chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client started to feel faint about 10 minutes after she had the vaccine administered. She informed the nurse. Her blood pressure was 100/62 hr 58. She sat for a few minutes and then vomited. She had bcome very diaphoretic. Her bp was 146/100 and hr was 96. She was responsive and she refused a shot of Benadryl. We called for an ambulance. We continued to monitor her bp and hr. Her husband arrived. She left with her husband. Her last bp was 136/100 hr was 70 ab she was not longer diapheretic. He husband took her to the ER. I spoke to patient today at (9:10 am. The ER doctor told her she had a vasovagal incident. He told her she can get the second dose if she is in a supine position with monitoring.
Began experiencing left lateral knee pain approximately 6 weeks after vaccine.  Pain progressed to medial.  XRAY at 4 months normal, but meniscus tear shown on MRI.  Pain increased in intensity to 8 out of 10.  By 3 months later, new XRAY showed complete lost of medial knee cartilage, bone on bone OA.  I had no prior history of knee issues ever, and never abused my knees, am healthy with BMI WNL.  My parents lived to age 86 and had no history of knee or hip OA.  Underwent total knee replacement December 2021.
Employee was vaccinated on 12/17/2020 and 1/5/2021, she tested positive for Covid-19 on 4/14/21 using the anterior nasal swab and PCR testing.
Initial information received on 05-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2019SA036951 and 2019SA036959 same reporter. This case involves a 15 months old patient who received 0.5 mL dose of vaccine ACT-HIB lot UI914AA, expiry date- 28-Nov-2019 via unknown route in the left thigh on 09-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that three patients received ACTHIB. One of these patients received it incorrectly, it was reconstituted with a Merck diluent. It is unknown which of these patients received it. It was unknown if any adverse event was occurred. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. Documents held by sender: none.
Early 2nd dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 47-year-old female patient who received HAV (Havrix) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   Previously administered products included Havrix (1st dose received on 8th May 2023).   On 13-JUN-2023, the patient received the 2nd dose of Havrix. On 13-JUN-2023, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: Early 2nd dose.). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 13-JUN-2022 A pharmacist called to inform that earlier that day, a patient received the 2nd dose of Havrix.  The reporter consented to follow up.  The patient received 2nd dose of Havrix earlier than recommended interval, which led to shortening of vaccination schedule.
minutes after the injection the tip of my tongue and lips began tingling and my tongue went numb, the roof of my mouth began to tingle and go numb as.  NO difficulty swallowing or breathing,  No changes in the vitals and I was given benedryl by mouth and observed for 30 minutes with no further issues and all symptoms resolved.  My right arm was tingling and weak also but to date all symptoms has resolved.
Burning pain near injection site for a few minutes. Next day, kept burning, bruise and slight lump appeared. On 9/17/2015 a large scab (size of a quarter, colored yellowish brown) appeared. Patient saw MD Sept 18. He reportedly said it is a strange reaction. Patient called me 9/21/2015 to verify which arm was injected. Now reporting peeling, black around edges, large lump with occasional pain.
Uncontrollable cough; Fever of 101; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Uncontrollable cough) and PYREXIA (Fever of 101) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Bronchial asthma. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), LOSARTAN and METFORMIN for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced COUGH (Uncontrollable cough) and PYREXIA (Fever of 101). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency and OXYMETAZOLINE HYDROCHLORIDE (CORICIDIN [OXYMETAZOLINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, COUGH (Uncontrollable cough) and PYREXIA (Fever of 101) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Body temperature: 101 f 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Day 3 - Tinnitus This ringing continues to this day (2-12-22) but is louder
Information has been received from a consumer, concerning his 12 year old daughter with no known allergies, who in June 2007, was vaccinated with the first dose of Gardasil (lot # not reported). Concomitant therapy included an unspecified beta blocker (indication not reported). Following the vaccination (date not specified), his daughter saw a cardiologist and had an electrocardiogram (EKG) result of an elongated QTC level of 494 (units not specified), with the potential for arrhythmia. In August 2007, his daughter was vaccinated with the second dose of Gardasil (lot # not reported). Following the second vaccination, her "LQTC" level was higher at 502 (date and units not specified). At the time of this report, the patient had not recovered. Additional information has been requested. Follow up information from the physician indicated that on 22-JUN-2007, the patient (a caucasian  student), with a heart murmur and a possible allergy to CEFZIL but otherwise well, was vaccinated IM in the right arm with the first dose of GARDASIL (lot # 658094/0524U). Concomitant vaccine therapy, administered IM in the left arm at the visit, included the first dose of BOOSTRIX (lot #AC52B006BA). There was no illness at the time of vaccination. The physician stated that, "we noted a murmur at that visit which lead to a cardiac eval which lead to diagnosis for elongated QT." There was no immediate reaction noted. The diagnosis was confirmed on 18-JUL-2007, when the patient's QT, on a holter monitor, was between 0.46 and 0.54. The findings were reported to the physician by cardiology. Additional information has been requsted.
