chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Psoriasis flare-up; Flu; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) and INFLUENZA (Flu) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up) and INFLUENZA (Flu). At the time of the report, PSORIASIS (Psoriasis flare-up) had not resolved and INFLUENZA (Flu) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
ONE DAY AFTER PATIENT RECEIVED THE VACCINATION SHE REPORTED SORENESS AND REDNESS AT THE INJECTION SITE. SHE ALSO STATED IT WAS HOT TO THE TOUCH.  SHE WENT TO HER MD, WHO STATED IT WAS AN INFECTION FROM THE VACCINE AND THAT THE PHARMACY NEEEDED TO REPORT IT TO VAERS.
Patient came in for Covid 19 booster dose today. Staff that was preparing the vaccine did not dilute the vaccine prior to giving it. 0.2 mL IM was given, but not diluted, thus resulting in getting a larger dose than intended. MD was notified, pfizer was contacted for adverse reaction information to watch for, family was notified. Family was told to watch for local/systemic adverse reactions to higher dose, call clinic and be seen if any concerns. Staff was re-educated on proper dilution of vaccine, variance was done, point of contact notified, report made with Pfizer, and VAERS forms completed. Patient reports no adverse effects at this time. If adverse effects occur, VAERS will be notified by clinic staff.
Vaccination adverse reaction; dried up her body, her stomach and then her face; limbs swell; back swell; pretty extreme pain; very sick; It has been more than 36 days since the first dose and patient has not received a second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction), DRY SKIN (dried up her body, her stomach and then her face), PERIPHERAL SWELLING (limbs swell), SWELLING (back swell) and PAIN (pretty extreme pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE for Allergy, CHLORTHALIDONE for Blood pressure management, ESCITALOPRAM for Depression NOS, LOSARTAN and VITAMINS NOS for an unknown indication.    On 26-Feb-2021, 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 (Vaccination adverse reaction), DRY SKIN (dried up her body, her stomach and then her face), PERIPHERAL SWELLING (limbs swell), SWELLING (back swell), PAIN (pretty extreme pain), ILLNESS (very sick) and PRODUCT DOSE OMISSION ISSUE (It has been more than 36 days since the first dose and patient has not received a second dose). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction), DRY SKIN (dried up her body, her stomach and then her face), PERIPHERAL SWELLING (limbs swell), SWELLING (back swell), PAIN (pretty extreme pain), ILLNESS (very sick) and PRODUCT DOSE OMISSION ISSUE (It has been more than 36 days since the first dose and patient has not received a second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not reported.  Lab data included an X-Ray which resulted normal (no infection).
RED AND TENDERDNESS AT THE SITE. THE SITE IS GETTING BETTER EVERY DAY.
Red circular rash around injection site. Developed ~7-8 days after first shot. Not itchy, sore or sensitive as of 2/2. Has grown slightly since 2/1
I suffered heart damage from the vaccine; This spontaneous case was reported by a paramedic and describes the occurrence of CARDIAC DISORDER (I suffered heart damage from the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     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 CARDIAC DISORDER (I suffered heart damage from the vaccine). At the time of the report, CARDIAC DISORDER (I suffered heart damage from the vaccine) 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.  Treatment information was not provided by the reporter.
Expired Vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient received booster dose. The vial was placed in refrigerator on 26-Oct-2021 Vial did not undergone to any temperature excursion. No adverse event was reported. No treatment medications were reported.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Syncope, light head, blurry vision.
Severe headache and redness/rash at the site. Both shots were given on the left arm with the PNEUMOVAX being 1 inch above the SHINGRIX.
This is a spontaneous report by a contactable office staff. This office staff person reported on behalf of a physician for a currently 15-month-old male who received PREVNAR 13 0.5ml injection intramuscularly in the morning on left thigh for pneumonia in Jun2010 at the age of 7 months. Relevant medical history was none. Relevant concomitant medication was none. Vaccines given on the same day were none. Vaccines taken within the last four weeks were none. On 07Jun2010 he experienced rise in temperature to 103 degrees Fahrenheit. Therapeutic medication in response to the event was unknown. At the time of the report he had recovered from the above mentioned event in 48 hours.
The unexpected reaction was localized constant left chest pain. It is believed to be due to swollen lymph nodes in the pectoral area (as all other testing at the ER was normal). Also sharp pain when breathing in deeply.
