chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a 20 year old female who on 19-FEB-2007 was vaccinated IM with a dose of Gardasil (Lot # 654741/0013U). On 19-FEB-2007, the patient fainted after receiving the Gardasil injection. The patient was known by the provider to be squeamish with injections. After the fainting episode, the patient was observed for a brief period of the time and then was discharged from the physician's office. On 19-FEB-2007, the patient recovered. No product quality complaint was involved. Additional information has been requested.
This spontaneous report was received from a Registered Nurse concerning a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot number M046924, expiration date 23-NOV-2018, lot number reported as M048200, expiration date 07-DEC-2018, lot number M045205, expiration date 11-NOV-2018, lot number M042857, expiration date 21-OCT-2018, lot number M032358, expiration date 05-JUL-2018, lot number M033906, expiration date 20-JUL-2018, lot number M037642, expiration date 01-SEP-2018 (doses and routes were not reported) for prophylaxis. Concomitant medication included sterile diluent (STERILE DILUENT). The temperature involved was -14 degrees Celsius to -10 degrees Celsius for 1 minute. The previous temperature excursion was -14 degrees Celsius to -10 degrees Celsius for 9 minutes. A data logger was involved. This is one of three cases received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA010562: Original Case: 1705USA010469 US-009507513-1705USA010561: Original Case : 1705USA010469.
About 2 hours after receiving the vaccine I began to experience flu-like symptoms such as joint aches, including headache, neck ache, etc.  Experienced a general feeling of malaise. Lasted about 24 hours.
Lump that continues to grow, fever, chills, fatigue, soreness, itching. About 6cm blanchable eryth, mild fever, chills
Rash at injection site, smaller rash on left foot, back of left calf, right thigh. Took antihistamines
I experienced pain in my left arm/shoulder. I went to my PCP, He had me do exercises at home to help my shoulder but it did not help anything. The pain is still in my arm and has not gone away. It has affected my strength and my range of motion.
Woke up with chills and shaking so much my hands moved over 5 inches, was dizzy, and had jaw clenching.  Symptoms lasted over 1/2 an hour. the next morning I was nauseated and I broke out in a bright red rash
This is a 72y.o. male  with PMH significant for ESRD on HD T/T/S, HTN, DM, CVA, BPH, GERD, HLD who was sent  to ED from a center for syncopal episode while getting HD.  The patient doesn't recall the event, he only remembers that he had breakfast prior to HD and went to his session as usual, he says he was told he had completed HD session. Per primary note he had another syncopal episode 3 weeks ago due to low BP.  ED his vitals were stable, labs showed creatinine 4.29, trop 0.04, hgb 10.5. CXR unremarkable.  Head CT no acute process. He was admitted to medicine for further management, nephrology is consulted to resume HD
Fever General body pains it felt like my pain medications stopped working Migraine Nausea Fatigue
This case was reported by a pharmacist via other manufacturer and described the occurrence of pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age group was not reported, but was selected as adult as per vaccine indication. The patient received 1st dose of SHINGRIX approximately 1 month ago from the date of reporting and experienced significant pain. The patient wanted to re-administer the SHINGRIX. No further information was provided. Contact for additional information was not allowed. Any follow up information received by Merck would be forwarded upon receipt.
Patient was give 0. 5 mL of Moderna Bivalent vaccine for a first primary dose instead of the monovalent moderna vaccine.
Fever for 2 days 100-102 F, generalized rash, hives, body aches, joint pain, sore throat, runny nose, itchy red eyes
Pfizer Covid Bivalent was given to patient past its use by date. Patient had no symptoms and was advised to repeat dose.
Patient is a 30 y.o. female presenting with fever. Primary symptoms of the febrile illness include fever, headaches, abdominal pain, nausea and myalgias (generalized). Primary symptoms do not include cough, vomiting, dysuria or rash. The headache is not associated with weakness. The myalgias are not associated with weakness. 30 y.o. female presents to ED with c/o HA onset 1.5 ago s/p receiving flu shot, hives onset 3 days ago and fever of 102 onset 2 days ago. (+)Muscle aches and decreased appetite. Pt states that she took BENADRYL for the hives which resolved. Has been taking TYLENOL for fever without relief. Pt also c/o abd pain. Hx of iron deficiency and Von Willebrand disease.
