chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cold sore; This is a spontaneous report from a contactable consumer (the patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient asked if they could take another medication after taking Pfizer-BioNTech COVID-19 Vaccine. The patient had the vaccine yesterday and had a cold sore. The patient wanted to know if they could take an antiviral medication. The clinical outcome of cold sore was unknown.   Information on the batch/lot number has been requested.
PT REPORTED TO PHARMACY THAT SHE HAD REDNESS OF SKIN ON THE  LEFT ARM WHERE INJECTION WAS GIVEN
vaginal bleeding.  I have not had a period in over a year and 2 days after the shot I started bleeding. After talking to others that have had the vaccine, several have had breakthrough bleeding a couple days after the vaccine and thought nothing of it, but people aren't reporting because they think its just them. I think it should be reported, and maybe some investigation  follow up as to why this may have occurred.
pt adm to hosp overnoc for poss sz;pt exp screaming followed by 2hr of limpness;grandma felt pt not self;pt began to arch back;mom though pt was not breathing;did not sleep;wanted to be held by one person;pt did not recognize family
episode of syncope ~15 hours after vaccine administration (next morning). sudden onset of lightheadedness which persisted for few minutes then lost consciousness. have never fainted before. tests in ER suggest low blood pressure but nothing else abnormal.
bollous pemphigold a diffuse reaction: back, chest, arm, back, thighs, and feet; This spontaneous case was reported by a physician and describes the occurrence of PEMPHIGOID (bollous pemphigold a diffuse reaction: back, chest, arm, back, thighs, and feet) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history) and Biopsy.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced PEMPHIGOID (bollous pemphigold a diffuse reaction: back, chest, arm, back, thighs, and feet) (seriousness criterion medically significant). At the time of the report, PEMPHIGOID (bollous pemphigold a diffuse reaction: back, chest, arm, back, thighs, and feet) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Biopsy skin: abnormal (abnormal) Diffuse bullous pemphigoid.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment information was not provided.  Concomitant medication were not reported.  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.; Sender'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.
Right jaw is sore when chewing and opening the mouth.  The highest level of pain is in the morning but soreness last throughout the day.
Immediately felt warmth and tingling to Left Deltoid at injection site, then started to feel itching and feeling of swelling to throat and mouth. Denies any SOB. No obvious hives. Treated with Solumedrol 125 mg IV, Benadryl 25 mg IV, Pepcid20 mg IV. Given Rx for Benadryl 25 mg PO every 6 hour PRN.
reddened purplish raised area 1" x 2" @ lt leg w/underlying induration;no tenderness or limitation of movement;
no adverse event has occurred gave pt who is 14yoa flublok which is not recommended until 18
on 1-21-2021 the injection site became swollen with a lump that both itched and is painful. There is a blotchy rash and the area is hot. Twenty four hours later, the rash has spread and the discomfort continues.
vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
10 hours after my 2nd dose, I developed a fever, and a very strong headache and entire body soreness. I took Tylenol for the fever but it was a mistake that I did not took off work the next day which triggered my symptoms to be worse than how it is. That's when I developed my vertigo which continued until May 1st and that's when I decided to see a doctor diagnosed me with Bell's Palsy and  was prescribed with Antivirus (Valacyclovir) for Bell's Palsy and Steroids (Prednisone)  and I took both for 10 days. I have fully recovered after 2 months.
Patient experienced allergic reaction and skin rash (diffuse neck trunk, upper and lower extremity) post administration. Patient complained of itching and swelling.  In the ED, patient was treated with prednisone and Benadryl and tryptan levels sent.  Patient was also send home with hydroxyzine, prednisone and famotidine.
