the event period arrived 9 days earlier than usual was resolved on an unknown date in May2021.    No follow-up attempts are needed. No further information is expected.
I had arm pain in my left arm initially with a 4" diameter pink circle around injection site.  It became itchy 2 days post shot and the hives developed on my left shoulder which within another couple of days spread across my chest and upper back.  By the end of the week, the hives covered my whole back and had spread across to my right shoulder.
Bradycardia, arrythmias, heart block, syncope, chest pains. Taking 3 kinds of medicine daily. Has plenty of follow ups with cardiologists, possibly put in a pacemaker.  9/25/09 ER records reeived DOS 11/10/08 and 11/22/08. Assessment: syncopal episodes, sinusitis, sinus arrhythmia. Patient felt dizzy, passed out, hit side of head. Presents at ER awake and alert saying she feels tired. Lost 40 lbs during the past year. Irregular periods. Nose stuffy. Drowsy. Bump on side of head. Systolic murmur left sternal border. 11/2/2009 records from 6/4-6/7/2009 and ED visit 8/5/2009. Patient was seen for c/o's syncope on both occasions. Tx: telemetry, lab and echo normal, Ekg noted bradycardia. Patient discharged with Holter monitor. Dx: vasovagal syncope
Patient at check out desk approx. 15 min after her Gardasil injection had syncope episode. Brief loss of consciousness - hit her head knocking the telephone off the wall. No visible injury from fall. Ambulance responded - pt declined going to Emergency Room.
After the vaccine booster, on Monday the 8th of November, swelling in my lips gradually became worse until Monday the 15th of November where I had a telehealth visit with the NP, I was prescribed Allegra in the morning and Xyzal at night. Symptoms do flair at times and come and go with swelling.
Information has been received from a pharmacist concerning a female who was vaccinated with one dose of varicella virus vaccine live. It was reported by the patient's husband that her assay shows very little immunity. Unspecified medical attention as sought. No further information was available. No product quality complaint was involved. Additional information has been requested.
On 5/13/22 I started feeling like a circle in my throat that was burning and in my head that started like a burning in my ear and that was the onset. After that I had major heartburn that made it difficult to breath with lots of chest pressure. My symptoms are still happening with sanding around my throat and really dry and my ear canals are also congested. My symptoms are very mild.
Second dose recieved more than the 35 days duration after first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose recieved more than the 35 days duration after first dose) in a 53-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 056A22A and 091DZA) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Less than 3 months ago).   On 17-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Apr-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose recieved more than the 35 days duration after first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose recieved more than the 35 days duration after first dose) outcome was unknown.            No concomitant medication was reported.  Patient did not have acute and chronic illnesses at the time of vaccination. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  No treatment medication was reported.   This case was linked to MOD-2022-546698 (Patient Link).
diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for an unknown indication.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 15-Mar-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sore arm for a day after the shot accompanied by a headache.  One week after the shot, a severe rash covering the whole body, along with vomiting and nausea
Nocturnal headache that improves during the day with associated vertigo that is persistent thus far.
Itchy swollen fingers and palms the following morning (Thursday, 3/11).  Red itchy bumps (hives?) on left wrist, then later on right wrist. Heels and feet had same reaction on Friday. I took Benadryl and was OK for all of Saturday. Today (Sunday, 3/14), I broke out the same rash but one my face,  mostly around my jaw and hair line, and my neck. Some coughing and wheezing, which I had not been experiencing prior
Mid August-September 1999, swelling of both hands and feet, joints, forearm, and wrist. Intense pain in left hand and arch of left foot. Fatigue.
Within 1 minute of receiving vaccine, patient felt extremely dizzy and starting to blackout.  Patient was sitting down with his head between his knees.  He began to perspire.  His first blood pressure reading was 83/38 & pulse of 40.  Patient was instructed to remain seating and after 5 minutes a second reading of 88/42 & pulse of 45 but patient was still very dizzy.  A third reading after another 5 minutes, see improvement to 95/48 & pulse of 50.  Patient begin to feel less dizzy and perspiration stop.  A fourth reading after another 5 minutes, reading was high at 170/110 & pulse of 105.  A fifth and sixth reading (17-20  minutes after incidence), see vital sign stabilized at 140/88, P:80 and then 120/77, P:70.  Patient fully recovered after 20 minutes after incidence.  Vital signs returned to normal and no longer feel dizzy.  No treatment needed.
pt recvd vax;12:30 felt difficulty breathing;3:30 devel inc t;ha; eye became blood shot;swollen glands/throat area & very lethargic;6:30 n,8:30 abdo cramping;lethargy,ha persisted thru noc;next day tired,ha but improved;
Patient fainted, was sweating, unable to respond to verbal commands.  Disoriented and dizzy for 30-40 minutes.
Had annual exam, all normal and bp 122/81 and got SHINGRIX vaccine first shot. 24 hrs later had high fever of 102 and severe headache and lightheaded. Went back to Dr right then thinking picked up the flu. Flu test negative but bp now 166/104. Dr had me take Ibuprofen and lie down for awhile. Bp down to about 144/90. Went home and back to Dr next day then another 3 days after that. Bp running in 140s/90s consistently. Been monitoring at home and always high, 140-160/90-105 or so. Never ever had high bp in my entire life. Do all my yearly visits, preventative care etc. Never had a single high reading before. 51 yr old woman with no family history of high bp, both parents alive in their 80s with no bp problems. High bp hit overnight and not coming down 2 wks later.