chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of injection site cellulitis in a female patient who received FLULAVAL TETRA (batch number 7KK33, expiry date 30th April 2017). On 3rd October 2016, the patient received FLULAVAL TETRA 0.5 ml. On 3rd October 2016, an unknown time after receiving FLULAVAL TETRA, the patient experienced intramuscular formulation administered by other route. In October 2016, the patient experienced injection site cellulitis. On an unknown date, the outcome of the injection site cellulitis and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site cellulitis to be related to FLULAVAL TETRA. Additional details were provided as follows: The age at vaccination was not reported. The patient accidentally received FLULAVAL TETRA subcutaneously, which led to intramuscular formulation administered by other route. In October 2016, less than a week after receiving FLULAVAL TETRA, the patient experienced injection site cellulitis. No other information was known about the event.
Pt had 4mo vax & 4 days a/being brought in DOA w/probable SIDS; MD didn't feel this was a rxn to the vax but thought it should be reported;
Patient is a 77-year-old male with a history of factor V Leiden, hyperlipidemia, prior history of DVTs, and diabetes mellitus type 2, who presented to the hospital on 11/21/2008 complaining of 2 days of fever, nausea, and generalized weakness and malaise.  Pt had Yellow Fever vaccination on 11/14/08 prior to his planned trip abroad. Pt has been otherwise in good health prior to admission. Influenza vaccine was given on 10/30/08. HOSPITAL COURSE:  The patient quickly progressed to hemodynamic instability and sepsis syndrome exhibited by tachypnea, tachycardia, hypotension and confusion.  Therefore, he was transferred to the MICU on 11/22/2008.  The patient was intubated for airway protection at that time and increased work of breathing.  The patient required vasopressor support for his blood pressure and was started on broad-spectrum antibiotics.  The patient subsequently developed multiorgan system failure, including respiratory failure requiring ventilator support, and oliguric renal failure requiring hemodialysis support.  Multiple cultures were sent to try and determine the etiology of the patient's symptoms and reason for septic shock.  It was noted the patient was on broad-spectrum antibiotic, antiviral and antifungal coverage.  No specific infection inciting these symptoms was ever identified.  The only cultures that were positive were drawn from the patient's access lines, which grew out Candida albicans. Infectious Disease was following along with the patient the entire time of his stay in the MICU.  Over the ensuing days, the patient failed to progress and actually worsened from 12/02 and 12/03 as exhibited by increased tachypnea and work of breathing, hypotension with continued pressor support, and  oozing from some of his lines and orifices.  At this time, the patient's family requested that the patient be made DNR and that supportive measures be withdrawn. Therefore, these steps were undertaken on the afternoon of 12/03/2008. The patient passed away officially at 1425 on 12/03/2008.  Physical exam was performed to confirm the patient's death.  The family was offered autopsy and declined. 2/3/09-records received for DOS 11/21-12/03/08-C/O Presented to ED with C/O malaise, weakness, nausea, fever and fatigue. Mechanical ventilation. Sepsis. Metabolic acidosis. Septic encephalopathy.  3/30/09-COD multi-organ failure. Septic shock.
on awakening 16JUN93, had blister as mom called it on back; Calamine applied because of itching; taken to babysitter while mom worked; brought to clinic 345PM; felt hot; temp not taken; generalized hives covering body; referred to pvt MD;
104 fever, dangerous tachycardia, incessant vomiting, dehydration, difficulty breathing. Urgent care immediately called ambulance and taken to ER. Admitted to step down unit to reduce fever and monitor dangerous. tachycardia. Ruled out bacterial, fungal or viral infection.
eczema got worse; This spontaneous case was reported by an other health care professional and describes the occurrence of ECZEMA (eczema got worse) in a female patient of an unknown age 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 ECZEMA (eczema got worse). At the time of the report, ECZEMA (eczema got worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Pt complained of severe redness, swelling and bruising to right arm. Also, had severe swelling to neck and down back. After visit to ER, he was dx'd with cellulitis.
Less than 15 minutes post vaccination, the patient described a "flushing feeling" with feeling hot and sweaty. Patient denied any drug allergies and post vaccination reactions. She sated she was just "really nervous about this vaccine." Patient consented and was given a 50mg dose of diphenhydramine and water to sip. She laid down on the immunization bench and felt better in less than 10 minutes. She had her roommate with her to drive her home. Patient was advised to notify her doctor of this reaction. She was advised to take additional diphenhydramine doses Q 4-6 H PRN, keep hydrated and rest for the day.
