chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that over the past 2 decades he had experienced flu-like symptoms after receiving the flu vaccine (unknown manufacturer). The patient did not provide any additional details. The patient did not wish to provide any contact information and ended the call before any additional details could be obtained. For tolerability after receiving SHINGRIX vaccine, refer case US2018133471.
Pharmacist discovered vial did not have enough serum to draw a sixth and final dose. Another pharmacist had done two prior vaccines. Pharmacist has made patient aware there is a possibility (however unlikely) that she may have received a larger dose than intended (0.3 ml). Pharmacist was waiting to try and confirm through camera footage but not able to be done. It is also not known if different calibrated syringes were used thus making easier to waste product. Product could also have been a quality issue as well.  Pharmacist is brain storming all possibilities even if an error has not occurred but treating as such due to nature of vaccine and EUA.
No additional adverse events reported; nurse with credentials L.V.N. administered a dose of GARDASIL 9 that expired 5/30/2021; This spontaneous report as received from a registered nurse concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.     On 01-JUN-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), dose reported as 1 dose, lot # R024259, expiration date: 30-MAY-2021 for prophylaxis (dose, and route of administration, were not reported) . It was reported that dose was properly stored.No additional adverse events reported. No product quality complaint.
Received KINRIX & MMR IM (L) arm on 8/20/12 --> pain 8/21/12 --> red 8/22/12 --> I put patient on KEFLEX, TYLENOL on 8/22/12.
Administration site reaction-Red and warm 3" diameter with hard lump in middle about 1" in diameter. L Deltoid region.
Significant swelling around the injection site. Patient saw his doctor, who prescribed a zithromycin 250mg dose pack for 5 days. Patient was back to normal within two days.
Woke up with fever of 104.3 F, chills unbeliever with heat and quilts, frontal headache, pain all over unbeliever by Tylenol,  expected right deltoid soreness, neck tightness- hard to turn my head, is all of this expected? I need to know if these are normal with the vaccine, thanks.
Unsure if related to vaccine (I hope not?) but developed: narcoleptic symptoms relatively soon after first dose (exact day unsure). Excessive daytime sleepiness, sleep paralysis, dream-wake irregularities etc. Had been experiencing mild cataplexy since 2013 but not other symptoms until April 2021. Doctor says it could be related to flu vaccine as well.
Information has been received from a physician referring to a female patient of unknown age who was currently 7 weeks postpartum. No other relevant medical history or concurrent conditions were reported. On an unknown date in February 2014 the patient was vaccinated with the first dose of GARDASIL (0.5ml; lot# and expiration date unknown) intramuscularly. The patient became pregnant on an unspecified date after receiving the vaccine. On 5-MAY-2015, the patient who was currently nursing her 7 week old infant, was in the physician's office to receive the dose number two of GARDASIL (0.5ml: lot# and expiration date unknown). Other than pregnancy, no adverse experiences were reported. Additional information has been requested.
felt like I had the flu a day after but went away then the Tingling fingers, Tingling/ numb feet, legs giving out, eyes contantly watering all started 3 weeks after shot
7/10/98 fever, sore throat - resolved, 7/14/98 vax, 7/15/98 itchy rash on trunk extremities & head
Headache, weakness, fever of 100.8, nausea,  lack of appetite, body aches
Diffuse urticarial rash started within 24 hours (both arms, both legs)
Redness and swelling around insertion site. Warm to touch . Given Benadryl cream
Patient reported anxiety and felt shaky and nauseous. Medical attention was administered. Patient vital signs within normal range.
Pt reports single pustular lesion on an erythematous base on her face / non tender / her hx of zoster in her past with non tender lesions on her face x 2 / I treated her with antiviral medication suspecting lesion zoster due to time near to vaccine administration.
Almost 4 years subsequent to receiving one dose of varicella virus vaccine live the pt developed chickenpox with approximately 10 lesions.
Bad reaction to immunization per nurse.  Left arm really swollen, red, hot to touch per grandmother.
This case was reported by a consumer via call center representative and described the occurrence of skin eruption in a elderly female patient who received SHINGRIX for prophylaxis. On 24th September 2018, the patient received SHINGRIX. On 8th October 2018, 14 days after receiving SHINGRIX, the patient experienced skin eruption and shingles. On an unknown date, the outcome of the skin eruption and shingles were unknown. It was unknown if the reporter considered the skin eruption and shingles to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. On Monday or Tuesday of this reporting week, the patient experienced breaking out. The call center representative asked for the health care professional information, but the patient stated that the health care professional was going to give GlaxoSmithKline a call.
Sudden onset of abdominal cramping, nausea, chest pain and numbness and tingling of her lips and palpitations. Went to the emergency department with diagnosis of Allergic reaction-Vasovagal.
Pt vaccinated with Recombivax HB developed swollen, tender anterior cervical lymph nodes & a temp of 100.4 also arthralgia then within 24 hrs developed aseptic meningitis, headache & photophobia.
Within 24hrs, itching scalp, red itchy blotches on cheeks; small (quarter sized) bumpy itchy patches on upper right arm, several "pock marks" on different body parts -- still scratching scalp, face spots at 48hrs.  Entries on which shot/which leg and manufacturer is taken from shot record which is handwritten and difficult to read - technician used initials only.
Patient presented with 2 shingles / zoster blisters on 2/10/22 on right buttocks and upper right leg Shingles blisters expanded on buttocks, leg and torso. Original shingles blisters became infected and patient was treated with Bactrim antibiotic on 2/17/2022. Pt was seen by Dr who diagnosed a cellulitis infection (a life-threatening infection if left untreated) which was treated with Prednisone steroids on 2/18/22. Steroid topical. Valtrex 2/19 Pt was unable to walk normally and limped while walking. Discomfort with red, swollen, painful and warm to touch 10?x8? area on right upper leg and buttocks. Headache. Pt was dizzy, extremely exhausted and unable to care for kids (her job) for more than 3 hours 2/20/22 through 2/27/22 Pt seen 2/24/22 by Dr., cellulitis resolved, shingles blisters present. Elevated heart rate and heart pressure.
Light rash on trunk, breasts and back developed that was itchy and stinging.  The rash resoved by the next day.
After my vaccine I had tenderness in my right arm at injection site and a sharp pain in my right clavicle bone. The clavicle bone pain slowly went to an ache. But then I noticed my arm was ballooning up a d the injection site was hard. Then, About a week after my COVID vaccine, I experienced leg pain (left) behind my knee and my arm was getting larger and warm to the touch. My first appointment with my doctor was 3/24/2021 at 1215pm. He checked out the areas and ordered a ultrasound Doppler of my left knee. I called the vaccine center as it says on the paper given with the vaccine. I spoke to someone and explained my symptoms. She suggested a ultrasound of my arm as well. I called my primary care doctor who added my arm to the order.
Patient was feverish, administered Tylenol throughout the day which didn't control the fever, causing a febrile seizure and the patient to stop breathing. Patient had no other symptoms of illness besides a fever of approx 104 when he arrived at the hospital. Was given a double dose of Tylenol and Ibuprofen upon arrival and diagnosis. All tests came back negative except for a few white blood cells in his urine.
Information has been received from a physician's assistant concerning a 22 year old female patient who in January 2009, was vaccinated with the third dose of GARDASIL. In February 2009, the patient experienced neurogenic bladder symptoms and fibromyalgia after receiving the 3rd dose of GARDASIL. On an unspecified date, a magnetic resonance image was performed; results were not reported. The patient sought medical attention with the physician's assistant. At the time of reporting the patient's outcome was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information was received from a physician's assistant who reported that the 23 year old patient (previously reported as 22 year old) had experienced multitudes of symptoms including migraines, syncope, neurogenic bladder and chest pains since GARDASIL. According to the reporter the last vaccine was given in January 2009 and the symptoms began in February 2009. The reporter mentioned that the patient has been seeing many specialist including neurologist and an urologist. The physician's assistant also reported that the patient had been to a university medical center for evaluation. The patient had emergency room visits for above. Patient was found to be vitamin D deficient and at the time of reporting she was taking supplements. The physician's assistant reported as well that GARDASIL was administered by the patient's gynecologist. It was also reported that the experiences were still being treated. The patient's outcome was unknown. No further information is available.
pt began c/o having something in throat about 5 mins p/vax; c/o being unable to cough; pt was holding throat; became diaphoretic & pulse was weak; 911 was called, paramedics administered 02 & took pt hosp
Non stated. Vaccines order by physician that child had already received. There where no reactions. Told my manufacture body will only use what is needed and rid itself of the rest. 6-6-08
Been a while since the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Been a while since the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Been a while since the first dose). On 15-Feb-2021, PRODUCT DOSE OMISSION ISSUE (Been a while since the first dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
TOOK TWO DOSES IN A ROW; This spontaneous case (PVX2019-1507) was received from a nurse on 11-Jun-2019. It describes an adult female consumer who "took two doses in a row". The consumer was receiving oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took two doses of Vivotif in a row. The doses were taken on 06-Jun-2019 and 07-Jun-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.
Could not sleep good; difficulty in breathing; Fast heartbeat; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Last night, 16Feb2021, the patient could not sleep good because of difficulty in breathing and having a fast heartbeat. The patient mentioned having had the COVID-19 vaccine and does not know if these were side effects but, he/she could not sleep last night. The patient wanted to know what he/she could do. The outcome of the events was unknown.  Information about the lot/batch number has been requested.
Immediately following administration, patient walked out of room and sat down in waiting area.  Patient felt very dizzy and almost fainted. Complained of hearing loss then tinnitus. Initial BP was 82/31 then gradually increased back towards normal over 20-30 minute period.  Hearing loss recovered after 1-2 minutes then complaint of tinnitus which then stopped after 5-6 minutes. Approx 30 min after admin, pt felt much closer to normal and parent felt comfortable bringing her home.
Case number PHEH2014US025162 is an initial spontaneous report received from a pharmacist on 11 Dec 2014. This report refers to a 34 years old female patient. Past medical history and concomitant medications were not reported. On 10 Dec 2014, she was vaccinated with FLUVIRIN (batch number: 146701) intramuscularly that had been stored at 33.4F prior to administration. No adverse event was reported following this administration error.
pain all over; temp of 102; fever blister; skin darken/ peeling around mouth/chin; skin darken/ peeling around mouth/chin; injection site sore/ Vaccination site pain; Felt weak/ nauseated; Felt weak/nauseated; thirsty; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 50-years-old non-pregnant female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0172, expiry date: unknown) via an unspecified route of administration in left arm on 01Jun2021 at 10:00 (at the age of 50-years-old) as dose 2, single for COVID-19 immunization at pharmacy/drug store. The patient was non-pregnant at the time of vaccination. The patient's medical history included gallbladder removed on 21May2021 (surgery follow-up was on 01Jun2021), gastritis, gastroparesis, chronic fatigue syndrome, type 2 diabetes, venous inefficacy and Penicillin allergy. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took erythromycin, sulfa [sulfanilamide], morphine, demerol and experienced drug hypersensitivity with them. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0172, expiry date: unknown) via an unspecified route of administration in left arm on 21Apr2021 at 11:45 (at the age of 50-years-old) as historical vaccine as dose 1, single for COVID-19 immunization and experienced gout. Few days after surgery patient called the nurse to inquire about scheduling second injection. After follow-up appointment, she had a good report but never had gout before but was diagnosis & prescribed Meloxicam. On 01Jun2021 at 15:00, symptoms on the day of second injection, the patient experienced pain all over, temp of 102, fever blister, skin darken/ peeling around mouth/chin, injection site sore, felt weak, nauseated, & thirsty. Symptoms lasted about a week except skin peeling around mouth/chin which was ongoing. Patient did not have COVID prior to vaccination and was not tested for it post vaccination. The patient underwent lab tests and procedures which included body temperature 102 on 01Jun2021. Therapeutic measures were taken as a result of events as home remedy, Tylenol, Hydrocodone and rest. The outcome of the event skin peeling around mouth/chin' was not recovered, while the outcome of remaining events was recovering at the time of reporting.  Follow-up attempts are completed. No further information is expected.
ain at injection site 8 hrs after injection,   fever, chills, joint and muscle pain, tiredness 16 hrs after infection.  temp reached 101.0.about 20 hrs after injection.   temp down to 99.6 after 36 hrs, just still running some low grade temp.  soreness, joint pain better.
Starting Monday at work I began to feel very tired, my muscles started aching across my back at shoulder level, and my hands went numb.  I went home and took Tuesday off to rest. Wednesday this has continued and I may leave work again.  I have also had some very sharp pains in my joints.
Rash on both legs from mid thigh to ankle and inside wrist and left arm.; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 16Mar2021 at 12:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had a history of allergy to pineapples. The concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 19Mar2021 at 19:00, the patient experienced rash on both legs from mid-thigh to ankle and inside wrist and left arm (rash). It lasted for 3 days, but did not start until 19Mar2021, 3 days after vaccination. The second dose was scheduled on 06Apr2021. No therapeutic measures were taken for the reported event. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. The clinical outcome of the event rash was resolved on 22Mar2021.   Information about lot/batch number cannot be obtained. No further information is expected.
SEVERE DIARRHEA, FAINT FEELING, AND SWEATING WITHIN 12 HOURS OF VACCINATION
Reason for Admission: Covid pneumonitis with large PE and hypoxia with known metastatic Breast Cancer
2/23/21:Headache, sore arm 2/24/21: High Fever  100 degrees: 8:00 p.m. Blurry eyes, Stuffy, runny nose. Sore arm. Sneezing.  Felt ill. 2/25/21: Fever slowly came down during the day. Arm itchy and sore. Hot arm. 2/26/21:  Hot, itchy, sore arm. Red area near injection site. 2/27/27: Arm still red, sore itchy. nausea.
Diarrhea and concern for abdominal pain, increased fussiness x several days after oral rotavirus vaccine (+ IM PEDIARIX, PREVNAR, Hib).
TRANSIENT DIZZINESS AND LIGHT HEADED; STOMACH PAIN; SWOLLEN LEGS; LEG PAIN; MIGRAINES /MIGRAINE TYPE HEADACHE TOWARDS  RIGHT EYE; HEAVY LEGS; RASH ON BOTH LEGS; DIARRHEA; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included no medical history. The patient had no known allergies and no drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042821A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced diarrhea. On APR-2021, the subject experienced rash on both legs. On 06-APR-2021, the subject experienced migraines /migraine type headache towards right eye. On 06-APR-2021, the subject experienced heavy legs. On 12-APR-2021, the subject experienced stomach pain. On 12-APR-2021, the subject experienced swollen legs. On 12-APR-2021, the subject experienced leg pain. On 15-APR-2021, the subject experienced transient dizziness and light headed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraines /migraine type headache towards right eye, stomach pain, and swollen legs on APR-2021, had not recovered from rash on both legs, leg pain, transient dizziness and light headed, and heavy legs, and the outcome of diarrhea was not reported. This report was non-serious.
Toddler with development of herpes zoster.  Previously vaccinated for Varicella.  No history chicken pox.  Varicella titer negative for immunity.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: EMS on site and evaluated patient.
I21.4 ACUTE NON ST ELEVATION MI 7/11/2021 BRAIN LESION J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/12/2021 BRAIN LESION R09.02 HYPOXIA 7/9/2021 BRAIN LESION I21.4 ACUTE NON ST ELEVATION MI 7/11/2021 UPPER GI HEMORRHAGE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/12/2021 UPPER GI HEMORRHAGE R09.02 HYPOXIA 7/9/2021 UPPER GI HEMORRHAGE I21.4 ACUTE NON ST ELEVATION MI 7/11/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/12/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE R09.02 HYPOXIA 7/9/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE I21.4 ACUTE NON ST ELEVATION MI 7/11/2021 THORACIC AORTIC DISSECTION, STANFORD TYPE A. J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/12/2021 THORACIC AORTIC DISSECTION, STANFORD TYPE A. R09.02 HYPOXIA 7/9/2021 THORACIC AORTIC DISSECTION, STANFORD TYPE A. I21.4 ACUTE NON ST ELEVATION MI 7/11/2021 THORACIC AORTIC DISSECTION, STANFORD TYPE A. J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/12/2021 THORACIC AORTIC DISSECTION, STANFORD TYPE A. R09.02 HYPOXIA 7/9/2021 THORACIC AORTIC DISSECTION, STANFORD TYPE A.
Immediately following the vaccine, I got chills, and my face tingled. I developed tonsillitis. Had to take a day off work for a COVID test, was negative.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 57-year-old male patient who received SHINGRIX. On 30th January 2018, the patient received SHINGRIX. On 31st January 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema. On 5th February 2018, the patient experienced neuralgia and localized feeling of warmth. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the neuralgia and localized feeling of warmth were not recovered/not resolved. The reporter considered the injection site erythema and neuralgia to be possibly related to SHINGRIX. It was unknown if the reporter considered the localized feeling of warmth to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to any one. The patient vaccinated with SHINGRIX in the left arm by staff pharmacist. In the next morning, the patient had redness at the injection site. On 5th January 2018, 6 days after receiving SHINGRIX, the patient awoke with some back nerve-like pain, described as a warm sensation on his back. At the time of reporting, the patient noted that the nerve pain in the back only occurs at night.