HIGH FEVER OVER 102, ENTIRE FACE COVERED IN RED SWOLLEN RASH WITH RED HARD PIMPLE LIKE LOOKING DOTS THROUGH OUT IT EXTEND ACROSS MY FACE AND DOWN MY NECK DIRECTLY TO THE PLACE WHERE THE INJECTION SITE WAS. I ENDED UP REALLY OUT OF IT DUE TO THE HIGH FEVER AND COUDLN'T KEEP FLUID DOWN AND KEPT VOMITING FOR THE NEXT FOUR DAYS. THEN THE RASH STARTED TO HEAL AND MY TEMPERATURE DROPPED AND I SLOWLY FELT MORE NORMAL. IT'S NOW BEEN A WEEK AND A HALF SINCE THE VACCINATION AND I STILL GET VERY EASILY WINDED JUST BY WALKING AND FEEL REALLY WEAK ALL THE TIME.
Patient received dose #1 of pediatric Pfizer on 11/9/21 in left deltoid LOT: FK5127 EXP: 01/17/22 Well tolerated per Mother.  Patient received dose #2 of pediatric Pfizer on 11/30/21 in right deltoid LOT: FK5127 EXP: 01/17/22  Patient tolerated well and sat the required 15 minutes following immunization. Mom contacted office on 12/2 stating that beginning the evening of 12/1 patient complained of itchy skin. On 12/2 Mom noticed a scattered red rash on trunk, collar bone, and back. She also looked ?red and puffy? under her eyes. As mother called just prior to clinic closing, APRN advised Mom take patient to ensure this was a simple dermatitis rather than other disease process. APRN called Mother the morning of 12/3 and Mom confirmed that  examined the patient and confirmed suspected dermatitis related to vaccine. Patient was treated with Benadryl and per Mom is doing better today. Of note, patient did experience significant post-injection swelling of the arm following a flu vaccine ?in a trial? years ago. Per Mom she has never had reaction to any other vaccinations or medication and does have sensitive skin.
not received second dose due to COVID-19 pandemic; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that, the patient did not receive 2nd dose of Shingrix due to COVID 19 pandemic, which led to social problem. The reporter did not provide batch number neither expiration date. The reporter consented to follow up. The VAERS details were reported for 1st dose of Shingrix.
This spontaneous report as received from a physician and a healthcare worker refers to a patients of unknown age and gender. Information on concurrent condition and medical history was not reported. On an unknown dates, the patients were vaccinated with improperly M-M-R II lot # L026551 (expiry 16-JUL-2017) and L002859 (expiry date 05-FEB-2017) (dose and route not reported). The temperature excursion time frame was reported as "11 C for 3 hours (also reported as 34 hours)". No previous excursion was reported. No adverse effects was reported. This case is one of the several reports from the same reporter. Additional information has been requested.
local large (10 cm x 12 cm) erythematous, warm, tender patch. Pt complains of pain. (L) arm circumference 2mm > than (R) arm circumference.
Systemic: heart attack-Severe, Additional Details: Patient suffered from a heart attack following immunizations per pt reports
shingles flare-up/ The rash is mainly on my left arm; The rash is mainly on my left arm, which is the same arm where I got the vaccination shot; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: EM9810) via an unspecified route of administration in the left arm on 02Feb2021 (at the age of 52-years-old) as a single dose for COVID-19 Immunization in the workplace clinic. The patient medical history included depression. The patient had no allergies to medications, food, or other products. The patient concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249) on 12Jan2021 08:30 via an unspecified route of administration in the left arm as a single dose for COVID-19 Immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with Covid-19 prior to vaccination and not tested for COVID-19 since vaccination. On 03Feb2021 05:30, the patient had the 1st shingles flare-up of his life and it began the day after receiving the second dose of vaccine. The rash was mainly on his left arm, which is the same arm where he got the vaccination shot (both times). On 09Feb2021 doctor's nurse-practitioner confirmed suspicion of shingles. The event assessed as non-serious by the reporter. The patient prescribed Valtrex for the treatment of the event. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information was expected.
Felt dizzy/nausea after vaccines. Had pt lie down for 15 min. 11R:64. Drank water. Sat for another 10 min. felt well at this point/no further nausea/no vomiting.