Have a odor that wont go away. Not able to distinguish the scent. Since April 9 2021.  everything else still smell ok. When I go  to bathroom it's really strong. It all day long and night
TINGLING IN THE FACE, ARMS AND HANDS. SWEATY PALMS AND FLUSHED FACE.
Fluzone exposure during pregnancy, with no reported adverse event; Initial information received on 31-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 24 years old pregnant female patient who was exposed to vaccine Influenza Quadrival A-B Vaccine Preserved [Fluzone Quadrivalent] with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported Fluzone exposure during pregnancy, with no reported adverse event occurred at 9 weeks of pregnancy and the patient was exposed Influenza Quadrival A-B Vaccine Preserved at 9 weeks of pregnancy, during first pregnancy trimester for Influenza Quadrival A-B Vaccine Preserved.  The date of last menstrual period was reported as 13-Jul-2023. The estimated due date is 13-Apr-2024. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.  On 31-Aug-2023, the pregnant patient received an unknown dose of suspect Influenza Quadrival A-B Multidose Vaccine Preserved (exposure during pregnancy) (latency: same day) (strength: unknown , expiry date: Jun-2024, lot UT8040NA) via intramuscular route in the G. deltoid NOS (Not otherwise specified) as Influenza immunization.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  Additionally, at time of reporting, the pregnancy is still ongoing.
One week and a day after receiving the vaccine:  Fever (101+), chills, headache, body aches.
This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On an unknown date, since 15-DEC-2016, the patients were vaccinated with improperly stored doses of PROQUAD lot # reported as M017348, expiration date: 06-APR-2018; lot # reported as M035144, and expiration date: 30-JAN-2018; lot # M026879, expiration date: 27-NOV-2017; lot # M017334 and expiration date: 05-OCT-2017 (strength, dose and route were not reported) for prophylaxis (incorrect product storage). No adverse effects were reported. The temperature was between >5 °F to <14°F, for a time frame of 50 minutes and >14 °F to <46°F, for a time frame of 5 hours, the cumulative time frame was 5 hours and 50 minutes. There were no previous temperature excursions. The call was  because of a data logger (reported as log tag in use). This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA003204.
Discomfort in arm; Fever; Fatigue / tiredness; Nausea that are increasing; Patient feels that she is decaying with the days; Not felt well; Body aches; Constant tingling in the body; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Discomfort in arm), FEELING ABNORMAL (Patient feels that she is decaying with the days), MALAISE (Not felt well), PAIN (Body aches) and PARAESTHESIA (Constant tingling in the body) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D37D2NA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced LIMB DISCOMFORT (Discomfort in arm) and PYREXIA (Fever). In April 2021, the patient experienced FEELING ABNORMAL (Patient feels that she is decaying with the days), MALAISE (Not felt well), PAIN (Body aches), PARAESTHESIA (Constant tingling in the body), DIZZINESS (Dizziness), FATIGUE (Fatigue / tiredness) and NAUSEA (Nausea that are increasing). The patient was treated with ACETAMINOPHEN on 09-Apr-2021 for Fever, at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (Discomfort in arm), FEELING ABNORMAL (Patient feels that she is decaying with the days), MALAISE (Not felt well), PAIN (Body aches), PARAESTHESIA (Constant tingling in the body), DIZZINESS (Dizziness), PYREXIA (Fever), FATIGUE (Fatigue / tiredness) and NAUSEA (Nausea that are increasing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided
bleeding from nose; dizziness; myalgia; pain at the site of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (bleeding from nose), DIZZINESS (dizziness), MYALGIA (myalgia) and VACCINATION SITE PAIN (pain at the site of vaccination) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (bleeding from nose), DIZZINESS (dizziness), MYALGIA (myalgia) and VACCINATION SITE PAIN (pain at the site of vaccination). At the time of the report, EPISTAXIS (bleeding from nose) had not resolved and DIZZINESS (dizziness), MYALGIA (myalgia) and VACCINATION SITE PAIN (pain at the site of vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided. Action taken with mRNA-1273 in response to the event was unknown
Patient called today to report having hives on her arm after her 2nd covid shot on 5/20/21. She received moderna.  I filled out the report.   advised her to take benadryl and keep an eye on it to be sure it did not spread or worsen. Also advised her to report to vsafe. pt was going to call me back this evening to get website since she did not have paper to write on.  She did not call back
Wrong vaccine given: No adverse events Reported Prescribed: Covid-19 Moderna bivalent booster NDC: 80777-0282-05 0.5 mL injected im into deltoid. Given: Covid-19 Moderna Pediatric vaccine NDC: 80777-0275-05 0.5 mL injected im into deltoid
Since the 3rd shot, starting 10/9/21 I have been smelling cigarette smoke. I never had covid-19, only the vaccines.  I got the booster on 10/3/21 and on 10/9/21 started smelling cigarette smoke and I am still smelling it.
