chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5 days after the 1st dose, I had the 1st nose bleed ever in my life. I had a few others before the 2nd dose. After the 2nd dose, the number of nose bleeds have increased. I now have several per day, each lasting about 15 minutes; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 18Mar2021 (at the age of 65-years-old) and also 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 08Apr2021 at 14:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, fibromyalgia, cluster headaches and hernia surgery. The patient had unspecified 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. Concomitant medications included verapamil (MANUFACTURER UNKNOWN), tizanidine (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) and chromium (MANUFACTURER UNKNOWN); all from an unknown date taken for unknown indications and unknown if ongoing. On 23Mar2021 at 14:00, 5 days after the first dose the patient had the first nose bleed ever in his life and also had a few others before the second dose. On an unknown date in Apr2021, after the second dose, the number of nose bleeds had increased. He now (at the time of this report) had several per day, each lasting about 15 minutes. 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 not been tested for COVID-19. The clinical outcome of the event 5 days after the first dose had the first nose bleed ever in his life and also had a few others before the second dose and the number of nose bleeds had increased after second dose, now he had several per day, each lasting about 15 minutes was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Permanent congestion starting a few weeks after the injection. I?ve visited the doctor numerous times and have been prescribed a few different medications but nothing has relieved the congestion. I have been congested since March 2021.
Numbness and tingling in both of his arms; Numbness and tingling in both of his arms; This is a spontaneous report from a contactable pharmacist through Pfizer sponsored program. A male patient of an unspecified age received 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 on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date (two to three days after receiving the first dose of the vaccine), patient experienced numbness and tingling in both of his arms. No patient identifiers were provided but the reporter has first hand knowledge of the patient and was reporting on a specific patient. Pharmacist wanted to know if there had been reports like this. The outcome of both the events was unknown.
shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or around 19-AUG-2011, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered and was diagnosed with shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered/not resolved. The reporter regarded the event as related to zoster vaccine live (ZOSTAVAX).  The reporter considered the event of herpes zoster to be disabling.
Anaphylaxis, change in voice, throat tightness, per pt report, similar reaction to what he experiences after eating almonds Narrative: 1535- Epinephrine 0.3mg IM given left deltoid 1540- IV access establised 1545- Solumedrol 125mg IV given States feels much better, throat not so tight/irritated 1550- Benadryl 50mg IV given 1555- Famotidine 20mg IV given No further symptoms after 3 hours of observation Discharged home with EpiPen, prednisone and diphenhydramine
Pinkish red rash on legs, arms and abdomen. Not raised, not itching. Non diffuse, blotchy rash.
sick; Initial information received on 20-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves patient (unknown demographics) who experienced sick (illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination 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 expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.
On 12/30/2021 3pm took covid 19 boost shot(Moderna) at facility, same night felt chill and headache, then left arm axillary and inguinal lymph notes swelling, stomach cramping, then next day noon had periods happen( post menopause for one year and half). prolong , heavy bleeding for 8 days. set appt to see my OB doctor. doctor suggusted to do the following percedure:  1. blood work for checking hormone level 2. ultrsound for abnormal finding 3. endometrial biopsy for further abnormal finding after ultrsound 4. office visit for check uterus size. uterus thicken than normal range per menopause patient.
HE WAS UNABLE TO LIFT ARM. AFTER GOING FOR A 3 MILE WALK FELT FAINT AND SWEATY. (TEMP WAS HOT OUTSIDE). WIFE CAME INTO PHARMACY TO TELL US ON 4-9-15, THEY BELIEVE THE REACTION WAS DUE TO THE VACCINE SINCE HE HAD A SIMILAR REACTION SEVERAL YEARS AGO WHEN HE HAD ANOTHER PNEUMO VACCINE.