Arm redness; Arm redness/pain; Arm redness/pain/burning; This is a spontaneous report from a contactable other healthcare professional (Nurse). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 41-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm redness/pain/burning on an unspecified date. Seriousness of the events was reported as non-serious. The outcome of events was unknown.  The lot/batch number is not available despite the follow-up attempts made. Information about lot/batch number cannot be obtained. No further information expected.
Chills, sweating, muscular aches, neck and headache, weakness, diarrhea, nausea
Red rash under left breast and down side; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN9581, first dose) solution for injection intramuscular in the left arm on 02Feb2021 at 15:00 (at the age of 76-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included high blood pressure. Concomitant medications were not reported. Past drug history included known allergies: amoxicillin. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 02Feb2021, the patient experienced red rash under left breast and down side. No treatment was provided for the event red rash. The outcome of the event red rash was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
Breakthrough COVID-19 Infection in fully vaccinated individual. The patient received the Pfizer vaccine on 3/1/21 and the second dose on 3/22/21. She was tested positive for COVID on 4/27/21 and is asymptomatic.
25 Reasons to Avoid the GARDASIL Vaccine that Never Should Have Been Approved by the FDA; This spontaneous report has been received from a consumer via a company representative concerning a female patient of unknown age. Information about concurrent condition, concomitant medication and medical history was not provided.  On an unknown date the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date the patient experienced adverse event (AE). The written AE information located on the website vaccineimpact.com in an article titled "25 Reasons to Avoid the GARDASIL Vaccine that Never Should Have Been Approved by the FDA". The outcome of adverse event is unknown. Causality assessment was not provided by the reporter.
MOMENTS AFTER VACCINE, REPORTED DIZZY, HEADACHE WITH TINNITUS, HAS HISTORY OF, AND NAUSEA. ARRIVED TO OBS, PLACED ON STRETCHER, STATES RELIEF, OFFERED WATER. VSS, NAUSEA WORSENED SO PATIENT SAT UP ON SIDE OF STRETCHER, DID NOT VOMIT, BREATHING EXERCISES REINFORCED, AND PATIENT TOOK OWN TYLENOL FOR HEADACHE. FELT MUCH BETTER AFTER SITTING ON SIDE OF BED FOR A FEW MINUTES. ESCORTED TO EXIT PER PATIENT REQUEST AS S/S RESOLVED, NO ISSUES, AT 1215; 1145 INITIAL BP 143/86 HR 67 RR 22 SATS 99% ON RA; 12P SITTING BP 156/93 HR 67 RR 18 SATS 99% ON RA; 1210 BP 149/84 HR 65 RR 18 SATS 99% ON RA
but then hives appeared and she was itching all over; Aching all over/hurting so bad; Had a very bad night with the discomfort; This spontaneous case was received on 26-Oct-2022 from consumer via Communications (reference number: SEQW22-05056) and concerned a 91-year-old, female patient.  The patient's concurrent conditions included atrial fibrillation and bad back. The patient's past medical history included surgeries. The patient's concomitant medications included amiodarone and Kreon 24000 (pancreatin), both used for unreported indications. The patient's historical vaccine included unspecified influenza vaccine (reported as 'flu shot') which caused a little soreness in the arm.  On 29-Sep-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration and anatomical location: not reported) for active immunization of persons 65 years of age and older against influenza subtypes A and B contained in the vaccine. The batch number reported was 346335 and expiration date was 13-Apr-2023.  On the same day, a few hours after Fluad Quadrivalent administration, the patient started aching all over and in the evening it just got worse, it hurt so bad all over her body that she could not even wash her face. The patient went to bed, but walking down the hall she was hurting so bad that she had to be very careful during walking and then just fell into bed. She had a very bad night with the discomfort.  On 30-Sep-2022, the next morning after Fluad Quadrivalent administration, the patient was not hurting so bad, but then hives appeared and she was itching all over. About two and half days later, the patient had no symptom. The itching, the hives, and the aching stopped.  The patient did not take any medication to deal with the reported symptoms.  On 02-Oct-2022, the patient had recovered from the events of 'hives', 'discomfort' and 'general body pain'.  The reporter assessed the events to be related to Fluad Quadrivalent.  The case was assessed as non-serious.  This case is linked to case 202206470 (the same patient/reporter).  Company comment: A 91-year-old, female patient was vaccinated with the suspect product Fluad Quadrivalent. As reported, a few hours after vaccination the patient developed general body pain, urticaria and discomfort. Based on plausible time relationship, causality is assessed as possibly related.; Reporter's Comments: The reporter assessed the events to be related to Fluad Quadrivalent.; Sender's Comments: A 91-year-old, female patient was vaccinated with the suspect product Fluad Quadrivalent. As reported, a few hours after vaccination the patient developed general body pain, urticaria and discomfort. Based on plausible time relationship, causality is assessed as possibly related.