ACTHIB diluted with a sterile diluent from a different manufacturer and not with approved sterile diluent provided with the ACTHIB with no adverse event; Initial information received on 13-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 2 months old male patient who was administered acthib diluted with a sterile diluent from a different manufacturer and not with approved sterile diluent provided with the acthib with no adverse event w, after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Prophylactic vaccination; DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Prophylactic vaccination; and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Prophylactic vaccination.  On 24-Aug-2022, the patient received a  dose number 1 of suspect HIB (PRP/T) VACCINE( lot UJ650AAA and expiration date: 05-Mar-2023) at a dose of 0.5ml once via intramuscular route in the right vastus lateralis for immunization.  On 24-Aug-2022(Latency: same day), the patient was administered acthib diluted with a sterile diluent from a different manufacturer and not with approved sterile diluent provided with the acthib with no adverse event (product preparation error).   Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event .   Outcome: unknown     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
The brand Fluzone injection is supposed to be given to individuals under 18 years of age.  A dose of Fluarix prefilled vaccine was given by mistake.  The fluarix is used for the same purpose, it just hasn't been tested for safety yet under 18 years of age.  The patient's mother was not upset, she said her daughter was feeling fine.
Info has been received from an RN concerning a 46 month old white female with a tracheostomy who on 12/19/03 was vaccinated, SC, with a 1st dose of varicella virus vaccine live (lot 641596/0767M). There was no illness at the time of vaccination. Concomitant therapy included dornase alfa (Pulmozyme), ipratropium bromide (Atrovent), and tobramycin sulfate (Tobra) via a nebulizer prn. On 11/14/05, the pt had a temperature of 102.8 for 1-2 days and had less than 50 lesions. It was noted that the pt had pneumonia first and then developed chickenpox. The pt totally recovered on 11/18/05 and is now fine. Additional info has been requested.
Information has been received from a certified nurse midwife (C.N.M.) concerning a 21 year old female who on 18-SEP-2007 (lot # 658558/1061U), 13-NOV-2007 (lot # 659435/1265U) and 25-MAR-2008 (660387/1967U) was vaccinated with the first, second and third dose of GARDASIL in the deltoid respectively. The patient had 3 negative pap smears results since 2006. She was determined to HPV high risk on 03-NOV-2008 with a positive result. The patient underwent a colposcopy procedure related to abnormal paps. The patient had been sexually active prior to GARDASIL and described "occl" condom use. The C.N.M. considered the positive HPV to be disabling. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to an adult patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-JUL-2018, the patient was inadvertently administered a pediatric/adolescent dose of RECOMBIVAX HB, lot # M033334, expiry date 11-AUG-2018, intramuscularly for prophylaxis. No adverse effects were reported in the patient.
Pt recvd 1 dose of Recombivax HB 28NOV89, & 2 doses of Engerix-B 28DEC89, & 22MAY90 & was found to be a non-responder;
Right arm, 70-80mm induration, warmth, redness, 36 hours after vaccination. By 5-20-08 redness was decreasing and child "doing much better."
DIED; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total dose administered for prophylactic vaccination. The batch no was not reported ,The company is unable to performed follow up to request batch /Lot numbers .No concomitant medications were reported. It was reported that on an unspecified date, the patient died from covid-19 vaccine ad26.cov2.s. The cause of death was unknown. it was unspecified if an autopsy  was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death); Sender's Comments: V0: 20210546018-covid-19 vaccine ad26.cov2. s Death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
This spontaneous report as received from an 82 years old female consumer reporting on herself, with no pertinent medical history and no known drug reactions/allergies. The patient was vaccinated with a dose of ZOSTAVAX in April 2011. No other co-suspects were reported. Concomitant medications included: DEXAMETHAZON. In May 2011 the patient experienced that her ankle began to swell and had been swollen since then. The patient sought unspecified medical attention. No treatment information was reported. The outcome of her ankle began to swell and has been swollen was reported as "NA" (also reported "has been swollen since then"). The relatedness for her ankle began to swell and has been swollen was unknown for ZOSTAVAX. Additional information has been requested.