No adverse event; Patient was administered the first dose of the Moderna COVID-19 vaccine from an incorrect vial/ incorrectly received a 0.5 mL dose from the adult Moderna COVID-19 vaccine vial; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was administered the first dose of the Moderna COVID-19 vaccine from an incorrect vial/ incorrectly received a 0.5 mL dose from the adult Moderna COVID-19 vaccine vial) and NO ADVERSE EVENT (No adverse event) in a 7-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Dec-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Patient was administered the first dose of the Moderna COVID-19 vaccine from an incorrect vial/ incorrectly received a 0.5 mL dose from the adult Moderna COVID-19 vaccine vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was administered the first dose of the Moderna COVID-19 vaccine from an incorrect vial/ incorrectly received a 0.5 mL dose from the adult Moderna COVID-19 vaccine vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient was administered the first dose of the Moderna COVID-19 vaccine from an incorrect vial/ incorrectly received a 0.5 mL dose from the adult Moderna COVID-19 vaccine vial).    Concomitant product information was not provided by the reporter.   It was reported that recently discovered the pediatric patient was administered the first dose of the Moderna COVID-19 vaccine from an incorrect vial. Patient incorrectly received a 0.5 mL dose from the adult Moderna COVID-19 vaccine vial as the facility didn't carry the pediatric vials and no adverse reactions have been reported by the patient so far.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-695008 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-695008:Same reporter
Lightheadedness 15-30 minutes after vaccination. Blotchy face, itching lips, and itching tongue developed after she had some gummy bears and water. Vital signs stable throughout. Patient took OTC Benadryl, felt better, and was discharged home.
PATIENT STATE BACK OF ARM AND PROCEEDING DOWN ARM TOWARD ELBOW, AREA ALSO SWOLLEN AND WARM TO TOUCH. AS REDNESS AND SWELLING RESOLVED, AREA CHANGED TO ITCHING.
99 y.o. nursing home resident received 1st Moderna Covid vaccine on 7/13/21. On 7/17/21, Resident complained of chest pain and was transferred to ER and admitted to Acute with A-FIB.  Resident returned to LTC unit 7/20/21 on hospice.
Itching of left arm,close to injection site. Reports no difficulty breathing. No visible rash. Remains in medical screening for monitoring beyond 15 minutes. No interventions. Patient left at 16:48.
urticarial rash on chest and posterior neck. recommend 1st and 2nd gen antihistamines as well as topical corticosteroid
Red sore arm approximately 3 inches below injection site.  Red rash like area on left inside area of lower leg. Pictures available.
2 days post vaccine patient developed lower extremity edema which over the next 3 weeks progressed to anasarca and renal failure requiring hospitalization, renal biopsy and eventual hemodialysis.
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized with bronchopneumonia.  Vaccination took place on 10/10/07 and hospital admission was 11/21/07. According to physician, relationship to study treatment is 'Unlikely'. We would be happy to forward the Study's SAE Report Form upon request.  2/19/08 Reviewed SAE report which states pt admitted to hospital 11/21-11/26/2007 w/increased SOB & productive cough.  Tx w/antibiotics & steroids. FINAL DX: bronchopneumonia.
Pt. sat for 20 minutes after vaccine. noted some pain in left back (same side as arm vaccine was given in). Left to car and came right back in 5 minutes saying it was hurting even with walking, and thought it was the chair she was sitting in but it wasn't going away. One the vaccination RN's examined her back but there was no evidence of any reaction on her skin. Backpain continued until later that day.   Followed up with PCP wanted her to get covid tested 1/5, negative results, due to developing more symptoms days later (fatigue, slight cough, back pain (resolved that same day).
pt elevated temp since given vax; ranging from T99-104; no other symptoms; saw MD-WBCs were sl elevated/sl anemic; but no underlying illness found; possible viral per MD;
15 minutes after injection, felt chest tighten, warm and flushed.  Pulse irregular.  Stated she had hx of atrial fib.  States L ear is warm.  Chest tightness subsided after 2 or 3 minutes.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was infection control manager.  Concomitant medication of the patient was not reported.  Date the vial was placed in the refrigerator was 03-NOV-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Additional Details: Hx of syncope w vaccinations,uneventful admin,pt fainted 10 min into observation period,regained consciousness immediately,elevated legs,ice pack for minor head contusion,pt said he felt nauseous just before fainting,BP 112/44 HR 99@3:10p,pt rested in chair,BP 121/78 HR 64@3:25p,released @3:35. He called @430p to report he was feeling fine.