Itchiness at the site; It started getting red and swollen she also has itchiness at the site; It started getting red and swollen she also has itchiness at the site; She had normal pain like you would get with any injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at the site), VACCINATION SITE PAIN (She had normal pain like you would get with any injection), VACCINATION SITE ERYTHEMA (It started getting red and swollen she also has itchiness at the site) and VACCINATION SITE SWELLING (It started getting red and swollen she also has itchiness at the site) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037S21A) for COVID-19 vaccination.     No Medical History information was reported.  On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced VACCINATION SITE PAIN (She had normal pain like you would get with any injection). On 07-Sep-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at the site), VACCINATION SITE ERYTHEMA (It started getting red and swollen she also has itchiness at the site) and VACCINATION SITE SWELLING (It started getting red and swollen she also has itchiness at the site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness at the site), VACCINATION SITE PAIN (She had normal pain like you would get with any injection), VACCINATION SITE ERYTHEMA (It started getting red and swollen she also has itchiness at the site) and VACCINATION SITE SWELLING (It started getting red and swollen she also has itchiness at the site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications were reported.  No treatment information was provided.
Pain in arm for 7 days with knot like bump, nausea, headache chills, extreme tiredness for 7 days
Information has been received from a registered nurse concerning a 20 year old female with no pertinent medical history or allergies who on 04-JUN-2008 and 27-AUG-2008 was vaccinated intramuscularly with her 0.5 mL first and second doses of GARDASIL (lot #660391/0063X, 660557/0072X), respectively. There was no concomitant medication. On 29-AUG-2008 the patient developed a small bump in her right axilla. Medical attention was sought via call by the patient's mother. No laboratory or diagnostics tests were performed. The bump resolved without treatment within 12 hours. On 04-SEP-2008 the patient developed a large bump in her left axilla which resolved without treatment in 2 days. Additional information has been requested.
PATIENT TOOK HEP-A LOT# 0494U EXP DATE 03/06/2010 ALSO VARICELLA LOT # 1030U EXP DATE 06/27/2009 AFTER THREE MIN PATIENT FELT DIZZY, PATIENT LAID DOWN AND DRANK A CUP OF WATER AND 1/2 CUP OF GATORADE JUICE. PT RECOVERED IN 2 MIN WENT HOME. PT MOTHER SAID PT DID NOT EAT ANYTHING PRIOR THE DAY BEFORE. DOCTOR THOUGHT IT WAS JUST A MILD VASO VAGAL REACTION.
Patient was given undiluted Pfizer Omicron Bivalent 5yrs-11yrs vaccine resulting in a higher dose. Patient's parent has been notified of the vaccine administration error.  Mom states patient did not have any adverse reactions.
Hand swelling, rash (whole body), fever, itching.  Tx: Benadryl, Solumedrol.