right side of her face was swollen and rugged; right side of her face was swollen and rugged; eyes were itchy; inside of her nose felt a little itchy and numb; inside of her nose felt a little itchy and numb; headache; lethargic; throat started swelling; pale; legs were shaking; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (wife). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 12Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history included swelling (something similar happened to her 10 years ago) from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. It was reported that on 12Apr2021, the patient experienced after 10 minutes she had a small headache and was feeling lethargic. After 30 minutes her throat started swelling / picking up, so they went back to the clinic. One hour later, she was very pale, and her legs were shaking. On 13Apr2021, the patient experienced right side of her face was swollen and rugged, eyes were itchy, inside of her nose felt a little itchy and numb. He gave her some leftover Cetirizine Hydrochloride for the swelling which was in a small region but very swollen. On an unspecified date, the patient underwent lab tests and procedures which included blood pressure was 120/75 which was normal, temperature was 98 Fahrenheit (which was normal), oxygen was 98%. Therapeutic measures were taken as a result of events includes 2 pills of Benadryl with an unknown strength. It was stated that, she slept the whole day and the whole night due to the Benadryl and some leftover Cetirizine Hydrochloride. The outcome of the events was unknown.  No follow-up attempts are possible, Information about Lot/Batch number cannot be obtained.
A report has been received from a Physician concerning a 10 year old, male subject who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUARIVALENT (intranasal) started on an unknown date. The patient reported administered expired FLUMIST QUADRIVALENT which started on 08-Sep-2014. The outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Shortness of breath/difficulty breathing, Nausea/Vomiting, Loss of smell or taste, Cough
Pt's mother states 1 week after receiving vaccination the child experienced diarrhea, a fever of 99-100 and a rash beginning at his ears and spreading all over the child's body. Pt's mother state this lasted for 3-4 days.
ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY
INFECTED/PUFFY/HOLE IN THE LEFT ARM; MUSCLE ARE DAMAGED; TISSUES ARE DAMAGED; WON'T BE ABLE TO USE ARM SAME WAY; ARM HURTING REALLY BAD; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included: brain injury in the right frontal lobe, and concurrent conditions included: degenerative disease, iodine allergy, seafood allergy, lyrica allergy, and sulpha antibiotics allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, expiry: 29-SEP-2021) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-JUN-2021, the patient experienced arm hurting really bad. On an unspecified date, the patient experienced infected/puffy/hole in the left arm, muscle are damaged, tissues are damaged, and won't be able to use arm same way. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the infected/puffy/hole in the left arm, arm hurting really bad, muscle are damaged, tissues are damaged and won't be able to use arm same way was not reported. This report was non-serious.
From the initial injection there was a problem.  It didnt come out the needle at first and had to be tried again, pushing harder.  It bunred immediately.  Shortly after that, I began having stomach pains; heaviness in my arm where the injection site was; tingling in my fingers on that arm and a taste of metal in my mouth.  I went to the walk in emergency room and the receptionist noted that my throat, neck and chest were red.  When the doctor examined me, he also noted that I had a bad reaction to it because my arm was swollen and puffy.
On 05/25/2000 the patient developed a red, macular and papular eruption over his face, chest, abdomen, upper and lower back and diaper area. There was no pruritus. The rash appeared immediately after the fever subsided. The patient was treated with Benadryl and the patient recovered. The patient had a similar experience following hepatitis b vaccine.
Fatigue; Chills; Headache; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 01Apr2021 at 12:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergy from an unknown date. The patient had no known allergies to medications, food, or other products. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) taken within two weeks of vaccination but not within 3 days of the vaccine for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 14Mar2021 at 13:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. 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 COVID-19 vaccination. On 02Apr2021 at 08:00, the patient experienced fatigue, chills, headache and diarrhea. 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. The patient did not receive any treatment for the reported events. The clinical outcome of the events fatigue, chills, headache and diarrhea was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Extreme headache, and this what we would like to report....hallucinations.  Still having some hallucinations but getting better after 3 days.
Nausea; fatigue; muscle aches; chills; transient SOB; runny nose; weird headaches or fullness; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), intramuscularly on 22Dec2020 at 15:00 on Left arm at single dose for COVID-19 immunization. The patient medical history included known allergies with Chloreseptic spray. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included ergocalciferol (VIT D); ascorbic acid (VIT C); probiotics (reported as probiotic); alpha-amylase swine pancreas, cellulase, lipase, protease nos (DIGESTIVE ENZYME); trazodone (reported as trazadone) for sleep; fluticasone. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Nausea, fatigue, muscle aches, chills, transient SOB (Shortness of breath), and runny nose, weird headaches or fullness on 22Dec2020 at 19:00. Since the vaccination, patient had been tested for COVID-19 via Nasal Swab on 04Jan2021, result: Negative. No treatment was received for the events. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
Hives followed by a fever which began at 8:30am in  04/09/2021.  Highest measured fever was 103.4 at 2:30pm. Took 3 200mg ibuprofen liquigel capsules. Fever dropped to 101.4 at 4:14pm.