tested positive for covid; tested positive for covid; coughing; congestion; could not sleep that night; her temperature is still low/temperature was lower around 96 or 97; fever; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EH9899), via an unspecified route of administration on 15Dec2020 at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the Covid-19 shot 8 days ago on 15Dec2020. She tested positive for COVID on 23Dec2020. She worked in the emergency room, clarified she was a certified Nurse Assistant (CNA). She was hesitant about taking the COVID-19 vaccine. She was curious since she has been around the virus 24/7 since the pandemic started since she works in the emergency room. When she took the COVID-19 shot, stated she felt great the next day and could not sleep at night in Dec2020 which is not normal for her. It's nothing like the flu shot. It was strange since she has been around the virus all this time, she felt like she had COVID in Feb2020, but she was not tested then. She does not ever get sick and she was down for two days with a fever in Dec2020. After those two days, she always had a low-grade fever of 98 or 99 which was constant. After she took the COVID vaccine her temperature was normal, her temperature was lower around 96 or 97 in Dec2020. She woke up on 23Dec2020 and she had congestion and her temperature was still low. She went to work, and she was told she looked like she had no sleep. She was coughing 23Dec2020 morning, but she did not have any symptoms as far as temperature. She realized that the COVID 19 shot is only 50% effective. She is asking if she should get the second dose. The outcome of events was unknown.
Chills, body aches, nausea, vomiting, diarrhea, low grade fever
Patient received expired Moderna COVID-19 Vaccine; Vaccine was expired on 01-Apr-2022 and was stored in refrigerator on 04-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 Vaccine) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022 and was stored in refrigerator on 04-Apr-2022) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 Vaccine). In April 2022, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022 and was stored in refrigerator on 04-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 Vaccine) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022 and was stored in refrigerator on 04-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was reported that, when the vaccine lot received to pharmacy on 23-Feb-2022, the pharmacy staff member looked up the expiration date and came up with expiry date of June 2022. However, the correct expiry date for lot was 01-Apr-2022. The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursions.  No treatment details were reported.
Mother states swelling and redness at left upper arm injection site for 2 days. Mother applied ice which reduced swelling and redness. 6/11/04: Presented to office with localized inflammation and erythema at left deltoid area. Slightly warm to touch. Instructed to continue with ice packs and follow up with PMD.
tingling; tightness in her neck and throat; tightness in her neck and throat; numbness and tingling on the left side of her neck; really anxious; This is a spontaneous report from a contactable Pharmacist via Medical Information Team.   A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0217; Expiration date: Sep2021), via an unspecified route of administration in left deltoid on 13Jul2021 at 10:47 (at the age of 36 years old) as dose 1, 0.3 mL single for covid-19 immunisation.The patient medical history and concomitant medications were not reported. The patient not had history of previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive additional vaccines on same date of the Pfizer suspect.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Jul2021 patient experienced tingling, tightness in her neck and throat, tightness in her neck and throat, numbness and tingling on the left side of her neck, really anxious. Reporter stated that she was a pharmacist and administered the vaccine to a patient who experienced tingling and tightness in her neck and throat on 13Jul2021.Tingling in the neck and throat included she did not let them know until the 15-minute observation period was over. She just kind of felt like her throat was tight and tingling in her neck. Reporter was not sure if she was still experiencing this now. Reporter stated that the patient was describing it as kind of a tight feeling but was not struggling to breathe. She was still breathing and everything, she was just really anxious. She just stood up and walked to the counter. She has been sitting there about 25 minutes. Reporter stated that the tightness has gone away now, the patient has been sitting at the pharmacy for 45 minutes and she was not struggling to breathe, and she was able to swallow water. The patient does still have some numbness and tingling on the left side of her neck. Reporter stated that the patient was now stating that the numbness and tightness have gone away but she was feeling tingling in her neck, on the side of administration, which was the left side. No family medical history relevant to adverse events was provided and no relevant tests were performed. The patient did not visit emergency room or physician office. Relatedness of drug to tingling in neck and throat and throat tightness and numbness reaction: Related as per source of assessment: Primary Source Reporter, method of assessment: Global Introspection.The outcome of events was unknown.
pt felt heart racing, warm ears and face. Pt monitored and given water. Symptoms resolved at 1721.