C/O itching around mouth after receiving vaccine.  No swelling, dysphagia, sob or other symptoms noted.  No rash visualized.  Gave Benadryl 25mg IM per RN, and patient improved shortly after.  Continued monitoring and patient discharged home with husband as driver with precautions and close monitoring.  Given epi-pen in case other symptoms develop at home.
started Sat AM, eyes drainage, sore, puffiness then started around eyes, Sunday eyes burned, hurt really bad, more swelling
Fever 102.4 F/ 39.1 C lasting 3 1/2 days.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient received ZOSTAVAX, (lot# and route unknown) on 06-OCT-2016 for its intended purpose: the prevention of shingles. Shortly after receiving ZOSTAVAX the patient suffered sudden acute loss of vision with temporal arteritis, an embolic accident, and retinal detachment. The patient was then diagnosed with central retinal artery occlusion of the right eye. The patient also suffered and was diagnosed with a vitreous hemorrhage in her right eye and a retinal tear in her left eye. As a direct and proximate result of ZOSTAVAX the patient suffered painful injuries and damages,  and required extensive medical care and treatment. The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. As a result of ZOSTAVAX the patient sustained severe and permanent personal injuries. Further as a tragic consequence the patient 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. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Sudden acute loss of vision with temporal arteritis, embolic accident, retinal detachment, central retinal artery occlusion of the right eye, vitreous hemorrhage in her right eye, retinal tear in her left eye were reported to be disabling. Upon internal review, sudden acute loss of vision with temporal arteritis, embolic accident, retinal detachment, central retinal artery occlusion of the right eye, vitreous hemorrhage in her right eye, retinal tear in her left eye were considered medically significant events. Additional information has been requested.
PC to on call MD cont screaming DTP today, leg red & swollen 1hr + 857PM;
Information has been received from a physician concerning a female who was vaccinated with the third dose of GARDASIL on an unspecified date. After receiving the vaccination the patient had been experiencing passing out periodically. The patient had also developed "scleroma in retinal" which was indicative of multiple sclerosis (MS). At the time of the report, the outcome was unknown. Upon internal review, multiple sclerosis was considered to be an other important medical event. Additional information has been requested.
Information has been received from a 31 year old female, for VARIVAX (Merck), a Pregnancy Registry product, who on 22-OCT-2010 was vaccinated with a dose of VARIVAX (Merck) (route, dose and lot # not reported). On 14-NOV-2010 the patient developed "2-3 lesions" which she showed to her physician. The patient believed she was pregnant. The patient's date of last menstrual period was 18-OCT2010. The estimated delivery date would be 25-JUL-2011. Follow-up information was received from a physician. A 31 year old female with a history of 0 pregnancy and 0 premature birth and a negative test for varicella antibodies on 21-OCT-2010, on 22-OCT-2010 at 16:29 PM was vaccinated in the deltoid of her right arm with a first dose of VARIVAX (Merck) (lot # 660214/0439X). On 14-NOV-2010 the patient experienced mild varicella like illness post vaccination. On 07-JAN-2011 the patient experienced spontaneous abortion. Upon internal review, spontaneous abortion was determined to be an other important medical event. Additional information has been requested.
A report has been received from a Health Professional concerning a 24-year-old pregnant, female patient. It was reported, that patient had spotting and other problems (not specified) prior to vaccination with FLUMIST. Concomitant medications were not reported. FLUMIST was administered on 12-Oct-2012. The patient has already been pregnant when the vaccine was received. Start date of pregnancy, last menstruation date or any other details of the pregnancy was not provided. The reporting nurse assessed the patient on 25-Oct-2012 and her vital signs were stable and she was doing well. Three days after her visit (on 28-Oct-2012), the patient had a miscarriage. At the time of the reporting the outcome of the administration to pregnant female and miscarriage was unknown. According to the reporting health professional, the event of miscarriage was considered to be serious with the seriousness criteria of important medical event. Company physician assessed the event of administration to pregnant female to be serious due to important medical event criteria. Follow-up of insignificant information received by AstraZeneca/MedImmune on 24-Oct-2012 from health professional: LOT number and expiration date added for FLUMIST. Follow-up of insignificant information received by AstraZeneca/MedImmune on 07-Nov-2012 from health professional: reference number added, narrative updated. Follow-up information received by AstraZeneca/MedImmune on 14-Nov-2012 from health professional, upgraded this case to expeditable: New serious event (miscarriage), medical history and second reporter of health professional added. Narrative updated accordingly. Event of administration to pregnant female was upgraded from non-serious to serious (important medical event). Corrected report on 27-Nov-2012: Action taken amended to not applicable, and expiry date of FLUMIST to 03-Dec-2012.
hx apnea spells is on monitor; inc episodes of apnea spells-w/Tetramune vax- inc fussiness, irritability;
On 11-16-07, noted rash above injection sites right leg covering upper thigh and lower abdomen, but not diaper rash. Rash hive-like. No fever no unusual crying. Went to regular doctors check up appointment on 11-21-07 Rash resolving. No treatment needed.
rapid heart beat; high fever; horrid headache; uncontrollable chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heart beat), PYREXIA (high fever), HEADACHE (horrid headache), CHILLS (uncontrollable chills) and MYALGIA (body aches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (rapid heart beat), PYREXIA (high fever), HEADACHE (horrid headache), CHILLS (uncontrollable chills) and MYALGIA (body aches). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (rapid heart beat) was resolving and PYREXIA (high fever), HEADACHE (horrid headache), CHILLS (uncontrollable chills) and MYALGIA (body aches) outcome was unknown.            No Concomitant were reported   This case was linked to MOD-2021-303864 (Patient Link).