G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 4/11/2023 AORTIC VALVE STENOSIS R09.02 HYPOXIA 3/23/2023 AORTIC VALVE STENOSIS G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 4/11/2023 PNEUMONIA R09.02 HYPOXIA 3/23/2023 PNEUMONIA
Initial information received on 09-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves 32 years old male patient who received a 0.5 mL dose of vaccine FLUZONE HIGH DOSE batch number UJ000AA (expiry date 28-Mar-2019) via unknown route in left deltoid. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patients' medical history and concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose. It was not reported that if any adverse reaction was experienced. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. Documents held by sender: none.
This spontaneous report was received from an office administrator and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 17-FEB-2017, the patient was vaccinated with an expired dose of RECOMBIVAX HB batch# K005424, expiration date 11-JUN-2016 (dose, route of administration were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
SWELLING OF EXTREMITIES - RIGHT THIGH FROM KNEE UP, LIMPING THE DAY OF AND DAY AFTER, BLISTER AT INJECTION SITE TWO DAYS AFTER, FLUSHED SKIN AND REDNESS, WARM TO THE TOUCH TWO DAYS AFTER, PAIN IN LEG FOR FOUR DAYS AFTER INJECTION.
Post vaccine-developed swollen lymph node under Left arm, headache, nausea, lethargy. This resolved by day three. Day 4 started having periods of extreme vertigo, this is happening more frequently and with more severity up to today 2/2/2021 woke with severe dizziness and nausea, fell over when rising from bed. continue to be very dizzy and nauseated
This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a 71-year-old female patient who received SHINGRIX (batch number 954K9, expiry date 24th February 2021) (GSK note: the reported lot number did not match with any GSK lot number) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date, without any adverse event). On 10th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 10th August 2018, immediately after receiving SHINGRIX, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was not recovered/not resolved. It was unknown if the reporter considered the vesicular rash to be related to SHINGRIX. Additional information received as follows: The healthcare professional reported that the patient did well after the first dose. The healthcare professional reported that the patient experienced the shingles-like rash right after receiving the dose of SHINGRIX. The patient had the rash on her trunk and legs. The healthcare professional reported that the patient did well after the first dose. The patient had been in touch with her physician. She informed to the healthcare professional about the reaction on the reporting day.
Mom reported temp 100.3 and vomiting on 2/9/05 was better by that night. On Sunday 2/13/05 had temp 101.8. Seen at ER with diagnosis of pneumonia. Treated with steroids and nebulizer. Admitted to hospital on 2/14/05. Discharged on 2/17/05. 6 mo BM product of a term C-section delivery c/o severe diffuse non productive cough with wheezing, worse at night, improved with Rocephin, Solumedrol and Amoxil onset for 2 days. He now c/o of Diarrhea, CXR in ER 2/13/05 documented Pneumonia. He has a prior hx of UTI at 2 months and has a congenitally displaced inferior urethral reaction. Impression: Bronchiolitis, possible early pneumonia. Tx: The pt was given Albuterol and Atrovent nebulizer here in the ER and after this he is not having any retractions and faint wheezes. He is also given Motrin for his fever and Solu-Medrol IM. He will be placed on Prednisolone and Augmentin at home. Mother is also instructed to give Albuterol by nebulizer every 4 hrs. The child is discharged with instructions to follow up with Dr who is on call for the ER if he is not better in the next 1-2 days. If he developed any respiratory distress, she is to bring him back to the ER immediately. He is discharged in good condition.
1.At time of injection, left arm (injection site) sore for several days. As of 02-01-22, range of motion has been compromised. Cannot fully move left arm around or up completly. 2.Menstral cycle off. As of 02-10-22, started bleeding vaginally. Not time for period. No symptoms of PMS. Still bleeding as of today 02-15-22.
This spontaneous report as received from a nurse refers to an 8 months 27 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Following day, post vaccine the right deltoid area large amount of induration, erythema, warmth, pruritis covering all deltoid. vesicles formed pt. c/o pruritis no pain.
Patient states vaccination was painful at time of injection and the site was higher in the arm/shoulder than normal (confirmed by another pharmacist related to the patient).  Also states that an alcohol swab was not used prior to administration.  The injection site itself was not swollen or painful, but patient states that it is painful lay on and hurts with movement or lifting weight.  She did take acetaminophen for a few days but it did not seem to help.  Pain has not improved since injection was given.