Increased intensity in menstrual cramps by a noticeable degree, lightheaded was/dizziness
rue w/4x2 red, raised, warm area; pt denies discomfort;
Tingling and numbness in hands and feet within minutes after injection as well as shortness of breath. Would last a few minutes.  Happened 3 times that day.  Started seeing eye floaters within a few hours after vaccination. Still have floaters in right eye almost 2 weeks later.  Also, have been having heart palpitations. Had an eye exam done and everything was normal.  Also went to PCP, she changed my anxiety/depression medication back to Zoloft. Said she thinks heart palpitations could be due to anxiety, if they do not go away she will send for an EKG. Also I now get tired really easily.
8 days post injection (November20th) I started having hives on the back of my neck and shoulders. It worsened overnight and I went to urgent care the following evening. They gave me an injection of Benadryl only as they were afraid a steroid shot would interfere with the vaccine. My symptoms continued to worsen over the next 24 hours--the pain was so bad I couldn't sleep and hives were covering my entire body. On the morning of November 23rd, I was feeling extremely weak,  nauseous and in a lot of pain. My hives were also starting to turn purple. I went back to urgent care and they said I needed an ambulance. I was taken to emergency room and was treated with IV steriods, Zofran, Benadryl and fluids as I was dehydrated. Once my vitals stabilized and the pain was under control, I was discharged. The doctor told me to follow up with a dermatologist the following week if I still had hives as he suspected I could have vasculitis. He cleared me to travel to be with family for the holiday as long as someone else drove me and as long as we mapped out hospitals along the way. He said he'd prefer that I have "eyes on me" all the time versus staying alone. He also prescribed Prednisone, Zyrtec, and Rx strength Prevacid.   My cousin drove us to another city that night. Once the meds started to wear off, the pain came back and I only slept about 2-3 hours. I felt extremely weak that morning, with uncontrollable chills, lots of pain and I almost passed out. Once the Prednisone kicked in, I was able to tolerate the car ride with ice packs for the pain. I also have lots of bruising on my legs, along with hives. I'm miserable again that night, covered in hives, and only sleep about 3 hours.   November 25: I was in extreme pain in the morning and almost passed out 2 times (vision went black). I was extremely weak and was also having joint and muscle pain. My sinuses were also completely blocked and my chest feels tighter as the day goes on. I could barely eat and if I didn't keep my feet elevated (due to swelling) they'd go numb.  My stepsister (a nurse practitioner) suggests I monitor my O2 sats due to my chest feeling tight.  2 days later I end up back in the ER b/c my O2 sats dropped to 87. I am prescribed more antihistamines and I start using an inhaler. A month after the booster shot I am still dealing with hives, extreme fatigue/weakness, shortness of breath and headaches. I missed 2 weeks of work and it has been extremely difficult to do my job, which is very physical.
mom called 21APR95 AM states pt rt upper arm where recv vax 4APR95 was swollen, painful & could feel a hard knot under the skin; pt taken to  MD 20APR95 for arm & MD measured it & rt upper arm was 1" larger than lt; prob cyst
I received the regular flu vaccination and the pneumococcal in the left arm.  Within 10 min., I was dizzy.  Then 30 min later I had a throbbing headache.  The headache lasted for 2 hours, then it was totally gone.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown dates, an unspecified number of patients were vaccinated with unknown number of PROQUAD (Merck), (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was involved. Follow up information was received from a certified medical assistant during a phone call on 25-MAR-2015. The certified medical assistant was unavailable at the time of the call. The call was transferred to the manager who indicated that the PROQUAD (Merck) lot # was J011330 with expiration date: 13-MAR-2015 and indicated that the patient identification information was not readily available at the time of the call. Additionally, the reporter indicated that there had been no reports of adverse events following the administration of PROQUAD (Merck) vaccinations. The office was in the process of contacting the patients revaccination. The correspondence process was reviewed and telephone number was provided should information become available. This is one of several reports received from the same reporter. Additional information has been requested.