DIARRHEA; FATIGUE; This 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, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diarrhea and fatigue was not reported. This report was non-serious.
"Itchy" rash and slight swelling on Right knee cap (vaccinated 6/8/16). 6/9/16 pen-like cramping across my chest.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 20-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9, 0.5 ml injection, lot # L007495 with expiration date 24-FEB-2017 (route and dose were not reported). This specified lot number vaccine was exposed to temperature excursion. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) was 208, 31 and R, respectively. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a other health professional and described the occurrence of extra dose administered in a 24-month-old female patient who received HAVRIX (batch number 4735D, expiry date 15th November 2015). Previously administered products included HAVRIX pediatric (dose 1) and HAVRIX pediatric (dose 2). On 5th November 2013, the patient received the 3rd dose of HAVRIX. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional information received: Child got 3 doses of HAVRIX by mistake. 1st dose on 13 November 2012, then 25 July 2013 and 05 November 2013. No adverse event reported.
HBSAG:POSITIVE 5 DAYS POST IMMUNIZATION.5 DAYS AFTER PT RECEIVED FIRST DOSE(2 x 1ml VIALS=40 MCG)OF ENGERIX-B PT PRESENTED WITH HBSAG POS.NO TREATMENT GIVEN. TO DATE "NO CHANGE IN PTS CLINICAL COND.  FOLLOW UP1:RETEST FOUND PT NEG FOR HBSAG
Potential AE due to doses administered from vials that may have been compromised; Administered vaccine from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reporter stated that, they had a group of 13 pharmacies and have administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines have never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper-logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The reporter was concerned that the vials have been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised.  The beyond use date for vial was reported as 01-Dec-2021 to 15-Dec-2021.  No treatment medication was reported.
hips have become so loose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (hips have become so loose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hip discomfort (She says that she was having problems with her hips for a long time.). Concomitant products included AMLODIPINE, METOPROLOL, BENAZEPRIL, HYDROCHLOROTHIAZIDE, IPRATROPIUM BROMIDE, BUDESONIDE, ARFORMOTEROL TARTRATE (BROVANA), BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) and SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (hips have become so loose). At the time of the report, MUSCULOSKELETAL DISCOMFORT (hips have become so loose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Localized itching, edema, redness and warmth around 15 cm diameter at site of injection. Starting around 6 hours after administration, evaluated around 24 hours after administration.
Vaccine administered on 4/19/23 had a beyond use date of 3/22/23 (thawed and kept in refrigerator since 01/25/23
Vaccine was placed in refrigerator on 18Oct2021; doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 18Oct2021) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 18Oct2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 18Oct2021) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The vial was placed in the refrigerator on 18-OCT-2021.Vial did not undergo any temperature excursion. No adverse event was reported.  No treatment medications were reported.
It started off with a few days of intense fatigued, then I had acute diarrhea made me dehydrated and nausea and could not eat. I had a fever between 99 to 100. I had four days of feeling relatively well then I started having respiratory symptoms, very sore throat, high fever, lots of mucus and sinus pressure. Those symptoms last about a week the clinic gave me Molnupiravir. I'm still suffering from post nasal drip and bad fatigue.
Event began with discomfort at injection site and mild irratability.  By next morning, severe discomfort, baseball-sized knot at injection site.  Fever began, at first low-grade <101.  By Tuesday night, fever was 103.9 accompanied by Muscle aches throughout body. Fever subsequently broke shortly after reading and dropped down to about 101 by Wednesday morning (+48 hours after vaccination).  Blisters also formed at injection site with weeping from a 3rd location in/around swelling.  Redness and swelling at injection site persistant 7+ days at reducing size.