Paxlovid indication=Treatment of COVID-19; Paxlovid indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: En6208), in left arm and on 07Apr2021 as dose 2, single (Lot number: Er8731) at the age of 38 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Mar2022 as dose 3 (booster), single (Lot number: 026lub), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Paxlovid indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Roche at home rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:  Tested positive (at home rapid test) for Covid after testing negative 5 days prior. Recurrence/worsening of covid symptoms led to retest. Testing positive (today) 13 days after first positive test. Started paxlovid the day after first Positive test. Timeline: PCR test negative on 10Jun (test12ed at 2pm), antigen test positive 12Jun, started Paxlovid on the 13Jun. Tested negative (at home) on the 17Jun and 18Jun. Felt worse on the 22Jun, and tested positive again on the 23Jun and the 25Jun. if vaccine received. The patient got COVID-19 treatment with antiviral paxlovid from 12Jun2022 to 16Jun2022. The patient had taken other medication in 2weeks were Sudafed, Zyrtec, Tylenol, Dayquil, Vitamin B12.  No follow-up attempts are needed. No further information is expected.
Approximately 5 min after injection my lips became numb.  Three days later tongue was numb.  By Monday there was noticeable droopiness of the face and lack of movement on the right side of my face.  I went to the emergency room and was diagnosed with having Bell's Palsy,
small metal such as paper clip, quarter coin and safety pin sticks to my arm near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (small metal such as paper clip, quarter coin and safety pin sticks to my arm near injection site) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013AB1A and 002B2IA) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2021, the patient experienced VACCINATION COMPLICATION (small metal such as paper clip, quarter coin and safety pin sticks to my arm near injection site). At the time of the report, VACCINATION COMPLICATION (small metal such as paper clip, quarter coin and safety pin sticks to my arm near injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Chest pain, found to have elevated troponins, BNP, and CK diagnosed with myocarditis
mom relates pt devel hives 12-14 hr p/vax;mom states they remained bad for 4-5 days;then resolved in about a wk;no tx, no residual;
Vasovagal event after receiving HPV vaccine - nonresponsive 5 seconds.  No fall, no injury.
Joints ache all over. No energy. Fever spiking at 102.1.
Excruciating pain night after injection of PNEUMONIA shot from shoulder to wrist.  Abated next day.  Sore spot for about a week.
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 84 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 17-NOV-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
pt c/o lt arm soreness, redness, swelling started about 2hr p/vax given lt arm swollen, warm to touch from shoulder to elbow per pt swelling, pain, redness decreased but it is still painful;
Pt received 2nd dose of COVID vaccine at 21 days after 1st dose instead of 28 days.
like "getting a punch in the arm or something"/ went away; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (like "getting a punch in the arm or something"/ went away) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Aug-2021, the patient experienced VACCINATION SITE PAIN (like "getting a punch in the arm or something"/ went away). At the time of the report, VACCINATION SITE PAIN (like "getting a punch in the arm or something"/ went away) had resolved.            No relevant concomitant medications were reported. No treatment medication was  reported.
I can hardly move; sick; Bad reaction that I had from the vaccine, the second one; This is a spontaneous report from a contactable consumer (patient). The 76-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunization. The patient reported " i can hardly move,  I have been sick from so long, bad reaction that i had from the vaccine, the second one" on an unspecified date. Reported as: Consumer stated, "I was calling because of a bad reaction that I had from the vaccine, the second one, not the first one." "I can hardly move, the side effect. I have been sick from so long."Regarding Height and weight: Consumer stated, "I used to be # feet # inches but I am shrunk down to # feet and I am about # pounds."The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient presented to another hospital 6/16/21 will cough fever illness was discharged from ED to recover at home, no cultures drawn at that time. Subsequently remained ill and came to our facility 6/30/21 was diagnosed with MSSA bacteremia. After persistent bacteremia despite appropriate antibiotics TTE was performed revealing large pericardial effusion requiring intervention. Patient still admitted and treatment ongoing.