Swollen injection site and body aches within 24 hours.  Within 48 hours a rash developed at injection site.  Body aches were relieved within 36 hours.  Rash persists at the time of completing this form.
3/20 Shot at 10:50 am, started to get chills about 8:30 pm. Fever through the night reaching 101.9.  3/21 fever reaching 100.8, took tylenol, felt run down all day.  3/22 Fever is gone
Pins needles; dry mouth; mild heart pressure; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO151) via an unspecified route of administration in the left arm on 10Apr2021 at 12:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021, the patient experienced pins and needles, dry mouth and mild heart pressure. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event pins and needles, dry mouth and mild heart pressure were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Had Covid- 19 Vaccine 3-4-21. R deltoid had usual arm soreness 2 says later pt stared feeling a pulling sensation into her R armpit in down her R arm.
Arm red, swollen and bruised at injection site (Day 2-7) Remains red, slightly swollen, bruise improving but now has a red raised welts/bumps at/around insertion site. (Day 8)
Injected limb mobility decreased; Itchiness; Her arm was also sore later that night at the injection site; Getting a rash almost immediately, from her shoulder to her elbow/ Rash spread from bottom of bra area, to her belly button area, then lower to her waist, & the scalp on the right side; This spontaneous case was reported by a consumer and describes the occurrence of INJECTED LIMB MOBILITY DECREASED (Injected limb mobility decreased), PRURITUS (Itchiness), RASH (Getting a rash almost immediately, from her shoulder to her elbow/ Rash spread from bottom of bra area, to her belly button area, then lower to her waist, & the scalp on the right side) and VACCINATION SITE PAIN (Her arm was also sore later that night at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 013A21A) for COVID-19 vaccination.     The patient's past medical history included Hysterectomy. Concurrent medical conditions included Sensitive skin. Concomitant products included OXYCODONE for Neck pain and Back pain, METFORMIN, LISINOPRIL, ESTROGENS CONJUGATED (PREMARIN) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 02-Apr-2021, the patient experienced RASH (Getting a rash almost immediately, from her shoulder to her elbow/ Rash spread from bottom of bra area, to her belly button area, then lower to her waist, & the scalp on the right side). On 03-Apr-2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (Injected limb mobility decreased), PRURITUS (Itchiness) and VACCINATION SITE PAIN (Her arm was also sore later that night at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, at a dose of UNK dosage form and CORTISONE for Allergy, at a dose of UNK dosage form. At the time of the report, INJECTED LIMB MOBILITY DECREASED (Injected limb mobility decreased), PRURITUS (Itchiness), RASH (Getting a rash almost immediately, from her shoulder to her elbow/ Rash spread from bottom of bra area, to her belly button area, then lower to her waist, & the scalp on the right side) and VACCINATION SITE PAIN (Her arm was also sore later that night at the injection site) outcome was unknown.            The patient was advised to stop Benadryl (diphenhydramine HCL) and use Cortisone 10 (hydrocortisone) as treatment of the events. Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-100469, MOD-2021-100469 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up received on 30-Apr-2021: event itchiness was updated. On 01-Jun-2021: Follow up received on 01-Jun-2021  contains no new information. On 04-Jun-2021: Follow up received on 04-JUN-2021: Non-significant follow up appended
Round rash on left arm at injection site. Developed after 10 days. Itching, rash, and tender and warm to touch
Fever; Shivering; Fatigue; Gastrointestinal symptoms; Headache; Malaise; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2021, the patient received the 1st dose of Shingrix. On 15th September 2021, immediately after receiving Shingrix, the patient experienced headache, malaise, fever, shivering, fatigue and gastrointestinal symptom nos. On an unknown date, the outcome of the headache, malaise, fever, shivering, fatigue and gastrointestinal symptom nos were unknown.   It was unknown if the reporter considered the headache, malaise, fever, shivering, fatigue and gastrointestinal symptom nos to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. This case was reported by the patient's father. The patient received dose of Shingrix vaccine and immediately began experiencing headache, malaise, fever, shivering, fatigue, and gastrointestinal symptoms. The reporter did not provide details regarding whether symptoms have resolved. The reporter declined to provide demographics for daughter/patient. The reporter did not consent to follow up.
I received vaccine on 6/21. I got my period right before July 4th. It is now August 9th and I have not gotten my period for August. My period is never late and I took a pregnancy test and am not pregnant.