I had numbness in my arm and heart started racing and I went to the doctor, and they did EKG and some other tests. The specialist said that it will get worst and gave me some medications and then it took some while for it to go away.
PATIENT HAD REDNESS AND SWELLING , WARM AROUND INJECTION SITE , MILD FEVER , DID NOT FEEL WELL  FOR A COUPLE OF DAYS . SHE DID NOT GO TO DOCTOR  IS FEELING BETTER NOW
Bell's Palsy; A spontaneous report was received from a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's Palsy.  The patient's medical history and concomitant medications were not provided.     On an unknown date, the patient received a dose of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date after receiving the Moderna's COVID-19 vaccine, the patient experienced Bell's Palsy.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Vaccine administered for age less than what is indicated. Janssen is for 18+, this was given to a 17 year old
covid vaccine breakthrough case  dose 1 Pfizer 3/4/21  EN6204 dose 2 Pfizer 3/25/21 ER8733
Patient developed new-onset hypertension the day after immunization that has persisted for the past 4 days. Patient not having chest pain, shortness of breath, or palpitations. Patient does endorse forceful heartbeat.
Fever; headache; tiredness; arm pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EP6955 and expiry date was not reported), via intramuscular, in Arm Left, on 06Apr2021 at 10:00 AM (age at vaccination: 50 years), as dose 2, single dose for COVID-19 immunization at workplace clinic. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications included bupropion hydrochloride (WELLBUTRIN), ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN), and sertraline hydrochloride (ZOLOFT). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EP6955 and expiry date was not reported), via intramuscular, in Arm Left, on 16Mar2021 at 10:00 AM, as a single dose for COVID-19 immunization at workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 06Apr2021, the patient experienced fever, headache, tiredness, and arm pain. The patient did not receive treatment for the adverse events. She continued to have side effects until 09Apr2021. Outcome of the events was recovered on 10Apr2021.  No follow-up attempts are needed. No further information is expected.
About a week after receiving the vaccine, I began experiencing bad urgency and diarrhea. I got supraventricular tachycardia on 2/7/2021.  I've never had that before so I went to the hospital. I was standing there and my heart rate went up to 150-160 and I felt dizzy. I also didnt feel well so I checked my watch where I did an EKG. I was then told to go to the doctor. An echo was done, I had to wear cardiac halter for a month. I now have to take metroporal extended release 25mg.   Dr. #1 Dr. #2
In the days and weeks after receiving my second dose, I had intermittent episodes of feeling feverish, but not sweating. It was like a flush, hot feeling in my body, as if I had a fever. The episodes would last about 15-20 minutes and would happen multiple times per day. I was also experiencing fatigue with the feverish feeling. After receiving my first two doses, I felt an instant rush of flush in my body and face. I would like to add that even though I experienced this adverse event, it will not prevent me from getting any future boosters or vaccines.
Vial was being stored in the freezer past the two weeks. Vial was taken out to thaw at room temperature and administered outside the recommended stability information provided by Pfizer and the CDC.
administrated with an expired dose of Twinrix; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 54-year-old female patient who received HAB (Twinrix) (batch number 57e3g, expiry date 20th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th March 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 29th March 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-Mar-2022 Reporter's Comment: No adverse event was reported. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. Additional supportive information: The patient was administrated with an expired dose of Twinrix, which led to expired vaccine used.
This case was reported by a healthcare professional and described the occurrence of passing out in a 11-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline), INFLUENZA (non-gsk). Concurrent medical conditions included syncope. There were no concurrent medications. On the afternoon of 29 December 2011 the subject received 2nd dose of HAVRIX at 0.5 ml in the right arm and 1st dose of INFLUENZA (Sanofi) in the left arm. On 29 December 2011, 2 minutes after vaccination with HAVRIX and INFLUENZA (sanofi), the subject went into the bathroom to find her brother and passed out. This case was assessed as medically serious by GSK. On 29 December 2011, the event was resolved. The healthcare professional considered the event was possibly related to vaccination with HAVRIX and INFLUENZA (Sanofi).
Presented with SOB, AMS; dx with Covid PNA; treated with steroids, 2 doses of remdesivir, Vit C, Zinc, supplemental O2; developing renal failure; family decided on comfort measures; pt died on 8/17
Pt has history of story telling per care taker.. pt appears to have Down syndrome.  Pt complained of Chest pain.  12 lead neagtive for MI. negative SOB, Abdominal, Nausea.  No visual signes. M-4 transport to ER.  Pt does not make decisions for her self.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe