chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer via a website concerning a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot#, dose, and route not provided). On an unknown date, the patient died in her shower. The patient was so healthy prior to the vaccination. The post mortem result stated cause of death unknown. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received via a company representative from a registered nurse refers to a 14 years old female patient with milk allergy. The patient was vaccinated with dose 2 GARDASIL (reported lot number H009746, expiry date 11-JAN-2015, route and dose not reported) on 08-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 08-OCT-2012 the patient fainted after receiving the 2nd dose of GARDASIL. The patient had previously received her first (date, dose and route not reported) without experiencing an adverse event. The patient did not receive any treatment. No relevant tests were performed. The patient seemed recovered after a few minutes. A reporter causality for fainted was not provided for GARDASIL. The registered nurse reported about 2 patients (sisters) who fainted after receiving the 2nd dose of GARDASIL: Linked case report is 1210USA005725. Additional information is not expected.
Suspected vaccination failure; influenza; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received flu vaccine and the flu vaccine did not work properly. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for infuenza, time to onset for event and laboratory confirmation for influenza were not provided.
Pt recvd 3 doses of Engerix-B vax on 1NOV90, 27NOV90, & 30APR91 & 7OCT91 it was determined that pts titer was neg p/3 doses of Engerix-B;
This spontaneous report as received from a reporter (role unspecified) via a company representative refers to a 16-year-old male patient. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient was intramuscularly vaccinated with a dose of GARDASIL 9 injection (exact dose, lot# and expiry date were not reported). Concomitant therapies included unspecified antibiotics. On an unknown date, reported as "several days later", the patient experienced itchiness, joint pain and hives. The patient then went to an emergency room due to breathing issues. The outcome of the events was not reported. The relatedness between the events and GARDASIL 9 was not provided. Additional information is not expected as there was no consent to contact the patient's physician.
aggravated arm at the site of the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (aggravated arm at the site of the shot) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (aggravated arm at the site of the shot). At the time of the report, VACCINATION SITE REACTION (aggravated arm at the site of the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient states her husband that is 20 years her senior received his first shot and had no reaction except an aggravated arm at the site of the shot   This case was linked to MOD-2021-032203, MOD-2021-032170 (Patient Link).
Localized redness, swelling, and pain. Getting better as of 1/16/20
Pt's arm has become swollen. Pt states she was put on KEFLEX 500 qid b/c of rxn at injection site.
7 COVID-19 BOOSTER DOSES OF MODERNA WERE THAWED AND ADMINISTERED ON JAN 19. THE VIAL HAD INFACT EXPIRED ON JAN 14.
Received first dose of Heplisav-B, second dose was given with Twinrix; Initial Report Received on 06-Jan-2021  A registered nurse in the reported that a 56 year-old male (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and was administered Twinrix (Hepatitis A and Hepatitis B Recombinant Vaccine) as the second dose for hepatitis B immunization.  Medical history was reported as unknown.    Concomitant medications was reported as unknown.  On 12-Nov-2020, the patient received the first dose of HEPLISAV-B (Lot # 933623, expiration date 22-Aug-2021, NDC #43528-0003-05 and serial number 611405742605) at an unknown facility.  On 16-Dec-2020, 35 days after receiving the first dose of HEPLISAV-B, the patient received Twinrix (Hepatitis A and Hepatitis B Recombinant Vaccine) as the second dose (Lot #, expiration date and NDC # not provided) of hepatitis B vaccination at an unknown facility.  No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Rash, dizziness, syncope, fever/chills, nausea, hives, fatigue.  Went to ER received Benadryl, and epinephrine, methyl prednisone inj, pepcid inj.   rested and continued Benadryl and prednisone for 5 days.  Now feeling good.
Tight band of pain across belly, from belly button down to waist, very slow digestion. Also knees were sore, felt odd three hours after the shot and when I woke up they were very sore but resolved during the day.
REDNESS AT SITE, HOT TO THE TOUCH, 4" X 3" RASH AREA, SWELLING. VACCINE ADMINISTERED 8/14/20, SYMPTOMS STARTED 8/20/20.
ERT NURSE (DEPARTMENTOF HEALTH RECEIVED CALL 06/16/2003 FROM PATIENT WANTING TO SHARE MEDICAL INFORMATION WITH NURSE TO INCLUDE IN HIS MEDICAL FILE.  PATIENT ADVISED NURSE THAT HIS RIGHT EYE STARTED WATERING EXTENSIVELY ON SATURDAY JUNE 7, 2003.  THIS CONTINUED OVER THE WEEKEND ALONG WITH NUMBING TO HIS RIGHT CHEEK.  MONDAY MORNING JUNE 09, 2003 HE FELT THE SIDE OF HIS FACE TOTALLY NUMB.  HE WENT TO HIS PRIMARY PHYSICIAN THAT MORNING.  AFTER SEVERAL EXAMS, BLOOD TESTS, AND CT SCAN HE WAS DIAGNOSED WITH BELLS PALSY.  ONE OF THE QUESTIONS THE PHYSICIAN ASKED HIM WAS IF HE HAD A CHICKEN POX OR SMALLPOX VACCINATION.  PATIENT IS A 43 YEAR OLD MALE WITH NEGATIVE MEDICAL HISTORY.  HE HAD SMALLPOX VACCINATION ON 03/06/2003 (WYETH LOT #4020077).  TAKE READING WAS EQUIVOCAL (SMALL ELEVATED POSTULE WITH PRURITUS) DONE 03/13/2003 BY DOCTOR.  NURSE ASKED PATIENT IF ANYONE IN HIS FAMILY HAD BELLS PALSY, DIABETES, OR IF HE HAD AN INFECTION/COLD SORES WITHIN THE LAST 6 MONTHS.  HE NOTIFIED TDH NURSE THAT HIS BROTHER ALSO HAD BELLS PALSY ALONG WITH OTHER SEVERAL OTHER MEDICAL PROBLEMS.  PATIENT STATED HE IS DOING A LITTLE BIT BETTER WITH MEDICATION BUT CONTINUES WITH HIS SYMPTOMS.  HE IS ALSO BEING WORKED UP FOR HIGH BLOOD PRESSURE.  PATIENT WAS VERY PLEASANT THROUGHOUT THE CONVERSATION AND TDH NURSE OFFERED HIME ANY INFORMATION HE NEEDED COULD BE OBTAINED FROM TWO DOCTORS, AS WELL AS ERT NURSE.
Pt pruented in office 2 days post VARIVAX vaccine with swelling and itching around injection site, starting 1 day prior.
About 25% to 50% of the vaccine was injected; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (About 25% to 50% of the vaccine was injected) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (About 25% to 50% of the vaccine was injected). At the time of the report, ACCIDENTAL UNDERDOSE (About 25% to 50% of the vaccine was injected) outcome was unknown. Not Provided      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.
It's like experiencing dementia; Stiffness; Slight constipation; Nausea; Body aches (upper and lower body); Consistent headaches (front and back of head); Scratchy throat; Needle pain after the injection; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (It's like experiencing dementia) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Acute lymphoblastic leukemia (Acute Lymphoblastic Leukemia  with radiation treatment therapy to brain and central nervous system.) since 1972 and Immunocompromised (Patient belongs to "Immunocompromised population".). Concomitant products included MULTIVITAMIN [VITAMINS NOS] and DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID]) for an unknown indication.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Needle pain after the injection). On 24-Jun-2021, the patient experienced THROAT IRRITATION (Scratchy throat). On an unknown date, the patient experienced DEMENTIA (It's like experiencing dementia) (seriousness criteria hospitalization and medically significant), MUSCULOSKELETAL STIFFNESS (Stiffness), CONSTIPATION (Slight constipation), NAUSEA (Nausea), MYALGIA (Body aches (upper and lower body)) and HEADACHE (Consistent headaches (front and back of head)). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, DEMENTIA (It's like experiencing dementia), MUSCULOSKELETAL STIFFNESS (Stiffness), CONSTIPATION (Slight constipation), THROAT IRRITATION (Scratchy throat), NAUSEA (Nausea), MYALGIA (Body aches (upper and lower body)), HEADACHE (Consistent headaches (front and back of head)) and VACCINATION SITE PAIN (Needle pain after the injection) outcome was unknown.            The patient stated that he has no history of any illicit drugs use, marijuana, or tobacco.  Company Comment: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Very limited information regarding the event Dementia has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-235743 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Very limited information regarding the event Dementia has been provided at this time.  Further information has been requested.
local swelling (arm) at injection site, fever, chills, nausea, tingling lips, arm pain, occurred 1 day after vaccine.
Started with swollen gland in neck on 12/9. On 12/11 started feeling bad (achy and tired). On 12/12, call facility and was told adverse reactions are rare and to take Tylenol. 12/12 PM went to Hospital. Was diagnosed with acute viral illness with reactive leukopenia. Was given a shot and sent home. After feeling worse and a call to CDC, went to Medical Center. Was diagnosed with neutropenia post yellow fever injection and was admitted. Symptoms were: tingling down legs,  severe pain everywhere, especially lower back, severe joint pains, even her toe joints and fingers joints hurt, but especially her lower back, stiffness in neck, but she said it hard to move everything, headache, fever, swollen lymph node in neck, nauseous, dizzy when she moved, excessive fatigue.
Narrative:  Patient C/O mild itching 10 minutes after Pfizer covid vaccine administration. No berthing issue or other symptoms. VS: BP 137/79, 96, PO2 100%. PE: Mild erythema on upper arms, no hives. Symptoms decreased significantly after 10 minutes if observation. Patient released with instructions to take Benadryl if itching recurs or repot to ED if worse symptoms develop.
By the next day, on the 26th I had mild injection site pain. During the night then between the 26th and 27th a lymph node in the r. axilla became enlarged and sore. The entire r. arm is just achey other than the injection site pain and axillary discomfort.  I do have a migraine as well, but I believe it is due to my mentrual cycle.
Same Day: Severe chills and muscular/joint pain (unable to move in bed without severe pain). No fever. Tylenol helped to sleep later after chills and pain for 12 continuous hours.  Next Day: new tinnitus/both ears ("jingle bell" only when speaking or touching ears. [Old tinnitus/40 years ago: constant "static" sound/both ears, from Influenza.]  Now:  Hypertension elevated/under care of Cardiologist. Pulsatine Tinnitus; appointment w/ENT doctor Jan. 19,2022.
What I felt the morning after receiving the vaccine was: dizziness upon moving from side to side, dizziness when standing up, and vertigo. Also experiencing severe headache, fatigue. 5 days later I am still experiencing dizziness.  I went to the ENT specialist.- on 11/16/23.
Pt started to experience bradycardia, significant fatigue in mid December, upon exam a TSH was completed and levels indicated an acute on set of hypothyroidism.  Pt has been treated with levothyroxine and symptoms have resolved.
This spontaneous report was received from a pharmacist referring to an unspecified number of patients of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # L035505 expiration date: 16-DEC-2016; and lot # L039096 expiration date: 08-JAN-2017, (administration routes were not reported). No concomitant therapies were reported. The pharmacist stated that he had no knowledge if adverse events were reported or not. This is one of several reports from the same reporter. Additional information is not expected, since there was no consent to contact the reporter to follow up.
Information has been received from a RN concerning a pt who on 15Nov95 was vaccinated with a dose of varicella virus vaccine live (lot 610255/0748B). Subsequently, on 23May99, the pt developed chickenpox. The pt was seen in the office. The reporter also indicated that 30 other pts were vaccinated with varicella virus vaccine live and developed chickenpox (WAES0409USA00600, WAES0409USA01045, WAES0409USA01046, WAES0409USA01047, WAES0409USA01048, WAES0409USA01049, WAES0409USA01050, WAES0409USA01051, WAES0409USA01052, WAES0409USA01053, WAES0409USA01054, WAES0409USA01055, WAES0409USA01056, WAES0409USA01058, WAES0409USA01059, WAES0409USA01060, WAES0409USA01061, WAES0409USA01062, WAES0409USA01063, WAES0409USA01064, WAES0409USA01065, WAES0409USA01066, WAES0409USA01067, WAES0409USA01068, WAES0409USA01069, WAES0409USA01070, WAES0409USA01071, WAES0409USA01072, WAES0409USA01073, WAES0409USA01074). No further information is expected.
postherpetic neuralgia; multiple outbreaks of herpes zoster; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the patient suffered multiple outbreaks of herpes zoster and postherpetic neuralgia. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter determined the events to be related to zoster vaccine live (ZOSTAVAX).  The events of multiple outbreaks of herpes zoster and postherpetic neuralgia were considered to be disabling.
Migraine, chills, soreness at injection site, sore arm, nausea listed about 36 hours
Patient is feeling pain from shoulder down to fingertips. Feels like joint pain and muscle pain.
Pt entered the monitoring area of the high-risk anaphylaxis clinic at noon for her 30 minutes of monitoring. At 12:30pm when her 30 minutes had passed and the patient was ready to leave, patient reported to RN that her tongue felt itchy and mild tingling. Evaluation of her tongue revealed no redness or swelling. Pt states she is allergic to dogs, latex, codeine, and Augmentin (severe reaction). She does have a dog at home and reacts to his dander for which she take a Benadryl nightly. Pt was given diphenhydramine 25mg PO x 1. VS = 78, 148/85, 98% O2 sat. Pt reported resolution of tongue symptoms at 12:56pm. VS 71, 159/65, 98% O2 sat. Pt discharged home in no apparent distress at 1:05pm.
pulmonary embolism; lungs "looked like lungs of covid patients look"; 5 separate covid tests were negative. I spent 4 days and 3 nights in the hospital, given injections of blood thinners and am now permanently. No family history of blood clots, though my brother experienced the same thing after his Pfizer booster shot last month.
pt recvd vax 26MAy93 pt devel fever 2JUN thru 5JUN; range nl to 104; pt seen @ clinic; poss OM; TM's not visualized, pt too restless; rash noted maculopapular rash; lt OM;
Patient mentioned when she came for her 2nd COVID vaccine that she had some pain in her inner thigh up to her groin (on the same side as her shot) that started soon after her 1st dose and lasted about 4 hours. She also started bleeding 4 hours after her shot and this lasted for about 6 hours along with some mild cramping. She did not report this after the 1st dose because she didn't really know if it was related to her vaccine or not.  After receiving her 2nd dose she started having some  pain in her ankle that went to her shin and lasted about 2 hours. She also had some mild cramping right after the shot. She called the pharmacy later to report that she started bleeding again 4 hours after the shot. The bleeding was off and on for the rest of the night and into the next morning.  She has  a Mirena IUD for birth control and hasn't had a period in years. She did contact her OBGYN after the 2nd shot and her MD had not heard of any of these reactions with any patients with the Mirena IUD.
ASYMETRICAL RASH SEVERAL INCHES IN DIAMETER AROUND INJECTION SITE OF LEFT ARM
I started having a headache that became stronger. On Wednesday 3/16 I also woke up shaking and with a fever, so I decided to see my doctor.  After speaking with him, he said that was a normal reaction to the vaccine and to monitor the symptoms and if they worsen or don't go away to see him again. They went away after a day or two.
bruising  pain in the muscle on the left arm; bruising  pain in the muscle on the left arm; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that the 87-year-old male patient received first dose of bnt162b2 (BNT162B2, Pfizer COVID 19 Vaccine), by injection via an unspecified route of administration, administered in Arm Left on 01Apr2021 noon (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. The patient medical history was none. Family History was none. The patient's concomitant medications were not reported. The patient experienced bruising  pain in the muscle on the left arm  started at noon or short time after on 01Apr2021 with outcome of recovered in Apr2021.   The clinical course was reported as follows: Caller states he was down there a week and a half ago to the health center SSM to get his shot. He is hearing all kinds of things on TV. Mentions he is 83 years old, later corrects to 87 years old and in good shape. Adds he only had bruising pain in the muscle on the left arm that happened almost right away and went away in a day or two. Adds his daughter and son-in-law were upset with their physical being by themselves in they are in their late 50s and 60s. He is asking should he get the second shot? Adds he is He is due to come back on the 15Apr2021, later corrects to 19Apr2021. States he received the first dose of the Pfizer COVID 19 vaccine on 01Apr2021 at noon in his left shoulder muscle. He is supposed to go back next Monday on 19Apr2021 for the second dose. Mentions his wife died a year ago and he is a Christian and he knows he is going to be with his wife in heaven. Adds she had the thing where they put the thing in her arm and you go three days a week. She has a cleaning out of the thing and he never saw her again. He didn't get to say goodbye. Adds she died on Easter Sunday. Mentions he is going to see his doctor very soon. Adds he has had no signs of COVID. Asking is it okay for him to not get the second dose. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none.No AE(s) require a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks) was none. Relevant test was none  No follow-up attempts are needed. No further information is expected.
received shot around 3:30 3/26 the next day could not formulate words or communicte
24 - 36 hours after DTaP#3 vaccination @ 6 months old on 6/14/02, he had hyperpigmenations @ site of vaccine (R Thigh).  Hyperpigmentation did not fade after 2 months.  Hyperpigmentation looks similar to a cafe au laut.  Measures 3 inches by 2 inches.
Pt fine 1st 24 hrs; a fever of 102.6 w/APAP, vomiting, diarrhea seen by MD, told to induce fluids; @ clinic w/101 fever, diarrhea;
presented to ER for evaluation of vomiting.  also complains of increasing shortness of breath over the past several days. found COVID+